Additional Evidence for the Reliability and Validity of the Student Risk Screening Scale at the High School Level: A Replication and Extension

ERIC Educational Resources Information Center

Lane, Kathleen Lynne; Oakes, Wendy P.; Ennis, Robin Parks; Cox, Meredith Lucille; Schatschneider, Christopher; Lambert, Warren

2013-01-01

This study reports findings from a validation study of the Student Risk Screening Scale for use with 9th- through 12th-grade students (N = 1854) attending a rural fringe school. Results indicated high internal consistency, test-retest stability, and inter-rater reliability. Predictive validity was established across two academic years, with Spring…

Development and Validation of Stability Indicating Spectroscopic Method for Content Analysis of Ceftriaxone Sodium in Pharmaceuticals

PubMed Central

Ethiraj, Revathi; Thiruvengadam, Ethiraj; Sampath, Venkattapuram Saravanan; Vahid, Abdul; Raj, Jithin

2014-01-01

A simple, selective, and stability indicating spectroscopic method has been selected and validated for the assay of ceftriaxone sodium in the powder for injection dosage forms. Proposed method is based on the measurement of absorbance of ceftriaxone sodium in aqueous medium at 241 nm. The method obeys Beer's law in the range of 5–50 μg/mL with correlation coefficient of 0.9983. Apparent molar absorptivity and Sandell's sensitivity were found to be 2.046 × 103 L mol−1 cm−1 and 0.02732 μg/cm2/0.001 absorbance units. This study indicated that ceftriaxone sodium was degraded in acid medium and also underwent oxidative degradation. Percent relative standard deviation associated with all the validation parameters was less than 2, showing compliance with acceptance criteria of Q2 (R1), International Conference on Harmonization (2005) guidelines. Then the proposed method was successfully applied to the determination of ceftriaxone sodium in sterile preparation and results were comparable with reported methods. PMID:27355020

Test-retest stability of the Task and Ego Orientation Questionnaire.

PubMed

Lane, Andrew M; Nevill, Alan M; Bowes, Neal; Fox, Kenneth R

2005-09-01

Establishing stability, defined as observing minimal measurement error in a test-retest assessment, is vital to validating psychometric tools. Correlational methods, such as Pearson product-moment, intraclass, and kappa are tests of association or consistency, whereas stability or reproducibility (regarded here as synonymous) assesses the agreement between test-retest scores. Indexes of reproducibility using the Task and Ego Orientation in Sport Questionnaire (TEOSQ; Duda & Nicholls, 1992) were investigated using correlational (Pearson product-moment, intraclass, and kappa) methods, repeated measures multivariate analysis of variance, and calculating the proportion of agreement within a referent value of +/-1 as suggested by Nevill, Lane, Kilgour, Bowes, and Whyte (2001). Two hundred thirteen soccer players completed the TEOSQ on two occasions, 1 week apart. Correlation analyses indicated a stronger test-retest correlation for the Ego subscale than the Task subscale. Multivariate analysis of variance indicated stability for ego items but with significant increases in four task items. The proportion of test-retest agreement scores indicated that all ego items reported relatively poor stability statistics with test-retest scores within a range of +/-1, ranging from 82.7-86.9%. By contrast, all task items showed test-retest difference scores ranging from 92.5-99%, although further analysis indicated that four task subscale items increased significantly. Findings illustrated that correlational methods (Pearson product-moment, intraclass, and kappa) are influenced by the range in scores, and calculating the proportion of agreement of test-retest differences with a referent value of +/-1 could provide additional insight into the stability of the questionnaire. It is suggested that the item-by-item proportion of agreement method proposed by Nevill et al. (2001) should be used to supplement existing methods and could be especially helpful in identifying rogue items in the initial stages of psychometric questionnaire validation.

Nifedipine-loaded polymeric nanocapsules: validation of a stability-indicating HPLC method to evaluate the drug entrapment efficiency and in vitro release profiles.

PubMed

Granada, Andréa; Tagliari, Monika Piazzon; Soldi, Valdir; Silva, Marcos António Segatto; Zanetti-Ramos, Betina Ghiel; Fernandes, Daniel; Stulzer, Hellen Karine

2013-01-01

A simple stability-indicating analytical method was developed and validated to quantify nifedipine in polymeric nanocapsule suspensions; an in vitro drug release study was then carried out. The analysis was performed using an RP C18 column, UV-Vis detection at 262 nm, and methanol-water (70 + 30, v/v) mobile phase at a flow rate of 1.2 mL/min. The method was validated in terms of specificity, linearity and range, LOQ, accuracy, precision, and robustness. The results obtained were within the acceptable ranges. The nanocapsules, made of poly(epsilon-caprolactone), were prepared by the solvent displacement technique and showed high entrapment efficiency. The entrapment efficiency was 97.6 and 98.2% for the nifedipine-loaded polymeric nanocapsules prepared from polyvinyl alcohol (PVA) and Pluronic F68 (PF68), respectively. The particle size and zeta potential of nanocapsules were found to be influenced by the nature of the stabilizer used. The mean diameter and zeta potential for nanocapsules with PVA and PF68 were 290.9 and 179.9 nm, and -17.7 mV and -32.7 mV, respectively. The two formulations prepared showed a drug release of up to 70% over 4 days. This behavior indicates the viability of this drug delivery system for use as a controlled-release system.

Development and Validation of a Stability-Indicating Assay of Etofenamate by RP-HPLC and Characterization of Degradation Products

PubMed Central

Peraman, Ramalingam; Nayakanti, Devanna; Dugga, Hari Hara Theja; Kodikonda, Sudhakara

2013-01-01

A validated stability-indicating RP-HPLC method for etofenamate (ETF) was developed by separating its degradation products on a C18 (250 mm × 4.6 mm 5 μm) Qualisil BDS column using a phosphate buffer (pH-adjusted to 6.0 with orthophosphoric acid) and methanol in the ratio of 20:80 % v/v as the mobile phase at a flow rate of 1.0 mL/min. The column effluents were monitored by a photodiode array detector set at 286 nm. The method was validated in terms of specificity, linearity, accuracy, precision, detection limit, quantification limit, and robustness. Forced degradation of etofenamate was carried out under acidic, basic, thermal, photo, and peroxide conditions and the major degradation products of acidic and basic degradation were isolated and characterized by 1H-NMR, 13C-NMR, and mass spectral studies. The mass balance of the method varied between 92–99%. PMID:24482770

Stability-indicating RP-HPLC method for the simultaneous determination of escitalopram oxalate and clonazepam.

PubMed

Kakde, Rajendra B; Satone, Dinesh D; Gadapayale, Kamalesh K; Kakde, Megha G

2013-07-01

The objective of the current study was to develop a validated, specific stability-indicating reversed-phase liquid chromatographic (LC) method for the quantitative determination of escitalopram oxalate and clonazepam and their related substances in bulk drugs and pharmaceutical dosage forms in the presence of degradation products. Forced degradation studies were performed on the pure drugs of escitalopram oxalate and clonazepam, as per the stress conditions prescribed by the International Conference on Harmonization (ICH) using acid, base, oxidation, thermal stress and photolytic degradation to show the stability-indicating power of the method. Significant degradation was observed during acid and alkaline hydrolysis and no degradation was observed in other stress conditions. The chromatographic method was optimized using the samples generated from forced degradation studies. Good resolution between the peaks corresponded to the active pharmaceutical ingredients, escitalopram oxalate and clonazepam, and degradation products from the analyte were achieved on an ODS Hypersil C18 column (250 × 4.6 mm) using a mobile phase consisting of a mixture of acetonitrile-50 mM phosphate buffer + 10 mM triethylamine (70:30, v/v). The detection was conducted at 268 nm. The limit of detection and the limit of quantitation for escitalopram oxalate and clonazepam were established. The stress test solutions were assayed against the qualified working standards of escitalopram oxalate and clonazepam, which indicated that the developed LC method was stability-indicating. Validation of the developed LC method was conducted as per ICH requirements. The developed LC method was found to be suitable to check the quality of bulk samples of escitalopram oxalate and clonazepam.

Examination of the Psychometric Properties of the Adult Manifest Anxiety Scale-Elderly Version Scores

ERIC Educational Resources Information Center

Lowe, Patricia A.; Reynolds, Cecil R.

2006-01-01

The psychometric properties of the Adult Manifest Anxiety Scale-Elderly Version (AMAS-E) scores were evaluated in two studies. In Study 1, the temporal stability and construct validity of the AMAS-E test scores were examined in a group of 226 older adults, aged 60 years and older. Results indicated adequate to excellent temporal stability (2-week…

EO-1 Hyperion reflectance time series at calibration and validation sites: stability and sensitivity to seasonal dynamics

Treesearch

Petya K. Entcheva Campbell; Elizabeth M. Middleton; Kurt J. Thome; Raymond F. Kokaly; Karl Fred Huemmrich; David Lagomasino; Kimberly A. Novick; Nathaniel A. Brunsell

2013-01-01

This study evaluated Earth Observing 1 (EO-1) Hyperion reflectance time series at established calibration sites to assess the instrument stability and suitability for monitoring vegetation functional parameters. Our analysis using three pseudo-invariant calibration sites in North America indicated that the reflectance time series are devoid of apparent spectral trends...

Simultaneous determination of aliskiren and hydrochlorothiazide from their pharmaceutical preparations using a validated stability-indicating MEKC method.

PubMed

Sangoi, Maximiliano S; Wrasse-Sangoi, Micheli; Oliveira, Paulo R; Rolim, Clarice M B; Steppe, Martin

2011-08-01

A stability-indicating MEKC method was developed and validated for the simultaneous determination of aliskiren (ALI) and hydrochlorothiazide (HCTZ) in pharmaceutical formulations using ranitidine as an internal standard (IS). Optimal conditions for the separation of ALI, HCTZ and its major impurity chlorothiazide (CTZ), IS and degradation products were investigated. The method employed 47 mM Tris buffer and 47 mM anionic detergent SDS solution at pH 10.2 as the background electrolyte. MEKC method was performed on a fused-silica capillary (40 cm) at 28°C. Applied voltage was 26 kV (positive polarity) and photodiode array (PDA) detector was set at 217 nm. The method was validated in accordance with the ICH requirements. The method was linear over the concentration range of 5-100 and 60-1200 μg/mL for HCTZ and ALI, respectively (r(2) >0.9997). The stability-indicating capability of the method was established by enforced degradation studies combined with peak purity assessment using the PDA detection. Precision and accuracy evaluated by RSD were lower than 2%. The method proved to be robust by a fractional factorial design evaluation. The proposed MEKC method was successfully applied for the quantitative analysis of ALI and HCTZ both individually and in a combined dosage tablet formulation to support the quality control. Copyright © 2011 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

A Validated Stability-Indicating RP-UPLC Method for Simultaneous Determination of Desloratadine and Sodium Benzoate in Oral Liquid Pharmaceutical Formulations.

PubMed

Kumar, Navneet; Sangeetha, Dhanaraj; Reddy, Pingili Sunil; Prakash, Lakkireddy

2012-01-01

A novel, sensitive and selective stability-indicating gradient reverse phase ultra performance liquid chromatographic method was developed and validated for the quantitative determination of desloratadine and sodium benzoate in pharmaceutical oral liquid formulation. The chromatographic separation was achieved on Acquity BEH C8 (100 mm × 2.1 mm) 1.7 μm column by using mobile phase containing a gradient mixture of solvent A (0.05 M KH(2)PO(4) and 0.07 M triethylamine, pH 3.0) and B (50:25:25 v/v/v mixture of acetonitrile, methanol and water) at flow rate of 0.4 mL/min. Column temperature was maintained at 40°C and detection was carried out at a wavelength of 272 nm. The described method shows excellent linearity over a range of 0.254 μg/mL to 76.194 μg/mL for desloratadine and 1.006 μg/mL to 301.67 μg/mL for sodium benzoate. The correlation coefficient for desloratadine and sodium benzoate was more than 0.999. To establish stability-indicating capability of the method, drug product was subjected to the stress conditions of acid, base, oxidative, hydrolytic, thermal and photolytic degradation. The degradation products were well resolved from desloratadine and sodium benzoate. The developed method was validated as per international ICH guidelines with respect to specificity, linearity, LOD, LOQ, accuracy, precision and robustness.

Development and Validation of a Stability-indicating Reversed-phase UPLC-UV Method for the Assay of Imidacloprid and Estimation of its Related Compounds.

PubMed

Tian, Jingzhi; Rustum, Abu

2018-02-01

Imidacloprid is used as an active pharmaceutical ingredient (API) in veterinary drugs to control fleas and ticks for dogs and cats. Here we are reporting for the first time a validated stability-indicating reversed-phase UPLC-UV method for the assay of imidacloprid and estimation of its related compounds. The stability-indicating capability of this method has been demonstrated by a forced degradation study. All related compounds including processing impurities, imidacloprid API and degradates from stressed samples were well separated from each other. Structures of major degradates from forced degradation study were elucidated through UPLC-MS/MS and key degradation pathways were proposed from the proposed chemical structures of major degradates. The UPLC-UV method is carried out using an HSS T3 column (C18, 2.1 × 30 mm, 1.8 μm particle size) maintained at 30°C with mobile phase A (0.05% v/v of phosphoric acid in water) and mobile phase B (methanol/acetonitrile 75/25 v/v). Analytes are separated by a gradient elution and detected at 270 nm. The UPLC method is green and fast with only 6.5 min run time and about 3.5 ml mobile phase consumption for each sample analysis. The UPLC-UV method was validated according to ICH guidelines. © The Author 2017. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Validation of a stability-indicating hydrophilic interaction liquid chromatographic method for the quantitative determination of vitamin k3 (menadione sodium bisulfite) in injectable solution formulation.

PubMed

Ghanem, Mashhour M; Abu-Lafi, Saleh A; Hallak, Hussein O

2013-01-01

A simple, specific, accurate, and stability-indicating method was developed and validated for the quantitative determination of menadione sodium bisulfite in the injectable solution formulation. The method is based on zwitterionic hydrophilic interaction liquid chromatography (ZIC-HILIC) coupled with a photodiode array detector. The desired separation was achieved on the ZIC-HILIC column (250 mm × 4.6 mm, 5 μm) at 25°C temperature. The optimized mobile phase consisted of an isocratic solvent mixture of 200mM ammonium acetate (NH4AC) solution and acetonitrile (ACN) (20:80; v/v) pH-adjusted to 5.7 by glacial acetic acid. The mobile phase was fixed at 0.5 ml/min and the analytes were monitored at 261 nm using a photodiode array detector. The effects of the chromatographic conditions on the peak retention, peak USP tailing factor, and column efficiency were systematically optimized. Forced degradation experiments were carried out by exposing menadione sodium bisulfite standard and the injectable solution formulation to thermal, photolytic, oxidative, and acid-base hydrolytic stress conditions. The degradation products were well-resolved from the main peak and the excipients, thus proving that the method is a reliable, stability-indicating tool. The method was validated as per ICH and USP guidelines (USP34/NF29) and found to be adequate for the routine quantitative estimation of menadione sodium bisulfite in commercially available menadione sodium bisulfite injectable solution dosage forms.

Facultative Stabilization Pond: Measuring Biological Oxygen Demand using Mathematical Approaches

NASA Astrophysics Data System (ADS)

Wira S, Ihsan; Sunarsih, Sunarsih

2018-02-01

Pollution is a man-made phenomenon. Some pollutants which discharged directly to the environment could create serious pollution problems. Untreated wastewater will cause contamination and even pollution on the water body. Biological Oxygen Demand (BOD) is the amount of oxygen required for the oxidation by bacteria. The higher the BOD concentration, the greater the organic matter would be. The purpose of this study was to predict the value of BOD contained in wastewater. Mathematical modeling methods were chosen in this study to depict and predict the BOD values contained in facultative wastewater stabilization ponds. Measurements of sampling data were carried out to validate the model. The results of this study indicated that a mathematical approach can be applied to predict the BOD contained in the facultative wastewater stabilization ponds. The model was validated using Absolute Means Error with 10% tolerance limit, and AME for model was 7.38% (< 10%), so the model is valid. Furthermore, a mathematical approach can also be applied to illustrate and predict the contents of wastewater.

Nursing Intensive-Care Satisfaction Scale [NICSS]: Development and validation of a patient-centred instrument.

PubMed

Romero-García, Marta; de la Cueva-Ariza, Laura; Benito-Aracil, Llucia; Lluch-Canut, Teresa; Trujols-Albet, Joan; Martínez-Momblan, Maria Antonia; Juvé-Udina, Maria-Eulàlia; Delgado-Hito, Pilar

2018-06-01

The aim of this study was to develop and validate the Nursing Intensive-Care Satisfaction Scale to measures satisfaction with nursing care from the critical care patient's perspective. Instruments that measure satisfaction with nursing cares have been designed and validated without taking the patient's perspective into consideration. Despite the benefits and advances in measuring satisfaction with nursing care, none instrument is specifically designed to assess satisfaction in intensive care units. Instrument development. The population were all discharged patients (January 2013 - January 2015) from three Intensive Care Units of a third level hospital (N = 200). All assessment instruments were given to discharged patients and 48 hours later, to analyse the temporal stability, only the questionnaire was given again. The validation process of the scale included the analysis of internal consistency, temporal stability; validity of construct through a confirmatory factor analysis; and criterion validity. Reliability was 0.95. The intraclass correlation coefficient for the total scale was 0.83 indicating a good temporal stability. Construct validity showed an acceptable fit and factorial structure with four factors, in accordance with the theoretical model, being Consequences factor the best correlated with other factors. Criterion validity, presented a correlation between low and high (range: 0.42-0.68). The scale has been designed and validated incorporating the perspective of critical care patients. Thanks to its reliability and validity, this questionnaire can be used both in research and in clinical practice. The scale offers a possibility to assess and develop interventions to improve patient satisfaction with nursing care. © 2018 John Wiley & Sons Ltd.

A New Symptom Model for Autism Cross-Validated in an Independent Sample

ERIC Educational Resources Information Center

Boomsma, A.; Van Lang, N. D. J.; De Jonge, M. V.; De Bildt, A. A.; Van Engeland, H.; Minderaa, R. B.

2008-01-01

Background: Results from several studies indicated that a symptom model other than the DSM triad might better describe symptom domains of autism. The present study focused on a) investigating the stability of a new symptom model for autism by cross-validating it in an independent sample and b) examining the invariance of the model regarding three…

Reliability and validity of the closed kinetic chain upper extremity stability test.

PubMed

Lee, Dong-Rour; Kim, Laurentius Jongsoon

2015-04-01

[Purpose] The purpose of this study was to examine the reliability and validity of the Closed Kinetic Chain Upper Extremity Stability (CKCUES) test. [Subjects and Methods] A sample of 40 subjects (20 males, 20 females) with and without pain in the upper limbs was recruited. The subjects were tested twice, three days apart to assess the reliability of the CKCUES test. The CKCUES test was performed four times, and the average was calculated using the data of the last 3 tests. In order to test the validity of the CKCUES test, peak torque of internal/external shoulder rotation was measured using an isokinetic dynamometer, and maximum grip strength was measured using a hand dynamometer, and their Pearson correlation coefficients with the average values of the CKCUES test were calculated. [Results] The reliability of the CKCUES test was very high (ICC=0.97). The correlations between the CKCUES test and maximum grip strength (r=0.78-0.79), and the peak torque of internal/external shoulder rotation (r=0.87-0.94) were high indicating its validity. [Conclusion] The reliability and validity of the CKCUES test were high. The CKCUES test is expected to be used for clinical tests on upper limb stability at low price.

Design and Validation of a Low-Cost Portable Device to Quantify Postural Stability.

PubMed

Zhu, Yong

2017-03-18

Measurement of the displacement of the center-of-pressure (COP) is an important tool used in biomechanics to assess postural stability and human balance. The goal of this research was to design and validate a low-cost portable device that can offer a quick indication of the state of postural stability and human balance related conditions. Approximate entropy (ApEn) values reflecting the amount of irregularity hiding in COP oscillations were used to calculate the index. The prototype adopted a portable design using the measurements of the load cells located at the four corners of a low-cost force platform. The test subject was asked to stand on the device in a quiet, normal, upright stance for 30 s with eyes open and subsequently for 30 s with eyes closed. Based on the COP displacement signals, the ApEn values were calculated. The results indicated that the prototype device was capable of capturing the increase in regularity of postural control in the visual-deprivation conditions. It was also able to decipher the subtle postural control differences along anterior-posterior and medial-lateral directions. The data analysis demonstrated that the prototype would enable the quantification of postural stability and thus provide a low-cost portable device to assess many conditions related to postural stability and human balance such as aging and pathologies.

A measure of satisfaction with food-related life.

PubMed

Grunert, Klaus G; Dean, Moira; Raats, Monique M; Nielsen, Niels Asger; Lumbers, Margaret

2007-09-01

A measure of satisfaction with food-related life is developed and tested in three studies in eight European countries. Five items are retained from an original pool of seven; these items exhibit good reliability as measured by Cronbach's alpha, good temporal stability, convergent validity with two related measures, and construct validity as indicated by relationships with other indicators of quality of life, including the Satisfaction With Life and the SF-8 scales. It is concluded that this scale will be useful in studies trying to identify factors contributing to satisfaction with food-related life.

Stability of florfenicol in drinking water.

PubMed

Hayes, John M; Eichman, Jonathan; Katz, Terry; Gilewicz, Rosalia

2003-01-01

Florfenicol, a broad-spectrum antibiotic, is being developed for veterinary application as an oral concentrate intended for dilution with drinking water. When a drug product is dosed via drinking water in a farm setting, a number of variables, including pH, chlorine content, hardness of the water used for dilution, and container material, may affect its stability, leading to a decrease in drug potency. The stability of florfenicol after dilution of Florfenicol Drinking Water Concentrate Oral Solution, 23 mg/mL, with drinking water was studied. A stability-indicating, validated liquid chromatographic method was used to evaluate florfenicol stability at 25 degrees C at 5, 10, and 24 h after dilution. The results indicate that florfenicol is stable under a range of simulated field conditions, including various pipe materials and conditions of hard or soft and chlorinated or nonchlorinated water at low or high pH. Significant degradation (> 10%) was observed only for isolated combinations in galvanized pipes. Analysis indicated that the florfenicol concentration in 8 of the 12 water samples stored in galvanized pipes remained above 90% of the initial concentration (100 mg/L) for 24 h after dilution.

Storage stability study of porcine hepatic and intestinal cytochrome P450 isoenzymes by use of a newly developed and fully validated highly sensitive HPLC-MS/MS method.

PubMed

Schelstraete, Wim; Devreese, Mathias; Croubels, Siska

2018-02-01

Microsomes are an ideal medium to investigate cytochrome P450 (CYP450) enzyme-mediated drug metabolism. However, before microsomes are prepared, tissues can be stored for a long time. Studies about the stability of these enzymes in porcine hepatic and intestinal tissues upon storage are lacking. To be able to investigate CYP450 stability in microsomes prepared from these tissues, a highly sensitive and rapid HPLC-MS/MS method for the simultaneous determination of six CYP450 metabolites in incubation medium was developed and validated. The metabolites, paracetamol (CYP1A), 7-hydroxy-coumarin (CYP2A), 1-hydroxy-midazolam (CYP3A), 4-hydroxy-tolbutamide (CYP2C), dextrorphan (CYP2D), and 6-hydroxy-chlorzoxazone (CYP2E) were extracted with ethyl acetate at pH 1.0, followed by evaporation and separation on an Agilent Zorbax Eclipse Plus C18 column. The method was fully validated in a GLP-compliant laboratory according to European guidelines and was highly sensitive (LOQ = 0.25-2.5 ng/mL), selective, had good precision (RSD-within, 1.0-9.1%; RSD-between, 1.0-18.4%) and accuracy (within-run, 83.3-102%; between-run, 78.5-102%), and showed no relative signal suppression and enhancement. Consequently, this method was applied to study the stability of porcine hepatic and intestinal CYP450 isoenzymes when tissues were stored at - 80 °C. The results indicate that porcine CYP450 isoenzymes are stable in tissues at least up to 4 months when snap frozen and stored at - 80 °C. Moreover, the results indicate differences in porcine CYP450 stability compared to rat, rabbit, and fish CYP450, as observed by other research groups, hence stressing the importance to investigate the CYP450 stability of a specific species.

Design of an unified chassis controller for rollover prevention, manoeuvrability and lateral stability

NASA Astrophysics Data System (ADS)

Yoon, Jangyeol; Yim, Seongjin; Cho, Wanki; Koo, Bongyeong; Yi, Kyongsu

2010-11-01

This paper describes a unified chassis control (UCC) strategy to prevent vehicle rollover and improve both manoeuvrability and lateral stability. Since previous researches on rollover prevention are only focused on the reduction of lateral acceleration, the manoeuvrability and lateral stability cannot be guaranteed. For this reason, it is necessary to design a UCC controller to prevent rollover and improve lateral stability by integrating electronic stability control, active front steering and continuous damping control. This integration is performed through switching among several control modes and a simulation is performed to validate the proposed method. Simulation results indicate that a significant improvement in rollover prevention, manoeuvrability and lateral stability can be expected from the proposed UCC system.

Computational evaluation of load carriage effects on gait balance stability.

PubMed

Mummolo, Carlotta; Park, Sukyung; Mangialardi, Luigi; Kim, Joo H

2016-01-01

Evaluating the effects of load carriage on gait balance stability is important in various applications. However, their quantification has not been rigorously addressed in the current literature, partially due to the lack of relevant computational indices. The novel Dynamic Gait Measure (DGM) characterizes gait balance stability by quantifying the relative effects of inertia in terms of zero-moment point, ground projection of center of mass, and time-varying foot support region. In this study, the DGM is formulated in terms of the gait parameters that explicitly reflect the gait strategy of a given walking pattern and is used for computational evaluation of the distinct balance stability of loaded walking. The observed gait adaptations caused by load carriage (decreased single support duration, inertia effects, and step length) result in decreased DGM values (p < 0.0001), which indicate that loaded walking motions are more statically stable compared with the unloaded normal walking. Comparison of the DGM with other common gait stability indices (the maximum Floquet multiplier and the margin of stability) validates the unique characterization capability of the DGM, which is consistently informative of the presence of the added load.

Development and validation of stability indicating method for the quantitative determination of venlafaxine hydrochloride in extended release formulation using high performance liquid chromatography

PubMed Central

Kaur, Jaspreet; Srinivasan, K. K.; Joseph, Alex; Gupta, Abhishek; Singh, Yogendra; Srinivas, Kona S.; Jain, Garima

2010-01-01

Objective: Venlafaxine,hydrochloride is a structurally novel phenethyl bicyclic antidepressant, and is usually categorized as a serotonin–norepinephrine reuptake inhibitor (SNRI) but it has been referred to as a serotonin–norepinephrine–dopamine reuptake inhibitor. It inhibits the reuptake of dopamine. Venlafaxine HCL is widely prescribed in the form of sustained release formulations. In the current article we are reporting the development and validation of a fast and simple stability indicating, isocratic high performance liquid chromatographic (HPLC) method for the determination of venlafaxine hydrochloride in sustained release formulations. Materials and Methods: The quantitative determination of venlafaxine hydrochloride was performed on a Kromasil C18 analytical column (250 × 4.6 mm i.d., 5 μm particle size) with 0.01 M phosphate buffer (pH 4.5): methanol (40: 60) as a mobile phase, at a flow rate of 1.0 ml/min. For HPLC methods, UV detection was made at 225 nm. Results: During method validation, parameters such as precision, linearity, accuracy, stability, limit of quantification and detection and specificity were evaluated, which remained within acceptable limits. Conclusions: The method has been successfully applied for the quantification and dissolution profiling of Venlafaxine HCL in sustained release formulation. The method presents a simple and reliable solution for the routine quantitative analysis of Venlafaxine HCL. PMID:21814426

Identification and characterization of stress degradants of lacosamide by LC-MS and ESI-Q-TOF-MS/MS: development and validation of a stability indicating RP-HPLC method.

PubMed

Ramisetti, Nageswara Rao; Kuntamukkala, Ramakrishna; Lakshetti, Sridhar; Sripadi, Prabhakar

2014-07-01

The current study dealt with the degradation behavior of lacosamide (LAC) under ICH prescribed stress conditions. LAC was found to be labile under acid and base hydrolytic stress conditions, while it was stable to neutral hydrolytic, oxidative, photolytic and thermal stress. In total, seven degradation products (DPs) were formed, which were separated on a C18 column using a stability-indicating method. LC-MS analyses indicated that one of the DPs had the same molecular mass as that of the drug. Structural characterization of DPs was carried out using ESI-Q-TOF-MS/MS technique. The degradation pathways and mechanisms of degradation of the drug were delineated by carrying out the degradation in different co-solvents viz. methanol, deuterated methanol, ethanol, 1-propanol and acetonitrile. The developed LC method was validated for the determination of related substances and assay of LAC as per ICH guidelines. This study demonstrates a comprehensive approach of LAC degradation studies during its development phase. Copyright © 2014. Published by Elsevier B.V.

Development of a Stability-Indicating Stereoselective Method for Quantification of the Enantiomer in the Drug Substance and Pharmaceutical Dosage Form of Rosuvastatin Calcium by an Enhanced Approach

PubMed Central

Rajendra Reddy, Gangireddy; Ravindra Reddy, Papammagari; Siva Jyothi, Polisetty

2015-01-01

A novel, simple, precise, and stability-indicating stereoselective method was developed and validated for the accurate quantification of the enantiomer in the drug substance and pharmaceutical dosage forms of Rosuvastatin Calcium. The method is capable of quantifying the enantiomer in the presence of other related substances. The chromatographic separation was achieved with an immobilized cellulose stationary phase (Chiralpak IB) 250 mm x 4.6 mm x 5.0 μm particle size column with a mobile phase containing a mixture of n-hexane, dichloromethane, 2-propanol, and trifluoroacetic acid in the ratio 82:10:8:0.2 (v/v/v/v). The eluted compounds were monitored at 243 nm and the run time was 18 min. Multivariate analysis and statistical tools were used to develop this highly robust method in a short span of time. The stability-indicating power of the method was established by subjecting Rosuvastatin Calcium to the stress conditions (forced degradation) of acid, base, oxidative, thermal, humidity, and photolytic degradation. Major degradation products were identified and found to be well-resolved from the enantiomer peak, proving the stability-indicating power of the method. The developed method was validated as per International Conference on Harmonization (ICH) guidelines with respect to specificity, limit of detection and limit of quantification, precision, linearity, accuracy, and robustness. The method exhibited consistent, high-quality recoveries (100 ± 10%) with a high precision for the enantiomer. Linear regression analysis revealed an excellent correlation between the peak responses and concentrations (r2 value of 0.9977) for the enantiomer. The method is sensitive enough to quantify the enantiomer above 0.04% and detect the enantiomer above 0.015% in Rosuvastatin Calcium. The stability tests were also performed on the drug substances as per ICH norms. PMID:26839815

Development and validation of a stability-indicating RP-HPLC method for assay of betamethasone and estimation of its related compounds.

PubMed

Fu, Qiang; Shou, Minshan; Chien, Dwight; Markovich, Robert; Rustum, Abu M

2010-02-05

Betamethasone (9alpha-fluoro-16beta-methylprednisolone) is one of the members of the corticosteriod family of active pharmaceutical ingredient (API), which is widely used as an anti-inflammatory agent and also as a starting material to manufacture various esters of betamethasone. A stability-indicating reverse-phase high performance liquid chromatography (RP-HPLC) method has been developed and validated which can separate and accurately quantitate low levels of 26 betamethasone related compounds. The stability-indicating capability of the method was demonstrated through adequate separation of all potential betamethasone related compounds from betamethasone and also from each other that are present in aged and stress degraded betamethasone stability samples. Chromatographic separation of betamethasone and its related compounds was achieved by using a gradient elution at a flow rate of 1.0mL/min on a ACE 3 C18 column (150mmx4.6mm, 3microm particle size, 100A pore size) at 40 degrees C. Mobile phase A of the gradient was 0.1% methanesulfonic acid in aqueous solution and mobile phase B was a mixture of tert-butanol and 1,4-dioxane (7:93, v/v). UV detection at 254nm was employed to monitor the analytes. For betamethasone 21-aldehyde, the QL and DL were 0.02% and 0.01% respectively. For betamethasone and the rest of the betamethasone related compounds, the QL and DL were 0.05% and 0.02%. The precision of betamethasone assay is 0.6% and the accuracy of betamethasone assay ranged from 98.1% to 99.9%.

Stability-indicating assay of repaglinide in bulk and optimized nanoemulsion by validated high performance thin layer chromatography technique.

PubMed

Akhtar, Juber; Fareed, Sheeba; Aqil, Mohd

2013-07-01

A sensitive, selective, precise and stability-indicating high-performance thin-layer chromatographic (HPTLC) method for analysis of repaglinide both as a bulk drug and in nanoemulsion formulation was developed and validated. The method employed TLC aluminum plates precoated with silica gel 60F-254 as the stationary phase. The solvent system consisted of chloroform/methanol/ammonia/glacial acetic acid (7.5:1.5:0.9:0.1, v/v/v/v). This system was found to give compact spots for repaglinide (R f value of 0.38 ± 0.02). Repaglinide was subjected to acid and alkali hydrolysis, oxidation, photodegradation and dry heat treatment. Also, the degraded products were well separated from the pure drug. Densitometric analysis of repaglinide was carried out in the absorbance mode at 240 nm. The linear regression data for the calibration plots showed good linear relationship with r (2)= 0.998 ± 0.032 in the concentration range of 50-800 ng. The method was validated for precision, accuracy as recovery, robustness and specificity. The limits of detection and quantitation were 0.023 and 0.069 ng per spot, respectively. The drug undergoes degradation under acidic and basic conditions, oxidation and dry heat treatment. All the peaks of the degraded product were resolved from the standard drug with significantly different R f values. Statistical analysis proves that the method is reproducible and selective for the estimation of the said drug. As the method could effectively separate the drug from its degradation products, it can be employed as a stability-indicating one. Moreover, the proposed HPTLC method was utilized to investigate the degradation kinetics in 1M NaOH.

UPLC and LC-MS studies on degradation behavior of irinotecan hydrochloride and development of a validated stability-indicating ultra-performance liquid chromatographic method for determination of irinotecan hydrochloride and its impurities in pharmaceutical dosage forms.

PubMed

Kumar, Navneet; Sangeetha, Dhanaraj; Reddy, Sunil P

2012-10-01

The objective of the current investigation was to study the degradation behavior of irinotecan hydrochloride under different International Conference on Harmonization (ICH) recommended stress conditions using ultra-performance liquid chromatography and liquid chromatography-mass spectrometry and to establish a validated stability-indicating reverse-phase ultra-performance liquid chromatographic method for the quantitative determination of irinotecan hydrochloride and its seven impurities and degradation products in pharmaceutical dosage forms. Irinotecan hydrochloride was subjected to the stress conditions of oxidative, acid, base, hydrolytic, thermal and photolytic degradation. Irinotecan hydrochloride was found to degrade significantly in oxidative and base hydrolysis and photolytic degradation conditions. The degradation products were well resolved from the main peak and its impurities, thus proving the stability-indicating power of the method. Chromatographic separation was achieved on a Waters Acquity BEH C8 (100 × 2.1 mm) 1.7-µm column with a mobile phase containing a gradient mixture of solvent A (0.02M KH(2)PO(4) buffer, pH 3.4) and solvent B (a mixture of acetonitrile and methanol in the ratio of 62:38 v/v). The mobile phase was delivered at a flow rate of 0.3 mL/min with ultraviolet detection at 220 nm. The run time was 8 min, within which irinotecan and its seven impurities and degradation products were satisfactorily separated. The developed method was validated as per ICH guidelines with respect to specificity, linearity, limit of detection, limit of quantification, accuracy, precision and robustness. This method was also suitable for the assay determination of irinotecan hydrochloride in pharmaceutical dosage forms.

Analytical Stability-Indicating Methods for Alogliptin in Tablets by LC-CAD and LC-UV.

PubMed

Bertol, Charise Dallazem; Friedrich, Maria Tereza; Carlos, Graciela; Froehlich, Pedro Eduardo

2017-03-01

Stability-indicating LC methods using a UV detector and a charged aerosol detector (CAD) simultaneously were validated for the assessment of alogliptin (ALG) in tablets. The analysis was performed on a C8 column (250 × 4.6 mm, 5 μm) at a flow of 0.8 mL/min, using acetonitrile-10 mM ammonium acetate buffer (pH 3.5; 90 + 10, v/v) as mobile phase and UV detection at 275 nm. Validation followed the International Conference on Harmonization guidelines. The method was linear over the range of 25-200 μg/mL. Normality of the residuals showed a normal distribution, no autocorrelation, and homoscedasticity. LODs were 6.25 and 2.65 µg/mL and LOQs were 20.85 and 8.84 µg/mL for the CAD and the UV detector, respectively. The methods were precise and accurate. Excipients and degradation products did not interfere in the methods in studies of specificity. None of the factors studied in the analysis of robustness had a significant effect on the quantification of the ALG by the Pareto chart. The results of the assay obtained with LC-CAD and LC-UV were similar. The methods could be considered interchangeable and stability-indicating, and can be applied as an appropriate QC tool for analysis of ALG in tablets.

Longitudinal data analysis in support of functional stability concepts for leachate management at closed municipal landfills

DOE Office of Scientific and Technical Information (OSTI.GOV)

Gibbons, Robert D., E-mail: rdg@uchicago.edu; Morris, Jeremy W.F., E-mail: jmorris@geosyntec.com; Prucha, Christopher P., E-mail: cprucha@wm.com

2014-09-15

Highlights: • Longitudinal data analysis using a mixed-effects regression model. • Dataset consisted of a total of 1402 samples from 101 closed municipal landfills. • Target analytes and classes generally showed predictable degradation trends. • Validates historical studies focused on macro organic indicators such as BOD. • BOD can serve as “gateway” indicator for planning leachate management. - Abstract: Landfill functional stability provides a target that supports no environmental threat at the relevant point of exposure in the absence of active control systems. With respect to leachate management, this study investigates “gateway” indicators for functional stability in terms of themore » predictability of leachate characteristics, and thus potential threat to water quality posed by leachate emissions. Historical studies conducted on changes in municipal solid waste (MSW) leachate concentrations over time (longitudinal analysis) have concentrated on indicator compounds, primarily chemical oxygen demand (COD) and biochemical oxygen demand (BOD). However, validation of these studies using an expanded database and larger constituent sets has not been performed. This study evaluated leachate data using a mixed-effects regression model to determine the extent to which leachate constituent degradation can be predicted based on waste age or operational practices. The final dataset analyzed consisted of a total of 1402 samples from 101 MSW landfills. Results from the study indicated that all leachate constituents exhibit a decreasing trend with time in the post-closure period, with 16 of the 25 target analytes and aggregate classes exhibiting a statistically significant trend consistent with well-studied indicators such as BOD. Decreasing trends in BOD concentration after landfill closure can thus be considered representative of trends for many leachate constituents of concern.« less

Nonclinical dose formulation analysis method validation and sample analysis.

PubMed

Whitmire, Monica Lee; Bryan, Peter; Henry, Teresa R; Holbrook, John; Lehmann, Paul; Mollitor, Thomas; Ohorodnik, Susan; Reed, David; Wietgrefe, Holly D

2010-12-01

Nonclinical dose formulation analysis methods are used to confirm test article concentration and homogeneity in formulations and determine formulation stability in support of regulated nonclinical studies. There is currently no regulatory guidance for nonclinical dose formulation analysis method validation or sample analysis. Regulatory guidance for the validation of analytical procedures has been developed for drug product/formulation testing; however, verification of the formulation concentrations falls under the framework of GLP regulations (not GMP). The only current related regulatory guidance is the bioanalytical guidance for method validation. The fundamental parameters for bioanalysis and formulation analysis validations that overlap include: recovery, accuracy, precision, specificity, selectivity, carryover, sensitivity, and stability. Divergence in bioanalytical and drug product validations typically center around the acceptance criteria used. As the dose formulation samples are not true "unknowns", the concept of quality control samples that cover the entire range of the standard curve serving as the indication for the confidence in the data generated from the "unknown" study samples may not always be necessary. Also, the standard bioanalytical acceptance criteria may not be directly applicable, especially when the determined concentration does not match the target concentration. This paper attempts to reconcile the different practices being performed in the community and to provide recommendations of best practices and proposed acceptance criteria for nonclinical dose formulation method validation and sample analysis.

Degradation Kinetics Study of Alogliptin Benzoate in Alkaline Medium by Validated Stability-Indicating HPTLC Method.

PubMed

Bodiwala, Kunjan Bharatkumar; Shah, Shailesh; Thakor, Jeenal; Marolia, Bhavin; Prajapati, Pintu

2016-11-01

A rapid, sensitive, and stability-indicating high-performance thin-layer chromatographic method was developed and validated to study degradation kinetics of Alogliptin benzoate (ALG) in an alkaline medium. ALG was degraded under acidic, alkaline, oxidative, and thermal stress conditions. The degraded samples were chromatographed on silica gel 60F254-TLC plates, developed using a quaternary-solvent system (chloroform-methanol-ethyl acetate-triethyl amine, 9+1+1+0.5, v/v/v/v), and scanned at 278 nm. The developed method was validated per International Conference on Harmonization guidelines using validation parameters such as specificity, linearity and range, precision, accuracy, LOD, and LOQ. The linearity range for ALG was 100-500 ng/band (correlation coefficient = 0.9997) with an average recovery of 99.47%. The LOD and LOQ for ALG were 9.8 and 32.7 ng/band, respectively. The developed method was successfully applied for the quantitative estimation of ALG in its synthetic mixture with common excipients. Degradation kinetics of ALG in an alkaline medium was studied by degrading it under three different temperatures and three different concentrations of alkali. Degradation of ALG in the alkaline medium was found to follow first-order kinetics. Contour plots have been generated to predict degradation rate constant, half-life, and shelf life of ALG in various combinations of temperature and concentration of alkali using Design Expert software.

The Resilience Questionnaire for Bipolar Disorder: Development and validation.

PubMed

Echezarraga, Ainara; Las Hayas, Carlota; González-Pinto, Ana María; Jones, Steven

2017-08-01

The goal of this research project was to develop a new questionnaire to assess resilience in Bipolar Disorder (BD), the Resilience Questionnaire for Bipolar Disorder (RBD). To examine its psychometric properties, a sample of 125 patients diagnosed with BD and a comparison sample of 107 people completed the new RBD and established measures of generic resilience and health-related outcomes. Exploratory factor analysis for the RBD yielded a 23-item 5-factor solution, and confirmatory factor analysis indicated adequate fit indices. Internal consistency, stability, concurrent validation and known-groups' validity were also supported. The RBD obtained higher responsiveness (6-month follow-up) than the generic resilience scale (BD sample). The RBD is a robust measure to monitor resilience in BD. Copyright © 2017 Elsevier Inc. All rights reserved.

Euclidean distance and Kolmogorov-Smirnov analyses of multi-day auditory event-related potentials: a longitudinal stability study

NASA Astrophysics Data System (ADS)

Durato, M. V.; Albano, A. M.; Rapp, P. E.; Nawang, S. A.

2015-06-01

The validity of ERPs as indices of stable neurophysiological traits is partially dependent on their stability over time. Previous studies on ERP stability, however, have reported diverse stability estimates despite using the same component scoring methods. This present study explores a novel approach in investigating the longitudinal stability of average ERPs—that is, by treating the ERP waveform as a time series and then applying Euclidean Distance and Kolmogorov-Smirnov analyses to evaluate the similarity or dissimilarity between the ERP time series of different sessions or run pairs. Nonlinear dynamical analysis show that in the absence of a change in medical condition, the average ERPs of healthy human adults are highly longitudinally stable—as evaluated by both the Euclidean distance and the Kolmogorov-Smirnov test.

Validated stability-indicating HPLC method for paricalcitol in pharmaceutical dosage form according to ICH guidelines: application to stability studies.

PubMed

Ortega, Raquel; Navas, Natalia; Salmerón, Antonio; Cabeza, José; Capitán-Vallvey, Luís F

2011-01-01

A stability-indicating HPLC method with diode array detection for the determination of paricalcitol, a synthetic vitamin D2 analog, was developed. Analytical parameters were studied according to International Conference on Harmonization guidelines. A C18 column (250 x 4.6 mm, 5 microm particle size) maintained at 25 degrees C was used as the stationary phase, and acetonitrile-water (70 + 30, v/v) as the mobile phase. Chromatograms were recorded at 250 nm. In forced degradation studies, the effects of acid, base, oxidation, temperature, and UV light were investigated and showed no interference with the drug peak. The method was found to be linear (r = 0.9989) at concentrations ranging from 0.6 to 10.0 mg/L paricalcitol, precise (repeatability and intermediate precision estimated as RSD less than 3.5%), accurate (recoveries higher than 95%), specific, and robust. The LOD and LOQ were 0.6 and 0.2 mg/L, respectively. The validated method was used for paricalcitol determination in a formal stability study of its pharmaceutical dosage form in preloaded syringes. The stability of a diluted solution of its pharmaceutical form in Viaflo bags was also tested. The results showed that paricalcitol was stable in preloaded syringes during a period of 30 days from preparation in the different storage conditions tested (room temperature without protection from daylight and 4.4 degrees C with protection from daylight). On the contrary, paricalcitol was quickly lost when stored in Viaflo bags by adsorption onto the walls of the container.

Stress Studies of Tenofovir Disoproxil Fumarate by HPTLC in Bulk Drug and Pharmaceutical Formulation

PubMed Central

Havele, Shweta; Dhaneshwar, Sunil R.

2012-01-01

A stability-indicating high-performance thin-layer chromatographic (HPTLC) method for determination of tenofovir disoproxil fumarate in bulk drug and in tablet has been developed and validated. The mobile phase selected was chloroform : methanol (9.0 : 1.0, v/v) with ultraviolet (UV) detection at 260 nm. The retention factor was found to be 0.49 ± 0.03 with correlation coefficients of 0.9994 in the range 300–1500 ng/spot and with an accuracy of 99.25%. Method had the potential to determine tenofovir disoproxil fumarate from tablet without any interference, and it was a stability-indicating one. PMID:22606065

Stability indicating high performance thin-layer chromatographic method for simultaneous estimation of pantoprazole sodium and itopride hydrochloride in combined dosage form

PubMed Central

Bageshwar, Deepak; Khanvilkar, Vineeta; Kadam, Vilasrao

2011-01-01

A specific, precise and stability indicating high-performance thin-layer chromatographic method for simultaneous estimation of pantoprazole sodium and itopride hydrochloride in pharmaceutical formulations was developed and validated. The method employed TLC aluminium plates precoated with silica gel 60F254 as the stationary phase. The solvent system consisted of methanol:water:ammonium acetate; 4.0:1.0:0.5 (v/v/v). This system was found to give compact and dense spots for both itopride hydrochloride (Rf value of 0.55±0.02) and pantoprazole sodium (Rf value of 0.85±0.04). Densitometric analysis of both drugs was carried out in the reflectance–absorbance mode at 289 nm. The linear regression analysis data for the calibration plots showed a good linear relationship with R2=0.9988±0.0012 in the concentration range of 100–400 ng for pantoprazole sodium. Also, the linear regression analysis data for the calibration plots showed a good linear relationship with R2=0.9990±0.0008 in the concentration range of 200–1200 ng for itopride hydrochloride. The method was validated for specificity, precision, robustness and recovery. Statistical analysis proves that the method is repeatable and selective for the estimation of both the said drugs. As the method could effectively separate the drug from its degradation products, it can be employed as a stability indicating method. PMID:29403710

Stability indicating high performance thin-layer chromatographic method for simultaneous estimation of pantoprazole sodium and itopride hydrochloride in combined dosage form.

PubMed

Bageshwar, Deepak; Khanvilkar, Vineeta; Kadam, Vilasrao

2011-11-01

A specific, precise and stability indicating high-performance thin-layer chromatographic method for simultaneous estimation of pantoprazole sodium and itopride hydrochloride in pharmaceutical formulations was developed and validated. The method employed TLC aluminium plates precoated with silica gel 60F 254 as the stationary phase. The solvent system consisted of methanol:water:ammonium acetate; 4.0:1.0:0.5 (v/v/v). This system was found to give compact and dense spots for both itopride hydrochloride ( R f value of 0.55±0.02) and pantoprazole sodium ( R f value of 0.85±0.04). Densitometric analysis of both drugs was carried out in the reflectance-absorbance mode at 289 nm. The linear regression analysis data for the calibration plots showed a good linear relationship with R 2 =0.9988±0.0012 in the concentration range of 100-400 ng for pantoprazole sodium. Also, the linear regression analysis data for the calibration plots showed a good linear relationship with R 2 =0.9990±0.0008 in the concentration range of 200-1200 ng for itopride hydrochloride. The method was validated for specificity, precision, robustness and recovery. Statistical analysis proves that the method is repeatable and selective for the estimation of both the said drugs. As the method could effectively separate the drug from its degradation products, it can be employed as a stability indicating method.

Validation and application of a stability-indicating HPLC method for the in vitro determination of gastric and intestinal stability of venlafaxine.

PubMed

Asafu-Adjaye, Ebenezer B; Faustino, Patrick J; Tawakkul, Mobin A; Anderson, Lawrence W; Yu, Lawrence X; Kwon, Hyojong; Volpe, Donna A

2007-04-11

Gastrointestinal stability of venlafaxine was evaluated in vitro in simulated gastric (SGF) and intestinal (SIF) fluids using a stability indicating HPLC method. The method was validated using a 5 microm Ascentis C18 column (150 mm x 4.6 mm) and mobile phase consisting of 30% acetonitrile in 20 mM potassium phosphate buffer (pH 6.5) delivered isocratically at a flow rate of 1 mL/min with UV detection at 228 nm. Venlafaxine in USP simulated gastric and intestinal fluids (0.4 mg/mL) was incubated at 37 degrees C in a shaking water bath. The gastric stability study samples were assayed at 0, 15, 30 and 60 min intervals while sampling for the intestinal stability study was at 0, 1, 2 and 3 h. System suitability determinations gave R.S.D.s of 0.68, 0.5 and 3.9% for retention factor (k'), peak area and tailing factor, respectively. The method was shown to be accurate, precise, specific, and linear over the analytical range. Intra- and inter-day precision was <5.3%. Forced degradation studies of drug substance in basic media at 70 degrees C as well as in H2O2 for 1 h and ultra-violet photostability studies at 255 and 365 nm for 24 h did not produce any detectable degradation products. Forced degradation studies of drug substance in acidic media at 70 degrees C for 1 h produced the dehydro-venlafaxine degradant. Venlafaxine was stable in SGF (pH approximately 1.2) for the 1-h incubation period and in SIF (pH 6.8) up to 3 h with <1.5% relative difference (RD) between the amount of drug added and that found for all time points. This stability experiment in simulated gastric and intestinal fluids suggests that drug loss in the gastrointestinal tract takes place by membrane permeation rather than a degradation process.

Cultural adaptation of an instrument to assess physical fitness in cardiac patients.

PubMed

Domingues, Gabriela de Barros Leite; Gallani, Maria Cecília; Gobatto, Claudio Alexandre; Miura, Cinthya Tamie Passos; Rodrigues, Roberta Cunha Matheus; Myers, Jonathan

2011-04-01

To validate the content and to evaluate the reliability of the Veterans Specific Activity Questionnaire instrument, culturally adapted for use in the Brazilian population of cardiac patients. The instrument was translated and back-translated and subsequently analyzed by a committee of judges to evaluate its semantic-idiomatic and cultural equivalences. Physical activities were replaced when indicated in the instrument, but uncommon in the daily life of the target population. Another committee of specialists analyzed the metabolic equivalence of replaced activities. The proportion of agreement of evaluation of the judges was quantified by the Content Validity Index. The pre-test was performed in two stages (n1 and n2=15). Reliability was assessed using the test-retest (interval of 7-15 days, n = 50). In the evaluation of semantic-idiomatic and cultural equivalences, items with a Content Validity Index < 1 were reviewed until consensus among the judges was obtained. The second committee found 100% of agreement in the analysis of metabolic equivalence between original and replaced activities. Test-retest analysis indicated a Kappa coefficient of agreement (k = 0.86; (p<0.001), suggesting temporal stability of the instrument. The Brazilian version of the Veterans Specific Activity Questionnaire showed evidence of reliability, according to the temporal stability criterion and adequate cultural content.

Smart stability-indicating spectrophotometric methods for determination of binary mixtures without prior separation.

PubMed

El-Bardicy, Mohammad G; Lotfy, Hayam M; El-Sayed, Mohammad A; El-Tarras, Mohammad F

2008-01-01

Ratio subtraction and isosbestic point methods are 2 innovating spectrophotometric methods used to determine vincamine in the presence of its acid degradation product and a mixture of cinnarizine (CN) and nicergoline (NIC). Linear correlations were obtained in the concentration range from 8-40 microg/mL for vincamine (I), 6-22 microg/mL for CN (II), and 6-36 microg/mL for NIC (III), with mean accuracies 99.72 +/- 0.917% for I, 99.91 +/- 0.703% for II, and 99.58 +/- 0.847 and 99.83 +/- 1.039% for III. The ratio subtraction method was utilized for the analysis of laboratory-prepared mixtures containing different ratios of vincamine and its degradation product, and it was valid in the presence of up to 80% degradation product. CN and NIC in synthetic mixtures were analyzed by the 2 proposed methods with the total content of the mixture determined at their respective isosbestic points of 270.2 and 235.8 nm, and the content of CN was determined by the ratio subtraction method. The proposed method was validated and found to be suitable as a stability-indicating assay method for vincamine in pharmaceutical formulations. The standard addition technique was applied to validate the results and to ensure the specificity of the proposed methods.

Theoretical optimum of implant positional index design.

PubMed

Semper, W; Kraft, S; Krüger, T; Nelson, K

2009-08-01

Rotational freedom of the implant-abutment connection influences its screw joint stability; for optimization, influential factors need to be evaluated based on a previously developed closed formula. The underlying hypothesis is that the manufacturing tolerances, geometric pattern, and dimensions of the index do not influence positional stability. We used the dimensions of 5 commonly used implant systems with a clearance of 20 microm to calculate the extent of rotational freedom; a 3D simulation (SolidWorks) validated the analytical findings. Polygonal positional indices showed the highest degrees of rotational freedom. The polygonal profile displayed higher positional stability than the polygons, but less positional accuracy than the cam-groove connection. Features of a maximal rotation-safe positional index were determined. The analytical calculation of rotational freedom of implant positional indices is possible. Rotational freedom is dependent on the geometric design of the index and may be decreased by incorporating specific aspects into the positional index design.

Application of normal fluorescence and stability-indicating derivative synchronous fluorescence spectroscopy for the determination of gliquidone in presence of its fluorescent alkaline degradation product

NASA Astrophysics Data System (ADS)

El-ghobashy, Mohamed R.; Yehia, Ali M.; Helmy, Aya H.; Youssef, Nadia F.

2018-01-01

Simple, smart and sensitive normal fluorescence and stability-indicating derivative synchronous spectrofluorimetric methods have been developed and validated for the determination of gliquidone in the drug substance and drug product. Normal spectrofluorimetric method of gliquidone was established in methanol at λ excitation 225 nm and λ emission 400 nm in concentration range 0.2-3 μg/ml with LOD equal 0.028. The fluorescence quantum yield of gliquidone was calculated using quinine sulfate as a reference and found to be 0.542. Stability-indicating first and third derivative synchronous fluorescence spectroscopy were successfully utilized to overcome the overlapped spectra in normal fluorescence of gliquidone and its alkaline degradation product. Derivative synchronous methods are based on using the synchronous fluorescence of gliquidone and its degradation product in methanol at Δ λ50 nm. Peak amplitude in the first derivative of synchronous fluorescence spectra was measured at 309 nm where degradation product showed zero-crossing without interference. The peak amplitudes in the third derivative of synchronous fluorescence spectra, peak to trough were measured at 316,329 nm where degradation product showed zero-crossing. The different experimental parameters affecting the normal and synchronous fluorescence intensity of gliquidone were studied and optimized. Moreover, the cited methods have been validated as per ICH guidelines. The peak amplitude-concentration plots of the derivative synchronous fluorescence were linear over the concentration range 0.05-2 μg/ml for gliquidone. Limits of detection were 0.020 and 0.022 in first and third derivative synchronous spectra, respectively. The adopted methods were successfully applied to commercial tablets and the results demonstrated that the derivative synchronous fluorescence spectroscopy is a powerful stability-indicating method, suitable for routine use with a short analysis time. Statistical comparison between the results obtained by normal fluorescence and derivative synchronous methods and the official one using student's t-test and F-ratio showed no significant difference regarding accuracy and precision.

Development and validation of a stability-indicating size-indicating size-exclusion LC method for the determination of rhIFN-alpha2a in pharmaceutical formulations.

PubMed

Zimmermann, Estevan Sonego; da Silva, Lucélia Magalhães; Calegari, Guilherme Zanini; Stamm, Fernanda Pavani; Souto, Ricardo Bizogne; Dalmora, Sérgio Luiz

2013-01-01

A size-exclusion LC method was validated for the determination of interferon-a2a (rhlFN-alpha2a) in pharmaceutical formulations without interference from human serum albumin. Chromatographic separation was performed on a BioSep-SEC-S 2000 column (300 x 7.8 mm id). The mobile phase consisted of 0.001 M monobasic potassium phosphate, 0.008 M sodium phosphate dibasic; 0.2 M sodium chloride buffer, pH 7.4, run at a gradient flow rate and using photodiode array detection at 214 nm, was used. Chromatographic separation was achieved with a retention time of 17.2 min, and the analysis was linear over the concentration range of 1.98 to 198 microg/mL (r2 = 0.9996). The accuracy was 101.39%, with bias lower than 1.67%. The LOD and LOQ were 0.87 and 1.98 microg/mL, respectively. Moreover, method validation demonstrated acceptable results for precision and robustness. The method was applied to the assessment of rhlFN-alpha2a and related proteins in biopharmaceutical dosage forms, and the content/potencies were correlated to those given by a validated RP-LC method and an in vitro bioassay. It was concluded that use of the methods in conjunction allows a great improvement in monitoring stability and QC, thereby ensuring the therapeutic efficacy of the biotechnology-derived medicine.

Stability of Cyclophosphamide in Extemporaneous Oral Suspensions

PubMed Central

Kennedy, Rachel; Groepper, Daniel; Tagen, Michael; Christensen, Robbin; Navid, Fariba; Gajjar, Amar; Stewart, Clinton F.

2010-01-01

Background Cyclophosphamide, an alkylating agent, is widely used for the treatment of many adult and pediatric malignancies. The stability of cyclophosphamide in aqueous- and methylcellulose-based oral suspending vehicles is currently unknown. Objectives The goals of this study were (1) to develop and validate a stability-indicating HPLC method to measure cyclophosphamide concentrations in simple syrup and Ora-Plus, and (2) to assess the 56-day chemical stability and physical appearance of cyclophosphamide in these suspensions at both room temperature and 4°C. Methods The i.v. formulation of cyclophosphamide was diluted to 20 mg/mL in normal saline, compounded 1:1 with either suspending vehicle, and stored in the dark in 3mL amber polypropylene oral syringes at 4°C and 22°C. Aliquots from each syringe were obtained on days 0, 3, 7, 14, 21, 28, 35, 42, 49, and 56 and assayed using the validated stability-indicating HPLC-UV method. A C18 analytical column was used to separate cyclophosphamide from the internal standard, ifosfamide, with a mobile phase of 21% acetonitrile in 79% sodium phosphate buffer. The suspension was examined for odor change, visually examined under normal fluorescent light for color change, and examined under a light microscope for evidence of microbial growth. Results Samples of cyclophosphamide in both simple syrup and Ora-Plus were stable when kept at 4°C for at least 56 days. At room temperature, cyclophosphamide in simple syrup and Ora-Plus had a shelf life of 8 and 3 days, respectively. No changes in color or odor or evidence of microbial growth were observed. Conclusion Cyclophosphamide can be extemporaneously prepared in simple syrup or Ora-Plus and stored at least 2 months under refrigeration without significant degradation. PMID:20103616

Stability of cyclophosphamide in extemporaneous oral suspensions.

PubMed

Kennedy, Rachel; Groepper, Daniel; Tagen, Michael; Christensen, Robbin; Navid, Fariba; Gajjar, Amar; Stewart, Clinton F

2010-02-01

Cyclophosphamide, an alkylating agent, is widely used for the treatment of many adult and pediatric malignancies. The stability of cyclophosphamide in aqueous- and methylcellulose-based oral suspending vehicles is currently unknown. To develop and validate a stability-indicating high-performance liquid chromatography (HPLC) method to measure cyclophosphamide concentrations in simple syrup and Ora-Plus, and assess the 56-day chemical stability and physical appearance of cyclophosphamide in these suspensions at both room temperature (22 degrees C) and 4 degrees C. The intravenous formulation of cyclophosphamide was diluted to 20 mg/mL in NaCl 0.9%, compounded 1:1 with either suspending vehicle, and stored in the dark in 3-mL amber polypropylene oral syringes at 4 degrees C and 22 degrees C. Aliquots from each syringe were obtained on days 0, 3, 7, 14, 21, 28, 35, 42, 49, and 56 and assayed using the validated stability-indicating HPLC-UV method. A C18 analytical column was used to separate cyclophosphamide from the internal standard, ifosfamide, with a mobile phase of 21% acetonitrile in 79% sodium phosphate buffer. The suspension was examined for odor change, visually examined under normal fluorescent light for color change, and examined under a light microscope for evidence of microbial growth. Samples of cyclophosphamide in both simple syrup and Ora-Plus were stable when kept at 4 degrees C for at least 56 days. At room temperature, cyclophosphamide in simple syrup and Ora-Plus had a shelf life of 8 and 3 days, respectively. No changes in color or odor or evidence of microbial growth were observed. Cyclophosphamide can be extemporaneously prepared in simple syrup or Ora-Plus and stored for at least 2 months under refrigeration without significant degradation.

Psychometric properties evaluation of a new ergonomics-related job factors questionnaire developed for nursing workers.

PubMed

Coluci, Marina Zambon Orpinelli; Alexandre, Neusa Maria Costa

2014-11-01

The objectives of this study were to develop a questionnaire that evaluates the perception of nursing workers to job factors that may contribute to musculoskeletal symptoms, and to evaluate its psychometric properties. Internationally recommended methodology was followed: construction of domains, items and the instrument as a whole, content validity, and pre-test. Psychometric properties were evaluated among 370 nursing workers. Construct validity was analyzed by the factorial analysis, known-groups technique, and convergent validity. Reliability was assessed through internal consistency and stability. Results indicated satisfactory fit indices during confirmatory factor analysis, significant difference (p < 0.01) between the responses of nursing and office workers, and moderate correlations between the new questionnaire and Numeric Pain Scale, SF-36 and WRFQ. Cronbach's alpha was close to 0.90 and ICC values ranged from 0.64 to 0.76. Therefore, results indicated that the new questionnaire had good psychometric properties for use in studies involving nursing workers. Copyright © 2014 Elsevier Ltd and The Ergonomics Society. All rights reserved.

Stability of extemporaneous oral ribavirin liquid preparation.

PubMed

Chan, John P; Tong, Henry H Y; Chow, Albert H L

2004-01-01

Ribavirin is an antiviral agent commonly used in Hong Kong for the treatment of severe acute respiratory syndrome. The choice of oral ribavirin therapeutic products available in the local market is currently limited to capsules. The present study investigated the chemical stability of an oral ribavirin suspension (200 mg/5mL) prepared extemporaneously from oral capsules using a sugar-free suspension formula. The suspension was subjected to stability testing at 4 deg C for up to 28 days. Employing a validated stability-indicating high-performance liquid chromatographic method, the ribavirin content of the extemporaneous preparation has been demonstrated to exhibit negligible changes throughout the storage period. No degradation product was observable in all high-peroformance liquid chromatograms, suggesting that the suspension remained chermically stable under the stated conditions.

Boundary layer stability on a yawed spinning body of revolution and its effect on the magnus force and moment

NASA Technical Reports Server (NTRS)

Jacobson, I. D.; Morton, J. B.

1972-01-01

The parameters are established which are important to the stability of a boundary layer flow over a yawed spinning cylinder in a uniform stream. It is shown that transition occurs asymmetrically in general and this asymmetry can be important for the prediction of aerodynamic forces and moments (e.g., the Magnus effect). Instability of the steady-state boundary layer flow is determined using small disturbance theory. Although the approach is strictly valid only for the calculation of the conditions for stability in the small, experimental data indicate that in many problems, it provides a good estimate for the transition to turbulence.

Application of a validated stability-indicating densitometric thin-layer chromatographic method to stress degradation studies on moxifloxacin.

PubMed

Motwani, Sanjay K; Khar, Roop K; Ahmad, Farhan J; Chopra, Shruti; Kohli, K; Talegaonkar, S

2007-01-16

A simple, sensitive, selective, precise and stability-indicating high-performance thin-layer chromatographic (HPTLC) method for densitometric determination of moxifloxacin both as a bulk drug and from pharmaceutical formulation was developed and validated as per the International Conference on Harmonization (ICH) guidelines. The method employed TLC aluminium plates pre-coated with silica gel 60F-254 as the stationary phase and the mobile phase consisted of n-propanol-ethanol-6M ammonia solution (4:1:2, v/v/v). Densitometric analysis of moxifloxacin was carried out in the absorbance mode at 298 nm. Compact spots for moxifloxacin were found at R(f) value of 0.58+/-0.02. The linear regression analysis data for the calibration plots showed good linear relationship with r=0.9925 in the working concentration range of 100-800 ng spot(-1). The method was validated for precision, accuracy, ruggedness, robustness, specificity, recovery, limit of detection (LOD) and limit of quantitation (LOQ). The LOD and LOQ were 3.90 and 11.83 ng spot(-1), respectively. Drug was subjected to acid and alkali hydrolysis, oxidation, dry heat, wet heat treatment and photodegradation. All the peaks of degradation products were well resolved from the standard drug with significantly different R(f) values. Statistical analysis proves that the developed HPTLC method is reproducible and selective. As the method could effectively separate the drug from its degradation products, it can be employed as stability-indicating one. Moreover, the proposed HPTLC method was utilized to investigate the kinetics of the acidic and alkaline degradation processes at different temperatures. Arrhenius plot was constructed and apparent pseudo-first-order rate constant, half-life and activation energy were calculated. In addition the pH-rate profile for degradation of moxifloxacin in constant ionic strength buffer solutions within the pH range 1.2-10.8 was studied.

Stability Indicating HPLC Determination of Risperidone in Bulk Drug and Pharmaceutical Formulations

PubMed Central

Dedania, Zarna R.; Dedania, Ronak R.; Sheth, Navin R.; Patel, Jigar B.; Patel, Bhavna

2011-01-01

The objective of the current study was to develop a validated stability-indicating assay method (SIAM) for risperidone after subjecting it to forced decomposition under hydrolysis, oxidation, photolysis, and thermal stress conditions. The liquid chromatographic separation was achieved isocratically on a symmetry C18 column (5 μm size, 250 mm × 4.6 mm i.d.) using a mobile phase containing methanol: acetonitrile (80 : 20, v/v) at a flow rate of 1 mL/min and UV detection at 280 nm. Retention time of risperidone was found to be 3.35 ± 0.01. The method was linear over the concentration range of 10–60 μg/mL(r 2 = 0.998) with a limit of detection and quantitation of 1.79 and 5.44 μg/mL, respectively. The method has the requisite accuracy, specificity, sensitivity, and precision to assay risperidone in bulk form and pharmaceutical dosage forms. Degradation products resulting from the stress studies did not interfere with the detection of Risperidone, and the assay is thus stability indicating. PMID:22007220

Development of validated stability indicating assay method for simultaneous estimation of metformin hydrochloride and vildagliptin by RP-HPLC.

PubMed

Satheeshkumar, N; Pradeepkumar, M; Shanthikumar, S; Rao, V J

2014-03-01

A simple, precise and stability-indicating HPLC method was developed and validated for the simultaneous determination of metformin hydrochloride (MET) and vildagliptin (VLG) in pharmaceutical dosage forms. The method involves use of easily available inexpensive laboratory reagents. The separation was achieved on Grace Cyano column (250 mm×4.6 mm) 5 µm with isocratic flow. The mobile phase was pumped at a flow rate of 1.0 mL/min, consisted of 25 mM ammonium bicarbonate buffer and acetonitrile (65:35, v/v). The UV detection was carried out at 207 nm. A linear response was observed over the concentration range of 25-125 µg/mL for MET and 50-250 µg/mL for VLG respectively. Limit of detection and limit of quantification for MET were 0.36 µg/mL and 1.22 µg/mL, and for VLG were 0.75 µg/mL and 2.51 µg/mL respectively. The method was successfully validated in accordance to ICH guidelines acceptance criteria for specificity, linearity, accuracy, precision, robustness, and system suitability. Individual drugs (MET and VLG) were exposed to thermal, photolytic, hydrolytic and oxidative stress conditions. The resultant stressed samples were analyzed by the proposed method. The method gave high resolution among the degradation products and the analytes. The peak purity of analyte peak in the stressed samples was confirmed by photo diode array detector. The proposed method was successfully applied for the quantitative analysis of MET and VLG in tablet dosage form, which will help to improve quality control and contribute to stability studies of pharmaceutical tablets containing these drugs. © Georg Thieme Verlag KG Stuttgart · New York.

A validated stability-indicating LC method for the separation of enantiomer and potential impurities of Linezolid using polar organic mode.

PubMed

Satyanarayana Raju, T; Vishweshwari Kutty, O; Ganesh, V; Yadagiri Swamy, P

2012-08-01

Although a number of methods are available for evaluating Linezolid and its possible impurities, a common method for separation if its potential impurities, degradants and enantiomer in a single method with good efficiency remain unavailable. With the objective of developing an advanced method with shorter runtimes, a simple, precise, accurate stability-indicating LC method was developed for the determination of purity of Linezolid drug substance and drug products in bulk samples and pharmaceutical dosage forms in the presence of its impurities and degradation products. This method is capable of separating all the related substances of Linezolid along with the chiral impurity. This method can also be used for the estimation of assay of Linezolid in drug substance as well as in drug product. The method was developed using Chiralpak IA (250 mm×4.6 mm, 5 μm) column. A mixture of acetonitrile, ethanol, n-butyl amine and trifluoro acetic acid in 96:4:0.10:0.16 (v/v/v/v) ratio was used as a mobile phase. The eluted compounds were monitored at 254 nm. Linezolid was subjected to the stress conditions of oxidative, acid, base, hydrolytic, thermal and photolytic degradation. The degradation products were well resolved from main peak and its impurities, proving the stability-indicating power of the method. The developed method was validated as per International Conference on Harmonization (ICH) guidelines with respect to specificity, limit of detection, limit of quantification, precision, linearity, accuracy, robustness and system suitability.

Least-Squares Regression and Spectral Residual Augmented Classical Least-Squares Chemometric Models for Stability-Indicating Analysis of Agomelatine and Its Degradation Products: A Comparative Study.

PubMed

Naguib, Ibrahim A; Abdelrahman, Maha M; El Ghobashy, Mohamed R; Ali, Nesma A

2016-01-01

Two accurate, sensitive, and selective stability-indicating methods are developed and validated for simultaneous quantitative determination of agomelatine (AGM) and its forced degradation products (Deg I and Deg II), whether in pure forms or in pharmaceutical formulations. Partial least-squares regression (PLSR) and spectral residual augmented classical least-squares (SRACLS) are two chemometric models that are being subjected to a comparative study through handling UV spectral data in range (215-350 nm). For proper analysis, a three-factor, four-level experimental design was established, resulting in a training set consisting of 16 mixtures containing different ratios of interfering species. An independent test set consisting of eight mixtures was used to validate the prediction ability of the suggested models. The results presented indicate the ability of mentioned multivariate calibration models to analyze AGM, Deg I, and Deg II with high selectivity and accuracy. The analysis results of the pharmaceutical formulations were statistically compared to the reference HPLC method, with no significant differences observed regarding accuracy and precision. The SRACLS model gives comparable results to the PLSR model; however, it keeps the qualitative spectral information of the classical least-squares algorithm for analyzed components.

Stabilized display of coronary x-ray image sequences

NASA Astrophysics Data System (ADS)

Close, Robert A.; Whiting, James S.; Da, Xiaolin; Eigler, Neal L.

2004-05-01

Display stabilization is a technique by which a feature of interest in a cine image sequence is tracked and then shifted to remain approximately stationary on the display device. Prior simulations indicate that display stabilization with high playback rates ( 30 f/s) can significantly improve detectability of low-contrast features in coronary angiograms. Display stabilization may also help to improve the accuracy of intra-coronary device placement. We validated our automated tracking algorithm by comparing the inter-frame difference (jitter) between manual and automated tracking of 150 coronary x-ray image sequences acquired on a digital cardiovascular X-ray imaging system with CsI/a-Si flat panel detector. We find that the median (50%) inter-frame jitter between manual and automatic tracking is 1.41 pixels or less, indicating a jump no further than an adjacent pixel. This small jitter implies that automated tracking and manual tracking should yield similar improvements in the performance of most visual tasks. We hypothesize that cardiologists would perceive a benefit in viewing the stabilized display as an addition to the standard playback of cine recordings. A benefit of display stabilization was identified in 87 of 101 sequences (86%). The most common tasks cited were evaluation of stenosis and determination of stent and balloon positions. We conclude that display stabilization offers perceptible improvements in the performance of visual tasks by cardiologists.

A Validated Stability Indicating RP-HPLC Method for the Determination of Emtricitabine, Tenofovir Disoproxil Fumarate, Elvitegravir and Cobicistat in Pharmaceutical Dosage Form

PubMed Central

Runja, Chinnalalaiah; Ravi Kumar, Pigili; Avanapu, Srinivasa Rao

2016-01-01

A new simple, rapid stability indicating assay method has been developed and validated for the determination of emtricitabine, tenofovir disoproxil fumarate, elvitegravir and cobicistat using reverse-phase high-performance liquid chromatography in their pharmaceutical dosage form. The chromatographic separation was performed on an ODS column (250 × 4.6 mm, 5 µm) using mobile phase A (potassium dihydrogen orthophosphate, pH adjusted to 2.5) and mobile phase B (acetonitrile) in the ratio of 55:45% v/v at a flow rate of 1 mL/min. The analytes were detected at 250 nm. The method was found to be linear in the concentration range of 2–12 µg/mL for EMT, 3–18 µg/mL for TNDF, 1.5–9 µg/mL for ELV and COB, with the coefficient value (R2) of >0.9990. The accuracy was measured via recovery studies and found to be acceptable, and the percentage recoveries were found in the range of 99.93–100.08 ± 0.5%. Forced degradation studies were also conducted, and the drugs were subjected to various stress conditions such as acid hydrolysis, base hydrolysis, oxidative, photolytic and thermal degradation. The proposed method was successfully validated and applied for the quantitative estimation of these drugs in both bulk and tablet dosage forms. PMID:26865655

Stress Degradation Studies on Varenicline Tartrate and Development of a Validated Stability-Indicating HPLC Method

PubMed Central

Pujeri, Sudhakar S.; Khader, Addagadde M. A.; Seetharamappa, Jaldappagari

2012-01-01

A simple, rapid and stability-indicating reversed-phase liquid chromatographic method was developed for the assay of varenicline tartrate (VRT) in the presence of its degradation products generated from forced decomposition studies. The HPLC separation was achieved on a C18 Inertsil column (250 mm × 4.6 mm i.d. particle size is 5 μm) employing a mobile phase consisting of ammonium acetate buffer containing trifluoroacetic acid (0.02M; pH 4) and acetonitrile in gradient program mode with a flow rate of 1.0 mL min−1. The UV detector was operated at 237 nm while column temperature was maintained at 40 °C. The developed method was validated as per ICH guidelines with respect to specificity, linearity, precision, accuracy, robustness and limit of quantification. The method was found to be simple, specific, precise and accurate. Selectivity of the proposed method was validated by subjecting the stock solution of VRT to acidic, basic, photolysis, oxidative and thermal degradation. The calibration curve was found to be linear in the concentration range of 0.1–192 μg mL−1 (R2 = 0.9994). The peaks of degradation products did not interfere with that of pure VRT. The utility of the developed method was examined by analyzing the tablets containing VRT. The results of analysis were subjected to statistical analysis. PMID:22396908

The Self-esteem Stability Scale (SESS) for Cross-Sectional Direct Assessment of Self-esteem Stability

PubMed Central

Altmann, Tobias; Roth, Marcus

2018-01-01

Self-esteem stability describes fluctuations in the level of self-esteem experienced by individuals over a brief period of time. In recent decades, self-esteem stability has repeatedly been shown to be an important variable affecting psychological functioning. However, measures of self-esteem stability are few and lacking in validity. In this paper, we present the Self-Esteem Stability Scale (SESS), a unidimensional and very brief scale to directly assess self-esteem stability. In four studies (total N = 826), we describe the development of the SESS and present evidence for its validity with respect to individual outcomes (life satisfaction, neuroticism, and vulnerable narcissism) and dyadic outcomes (relationship satisfaction in self- and partner ratings) through direct comparisons with existing measures. The new SESS proved to be a stronger predictor than the existing scales and had incremental validity over and above self-esteem level. The results also showed that all cross-sectional measures of self-esteem stability were only moderately associated with variability in self-esteem levels assessed longitudinally with multiple administrations of the Rosenberg Self-Esteem Scale. We discuss this validity issue, arguing that direct and indirect assessment approaches measure relevant, yet different aspects of self-esteem stability. PMID:29487551

The Self-esteem Stability Scale (SESS) for Cross-Sectional Direct Assessment of Self-esteem Stability.

PubMed

Altmann, Tobias; Roth, Marcus

2018-01-01

Self-esteem stability describes fluctuations in the level of self-esteem experienced by individuals over a brief period of time. In recent decades, self-esteem stability has repeatedly been shown to be an important variable affecting psychological functioning. However, measures of self-esteem stability are few and lacking in validity. In this paper, we present the Self-Esteem Stability Scale (SESS), a unidimensional and very brief scale to directly assess self-esteem stability. In four studies (total N = 826), we describe the development of the SESS and present evidence for its validity with respect to individual outcomes (life satisfaction, neuroticism, and vulnerable narcissism) and dyadic outcomes (relationship satisfaction in self- and partner ratings) through direct comparisons with existing measures. The new SESS proved to be a stronger predictor than the existing scales and had incremental validity over and above self-esteem level. The results also showed that all cross-sectional measures of self-esteem stability were only moderately associated with variability in self-esteem levels assessed longitudinally with multiple administrations of the Rosenberg Self-Esteem Scale. We discuss this validity issue, arguing that direct and indirect assessment approaches measure relevant, yet different aspects of self-esteem stability.

Cross-cultural validity of Morningness-Eveningness Stability Scale improved (MESSi) in Iran, Spain and Germany.

PubMed

Rahafar, Arash; Randler, Christoph; Díaz-Morales, Juan F; Kasaeian, Ali; Heidari, Zeinab

2017-01-01

Morningness-Eveningness Stability Scale improved (MESSi) is a newly constructed measure to assess circadian types and amplitude. In this study, we applied this measure to participants from three different countries: Germany, Spain and Iran. Confirmatory factorial analysis (CFA) of MESSi displayed mediocre fit in the three countries. Comparing increasingly stringent models using multigroup confirmatory factor analyses indicated at least partial measurement invariance (metric invariance) by country for Morning Affect and Distinctness subscales. Age was positively related to Morning Affect (MA), and negatively related to Eveningness (EV) and Distinctness (DI). Men reported higher MA than women, whereas women reported higher DI than men. Regarding country effect, Iranian participants reported highest MA compared to Spaniards and Germans, whereas Germans reported higher DI compared to Iranians and Spaniards. As a conclusion, our study corroborated the validity and reliability of MESSi across three different countries with different geographical and cultural characteristics.

Development and validation of a stability-indicating RP-HPLC method for determination of atomoxetine hydrochloride in tablets.

PubMed

Patel, Sejal K; Patel, Natvarlal J

2010-01-01

This paper describes the development of a stability-indicating RP-HPLC method for the determination of atomoxetine hydrochloride (ATX) in the presence of its degradation products generated from forced decomposition studies. The drug substance was subjected to stress conditions of acid, base, oxidation, wet heat, dry heat, and photodegradation. In stability tests, the drug was susceptible to acid, base, oxidation, and dry and wet heat degradation. It was found to be stable under the photolytic conditions tested. The drug was successfully separated from the degradation products formed under stress conditions on a Phenomenex C18 column (250 x 4.6 mm id, 5 microm particle size) by using acetonitrile-methanol-0.032 M ammonium acetate (55 + 05 + 40, v/v/v) as the mobile phase at 1.0 mL/min and 40 degrees C. Photodiode array detection at 275 nm was used for quantitation after RP-HPLC over the concentration range of 0.5-5 microg/mL with a mean recovery of 100.8 +/- 0.4% for ATX. Statistical analysis demonstrated that the method is repeatable, specific, and accurate for the estimation of ATX. Because the method effectively separates the drug from its degradation products, it can be used as a stability-indicating method.

