Formulation and process factors influencing product quality and in vitro performance of ophthalmic ointments.

PubMed

Xu, Xiaoming; Al-Ghabeish, Manar; Rahman, Ziyaur; Krishnaiah, Yellela S R; Yerlikaya, Firat; Yang, Yang; Manda, Prashanth; Hunt, Robert L; Khan, Mansoor A

2015-09-30

Owing to its unique anatomical and physiological functions, ocular surface presents special challenges for both design and performance evaluation of the ophthalmic ointment drug products formulated with a variety of bases. The current investigation was carried out to understand and identify the appropriate in vitro methods suitable for quality and performance evaluation of ophthalmic ointment, and to study the effect of formulation and process variables on its critical quality attributes (CQA). The evaluated critical formulation variables include API initial size, drug percentage, and mineral oil percentage while the critical process parameters include mixing rate, temperature, time and cooling rate. The investigated quality and performance attributes include drug assay, content uniformity, API particle size in ointment, rheological characteristics, in vitro drug release and in vitro transcorneal drug permeation. Using design of experiments (DoE) as well as a novel principle component analysis approach, five of the quality and performance attributes (API particle size, storage modulus of ointment, high shear viscosity of ointment, in vitro drug release constant and in vitro transcorneal drug permeation rate constant) were found to be highly influenced by the formulation, in particular the strength of API, and to a lesser degree by processing variables. Correlating the ocular physiology with the physicochemical characteristics of acyclovir ophthalmic ointment suggested that in vitro quality metrics could be a valuable predictor of its in vivo performance. Published by Elsevier B.V.

Scientific and Regulatory Considerations in Solid Oral Modified Release Drug Product Development.

PubMed

Li, Min; Sander, Sanna; Duan, John; Rosencrance, Susan; Miksinski, Sarah Pope; Yu, Lawrence; Seo, Paul; Rege, Bhagwant

2016-11-01

This review presents scientific and regulatory considerations for the development of solid oral modified release (MR) drug products. It includes a rationale for patient-focused development based on Quality-by-Design (QbD) principles. Product and process understanding of MR products includes identification and risk-based evaluation of critical material attributes (CMAs), critical process parameters (CPPs), and their impact on critical quality attributes (CQAs) that affect the clinical performance. The use of various biopharmaceutics tools that link the CQAs to a predictable and reproducible clinical performance for patient benefit is emphasized. Product and process understanding lead to a more comprehensive control strategy that can maintain product quality through the shelf life and the lifecycle of the drug product. The overall goal is to develop MR products that consistently meet the clinical objectives while mitigating the risks to patients by reducing the probability and increasing the detectability of CQA failures.

Fuzzy Logic-based expert system for evaluating cake quality of freeze-dried formulations.

PubMed

Trnka, Hjalte; Wu, Jian X; Van De Weert, Marco; Grohganz, Holger; Rantanen, Jukka

2013-12-01

Freeze-drying of peptide and protein-based pharmaceuticals is an increasingly important field of research. The diverse nature of these compounds, limited understanding of excipient functionality, and difficult-to-analyze quality attributes together with the increasing importance of the biosimilarity concept complicate the development phase of safe and cost-effective drug products. To streamline the development phase and to make high-throughput formulation screening possible, efficient solutions for analyzing critical quality attributes such as cake quality with minimal material consumption are needed. The aim of this study was to develop a fuzzy logic system based on image analysis (IA) for analyzing cake quality. Freeze-dried samples with different visual quality attributes were prepared in well plates. Imaging solutions together with image analytical routines were developed for extracting critical visual features such as the degree of cake collapse, glassiness, and color uniformity. On the basis of the IA outputs, a fuzzy logic system for analysis of these freeze-dried cakes was constructed. After this development phase, the system was tested with a new screening well plate. The developed fuzzy logic-based system was found to give comparable quality scores with visual evaluation, making high-throughput classification of cake quality possible. © 2013 Wiley Periodicals, Inc. and the American Pharmacists Association.

Application of ICH Q9 Quality Risk Management Tools for Advanced Development of Hot Melt Coated Multiparticulate Systems.