Assessing the stability of human locomotion: a review of current measures

PubMed Central

Bruijn, S. M.; Meijer, O. G.; Beek, P. J.; van Dieën, J. H.

2013-01-01

Falling poses a major threat to the steadily growing population of the elderly in modern-day society. A major challenge in the prevention of falls is the identification of individuals who are at risk of falling owing to an unstable gait. At present, several methods are available for estimating gait stability, each with its own advantages and disadvantages. In this paper, we review the currently available measures: the maximum Lyapunov exponent (λS and λL), the maximum Floquet multiplier, variability measures, long-range correlations, extrapolated centre of mass, stabilizing and destabilizing forces, foot placement estimator, gait sensitivity norm and maximum allowable perturbation. We explain what these measures represent and how they are calculated, and we assess their validity, divided up into construct validity, predictive validity in simple models, convergent validity in experimental studies, and predictive validity in observational studies. We conclude that (i) the validity of variability measures and λS is best supported across all levels, (ii) the maximum Floquet multiplier and λL have good construct validity, but negative predictive validity in models, negative convergent validity and (for λL) negative predictive validity in observational studies, (iii) long-range correlations lack construct validity and predictive validity in models and have negative convergent validity, and (iv) measures derived from perturbation experiments have good construct validity, but data are lacking on convergent validity in experimental studies and predictive validity in observational studies. In closing, directions for future research on dynamic gait stability are discussed. PMID:23516062

Development and validation of a stability-indicating RP-HPLC-FLD method for determination of 5-[(4-chlorophenoxy) methyl]-1, 3, 4-oxadiazole-2-thiol; A novel drug candidate.

PubMed

Shehzadi, Naureen; Hussain, Khalid; Islam, Muhammad; Bukhari, Nadeem Irfan; Asif, Noman; Khan, Muhammad Tanveer; Salman, Muhammad; Qamar, Shaista; Parveen, Sajida; Zahid, Fakhra; Shah, Arshad Ali; Bilal, Abida; Abbasi, Muhammad Athar; Siddiqui, Sabahat Zahra; Rehman, Azizur

2018-03-01

The present study describes the development and validation of a simple high performance liquid chromatographic method for the determination of a novel drug candidate, 5-[(4-chlorophenoxy) methyl]-1, 3, 4-oxadiazole-2-thiol. The stability-indicating capacity of the method was evaluated by subjecting the compound's solution to hydrolytic, oxidative, photolytic, transition metal- and thermal- stress. The chromatographic separation was achieved over a C18 column (Promosil, 5 µm, 4.60 × 250 mm), maintained at 25°C, using an isocratic mobile phase comprising a mixture of acetonitrile and acidified water of pH 2.67 (1:1, v/v), at a flow rate of 1.00 mL/min and detection using a fluorescent light detector (excitation at 250 nm and emission at 410 nm). The Beer's law was followed over the concentration range 2.50-50.00 μg/ml. The recovery (98.56-100.19%, SD <5%), intraday accuracy and precision (97.31-100.81%, RSD <5%), inter-day accuracy and precision (97.50-100.75%, RSD <5%) and intermediate accuracy and precision (98.10-99.91%, RSD <5%) indicated that the method was reliable, repeatable, reproducible and rugged. The resolution and selectivity factors of the compound's peak from the nearest resolving peak, particularly in case of dry heat and copper metal stress, were found to be greater than 2 and 1, respectively, which indicated specificity and selectivity. The compound was extensively decomposed in alkaline-hydrolytic, oxidative, metal- and dry heat- stress. However, the compound in acidic and neutral conditions was resistant to photolysis. The results of the present study indicate that the developed method is specific, selective, sensitive and suitable, hence, may be used for quality control, stability testing and preformulation studies.

Evaluation of the stability indices for the thunderstorm forecasting in the region of Belgrade, Serbia

NASA Astrophysics Data System (ADS)

Vujović, D.; Paskota, M.; Todorović, N.; Vučković, V.

2015-07-01

The pre-convective atmosphere over Serbia during the ten-year period (2001-2010) was investigated using the radiosonde data from one meteorological station and the thunderstorm observations from thirteen SYNOP meteorological stations. In order to verify their ability to forecast a thunderstorm, several stability indices were examined. Rank sum scores (RSSs) were used to segregate indices and parameters which can differentiate between a thunderstorm and no-thunderstorm event. The following indices had the best RSS values: Lifted index (LI), K index (KI), Showalter index (SI), Boyden index (BI), Total totals (TT), dew-point temperature and mixing ratio. The threshold value test was used in order to determine the appropriate threshold values for these variables. The threshold with the best skill scores was chosen as the optimal. The thresholds were validated in two ways: through the control data set, and comparing the calculated indices thresholds with the values of indices for a randomly chosen day with an observed thunderstorm. The index with the highest skill for thunderstorm forecasting was LI, and then SI, KI and TT. The BI had the poorest skill scores.

Clarifying the Behavioral Economics of Social Anxiety Disorder: Effects of Interpersonal Problems and Symptom Severity on Generosity.

PubMed

Rodebaugh, Thomas L; Heimberg, Richard G; Taylor, Kristin P; Lenze, Eric J

2016-01-01

Social anxiety disorder is associated with lower interpersonal warmth, possibly explaining its associated interpersonal impairment. Across two samples, we attempted to replicate previous findings that the disorder's constraint of interpersonal warmth can be detected via behavioral economic tasks. We also tested the test-retest stability of task indices. Results indicated that factors associated with social anxiety disorder (and not the disorder itself), such as the severity of social anxiety and more extreme interpersonal problems, lead to less generous behavior on the economic task examined. Results were clearest regarding fine-grained indices derived from latent trajectories. Unexpectedly, the combination of generalized anxiety disorder and higher depression also restricted generosity. Two of three indices showed acceptable test-retest stability. Maladaptive giving behavior may be a treatment target to improve interpersonal functioning in psychiatric disorders; therefore, future work should more precisely characterize behavioral economic tasks, including basic psychometric work (i.e., tests of reliability and validity).

Clarifying the Behavioral Economics of Social Anxiety Disorder: Effects of Interpersonal Problems and Symptom Severity on Generosity

PubMed Central

Rodebaugh, Thomas L.; Heimberg, Richard G.; Taylor, Kristin P.; Lenze, Eric J.

2015-01-01

Social anxiety disorder is associated with lower interpersonal warmth, possibly explaining its associated interpersonal impairment. Across two samples, we attempted to replicate previous findings that the disorder’s constraint of interpersonal warmth can be detected via behavioral economic tasks. We also tested the test-retest stability of task indices. Results indicated that factors associated with social anxiety disorder (and not the disorder itself), such as the severity of social anxiety and more extreme interpersonal problems, lead to less generous behavior on the economic task examined. Results were clearest regarding fine-grained indices derived from latent trajectories. Unexpectedly, the combination of generalized anxiety disorder and higher depression also restricted generosity. Two of three indices showed acceptable test-retest stability. Maladaptive giving behavior may be a treatment target to improve interpersonal functioning in psychiatric disorders; therefore, future work should more precisely characterize behavioral economic tasks, including basic psychometric work (i.e., tests of reliability and validity). PMID:27034911

ESI-MSn and LC-ESI-MS studies to characterize forced degradation products of bosentan and a validated stability-indicating LC-UV method.

PubMed

Bansal, Gulshan; Singh, Ranjit; Saini, Balraj; Bansal, Yogita

2013-01-01

The present study reports the characterization of forced degradation products of bosentan and a validated stability-indicating HPLC method for the stability testing of bosentan tablets. The forced degradation was carried out under the conditions of hydrolysis, oxidation, dry heat and photolysis. The drug was found unstable in acid, alkali and oxidative media whereas stable to the hydrolysis in water, to dry heat and to photolysis. In total, six degradation products were formed in all conditions which were resolved in a single run on a C-18 column with gradient elution using ammonium acetate buffer (pH 4.5, 5.0mM), methanol and acetonitrile. Structures of all the degradation products were characterized through +ESI-MS(n) and LC-ESI-MS spectral data of bosentan as well as LC-ESI-MS spectral data of the products. The products II-VI were characterized as 6-amino-[2,2']bipyrimidinyl-4,5-diol, 6-amino-5-(2-methoxyphenoxy)-[2,2']-bipyrimidinyl-4-ol, 2-[6-amino-5-(2-methoxyphenoxy)-[2,2']-bipyrimidinyl-4-yloxy]-ethanol, 4-tert-butyl-N-[6-(1-methoxyethoxy)-5-(2-methoxyphenoxy)-[2,2']-bipyrimidinyl-4-yl]-benzenesulfonamide and 4-tert-butyl-N-[6-hydroxy-5-(2-methoxyphenoxy)-[2,2']bipyrimidinyl-4-yl]-benzenesulfonamide, respectively. The peak of the product I was found to be due to two secondary degradation products which co-eluted and were characterized as β-hydroxyethyl p-tert-butylphenylsulfonate (Ia) and 2-[2-(2-hydroxyethoxy)-phenoxy]-ethanol (Ib). These products were formed due to hydrolysis of sulfonamide and alkylaryl ether and the diaryl ether linkages as well as dehydration of the primary alcohol group. The most probable degradation mechanisms were proposed. The HPLC method was found to be stability-indicating, linear (2-100 μg ml(-1)), accurate, precise, sensitive, specific, rugged and robust for quantitation of the drug. The method was applied to the stability testing of the commercially available bosentan tablets successfully. Copyright © 2012 Elsevier B.V. All rights reserved.

Impact of syncope on quality of life: validation of a measure in patients undergoing tilt testing.

PubMed

Nave-Leal, Elisabete; Oliveira, Mário; Pais-Ribeiro, José; Santos, Sofia; Oliveira, Eunice; Alves, Teresa; Cruz Ferreira, Rui

2015-03-01

Recurrent syncope has a significant impact on quality of life. The development of measurement scales to assess this impact that are easy to use in clinical settings is crucial. The objective of the present study is a preliminary validation of the Impact of Syncope on Quality of Life questionnaire for the Portuguese population. The instrument underwent a process of translation, validation, analysis of cultural appropriateness and cognitive debriefing. A population of 39 patients with a history of recurrent syncope (>1 year) who underwent tilt testing, aged 52.1 ± 16.4 years (21-83), 43.5% male, most in active employment (n=18) or retired (n=13), constituted a convenience sample. The resulting Portuguese version is similar to the original, with 12 items in a single aggregate score, and underwent statistical validation, with assessment of reliability, validity and stability over time. With regard to reliability, the internal consistency of the scale is 0.9. Assessment of convergent and discriminant validity showed statistically significant results (p<0.01). Regarding stability over time, a test-retest of this instrument at six months after tilt testing with 22 patients of the sample who had not undergone any clinical intervention found no statistically significant changes in quality of life. The results indicate that this instrument is of value for assessing quality of life in patients with recurrent syncope in Portugal. Copyright © 2014 Sociedade Portuguesa de Cardiologia. Published by Elsevier España. All rights reserved.

Jacobi Shape Transitions Within the LSD Model and the Skyrme-Etf Approach

NASA Astrophysics Data System (ADS)

Bartel, Johann; Pomorski, Krzysztof

The "Modified Funny-Hills parametrisation" is used together with the Lublin-Strasbourg Drop Model to evaluate the stability of rotating nuclei. The Jacobi transition into triaxial shapes is studied. By a comparison with selfconsistent semiclassical calculations in the framework of the Extended Thomas-Fermi method, the validity of the present approach is demonstrated and possible improvements are indicated.

Development and validation of stability indicating the RP-HPLC method for the estimation of related compounds of guaifenesin in pharmaceutical dosage forms.

PubMed

Reddy, Sunil Pingili; Babu, K Sudhakar; Kumar, Navneet; Sekhar, Y V V Sasi

2011-10-01

A stability-indicating gradient reverse phase liquid chromatographic (RP-LC) method was developed for the quantitative determination of related substances of guaifenesin in pharmaceutical formulations. The baseline separation for guaifenesin and all impurities was achieved by utilizing a Water Symmetry C18 (150 mm × 4.6 mm) 5 μm column particle size and a gradient elution method. The mobile phase A contains a mixture of 0.02 M KH2PO4 (pH 3.2) and methanol in the ratio of 90:10 v/v, while the mobile phase B contains 0.02 M KH2PO4 (pH 3.2) and methanol in the ratio of 10:90 v/v, respectively. The flow rate of the mobile phase was 0.8 ml/min with a column temperature of 25°C and detection wavelength at 273 nm. Guaifenesin was subjected to the stress conditions of oxidative, acid, base, hydrolytic, thermal, and photolytic degradation. The developed method was validated as per ICH guidelines with respect to specificity, linearity, limit of detection and quantification, accuracy, precision, and robustness.

Development and validation of stability indicating the RP-HPLC method for the estimation of related compounds of guaifenesin in pharmaceutical dosage forms

PubMed Central

Reddy, Sunil Pingili; Babu, K. Sudhakar; Kumar, Navneet; Sekhar, Y. V. V. Sasi

2011-01-01

Aim and background: A stability-indicating gradient reverse phase liquid chromatographic (RP-LC) method was developed for the quantitative determination of related substances of guaifenesin in pharmaceutical formulations. Materials and methods: The baseline separation for guaifenesin and all impurities was achieved by utilizing a Water Symmetry C18 (150 mm × 4.6 mm) 5 μm column particle size and a gradient elution method. The mobile phase A contains a mixture of 0.02 M KH2PO4 (pH 3.2) and methanol in the ratio of 90:10 v/v, while the mobile phase B contains 0.02 M KH2PO4 (pH 3.2) and methanol in the ratio of 10:90 v/v, respectively. The flow rate of the mobile phase was 0.8 ml/min with a column temperature of 25°C and detection wavelength at 273 nm. Results: Guaifenesin was subjected to the stress conditions of oxidative, acid, base, hydrolytic, thermal, and photolytic degradation. Conclusion: The developed method was validated as per ICH guidelines with respect to specificity, linearity, limit of detection and quantification, accuracy, precision, and robustness. PMID:23781462

Validated stability-indicating densitometric thin-layer chromatography: application to stress degradation studies of minocycline.

PubMed

Jain, Nilu; Jain, Gaurav Kumar; Ahmad, Farhan Jalees; Khar, Roop Krishen

2007-09-19

A simple, stability-indicating high-performance thin-layer liquid chromatographic (HPTLC) method for analysis of minocycline was developed and validated. The densitometric analysis was carried out at 345 nm using methanol-acetonitrile-isopropyl alcohol-water (5:4:0.5:0.5, v/v/v/v) as mobile phase. The method employed TLC aluminium plates pre-coated with silica gel 60F-254 as the stationary phase. To achieve good result, plates were sprayed with a 10% (w/v) solution of disodium ethylene diaminetetraacetic acid (EDTA), the pH of which was adjusted to 9.0. Compact spots of minocycline were found at R(f) = 0.30+/-0.02. For proposed procedure, linearity (r = 0.9997), limit of detection (3.7 ng spot(-1)), recovery (99.23-100.16%), and precision (% R.S.D. < or = 0.364) was found to be satisfactory. The drug undergoes acidic and basic degradation, oxidation and photodegradation. All the peaks of degradation products were well resolved from the pure drug with significantly different R(f) values. The acidic and alkaline degradation kinetics of minocycline, evaluated using this method, is found to be of first order.

Determination of degradation products and process related impurities of asenapine maleate in asenapine sublingual tablets by UPLC

NASA Astrophysics Data System (ADS)

Kumar, Nitin; Sangeetha, D.; Kalyanraman, L.

2017-11-01

For determination of process related impurities and degradation products of asenapine maleate in asenapine sublingual Tablets, a reversed phase, stability indicating UPLC method was developed. Acetonitrile, methanol and potassium dihydrogen phosphate buffer with tetra-n- butyl ammonium hydrogen sulphate as ion pair (pH 2.2; 0.01 M) at flow rate of 0.2 ml/min were used in gradient elution mode. Separation was achieved by using acquity BEH Shield RP18 column (1.7 μm, 2.1 mm×100 mm) at 35 ºC. UV detection was performed at 228 nm. Subsequently the liquid chromatography method was validated as per ICH. The drug product was exposed to the stress conditions of acid hydrolysis, base hydrolysis, water hydrolysis, oxidative, thermal, and photolytic. In oxidative stress and thermal stress significant degradation was observed. All the degradation products were well separated from analyte peak and its impurities. Stability indicating nature of the method was proved by demonstrating the peak purity of Asenapine peak in all the stressed samples. The mass balance was found >95% for all the stress conditions. Based on method validation, the method was found specific, linear, accurate, precise, rugged and robust.

Validation of a Stability-Indicating Method for Methylseleno-l-Cysteine (l-SeMC)

PubMed Central

Canady, Kristin; Cobb, Johnathan; Deardorff, Peter; Larson, Jami; White, Jonathan M.; Boring, Dan

2016-01-01

Methylseleno-l-cysteine (l-SeMC) is a naturally occurring amino acid analogue used as a general dietary supplement and is being explored as a chemopreventive agent. As a known dietary supplement, l-SeMC is not regulated as a pharmaceutical and there is a paucity of analytical methods available. To address the lack of methodology, a stability-indicating method was developed and validated to evaluate l-SeMC as both the bulk drug and formulated drug product (400 µg Se/capsule). The analytical approach presented is a simple, nonderivatization method that utilizes HPLC with ultraviolet detection at 220 nm. A C18 column with a volatile ion-pair agent and methanol mobile phase was used for the separation. The method accuracy was 99–100% from 0.05 to 0.15 mg/mL l-SeMC for the bulk drug, and 98–99% from 0.075 to 0.15 mg/mL l-SeMC for the drug product. Method precision was <1% for the bulk drug and was 3% for the drug product. The LOQ was 0.1 µg/mL l-SeMC or 0.002 µg l-SeMC on column. PMID:26199341

Development and validation of stability-indicating high performance liquid chromatography method to analyze gatifloxacin in bulk drug and pharmaceutical preparations.

PubMed

Aljuffali, Ibrahim A; Kalam, Mohd Abul; Sultana, Yasmin; Imran, Ahamad; Alshamsan, Aws

2015-01-01

Quantitative determination of gatifloxacin in tablets, solid lipid nanoparticles (SLNs) and eye-drops using a very simple and rapid chromatographic technique was validated and developed. Formulations were analyzed using a reverse phase SUPELCO® 516 C-18-DB, 50306-U, HPLC column (250 mm × 4.6 mm, 5 μm) and a mobile phase consisting of disodium hydrogen phosphate buffer:acetonitrile (75:25, v/v) and with orthophosphoric acid pH was adjusted to 3.3 The flow rate was 1.0 mL/min and analyte concentrations were measured using a UV-detector at 293 nm. The analyses were performed at room temperature (25 ± 2 °C). Gatifloxacin was separated in all the formulations within 2.767 min. There were linear calibration curves over a concentration range of 4.0-40 μg.mL(-1) and correlation coefficients of 0.9998 with an average recovery above 99.91%. Detection of analyte from different dosage forms at the same Rt indicates the specificity and stability of the developed method.

Stability of extemporaneously prepared preservative-free prochlorperazine nasal spray.

PubMed

Yellepeddi, Venkata K

2018-01-01

The stability of an extemporaneously prepared preservative-free prochlorperazine 5-mg/mL nasal spray was evaluated. The preservative-free prochlorperazine nasal spray was prepared by adding 250 mg of prochlorperazine edisylate to 50 mL of citrate buffer in a low-density polyethylene nasal spray bottle. A stability-indicating high-performance liquid chromatography (HPLC) method was developed and validated using the major degradant prochlorperazine sulfoxide and by performing forced-degradation studies. For chemical stability studies, 3 100-μL samples of the preservative-free prochlorperazine from 5 nasal spray bottles stored at room temperature were collected at days 0, 20, 30, 45, and 60 and were assayed in triplicate using the stability-indicating HPLC method. Microbiological testing involved antimicrobial effectiveness testing based on United States Pharmacopeia ( USP ) chapter 51 and quantitative microbiological enumeration of aerobic bacteria, yeasts, and mold based on USP chapter 61. Samples for microbiological testing were collected at days 0, 30, and 60. The stability-indicating HPLC method clearly identified the degradation product prochlorperazine sulfoxide without interference from prochlorperazine. All tested solutions retained over 90% of the initial prochlorperazine concentration for the 60-day study period. There were no detectable changes in color, pH, and viscosity in any sample. There was no growth of bacteria, yeast, and mold for 60 days in all samples tested. An extemporaneously prepared preservative-free nasal spray solution of prochlorperazine edisylate 5 mg/mL was physically, chemically, and microbiologically stable for 60 days when stored at room temperature in low-density polyethylene bottles. Copyright © 2018 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

Trends in Thermostability Provide Information on the Nature of Substrate, Inhibitor, and Lipid Interactions with Mitochondrial Carriers*

PubMed Central

Crichton, Paul G.; Lee, Yang; Ruprecht, Jonathan J.; Cerson, Elizabeth; Thangaratnarajah, Chancievan; King, Martin S.; Kunji, Edmund R. S.

2015-01-01

Mitochondrial carriers, including uncoupling proteins, are unstable in detergents, which hampers structural and mechanistic studies. To investigate carrier stability, we have purified ligand-free carriers and assessed their stability with a fluorescence-based thermostability assay that monitors protein unfolding with a thiol-reactive dye. We find that mitochondrial carriers from both mesophilic and thermophilic organisms exhibit poor stability in mild detergents, indicating that instability is inherent to the protein family. Trends in the thermostability of yeast ADP/ATP carrier AAC2 and ovine uncoupling protein UCP1 allow optimal conditions for stability in detergents to be established but also provide mechanistic insights into the interactions of lipids, substrates, and inhibitors with these proteins. Both proteins exhibit similar stability profiles across various detergents, where stability increases with the size of the associated detergent micelle. Detailed analysis shows that lipids stabilize carriers indirectly by increasing the associated detergent micelle size, but cardiolipin stabilizes by direct interactions as well. Cardiolipin reverses destabilizing effects of ADP and bongkrekic acid on AAC2 and enhances large stabilizing effects of carboxyatractyloside, revealing that this lipid interacts in the m-state and possibly other states of the transport cycle, despite being in a dynamic interface. Fatty acid activators destabilize UCP1 in a similar way, which can also be prevented by cardiolipin, indicating that they interact like transport substrates. Our controls show that carriers can be soluble but unfolded in some commonly used detergents, such as the zwitterionic Fos-choline-12, which emphasizes the need for simple validation assays like the one used here. PMID:25653283

Developing and testing the CHORDS: Characteristics of Responsible Drinking Survey.

PubMed

Barry, Adam E; Goodson, Patricia

2011-01-01

Report on the development and psychometric testing of a theoretically and evidence-grounded instrument, the Characteristics of Responsible Drinking Survey (CHORDS). Instrument subjected to four phases of pretesting (cognitive validity, cognitive and motivational qualities, pilot test, and item evaluation) and a final posttest implementation. Large public university in Texas. Randomly selected convenience sample (n  =  729) of currently enrolled students. This 78-item questionnaire measures individuals' responsible drinking beliefs, motivations, intentions, and behaviors. Cronbach α, split-half reliability, principal components analysis and Spearman ρ were conducted to investigate reliability, stability, and validity. Measures in the CHORDS exhibited high internal consistency reliability and strong correlations of split-half reliability. Factor analyses indicated five distinct scales were present, as proposed in the theoretical model. Subscale composite scores also exhibited a correlation to alcohol consumption behaviors, indicating concurrent validity. The CHORDS represents the first instrument specifically designed to assess responsible drinking beliefs and behaviors. It was found to elicit valid and reliable data among a college student sample. This instrument holds much promise for practitioners who desire to empirically investigate dimensions of responsible drinking.

Stability Indicating Reverse Phase HPLC Method for Estimation of Rifampicin and Piperine in Pharmaceutical Dosage Form.

PubMed

Shah, Umang; Patel, Shraddha; Raval, Manan

2018-01-01

High performance liquid chromatography is an integral analytical tool in assessing drug product stability. HPLC methods should be able to separate, detect, and quantify the various drug-related degradants that can form on storage or manufacturing, plus detect any drug-related impurities that may be introduced during synthesis. A simple, economic, selective, precise, and stability-indicating HPLC method has been developed and validated for analysis of Rifampicin (RIFA) and Piperine (PIPE) in bulk drug and in the formulation. Reversed-phase chromatography was performed on a C18 column with Buffer (Potassium Dihydrogen Orthophosphate) pH 6.5 and Acetonitrile, 30:70), (%, v/v), as mobile phase at a flow rate of 1 mL min-1. The detection was performed at 341 nm and sharp peaks were obtained for RIFA and PIPE at retention time of 3.3 ± 0.01 min and 5.9 ± 0.01 min, respectively. The detection limits were found to be 2.385 ng/ml and 0.107 ng/ml and quantification limits were found to be 7.228ng/ml and 0.325ng/ml for RIFA and PIPE, respectively. The method was validated for accuracy, precision, reproducibility, specificity, robustness, and detection and quantification limits, in accordance with ICH guidelines. Stress study was performed on RIFA and PIPE and it was found that these degraded sufficiently in all applied chemical and physical conditions. Thus, the developed RP-HPLC method was found to be suitable for the determination of both the drugs in bulk as well as stability samples of capsule containing various excipients. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

A novel integrated framework and improved methodology of computer-aided drug design.

PubMed

Chen, Calvin Yu-Chian

2013-01-01

Computer-aided drug design (CADD) is a critical initiating step of drug development, but a single model capable of covering all designing aspects remains to be elucidated. Hence, we developed a drug design modeling framework that integrates multiple approaches, including machine learning based quantitative structure-activity relationship (QSAR) analysis, 3D-QSAR, Bayesian network, pharmacophore modeling, and structure-based docking algorithm. Restrictions for each model were defined for improved individual and overall accuracy. An integration method was applied to join the results from each model to minimize bias and errors. In addition, the integrated model adopts both static and dynamic analysis to validate the intermolecular stabilities of the receptor-ligand conformation. The proposed protocol was applied to identifying HER2 inhibitors from traditional Chinese medicine (TCM) as an example for validating our new protocol. Eight potent leads were identified from six TCM sources. A joint validation system comprised of comparative molecular field analysis, comparative molecular similarity indices analysis, and molecular dynamics simulation further characterized the candidates into three potential binding conformations and validated the binding stability of each protein-ligand complex. The ligand pathway was also performed to predict the ligand "in" and "exit" from the binding site. In summary, we propose a novel systematic CADD methodology for the identification, analysis, and characterization of drug-like candidates.

[Toward a deeper understanding of motivation towards exercise: measurement of integrated regulation in the Spanish context].

PubMed

González-Cutre, David; Sicilia, Álvaro; Fernández, Alberto

2010-11-01

The purpose of this study was to validate the Behavioural Regulation in Exercise Questionnaire in the Spanish context, including items to measure integrated regulation. Participants were 524 exercisers, mean age 29.59 years. The results revealed acceptable fit indices in the confirmatory factor analysis and good internal consistency (with a Cronbach alpha of .87 for integrated regulation). The diverse subscales also conformed to a simplex pattern and the factor structure was invariant across gender and age. Integrated regulation reflected high temporal stability over a 4-week period (ICC=.90). The criterion validity analysis of integrated regulation indicated that this variable was positively predicted by satisfaction of the needs for competence and autonomy. The results regarding the importance of measuring integrated regulation in exercise are discussed.

Stability indicating RP-HPLC method development and validation for the simultaneous determination of aminexil and minoxidil in pharmaceutical dosage form.

PubMed

Siddiraju, S; Sahithi, M

2015-03-01

The objective of the present work is to develop stability indicating high-performance liquid chromatographic method for the simultaneous determination of aminexil and minoxidil in pharmaceutical dosage form. The chromatographic separation was achieved with BDS Hypersil C18 column (250 mm×4.6 mm×5 μ) as stationary phase and phosphate buffer and acetonitrile (78:22) as mobile phase. The method was employed by using a flow rate of 1.1 mL/min kept at 30°C. The detection wavelength was kept at 238 nm by using photo-diode array detector. The retention times of the aminexil and minoxidil were found to be 2.3 min and 3.9 min, respectively. The method developed was validated in accordance with ICH guidelines with respect to the stability indicating capacity of the method including system suitability, accuracy, precision, linearity, range, limit of detection, limit of quantification and robustness. The linearity responses of aminexil and minoxidil were found to be in the concentration ranges of 18.75-112.5 μg/mL and 25-150 μg/mL, respectively. The LOD and LOQ values for aminexil were found to be 0.31 and 0.92 μg/mL and minoxidil were found to be 0.03 and 0.10 μg/mL respectively. The percentage recoveries for both the drugs were found in the range of 98-101%. This method is accurate, precise and sensitive; hence, it can be employed for routine quality control of aminexil and minoxidil in pharmaceutical industries and drug testing laboratories. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

NIKE: a new clinical tool for establishing levels of indications for cataract surgery.

PubMed

Lundström, Mats; Albrecht, Susanne; Håkansson, Ingemar; Lorefors, Ragnhild; Ohlsson, Sven; Polland, Werner; Schmid, Andrea; Svensson, Göran; Wendel, Eva

2006-08-01

The purpose of this study was to construct a new clinical tool for establishing levels of indications for cataract surgery, and to validate this tool. Teams from nine eye clinics reached an agreement about the need to develop a clinical tool for setting levels of indications for cataract surgery and about the items that should be included in the tool. The tool was to be called 'NIKE' (Nationell Indikationsmodell för Kataraktextraktion). The Canadian Cataract Priority Criteria Tool served as a model for the NIKE tool, which was modified for Swedish conditions. Items included in the tool were visual acuity of both eyes, patients' perceived difficulties in day-to-day life, cataract symptoms, the ability to live independently, and medical/ophthalmic reasons for surgery. The tool was validated and tested in 343 cataract surgery patients. Validity, stability and reliability were tested and the outcome of surgery was studied in relation to the indication setting. Four indication groups (IGs) were suggested. The group with the greatest indications for surgery was named group 1 and that with the lowest, group 4. Validity was proved to be good. Surgery had the greatest impact on the group with the highest indications for surgery. Test-retest reliability test and interexaminer tests of indication settings showed statistically significant intraclass correlations (intraclass correlation coefficients [ICCs] 0.526 and 0.923, respectively). A new clinical tool for indication setting in cataract surgery is presented. This tool, the NIKE, takes into account both visual acuity and the patient's perceived problems in day-to-day life because of cataract. The tool seems to be stable and reliable and neutral towards different examiners.

The Psychometric Parameters of the Farsi Form of the Arabic Scale of Death Anxiety

PubMed Central

Abdel-Khalek, Ahmed M.; Lester, David

2017-01-01

The aim of this study was to describe the psychometric properties of the Farsi Form of the Arabic Scale of Death Anxiety (ASDA). The original scale was first translated into Farsi by language experts using the back translation procedure and then administered to a total of 252 Iranian college students and 52 psychiatric outpatients from psychiatric and psychological clinics. The one-week test-retest reliability of the Farsi version in a sample of college students was 0.78, indicating good temporal stability and corroborating the trait-like nature of scores. Cronbach's α was 0.90 for the college students and 0.92 for the psychiatric outpatients, indicating high internal consistency. Scale scores correlated 0.46 with Death Obsession Scale scores, 0.56 with Death Depression Scale scores, 0.41 with Death Anxiety Scale scores, and 0.40 with Wish to be Dead Scale scores, indicating good construct and criterion-related validity. A principal component analysis with a Varimax rotation yielded four factors in the sample of Iranian college students, indicating a lack of homogeneity in the content of the scale. Male students obtained a significant higher mean score than did females. It was concluded that the Farsi ASDA had good internal consistency, temporal stability, criterion-related validity, and a factor structure reflecting important features of death anxiety. In general, the Farsi ASDA could be recommended for use in research on death anxiety among Iranian college students and psychiatric outpatients. PMID:28698887

The Psychometric Parameters of the Farsi Form of the Arabic Scale of Death Anxiety.

PubMed

Dadfar, Mahboubeh; Abdel-Khalek, Ahmed M; Lester, David; Atef Vahid, Mohammad Kazem

2017-01-01

The aim of this study was to describe the psychometric properties of the Farsi Form of the Arabic Scale of Death Anxiety (ASDA). The original scale was first translated into Farsi by language experts using the back translation procedure and then administered to a total of 252 Iranian college students and 52 psychiatric outpatients from psychiatric and psychological clinics. The one-week test-retest reliability of the Farsi version in a sample of college students was 0.78, indicating good temporal stability and corroborating the trait-like nature of scores. Cronbach's α was 0.90 for the college students and 0.92 for the psychiatric outpatients, indicating high internal consistency. Scale scores correlated 0.46 with Death Obsession Scale scores, 0.56 with Death Depression Scale scores, 0.41 with Death Anxiety Scale scores, and 0.40 with Wish to be Dead Scale scores, indicating good construct and criterion-related validity. A principal component analysis with a Varimax rotation yielded four factors in the sample of Iranian college students, indicating a lack of homogeneity in the content of the scale. Male students obtained a significant higher mean score than did females. It was concluded that the Farsi ASDA had good internal consistency, temporal stability, criterion-related validity, and a factor structure reflecting important features of death anxiety. In general, the Farsi ASDA could be recommended for use in research on death anxiety among Iranian college students and psychiatric outpatients.

Structure-activity relationships between sterols and their thermal stability in oil matrix.

PubMed

Hu, Yinzhou; Xu, Junli; Huang, Weisu; Zhao, Yajing; Li, Maiquan; Wang, Mengmeng; Zheng, Lufei; Lu, Baiyi

2018-08-30

Structure-activity relationships between 20 sterols and their thermal stabilities were studied in a model oil system. All sterol degradations were found to be consistent with a first-order kinetic model with determination of coefficient (R 2 ) higher than 0.9444. The number of double bonds in the sterol structure was negatively correlated with the thermal stability of sterol, whereas the length of the branch chain was positively correlated with the thermal stability of sterol. A quantitative structure-activity relationship (QSAR) model to predict thermal stability of sterol was developed by using partial least squares regression (PLSR) combined with genetic algorithm (GA). A regression model was built with R 2 of 0.806. Almost all sterol degradation constants can be predicted accurately with R 2 of cross-validation equals to 0.680. Four important variables were selected in optimal QSAR model and the selected variables were observed to be related with information indices, RDF descriptors, and 3D-MoRSE descriptors. Copyright © 2018 Elsevier Ltd. All rights reserved.

Parameter Stability of the Functional–Structural Plant Model GREENLAB as Affected by Variation within Populations, among Seasons and among Growth Stages

PubMed Central

Ma, Yuntao; Li, Baoguo; Zhan, Zhigang; Guo, Yan; Luquet, Delphine; de Reffye, Philippe; Dingkuhn, Michael

2007-01-01

Background and Aims It is increasingly accepted that crop models, if they are to simulate genotype-specific behaviour accurately, should simulate the morphogenetic process generating plant architecture. A functional–structural plant model, GREENLAB, was previously presented and validated for maize. The model is based on a recursive mathematical process, with parameters whose values cannot be measured directly and need to be optimized statistically. This study aims at evaluating the stability of GREENLAB parameters in response to three types of phenotype variability: (1) among individuals from a common population; (2) among populations subjected to different environments (seasons); and (3) among different development stages of the same plants. Methods Five field experiments were conducted in the course of 4 years on irrigated fields near Beijing, China. Detailed observations were conducted throughout the seasons on the dimensions and fresh biomass of all above-ground plant organs for each metamer. Growth stage-specific target files were assembled from the data for GREENLAB parameter optimization. Optimization was conducted for specific developmental stages or the entire growth cycle, for individual plants (replicates), and for different seasons. Parameter stability was evaluated by comparing their CV with that of phenotype observation for the different sources of variability. A reduced data set was developed for easier model parameterization using one season, and validated for the four other seasons. Key Results and Conclusions The analysis of parameter stability among plants sharing the same environment and among populations grown in different environments indicated that the model explains some of the inter-seasonal variability of phenotype (parameters varied less than the phenotype itself), but not inter-plant variability (parameter and phenotype variability were similar). Parameter variability among developmental stages was small, indicating that parameter values were largely development-stage independent. The authors suggest that the high level of parameter stability observed in GREENLAB can be used to conduct comparisons among genotypes and, ultimately, genetic analyses. PMID:17158141

Stability of an ophthalmic formulation of polyhexamethylene biguanide in gamma-sterilized and ethylene oxide sterilized low density polyethylene multidose eyedroppers

PubMed Central

Wasiak, Mathieu; Jouannet, Mireille; Sautou, Valérie

2018-01-01

Background Polyhexamethylene biguanide (PHMB) eye drops are a frequently used medication to treat Acanthamoeba keratitis. In the absence of marketed PHMB eye drops, pharmacy-compounding units are needed to prepare this much needed treatment, but the lack of validated PHMB stability data severely limits their conservation by imposing short expiration dates after preparation. In this study we aim to assess the physicochemical and microbiological stability of a 0.2 mg/mL PHMB eye drop formulation stored in two kinds of polyethylene bottles at two different temperatures. Methods A liquid chromatography coupled with diode array detector stability-indicating method was validated to quantify PHMB, using a cyanopropyl bonded phase (Agilent Zorbax Eclipse XDB-CN column 4.6 × 75 mm with particle size of 3.5 μm) and isocratic elution consisting of acetonitrile/deionized water (3/97 v/v) at a flow rate of 1.3 mL/min. PHMB eye drops stability was assessed for 90 days of storage at 5 and 25 °C in ethylene oxide sterilized low density polyethylene (EOS-LDPE) and gamma sterilized low density polyethylene (GS-LDPE) bottles. The following analyses were performed: visual inspection, PHMB quantification and breakdown products (BPs) screening, osmolality and pH measurements, and sterility assessment. PHMB quantification and BP screening was also performed on the drops emitted from the multidose eyedroppers to simulate in-use condition. Results The analytical method developed meets all the qualitative and quantitative criteria for validation with an acceptable accuracy and good linearity, and is stability indicating. During 90 days of storage, no significant decrease of PHMB concentration was found compared to initial concentration in all stored PHMB eye drops. However, BP were found at day 30 and at day 90 of monitoring in both kind of bottles, stored at 5 and 25 °C, respectively. Although no significant variation of osmolality was found and sterility was maintained during 90 days of monitoring, a significant decrease of pH in GS-LDPE PHMB eye drops was noticed reaching 4 and 4.6 at 25 °C and 5 °C respectively, compared to initial pH of 6.16. Discussion Although no significant decrease in PHMB concentration was found during 90 days of monitoring in all conditions, the appearance of BPs and their unknown toxicities let us believe that 0.2 mg/mL PHMB solution should be conserved for no longer than 60 days in EOS-LDPE bottles at 25 °C. PMID:29682408

Validation of the Weight Concerns Scale Applied to Brazilian University Students.

PubMed

Dias, Juliana Chioda Ribeiro; da Silva, Wanderson Roberto; Maroco, João; Campos, Juliana Alvares Duarte Bonini

2015-06-01

The aim of this study was to evaluate the validity and reliability of the Portuguese version of the Weight Concerns Scale (WCS) when applied to Brazilian university students. The scale was completed by 1084 university students from Brazilian public education institutions. A confirmatory factor analysis was conducted. The stability of the model in independent samples was assessed through multigroup analysis, and the invariance was estimated. Convergent, concurrent, divergent, and criterion validities as well as internal consistency were estimated. Results indicated that the one-factor model presented an adequate fit to the sample and values of convergent validity. The concurrent validity with the Body Shape Questionnaire and divergent validity with the Maslach Burnout Inventory for Students were adequate. Internal consistency was adequate, and the factorial structure was invariant in independent subsamples. The results present a simple and short instrument capable of precisely and accurately assessing concerns with weight among Brazilian university students. Copyright © 2015 Elsevier Ltd. All rights reserved.

Development and validation of the Cancer Exercise Stereotypes Scale.

PubMed

Falzon, Charlène; Sabiston, Catherine; Bergamaschi, Alessandro; Corrion, Karine; Chalabaev, Aïna; D'Arripe-Longueville, Fabienne

2014-01-01

The objective of this study was to develop and validate a French-language questionnaire measuring stereotypes related to exercise in cancer patients: The Cancer Exercise Stereotypes Scale (CESS). Four successive steps were carried out with 806 participants. First, a preliminary version was developed on the basis of the relevant literature and qualitative interviews. A test of clarity then led to the reformulation of six of the 30 items. Second, based on the modification indices of the first confirmatory factorial analysis, 11 of the 30 initial items were deleted. A new factorial structure analysis showed a good fit and validated a 19-item instrument with five subscales. Third, the stability of the instrument was tested over time. Last, tests of construct validity were conducted to examine convergent validity and discriminant validity. The French-language CESS appears to have good psychometric qualities and can be used to test theoretical tenets and inform intervention strategies on ways to foster exercise in cancer patients.

Determination of aliskiren in tablet dosage forms by a validated stability-indicating RP-LC method.

PubMed

Wrasse-Sangoi, M; Sangoi, M S; Oliveira, P R; Secretti, L T; Rolim, C M B

2011-02-01

A reversed-phase liquid chromatography (RP-LC) method is validated for the determination of aliskiren in tablet dosage form. The LC method is carried out on a Waters XBridge C(18) column (150 × 4.6 mm i.d.), maintained at 25°C. The mobile phase consisted of acetonitrile:water (95:5, v/v)/phosphoric acid (25 mM, pH 3.0) (40:60, v/v), run at a flow rate of 1.0 mL/min, with photodiode array detector set at 229 nm. The chromatographic separation is obtained with aliskiren retention time of 3.68 min, and it is linear in the range of 10-300 μg/mL (r = 0.9999). The limits of detection and quantitation are 2.38 and 7.93 μg/mL, respectively. The specificity and stability-indicating capability of the method are proven through degradation studies, which also showed that there is no interference of the formulation excipients, showing that peak is free from any coeluting peak. The method showed adequate precision, with a relative standard deviation (RSD) values lower than 0.92%. Good values of accuracy were also obtained, with a mean value of 99.55%. Experimental design is used during validation to calculate method robustness. The proposed method is applied for the analysis of the tablet dosage forms, contributing to improve the quality control and to assure the therapeutic efficacy.

[Multicenter validation of an evaluation tool for clinical training activities (SVAT) of the nursing students].

PubMed

Finotto, Sergio; Gradellini, Cinzia; Bandini, Stefania; Burrai, Francesco; Lucchi Casadei, Sandra; Villani, Carolina; Vincenzi, Simone; Mecugni, Daniela

2017-01-01

To evaluate the psychometric characteristics of the Scheda di Valutazione delle Attività di Tirocinio (SVAT). The degree courses in Nursing of the University of Modena and Reggio Emilia, site of Reggio Emilia, the University of Bologna Formative Section BO1, Imola and training center of Cesena, the University of Ferrara training centers of Ferrara and Codigoro were all enrolled in the research. For the content validation the reactive Delphi method was chosen. The panel of experts expressed a qualitative-intuitive judgment on the adequacy of language and on the stimulus material (SVAT). For internal consistency Cronbach's alpha was calculated the. The test-retest method was used for the reliability of stability. all indicators of the SVAT have achieved a degree of consensus not less than 80% demonstrating its content validity. The face validity is demonstrated by an average score equal to or greater than 7 obtained by all indicators. The reliability of internal consistency of the SVAT was appraised by Cronbach's alpha that was 0.987 for the entire instrument. The reliability of the stability has been calculated through the correlation's coefficient expressed by Pearson's r that was 0.983 (p = 1.3E-198). in Italy there is no a "gold standard" tool to evaluate the clinical performance of nursing students during and at the end of their clinical training. The SVAT proves to be a valuable and reliable tool it furthermore could stimulate the discussion and the debate among educators and nurses, so that also in our country, it may be possible develop and refine tools that support the evaluation of clinical skills of nursing students.

A preliminary correlation of the orbiter stability and control aerodynamics from the first two Space Shuttle flights /STS-1 & 2/ with preflight predictions

NASA Technical Reports Server (NTRS)

Underwood, J. M.; Cooke, D. R.

1982-01-01

A correlation of the stability and control derivatives from flight (STS-1 & 2) with preflight predictions is presented across the Mach range from 0.9 to 25. Flight data obtained from specially designed flight test maneuvers as well as from conventional bank maneuvers generally indicate good agreement with predicted data. However, the vehicle appears to be lateral-directionally more stable than predicted in the transonic regime. Aerodynamic 'reasonableness tests' are employed to test for validity of flight data. The importance of testing multiple models in multiple wind tunnels at the same test conditions is demonstrated.

Transport and stability analyses supporting disruption prediction in high beta KSTAR plasmas

NASA Astrophysics Data System (ADS)

Ahn, J.-H.; Sabbagh, S. A.; Park, Y. S.; Berkery, J. W.; Jiang, Y.; Riquezes, J.; Lee, H. H.; Terzolo, L.; Scott, S. D.; Wang, Z.; Glasser, A. H.

2017-10-01

KSTAR plasmas have reached high stability parameters in dedicated experiments, with normalized beta βN exceeding 4.3 at relatively low plasma internal inductance li (βN/li>6). Transport and stability analyses have begun on these plasmas to best understand a disruption-free path toward the design target of βN = 5 while aiming to maximize the non-inductive fraction of these plasmas. Initial analysis using the TRANSP code indicates that the non-inductive current fraction in these plasmas has exceeded 50 percent. The advent of KSTAR kinetic equilibrium reconstructions now allows more accurate computation of the MHD stability of these plasmas. Attention is placed on code validation of mode stability using the PEST-3 and resistive DCON codes. Initial evaluation of these analyses for disruption prediction is made using the disruption event characterization and forecasting (DECAF) code. The present global mode kinetic stability model in DECAF developed for low aspect ratio plasmas is evaluated to determine modifications required for successful disruption prediction of KSTAR plasmas. Work supported by U.S. DoE under contract DE-SC0016614.

Improvement of a stability-indicating method by Quality-by-Design versus Quality-by-Testing: a case of a learning process.

PubMed

Hubert, C; Lebrun, P; Houari, S; Ziemons, E; Rozet, E; Hubert, Ph

2014-01-01

The understanding of the method is a major concern when developing a stability-indicating method and even more so when dealing with impurity assays from complex matrices. In the presented case study, a Quality-by-Design approach was applied in order to optimize a routinely used method. An analytical issue occurring at the last stage of a long-term stability study involving unexpected impurities perturbing the monitoring of characterized impurities needed to be resolved. A compliant Quality-by-Design (QbD) methodology based on a Design of Experiments (DoE) approach was evaluated within the framework of a Liquid Chromatography (LC) method. This approach allows the investigation of Critical Process Parameters (CPPs), which have an impact on Critical Quality Attributes (CQAs) and, consequently, on LC selectivity. Using polynomial regression response modeling as well as Monte Carlo simulations for error propagation, Design Space (DS) was computed in order to determine robust working conditions for the developed stability-indicating method. This QbD compliant development was conducted in two phases allowing the use of the Design Space knowledge acquired during the first phase to define the experimental domain of the second phase, which constitutes a learning process. The selected working condition was then fully validated using accuracy profiles based on statistical tolerance intervals in order to evaluate the reliability of the results generated by this LC/ESI-MS stability-indicating method. A comparison was made between the traditional Quality-by-Testing (QbT) approach and the QbD strategy, highlighting the benefit of this QbD strategy in the case of an unexpected impurities issue. On this basis, the advantages of a systematic use of the QbD methodology were discussed. Copyright © 2013 Elsevier B.V. All rights reserved.

LOX/hydrocarbon rocket engine analytical design methodology development and validation. Volume 2: Appendices

NASA Technical Reports Server (NTRS)

Niiya, Karen E.; Walker, Richard E.; Pieper, Jerry L.; Nguyen, Thong V.

1993-01-01

This final report includes a discussion of the work accomplished during the period from Dec. 1988 through Nov. 1991. The objective of the program was to assemble existing performance and combustion stability models into a usable design methodology capable of designing and analyzing high-performance and stable LOX/hydrocarbon booster engines. The methodology was then used to design a validation engine. The capabilities and validity of the methodology were demonstrated using this engine in an extensive hot fire test program. The engine used LOX/RP-1 propellants and was tested over a range of mixture ratios, chamber pressures, and acoustic damping device configurations. This volume contains time domain and frequency domain stability plots which indicate the pressure perturbation amplitudes and frequencies from approximately 30 tests of a 50K thrust rocket engine using LOX/RP-1 propellants over a range of chamber pressures from 240 to 1750 psia with mixture ratios of from 1.2 to 7.5. The data is from test configurations which used both bitune and monotune acoustic cavities and from tests with no acoustic cavities. The engine had a length of 14 inches and a contraction ratio of 2.0 using a 7.68 inch diameter injector. The data was taken from both stable and unstable tests. All combustion instabilities were spontaneous in the first tangential mode. Although stability bombs were used and generated overpressures of approximately 20 percent, no tests were driven unstable by the bombs. The stability instrumentation included six high-frequency Kistler transducers in the combustion chamber, a high-frequency Kistler transducer in each propellant manifold, and tri-axial accelerometers. Performance data is presented, both characteristic velocity efficiencies and energy release efficiencies, for those tests of sufficient duration to record steady state values.

Wavelet Filtering to Reduce Conservatism in Aeroservoelastic Robust Stability Margins

NASA Technical Reports Server (NTRS)

Brenner, Marty; Lind, Rick

1998-01-01

Wavelet analysis for filtering and system identification was used to improve the estimation of aeroservoelastic stability margins. The conservatism of the robust stability margins was reduced with parametric and nonparametric time-frequency analysis of flight data in the model validation process. Nonparametric wavelet processing of data was used to reduce the effects of external desirableness and unmodeled dynamics. Parametric estimates of modal stability were also extracted using the wavelet transform. Computation of robust stability margins for stability boundary prediction depends on uncertainty descriptions derived from the data for model validation. F-18 high Alpha Research Vehicle aeroservoelastic flight test data demonstrated improved robust stability prediction by extension of the stability boundary beyond the flight regime.

Double Cross-Validation in Multiple Regression: A Method of Estimating the Stability of Results.

ERIC Educational Resources Information Center

Rowell, R. Kevin

In multiple regression analysis, where resulting predictive equation effectiveness is subject to shrinkage, it is especially important to evaluate result replicability. Double cross-validation is an empirical method by which an estimate of invariance or stability can be obtained from research data. A procedure for double cross-validation is…

Validity and reliability assessment of the Brazilian version of the game addiction scale (GAS).

PubMed

Lemos, Igor Lins; Cardoso, Adriana; Sougey, Everton Botelho

2016-05-01

The uncontrolled use of video games can be addictive. The Game Addiction Scale (GAS) is an instrument that was developed to assess this type of addiction. The GAS consists of 21 items that are divided into the following seven factors: salience, tolerance, mood modification, relapse, withdrawal, conflict and problems. This study assessed the convergent validity and reliability of the GAS according to measures of internal consistency and test-retest stability. Three hundred and eighty four students completed the GAS, the Internet Addiction Test (IAT), the Liebowitz Social Anxiety Scale (LSAS), the Beck Depression Inventory (BDI) and the Video Game Addiction Test (VAT). A subgroup of the participants (n=76) completed the GAS again after 30days to determine test-retest stability. The GAS demonstrated excellent internal consistency (Cronbach's alpha=0.92), was highly correlated with the VAT (r=0.883) and was moderately correlated with the BDI (r=0.358), the LSAS (r=0.326) and the IAT (r=0.454). In the Brazilian Portuguese population, the GAS shows good internal consistency. These data indicate that the GAS can be used to assess video game addiction due to its demonstrated psychometric validity. Copyright © 2016 Elsevier Inc. All rights reserved.

[Maslach Burnout Inventory - Student Survey: Portugal-Brazil cross-cultural adaptation].

PubMed

Campos, Juliana Alvares Duarte Bonini; Maroco, João

2012-10-01

To perform a cross-cultural adaptation of the Portuguese version of the Maslach Burnout Inventory for students (MBI-SS), and investigate its reliability, validity and cross-cultural invariance. The face validity involved the participation of a multidisciplinary team. Content validity was performed. The Portuguese version was completed in 2009, on the internet, by 958 Brazilian and 556 Portuguese university students from the urban area. Confirmatory factor analysis was carried out using as fit indices: the χ²/df, the Comparative Fit Index (CFI), the Goodness of Fit Index (GFI) and the Root Mean Square Error of Approximation (RMSEA). To verify the stability of the factor solution according to the original English version, cross-validation was performed in 2/3 of the total sample and replicated in the remaining 1/3. Convergent validity was estimated by the average variance extracted and composite reliability. The discriminant validity was assessed, and the internal consistency was estimated by the Cronbach's alpha coefficient. Concurrent validity was estimated by the correlational analysis of the mean scores of the Portuguese version and the Copenhagen Burnout Inventory, and the divergent validity was compared to the Beck Depression Inventory. The invariance of the model between the Brazilian and the Portuguese samples was assessed. The three-factor model of Exhaustion, Disengagement and Efficacy showed good fit (c 2/df = 8.498, CFI = 0.916, GFI = 0.902, RMSEA = 0.086). The factor structure was stable (λ:χ²dif = 11.383, p = 0.50; Cov: χ²dif = 6.479, p = 0.372; Residues: χ²dif = 21.514, p = 0.121). Adequate convergent validity (VEM = 0.45;0.64, CC = 0.82;0.88), discriminant (ρ² = 0.06;0.33) and internal consistency (α = 0.83;0.88) were observed. The concurrent validity of the Portuguese version with the Copenhagen Inventory was adequate (r = 0.21, 0.74). The assessment of the divergent validity was impaired by the approach of the theoretical concept of the dimensions Exhaustion and Disengagement of the Portuguese version with the Beck Depression Inventory. Invariance of the instrument between the Brazilian and Portuguese samples was not observed (λ:χ²dif = 84.768, p<0.001; Cov: χ²dif = 129.206, p < 0.001; Residues: χ²dif = 518.760, p < 0.001). The Portuguese version of the Maslach Burnout Inventory for students showed adequate reliability and validity, but its factor structure was not invariant between the countries, indicating the absence of cross-cultural stability.

Validity of the Nintendo Wii® balance board for the assessment of standing balance in Parkinson's disease.

PubMed

Holmes, Jeffrey D; Jenkins, Mary E; Johnson, Andrew M; Hunt, Michael A; Clark, Ross A

2013-04-01

Impaired postural stability places individuals with Parkinson's at an increased risk for falls. Given the high incidence of fall-related injuries within this population, ongoing assessment of postural stability is important. To evaluate the validity of the Nintendo Wii(®) balance board as a measurement tool for the assessment of postural stability in individuals with Parkinson's. Twenty individuals with Parkinson's participated. Subjects completed testing on two balance tasks with eyes open and closed on a Wii(®) balance board and biomechanical force platform. Bland-Altman plots and a two-way, random-effects, single measure intraclass correlation coefficient model were used to assess concurrent validity of centre-of-pressure data. Concurrent validity was demonstrated to be excellent across balance tasks (intraclass correlation coefficients = 0.96, 0.98, 0.92, 0.94). This study suggests that the Wii(®) balance board is a valid tool for the quantification of postural stability among individuals with Parkinson's.

The temporal stability and predictive validity of pupils' causal attributions for difficult classroom behaviour.

PubMed

Lambert, Nathan; Miller, Andy

2010-12-01

Recent studies have investigated the causal attributions for difficult pupil behaviour made by teachers, pupils, and parents but none have investigated the temporal stability or predictive validity of these attributions. This study examines the causal attributions made for difficult classroom behaviour by students on two occasions 30 months apart. The longitudinal stability of these attributions is considered as is the predictive validity of the first set of attributions in relation to teachers' later judgments about individual students' behaviour. Two hundred and seventeen secondary school age pupils (114 males, 103 females) provided data on the two occasions. Teachers also rated each student's behaviour at the two times. A questionnaire listing 63 possible causes of classroom misbehaviour was delivered to pupils firstly when they were in Year 7 (aged 11-12) and then again, 30 months later. Responses were analysed through exploratory factor analysis (EFA). Additionally, teachers were asked to rate the standard of behaviour of each of the students on the two occasions. EFA of the Years 7 and 10 data indicated that pupils' attributions yielded broadly similar five-factor models with the perceived relative importance of these factors remaining the same. Analysis also revealed a predictive relationship between pupils' attributions regarding the factor named culture of misbehaviour in Year 7, and teachers' judgments of their standard of behaviour in Year 10. The present study suggests that young adolescents' causal attributions for difficult classroom behaviour remain stable over time and are predictive of teachers' later judgments about their behaviour.

Development and validation of a disease-specific scale to assess psychosocial well-being of patients living with unruptured intracranial aneurysm.

PubMed

Fujishima-Hachiya, Asami; Inoue, Tomoko

2012-12-01

Although the detection rate for unruptured intracranial aneurysm (UIA) has improved since the 1990s, the quality of life and psychosocial status of patients living with UIA have been negatively affected. However, a comprehensive assessment tool for UIA patients is still awaited. This study aimed to develop and validate a disease-specific scale to assess UIA patients' psychosocial well-being in their daily lives. On the basis of previous qualitative research, 52 items on a six-dimension scale were generated. After a pilot study, statistical analysis was conducted to examine construct validity-including convergent validity, discriminant and known-group validity, and internal reliability. Between 2010 and 2011, 124 patients across three hospitals in Japan were tested using a tentative scale. As a result of exploratory factor analysis, we identified 25 items based on five conceptually derived dimensions (psychological stability, trust in healthcare resources, satisfaction with the decision-making process, positive perception of self-management, and confidence in UIA knowledge) as a final psychosocial well-being scale for UIA patients (UIA-PW scale). Cronbach's alpha coefficients for each subscale ranged between .76 and .90, with .83 for the total score, which indicated satisfactory internal consistency. The total score for the UIA-PW scale correlated significantly with the existing quality of life and mental health scales, but it is important to note that psychological stability and positive perception of self-management were negatively correlated. Although additional investigation is needed, the UIA-PW scale shows reasonable validity and reliability in assessing psychosocial well-being of patients living with UIA.

Pressure ulcers: development and psychometric evaluation of the attitude towards pressure ulcer prevention instrument (APuP).

PubMed

Beeckman, D; Defloor, T; Demarré, L; Van Hecke, A; Vanderwee, K

2010-11-01

Pressure ulcers continue to be a significant problem in hospitals, nursing homes and community care settings. Pressure ulcer incidence is widely accepted as an indicator for the quality of care. Negative attitudes towards pressure ulcer prevention may result in suboptimal preventive care. A reliable and valid instrument to assess attitudes towards pressure ulcer prevention is lacking. Development and psychometric evaluation of the Attitude towards Pressure ulcer Prevention instrument (APuP). Prospective psychometric instrument validation study. A literature review was performed to design the instrument. Content validity was evaluated by nine European pressure ulcer experts and five experts in psychometric instrument validation in a double Delphi procedure. A convenience sample of 258 nurses and 291 nursing students from Belgium and The Netherlands participated in order to evaluate construct validity and stability reliability of the instrument. The data were collected between February and May 2008. A factor analysis indicated the construct of a 13 item instrument in a five factor solution: (1) attitude towards personal competency to prevent pressure ulcers (three items); (2) attitude towards the priority of pressure ulcer prevention (three items); (3) attitude towards the impact of pressure ulcers (three items); (4) attitude towards personal responsibility in pressure ulcer prevention (two items); and (5) attitude towards confidence in the effectiveness of prevention (two items). This five factor solution accounted for 61.4% of the variance in responses related to attitudes towards pressure ulcer prevention. All items demonstrated factor loadings over 0.60. The instrument produced similar results during stability testing [ICC=0.88 (95% CI=0.84-0.91, P<0.001)]. For the total instrument, the internal consistency (Cronbachs alpha) was 0.79. The APuP is a psychometrically sound instrument that can be used to effectively assess attitudes towards pressure ulcer prevention in patient care, education, and research. In further research, the association between attitude, knowledge and clinical performance should be explored. Copyright 2010 Elsevier Ltd. All rights reserved.

A Study of Method Development, Validation, and Forced Degradation for Simultaneous Quantification of Paracetamol and Ibuprofen in Pharmaceutical Dosage Form by RP-HPLC Method

PubMed Central

Jahan, Md. Sarowar; Islam, Md. Jahirul; Begum, Rehana; Kayesh, Ruhul; Rahman, Asma

2014-01-01

A rapid and stability-indicating reversed phase high-performance liquid chromatography (RP-HPLC) method was developed for simultaneous quantification of paracetamol and ibuprofen in their combined dosage form especially to get some more advantages over other methods already developed for this combination. The method was validated according to United States Pharmacopeia (USP) guideline with respect to accuracy, precision, specificity, linearity, solution stability, robustness, sensitivity, and system suitability. Forced degradation study was validated according to International Conference on Harmonisation (ICH). For this, an isocratic condition of mobile phase comprising phosphate buffer (pH 6.8) and acetonitrile in a ratio of 65:35, v/v at a flow rate of 0.7 mL/minute over RP C18 (octadecylsilane (ODS), 150 × 4.6 mm, 5 μm, Phenomenex Inc.) column at ambient temperature was maintained. The method showed excellent linear response with correlation coefficient (R2) values of 0.999 and 1.0 for paracetamol and ibuprofen respectively, which were within the limit of correlation coefficient (R2 > 0.995). The percent recoveries for two drugs were found within the acceptance limit of (97.0–103.0%). Intra-and inter-day precision studies of the new method were less than the maximum allowable limit percentage of relative standard deviation (%RSD) ≤ 2.0. Forced degradation of the drug product was carried out as per the ICH guidelines with a view to establishing the stability-indicating property of this method and providing useful information about the degradation pathways, degradation products, and how the quality of a drug substance and drug product changes with time under the influence of various stressing conditions. The degradation of ibuprofen was within the limit (5–20%, according to the guideline of ICH), while paracetamol showed <20% degradation in oxidation and basic condition. PMID:25452691

A Study of Method Development, Validation, and Forced Degradation for Simultaneous Quantification of Paracetamol and Ibuprofen in Pharmaceutical Dosage Form by RP-HPLC Method.

PubMed

Jahan, Md Sarowar; Islam, Md Jahirul; Begum, Rehana; Kayesh, Ruhul; Rahman, Asma

2014-01-01

A rapid and stability-indicating reversed phase high-performance liquid chromatography (RP-HPLC) method was developed for simultaneous quantification of paracetamol and ibuprofen in their combined dosage form especially to get some more advantages over other methods already developed for this combination. The method was validated according to United States Pharmacopeia (USP) guideline with respect to accuracy, precision, specificity, linearity, solution stability, robustness, sensitivity, and system suitability. Forced degradation study was validated according to International Conference on Harmonisation (ICH). For this, an isocratic condition of mobile phase comprising phosphate buffer (pH 6.8) and acetonitrile in a ratio of 65:35, v/v at a flow rate of 0.7 mL/minute over RP C18 (octadecylsilane (ODS), 150 × 4.6 mm, 5 μm, Phenomenex Inc.) column at ambient temperature was maintained. The method showed excellent linear response with correlation coefficient (R (2)) values of 0.999 and 1.0 for paracetamol and ibuprofen respectively, which were within the limit of correlation coefficient (R (2) > 0.995). The percent recoveries for two drugs were found within the acceptance limit of (97.0-103.0%). Intra-and inter-day precision studies of the new method were less than the maximum allowable limit percentage of relative standard deviation (%RSD) ≤ 2.0. Forced degradation of the drug product was carried out as per the ICH guidelines with a view to establishing the stability-indicating property of this method and providing useful information about the degradation pathways, degradation products, and how the quality of a drug substance and drug product changes with time under the influence of various stressing conditions. The degradation of ibuprofen was within the limit (5-20%, according to the guideline of ICH), while paracetamol showed <20% degradation in oxidation and basic condition.

Stability indicating validated HPLC method for quantification of levothyroxine with eight degradation peaks in the presence of excipients.

PubMed

Shah, R B; Bryant, A; Collier, J; Habib, M J; Khan, M A

2008-08-06

A simple, sensitive, accurate, and robust stability indicating analytical method is presented for identification, separation, and quantitation of l-thyroxine and eight degradation impurities with an internal standard. The method was used in the presence of commonly used formulation excipients such as butylated hydroxyanisole, povidone, crospovidone, croscarmellose sodium, mannitol, sucrose, acacia, lactose monohydrate, confectionary sugar, microcrystalline cellulose, sodium laurel sulfate, magnesium stearate, talc, and silicon dioxide. The two active thyroid hormones: 3,3',5,5'-tetra-iodo-l-thyronine (l-thyroxine-T4) and 3,3',5-tri-iodo-l-thyronine (T3) and degradation products including di-iodothyronine (T2), thyronine (T0), tyrosine (Tyr), di-iodotyrosine (DIT), mono-iodotyrosine (MIT), 3,3',5,5'-tetra-iodothyroacetic acid (T4AA) and 3,3',5-tri-iodothyroacetic acid (T3AA) were assayed by the current method. The separation of l-thyroxine and eight metabolites along with theophylline (internal standard) was achieved using a C18 column (25 degrees C) with a mobile phase of trifluoroacetic acid (0.1%, v/v, pH 3)-acetonitrile in gradient elution at 0.8 ml/min at 223 nm. The sample diluent was 0.01 M methanolic NaOH. Method was validated according to FDA, USP, and ICH guidelines for inter-day accuracy, precision, and robustness after checking performance with system suitability. Tyr (4.97 min), theophylline (9.09 min), MIT (9.55 min), DIT (11.37 min), T0 (11.63 min), T2 (14.47 min), T3 (16.29 min), T4 (17.60 min), T3AA (22.71 min), and T4AA (24.83 min) separated in a single chromatographic run. Linear relationship (r2>0.99) was observed between the peak area ratio and the concentrations for all of the compounds within the range of 2-20 microg/ml. The total time for analysis, equilibration and recovery was 40 min. The method was shown to separate well from commonly employed formulation excipients. Accuracy ranged from 95 to 105% for T4 and 90 to 110% for all other compounds. Precision was <2% for all the compounds. The method was found to be robust with minor changes in injection volume, flow rate, column temperature, and gradient ratio. Validation results indicated that the method shows satisfactory linearity, precision, accuracy, and ruggedness and also stress degradation studies indicated that the method can be used as stability indicating method for l-thyroxine in the presence of excipients.

Fractional Stability of Trunk Acceleration Dynamics of Daily-Life Walking: Toward a Unified Concept of Gait Stability

PubMed Central

Ihlen, Espen A. F.; van Schooten, Kimberley S.; Bruijn, Sjoerd M.; Pijnappels, Mirjam; van Dieën, Jaap H.

2017-01-01

Over the last decades, various measures have been introduced to assess stability during walking. All of these measures assume that gait stability may be equated with exponential stability, where dynamic stability is quantified by a Floquet multiplier or Lyapunov exponent. These specific constructs of dynamic stability assume that the gait dynamics are time independent and without phase transitions. In this case the temporal change in distance, d(t), between neighboring trajectories in state space is assumed to be an exponential function of time. However, results from walking models and empirical studies show that the assumptions of exponential stability break down in the vicinity of phase transitions that are present in each step cycle. Here we apply a general non-exponential construct of gait stability, called fractional stability, which can define dynamic stability in the presence of phase transitions. Fractional stability employs the fractional indices, α and β, of differential operator which allow modeling of singularities in d(t) that cannot be captured by exponential stability. The fractional stability provided an improved fit of d(t) compared to exponential stability when applied to trunk accelerations during daily-life walking in community-dwelling older adults. Moreover, using multivariate empirical mode decomposition surrogates, we found that the singularities in d(t), which were well modeled by fractional stability, are created by phase-dependent modulation of gait. The new construct of fractional stability may represent a physiologically more valid concept of stability in vicinity of phase transitions and may thus pave the way for a more unified concept of gait stability. PMID:28900400

Influence of sodium metabisulfite and glutathione on the stability of vitamin C in O/W emulsion and extemporaneous aqueous gel.

PubMed

Maia, Adriana M; Baby, André Rolim; Pinto, Claudinéia A S O; Yasaka, Wilson J; Suenaga, Eunice; Kaneko, Telma M; Velasco, Maria Valéria Robles

2006-09-28

Vitamin C exerts several functions on skin as collagen synthesis, depigmentant and antioxidant activity. Vitamin C is unstable in the presence of oxygen, luminosity, humidity, high temperatures and heavy metals, which presents a significant challenge to the development of cosmetic formulations. Therefore, the utilization of an effective antioxidant system is required to maintain the vitamin C stability. The purpose of this research work was to develop prototypes of cosmetic formulations, as O/W emulsion and extemporaneous aqueous gel, containing vitamin C and to evaluate the influence of sodium metabisulfite (SMB) and glutathione (GLT), as antioxidants, on the stability of the active substance. A HPLC stability-indicating method was developed and validated for this study and stability assays were performed in 90 and 26 days and storage conditions were 5.0+/-0.5, 24+/-2 and 40.0+/-0.5 degrees C. The HPLC stability-indicating method showed linearity (r(2)>0.99), specificity, R.S.D.<1.22% and accuracy/recovery ranging from 95.46 to 101.54%. Preparations with SMB or GLT and the antioxidant-free presented results statistically distinct, demonstrating the necessity of the antioxidant system addition. O/W emulsions with SMB or GLT retained the vitamin C content >90.38% stored at 5.0+/-0.5 and 24+/-2 degrees C. For the aqueous gel with SMB or GLT, the active substance concentration was maintained >94.03%. Considering the vitamin C stability, the SMB and the GLT showed to be statistically adequate, as antioxidants, for the cosmetic formulations.

Climate Change, State Stability, and Political Risk in Africa

DTIC Science & Technology

2016-09-30

instructions , searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information ...with a collection of information if it does not display a currently valid OMB control number. PLEASE DO NOT RETURN YOUR FORM TO THE ABOVE ADDRESS...model. For a number of indicators, particularly in the household and community resilience basket, data from the USAID Demographic and Health Surveys

Validation of a Stability-Indicating Method for Methylseleno-L-Cysteine (L-SeMC).

PubMed

Canady, Kristin; Cobb, Johnathan; Deardorff, Peter; Larson, Jami; White, Jonathan M; Boring, Dan

2016-01-01

Methylseleno-L-cysteine (L-SeMC) is a naturally occurring amino acid analogue used as a general dietary supplement and is being explored as a chemopreventive agent. As a known dietary supplement, L-SeMC is not regulated as a pharmaceutical and there is a paucity of analytical methods available. To address the lack of methodology, a stability-indicating method was developed and validated to evaluate L-SeMC as both the bulk drug and formulated drug product (400 µg Se/capsule). The analytical approach presented is a simple, nonderivatization method that utilizes HPLC with ultraviolet detection at 220 nm. A C18 column with a volatile ion-pair agent and methanol mobile phase was used for the separation. The method accuracy was 99-100% from 0.05 to 0.15 mg/mL L-SeMC for the bulk drug, and 98-99% from 0.075 to 0.15 mg/mL L-SeMC for the drug product. Method precision was <1% for the bulk drug and was 3% for the drug product. The LOQ was 0.1 µg/mL L-SeMC or 0.002 µg L-SeMC on column. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Spectrofluorimetric methods of stability-indicating assay of certain drugs affecting the cardiovascular system

NASA Astrophysics Data System (ADS)

Moussa, B. A.; Mohamed, M. F.; Youssef, N. F.

2011-01-01

Two stability-indicating spectrofluorimetric methods have been developed for the determination of ezetimibe and olmesartan medoxomil, drugs affecting the cardiovascular system, and validated in the presence of their degradation products. The first method, for ezetimibe, is based on an oxidative coupling reaction of ezetimibe with 3-methylbenzothiazolin-2-one hydrazone hydrochloride in the presence of cerium (IV) ammonium sulfate in an acidic medium. The quenching effect of ezetimibe on the fluorescence of excess cerous ions is measured at the emission wavelength, λem, of 345 nm with the excitation wavelength, λex, of 296 nm. Factors affecting the reaction were carefully studied and optimized. The second method, for olmesartan medoxomil, is based on measuring the native fluorescence intensity of olmesartan medoxomil in methanol at λem = 360 nm with λex = 286 nm. Regression plots revealed good linear relationships in the assay limits of 10-120 and 8-112 g/ml for ezetimibe and olmesartan medoxomil, respectively. The validity of the methods was assessed according to the United States Pharmacopeya guidelines. Statistical analysis of the results exposed good Student's t-test and F-ratio values. The introduced methods were successfully applied to the analysis of ezetimibe and olmesartan medoxomil in drug substances and drug products as well as in the presence of their degradation products.

Concurrent Validation of the Clinical Opiate Withdrawal Scale (COWS) and Single-Item Indices against the Clinical Institute Narcotic Assessment (CINA) Opioid Withdrawal Instrument

PubMed Central

Tompkins, D. Andrew; Bigelow, George E.; Harrison, Joseph A.; Johnson, Rolley E.; Fudala, Paul J.; Strain, Eric C.

2009-01-01

Introduction The Clinical Opiate Withdrawal Scale (COWS) is an 11-item clinician-administered scale assessing opioid withdrawal. Though commonly used in clinical practice, it has not been systematically validated. The present study validated the COWS in comparison to the validated Clinical Institute Narcotic Assessment (CINA) scale. Method Opioid-dependent volunteers were enrolled in a residential trial and stabilized on morphine 30 mg given subcutaneously four times daily. Subjects then underwent double-blind, randomized challenges of intramuscularly administered placebo and naloxone (0.4 mg) on separate days, during which the COWS, CINA, and visual analog scale (VAS) assessments were concurrently obtained. Subjects completing both challenges were included (N=46). Correlations between mean peak COWS and CINA scores as well as self-report VAS questions were calculated. Results Mean peak COWS and CINA scores of 7.6 and 24.4, respectively, occurred on average 30 minutes post-injection of naloxone. Mean COWS and CINA scores 30 minutes after placebo injection were 1.3 and 18.9, respectively. The Pearson correlation coefficient for peak COWS and CINA scores during the naloxone challenge session was 0.85 (p<0.001). Peak COWS scores also correlated well with peak VAS self-report scores of bad drug effect (r=0.57, p<0.001) and feeling sick (r=0.57, p<0.001), providing additional evidence of concurrent validity. Placebo was not associated with any significant elevation of COWS, CINA, or VAS scores, indicating discriminant validity. Cronbach’s alpha for the COWS was 0.78, indicating good internal consistency (reliability). Discussion COWS, CINA, and certain VAS items are all valid measurement tools for acute opiate withdrawal. PMID:19647958

Cognitive vulnerability to depression during middle childhood: Stability and associations with maternal affective styles and parental depression

PubMed Central

Hayden, Elizabeth P.; Olino, Thomas M.; Mackrell, Sarah V.M.; Jordan, Patricia L.; Desjardins, Jasmine; Katsiroumbas, Patrice

2014-01-01

Theories of cognitive vulnerability to depression (CVD) imply that CVD is early-emerging and trait-like; however, little longitudinal work has tested this premise in middle childhood, or examined theoretically relevant predictors of child CVD. We examined test–retest correlations of self-referent encoding task performance and self-reported attributional styles and their associations with parental characteristics in 205 seven-year-olds. At baseline, child CVD was assessed, structured clinical interviews were conducted with parents, and ratings of observed maternal affective styles were made. Children’s CVD was re-assessed approximately one and two years later. Both measures of children’s CVD were prospectively and concurrently associated with children’s depressive symptoms and showed modest stability. Multilevel modeling indicated that maternal criticism and paternal depression were related to children’s CVD. Findings indicate that even early-emerging CVD is a valid marker of children’s depression risk. PMID:25392596

Validation of the measure automobile emissions model : a statistical analysis

DOT National Transportation Integrated Search

2000-09-01

The Mobile Emissions Assessment System for Urban and Regional Evaluation (MEASURE) model provides an external validation capability for hot stabilized option; the model is one of several new modal emissions models designed to predict hot stabilized e...

Longitudinal data analysis in support of functional stability concepts for leachate management at closed municipal landfills.

PubMed

Gibbons, Robert D; Morris, Jeremy W F; Prucha, Christopher P; Caldwell, Michael D; Staley, Bryan F

2014-09-01

Landfill functional stability provides a target that supports no environmental threat at the relevant point of exposure in the absence of active control systems. With respect to leachate management, this study investigates "gateway" indicators for functional stability in terms of the predictability of leachate characteristics, and thus potential threat to water quality posed by leachate emissions. Historical studies conducted on changes in municipal solid waste (MSW) leachate concentrations over time (longitudinal analysis) have concentrated on indicator compounds, primarily chemical oxygen demand (COD) and biochemical oxygen demand (BOD). However, validation of these studies using an expanded database and larger constituent sets has not been performed. This study evaluated leachate data using a mixed-effects regression model to determine the extent to which leachate constituent degradation can be predicted based on waste age or operational practices. The final dataset analyzed consisted of a total of 1402 samples from 101 MSW landfills. Results from the study indicated that all leachate constituents exhibit a decreasing trend with time in the post-closure period, with 16 of the 25 target analytes and aggregate classes exhibiting a statistically significant trend consistent with well-studied indicators such as BOD. Decreasing trends in BOD concentration after landfill closure can thus be considered representative of trends for many leachate constituents of concern. Copyright © 2014 Elsevier Ltd. All rights reserved.

Quality of prenatal care questionnaire: instrument development and testing.

PubMed

Heaman, Maureen I; Sword, Wendy A; Akhtar-Danesh, Noori; Bradford, Amanda; Tough, Suzanne; Janssen, Patricia A; Young, David C; Kingston, Dawn A; Hutton, Eileen K; Helewa, Michael E

2014-06-03

Utilization indices exist to measure quantity of prenatal care, but currently there is no published instrument to assess quality of prenatal care. The purpose of this study was to develop and test a new instrument, the Quality of Prenatal Care Questionnaire (QPCQ). Data for this instrument development study were collected in five Canadian cities. Items for the QPCQ were generated through interviews with 40 pregnant women and 40 health care providers and a review of prenatal care guidelines, followed by assessment of content validity and rating of importance of items. The preliminary 100-item QPCQ was administered to 422 postpartum women to conduct item reduction using exploratory factor analysis. The final 46-item version of the QPCQ was then administered to another 422 postpartum women to establish its construct validity, and internal consistency and test-retest reliability. Exploratory factor analysis reduced the QPCQ to 46 items, factored into 6 subscales, which subsequently were validated by confirmatory factor analysis. Construct validity was also demonstrated using a hypothesis testing approach; there was a significant positive association between women's ratings of the quality of prenatal care and their satisfaction with care (r = 0.81). Convergent validity was demonstrated by a significant positive correlation (r = 0.63) between the "Support and Respect" subscale of the QPCQ and the "Respectfulness/Emotional Support" subscale of the Prenatal Interpersonal Processes of Care instrument. The overall QPCQ had acceptable internal consistency reliability (Cronbach's alpha = 0.96), as did each of the subscales. The test-retest reliability result (Intra-class correlation coefficient = 0.88) indicated stability of the instrument on repeat administration approximately one week later. Temporal stability testing confirmed that women's ratings of their quality of prenatal care did not change as a result of giving birth or between the early postpartum period and 4 to 6 weeks postpartum. The QPCQ is a valid and reliable instrument that will be useful in future research as an outcome measure to compare quality of care across geographic regions, populations, and service delivery models, and to assess the relationship between quality of care and maternal and infant health outcomes.

Development and validation of a stability-indicating high performance liquid chromatographic assay for benoxinate.

PubMed

Chorny, Michael; Levy, Daniel; Schumacher, Ilana; Lichaa, Chaim; Gruzman, Boris; Livshits, Oleg; Lomnicky, Yossi

2003-04-24

Benoxinate is a local anaesthetic used for ophthalmic applications. The aim of this study was to develop a rapid and simple stability-indicating method for the determination of benoxinate formulated for ophthalmic use, evaluate its long-term stability and identify its major degradation product. Benoxinate was eluted on a 10 microm Spherisorb phenyl column, 250 x 3.2 mm, with a mobile phase consisting of acetonitrile-buffer (pH 3.5) (35:65, v/v), pumped at 0.8 ml min(-1) flow rate. The buffer was composed of sodium dihydrogen phosphate (50 mM), sodium hydrogen sulfate (2.5 mM) and 1-heptanesulfonic acid sodium salt (5 mM). The analyte was quantified spectrophotometrically at 308 nm. The chromatograms of benoxinate formulations obtained by this method showed benoxinate (t = 4.5 min) well resolved from its degradation product (t = 2.3 min), which was separately identified by means of HPLC-MS as 4-amino-3-butoxybenzoic acid. The assay was demonstrated to have high accuracy, precision and linearity. The method was implemented in investigating the long-term stability of benoxinate 0.4% ophthalmic solutions. The method was found to be simple, quick and selective in determining benoxinate concentrations in fresh and aged preparations.

Development and validation of a rapid stability indicating HPLC-method using monolithic stationary phase and two spectrophotometric methods for determination of antihistaminic acrivastine in capsules

NASA Astrophysics Data System (ADS)

Gouda, Ayman A.; Hashem, Hisham; Jira, Thomas

2014-09-01

Simple, rapid and accurate high performance liquid chromatographic (HPLC) and spectrophotometric methods are described for determination of antihistaminic acrivastine in capsules. The first method (method A) is based on accurate, sensitive and stability indicating chromatographic separation method. Chromolith® Performance RP-18e column, a relatively new packing material consisting of monolithic rods of highly porous silica, was used as stationary phase applying isocratic binary mobile phase of ACN and 25 mM NaH2PO4 pH 4.0 in the ratio of 22.5:77.5 at flow rate of 5.0 mL/min and 40 °C. A diode array detector was used at 254 nm for detection. The elution time of acrivastine was found to be 2.080 ± 0.032. The second and third methods (methods B and C) are based on the oxidation of acrivastine with excess N-bromosuccinimide (NBS) and determination of the unconsumed NBS with, metol-sulphanilic acid (λmax: 520 nm) or amaranth dye (λmax: 530 nm). The reacted oxidant corresponds to the drug content. Beer’s law is obeyed over the concentration range 1.563-50, 2.0-20 and 1.0-10 μg mL-1 for methods A, B and C, respectively. The limits of detection and quantitation were 0.40, 0.292 and 0.113 μg mL-1 and 0.782, 0.973 and 0.376 μg mL-1 for methods A, B and C, respectively. The HPLC method was validated for system suitability, linearity, precision, limits of detection and quantitation, specificity, stability and robustness. Stability tests were done through exposure of the analyte solution for four different stress conditions and the results indicate no interference of degradants with HPLC-method. The proposed methods was favorably applied for determination of acrivastine in capsules formulation. Statistical comparison of the obtained results from the analysis of the studied drug to those of the reported method using t- and F-tests showed no significant difference between them.

Pitching stability analysis of half-rotating wing air vehicle

NASA Astrophysics Data System (ADS)

Wang, Xiaoyi; Wu, Yang; Li, Qian; Li, Congmin; Qiu, Zhizhen

2017-06-01

Half-Rotating Wing (HRW) is a new power wing which had been developed by our work team using rotating-type flapping instead of oscillating-type flapping. Half-Rotating Wing Air Vehicle (HRWAV) is similar as Bionic Flapping Wing Air Vehicle (BFWAV). It is necessary to guarantee pitching stability of HRWAV to maintain flight stability. The working principle of HRW was firstly introduced in this paper. The rule of motion indicated that the fuselage of HRWAV without empennage would overturn forward as it generated increased pitching movement. Therefore, the empennage was added on the tail of HRWAV to balance the additional moment generated by aerodynamic force during flight. The stability analysis further shows that empennage could weaken rapidly the pitching disturbance on HRWAV and a new balance of fuselage could be achieved in a short time. Case study using numerical analysis verified correctness and validity of research results mentioned above, which could provide theoretical guidance to design and control HRWAV.

Primary Stability Recognition of the Newly Designed Cementless Femoral Stem Using Digital Signal Processing

PubMed Central

Salleh, Sh-Hussain; Hamedi, Mahyar; Zulkifly, Ahmad Hafiz; Lee, Muhammad Hisyam; Mohd Noor, Alias; Harris, Arief Ruhullah A.; Abdul Majid, Norazman

2014-01-01

Stress shielding and micromotion are two major issues which determine the success of newly designed cementless femoral stems. The correlation of experimental validation with finite element analysis (FEA) is commonly used to evaluate the stress distribution and fixation stability of the stem within the femoral canal. This paper focused on the applications of feature extraction and pattern recognition using support vector machine (SVM) to determine the primary stability of the implant. We measured strain with triaxial rosette at the metaphyseal region and micromotion with linear variable direct transducer proximally and distally using composite femora. The root mean squares technique is used to feed the classifier which provides maximum likelihood estimation of amplitude, and radial basis function is used as the kernel parameter which mapped the datasets into separable hyperplanes. The results showed 100% pattern recognition accuracy using SVM for both strain and micromotion. This indicates that DSP could be applied in determining the femoral stem primary stability with high pattern recognition accuracy in biomechanical testing. PMID:24800230

Primary stability recognition of the newly designed cementless femoral stem using digital signal processing.

PubMed

Baharuddin, Mohd Yusof; Salleh, Sh-Hussain; Hamedi, Mahyar; Zulkifly, Ahmad Hafiz; Lee, Muhammad Hisyam; Mohd Noor, Alias; Harris, Arief Ruhullah A; Abdul Majid, Norazman

2014-01-01

Stress shielding and micromotion are two major issues which determine the success of newly designed cementless femoral stems. The correlation of experimental validation with finite element analysis (FEA) is commonly used to evaluate the stress distribution and fixation stability of the stem within the femoral canal. This paper focused on the applications of feature extraction and pattern recognition using support vector machine (SVM) to determine the primary stability of the implant. We measured strain with triaxial rosette at the metaphyseal region and micromotion with linear variable direct transducer proximally and distally using composite femora. The root mean squares technique is used to feed the classifier which provides maximum likelihood estimation of amplitude, and radial basis function is used as the kernel parameter which mapped the datasets into separable hyperplanes. The results showed 100% pattern recognition accuracy using SVM for both strain and micromotion. This indicates that DSP could be applied in determining the femoral stem primary stability with high pattern recognition accuracy in biomechanical testing.

Stability-indicating UPLC method for determination of Valsartan and their degradation products in active pharmaceutical ingredient and pharmaceutical dosage forms.

PubMed

Krishnaiah, Ch; Reddy, A Raghupathi; Kumar, Ramesh; Mukkanti, K

2010-11-02

A simple, precise, accurate stability-indicating gradient reverse phase ultra-performance liquid chromatographic (RP-UPLC) method was developed for the quantitative determination of purity of Valsartan drug substance and drug products in bulk samples and pharmaceutical dosage forms in the presence of its impurities and degradation products. The method was developed using Waters Aquity BEH C18 (100 mm x 2.1 mm, 1.7 microm) column with mobile phase containing a gradient mixture of solvents A and B. The eluted compounds were monitored at 225 nm, the run time was within 9.5 min, which Valsartan and its seven impurities were well separated. Valsartan was subjected to the stress conditions of oxidative, acid, base, hydrolytic, thermal and photolytic degradation. Valsartan was found to degrade significantly in acid and oxidative stress conditions and stable in base, hydrolytic and photolytic degradation conditions. The degradation products were well resolved from main peak and its impurities, proving the stability-indicating power of the method. The developed method was validated as per international conference on harmonization (ICH) guidelines with respect to specificity, linearity, limit of detection, limit of quantification, accuracy, precision and robustness. This method was also suitable for the assay determination of Valsartan in pharmaceutical dosage forms.

Development and Validation of a Stability-Indicating RP-HPLC Method for Duloxetine Hydrochloride in its Bulk and Tablet Dosage Form

PubMed Central

Chhalotiya, Usmangani K.; Bhatt, Kashyap K.; Shah, Dimal A.; Baldania, Sunil L.

2010-01-01

The objective of the present work was to develop a stability-indicating RP-HPLC method for duloxetine hydrochloride (DUL) in the presence of its degradation products generated from forced decomposition studies. The drug substance was found to be susceptible to stress conditions of acid hydrolysis. The drug was found to be stable to dry heat, photodegradation, oxidation and basic condition attempted. Successful separation of the drug from the degradation products formed under acidic stress conditions was achieved on a Hypersil C-18 column (250 mm × 4.6 mm id, 5μm particle size) using acetonitrile: 0.01 M potassium dihydrogen phosphate buffer (pH 5.4 adjusted with orthophosphoric acid) (50:50, v/v) as the mobile phase at a flow rate of 1.0 ml/min. Quantification was achieved with photodiode array detection at 229 nm over the concentration range 1–25 μg/ml with range of recovery 99.8–101.3 % for DUL by the RP-HPLC method. Statistical analysis proved the method to be repeatable, specific, and accurate for estimation of DUL. It can be used as a stability-indicating method due to its effective separation of the drug from its degradation products, PMID:21179321

Experimental and theoretical investigations on the validity of the geometrical optics model for calculating the stability of optical traps.

PubMed

Schut, T C; Hesselink, G; de Grooth, B G; Greve, J

1991-01-01

We have developed a computer program based on the geometrical optics approach proposed by Roosen to calculate the forces on dielectric spheres in focused laser beams. We have explicitly taken into account the polarization of the laser light and thd divergence of the laser beam. The model can be used to evaluate the stability of optical traps in a variety of different optical configurations. Our calculations explain the experimental observation by Ashkin that a stable single-beam optical trap, without the help of the gravitation force, can be obtained with a strongly divergent laser beam. Our calculations also predict a different trap stability in the directions orthogonal and parallel to the polarization direction of the incident light. Different experimental methods were used to test the predictions of the model for the gravity trap. A new method for measuring the radiation force along the beam axis in both the stable and instable regions is presented. Measurements of the radiation force on polystyrene spheres with diameters of 7.5 and 32 microns in a TEM00-mode laser beam showed a good qualitative correlation with the predictions and a slight quantitative difference. The validity of the geometrical approximations involved in the model will be discussed for spheres of different sizes and refractive indices.

Validity and reliability of the Diagnostic Adaptive Behaviour Scale.

PubMed

Tassé, M J; Schalock, R L; Balboni, G; Spreat, S; Navas, P

2016-01-01

The Diagnostic Adaptive Behaviour Scale (DABS) is a new standardised adaptive behaviour measure that provides information for evaluating limitations in adaptive behaviour for the purpose of determining a diagnosis of intellectual disability. This article presents validity evidence and reliability data for the DABS. Validity evidence was based on comparing DABS scores with scores obtained on the Vineland Adaptive Behaviour Scale, second edition. The stability of the test scores was measured using a test and retest, and inter-rater reliability was assessed by computing the inter-respondent concordance. The DABS convergent validity coefficients ranged from 0.70 to 0.84, while the test-retest reliability coefficients ranged from 0.78 to 0.95, and the inter-rater concordance as measured by intraclass correlation coefficients ranged from 0.61 to 0.87. All obtained validity and reliability indicators were strong and comparable with the validity and reliability coefficients of the most commonly used adaptive behaviour instruments. These results and the advantages of the DABS for clinician and researcher use are discussed. © 2015 MENCAP and International Association of the Scientific Study of Intellectual and Developmental Disabilities and John Wiley & Sons Ltd.

Healing of voids in the aluminum metallization of integrated circuit chips

NASA Technical Reports Server (NTRS)

Cuddihy, Edward F.; Lawton, Russell A.; Gavin, Thomas R.

1990-01-01

The thermal stability of GaAs modulation-doped field effect transistors (MODFETs) is evaluated in order to identify failure mechanisms and validate the reliability of these devices. The transistors were exposed to thermal step-stress and characterized at ambient temperatures to indicate device reliability, especially that of the transistor ohmic contacts with and without molybdenum diffusion barriers. The devices without molybdenum exhibited important transconductance deterioration. MODFETs with molybdenum diffusion barriers were tolerant to temperatures above 300 C. This tolerance indicates that thermally activated failure mechanisms are slow at operational temperatures. Therefore, high-reliability MODFET-based circuits are possible.

The electromagnetic environment in CFC structures

NASA Technical Reports Server (NTRS)

Hardwick, C. J.; Haigh, S. J.

1991-01-01

Extensive measurements of induced voltages and currents were made using a CFC (carbon fiber composites) horizontal stabilizer from the A320 as a test bed. The work was done to investigate the efficacy of various protection schemes to reduce the magnitudes of the induced voltages and validate a computer program INDCAL. Results indicate that a good understanding of the various induced voltage mechanisms including the long wave effect due to current redistribution was obtained.

Resilience in a reborn nation: Validation of the Lithuanian Resilience Scale for Adults (RSA).

PubMed

Hilbig, Jan; Viliūnienė, Rima; Friborg, Oddgeir; Pakalniškienė, Vilmantė; Danilevičiūtė, Vita

2015-07-01

Resilience, as an ability to withstand or rebound from crisis or adversity, is becoming an increasingly significant concept in health promotion and well-being. Individuals exhibiting resilience use skills or resources flexibly to solve situational demands. The Resilience Scale for Adults (RSA) may be used to assess protective resources, and the aim of the present study was to validate the Lithuanian translation. The translated RSA was administered to a clinical (n=125) and a non clinical sample (n=499) to examine the discriminant validity of the RSA items with a confirmatory factor analysis, the internal consistency as well as construct validity by correlating it with the Quick Psycho-Affective Symptoms Scan (QPASS). The internal consistency, the test-retest stability and the factor structure were replicated as adequate, thus indicating good psychometric properties and support of discriminant validity. Females reported more resilience resources for the domains of social competence, family cohesion and social resources compared to men. The RSA subscales correlated negatively with the QPASS scores, and patients reported significantly less resilience resources than non-patients, thus indicating construct validity. Valid psychometric tools for research purposes and routine every-day use are urgently needed in Lithuania, a young nation still under numerous challenges due to social, economic and political transitions. The RSA represents a reliable and valid tool for assessing protective factors. Assessing resilience factors may extend the understanding of factors relevant for mental health problems as well as treatment prognosis beyond the capabilities of mere symptom oriented approaches. Copyright © 2015 Elsevier Inc. All rights reserved.

Validation of the solidifying soil process using laser-induced breakdown spectroscopy

NASA Astrophysics Data System (ADS)

Lin, Zhao-Xiang; Liu, Lin-Mei; Liu, Lu-Wen

2016-09-01

Although an Ionic Soil Stabilizer (ISS) has been widely used in landslide control, it is desirable to effectively monitor the stabilization process. With the application of laser-induced breakdown spectroscopy (LIBS), the ion contents of K, Ca, Na, Mg, Al, and Si in the permeable fluid are detected after the solidified soil samples have been permeated. The processes of the Ca ion exchange are analyzed at pressures of 2 and 3 atm, and it was determined that the cation exchanged faster as the pressure increased. The Ca ion exchanges were monitored for different stabilizer mixtures, and it was found that a ratio of 1:200 of ISS to soil is most effective. The investigated plasticity and liquidity indexes also showed that the 1:200 ratio delivers the best performance. The research work indicates that it is possible to evaluate the engineering performances of soil solidified by ISS in real time and online by LIBS.

Stability characterization and modeling of robust distributed benthic microbial fuel cell (DBMFC) system.

PubMed

Karra, Udayarka; Huang, Guoxian; Umaz, Ridvan; Tenaglier, Christopher; Wang, Lei; Li, Baikun

2013-09-01

A novel and robust distributed benthic microbial fuel cell (DBMFC) was developed to address the energy supply issues for oceanographic sensor network applications, especially under scouring and bioturbation by aquatic life. Multi-anode/cathode configuration was employed in the DBMFC system for enhanced robustness and stability in the harsh ocean environment. The results showed that the DBMFC system achieved peak power and current densities of 190mW/m(2) and 125mA/m(2) respectively. Stability characterization tests indicated the DBMFC with multiple anodes achieved higher power generation over the systems with single anode. A computational model that integrated physical, electrochemical and biological factors of MFCs was developed to validate the overall performance of the DBMFC system. The model simulation well corresponded with the experimental results, and confirmed the hypothesis that using a multi anode/cathode MFC configuration results in reliable and robust power generation. Published by Elsevier Ltd.

The Rosenberg Self-Esteem Scale: translation and validation in university students.

PubMed

Martín-Albo, José; Núñiez, Juan L; Navarro, José G; Grijalvo, Fernando

2007-11-01

The aim of this study was to translate into Spanish and to validate the Rosenberg Self-Esteem Scale (RSES), completed by 420 university students. Confirmatory factor analysis revealed that the model that best fit the data, both in the total sample and in the male and female subsamples, was the one-factor structure with method effects associated with positively worded items. The results indicated high, positive correlations between self-esteem and the five dimensions of self-concept. The scale showed satisfactory levels of internal consistency and temporal stability over a four-week period. Lastly, gender differences were obtained. These findings support the use of the RSES for the assessment of self-esteem in higher education.

Post-Flash Validation of the new ACS/WFC Subarrays

NASA Astrophysics Data System (ADS)

Bellini, A.; Grogin, N. A.; Lim, P. L.; Golimowski, D.

2017-05-01

We made use of the new ACS/WFC subarray images of CAL-14410, taken taken with a large range of flash exposure times (0.1-30 seconds), to probe the temporal stability of the reference flash file and to validate the current post-flash correction pipeline of CALACS and ACS DESTRIPE PLUS on the new subarray modes. No statistically-significant deviations are found between the new post-flashed subarray exposures and the flash reference file, indicating that the LED lamp used to post-flash ACS images has been stable over several years. The current calibration pipelines (both CALACS and ACS DESTRIPE PLUS can be successfully used with the new subarray modes.

French-Canadian translation and validation of four questionnaires assessing hearing impairment and handicap.

PubMed

Vincent, Claude; Gagné, Jean-Pierre; Leroux, Tony; Clothier, Audrey; Larivière, Marianne; Dumont, Frédéric S; Gendron, Martine

2017-04-01

Questionnaires evaluating hearing impairment are available in English but there is a need for French standardised questionnaires for researchers as well as for audiologists and other clinicians. The objective of this study is to describe the translation and validation of four questionnaires that assess different aspects of hearing impairment and handicap among elders with hearing loss, by comparing the main score and psychometric evaluation of original and French-Canadian (FC) versions of the World Health Organization Disability Assessment Scale II (WHO-DAS II), the Screening Test for Hearing Problems (STHP), the Abbreviated Profile of Hearing Aid Benefit (APHAB) and the Measure of Audiologic Rehabilitation Self-Efficacy for Hearing Aids (MARS-HA). Vallerand method: translation and back-translation by two translators, revision by a committee of experts and pre-tested with five bilingual older participants. Participants (n = 29) were 65 years of age or older including 21 with hearing aids. The psychometric properties (internal consistency, temporal stability after four weeks) indicate good reliability for most of the translated questionnaires and their subscales, especially the WHO-DAS II. The translations in FC of two hearing loss and two hearing aid questionnaires were validated. It is recommended to pursue the demonstration for temporal stability for the STHP.

Length of stay after reaching clinical stability drives hospital costs associated with adult community-acquired pneumonia.

PubMed

Cortoos, Pieter-Jan; Gilissen, Christa; Laekeman, Gert; Peetermans, Willy E; Leenaers, Hilde; Vandorpe, Luc; Simoens, Steven

2013-03-01

Community-acquired pneumonia (CAP) has a considerable clinical and economic impact. The aim of this study was to identify drivers of hospital costs associated with CAP in 2 Belgian hospitals. Specifically, the influence of patient characteristics, quality indicators, and other treatment aspects on hospital costs was explored. The following were registered for patients admitted with a confirmed diagnosis of CAP in a large university hospital (Universitaire Ziekenhuizen Leuven, UZL) and a medium-sized secondary care hospital (Ziekenhuis Oost-Limburg, ZOL) in Belgium: the pneumonia severity index (PSI), time to clinical stability, length of stay, antibiotic therapy, outcomes, compliance with validated quality indicators, and the different costs (pharmacy, laboratory, and radiology, and total). Regression analysis was used to identify influential variables. Between October 2007 and June 2010, 803 patients were included, with a median total cost of €4794.57. The length of stay after clinical stability and time to clinical stability had the highest influence on the total cost (+6.3% and +4.9% per additional day, respectively; p < 0.0001). Other important drivers of higher costs were total therapy duration, PSI score, age, and admission to intensive care. Patients treated with moxifloxacin had significantly, but limited, lower costs. Quality indicator compliance, including guideline-compliant antibiotic treatment and therapy streamlining, had little influence. The most important driver of hospital costs associated with CAP was the time between clinical stability and actual hospital discharge. In order to substantially decrease the costs of CAP treatment, this period should be rigorously evaluated for possible intervention targets that would allow costs in CAP treatment to be decreased in a substantial manner.

Integrating a Motion Base into a CAVE Automatic Virtual Environment: Phase 1

DTIC Science & Technology

2001-07-01

this, a CAVE system must perform well in the following motion-related areas: visual gaze stability, simulator sickness, realism (or face validity...and performance validity. Visual Gaze Stability Visual gaze stability, the ability to maintain eye fixation on a particular target, depends upon human...reflexes such as the vestibulo-ocular reflex (VOR) and the optokinetic nystagmus (OKN). VOR is a reflex that counter-rotates the eye relative to the

Fundamental Movement Skills Are More than Run, Throw and Catch: The Role of Stability Skills.

PubMed

Rudd, James R; Barnett, Lisa M; Butson, Michael L; Farrow, Damian; Berry, Jason; Polman, Remco C J

2015-01-01

In motor development literature fundamental movement skills are divided into three constructs: locomotive, object control and stability skills. Most fundamental movement skills research has focused on children's competency in locomotor and object control skills. The first aim of this study was to validate a test battery to assess the construct of stability skills, in children aged 6 to 10 (M age = 8.2, SD = 1.2). Secondly we assessed how the stability skills construct fitted into a model of fundamental movement skill. The Delphi method was used to select the stability skill battery. Confirmatory factor analysis (CFA) was used to assess if the skills loaded onto the same construct and a new model of FMS was developed using structural equation modelling. Three postural control tasks were selected (the log roll, rock and back support) because they had good face and content validity. These skills also demonstrated good predictive validity with gymnasts scoring significantly better than children without gymnastic training and children from a high SES school performing better than those from a mid and low SES schools and the mid SES children scored better than the low SES children (all p < .05). Inter rater reliability tests were excellent for all three skills (ICC = 0.81, 0.87, 0.87) as was test re-test reliability (ICC 0.87-0.95). CFA provided good construct validity, and structural equation modelling revealed stability skills to be an independent factor in an overall FMS model which included locomotor (r = .88), object control (r = .76) and stability skills (r = .81). This study provides a rationale for the inclusion of stability skills in FMS assessment. The stability skills could be used alongside other FMS assessment tools to provide a holistic assessment of children's fundamental movement skills.

Aeroservoelastic Model Validation and Test Data Analysis of the F/A-18 Active Aeroelastic Wing

NASA Technical Reports Server (NTRS)

Brenner, Martin J.; Prazenica, Richard J.

2003-01-01

Model validation and flight test data analysis require careful consideration of the effects of uncertainty, noise, and nonlinearity. Uncertainty prevails in the data analysis techniques and results in a composite model uncertainty from unmodeled dynamics, assumptions and mechanics of the estimation procedures, noise, and nonlinearity. A fundamental requirement for reliable and robust model development is an attempt to account for each of these sources of error, in particular, for model validation, robust stability prediction, and flight control system development. This paper is concerned with data processing procedures for uncertainty reduction in model validation for stability estimation and nonlinear identification. F/A-18 Active Aeroelastic Wing (AAW) aircraft data is used to demonstrate signal representation effects on uncertain model development, stability estimation, and nonlinear identification. Data is decomposed using adaptive orthonormal best-basis and wavelet-basis signal decompositions for signal denoising into linear and nonlinear identification algorithms. Nonlinear identification from a wavelet-based Volterra kernel procedure is used to extract nonlinear dynamics from aeroelastic responses, and to assist model development and uncertainty reduction for model validation and stability prediction by removing a class of nonlinearity from the uncertainty.

Parental Flooding During Conflict: A Psychometric Evaluation of a New Scale

PubMed Central

Del Vecchio, Tamara; Lorber, Michael F.; Slep, Amy M. Smith; Malik, Jill; Heyman, Richard E.; Foran, Heather M.

2016-01-01

Parents who are overwhelmed by the intensity and aversive nature of child negative affect — those who are experiencing flooding — may be less likely to react effectively and instead may focus on escaping the aversive situation, disciplining either overly permissively or punitively to escape quickly from child negative affect. However, there are no validated self-report measures of the degree to which parents experience flooding, impeding the exploration of these relations. Thus, we created and evaluated the Parent Flooding scale (PFS), assessing the extent to which parents believe their children's negative affect during parent-child conflicts is unexpected, overwhelming and distressing. We studied its factorial validity, reliability, and concurrent validity in a community sample of 453 couples with 3- to 7-year-old children (51.9% girls) recruited via random digit dialing. Confirmatory factor analyses indicated a one-factor solution with excellent internal consistency. Test-retest stability over an average of 5.6 months was high. Concurrent validity was suggested by the associations of flooding with parents’ aggression toward their children, overreactive and lax discipline, parenting satisfaction, and parents’ anger, as well as with child externalizing behavior and negative affect. Incrementally concurrent validity analyses indicated that flooding was a unique predictor of mothers’ and fathers’ overreactive discipline and fathers’ parent-child aggression and lax discipline, over and above the contributions of parents’ anger and children's negative affect. The present results support the psychometric validity of the PFS. PMID:26909682

Cross-cultural adaptation and validation of the Peripheral Artery Questionnaire: Korean version for patients with peripheral vascular diseases.

PubMed

Lee, Ji Hyun; Cho, Kyoung Im; Spertus, John; Kim, Seong Man

2012-08-01

The Peripheral Artery Questionnaire (PAQ), as developed in US English, is a validated scale to evaluate the health status of patients with peripheral artery disease (PAD). The aim of this study was to translate the PAQ into Korean and to evaluate its reliability and validity. A multi-step process of forward-translation, reconciliation, consultation with the developer, back-translation and proofreading was conducted. The test-retest reliability was evaluated at a 2-week interval using the intra-class correlation coefficient (ICC). The validity was assessed by identifying associations between Korean PAQ (KPAQ) scores and Korean Health Assessment Questionnaire (KHAQ) scores. A total of 100 PAD patients were enrolled: 63 without and 37 with severe claudication. The reliability of the KPAQ was adequate, with an ICC of 0.71. There were strong correlations between KPAQ's subscales. Cronbach's alpha for the summary score was 0.94, indicating good internal consistency and congruence with the original US version. The validity was supported by a significant correlation between the total KHAQ score and KPAQ physical function, stability, symptom, social limitation and quality of life scores (r = -0.24 to -0.90; p < 0.001) as well as between the KHAQ walking subscale and the KPAQ physical function score (r = -0.55, p < 0.001). Our results indicate that the KPAQ is a reliable, valid instrument to evaluate the health status of Korean patients with PAD.

A validated stability-indicating HPLC method for determination of varenicline in its bulk and tablets

PubMed Central

2011-01-01

A simple, sensitive and accurate stability-indicating HPLC method has been developed and validated for determination of varenicline (VRC) in its bulk form and pharmaceutical tablets. Chromatographic separation was achieved on a Zorbax Eclipse XDB-C8 column (150 mm × 4.6 mm i.d., particle size 5 μm, maintained at ambient temperature) by a mobile phase consisted of acetonitrile and 50 mM potassium dihydrogen phosphate buffer (10:90, v/v) with apparent pH of 3.5 ± 0.1 and a flow rate of 1.0 ml/min. The detection wavelength was set at 235 nm. VRC was subjected to different accelerated stress conditions. The degradation products, when any, were well resolved from the pure drug with significantly different retention time values. The method was linear (r = 0.9998) at a concentration range of 2 - 14 μg/ml. The limit of detection and limit of quantitation were 0.38 and 1.11 μg/ml, respectively. The intra- and inter-assay precisions were satisfactory; the relative standard deviations did not exceed 2%. The accuracy of the method was proved; the mean recovery of VRC was 100.10 ± 1.08%. The proposed method has high throughput as the analysis involved short run-time (~ 6 min). The method met the ICH/FDA regulatory requirements. The proposed method was successfully applied for the determination of VRC in bulk and tablets with acceptable accuracy and precisions; the label claim percentages were 99.65 ± 0.32%. The results demonstrated that the method would have a great value when applied in quality control and stability studies for VRC. PMID:21672253

The Stability and Validity of Automated Vocal Analysis in Preverbal Preschoolers With Autism Spectrum Disorder

PubMed Central

Woynaroski, Tiffany; Oller, D. Kimbrough; Keceli-Kaysili, Bahar; Xu, Dongxin; Richards, Jeffrey A.; Gilkerson, Jill; Gray, Sharmistha; Yoder, Paul

2017-01-01

Theory and research suggest that vocal development predicts “useful speech” in preschoolers with autism spectrum disorder (ASD), but conventional methods for measurement of vocal development are costly and time consuming. This longitudinal correlational study examines the reliability and validity of several automated indices of vocalization development relative to an index derived from human coded, conventional communication samples in a sample of preverbal preschoolers with ASD. Automated indices of vocal development were derived using software that is presently “in development” and/or only available for research purposes and using commercially available Language ENvironment Analysis (LENA) software. Indices of vocal development that could be derived using the software available for research purposes: (a) were highly stable with a single day-long audio recording, (b) predicted future spoken vocabulary to a degree that was nonsignificantly different from the index derived from conventional communication samples, and (c) continued to predict future spoken vocabulary even after controlling for concurrent vocabulary in our sample. The score derived from standard LENA software was similarly stable, but was not significantly correlated with future spoken vocabulary. Findings suggest that automated vocal analysis is a valid and reliable alternative to time intensive and expensive conventional communication samples for measurement of vocal development of preverbal preschoolers with ASD in research and clinical practice. PMID:27459107

Psychometrics and life history strategy: the structure and validity of the High K Strategy Scale.

PubMed

Copping, Lee T; Campbell, Anne; Muncer, Steven

2014-03-22

In this paper, we critically review the conceptualization and implementation of psychological measures of life history strategy associated with Differential K theory. The High K Strategy Scale (HKSS: Giosan, 2006) was distributed to a large British sample (n = 809) with the aim of assessing its factor structure and construct validity in relation to theoretically relevant life history variables: age of puberty, age of first sexual encounter, and number of sexual partners. Exploratory and confirmatory factor analyses indicated that the HKSS in its current form did not show an adequate statistical fit to the data. Modifications to improve fit indicated four correlated factors (personal capital, environmental stability, environmental security, and social capital). Later puberty in women was positively associated with measures of the environment and personal capital. Among men, contrary to Differential K predictions but in line with female mate preferences, earlier sexual debut and more sexual partners were positively associated with more favorable environments and higher personal and social capital. We raise concerns about the use of psychometric indicators of lifestyle and personality as proxies for life history strategy when they have not been validated against objective measures derived from contemporary life history theory and when their status as causes, mediators, or correlates has not been investigated.

On-Line Robust Modal Stability Prediction using Wavelet Processing

NASA Technical Reports Server (NTRS)

Brenner, Martin J.; Lind, Rick

1998-01-01

Wavelet analysis for filtering and system identification has been used to improve the estimation of aeroservoelastic stability margins. The conservatism of the robust stability margins is reduced with parametric and nonparametric time- frequency analysis of flight data in the model validation process. Nonparametric wavelet processing of data is used to reduce the effects of external disturbances and unmodeled dynamics. Parametric estimates of modal stability are also extracted using the wavelet transform. Computation of robust stability margins for stability boundary prediction depends on uncertainty descriptions derived from the data for model validation. The F-18 High Alpha Research Vehicle aeroservoelastic flight test data demonstrates improved robust stability prediction by extension of the stability boundary beyond the flight regime. Guidelines and computation times are presented to show the efficiency and practical aspects of these procedures for on-line implementation. Feasibility of the method is shown for processing flight data from time- varying nonstationary test points.

Temporal Stability and Convergent Validity of the Behavior Assessment System for Children.

ERIC Educational Resources Information Center

Merydith, Scott P.

2001-01-01

Assesses the temporal stability and convergent validity of the Behavioral Assessment System for Children (BASC). Teachers and parents rated kindergarten and first-grade students using BASC. Teachers were more stable in rating children's externalizing behaviors and attention problems. Discusses results in terms of the accuracy of information…

A simple, rapid and stability indicating validated method for quantification of lamotrigine in human plasma and dry plasma spot using LC-ESI-MS/MS: Application in clinical study.

PubMed

Namdev, Kuldeep Kumar; Dwivedi, Jaya; Chilkoti, Deepak Chandra; Sharma, Swapnil

2018-01-01

Lamotrigine (LTZ) is a phenyltriazine derivative which belongs to anti-epileptic drugs (AEDs) class and prescribed as mono- or adjunctive-therapy in treatment of epilepsy. Therapeutic drug monitoring (TDM) of AEDs provides a valid clinical tool in optimization of overall therapy. However, TDM is challenging due to the high biological samples (plasma/blood) storage/shipment costs and the limited availability of laboratories providing TDM services. Sampling in the form of dry plasma spot (DPS) or dry blood spot (DBS) are suitable alternative to overcome these issues. We developed and validated a new method for quantification of LTZ in human plasma and DPS. The extraction of LTZ from plasma and DPS was performed using liquid-liquid extraction with diethyl ether and an extraction solution composed of diethyl ether- methyl tert-butyl ether- acetone (50:30:20, v/v/v), respectively. Lamotrigine- 13C3, d3 was used as internal standard (ISTD) and the chromatographic separation was achieved on Hypurity Advance C18 column (150×4.6mm, 5μm). Quantitative estimation of LTZ and ISTD was performed on a liquid chromatography tandem mass spectrometer coupled with electrospray ionization interface operated under positive mode of ionization. Calibration curves were linear (r 2 >0.99) over the concentration range of 10-3020ng/mL for both plasma and DPS. Statistical analysis provides insignificant difference between LTZ concentration extracted from plasma and DPS samples. The method is found suitable for application in clinical study and in therapeutic monitoring of LTZ. To the best of our knowledge this is the first report which describing a validated stability indicating assay for quantification of LTZ in dry plasma spot. Copyright © 2017 Elsevier B.V. All rights reserved.

Weight concerns scale applied to college students: comparison between pencil-and-paper and online formats.

PubMed

Dias, Juliana Chioda Ribeiro; Maroco, João; Campos, Juliana Alvares Duarte Bonini

2015-03-01

Online data collection is becoming increasingly common and has some advantages compared to traditional paper-and-pencil formats, such as reducing loss of data, increasing participants' privacy, and decreasing the effect of social desirability. However, the validity and reliability of this administration format must be established before results can be considered acceptable. The aim of this study was to evaluate the validity, reliability, and equivalence of paper-and-pencil and online versions of the Weight Concerns Scale (WCS) when applied to Brazilian university students. A crossover design was used, and the Portuguese version of the WCS (in both paper-and-pencil and online formats) was completed by 100 college students. The results indicated adequate fit in both formats. The simultaneous fit of data for both groups was excellent, with strong invariance between models. Adequate convergent validity, internal consistency, and mean score equivalence of the WCS in both formats were observed. Thus, the WCS presented adequate reliability and validity in both administration formats, with equivalence/stability between answers.

Dependence and physical exercise: Spanish validation of the Exercise Dependence Scale-Revised (EDS-R).

PubMed

Sicilia, Alvaro; González-Cutre, David

2011-05-01

The purpose of this study was to validate the Spanish version of the Exercise Dependence Scale-Revised (EDS-R). To achieve this goal, a sample of 531 sport center users was used and the psychometric properties of the EDS-R were examined through different analyses. The results supported both the first-order seven-factor model and the higher-order model (seven first-order factors and one second-order factor). The structure of both models was invariant across age. Correlations among the subscales indicated a related factor model, supporting construct validity of the scale. Alpha values over .70 (except for Reduction in Other Activities) and suitable levels of temporal stability were obtained. Users practicing more than three days per week had higher scores in all subscales than the group practicing with a frequency of three days or fewer. The findings of this study provided reliability and validity for the EDS-R in a Spanish context.

Dual Wavelength RP-HPLC Method for Simultaneous Determination of Two Antispasmodic Drugs: An Application in Pharmaceutical and Human Serum.

PubMed

Hasan, Najmul; Chaiharn, Mathurot; Khan, Sauleha; Khalid, Hira; Sher, Nawab; Siddiqui, Farhan Ahmed; Siddiqui, Muhammad Zain

2013-01-01

A reverse phase stability indicating HPLC method for simultaneous determination of two antispasmodic drugs in pharmaceutical parenteral dosage forms (injectable) and in serum has been developed and validated. Mobile phase ingredients consist of Acetonitrile : buffer : sulfuric acid 0.1 M (50 : 50 : 0.3 v/v/v), at flow rate 1.0 mL/min using a Hibar μ Bondapak ODS C18 column monitored at dual wavelength of 266 nm and 205 nm for phloroglucinol and trimethylphloroglucinol, respectively. The drugs were subjected to stress conditions of hydrolysis (oxidation, base, acid, and thermal degradation). Oxidation degraded the molecule drastically while there was not so much significant effect of other stress conditions. The calibration curve was linear with a correlation coefficient of 0.9999 and 0.9992 for PG and TMP, respectively. The drug recoveries fall in the range of 98.56% and 101.24% with 10 pg/mL and 33 pg/mL limit of detection and limit of quantification for both phloroglucinol and trimethylphloroglucinol. The method was validated in accordance with ICH guidelines and was applied successfully to quantify the amount of trimethylphloroglucinol and phloroglucinol in bulk, injectable form and physiological fluid. Forced degradation studies proved the stability indicating abilities of the method.

Does early childhood callous-unemotional behavior uniquely predict behavior problems or callous-unemotional behavior in late childhood?

PubMed Central

Waller, Rebecca; Dishion, Thomas J.; Shaw, Daniel S.; Gardner, Frances; Wilson, Melvin N.; Hyde, Luke W.

2016-01-01

Callous unemotional (CU) behavior has been linked to behavior problems in children and adolescents. However, few studies have examined whether CU behavior in early childhood predicts behavior problems or CU behavior in late childhood. This study examined whether indicators of CU behavior at ages 2–4 predicted aggression, rule-breaking, and CU behavior across informants at age 9.5. To test the unique predictive and convergent validity of CU behavior in early childhood, we accounted for stability in behavior problems and method effects to rule out the possibility that rater biases inflated the magnitude of any associations found. Cross-informant data were collected from a multi-ethnic, high-risk sample (N = 731; female = 49%) at ages 2–4 and again at age 9.5. From age 3, CU behavior uniquely predicted aggression and rule-breaking across informants. There were also unique associations between CU behavior assessed at ages 3 and 4 and CU behavior assessed at age 9.5. Findings demonstrate that early-childhood indicators of CU behavior account for unique variance in later childhood behavior problems and CU behavior, taking into account stability in behavior problems over time and method effects. Convergence with a traditional measure of CU behavior in late childhood provides support for the construct validity of a brief early childhood measure of CU behavior. PMID:27598253

A Simple and Specific Stability- Indicating RP-HPLC Method for Routine Assay of Adefovir Dipivoxil in Bulk and Tablet Dosage Form.

PubMed

Darsazan, Bahar; Shafaati, Alireza; Mortazavi, Seyed Alireza; Zarghi, Afshin

2017-01-01

A simple and reliable stability-indicating RP-HPLC method was developed and validated for analysis of adefovir dipivoxil (ADV).The chromatographic separation was performed on a C 18 column using a mixture of acetonitrile-citrate buffer (10 mM at pH 5.2) 36:64 (%v/v) as mobile phase, at a flow rate of 1.5 mL/min. Detection was carried out at 260 nm and a sharp peak was obtained for ADV at a retention time of 5.8 ± 0.01 min. No interferences were observed from its stress degradation products. The method was validated according to the international guidelines. Linear regression analysis of data for the calibration plot showed a linear relationship between peak area and concentration over the range of 0.5-16 μg/mL; the regression coefficient was 0.9999and the linear regression equation was y = 24844x-2941.3. The detection (LOD) and quantification (LOQ) limits were 0.12 and 0.35 μg/mL, respectively. The results proved the method was fast (analysis time less than 7 min), precise, reproducible, and accurate for analysis of ADV over a wide range of concentration. The proposed specific method was used for routine quantification of ADV in pharmaceutical bulk and a tablet dosage form.

Field Validation of the Stability Limit of a Multi MW Turbine

NASA Astrophysics Data System (ADS)

Kallesøe, Bjarne S.; Kragh, Knud A.

2016-09-01

Long slender blades of modern multi-megawatt turbines exhibit a flutter like instability at rotor speeds above a critical rotor speed. Knowing the critical rotor speed is crucial to a safe turbine design. The flutter like instability can only be estimated using geometrically non-linear aeroelastic codes. In this study, the estimated rotor speed stability limit of a 7 MW state of the art wind turbine is validated experimentally. The stability limit is estimated using Siemens Wind Powers in-house aeroelastic code, and the results show that the predicted stability limit is within 5% of the experimentally observed limit.

Comparison of five cluster validity indices performance in brain [18 F]FET-PET image segmentation using k-means.

PubMed

Abualhaj, Bedor; Weng, Guoyang; Ong, Melissa; Attarwala, Ali Asgar; Molina, Flavia; Büsing, Karen; Glatting, Gerhard

2017-01-01

Dynamic [ 18 F]fluoro-ethyl-L-tyrosine positron emission tomography ([ 18 F]FET-PET) is used to identify tumor lesions for radiotherapy treatment planning, to differentiate glioma recurrence from radiation necrosis and to classify gliomas grading. To segment different regions in the brain k-means cluster analysis can be used. The main disadvantage of k-means is that the number of clusters must be pre-defined. In this study, we therefore compared different cluster validity indices for automated and reproducible determination of the optimal number of clusters based on the dynamic PET data. The k-means algorithm was applied to dynamic [ 18 F]FET-PET images of 8 patients. Akaike information criterion (AIC), WB, I, modified Dunn's and Silhouette indices were compared on their ability to determine the optimal number of clusters based on requirements for an adequate cluster validity index. To check the reproducibility of k-means, the coefficients of variation CVs of the objective function values OFVs (sum of squared Euclidean distances within each cluster) were calculated using 100 random centroid initialization replications RCI 100 for 2 to 50 clusters. k-means was performed independently on three neighboring slices containing tumor for each patient to investigate the stability of the optimal number of clusters within them. To check the independence of the validity indices on the number of voxels, cluster analysis was applied after duplication of a slice selected from each patient. CVs of index values were calculated at the optimal number of clusters using RCI 100 to investigate the reproducibility of the validity indices. To check if the indices have a single extremum, visual inspection was performed on the replication with minimum OFV from RCI 100 . The maximum CV of OFVs was 2.7 × 10 -2 from all patients. The optimal number of clusters given by modified Dunn's and Silhouette indices was 2 or 3 leading to a very poor segmentation. WB and I indices suggested in median 5, [range 4-6] and 4, [range 3-6] clusters, respectively. For WB, I, modified Dunn's and Silhouette validity indices the suggested optimal number of clusters was not affected by the number of the voxels. The maximum coefficient of variation of WB, I, modified Dunn's, and Silhouette validity indices were 3 × 10 -2 , 1, 2 × 10 -1 and 3 × 10 -3 , respectively. WB-index showed a single global maximum, whereas the other indices showed also local extrema. From the investigated cluster validity indices, the WB-index is best suited for automated determination of the optimal number of clusters for [ 18 F]FET-PET brain images for the investigated image reconstruction algorithm and the used scanner: it yields meaningful results allowing better differentiation of tissues with higher number of clusters, it is simple, reproducible and has an unique global minimum. © 2016 American Association of Physicists in Medicine.

Clinical Validation of the Nursing Outcome "Swallowing Status" in People with Stroke: Analysis According to the Classical and Item Response Theories.

PubMed

Oliveira-Kumakura, Ana Railka de Souza; de Araujo, Thelma Leite; Costa, Alice Gabrielle de Sousa; Cavalcante, Tahissa Frota; Lopes, Marcos Venícios de Oliveira; Carvalho, Emilia Campos

2017-09-19

To validate clinically the nursing outcome "Swallowing status". The adjustment of the nursing outcome was investigated according to the Classical and Item Response Theories. The models were compared regarding information loss, goodness-of-fit, and differential item functioning. Stability and internal consistency were examined. The nursing outcome has the best fit in the generalized partial credit model with different discrimination parameters. Strong correlations among the scores of each indicator were observed. There was no differential item functioning of the outcome indicators. The scale presented high internal consistency (Cronbach's α = .954) and stability (and > .800). This study presents a valid nursing outcome. Most accurate monitoring of sensitivity to an intervention. Validar clinicamente o resultado de enefermagem "Estado da Deglutição". MÉTODOS: O ajustamento do resultado foi investigado de acordo com as teorias Clássica e de Resposta ao Item. Os modelos foram comparados assumindo parâmetros de itens cruzados de igual discriminação. Investigaram-se as propriedades de bondade do ajuste, funcionamento diferencial dos itens, estabilidade e consistência interna. O resultado se ajustou melhor a partir do Modelo de crédito parcial generalizado, o qual demonstrou unidimensionalidade do resultado e forte correlação entre os escores de cada indicador. Não houve funcionamento diferencial dos indicadores. A consistência interna para a escala global (Cronbach's α = .954) e a estabilidade (>.800) mantiveram-se elevadas. CONCLUSÃO: O estudo apresenta um resultado de enfermagem válido. RELEVÂNCIA PARA A PRÁTICA CLÍNICA: Maior acurácia para monitorar a sensibilidade da intervenção. © 2017 NANDA International, Inc.

The Stability of Medicinal Plant microRNAs in the Herb Preparation Process.

PubMed

Xie, Wenyan; Melzig, Matthias F

2018-04-16

Herbal medicine is now globally accepted as a valid alternative system of pharmaceutical therapies. Various studies around the world have been initiated to develop scientific evidence-based herbal therapies. Recently, the therapeutic potential of medicinal plant derived miRNAs has attracted great attraction. MicroRNAs have been indicated as new bioactive ingredients in medicinal plants. However, the stability of miRNAs during the herbal preparation process and their bioavailability in humans remain unclear. Viscum album L. (European mistletoe) has been widely used in folk medicine for the treatment of cancer and cardiovascular diseases. Our previous study has indicated the therapeutic potential of mistletoe miRNAs by using bioinformatics tools. To evaluate the stability of these miRNAs, various mistletoe extracts that mimic the clinical medicinal use as well as traditional folk medicinal use were prepared. The mistletoe miRNAs including miR166a-3p, miR159a, miR831-5p, val-miR218 and val-miR11 were quantified by stem-loop qRT-PCR. As a result, miRNAs were detectable in the majority of the extracts, indicating that consumption of medicinal plant preparations might introduce miRNAs into mammals. The factors that might cause miRNA degradation include ultrasonic treatment, extreme heat, especially RNase treatment, while to be associated with plant molecules (e.g., proteins, exosomes) might be an efficient way to protect miRNAs against degradation. Our study confirmed the stability of plant derived miRNAs during herb preparations, suggesting the possibility of functionally intact medicinal plant miRNAs in mammals.

Aeromechanical stability analysis of COPTER

NASA Technical Reports Server (NTRS)

Yin, Sheng K.; Yen, Jing G.

1988-01-01

A plan was formed for developing a comprehensive, second-generation system with analytical capabilities for predicting performance, loads and vibration, handling qualities, aeromechanical stability, and acoustics. This second-generation system named COPTER (COmprehensive Program for Theoretical Evaluation of Rotorcraft) is designed for operational efficiency, user friendliness, coding readability, maintainability, transportability, modularity, and expandability for future growth. The system is divided into an executive, a data deck validator, and a technology complex. At present a simple executive, the data deck validator, and the aeromechanical stability module of the technology complex were implemented. The system is described briefly, the implementation of the technology module is discussed, and correlation data presented. The correlation includes hingeless-rotor isolated stability, hingeless-rotor ground-resonance stability, and air-resonance stability of an advanced bearingless-rotor in forward flight.

Physical and Chemical Stability of Urapidil in 0.9% Sodium Chloride in Elastomeric Infusion Pump.

PubMed

Tomasello, Cristina; Leggieri, Anna; Rabbia, Franco; Veglio, Franco; Baietto, Lorena; Fulcheri, Chiara; De Nicolò, Amedeo; De Perri, Giovanni; D'Avolio, Antonio

2016-01-01

Urapidil is an antihypertensive agent, usually administered through intravenous bolus injection, slow-intravenous infusion, or continuous-drug infusion by perfusor. Since to date no evidences are available on drug stability in elastomeric pumps, patients have to be hospitalized. The purpose of this study was to validate an ultra-performance liquid chromatographic method to evaluate urapidil stability in an elastomeric infusion pump, in order to allow continuous infusion as home-care treatment. Analyses were conducted by diluting urapidil in an elastomeric pump. Two concentrations were evaluated: 1.6 mg/mL and 3.3 mg/mL. For the analyses, a reverse-phase ultra-performance liquid chromatographic- photodiode array detection instrument was used. Stressed degradation, pH changes, and visual clarity were used as stability indicators up to 10 days after urapidil solution preparation. The drug showed no more than 5% degradation during the test period at room temperature. No pH changes and no evidences of incompatibility were observed. Stress tests resulted in appreciable observation of degradation products. Considering the observed mean values, urapidil hydrochloride in sodium chloride 0.9% in elastomeric infusion pumps is stable for at least 10 days. These results indicate that this treatment could be administered at home for a prolonged duration (at least 7 days) with a satisfactory response. Copyright© by International Journal of Pharmaceutical Compounding, Inc.

Perceived match or mismatch on the Gottman conflict styles: associations with relationship outcome variables.

PubMed

Busby, Dean M; Holman, Thomas B

2009-12-01

Gottman has proposed that there are 3 functional styles of conflict management in couple relationships, labeled Avoidant, Validating, and Volatile, and 1 dysfunctional style, labeled Hostile. Using a sample of 1,983 couples in a committed relationship, we test the association of perceived matches or mismatches on these conflict styles with relationship outcome variables. The results indicate that 32% of the participants perceive there is a mismatch with their conflict style and that of their partner. The Volatile-Avoidant mismatch was particularly problematic and was associated with more stonewalling, relationship problems, and lower levels of relationship satisfaction and stability than the Validating matched style and than other mismatched styles. The most problematic style was the Hostile style. Contrary to existing assumptions by Gottman, the 3 matched functional styles were not equivalent, as the Validating Style was associated with substantially better results on relationship outcome measures than the Volatile and Avoidant styles.

Stability-Indicating HPLC Determination of Gemcitabine in Pharmaceutical Formulations

PubMed Central

Singh, Rahul; Shakya, Ashok K.; Naik, Rajashri; Shalan, Naeem

2015-01-01

A simple, sensitive, inexpensive, and rapid stability indicating high performance liquid chromatographic method has been developed for determination of gemcitabine in injectable dosage forms using theophylline as internal standard. Chromatographic separation was achieved on a Phenomenex Luna C-18 column (250 mm × 4.6 mm; 5μ) with a mobile phase consisting of 90% water and 10% acetonitrile (pH 7.00 ± 0.05). The signals of gemcitabine and theophylline were recorded at 275 nm. Calibration curves were linear in the concentration range of 0.5–50 μg/mL. The correlation coefficient was 0.999 or higher. The limit of detection and limit of quantitation were 0.1498 and 0.4541 μg/mL, respectively. The inter- and intraday precision were less than 2%. Accuracy of the method ranged from 100.2% to 100.4%. Stability studies indicate that the drug was stable to sunlight and UV light. The drug gives 6 different hydrolytic products under alkaline stress and 3 in acidic condition. Aqueous and oxidative stress conditions also degrade the drug. Degradation was higher in the alkaline condition compared to other stress conditions. The robustness of the methods was evaluated using design of experiments. Validation reveals that the proposed method is specific, accurate, precise, reliable, robust, reproducible, and suitable for the quantitative analysis. PMID:25838825

Stability-indicating RP-HPLC Method for the Simultaneous Determination of Sitagliptin and Simvastatin in Tablets

PubMed Central

Ramalingam, P.; Bhaskar, V. Udaya; Reddy, Y. Padmanabha; Kumar, K. Vinod

2014-01-01

A new stability-indicating high-performance liquid chromatographic method for simultaneous analysis of sitagliptin and simvastatin in pharmaceutical dosage form was developed and validated. The mobile phase consisted of methanol and water (70:30, v/v) with 0.2 % of n-heptane sulfonic acid adjusted to pH 3.0 with ortho phosphoric acid was used. Retentions of sitagliptin and simvastatin were 4.3 min and 30.4 min, respectively with a flow rate of 1 ml/min on C8 (Qualisil BDS, 250×4.6 mm, 5 μ). Eluents were detected at 253 nm using photodiode diode array detector. The linear regression analysis data for the linearity plot showed correlation coefficient values of 0.9998 and 0.9993 for sitagliptin and simvastatin, with respective concentration ranges of 20-150 μg/ml and 8-60 μg/ml. The relative standard deviation for inter-day precision was lower than 2.0%. The assay of sitagliptin and simvastatin was determined in tablet dosage form was found to be within limits. Both drugs were subjected to a variety of stress conditions such as acidic, basic, oxidation, photolytic, neutral and thermal stress in order to achieve adequate degradation. Results revealed that considerable degradation was found in all stress conditions except oxidative degradations. The method has proven specificity for stability indicating assay method. PMID:25425754

Thirty-Year Stability and Predictive Validity of Vocational Interests

ERIC Educational Resources Information Center

Rottinghaus, Patrick J.; Coon, Kristin L.; Gaffey, Abigail R.; Zytowski, Donald G.

2007-01-01

This study reports a 30-year follow-up of 107 former high school juniors and seniors from a rural Midwestern community who completed the Kuder Occupational Interest Survey (KOIS) in 1975 and 2005. Absolute, intra-individual, and test-retest stability of interests, and predictive validity of occupations were examined. Results showed minor absolute…

Stability of Prednisone in Oral Mix Suspending Vehicle.

PubMed

Friciu, Mihaela; Plourde, Kevin; Leclair, Grégoire; Danopoulos, Panagiota; Savji, Taslim

2015-01-01

The stability of prednisone (5 mg/mL) formulated as a suspension in Oral Mix vehicle was evaluated. Oral Mix is a novel oral, dye-free suspending vehicle developed by Medisca Pharmaceutique Inc. for preparation of extemporaneous dosage forms. This drug was chosen based on its high frequency of prescription among the pediatric population. Suspensions were prepared from both pure active and commercial tablets utilizing two different container closures: amber glass bottles and polypropylene syringes (PreciseDose Dispenser Medisca Pharmaceutique Inc.). Formulations were stored at 5°C or 25°C and organoleptic properties, pH, and concentration were evaluated at predetermined time points up to 90 days. Validated stability-indicating high-performance liquid chromatography methods were developed. Beyond-use date was evaluated by statistical analysis of the overall degradation trend. Prednisone was stable for at least 90 days at 25°C. No changes in organoleptic properties or pH were observed for either of the formulations, and the global stability was roughly equivalent and sometimes superior to the stability of the same drugs in other previously used vehicles. Thus, Oral Mix was found to be a suitable dye-free vehicle for extemporaneous formulations.

A comparative study between three stability indicating spectrophotometric methods for the determination of diatrizoate sodium in presence of its cytotoxic degradation product based on two-wavelength selection

NASA Astrophysics Data System (ADS)

Riad, Safaa M.; El-Rahman, Mohamed K. Abd; Fawaz, Esraa M.; Shehata, Mostafa A.

2015-06-01

Three sensitive, selective, and precise stability indicating spectrophotometric methods for the determination of the X-ray contrast agent, diatrizoate sodium (DTA) in the presence of its acidic degradation product (highly cytotoxic 3,5-diamino metabolite) and in pharmaceutical formulation, were developed and validated. The first method is ratio difference, the second one is the bivariate method, and the third one is the dual wavelength method. The calibration curves for the three proposed methods are linear over a concentration range of 2-24 μg/mL. The selectivity of the proposed methods was tested using laboratory prepared mixtures. The proposed methods have been successfully applied to the analysis of DTA in pharmaceutical dosage forms without interference from other dosage form additives. The results were statistically compared with the official US pharmacopeial method. No significant difference for either accuracy or precision was observed.

A comparative study between three stability indicating spectrophotometric methods for the determination of diatrizoate sodium in presence of its cytotoxic degradation product based on two-wavelength selection.

PubMed

Riad, Safaa M; El-Rahman, Mohamed K Abd; Fawaz, Esraa M; Shehata, Mostafa A

2015-06-15

Three sensitive, selective, and precise stability indicating spectrophotometric methods for the determination of the X-ray contrast agent, diatrizoate sodium (DTA) in the presence of its acidic degradation product (highly cytotoxic 3,5-diamino metabolite) and in pharmaceutical formulation, were developed and validated. The first method is ratio difference, the second one is the bivariate method, and the third one is the dual wavelength method. The calibration curves for the three proposed methods are linear over a concentration range of 2-24 μg/mL. The selectivity of the proposed methods was tested using laboratory prepared mixtures. The proposed methods have been successfully applied to the analysis of DTA in pharmaceutical dosage forms without interference from other dosage form additives. The results were statistically compared with the official US pharmacopeial method. No significant difference for either accuracy or precision was observed. Copyright © 2015 Elsevier B.V. All rights reserved.

Development of an advanced pitch active control system for a wide body jet aircraft

NASA Technical Reports Server (NTRS)

Guinn, Wiley A.; Rising, Jerry J.; Davis, Walt J.

1984-01-01

An advanced PACS control law was developed for a commercial wide-body transport (Lockheed L-1011) by using modern control theory. Validity of the control law was demonstrated by piloted flight simulation tests on the NASA Langley visual motion simulator. The PACS design objective was to develop a PACS that would provide good flying qualities to negative 10 percent static stability margins that were equivalent to those of the baseline aircraft at a 15 percent static stability margin which is normal for the L-1011. Also, the PACS was to compensate for high-Mach/high-g instabilities that degrade flying qualities during upset recoveries and maneuvers. The piloted flight simulation tests showed that the PACS met the design objectives. The simulation demonstrated good flying qualities to negative 20 percent static stability margins for hold, cruise and high-speed flight conditions. Analysis and wind tunnel tests performed on other Lockheed programs indicate that the PACS could be used on an advanced transport configuration to provide a 4 percent fuel savings which results from reduced trim drag by flying at negative static stability margins.

Stability of Metronidazole Suspensions.

PubMed

Donnelly, Ronald F; Ying, James

2015-01-01

Metronidazole is an antiprotozoal agent used in the treatment of bacterial and protozoal anaerobic infections. The objectives of this study were to develop concentrated metronidazole suspensions that are inexpensive and easy to prepare and determine the stability of these suspensions after storage in amber polyvinyl chloride bottles at room temperature (23°C) and under refrigeration (5°C). Metronidazole suspensions (50 mg/mL) were prepared from powder using Ora-Blend or simple syrup as the vehicles. Samples were collected in triplicate from each container on days 0, 7, 14, 28, 56, and 93. Samples were assayed using a high-performance liquid chromatography method that had been validated as stability indicating. Color, change in physical appearance, and pH were also monitored at each time interval. There was no apparent change in color or physical appearance. The pH values changed by less than 0.20 units over the 93 days. The stability of metronidazole suspensions compounded from United States Pharmacopeia powder using Ora-Blend or simple syrup and packaged in amber polyvinyl chloride bottles was determined to be 93 days when stored at either room temperature or under refrigeration.

Enhanced thermal stability of RuO2/polyimide interface for flexible device applications

NASA Astrophysics Data System (ADS)

Music, Denis; Schmidt, Paul; Chang, Keke

2017-09-01

We have studied the thermal stability of RuO2/polyimide (Kapton) interface using experimental and theoretical methods. Based on calorimetric and spectroscopic analyses, this inorganic-organic system does not exhibit any enthalpic peaks as well as all bonds in RuO2 and Kapton are preserved up to 500 °C. In addition, large-scale density functional theory based molecular dynamics, carried out in the same temperature range, validates the electronic structure and points out that numerous Ru-C and a few Ru-O covalent/ionic bonds form across the RuO2/Kapton interface. This indicates strong adhesion, but there is no evidence of Kapton degradation upon thermal excitation. Furthermore, RuO2 does not exhibit any interfacial bonds with N and H in Kapton, providing additional evidence for the thermal stability notion. It is suggested that the RuO2/Kapton interface is stable due to aromatic architecture of Kapton. This enhanced thermal stability renders Kapton an appropriate polymeric substrate for RuO2 containing systems in various applications, especially for flexible microelectronic and energy devices.

Validation and use of three complementary analytical methods (LC-FLS, LC-MS/MS and ICP-MS) to evaluate the pharmacokinetics, biodistribution and stability of motexafin gadolinium in plasma and tissues.

PubMed

Miles, Dale R; Mesfin, Mimi; Mody, Tarak D; Stiles, Mark; Lee, Jean; Fiene, John; Denis, Bernie; Boswell, Garry W

2006-05-01

Liquid chromatography-fluorescence (LC-FLS), liquid chromatography-tandem mass spectrometry (LC-MS/MS) and inductively coupled plasma-mass spectrometry (ICP-MS) methods were developed and validated for the evaluation of motexafin gadolinium (MGd, Xcytrin) pharmacokinetics and biodistribution in plasma and tissues. The LC-FLS method exhibited the greatest sensitivity (0.0057 microg mL(-1)), and was used for pharmacokinetic, biodistribution, and protein binding studies with small sample sizes or low MGd concentrations. The LC-MS/MS method, which exhibited a short run time and excellent selectivity, was used for routine clinical plasma sample analysis. The ICP-MS method, which measured total Gd, was used in conjunction with LC methods to assess MGd stability in plasma. All three methods were validated using human plasma. The LC-FLS method was also validated using plasma, liver and kidneys from mice and rats. All three methods were shown to be accurate, precise and robust for each matrix validated. For three mice, the mean (standard deviation) concentration of MGd in plasma/tissues taken 5 hr after dosing with 23 mg kg(-1) MGd was determined by LC-FLS as follows: plasma (0.025+/-0.002 microg mL(-1)), liver (2.89+/-0.45 microg g(-1)), and kidney (6.09+/-1.05 microg g(-1)). Plasma samples from a subset of patients with brain metastases from extracranial tumors were analyzed using both LC-MS/MS and ICP-MS methods. For a representative patient, > or = 90% of the total Gd in plasma was accounted for as MGd over the first hour post dosing. By 24 hr post dosing, 63% of total Gd was accounted for as MGd, indicating some metabolism of MGd.

The Turkish Adaptation of the Ten-Item Personality Inventory

PubMed Central

ATAK, Hasan

2013-01-01

Introduction Personality is one of the important domains of psychology, and it is an integration of emotional, cognitive, social and physical properties. In this study, we aimed to assess the applicability of the “Ten-Item Personality Inventory (TIPI)” which measures five basic personality traits in Turkish young people. Method Data from a total of 420 participants - 208 male (49.1%) and 212 female (50.9%) - were employed for the validity and reliability analyses. Of the participants, 230 (54,8%; mean age: 23.2 years; sd=1.6) were university students and the rest were not (n=190; 45.2%; mean age: 23.4 years; df=1.7). The mean age of the participants was 22.1 years (df=1.3), ranging from 18 to 25 years. Results Language validity (correlations between 0.92 and 0.97), exploratory factor analysis yielded 10 items and five-factor model explaining 65.21% of the variance. Confirmatory factor analyses (χ2/df: 2.20, GFI=0.95, AGFI=0.92, CFI=0.93, NNFI=0.91, RMR=0.04, and RMSEA=0.03), item analysis, and convergent validity results indicated that a five-factor solution with 10 items met the criteria standards for adequacy of fit among Turkish young people. The internal consistency (Openness to Experiences 0.83, Agreeableness 0.81, Emotional Stability 0.83, Conscientiousness 0.84, and Extraversion 0.86) and test-retest stability (=54; Openness to Experiences 0.89, Agreeableness 0.87, Emotional Stability 0.89, Conscientiousness 0.87, and Extraversion 0.88) revealed a moderate to acceptable reliabilities. Conclusion The results demonstrated that the TIPI could be used in studies that evaluate personality in Turkish young people. PMID:28360563

Music psychopathology. II. Assessment of musical expression.

PubMed

Steinberg, R; Raith, L

1985-01-01

A short polarity profile which was well suited for the assessment of the musical expression of performances recorded from mentally ill patients and controls is described. 9 out of 12 polarities showed sufficient differentiating qualities, ranging from professional to poor amateur performances. Only 3 polarities had to be reformulated. The assessments of the 3 experts had a high interrater reliability and retest stability. The very significant correlation between the results of the experts and 50 independent subjects indicates the validity of the experiment.

Persian language version of the "Tinnitus Handicap Inventory": translation, standardization, validity and reliability.

PubMed

Mahmoudian, Saeid; Shahmiri, Elaheh; Rouzbahani, Masoumeh; Jafari, Zahra; Keyhani, Mohammad; Rahimi, Farzad; Mahmoudian, Guiti; Akbarvand, Leila; Barzegar, Gholamreza; Farhadi, Mohammad

2011-01-01

Tinnitus is a debilitating condition that is widespread yet difficult to successfully diagnose and treat. This symptom can seriously affect the individual's life quality. The aim of current study was to compose and validate a Persian version of the Tinnitus Handicap Inventory (THI-P). The linguistic validation of the original version of THI into Persian version (THI-P) included translation, back translation and data gathering. The THI-P was administered to 112 tinnitus subjects. Age, gender, medical history and tinnitus characteristics were recorded as baseline information. All participants complained of chronic unilateral or bilateral subjective idiopathic tinnitus lasting for at least 6 months before consulting about their tinnitus. There was no significant difference between gender, age, hearing impairment and total score and subscales of THI-P. Pearson product-moment correlations revealed adequate test-retest reliability for the THI-P (r = 0.96). Cronbach's-alpha coefficient indicated adequate internal stability of the THI-P (r= 0.943), with a total item correction varying between r=0.939 and r=0.944, indicating its reproducibility. The present study proved the internal consistency/ coherency of the Persian version of THI (THI-P). This provides satisfactory application in clinical/research environments.

In silico selection of expression reference genes with demonstrated stability in barley among a diverse set of tissues and cultivars

USDA-ARS?s Scientific Manuscript database

Premise of the study: Reference genes are selected based on the assumption of temporal and spatial expression stability and on their widespread use in model species. They are often used in new target species without validation, presumed as stable. For barley, reference gene validation is lacking, bu...

Development and Validation of an Inductively Coupled Plasma Mass Spectrometry (ICP-MS) Method for Quantitative Analysis of Platinum in Plasma, Urine, and Tissues.

PubMed

Zhang, Ti; Cai, Shuang; Forrest, Wai Chee; Mohr, Eva; Yang, Qiuhong; Forrest, M Laird

2016-09-01

Cisplatin, a platinum chemotherapeutic, is one of the most commonly used chemotherapeutic agents for many solid tumors. In this work, we developed and validated an inductively coupled plasma mass spectrometry (ICP-MS) method for quantitative determination of platinum levels in rat urine, plasma, and tissue matrices including liver, brain, lungs, kidney, muscle, heart, spleen, bladder, and lymph nodes. The tissues were processed using a microwave accelerated reaction system (MARS) system prior to analysis on an Agilent 7500 ICP-MS. According to the Food and Drug Administration guidance for industry, bioanalytical validation parameters of the method, such as selectivity, accuracy, precision, recovery, and stability were evaluated in rat biological samples. Our data suggested that the method was selective for platinum without interferences caused by other presenting elements, and the lower limit of quantification was 0.5 ppb. The accuracy and precision of the method were within 15% variation and the recoveries of platinum for all tissue matrices examined were determined to be 85-115% of the theoretical values. The stability of the platinum-containing solutions, including calibration standards, stock solutions, and processed samples in rat biological matrices was investigated. Results indicated that the samples were stable after three cycles of freeze-thaw and for up to three months. © The Author(s) 2016.

Development and Validation of an Inductively Coupled Plasma Mass Spectrometry (ICP-MS) Method for Quantitative Analysis of Platinum in Plasma, Urine, and Tissues

PubMed Central

Zhang, Ti; Cai, Shuang; Forrest, Wai Chee; Mohr, Eva; Yang, Qiuhong; Forrest, M. Laird

2016-01-01

Cisplatin, a platinum chemotherapeutic, is one of the most commonly used chemotherapeutic agents for many solid tumors. In this work, we developed and validated an inductively coupled plasma mass spectrometry (ICP-MS) method for quantitative determination of platinum levels in rat urine, plasma, and tissue matrices including liver, brain, lungs, kidney, muscle, heart, spleen, bladder, and lymph nodes. The tissues were processed using a microwave accelerated reaction system (MARS) system prior to analysis on an Agilent 7500 ICP-MS. According to the Food and Drug Administration guidance for industry, bioanalytical validation parameters of the method, such as selectivity, accuracy, precision, recovery, and stability were evaluated in rat biological samples. Our data suggested that the method was selective for platinum without interferences caused by other presenting elements, and the lower limit of quantification was 0.5 ppb. The accuracy and precision of the method were within 15% variation and the recoveries of platinum for all tissue matrices examined were determined to be 85–115% of the theoretical values. The stability of the platinum-containing solutions, including calibration standards, stock solutions, and processed samples in rat biological matrices was investigated. Results indicated that the samples were stable after three cycles of freeze–thaw and for up to three months. PMID:27527103

Fundamental Movement Skills Are More than Run, Throw and Catch: The Role of Stability Skills

PubMed Central

Rudd, James R.; Barnett, Lisa M.; Butson, Michael L.; Farrow, Damian; Berry, Jason; Polman, Remco C. J.

2015-01-01

Introduction In motor development literature fundamental movement skills are divided into three constructs: locomotive, object control and stability skills. Most fundamental movement skills research has focused on children’s competency in locomotor and object control skills. The first aim of this study was to validate a test battery to assess the construct of stability skills, in children aged 6 to 10 (M age = 8.2, SD = 1.2). Secondly we assessed how the stability skills construct fitted into a model of fundamental movement skill. Method The Delphi method was used to select the stability skill battery. Confirmatory factor analysis (CFA) was used to assess if the skills loaded onto the same construct and a new model of FMS was developed using structural equation modelling. Results Three postural control tasks were selected (the log roll, rock and back support) because they had good face and content validity. These skills also demonstrated good predictive validity with gymnasts scoring significantly better than children without gymnastic training and children from a high SES school performing better than those from a mid and low SES schools and the mid SES children scored better than the low SES children (all p < .05). Inter rater reliability tests were excellent for all three skills (ICC = 0.81, 0.87, 0.87) as was test re-test reliability (ICC 0.87–0.95). CFA provided good construct validity, and structural equation modelling revealed stability skills to be an independent factor in an overall FMS model which included locomotor (r = .88), object control (r = .76) and stability skills (r = .81). Discussion This study provides a rationale for the inclusion of stability skills in FMS assessment. The stability skills could be used alongside other FMS assessment tools to provide a holistic assessment of children’s fundamental movement skills. PMID:26468644

Quality indicators for eye bank.

PubMed

Acharya, Manisha; Biswas, Saurabh; Das, Animesh; Mathur, Umang; Dave, Abhishek; Singh, Ashok; Dubey, Suneeta

2018-03-01

The aim of this study is to identify quality indicators of the eye bank and validate their effectivity. Adverse reaction rate, discard rate, protocol deviation rate, and compliance rate were defined as Quality Indicators of the eye bank. These were identified based on definition of quality that captures two dimensions - "result quality" and "process quality." The indicators were measured and tracked as part of quality assurance (QA) program of the eye bank. Regular audits were performed to validate alignment of standard operating procedures (SOP) with regulatory and surgeon acceptance standards and alignment of activities performed in the eye bank with the SOP. Prospective study of the indicators was performed by comparing their observed values over the period 2011-2016. Adverse reaction rate decreased more than 8-fold (from 0.61% to 0.07%), discard rate decreased and stabilized at 30%, protocol deviation rate decreased from 1.05% to 0.08%, and compliance rate reported by annual quality audits improved from 59% to 96% at the same time. In effect, adverse reaction rate, discard rate, and protocol deviation rate were leading indicators, and compliance rate was the trailing indicator. These indicators fulfill an important gap in available literature on QA in eye banking. There are two ways in which these findings can be meaningful. First, eye banks which are new to quality measurement can adopt these indicators. Second, eye banks which are already deeply engaged in quality improvement can test these indicators in their eye bank, thereby incorporating them widely and improving them over time.

Advanced stability indicating chemometric methods for quantitation of amlodipine and atorvastatin in their quinary mixture with acidic degradation products

NASA Astrophysics Data System (ADS)

Darwish, Hany W.; Hassan, Said A.; Salem, Maissa Y.; El-Zeany, Badr A.

2016-02-01

Two advanced, accurate and precise chemometric methods are developed for the simultaneous determination of amlodipine besylate (AML) and atorvastatin calcium (ATV) in the presence of their acidic degradation products in tablet dosage forms. The first method was Partial Least Squares (PLS-1) and the second was Artificial Neural Networks (ANN). PLS was compared to ANN models with and without variable selection procedure (genetic algorithm (GA)). For proper analysis, a 5-factor 5-level experimental design was established resulting in 25 mixtures containing different ratios of the interfering species. Fifteen mixtures were used as calibration set and the other ten mixtures were used as validation set to validate the prediction ability of the suggested models. The proposed methods were successfully applied to the analysis of pharmaceutical tablets containing AML and ATV. The methods indicated the ability of the mentioned models to solve the highly overlapped spectra of the quinary mixture, yet using inexpensive and easy to handle instruments like the UV-VIS spectrophotometer.

The predictive validity of quality of evidence grades for the stability of effect estimates was low: a meta-epidemiological study.

PubMed

Gartlehner, Gerald; Dobrescu, Andreea; Evans, Tammeka Swinson; Bann, Carla; Robinson, Karen A; Reston, James; Thaler, Kylie; Skelly, Andrea; Glechner, Anna; Peterson, Kimberly; Kien, Christina; Lohr, Kathleen N

2016-02-01

To determine the predictive validity of the U.S. Evidence-based Practice Center (EPC) approach to GRADE (Grading of Recommendations Assessment, Development and Evaluation). Based on Cochrane reports with outcomes graded as high quality of evidence (QOE), we prepared 160 documents which represented different levels of QOE. Professional systematic reviewers dually graded the QOE. For each document, we determined whether estimates were concordant with high QOE estimates of the Cochrane reports. We compared the observed proportion of concordant estimates with the expected proportion from an international survey. To determine the predictive validity, we used the Hosmer-Lemeshow test to assess calibration and the C (concordance) index to assess discrimination. The predictive validity of the EPC approach to GRADE was limited. Estimates graded as high QOE were less likely, estimates graded as low or insufficient QOE more likely to remain stable than expected. The EPC approach to GRADE could not reliably predict the likelihood that individual bodies of evidence remain stable as new evidence becomes available. C-indices ranged between 0.56 (95% CI, 0.47 to 0.66) and 0.58 (95% CI, 0.50 to 0.67) indicating a low discriminatory ability. The limited predictive validity of the EPC approach to GRADE seems to reflect a mismatch between expected and observed changes in treatment effects as bodies of evidence advance from insufficient to high QOE. Copyright © 2016 Elsevier Inc. All rights reserved.

Identification of reference genes for RT-qPCR analysis in peach genotypes with contrasting chilling requirements.

PubMed

Marini, N; Bevilacqua, C B; Büttow, M V; Raseira, M C B; Bonow, S

2017-05-25

Selecting and validating reference genes are the first steps in studying gene expression by reverse transcriptase-quantitative polymerase chain reaction (RT-qPCR). The present study aimed to evaluate the stability of five reference genes for the purpose of normalization when studying gene expression in various cultivars of Prunus persica with different chilling requirements. Flower bud tissues of nine peach genotypes from Embrapa's peach breeding program with different chilling requirements were used, and five candidate reference genes based on the RT-qPCR that were useful for studying the relative quantitative gene expression and stability were evaluated using geNorm, NormFinder, and bestKeeper software packages. The results indicated that among the genes tested, the most stable genes to be used as reference genes are Act and UBQ10. This study is the first survey of the stability of reference genes in peaches under chilling stress and provides guidelines for more accurate RT-qPCR results.

Y balance test has no correlation with the Stability Index of the Biodex Balance System.

PubMed

Almeida, Gabriel Peixoto Leão; Monteiro, Isabel Oliveira; Marizeiro, Débora Fortes; Maia, Laísa Braga; de Paula Lima, Pedro Olavo

2017-02-01

A cross-sectional study design. The Stability Index of the Biodex Balance System (SI-BBS) and Y Balance Test (YBT) has been used in studies assessing postural stability but no studies have verified the association of the YBT with the SI-BBS. To analyze the association of the Y Balance Test (YBT) with the Stability Index of the Biodex Balance System (SI-BBS) to evaluate postural stability. Forty participants who engaged in recreational physical activities, 12 of whom had a history of injury to the lower limbs. Was used the SI-BBS and the anterior, posterolateral, posteromedial, and composite measures of the YBT. The order of execution of the tests and of the lower limbs evaluated was randomized and blind tested by two evaluators. Pearson's correlation coefficient was used to check the strength of the relationship between the distances achieved on the YBT and the SI-BBS. The YBT showed excellent reliability in the anterior, posteromedial, and posterolateral directions. However, the YBT showed no statistically significant correlation with any variables in the SI-BBS, indicating poor validity between YBT and SI-BBS assessments of postural stability in people with and without history of lower limb injuries. The results of this study showed the YBT is not correlated with the SI-BBS as an assessment of postural stability. This finding has implications for researchers and clinicians using YBT results as the only measure of postural stability. Copyright © 2016 Elsevier Ltd. All rights reserved.

Development of a job stressor scale for nurses caring for patients with intractable neurological diseases.

PubMed

Ando, Yukako; Kataoka, Tsuyoshi; Okamura, Hitoshi; Tanaka, Katsutoshi; Kobayashi, Toshio

2013-12-01

The purpose of this research is to verify the reliability and validity of a job stressor scale for nurses caring for patients with intractable neurological diseases. A mail survey was conducted using a self-report questionnaire. The subjects were 263 nurses and assistant nurses working in wards specializing in intractable neurological diseases. The response rate was 71.9% (valid response rate, 66.2%). With regard to reliability, internal consistency and stability were assessed. Internal consistency was examined via Cronbach's alpha. For stability, the test-retest method was performed and stability was examined via intraclass correlation coefficients. With regard to validity, factor validity, criterion-related validity, and content validity were assessed. Exploratory factor analysis was used for factor validity. For criterion-related validity, an existing scale was used as an external criterion; concurrent validity was examined via Spearman's rank correlation coefficients. As a result of analysis, there were 26 items in the scale created with an eight factor structure. Cronbach's a for the 26 items was 0.90; with the exception of two factors, alpha for all of the individual sub-factors was high at 0.7 or higher. The intraclass correlation coefficient for the 26 items was 0.89 (p < 0.001). With regard to criterion-related validity, concurrent validity was confirmed and the correlation coefficient with an external criterion was 0.73 (p < 0.001). For content validity, subjects who responded that "The questionnaire represents a stressor well or to a degree" accounted for 81% of the total responses. Reliability and validity were confirmed, so the scale created in the current research is a usable scale.

Validity of maximal isometric knee extension strength measurements obtained via belt-stabilized hand-held dynamometry in healthy adults.

PubMed

Ushiyama, Naoko; Kurobe, Yasushi; Momose, Kimito

2017-11-01

[Purpose] To determine the validity of knee extension muscle strength measurements using belt-stabilized hand-held dynamometry with and without body stabilization compared with the gold standard isokinetic dynamometry in healthy adults. [Subjects and Methods] Twenty-nine healthy adults (mean age, 21.3 years) were included. Study parameters involved right side measurements of maximal isometric knee extension strength obtained using belt-stabilized hand-held dynamometry with and without body stabilization and the gold standard. Measurements were performed in all subjects. [Results] A moderate correlation and fixed bias were found between measurements obtained using belt-stabilized hand-held dynamometry with body stabilization and the gold standard. No significant correlation and proportional bias were found between measurements obtained using belt-stabilized hand-held dynamometry without body stabilization and the gold standard. The strength identified using belt-stabilized hand-held dynamometry with body stabilization may not be commensurate with the maximum strength individuals can generate; however, it reflects such strength. In contrast, the strength identified using belt-stabilized hand-held dynamometry without body stabilization does not reflect the maximum strength. Therefore, a chair should be used to stabilize the body when performing measurements of maximal isometric knee extension strength using belt-stabilized hand-held dynamometry in healthy adults. [Conclusion] Belt-stabilized hand-held dynamometry with body stabilization is more convenient than the gold standard in clinical settings.

Investigating the potential of Bacillus subtilis alpha-amylase as a pressure-temperature-time indicator for high hydrostatic pressure pasteurization processes.