PubMed

Stocker, Elena; Becker, Karin; Hate, Siddhi; Hohl, Roland; Schiemenz, Wolfgang; Sacher, Stephan; Zimmer, Andreas; Salar-Behzadi, Sharareh

2017-01-01

This study aimed to apply quality risk management based on the The International Conference on Harmonisation guideline Q9 for the early development stage of hot melt coated multiparticulate systems for oral administration. N-acetylcysteine crystals were coated with a formulation composing tripalmitin and polysorbate 65. The critical quality attributes (CQAs) were initially prioritized using failure mode and effects analysis. The CQAs of the coated material were defined as particle size, taste-masking efficiency, and immediate release profile. The hot melt coated process was characterized via a flowchart, based on the identified potential critical process parameters (CPPs) and their impact on the CQAs. These CPPs were prioritized using a process failure mode, effects, and criticality analysis and their critical impact on the CQAs was experimentally confirmed using a statistical design of experiments. Spray rate, atomization air pressure, and air flow rate were identified as CPPs. Coating amount and content of polysorbate 65 in the coating formulation were identified as critical material attributes. A hazard and critical control points analysis was applied to define control strategies at the critical process points. A fault tree analysis evaluated causes for potential process failures. We successfully demonstrated that a standardized quality risk management approach optimizes the product development sustainability and supports the regulatory aspects. Copyright © 2016 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

HIGH-SHEAR GRANULATION PROCESS: INFLUENCE OF PROCESSING PARAMETERS ON CRITICAL QUALITY ATTRIBUTES OF ACETAMINOPHEN GRANULES AND TABLETS USING DESIGN OF EXPERIMENT APPROACH.

PubMed

Fayed, Mohamed H; Abdel-Rahman, Sayed I; Alanazi, Fars K; Ahmed, Mahrous O; Tawfeek, Hesham M; Al-Shedfat, Ramadan I

2017-01-01

Application of quality by design (QbD) in high shear granulation process is critical and need to recognize the correlation between the granulation process parameters and the properties of intermediate (granules) and corresponding final product (tablets). The present work examined the influence of water amount (X,) and wet massing time (X2) as independent process variables on the critical quality attributes of granules and corresponding tablets using design of experiment (DoE) technique. A two factor, three level (32) full factorial design was performed; each of these variables was investigated at three levels to characterize their strength and interaction. The dried granules have been analyzed for their size distribution, density and flow pattern. Additionally, the produced tablets have been investigated for weight uniformity, crushing strength, friability and percent capping, disintegration time and drug dissolution. Statistically significant impact (p < 0.05) of water amount was identified for granule growth, percent fines and distribution width and flow behavior. Granule density and compressibility were found to be significantly influenced (p < 0.05) by the two operating conditions. Also, water amount has significant effect (p < 0.05) on tablet weight unifornity, friability and percent capping. Moreover, tablet disintegration time and drug dissolution appears to be significantly influenced (p < 0.05) by the two process variables. On the other hand, the relationship of process parameters with critical quality attributes of granule and final product tablet was identified and correlated. Ultimately, a judicious selection of process parameters in high shear granulation process will allow providing product of desirable quality.

Quality by design approach for understanding the critical quality attributes of cyclosporine ophthalmic emulsion.

PubMed

Rahman, Ziyaur; Xu, Xiaoming; Katragadda, Usha; Krishnaiah, Yellela S R; Yu, Lawrence; Khan, Mansoor A

2014-03-03

Restasis is an ophthalmic cyclosporine emulsion used for the treatment of dry eye syndrome. There are no generic products for this product, probably because of the limitations on establishing in vivo bioequivalence methods and lack of alternative in vitro bioequivalence testing methods. The present investigation was carried out to understand and identify the appropriate in vitro methods that can discriminate the effect of formulation and process variables on critical quality attributes (CQA) of cyclosporine microemulsion formulations having the same qualitative (Q1) and quantitative (Q2) composition as that of Restasis. Quality by design (QbD) approach was used to understand the effect of formulation and process variables on critical quality attributes (CQA) of cyclosporine microemulsion. The formulation variables chosen were mixing order method, phase volume ratio, and pH adjustment method, while the process variables were temperature of primary and raw emulsion formation, microfluidizer pressure, and number of pressure cycles. The responses selected were particle size, turbidity, zeta potential, viscosity, osmolality, surface tension, contact angle, pH, and drug diffusion. The selected independent variables showed statistically significant (p < 0.05) effect on droplet size, zeta potential, viscosity, turbidity, and osmolality. However, the surface tension, contact angle, pH, and drug diffusion were not significantly affected by independent variables. In summary, in vitro methods can detect formulation and manufacturing changes and would thus be important for quality control or sameness of cyclosporine ophthalmic products.