PubMed

Grauwet, Tara; Van der Plancken, Iesel; Vervoort, Liesbeth; Hendrickx, Marc E; Van Loey, Ann

2009-01-01

The potential of Bacillus subtilis alpha-amylase (BSA) as a pressure-temperature-time indicator (pTTI) for high pressure pasteurization processing (400-600 MPa; T(i) 10-40 degrees C; 1-15 min) was investigated. A stepwise approach was followed for the development of an enzyme-based, extrinsic, isolated pTTI. First, based on literature data on the pressure stability, BSA was selected as a candidate indicator. Next to the accuracy and ease of the measurement of the indicator's response (residual activity) to the pressure treatment, the storage and handling stability of BSA at atmospheric pressure was verified. Second, the stability of BSA at a constant temperature (T) and time in function of pressure (p) was investigated. Solvent engineering was used to shift the inactivation window of BSA in the processing range of interest. Third, the enzyme (1 g/L BSA-MES 0.05 M pH 5.0) was kinetically calibrated under isobaric-isothermal conditions. Time dependent changes in activity could be modeled best by a first-order model. Except for low pressures and high temperatures, a synergistic effect between pressure and temperature could be observed. Based on the model selected to describe the combined p,T-dependency of the inactivation rate constant, an elliptically shaped isorate contour plot could be constructed, illustrating the processing range where BSA can be used to demonstrate temperature gradients. Fourth, the validity of the kinetic model was tested successfully under dynamic conditions similar to those used in food industry. Finally, the indicator was found suitable to demonstrate nonuniformity in two-sectional planes of a vertical, single vessel system. (c) 2009 American Institute of Chemical Engineers. Biotechnol. Prog., 2009.

Longitudinal Stability of Person Characteristics: Intelligence and Creativity.

ERIC Educational Resources Information Center

Magnusson, D.; Backteman, G.

1979-01-01

A longitudinal study of approximately 1,000 students aged 10-16 showed high stability of intelligence and creativity. Stability coefficients for intelligence were higher than those for creativity. Results supported the construct validity of creativity. (MH)

Psychometric Properties of Eating Disorder Instruments in Black and White Young Women: Internal Consistency, Temporal Stability, and Validity

ERIC Educational Resources Information Center

Bardone-Cone, Anna M.; Boyd, Clarissa A.

2007-01-01

Most of the major instruments in the eating disorder field have documented psychometric support only in predominantly White samples. The current study examined the internal consistency, temporal stability, and convergent and discriminant validity of a variety of eating disorder measures in Black (n = 97) and White (n = 179) female undergraduates.…

EO-1 Hyperion Reflectance Time Series at Calibration and Validation Sites: Stability and Sensitivity to Seasonal Dynamics

NASA Technical Reports Server (NTRS)

Campbell, Petya K. Entcheva; Middleton, Elizabeth M.; Thome, Kurt J.; Kokaly, Raymond F.; Huemmrich, Karl Fred; Lagomasino, David; Novick, Kimberly A.; Brunsell, Nathaniel A.

2013-01-01

This study evaluated Earth Observing 1 (EO-1) Hyperion reflectance time series at established calibration sites to assess the instrument stability and suitability for monitoring vegetation functional parameters. Our analysis using three pseudo-invariant calibration sites in North America indicated that the reflectance time series are devoid of apparent spectral trends and their stability consistently is within 2.5-5 percent throughout most of the spectral range spanning the 12-plus year data record. Using three vegetated sites instrumented with eddy covariance towers, the Hyperion reflectance time series were evaluated for their ability to determine important variables of ecosystem function. A number of narrowband and derivative vegetation indices (VI) closely described the seasonal profiles in vegetation function and ecosystem carbon exchange (e.g., net and gross ecosystem productivity) in three very different ecosystems, including a hardwood forest and tallgrass prairie in North America, and a Miombo woodland in Africa. Our results demonstrate the potential for scaling the carbon flux tower measurements to local and regional landscape levels. The VIs with stronger relationships to the CO2 parameters were derived using continuous reflectance spectra and included wavelengths associated with chlorophyll content and/or chlorophyll fluorescence. Since these indices cannot be calculated from broadband multispectral instrument data, the opportunity to exploit these spectrometer-based VIs in the future will depend on the launch of satellites such as EnMAP and HyspIRI. This study highlights the practical utility of space-borne spectrometers for characterization of the spectral stability and uniformity of the calibration sites in support of sensor cross-comparisons, and demonstrates the potential of narrowband VIs to track and spatially extend ecosystem functional status as well as carbon processes measured at flux towers.

EO-1 Hyperion reflectance time series at calibration and validation sites: stability and sensitivity to seasonal dynamics

USGS Publications Warehouse

Campbell, P.K.E.; Middleton, E.M.; Thome, K.J.; Kokaly, Raymond F.; Huemmrich, K.F.; Novick, K.A.; Brunsell, N.A.

2013-01-01

This study evaluated Earth Observing 1 (EO-1) Hyperion reflectance time series at established calibration sites to assess the instrument stability and suitability for monitoring vegetation functional parameters. Our analysis using three pseudo-invariant calibration sites in North America indicated that the reflectance time series are devoid of apparent spectral trends and their stability consistently is within 2.5-5 percent throughout most of the spectral range spanning the 12+ year data record. Using three vegetated sites instrumented with eddy covariance towers, the Hyperion reflectance time series were evaluated for their ability to determine important variables of ecosystem function. A number of narrowband and derivative vegetation indices (VI) closely described the seasonal profiles in vegetation function and ecosystem carbon exchange (e.g., net and gross ecosystem productivity) in three very different ecosystems, including a hardwood forest and tallgrass prairie in North America, and a Miombo woodland in Africa. Our results demonstrate the potential for scaling the carbon flux tower measurements to local and regional landscape levels. The VIs with stronger relationships to the CO2 parameters were derived using continuous reflectance spectra and included wavelengths associated with chlorophyll content and/or chlorophyll fluorescence. Since these indices cannot be calculated from broadband multispectral instrument data, the opportunity to exploit these spectrometer-based VIs in the future will depend on the launch of satellites such as EnMAP and HyspIRI. This study highlights the practical utility of space-borne spectrometers for characterization of the spectral stability and uniformity of the calibration sites in support of sensor cross-comparisons, and demonstrates the potential of narrowband VIs to track and spatially extend ecosystem functional status as well as carbon processes measured at flux towers.

How PEGylation enhances the stability and potency of insulin: a molecular dynamics simulation.

PubMed

Yang, Cheng; Lu, Diannan; Liu, Zheng

2011-04-05

While the effectiveness of PEGylation in enhancing the stability and potency of protein pharmaceuticals has been validated for years, the underlying mechanism remains poorly understood, particularly at the molecular level. A molecular dynamics simulation was developed using an annealing procedure that allowed an all-atom level examination of the interaction between PEG polymers of different chain lengths and a conjugated protein represented by insulin. It was shown that PEG became entangled around the protein surface through hydrophobic interaction and concurrently formed hydrogen bonds with the surrounding water molecules. In addition to enhancing its structural stability, as indicated by the root-mean-square difference (rmsd) and secondary structure analyses, conjugation increased the size of the protein drug while decreasing the solvent accessible surface area of the protein. All these thus led to prolonged circulation life despite kidney filtration, proteolysis, and immunogenic side effects, as experimentally demonstrated elsewhere. Moreover, the simulation results indicated that an optimal chain length exists that would maximize drug potency underpinned by the parameters mentioned above. The simulation provided molecular insight into the interaction between PEG and the conjugated protein at the all-atom level and offered a tool that would allow for the design of PEGylated protein pharmaceuticals for given applications.

A risk-model for hospital mortality among patients with severe sepsis or septic shock based on German national administrative claims data

PubMed Central

Fleischmann-Struzek, Carolin; Rüddel, Hendrik; Reinhart, Konrad; Thomas-Rüddel, Daniel O.

2018-01-01

Background Sepsis is a major cause of preventable deaths in hospitals. Feasible and valid methods for comparing quality of sepsis care between hospitals are needed. The aim of this study was to develop a risk-adjustment model suitable for comparing sepsis-related mortality between German hospitals. Methods We developed a risk-model using national German claims data. Since these data are available with a time-lag of 1.5 years only, the stability of the model across time was investigated. The model was derived from inpatient cases with severe sepsis or septic shock treated in 2013 using logistic regression with backward selection and generalized estimating equations to correct for clustering. It was validated among cases treated in 2015. Finally, the model development was repeated in 2015. To investigate secular changes, the risk-adjusted trajectory of mortality across the years 2010–2015 was analyzed. Results The 2013 deviation sample consisted of 113,750 cases; the 2015 validation sample consisted of 134,851 cases. The model developed in 2013 showed good validity regarding discrimination (AUC = 0.74), calibration (observed mortality in 1st and 10th risk-decile: 11%-78%), and fit (R2 = 0.16). Validity remained stable when the model was applied to 2015 (AUC = 0.74, 1st and 10th risk-decile: 10%-77%, R2 = 0.17). There was no indication of overfitting of the model. The final model developed in year 2015 contained 40 risk-factors. Between 2010 and 2015 hospital mortality in sepsis decreased from 48% to 42%. Adjusted for risk-factors the trajectory of decrease was still significant. Conclusions The risk-model shows good predictive validity and stability across time. The model is suitable to be used as an external algorithm for comparing risk-adjusted sepsis mortality among German hospitals or regions based on administrative claims data, but secular changes need to be taken into account when interpreting risk-adjusted mortality. PMID:29558486

A risk-model for hospital mortality among patients with severe sepsis or septic shock based on German national administrative claims data.

PubMed

Schwarzkopf, Daniel; Fleischmann-Struzek, Carolin; Rüddel, Hendrik; Reinhart, Konrad; Thomas-Rüddel, Daniel O

2018-01-01

Sepsis is a major cause of preventable deaths in hospitals. Feasible and valid methods for comparing quality of sepsis care between hospitals are needed. The aim of this study was to develop a risk-adjustment model suitable for comparing sepsis-related mortality between German hospitals. We developed a risk-model using national German claims data. Since these data are available with a time-lag of 1.5 years only, the stability of the model across time was investigated. The model was derived from inpatient cases with severe sepsis or septic shock treated in 2013 using logistic regression with backward selection and generalized estimating equations to correct for clustering. It was validated among cases treated in 2015. Finally, the model development was repeated in 2015. To investigate secular changes, the risk-adjusted trajectory of mortality across the years 2010-2015 was analyzed. The 2013 deviation sample consisted of 113,750 cases; the 2015 validation sample consisted of 134,851 cases. The model developed in 2013 showed good validity regarding discrimination (AUC = 0.74), calibration (observed mortality in 1st and 10th risk-decile: 11%-78%), and fit (R2 = 0.16). Validity remained stable when the model was applied to 2015 (AUC = 0.74, 1st and 10th risk-decile: 10%-77%, R2 = 0.17). There was no indication of overfitting of the model. The final model developed in year 2015 contained 40 risk-factors. Between 2010 and 2015 hospital mortality in sepsis decreased from 48% to 42%. Adjusted for risk-factors the trajectory of decrease was still significant. The risk-model shows good predictive validity and stability across time. The model is suitable to be used as an external algorithm for comparing risk-adjusted sepsis mortality among German hospitals or regions based on administrative claims data, but secular changes need to be taken into account when interpreting risk-adjusted mortality.

Advancement of the Subjective Vitality Scale: examination of alternative measurement models for Japanese and Singaporeans.

PubMed

Kawabata, M; Yamazaki, F; Guo, D W; Chatzisarantis, N L D

2017-12-01

The Subjective Vitality Scale (SVS: Ryan & Frederick, 1997) is a 7-item self-report instrument to measure one's level of vitality and has been widely used in psychological studies. However, there have been discrepancies in which version of the SVS (7- or 6-item version) employed between as well as within researchers. Moreover, Item 5 seems not be a good indicator of vitality from a content validity perspective. Therefore, the present study aimed to evaluate the validity and reliability of the SVS for Japanese and Singaporeans rigorously by comparing 3 measurement models (5-, 6-, and 7-item models). To this end, the scale was first translated from English to Japanese and then the Japanese and English versions of the scale were administered to Japanese (n = 268) and Singaporean undergraduate students (n = 289), respectively. The factorial and concurrent validity of the three models were examined independently on each of the samples. Furthermore, the covariance stability of the vitality responses was assessed over a 4-week time period for another independent Japanese sample (n = 140). The findings from this study indicated that from methodological and content validity perspectives, the 5-item model is considered most preferable for both language versions of the SVS. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

QbD-Based Development and Validation of a Stability-Indicating HPLC Method for Estimating Ketoprofen in Bulk Drug and Proniosomal Vesicular System.

PubMed

Yadav, Nand K; Raghuvanshi, Ashish; Sharma, Gajanand; Beg, Sarwar; Katare, Om P; Nanda, Sanju

2016-03-01

The current studies entail systematic quality by design (QbD)-based development of simple, precise, cost-effective and stability-indicating high-performance liquid chromatography method for estimation of ketoprofen. Analytical target profile was defined and critical analytical attributes (CAAs) were selected. Chromatographic separation was accomplished with an isocratic, reversed-phase chromatography using C-18 column, pH 6.8, phosphate buffer-methanol (50 : 50v/v) as a mobile phase at a flow rate of 1.0 mL/min and UV detection at 258 nm. Systematic optimization of chromatographic method was performed using central composite design by evaluating theoretical plates and peak tailing as the CAAs. The method was validated as per International Conference on Harmonization guidelines with parameters such as high sensitivity, specificity of the method with linearity ranging between 0.05 and 250 µg/mL, detection limit of 0.025 µg/mL and quantification limit of 0.05 µg/mL. Precision was demonstrated using relative standard deviation of 1.21%. Stress degradation studies performed using acid, base, peroxide, thermal and photolytic methods helped in identifying the degradation products in the proniosome delivery systems. The results successfully demonstrated the utility of QbD for optimizing the chromatographic conditions for developing highly sensitive liquid chromatographic method for ketoprofen. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Fault parameter constraints using relocated earthquakes: A validation of first-motion focal-mechanism data

USGS Publications Warehouse

Kilb, Debi; Hardebeck, J.L.

2006-01-01

We estimate the strike and dip of three California fault segments (Calaveras, Sargent, and a portion of the San Andreas near San Jaun Bautistia) based on principle component analysis of accurately located microearthquakes. We compare these fault orientations with two different first-motion focal mechanism catalogs: the Northern California Earthquake Data Center (NCEDC) catalog, calculated using the FPFIT algorithm (Reasenberg and Oppenheimer, 1985), and a catalog created using the HASH algorithm that tests mechanism stability relative to seismic velocity model variations and earthquake location (Hardebeck and Shearer, 2002). We assume any disagreement (misfit >30° in strike, dip, or rake) indicates inaccurate focal mechanisms in the catalogs. With this assumption, we can quantify the parameters that identify the most optimally constrained focal mechanisms. For the NCEDC/FPFIT catalogs, we find that the best quantitative discriminator of quality focal mechanisms is the station distribution ratio (STDR) parameter, an indicator of how the stations are distributed about the focal sphere. Requiring STDR > 0.65 increases the acceptable mechanisms from 34%–37% to 63%–68%. This suggests stations should be uniformly distributed surrounding, rather than aligning, known fault traces. For the HASH catalogs, the fault plane uncertainty (FPU) parameter is the best discriminator, increasing the percent of acceptable mechanisms from 63%–78% to 81%–83% when FPU ≤ 35°. The overall higher percentage of acceptable mechanisms and the usefulness of the formal uncertainty in identifying quality mechanisms validate the HASH approach of testing for mechanism stability.

Stability-Indicating TLC-Densitometric and HPLC Methods for the Simultaneous Determination of Piracetam and Vincamine in the Presence of Their Degradation Products.

PubMed

Ahmed, Amal B; Abdelrahman, Maha M; Abdelwahab, Nada S; Salama, Fathy M

2016-11-01

Newly established TLC-densitometric and RP-HPLC methods were developed and validated for the simultaneous determination of Piracetam (PIR) and Vincamine (VINC) in their pharmaceutical formulation and in the presence of PIR and VINC degradation products, PD and VD, respectively. The proposed TLC-densitometric method is based on the separation and quantitation of the studied components using a developing system that consists of chloroform-methanol-glacial acetic acid-triethylamine (8 + 2 + 0.1 + 0.1, v/v/v/v) on TLC silica gel 60 F254 plates, followed by densitometric scanning at 230 nm. On the other hand, the developed RP-HPLC method is based on the separation of the studied components using an isocratic elution of 0.05 M KH2PO4 (containing 0.1% triethylamine adjusted to pH 3 with orthophosphoric acid)-methanol (95 + 5, v/v) on a C8 column at a flow rate of 1 mL/min with diode-array detection at 230 nm. The developed methods were validated according to International Conference on Harmonization guidelines and demonstrated good accuracy and precision. Moreover, the developed TLC-densitometric and RP-HPLC methods are suitable as stability-indicating assay methods for the simultaneous determination of PD and VD either in bulk powder or pharmaceutical formulation. The results were statistically compared with those obtained by the reported RP-HPLC method using t- and F-tests.

Rank Order Entropy: why one metric is not enough

PubMed Central

McLellan, Margaret R.; Ryan, M. Dominic; Breneman, Curt M.

2011-01-01

The use of Quantitative Structure-Activity Relationship models to address problems in drug discovery has a mixed history, generally resulting from the mis-application of QSAR models that were either poorly constructed or used outside of their domains of applicability. This situation has motivated the development of a variety of model performance metrics (r2, PRESS r2, F-tests, etc) designed to increase user confidence in the validity of QSAR predictions. In a typical workflow scenario, QSAR models are created and validated on training sets of molecules using metrics such as Leave-One-Out or many-fold cross-validation methods that attempt to assess their internal consistency. However, few current validation methods are designed to directly address the stability of QSAR predictions in response to changes in the information content of the training set. Since the main purpose of QSAR is to quickly and accurately estimate a property of interest for an untested set of molecules, it makes sense to have a means at hand to correctly set user expectations of model performance. In fact, the numerical value of a molecular prediction is often less important to the end user than knowing the rank order of that set of molecules according to their predicted endpoint values. Consequently, a means for characterizing the stability of predicted rank order is an important component of predictive QSAR. Unfortunately, none of the many validation metrics currently available directly measure the stability of rank order prediction, making the development of an additional metric that can quantify model stability a high priority. To address this need, this work examines the stabilities of QSAR rank order models created from representative data sets, descriptor sets, and modeling methods that were then assessed using Kendall Tau as a rank order metric, upon which the Shannon Entropy was evaluated as a means of quantifying rank-order stability. Random removal of data from the training set, also known as Data Truncation Analysis (DTA), was used as a means for systematically reducing the information content of each training set while examining both rank order performance and rank order stability in the face of training set data loss. The premise for DTA ROE model evaluation is that the response of a model to incremental loss of training information will be indicative of the quality and sufficiency of its training set, learning method, and descriptor types to cover a particular domain of applicability. This process is termed a “rank order entropy” evaluation, or ROE. By analogy with information theory, an unstable rank order model displays a high level of implicit entropy, while a QSAR rank order model which remains nearly unchanged during training set reductions would show low entropy. In this work, the ROE metric was applied to 71 data sets of different sizes, and was found to reveal more information about the behavior of the models than traditional metrics alone. Stable, or consistently performing models, did not necessarily predict rank order well. Models that performed well in rank order did not necessarily perform well in traditional metrics. In the end, it was shown that ROE metrics suggested that some QSAR models that are typically used should be discarded. ROE evaluation helps to discern which combinations of data set, descriptor set, and modeling methods lead to usable models in prioritization schemes, and provides confidence in the use of a particular model within a specific domain of applicability. PMID:21875058

Improved Chemical Stability and Antiproliferative Activities of Curcumin-Loaded Nanoparticles with a Chitosan Chlorogenic Acid Conjugate.

PubMed

Fan, Yuting; Yi, Jiang; Zhang, Yuzhu; Yokoyama, Wallace

2017-12-13

A chitosan (CS)-chlorogenic acid (CA) conjugate was successfully prepared through free-radical-induced protocols with a substitution of CA on CS of 103.5 mg/g. ATR-FTIR and 1 H NMR results validated the covalent conjugation of CA onto CS. XRD results indicated the decrease of crystallinity after CA conjugation. DPPH-scavenging activity and reducing-power studies indicated that the CS-CA conjugate had stronger antioxidant activity than chitosan. The particle diameters of curcumin-loaded CS and CS-CA nanoparticles simultaneously formed by ionic gelling in the presence of tripolyphosphate (TPP) were less than 300 nm (243.6 and 256.5 nm, respectively), and zeta-potential values between 25 and 30 mV were obtained. TEM results showed that the nanoparticles were spherically shaped and homogeneously dispersed. Curcumin with the CS-CA conjugate showed better heat stability than with CA at both temperatures (25 and 95 °C) (p <0.05). Curcumin release was inhibited by the CS-CA conjugate. The total release amount of curcumin from CS and CS-CA-conjugate nanoparticles were 70.5 and 61.7%, respectively (p <0.05). A methyl thiazolyl tetrazolium (MTT) assay showed that the antiproliferative activity of curcumin in CS-CA nanoparticles was remarkably higher than that in CS nanoparticles because of the higher chemical stability. The results suggest that CS-CA-based nanoparticles are promising candidates for the encapsulation and controlled release of hydrophobic, bioactive compounds and can improve these compounds' chemical stabilities and anticancer activities.

Stability of alemtuzumab solutions at room temperature.

PubMed

Goldspiel, Justin T; Goldspiel, Barry R; Grimes, George J; Yuan, Peng; Potti, Gopal

2013-03-01

The 24-hour stability of alemtuzumab solutions prepared at concentrations not included in the product label and stored in glass or polyolefin containers at room temperature was evaluated. Triplicate solutions of alemtuzumab (6.67, 40, and 120 μg/mL) in 0.9% sodium chloride were prepared in either glass bottles or polyolefin containers and stored at room temperature under normal fluorescent lighting conditions. The solutions were analyzed by a validated stability-indicating high-performance liquid chromatography (HPLC) assay at time zero and 8, 14, and 24 hours after preparation; solution pH values were measured and the containers visually inspected at all time points. Stability was defined as the retention of ≥90% of the initial alemtuzumab concentration. HPLC analysis indicated that the percentage of the initial alemtuzumab concentration retained was >90% for all solutions evaluated, with no significant changes over the study period. The most dilute alemtuzumab solution (6.67 μg/mL) showed some degradation (91% of the initial concentration retained at hour 24), whereas the retained concentration was >99% for all other preparations throughout the study period. Solution pH values varied by drug concentration but did not change significantly over 24 hours. No evidence of particle formation was detected in any solution by visual inspection at any time during the study. Solutions of alemtuzumab 6.67 μg/mL stored in glass bottles and solutions of 40 and 120 μg/mL stored in polyolefin containers were stable for at least 24 hours at room temperature.

Quantitative assessment of the risk of microbial spoilage in foods. Prediction of non-stability at 55 °C caused by Geobacillus stearothermophilus in canned green beans.

PubMed

Rigaux, Clémence; André, Stéphane; Albert, Isabelle; Carlin, Frédéric

2014-02-03

Microbial spoilage of canned foods by thermophilic and highly heat-resistant spore-forming bacteria, such as Geobacillus stearothermophilus, is a persistent problem in the food industry. An incubation test at 55 °C for 7 days, then validation of biological stability, is used as an indicator of compliance with good manufacturing practices. We propose a microbial risk assessment model predicting the percentage of non-stability due to G. stearothermophilus in canned green beans manufactured by a French company. The model accounts for initial microbial contaminations of fresh unprocessed green beans with G. stearothermophilus, cross-contaminations in the processing chain, inactivation processes and probability of survival and growth. The sterilization process is modeled by an equivalent heating time depending on sterilization value F₀ and on G. stearothermophilus resistance parameter z(T). Following the recommendations of international organizations, second order Monte-Carlo simulations are used, separately propagating uncertainty and variability on parameters. As a result of the model, the mean predicted non-stability rate is of 0.5%, with a 95% uncertainty interval of [0.1%; 1.2%], which is highly similar to data communicated by the French industry. A sensitivity analysis based on Sobol indices and some scenario tests underline the importance of cross-contamination at the blanching step, in addition to inactivation due to the sterilization process. Copyright © 2013 Elsevier B.V. All rights reserved.

Sexual compulsivity scale: adaptation and validation in the spanish population.

PubMed

Ballester-Arnal, Rafael; Gómez-Martínez, Sandra; Llario, M Dolores-Gil; Salmerón-Sánchez, Pedro

2013-01-01

Sexual compulsivity has been studied in relation to high-risk behavior for sexually transmitted infections. The aim of this study was the adaptation and validation of the Sexual Compulsivity Scale to a sample of Spanish young people. This scale was applied to 1,196 (891 female, 305 male) Spanish college students. The results of principal components factor analysis using a varimax rotation indicated a two-factor solution. The reliability of the Sexual Compulsivity Scale was found to be high. Moreover, the scale showed good temporal stability. External correlates were examined through Pearson correlations between the Sexual Compulsivity Scale and other constructs related with HIV prevention. The authors' results suggest that the Sexual Compulsivity Scale is an appropriate measure for assessing sexual compulsivity, showing adequate psychometric properties in the Spanish population.

A Statistical Study on the Effect of Hydrostatic Pressure on Metastable Pitting Corrosion of X70 Pipeline Steel.

PubMed

Yang, Zixuan; Kan, Bo; Li, Jinxu; Qiao, Lijie; Volinsky, Alex A; Su, Yanjing

2017-11-14

Hydrostatic pressure effects on pitting initiation and propagation in X70 steel are investigated by evaluating metastable pitting probability using electrochemical methods and immersion corrosion tests in containing chlorine ion solution. Potentiodynamic tests indicated that hydrostatic pressure can decrease the breakdown potential and lead to a reduced transpassivity region. Metastable test results revealed that hydrostatic pressure can increase metastable pitting formation frequency and promote stabilization of metastable pitting growth. Electrochemical impedance spectroscopy (EIS) results indicate that Hydrostatic pressure decreases the charge transfer resistance and increases the dissolution rate within the cavities. Corrosion test results also indicated that pitting initiation and propagation are accelerated by hydrostatic pressure. Result validity was verified by evaluating metastable pitting to predict pitting corrosion resistance.

A Statistical Study on the Effect of Hydrostatic Pressure on Metastable Pitting Corrosion of X70 Pipeline Steel

PubMed Central

Yang, Zixuan; Kan, Bo; Li, Jinxu; Su, Yanjing; Qiao, Lijie; Volinsky, Alex A.

2017-01-01

Hydrostatic pressure effects on pitting initiation and propagation in X70 steel are investigated by evaluating metastable pitting probability using electrochemical methods and immersion corrosion tests in containing chlorine ion solution. Potentiodynamic tests indicated that hydrostatic pressure can decrease the breakdown potential and lead to a reduced transpassivity region. Metastable test results revealed that hydrostatic pressure can increase metastable pitting formation frequency and promote stabilization of metastable pitting growth. Electrochemical impedance spectroscopy (EIS) results indicate that Hydrostatic pressure decreases the charge transfer resistance and increases the dissolution rate within the cavities. Corrosion test results also indicated that pitting initiation and propagation are accelerated by hydrostatic pressure. Result validity was verified by evaluating metastable pitting to predict pitting corrosion resistance. PMID:29135912

Development and validation of a measure of food choice values.

PubMed

Lyerly, Jordan E; Reeve, Charlie L

2015-06-01

Food choice values (FCVs) are factors that individuals consider when deciding which foods to purchase and/or consume. Given the potentially important implications for health, it is critical for researchers to have access to a validated measure of FCV. Though there is an existing measure of FCV, this measure was developed 20 years ago and recent research suggests additional FCVs exist that are not included in this measure. A series of four studies was conducted to develop a new expanded measure of FCV. An eight-factor model of FCV was supported and confirmed. In aggregate, results from the four studies indicate that the measure is content valid, and has internally consistent scales that also demonstrated acceptable temporal stability and convergent validity. In addition, the eight scales of the measures were independent of social desirability, met criteria for measurement invariance across income groups, and predicted dietary intake. The development of this new measure of FCV may be useful for researchers examining FCVs (FCVs) in the future, as well as for use in intervention and prevention efforts targeting dietary choices. Copyright © 2015 Elsevier Ltd. All rights reserved.

Exercise stereotypes and health-related outcomes in French people living with HIV: development and validation of an HIV Exercise Stereotypes Scale (HIVESS).

PubMed

Gray, Laura; Falzon, Charlène; Bergamaschi, Alessandro; Schuft, Laura; Durant, Jacques; Rosenthal, Eric; Pradier, Christian; Duracinsky, Martin; Rouanet, Isabelle; Colson, Serge S; d'Arripe-Longueville, Fabienne

2016-11-14

The main objective of the current study was to develop and validate a French exercise stereotype scale for people living with HIV (PLHIV) in order to gain visibility to the possible barriers and facilitators for exercise in PLHIV and thus enhance their quality of life. A series of four complementary studies was carried out with a total sample of 524 participants to: (a) develop a preliminary version of the HIV Exercise Stereotype Scale (HIVESS) (Stage 1), (b) confirm the factorial structure of the instrument (Stage 2), (c) evaluate the stability of the instrument (Stage 3), and (d) examine the construct and divergent validity of the scale (Stage 4). Results provided support for a 14-item scale with three sub-scales reporting stereotypes related to exercise benefits, exercise risks and lack of capacity for exercise with Cronbach's alphas of .77, .69 and .76 respectively. Results showed good factorial structure, strong reliability and indicators of convergent validity relating to self-efficacy, exercise and quality of life. The HIVESS presented satisfactory psychometric properties, constitutes a reliable and valid instrument to measure exercise stereotypes among PLHIV and has applications for future research and clinical practice.

Validation of a liquid chromatography method for the simultaneous determination of sulfadimethoxine and trimethoprim and application to a stability study.

PubMed

Louati, K; Mistiri, F; Kallel, M; Safta, F

2010-03-01

A liquid chromatography method is described for the simultaneous determination of sulfadimetoxine and trimethoprim from a veterinary formulation at the proportion of 187 mg and 40 mg respectively in presence of some excipient. The solution was subjected to different International Conference On Harmonisation prescribed stress conditions (hydrolysis, oxidation and photolysis). A stability-indicating high-performance liquid chromatography method was developed for the analysis of active substances in presence of their major degradation products. It involved a Knauer Eurospher C18 thermostated column at 25 degrees C, and 9.57 mM phosphate buffer (pH adjusted to 2.0 with orthophosphoric acid)-acetonitrile (70:30 v/v) as mobile phase. The mobile phase flow rate and sample volume injected were 1.2 mL/min and 20 microL, respectively. The selected wavelength for the determination was 248 nm. The method was validated for linearity, precision, accuracy and specificity, and then applied to a stability study of sulfadimetoxine and trimethoprim in the veterinary solution packaged in high density polyethylene plastic bottles of 1 L and 100 mL thermosealed and no thermosealed and corked by a white cap, at both accelerated and long-term conditions required by the International Conference On Harmonisation. The method developed, which separates all of the most degradation products formed under variety of conditions, proved to be simple, accurate, precise and specific. The results of the stress degradation show that the solution is more sensitive to hydrolysis. The stability studies carried out on three batches of each presentation show that the finished product remains stable for six months. Copyright 2010 Elsevier Masson SAS. All rights reserved.

Stability-indicating UPLC method for determining related substances and degradants in dronedarone.

PubMed

Pydimarry, Surya Prakash Rao; Cholleti, Vijay Kumar; Vangala, Ranga Reddy

2014-08-01

A simple, sensitive and reproducible method was developed on ultra-performance liquid chromatography coupled with photodiode array detection for the quantitative determination of dronedarone hydrochloride (DRO) in drug substance and pharmaceutical dosage forms. The method is applicable for the quantification of related substances and assays of drug substances. Chromatographic separation was achieved on Acquity UPLC BEH C8 100 mm, 2.1 mm and 1.7 µm columns, using gradient elution within a short run time of 10.0 min. The eluted compounds were monitored at 288 nm, the flow rate was 0.5 mL/min and the column oven temperature was maintained at 40°C. The resolution of DRO and 11 impurities (potentials and by-products) was greater than 2.0 for all pairs of components. The high correlation coefficient value (>0.9995) indicates the clear correlations between the concentrations of investigated compound and their peak areas within the test ranges. The repeatability and intermediate precision, expressed by the relative standard deviation, were less than 2.5%. The accuracy and validity of the method were further ascertained by performing recovery studies via a spike method. The accuracy of the method, expressed as relative error, was satisfactory. No interference was observed from concomitant substances normally added to the tablets. DRO was subjected to the stress conditions of oxidative, acid, base, hydrolytic, thermal and photolytic degradation. DRO was found to degrade significantly in acid and base stress conditions and to remain stable in thermal, photolytic degradation, oxidative and hydrolytic conditions. The degradation products were well resolved from primary peak and its impurities, proving that the method is stability indicating. The developed method was validated as per International Conference on Harmonization guidelines with respect to specificity, limit of detection, limit of quantification, linearity, accuracy, precision, solution stability and robustness. This method is also suitable for the determination of DRO drug substance and pharmaceutical dosage forms. © The Author [2013]. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Early Identification of Children at Risk for Academic Difficulties Using Standardized Assessment: Stability and Predictive Validity of Preschool Math and Language Scores

ERIC Educational Resources Information Center

Frans, Niek; Post, Wendy J.; Huisman, Mark; Oenema-Mostert, Ineke C. E.; Keegstra, Anne L.; Minnaert, Alexander E. M. G.

2017-01-01

Despite the claim by several researchers that variability in performance may complicate the identification of "at-risk" children, variability in the academic performance of young children remains an undervalued area of research. The goal of this study is to examine the predictive validity for future scores and the score stability of two…

Stability of the thermodynamic equilibrium - A test of the validity of dynamic models as applied to gyroviscous perpendicular magnetohydrodynamics

NASA Astrophysics Data System (ADS)

Faghihi, Mustafa; Scheffel, Jan; Spies, Guenther O.

1988-05-01

Stability of the thermodynamic equilibrium is put forward as a simple test of the validity of dynamic equations, and is applied to perpendicular gyroviscous magnetohydrodynamics (i.e., perpendicular magnetohydrodynamics with gyroviscosity added). This model turns out to be invalid because it predicts exponentially growing Alfven waves in a spatially homogeneous static equilibrium with scalar pressure.

Chemical stability of oseltamivir in oral solutions.

PubMed

Albert, K; Bockshorn, J

2007-09-01

The stability of oseltamivir in oral aqueous solutions containing the preservative sodium benzoate was studied by a stability indicating HPLC-method. The separation was achieved on a RP-18 ec column using a gradient of mobile phase A (aqueous solution of 50 mM ammonium acetate) and mobile phase B (60% (v/v) acetonitrile/40% (v/v) mobile phase A). The assay was subsequently validated according to the ICH guideline Q2(R1). The extemporaneously prepared "Oseltamivir Oral Solution 15 mg/ml for Adults or for Children" (NRF 31.2.) according to the German National Formulary ("Neues Rezeptur-Formularium") was stable for 84 days if stored under refrigeration. After storage at 25 degrees C the content of oseltamivir decreased to 98.4%. Considering the toxicological limit of 0.5% of the 5-acetylamino derivative (the so-called isomer I) the solution is stable for 46 days. Oseltamivir was less stable in a solution prepared with potable water instead of purified water. Due to an increasing pH the stability of this solution decreased to 14 days. Furthermore a white precipitate of mainly calcium phosphate was observed. The addition of 0.1% anhydrous citric acid avoided these problems and improved the stability of the solution prepared with potable water to 63 days. Sodium benzoate was stable in all oral solutions tested.

Recent Advances in Heliogyro Solar Sail Structural Dynamics, Stability, and Control Research

NASA Technical Reports Server (NTRS)

Wilkie, W. Keats; Warren, Jerry E.; Horta, Lucas G.; Lyle, Karen H.; Juang, Jer-Nan; Gibbs, S. Chad; Dowell, Earl H.; Guerrant, Daniel V.; Lawrence, Dale

2015-01-01

Results from recent NASA sponsored research on the structural dynamics, stability, and control characteristics of heliogyro solar sails are summarized. Specific areas under investigation include coupled nonlinear finite element analysis of heliogyro membrane blade with solar radiation pressure effects, system identification of spinning membrane structures, and solarelastic stability analysis of heliogyro solar sails, including stability during blade deployment. Recent results from terrestrial 1-g blade dynamics and control experiments on "rope ladder" membrane blade analogs, and small-scale in vacuo system identification experiments with hanging and spinning high-aspect ratio membranes will also be presented. A low-cost, rideshare payload heliogyro technology demonstration mission concept is used as a mission context for these heliogyro structural dynamics and solarelasticity investigations, and is also described. Blade torsional dynamic response and control are also shown to be significantly improved through the use of edge stiffening structural features or inclusion of modest tip masses to increase centrifugal stiffening of the blade structure. An output-only system identification procedure suitable for on-orbit blade dynamics investigations is also developed and validated using ground tests of spinning sub-scale heliogyro blade models. Overall, analytical and experimental investigations to date indicate no intractable stability or control issues for the heliogyro solar sail concept.

Reliability and Concurrent Validity of Dynamic Rotator Stability Test-A Cross Sectional study.

PubMed

Binoy Mathew, K V; Eapen, Charu; Kumar, P Senthil

2012-01-01

To find intra rater and inter rater reliability of Dynamic Rotator Stability Test (DRST) and to find concurrent validity of Dynamic Rotator Stability Test (DRST) with University of Pennsylvania Shoulder Score (PENN) Scale. 40 subjects of either gender between the age group of 18-70 with painful shoulder conditions of musculoskeletal origin was selected through convenient sampling. Tester 1 and tester 2 administered DRST and PENN scale randomly. In a subgroup of 20 subjects DRST was administered by both the testers to find the inter rater reliability. 180° Standard Universal Goniometer was used to take measurements. For intra-rater reliability, all the test variables were showing highly significant correlation (p=.94 - 1). For inter -rater, with tester 2, test variables like position, ROM, force, direction of abnormal translation, pain during the test, compensatory movement during test were found to be significant (p=.71-1).only some variables of DRST showed significant correlation with PENN scale (P=.320-.450). Dynamic Rotator Stability Test has good intra rater and moderate inter rater reliability. Concurrent validity of Dynamic Rotator Stability Test was found to be poor when compared to PENN Shoulder Score.

Analyses of soft tissue from Tyrannosaurus rex suggest the presence of protein.

PubMed

Schweitzer, Mary Higby; Suo, Zhiyong; Avci, Recep; Asara, John M; Allen, Mark A; Arce, Fernando Teran; Horner, John R

2007-04-13

We performed multiple analyses of Tyrannosaurus rex (specimen MOR 1125) fibrous cortical and medullary tissues remaining after demineralization. The results indicate that collagen I, the main organic component of bone, has been preserved in low concentrations in these tissues. The findings were independently confirmed by mass spectrometry. We propose a possible chemical pathway that may contribute to this preservation. The presence of endogenous protein in dinosaur bone may validate hypotheses about evolutionary relationships, rates, and patterns of molecular change and degradation, as well as the chemical stability of molecules over time.

The Italian version of the Inventory of Interpersonal Problems Personality Disorders Scales (IIP-47): psychometric properties and clinical usefulness as a screening measure.

PubMed

Ubbiali, Alessandro; Chiorri, Carlo; Donati, Deborah

2011-08-01

The Inventory of Interpersonal Problems-47 (IIP-47) is a brief and valid self-report measure for screening Personality Disorders (PDs). This study examined internal consistency, factor structure, criterion validity, temporal stability, and operating characteristics of the Italian version of the IIP-47 in two independent samples: PD subjects (n = 120) and nonclinical subjects (n = 475). Alpha coefficients ranged from .70 to .90. Multiple-Group Confirmatory Factor Analyses showed that the five-correlated-factor model reported in literature had the highest measurement invariance across the two groups. Criterion validity was supported by correlations among IIP-47 scale scores and scores on established measures of personality dimensions and pathology. Test-retest indices ranged from .71 to .95. PD subjects scored significantly higher than nonclinical subjects on all IIP-47 scales and cut-off scores for different levels of specificity and sensibility are reported. It is concluded that the psychometric properties of the original IIP-47 were preserved in its Italian version.

Examination of the validity and reliability of the French version of the Brief Self-Control Scale

PubMed Central

Brevers, Damien; Foucart, Jennifer; Verbanck, Paul; Turel, Ofir

2017-01-01

This study aims to develop and to validate a French version of the Brief Self-Control Scale (BSCS; Tangney et al., 2004). This instrument is usually applied as a unidimensional self-report measure for assessing trait self-control, which captures one’s dispositional ability to resist short-term temptation in order to reach more valuable long-term goals. Data were collected from two independent samples of French-speaking individuals (n1 = 287; n2 = 160). Results indicated that the French version of the BSCS can be treated as unidimensional, like the original questionnaire. Data also showed consistent acceptable reliability and reasonable test-retest stability. Acceptable external validity of constructs was supported by relationships with self-reported measures of impulsivity (UPPS), including urgency, lack of premeditation, and lack of perseverance. Overall, the findings suggest that the average score of the French version of the BSCS is a viable option for assessing trait self-control in French speaking populations. PMID:29200467

Reliability and validity of the Computerized Comprehension Task (CCT): data from American English and Mexican Spanish infants*

PubMed Central

FRIEND, MARGARET; KEPLINGER, MELANIE

2017-01-01

Early language comprehension may be one of the most important predictors of developmental risk. The need for performance-based assessment is predicated on limitations identified in the exclusive use of parent report and on the need for a performance measure with which to assess the convergent validity of parent report of comprehension. Child performance data require the development of procedures to facilitate infant attention and compliance. Forty infants (20 at 1;4 and 20 at 1;8) acquiring English completed a standard picture book task and the same task was administered on a touch-sensitive screen. The computerized task significantly improved task attention, compliance and performance. Reliability was high, indicating that infants were not responding randomly. Convergent validity with parent report and 4-month stability was substantial. Preliminary data extending this approach to Mexican-Spanish are presented. Results are discussed in terms of the promise of this technique for clinical and research settings and the potential influences of cultural factors on performance. PMID:18300430

Examination of the validity and reliability of the French version of the Brief Self-Control Scale.

PubMed

Brevers, Damien; Foucart, Jennifer; Verbanck, Paul; Turel, Ofir

2017-10-01

This study aims to develop and to validate a French version of the Brief Self-Control Scale (BSCS; Tangney et al., 2004). This instrument is usually applied as a unidimensional self-report measure for assessing trait self-control, which captures one's dispositional ability to resist short-term temptation in order to reach more valuable long-term goals. Data were collected from two independent samples of French-speaking individuals ( n 1 = 287; n 2 = 160). Results indicated that the French version of the BSCS can be treated as unidimensional, like the original questionnaire. Data also showed consistent acceptable reliability and reasonable test-retest stability. Acceptable external validity of constructs was supported by relationships with self-reported measures of impulsivity (UPPS), including urgency, lack of premeditation, and lack of perseverance. Overall, the findings suggest that the average score of the French version of the BSCS is a viable option for assessing trait self-control in French speaking populations.

New Stability Indicating RP-HPLC Method for the Estimation of Cefpirome Sulphate in Bulk and Pharmaceutical Dosage Forms.

PubMed

Rao, Kareti Srinivasa; Kumar, Keshar Nargesh; Joydeep, Datta

2011-01-01

A simple stability indicating reversed-phase HPLC method was developed and subsequently validated for estimation of Cefpirome sulphate (CPS) present in pharmaceutical dosage forms. The proposed RP-HPLC method utilizes a LiChroCART-Lichrosphere100, C18 RP column (250 mm × 4mm × 5 μm) in an isocratic separation mode with mobile phase consisting of methanol and water in the proportion of 50:50 % (v/v), at a flow rate 1ml/min, and the effluent was monitored at 270 nm. The retention time of CPS was 2.733 min and its formulation was exposed to acidic, alkaline, photolytic, thermal and oxidative stress conditions, and the stressed samples were analyzed by the proposed method. The described method was linear over a range of 0.5-200μg/ml. The percentage recovery was 99.46. F-test and t-test at 95% confidence level were used to check the intermediate precision data obtained under different experimental setups; the calculated value was found to be less than the critical value.

A Stability Indicating HPLC Method for the Determination of Fluvoxamine in Pharmaceutical Dosage Forms.

PubMed

Souri, Effat; Donyayi, Hassan; Khaniha, Reza Ahmad; Barazandeh Tehrani, Maliheh

2015-01-01

Fluvoxamine maleate is a selective serotonin reuptake inhibitor, which is used for the treatment of different types of depressive disorders. In the present study, a stability indicating HPLC method was developed and validated for the determination of fluvoxamine maleate. The chromatographic separation was carried out using a Nova-Pak CN column and a mixture of K2HPO4 50 mM (pH 7.0) and acetonitrile (60: 40, v/v) as the mobile phase. Target compounds were detected using a UV detector set at 235 nm. The developed method was linear over the concentration range of 1-80 μg/ml with acceptable precision (CV values < 2.0%) and accuracy (error values < 1.6%). The degradation studies showed that fluvoxamine maleate is relatively unstable under acidic, basic and oxidative conditions and also when exposed to UV radiation. On the other hand, the bulk powder of fluvoxamine maleate was relatively stable when exposed to visible light or heat. The proposed method was successfully applied for the determination of active ingredient of fluvoxamine dosage form without any interference from tablet excipients.

Validation of reference genes for RT-qPCR analysis in Herbaspirillum seropedicae.

PubMed

Pessoa, Daniella Duarte Villarinho; Vidal, Marcia Soares; Baldani, José Ivo; Simoes-Araujo, Jean Luiz

2016-08-01

The RT-qPCR technique needs a validated set of reference genes for ensuring the consistency of the results from the gene expression. Expression stabilities for 9 genes from Herbaspirillum seropedicae, strain HRC54, grown with different carbon sources were calculated using geNorm and NormFinder, and the gene rpoA showed the best stability values. Copyright © 2016 Elsevier B.V. All rights reserved.

Computational simulations assessment of mutations impact on streptokinase (SK) from a group G streptococci with enhanced activity - insights into the functional roles of structural dynamics flexibility of SK and stabilization of SK-μplasmin catalytic complex.

PubMed

Kazemi, Faegheh; Arab, Seyed Shahriar; Mohajel, Nasir; Keramati, Malihe; Niknam, Niloofar; Aslani, Mohammad Mehdi; Roohvand, Farzin

2018-05-28

Streptokinase (SK), a plasminogen activator (PA) that converts inactive plasminogen (Pg) to plasmin (Pm), is a protein secreted by groups A, C, and G streptococci (GAS, GCS, and GGS, respectively), with high sequence divergence and functional heterogeneity. While roles of some residual changes in altered SK functionality are shown, the underlying structural mechanisms are less known. Herein, using computational approaches, we analyzed the conformational basis for the increased activity of SK from a GGS (SKG132) isolate with four natural residual substitutions (Ile33Phe, Arg45Gln, Asn228Lys, Phe287Ile) compared to the standard GCS (SKC). Using the crystal structure of SK.Pm catalytic complex as main template SKC.μPm catalytic complex was modeled through homology modeling process and validated by several online validation servers. Subsequently, SKG132.μPm structure was constructed by altering the corresponding residual substitutions. Results of three independent MD simulations showed increased RMSF values for SKG132.μPm, indicating the enhanced structural flexibility compared to SKC.μPm, specially in 170 and 250 loops and three regions: R1 (149-161), R2 (182-215) and R3 (224-229). In parallel, the average number of Hydrogen bonds in 170 loop, R2 and R3 (especially for Asn228Lys) of SKG132 compared to that of the SKC was decreased. Accordingly, residue interaction networks (RINs) analyses indicated that Asn228Lys might induce more level of structural flexibility by generation of free Lys256, while Phe287Ile and Ile33Phe enhanced the stabilization of the SKG132.μPm catalytic complex. These results denoted the potential role of the optimal dynamic state and stabilized catalytic complex for increased PA potencies of SK as a thrombolytic drug.

Social Anxiety Scale for Adolescents (SAS-A): measuring social anxiety among Finnish adolescents.

PubMed

Ranta, Klaus; Junttila, Niina; Laakkonen, Eero; Uhmavaara, Anni; La Greca, Annette M; Niemi, Päivi M

2012-08-01

The aim of this study was to investigate symptoms of social anxiety and the psychometric properties of the Social Anxiety Scale for Adolescents (SAS-A) among Finnish adolescents, 13-16 years of age. Study 1 (n = 867) examined the distribution of SAS-A scores according to gender and age, and the internal consistency and factor structure of the SAS-A. In a subsample (n = 563; Study 2) concurrent and discriminant validity of the SAS-A were examined relative to the Social Phobia Inventory and the Beck Depression Inventory. Test-retest stability was examined over a 30-month period by repeated measures every 6 months in another subsample (n = 377; Study 3). Results mostly revealed no gender differences in social anxiety, except that boys reported more general social avoidance and distress than girls. Older adolescents (14-16-year-olds) reported higher social anxiety than younger adolescents (12-13-year-olds). Internal consistency for the SAS-A was acceptable for both genders and for all three SAS-A subscales. Confirmatory factor analysis replicated the original 18-item three-factor structure of the SAS-A, accounting for 61% of the variance between items. Evidence for concurrent and discriminant validity was found. Test-retest stability over 6 months was satisfactory. Results support the reliability and validity of the Finnish adaptation of the SAS-A, and further indicate that gender differences in adolescents' social anxiety may vary across Western countries.

Validation of the Persian version of the Daily Spiritual Experiences Scale (DSES) in Pregnant Women: A Proper Tool to Assess Spirituality Related to Mental Health.

PubMed

Saffari, Mohsen; Amini, Hossein; Sheykh-Oliya, Zarindokht; Pakpour, Amir H; Koenig, Harold G

2017-12-01

Assessing spirituality in healthy pregnant women may lead to supportive interventions that will improve their care. A psychometrically valid measure such as the Daily Spiritual Experiences Scale (DSES) may be helpful in this regard. The current study sought to adapt a Persian version of DSES for use in pregnancy. A total of 377 pregnant women were recruited from three general hospitals located in Tehran, Iran. Administered scales were the DSES, Duke University Religion Index, Santa Clara Strength of Religious Faith scale, and Depression Anxiety Stress Scale, as well as demographic measures. Reliability of the DSES was tested using Cronbach's alpha for internal consistency and the intraclass correlation coefficient (ICC) for test-retest stability. Scale validity was assessed by criterion-related tests, known-groups comparison, and exploratory factor analysis. Participant's mean age was 27.7 (4.1), and most were nulliparous (70%). The correlation coefficient between individual items on the scale and the total score was greater than 0.30 in most cases. Cronbach's alpha for the scale was 0.90. The ICC for 2-week test-retest reliability was high (0.86). Relationships between similar and dissimilar scales indicated acceptable convergent and divergent validity. The factor structure of the scale indicated a single factor that explained 59% of the variance. The DSES was found to be a reliable and valid measure of spirituality in pregnant Iranian women. This scale may be used to examine the relationship between spirituality and health outcomes, research that may lead to supportive interventions in this population.

An Investigation of Agility Issues in Scrum Teams Using Agility Indicators

NASA Astrophysics Data System (ADS)

Pikkarainen, Minna; Wang, Xiaofeng

Agile software development methods have emerged and become increasingly popular in recent years; yet the issues encountered by software development teams that strive to achieve agility using agile methods are yet to be explored systematically. Built upon a previous study that has established a set of indicators of agility, this study investigates what issues are manifested in software development teams using agile methods. It is focussed on Scrum teams particularly. In other words, the goal of the chapter is to evaluate Scrum teams using agility indicators and therefore to further validate previously presented agility indicators within the additional cases. A multiple case study research method is employed. The findings of the study reveal that the teams using Scrum do not necessarily achieve agility in terms of team autonomy, sharing, stability and embraced uncertainty. The possible reasons include previous organizational plan-driven culture, resistance towards the Scrum roles and changing resources.

Initial evidence for the validity of the California Bullying Victimization Scale (CBVS-R) as a retrospective measure for adults.

PubMed

Green, Jennifer Greif; Oblath, Rachel; Felix, Erika D; Furlong, Michael J; Holt, Melissa K; Sharkey, Jill D

2018-06-07

Childhood bullying is an important predictor of psychological and health outcomes in adulthood; however, validated retrospective measures of childhood bullying are lacking. This study investigates the psychometric properties of an adult retrospective version of the California Bullying Victimization Scale (CBVS). The CBVS self-report measure was developed for use with children and adolescents to assess the three definitional characteristics of bullying (aggression that is chronic, intentional, and involves an imbalance of power), without using the term "bullying." In the current study, we evaluate patterns of retrospective reports of bullying victimization, and compare results to a common definition-first measure of bullying. Concurrent validity and 4-year stability are addressed. In the fall of 2012, entering first-year students at 4 universities in the United States (N = 1,209; 65.2% female) completed the California Bullying Victimization Scale-Retrospective (CBVS-R) as part of an online survey. In spring of 2016, participants at 2 universities who provided contact information (N = 175) completed a 4-year follow-up survey. Results support the validity of the CBVS-R as a retrospective self-report measure of bullying victimization experienced in childhood. In particular, the percent of respondents classified as being bullied (27.9%) and age- and gender-related patterns of victimization were consistent with known patterns of childhood bullying. In addition, respondents reporting childhood victimization indicated increased psychological distress in adulthood. However, stability of reports across a 4-year follow-up period were lower than expected (κ = .38). Implications for the use of retrospective reports of childhood bullying victimization are discussed. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

9 CFR 114.13 - Expiration date determination.

Code of Federal Regulations, 2014 CFR

2014-01-01

... date of the initiation of the potency test. Prior to licensure, stability of each fraction shall be... this stability data shall be confirmed as follows: (a) Products consisting of viable organisms. Each... statistically valid stability record has been established. (b) Nonviable biological products. Each serial...

9 CFR 114.13 - Expiration date determination.

Code of Federal Regulations, 2012 CFR

2012-01-01

... date of the initiation of the potency test. Prior to licensure, stability of each fraction shall be... this stability data shall be confirmed as follows: (a) Products consisting of viable organisms. Each... statistically valid stability record has been established. (b) Nonviable biological products. Each serial...

9 CFR 114.13 - Expiration date determination.

Code of Federal Regulations, 2011 CFR

2011-01-01

... date of the initiation of the potency test. Prior to licensure, stability of each fraction shall be... this stability data shall be confirmed as follows: (a) Products consisting of viable organisms. Each... statistically valid stability record has been established. (b) Nonviable biological products. Each serial...

9 CFR 114.13 - Expiration date determination.

Code of Federal Regulations, 2013 CFR

2013-01-01

... date of the initiation of the potency test. Prior to licensure, stability of each fraction shall be... this stability data shall be confirmed as follows: (a) Products consisting of viable organisms. Each... statistically valid stability record has been established. (b) Nonviable biological products. Each serial...

Selecting clinical quality indicators for laboratory medicine.

PubMed

Barth, Julian H

2012-05-01

Quality in laboratory medicine is often described as doing the right test at the right time for the right person. Laboratory processes currently operate under the oversight of an accreditation body which gives confidence that the process is good. However, there are aspects of quality that are not measured by these processes. These are largely focused on ensuring that the most clinically appropriate test is performed and interpreted correctly. Clinical quality indicators were selected through a two-phase process. Firstly, a series of focus groups of clinical scientists were held with the aim of developing a list of quality indicators. These were subsequently ranked in order by an expert panel of primary and secondary care physicians. The 10 top indicators included the communication of critical results, comprehensive education to all users and adequate quality assurance for point-of-care testing. Laboratories should ensure their tests are used to national standards, that they have clinical utility, are calibrated to national standards and have long-term stability for chronic disease management. Laboratories should have error logs and demonstrate evidence of measures introduced to reduce chances of similar future errors. Laboratories should make a formal scientific evaluation of analytical quality. This paper describes the process of selection of quality indicators for laboratory medicine that have been validated sequentially by deliverers and users of the service. They now need to be converted into measureable variables related to outcome and validated in practice.

Developing and validating a scale to measure Food and Nutrition Literacy (FNLIT) in elementary school children in Iran.

PubMed

Doustmohammadian, Aazam; Omidvar, Nasrin; Keshavarz-Mohammadi, Nastaran; Abdollahi, Morteza; Amini, Maryam; Eini-Zinab, Hassan

2017-01-01

Food and nutrition literacy is an emerging term which is increasingly used in policy and research. Though research in this area is growing, progression is limited by the lack of an accepted method to measure food and nutrition literacy. The aim of this study is to develop a valid and reliable questionnaire to assess food and nutrition literacy in elementary school children in the city of Tehran. The study was conducted in three phases. To develop Food and Nutrition Literacy (FNLIT) questionnaire, a comprehensive literature review and a qualitative study were initially performed to identify food and nutrition literacy dimensions and its components. Content and face validity of the questionnaire were evaluated by an expert panel as well as students. In the second phase, construct validity of the scale was evaluated using Explanatory Factor Analyses (EFA) and Confirmatory Factor Analyses (CFA). In the last phase (confirmatory phase), the final version of the questionnaire was evaluated on 400 students. Findings show Content Validity Ratio (CVR) and Content Validity Index (CVI) of the 62-item questionnaire at acceptable levels of 0.87 and 0.92, respectively. EFA suggested a six-factor construct, namely, understanding food and nutrition information, knowledge, functional, interactive, food choice, and critical. The results of CFA indicated acceptable fit indices for the proposed models. All subscales demonstrated satisfactory internal consistency (Cronbach's alpha≥0.70), except for critical skill subscale (0.48). The intraclass correlation coefficient (ICC = 0.90, CI: 0.83-0.94) indicated that Food and Nutrition Literacy (FNLIT) scale had satisfactory stability. Each phase of development progressively improved the questionnaire, which resulted in a 46-item (42 likert-type items and 4 true-false items) Food and Nutrition Literacy (FNLIT) scale. The questionnaire measured two domains with 6 subscales, including: 1) cognitive domain: understanding and knowledge; 2) skill domain: functional, food choice, interactive, and critical skills. The developed food and nutrition literacy scale is a valid and reliable instrument to measure food and nutrition literacy in children. This measure lays a solid empirical and theoretical foundation for future research and tailored interventions to promote food and nutrition literacy in this age group.

Fuzzy Logic Controller Stability Analysis Using a Satisfiability Modulo Theories Approach

NASA Technical Reports Server (NTRS)

Arnett, Timothy; Cook, Brandon; Clark, Matthew A.; Rattan, Kuldip

2017-01-01

While many widely accepted methods and techniques exist for validation and verification of traditional controllers, at this time no solutions have been accepted for Fuzzy Logic Controllers (FLCs). Due to the highly nonlinear nature of such systems, and the fact that developing a valid FLC does not require a mathematical model of the system, it is quite difficult to use conventional techniques to prove controller stability. Since safety-critical systems must be tested and verified to work as expected for all possible circumstances, the fact that FLC controllers cannot be tested to achieve such requirements poses limitations on the applications for such technology. Therefore, alternative methods for verification and validation of FLCs needs to be explored. In this study, a novel approach using formal verification methods to ensure the stability of a FLC is proposed. Main research challenges include specification of requirements for a complex system, conversion of a traditional FLC to a piecewise polynomial representation, and using a formal verification tool in a nonlinear solution space. Using the proposed architecture, the Fuzzy Logic Controller was found to always generate negative feedback, but inconclusive for Lyapunov stability.

The stability and validity of automated vocal analysis in preverbal preschoolers with autism spectrum disorder.

PubMed

Woynaroski, Tiffany; Oller, D Kimbrough; Keceli-Kaysili, Bahar; Xu, Dongxin; Richards, Jeffrey A; Gilkerson, Jill; Gray, Sharmistha; Yoder, Paul

2017-03-01

Theory and research suggest that vocal development predicts "useful speech" in preschoolers with autism spectrum disorder (ASD), but conventional methods for measurement of vocal development are costly and time consuming. This longitudinal correlational study examines the reliability and validity of several automated indices of vocalization development relative to an index derived from human coded, conventional communication samples in a sample of preverbal preschoolers with ASD. Automated indices of vocal development were derived using software that is presently "in development" and/or only available for research purposes and using commercially available Language ENvironment Analysis (LENA) software. Indices of vocal development that could be derived using the software available for research purposes: (a) were highly stable with a single day-long audio recording, (b) predicted future spoken vocabulary to a degree that was nonsignificantly different from the index derived from conventional communication samples, and (c) continued to predict future spoken vocabulary even after controlling for concurrent vocabulary in our sample. The score derived from standard LENA software was similarly stable, but was not significantly correlated with future spoken vocabulary. Findings suggest that automated vocal analysis is a valid and reliable alternative to time intensive and expensive conventional communication samples for measurement of vocal development of preverbal preschoolers with ASD in research and clinical practice. Autism Res 2017, 10: 508-519. © 2016 International Society for Autism Research, Wiley Periodicals, Inc. © 2016 International Society for Autism Research, Wiley Periodicals, Inc.

Test-Retest Stability of the Task and Ego Orientation Questionnaire

ERIC Educational Resources Information Center

Lane, Andrew M.; Nevill, Alan M.; Bowes, Neal; Fox, Kenneth R.

2005-01-01

Establishing stability, defined as observing minimal measurement error in a test-retest assessment, is vital to validating psychometric tools. Correlational methods, such as Pearson product-moment, intraclass, and kappa are tests of association or consistency, whereas stability or reproducibility (regarded here as synonymous) assesses the…

Evaluation of the reliability and validity for X16 balance testing scale for the elderly.

PubMed

Ju, Jingjuan; Jiang, Yu; Zhou, Peng; Li, Lin; Ye, Xiaolei; Wu, Hongmei; Shen, Bin; Zhang, Jialei; He, Xiaoding; Niu, Chunjin; Xia, Qinghua

2018-05-10

Balance performance is considered as an indicator of functional status in the elderly, a large scale population screening and evaluation in the community context followed by proper interventions would be of great significance at public health level. However, there has been no suitable balance testing scale available for large scale studies in the unique community context of urban China. A balance scale named X16 balance testing scale was developed, which was composed of 3 domains and 16 items. A total of 1985 functionally independent and active community-dwelling elderly adults' balance abilities were tested using the X16 scale. The internal consistency, split-half reliability, content validity, construct validity, discriminant validity of X16 balance testing scale were evaluated. Factor analysis was performed to identify alternative factor structure. The Eigenvalues of factors 1, 2, and 3 were 8.53, 1.79, and 1.21, respectively, and their cumulative contribution to the total variance reached 72.0%. These 3 factors mainly represented domains static balance, postural stability, and dynamic balance. The Cronbach alpha coefficient for the scale was 0.933. The Spearman correlation coefficients between items and its corresponding domains were ranged from 0.538 to 0.964. The correlation coefficients between each item and its corresponding domain were higher than the coefficients between this item and other domains. With the increase of age, the scores of balance performance, domains static balance, postural stability, and dynamic balance in the elderly declined gradually (P < 0.001). With the increase of age, the proportion of the elderly with intact balance performance decreased gradually (P < 0.001). The reliability and validity of the X16 balance testing scale is both adequate and acceptable. Due to its simple and quick use features, it is practical to be used repeatedly and routinely especially in community setting and on large scale screening.

One-year temporal stability and predictive and incremental validity of the body, eating, and exercise comparison orientation measure (BEECOM) among college women.

PubMed

Fitzsimmons-Craft, Ellen E; Bardone-Cone, Anna M

2014-01-01

This study examined the one-year temporal stability and the predictive and incremental validity of the Body, Eating, and Exercise Comparison Measure (BEECOM) in a sample of 237 college women who completed study measures at two time points about one year apart. One-year temporal stability was high for the BEECOM total and subscale (i.e., Body, Eating, and Exercise Comparison Orientation) scores. Additionally, the BEECOM exhibited predictive validity in that it accounted for variance in body dissatisfaction and eating disorder symptomatology one year later. These findings held even after controlling for body mass index and existing measures of social comparison orientation. However, results regarding the incremental validity of the BEECOM, or its ability to predict change in these constructs over time, were more mixed. Overall, this study demonstrated additional psychometric properties of the BEECOM among college women, further establishing the usefulness of this measure for more comprehensively assessing eating disorder-related social comparison. Copyright © 2013 Elsevier Ltd. All rights reserved.

Development of RP-HPLC, Stability Indicating Method for Degradation Products of Linagliptin in Presence of Metformin HCl by Applying 2 Level Factorial Design; and Identification of Impurity-VII, VIII and IX and Synthesis of Impurity-VII.

PubMed

Jadhav, Sushant B; Reddy, P Sunil; Narayanan, Kalyanaraman L; Bhosale, Popatrao N

2017-06-27

The novel reverse phase-high performance liquid chromatography (RP-HPLC), stability indicating method was developed for determination of linagliptin (LGP) and its related substances in linagliptin and metformin HCl (MET HCl) tablets by implementing design of experiment to understand the critical method parameters and their relation with critical method attributes; to ensure robustness of the method. The separation of nine specified impurities was achieved with a Zorbax SB-Aq 250 × 4.6 mm, 5 µm column, using gradient elution and a detector wavelength of 225 nm, and validated in accordance with International Conference on Harmonization (ICH) guidelines and found to be accurate, precise, reproducible, robust, and specific . The drug was found to be degrading extensively in heat, humidity, basic, and oxidation conditions and was forming degradation products during stability studies. After slight modification in the buffer and the column, the same method was used for liquid chromatography-mass spectrometry (LC-MS) and ultra-performance liquid chromatography -time-of-flight/mass spectrometry UPLC-TOF/MS analysis, to identify m/z and fragmentation of maximum unspecified degradation products i.e., Impurity-VII ( 7 ), Impurity-VIII ( 8 ), and Impurity-IX ( 9 ) formed during stability studies. Based on the results, a degradation pathway for the drug has been proposed and synthesis of Impurity-VII ( 7 ) is also discussed to ensure an in-depth understanding of LGP and its related degradation products and optimum performance during the lifetime of the product.

Advanced stability indicating chemometric methods for quantitation of amlodipine and atorvastatin in their quinary mixture with acidic degradation products.

PubMed

Darwish, Hany W; Hassan, Said A; Salem, Maissa Y; El-Zeany, Badr A

2016-02-05

Two advanced, accurate and precise chemometric methods are developed for the simultaneous determination of amlodipine besylate (AML) and atorvastatin calcium (ATV) in the presence of their acidic degradation products in tablet dosage forms. The first method was Partial Least Squares (PLS-1) and the second was Artificial Neural Networks (ANN). PLS was compared to ANN models with and without variable selection procedure (genetic algorithm (GA)). For proper analysis, a 5-factor 5-level experimental design was established resulting in 25 mixtures containing different ratios of the interfering species. Fifteen mixtures were used as calibration set and the other ten mixtures were used as validation set to validate the prediction ability of the suggested models. The proposed methods were successfully applied to the analysis of pharmaceutical tablets containing AML and ATV. The methods indicated the ability of the mentioned models to solve the highly overlapped spectra of the quinary mixture, yet using inexpensive and easy to handle instruments like the UV-VIS spectrophotometer. Copyright © 2015 Elsevier B.V. All rights reserved.

Characterization and Storage Stability Study of Bixin Extracted from Bixa orellana Using Organic Solvent

NASA Astrophysics Data System (ADS)

Husa, N. N.; Hamzah, F.; Said, H. M.

2018-05-01

Colorant is one of the additives to give a better appearance or improve the colour of the product. Synthetic colorant has been widely used in industrial due to its readiness in the market and its colour stability. However the arising issues related to the safety, nutrition and also the therapeutic effect has encouraged users to become more concern about the colouring component. Thus, the present research was conducted in order to produce natural colorant called bixin from Bixa orellana or also known as annatto seeds. The study was focusing on the effect of the solvent on the characteristic and concentration of the extracted bixin. While stability of the bixin during different storage condition was determined to further validate the effectiveness of the solvent. The result indicated that methanol and acetone gave darker of the bixin colour as compared to the water. However, the deterioration rate of the bixin in acetone and methanol were faster as compared to the water. The extracted bixin was analysed using Fourier-transform infrared spectroscopy (FTIR) and spectrophotometer analysis. The strong band for the bixin was observed at absorbance range of 1704 – 1740cm-1. The study indicates that the concentration of the extracted bixin was the highest in methanol which gave 817.7 ppm of bixin. Meanwhile, bixin concentration in acetone and water was 602.9 ppm and 477.19 ppm respectively.

Direct Simulation of Evolution and Control of Nonlinear Instabilities in Attachment-Line Boundary Layers

NASA Technical Reports Server (NTRS)

Joslin, Ronald D.

2004-01-01

The unsteady, incompressible Navier-Stokes equations are used for the direct numerical simulation (DNS) of spatially evolving disturbances in a three-dimensional (3-D) attachment-line boundary layer. Two-dimensional (2-D) disturbances are introduced either by forcing at the in ow or by harmonic-source generators at the wall; 3-D disturbances are introduced by harmonic-source generators at the wall. The DNS results are in good agreement with both 2-D non-parallel theory (for small-amplitude disturbances) and weakly nonlinear theory (for finite-amplitude disturbances), which validates the two theories. The 2-D DNS results indicate that nonlinear disturbance growth occurs near branch II of the neutral stability curve; however, steady suction can be used to stabilize this disturbance growth. For 3-D instabilities that are generated o the attachment line, spreading both toward and away from the attachment line causes energy transfer to the attachment-line and downstream instabilities; suction stabilizes these instabilities. Furthermore, 3-D instabilities are more stable than 2-D or quasi-2-D instabilities.

The influence of validity criteria on Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) test-retest reliability among high school athletes.

PubMed

Brett, Benjamin L; Solomon, Gary S

2017-04-01

Research findings to date on the stability of Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) Composite scores have been inconsistent, requiring further investigation. The use of test validity criteria across these studies also has been inconsistent. Using multiple measures of stability, we examined test-retest reliability of repeated ImPACT baseline assessments in high school athletes across various validity criteria reported in previous studies. A total of 1146 high school athletes completed baseline cognitive testing using the online ImPACT test battery at two time periods of approximately two-year intervals. No participant sustained a concussion between assessments. Five forms of validity criteria used in previous test-retest studies were applied to the data, and differences in reliability were compared. Intraclass correlation coefficients (ICCs) ranged in composite scores from .47 (95% confidence interval, CI [.38, .54]) to .83 (95% CI [.81, .85]) and showed little change across a two-year interval for all five sets of validity criteria. Regression based methods (RBMs) examining the test-retest stability demonstrated a lack of significant change in composite scores across the two-year interval for all forms of validity criteria, with no cases falling outside the expected range of 90% confidence intervals. The application of more stringent validity criteria does not alter test-retest reliability, nor does it account for some of the variation observed across previously performed studies. As such, use of the ImPACT manual validity criteria should be utilized in the determination of test validity and in the individualized approach to concussion management. Potential future efforts to improve test-retest reliability are discussed.

A composite stability index for dichotomous forecast of thunderstorms

NASA Astrophysics Data System (ADS)

Chaudhuri, Sutapa; Middey, Anirban

2012-12-01

Thunderstorms are the perennial feature of Kolkata (22° 32' N, 88° 20' E), India during the premonsoon season (April-May). Precise forecast of these thunderstorms is essential to mitigate the associated catastrophe due to lightning flashes, strong wind gusts, torrential rain, and occasional hail and tornadoes. The present research provides a composite stability index for forecasting thunderstorms. The forecast quality detection parameters are computed with the available indices during the period from 1997 to 2006 to select the most relevant indices with threshold ranges for the prevalence of such thunderstorms. The analyses reveal that the lifted index (LI) within the range of -5 to -12 °C, convective inhibition energy (CIN) within the range of 0-150 J/kg and convective available potential energy (CAPE) within the ranges of 2,000 to 7,000 J/kg are the most pertinent indices for the prevalence thunderstorms over Kolkata during the premonsoon season. A composite stability index, thunderstorm prediction index (TPI) is formulated with LI, CIN, and CAPE. The statistical skill score analyses show that the accuracy in forecasting such thunderstorms with TPI is 99.67 % with lead time less than 12 h during training the index whereas the accuracies are 89.64 % with LI, 60 % with CIN and 49.8 % with CAPE. The performance diagram supports that TPI has better forecast skill than its individual components. The forecast with TPI is validated with the observation of the India Meteorological Department during the period from 2007 to 2009. The real-time forecast of thunderstorms with TPI is provided for the year 2010.

Efficacy validation of synthesized retinol derivatives In vitro: stability, toxicity, and activity.

PubMed

Han, Hye-Sook; Kwon, Youn-Ja; Park, Myoung-Soon; Park, Si-Ho; Cho, So-Mi Kim; Rho, Young-Soy; Kim, Jin-Wou; Sin, Hong-Sig; Um, Soo-Jong

2003-08-15

Retinol (vitamin A) is used as an antiwrinkle agent in the cosmetics industry. However, its photo-instability makes it unsuitable for use in general cosmetic formulations. To improve the photo-stability of retinol, three derivatives (3, 4, and 5) were synthesized and their biological activities were analyzed. 1H NMR and HPLC analysis indicated that derivatives 3 and 5 were much more stable than retinol under our sunlight exposure conditions. When human adult fibroblasts were treated, the IC(50) of derivative 3 was 96 microM, which is similar to that of retinol, as determined by the MTT assay. Derivatives 4 and 5 were 2.5 and 8 times more toxic than retinol, respectively. At 1 microM treatment, like retinol, derivatives 3 and 4 were specifically active for RARalpha out of six retinoid receptors (RAR/RXRalpha, beta, gamma). Dose-dependent analysis confirmed that derivative 4 was as active as retinol and the other two derivatives were less active for RARalpha. The effect of our derivatives on the expression of collagenase, an indicator of wrinkle formation, was measured using the transient co-expression of c-Jun and RT-PCR in HaCaT cells. Collagenase promoter activity, which is increased by c-Jun expression, was reduced 42% by retinol treatment. The other derivatives inhibited collagenase promoter activity similarly. These results were further confirmed by RT-PCR analysis of the collagenase gene. Taken together, our results suggest that retinol derivative 3 is a promising antiwrinkle agent based on its higher photo-stability, lower RARalpha activity (possibly indicating reduced side effects), and similar effect on collagenase expression.

A New Rapid and Sensitive Stability-Indicating UPLC Assay Method for Tolterodine Tartrate: Application in Pharmaceuticals, Human Plasma and Urine Samples.

PubMed

Yanamandra, Ramesh; Vadla, Chandra Sekhar; Puppala, Umamaheshwar; Patro, Balaram; Murthy, Yellajyosula L N; Ramaiah, Parimi Atchuta

2012-01-01

A new rapid, simple, sensitive, selective and accurate reversed-phase stability-indicating Ultra Performance Liquid Chromatography (RP-UPLC) technique was developed for the assay of Tolterodine Tartrate in pharmaceutical dosage form, human plasma and urine samples. The developed UPLC method is superior in technology to conventional HPLC with respect to speed, solvent consumption, resolution and cost of analysis. Chromatographic run time was 6 min in reversed-phase mode and ultraviolet detection was carried out at 220 nm for quantification. Efficient separation was achieved for all the degradants of Tolterodine Tartrate on BEH C18 sub-2-μm Acquity UPLC column using Trifluoroacetic acid and acetonitrile as organic solvent in a linear gradient program. The active pharmaceutical ingredient was extracted from tablet dosage form using a mixture of acetonitrile and water as diluent. The calibration graphs were linear and the method showed excellent recoveries for bulk and tablet dosage form. The test solution was found to be stable for 40 days when stored in the refrigerator between 2 and 8 °C. The developed UPLC method was validated and meets the requirements delineated by the International Conference on Harmonization (ICH) guidelines with respect to linearity, accuracy, precision, specificity and robustness. The intra-day and inter-day variation was found be less than 1%. The method was reproducible and selective for the estimation of Tolterodine Tartrate. Because the method could effectively separate the drug from its degradation products, it can be employed as a stability-indicating one.

A New Rapid and Sensitive Stability-Indicating UPLC Assay Method for Tolterodine Tartrate: Application in Pharmaceuticals, Human Plasma and Urine Samples

PubMed Central

Yanamandra, Ramesh; Vadla, Chandra Sekhar; Puppala, Umamaheshwar; Patro, Balaram; Murthy, Yellajyosula. L. N.; Ramaiah, Parimi Atchuta

2012-01-01

A new rapid, simple, sensitive, selective and accurate reversed-phase stability-indicating Ultra Performance Liquid Chromatography (RP-UPLC) technique was developed for the assay of Tolterodine Tartrate in pharmaceutical dosage form, human plasma and urine samples. The developed UPLC method is superior in technology to conventional HPLC with respect to speed, solvent consumption, resolution and cost of analysis. Chromatographic run time was 6 min in reversed-phase mode and ultraviolet detection was carried out at 220 nm for quantification. Efficient separation was achieved for all the degradants of Tolterodine Tartrate on BEH C18 sub-2-μm Acquity UPLC column using Trifluoroacetic acid and acetonitrile as organic solvent in a linear gradient program. The active pharmaceutical ingredient was extracted from tablet dosage form using a mixture of acetonitrile and water as diluent. The calibration graphs were linear and the method showed excellent recoveries for bulk and tablet dosage form. The test solution was found to be stable for 40 days when stored in the refrigerator between 2 and 8 °C. The developed UPLC method was validated and meets the requirements delineated by the International Conference on Harmonization (ICH) guidelines with respect to linearity, accuracy, precision, specificity and robustness. The intra-day and inter-day variation was found be less than 1%. The method was reproducible and selective for the estimation of Tolterodine Tartrate. Because the method could effectively separate the drug from its degradation products, it can be employed as a stability-indicating one. PMID:22396907

Turbofan Engine Post-Instability Behavior - Computer Simulations, Test Validation, and Application of Simulations,

DTIC Science & Technology

COMPRESSORS, *AIR FLOW, TURBOFAN ENGINES , TRANSIENTS, SURGES, STABILITY, COMPUTERIZED SIMULATION, EXPERIMENTAL DATA, VALIDATION, DIGITAL SIMULATION, INLET GUIDE VANES , ROTATION, STALLING, RECOVERY, HYSTERESIS

Assessing Temporal Stability for Coarse Scale Satellite Moisture Validation in the Maqu Area, Tibet

PubMed Central

Bhatti, Haris Akram; Rientjes, Tom; Verhoef, Wouter; Yaseen, Muhammad

2013-01-01

This study evaluates if the temporal stability concept is applicable to a time series of satellite soil moisture images so to extend the common procedure of satellite image validation. The area of study is the Maqu area, which is located in the northeastern part of the Tibetan plateau. The network serves validation purposes of coarse scale (25–50 km) satellite soil moisture products and comprises 20 stations with probes installed at depths of 5, 10, 20, 40, 80 cm. The study period is 2009. The temporal stability concept is applied to all five depths of the soil moisture measuring network and to a time series of satellite-based moisture products from the Advance Microwave Scanning Radiometer (AMSR-E). The in-situ network is also assessed by Pearsons's correlation analysis. Assessments by the temporal stability concept proved to be useful and results suggest that probe measurements at 10 cm depth best match to the satellite observations. The Mean Relative Difference plot for satellite pixels shows that a RMSM pixel can be identified but in our case this pixel does not overlay any in-situ station. Also, the RMSM pixel does not overlay any of the Representative Mean Soil Moisture (RMSM) stations of the five probe depths. Pearson's correlation analysis on in-situ measurements suggests that moisture patterns over time are more persistent than over space. Since this study presents first results on the application of the temporal stability concept to a series of satellite images, we recommend further tests to become more conclusive on effectiveness to broaden the procedure of satellite validation. PMID:23959237

Validation of the Policy Advocacy Engagement Scale for frontline healthcare professionals.

PubMed

Jansson, Bruce S; Nyamathi, Adeline; Heidemann, Gretchen; Duan, Lei; Kaplan, Charles

2017-05-01

Nurses, social workers, and medical residents are ethically mandated to engage in policy advocacy to promote the health and well-being of patients and increase access to care. Yet, no instrument exists to measure their level of engagement in policy advocacy. To describe the development and validation of the Policy Advocacy Engagement Scale, designed to measure frontline healthcare professionals' engagement in policy advocacy with respect to a broad range of issues, including patients' ethical rights, quality of care, culturally competent care, preventive care, affordability/accessibility of care, mental healthcare, and community-based care. Cross-sectional data were gathered to estimate the content and construct validity, internal consistency, and test-retest reliability of the Policy Advocacy Engagement Scale. Participants and context: In all, 97 nurses, 94 social workers, and 104 medical residents (N = 295) were recruited from eight acute-care hospitals in Los Angeles County. Ethical considerations: Informed consent was obtained via Qualtrics and covered purposes, risks and benefits; voluntary participation; confidentiality; and compensation. Institutional Review Board approval was obtained from the University of Southern California and all hospitals. Results supported the validity of the concept and the instrument. In confirmatory factor analysis, seven items loaded onto one component with indices indicating adequate model fit. A Pearson correlation coefficient of .36 supported the scale's test-retest stability. Cronbach's α of .93 indicated strong internal consistency. The Policy Advocacy Engagement Scale demonstrated satisfactory psychometric properties in this initial test. Findings should be considered within the context of the study's limitations, which include a low response rate and limited geographic scope. The Policy Advocacy Engagement Scale appears to be the first validated scale to measure frontline healthcare professionals' engagement in policy advocacy. With it, researchers can analyze variations in professionals' levels of policy advocacy engagement, understand what factors are associated with it, and remedy barriers that might exist to their provision of it.

Transcriptome Wide Annotation of Eukaryotic RNase III Reactivity and Degradation Signals

PubMed Central

Gagnon, Jules; Lavoie, Mathieu; Catala, Mathieu; Malenfant, Francis; Elela, Sherif Abou

2015-01-01

Detection and validation of the RNA degradation signals controlling transcriptome stability are essential steps for understanding how cells regulate gene expression. Here we present complete genomic and biochemical annotations of the signals required for RNA degradation by the dsRNA specific ribonuclease III (Rnt1p) and examine its impact on transcriptome expression. Rnt1p cleavage signals are randomly distributed in the yeast genome, and encompass a wide variety of sequences, indicating that transcriptome stability is not determined by the recurrence of a fixed cleavage motif. Instead, RNA reactivity is defined by the sequence and structural context in which the cleavage sites are located. Reactive signals are often associated with transiently expressed genes, and their impact on RNA expression is linked to growth conditions. Together, the data suggest that Rnt1p reactivity is triggered by malleable RNA degradation signals that permit dynamic response to changes in growth conditions. PMID:25680180

Model Validation for Propulsion - On the TFNS and LES Subgrid Models for a Bluff Body Stabilized Flame

NASA Technical Reports Server (NTRS)

Wey, Thomas

2017-01-01

This paper summarizes the reacting results of simulating a bluff body stabilized flame experiment of Volvo Validation Rig using a releasable edition of the National Combustion Code (NCC). The turbulence models selected to investigate the configuration are the sub-grid scaled kinetic energy coupled large eddy simulation (K-LES) and the time-filtered Navier-Stokes (TFNS) simulation. The turbulence chemistry interaction used is linear eddy mixing (LEM).

Stabilized finite element methods to simulate the conductances of ion channels

NASA Astrophysics Data System (ADS)

Tu, Bin; Xie, Yan; Zhang, Linbo; Lu, Benzhuo

2015-03-01

We have previously developed a finite element simulator, ichannel, to simulate ion transport through three-dimensional ion channel systems via solving the Poisson-Nernst-Planck equations (PNP) and Size-modified Poisson-Nernst-Planck equations (SMPNP), and succeeded in simulating some ion channel systems. However, the iterative solution between the coupled Poisson equation and the Nernst-Planck equations has difficulty converging for some large systems. One reason we found is that the NP equations are advection-dominated diffusion equations, which causes troubles in the usual FE solution. The stabilized schemes have been applied to compute fluids flow in various research fields. However, they have not been studied in the simulation of ion transport through three-dimensional models based on experimentally determined ion channel structures. In this paper, two stabilized techniques, the SUPG and the Pseudo Residual-Free Bubble function (PRFB) are introduced to enhance the numerical robustness and convergence performance of the finite element algorithm in ichannel. The conductances of the voltage dependent anion channel (VDAC) and the anthrax toxin protective antigen pore (PA) are simulated to validate the stabilization techniques. Those two stabilized schemes give reasonable results for the two proteins, with decent agreement with both experimental data and Brownian dynamics (BD) simulations. For a variety of numerical tests, it is found that the simulator effectively avoids previous numerical instability after introducing the stabilization methods. Comparison based on our test data set between the two stabilized schemes indicates both SUPG and PRFB have similar performance (the latter is slightly more accurate and stable), while SUPG is relatively more convenient to implement.

A Multi-Domain Self-Report Measure of Coparenting

PubMed Central

Feinberg, Mark E.; Brown, Louis D.; Kan, Marni L.

2012-01-01

SYNOPSIS Objective This study reports the psychometric properties of a multi-domain measure of the coparenting relationship in dual-parent families. Method 152 couples participating in a transition to parenthood study completed the Coparenting Relationship Scale and additional measures during home visits at child age 6 months, 1 year, and 3 years. Results Psychometric and construct validity assessments indicated the measure performed satisfactorily. The 35-item measure demonstrated good reliability and strong stability. Subscales measuring theoretically and empirically important aspects of coparenting (coparenting agreement, coparenting closeness, exposure of child to conflict, coparenting support, coparenting undermining, endorsement of partner’s parenting, and division of labor) demonstrated good reliability as well. A 14-item brief overall measure showed very strong associations with the overall measure. Relations of the full scale with a measure of social desirability were weak, and the full scale was positively associated with positive dimensions of the dyadic couple relationship (love, sex/romance, couple efficacy) and inversely associated with negative dimensions (conflict, ineffective arguing)—as expected. Conclusions This initial examination of the Coparenting Relationship Scale suggests that it possesses good psychometric properties (reliability, stability, construct validity, and inter-rater agreement), can be flexibly administered in short and long forms, and is positioned to promote further conceptual and methodological progress in the study of coparenting. PMID:23166477

Validating the Riverside Acculturation Stress Inventory with Asian Americans.

PubMed

Miller, Matthew J; Kim, Jungeun; Benet-Martínez, Verónica

2011-06-01

An emerging body of empirical research highlights the impact of acculturative stress in the lives of culturally diverse populations. Therefore, to facilitate future research in this area, we conducted 3 studies to examine the psychometric properties of the Riverside Acculturation Stress Inventory (RASI; Benet-Martínez & Haritatos, 2005) and its 5 subscales in a total sample of 793 self-identified Asian American participants. The reliability and validity of RASI scores and the hypothesized 1-factor higher order model (with 1st-order factors Language Skills, Work Challenges, Intercultural Relations, Discrimination, and Cultural Isolation) of the RASI were examined in Study 1. The RASI higher order structure and score validity and reliability were examined across different generational groups in Study 2. The stability of RASI scores over a 3-week period was examined in Study 3. Overall, findings from these studies support the hypothesized structure of the RASI and indicate that this brief instrument provides reliable and valid acculturative stress scores. In addition, results suggest that RASI items are interpreted in an equivalent manner across different generations of Asian American individuals. Implications for research and assessment are discussed. 2011 APA, all rights reserved

Determination of vitamin C in foods: current state of method validation.

PubMed

Spínola, Vítor; Llorent-Martínez, Eulogio J; Castilho, Paula C

2014-11-21

Vitamin C is one of the most important vitamins, so reliable information about its content in foodstuffs is a concern to both consumers and quality control agencies. However, the heterogeneity of food matrixes and the potential degradation of this vitamin during its analysis create enormous challenges. This review addresses the development and validation of high-performance liquid chromatography methods for vitamin C analysis in food commodities, during the period 2000-2014. The main characteristics of vitamin C are mentioned, along with the strategies adopted by most authors during sample preparation (freezing and acidification) to avoid vitamin oxidation. After that, the advantages and handicaps of different analytical methods are discussed. Finally, the main aspects concerning method validation for vitamin C analysis are critically discussed. Parameters such as selectivity, linearity, limit of quantification, and accuracy were studied by most authors. Recovery experiments during accuracy evaluation were in general satisfactory, with usual values between 81 and 109%. However, few methods considered vitamin C stability during the analytical process, and the study of the precision was not always clear or complete. Potential future improvements regarding proper method validation are indicated to conclude this review. Copyright © 2014. Published by Elsevier B.V.

Validity of a gambling scale for the addiction severity index.

PubMed

Petry, Nancy M

2003-06-01

This study assessed the validity of an adaptation of the Addiction Severity Index (ASI) for evaluating severity of gambling problems. Participants (N = 597) from four different populations (pathological gamblers enrolled in a treatment study, pathological gamblers initiating outpatient treatment at a community-based program, frequent gamblers recruited from advertisement, and substance abusers) completed the ASI, along with a supplemental gambling subscale (ASI-G). Internal consistency of the ASI-G was good (alpha =.90), and a principal components analysis indicated a single factor explained 73% of the variance in responses. ASI-G scores demonstrated excellent convergent validity with other measures of gambling and convergent validity with external sources, including collateral informant and clinician-rated reports. ASI-G scores discriminated among the samples tested. Temporal stability of ASI-G scores was high during a 1-month period for patients with substance abuse disorder who were not seeking gambling treatment. For treatment-seeking gamblers, the number of treatment sessions attended was significantly associated with reductions in ASI-G scores. Together, these data suggest that the ASI-G subscale may be a useful tool for assessing severity of gambling problems in a variety of populations.

Validity, reliability and Norwegian adaptation of the Stroke-Specific Quality of Life (SS-QOL) scale

PubMed Central

Pedersen, Synne Garder; Heiberg, Guri Anita; Nielsen, Jørgen Feldbæk; Friborg, Oddgeir; Stabel, Henriette Holm; Anke, Audny; Arntzen, Cathrine

2018-01-01

Background: There is a paucity of stroke-specific instruments to assess health-related quality of life in the Norwegian language. The objective was to examine the validity and reliability of a Norwegian version of the 12-domain Stroke-Specific Quality of Life scale. Methods: A total of 125 stroke survivors were prospectively recruited. Questionnaires were administered at 3 months; 36 test–retests were performed at 12 months post stroke. The translation was conducted according to guidelines. The internal consistency was assessed with Cronbach’s alpha; convergent validity, with item-to-subscale correlations; and test–retest, with Spearman’s correlations. Scaling validity was explored by calculating both floor and ceiling effects. A priori hypotheses regarding the associations between the Stroke-Specific Quality of Life domain scores and scores of established measures were tested. Standard error of measurement was assessed. Results: The Norwegian version revealed no major changes in back translations. The internal consistency values of the domains were Cronbach’s alpha = 0.79–0.93. Rates of missing items were small, and the item-to-subscale correlation coefficients supported convergent validity (0.48–0.87). The observed floor effects were generally small, whereas the ceiling effects had moderate or high values (16%–63%). Test–retest reliability indicated stability in most domains, with Spearman’s rho = 0.67–0.94 (all p < 0.001), whereas the rho was 0.35 (p < 0.05) for the ‘Vision’ domain. Hypothesis testing supported the construct validity of the scale. Standard error of measurement values for each domain were generated to indicate the required magnitudes of detectable change. Conclusions: The Norwegian version of the Stroke-Specific Quality of Life scale is a reliable and valid instrument with good psychometric properties. It is suited for use in health research as well as in individual assessments of persons with stroke. PMID:29344360

Validity, reliability and Norwegian adaptation of the Stroke-Specific Quality of Life (SS-QOL) scale.

PubMed

Pedersen, Synne Garder; Heiberg, Guri Anita; Nielsen, Jørgen Feldbæk; Friborg, Oddgeir; Stabel, Henriette Holm; Anke, Audny; Arntzen, Cathrine

2018-01-01

There is a paucity of stroke-specific instruments to assess health-related quality of life in the Norwegian language. The objective was to examine the validity and reliability of a Norwegian version of the 12-domain Stroke-Specific Quality of Life scale. A total of 125 stroke survivors were prospectively recruited. Questionnaires were administered at 3 months; 36 test-retests were performed at 12 months post stroke. The translation was conducted according to guidelines. The internal consistency was assessed with Cronbach's alpha; convergent validity, with item-to-subscale correlations; and test-retest, with Spearman's correlations. Scaling validity was explored by calculating both floor and ceiling effects. A priori hypotheses regarding the associations between the Stroke-Specific Quality of Life domain scores and scores of established measures were tested. Standard error of measurement was assessed. The Norwegian version revealed no major changes in back translations. The internal consistency values of the domains were Cronbach's alpha = 0.79-0.93. Rates of missing items were small, and the item-to-subscale correlation coefficients supported convergent validity (0.48-0.87). The observed floor effects were generally small, whereas the ceiling effects had moderate or high values (16%-63%). Test-retest reliability indicated stability in most domains, with Spearman's rho = 0.67-0.94 (all p < 0.001), whereas the rho was 0.35 (p < 0.05) for the 'Vision' domain. Hypothesis testing supported the construct validity of the scale. Standard error of measurement values for each domain were generated to indicate the required magnitudes of detectable change. The Norwegian version of the Stroke-Specific Quality of Life scale is a reliable and valid instrument with good psychometric properties. It is suited for use in health research as well as in individual assessments of persons with stroke.

End-stage renal disease adherence questionnaire: translation and validation to the portuguese language.

PubMed

Poveda, Verónica; Amado, Leonilde; Filgueiras, Madalena; Teixeira, Laetitia; Miranda, Vasco; Santos-Silva, Alice; Paúl, Constança; Costa, Elísio

2016-11-01

Non-adherence to medical plans is recognized as an important problem in dialysis patients, since it has been associated with increased morbidity and mortality, resulting in disproportionately high costs of care. The success of renal replacement therapy depends on the adherence of patients to the different aspects of the therapeutic strategy, which includes a complex drug regimen involving a wide variety of drugs and doses, several prescribed dialysis sessions with different durations, dietetic recommendations and restriction of fluid intake. In this work, we aimed to translate and validate a previously described self-reported end-stage renal disease questionnaire (ESRD-AQ) to the Portuguese language (PESRD-AQ). After ESRD-AQ translation, a validation was performed by experts and by using a cohort of 185 Portuguese dialysis patients. PESRD-AQ reliability analysis showed strong test-retest stability across all items, with an intra-class correlation of 0.931. The average of the item-level content validity index by experts for the 46 items was 0.98, ranging from 0.94 to 1. Moreover, we found that PESRD-AQ scores indicative of non-adherence were associated with alterations in some biological and biochemical markers of non-adherence, including interdialytic weight gain. In conclusion, our results showed that PESRD-AQ, which presented an acceptable reliability and validity, is a valid tool to be used for adherence evaluation by Portuguese-speaking dialysis patients.

Development and validation of an abbreviated version of the Trust in Oncologist Scale-the Trust in Oncologist Scale-short form (TiOS-SF).

PubMed

Hillen, Marij A; Postma, Rosa-May; Verdam, Mathilde G E; Smets, Ellen M A

2017-03-01

The original 18-item, four-dimensional Trust in Oncologist Scale assesses cancer patients' trust in their oncologist. The current aim was to develop and validate a short form version of the scale to enable more efficient assessment of cancer patients' trust. Existing validation data of the full-length Trust in Oncologist Scale were used to create a short form of the Trust in Oncologist Scale. The resulting short form was validated in a new sample of cancer patients (n = 92). Socio-demographics, medical characteristics, trust in the oncologist, satisfaction with communication, trust in healthcare, willingness to recommend the oncologist to others and to contact the oncologist in case of questions were assessed. Internal consistency, reliability, convergent and structural validity were tested. The five-item Trust in Oncologist Scale Short Form was created by selecting the statistically best performing item from each dimension of the original scale, to ensure content validity. Mean trust in the oncologist was high in the validation sample (response rate 86%, M = 4.30, SD = 0.98). Exploratory factor analyses supported one-dimensionality of the short form. Internal consistency was high, and temporal stability was moderate. Initial convergent validity was suggested by moderate correlations between trust scores with associated constructs. The Trust in Oncologist Scale Short Form appears to efficiently, reliably and validly measures cancer patients' trust in their oncologist. It may be used in research and as a quality indicator in clinical practice. More thorough validation of the scale is recommended to confirm this initial evidence of its validity.

Validity of DSM-IV attention–deficit/hyperactivity disorder symptom dimensions and subtypes

PubMed Central

Willcutt, Erik G.; Nigg, Joel T.; Pennington, Bruce F.; Solanto, Mary V.; Rohde, Luis A.; Tannock, Rosemary; Loo, Sandra K.; Carlson, Caryn L.; McBurnett, Keith; Lahey, Benjamin B.

2013-01-01

DSM-IV criteria for ADHD specify two dimensions of inattention and hyperactivity-impulsivity symptoms that are used to define three nominal subtypes: predominantly hyperactive-impulsive type (ADHD-H), predominantly inattentive type (ADHD-I), and combined type (ADHD-C). To aid decision-making for DSM-5 and other future diagnostic systems, a comprehensive literature review and meta-analysis of 546 studies was completed to evaluate the validity of the DSM-IV model of ADHD. Results indicated that DSM-IV criteria identify individuals with significant and persistent impairment in social, academic, occupational, and adaptive functioning when intelligence, demographic factors, and concurrent psychopathology are controlled. Available data overwhelmingly support the concurrent, predictive, and discriminant validity of the distinction between inattention and hyperactivity-impulsivity symptoms, and indicate that nearly all differences among the nominal subtypes are consistent with the relative levels of inattention and hyperactivity-impulsivity symptoms that define the subtypes. In contrast, the validity of the DSM-IV subtype model is compromised by weak evidence for the validity of ADHD-H after first grade, minimal support for the distinction between ADHD-I and ADHD-C in studies of etiological influences, academic and cognitive functioning, and treatment response, and the marked longitudinal instability of all three subtypes. Overall, it is concluded that the DSM-IV ADHD subtypes provide a convenient clinical shorthand to describe the functional and behavioral correlates of current levels of inattention and hyperactivity-impulsivity symptoms, but do not identify discrete subgroups with sufficient long-term stability to justify the classification of distinct forms of the disorder. Empirical support is stronger for an alternative model that would replace the subtypes with dimensional modifiers that reflect the number of inattention and hyperactivity-impulsivity symptoms at the time of assessment. PMID:22612200

Stability of steviol glycosides in several food matrices.

PubMed

Jooken, Etienne; Amery, Ruis; Struyf, Tom; Duquenne, Barbara; Geuns, Jan; Meesschaert, Boudewijn

2012-10-24

As steviol glycosides are now allowed as a food additive in the European market, it is important to assess the stability of these steviol glycosides after they have been added to different food matrices. We analyzed and tested the stability of steviol glycosides in semiskimmed milk, soy drink, fermented milk drink, ice cream, full-fat and skimmed set yogurt, dry biscuits, and jam. The fat was removed by centrifugation from the dairy and soy drink samples. Proteins were precipitated by the addition of acetonitrile and also removed by centrifugation. Samples of jam were extracted with water. Dry biscuits were extracted with ethanol. The resulting samples were concentrated with solid-phase extraction and analyzed by high-performance liquid chromatography on a C18 stationary phase and a gradient of acetonitrile/aqueous 25 mM phosphoric acid. The accuracy was checked using a standard addition on some samples. For assessing the stability of the steviol glycosides, samples were stored in conditions relevant to each food matrix and analyzed periodically. The results indicate that steviol glycosides can be analyzed with good precision and accuracy in these food categories. The recovery was between 96 and 103%. The method was also validated by standard addition, which showed excellent agreement with the external calibration curve. No sign of decomposition of steviol glycosides was found in any of the samples.

Mid-Holocene stabilization of the Karakum and Kyzylkum sand seas, central Asia - evidence from OSL ages

NASA Astrophysics Data System (ADS)

Maman, Shimrit; Tsoar, Haim; Blumberg, Dan G.; Porat, Naomi

2013-04-01

Sand seas (ergs) are large areas of deserts covered by wind-swept sand with varying degrees of vegetation cover. The Kyzylkum and Karakum ergs have accumulated in the Turan basin, northwest of the Hindu Kush range, and span from south Turkmenistan to the Syrdarya River in Kazakhstan. These ergs are dissected by the Amudarya River; To the north lies the Kyzylkum (red sands) and to the south the Karakum (black sands). This area is understudied, and little information has been published regarding the sands stabilization processes and deposition ages. This research focuses on identifying and mapping the ergs of Central Asia and analyzing the climate factors that set the dunes into motion and that stabilized them. A variety of spaceborne imagery with varying spectral and spatial resolutions was used. These images provide the basis for mapping sand distribution, dune forms, and vegetation cover. Wilson (1973) defined these ergs as active based on precipitation. Our results show that they are mostly stabilized, with an estimated area of ~260,000 sq. Km for Kara-Kum , and ~195,500 sq. Km for the Kyzyl-Kum . Meteorological analysis of wind and precipitation data indicate a low wind energy environment (DP<200) and sufficient rainfall (>100 mm) to which is essential for vegetation cover. We present the first optically stimulated luminescence (OSL) ages from the upper meter of 14 exposed sections from both ergs. The age of the sand samples was determined as ~Mid-Holocene by OSL, which provides an insight into past climate characteristics. These ages indicate extensive sand and dune stabilization during the Mid-Holocene. GIS analysis was performed in parallel with field work to validate and verify the results. The OSL ages, coupled with a compilation of regional palaeoclimatic data, corroborate and reinforce the previously proposed Mid-Holocene Liavliakan phase, known to reflect a warmer, wetter, less windy climate than persists today and that resulted in dune stabilization around Mid-Holocene. This study emphasizes the importance of regional climatic control on aeolian activity and is the first to show when these vast sand seas were stabilized.

Linguistic and psychometric validation of the Malaysian version of Diabetes Quality of Life-Brief Clinical Inventory (DQoL-BCI).

PubMed

Samah, Syamimi; Neoh, Chin Fen; Wong, Yuet Yen; Hassali, Mohamed Azmi; Shafie, Asrul Akmal; Lim, Siong Meng; Ramasamy, Kalavathy; Mat Nasir, Nafiza; Han, Yung Wen; Burroughs, Thomas

2017-11-01

Quality of life (QoL) assessment provides valuable outcome to support clinical decision-making, particularly for patients with chronic diseases that are incurable. A brief, 15-item diabetes-specific tool [i.e. Diabetes Quality of Life-Brief Clinical Inventory (DQoL-BCI)] is known to be developed in English and validated for use in clinical practice. This simplified tool, however, is not readily available for use in the Malaysian setting. To translate the DQoL-BCI into a Malaysian version and to assess its construct validity (factorial validity, convergent validity and discriminant validity), reliability (internal consistency) and floor and ceiling effects among the Malaysian diabetic population. A forward-backward translation, involving professional translators and experts with vast experience in translation of patient reported outcome measures, was conducted. A total of 202 patients with Type 2 diabetes mellitus (T2DM) who fulfilled the inclusion criteria were invited to complete the translated DQoL-BCI. Data were analysed using SPSS for exploratory factor analysis (EFA), convergent and discriminant validity, reliability and test-retest, and AMOS software for confirmatory factor analysis (CFA). Findings from EFA indicated that the 4-factor structure of the Malaysian version of DQoL-BCI was optimal and explained 50.9% of the variance; CFA confirmed the 4-factor model fit. There was negative, moderate correlation between the scores of DQoL-BCI (Malaysian version) and EQ-5D-3L utility score (r = -0.329, p = 0.003). Patients with higher glycated haemoglobin levels (p = 0.008), diabetes macrovascular (p = 0.017) and microvascular (p = 0.013) complications reported poorer QoL. Cronbach's alpha coefficient and intraclass coefficient correlations (range) obtained were 0.703 and 0.86 (0.734-0.934), indicating good reliability and stability of the translated DQoL-BCI. This study had validated the linguistic and psychometric properties of DQoL-BCI (Malaysian version), thus providing a valid and reliable brief tool for assessing the QoL of Malaysian T2DM patients. Copyright © 2016 Elsevier Inc. All rights reserved.

Validation of the Filovirus Plaque Assay for Use in Preclinical Studies

PubMed Central

Shurtleff, Amy C.; Bloomfield, Holly A.; Mort, Shannon; Orr, Steven A.; Audet, Brian; Whitaker, Thomas; Richards, Michelle J.; Bavari, Sina

2016-01-01

A plaque assay for quantitating filoviruses in virus stocks, prepared viral challenge inocula and samples from research animals has recently been fully characterized and standardized for use across multiple institutions performing Biosafety Level 4 (BSL-4) studies. After standardization studies were completed, Good Laboratory Practices (GLP)-compliant plaque assay method validation studies to demonstrate suitability for reliable and reproducible measurement of the Marburg Virus Angola (MARV) variant and Ebola Virus Kikwit (EBOV) variant commenced at the United States Army Medical Research Institute of Infectious Diseases (USAMRIID). The validation parameters tested included accuracy, precision, linearity, robustness, stability of the virus stocks and system suitability. The MARV and EBOV assays were confirmed to be accurate to ±0.5 log10 PFU/mL. Repeatability precision, intermediate precision and reproducibility precision were sufficient to return viral titers with a coefficient of variation (%CV) of ≤30%, deemed acceptable variation for a cell-based bioassay. Intraclass correlation statistical techniques for the evaluation of the assay’s precision when the same plaques were quantitated by two analysts returned values passing the acceptance criteria, indicating high agreement between analysts. The assay was shown to be accurate and specific when run on Nonhuman Primates (NHP) serum and plasma samples diluted in plaque assay medium, with negligible matrix effects. Virus stocks demonstrated stability for freeze-thaw cycles typical of normal usage during assay retests. The results demonstrated that the EBOV and MARV plaque assays are accurate, precise and robust for filovirus titration in samples associated with the performance of GLP animal model studies. PMID:27110807

Development of Survey Scales for Measuring Exposure and Behavioral Responses to Disruptive Intraoperative Behavior.

PubMed

Villafranca, Alexander; Hamlin, Colin; Rodebaugh, Thomas L; Robinson, Sandra; Jacobsohn, Eric

2017-09-10

Disruptive intraoperative behavior has detrimental effects to clinicians, institutions, and patients. How clinicians respond to this behavior can either exacerbate or attenuate its effects. Previous investigations of disruptive behavior have used survey scales with significant limitations. The study objective was to develop appropriate scales to measure exposure and responses to disruptive behavior. We obtained ethics approval. The scales were developed in a sequence of steps. They were pretested using expert reviews, computational linguistic analysis, and cognitive interviews. The scales were then piloted on Canadian operating room clinicians. Factor analysis was applied to half of the data set for question reduction and grouping. Item response analysis and theoretical reviews ensured that important questions were not eliminated. Internal consistency was evaluated using Cronbach α. Model fit was examined on the second half of the data set using confirmatory factor analysis. Content validity of the final scales was re-evaluated. Consistency between observed relationships and theoretical predictions was assessed. Temporal stability was evaluated on a subsample of 38 respondents. A total of 1433 and 746 clinicians completed the exposure and response scales, respectively. Content validity indices were excellent (exposure = 0.96, responses = 1.0). Internal consistency was good (exposure = 0.93, responses = 0.87). Correlations between the exposure scale and secondary measures were consistent with expectations based on theory. Temporal stability was acceptable (exposure = 0.77, responses = 0.73). We have developed scales measuring exposure and responses to disruptive behavior. They generate valid and reliable scores when surveying operating room clinicians, and they overcome the limitations of previous tools. These survey scales are freely available.

Validation of the Long-term Difficulties Inventory (LDI) and the List of Threatening Experiences (LTE) as measures of stress in epidemiological population-based cohort studies.

PubMed

Rosmalen, J G M; Bos, E H; de Jonge, P

2012-12-01

Stress questionnaires are included in many epidemiological cohort studies but the psychometric characteristics of these questionnaires are largely unknown. The aim of this study was to describe these characteristics for two short questionnaires measuring the lifetime and past year occurrence of stress: the List of Threatening Events (LTE) as a measure of acute stress and the Long-term Difficulties Inventory (LDI) as a measure of chronic stress. This study was performed in a general population cohort consisting of 588 females (53.7%) and 506 males (46.3%), with a mean age of 53.5 years (s.d.=11.3 years). Respondents completed the LTE and the LDI for the past year, and for the age categories of 0-12, 13-18, 19-39, 40-60, and >60 years. They also completed questionnaires on perceived stress, psychological distress (the General Health Questionnaire, GHQ-12), anxiety and depression (the Symptom Checklist, SCL-8) and neuroticism (the Eysenck Personality Questionnaire - Revised Short Scale, EPQ-RSS-N). Approximately 2 years later, 976 respondents (89%) completed these questionnaires for a second time. The stability of the retrospective reporting of long-term difficulties and life events was satisfactory: 0.7 for the lifetime LDI and 0.6 for the lifetime LTE scores. The construct validity of these lists is indicated by their positive associations with psychological distress, mental health problems and neuroticism. This study in a large population-based sample shows that the LDI and LTE have sufficient validity and stability to include them in major epidemiological cohort studies.

11th GCC Closed Forum: cumulative stability; matrix stability; immunogenicity assays; laboratory manuals; biosimilars; chiral methods; hybrid LBA/LCMS assays; fit-for-purpose validation; China Food and Drug Administration bioanalytical method validation.

PubMed

Islam, Rafiq; Briscoe, Chad; Bower, Joseph; Cape, Stephanie; Arnold, Mark; Hayes, Roger; Warren, Mark; Karnik, Shane; Stouffer, Bruce; Xiao, Yi Qun; van der Strate, Barry; Sikkema, Daniel; Fang, Xinping; Tudoroniu, Ariana; Tayyem, Rabab; Brant, Ashley; Spriggs, Franklin; Barry, Colin; Khan, Masood; Keyhani, Anahita; Zimmer, Jennifer; Caturla, Maria Cruz; Couerbe, Philippe; Khadang, Ardeshir; Bourdage, James; Datin, Jim; Zemo, Jennifer; Hughes, Nicola; Fatmi, Saadya; Sheldon, Curtis; Fountain, Scott; Satterwhite, Christina; Colletti, Kelly; Vija, Jenifer; Yu, Mathilde; Stamatopoulos, John; Lin, Jenny; Wilfahrt, Jim; Dinan, Andrew; Ohorodnik, Susan; Hulse, James; Patel, Vimal; Garofolo, Wei; Savoie, Natasha; Brown, Michael; Papac, Damon; Buonarati, Mike; Hristopoulos, George; Beaver, Chris; Boudreau, Nadine; Williard, Clark; Liu, Yansheng; Ray, Gene; Warrino, Dominic; Xu, Allan; Green, Rachel; Hayward-Sewell, Joanne; Marcelletti, John; Sanchez, Christina; Kennedy, Michael; Charles, Jessica St; Bouhajib, Mohammed; Nehls, Corey; Tabler, Edward; Tu, Jing; Joyce, Philip; Iordachescu, Adriana; DuBey, Ira; Lindsay, John; Yamashita, Jim; Wells, Edward

2018-04-01

The 11th Global CRO Council Closed Forum was held in Universal City, CA, USA on 3 April 2017. Representatives from international CRO members offering bioanalytical services were in attendance in order to discuss scientific and regulatory issues specific to bioanalysis. The second CRO-Pharma Scientific Interchange Meeting was held on 7 April 2017, which included Pharma representatives' sharing perspectives on the topics discussed earlier in the week with the CRO members. The issues discussed at the meetings included cumulative stability evaluations, matrix stability evaluations, the 2016 US FDA Immunogenicity Guidance and recent and unexpected FDA Form 483s on immunogenicity assays, the bioanalytical laboratory's role in writing PK sample collection instructions, biosimilars, CRO perspectives on the use of chiral versus achiral methods, hybrid LBA/LCMS assays, applications of fit-for-purpose validation and, at the Global CRO Council Closed Forum only, the status and trend of current regulated bioanalytical practice in China under CFDA's new BMV policy. Conclusions from discussions of these topics at both meetings are included in this report.

Comparative Assessment of the Effect of Hyper-glycosylation on the Pattern and Kinetics of Degradation of Darbepoetin Alfa using a Stability-Indicating Orthogonal Testing Protocol.

PubMed

Moenes, Eman M; Al-Ghobashy, Medhat A; Mohamed, Abeer A; Salem, Maissa Y

2018-01-01

Darbepoetin alfa (DA); hyper-glycosylated Erythropoietin alfa (EPO) is an essential treatment of anemia in patients with chronic kidney failure and cancer. In this study, DA and EPO were subjected to physicochemical stress factors that might be encountered during production, transport and storage (pH, temperature, agitation, repeated freeze-thaw and oxidation). An orthogonal stability-indicating assay protocol comprised of SE-HPLC, RP-HPLC, ELISA and SDS-PAGE was developed and validated to investigate the effect of further glycosylation of DA on the pattern and kinetics of degradation. Results showed a relatively higher stability and lower tendency to form high molecular weight aggregates in the case of DA when compared to EPO, under equivalent stress conditions. Dimers and aggregates were formed for both drugs across the whole pH range and following incubation at temperatures higher than 2-8°C or repeated freeze/thaw. The same observation was noted upon agitation of standard samples prepared in the formulation buffers at high speed and upon oxidation with hydrogen peroxide. The agreement between SE-HPLC, supported with spectral purity data and ELISA confirmed the specificity of both techniques for the intact drugs. Results of RP-HPLC and SDS-PAGE indicated that dimerization occurred through disulfide and bi-tyrosine covalent bonds in the case of pH and oxidation, respectively. It was evident that aggregation was significantly suppressed upon increasing the glycan size and under any of the studied stress factors loss of the glycan has not been observed. These observations supported with the slow kinetics of degradation confirmed the superiority of glyco-engineering over chemical pegylation to enhance the stability of EPO. Formation of such potentially immunogenic product-related impurities at all tested stress factors confirmed the need for orthogonal testing protocols to investigate the complex pattern of degradation of such sensitive products. Copyright © 2017 Elsevier B.V. All rights reserved.

The outcome of tactile touch on stress parameters in intensive care: a randomized controlled trial.

PubMed

Henricson, Maria; Ersson, Anders; Määttä, Sylvia; Segesten, Kerstin; Berglund, Anna-Lena

2008-11-01

The study aimed to investigate the effects of a five-day tactile touch intervention in order to find new and unconventional measures to moderate the detrimental influence of patients' stressors during intensive care. The hypothesis was that tactile touch would decrease stress indicators such as anxiety, glucose metabolism, blood pressure, heart rate and requirements of sedative drugs and noradrenalin. A randomized controlled trial was undertaken with 44 patients, which were assigned either to tactile touch or standard treatment (a rest hour). Observations of the stress indicators were made before, during and after the intervention or standard treatment. The study showed that tactile touch led to significantly lower levels of anxiety. The circulatory parameters suggested increased circulatory stability indicated by a reduction in noradrenalin requirement. The results need to be further validated through studies with larger sample sizes.

Next-generation negative symptom assessment for clinical trials: validation of the Brief Negative Symptom Scale.

PubMed

Strauss, Gregory P; Keller, William R; Buchanan, Robert W; Gold, James M; Fischer, Bernard A; McMahon, Robert P; Catalano, Lauren T; Culbreth, Adam J; Carpenter, William T; Kirkpatrick, Brian

2012-12-01

The current study examined the psychometric properties of the Brief Negative Symptom Scale (BNSS), a next-generation rating instrument developed in response to the NIMH sponsored consensus development conference on negative symptoms. Participants included 100 individuals with a DSM-IV diagnosis of schizophrenia or schizoaffective disorder who completed a clinical interview designed to assess negative, positive, disorganized, and general psychiatric symptoms, as well as functional outcome. A battery of anhedonia questionnaires and neuropsychological tests were also administered. Results indicated that the BNSS has excellent internal consistency and temporal stability, as well as good convergent and discriminant validity in its relationships with other symptom rating scales, functional outcome, self-reported anhedonia, and neuropsychological test scores. Given its brevity (13-items, 15-minute interview) and good psychometric characteristics, the BNSS can be considered a promising new instrument for use in clinical trials. Copyright © 2012 Elsevier B.V. All rights reserved.

Initial validation of the Personality Assessment Inventory-Spanish version with clients from Mexican American communities.

PubMed

Rogers, R; Flores, J; Ustad, K; Sewell, K W

1995-04-01

Psychological assessment of Hispanic populations are thwarted by the absence of clinical research on comparability of Spanish translations and the stability of their findings. In this study we examined the potential usefulness of the Spanish Personality Assessment Inventory (PAI; Morey, 1991) for Hispanic clients residing in Mexican American communities. We administered the Spanish version on two occasions to 48 monolingual clients and the Spanish and English versions to 21 bilingual clients. Results indicated that the clinical scales had a moderate to good correspondence for Spanish-English (M r = .72) and good test-retest reliability for Spanish-Spanish (M r = .79). Much more variation was observed for the validity scales and the treatment/interpersonal scales. Also more variability was observed in the convergence of elevations across administrations. Because of these mixed results, we discuss the potential usefulness of the PAI clinical scales to screen for major psychopathology.

Observation of early childhood physical aggression: a psychometric study of the system for coding early physical aggression.

PubMed

Mesman, Judi; Alink, Lenneke R A; van Zeijl, Jantien; Stolk, Mirjam N; Bakermans-Kranenburg, Marian J; van Ijzendoorn, Marinus H; Juffer, Femmie; Koot, Hans M

2008-01-01

We investigated the reliability and (convergent and discriminant) validity of an observational measure of physical aggression in toddlers and preschoolers, originally developed by Keenan and Shaw [1994]. The observation instrument is based on a developmental definition of aggression. Physical aggression was observed twice in a laboratory setting, the first time when children were 1-3 years old, and again 1 year later. Observed physical aggression was significantly related to concurrent mother-rated physical aggression for 2- to 4-year-olds, but not to maternal ratings of nonaggressive externalizing problems, indicating the measure's discriminant validity. However, we did not find significant 1-year stability of observed physical aggression in any of the age groups, whereas mother-rated physical aggression was significantly stable for all ages. The observational measure shows promise, but may have assessed state rather than trait aggression in our study. Copyright 2008 Wiley-Liss, Inc.

Development of the Systems Thinking Scale for Adolescent Behavior Change.

PubMed

Moore, Shirley M; Komton, Vilailert; Adegbite-Adeniyi, Clara; Dolansky, Mary A; Hardin, Heather K; Borawski, Elaine A

2018-03-01

This report describes the development and psychometric testing of the Systems Thinking Scale for Adolescent Behavior Change (STS-AB). Following item development, initial assessments of understandability and stability of the STS-AB were conducted in a sample of nine adolescents enrolled in a weight management program. Exploratory factor analysis of the 16-item STS-AB and internal consistency assessments were then done with 359 adolescents enrolled in a weight management program. Test-retest reliability of the STS-AB was .71, p = .03; internal consistency reliability was .87. Factor analysis of the 16-item STS-AB indicated a one-factor solution with good factor loadings, ranging from .40 to .67. Evidence of construct validity was supported by significant correlations with established measures of variables associated with health behavior change. We provide beginning evidence of the reliability and validity of the STS-AB to measure systems thinking for health behavior change in young adolescents.

Development of the Systems Thinking Scale for Adolescent Behavior Change

PubMed Central

Moore, Shirley M.; Komton, Vilailert; Adegbite-Adeniyi, Clara; Dolansky, Mary A.; Hardin, Heather K.; Borawski, Elaine A.

2017-01-01

This report describes the development and psychometric testing of the Systems Thinking Scale for Adolescent Behavior Change (STS-AB). Following item development, initial assessments of understandability and stability of the STS-AB were conducted in a sample of nine adolescents enrolled in a weight management program. Exploratory factor analysis of the 16-item STS-AB and internal consistency assessments were then done with 359 adolescents enrolled in a weight management program. Test–retest reliability of the STS-AB was .71, p = .03; internal consistency reliability was .87. Factor analysis of the 16-item STS-AB indicated a one-factor solution with good factor loadings, ranging from .40 to .67. Evidence of construct validity was supported by significant correlations with established measures of variables associated with health behavior change. We provide beginning evidence of the reliability and validity of the STS-AB to measure systems thinking for health behavior change in young adolescents. PMID:28303755

Development and initial validation of a measure of work, family, and school conflict.

PubMed

Olson, Kristine J

2014-01-01

This study reports the development and initial validation of a theoretically based measure of conflict between work, family, and college student roles. The measure was developed through the assessment of construct definitions and an assessment of measurement items by subject matter experts. Then, the measurement items were assessed with data from 500 college students who were engaged in work and family responsibilities. The results indicate that conflict between work, family, and school are effectively measured by 12 factors assessing the direction of conflict (e.g., work-to-school conflict, and school-to-work conflict) as well as the form of conflict (i.e., time, strain, and behavior based conflict). Sets of exploratory and confirmatory factor analyses demonstrated that the 12 factors of the new measure are distinct from the 6 factors of the Carlson, Kacmar, and Williams (2000) work-family conflict measure. Criterion validity of the measure was established through a series of regression analyses testing hypothesized relationships between antecedent and outcome variables with role conflict. Results indicate that role demand was a robust predictor of role conflict. To extend the literature, core self-evaluations and emotional stability were established as predictors of role conflict. Further, work, family, and school role satisfaction were significantly impacted with the presence of role conflict between work, family, and school. PsycINFO Database Record (c) 2014 APA, all rights reserved.

Parent Attributions of Ambiguous Symptoms in Their Children: A Preliminary Measure Validation in Parents of Children with Chronic Pain.

PubMed

Heathcote, Lauren C; Williams, Sara E; Smith, Allison M; Sieberg, Christine B; Simons, Laura E

2018-06-13

How parents attribute cause to their child’s physical symptoms is likely important in understanding how the parent responds to the child, as well as the child’s health outcomes, especially within the context of chronic illness. Here, we adapt the Symptom Interpretation Questionnaire for parent report (SIQ-PR) and provide preliminary validation in a sample of parents of children with chronic pain ( N = 311). Confirmatory factor analysis revealed that the SIQ-PR structure is consistent with the original measure, with three distinct attribution types: psychological (emotional/affective), somatic (illness/disease), and environmental (situational/transient) causes. All three subscales demonstrated satisfactory to good internal consistency, and temporal stability. Parents typically endorsed more than one attribution for each symptom, indicating that parents of children with chronic pain have a multidimensional interpretation of physical symptoms in their children. Further, parent psychological and somatic attributions, but not environmental attributions, were significantly associated with (i) parent protective responses towards their child, and (ii) the child’s self-reported somatic and psychological symptoms, indicating convergent and divergent validity. The SIQ-PR may be a useful measure for future studies investigating intergenerational and interpersonal models of pediatric chronic pain, and more broadly, to examine parent attributions of children’s ambiguous symptoms within the context of childhood chronic illness.

Validated stability-indicating HPLC method for the determination of pridinol mesylate. Kinetics study of its degradation in acid medium.

PubMed

Bianchini, Romina M; Castellano, Patricia M; Kaufman, Teodoro S

2008-12-01

The stability of pridinol mesylate (PRI) was investigated under different stress conditions, including hydrolytic, oxidative, photolytic and thermal, as recommended by the ICH guidelines. Relevant degradation was found to take place under acidic (0.1N HCl) and photolytic (visible and long-wavelength UV-light) conditions, both yielding the product resulting from water elimination (ELI), while submission to an oxidizing environment gave the N-oxidation derivative (NOX). The standards of these degradation products were synthesized and characterized by IR, (1)H and (13)C NMR spectroscopy. A simple, sensitive and specific HPLC method was developed for the quantification of PRI, ELI and NOX in bulk drug, and the conditions were optimized by means of a statistical design strategy. The separation employs a C(18) column and a 51:9:40 (v/v/v) mixture of MeOH, 2-propanol and potassium phosphate solution (50mM, pH 6.0), as mobile phase, delivered at 1.0 ml min(-1); the analytes were detected and quantified at 220 nm. The method was validated, demonstrating to be accurate and precise (repeatability and intermediate precision levels) within the corresponding linear ranges of PRI (0.1-1.5 mg ml(-1); r=0.9983, n=18) and both impurities (0.1-1.3% relative to PRI, r=0.9996 and 0.9995 for ELI and NOX, respectively, n=18). Robustness against small modifications of pH and percentage of the aqueous mobile phase was ascertained and the limits of quantification of the analytes were also determined (0.4 and 0.5 microg ml(-1); 0.04% and 0.05% relative to PRI for ELI and NOX, respectively). Peak purity indices (>0.9997), obtained with the aid of diode-array detection, and satisfactory resolution (R(s)>2.0) between PRI and its impurities established the specificity of the determination, all these results proving the stability-indicating capability of the method. The kinetics of the degradation of PRI in acid medium was also studied, determining that this is a first-order process with regards to drug concentration, with an activation energy of 25.5 Kcal mol(-1) and a t(1/2)=10,830 h, in 0.1N HCl at 38 degrees C.

Influence of temperature on the rheological behavior of a new fucose-containing bacterial exopolysaccharide.

PubMed

Cruz, Madalena; Freitas, Filomena; Torres, Cristiana A V; Reis, Maria A M; Alves, Vítor D

2011-05-01

The effect of temperature on the rheology of a new fucose-containing extracellular polysaccharide (EPS) was evaluated. The steady state data revealed a shear-thinning behavior, with the viscosity being immediately recovered when the shear rate was decreased. The mechanical spectra indicated viscous solutions with entangled polymer molecules in the range of temperatures studied (from 15 °C to 65 °C). In addition, the Time-Temperature Superposition principle was successfully applied and the Cox-Merz rule was valid, reinforcing the idea of a thermorheologically simple behavior for the EPS in aqueous solution. Furthermore, the viscous and viscoelastic properties at 25 °C were maintained after consecutive heating and cooling cycles, indicating a good thermal stability under temperature fluctuations. Copyright © 2011 Elsevier B.V. All rights reserved.

Measurement of perceived competence in Dutch children with mild intellectual disabilities.

PubMed

Elias, C; Vermeer, A; 't Hart, H

2005-04-01

Little research has been conducted on the perceived competence of children with mild intellectual disabilities (MID). One of the reasons for the marked absence of research appears to be the lack of reliable and clearly valid measurement instruments for this particular group of children. In the present study, it was examined whether a pictorial scale originally designed to measure perceived competence in typically developing children could successfully be used with children with MID. The pictorial scale was administered to a group of 106 children with MID. The construct validity, reliability and stability of the scale were investigated. The results of the exploratory factor analyses and the confirmatory factor analyses supported the conceptual framework proposed. The construct validity was also supported by the pattern of intercorrelations between the subscales. The scale had adequate internal consistency and the stability analyses showed sufficient stability across a 4-month period. The findings show the psychometric properties of the pictorial scale to justify its use with children with MID.

Measuring sperm whales from their clicks: Stability of interpulse intervals and validation that they indicate whale length

NASA Astrophysics Data System (ADS)

Rhinelander, Marcus Q.; Dawson, Stephen M.

2004-04-01

Multiple pulses can often be distinguished in the clicks of sperm whales (Physeter macrocephalus). Norris and Harvey [in Animal Orientation and Navigation, NASA SP-262 (1972), pp. 397-417] proposed that this results from reflections within the head, and thus that interpulse interval (IPI) is an indicator of head length, and by extrapolation, total length. For this idea to hold, IPIs must be stable within individuals, but differ systematically among individuals of different size. IPI stability was examined in photographically identified individuals recorded repeatedly over different dives, days, and years. IPI variation among dives in a single day and days in a single year was statistically significant, although small in magnitude (it would change total length estimates by <3%). As expected, IPIs varied significantly among individuals. Most individuals showed significant increases in IPIs over several years, suggesting growth. Mean total lengths calculated from published IPI regressions were 13.1 to 16.1 m, longer than photogrammetric estimates of the same whales (12.3 to 15.3 m). These discrepancies probably arise from the paucity of large (12-16 m) whales in data used in published regressions. A new regression is offered for this size range.

Evolution of the Southern Oscillation as observed by the Nimbus-7 ERB experiment

NASA Technical Reports Server (NTRS)

Ardanuy, Philip E.; Kyle, H. Lee; Chang, Hyo-Duck

1987-01-01

The Nimbus-7 satellite has been in a 955-km, sun-synchronous orbit since October 1978. The Earth Radiation Budget (ERB) experiment has taken approximately 8 years of high-quality data during this time, of which seven complete years have been archived at the National Space Science Data Center. A final reprocessing of the wide-field-of-view channel dataset is underway. Error analyses indicate a long-term stability of 1 percent better over the length of the data record. As part of the validation of the ERB measurements, the archived 7-year Nimbus-7 ERB dataset is examined for the presence and accuracy of interannual variations including the Southern Oscillation signal. Zonal averages of broadband outgoing longwave radiation indicate a terrestrial response of more than 2 years to the oceanic and atmospheric manifestations of the 1982-83 El Nino/Southern Oscillation (ENSO) event, especially in the tropics. This signal is present in monthly and seasonal averages and is shown here to derive primarily from atmospheric responses to adjustments in the Pacific Ocean. The calibration stability of this dataset thus provides a powerful new tool to examine the physics of the ENSO phenomena.

A New Improved RP-HPLC Method for Assay of Rosuvastatin Calcium in Tablets

PubMed Central

Kaila, H. O.; Ambasana, M. A.; Thakkar, R. S.; Saravaia, H. T.; Shah, A. K.

2010-01-01

A reliable and sensitive isocratic stability indicating RP-HPLC method has been developed and validated for assay of rosuvastatin calcium in tablets and for determination of content uniformity. An isocratic separation of rosuvastatin calcium was achieved on YMC C8, 150×4.6 mm i.d., 5 μm particle size columns with a flow rate of 1.5 ml/min and using a photodiode array detector to monitor the eluate at 242 nm. The mobile phase consisted of acetonitrile: water (40:60, v/v) pH 3.5 adjusted with phosphoric acid. The drug was subjected to oxidation, hydrolysis, photolysis and thermal degradation. All degradation products in an overall analytical run time of approximately 10 min with the parent compound rosuvastatin eluting at approximately 5.2 min. Response was a linear function of drug concentration in the range of 0.5-80 μg/ml (r2= 0.9993) with a limit of detection and quantification of 0.1 and 0.5 μg/ml respectively. Accuracy (recovery) was between 99.6 and 101.7%. Degradation products resulting from the stress studies did not interfere with the detection of rosuvastatin and the assay is thus stability-indicating. PMID:21694991

[Reliability and validity of depression scales of Chinese version: a systematic review].

PubMed

Sun, X Y; Li, Y X; Yu, C Q; Li, L M

2017-01-10

Objective: Through systematically reviewing the reliability and validity of depression scales of Chinese version in adults in China to evaluate the psychometric properties of depression scales for different groups. Methods: Eligible studies published before 6 May 2016 were retrieved from the following database: CNKI, Wanfang, PubMed and Embase. The HSROC model of the diagnostic test accuracy (DTA) for Meta-analysis was used to calculate the pooled sensitivity and specificity of the PHQ-9. Results: A total of 44 papers evaluating the performance of depression scales were included. Results showed that the reliability and validity of the common depression scales were eligible, including the Beck depression inventory (BDI), the Hamilton depression scale (HAMD), the center epidemiological studies depression scale (CES-D), the patient health questionnaire (PHQ) and the Geriatric depression scale (GDS). The Cronbach' s coefficient of most tools were larger than 0.8, while the test-retest reliability and split-half reliability were larger than 0.7, indicating good internal consistency and stability. The criterion validity, convergent validity, discrimination validity and screening validity were acceptable though different cut-off points were recommended by different studies. The pooled sensitivity of the 11 studies evaluating PHQ-9 was 0.88 (95 %CI : 0.85-0.91) while the pooled specificity was 0.89 (95 %CI : 0.82-0.94), which demonstrated the applicability of PHQ-9 in screening depression. Conclusion: The reliability and validity of different depression scales of Chinese version are acceptable. The characteristics of different tools and study population should be taken into consideration when choosing a specific scale.

Stability evaluation of quality parameters for palm oil products at low temperature storage.

PubMed

Ramli, Nur Aainaa Syahirah; Mohd Noor, Mohd Azmil; Musa, Hajar; Ghazali, Razmah

2018-07-01

Palm oil is one of the major oils and fats produced and traded worldwide. The value of palm oil products is mainly influenced by their quality. According to ISO 17025:2005, accredited laboratories require a quality control procedure with respect to monitoring the validity of tests for determination of quality parameters. This includes the regular use of internal quality control using secondary reference materials. Unfortunately, palm oil reference materials are not currently available. To establish internal quality control samples, the stability of quality parameters needs to be evaluated. In the present study, the stability of quality parameters for palm oil products was examined over 10 months at low temperature storage (6 ± 2 °C). The palm oil products tested included crude palm oil (CPO); refined, bleached and deodorized (RBD) palm oil (RBDPO); RBD palm olein (RBDPOo); and RBD palm stearin (RBDPS). The quality parameters of the oils [i.e. moisture content, free fatty acid content (FFA), iodine value (IV), fatty acids composition (FAC) and slip melting point (SMP)] were determined prior to and throughout the storage period. The moisture, FFA, IV, FAC and SMP for palm oil products changed significantly (P < 0.05), whereas the moisture content for CPO, IV for RBDPO and RBDPOo, stearic acid composition for CPO and linolenic acid composition for CPO, RBDPO, RBDPOo and RBDPS did not (P > 0.05). The stability study indicated that the quality of the palm oil products was stable within the specified limits throughout the storage period at low temperature. The storage conditions preserved the quality of palm oil products throughout the storage period. These findings qualify the use of the palm oil products CPO, RBDPO, RBDPOo and RBDPS as control samples in the validation of test results. © 2017 Society of Chemical Industry. © 2017 Society of Chemical Industry.

Development of RP UPLC-TOF/MS, stability indicating method for omeprazole and its related substances by applying two level factorial design; and identification and synthesis of non-pharmacopoeial impurities.

PubMed

Jadhav, Sushant Bhimrao; Kumar, C Kiran; Bandichhor, Rakeshwar; Bhosale, P N

2016-01-25

A new UPLC-TOF/MS compatible, reverse phase-stability indicating method was developed for determination of Omeprazole (OMP) and its related substances in pharmaceutical dosage forms by implementing Design of Experiment (DoE) i.e. two level full factorial Design (2(3)+3 center points=11 experiments) to understand the Critical Method Parameters (CMP) and its relation with Critical Method Attribute (CMA); to ensure robustness of the method. The separation of eleven specified impurities including conversion product of OMP related compound F (13) and G (14) i.e. Impurity-I (1), OMP related compound-I (11) and OMP 4-chloro analog (12) was achieved in a single method on Acquity BEH shield RP18 100 × 2.1 mm, 1.7 μm column, with inlet filter (0.2 μm) using gradient elution and detector wavelength at 305 nm and validated in accordance with ICH guidelines and found to be accurate, precise, reproducible, robust and specific. The drug was found to degrade extensively in heat, humidity and acidic conditions and forms unknown degradation products during stability studies. The same method was used for LC-MS analysis to identify m/z and fragmentation of maximum unknown impurities (Non-Pharmacopoeial) i.e. Impurity-I (1), Impurity-III (3), Impurity-V (5) and Impurity-VIII (9) formed during stability studies. Based on the results, degradation pathway for the drug has been proposed and synthesis of identified impurities i.e. impurities (Impurity-I (1), Impurity-III (3), Impurity-V (5) and Impurity-VIII (9)) are discussed in detail to ensure in-depth understanding of OMP and its related impurities and optimum performance during lifetime of the product. Copyright © 2015. Published by Elsevier B.V.

High drug load, stable, manufacturable and bioavailable fenofibrate formulations in mesoporous silica: a comparison of spray drying versus solvent impregnation methods.

PubMed

Hong, Shiqi; Shen, Shoucang; Tan, David Cheng Thiam; Ng, Wai Kiong; Liu, Xueming; Chia, Leonard S O; Irwan, Anastasia W; Tan, Reginald; Nowak, Steven A; Marsh, Kennan; Gokhale, Rajeev

2016-01-01

Encapsulation of drugs in mesoporous silica using co-spray drying process has been recently explored as potential industrial method. However, the impact of spray drying on manufacturability, physiochemical stability and bioavailability in relation to conventional drug load processes are yet to be fully investigated. Using a 2(3) factorial design, this study aims to investigate the effect of drug-loading process (co-spray drying and solvent impregnation), mesoporous silica pore size (SBA-15, 6.5 nm and MCM-41, 2.5 nm) and percentage drug load (30% w/w and 50% w/w) on material properties, crystallinity, physicochemical stability, release profiles and bioavailability of fenofibrate (FEN) loaded into mesoporous silica. From the scanning electronic microscopy (SEM) images, powder X-ray diffraction and Differential scanning calorimetry measurements, it is indicated that the co-spray drying process was able to load up to 50% (w/w) FEN in amorphous form onto the mesoporous silica as compared to the 30% (w/w) for solvent impregnation. The in vitro dissolution rate of the co-spray dried formulations was also significantly (p = 0.044) better than solvent impregnated formulations at the same drug loading. Six-month accelerated stability test at 40 °C/75 RH in open dish indicated excellent physical and chemical stability of formulations prepared by both methods. The amorphous state of FEN and the enhanced dissolution profiles were well preserved, and very low levels of degradation were detected after storage. The dog data for the three selected co-spray-dried formulations revealed multiple fold increment in FEN bioavailability compared to the reference crystalline FEN. These results validate the viability of co-spray-dried mesoporous silica formulations with high amorphous drug load as potential drug delivery systems for poorly water soluble drugs.

Using Lunar Observations to Validate In-Flight Calibrations of Clouds and Earth Radiant Energy System Instruments

NASA Technical Reports Server (NTRS)

Daniels, Janet L.; Smith, G. Louis; Priestley, Kory J.; Thomas, Susan

2014-01-01

The validation of in-orbit instrument performance requires stability in both instrument and calibration source. This paper describes a method of validation using lunar observations scanning near full moon by the Clouds and Earth Radiant Energy System (CERES) instruments. Unlike internal calibrations, the Moon offers an external source whose signal variance is predictable and non-degrading. From 2006 to present, in-orbit observations have become standardized and compiled for the Flight Models-1 and -2 aboard the Terra satellite, for Flight Models-3 and -4 aboard the Aqua satellite, and beginning 2012, for Flight Model-5 aboard Suomi-NPP. Instrument performance parameters which can be gleaned are detector gain, pointing accuracy and static detector point response function validation. Lunar observations are used to examine the stability of all three detectors on each of these instruments from 2006 to present. This validation method has yielded results showing trends per CERES data channel of 1.2% per decade or less.

Stability-indicating HPLC Method for Simultaneous Determination of Terbutaline Sulphate, Bromhexine Hydrochloride and Guaifenesin

PubMed Central

Porel, A.; Haty, Sanjukta; Kundu, A.

2011-01-01

The aim of the present study was the development and subsequent validation of a simple, precise and stability-indicating reversed phase HPLC method for the simultaneous determination of guaifenesin, terbutaline sulphate and bromhexine hydrochloride in the presence of their potential impurities in a single run. The photolytic as well as hydrolytic impurities were detected as 3,5-dihydroxybenzoic acid, 3,5-dihydroxybenzaldehyde, 1-(3,5-dihydroxyphenyl)-2-[(1,1-dimethylethyl) amino]-ethanone from terbutaline, 2-methoxyphenol and an unknown impurity identified as (2RS)-3-(2-hydroxyphenoxy)-propane-1,2-diol from guaifenesin. The chromatographic separation of all the three active components and their impurities was achieved on Wakosil II column, using phosphate buffer (pH 3.0) and acetonitrile as mobile phase which was delivered initially in the ratio of 80:20 (v/v) for 18 min, then changed to 60:40 (v/v) for next 12 min, and finally equilibrated back to 80:20 (v/v) for 10 min. Other HPLC parameters were: Flow rate at 1.0 ml/min, detection wavelengths 248 and 280 nm, injection volume 10 μl. The calibration graphs plotted with five concentrations of each component were linear with a regression coefficient R2 >0.9999. The limit of detection and limit of quantitation were estimated for all the five impurities. The established method was then validated for linearity, precision, accuracy, and specificity and demonstrated to be applicable to the determination of the active ingredients in commercial and model cough syrup. No interference from the formulation excipients was observed. These results suggest that this LC method can be used for the determination of multiple active ingredients and their impurities in a cough and cold syrup. PMID:22131621

Stability-indicating HPLC Method for Simultaneous Determination of Terbutaline Sulphate, Bromhexine Hydrochloride and Guaifenesin.

PubMed

Porel, A; Haty, Sanjukta; Kundu, A

2011-01-01

The aim of the present study was the development and subsequent validation of a simple, precise and stability-indicating reversed phase HPLC method for the simultaneous determination of guaifenesin, terbutaline sulphate and bromhexine hydrochloride in the presence of their potential impurities in a single run. The photolytic as well as hydrolytic impurities were detected as 3,5-dihydroxybenzoic acid, 3,5-dihydroxybenzaldehyde, 1-(3,5-dihydroxyphenyl)-2-[(1,1-dimethylethyl) amino]-ethanone from terbutaline, 2-methoxyphenol and an unknown impurity identified as (2RS)-3-(2-hydroxyphenoxy)-propane-1,2-diol from guaifenesin. The chromatographic separation of all the three active components and their impurities was achieved on Wakosil II column, using phosphate buffer (pH 3.0) and acetonitrile as mobile phase which was delivered initially in the ratio of 80:20 (v/v) for 18 min, then changed to 60:40 (v/v) for next 12 min, and finally equilibrated back to 80:20 (v/v) for 10 min. Other HPLC parameters were: Flow rate at 1.0 ml/min, detection wavelengths 248 and 280 nm, injection volume 10 μl. The calibration graphs plotted with five concentrations of each component were linear with a regression coefficient R(2) >0.9999. The limit of detection and limit of quantitation were estimated for all the five impurities. The established method was then validated for linearity, precision, accuracy, and specificity and demonstrated to be applicable to the determination of the active ingredients in commercial and model cough syrup. No interference from the formulation excipients was observed. These results suggest that this LC method can be used for the determination of multiple active ingredients and their impurities in a cough and cold syrup.

Prospective, Head-to-Head Study of Three Computerized Neurocognitive Assessment Tools (CNTs): Reliability and Validity for the Assessment of Sport-Related Concussion.

PubMed

Nelson, Lindsay D; LaRoche, Ashley A; Pfaller, Adam Y; Lerner, E Brooke; Hammeke, Thomas A; Randolph, Christopher; Barr, William B; Guskiewicz, Kevin; McCrea, Michael A

2016-01-01

Limited data exist comparing the performance of computerized neurocognitive tests (CNTs) for assessing sport-related concussion. We evaluated the reliability and validity of three CNTs-ANAM, Axon Sports/Cogstate Sport, and ImPACT-in a common sample. High school and collegiate athletes completed two CNTs each at baseline. Concussed (n=165) and matched non-injured control (n=166) subjects repeated testing within 24 hr and at 8, 15, and 45 days post-injury. Roughly a quarter of each CNT's indices had stability coefficients (M=198 day interval) over .70. Group differences in performance were mostly moderate to large at 24 hr and small by day 8. The sensitivity of reliable change indices (RCIs) was best at 24 hr (67.8%, 60.3%, and 47.6% with one or more significant RCIs for ImPACT, Axon, and ANAM, respectively) but diminished to near the false positive rates thereafter. Across time, the CNTs' sensitivities were highest in those athletes who became asymptomatic within 1 day before neurocognitive testing but was similar to the tests' false positive rates when including athletes who became asymptomatic several days earlier. Test-retest reliability was similar among these three CNTs and below optimal standards for clinical use on many subtests. Analyses of group effect sizes, discrimination, and sensitivity and specificity suggested that the CNTs may add incrementally (beyond symptom scores) to the identification of clinical impairment within 24 hr of injury or within a short time period after symptom resolution but do not add significant value over symptom assessment later. The rapid clinical recovery course from concussion and modest stability probably jointly contribute to limited signal detection capabilities of neurocognitive tests outside a brief post-injury window. (JINS, 2016, 22, 24-37).

Prospective, Head-to-Head Study of Three Computerized Neurocognitive Assessment Tools (CNTs): Reliability and Validity for the Assessment of Sport-Related Concussion

PubMed Central

Nelson, Lindsay D.; LaRoche, Ashley A.; Pfaller, Adam Y.; Lerner, E. Brooke; Hammeke, Thomas A.; Randolph, Christopher; Barr, William B.; Guskiewicz, Kevin; McCrea, Michael A.

2016-01-01

Limited data exist comparing the performance of computerized neurocognitive tests (CNTs) for assessing sport-related concussion. We evaluated the reliability and validity of three CNTs—ANAM, Axon Sports/Cogstate Sport, and ImPACT—in a common sample. High school and collegiate athletes completed two CNTs each at baseline. Concussed (n = 165) and matched non-injured control (n = 166) subjects repeated testing within 24 hr and at 8, 15, and 45 days post-injury. Roughly a quarter of each CNT's indices had stability coefficients (M = 198 day interval) over .70. Group differences in performance were mostly moderate to large at 24 hr and small by day 8. The sensitivity of reliable change indices (RCIs) was best at 24 hr (67.8%, 60.3%, and 47.6% with one or more significant RCIs for ImPACT, Axon, and ANAM, respectively) but diminished to near the false positive rates thereafter. Across time, the CNTs' sensitivities were highest in those athletes who became asymptomatic within 1 day before neurocognitive testing but was similar to the tests' false positive rates when including athletes who became asymptomatic several days earlier. Test–retest reliability was similar among these three CNTs and below optimal standards for clinical use on many subtests. Analyses of group effect sizes, discrimination, and sensitivity and specificity suggested that the CNTs may add incrementally (beyond symptom scores) to the identification of clinical impairment within 24 hr of injury or within a short time period after symptom resolution but do not add significant value over symptom assessment later. The rapid clinical recovery course from concussion and modest stability probably jointly contribute to limited signal detection capabilities of neurocognitive tests outside a brief post-injury window. PMID:26714883

Stability-Indicating HPTLC Method for Studying Stress Degradation Behavior of Sulbutiamine HCl

PubMed Central

Farid, Nehal F.; Abdelwahab, Nada S.

2016-01-01

Sulbutiamine (SUL) is an ester of thiazides with neurotropic action. A new stability indicating HPTLC method has been developed and validated for the determination of SUL in the presence of different degradation products. The drug was subjected to different stress conditions following ICH strategy such as hydrolytic degradation (neutral, alkaline and acidic hydrolysis), oxidation, photodegradation and dry heat degradation. The drug demonstrated degradation under all decomposition conditions except neutral hydrolysis and dry heat, where the drug was completely degraded with 0.1 N NaOH, 1 N HCl and 30% H2O2 while it was partially degradaed by 0.1 N HCl, 3% H2O2 and UV light. Structure elucidation of the resulting degradation products was performed using ESI-Q-MS–MS. A well-defined peak for SUL was obtained at Rf = 0.46 and was completely separated from all obtained degradation products. Chromatographic separation was carried out on HPTLC aluminum plates precoated with silica gel 60 F254 using acetone–methylene chloride–ammonia buffer (pH 8.5 ± 0.2) (7:3:0.5, v/v) as a developing system. Densitometric scanning of the separated peaks was performed at 254 nm. System suitability testing parameters were calculated to ascertain the quality performance of the developed method. The method was validated with respect to USP guidelines regarding accuracy, precision, specificity, robustness and ruggedness. Good correlation coefficients were achieved in the range of 0.4–5.0 µg/band, and the limit of detection and limit of quantitation were found to be 0.11 and 0.33 µg/band, respectively. The utility of the suggested method was verified by application to Arcalion forte® tablets where no interference from additives was found. PMID:26759487

Stability indicating HPLC-DAD method for analysis of Ketorolac binary and ternary mixtures in eye drops: Quantitative analysis in rabbit aqueous humor.

PubMed

El Yazbi, Fawzy A; Hassan, Ekram M; Khamis, Essam F; Ragab, Marwa A A; Hamdy, Mohamed M A

2017-11-15

Ketorolac tromethamine (KTC) with phenylephrine hydrochloride (PHE) binary mixture (mixture 1) and their ternary mixture with chlorpheniramine maleate (CPM) (mixture 2) were analyzed using a validated HPLC-DAD method. The developed method was suitable for the in vitro as well as quantitative analysis of the targeted mixtures in rabbit aqueous humor. The analysis in dosage form (eye drops) was a stability indicating one at which drugs were separated from possible degradation products arising from different stress conditions (in vitro analysis). For analysis in aqueous humor, Guaifenesin (GUF) was used as internal standard and the method was validated according to FDA regulation for analysis in biological fluids. Agilent 5 HC-C18(2) 150×4.6mm was used as stationary phase with a gradient eluting solvent of 20mM phosphate buffer pH 4.6 containing 0.2% triethylamine and acetonitrile. The drugs were resolved with retention times of 2.41, 5.26, 7.92 and 9.64min for PHE, GUF, KTC and CPM, respectively. The method was sensitive and selective to analyze simultaneously the three drugs in presence of possible forced degradation products and dosage form excipients (in vitro analysis) and also with the internal standard, in presence of aqueous humor interferences (analysis in biological fluid), at a single wavelength (261nm). No extraction procedure was required for analysis in aqueous humor. The simplicity of the method emphasizes its capability to analyze the drugs in vivo (in rabbit aqueous humor) and in vitro (in pharmaceutical formulations). Copyright © 2017 Elsevier B.V. All rights reserved.

Simultaneous determination of some water-soluble vitamins and preservatives in multivitamin syrup by validated stability-indicating high-performance liquid chromatography method.

PubMed

Vidović, Stojanka; Stojanović, Biljana; Veljković, Jelena; Prazić-Arsić, Ljiljana; Roglić, Goran; Manojlović, Dragan

2008-08-22

HPLC stability-indicating method has been developed for the simultaneous determination of some water-soluble vitamins (ascorbic acid, thiamine hydrochloride, riboflavin-5'-phosphate sodium, pyridoxine hydrochloride, nicotinamide, D(+)-panthenol) and two preservatives (methylparaben and sodium benzoate) in multivitamin syrup preparation. Water-soluble vitamins, preservatives and their degradants were separated on Zorbax SB-Aq (C(18)) (250 mm x 4.6 mm, 5 microm) column at an ambient temperature. Combined isocratic and gradient elution was performed with a mobile phase consisting of 0.0125 M hexane-1-sulfonic acid sodium salt in 0.1% (m/v) o-phosphoric acid, pH 2.4-2.5 (solvent A) and acetonitrile (solvent B) at the flow-rate 1 ml min(-1). Starting with solvent A an isocratic elution was performed for 15 min, then the composition was changed to 85% of A and 15% of B during the next 20 min and it was constant for 5 min, then the composition was changed to 70% of A and 30% of B during next 15 min and it was constant for 5 min and finally was changed to 100% of A as at the beginning of the elution. Detection was performed with diode array detector at 210, 230 and 254 nm. Multivitamin syrup preparation was subjected to stress testing (forced degradation) in order to demonstrate that degradants from the vitamins, preservatives and/or product excipients do not interfere with the quantification of vitamins and preservatives. Typical validation characteristics: selectivity, accuracy, precision, linearity, range, limit of quantification and limit of detection were evaluated for vitamins and preservatives.

Analytical Method Validation of High-Performance Liquid Chromatography and Stability-Indicating Study of Medroxyprogesterone Acetate Intravaginal Sponges

PubMed Central

Batrawi, Nidal; Wahdan, Shorouq; Abualhasan, Murad

2017-01-01

Medroxyprogesterone acetate is widely used in veterinary medicine as intravaginal dosage for the synchronization of breeding cycle in ewes and goats. The main goal of this study was to develop reverse-phase high-performance liquid chromatography method for the quantification of medroxyprogesterone acetate in veterinary vaginal sponges. A single high-performance liquid chromatography/UV isocratic run was used for the analytical assay of the active ingredient medroxyprogesterone. The chromatographic system consisted of a reverse-phase C18 column as the stationary phase and a mixture of 60% acetonitrile and 40% potassium dihydrogen phosphate buffer as the mobile phase; the pH was adjusted to 5.6. The method was validated according to the International Council for Harmonisation (ICH) guidelines. Forced degradation studies were also performed to evaluate the stability-indicating properties and specificity of the method. Medroxyprogesterone was eluted at 5.9 minutes. The linearity of the method was confirmed in the range of 0.0576 to 0.1134 mg/mL (R2 > 0.999). The limit of quantification was shown to be 3.9 µg/mL. Precision and accuracy ranges were found to be %RSD <0.2 and 98% to 102%, respectively. Medroxyprogesterone capacity factor value of 2.1, tailing factor value of 1.03, and resolution value of 3.9 were obtained in accordance with ICH guidelines. Based on the obtained results, a rapid, precise, accurate, sensitive, and cost-effective analysis procedure was proposed for quantitative determination of medroxyprogesterone in vaginal sponges. This analytical method is the only available method to analyse medroxyprogesterone in veterinary intravaginal dosage form. PMID:28469407

Support vector regression and artificial neural network models for stability indicating analysis of mebeverine hydrochloride and sulpiride mixtures in pharmaceutical preparation: A comparative study

NASA Astrophysics Data System (ADS)

Naguib, Ibrahim A.; Darwish, Hany W.

2012-02-01

A comparison between support vector regression (SVR) and Artificial Neural Networks (ANNs) multivariate regression methods is established showing the underlying algorithm for each and making a comparison between them to indicate the inherent advantages and limitations. In this paper we compare SVR to ANN with and without variable selection procedure (genetic algorithm (GA)). To project the comparison in a sensible way, the methods are used for the stability indicating quantitative analysis of mixtures of mebeverine hydrochloride and sulpiride in binary mixtures as a case study in presence of their reported impurities and degradation products (summing up to 6 components) in raw materials and pharmaceutical dosage form via handling the UV spectral data. For proper analysis, a 6 factor 5 level experimental design was established resulting in a training set of 25 mixtures containing different ratios of the interfering species. An independent test set consisting of 5 mixtures was used to validate the prediction ability of the suggested models. The proposed methods (linear SVR (without GA) and linear GA-ANN) were successfully applied to the analysis of pharmaceutical tablets containing mebeverine hydrochloride and sulpiride mixtures. The results manifest the problem of nonlinearity and how models like the SVR and ANN can handle it. The methods indicate the ability of the mentioned multivariate calibration models to deconvolute the highly overlapped UV spectra of the 6 components' mixtures, yet using cheap and easy to handle instruments like the UV spectrophotometer.

Developing and validating a scale to measure Food and Nutrition Literacy (FNLIT) in elementary school children in Iran

PubMed Central

Doustmohammadian, Aazam; Omidvar, Nasrin; Keshavarz-Mohammadi, Nastaran; Abdollahi, Morteza; Amini, Maryam; Eini-Zinab, Hassan

2017-01-01

Background Food and nutrition literacy is an emerging term which is increasingly used in policy and research. Though research in this area is growing, progression is limited by the lack of an accepted method to measure food and nutrition literacy. The aim of this study is to develop a valid and reliable questionnaire to assess food and nutrition literacy in elementary school children in the city of Tehran. Methods The study was conducted in three phases. To develop Food and Nutrition Literacy (FNLIT) questionnaire, a comprehensive literature review and a qualitative study were initially performed to identify food and nutrition literacy dimensions and its components. Content and face validity of the questionnaire were evaluated by an expert panel as well as students. In the second phase, construct validity of the scale was evaluated using Explanatory Factor Analyses (EFA) and Confirmatory Factor Analyses (CFA). In the last phase (confirmatory phase), the final version of the questionnaire was evaluated on 400 students. Results Findings show Content Validity Ratio (CVR) and Content Validity Index (CVI) of the 62-item questionnaire at acceptable levels of 0.87 and 0.92, respectively. EFA suggested a six-factor construct, namely, understanding food and nutrition information, knowledge, functional, interactive, food choice, and critical. The results of CFA indicated acceptable fit indices for the proposed models. All subscales demonstrated satisfactory internal consistency (Cronbach’s alpha≥0.70), except for critical skill subscale (0.48). The intraclass correlation coefficient (ICC = 0.90, CI: 0.83–0.94) indicated that Food and Nutrition Literacy (FNLIT) scale had satisfactory stability. Each phase of development progressively improved the questionnaire, which resulted in a 46-item (42 likert-type items and 4 true-false items) Food and Nutrition Literacy (FNLIT) scale. The questionnaire measured two domains with 6 subscales, including: 1) cognitive domain: understanding and knowledge; 2) skill domain: functional, food choice, interactive, and critical skills. Conclusion The developed food and nutrition literacy scale is a valid and reliable instrument to measure food and nutrition literacy in children. This measure lays a solid empirical and theoretical foundation for future research and tailored interventions to promote food and nutrition literacy in this age group. PMID:28654646

Modeling and optimization of lime-based stabilization in high alkaline arsenic-bearing sludges with a central composite design.

PubMed

Lei, Jie; Peng, Bing; Min, Xiaobo; Liang, Yanjie; You, Yang; Chai, Liyuan

2017-04-16

This study focuses on the modeling and optimization of lime-based stabilization in high alkaline arsenic-bearing sludges (HAABS) and describes the relationship between the arsenic leachate concentration (ALC) and stabilization parameters to develop a prediction model for obtaining the optimal process parameters and conditions. A central composite design (CCD) along with response surface methodology (RSM) was conducted to model and investigate the stabilization process with three independent variables: the Ca/As mole ratio, reaction time and liquid/solid ratio, along with their interactions. The obvious characteristic changes of the HAABS before and after stabilization were verified by X-ray diffraction (XRD), scanning electron microscopy (SEM), particle size distribution (PSD) and the community bureau of reference (BCR) sequential extraction procedure. A prediction model Y (ALC) with a statistically significant P-value <0.01 and high correlation coefficient R 2 = 93.22% was obtained. The optimal parameters were successfully predicted by the model for the minimum ALC of 0.312 mg/L, which was validated with the experimental result (0.306 mg/L). The XRD, SEM and PSD results indicated that crystal calcium arsenate Ca 5 (AsO 4 ) 3 OH and Ca 4 (OH) 2 (AsO 4 ) 2 ·4H 2 O formation played an important role in minimizing the ALC. The BCR sequential extraction results demonstrated that the treated HAABS were stable in a weak acidic environment for a short time but posed a potential environmental risk after a long time. The results clearly confirm that the proposed three-factor CCD is an effective approach for modeling the stabilization of HAABS. However, further solidification technology is suggested for use after lime-based stabilization treatment of arsenic-bearing sludges.

Suitability of differently formulated dry powder Newcastle disease vaccines for mass vaccination of poultry.

PubMed

Huyge, Katrien; Van Reeth, Kristien; De Beer, Thomas; Landman, Wil J M; van Eck, Jo H H; Remon, Jean Paul; Vervaet, Chris

2012-04-01

Dry powders containing a live-attenuated Newcastle disease vaccine (LZ58 strain) and intended for mass vaccination of poultry were prepared by spray drying using mannitol in combination with trehalose or inositol, polyvinylpyrrolidone (PVP) and/or bovine serum albumin (BSA) as stabilizers. These powders were evaluated for vaccine stabilizing capacity during production and storage (at 6 °C and 25 °C), moisture content, hygroscopicity and dry powder dispersibility. A mixture design, varying the ratio of mannitol, inositol and BSA, was used to select the stabilizer combination which resulted in the desired powder properties (i.e. good vaccine stability during production and storage, low moisture content and hygroscopicity and good dry dispersibility). Inositol-containing powders had the same vaccine stabilizing capacity as trehalose powders, but were less hygroscopic. Incorporation of BSA enhanced the vaccine stability in the powders compared to PVP-containing formulations. However, increasing the BSA concentration increased the hygroscopicity and reduced the dry dispersibility of the powder. No valid mathematical model could be calculated for vaccine stability during production or storage, but the individual experiments indicated that a formulation combining mannitol, inositol and BSA in a ratio of 73.3:13.3:13.3 (wt/wt) resulted in the lowest vaccine titre loss during production (1.6-2.0 log(10) 50% egg infectious dose (EID(50)) and storage at 6 °C (max. 0.8 log(10) EID(50) after 6 months) in combination with a low moisture content (1.1-1.4%), low hygroscopicity (1.9-2.1% water uptake at 60% relative humidity) and good dry dispersibility properties. Copyright © 2011 Elsevier B.V. All rights reserved.

The 12-item medical outcomes study short form health survey version 2.0 (SF-12v2): a population-based validation study from Tehran, Iran

PubMed Central

2011-01-01

Background The SF-12v2 is the improved version of the SF-12v1. This study aimed to validate the SF-12v2 in Iran. Methods A random sample of the general population aged 18 years and over living in Tehran, Iran completed the instrument. Reliability was estimated using internal consistency and validity was assessed using known-groups comparison and convergent validity. In addition the factor structure of the questionnaire was extracted by performing both exploratory and confirmatory factor analyses (EFA and CFA). Results In all, 3685 individuals were studied (1887male and 1798 female). Internal consistency for both summary measures was satisfactory. Cronbach's α for the Physical Component Summary (PCS-12) was 0.87 and for the Mental Component Summary (MCS-12) it was 0.82. Known-groups comparison showed that the SF-12v2 discriminated well between men and women and those who differed in age and educational status (P < 0.05). Furthermore, as hypothesized the physical functioning, role physical, bodily pain and general health subscales correlated higher with the PCS-12, while the vitality, social functioning, role emotional and mental health subscales correlated higher with the MCS-12. Finally the exploratory factor analysis indicated a two-factor structure (physical and mental health) that jointly accounted for 59.9% of the variance. The confirmatory factory analysis also indicated a good fit to the data for the two-latent structure (physical and mental health). Conclusion Although the findings could not be generalized to the Iranian population, overall the findings suggest that the SF-12v2 is a reliable and valid measure of health related quality of life among Iranians and now could be used in future health outcome studies. However, further studies are recommended to establish its stability, responsiveness to change, and concurrent validity for this health survey in Iran. PMID:21385359

The 12-item medical outcomes study short form health survey version 2.0 (SF-12v2): a population-based validation study from Tehran, Iran.

PubMed

Montazeri, Ali; Vahdaninia, Mariam; Mousavi, Sayed Javad; Asadi-Lari, Mohsen; Omidvari, Sepideh; Tavousi, Mahmoud

2011-03-07

The SF-12v2 is the improved version of the SF-12v1. This study aimed to validate the SF-12v2 in Iran. A random sample of the general population aged 18 years and over living in Tehran, Iran completed the instrument. Reliability was estimated using internal consistency and validity was assessed using known-groups comparison and convergent validity. In addition the factor structure of the questionnaire was extracted by performing both exploratory and confirmatory factor analyses (EFA and CFA). In all, 3685 individuals were studied (1887 male and 1798 female). Internal consistency for both summary measures was satisfactory. Cronbach's α for the Physical Component Summary (PCS-12) was 0.87 and for the Mental Component Summary (MCS-12) it was 0.82. Known-groups comparison showed that the SF-12v2 discriminated well between men and women and those who differed in age and educational status (P < 0.05). Furthermore, as hypothesized the physical functioning, role physical, bodily pain and general health subscales correlated higher with the PCS-12, while the vitality, social functioning, role emotional and mental health subscales correlated higher with the MCS-12. Finally the exploratory factor analysis indicated a two-factor structure (physical and mental health) that jointly accounted for 59.9% of the variance. The confirmatory factory analysis also indicated a good fit to the data for the two-latent structure (physical and mental health). Although the findings could not be generalized to the Iranian population, overall the findings suggest that the SF-12v2 is a reliable and valid measure of health related quality of life among Iranians and now could be used in future health outcome studies. However, further studies are recommended to establish its stability, responsiveness to change, and concurrent validity for this health survey in Iran.

Health risk behaviors in adolescents and emerging adults with congenital heart disease: psychometric properties of the Health Behavior Scale-Congenital Heart Disease.

PubMed

Goossens, Eva; Luyckx, Koen; Mommen, Nele; Gewillig, Marc; Budts, Werner; Zupancic, Nele; Moons, Philip

2013-12-01

To optimize long-term outcomes, patients with congenital heart disease (CHD) should adopt health-promoting behaviors. Studies on health behavior in afflicted patients are scarce and comparability of study results is limited. To enlarge the body of evidence, we have developed the Health Behavior Scale-Congenital Heart Disease (HBS-CHD). We examined the psychometric properties of the HBS-CHD by providing evidence for (a) the content validity; (b) validity based on the relationships with other variables; (c) reliability in terms of stability; and (d) responsiveness. Ten experts rated the relevance of the HBS-CHD items. The item content validity index (I-CVI) and the averaged scale content validity index (S-CVI/Ave); the modified multi-rater Kappa and proportion of missing values for each question were calculated. Relationships with other variables were evaluated using six hypotheses that were tested in 429 adolescents with CHD. Stability of the instrument was assessed using Heise's method; and responsiveness was tested by calculating the Guyatt's Responsiveness Index (GRI). Overall, 86.3% of the items had a good to excellent content validity; the S-CVI/Ave (0.81) and multi-rater Kappa (0.78) were adequate. The average proportion of missing values was low (1.2%). Because five out of six hypotheses were confirmed, evidence for the validity of the HBS-CHD based on relationships with other variables was provided. The stability of the instrument could not be confirmed based on our data. The GRI showed good to excellent capacity of the HBS-CHD to detect clinical changes in the health behavior over time. We found that the HBS-CHD is a valid and responsive questionnaire to assess health behaviors in patients with CHD.

PFAT5 and the Evolution of Lipid Admixture Stability.

PubMed

Klang, Mark G

2015-09-01

PFAT5 is defined by United States Pharmacopeia Chapter 729 as follows: the "percentage of fat residing in globules larger than 5 µm (PFAT5) for a given lipid injectable emulsion [is] not to exceed 0.05%." The unstable aggregates are trapped in lungs, liver, and the reticuloendothelial system. Large particles will accumulate in pulmonary capillaries, which are between 4 and 9 µm in diameter. Over the years, there has been an evolution of methods to characterize and define intravenous fat emulsion (IVFE) stability when combined as a total nutrient admixture (TNA). Many studies have claimed IVFE stability measuring mean particle size, zeta potential, and visual checks. Interestingly, none of the studies that claimed the TNA as stable identified an unstable one through testing. This report reviews those parameters and shows they were not a valid measure of lipid stability. The PFAT5 parameter has emerged as the only validated measure of lipid stability. There are clinical consequences of using lipids that exceed the PFAT5 limit. This parameter is applicable to both manufactured and compounded lipid preparations. The clinician should be aware of the limitations of much of the literature concerning the lipid stability assessment. More stability studies are needed using PFAT5 to identify the actual limits of TNA compounding. © 2015 American Society for Parenteral and Enteral Nutrition.

Flight Test Results on the Stability and Control of the F-15 Quiet Spike(TradeMark) Aircraft

NASA Technical Reports Server (NTRS)

Moua, Cheng M.; McWherter, Shaun C.; Cox, Timothy H.; Gera, Joe

2012-01-01

The Quiet Spike F-15B flight research program investigated supersonic shock reduction using a 24-ft sub-scale telescoping nose boom on an F-15B airplane. The program primary flight test objective was to collect flight data for aerodynamic and structural models validation up to 1.8 Mach. Other objectives were to validate the mechanical feasibility of a morphing fuselage at the operational conditions and determine the near-field shock wave characterization. The stability and controls objectives were to assess the effect of the spike on the stability, controllability, and handling qualities of the aircraft and to ensure adequate stability margins across the entire research flight envelop. The two main stability and controls issues were the effects of the telescoping nose boom influenced aerodynamics on the F-15B aircraft flight dynamics and air data and angle of attack sensors. This paper reports on the stability and controls flight envelope clearance methods and flight test analysis of the F-15B Quiet Spike. Brief pilot commentary on typical piloting tasks, approach and landing, refueling task, and air data sensitivity to the flight control system are also discussed in this report.

ELISA: a cryocooled 10 GHz oscillator with 10(-15) frequency stability.

PubMed

Grop, S; Bourgeois, P Y; Bazin, N; Kersalé, Y; Rubiola, E; Langham, C; Oxborrow, M; Clapton, D; Walker, S; De Vicente, J; Giordano, V

2010-02-01

This article reports the design, the breadboarding, and the validation of an ultrastable cryogenic sapphire oscillator operated in an autonomous cryocooler. The objective of this project was to demonstrate the feasibility of a frequency stability of 3x10(-15) between 1 and 1000 s for the European Space Agency deep space stations. This represents the lowest fractional frequency instability ever achieved with cryocoolers. The preliminary results presented in this paper validate the design we adopted for the sapphire resonator, the cold source, and the oscillator loop.

Developing and Validating a Synthetic Teammate

DTIC Science & Technology

2010-01-31

reveals the stability of team coordination dynamics, the Hurst exponent , was also analyzed to determine if there was a coordination stability...difference between communication groups. An independent samples Mest on the average Hurst exponents across teams revealed that text-comm teams were, on

Stability of the guinea pigs personality - cognition - linkage over time.

PubMed

Brust, Vera; Guenther, Anja

2017-01-01

In human psychological research, personality traits as well as cognitive traits are usually validated for both, their stability over time and contexts. While stability over time gives an estimate on how genetically fixated a trait can be, correlations across traits have the power to reveal linkages or trade - offs. In animals, these validations have widely been done for personality but not for cognitive traits. We tested guinea pigs in four consecutive discrimination tasks using four unique pairs of objects with two objects of the same form but different size in each pair. The same animals were tested twice each for three personality traits, i.e. boldness, aggression and sociopositive behaviour. The animals did not learn to "always choose the larger item" in the cognitive task but learned to discriminate the two objects of each stimulus pair anew, so that we did test for learning speed in four slightly different task setups. Performance over the four tasks was significantly repeatable as well as all tested personality traits. A stable linkage over time was found between sociopositive behaviour and learning performance, probably indicating an ecological relevance for a correlation between these two traits. Still, not all traits seem to be connected amongst each other, as in our case boldness and aggression are both not linked to individual learning performance. Future studies will hopefully further investigate the repeatability of various cognitive traits in several species and thus lead to a better understanding of the interdependence of personality and cognition. This will help to unravel which suites of traits facilitate individual life histories and hence improve our understanding of the emergence and maintenance of individual differences. Copyright © 2016 Elsevier B.V. All rights reserved.

Evaluation of stability and validation of reference genes for RT-qPCR expression studies in rice plants under water deficit.

PubMed

Auler, Priscila Ariane; Benitez, Letícia Carvalho; do Amaral, Marcelo Nogueira; Vighi, Isabel Lopes; Dos Santos Rodrigues, Gabriela; da Maia, Luciano Carlos; Braga, Eugenia Jacira Bolacel

2017-05-01

Many studies use strategies that allow for the identification of a large number of genes expressed in response to different stress conditions to which the plant is subjected throughout its cycle. In order to obtain accurate and reliable results in gene expression studies, it is necessary to use reference genes, which must have uniform expression in the majority of cells in the organism studied. RNA isolation of leaves and expression analysis in real-time quantitative polymerase chain reaction (RT-qPCR) were carried out. In this study, nine candidate reference genes were tested, actin 11 (ACT11), ubiquitin conjugated to E2 enzyme (UBC-E2), glyceraldehyde-3-phosphate dehydrogenase (GAPDH), beta tubulin (β-tubulin), eukaryotic initiation factor 4α (eIF-4α), ubiquitin 10 (UBQ10), ubiquitin 5 (UBQ5), aquaporin TIP41 (TIP41-Like) and cyclophilin, in two genotypes of rice, AN Cambará and BRS Querência, with different levels of soil moisture (20%, 10% and recovery) in the vegetative (V5) and reproductive stages (period preceding flowering). Currently, there are different softwares that perform stability analyses and define the most suitable reference genes for a particular study. In this study, we used five different methods: geNorm, BestKeeper, ΔCt method, NormFinder and RefFinder. The results indicate that UBC-E2 and UBQ5 can be used as reference genes in all samples and softwares evaluated. The genes β-tubulin and eIF-4α, traditionally used as reference genes, along with GAPDH, presented lower stability values. The gene expression of basic leucine zipper (bZIP23 and bZIP72) was used to validate the selected reference genes, demonstrating that the use of an inappropriate reference can induce erroneous results.

[Physical and chemical stability of fortified ophtalmic ready-to-use solutions: review of literature].

PubMed

Sourdeau, P; Evrard, J-M; Remy, G; Hecq, J-D

2012-03-01

Ophtalmic infections and inflammations are often encountered during hospitalization. They require the preparation of "fortified" ophtalmic solutions, i.e. pharmaceutical ophtalmic solutions which are hyperconcentrated in active substance. The data of physicochemical stabilities are modified and it is therefore essential to gather the results of the various publications devoted to this subject. In 2006, an initial literature review was undertaken to identify the molecules mostly used in the preparation of fortified ophtalmic solutions in hospital. A second review of the literature in 2010 has enriched the knowledge about it. Two new drugs have entered the summary table: amikacin and ticarcillin disodium. Date on 12 molecules already known in 2006 were updated to improve clinical practices. A review of the literature was undertaken in order to collect the results of the molecules mostly used for the preparation of the fortified ophtalmic solutions in hospitals. A summary table, indicating the active substance, its concentration, the assay method, the storage temperature and physicochemical modifications, presents all the results. This review of literature makes it possible to match stability and validity period to these preparations. Copyright © 2011 Elsevier Masson SAS. All rights reserved.

Thermophoretic melting curves quantify the conformation and stability of RNA and DNA

PubMed Central

Wienken, Christoph J.; Baaske, Philipp; Duhr, Stefan; Braun, Dieter

2011-01-01

Measuring parameters such as stability and conformation of biomolecules, especially of nucleic acids, is important in the field of biology, medical diagnostics and biotechnology. We present a thermophoretic method to analyse the conformation and thermal stability of nucleic acids. It relies on the directed movement of molecules in a temperature gradient that depends on surface characteristics of the molecule, such as size, charge and hydrophobicity. By measuring thermophoresis of nucleic acids over temperature, we find clear melting transitions and resolve intermediate conformational states. These intermediate states are indicated by an additional peak in the thermophoretic signal preceding most melting transitions. We analysed single nucleotide polymorphisms, DNA modifications, conformational states of DNA hairpins and microRNA duplexes. The method is validated successfully against calculated melting temperatures and UV absorbance measurements. Interestingly, the methylation of DNA is detected by the thermophoretic amplitude even if it does not affect the melting temperature. In the described setup, thermophoresis is measured all-optical in a simple setup using a reproducible capillary format with only 250 nl probe consumption. The thermophoretic analysis of nucleic acids shows the technique’s versatility for the investigation of nucleic acids relevant in cellular processes like RNA interference or gene silencing. PMID:21297115

Multivariate approaches for stability control of the olive oil reference materials for sensory analysis - part II: applications.

PubMed

Valverde-Som, Lucia; Ruiz-Samblás, Cristina; Rodríguez-García, Francisco P; Cuadros-Rodríguez, Luis

2018-02-09

The organoleptic quality of virgin olive oil depends on positive and negative sensory attributes. These attributes are related to volatile organic compounds and phenolic compounds that represent the aroma and taste (flavour) of the virgin olive oil. The flavour is the characteristic that can be measured by a taster panel. However, as for any analytical measuring device, the tasters, individually, and the panel, as a whole, should be harmonized and validated and proper olive oil standards are needed. In the present study, multivariate approaches are put into practice in addition to the rules to build a multivariate control chart from chromatographic volatile fingerprinting and chemometrics. Fingerprinting techniques provide analytical information without identify and quantify the analytes. This methodology is used to monitor the stability of sensory reference materials. The similarity indices have been calculated to build multivariate control chart with two olive oils certified reference materials that have been used as examples to monitor their stabilities. This methodology with chromatographic data could be applied in parallel with the 'panel test' sensory method to reduce the work of sensory analysis. © 2018 Society of Chemical Industry. © 2018 Society of Chemical Industry.

Validity of the Instrumented Push and Release Test to Quantify Postural Responses in Persons With Multiple Sclerosis.

PubMed

El-Gohary, Mahmoud; Peterson, Daniel; Gera, Geetanjali; Horak, Fay B; Huisinga, Jessie M

2017-07-01

To test the validity of wearable inertial sensors to provide objective measures of postural stepping responses to the push and release clinical test in people with multiple sclerosis. Cross-sectional study. University medical center balance disorder laboratory. Total sample N=73; persons with multiple sclerosis (PwMS) n=52; healthy controls n=21. Stepping latency, time and number of steps required to reach stability, and initial step length were calculated using 3 inertial measurement units placed on participants' lumbar spine and feet. Correlations between inertial sensor measures and measures obtained from the laboratory-based systems were moderate to strong and statistically significant for all variables: time to release (r=.992), latency (r=.655), time to stability (r=.847), time of first heel strike (r=.665), number of steps (r=.825), and first step length (r=.592). Compared with healthy controls, PwMS demonstrated a longer time to stability and required a larger number of steps to reach stability. The instrumented push and release test is a valid measure of postural responses in PwMS and could be used as a clinical outcome measures for patient care decisions or for clinical trials aimed at improving postural control in PwMS. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

An Improved LC-ESI-MS/MS Method to Quantify Pregabalin in Human Plasma and Dry Plasma Spot for Therapeutic Monitoring and Pharmacokinetic Applications.

PubMed

Dwivedi, Jaya; Namdev, Kuldeep K; Chilkoti, Deepak C; Verma, Surajpal; Sharma, Swapnil

2018-06-06

Therapeutic drug monitoring (TDM) of anti-epileptic drugs provides a valid clinical tool in optimization of overall therapy. However, TDM is challenging due to the high biological samples (plasma/blood) storage/shipment costs and the limited availability of laboratories providing TDM services. Sampling in the form of dry plasma spot (DPS) or dry blood spot (DBS) is a suitable alternative to overcome these issues. An improved, simple, rapid, and stability indicating method for quantification of pregabalin in human plasma and DPS has been developed and validated. Analyses were performed on liquid chromatography tandem mass spectrometer under positive ionization mode of electrospray interface. Pregabain-d4 was used as internal standard, and the chromatographic separations were performed on Poroshell 120 EC-C18 column using an isocratic mobile phase flow rate of 1 mL/min. Stability of pregabalin in DPS was evaluated under simulated real-time conditions. Extraction procedures from plasma and DPS samples were compared using statistical tests. The method was validated considering the FDA method validation guideline. The method was linear over the concentration range of 20-16000 ng/mL and 100-10000 ng/mL in plasma and DPS, respectively. DPS samples were found stable for only one week upon storage at room temperature and for at least four weeks at freezing temperature (-20 ± 5 °C). Method was applied for quantification of pregabalin in over 600 samples of a clinical study. Statistical analyses revealed that two extraction procedures in plasma and DPS samples showed statistically insignificant difference and can be used interchangeably without any bias. Proposed method involves simple and rapid steps of sample processing that do not require a pre- or post-column derivatization procedure. The method is suitable for routine pharmacokinetic analysis and therapeutic monitoring of pregabalin.

A novel household water insecurity scale: Procedures and psychometric analysis among postpartum women in western Kenya.

PubMed

Boateng, Godfred O; Collins, Shalean M; Mbullo, Patrick; Wekesa, Pauline; Onono, Maricianah; Neilands, Torsten B; Young, Sera L

2018-01-01

Our ability to measure household-level food insecurity has revealed its critical role in a range of physical, psychosocial, and health outcomes. Currently, there is no analogous, standardized instrument for quantifying household-level water insecurity, which prevents us from understanding both its prevalence and consequences. Therefore, our objectives were to develop and validate a household water insecurity scale appropriate for use in our cohort in western Kenya. We used a range of qualitative techniques to develop a preliminary set of 29 household water insecurity questions and administered those questions at 15 and 18 months postpartum, concurrent with a suite of other survey modules. These data were complemented by data on quantity of water used and stored, and microbiological quality. Inter-item and item-total correlations were performed to reduce scale items to 20. Exploratory factor and parallel analyses were used to determine the latent factor structure; a unidimensional scale was hypothesized and tested using confirmatory factor and bifactor analyses, along with multiple statistical fit indices. Reliability was assessed using Cronbach's alpha and the coefficient of stability, which produced a coefficient alpha of 0.97 at 15 and 18 months postpartum and a coefficient of stability of 0.62. Predictive, convergent and discriminant validity of the final household water insecurity scale were supported based on relationships with food insecurity, perceived stress, per capita household water use, and time and money spent acquiring water. The resultant scale is a valid and reliable instrument. It can be used in this setting to test a range of hypotheses about the role of household water insecurity in numerous physical and psychosocial health outcomes, to identify the households most vulnerable to water insecurity, and to evaluate the effects of water-related interventions. To extend its applicability, we encourage efforts to develop a cross-culturally valid scale using robust qualitative and quantitative techniques.

Validation of a model for the cast-film process

DOE Office of Scientific and Technical Information (OSTI.GOV)

Chambon, F.; Ohlsson, S.; Silagy, D.

1996-12-31

We have developed a model of the cast-film process and compared theoretical predictions against experiments on a pilot line. Three polyethylenes with a markedly different level of melt elasticity were used in this evaluation; namely, a high pressure low density polyethylene, LDPE, and two linear low density polyethylenes, LLDPE-1 and LLDPE-2. The final film dimensions of the LDPE were found to be in good agreement with 1-D viscoelastic stationary predictions. Flow field visualization experiments indicate, however, a 2-D velocity field in the airgap between the extrusion die and the chill roll. Taking this observation into account, evolutions of the freemore » surface of the web along the airgap were recorded with LLDPE-2, our least elastic melt. An excellent agreement is found between these measurements and predictions of neck-in and edge bead with 2-D Newtonian stationary simulations. The time-dependent solution, which is based on a linear stability analysis, allows to identify a zone of draw resonance within the working space of the process, defined by the draw ratio, the Deborah number, and the web aspect ratio. It is predicted that increasing this latter parameter stabilizes the process until an optimum value is reached. Experiments with LLDPE-1 are shown to validate this unique theoretical result, thus allowing to increase the draw ratio by about 75%.« less

Stability-indicating validation of acitretin and isoacitretin in human plasma by LC-ESI-MS/MS bioanalytical method and its application to pharmacokinetic analysis.

PubMed

Kumar, Ajay; Monif, Tausif; Khuroo, Arshad; Sasmal, Dinakar; Goswami, Dipanjan; Lahkar, Vijay Kumar

2011-06-01

LC- ESI- MS/MS simultaneous bioanalytical method was developed to determine acitretin and its metabolite isoacitretin in human plasma using acitretin-d3 used as the internal standard for both analytes. The compounds were extracted using protein precipitation coupled with liquid-liquid extraction with flash freezing technique. Negative mass transitions (m/z) of acitretin, isoacitretin and acitretin-d3 were detected in multiple reactions monitoring (MRM) mode at 325.4 → 266.3, 325.2 → 266.1 and 328.3 → 266.3, respectively, with a turbo ion spray interface. The chromatographic separation was achieved on an Ascentis-RP amide column (4.6 × 150 mm, 5 µm) with mobile phase delivered in isocratic mode. The method was validated over a concentration range of 1.025-753.217 ng/mL for acitretin and 0.394-289.234 ng/mL for isoacitretin with a limit of quantification of 1.025 and 0.394 ng/mL. The intra-day and inter-day precisions were below 8.1% for acitretin and below 13.8% for isoacitretin, while accuracy was within ±7.0 and ±10.6% respectively. For the first time, the best possible conditions for plasma stability of acitretin and isoacitretin are presented and discussed with application to clinical samples. Copyright © 2010 John Wiley & Sons, Ltd.

Validity of a New Patient Engagement Measure: The Altarum Consumer Engagement (ACE) Measure.

PubMed

Duke, Christopher C; Lynch, Wendy D; Smith, Brad; Winstanley, Julie

2015-12-01

The objective of this study was to report on the validation of new scales [called the Altarum Consumer Engagement (ACE) Measure] that are indicative of an individual's engagement in health and healthcare decisions. The instrument was created to broaden the scope of how engagement is measured and understood, and to update the concept of engagement to include modern information sources, such as online health resources and ratings of providers and patient health. Data were collected through an online survey with a US population of 2079 participants. A combination of Principal Component Analysis (PCA) and detailed Rasch analyses were conducted to identify specific subscales of engagement. Results were compared to another commonly used survey instrument, and outcomes were compared for construct validity. The PCA identified a four-factor structure composed of 21 items. The factors were named Commitment, Informed Choice, Navigation, and Ownership. Rasch analyses confirmed scale stability. Relevant outcomes were correlated in the expected direction, such as health status, lifestyle behaviors, medication adherence, and observed expected group differences. This study confirmed the validity of the new ACE Measure and its utility in screening for and finding group differences in activities related to patient engagement and health consumerism, such as using provider comparison tools and asking about medical costs.

Validation of the Perception of Change Scale - Family Version (EMP-F) as a treatment outcome measure in mental health services.

PubMed

Bandeira, Marina; Felicio, Cynthia Mara; Cesari, Luciana

2010-09-01

This study aimed to validate the Perception of Change Scale - Family Version, which evaluates the perception of family caregivers in regard to the treatment outcomes of psychiatric patients in mental health services. Family caregivers (N = 300) of psychiatric patients attending mental health services completed the Perception of Change Scale - Family Version. The scale has 19 items rated in a three-point Likert scale that evaluate changes perceived in the patient's life as a result of treatment. The factorial analysis revealed a four-factor structure, with the following dimensions: 1) occupation, 2) psychological factors, 3) relationships, and 4) physical health. In the internal consistency analysis, Cronbach's alpha coefficient was 0.85. The test-retest temporal stability analysis yielded a significant intraclass correlation coefficient (r = 0.96; p < 0.005). The convergent validity analysis revealed a positive significant correlation with another scale evaluating a distinct but theoretically related construct of family satisfaction with services (r = 0.41; p < 0.05). The Perception of Change Scale - Family Version has adequate reliability and construct and convergent validity. It can be used to evaluate treatment outcome in mental health services from the perspective of family caregivers, indicating targets to improve treatment.

Identification and validation of reference genes for qRT-PCR studies of the obligate aphid pathogenic fungus Pandora neoaphidis during different developmental stages.

PubMed

Zhang, Shutao; Chen, Chun; Xie, Tingna; Ye, Sudan

2017-01-01

The selection of stable reference genes is a critical step for the accurate quantification of gene expression. To identify and validate the reference genes in Pandora neoaphidis-an obligate aphid pathogenic fungus-the expression of 13classical candidate reference genes were evaluated by quantitative real-time reverse transcriptase polymerase chain reaction(qPCR) at four developmental stages (conidia, conidia with germ tubes, short hyphae and elongated hyphae). Four statistical algorithms, including geNorm, NormFinder, BestKeeper and Delta Ct method were used to rank putative reference genes according to their expression stability and indicate the best reference gene or combination of reference genes for accurate normalization. The analysis of comprehensive ranking revealed that ACT1and 18Swas the most stably expressed genes throughout the developmental stages. To further validate the suitability of the reference genes identified in this study, the expression of cell division control protein 25 (CDC25) and Chitinase 1(CHI1) genes were used to further confirm the validated candidate reference genes. Our study presented the first systematic study of reference gene(s) selection for P. neoaphidis study and provided guidelines to obtain more accurate qPCR results for future developmental efforts.

[Design and validation of a questionnaire on attitudes to prevention and health promotion in primary care (CAPPAP)].

PubMed

Ramos-Morcillo, Antonio Jesús; Martínez-López, Emilio J; Fernández-Salazar, Serafín; del-Pino-Casado, Rafael

2013-12-01

To develop and validate a questionnaire to measure attitudes towards prevention and health promotion. Cross-sectional study for the validation of a questionnaire. Primary Health Care (autonomous community of Andalusia, Spain). 282 professionals (nurses and doctors) belonging to the Public Health System. Content validation by experts, ceiling effects and floor effects, correlation between items, internal consistency, stability and exploratory factor analysis. The 56 items of the tool (CAPPAP) obtained, including those from the review of other tools and the contributions of the experts, were grouped into 5 dimensions. The percentage of expert agreement was over 70% on all items, and a high concordance between prevention and promotion item was obtained, thus, duplicates were removed leaving a final tool with 44 items. The internal consistency, measured by Cronbach's alpha, was 0.888. The test retest indicated concordance from substantial to almost perfect. Exploratory factor analysis identified five factors that accounted for 48.92% of the variance. CAPPAP is a tool that is quick and easy to administer, that is well accepted by professionals, and that has acceptable psychometric results, both globally and at the level of each dimension. Copyright © 2012 Elsevier España, S.L. All rights reserved.

Use of a Computer-Mediated Delphi Process to Validate a Mass Casualty Conceptual Model

PubMed Central

CULLEY, JOAN M.

2012-01-01

Since the original work on the Delphi technique, multiple versions have been developed and used in research and industry; however, very little empirical research has been conducted that evaluates the efficacy of using online computer, Internet, and e-mail applications to facilitate a Delphi method that can be used to validate theoretical models. The purpose of this research was to develop computer, Internet, and e-mail applications to facilitate a modified Delphi technique through which experts provide validation for a proposed conceptual model that describes the information needs for a mass-casualty continuum of care. Extant literature and existing theoretical models provided the basis for model development. Two rounds of the Delphi process were needed to satisfy the criteria for consensus and/or stability related to the constructs, relationships, and indicators in the model. The majority of experts rated the online processes favorably (mean of 6.1 on a seven-point scale). Using online Internet and computer applications to facilitate a modified Delphi process offers much promise for future research involving model building or validation. The online Delphi process provided an effective methodology for identifying and describing the complex series of events and contextual factors that influence the way we respond to disasters. PMID:21076283

Use of a computer-mediated Delphi process to validate a mass casualty conceptual model.

PubMed

Culley, Joan M

2011-05-01

Since the original work on the Delphi technique, multiple versions have been developed and used in research and industry; however, very little empirical research has been conducted that evaluates the efficacy of using online computer, Internet, and e-mail applications to facilitate a Delphi method that can be used to validate theoretical models. The purpose of this research was to develop computer, Internet, and e-mail applications to facilitate a modified Delphi technique through which experts provide validation for a proposed conceptual model that describes the information needs for a mass-casualty continuum of care. Extant literature and existing theoretical models provided the basis for model development. Two rounds of the Delphi process were needed to satisfy the criteria for consensus and/or stability related to the constructs, relationships, and indicators in the model. The majority of experts rated the online processes favorably (mean of 6.1 on a seven-point scale). Using online Internet and computer applications to facilitate a modified Delphi process offers much promise for future research involving model building or validation. The online Delphi process provided an effective methodology for identifying and describing the complex series of events and contextual factors that influence the way we respond to disasters.

Optic Nerve Sheath Meningocele: A Case Report

PubMed Central

Halimi, E.; Wavreille, O.; Rosenberg, R.; Bouacha, I.; Lejeune, J.-P.; Defoort-Dhellemmes, S.

2013-01-01

Abstract Isolated optic nerve sheath meningocele is a rare affection defined as the cystic enlargement of the optic nerve sheath filled with cerebrospinal fluid. We report the case of a 39-year-old woman presenting with bilateral meningocele uncovered during a routine examination for headache complaints. A 5-year follow-up validated the lesion’s clinical and imaging stability. Magnetic resonance imaging (MRI) is an essential tool in the diagnosis of this pathology, alongside characteristic symptoms indicating that the meningocele might have progressively expanded into the orbit. In this case we present a therapeutic approach based on pathophysiological hypotheses and review of the literature. PMID:28163760

The validity, stability, and utility of measuring uric acid in saliva.

PubMed

Riis, Jenna L; Bryce, Crystal I; Matin, Marla J; Stebbins, John L; Kornienko, Olga; Huisstede, Lauren van; Granger, Douglas A

2018-06-06

Serum uric acid (UA) is associated with many health conditions, including kidney, cardiovascular, and metabolic disorders. We examined the validity and stability of salivary UA as a noninvasive measure of serum UA. Using serum and salivary UA data from healthy adults (n = 99), we examined the UA serum-saliva correlation, and UA associations with adiponectin and C-reactive protein. Using longitudinal data from young adults (n = 182), we examined salivary UA stability. We found robust positive serum-saliva correlations for UA. UA and adiponectin were inversely related in serum and saliva. Salivary UA was relatively stable; 62-66% of variance could be attributed to a latent trait-like component. Salivary UA may be an important biomarker indexing health and disease risk.

Development and validation of a novel stability-indicating HPLC method for the quantitative determination of eleven related substances in ezetimibe drug substance and drug product.

PubMed

Luo, Zhiqiang; Deng, Zhongqing; Liu, Yang; Wang, Guopeng; Yang, Wenning; Hou, Chengbo; Tang, Minming; Yang, Ruirui; Zhou, Huaming

2015-07-01

Ezetimibe is a novel lipid-lowering agent that inhibits intestinal absorption of dietary and biliary cholesterol. In the present work, a simple, sensitive and reproducible gradient reverse phase high performance liquid chromatographic (RP-HPLC) method for separation and determination of the related substances of ezetimibe was developed and validated. Eleven potential process-related impurities (starting materials, (3S,4S,3'S)-isomer, degradants and byproducts) were identified in the crude samples. Tentative structures for all the impurities were assigned primarily based on comparison of their retention time and mass spectrometric data with that of available standards and references. This method can be applied to routine analysis in quality control of both bulk drugs and commercial tablets. Separation of all these compounds was performed on a Phenomenex Luna Phenyl-Hexyl (100mm×4.6mm, 5μm) analytical column. The mobile phase-A consists of acetonitrile-water (pH adjusted to 4.0 with phosphoric acid)-methanol at 15:75:10 (v/v/v), and mobile phase-B contains acetonitrile. The eluted compounds were monitored at 210nm. Ezetimibe was subjected to hydrolytic, acid, base, oxidative, photolytic and thermal stress conditions as per ICH serves to generate degradation products that can be used as a worst case to assess the analytical method performance. The drug showed extensive degradation in thermal, acid, oxidative, base and hydrolytic stress conditions, while it was stable to photolytic degradation conditions. The main degradation product formed under thermal, acid, oxidative, base and hydrolytic stress conditions corresponding to (2R,3R,6S)-N, 6-bis(4-fluorophenyl)-2-(4-hydroxyphenyl)-oxane-3-carboxamide (Ezetimibe tetrahydropyran impurity) was characterized by LC-MS/MS analysis. The degradation products were well resolved from the main peak and its impurities, thus proved the stability-indicating power of the method. The developed method was validated as per international conference on harmonization (ICH) guidelines with respect to specificity, linearity, limit of detection (LOD), limit of quantification (LOQ), accuracy, precision and robustness. Copyright © 2015 Elsevier B.V. All rights reserved.

On the experimental prediction of the stability threshold speed caused by rotating damping

NASA Astrophysics Data System (ADS)

Vervisch, B.; Derammelaere, S.; Stockman, K.; De Baets, P.; Loccufier, M.

2016-08-01

An ever increasing demand for lighter rotating machinery and higher operating speeds results in a raised probability of instabilities. Rotating damping is one of the reasons, instability occurs. Rotating damping, or rotor internal damping, is the damping related to all rotating parts while non-rotating damping appearing in the non-rotating parts. The present study describes a rotating setup, designed to investigate rotating damping experimentally. An efficient experimental procedure is presented to predict the stability threshold of a rotating machine. The setup consists of a long thin shaft with a disk in the middle and clamped boundary conditions. The goal is to extract the system poles as a function of the rotating speed. The real parts of these poles are used to construct the decay rate plot, which is an indication for the stability. The efficiency of the experimental procedure relies on the model chosen for the rotating shaft. It is shown that the shaft behavior can be approximated by a single degree of freedom model that incorporates a speed dependent damping. As such low measurement effort and only one randomly chosen measurement location are needed to construct the decay rate plot. As an excitation, an automated impact hammer is used and the response is measured by eddy current probes. The proposed method yields a reliable prediction of the stability threshold speed which is validated through measurements.

Unveiling the potential of novel yeast protein extracts in white wines clarification and stabilization

PubMed Central

Fernandes, Joana P.; Neto, Rodrigo; Centeno, Filipe; De Fátima Teixeira, Maria; Gomes, Ana Catarina

2015-01-01

Fining agents derived from animal and mineral sources are widely used to clarify and stabilize white wines. Nevertheless, health and environmental problems are being raised, concerning the allergenic and environmental impact of some of those fining products. In this study, our aim is to validate the potential of yeast protein extracts, obtained from an alternative and safe source, naturally present in wine: oenological yeasts. Three untreated white wines were used in this work in order to evaluate the impact of these novel yeast protein extracts (YPE) in terms of the wine clarification and stabilization improvement. Two separated fining trials were thus conducted at laboratory scale and the yeast alternatives were compared with reference fining agents, obtained from mineral, animal and vegetable origins. Our results indicate that YPE were capable to promote (i) brilliance/color improvement, (ii) turbidity reduction (76–89% comparing with the untreated wines), and (iii) production of compact and homogeneous lees (44% smaller volume than obtained with bentonite). Additionally, after submitting wines to natural and forced oxidations, YPE treatments revealed (iv) different forms of colloidal stabilization, by presenting comparable or superior effects when particularly compared to casein. Altogether, this study reveals that YPE represent a promising alternative for white wine fining, since they are resultant from a natural and more sustainable origin, at present not regarded as potential allergenic according to Regulation (EC) No. 1169/2011. PMID:25853122

Numerical analysis of the angular motion of a neutrally buoyant spheroid in shear flow at small Reynolds numbers.

PubMed

Rosén, T; Einarsson, J; Nordmark, A; Aidun, C K; Lundell, F; Mehlig, B

2015-12-01

We numerically analyze the rotation of a neutrally buoyant spheroid in a shear flow at small shear Reynolds number. Using direct numerical stability analysis of the coupled nonlinear particle-flow problem, we compute the linear stability of the log-rolling orbit at small shear Reynolds number Re(a). As Re(a)→0 and as the box size of the system tends to infinity, we find good agreement between the numerical results and earlier analytical predictions valid to linear order in Re(a) for the case of an unbounded shear. The numerical stability analysis indicates that there are substantial finite-size corrections to the analytical results obtained for the unbounded system. We also compare the analytical results to results of lattice Boltzmann simulations to analyze the stability of the tumbling orbit at shear Reynolds numbers of order unity. Theory for an unbounded system at infinitesimal shear Reynolds number predicts a bifurcation of the tumbling orbit at aspect ratio λ(c)≈0.137 below which tumbling is stable (as well as log rolling). The simulation results show a bifurcation line in the λ-Re(a) plane that reaches λ≈0.1275 at the smallest shear Reynolds number (Re(a)=1) at which we could simulate with the lattice Boltzmann code, in qualitative agreement with the analytical results.

Targeting G-quadruplex DNA structures in the telomere and oncogene promoter regions by benzimidazole‒carbazole ligands.

PubMed

Kaulage, Mangesh H; Maji, Basudeb; Pasadi, Sanjeev; Ali, Asfa; Bhattacharya, Santanu; Muniyappa, K

2018-03-25

Recent studies support the idea that G-quadruplex structures in the promoter regions of oncogenes and telomere DNA can serve as potential therapeutic targets in the treatment of cancer. Accordingly, several different types of organic small molecules that stabilize G-quadruplex structures and inhibit telomerase activity have been discerned. Here, we describe the binding of benzimidazole-carbazole ligands to G-quadruplex structures formed in G-rich DNA sequences containing the promoter regions of human c-MYC, c-KIT1, c-KIT2, VEGF and BCL2 proto-oncogenes. The fluorescence spectroscopic data indicate that benzimidazole-carbazole ligands bind and stabilize the G-quadruplexes in the promoter region of oncogenes. The molecular docking studies provide insights into the mode and extent of binding of this class of ligands to the G-quadruplexes formed in oncogene promoters. The high stability of these G-quadruplex structures was validated by thermal denaturation and telomerase-catalyzed extension of the 3' end. Notably, benzimidazole-carbazole ligands suppress the expression of oncogenes in cancer cells in a dose-dependent manner. We anticipate that benzimidazole-carbazole ligands, by virtue of their ability to stabilize G-quadruplex structures in the promoter regions of oncogenes, might reduce the risk of cancer through the loss of function in the proteins encoded by these genes. Copyright © 2018 Elsevier Masson SAS. All rights reserved.

Low-Severity Hydroprocessing to Stabilize Bio-oil: TechnoEconomic Assessment

DOE Office of Scientific and Technical Information (OSTI.GOV)

Tews, Iva J.; Elliott, Douglas C.

The impetus for this study was the suggestion that recent developments in fast pyrolysis (FP) bio-oil production had indicated instability of the bio-oil in storage which might lead to unacceptable viscosity increases. Commercial operation of FP in Finland began in 2014 and the distribution of the bio-oil to isolated users has been proposed as the long-term plan. Stability of the shipped bio-oil therefore became a concern. Experimental results at PNNL with low-severity hydroprocessing of bio-oil for stabilization has validated a process in which the stability of the bio-oil could be improved, as measured by viscosity increase following storage of themore » product at 80 °C for 24h. In the work reported here the assessed process configuration consists of fast pyrolysis followed by low temperature and pressure hydroprocessing to produce a stable fuel oil product. The product could then be stored for an extended period of time without significant viscosity increase. This work was carried out as part of a collaborative project between Technical Research Centre of Finland (VTT) and Pacific Northwest National Laboratory (PNNL). The public funding agents for the work were Tekes in Finland and the Bioenergy Technologies Office of the U.S. Department of Energy. The effort was proposed as an evaluation of the process developed in earlier collaboration and jointly invented by VTT and PNNL researchers.« less

Stability of physical assessment of older drivers over 1 year.

PubMed

Smith, Andrew; Marshall, Shawn; Porter, Michelle; Ha, Linda; Bédard, Michel; Gélinas, Isabelle; Man-Son-Hing, Malcolm; Mazer, Barbara; Rapoport, Mark; Tuokko, Holly; Vrkljan, Brenda

2013-12-01

Older adults represent the fastest-growing population of drivers with a valid driver's licence. Also common in this age group are multiple chronic medical conditions that may have an effect on physical function and driving ability. Determining the reliability of physical measures used to assess older drivers' functional ability is important to identifying those who are safe to continue driving. Most previous reliability studies of clinical physical measures of health used test-retest intervals shorter than those between patient visits with a clinician. In the present study we examined a more clinically representative interval of 1 year to determine the stability of commonly used physical measures collected during the Candrive II prospective cohort study of older drivers. Reliability statistics indicate that the sequential finger-thumb opposition, rapid pace walk and the Pelli-Robson contrast sensitivity tests have adequate stability over 1 year. Poor stability was observed for the one-legged stance and Snellen visual acuity test. Several assessments with nominal data (Marottoli method [functional neck range of motion], whispered voice test, range of motion and strength testing) lacked sufficient variability to conduct reliability analyses; however, a lack of variability between test days suggests consistency over a 1-year time frame. Our results provide evidence that specific physical measures are stable in monitoring functional ability over the course of a year. Copyright © 2013 Elsevier Ltd. All rights reserved.

Wavelet modeling and prediction of the stability of states: the Roman Empire and the European Union

NASA Astrophysics Data System (ADS)

Yaroshenko, Tatyana Y.; Krysko, Dmitri V.; Dobriyan, Vitalii; Zhigalov, Maksim V.; Vos, Hendrik; Vandenabeele, Peter; Krysko, Vadim A.

2015-09-01

How can the stability of a state be quantitatively determined and its future stability predicted? The rise and collapse of empires and states is very complex, and it is exceedingly difficult to understand and predict it. Existing theories are usually formulated as verbal models and, consequently, do not yield sharply defined, quantitative prediction that can be unambiguously validated with data. Here we describe a model that determines whether the state is in a stable or chaotic condition and predicts its future condition. The central model, which we test, is that growth and collapse of states is reflected by the changes of their territories, populations and budgets. The model was simulated within the historical societies of the Roman Empire (400 BC to 400 AD) and the European Union (1957-2007) by using wavelets and analysis of the sign change of the spectrum of Lyapunov exponents. The model matches well with the historical events. During wars and crises, the state becomes unstable; this is reflected in the wavelet analysis by a significant increase in the frequency ω (t) and wavelet coefficients W (ω, t) and the sign of the largest Lyapunov exponent becomes positive, indicating chaos. We successfully reconstructed and forecasted time series in the Roman Empire and the European Union by applying artificial neural network. The proposed model helps to quantitatively determine and forecast the stability of a state.

CS-AMPPred: An Updated SVM Model for Antimicrobial Activity Prediction in Cysteine-Stabilized Peptides

PubMed Central

Porto, William F.; Pires, Állan S.; Franco, Octavio L.

2012-01-01

The antimicrobial peptides (AMP) have been proposed as an alternative to control resistant pathogens. However, due to multifunctional properties of several AMP classes, until now there has been no way to perform efficient AMP identification, except through in vitro and in vivo tests. Nevertheless, an indication of activity can be provided by prediction methods. In order to contribute to the AMP prediction field, the CS-AMPPred (Cysteine-Stabilized Antimicrobial Peptides Predictor) is presented here, consisting of an updated version of the Support Vector Machine (SVM) model for antimicrobial activity prediction in cysteine-stabilized peptides. The CS-AMPPred is based on five sequence descriptors: indexes of (i) α-helix and (ii) loop formation; and averages of (iii) net charge, (iv) hydrophobicity and (v) flexibility. CS-AMPPred was based on 310 cysteine-stabilized AMPs and 310 sequences extracted from PDB. The polynomial kernel achieves the best accuracy on 5-fold cross validation (85.81%), while the radial and linear kernels achieve 84.19%. Testing in a blind data set, the polynomial and radial kernels achieve an accuracy of 90.00%, while the linear model achieves 89.33%. The three models reach higher accuracies than previously described methods. A standalone version of CS-AMPPred is available for download at and runs on any Linux machine. PMID:23240023

An intelligent re-shieldable targeting system for enhanced tumor accumulation.

PubMed

Hu, Zhenpeng; Ma, Jinlong; Fu, Fei; Cui, Chen; Li, Xiaomin; Wang, Xinyu; Wang, Wei; Wan, Yeda; Yuan, Zhi

2017-12-28

Programmed ligand targeting strategy promotes the blood circulation stability of nanoparticles by shielding the ligand. However, the irreversible shielding causes the deshielded nanoparticles to be easily recognized and cleared by the reticuloendothelial system (RES), impeding their further retention in the tumor. Here, we for the first time prove the superiority of the intelligent re-shieldable targeting system that is based on the pH-responsive self-assembly/disassembly of gold nanoparticles. The system can enhance the stability of gold nanoparticles in the blood circulation (2.6-fold at 24h), reduce uptake by the RES (35% lower) and improve tumor accumulation (41% higher by analysis of gold content in tumor) effectively compared with the conventional irreversible system. Furthermore, preliminary study indicates that the system could be applied as computed tomography contrast agent in tumor imaging. The in vivo validity of the intelligent re-shieldable targeting system provides inspiration for the design of nanomaterials for cancer diagnosis and treatment. Copyright © 2017. Published by Elsevier B.V.

Corrosion testing of candidates for the alkaline fuel cell cathode

NASA Technical Reports Server (NTRS)

Singer, Joseph; Fielder, William L.

1989-01-01

Current/voltage data was obtained for specially made corrosion electrodes of some oxides and of gold materials for the purpose of developing a screening test of catalysts and supports for use at the cathode of the alkaline fuel cell. The data consists of measurements of current at fixed potentials and cyclic voltammograms. These data will have to be correlated with longtime performance data in order to fully evaluate this approach to corrosion screening. Corrosion test screening of candidates for the oxygen reduction electrode of the alkaline fuel cell was applied to two substances, the pyrochlore Pb2Ru2O6.5 and the spinel NiCo2O4. The substrate gold screen and a sample of the IFC Orbiter Pt-Au performance electrode were included as blanks. The pyrochlore data indicate relative stability, although nothing yet can be said about long term stability. The spinel was plainly unstable. For this type of testing to be validated, comparisons will have to be made with long term performance tests.

Preparation, characterization and pharmacokinetics of fluorescence labeled propylene glycol alginate sodium sulfate

NASA Astrophysics Data System (ADS)

Li, Pengli; Li, Chunxia; Xue, Yiting; Zhang, Yang; Liu, Hongbing; Zhao, Xia; Yu, Guangli; Guan, Huashi

2014-08-01

A rapid and sensitive fluorescence labeling method was developed and validated for the microanalysis of a sulfated polysaccharide drug,namely propylene glycol alginate sodium sulfate (PSS), in rat plasma. Fluorescein isothiocyanate (FITC) was selected to label PSS, and 1, 6-diaminohexane was used to link PSS and FITC in order to prepare FITC-labeled PSS (F-PSS) through a reductive amination reaction. F-PSS was identified by UV-Vis, FT-IR and 1H-NMR spectrum. The cell stability and cytotoxicity of F-PSS were tested in Madin-Darby canine kidney (MDCK) cells. The results indicated that the labeling efficiency of F-PSS was 0.522% ± 0.0248% and the absolute bioavailability was 8.39%. F-PSS was stable in MDCK cells without obvious cytotoxicity. The method was sensitive and reliable; it showed a good linearity, precision, recovery and stability. The FITC labeling method can be applied to investigating the absorption and metabolism of PSS and other polysaccharides in biological samples.

Mechanism of partial agonism in AMPA-type glutamate receptors

PubMed Central

Salazar, Hector; Eibl, Clarissa; Chebli, Miriam; Plested, Andrew

2017-01-01

Neurotransmitters trigger synaptic currents by activating ligand-gated ion channel receptors. Whereas most neurotransmitters are efficacious agonists, molecules that activate receptors more weakly—partial agonists—also exist. Whether these partial agonists have weak activity because they stabilize less active forms, sustain active states for a lesser fraction of the time or both, remains an open question. Here we describe the crystal structure of an α-amino-3-hydroxy-5-methyl-4-isoxazolepropionate receptor (AMPAR) ligand binding domain (LBD) tetramer in complex with the partial agonist 5-fluorowillardiine (FW). We validate this structure, and others of different geometry, using engineered intersubunit bridges. We establish an inverse relation between the efficacy of an agonist and its promiscuity to drive the LBD layer into different conformations. These results suggest that partial agonists of the AMPAR are weak activators of the receptor because they stabilize multiple non-conducting conformations, indicating that agonism is a function of both the space and time domains. PMID:28211453

Development of new method for simultaneous analysis of piracetam and levetiracetam in pharmaceuticals and biological fluids: application in stability studies.

PubMed

Siddiqui, Farhan Ahmed; Sher, Nawab; Shafi, Nighat; Wafa Sial, Alisha; Ahmad, Mansoor; Mehjebeen; Naseem, Huma

2014-01-01

RP-HPLC ultraviolet detection simultaneous quantification of piracetam and levetiracetam has been developed and validated. The chromatography was obtained on a Nucleosil C18 column of 25 cm×0.46 cm, 10 μm, dimension. The mobile phase was a (70:30 v/v) mixture of 0.1 g/L of triethylamine and acetonitrile. Smooth flow of mobile phase at 1 mL/min was set and 205 nm wavelength was selected. Results were evaluated through statistical parameters which qualify the method reproducibility and selectivity for the quantification of piracetam, levetiracetam, and their impurities hence proving stability-indicating properties. The proposed method is significantly important, permitting the separation of the main constituent piracetam from levetiracetam. Linear behavior was observed between 20 ng/mL and 10,000 ng/mL for both drugs. The proposed method was checked in bulk drugs, dosage formulations, physiological condition, and clinical investigations and excellent outcome was witnessed.

Stability-indicating spectrophotometric methods for determination of the anticoagulant drug apixaban in the presence of its hydrolytic degradation product

NASA Astrophysics Data System (ADS)

Tantawy, Mahmoud A.; El-Ragehy, Nariman A.; Hassan, Nagiba Y.; Abdelkawy, Mohamed

2016-04-01

Apixaban (a novel anticoagulant agent) was subjected to a stress stability study including acid, alkali, oxidative, photolytic, and thermal degradation. The drug was found to be only liable to acidic and alkaline hydrolysis. The degradation product was then isolated and identified by IR and GC-mass spectrometry. Four spectrophotometric methods, namely; first derivative (D1), derivative ratio (DR), ratio difference (RD) and mean centering of ratio spectra (MCR), have been suggested for the determination of apixaban in presence of its hydrolytic degradation product. The proposed methods do not require any preliminary separation step. The accuracy, precision and linearity ranges of the proposed methods were determined, and the methods were validated as per ICH guidelines and the specificity was assessed by analyzing synthetic mixtures containing different percentages of the degradation product with the drug. The developed methods were successfully applied for the determination of apixaban in bulk powder and its tablet dosage form.

Stability-indicating spectrophotometric methods for determination of the anticoagulant drug apixaban in the presence of its hydrolytic degradation product.

PubMed

Tantawy, Mahmoud A; El-Ragehy, Nariman A; Hassan, Nagiba Y; Abdelkawy, Mohamed

2016-04-15

Apixaban (a novel anticoagulant agent) was subjected to a stress stability study including acid, alkali, oxidative, photolytic, and thermal degradation. The drug was found to be only liable to acidic and alkaline hydrolysis. The degradation product was then isolated and identified by IR and GC-mass spectrometry. Four spectrophotometric methods, namely; first derivative (D(1)), derivative ratio (DR), ratio difference (RD) and mean centering of ratio spectra (MCR), have been suggested for the determination of apixaban in presence of its hydrolytic degradation product. The proposed methods do not require any preliminary separation step. The accuracy, precision and linearity ranges of the proposed methods were determined, and the methods were validated as per ICH guidelines and the specificity was assessed by analyzing synthetic mixtures containing different percentages of the degradation product with the drug. The developed methods were successfully applied for the determination of apixaban in bulk powder and its tablet dosage form. Copyright © 2016 Elsevier B.V. All rights reserved.

Phase stability in nanoscale material systems: extension from bulk phase diagrams

NASA Astrophysics Data System (ADS)

Bajaj, Saurabh; Haverty, Michael G.; Arróyave, Raymundo; Goddard Frsc, William A., III; Shankar, Sadasivan

2015-05-01

Phase diagrams of multi-component systems are critical for the development and engineering of material alloys for all technological applications. At nano dimensions, surfaces (and interfaces) play a significant role in changing equilibrium thermodynamics and phase stability. In this work, it is shown that these surfaces at small dimensions affect the relative equilibrium thermodynamics of the different phases. The CALPHAD approach for material surfaces (also termed ``nano-CALPHAD'') is employed to investigate these changes in three binary systems by calculating their phase diagrams at nano dimensions and comparing them with their bulk counterparts. The surface energy contribution, which is the dominant factor in causing these changes, is evaluated using the spherical particle approximation. It is first validated with the Au-Si system for which experimental data on phase stability of spherical nano-sized particles is available, and then extended to calculate phase diagrams of similarly sized particles of Ge-Si and Al-Cu. Additionally, the surface energies of the associated compounds are calculated using DFT, and integrated into the thermodynamic model of the respective binary systems. In this work we found changes in miscibilities, reaction compositions of about 5 at%, and solubility temperatures ranging from 100-200 K for particles of sizes 5 nm, indicating the importance of phase equilibrium analysis at nano dimensions.Phase diagrams of multi-component systems are critical for the development and engineering of material alloys for all technological applications. At nano dimensions, surfaces (and interfaces) play a significant role in changing equilibrium thermodynamics and phase stability. In this work, it is shown that these surfaces at small dimensions affect the relative equilibrium thermodynamics of the different phases. The CALPHAD approach for material surfaces (also termed ``nano-CALPHAD'') is employed to investigate these changes in three binary systems by calculating their phase diagrams at nano dimensions and comparing them with their bulk counterparts. The surface energy contribution, which is the dominant factor in causing these changes, is evaluated using the spherical particle approximation. It is first validated with the Au-Si system for which experimental data on phase stability of spherical nano-sized particles is available, and then extended to calculate phase diagrams of similarly sized particles of Ge-Si and Al-Cu. Additionally, the surface energies of the associated compounds are calculated using DFT, and integrated into the thermodynamic model of the respective binary systems. In this work we found changes in miscibilities, reaction compositions of about 5 at%, and solubility temperatures ranging from 100-200 K for particles of sizes 5 nm, indicating the importance of phase equilibrium analysis at nano dimensions. Electronic supplementary information (ESI) available. See DOI: 10.1039/c5nr01535a

Investigating Strategies to Increase Persistence and Success Rates among Anatomy & Physiology Students: A Case Study at Austin Community College District

NASA Astrophysics Data System (ADS)

Vedartham, Padmaja B.

Snap-through buckling provides an intricate force-displacement relationship for study. With the possibility for multiple limit points and pitchfork bifurcations and large regions of instability, experimental validation of numerical analysis can become difficult. This requires stabilization of unstable static equilibria, for which limited prior research exists. For all but the simplest cases, more than one actuator is needed, increasing the complexity of the experiment to the point of intractability without a control system. In this thesis, the necessary conditions for stabilization of a buckled beam with pinned boundaries under transverse loading were determined. By combining various nonlinear solution methods, a control system was created that could stabilize any branch of the force-displacement response. Experimental traversal of an unstable branch are presented along with other unstable static equilibrium configurations. The control system had numerical limitations, losing convergence near singular points. The groundwork for experimental stabilization was validated and demonstrated.

Validation of the dutch version of the health education impact questionnaire (HEIQ) and comparison of the Dutch translation with the English, German and French HEIQ.

PubMed

Ammerlaan, Judy W; van Os-Medendorp, Harmieke; Sont, Jacob K; Elsworth, Gerald R; Osborne, Richard H

2017-01-31

The Health Education Impact Questionnaire (heiQ) evaluates the effectiveness of health education and self-management programs provided to people dealing with a wide range of conditions. Aim of this study was to translate, culturally adapt and validate the Dutch translation of the heiQ and to compare the results with the English, German and French translations. A systematic translation process was undertaken. Psychometric properties were studied among patients with arthritis, atopic dermatitis, food allergy and asthma (n = 286). Factorial validity using confirmatory factor analysis, item difficulty (D), item remainder correlation and composite reliability were conducted. Stability was tested using the intra-class correlation coefficient (ICC). Items were well understood and only minor language adjustments were required. Confirmatory fit indices were >0.95 and item difficulty was D ≥ 0.65 for all items in scales showing acceptable fit indices, except for the reversed Emotional distress scale. Composite reliability ranged between 0.67 and 0.85. Test-retest reliability (n = 93) ICC varied between 0.61 and 0.84. Comparisons with other translations showed comparable fit indices. A lower ICC on Self-monitoring and insight scale was observed. The Dutch translation of the heiQ was found to be well understood and user friendly by patients with Rheumatoid Arthritis, Atopic Dermatitis, Food allergy and asthma and to have robust psychometric properties for evaluating the impact of health education and self-management programs. Given the wide applications of the heiQ and the comparability of the Dutch results with the English, German and French version, the heiQ is a practical and useful questionnaire to evaluate the impact of self-management support programs in different countries and populations with different diseases.

The adolescent child health and illness profile. A population-based measure of health.

PubMed

Starfield, B; Riley, A W; Green, B F; Ensminger, M E; Ryan, S A; Kelleher, K; Kim-Harris, S; Johnston, D; Vogel, K

1995-05-01

This study was designed to test the reliability and validity of an instrument to assess adolescent health status. Reliability and validity were examined by administration to adolescents (ages 11-17 years) in eight schools in two urban areas, one area in Appalachia, and one area in the rural South. Integrity of the domains and subdomains and construct validity were tested in all areas. Test/retest stability, criterion validity, and convergent and discriminant validity were tested in the two urban areas. Iterative testing has resulted in the final form of the CHIP-AE (Child Health and Illness Profile-Adolescent Edition) having 6 domains with 20 subdomains. The domains are Discomfort, Disorders, Satisfaction with Health, Achievement (of age-appropriate social roles), Risks, and Resilience. Tested aspects of reliability and validity have achieved acceptable levels for all retained subdomains. The CHIP-AE in its current form is suitable for assessing the health status of populations and subpopulations of adolescents. Evidence from test-retest stability analyses suggests that the CHIP-AE also can be used to assess changes occurring over time or in response to health services interventions targeted at groups of adolescents.

Development and psychometric properties of a new social support scale for self-care in middle-aged patients with type II diabetes (S4-MAD)

PubMed Central

2012-01-01

Background Social support has proved to be one of the most effective factors on the success of diabetic self-care. This study aimed to develop a scale for evaluating social support for self-care in middle-aged patients (30–60 years old) with type II diabetes. Methods This was a two-phase qualitative and quantitative study. The study was conducted during 2009 to 2011 in Tehran, Iran. In the qualitative part, a sample of diabetic patients participated in four focus group discussions in order to develop a preliminary item pool. Consequently, content and face validity were performed to provide a pre-final version of the questionnaire. Then, in a quantitative study, reliability (internal consistency and test-retest analysis), validity and factor analysis (both exploratory and confirmatory) were performed to assess psychometric properties of the scale. Results A 38-item questionnaire was developed through the qualitative phase. It was reduced to a 33-item after content validity. Exploratory factor analysis loaded a 30-item with a five-factor solution (nutrition, physical activity, self monitoring of blood glucose, foot care and smoking) that jointly accounted for 72.3% of observed variance. The confirmatory factor analysis indicated a good fit to the data. The Cronbach’s alpha coefficient showed excellent internal consistency (alpha=0.94), and test-retest of the scale with 2-weeks intervals indicated an appropriate stability for the scale (ICC=0.87). Conclusion The findings showed that the designed questionnaire was a valid and reliable instrument for measuring social support for self-care in middle-aged patients with type II diabetes. It is an easy to use questionnaire and contains the most significant diabetes related behaviors that need continuous support for self-care. PMID:23190685

Comparative study of a novel application of automated HR HPV assay and stability in a previously untested Preservative media.

PubMed

Morel, Mike E; McBride, Simon E; Gomez, Maria P

2017-12-01

The suitability and stability of cervical cells in Novaprep media (NHQ) for certain HPV assays is unknown. We evaluated the accuracy of an automated HPV assay (Abbott RealTime HR HPV) for cervical cells prepared in NHQ and NHQ with a pre-treatment to mimic a worst case clinical use, compared to the assay manufacturers media; repeatability and reproducibility of HPV results and the stability of detectable HPV in NHQ over time compared to CE marked liquid based cytology preservatives. Cell lines were used to simulate patient samples. Cells stored in NHQ produced accurate, repeatable and reproducible results. Stability in NHQ was comparable to the best performing LBC, with at least 7 months' stability at 18-25°C, 2-8°C, -20°C and -80°C; and at least 3 months' stability at 40°C. Similar results were obtained for pre-treated NHQ except only 3.5 months' stability at 18-25°C. Cell line samples in all media and concentrations tested were detected appropriately by the assay. Based on this first stage validation analytical study, cervical cells stored in NHQ are suitable for the Realtime HPV assay. There should be no reservations for inclusion of NHQ in any further validation and clinical performance evaluation of this assay. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

Discovery and validation of gene classifiers for endocrine-disrupting chemicals in zebrafish (Danio rerio)

EPA Science Inventory

Development and application of transcriptomics-based gene classifiers for ecotoxicological applications lag far behind those of human biomedical science. Many such classifiers discovered thus far lack vigorous statistical and experimental validations, with their stability and rel...

Flight control optimization from design to assessment application on the Cessna Citation X business aircraft =

NASA Astrophysics Data System (ADS)

Boughari, Yamina

New methodologies have been developed to optimize the integration, testing and certification of flight control systems, an expensive process in the aerospace industry. This thesis investigates the stability of the Cessna Citation X aircraft without control, and then optimizes two different flight controllers from design to validation. The aircraft's model was obtained from the data provided by the Research Aircraft Flight Simulator (RAFS) of the Cessna Citation business aircraft. To increase the stability and control of aircraft systems, optimizations of two different flight control designs were performed: 1) the Linear Quadratic Regulation and the Proportional Integral controllers were optimized using the Differential Evolution algorithm and the level 1 handling qualities as the objective function. The results were validated for the linear and nonlinear aircraft models, and some of the clearance criteria were investigated; and 2) the Hinfinity control method was applied on the stability and control augmentation systems. To minimize the time required for flight control design and its validation, an optimization of the controllers design was performed using the Differential Evolution (DE), and the Genetic algorithms (GA). The DE algorithm proved to be more efficient than the GA. New tools for visualization of the linear validation process were also developed to reduce the time required for the flight controller assessment. Matlab software was used to validate the different optimization algorithms' results. Research platforms of the aircraft's linear and nonlinear models were developed, and compared with the results of flight tests performed on the Research Aircraft Flight Simulator. Some of the clearance criteria of the optimized H-infinity flight controller were evaluated, including its linear stability, eigenvalues, and handling qualities criteria. Nonlinear simulations of the maneuvers criteria were also investigated during this research to assess the Cessna Citation X's flight controller clearance, and therefore, for its anticipated certification.

Medium fidelity modelling of loads in wind farms under non-neutral ABL stability conditions - a full-scale validation study

NASA Astrophysics Data System (ADS)

Larsen, G. C.; Larsen, T. J.; Chougule, A.

2017-05-01

The aim of the present paper is to demonstrate the capability of medium fidelity modelling of wind turbine component fatigue loading, when the wind turbines are subjected to wake affected non-stationary flow fields under non-neutral atmospheric stability conditions. To accomplish this we combine the classical Dynamic Wake Meandering model with a fundamental conjecture stating: Atmospheric boundary layer stability affects primary wake meandering dynamics driven by large turbulent scales, whereas wake expansion in the meandering frame of reference is hardly affected. Inclusion of stability (i.e. buoyancy) in description of both large- and small scale atmospheric boundary layer turbulence is facilitated by a generalization of the classical Mann spectral tensor, which consistently includes buoyancy effects. With non-stationary wind turbine inflow fields modelled as described above, fatigue loads are obtained using the state-of-the art aeroelastic model HAWC2. The Lillgrund offshore wind farm (WF) constitute an interesting case study for wind farm model validation, because the WT interspacing is small, which in turn means that wake effects are significant. A huge data set, comprising 5 years of blade and tower load recordings, is available for model validation. For a multitude of wake situations this data set displays a considerable scatter, which to a large degree seems to be caused by atmospheric boundary layer stability effects. Notable is also that rotating wind turbine components predominantly experience high fatigue loading for stable stratification with significant shear, whereas high fatigue loading of non-rotating wind turbine components are associated with unstable atmospheric boundary layer stratification.

Quality by design approach for the separation of naproxcinod and its related substances by fused core particle technology column.

PubMed

Inugala, Ugandar Reddy; Pothuraju, Nageswara Rao; Vangala, Ranga Reddy

2013-01-01

This paper describes the development of a rapid, novel, stability-indicating gradient reversed-phase high-performance liquid chromatographic method and associated system suitability parameters for the analysis of naproxcinod in the presence of its related substances and degradents using a quality-by-design approach. All of the factors that affect the separation of naproxcinod and its impurities and their mutual interactions were investigated and robustness of the method was ensured. The method was developed using an Ascentis Express C8 150 × 4.6 mm, 2.7 µm column with a mobile phase containing a gradient mixture of two solvents. The eluted compounds were monitored at 230 nm, the run time was 20 min within which naproxcinod and its eight impurities were satisfactorily separated. Naproxcinod was subjected to the stress conditions of oxidative, acid, base, hydrolytic, thermal and photolytic degradation. Naproxcinod was found to degrade significantly in acidic and basic conditions and to be stable in thermal, photolytic, oxidative and aqueous degradation conditions. The degradation products were satisfactorily resolved from the primary peak and its impurities, proving the stability-indicating power of the method. The developed method was validated as per International Conference on Harmonization guidelines with respect to specificity, linearity, limit of detection, limit of quantification, accuracy, precision and robustness.

Preparation and characterization of two new forced degradation products of letrozole and development of a stability-indicating RP-LC method for its determination.

PubMed

Elkady, Ehab Farouk; Fouad, Marwa Ahmed

2015-11-01

Two new hydrolytic products of letrozole were identified and proved to be true degradation products obtained by alkaline and acidic degradation of the drug. The acid and amide forms of the nitrile groups of letrozole were prepared and identified by IR and mass spectroscopic techniques. Subsequently, a simple, precise and selective stability-indicating RPLC method was developed and validated for the determination of letrozole in the presence of its degradation products. Letrozole was subjected to alkali and acid hydrolysis, oxidation, thermal degradation and photo-degradation. The degradation products were well isolated from letrozole. The chromatographic method was achieved using gradient elution of the drug and its degradation products on a reversed phase Zorbax Eclipse C18 column (100mm x 4.6mm, 3.5 μm) using a mobile phase consisting of 0.01M KH₂PO₄and methanol at a flow rate of 1 mL min⁻¹. Quantitation was achieved with UV detection at 230 nm. Linearity, accuracy and precision were found to be acceptable over the concentration range of 0.01-80 μgmL⁻¹. The proposed method was successfully applied to the determination of letrozole in bulk, plasma and in its pharmaceutical preparation.

A validated stability indicating RP-HPLC method for estimation of Armodafinil in pharmaceutical dosage forms and characterization of its base hydrolytic product.

PubMed

Venkateswarlu, Kambham; Rangareddy, Ardhgeri; Narasimhaiah, Kanaka; Sharma, Hemraj; Bandi, Naga Mallikarjuna Raja

2017-01-01

The main objective of present study was to develop a RP-HPLC method for estimation of Armodafinil in pharmaceutical dosage forms and characterization of its base hydrolytic product. The method was developed for Armodafinil estimation and base hydrolytic products were characterized. The separation was carried out on C18 column by using mobile phase as mixture of water and methanol (45:55%v/v). Eluents were detected at 220nm at 1ml/min. Stress studies were performed with milder conditions followed by stronger conditions so as to get sufficient degradation around 20%. A total of five degradation products were detected and separated from analyte. The linearity of the proposed method was investigated in the range of 20-120µg/ml for Armodafinil. The detection limit and quantification limit was found to be 0.01183μg/ml and 0.035µg/ml respectively. The precision % RSD was found to be less than 2% and the recovery was between 98-102%. Armodafinil was found to be more sensitive to the base hydrolysis and yielded its carboxylic acid as degradant. The developed method was stability indicating assay, suitable to quantify Armodafinil in presence of possible degradants. The drug was sensitive to acid, base &photolytic stress and resistant to thermal &oxidation.

Self-Stigma of Mental Illness Scale – Short Form: Reliability and Validity

PubMed Central

Corrigan, Patrick W.; Michaels, Patrick J.; Vega, Eduardo; Gause, Michael; Watson, Amy C.; Rüsch, Nicolas

2012-01-01

The internalization of public stigma by persons with serious mental illnesses may lead to self-stigma, which harms self-esteem, self-efficacy, and empowerment. Previous research has evaluated a hierarchical model that distinguishes among stereotype awareness, agreement, application to self, and harm to self with the 40-item Self-Stigma of Mental Illness Scale (SSMIS). This study addressed SSMIS critiques (too long, contains offensive items that discourages test completion) by strategically omitting half of the original scale’s items. Here we report reliability and validity of the 20-item short form (SSMIS-SF) based on data from three previous studies. Retained items were rated less offensive by a sample of consumers. Results indicated adequate internal consistencies for each subscale. Repeated measures ANOVAs showed subscale means progressively diminished from awareness to harm. In support of its validity, the harm subscale was found to be inversely and significantly related to self-esteem, self-efficacy, empowerment, and hope. After controlling for level of depression, these relationships remained significant with the exception of the relation between empowerment and harm SSMIS-SF subscale. Future research with the SSMIS-SF should evaluate its sensitivity to change and its stability through test-rest reliability. PMID:22578819

Measuring Community Connectedness among Diverse Sexual Minority Populations

PubMed Central

Frost, David M.; Meyer, Ilan H.

2011-01-01

Theory and research agree that connectedness to the lesbian, gay, bisexual, and transgender (LGBT) community is an important construct to account for in understanding issues related to health and well-being among gay and bisexual men. However, the measurement of this construct among lesbian and bisexual women or racial/ethnic minority individuals has not yet been adequately investigated. This study examined the reliability and validity of an existing measure of Connectedness to the LGBT Community among a diverse group of sexual minority individuals in New York City and whether differences in connectedness existed across gender and race/ethnicity. Scores on the measure demonstrated both internal consistency and construct stability across subgroups defined by gender and race/ethnicity. The subgroups did not differ in their mean levels of connectedness and scores on the measure demonstrated factorial, convergent, and discriminate validity both generally and within each of the subgroups. Inconsistencies were observed with regard to which scores on the measure demonstrated predictive validity in their associations with indicators of mental health and well-being. The scale is a useful tool for researchers and practitioners interested in understanding the role of community connectedness in the lives of diverse populations of sexual minority individuals. PMID:21512945

Quantitative determination and validation of octreotide acetate using 1 H-NMR spectroscopy with internal standard method.

PubMed

Yu, Chen; Zhang, Qian; Xu, Peng-Yao; Bai, Yin; Shen, Wen-Bin; Di, Bin; Su, Meng-Xiang

2018-01-01

Quantitative nuclear magnetic resonance (qNMR) is a well-established technique in quantitative analysis. We presented a validated 1 H-qNMR method for assay of octreotide acetate, a kind of cyclic octopeptide. Deuterium oxide was used to remove the undesired exchangeable peaks, which was referred to as proton exchange, in order to make the quantitative signals isolated in the crowded spectrum of the peptide and ensure precise quantitative analysis. Gemcitabine hydrochloride was chosen as the suitable internal standard. Experimental conditions, including relaxation delay time, the numbers of scans, and pulse angle, were optimized first. Then method validation was carried out in terms of selectivity, stability, linearity, precision, and robustness. The assay result was compared with that by means of high performance liquid chromatography, which is provided by Chinese Pharmacopoeia. The statistical F test, Student's t test, and nonparametric test at 95% confidence level indicate that there was no significant difference between these two methods. qNMR is a simple and accurate quantitative tool with no need for specific corresponding reference standards. It has the potential of the quantitative analysis of other peptide drugs and standardization of the corresponding reference standards. Copyright © 2017 John Wiley & Sons, Ltd.

Development and validation of a rapid capillary zone electrophoresis method for the determination of aconite alkaloids in aconite roots.

PubMed

Song, Jing-Zheng; Han, Quan-Bin; Qiao, Chun-Feng; But, Paul Pui-Hay; Xu, Hong-Xi

2010-01-01

Aconites, with aconite alkaloids as the major therapeutic and toxic components, are used for the treatment of analgesic, antirheumatic and neurological symptoms. Quantification of the aconite alkaloids is important for the quality control of aconite-containing drugs. To establish a validated capillary zone electrophoresis (CZE) method for the simultaneous determination of six major alkaloids, namely aconitine, mesaconitine, hypaconitine, benzoylaconine, benzoylmesaconine and benzoylhypaconine, in crude and processed aconite roots. The CZE method was optimised and validated using a stability-indicating method. The optimised running buffer was a mixture of 200 mm Tris, 150 mm perchloric acid and 40% 1,4-dioxane (pH 7.8) with the capillary thermostated at 25 degrees C. Using the optimised method, six aconite alkaloids were well separated. The established method showed good precision, accuracy and recovery. Contents of these alkaloids in crude and processed aconites were determined and it was observed that the levels of individual alkaloids varied between samples. The developed CZE method was reliable for the quality control of aconites contained in herbal medicines. The method could also be used as an approach for toxicological studies.

Validation of a high performance liquid chromatography method for the stabilization of epigallocatechin gallate.

PubMed

Fangueiro, Joana F; Parra, Alexander; Silva, Amélia M; Egea, Maria A; Souto, Eliana B; Garcia, Maria L; Calpena, Ana C

2014-11-20

Epigallocatechin gallate (EGCG) is a green tea catechin with potential health benefits, such as anti-oxidant, anti-carcinogenic and anti-inflammatory effects. In general, EGCG is highly susceptible to degradation, therefore presenting stability problems. The present paper was focused on the study of EGCG stability in HEPES (N-2-hydroxyethylpiperazine-N'-2-ethanesulfonic acid) medium regarding the pH dependency, storage temperature and in the presence of ascorbic acid a reducing agent. The evaluation of EGCG in HEPES buffer has demonstrated that this molecule is not able of maintaining its physicochemical properties and potential beneficial effects, since it is partially or completely degraded, depending on the EGCG concentration. The storage temperature of EGCG most suitable to maintain its structure was shown to be the lower values (4 or -20 °C). The pH 3.5 was able to provide greater stability than pH 7.4. However, the presence of a reducing agent (i.e., ascorbic acid) was shown to provide greater protection against degradation of EGCG. A validation method based on RP-HPLC with UV-vis detection was carried out for two media: water and a biocompatible physiological medium composed of Transcutol®P, ethanol and ascorbic acid. The quantification of EGCG for purposes, using pure EGCG, requires a validated HPLC method which could be possible to apply in pharmacokinetic and pharmacodynamics studies. Copyright © 2014. Published by Elsevier B.V.

Are cannabis prevalence estimates comparable across countries and regions? A cross-cultural validation using search engine query data.

PubMed

Steppan, Martin; Kraus, Ludwig; Piontek, Daniela; Siciliano, Valeria

2013-01-01

Prevalence estimation of cannabis use is usually based on self-report data. Although there is evidence on the reliability of this data source, its cross-cultural validity is still a major concern. External objective criteria are needed for this purpose. In this study, cannabis-related search engine query data are used as an external criterion. Data on cannabis use were taken from the 2007 European School Survey Project on Alcohol and Other Drugs (ESPAD). Provincial data came from three Italian nation-wide studies using the same methodology (2006-2008; ESPAD-Italia). Information on cannabis-related search engine query data was based on Google search volume indices (GSI). (1) Reliability analysis was conducted for GSI. (2) Latent measurement models of "true" cannabis prevalence were tested using perceived availability, web-based cannabis searches and self-reported prevalence as indicators. (3) Structure models were set up to test the influences of response tendencies and geographical position (latitude, longitude). In order to test the stability of the models, analyses were conducted on country level (Europe, US) and on provincial level in Italy. Cannabis-related GSI were found to be highly reliable and constant over time. The overall measurement model was highly significant in both data sets. On country level, no significant effects of response bias indicators and geographical position on perceived availability, web-based cannabis searches and self-reported prevalence were found. On provincial level, latitude had a significant positive effect on availability indicating that perceived availability of cannabis in northern Italy was higher than expected from the other indicators. Although GSI showed weaker associations with cannabis use than perceived availability, the findings underline the external validity and usefulness of search engine query data as external criteria. The findings suggest an acceptable relative comparability of national (provincial) prevalence estimates of cannabis use that are based on a common survey methodology. Search engine query data are a too weak indicator to base prevalence estimations on this source only, but in combination with other sources (waste water analysis, sales of cigarette paper) they may provide satisfactory estimates. Copyright © 2012. Published by Elsevier B.V.

Dynamic Stability Analysis of Linear Time-varying Systems via an Extended Modal Identification Approach

NASA Astrophysics Data System (ADS)

Ma, Zhisai; Liu, Li; Zhou, Sida; Naets, Frank; Heylen, Ward; Desmet, Wim

2017-03-01

The problem of linear time-varying(LTV) system modal analysis is considered based on time-dependent state space representations, as classical modal analysis of linear time-invariant systems and current LTV system modal analysis under the "frozen-time" assumption are not able to determine the dynamic stability of LTV systems. Time-dependent state space representations of LTV systems are first introduced, and the corresponding modal analysis theories are subsequently presented via a stability-preserving state transformation. The time-varying modes of LTV systems are extended in terms of uniqueness, and are further interpreted to determine the system's stability. An extended modal identification is proposed to estimate the time-varying modes, consisting of the estimation of the state transition matrix via a subspace-based method and the extraction of the time-varying modes by the QR decomposition. The proposed approach is numerically validated by three numerical cases, and is experimentally validated by a coupled moving-mass simply supported beam experimental case. The proposed approach is capable of accurately estimating the time-varying modes, and provides a new way to determine the dynamic stability of LTV systems by using the estimated time-varying modes.

Testing Postural Stability: Are the Star Excursion Balance Test and Biodex Balance System Limits of Stability Tests Consistent?

PubMed

Glave, A Page; Didier, Jennifer J; Weatherwax, Jacqueline; Browning, Sarah J; Fiaud, Vanessa

2016-01-01

There are a variety of options to test postural stability; however many physical tests lack validity information. Two tests of postural stability - the Star Excursion Balance Test (SEBT) and Biodex Balance System Limits of Stability Test (LOS) - were examined to determine if similar components of balance were measured. Healthy adults (n=31) completed the LOS (levels 6 and 12) and SEBT (both legs). SEBT directions were offset by 180° to approximate LOS direction. Correlations and partial correlations controlling for height were analyzed. Correlations were significant for SEBT 45° and LOS back-left (6: r=-0.41; 12: r=-0.42; p<0.05), SEBT 90° and LOS 6 left (r=-0.51, p<0.05), SEBT 135(o) and LOS 6 front-left (r=-0.53, p<0.05), SEBT overall and LOS 6 overall (r=-0.43, p<0.05). Partial correlations were significant for SEBT 90° and LOS 6 left (rSEBT,LOS·H=-0.45, p<0.05) and SEBT 135° and LOS 6 front-left (rSEBT,LOS·H=-0.51, p<0.05), and SEBT overall and LOS 6 overall (rSEBT,LOS·H=-0.37, p<0.05). These findings indicate the tests seem to assess different components of balance. Research is needed to determine and define what specific components of balance are being assessed. Care must be taken when choosing balance tests to best match the test to the purpose of testing (fall risk, athletic performance, etc.). Copyright © 2015 Elsevier B.V. All rights reserved.

Physical stability and recrystallization kinetics of amorphous ibipinabant drug product by fourier transform raman spectroscopy.

PubMed

Sinclair, Wayne; Leane, Michael; Clarke, Graham; Dennis, Andrew; Tobyn, Mike; Timmins, Peter

2011-11-01

The solid-state physical stability and recrystallization kinetics during storage stability are described for an amorphous solid dispersed drug substance, ibipinabant, at a low concentration (1.0%, w/w) in a solid oral dosage form (tablet). The recrystallization behavior of the amorphous ibipinabant-polyvinylpyrrolidone solid dispersion in the tablet product was characterized by Fourier transform (FT) Raman spectroscopy. A partial least-square analysis used for multivariate calibration based on Raman spectra was developed and validated to detect less than 5% (w/w) of the crystalline form (equivalent to less than 0.05% of the total mass of the tablet). The method provided reliable and highly accurate predictive crystallinity assessments after exposure to a variety of stability storage conditions. It was determined that exposure to moisture had a significant impact on the crystallinity of amorphous ibipinabant. The information provided by the method has potential utility for predictive physical stability assessments. Dissolution testing demonstrated that the predicted crystallinity had a direct correlation with this physical property of the drug product. Recrystallization kinetics was measured using FT Raman spectroscopy for the solid dispersion from the tablet product stored at controlled temperature and relative humidity. The measurements were evaluated by application of the Johnson-Mehl-Avrami (JMA) kinetic model to determine recrystallization rate constants and Avrami exponent (n = 2). The analysis showed that the JMA equation could describe the process very well, and indicated that the recrystallization kinetics observed was a two-step process with an induction period (nucleation) followed by rod-like crystal growth. Copyright © 2011 Wiley-Liss, Inc.

Understanding criminals' thinking: further examination of the Measure of Offender Thinking Styles-Revised.

PubMed

Mandracchia, Jon T; Morgan, Robert D

2011-12-01

The Measure of Offender Thinking Styles (MOTS) was originally developed to examine the structure of dysfunctional thinking exhibited by criminal offenders. In the initial investigation, a three-factor model of criminal thinking was obtained using the MOTS. These factors included dysfunctional thinking characterized as Control, Cognitive Immaturity, and Egocentrism. In the present investigation, the stability of the three-factor model was examined with a confirmatory factor analysis of the revised version of the MOTS (i.e., MOTS-R). In addition, the internal consistency, test-retest reliability, and convergent validity of the MOTS-R were examined. Results indicated that the three-factor model of criminal thinking was supported. In addition, the MOTS-R demonstrated reliability and convergent validity with other measures of criminal thinking and attitudes. Overall, it appears that the MOTS-R may prove to be a valuable tool for use with an offender population, particularly because of the simple, intuitive structure of dysfunctional thinking that it represents.

Implementation and Validation of the Chien k-epsilon Turbulence Model in the Wind Navier-Stokes Code

NASA Technical Reports Server (NTRS)

Yoder, Dennis A.; Georgiadis, Nicholas J.

1999-01-01

The two equation k-epsilon turbulence model of Chien has been implemented in the WIND Navier-Stokes flow solver. Details of the numerical solution algorithm, initialization procedure, and stability enhancements are described. Results obtained with this version of the model are compared with those from the Chien k-epsilon model in the NPARC Navier-Stokes code and from the WIND SST model for three validation cases: the incompressible flow over a smooth flat plate, the incompressible flow over a backward facing step, and the shock-induced flow separation inside a transonic diffuser. The k-epsilon model results indicate that the WIND model functions very similarly to that in NPARC, though the WIND code appears to he slightly more accurate in the treatment of the near-wall region. Comparisons of the k-epsilon model results with those from the SST model were less definitive, as each model exhibited strengths and weaknesses for each particular case.

Development and Validation of RP-LC Method for the Determination of Cinnarizine/Piracetam and Cinnarizine/Heptaminol Acefyllinate in Presence of Cinnarizine Reported Degradation Products

PubMed Central

EL-Houssini, Ola M.; Zawilla, Nagwan H.; Mohammad, Mohammad A.

2013-01-01

Specific stability indicating reverse-phase liquid chromatography (RP-LC) assay method (SIAM) was developed for the determination of cinnarizine (Cinn)/piracetam (Pira) and cinnarizine (Cinn)/heptaminol acefyllinate (Hept) in the presence of the reported degradation products of Cinn. A C18 column and gradient mobile phase was applied for good resolution of all peaks. The detection was achieved at 210 nm and 254 nm for Cinn/Pira and Cinn/Hept, respectively. The responses were linear over concentration ranges of 20–200, 20–1000 and 25–1000 μgmL−1 for Cinn, Pira, and Hept respectively. The proposed method was validated for linearity, accuracy, repeatability, intermediate precision, and robustness via statistical analysis of the data. The method was shown to be precise, accurate, reproducible, sensitive, and selective for the analysis of Cinn/Pira and Cinn/Hept in laboratory prepared mixtures and in pharmaceutical formulations. PMID:24137049

The psychometric properties of the Portuguese version of the Personality Inventory for DSM-5.

PubMed

Pires, Rute; Sousa Ferreira, Ana; Guedes, David

2017-10-01

The DSM-5 Section III proposes a hybrid dimensional-categorical model of conceptualizing personality and its disorders that includes assessment of impairments in personality functioning (criterion A) and maladaptive personality traits (criterion B). The Personality Inventory for the DSM-5 is a new dimensional tool, composed of 220 items organized into 25 facets that delineate five higher order domains of clinically relevant personality differences, and was developed to operationalize the DSM-5 model of pathological personality traits. The current studies address the internal consistency (study 1), the test-retest reliability (study 2) and the criterion validity (studies 3 and 4) of the Portuguese version of the PID-5 in samples of native speaking psychology students. Results indicated good internal consistency reliabilities and good temporal stability reliabilities for the majority of the PID-5 traits. The correlational pattern of the PID-5 traits with two measures of personality was in accordance with theoretical expectations and showed its concurrent validity. © 2017 Scandinavian Psychological Associations and John Wiley & Sons Ltd.

The effects of extended working hours on health and social well-being--a comparative analysis of four independent samples.

PubMed

Wirtz, Anna; Nachreiner, Friedhelm

2010-07-01

Using structural equation modeling, it can be shown that long weekly working hours and work on weekends, nights, and in shifts have detrimental effects on psychovegetative health. Employees' reported subjective work-life balance also decreases with increasing number of hours worked/week, days worked on weekends, or at nights, and with working shifts. A decrease in work-life balance in turn increases the risk of psychovegetative impairments (PVIs). Thus, long and unusual working hours increase the risk of psychovegetative health impairments both directly and indirectly, moderated by the subjective work-life balance. In fact, the indirect effects of working time on PVIs via the work-life balance seem to be stronger than the direct effects. Results of a cross-validation study of four independent and representative samples from Germany and the European Union (N > 50,000) indicate high structural stability of these results and thus an increased validity and range for generalization.

Caught in the struggle with food craving: Development and validation of a new cognitive fusion measure.

PubMed

Duarte, Cristiana; Pinto-Gouveia, José; Ferreira, Cláudia; Silva, Bárbara

2016-06-01

Cognitive fusion has been related to the development and maintenance of a series of mental health difficulties. Specifically, growing research on eating psychopathology has been demonstrating the important role of cognitive fusion related to body image in these disorders. Nonetheless, cognitive fusion specifically focused on eating remained to be investigated. The current study aimed at developing and validating the Cognitive Fusion Questionnaire-Food Craving, a measure assessing the extent to which an individual is fused with food-craving undesirable and disturbing thoughts and urges. This study was conducted with distinct samples comprising men and women from the student and general population. A principal component analysis was conducted to assess the scale's structure, which was further examined in a confirmatory factor analysis. The scale's reliability and validities were also analysed. Results indicated that the CFQ-FC presented a one-dimensional structure with 7 items, accounting for 66.14% of the variance. A CFA confirmed the plausibility of the measurement model, which was found to be invariant in both sexes. The CFQ-FC also revealed very good internal consistency, construct reliability, temporal stability, and convergent and divergent validity, being positively associated with similar constructs and with indicators of eating and general psychopathology. CFQ-FC also discriminated individuals with clinically significant symptoms of binge eating from participants with no symptoms. Finally, the CFQ-FC presents incremental validity over a global measure of cognitive fusion in predicting eating psychopathology, namely binge eating. The CFQ-FC is a psychometrically sound measure that allows for a brief and reliable assessment of eating-related cognitive fusion. This is a novel measure that may significantly contribute for the assessment of this specific dimension of cognitive fusion and for the understanding of its role in eating psychopathology. Copyright © 2016 Elsevier Ltd. All rights reserved.

Psychometric Properties of the Multidimensional Pain Inventory Applied to Brazilian Patients with Orofacial Pain.

PubMed

Zucoloto, Miriane Lucindo; Maroco, João; Duarte Bonini Campos, Juliana Alvares

2015-01-01

To evaluate the psychometric properties of the Multidimensional Pain Inventory (MPI) in a Brazilian sample of patients with orofacial pain. A total of 1,925 adult patients, who sought dental care in the School of Dentistry of São Paulo State University's Araraquara campus, were invited to participate; 62.5% (n=1,203) agreed to participate. Of these, 436 presented with orofacial pain and were included. The mean age was 39.9 (SD=13.6) years and 74.5% were female. Confirmatory factor analysis was conducted using χ²/df, comparative fit index, goodness of fit index, and root mean square error of approximation as indices of goodness of fit. Convergent validity was estimated by the average variance extracted and composite reliability, and internal consistency by Cronbach's alpha standardized coefficient (α). The stability of the models was tested in independent samples (test and validation; dental pain and orofacial pain). The factorial invariance was estimated by multigroup analysis (Δχ²). Factorial, convergent validity, and internal consistency were adequate in all three parts of the MPI. To achieve this adequate fit for Part 1, item 15 needed to be deleted (λ=0.13). Discriminant validity was compromised between the factors "activities outside the home" and "social activities" of Part 3 of the MPI in the total sample, validation sample, and in patients with dental pain and with orofacial pain. A strong invariance between different subsamples from the three parts of the MPI was detected. The MPI produced valid, reliable, and stable data for pain assessment among Brazilian patients with orofacial pain.

Psychometric Testing of the Chinese-Version Glover-Nilsson Smoking Behavioral Questionnaire (GN-SBQ-C) for the Identification of Nicotine Dependence in Adult Smokers in Taiwan.

PubMed

Chen, Shu-Ching; Chen, Hsiu-Fang; Peng, Hsi-Ling; Lee, Li-Yun; Chiang, Ting-Yu; Chiu, Hui-Chuan

2017-04-01

The purposes of this study were to evaluate the psychometric properties, reliability, and validity of the Chinese-version Glover-Nilsson Smoking Behavioral Questionnaire (GN-SBQ-C) and assess the behavioral nicotine dependence among community-dwelling adult smokers in Taiwan. The methods used were survey design, administration, and validation. A total of 202 adult smokers completed a survey to assess behavioral dependence, nicotine dependence, depression, social support, and demographic and smoking characteristics. Data analysis included descriptive statistics, internal consistency reliability, t test, exploratory factor analysis, independent t test, and Pearson product moment correlation. The results showed that (1) the GN-SBQ-C has good internal consistency reliability and stability (2-week test-retest reliability); (2) the extracted one factor explained 41.80 % of the variance, indicating construct validity; (3) the scale has acceptable concurrent validity, with significant positive correlation between the GN-SBQ-C and nicotine dependence, depression, and time smoking and negative correlation between the GN-SBQ-C and age and exercise habit; and (4) the instrument has discriminant validity, supported by significant differences between those with high and low-to-moderate nicotine dependence, smokers greater than 43 years old and those 43 years old and younger, and those who smoked 10 years or less and those smoking more than 10 years. The 11-item GN-SBQ-C has satisfactory psychometric properties when applied in a sample of Taiwanese adult smokers. The scale is feasible and valid to use to assess smoking behavioral dependence.

Development and validation of a stability-indicating gas chromatographic method for quality control of residual solvents in blonanserin: a novel atypical antipsychotic agent.

PubMed

Peng, Ming; Liu, Jin; Lu, Dan; Yang, Yong-Jian

2012-09-01

Blonanserin is a novel atypical antipsychotic agent for the treatment of schizophrenia. Ethyl alcohol, isopropyl alcohol and toluene are utilized in the synthesis route of this bulk drug. A new validated gas chromatographic (GC) method for the simultaneous determination of residual solvents in blonanserin is described in this paper. Blonanserin was dissolved in N, N-dimethylformamide to make a sample solution that was directly injected into a DB-624 column. A postrun oven temperature at 240°C for approximately 2 h after the analysis cycle was performed to wash out blonanserin residue in the GC column. Quantitation was performed by external standard analyses and the validation was carried out according to International Conference on Harmonization validation guidelines Q2A and Q2B. The method was shown to be specific (no interference in the blank solution), linear (correlation coefficients ≥0.99998, n = 10), accurate (average recoveries between 94.1 and 101.7%), precise (intra-day and inter-day precision ≤2.6%), sensitive (limit of detection ≤0.2 ng, and limit of quantitation ≤0.7 ng), robust (small variations of carrier gas flow, initial oven temperature, temperature ramping rate, injector and detector temperatures did not significantly affect the system suitability test parameters and peak areas) and stable (reference standard and sample solutions were stable over 48 h). This extensively validated method is ready to be used for the quality control of blonanserin.

Targeted redox and energy cofactor metabolomics in Clostridium thermocellum and Thermoanaerobacterium saccharolyticum

DOE Office of Scientific and Technical Information (OSTI.GOV)

Sander, Kyle; Asano, Keiji G.; Bhandari, Deepak

Clostridium thermocellum and Thermoanaerobacterium saccharolyticum are prominent candidate biocatalysts that, together, can enable the direct biotic conversion of lignocellulosic biomass to ethanol. The imbalance and suboptimal turnover rates of redox cofactors are currently hindering engineering efforts to achieve higher bioproductivity in both organisms. Measuring relevant intracellular cofactor concentrations will help understand redox state of these cofactors and help identify a strategy to overcome these limitations; however, metabolomic determinations of these labile metabolites have historically proved challenging.Results: Through our validations, we verified the handling and storage stability of these metabolites, and verified extraction matrices and extraction solvent were not suppressing massmore » spectrometry signals. We recovered adenylate energy charge ratios (a main quality indicator) above 0.82 for all extractions. NADH/NAD+ values of 0.26 and 0.04 for an adhE-deficient strain of C. thermocellum and its parent, respectively, reflect the expected shift to a more reduced redox potential when a species lacks the ability to re-oxidize NADH by synthesizing ethanol. This method failed to yield reliable results with C. bescii and poor-growing strains of T. saccharolyticum. Lastly, our validated protocols demonstrate and validate the extraction and analysis of selected redox and energy-related metabolites from two candidate consolidated bioprocessing biocatalysts, C. thermocellum and T. saccharolyticum. This development and validation highlights the important, but often neglected, need to optimize and validate metabolomic protocols when adapting them to new cell or tissue types.« less

Targeted redox and energy cofactor metabolomics in Clostridium thermocellum and Thermoanaerobacterium saccharolyticum

DOE PAGES

Sander, Kyle; Asano, Keiji G.; Bhandari, Deepak; ...

2017-11-30

Clostridium thermocellum and Thermoanaerobacterium saccharolyticum are prominent candidate biocatalysts that, together, can enable the direct biotic conversion of lignocellulosic biomass to ethanol. The imbalance and suboptimal turnover rates of redox cofactors are currently hindering engineering efforts to achieve higher bioproductivity in both organisms. Measuring relevant intracellular cofactor concentrations will help understand redox state of these cofactors and help identify a strategy to overcome these limitations; however, metabolomic determinations of these labile metabolites have historically proved challenging.Results: Through our validations, we verified the handling and storage stability of these metabolites, and verified extraction matrices and extraction solvent were not suppressing massmore » spectrometry signals. We recovered adenylate energy charge ratios (a main quality indicator) above 0.82 for all extractions. NADH/NAD+ values of 0.26 and 0.04 for an adhE-deficient strain of C. thermocellum and its parent, respectively, reflect the expected shift to a more reduced redox potential when a species lacks the ability to re-oxidize NADH by synthesizing ethanol. This method failed to yield reliable results with C. bescii and poor-growing strains of T. saccharolyticum. Lastly, our validated protocols demonstrate and validate the extraction and analysis of selected redox and energy-related metabolites from two candidate consolidated bioprocessing biocatalysts, C. thermocellum and T. saccharolyticum. This development and validation highlights the important, but often neglected, need to optimize and validate metabolomic protocols when adapting them to new cell or tissue types.« less

[Validation of the knowledge and attitudes of health professionals in the Living Will Declaration process].

PubMed

Contreras-Fernández, Eugenio; Barón-López, Francisco Javier; Méndez-Martínez, Camila; Canca-Sánchez, José Carlos; Cabezón Rodríguez, Isabel; Rivas-Ruiz, Francisco

2017-04-01

Evaluate the validity and reliability of the knowledge and attitudes of health professionals questionnaire on the Living Will Declaration (LWD) process. Cross-sectional study structured into 3 phases: (i)pilot questionnaire administered with paper to assess losses and adjustment problems; (ii)assessment of the validity and internal reliability, and (iii)assessment of the pre-filtering questionnaire stability (test-retest). Costa del Sol (Malaga) Health Area. January 2014 to April 2015. Healthcare professionals of the Costa del Sol Primary Care District and the Costa del Sol Health Agency. There were 391 (23.6%) responses, and 100 participated in the stability assessment (83 responses). The questionnaire consisted of 2 parts: (i)Knowledge (5 dimensions and 41 items), and (ii)Attitudes (2 dimensions and 17 items). In the pilot study, none of the items lost over 10%. In the evaluation phase of validity and reliability, the questionnaire was reduced to 41 items (29 of knowledge, and 12 of attitudes). In the stability evaluation phase, all items evaluated met the requirement of a kappa higher than 0.2, or had a percentage of absolute agreement exceeding 75%. The questionnaire will identify the status and areas for improvement in the health care setting, and then will allow an improved culture of LWD process in general population. Copyright © 2016 Elsevier España, S.L.U. All rights reserved.

Validity and reliability of Nike + Fuelband for estimating physical activity energy expenditure.

PubMed

Tucker, Wesley J; Bhammar, Dharini M; Sawyer, Brandon J; Buman, Matthew P; Gaesser, Glenn A

2015-01-01

The Nike + Fuelband is a commercially available, wrist-worn accelerometer used to track physical activity energy expenditure (PAEE) during exercise. However, validation studies assessing the accuracy of this device for estimating PAEE are lacking. Therefore, this study examined the validity and reliability of the Nike + Fuelband for estimating PAEE during physical activity in young adults. Secondarily, we compared PAEE estimation of the Nike + Fuelband with the previously validated SenseWear Armband (SWA). Twenty-four participants (n = 24) completed two, 60-min semi-structured routines consisting of sedentary/light-intensity, moderate-intensity, and vigorous-intensity physical activity. Participants wore a Nike + Fuelband and SWA, while oxygen uptake was measured continuously with an Oxycon Mobile (OM) metabolic measurement system (criterion). The Nike + Fuelband (ICC = 0.77) and SWA (ICC = 0.61) both demonstrated moderate to good validity. PAEE estimates provided by the Nike + Fuelband (246 ± 67 kcal) and SWA (238 ± 57 kcal) were not statistically different than OM (243 ± 67 kcal). Both devices also displayed similar mean absolute percent errors for PAEE estimates (Nike + Fuelband = 16 ± 13 %; SWA = 18 ± 18 %). Test-retest reliability for PAEE indicated good stability for Nike + Fuelband (ICC = 0.96) and SWA (ICC = 0.90). The Nike + Fuelband provided valid and reliable estimates of PAEE, that are similar to the previously validated SWA, during a routine that included approximately equal amounts of sedentary/light-, moderate- and vigorous-intensity physical activity.

Components of Standing Postural Control Evaluated in Pediatric Balance Measures: A Scoping Review.

PubMed

Sibley, Kathryn M; Beauchamp, Marla K; Van Ooteghem, Karen; Paterson, Marie; Wittmeier, Kristy D

2017-10-01

To identify measures of standing balance validated in pediatric populations, and to determine the components of postural control captured in each tool. Electronic searches of MEDLINE, Embase, and CINAHL databases using key word combinations of postural balance/equilibrium, psychometrics/reproducibility of results/predictive value of tests, and child/pediatrics; gray literature; and hand searches. Inclusion criteria were measures with a stated objective to assess balance, with pediatric (≤18y) populations, with at least 1 psychometric evaluation, with at least 1 standing task, with a standardized protocol and evaluation criteria, and published in English. Two reviewers independently identified studies for inclusion. There were 21 measures included. Two reviewers extracted descriptive characteristics, and 2 investigators independently coded components of balance in each measure using a systems perspective for postural control, an established framework for balance in pediatric populations. Components of balance evaluated in measures were underlying motor systems (100% of measures), anticipatory postural control (72%), static stability (62%), sensory integration (52%), dynamic stability (48%), functional stability limits (24%), cognitive influences (24%), verticality (9%), and reactive postural control (0%). Assessing children's balance with valid and comprehensive measures is important for ensuring development of safe mobility and independence with functional tasks. Balance measures validated in pediatric populations to date do not comprehensively assess standing postural control and omit some key components for safe mobility and independence. Existing balance measures, that have been validated in adult populations and address some of the existing gaps in pediatric measures, warrant consideration for validation in children. Copyright © 2017 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Fixed-time stabilization of impulsive Cohen-Grossberg BAM neural networks.

PubMed

Li, Hongfei; Li, Chuandong; Huang, Tingwen; Zhang, Wanli

2018-02-01

This article is concerned with the fixed-time stabilization for impulsive Cohen-Grossberg BAM neural networks via two different controllers. By using a novel constructive approach based on some comparison techniques for differential inequalities, an improvement theorem of fixed-time stability for impulsive dynamical systems is established. In addition, based on the fixed-time stability theorem of impulsive dynamical systems, two different control protocols are designed to ensure the fixed-time stabilization of impulsive Cohen-Grossberg BAM neural networks, which include and extend the earlier works. Finally, two simulations examples are provided to illustrate the validity of the proposed theoretical results. Copyright © 2017 Elsevier Ltd. All rights reserved.

Facial attractiveness, symmetry, and physical fitness in young women.

PubMed

Hönekopp, Johannes; Bartholomé, Tobias; Jansen, Gregor

2004-06-01

This study explores the evolutionary-based hypothesis that facial attractiveness (a guiding force in mate selection) is a cue for physical fitness (presumably an important contributor to mate value in ancestral times). Since fluctuating asymmetry, a measure of developmental stability, is known to be a valid cue for fitness in several biological domains, we scrutinized facial asymmetry as a potential mediator between attractiveness and fitness. In our sample of young women, facial beauty indeed indicated physical fitness. The relationships that pertained to asymmetry were in the expected direction. However, a closer analysis revealed that facial asymmetry did not mediate the relationship between fitness and attractiveness. Unexpected problems regarding the measurement of facial asymmetry are discussed.

Identification of Forced Degradation Products of Itopride by LC-PDA and LC-MS.

PubMed

Joshi, Payal; Bhoir, Suvarna; Bhagwat, A M; Vishwanath, K; Jadhav, R K

2011-05-01

Degradation products of itopride formed under different forced conditions have been identified using LC-PDA and LC-MS techniques. Itopride was subjected to forced degradation under the conditions of hydrolysis, photolysis, oxidation, dry and wet heat, in accordance with the International Conference on Harmonization. The stress solutions were chromatographed on reversed phase C18 (250×4.6 mm, 5 μm) column with a mobile phase methanol:water (55:45, v/v) at a detection wavelength of 215 nm. Itopride degraded in acid, alkali and oxidative stress conditions. The stability indicating method was developed and validated. The degradation pathway of the drug to products II-VIII is proposed.

Identification of Forced Degradation Products of Itopride by LC-PDA and LC-MS

PubMed Central

Joshi, Payal; Bhoir, Suvarna; Bhagwat, A. M.; Vishwanath, K.; Jadhav, R. K.

2011-01-01

Degradation products of itopride formed under different forced conditions have been identified using LC-PDA and LC-MS techniques. Itopride was subjected to forced degradation under the conditions of hydrolysis, photolysis, oxidation, dry and wet heat, in accordance with the International Conference on Harmonization. The stress solutions were chromatographed on reversed phase C18 (250×4.6 mm, 5 μm) column with a mobile phase methanol:water (55:45, v/v) at a detection wavelength of 215 nm. Itopride degraded in acid, alkali and oxidative stress conditions. The stability indicating method was developed and validated. The degradation pathway of the drug to products II-VIII is proposed. PMID:22457552

Radiation Impact on Pharmaceutical Stability: Retrospective Data Review

NASA Technical Reports Server (NTRS)

Daniels, V. R.; Bayuse, T. M.; McGuire, K. M.; Antonsen, E. L.; Putcha, L.

2017-01-01

Historical studies performed by the JSC Pharmacotherapeutics Discipline suggest that exposure to spaceflight conditions may compromise the safety and efficacy of some medications. Follow-on studies have revealed that affected medications demonstrate reductions in active pharmaceutical ingredient (API) concentrations and altered release characteristics. It was hypothesized that the changes in API potency and release were from the medication's exposure to the harsh environmental conditions of spaceflight. Subsequent review of the spaceflight environmental control records from the time of these studies indicated that temperature and humidity levels aboard all spacecraft remained within United States Pharmacopeia (USP) recommended ranges to maintain optimal pharmaceutical stability. Therefore, space radiation was presumed to be the source of observed drug degradation. The Pharmacotherapeutics Discipline conducted a ground analog radiation experiment in 2006 at the NASA Space Radiation Laboratory (NSRL) at Brookhaven to validate this theory and to characterize the effects of high-energy radioactive particles on pharmaceutical stability. These data were never published. Recently, the Exploration Medical Capability (ExMC) Element finalized a research plan (RP) aimed at providing a safe and effective medication formulary for exploration spaceflight. As ExMC begins to design new flight and ground analog radiation studies, further analysis of the 2006 NSRL study data is essential for the characterization of the impact of radiation on medication potency and efficacy in the exploration spaceflight environment.

Machine Learning methods for Quantitative Radiomic Biomarkers.

PubMed

Parmar, Chintan; Grossmann, Patrick; Bussink, Johan; Lambin, Philippe; Aerts, Hugo J W L

2015-08-17

Radiomics extracts and mines large number of medical imaging features quantifying tumor phenotypic characteristics. Highly accurate and reliable machine-learning approaches can drive the success of radiomic applications in clinical care. In this radiomic study, fourteen feature selection methods and twelve classification methods were examined in terms of their performance and stability for predicting overall survival. A total of 440 radiomic features were extracted from pre-treatment computed tomography (CT) images of 464 lung cancer patients. To ensure the unbiased evaluation of different machine-learning methods, publicly available implementations along with reported parameter configurations were used. Furthermore, we used two independent radiomic cohorts for training (n = 310 patients) and validation (n = 154 patients). We identified that Wilcoxon test based feature selection method WLCX (stability = 0.84 ± 0.05, AUC = 0.65 ± 0.02) and a classification method random forest RF (RSD = 3.52%, AUC = 0.66 ± 0.03) had highest prognostic performance with high stability against data perturbation. Our variability analysis indicated that the choice of classification method is the most dominant source of performance variation (34.21% of total variance). Identification of optimal machine-learning methods for radiomic applications is a crucial step towards stable and clinically relevant radiomic biomarkers, providing a non-invasive way of quantifying and monitoring tumor-phenotypic characteristics in clinical practice.

Resolving Hot Spots in the C-Terminal Dimerization Domain that Determine the Stability of the Molecular Chaperone Hsp90

PubMed Central

Reimann, Sven; Smits, Sander H. J.; Schmitt, Lutz; Groth, Georg; Gohlke, Holger

2014-01-01

Human heat shock protein of 90 kDa (hHsp90) is a homodimer that has an essential role in facilitating malignant transformation at the molecular level. Inhibiting hHsp90 function is a validated approach for treating different types of tumors. Inhibiting the dimerization of hHsp90 via its C-terminal domain (CTD) should provide a novel way to therapeutically interfere with hHsp90 function. Here, we predicted hot spot residues that cluster in the CTD dimerization interface by a structural decomposition of the effective energy of binding computed by the MM-GBSA approach and confirmed these predictions using in silico alanine scanning with DrugScorePPI. Mutation of these residues to alanine caused a significant decrease in the melting temperature according to differential scanning fluorimetry experiments, indicating a reduced stability of the mutant hHsp90 complexes. Size exclusion chromatography and multi-angle light scattering studies demonstrate that the reduced stability of the mutant hHsp90 correlates with a lower complex stoichiometry due to the disruption of the dimerization interface. These results suggest that the identified hot spot residues can be used as a pharmacophoric template for identifying and designing small-molecule inhibitors of hHsp90 dimerization. PMID:24760083

Quality assurance and stability reference (QUASAR) monitoring concept for calibration/validation

NASA Astrophysics Data System (ADS)

Teillet, Philippe M.; Horler, D. N.; O'Neill, Norman T.

1997-12-01

The paper introduces the concept that calibration/validation (cal/val) can play an essential role in bringing remote sensing to mainstream consumers in an information-based society, provided that cal/val is an integral part of a quality-assurance strategy. A market model for remote sensing is introduced and used to demonstrate that quality assurance is the key to bridging the gap between early adopters of technology and mainstream markets. The paper goes on to propose the semi-continuous monitoring of quality assurance and stability reference (QUASAR) sites as an important first step towards a cal/val infrastructure beneficial to mainstream users. Prospective QUASAR test sites are described.

Geometrical analysis of the LiCN vibrational dynamics: a stability geometrical indicator.

PubMed

Vergel, A; Benito, R M; Losada, J C; Borondo, F

2014-02-01

The vibrational dynamics of the LiNC/LiCN molecular system is examined making use of the Riemannian geometry. Stability and chaoticity are analyzed, in this context, by means of the Jacobi-Levi-Civita equations, derived from the Jacobi metric, and its solutions. A dynamical indicator, called stability geometrical indicator, is introduced in order to ascertain the dynamical characteristics of stability and chaos in the molecule under study.

Development and application of a validated stability-indicating high-performance liquid chromatographic method using photodiode array detection for simultaneous determination of granisetron, methylparaben, propylparaben, sodium benzoate, and their main degradation products in oral pharmaceutical preparations.

PubMed

Hewala, Ismail; El-Fatatry, Hamed; Emam, Ehab; Mabrouk, Mokhtar

2011-01-01

A simple, rapid, and sensitive RP-HPLC method using photodiode array detection was developed and validated for the simultaneous determination of granisetron hydrochloride, 1-methyl-1H-indazole-3-carboxylic acid (the main degradation product of granisetron), sodium benzoate, methylparaben, propylparaben, and 4-hydroxybenzoic acid (the main degradation product of parabens) in granisetron oral drops and solutions. The separation of the compounds was achieved within 8 min on a SymmetryShield RP18 column (100 x 4.6 mm id, 3.5 microm particle size) using the mobile phase acetonitrile--0.05 M KH2PO4 buffered to pH 3 using H3PO4 (3+7, v/v). The photodiode array detector was used to test the purity of the peaks, and the chromatograms were extracted at 240 nm. The method was validated, and validation acceptance criteria were met in all cases. The robust method was successfully applied to the determination of granisetron and preservatives, as well as their degradation products in different batches of granisetron oral drops and solutions. The method proved to be sensitive for determination down to 0.04% (w/w) of granisetron degradation product relative to granisetron and 0.03% (w/w) 4-hydroxybenzoic acid relative to total parabens.

Psychometric properties of the French version of a scale measuring perceived emotional intelligence : the Trait Meta-Mood Scale (TMMS)

PubMed Central

Bourdier, Léna; Duclos, Jeanne; Ringuenet, Damien; Berthoz, Sylvie

2016-01-01

Objective: The Trait Meta-Mood Scale (TMMS), a 30-item self-assessment questionnaire, has been developed to measure perceived emotional intelligence (EI) level in 3 dimensions: Attention, Clarity and Repair. This study aimed to explore the psychometric properties of the French version of this instrument. Method: The instrument factor structure, normality, internal consistency, stability and concurrent validity were assessed in a sample of 824 young adults (456 female). Besides TMMS, participants completed self-assessment questionnaires for affectivity (Shortened Beck Depression Inventory, State and Trait Anxiety Inventory, Positive and Negative emotion scale), alexithymia (Bermond-Vorst Alexithymia Questionnaire-B) and interpersonal functioning (Empathy Quotient). Discriminant validity was tested in 64 female patients with anorexia nervosa, identified in literature as having difficulties with introspection, expression and emotional regulation. Results: Confirmatory factor analysis results replicate the 3-factor structure. Internal consistency and reliability indices are adequate. Direction and degree of correlation coefficients between TMMS dimensions and other questionnaires support the instrument concurrent validity. TMMS allows to highlight differences in perceived EI levels between men and women (Attention: p < 0.001 ; Clarity: p < 0.05) as well as between patients with anorexia nervosa and control subjects (p < 0.001 for all 3 dimensions). Conclusion: This first validation study shows satisfying psychometric properties for TMMS French version. PMID:27310229

Measurement of narcolepsy symptoms: The Narcolepsy Severity Scale.

PubMed

Dauvilliers, Yves; Beziat, Severine; Pesenti, Carole; Lopez, Regis; Barateau, Lucie; Carlander, Bertrand; Luca, Gianina; Tafti, Mehdi; Morin, Charles M; Billiard, Michel; Jaussent, Isabelle

2017-04-04

To validate the Narcolepsy Severity Scale (NSS), a brief clinical instrument to evaluate the severity and consequences of symptoms in patients with narcolepsy type 1 (NT1). A 15-item scale to assess the frequency and severity of excessive daytime sleepiness, cataplexy, hypnagogic hallucinations, sleep paralysis, and disrupted nighttime sleep was developed and validated by sleep experts with patients' feedback. Seventy untreated and 146 treated adult patients with NT1 were evaluated and completed the NSS in a single reference sleep center. The NSS psychometric properties, score changes with treatment, and convergent validity with other clinical parameters were assessed. The NSS showed good psychometric properties with significant item-total score correlations. The factor analysis indicated a 3-factor solution with good reliability, expressed by satisfactory Cronbach α values. The NSS total score temporal stability was good. Significant NSS score differences were observed between untreated and treated patients (dependent sample, 41 patients before and after sleep therapy; independent sample, 29 drug-free and 105 treated patients). Scores were lower in the treated populations (10-point difference between groups), without ceiling effect. Significant correlations were found among NSS total score and daytime sleepiness (Epworth Sleepiness Scale, Mean Sleep Latency Test), depressive symptoms, and health-related quality of life. The NSS can be considered a reliable and valid clinical tool for the quantification of narcolepsy symptoms to monitor and optimize narcolepsy management. © 2017 American Academy of Neurology.

Causal Relationships between the Psychological Acceptance Process of Athletic Injury and Athletic Rehabilitation Behavior

PubMed Central

Tatsumi, Tomonori; Takenouchi, Takashi

2014-01-01

[Purpose] The purpose of this study was to examine the causal relationships between the psychological acceptance process of athletic injury and athletic-rehabilitation behavior. [Subjects] One hundred forty-four athletes who had injury experiences participated in this study, and 133 (mean age = 20.21 years, SD = 1.07; mean weeks without playing sports = 7.97 weeks, SD = 11.26) of them provided valid questionnaire responses which were subjected to analysis. [Methods] The subjects were asked to answer our originally designed questionnaire, the Psychosocial Recovery Factor Scale (PSRF-S), and two other pre-existing scales, the Athletic Injury Psychological Acceptance Scale and the Athletic-Rehabilitation Dedication Scale. [Results] The results of factor analysis indicate “emotional stability”, “social competence in the team”, “temporal perspective”, and “communication with the teammates” are factors of the PSRF-S. Lastly, the causal model in which psychosocial recovery factors are mediated by psychological acceptance of athletic injury, and influence on rehabilitation behaviors, was examined using structural equation modeling (SEM). The results of SEM indicate that the factors of emotional stability and temporal perspective are mediated by the psychological acceptance of the injury, which positively influences athletic-rehabilitation dedication. [Conclusion] The causal model was confirmed to be valid. PMID:25202190

Optimal coordination and control of posture and movements.

PubMed

Johansson, Rolf; Fransson, Per-Anders; Magnusson, Måns

2009-01-01

This paper presents a theoretical model of stability and coordination of posture and locomotion, together with algorithms for continuous-time quadratic optimization of motion control. Explicit solutions to the Hamilton-Jacobi equation for optimal control of rigid-body motion are obtained by solving an algebraic matrix equation. The stability is investigated with Lyapunov function theory and it is shown that global asymptotic stability holds. It is also shown how optimal control and adaptive control may act in concert in the case of unknown or uncertain system parameters. The solution describes motion strategies of minimum effort and variance. The proposed optimal control is formulated to be suitable as a posture and movement model for experimental validation and verification. The combination of adaptive and optimal control makes this algorithm a candidate for coordination and control of functional neuromuscular stimulation as well as of prostheses. Validation examples with experimental data are provided.

Evaluation of biologic occupational risk control practices: quality indicators development and validation.

PubMed

Takahashi, Renata Ferreira; Gryschek, Anna Luíza F P L; Izumi Nichiata, Lúcia Yasuko; Lacerda, Rúbia Aparecida; Ciosak, Suely Itsuko; Gir, Elucir; Padoveze, Maria Clara

2010-05-01

There is growing demand for the adoption of qualification systems for health care practices. This study is aimed at describing the development and validation of indicators for evaluation of biologic occupational risk control programs. The study involved 3 stages: (1) setting up a research team, (2) development of indicators, and (3) validation of the indicators by a team of specialists recruited to validate each attribute of the developed indicators. The content validation method was used for the validation, and a psychometric scale was developed for the specialists' assessment. A consensus technique was used, and every attribute that obtained a Content Validity Index of at least 0.75 was approved. Eight indicators were developed for the evaluation of the biologic occupational risk prevention program, with emphasis on accidents caused by sharp instruments and occupational tuberculosis prevention. The indicators included evaluation of the structure, process, and results at the prevention and biologic risk control levels. The majority of indicators achieved a favorable consensus regarding all validated attributes. The developed indicators were considered validated, and the method used for construction and validation proved to be effective. Copyright (c) 2010 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Mosby, Inc. All rights reserved.

Validation of a Russian Language Oswestry Disability Index Questionnaire.

PubMed

Yu, Elizabeth M; Nosova, Emily V; Falkenstein, Yuri; Prasad, Priya; Leasure, Jeremi M; Kondrashov, Dimitriy G

2016-11-01

Study Design  Retrospective reliability and validity study. Objective  To validate a recently translated Russian language version of the Oswestry Disability Index (R-ODI) using standardized methods detailed from previous validations in other languages. Methods  We included all subjects who were seen in our spine surgery clinic, over the age of 18, and fluent in the Russian language. R-ODI was translated by six bilingual people and combined into a consensus version. R-ODI and visual analog scale (VAS) questionnaires for leg and back pain were distributed to subjects during both their initial and follow-up visits. Test validity, stability, and internal consistency were measured using standardized psychometric methods. Results Ninety-seven subjects participated in the study. No change in the meaning of the questions on R-ODI was noted with translation from English to Russian. There was a significant positive correlation between R-ODI and VAS scores for both the leg and back during both the initial and follow-up visits ( p  < 0.01 for all). The instrument was shown to have high internal consistency (Cronbach α = 0.82) and moderate test-retest stability (interclass correlation coefficient = 0.70). Conclusions  The R-ODI is both valid and reliable for use among the Russian-speaking population in the United States.

Validity of Social, Moral and Emotional Facets of Self-Description Questionnaire II

ERIC Educational Resources Information Center

Leung, Kim Chau; Marsh, Herbert W.; Yeung, Alexander Seeshing; Abduljabbar, Adel S.

2015-01-01

Studies adopting a construct validity approach can be categorized into within- and between-network studies. Few studies have applied between-network approach and tested the correlations of the social (same-sex relations, opposite-sex relations, parent relations), moral (honesty-trustworthiness), and emotional (emotional stability) facets of the…

Validation of the Simple Shoulder Test in a Portuguese-Brazilian population. Is the latent variable structure and validation of the Simple Shoulder Test Stable across cultures?

PubMed

Neto, Jose Osni Bruggemann; Gesser, Rafael Lehmkuhl; Steglich, Valdir; Bonilauri Ferreira, Ana Paula; Gandhi, Mihir; Vissoci, João Ricardo Nickenig; Pietrobon, Ricardo

2013-01-01

The validation of widely used scales facilitates the comparison across international patient samples. The objective of this study was to translate, culturally adapt and validate the Simple Shoulder Test into Brazilian Portuguese. Also we test the stability of factor analysis across different cultures. The objective of this study was to translate, culturally adapt and validate the Simple Shoulder Test into Brazilian Portuguese. Also we test the stability of factor analysis across different cultures. The Simple Shoulder Test was translated from English into Brazilian Portuguese, translated back into English, and evaluated for accuracy by an expert committee. It was then administered to 100 patients with shoulder conditions. Psychometric properties were analyzed including factor analysis, internal reliability, test-retest reliability at seven days, and construct validity in relation to the Short Form 36 health survey (SF-36). Factor analysis demonstrated a three factor solution. Cronbach's alpha was 0.82. Test-retest reliability index as measured by intra-class correlation coefficient (ICC) was 0.84. Associations were observed in the hypothesized direction with all subscales of SF-36 questionnaire. The Simple Shoulder Test translation and cultural adaptation to Brazilian-Portuguese demonstrated adequate factor structure, internal reliability, and validity, ultimately allowing for its use in the comparison with international patient samples.

Validation of the Simple Shoulder Test in a Portuguese-Brazilian Population. Is the Latent Variable Structure and Validation of the Simple Shoulder Test Stable across Cultures?

PubMed Central

Neto, Jose Osni Bruggemann; Gesser, Rafael Lehmkuhl; Steglich, Valdir; Bonilauri Ferreira, Ana Paula; Gandhi, Mihir; Vissoci, João Ricardo Nickenig; Pietrobon, Ricardo

2013-01-01

Background The validation of widely used scales facilitates the comparison across international patient samples. The objective of this study was to translate, culturally adapt and validate the Simple Shoulder Test into Brazilian Portuguese. Also we test the stability of factor analysis across different cultures. Objective The objective of this study was to translate, culturally adapt and validate the Simple Shoulder Test into Brazilian Portuguese. Also we test the stability of factor analysis across different cultures. Methods The Simple Shoulder Test was translated from English into Brazilian Portuguese, translated back into English, and evaluated for accuracy by an expert committee. It was then administered to 100 patients with shoulder conditions. Psychometric properties were analyzed including factor analysis, internal reliability, test-retest reliability at seven days, and construct validity in relation to the Short Form 36 health survey (SF-36). Results Factor analysis demonstrated a three factor solution. Cronbach’s alpha was 0.82. Test-retest reliability index as measured by intra-class correlation coefficient (ICC) was 0.84. Associations were observed in the hypothesized direction with all subscales of SF-36 questionnaire. Conclusion The Simple Shoulder Test translation and cultural adaptation to Brazilian-Portuguese demonstrated adequate factor structure, internal reliability, and validity, ultimately allowing for its use in the comparison with international patient samples. PMID:23675436

Physicochemical and microbiological stability of azathioprine in InOrpha suspending agent studied under various conditions.

PubMed

Amin, Alexandre; Bourget, Philippe; Vidal, Fabrice; Cartier, François; Beauvais, Raphaëlle; Afonso, Veronica Do Nascimento

2015-01-01

Azathioprine is an antineoplastic antimetabolite drug currently used as an immunosuppressive agent after organ transplantation and for several dysimmunitary diseases. The usual daily dose ranges from 1 to 5 mg/kg orally. Azathioprine is marketed in France under the trade name Imurel in tablet form for oral administration that contains either 25 mg or 50 mg of the active ingredient. This Galenic formulation is not suitable for pediatric use and often requires a grinding operation or a dose fractionation to facilitate administration. In addition to a potential risk of imprecision in the administered dose, tablet grinding might unnecessarily expose nurses and families to a toxic compound. To overcome this problem, the objective of this study was to develop and evaluate the physicochemical and microbiological stabilities of azathioprine in a sugar-free, alcohol-free, and paraben-free InOrpha suspending agent. The studied samples were formulated into a 10-mg/mL suspension and stored in 24 plastic bottles of 60 mL at two different temperature conditions (between 2 degrees C to 8 degrees C and room temperature). Two series of 12 samples were tested for physicochemical stability using high-performance liquid chromatography as well as for a microbiological status for 35 days (daily opening of the bottles from day 0 of compounding) and for 56 days, upon daily flask opening (first opening at day 28 from compounding and daily opening for 28 consecutive days). The high-performance liquid chromatography method developed is linear, accurate, precise, and robust. In addition, a forced degradation study validated the selectivity and the specificity requirements of the method validated as stability indicating. At room temperature storage, high-performance liquid chromatography analysis showed that tested samples had concentrations ranging from 90% to 110% of the initial concentration throughout the course of the study. Microbiological status remained stable during the 56 days of investigation. Based on the data collected, the study led to the development of a new Galenic formulation of azathioprine that is suitable for pediatric use and can be safely stored at room temperature for 28 days (before and after opening for a maximum of 56 consecutive days).

Is the Agency Shop Appropriate for Negotiated Settlements in Public Education?

ERIC Educational Resources Information Center

Ellmann, Erwin B.

In this report, the author presents examples from the field of private labor relations that demonstrate the value of agency shops. He argues that agency shops contribute to union stability which stability leads to a more businesslike union-management relationship. The author examines State and Federal constitutions to determine the validity of…

Step-Down Test Assessment of Postural Stability in Patients With Chronic Ankle Instability.

PubMed

Bolt, Doris; Giger, René; Wirth, Stefan; Swanenburg, Jaap

2018-01-23

The underlying mechanism in 27% of ankle sprains is a fall while navigating stairs. Therefore, the step-down test (SDT) may be useful to investigate dynamic postural stability deficits in individuals with chronic ankle instability (CAI). To investigate the test-retest reliability and validity of the forward and lateral SDT protocol between individuals with CAI and uninjured controls. Test-retest study. University hospital. A total of 46  individuals, 23 with CAI and 23 uninjured controls. Time to stabilization of the forward and lateral SDT. The absolute reliability (SEM = 0.04-0.12 s; SDD = 0.11-0.33 s) of the SDT protocol was acceptable, whereas the relative reliability (ICC 3 , k = 0.12-0.63) and discriminant validity (P = .42-.99; AUC = 0.50-0.57) were not. The SDT appears to not be challenging enough to detect dynamic postural stability differences between individuals with and without CAI. However, the SDT may be capable of measuring change over time based on its good absolute reliability.

Evaluation of the Stability of Mercaptopurine Suspension Compounded in a Commercial Vehicle and the Determination of an Appropriate Beyond-use Date.

PubMed

Peacock, Gina F; Sauvageot, Jurgita; Hill, Ashley; Killian, Alyssa

2016-01-01

Mercaptopurine is commonly used to treat acute lymphoblastic leukemia and has historically been commercially available only in tablet form. Since tablets may be difficult for children and elderly patients to swallow, many pharmacists have compounded mercaptopurine suspensions. The U.S. Food and Drug Administration recently approved a commercial suspension, but it is not widely available at this time. Therefore, pharmacists may still need to compound mercaptopurine suspension for use in areas where it is not available or if the commercial suspension is in short supply. Stability studies must be conducted in order to assign appropriate beyond-use dates for compounded preparations. The objective of this study was to evaluate the stability of extemporaneously compounded suspensions using commercially available mercaptopurine tablets, as well as active pharmaceutical ingredient in a vehicle of Ora-Sweet and Ora-Plus (1:1) stored in plastic and glass containers at room temperature. Each mercaptopurine preparation was analyzed using a validated stability-indicating high-performance liquid chromatography method at the following time points: 0, 7, 14, 21, 30, 60, and 90 days. Suspensions were also observed for changes in appearance or odor, and pH was tested at each time point. The suspension compounded from Roxane generic tablets was extremely viscous and was therefore eliminated from the study. All other suspensions showed no observed physical changes and maintained greater than 93% of initial concentration of mercaptopurine for the entire study period.

Liquid chromatography/tandem mass spectrometry method for simultaneous determination of cocaine and its metabolite (-)ecgonine methyl ester in human acidified stabilized plasma samples.

PubMed

Liu, Yongzhen; Zheng, Bo; Strafford, Stephanie; Orugunty, Ravi; Sullivan, Michael; Gus, Jeffrey; Heidbreder, Christian; Fudala, Paul J; Nasser, Azmi

2014-06-15

Two simple, sensitive and rapid liquid chromatography/electrospray ionization tandem mass spectrometry (LC-ESI-MS/MS) methods (low range and high range) were developed and validated for the quantification of cocaine and its metabolite (-)ecgonine methyl ester (EME) in human acidified stabilized plasma samples. In the low range assay, cocaine and the internal standard, cocaine-D3, were extracted using a single step liquid-liquid extraction from human acidified stabilized plasma. For the high range assay, human acidified stabilized plasma containing cocaine, EME, and the internal standards, cocaine-D3 and EME-D3, was mixed with acetonitrile, and the protein precipitate was separated by centrifugation. Both cocaine and EME extracted from both assays were separated on a HILIC column and detected in positive ion mode using multiple reaction monitoring (MRM). Both methods were validated and the specificity, linearity, lower limit of quantitation (LLOQ), precision, accuracy, recoveries and stability were determined. The linear range for the low range assay was 0.01-5ng/mL for cocaine; in the high range assay values were 5-1000ng/mL for cocaine and 1-200ng/mL for EME. The correlation coefficient (R(2)) values for both assays were 0.993 or greater. The precision and accuracy for intra-day and inter-day were better than 13.0%. The recovery was above 85% and matrix effects were low with the matrix factor ranging from 0.817 to 1.10 for both analytes in both assays. The validated methods were successfully used to quantify the plasma concentrations of cocaine and EME in clinical pharmacokinetic and pharmacodynamic studies. Copyright © 2014 Elsevier B.V. All rights reserved.

The premature ejaculation diagnostic tool (PEDT): linguistic validity of the Chinese version.

PubMed

Huang, Yan-Ping; Chen, Bin; Ping, Ping; Wang, Hong-Xiang; Hu, Kai; Zhang, Tao; Yang, Hao; Jin, Yan; Yang, Qi; Huang, Yi-Ran

2014-09-01

The premature ejaculation diagnostic tool (PEDT) was developed to standardize the diagnosis of PE and has been applied in many countries. However, a linguistic validation of the Chinese version of PEDT does not exist. This study aims to undertake the Chinese validation of the PEDT and to evaluate its association with self-estimated intravaginal ejaculatory latency time (IELT) and clinical expert diagnosis of PE. A Chinese version of PEDT was confirmed by andrologist and bilingual linguist. Participants were recruited among seven different communities of Shanghai from 2011 to 2012, and their information regarding self-reported PE, self-estimated IELT, expert diagnosis of PE, and PEDT scores were collected. Validity of the PEDT and its association with clinical expert diagnosis of PE and self-estimated IELT were analyzed. A total of 143 patients without PE (mean age 55.11 ± 7.65 years) and 100 men with PE (mean age 53.07 ± 8.08 years) were enrolled for validation. Of the patients in PE group, the number of men reporting self-estimated IELTs of ≤1, 1-2, and >2 minutes were 34 (34.0%), 22 (22.0%), and 44 (44.0%), respectively. The Cronbach's alpha score (α = 0.77) showed adequate internal consistency, and the test-retest correlation coefficients of each item (r ≥ 0.70, P < 0.001) indicated excellent stability over time. The frequency of agreement showed that there was excellent concordance between PEDT diagnosis and clinician diagnosis when the PEDT scores ≥11. An adequate correlation was found between total PEDT score and self-estimated IELT (ρ = -0.396, P < 0.001), and sensitivity and specificity analyses suggested a score of ≤8 indicated no time-defined PE (self-estimated IELT ≤1 minute). The Chinese version of PEDT is valid in screening the presence of PE among Chinese men. The PEDT showed an adequate negative correlation with self-estimated IELT and an excellent concordance with clinician diagnosis of PE. © 2014 International Society for Sexual Medicine.

Proteins QSAR with Markov average electrostatic potentials.

PubMed

González-Díaz, Humberto; Uriarte, Eugenio

2005-11-15

Classic physicochemical and topological indices have been largely used in small molecules QSAR but less in proteins QSAR. In this study, a Markov model is used to calculate, for the first time, average electrostatic potentials xik for an indirect interaction between aminoacids placed at topologic distances k within a given protein backbone. The short-term average stochastic potential xi1 for 53 Arc repressor mutants was used to model the effect of Alanine scanning on thermal stability. The Arc repressor is a model protein of relevance for biochemical studies on bioorganics and medicinal chemistry. A linear discriminant analysis model developed correctly classified 43 out of 53, 81.1% of proteins according to their thermal stability. More specifically, the model classified 20/28, 71.4% of proteins with near wild-type stability and 23/25, 92.0% of proteins with reduced stability. Moreover, predictability in cross-validation procedures was of 81.0%. Expansion of the electrostatic potential in the series xi0, xi1, xi2, and xi3, justified the use of the abrupt truncation approach, being the overall accuracy >70.0% for xi0 but equal for xi1, xi2, and xi3. The xi1 model compared favorably with respect to others based on D-Fire potential, surface area, volume, partition coefficient, and molar refractivity, with less than 77.0% of accuracy [Ramos de Armas, R.; González-Díaz, H.; Molina, R.; Uriarte, E. Protein Struct. Func. Bioinf.2004, 56, 715]. The xi1 model also has more tractable interpretation than others based on Markovian negentropies and stochastic moments. Finally, the model is notably simpler than the two models based on quadratic and linear indices. Both models, reported by Marrero-Ponce et al., use four-to-five time more descriptors. Introduction of average stochastic potentials may be useful for QSAR applications; having xik amenable physical interpretation and being very effective.

Assessing the Impacts of Atmospheric Conditions under Climate Change on Air Quality Profile over Hong Kong

NASA Astrophysics Data System (ADS)

Hei Tong, Cheuk

2017-04-01

Small particulates can cause long term impairment to human health as they can penetrate deep and deposit on the wall of the respiratory system. Under the projected climate change as reported by literature, atmospheric stability, which has strong effects on vertical mixing of air pollutants and thus air quality Hong Kong, is also varying from near to far future. In addition to domestic emission, Hong Kong receives also significant concentration of cross-boundary particulates that their natures and movements are correlated with atmospheric condition. This study aims to study the relation of atmospheric conditions with air quality over Hong Kong. Past meteorological data is based on Modern Era Retrospective Analysis for Research and Applications (MERRA) reanalysis data. Radiosonde data provided from HKO are also adopted in testing and validating the data. Future meteorological data is simulated by the Weather Research and Forecasting Model (WRF), which dynamically downscaled the past and future climate under the A1B scenario simulated by ECHAM5/MPIOM. Air quality data is collected on one hand from the ground station data provided by Environment Protection Department, with selected stations revealing local emission and trans-boundary emission respectively. On the other hand, an Atmospheric Light Detection and Ranging (LiDAR), which operates using the radar principle to detect Rayleigh and Mie scattering from atmospheric gas and aerosols, has also been adopted to measure vertical aerosol profile, which has been observed tightly related to the high level meteorology. Data from scattered signals are collected, averaged or some episode selected for characteristic comparison with the atmospheric stability indices and other meteorological factors. The relation between atmospheric conditions and air quality is observed by statistical analysis, and statistical models are built based on the stability indices to project the changes in sulphur dioxide, ozone and particulate matters due to changes in stability in future years.

Towards a full integration of optimization and validation phases: An analytical-quality-by-design approach.

PubMed

Hubert, C; Houari, S; Rozet, E; Lebrun, P; Hubert, Ph

2015-05-22

When using an analytical method, defining an analytical target profile (ATP) focused on quantitative performance represents a key input, and this will drive the method development process. In this context, two case studies were selected in order to demonstrate the potential of a quality-by-design (QbD) strategy when applied to two specific phases of the method lifecycle: the pre-validation study and the validation step. The first case study focused on the improvement of a liquid chromatography (LC) coupled to mass spectrometry (MS) stability-indicating method by the means of the QbD concept. The design of experiments (DoE) conducted during the optimization step (i.e. determination of the qualitative design space (DS)) was performed a posteriori. Additional experiments were performed in order to simultaneously conduct the pre-validation study to assist in defining the DoE to be conducted during the formal validation step. This predicted protocol was compared to the one used during the formal validation. A second case study based on the LC/MS-MS determination of glucosamine and galactosamine in human plasma was considered in order to illustrate an innovative strategy allowing the QbD methodology to be incorporated during the validation phase. An operational space, defined by the qualitative DS, was considered during the validation process rather than a specific set of working conditions as conventionally performed. Results of all the validation parameters conventionally studied were compared to those obtained with this innovative approach for glucosamine and galactosamine. Using this strategy, qualitative and quantitative information were obtained. Consequently, an analyst using this approach would be able to select with great confidence several working conditions within the operational space rather than a given condition for the routine use of the method. This innovative strategy combines both a learning process and a thorough assessment of the risk involved. Copyright © 2015 Elsevier B.V. All rights reserved.

Influence of foam on the stability characteristics of immiscible flow in porous media

NASA Astrophysics Data System (ADS)

van der Meer, J. M.; Farajzadeh, R.; Rossen, W. R.; Jansen, J. D.

2018-01-01

Accurate field-scale simulations of foam enhanced oil recovery are challenging, due to the sharp transition between gas and foam. Hence, unpredictable numerical and physical behavior is often observed, casting doubt on the validity of the simulation results. In this paper, a thorough stability analysis of the foam model is presented to validate the simulation results. We study the effect of a strongly non-monotonous total mobility function arising from foam models on the stability characteristics of the flow. To this end, we apply the linear stability analysis to nearly discontinuous relative permeability functions and compare the results with those of highly accurate numerical simulations. In addition, we present a qualitative analysis of the effect of different reservoir and fluid properties on the foam fingering behavior. In particular, we consider the effect of heterogeneity of the reservoir, injection rates, and foam quality. Relative permeability functions play an important role in the onset of fingering behavior of the injected fluid. Hence, we can deduce that stability properties are highly dependent on the non-linearity of the foam transition. The foam-water interface is governed by a very small total mobility ratio, implying a stable front. The transition between gas and foam, however, exhibits a huge total mobility ratio, leading to instabilities in the form of viscous fingering. This implies that there is an unstable pattern behind the front. We deduce that instabilities are able to grow behind the front but are later absorbed by the expanding wave. Moreover, the stability analysis, validated by numerical simulations, provides valuable insights about the important scales and wavelengths of the foam model. In this way, we remove the ambiguity regarding the effect of grid resolution on the convergence of the solutions. This insight forms an essential step toward the design of a suitable computational solver that captures all the appropriate scales, while retaining computational efficiency.

Validation of an HPLC method for the quantification of ambroxol hydrochloride and benzoic acid in a syrup as pharmaceutical form stress test for stability evaluation.

PubMed

Heinänen, M; Barbas, C

2001-03-01

A method is described for ambroxol, trans-4-(2-amino-3,5-dibromobenzylamino) cyclohexanol hydrochloride, and benzoic acid separation by HPLC with UV detection at 247 nm in a syrup as pharmaceutical presentation. Optimal conditions were: Column Symmetry Shield RPC8, 5 microm 250 x 4.6 mm, and methanol/(H(3)PO(4) 8.5 mM/triethylamine pH=2.8) 40:60 v/v. Validation was performed using standards and the pharmaceutical preparation which contains the compounds described above. Results from both standards and samples show suitable validation parameters. The pharmaceutical grade substances were tested by factors that could influence the chemical stability. These reaction mixtures were analysed to evaluate the capability of the method to separate degradation products. Degradation products did not interfere with the determination of the substances tested by the assay.

Dynamic modelling and experimental validation of three wheeled tilting vehicles

NASA Astrophysics Data System (ADS)

Amati, Nicola; Festini, Andrea; Pelizza, Luigi; Tonoli, Andrea

2011-06-01

The present paper describes the study of the stability in the straight running of a three-wheeled tilting vehicle for urban and sub-urban mobility. The analysis was carried out by developing a multibody model in the Matlab/SimulinkSimMechanics environment. An Adams-Motorcycle model and an equivalent analytical model were developed for the cross-validation and for highlighting the similarities with the lateral dynamics of motorcycles. Field tests were carried out to validate the model and identify some critical parameters, such as the damping on the steering system. The stability analysis demonstrates that the lateral dynamic motions are characterised by vibration modes that are similar to that of a motorcycle. Additionally, it shows that the wobble mode is significantly affected by the castor trail, whereas it is only slightly affected by the dynamics of the front suspension. For the present case study, the frame compliance also has no influence on the weave and wobble.

Stability analysis of free piston Stirling engines

NASA Astrophysics Data System (ADS)

Bégot, Sylvie; Layes, Guillaume; Lanzetta, François; Nika, Philippe

2013-03-01

This paper presents a stability analysis of a free piston Stirling engine. The model and the detailed calculation of pressures losses are exposed. Stability of the machine is studied by the observation of the eigenvalues of the model matrix. Model validation based on the comparison with NASA experimental results is described. The influence of operational and construction parameters on performance and stability issues is exposed. The results show that most parameters that are beneficial for machine power seem to induce irregular mechanical characteristics with load, suggesting that self-sustained oscillations could be difficult to maintain and control.

Illness denial questionnaire for patients and caregivers.

PubMed

Rossi Ferrario, Silvia; Giorgi, Ines; Baiardi, Paola; Giuntoli, Laura; Balestroni, Gianluigi; Cerutti, Paola; Manera, Marina; Gabanelli, Paola; Solara, Valentina; Fornara, Roberta; Luisetti, Michela; Omarini, Pierangela; Omarini, Giovanna; Vidotto, Giulio

2017-01-01

Interest in assessing denial is still present, despite the criticisms concerning its definition and measurement. We tried to develop a questionnaire (Illness Denial Questionnaire, IDQ) assessing patients' and caregivers' denial in relation to their illness/disturbance. After a preliminary study, a final version of 24 dichotomous items (true/false) was selected. We hypothesized a theoretical model with three dimensions: denial of negative emotions, resistance to change, and conscious avoidance, the first two composing the actual Denial and the last representing an independent component of the illness denial behavior. The IDQ was administered to 400 subjects (219 patients and 181 caregivers) together with the Anxiety-Depression Questionnaire - Reduced form (AD-R), in order to assess concurrent validity. Confirmatory factor analysis (CFA), internal consistency indices (Cronbach's α and McDonald's ω), and test-retest analysis were performed. CFA and internal consistency indices (Cronbach's α: 0.87-0.96) indicated a clear and meaningful three-factor structure of IDQ, for both patients and caregivers. Further analyses showed good concurrent validity, with Denial and its subscale negatively associated with anxiety and depression and avoidance positively associated with anxiety and depression. The IDQ also showed a good stability ( r from 0.71 to 0.87). The IDQ demonstrated good psychometric properties. Denial of negative emotions and resistance to change seem to contribute to a real expression of denial, and conscious avoidance seems to constitute a further step in the process of cognitive-affective elaboration of the illness.

Guidelines for the practical stability studies of anticancer drugs: a European consensus conference.

PubMed

Bardin, C; Astier, A; Vulto, A; Sewell, G; Vigneron, J; Trittler, R; Daouphars, M; Paul, M; Trojniak, M; Pinguet, F

2011-07-01

Stability studies performed by the pharmaceutical industry are only designed to fulfill licensing requirements. Thus, post-dilution or -reconstitution stability data are frequently limited to 24h only for bacteriological reasons regardless of the true chemical stability which could, in many cases, be longer. In practice, the pharmacy-based centralized preparation may require infusions to be made several days in advance to provide, for example, the filling of ambulatory devices for continuous infusions or batch preparations for dose banding. Furthermore, a non-justified limited stability for expensive products is obviously very costly. Thus, there is a compelling need for additional stability data covering practical uses of anticancer drugs. A European conference consensus was held in France, May 2010, under the auspices of the French Society of Oncology Pharmacy (SFPO) to propose adapted rules on stability in practical situations and guidelines to perform corresponding stability studies. For each anticancer drug, considering their therapeutic index, the pharmacokinetics/pharmacodynamics (PK/PD) variability, specific clinical use and risks related to degradation products, the classical limit of 10% of degradation can be inappropriate. Therefore, acceptance limits must be clinically relevant and should be defined for each drug individually. Design of stability studies has to reflect the different needs of the clinical practice (preparation for the week-ends, outpatient transportations, implantable devices, dose banding…). It is essential to use validated stability-indicating methods, separating degradation products being formed in the practical use of the drug. Sequential temperature designs should be encouraged to replicate problems seen in daily practice such as rupture of the cold-chain or temperature-cycling between refrigerated storage and ambient in-use conditions. Stressed conditions are recommended to evaluate not only the role of classical variables (pH, temperature, light) but also the mechanical stress. Physical stability such as particles' formation should be systematically evaluated. The consensus conference focused on the need to perform more studies on the stability of biotherapies, including a minimum of three complementary separating methods and a careful evaluation of submicron aggregates. The determination of the biological activity of proteins could be also useful. A guideline on the practical stability of anticancer drugs is proposed to cover current clinical and pharmaceutical practice. It should contribute to improved security of use, optimization of centralized handling and reduced costs. Finally, we have attempted to establish a new drug stability paradigm based on practical clinical needs, to complement regulatory guidelines which are essentially orientated to the stability of manufactured drugs. Copyright © 2011 Elsevier Masson SAS. All rights reserved.

The relationship between organizational trust and nurse administrators’ productivity in hospitals

PubMed Central

Bahrami, Susan; Hasanpour, Marzieh; Rajaeepour, Saeed; Aghahosseni, Taghi; Hodhodineghad, Nilofar

2012-01-01

Context: Management of health care organizations based on employee’s mutual trust will increase the improvement in functions and tasks. Aims: The present study was performed to investigate the relationship between organizational trust and the nurse administrators’ productivity in educational health centers of in Health-Education Centers of Isfahan University of Medical Sciences. Settings and Design: This research was a descriptive and correlational study. Materials and Methods: The population included all nurse administrators. In this research, 165 nurses were selected through random sampling method. Data collection instruments were organizational trust questionnaire based on Robbins’s model and productivity questionnaire based on Hersy and Blanchard’s model. Validity of these questionnaires was determined through content validity and their reliability was calculated through Cranach’s alpha. Statistical analysis was used: The data analysis was done using the SPSS (18) statistical software. Results: The indicators of organizational trust such as loyalty, competence, honesty, and stability were more than average level but explicitness indicator was at average level. The components of productivity such as ability, job knowledge, environmental compatibility, performance feedback, and validity were more than average level but motivation factor was at average level and organizational support was less than average level. There were a significant multiple correlations between organizational trust and productivity. Beta coefficients among organizational trust and productivity were significant and no autocorrelation existed and regression model was significant. Conclusions: Committed employees, timely performing the tasks and developing the sense of responsibility among employees can enhance production and productivity in the health care organizations. PMID:23922588

Big Five Personality Trait Short Questionnaire: Preliminary Validation with Spanish Adults.

PubMed

Ortet, Generós; Martínez, Tania; Mezquita, Laura; Morizot, Julien; Ibáñez, Manuel I

2017-02-09

There are two major advantages of the Big Five Personality Trait Short Questionnaire (BFPTSQ) over other non-commercial short Five-Factor Model personality measures: widen conceptual breadth, and its use in both adolescents and adults. The aim of this study was to explore the psychometric properties of this questionnaire in an adult Spanish sample. Factor, convergent (using the NEO-PI-R), and criterion (using scales that assess happiness and alcohol consumption) validities, internal consistency as well as test-retest reliabilities of the BFPTSQ were evaluated. The sample was composed of 262 participants; a subsample of 71 individuals also answered the NEO-PI-R, and another subsample of 42 respondents filled the BFPTSQ out again a month later. The results indicated that the expected factor structure was recovered using exploratory structural equation modeling (ESEM). The ESEM showed satisfactory fit indices, with CFI and TLI around .90, as well as RMSEA and SRMR below .06. Moreover, coefficient alphas ranged from .75 to .85 and test-retest correlations ranged from .72 to .93 (p < .001). Regarding the associations of BFPTSQ with NEO-PI-R scales, the correlations with the broad-trait scales ranged from .57 to .80 (p < .001), and 27 out of 30 correlations with the facet scales were significant (p < .05 or lower). We also found that extraversion and emotional stability were associated with subjective well-being (p < .001), and extraversion and conscientiousness were related to alcohol consumption (p < .01). This study supports the construct validity of the Spanish version of the BFPTSQ in adults.

Changes in performance: a 5-year longitudinal study of participants in a multi-source feedback programme.

PubMed

Violato, Claudio; Lockyer, Jocelyn M; Fidler, Herta

2008-10-01

Multi-source feedback (MSF) enables performance data to be provided to doctors from patients, co-workers and medical colleagues. This study examined the evidence for the validity of MSF instruments for general practice, investigated changes in performance for doctors who participated twice, 5 years apart, and determined the association between change in performance and initial assessment and socio-demographic characteristics. Data for 250 doctors included three datasets per doctor from, respectively, 25 patients, eight co-workers and eight medical colleagues, collected on two occasions. There was high internal consistency (alpha > 0.90) and adequate generalisability (Ep(2) > 0.70). D study results indicate adequate generalisability coefficients for groups of eight assessors (medical colleagues, co-workers) and 25 patient surveys. Confirmatory factor analyses provided evidence for the validity of factors that were theoretically expected, meaningful and cohesive. Comparative fit indices were 0.91 for medical colleague data, 0.87 for co-worker data and 0.81 for patient data. Paired t-test analysis showed significant change between the two assessments from medical colleagues and co-workers, but not between the two patient surveys. Multiple linear regressions explained 2.1% of the variance at time 2 for medical colleagues, 21.4% of the variance for co-workers and 16.35% of the variance for patient assessments, with professionalism a key variable in all regressions. There is evidence for the construct validity of the instruments and for their stability over time. Upward changes in performance will occur, although their effect size is likely to be small to moderate.

Stability and Control Analysis of the F-15B Quiet SpikeTM Aircraft

NASA Technical Reports Server (NTRS)

McWherter, Shaun C.; Moua, Cheng M.; Gera, Joseph; Cox, Timothy H.

2009-01-01

The primary purpose of the Quiet Spike(TradeMark) flight research program was to analyze the aerodynamic, structural, and mechanical proof-of-concept of a large multi-stage telescoping nose spike installed on the National Aeronautics and Space Administration Dryden Flight Research Center (Edwards, California) F-15B airplane. This report describes the preflight stability and control analysis performed to assess the effect of the spike on the stability, controllability, and handling qualities of the airplane; and to develop an envelope expansion approach to maintain safety of flight. The overall flight test objective was to collect flight data to validate the spike structural dynamics and loads model up to Mach 1.8. Other objectives included validating the mechanical feasibility of a morphing fuselage at operational conditions and determining the near-field shock wave characterization. The two main issues relevant to the stability and control objectives were the effects of the spike-influenced aerodynamics on the F-15B airplane flight dynamics, and the air data and angle-of-attack sensors. The analysis covered the sensitivity of the stability margins, and the handling qualities due to aerodynamic variation and the maneuvering limitations of the F-15B Quiet Spike configuration. The results of the analysis and the implications for the flight test program are also presented.

Stability-Indicating HPTLC Method for Studying Stress Degradation Behavior of Sulbutiamine HCl.

PubMed

Farid, Nehal F; Abdelwahab, Nada S

2016-04-01

Sulbutiamine (SUL) is an ester of thiazides with neurotropic action. A new stability indicating HPTLC method has been developed and validated for the determination of SUL in the presence of different degradation products. The drug was subjected to different stress conditions following ICH strategy such as hydrolytic degradation (neutral, alkaline and acidic hydrolysis), oxidation, photodegradation and dry heat degradation. The drug demonstrated degradation under all decomposition conditions except neutral hydrolysis and dry heat, where the drug was completely degraded with 0.1 N NaOH, 1 N HCl and 30% H2O2 while it was partially degradaed by 0.1 N HCl, 3% H2O2 and UV light. Structure elucidation of the resulting degradation products was performed using ESI-Q-MS-MS. A well-defined peak for SUL was obtained at Rf = 0.46 and was completely separated from all obtained degradation products. Chromatographic separation was carried out on HPTLC aluminum plates precoated with silica gel 60 F254 using acetone-methylene chloride-ammonia buffer (pH 8.5 ± 0.2) (7:3:0.5, v/v) as a developing system. Densitometric scanning of the separated peaks was performed at 254 nm. System suitability testing parameters were calculated to ascertain the quality performance of the developed method. The method was validated with respect to USP guidelines regarding accuracy, precision, specificity, robustness and ruggedness. Good correlation coefficients were achieved in the range of 0.4-5.0 µg/band, and the limit of detection and limit of quantitation were found to be 0.11 and 0.33 µg/band, respectively. The utility of the suggested method was verified by application to Arcalion forte® tablets where no interference from additives was found. © The Author 2016. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Reliability and Validity of the Hip Stability Isometric Test (HipSIT): A New Method to Assess Hip Posterolateral Muscle Strength.

PubMed

Almeida, Gabriel Peixoto Leão; das Neves Rodrigues, Helena Larissa; de Freitas, Bruno Wesley; de Paula Lima, Pedro Olavo

2017-12-01

Study Design Cross-sectional study. Background The Hip Stability Isometric Test (HipSIT) evaluates the strength of the hip posterolateral stabilizers in a position that favors greater activation of the gluteus maximus and gluteus medius and lower activation of the tensor fascia lata. Objectives To check the validity and reliability of the HipSIT and to evaluate the HipSIT in women with patellofemoral pain (PFP). Methods The HipSIT was evaluated with a handheld dynamometer. During testing, the participants were sidelying, with their legs positioned at 45° of hip flexion and 90° of knee flexion. Participants were instructed to raise the knee of the upper leg while keeping the upper and lower heels in contact. To establish reliability and validity, 49 women were tested with the HipSIT by 2 different evaluators on day 1, and then again 7 days later. The strength of the hip extensors, abductors, and external rotators was also evaluated. Twenty women with unilateral PFP were also evaluated. Results The HipSIT has excellent intrarater and interrater reliability. The standard error of measurement was 0.01 kgf/kg, and the minimal detectable change was 0.036 kgf/kg. The HipSIT showed good validity in isolated hip abduction, external rotation, and extension (P<.01). Women with PFP showed a 10% deficit in the HipSIT results for the symptomatic limb (P = .01). Conclusion The HipSIT showed excellent interrater and intrarater reliability, moderate to good validity in women, and was able to identify strength deficits in women with PFP. J Orthop Sports Phys Ther 2017;47(12):906-913. Epub 9 Oct 2017. doi:10.2519/jospt.2017.7274.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Dokhane, A.; Canepa, S.; Ferroukhi, H.

For stability analyses of the Swiss operating Boiling-Water-Reactors (BWRs), the methodology employed and validated so far at the Paul Scherrer Inst. (PSI) was based on the RAMONA-3 code with a hybrid upstream static lattice/core analysis approach using CASMO-4 and PRESTO-2. More recently, steps were undertaken towards a new methodology based on the SIMULATE-3K (S3K) code for the dynamical analyses combined with the CMSYS system relying on the CASMO/SIMULATE-3 suite of codes and which was established at PSI to serve as framework for the development and validation of reference core models of all the Swiss reactors and operated cycles. This papermore » presents a first validation of the new methodology on the basis of a benchmark recently organised by a Swiss utility and including the participation of several international organisations with various codes/methods. Now in parallel, a transition from CASMO-4E (C4E) to CASMO-5M (C5M) as basis for the CMSYS core models was also recently initiated at PSI. Consequently, it was considered adequate to address the impact of this transition both for the steady-state core analyses as well as for the stability calculations and to achieve thereby, an integral approach for the validation of the new S3K methodology. Therefore, a comparative assessment of C4 versus C5M is also presented in this paper with particular emphasis on the void coefficients and their impact on the downstream stability analysis results. (authors)« less

Design and Evaluation of the Psychometric Properties of a Paternal Adaptation Questionnaire.

PubMed

Eskandari, Narges; Simbar, Masoumeh; Vadadhir, AbouAli; Baghestani, Ahmad Reza

2016-07-25

The present study aimed to design and evaluate the psychometric properties of the Paternal Adaptation Questionnaire (PAQ). The study was a mixed (qualitative and quantitative) sequential exploratory study. In the qualitative phase, a preliminary questionnaire with 210 items emerged from in-depth interviews with 17 fathers and 15 key informants. In the quantitative phase, psychometric properties of the PAQ were assessed. Considering cutoff points as 1.5 for item impact, 0.49 for content validity ratio (CVR), and 0.7 for content validity index (CVI), items of the questionnaire were reduced from 210 to 132. Assessment of the content validity of the questionnaire demonstrated S-CVR = 0.68 and S-CVI = 0.92. Exploratory factor analysis resulted in the development of a PAQ with 38 items classified under five factors (ability in performing the roles and responsibilities; perceiving the parental development; stabilization in paternal position; spiritual stability and internal satisfaction; and challenges and concerns), which explained 52.19% of cumulative variance. Measurement of internal consistency reported a Cronbach's α of .89 for PAQ (.61-.86 for subscales), and stability assessment of the PAQ through the test-retest demonstrated Spearman's correlation coefficients and intraclass correlation coefficient of .96 (.81-.97 for subscales). It was identified that the PAQ is a valid and reliable instrument that could be used to assess fatherhood adaptation with the paternal roles and fathers' needs, as well as to design appropriate interventions and to evaluate their effectiveness. © The Author(s) 2016.

Classical workflow nets and workflow nets with reset arcs: using Lyapunov stability for soundness verification

NASA Astrophysics Data System (ADS)

Clempner, Julio B.

2017-01-01

This paper presents a novel analytical method for soundness verification of workflow nets and reset workflow nets, using the well-known stability results of Lyapunov for Petri nets. We also prove that the soundness property is decidable for workflow nets and reset workflow nets. In addition, we provide evidence of several outcomes related with properties such as boundedness, liveness, reversibility and blocking using stability. Our approach is validated theoretically and by a numerical example related to traffic signal-control synchronisation.

Stability analysis of piecewise non-linear systems and its application to chaotic synchronisation with intermittent control

NASA Astrophysics Data System (ADS)

Wang, Qingzhi; Tan, Guanzheng; He, Yong; Wu, Min

2017-10-01

This paper considers a stability analysis issue of piecewise non-linear systems and applies it to intermittent synchronisation of chaotic systems. First, based on piecewise Lyapunov function methods, more general and less conservative stability criteria of piecewise non-linear systems in periodic and aperiodic cases are presented, respectively. Next, intermittent synchronisation conditions of chaotic systems are derived which extend existing results. Finally, Chua's circuit is taken as an example to verify the validity of our methods.

A stabilized MFE reduced-order extrapolation model based on POD for the 2D unsteady conduction-convection problem.

PubMed

Xia, Hong; Luo, Zhendong

2017-01-01

In this study, we devote ourselves to establishing a stabilized mixed finite element (MFE) reduced-order extrapolation (SMFEROE) model holding seldom unknowns for the two-dimensional (2D) unsteady conduction-convection problem via the proper orthogonal decomposition (POD) technique, analyzing the existence and uniqueness and the stability as well as the convergence of the SMFEROE solutions and validating the correctness and dependability of the SMFEROE model by means of numerical simulations.

Psychometrics and Validation of a Brief Rating Measure of Parent-Infant Interaction: Manchester Assessment of Caregiver-Infant Interaction

ERIC Educational Resources Information Center

Wan, Ming Wai; Brooks, Ami; Green, Jonathan; Abel, Kathryn; Elmadih, Alya

2017-01-01

This study investigated the psychometrics of a recently developed global rating measure of videotaped parent-infant interaction, the "Manchester Assessment of Caregiver-Infant Interaction" (MACI), in a normative sample. Inter-rater reliability, stability over time, and convergent and discriminant validity were tested. Six-minute play…

A Note on the Incremental Validity of Aggregate Predictors.

ERIC Educational Resources Information Center

Day, H. D.; Marshall, David

Three computer simulations were conducted to show that very high aggregate predictive validity coefficients can occur when the across-case variability in absolute score stability occurring in both the predictor and criterion matrices is quite small. In light of the increase in internal consistency reliability achieved by the method of aggregation…

The Karakum and Kyzylkum sand seas dynamics; mapping and palaeoclimatic interpretations

NASA Astrophysics Data System (ADS)

Maman, Shimrit; Blumberg, Dan G.; Tsoar, Haim; Porat, Naomi

2015-04-01

Sand seas are large basins in deserts that are mantled by wind-swept sand and that exhibit varying degrees of vegetation cover. Wilson (1973) was the first to globally map and classify sand seas. Beyond Wilson's maps, however, little research has been published regarding the Karakum and Kyzylkum sand seas of Central Asia. Wilson's maps delineate active ergs from inactive ergs based solely on precipitation. His assumption of annual average rainfall as a factor determining mobility vs. stability of sand seas is too simplistic and does not take into consideration other factors such as biogenic soil crusts and wind power, both of which are known to have major effects on the dynamics of sand dunes. Literature related to mapping and classifying the Central Asian ergs by remote sensing or sand sea classification state (stable/active) is lacking. Moreover, the palaeoclimatic significance of dunes in Central Asia is difficult to assess, as there has been few studies of dune stratigraphy and numerical ages are lacking. Optically stimulated luminescence (OSL) is a firm optical dating method that is used to determine the elapsed time since quartz grains were last exposed to sunlight, thus, their burial. Yet, absolute ages indicating mobilization and stabilization of these sands, are still inadequately known and are here under discussion. The broad concern of this research was to determine the dynamics of the Central Asian sand seas and study the palaeoclimatic changes that brought to their stabilization. As there are no reliable maps or aeolian discussion of these sands, establishment of a digital data base was initially conducted, focusing on identifying and mapping these sand seas. The vast area and inaccessibility make traditional mapping methods virtually impossible. A variety of space-borne imagery both optical and radar, with varying spectral and spatial resolutions was used. These images provided the basis for mapping sand distribution, dune forms, and vegetation cover. GIS analysis was performed in parallel with field work to obtain validation and verification. The remote sensing and GIS results show that these ergs are mostly stabilized, with the estimated sand mantled area for the Karakum desert ~260,000 km2, and for the Kyzylkum it is ~195,500 km2. Meteorological analysis of wind and precipitation data indicate a low wind power environment (DP< 200) and sufficient rainfall (>100 mm) to support vegetation. Thus, these sands are indicative of past periods during which the climate in this region was different than today, enabling aeolian sand activity. Optically stimulated luminescence ages derived from the upper meter of the interdune of 14 exposed sections from both ergs, indicate sand stabilization during the mid-Holocene. This stabilization is understood to reflect a transition to a warmer, wetter, and less windy climate that generally persisted until today. The OSL ages, coupled with a compilation of regional palaeoclimatic data, corroborate and reinforce the previously proposed Mid-Holocene Liavliakan phase, known to reflect a warmer, wetter, and less windy climate that persists until today and resulted in dune stabilization around the Mid-Holocene.

Rotordynamic Instability Problems in High-Performance Turbomachinery

NASA Technical Reports Server (NTRS)

1984-01-01

Rotordynamics and predictions on the stability of characteristics of high performance turbomachinery were discussed. Resolutions of problems on experimental validation of the forces that influence rotordynamics were emphasized. The programs to predict or measure forces and force coefficients in high-performance turbomachinery are illustrated. Data to design new machines with enhanced stability characteristics or upgrading existing machines are presented.

Validated and longitudinally stable asthma phenotypes based on cluster analysis of the ADEPT study.

PubMed

Loza, Matthew J; Djukanovic, Ratko; Chung, Kian Fan; Horowitz, Daniel; Ma, Keying; Branigan, Patrick; Barnathan, Elliot S; Susulic, Vedrana S; Silkoff, Philip E; Sterk, Peter J; Baribaud, Frédéric

2016-12-15

Asthma is a disease of varying severity and differing disease mechanisms. To date, studies aimed at stratifying asthma into clinically useful phenotypes have produced a number of phenotypes that have yet to be assessed for stability and to be validated in independent cohorts. The aim of this study was to define and validate, for the first time ever, clinically driven asthma phenotypes using two independent, severe asthma cohorts: ADEPT and U-BIOPRED. Fuzzy partition-around-medoid clustering was performed on pre-specified data from the ADEPT participants (n = 156) and independently on data from a subset of U-BIOPRED asthma participants (n = 82) for whom the same variables were available. Models for cluster classification probabilities were derived and applied to the 12-month longitudinal ADEPT data and to a larger subset of the U-BIOPRED asthma dataset (n = 397). High and low type-2 inflammation phenotypes were defined as high or low Th2 activity, indicated by endobronchial biopsies gene expression changes downstream of IL-4 or IL-13. Four phenotypes were identified in the ADEPT (training) cohort, with distinct clinical and biomarker profiles. Phenotype 1 was "mild, good lung function, early onset", with a low-inflammatory, predominantly Type-2, phenotype. Phenotype 2 had a "moderate, hyper-responsive, eosinophilic" phenotype, with moderate asthma control, mild airflow obstruction and predominant Type-2 inflammation. Phenotype 3 had a "mixed severity, predominantly fixed obstructive, non-eosinophilic and neutrophilic" phenotype, with moderate asthma control and low Type-2 inflammation. Phenotype 4 had a "severe uncontrolled, severe reversible obstruction, mixed granulocytic" phenotype, with moderate Type-2 inflammation. These phenotypes had good longitudinal stability in the ADEPT cohort. They were reproduced and demonstrated high classification probability in two subsets of the U-BIOPRED asthma cohort. Focusing on the biology of the four clinical independently-validated easy-to-assess ADEPT asthma phenotypes will help understanding the unmet need and will aid in developing tailored therapies. NCT01274507 (ADEPT), registered October 28, 2010 and NCT01982162 (U-BIOPRED), registered October 30, 2013.

Stability of tacrolimus injection diluted in 0.9% sodium chloride injection and stored in Excel bags.

PubMed

Myers, Alan L; Zhang, Yanping; Kawedia, Jitesh D; Shank, Brandon R; Deaver, Melissa A; Kramer, Mark A

2016-12-15

The chemical stability and physical compatibility of tacrolimus i.v. infusion solutions prepared in Excel bags and stored at 23 or 4 °C for up to nine days were studied. Tacrolimus admixtures (2, 4, and 8 μg/mL) were prepared in Excel bags using 0.9% sodium chloride injection and stored at 23 °C without protection from light or at 4 °C in the dark. Test samples were withdrawn from triplicate bag solutions immediately after preparation and at predetermined time intervals (1, 3, 5, 7, and 9 days). Chemical stability was assessed by measuring tacrolimus concentrations using a validated stability-indicating high-performance liquid chromatography assay. The physical stability of the admixtures was assessed by visual examination and by measuring turbidity, particle size, and drug content. All test solutions stored at 23 or 4 °C had a no greater than 6% loss of the initial tacrolimus concentration throughout the nine-day study period. All test samples of tacrolimus admixtures, under both storage conditions, were without precipitation and remained clear initially and throughout the nine-day observation period. Changes in turbidities were minor; measured particulates remained few in number in all samples throughout the study. Extemporaneously prepared infusion solutions of tacrolimus 2, 4, and 8 μg/mL in 0.9% sodium chloride injection in Excel bags were chemically and physically stable for at least nine days when stored at room temperature (23 °C) without protection from light and when stored in a refrigerator (4 °C) in the dark. Copyright © 2016 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

Modification of the USLE K factor for soil erodibility assessment on calcareous soils in Iran

NASA Astrophysics Data System (ADS)

Ostovari, Yaser; Ghorbani-Dashtaki, Shoja; Bahrami, Hossein-Ali; Naderi, Mehdi; Dematte, Jose Alexandre M.; Kerry, Ruth

2016-11-01

The measurement of soil erodibility (K) in the field is tedious, time-consuming and expensive; therefore, its prediction through pedotransfer functions (PTFs) could be far less costly and time-consuming. The aim of this study was to develop new PTFs to estimate the K factor using multiple linear regression, Mamdani fuzzy inference systems, and artificial neural networks. For this purpose, K was measured in 40 erosion plots with natural rainfall. Various soil properties including the soil particle size distribution, calcium carbonate equivalent, organic matter, permeability, and wet-aggregate stability were measured. The results showed that the mean measured K was 0.014 t h MJ- 1 mm- 1 and 2.08 times less than the estimated mean K (0.030 t h MJ- 1 mm- 1) using the USLE model. Permeability, wet-aggregate stability, very fine sand, and calcium carbonate were selected as independent variables by forward stepwise regression in order to assess the ability of multiple linear regression, Mamdani fuzzy inference systems and artificial neural networks to predict K. The calcium carbonate equivalent, which is not accounted for in the USLE model, had a significant impact on K in multiple linear regression due to its strong influence on the stability of aggregates and soil permeability. Statistical indices in validation and calibration datasets determined that the artificial neural networks method with the highest R2, lowest RMSE, and lowest ME was the best model for estimating the K factor. A strong correlation (R2 = 0.81, n = 40, p < 0.05) between the estimated K from multiple linear regression and measured K indicates that the use of calcium carbonate equivalent as a predictor variable gives a better estimation of K in areas with calcareous soils.

A bioanalytical HPLC method for coumestrol quantification in skin permeation tests followed by UPLC-QTOF/HDMS stability-indicating method for identification of degradation products.

PubMed

Bianchi, Sara E; Teixeira, Helder F; Kaiser, Samuel; Ortega, George G; Schneider, Paulo Henrique; Bassani, Valquiria L

2016-05-01

Coumestrol is present in several species of the Fabaceae family widely distributed in plants. The estrogenic and antioxidant activities of this molecule show its potential as skin anti-aging agent. These characteristics reveal the interest in developing analytical methodology for permeation studies, as well as to know the stability of coumestrol identifying the major degradation products. Thus, the present study was designed, first, to develop and validate a versatile liquid chromatography (HPLC) method to quantify coumestrol in a hydrogel formulation in different porcine skin layers (stratum corneum, epidermis, and dermis) in permeation tests. In the stability-indicating test coumestrol samples were exposed to stress conditions: temperature, UVC light, oxidative, acid and alkaline media. The degradation products, as well as the constituents extracted from the hydrogel, adhesive tape or skin were not eluted in the retention time of the coumestrol. Hence, the HPLC method showed to be versatile, specific, accurate, precise and robust showing excellent performance for quantifying coumestrol in complex matrices involving skin permeation studies. Coumestrol recovery from porcine ear skin was found to be in the range of 97.07-107.28 μg/mL; the intra-day precision (repeatability) and intermediate precision (inter-day precision), respectively lower than 4.71% and 2.09%. The analysis using ultra-performance liquid chromatography coupled to a quadrupole time-of-flight high definition mass spectrometry detector (UPLC-QTOF/HDMS) suggest the MS fragmentation patterns and the chemical structure of the main degradation products. These results represent new and relevant findings for the development of coumestrol pharmaceutical and cosmetic products. Copyright © 2016 Elsevier B.V. All rights reserved.

Stability-Indicating Liquid Chromatographic Methods with Photodiode Array Detection and Light Scattering Detection for Simultaneous Determination of Candesartan and Hydrochlorothiazide.

PubMed

de Diego, Marta; Godoy, Ricardo; Mennickent, Sigrid; Vergara, Carola; Miranda, Daniel; Navarro, Pía

2018-02-01

Development, validation and comparison of two stability-indicating LC methods, one with photodiode array detector (DAD) and the other with evaporative light scattering detector (ELSD), were performed for simultaneous determination of candesartan cilexetil (CANC) and hydrochlorothiazide (HCTZ), in pharmaceutical samples. A RP-18 column (125 mm × 4 mm, 5 μm) was used for separation of CANC, HCTZ and its major degradation products, using acetonitrile and phosphate buffer (pH 6.0) for DAD method and acetonitrile and water with acetic acid and triethylamine (pH 4.1) for ELSD method, as mobile phase in a gradient mode. The response with ELSD was fitted to a power function and the DAD response by a linear model over a range of 32-160 μg/mL for CANC and 25-125 μg/mL for HCTZ. The precision and accuracy of the methods were similar, with RSD below 3.0% and recovery between 98.1% and 103.9%. The drugs were subjected to stress conditions of hydrolysis, oxidation, photolysis, humidity and temperature. The degradation products were satisfactory separated from the main peaks and from each other. Both drugs mainly degrade by hydrolysis, showing the formation of one degradation product for HCTZ and two for CANC; its identification was conducted by LC/MS/MS. The methods were successfully applied to the analysis of CANC and HCTZ in combined commercial tablets. The performance of DAD and ELSD methods are comparable, therefore both methods are suitable for stability study and determination of CANC and HCTZ in pharmaceutical samples. © The Author 2017. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

A new, rapid, stability-indicating UPLC method for separation and determination of impurities in amlodipine besylate, valsartan and hydrochlorothiazide in their combined tablet dosage form.

PubMed

Vojta, Jiří; Jedlička, Aleš; Coufal, Pavel; Janečková, Lucie

2015-05-10

A new rapid stability-indicating UPLC method for separation and determination of impurities in amlodipine besylate, valsartan and hydrochlorothiazide in their combined tablet dosage form was developed. The separation of Ph. Eur. related substances of amlodipine besylate (A, B, D, E, F, G), hydrochlorothiazide (A, B, C), valsartan (B, C), two other valsartan impurities (S)-2-(N-{[2'-cyanobiphenyl-4-yl]methyl}pentanamido)-3-methylbutanoic acid and (S)-3-methyl-2-{[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methylamino}butanoic acid and several unknown impurities was achieved by reversed phase liquid chromatography with UV detection. The detection wavelengths were set as follows: 225nm for valsartan, its impurities and for the impurity D of amlodipine, 271nm for hydrochlorothiazide and its impurities and 360nm for amlodipine and its impurities except for impurity D. Zorbax Eclipse C8 RRHD (100mm×3.0mm, 1.8μm) was used as a separation column and the analytes were eluted within 11min by a programmed gradient mixture of 0.01M phosphate buffer pH 2.5 and acetonitrile. The method was successfully validated in accordance to the International Conference of Harmonization (ICH) guidelines for amlodipine besylate and its impurity D, valsartan and its impurity C and hydrochlorothiazide and its impurities A, B and C. The triple-combined tablets were exposed to thermal, higher humidity, acid, alkaline, oxidative and photolytic stress conditions. Stressed samples were analyzed by the proposed method. All the significant degradation products and impurities were satisfactory separated from each other and from the principal peaks of drug substances. The peak purity test complied for peaks of amlodipine, valsartan and hydrochlorothiazide in all the stressed samples and indicated no co-elution of degradation products. The method was found to be precise, linear, accurate, sensitive, specific, robust and stability-indicating and could be used as a routine purity test method for amlodipine besylate, valsartan, hydrochlorothiazide and their pharmaceutical combinations. Copyright © 2015 Elsevier B.V. All rights reserved.

DEVELOPMENT AND VALIDATION OF 'SURE': A PATIENT REPORTED OUTCOME MEASURE (PROM) FOR RECOVERY FROM DRUG AND ALCOHOL DEPENDENCE.

PubMed

Neale, Joanne; Vitoratou, Silia; Finch, Emily; Lennon, Paul; Mitcheson, Luke; Panebianco, Daria; Rose, Diana; Strang, John; Wykes, Til; Marsden, John

2016-08-01

Patient Reported Outcome Measures (PROMs) assess health status and health-related quality of life from the patient/service user perspective. Our study aimed to: i. develop a PROM for recovery from drug and alcohol dependence that has good face and content validity, acceptability and usability for people in recovery; ii. evaluate the psychometric properties and factorial structure of the new PROM ('SURE'). Item development included Delphi groups, focus groups, and service user feedback on draft versions of the new measure. A 30-item beta version was completed by 575 service users (461 in person [IP] and 114 online [OL]). Analyses comprised rating scale evaluation, assessment of psychometric properties, factorial structure, and differential item functioning. The beta measure had good face and content validity. Nine items were removed due to low stability, low factor loading, low construct validity or high complexity. The remaining 21 items were re-scaled (Rasch model analyses). Exploratory and confirmatory factor analyses revealed 5 factors: substance use, material resources, outlook on life, self-care, and relationships. The MIMIC model indicated 95% metric invariance across the IP and OL samples, and 100% metric invariance for gender. Internal consistency and test-retest reliability were granted. The 5 factors correlated positively with the corresponding WHOQOL-BREF and ARC subscales and score differences between participant sub-groups confirmed discriminative validity. 'SURE' is a psychometrically valid, quick and easy-to-complete outcome measure, developed with unprecedented input from people in recovery. It can be used alongside, or instead of, existing outcome tools. Copyright © 2016 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

Psychometric properties of the Chinese version of the Life Attitude Schedule (LAS-C) in a sample of Taiwanese adolescents.

PubMed

Chang, Hsiu-Ju; Wu, Chiung-Jane; Chen, Tzen Wen; Cheng, Andrew Tai Ann; Lin, Kuan-Chia; Rong, Jiin-Ru; Lee, Hsin-Chien

2011-05-01

Although prior research has proposed that several risk factors are conceptually and positively related to suicidal behavior, researchers have also suggested that suicide may be multifaceted. The Life Attitude Schedule (LAS) measures a broad range of suicide-related behaviors, including life-enhancing and life-threatening behaviors. This study aimed to translate the LAS into Chinese and evaluate the psychometric properties of the new version (LAS-C). A cross-sectional and descriptive design was used. Data were collected from high schools in the city of Taipei in northern Taiwan. A convenience sample of 1492 high school students was recruited from five high schools in Taipei. We used the Multi-Health Systems (MHS) translation policy to guide the translation process. Reliability was evaluated by internal consistency (represented by Cronbach's α coefficients) and test-retest (represented by intraclass correlation). Validity was demonstrated by content, convergent, divergent, concurrent, and contrast group comparison. Confirmatory factor analysis was further used to examine the theoretical model and to support construct validity. The Cronbach's α coefficient for the whole scale of the LAS-C and its subscales ranged from 0.70 to 0.91. The Intraclass Correlation Coefficient (ICC) ranged from 0.76 to 0.89 on the whole scale and its subscales, and were all statistically significant, at least at the p<0.05 level, indicating good stability over a three-week period. Validity was supported by a Content Validity Index (CVI) of 0.99, convergent, divergent, current, and contrast group comparison validity. Confirmatory factor analysis supported the theoretical model, further providing solid evidence of construct validity. The LAS-C has proper psychometric properties. Future studies must be conducted to shorten the items to form a briefer version. Copyright © 2010 Elsevier Ltd. All rights reserved.

Validation of the Acoustic Voice Quality Index in the Japanese Language.

PubMed

Hosokawa, Kiyohito; Barsties, Ben; Iwahashi, Toshihiko; Iwahashi, Mio; Kato, Chieri; Iwaki, Shinobu; Sasai, Hisanori; Miyauchi, Akira; Matsushiro, Naoki; Inohara, Hidenori; Ogawa, Makoto; Maryn, Youri

2017-03-01

The Acoustic Voice Quality Index (AVQI) is a multivariate construct for quantification of overall voice quality based on the analysis of continuous speech and sustained vowel. The stability and validity of the AVQI is well established in several language families. However, the Japanese language has distinct characteristics with respect to several parameters of articulatory and phonatory physiology. The aim of the study was to confirm the criterion-related concurrent validity of AVQI, as well as its responsiveness to change and diagnostic accuracy for voice assessment in the Japanese-speaking population. This is a retrospective study. A total of 336 voice recordings, which included 69 pairs of voice recordings (before and after therapeutic interventions), were eligible for the study. The auditory-perceptual judgment of overall voice quality was evaluated by five experienced raters. The concurrent validity, responsiveness to change, and diagnostic accuracy of the AVQI were estimated. The concurrent validity and responsiveness to change based on the overall voice quality was indicated by high correlation coefficients 0.828 and 0.767, respectively. Receiver operating characteristic analysis revealed an excellent diagnostic accuracy for discrimination between dysphonic and normophonic voices (area under the curve: 0.905). The best threshold level for the AVQI of 3.15 corresponded with a sensitivity of 72.5% and specificity of 95.2%, with the positive and negative likelihood ratios of 15.1 and 0.29, respectively. We demonstrated the validity of the AVQI as a tool for assessment of overall voice quality and that of voice therapy outcomes in the Japanese-speaking population. Copyright © 2017 The Voice Foundation. Published by Elsevier Inc. All rights reserved.

Validation of the Illness Perception Questionnaire for Schizophrenia in a German-speaking sample of outpatients with chronic schizophrenia.

PubMed

Cavelti, Marialuisa; Contin, Giuliana; Beck, Eva-Marina; Kvrgic, Sara; Kossowsky, Joe; Stieglitz, Rolf-Dieter; Vauth, Roland

2012-01-01

Because the mere definition of insight from the therapist's viewpoint may not be sufficient to identify treatment targets for adherence enhancement, we need assessment strategies which are more sensitive to the patient's perspective. Illness perception (IP), defined as the beliefs a patient holds about his/her health problems, has been shown to affect coping in the context of a physical or mental illness, e.g. compliance behaviour. To assess IP in people diagnosed with schizophrenia, the Illness Perception Questionnaire for Schizophrenia (IPQS) was developed. The aim of the present study was to analyse the psychometric properties of the German version of the IPQS. The study sample consisted of 128 German-speaking outpatients suffering from chronic schizophrenia or schizoaffective disorder. To achieve comparability with the validation of the English scale version, the same constructs were assessed: psychopathology, depression, and beliefs about medication. Furthermore, insight into one's illness was assessed. Internal consistency, test-retest reliability and construct validity including convergent and discriminant validity were analysed. Five of eight IPQS subscales were found to be internally reliable and all subscales demonstrated high stability over time. Correlations with validity measures indicated that the subscales assess dimensions of a construct, which is distinct from psychopathology, depression, beliefs about medication and insight, except for the Identity subscale which substantially overlapped with measures of insight. The German version of the IPQS is an essentially reliable and valid measure of IP for German-speaking people with a schizophrenia spectrum disorder. This may encourage its usage in further studies investigating the impact of subjective beliefs about mental health problems on outcome and recovery in schizophrenia. Copyright © 2012 S. Karger AG, Basel.

Circulating Tumor DNA Analysis in Patients With Cancer: American Society of Clinical Oncology and College of American Pathologists Joint Review.

PubMed

Merker, Jason D; Oxnard, Geoffrey R; Compton, Carolyn; Diehn, Maximilian; Hurley, Patricia; Lazar, Alexander J; Lindeman, Neal; Lockwood, Christina M; Rai, Alex J; Schilsky, Richard L; Tsimberidou, Apostolia M; Vasalos, Patricia; Billman, Brooke L; Oliver, Thomas K; Bruinooge, Suanna S; Hayes, Daniel F; Turner, Nicholas C

2018-06-01

Purpose Clinical use of analytical tests to assess genomic variants in circulating tumor DNA (ctDNA) is increasing. This joint review from ASCO and the College of American Pathologists summarizes current information about clinical ctDNA assays and provides a framework for future research. Methods An Expert Panel conducted a literature review on the use of ctDNA assays for solid tumors, including pre-analytical variables, analytical validity, interpretation and reporting, and clinical validity and utility. Results The literature search identified 1,338 references. Of those, 390, plus 31 references supplied by the Expert Panel, were selected for full-text review. There were 77 articles selected for inclusion. Conclusion The evidence indicates that testing for ctDNA is optimally performed on plasma collected in cell stabilization or EDTA tubes, with EDTA tubes processed within 6 hours of collection. Some ctDNA assays have demonstrated clinical validity and utility with certain types of advanced cancer; however, there is insufficient evidence of clinical validity and utility for the majority of ctDNA assays in advanced cancer. Evidence shows discordance between the results of ctDNA assays and genotyping tumor specimens and supports tumor tissue genotyping to confirm undetected results from ctDNA tests. There is no evidence of clinical utility and little evidence of clinical validity of ctDNA assays in early-stage cancer, treatment monitoring, or residual disease detection. There is no evidence of clinical validity and clinical utility to suggest that ctDNA assays are useful for cancer screening, outside of a clinical trial. Given the rapid pace of research, re-evaluation of the literature will shortly be required, along with the development of tools and guidance for clinical practice.

The Bahasa Melayu version of the Nursing Stress Scale among nurses: a reliability study in Malaysia.

PubMed

Rosnawati, Muhamad Robat; Moe, Htay; Masilamani, Retneswari; Darus, A

2010-10-01

The Nursing Stress Scale (NSS) has been shown to be a valid and reliable instrument to assess occupational stressors among nurses. The NSS, which was previously used in the English version, was translated and back-translated into Bahasa Melayu. This study was conducted to assess the reliability of the Bahasa Melayu version of the NSS among nurses for future studies in this country. The reliability of the NSS was assessed after its readministration to 30 nurses with a 2-week interval. The Spearman coefficient was calculated to assess its stability. The internal consistency was measured through 4 measures: Cronbach's α, Spearman-Brown, Guttman split-half, and standardized item α coefficients. The total response rate was 70%. Test-retest reliability showed remarkable stability (Spearman's ρ exceeded .70). All 4 measures of internal consistency among items indicated a satisfactory level (coefficients in the range of .68 to .87). In conclusion, the Bahasa Melayu version of the NSS is a reliable and useful instrument for measuring the possible stressors at the workplace among nurses.

Surface symmetry energy of nuclear energy density functionals

NASA Astrophysics Data System (ADS)

Nikolov, N.; Schunck, N.; Nazarewicz, W.; Bender, M.; Pei, J.

2011-03-01

We study the bulk deformation properties of the Skyrme nuclear energy density functionals (EDFs). Following simple arguments based on the leptodermous expansion and liquid drop model, we apply the nuclear density functional theory to assess the role of the surface symmetry energy in nuclei. To this end, we validate the commonly used functional parametrizations against the data on excitation energies of superdeformed band heads in Hg and Pb isotopes and fission isomers in actinide nuclei. After subtracting shell effects, the results of our self-consistent calculations are consistent with macroscopic arguments and indicate that experimental data on strongly deformed configurations in neutron-rich nuclei are essential for optimizing future nuclear EDFs. The resulting survey provides a useful benchmark for further theoretical improvements. Unlike in nuclei close to the stability valley, whose macroscopic deformability hangs on the balance of surface and Coulomb terms, the deformability of neutron-rich nuclei strongly depends on the surface symmetry energy; hence, its proper determination is crucial for the stability of deformed phases of the neutron-rich matter and description of fission rates for r-process nucleosynthesis.

Stability of Two Antifungal Agents, Fluconazole and Miconazole, Compounded in HUMCO RECURA Topical Cream to Determine Beyond-Use Date.

PubMed

Gautam, Pradeep; Light, Bob; Purvis, Troy

2017-01-01

A novel compounding vehicle (RECURA) has previously been proven to penetrate the nail bed when compounded with the antifungal agent miconazole or fluconazole, providing for an effective treatment for onychomycosis. In this study, miconazole and fluconazole were compounded separately in RECURA compounding cream, and they were tested at different time points (0, 7, 14, 28, 45, 60, 90, and 180 days) to determine the beyond-use date of those formulations. The beyond-use date testing of both formulations (10% miconazole in RECURA and 10% fluconazole in RECURA) proved them to be physically, chemically, and microbiologically stable under International Conference of Harmonisation controlled room temperature (25°C ± 2°C/60% RH ±5%) for at least 180 days from the date of compounding. Stability-indicating analytical method validation was completed for the simultaneous determination of miconazole and fluconazole in RECURA base using high-performance liquid chromatography coupled with photodiode array detector prior to the study. Copyright© by International Journal of Pharmaceutical Compounding, Inc.

Conformational co-dependence between Plasmodium berghei LCCL proteins promotes complex formation and stability.

PubMed

Saeed, Sadia; Tremp, Annie Z; Dessens, Johannes T

2012-10-01

Malaria parasites express a conserved family of LCCL-lectin adhesive-like domain proteins (LAPs) that have essential functions in sporozoite transmission. In Plasmodium falciparum all six family members are expressed in gametocytes and form a multi-protein complex. Intriguingly, knockout of P. falciparum LCCL proteins adversely affects expression of other family members at protein, but not at mRNA level, a phenomenon termed co-dependent expression. Here, we investigate this in Plasmodium berghei by crossing a PbLAP1 null mutant parasite with a parasite line expressing GFP-tagged PbLAP3 that displays strong fluorescence in gametocytes. Selected and validated double mutants show normal synthesis and subcellular localization of PbLAP3::GFP. However, GFP-based fluorescence is dramatically reduced without PbLAP1 present, indicating that PbLAP1 and PbLAP3 interact. Moreover, absence of PbLAP1 markedly reduces the half-life of PbLAP3, consistent with a scenario of misfolding. These findings unveil a potential mechanism of conformational interdependence that facilitates assembly and stability of the functional LCCL protein complex. Copyright © 2012 Elsevier B.V. All rights reserved.

Transonic aeroelastic analysis of launch vehicle configurations. Ph.D. Thesis

NASA Technical Reports Server (NTRS)

Filgueirasdeazevedo, Joao Luiz

1988-01-01

A numerical study of the aeroelastic stability of typical launch vehicle configurations in transonic flight is performed. Recent computational fluid dynamics techniques are used to simulate the transonic aerodynamic flow fields, as opposed to relying on experimental data for the unsteady aerodynamic pressures. The flow solver is coupled to an appropriate structural representation of the vehicle. The aerodynamic formulation is based on the thin layer approximation to the Reynolds-Averaged Navier-Stokes equations, where the account for turbulent mixing is done by the two-layer Baldwin and Lomax algebraic eddy viscosity model. The structural-dynamic equations are developed considering free-free flexural vibration of an elongated beam with variable properties and are cast in modal form. Aeroelastic analyses are performed by integrating simultaneously in the two sets of equations. By tracing the growth or decay of a perturbed oscillation, the aeroelastic stability of a given constant configuration can be ascertained. The method is described in detail, and results that indicate its application are presented. Applications include some validation cases for the algorithm developed, as well as the study of configurations known to have presented flutter programs in the past.

Development of New Method for Simultaneous Analysis of Piracetam and Levetiracetam in Pharmaceuticals and Biological Fluids: Application in Stability Studies

PubMed Central

Siddiqui, Farhan Ahmed; Sher, Nawab; Shafi, Nighat; Wafa Sial, Alisha; Ahmad, Mansoor; Mehjebeen

2014-01-01

RP-HPLC ultraviolet detection simultaneous quantification of piracetam and levetiracetam has been developed and validated. The chromatography was obtained on a Nucleosil C18 column of 25 cm × 0.46 cm, 10 μm, dimension. The mobile phase was a (70 : 30 v/v) mixture of 0.1 g/L of triethylamine and acetonitrile. Smooth flow of mobile phase at 1 mL/min was set and 205 nm wavelength was selected. Results were evaluated through statistical parameters which qualify the method reproducibility and selectivity for the quantification of piracetam, levetiracetam, and their impurities hence proving stability-indicating properties. The proposed method is significantly important, permitting the separation of the main constituent piracetam from levetiracetam. Linear behavior was observed between 20 ng/mL and 10000 ng/mL for both drugs. The proposed method was checked in bulk drugs, dosage formulations, physiological condition, and clinical investigations and excellent outcome was witnessed. PMID:25114921

Rational design of mutations that change the aggregation rate of a protein while maintaining its native structure and stability

NASA Astrophysics Data System (ADS)

Camilloni, Carlo; Sala, Benedetta Maria; Sormanni, Pietro; Porcari, Riccardo; Corazza, Alessandra; De Rosa, Matteo; Zanini, Stefano; Barbiroli, Alberto; Esposito, Gennaro; Bolognesi, Martino; Bellotti, Vittorio; Vendruscolo, Michele; Ricagno, Stefano

2016-05-01

A wide range of human diseases is associated with mutations that, destabilizing proteins native state, promote their aggregation. However, the mechanisms leading from folded to aggregated states are still incompletely understood. To investigate these mechanisms, we used a combination of NMR spectroscopy and molecular dynamics simulations to compare the native state dynamics of Beta-2 microglobulin (β2m), whose aggregation is associated with dialysis-related amyloidosis, and its aggregation-resistant mutant W60G. Our results indicate that W60G low aggregation propensity can be explained, beyond its higher stability, by an increased average protection of the aggregation-prone residues at its surface. To validate these findings, we designed β2m variants that alter the aggregation-prone exposed surface of wild-type and W60G β2m modifying their aggregation propensity. These results allowed us to pinpoint the role of dynamics in β2m aggregation and to provide a new strategy to tune protein aggregation by modulating the exposure of aggregation-prone residues.

Preparation and stability evaluation of extemporaneous oral suspension of valsartan using commercially available tablets.

PubMed

Zaid, Abdel Naser; Assali, Mohyeddin; Qaddomi, Aiman; Ghanem, Mashhour; Zaaror, Yara Abu

2014-01-01

The aim of this study was to develop an extemporaneous valsartan suspension (80 mg valsartan/5 mL) starting from commercial tablets (80-mg/ tablet). A high-performance liquid chromatographic system was used for the analysis and quantification of valsartan in the samples studied. Samples of valsartan suspension for analysis were prepared as reported by the validated high-performance liquid chromatographic method and the dissolution tests were performed according to the U.S. Food and Drug Administration's method. The high-performance liquid chromatographic assay indicated that the 80-mg/5-mL valsartan suspension was stable for 30 days when stored at long-term and accelerated storage conditions. Valsartan release profile showed that approximately 85% of valsartan dissolved after 10 minutes and, accordingly, the calculation of similarity factor was not necessary. It is possible for the pharmacist to crush valsartan 80-mg tablets and prepare a suspension which has dosage flexibility that can be calculated according to body-surface area, kidney, and liver functions, without affecting the chemical stability of the active ingredient nor its dissolution profile and also have a cost-effective dosage form.

Validation of value of actual micromotion as a direct measure of implant micromobility after healing (secondary implant stability). An in vivo histologic and biomechanical study.

PubMed

Trisi, Paolo; Berardini, Marco; Falco, Antonello; Podaliri Vulpiani, Michele

2016-11-01

The osseointegration process replaces the surgically damaged bone with newly formed bone in contact to the implant surface. This involves some loss of primary stability, which will continue until new bone is formed providing a new stability, known as "secondary stability." A direct measurement of secondary implant stability appears fundamental to determine the period and modalities for implant loading. The aim of this study was to validate the measurement of the implant micromotion to test secondary implant stability. Twenty-four 3.8 × 11.5 mm implants (Dynamix, Cortex, Shlomi, Israel) were inserted in sheep iliac crests. The animals were sacrificed after 2 months, and the freshly retrieved bone blocks were immediately fixed on a customized device to calculate the value of actual micromotion (VAM) according to a previously described technique. Implant stability quotient (ISQ) values, reverse torque value (RTV), %bone-to-implant contact (%BIC), bone volume percentage (%BV) and crestal bone loss (CBL) were also calculated for each implant. Statistical correlations between VAM and the other parameters were calculated. Data correlation analysis between the examined parameters showed that VAM significantly correlates (P < 0.05) to RTV, %BIC, ISQ and CBL. As VAM showed to be statistical correlated to the other parameters of osseointegration, it may be used to clinically check the amount of implant osseointegration, secondary stability and CBL. Future studies are needed to confirm these results moreover. An instrument to measure VAM in the oral cavity still needs to be developed. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

A critical analysis of test-retest reliability in instrument validation studies of cancer patients under palliative care: a systematic review

PubMed Central

2014-01-01

Background Patient-reported outcome validation needs to achieve validity and reliability standards. Among reliability analysis parameters, test-retest reliability is an important psychometric property. Retested patients must be in a clinically stable condition. This is particularly problematic in palliative care (PC) settings because advanced cancer patients are prone to a faster rate of clinical deterioration. The aim of this study was to evaluate the methods by which multi-symptom and health-related qualities of life (HRQoL) based on patient-reported outcomes (PROs) have been validated in oncological PC settings with regards to test-retest reliability. Methods A systematic search of PubMed (1966 to June 2013), EMBASE (1980 to June 2013), PsychInfo (1806 to June 2013), CINAHL (1980 to June 2013), and SCIELO (1998 to June 2013), and specific PRO databases was performed. Studies were included if they described a set of validation studies. Studies were included if they described a set of validation studies for an instrument developed to measure multi-symptom or multidimensional HRQoL in advanced cancer patients under PC. The COSMIN checklist was used to rate the methodological quality of the study designs. Results We identified 89 validation studies from 746 potentially relevant articles. From those 89 articles, 31 measured test-retest reliability and were included in this review. Upon critical analysis of the overall quality of the criteria used to determine the test-retest reliability, 6 (19.4%), 17 (54.8%), and 8 (25.8%) of these articles were rated as good, fair, or poor, respectively, and no article was classified as excellent. Multi-symptom instruments were retested over a shortened interval when compared to the HRQoL instruments (median values 24 hours and 168 hours, respectively; p = 0.001). Validation studies that included objective confirmation of clinical stability in their design yielded better results for the test-retest analysis with regard to both pain and global HRQoL scores (p < 0.05). The quality of the statistical analysis and its description were of great concern. Conclusion Test-retest reliability has been infrequently and poorly evaluated. The confirmation of clinical stability was an important factor in our analysis, and we suggest that special attention be focused on clinical stability when designing a PRO validation study that includes advanced cancer patients under PC. PMID:24447633

Validity and reliability of the Cohen 10-item Perceived Stress Scale in patients with chronic headache: Persian version.

PubMed

Khalili, Robabe; Sirati Nir, Masoud; Ebadi, Abbas; Tavallai, Abbas; Habibi, Mehdi

2017-04-01

The Cohen Perceived Stress Scale is being used widely in various countries. The present study evaluated the validity and reliability of the Cohen 10-item Perceived Stress Scale (PSS-10) in assessing tension headache, migraine, and stress-related diseases in Iran. This study is a methodological and cross-sectional descriptive investigation of 100 patients with chronic headache admitted to the pain clinic of Baqiyatallah Educational and Therapeutic Center. Convenience sampling was used for subject selection. PSS psychometric properties were evaluated in two stages. First, the standard scale was translated. Then, the face validity, content, and construct of the translated version were determined. The average age of participants was 38 years with a standard deviation (SD) of 13.2. As for stress levels, 12% were within the normal range, 36% had an intermediate level, and 52% had a high level of stress. The face validity and scale content were remarkable, and the KMO coefficient was 0.82. Bartlett's test yielded 0.327 which was statistically significant (p<0.0001) representing the quality of the sample. In factor analysis of the scale, the two elements of "coping" and "distress" were determined. A Cronbach's Alpha coefficient of 0.72 was obtained. This confirmed the remarkable internal consistency and stability of the scale through repeated measure tests (0.93). The Persian PSS-10 has good internal consistency and reliability. The availability of a validated Persian PSS-10 would indicate a link between stress and chronic headache. Copyright © 2017 Elsevier B.V. All rights reserved.

Validity and reliability of Arabic MOS social support survey.

PubMed

Dafaalla, Mohamed; Farah, Abdulraheem; Bashir, Sheima; Khalil, Ammar; Abdulhamid, Rabab; Mokhtar, Mousab; Mahadi, Mohamed; Omer, Zulfa; Suliman, Asgad; Elkhalifa, Mohammed; Abdelgadir, Hanin; Kheir, Abdelmoneim E M; Abdalrahman, Ihab

2016-01-01

We aimed to generate a valid reliable Arabic version of MOS social support survey (MOS-SSS). We did a cross sectional study in medical students of Faculty of Medicine in Khartoum, Sudan. We did a clustered random sampling in 500 students of which 487 were suitable for analysis. We followed the standard translation process for translating the MOS-SSS. We accomplished factor analysis to assess construct validity, and generated item-scales correlations to evaluate the convergent and discriminant validity. We extracted the Cronbach's α and Spearman Brown coefficient of spit half method to determine internal consistency. We measured stability by correlation between the scores of the MOS survey taken at two different occasions with ten days apart in 252 participants. All items correlated highly (0.788 or greater) with their hypothesized scales. All items in subscales correlated higher by two standard errors with their own scale than with any other scale. Principle component analysis with varimax rotation was conducted on the 19 items and examination of scree plot graphically suggested 4 predominant factors that account for 72 % of variance. It showed high loadings, ranging from 0.720 to 0.84 for items of emotional support, 0.699-0.845 for tangible support, 0.518-0.823 for affectionate support, and 0.740-0.816 for positive social interaction. Cronbach's alpha for overall MOS scale and subscales indicated high internal consistency. The test-retest correlation showed weak correlation between the test and retest (ranges from 0.04 to 0.104). The Arabic MOS-SSS had high validity and internal consistency.

University student depression inventory (USDI): confirmatory factor analysis and review of psychometric properties.

PubMed

Romaniuk, Madeline; Khawaja, Nigar G

2013-09-25

The 30-item USDI is a self-report measure that assesses depressive symptoms among university students. It consists of three correlated three factors: lethargy, cognitive-emotional and academic motivation. The current research used confirmatory factor analysis to asses construct validity and determine whether the original factor structure would be replicated in a different sample. Psychometric properties were also examined. Participants were 1148 students (mean age 22.84 years, SD=6.85) across all faculties from a large Australian metropolitan university. Students completed a questionnaire comprising of the USDI, the depression anxiety stress scale (DASS) and Life Satisfaction Scale (LSS). The three correlated factor model was shown to be an acceptable fit to the data, indicating sound construct validity. Internal consistency of the scale was also demonstrated to be sound, with high Cronbach alpha values. Temporal stability of the scale was also shown to be strong through test-retest analysis. Finally, concurrent and discriminant validity was examined with correlations between the USDI and DASS subscales as well as the LSS, with sound results further supporting the construct validity of the scale. Cut-off points were also developed to aid total score interpretation. Response rates are unclear. In addition, the representativeness of the sample could be improved potentially through targeted recruitment (i.e. reviewing the online sample statistics during data collection, examining the representativeness trends and addressing particular faculties within the university that were underrepresented). The USDI provides a valid and reliable method of assessing depressive symptoms found among university students. © 2013 Elsevier B.V. All rights reserved.

The development and psychometric assessment of a questionnaire to assess sleep and daily troubles in parents of children and young adults with severe psychomotor impairment.

PubMed

Tietze, Anna L; Zernikow, Boris; Otto, Michael; Hirschfeld, Gerrit; Michel, Erik; Koh, Michelle; Blankenburg, Markus

2014-02-01

Children with severe psychomotor impairment (SPMI) often experience sleep disturbances that severely distress both the child and his or her parents. Validated questionnaires for the assessment of parents' distress related to their child's sleep disturbances are lacking. We developed and validated a new questionnaire, the HOST (holistic assessment of sleep and daily troubles in parents of children with SPMI) to assess the effect of the sleep disturbances in children with SPMI on their parents. The questionnaire was developed based on published data and expert opinion, and it was refined via direct consultation with affected parents. Its psychometric characteristics were assessed in a sample of parents of 214 children with SPMI. It was retested using a random subsample of the participants. Explorative factor analysis revealed that the HOST was composed of four scales. Fit indices, item analysis, and convergent validity (coherence with preexisting instruments of sleep disturbances and health status) were adequate. Retest analysis (n=62) revealed high stability of the HOST questionnaire and adequate replication validity. Sleep-related difficulties significantly impact the sociomedical characteristics of the parents of children with complex neurologic diseases. Typically, parents are severely affected in various aspects of daily life (i.e., medical health, social life, professional life). The HOST proved to be a valid, reliable and economical assessment tool of sleep-related difficulties in parents and relatives of children with SPMI. The HOST is capable of identifying individuals and specific areas requiring intervention. Copyright © 2013 Elsevier B.V. All rights reserved.

Relapse Risk Assessment for Schizophrenia Patients (RASP): A New Self-Report Screening Tool.

PubMed

Velligan, Dawn; Carpenter, William; Waters, Heidi C; Gerlanc, Nicole M; Legacy, Susan N; Ruetsch, Charles

2018-01-01

The Relapse Assessment for Schizophrenia Patients (RASP) was developed as a six-question self-report screener that measures indicators of Increased Anxiety and Social Isolation to assess patient stability and predict imminent relapse. This paper describes the development and psychometric characteristics of the RASP. The RASP and Positive and Negative Syndrome Scale (PANSS) were administered to patients with schizophrenia (n=166) three separate times. Chart data were collected on a subsample of patients (n=81). Psychometric analyses of RASP included tests of reliability, construct validity, and concurrent validity of items. Factors from RASP were correlated with subscales from PANSS (sensitivity to change and criterion validity [agreement between RASP and evidence of relapse]). Test-retest reliability returned modest to strong agreement at the item level and strong agreement at the questionnaire level. RASP showed good item response curves and internal consistency for the total instrument and within each of the two subscales (Increased Anxiety and Social Isolation). RASP Total Score and subscales showed good concurrent validity when correlated with PANSS Total Score, Positive, Excitement, and Anxiety subscales. RASP correctly predicted relapse in 67% of cases, with good specificity and negative predictive power and acceptable positive predictive power and sensitivity. The reliability and validity data presented support the use of RASP in settings where addition of a brief self-report assessment of relapse risk among patients with schizophrenia may be of benefit. Ease of use and scoring, and the ability to administer without clinical supervision allows for routine administration and assessment of relapse risk.

Development and psychometric evaluation of a cardiovascular risk and disease management knowledge assessment tool.

PubMed

Rosneck, James S; Hughes, Joel; Gunstad, John; Josephson, Richard; Noe, Donald A; Waechter, Donna

2014-01-01

This article describes the systematic construction and psychometric analysis of a knowledge assessment instrument for phase II cardiac rehabilitation (CR) patients measuring risk modification disease management knowledge and behavioral outcomes derived from national standards relevant to secondary prevention and management of cardiovascular disease. First, using adult curriculum based on disease-specific learning outcomes and competencies, a systematic test item development process was completed by clinical staff. Second, a panel of educational and clinical experts used an iterative process to identify test content domain and arrive at consensus in selecting items meeting criteria. Third, the resulting 31-question instrument, the Cardiac Knowledge Assessment Tool (CKAT), was piloted in CR patients to ensure use of application. Validity and reliability analyses were performed on 3638 adults before test administrations with additional focused analyses on 1999 individuals completing both pretreatment and posttreatment administrations within 6 months. Evidence of CKAT content validity was substantiated, with 85% agreement among content experts. Evidence of construct validity was demonstrated via factor analysis identifying key underlying factors. Estimates of internal consistency, for example, Cronbach's α = .852 and Spearman-Brown split-half reliability = 0.817 on pretesting, support test reliability. Item analysis, using point biserial correlation, measured relationships between performance on single items and total score (P < .01). Analyses using item difficulty and item discrimination indices further verified item stability and validity of the CKAT. A knowledge instrument specifically designed for an adult CR population was systematically developed and tested in a large representative patient population, satisfying psychometric parameters, including validity and reliability.

Body surface posture evaluation: construction, validation and protocol of the SPGAP system (Posture evaluation rotating platform system).

PubMed

Schwertner, Debora Soccal; Oliveira, Raul; Mazo, Giovana Zarpellon; Gioda, Fabiane Rosa; Kelber, Christian Roberto; Swarowsky, Alessandra

2016-05-04

Several posture evaluation devices have been used to detect deviations of the vertebral column. However it has been observed that the instruments present measurement errors related to the equipment, environment or measurement protocol. This study aimed to build, validate, analyze the reliability and describe a measurement protocol for the use of the Posture Evaluation Rotating Platform System (SPGAP, Brazilian abbreviation). The posture evaluation system comprises a Posture Evaluation Rotating Platform, video camera, calibration support and measurement software. Two pilot studies were carried out with 102 elderly individuals (average age 69 years old, SD = ±7.3) to establish a protocol for SPGAP, controlling the measurement errors related to the environment, equipment and the person under evaluation. Content validation was completed with input from judges with expertise in posture measurement. The variation coefficient method was used to validate the measurement by the instrument of an object with known dimensions. Finally, reliability was established using repeated measurements of the known object. Expert content judges gave the system excellent ratings for content validity (mean 9.4 out of 10; SD 1.13). The measurement of an object with known dimensions indicated excellent validity (all measurement errors <1 %) and test-retest reliability. A total of 26 images were needed to stabilize the system. Participants in the pilot studies indicated that they felt comfortable throughout the assessment. The use of only one image can offer measurements that underestimate or overestimate the reality. To verify the images of objects with known dimensions the values for the width and height were, respectively, CV 0.88 (width) and 2.33 (height), SD 0.22 (width) and 0.35 (height), minimum and maximum values 24.83-25.2 (width) and 14.56 - 15.75 (height). In the analysis of different images (similar) of an individual, greater discrepancies were observed in the values found. The cervical index, for example, presented minimum and maximum values of 15.38 and 37.5, a coefficient of variation of 0.29 and a standard deviation of 6.78. The SPGAP was shown to be a valid and reliable instrument for the quantitative analysis of body posture with applicability and clinical use, since it managed to reduce several measurement errors, amongst which parallax distortion.

Stability-indicating LC assay for butenafine hydrochloride in creams using an experimental design for robustness evaluation and photodegradation kinetics study.

PubMed

Barth, Aline Bergesch; de Oliveira, Gabriela Bolfe; Malesuik, Marcelo Donadel; Paim, Clésio Soldatelli; Volpato, Nadia Maria

2011-08-01

A stability-indicating liquid chromatography method for the determination of the antifungal agent butenafine hydrochloride (BTF) in a cream was developed and validated using the Plackett-Burman experimental design for robustness evaluation. Also, the drug photodegradation kinetics was determined. The analytical column was operated with acetonitrile, methanol and a solution of triethylamine 0.3% adjusted to pH 4.0 (6:3:1) at a flow rate of 1 mL/min and detection at 283 nm. BTF extraction from the cream was done with n-butyl alcohol and methanol in ultrasonic bath. The performed degradation conditions were: acid and basic media with HCl 1M and NaOH 1M, respectively, oxidation with H(2)O(2) 10%, and the exposure to UV-C light. No interference in the BTF elution was verified. Linearity was assessed (r(2) = 0.9999) and ANOVA showed non-significative linearity deviation (p > 0.05). Adequate results were obtained for repeatability, intra-day precision, and accuracy. Critical factors were selected to examine the method robustness with the two-level Plackett-Burman experimental design and no significant factors were detected (p > 0.05). The BTF photodegradation kinetics was determined for the standard and for the cream, both in methanolic solution, under UV light at 254 nm. The degradation process can be described by first-order kinetics in both cases.

Investigation at low speeds of the effect of aspect ratio and sweep on rolling stability derivatives of untapered wings

NASA Technical Reports Server (NTRS)

Goodman, Alex; Fisher, Lewis R.

1949-01-01

A low scale wind tunnel investigation was conducted in rolling flow to determine the effects of aspect ratio and sweep (when varied independently) on the rolling stability derivatives for a series of untapered wings. Test results indicate that when the aspect ratio was held constant, an increase in the sweepback angle caused a significant reduction in the damping in roll at low lift coefficients for only the higher aspect ratios that were tested. This result was in agreement with available swept wing theory which indicated no effect of sweep for aspect ratios near zero. The result of the linear theory that the damping in roll is independent of lift coefficient and that the yawing moment and lateral force due to rolling are directly proportional to the lift coefficient was found to be valid for only a very limited lift coefficient range when the wings were highly swept. For such wings, the damping was found to increase in magnitude and the yawing moment due to rolling, to change from negative to positive at moderate lift coefficients. The effect of wing tip suction, not acounted for by present theory, was found to be very important with regard to the yawing moment due to rolling, particularly for low aspect ratio swept wings. An empirical means of correcting present theory for the effect of tip suction is suggested.

Stress degradation studies and development of stability-indicating TLC-densitometry method for determination of prednisolone acetate and chloramphenicol in their individual and combined pharmaceutical formulations

PubMed Central

2012-01-01

A rapid and reproducible stability indicating TLC method was developed for the determination of prednisolone acetate and chloramphenicol in presence of their degraded products. Uniform degradation conditions were maintained by refluxing sixteen reaction mixtures for two hours at 80°C using parallel synthesizer including acidic, alkaline and neutral hydrolysis, oxidation and wet heating degradation. Oxidation at room temperature, photochemical and dry heating degradation studies were also carried out. Separation was done on TLC glass plates, pre-coated with silica gel 60F-254 using chloroform: methanol (14:1 v/v). Spots at Rf 0.21 ± 0.02 and Rf 0.41 ± 0.03 were recognized as chloramphenicol and prednisolone acetate, respectively. Quantitative analysis was done through densitometric measurements at multiwavelength (243 nm, λmax of prednisolone acetate and 278 nm, λmax of chloramphenicol), simultaneously. The developed method was optimized and validated as per ICH guidelines. Method was found linear over the concentration range of 200-6000 ng/spot with the correlation coefficient (r2 ± S.D.) of 0.9976 ± 3.5 and 0.9920 ± 2.5 for prednisolone acetate and chloramphenicol, respectively. The developed TLC method can be applied for routine analysis of prednisolone acetate and chloramphenicol in presence of their degraded products in their individual and combined pharmaceutical formulations. PMID:22264235

Development and Validation of a Stability-Indicating HPLC Method for Imidapril and Its Degradation Products Using a Design of Experiment (DoE) Approach.

PubMed

Arumugam, Abiramasundari; Joshi, Amita; Vasu, Kamala K

2017-11-01

The present work focused on the application of design of experiment (DoE) principles to the development and optimization of a stability-indicating method (SIM) for the drug imidapril hydrochloride and its degradation products (DPs). The resolution of peaks for the DPs and their drug in a SIM can be influenced by many factors. The factors studied here were pH, gradient time, organic modifier, flow rate, molar concentration of the buffer, and wavelength, with the aid of a Plackett-Burman design. Results from the Plackett-Burman study conspicuously showed influence of two factors, pH and gradient time, on the analyzed response, particularly, the resolution of the closely eluting DPs (DP-5 and DP-6) and the retention time of the last peak. Optimization of the multiresponse processes was achieved through Derringer's desirability function with the assistance of a full factorial design. Separation was achieved using a C18 Phenomenex Luna column (250 × 4.6 mm id, 5 µm particle size) at a flow rate of 0.8 mL/min at 210 nm. The optimized mobile phase composition was ammonium-acetate buffer (pH 5) in pump A and acetonitrile-methanol (in equal ratio) in pump B with a run time of 40 min using a gradient method.

Stability-Indicating Reversed-Phase UHPLC Method Development and Characterization of Degradation Products of Almotriptan Maleate by LC-QTOF-MS/MS.

PubMed

Saibaba, B; Vishnuvardhan, Ch; Johnsi Rani, P; Satheesh Kumar, N

2018-01-01

Almotriptan maleate (ALMT), a highly selective 5-hydroxy tryptamine 1B/1D (5-HT1B/1D) receptor agonist used in the treatment of migraine headache was subjected to various ICH (Q1A (R2)) specified guidelines. The drug underwent significant degradation under hydrolytic (acid, base and neutral), oxidative and photolytic stress conditions, while it was stable under thermal stress condition. A total of seven significant degradation products (DPs) were obtained. A simple, selective and reliable UPLC method has been developed for the separation of ALMT and its DPs using Acquity UPLC HSS Cyano (100 × 2.1 mm, 1.8 μm) column with mobile phase consisting of ammonium acetate (10 mM, pH 4.4) buffer and acetonitrile in gradient elution mode. Chromatographic analysis was performed at a flow rate of 0.3 mL/min using a PDA detector at a wavelength of 230 nm. All the DPs (DP-1 to DP-7) were characterized using UHPLC-ESI-QTOF based on mass fragmentation pattern and accurate m/z values. The developed UPLC method was validated in terms of specificity, linearity, precision and accuracy. The developed stability-indicating method helps in quantification of drug in the presence of DPs. © The Author 2017. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

A Rapid Novel HPLC Method for Estimation of Eight Related Compounds in Azilsartan Kamedoxomil and Identification of Degradation Compounds by Using LC-MS.

PubMed

Sreenivasulu, J; Venkata Ramana, P; Sampath Kumar Reddy, G; Nagaraju, Ch V S; Thirumalai Rajan, S; Eswaraiah, S

2015-10-01

A novel, rapid, specific and stability-indicating reverse-phase high-performance liquid chromatography method was developed for the quantitative determination of related compounds, obtained from two different synthetic routes and degradation products of Azilsartan kamedoxomil (AZL). The method was developed by using a YMC-Pack pro C18 (150 × 4.6 mm, 3 µm) column with a mobile phase containing a gradient mobile phase combination. The eluted compounds were measured at wavelength 220 nm. The developed method run time was 25 min, within which AZL and its eight impurities were well separated with minimum 3.0 resolution. The drug substance was subjected to stress conditions of hydrolysis (acid, base and water), oxidation, photolysis, sunlight, 75% relative humidity and thermal degradation as per International Conference on Harmonization (ICH) prescribed stress conditions to ascertain the stability-indicating power of the method. Significant degradation was observed during acid, base, peroxide, water hydrolysis and 75% relative humidity studies. The mass balance of AZL was close to 100% in all the stress condition. The developed method was validated as per the ICH guidelines with respect to specificity, linearity, limit of detection, limit of quantification, accuracy, precision and robustness. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Selection and Validation of Appropriate Reference Genes for qRT-PCR Analysis in Isatis indigotica Fort.

PubMed Central

Li, Tao; Wang, Jing; Lu, Miao; Zhang, Tianyi; Qu, Xinyun; Wang, Zhezhi

2017-01-01

Due to its sensitivity and specificity, real-time quantitative PCR (qRT-PCR) is a popular technique for investigating gene expression levels in plants. Based on the Minimum Information for Publication of Real-Time Quantitative PCR Experiments (MIQE) guidelines, it is necessary to select and validate putative appropriate reference genes for qRT-PCR normalization. In the current study, three algorithms, geNorm, NormFinder, and BestKeeper, were applied to assess the expression stability of 10 candidate reference genes across five different tissues and three different abiotic stresses in Isatis indigotica Fort. Additionally, the IiYUC6 gene associated with IAA biosynthesis was applied to validate the candidate reference genes. The analysis results of the geNorm, NormFinder, and BestKeeper algorithms indicated certain differences for the different sample sets and different experiment conditions. Considering all of the algorithms, PP2A-4 and TUB4 were recommended as the most stable reference genes for total and different tissue samples, respectively. Moreover, RPL15 and PP2A-4 were considered to be the most suitable reference genes for abiotic stress treatments. The obtained experimental results might contribute to improved accuracy and credibility for the expression levels of target genes by qRT-PCR normalization in I. indigotica. PMID:28702046

Developmental validation of an X-Insertion/Deletion polymorphism panel and application in HAN population of China.

PubMed

Zhang, Suhua; Sun, Kuan; Bian, Yingnan; Zhao, Qi; Wang, Zheng; Ji, Chaoneng; Li, Chengtao

2015-12-14

InDels are short-length polymorphisms characterized by low mutation rates, high inter-population diversity, short amplicon strategy and simplicity of laboratory analysis. This work describes the developmental validation of an X-InDels panel amplifying 18 bi-allelic markers and Amelogenin in one single PCR system. Developmental validation indicated that this novel panel was reproducible, accurate, sensitive and robust for forensic application. Sensitivity testing of the panel was such that a full profile was obtainable even with 125 pg of human DNA with intra-locus balance above 70%. Specificity testing was demonstrated by the lack of cross-reactivity with a variety of commonly encountered animal species and microorganisms. For the stability testing in cases of PCR inhibition, full profiles have been obtained with hematin (≤1000 μM) and humic acid (≤150 ng/μL). For the forensic investigation of the 18 X-InDels in the HAN population of China, no locus deviated from the Hardy-Weinberg equilibrium and linkage disequilibrium. Since they are independent from each other, the CDPfemale was 0.999999726 and CDPmale was 0.999934223. The forensic parameters suggested that this X-Indel panel is polymorphic and informative, which provides valuable X-linked information for deficient relationship cases where autosomal markers are uninformative.

Developmental validation of an X-Insertion/Deletion polymorphism panel and application in HAN population of China

PubMed Central

Zhang, Suhua; Sun, Kuan; Bian, Yingnan; Zhao, Qi; Wang, Zheng; Ji, Chaoneng; Li, Chengtao

2015-01-01

InDels are short-length polymorphisms characterized by low mutation rates, high inter-population diversity, short amplicon strategy and simplicity of laboratory analysis. This work describes the developmental validation of an X-InDels panel amplifying 18 bi-allelic markers and Amelogenin in one single PCR system. Developmental validation indicated that this novel panel was reproducible, accurate, sensitive and robust for forensic application. Sensitivity testing of the panel was such that a full profile was obtainable even with 125 pg of human DNA with intra-locus balance above 70%. Specificity testing was demonstrated by the lack of cross-reactivity with a variety of commonly encountered animal species and microorganisms. For the stability testing in cases of PCR inhibition, full profiles have been obtained with hematin (≤1000 μM) and humic acid (≤150 ng/μL). For the forensic investigation of the 18 X-InDels in the HAN population of China, no locus deviated from the Hardy–Weinberg equilibrium and linkage disequilibrium. Since they are independent from each other, the CDPfemale was 0.999999726 and CDPmale was 0.999934223. The forensic parameters suggested that this X-Indel panel is polymorphic and informative, which provides valuable X-linked information for deficient relationship cases where autosomal markers are uninformative. PMID:26655948

The main concept analysis in cantonese aphasic oral discourse: external validation and monitoring chronic aphasia.

PubMed

Kong, Anthony Pak-Hin

2011-02-01

The 1st aim of this study was to further establish the external validity of the main concept (MC) analysis by examining its relationship with the Cantonese Linguistic Communication Measure (CLCM; Kong, 2006; Kong & Law, 2004)-an established quantitative system for narrative production-and the Cantonese version of the Western Aphasia Battery (CAB; Yiu, 1992). The 2nd purpose of the study was to evaluate how well the MC analysis reflects the stability of discourse production among chronic Cantonese speakers with aphasia. Sixteen participants with aphasia were evaluated on the MC analysis, CAB, and CLCM in the summer of 2008 and were subsequently reassessed in the summer of 2009. They encompassed a range of aphasia severity (with an Aphasia Quotient ranging between 30.2/100 and 94.8/100 at the time of the 1st evaluation). Significant associations were found between the MC measures and the corresponding CLCM indices and CAB performance scores that were relevant to the presence, accuracy, and completeness of content in oral narratives. Moreover, the MC analysis was found to yield comparable scores for chronic speakers on 2 occasions 1 year apart. The present study has further established the external validity of MC analysis in Cantonese. Future investigations involving more speakers with aphasia will allow adequate description of its psychometric properties.

Development and validation of the Self-Stigma Questionnaire (SSQ) for people with schizophrenia and its relation to social functioning.

PubMed

Ochoa, Susana; Martínez-Zambrano, Francisco; Garcia-Franco, Mar; Vilamala, Sonia; Ribas, Maria; Arenas, Oti; Garcia-Morales, Esther; Álvarez, Irene; Escartin, Gemma; Villellas, Raul; Escandell, Maria Jose; Martínez-Raves, Mónica; López-Arias, Elisabeth; Cunyat, Christian; Haro, Josep Maria

2015-10-01

Self-stigma specifically in people with schizophrenia has been little studied. The aims of the present study were to validate a new instrument for the assessment of self-stigma (SSQ) and to assess the relationship between self-stigma and social functioning in people with schizophrenia. A sample of 76 people with schizophrenia was assessed at two moments in time with the SSQ, the PDD (stigma), two scales of social functioning (LSP, SFS), and a scale of general functioning (GAF). The results indicated that SSQ presented good psychometric properties, with Cronbach's alpha ranging between 0.75 and 0.901. The stability of the instrument was between 0.836 and 0.402. Three factors were found in the factor analysis (social discrimination, perceived capabilities, concealment of the disease), explaining 62.66% of the total variance. A relationship was found between self-stigma and social functioning in people with schizophrenia, especially in relation to social contact. In conclusion, the SSQ seems to be a valid and reliable questionnaire for the assessment of self-stigma in people with schizophrenia, and interventions should be designed to cope with self-stigma in order to improve the social functioning of people who suffer schizophrenia. Copyright © 2015 Elsevier Inc. All rights reserved.

Validation of the MCNP6 electron-photon transport algorithm: multiple-scattering of 13- and 20-MeV electrons in thin foils

NASA Astrophysics Data System (ADS)

Dixon, David A.; Hughes, H. Grady

2017-09-01

This paper presents a validation test comparing angular distributions from an electron multiple-scattering experiment with those generated using the MCNP6 Monte Carlo code system. In this experiment, a 13- and 20-MeV electron pencil beam is deflected by thin foils with atomic numbers from 4 to 79. To determine the angular distribution, the fluence is measured down range of the scattering foil at various radii orthogonal to the beam line. The characteristic angle (the angle for which the max of the distribution is reduced by 1/e) is then determined from the angular distribution and compared with experiment. Multiple scattering foils tested herein include beryllium, carbon, aluminum, copper, and gold. For the default electron-photon transport settings, the calculated characteristic angle was statistically distinguishable from measurement and generally broader than the measured distributions. The average relative difference ranged from 5.8% to 12.2% over all of the foils, source energies, and physics settings tested. This validation illuminated a deficiency in the computation of the underlying angular distributions that is well understood. As a result, code enhancements were made to stabilize the angular distributions in the presence of very small substeps. However, the enhancement only marginally improved results indicating that additional algorithmic details should be studied.

The teamwork in assertive community treatment (TACT) scale: development and validation.

PubMed

Wholey, Douglas R; Zhu, Xi; Knoke, David; Shah, Pri; Zellmer-Bruhn, Mary; Witheridge, Thomas F

2012-11-01

Team design is meticulously specified for assertive community treatment (ACT) teams, yet performance can vary across ACT teams, even those with high fidelity. By developing and validating the Teamwork in Assertive Community Treatment (TACT) scale, investigators examined the role of team processes in ACT performance. The TACT scale measuring ACT teamwork was developed from a conceptual model grounded in organizational research and adapted for the ACT and mental health context. TACT subscales were constructed after exploratory and confirmatory factor analyses. The reliability, discriminant validity, predictive validity, temporal stability, internal consistency, and within-team agreement were established with surveys from approximately 300 members of 26 Minnesota ACT teams who completed the questionnaire three times, at six-month intervals. Nine TACT subscales emerged from the analyses: exploration, exploitation of new and existing knowledge, psychological safety, goal agreement, conflict, constructive controversy, information accessibility, encounter preparedness, and consumer-centered care. These nine subscales demonstrated fit and temporal stability (confirmatory factor analysis), high internal consistency (Cronbach's alpha), and within-team agreement and between-team differences (rwg and intraclass correlations). Correlational analyses of the subscales revealed that they measure related yet distinctive aspects of ACT team processes, and regression analyses demonstrated predictive validity (encounter preparedness is related to staff outcomes). The TACT scale demonstrated high reliability and validity and can be included in research and evaluation of teamwork in ACT and mental health teams.

Characteristics of Residual Symptoms in Korean Patients with Major Depressive Disorder: A Validation Study for the Korean Version of Depression Residual Symptom Scale.

PubMed

Park, Sol A; Jeon, Sang Won; Yoon, Ho-Kyoung; Yoon, Seo Young; Shin, Cheolmin; Ko, Young-Hoon

2018-02-01

Residual symptoms of depression are related to more severe and chronic course of functional impairment with higher risk of relapse. The objective of this study was to validate, and determine psychometric properties of the Korean version of Depression Residual Symptom Scale (KDRSS). A total of 203 outpatients with recent episode of major depression based on DSM-IV criteria were enrolled in this study. They had been treated with antidepressants and assessed by KDRSS, Hamilton Depression Rating Scale-24 (HDRS-24), and Montgomery-Åsberg Depression Rating Scale (MARDS). The validity and reliability of KDRSS were assessed, including internal consistency reliability, concurrent validity, temporal stability, factorial validity, and discriminative validity. Internal consistency (Cronbach's alpha=0.961), concurrent validity (MADRS: r=0.731, p<0.01, HDRS-24: r=0.663, p<0.01), and temporal stability (r=0.726, p<0.01) of KDRSS were all excellent. KDRSS showed good discriminative validity based on MARDS. KDRSS consisted of one-factor structure accounting for 63.8% of total variance. All subjects except two in full remission group had one or more residual symptoms. In 7 subscales of KDRSS consisting of similar items respectively, 'lack of energy' was the most commonly reported, followed by 'increased emotionalism' in this group. KDRSS is a useful and sensitive instrument for measuring residual depressive symptoms. Since some depressive symptoms including 'lack of energy' and 'increased emotionalism' in patients with full remission might be persistent during psychiatric intervention, these symptoms need to be focused on in clinical practice.

Gene expression studies of reference genes for quantitative real-time PCR: an overview in insects.

PubMed

Shakeel, Muhammad; Rodriguez, Alicia; Tahir, Urfa Bin; Jin, Fengliang

2018-02-01

Whenever gene expression is being examined, it is essential that a normalization process is carried out to eliminate non-biological variations. The use of reference genes, such as glyceraldehyde-3-phosphate dehydrogenase, actin, and ribosomal protein genes, is the usual method of choice for normalizing gene expression. Although reference genes are used to normalize target gene expression, a major problem is that the stability of these genes differs among tissues, developmental stages, species, and responses to abiotic factors. Therefore, the use and validation of multiple reference genes are required. This review discusses the reasons that why RT-qPCR has become the preferred method for validating results of gene expression profiles, the use of specific and non-specific dyes and the importance of use of primers and probes for qPCR as well as to discuss several statistical algorithms developed to help the validation of potential reference genes. The conflicts arising in the use of classical reference genes in gene normalization and their replacement with novel references are also discussed by citing the high stability and low stability of classical and novel reference genes under various biotic and abiotic experimental conditions by employing various methods applied for the reference genes amplification.

Measuring children's regulation of emotion-expressive behavior.

PubMed

Bar-Haim, Yair; Bar-Av, Gali; Sadeh, Avi

2011-04-01

Emotion regulation has become a pivotal concept in developmental and clinical research. However, the measurement of regulatory processes has proved extremely difficult, particularly in the context of within-subject designs. Here, we describe a formal conceptualization and a new experimental procedure, the Balloons Game, to measure a regulatory component of emotion-expressive behavior. We present the internal consistency and stability of the indices derived from the Balloons Game in a sample of 121 kindergarten children. External validation against measures that have been associated with emotion regulation processes is also provided. The findings suggest that the Balloons Game provides a reliable tool for the study of regulation of emotion expression in young children. PsycINFO Database Record (c) 2011 APA, all rights reserved.

Transonic airfoil analysis and design in nonuniform flow

NASA Technical Reports Server (NTRS)

Chang, J. F.; Lan, C. E.

1986-01-01

A nonuniform transonic airfoil code is developed for applications in analysis, inverse design and direct optimization involving an airfoil immersed in propfan slipstream. Problems concerning the numerical stability, convergence, divergence and solution oscillations are discussed. The code is validated by comparing with some known results in incompressible flow. A parametric investigation indicates that the airfoil lift-drag ratio can be increased by decreasing the thickness ratio. A better performance can be achieved if the airfoil is located below the slipstream center. Airfoil characteristics designed by the inverse method and a direct optimization are compared. The airfoil designed with the method of direct optimization exhibits better characteristics and achieves a gain of 22 percent in lift-drag ratio with a reduction of 4 percent in thickness.

Advanced Structural Optimization Under Consideration of Cost Tracking

NASA Astrophysics Data System (ADS)

Zell, D.; Link, T.; Bickelmaier, S.; Albinger, J.; Weikert, S.; Cremaschi, F.; Wiegand, A.

2014-06-01

In order to improve the design process of launcher configurations in the early development phase, the software Multidisciplinary Optimization (MDO) was developed. The tool combines different efficient software tools such as Optimal Design Investigations (ODIN) for structural optimizations, Aerospace Trajectory Optimization Software (ASTOS) for trajectory and vehicle design optimization for a defined payload and mission.The present paper focuses to the integration and validation of ODIN. ODIN enables the user to optimize typical axis-symmetric structures by means of sizing the stiffening designs concerning strength and stability while minimizing the structural mass. In addition a fully automatic finite element model (FEM) generator module creates ready-to-run FEM models of a complete stage or launcher assembly.Cost tracking respectively future improvements concerning cost optimization are indicated.

Disruption of current filaments and isotropization of magnetic field in counter-streaming plasmas

DOE Office of Scientific and Technical Information (OSTI.GOV)

Fiuza, Frederico

We study the stability of current filaments produced by the Weibel, or current filamentation, instability in weakly magnetized counter-streaming plasmas. It is shown that a resonance exists between the current-carrying ions and a longitudinal drift-kink mode that strongly deforms and eventually breaks the current filaments. Analytical estimates of the wavelength, growth rate and saturation level of the resonant mode are derived and validated by three-dimensional particle-in-cell simulations. Furthermore, self-consistent simulations of counter-streaming plasmas indicate that this drift-kink mode is dominant in the slow down of the flows and in the isotropization of the magnetic field, playing an important role inmore » the formation of collision less shocks.« less

A novel adaptive finite time controller for bilateral teleoperation system

NASA Astrophysics Data System (ADS)

Wang, Ziwei; Chen, Zhang; Liang, Bin; Zhang, Bo

2018-03-01

Most bilateral teleoperation researches focus on the system stability within time-delays. However, practical teleoperation tasks require high performances besides system stability, such as convergence rate and accuracy. This paper investigates bilateral teleoperation controller design with transient performances. To ensure the transient performances and system stability simultaneously, an adaptive non-singular fast terminal mode controller is proposed to achieve practical finite-time stability considering system uncertainties and time delays. In addition, a novel switching scheme is introduced, in which way the singularity problem of conventional terminal sliding manifold is avoided. Finally, numerical simulations demonstrate the effectiveness and validity of the proposed method.

The stability cycle—A universal pathway for the stability of films over topography

NASA Astrophysics Data System (ADS)

Schörner, Mario; Aksel, Nuri

2018-01-01

In the present study on the linear stability of gravity-driven Newtonian films flowing over inclined topographies, we consider a fundamental question: Is there a universal principle, being valid to describe the parametric evolution of the flow's stability chart for variations of different system parameters? For this sake, we first screened all experimental and numerical stability charts available in the literature. In a second step, we performed experiments to fill the gaps which remained. Variations of the fluid's viscosity and the topography's specific shape, amplitude, wavelength, tip width, and inclination were considered. That way, we identified a set of six characteristic patterns of stability charts to be sufficient to describe and unify all results on the linear stability of Newtonian films flowing over undulated inclines. We unveiled a universal pathway—the stability cycle—along which the linear stability charts of all considered Newtonian films flowing down periodically corrugated inclines evolved when the system parameters were changed.

The Reliability, Validity, and Evaluation of the Objective Structured Clinical Examination in Podiatry (Chiropody).

ERIC Educational Resources Information Center

Woodburn, Jim; Sutcliffe, Nick

1996-01-01

The Objective Structured Clinical Examination (OSCE), initially developed for undergraduate medical education, has been adapted for assessment of clinical skills in podiatry students. A 12-month pilot study found the test had relatively low levels of reliability, high construct and criterion validity, and good stability of performance over time.…

Effects of Inspired CO2 and Breathing Resistance on Neurocognitive and Postural Stability in U.S. Navy Divers

DTIC Science & Technology

2015-08-01

Wii Balance Board . Amplitude and sample entropy...of the subtests. Balance testing Alterations in postural stability (i.e., balance ) were assessed using a Nintendo Wii Balance Board (Nintendo...29. P. Scaglioni-Solano, L. F. Aragón-Vargas, "Validity and Reliability of the Nintendo Wii Balance Board to Assess Standing Balance and

Implementation and Validation of Bioplausible Visual Servoing Control

DTIC Science & Technology

2013-03-01

achieve pose stabilization in the context of one -dimensional (1-D) attitude stabilization. These results have been benchmarked against an ideal...scenes representing low (bottom) and high (top) contrast environments used in testing the TurtleBot on the two algorithms...The graph on the left corresponds to the high-contrast simulation environment, and the image on the right corresponds to the low-contrast

The Stability of Self-Reported Anxiety in Youth with Autism versus ADHD or Typical Development

ERIC Educational Resources Information Center

Schiltz, Hillary; McIntyre, Nancy; Swain-Lerro, Lindsay; Zajic, Matthew; Mundy, Peter

2017-01-01

Children with autism spectrum disorder (ASD) are at risk for anxiety symptoms. Few anxiety measures are validated for individuals with ASD, and the nature of ASD raises questions about reliability of self-reported anxiety. This study examined longitudinal stability and change of self-reported anxiety in higher functioning youth with ASD (HFASD)…

The Prosocial and Antisocial Behaviour in Sport Scale: further evidence for construct validity and reliability.

PubMed

Kavussanu, Maria; Stanger, Nicholas; Boardley, Ian D

2013-01-01

The purpose of this research was to provide further evidence for the construct validity (i.e., convergent, concurrent, and discriminant validity) of the Prosocial and Antisocial Behaviour in Sport Scale (PABSS), an instrument that has four subscales measuring prosocial and antisocial behaviour toward teammates and opponents. We also investigated test-retest reliability and stability of the PABSS. We conducted three studies using athletes from a variety of team sports. In Study 1, participants (N = 129) completed the PABSS and measures of physical and verbal aggression, hostility, anger, moral identity, and empathy; a sub-sample (n = 111) also completed the PABSS one week later. In Study 2, in addition to the PABSS, participants (N = 89) completed measures of competitive aggressiveness and anger, moral attitudes, moral disengagement, goal orientation, and anxiety. In Study 3, participants (N = 307) completed the PABSS and a measure of social goals. Across the three studies, the four subscales evidenced the hypothesised relationships with a number of variables. Correlations were large between the two antisocial behaviours and small between the two prosocial behaviours. Overall, the findings supported the convergent, concurrent, and discriminant validity of the scale, provided evidence for its test-retest reliability and stability, and suggest that the instrument is a valid and reliable measure of prosocial and antisocial behaviour in sport.

[Translation and validation of the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) into Portuguese].

PubMed

de Carvalho, Karla Emanuelle Cotias; Gois Júnior, Miburge Bolívar; Sá, Katia Nunes

2014-01-01

To translate and validate the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) into Brazilian Portuguese. Certified translators translated and back-translated Quest. Content validity (CVI) was determined by 5 experts and, after the final version of B-Quest, a pre-test was applied to users of manual wheelchairs, walkers and crutches. The psychometric properties were tested to assure the validity of items and the reliability and stability of the scale. Data were obtained from 121 users of the above-mentioned devices. Our study showed a CVI of 91.66% and a satisfactory factor analysis referent to the two-dimensional structure of the instrument that ensured the representativeness of the items. The Cron-bach's alpha of the items device, service and total score of B-Quest were 0.862, 0.717 and 0.826, respectively. Test-retest stability conducted after a time interval of 2 months was analyzed using Spearman's correlation test, which showed high correlation (ρ >0.6) for most items. The study suggests that the B-Quest is a reliable, representative, and valid instrument to measure the satisfaction of users of assistive technology in Brazil. Copyright © 2014 Elsevier Editora Ltda. All rights reserved.

Validation of a rapid conductimetric test for the measurement of wine tartaric stability.

PubMed

Bosso, Antonella; Motta, Silvia; Petrozziello, Maurizio; Guaita, Massimo; Asproudi, Andriani; Panero, Loretta

2016-12-01

This work was aimed at optimizing a rapid and reproducible conductivity test for the evaluation of wine tartaric stability, in order to improve the practices for the prevention of tartaric precipitations during bottle aging. The test consists in measuring the drop of conductivity in wines kept under stirring for a fixed time, at low temperature, after the addition of micronized potassium bitartrate crystals (KHT). An experimental design was planned to study three factors affecting the test: temperature, duration and dose of added potassium bitartrate. A standard protocol was defined to produce a micronized potassium bitartrate starting from available commercial products, since the dimensions of the crystals can affect the final conductivity values. After the choice of the best conditions the method was validated. Two different stability thresholds were defined for white wines and for red/rosé wines by comparing the results of the mini-contact test with those of the cold test. Copyright © 2016 Elsevier Ltd. All rights reserved.

Letter to the Editor: On "Advantages and disadvantages of stiffness instructions when studying postural control" by C.T. Bonnet: You just can't win: Advantages and disadvantages of the postural stability requirement.

PubMed

Lajoie, Y; Richer, N; Jehu, D A; Polskaia, N; Saunders, D

2016-05-01

In the examination of postural control, instructions to stand as still as possible are common and promote a relatively unnatural sway pattern. The validity of the stability requirement is discussed in the present commentary in response to the discussion initiated by Cedrick T. Bonnet. The advantages of using the stability requirement include: evaluating unbiased postural control, reducing variability in postural sway, manipulating focus of attention, examining the ability to maintain an upright stance, and ecological validity of testing. The disadvantages include: constraining natural postural sway, increasing the complexity of the control condition, promoting an internal focus of attention, and reducing the ability to detect exploratory behaviour. After evaluating the aforementioned advantages and disadvantages, the present commentary suggests that researchers should strive to provide specific instructions to maintain feet, arm and eye position without specifically requiring participants to reduce their postural sway. Copyright © 2015 Elsevier B.V. All rights reserved.

Subjective sleepiness is a sensitive indicator of insufficient sleep and impaired waking function.

PubMed

Akerstedt, Torbjörn; Anund, Anna; Axelsson, John; Kecklund, Göran

2014-06-01

The main consequence of insufficient sleep is sleepiness. While measures of sleep latency, continuous encephalographical/electro-oculographical (EEG/EOG) recording and performance tests are useful indicators of sleepiness in the laboratory and clinic, they are not easily implemented in large, real-life field studies. Subjective ratings of sleepiness, which are easily applied and unobtrusive, are an alternative, but whether they measure sleepiness sensitively, reliably and validly remains uncertain. This review brings together research relevant to these issues. It is focused on the Karolinska Sleepiness Scale (KSS), which is a nine-point Likert-type scale. The diurnal pattern of sleepiness is U-shaped, with high KSS values in the morning and late evening, and with great stability across years. KSS values increase sensitively during acute total and repeated partial sleep deprivation and night work, including night driving. The effect sizes range between 1.5 and 3. The relation to driving performance or EEG/EOG indicators of sleepiness is highly significant, strongly curvilinear and consistent across individuals. High (>6) KSS values are associated particularly with impaired driving performance and sleep intrusions in the EEG. KSS values are also increased in many clinical conditions such as sleep apnea, depression and burnout. The context has a strong influence on KSS ratings. Thus, physical activity, social interaction and light exposure will reduce KSS values by 1-2 units. In contrast, time-on-task in a monotonous context will increase KSS values by 1-2 units. In summary, subjective ratings of sleepiness as described here is as sensitive and valid an indicator of sleepiness as objective measures, and particularly suitable for field studies. © 2014 European Sleep Research Society.