Quality by control: Towards model predictive control of mammalian cell culture bioprocesses.

PubMed

Sommeregger, Wolfgang; Sissolak, Bernhard; Kandra, Kulwant; von Stosch, Moritz; Mayer, Martin; Striedner, Gerald

2017-07-01

The industrial production of complex biopharmaceuticals using recombinant mammalian cell lines is still mainly built on a quality by testing approach, which is represented by fixed process conditions and extensive testing of the end-product. In 2004 the FDA launched the process analytical technology initiative, aiming to guide the industry towards advanced process monitoring and better understanding of how critical process parameters affect the critical quality attributes. Implementation of process analytical technology into the bio-production process enables moving from the quality by testing to a more flexible quality by design approach. The application of advanced sensor systems in combination with mathematical modelling techniques offers enhanced process understanding, allows on-line prediction of critical quality attributes and subsequently real-time product quality control. In this review opportunities and unsolved issues on the road to a successful quality by design and dynamic control implementation are discussed. A major focus is directed on the preconditions for the application of model predictive control for mammalian cell culture bioprocesses. Design of experiments providing information about the process dynamics upon parameter change, dynamic process models, on-line process state predictions and powerful software environments seem to be a prerequisite for quality by control realization. © 2017 The Authors. Biotechnology Journal published by WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Development of nanostructured lipid carriers containing salicyclic acid for dermal use based on the Quality by Design method.

PubMed

Kovács, A; Berkó, Sz; Csányi, E; Csóka, I

2017-03-01

The aim of our present work was to evaluate the applicability of the Quality by Design (QbD) methodology in the development and optimalization of nanostructured lipid carriers containing salicyclic acid (NLC SA). Within the Quality by Design methology, special emphasis is layed on the adaptation of the initial risk assessment step in order to properly identify the critical material attributes and critical process parameters in formulation development. NLC SA products were formulated by the ultrasonication method using Compritol 888 ATO as solid lipid, Miglyol 812 as liquid lipid and Cremophor RH 60® as surfactant. LeanQbD Software and StatSoft. Inc. Statistica for Windows 11 were employed to indentify the risks. Three highly critical quality attributes (CQAs) for NLC SA were identified, namely particle size, particle size distribution and aggregation. Five attributes of medium influence were identified, including dissolution rate, dissolution efficiency, pH, lipid solubility of the active pharmaceutical ingredient (API) and entrapment efficiency. Three critical material attributes (CMA) and critical process parameters (CPP) were identified: surfactant concentration, solid lipid/liquid lipid ratio and ultrasonication time. The CMAs and CPPs are considered as independent variables and the CQAs are defined as dependent variables. The 2 3 factorial design was used to evaluate the role of the independent and dependent variables. Based on our experiments, an optimal formulation can be obtained when the surfactant concentration is set to 5%, the solid lipid/liquid lipid ratio is 7:3 and ultrasonication time is 20min. The optimal NLC SA showed narrow size distribution (0.857±0.014) with a mean particle size of 114±2.64nm. The NLC SA product showed a significantly higher in vitro drug release compared to the micro-particle reference preparation containing salicylic acid (MP SA). Copyright © 2016 Elsevier B.V. All rights reserved.

Implementation of quality by design principles in the development of microsponges as drug delivery carriers: Identification and optimization of critical factors using multivariate statistical analyses and design of experiments studies.

PubMed

Simonoska Crcarevska, Maja; Dimitrovska, Aneta; Sibinovska, Nadica; Mladenovska, Kristina; Slavevska Raicki, Renata; Glavas Dodov, Marija

2015-07-15

Microsponges drug delivery system (MDDC) was prepared by double emulsion-solvent-diffusion technique using rotor-stator homogenization. Quality by design (QbD) concept was implemented for the development of MDDC with potential to be incorporated into semisolid dosage form (gel). Quality target product profile (QTPP) and critical quality attributes (CQA) were defined and identified, accordingly. Critical material attributes (CMA) and Critical process parameters (CPP) were identified using quality risk management (QRM) tool, failure mode, effects and criticality analysis (FMECA). CMA and CPP were identified based on results obtained from principal component analysis (PCA-X&Y) and partial least squares (PLS) statistical analysis along with literature data, product and process knowledge and understanding. FMECA identified amount of ethylcellulose, chitosan, acetone, dichloromethane, span 80, tween 80 and water ratio in primary/multiple emulsions as CMA and rotation speed and stirrer type used for organic solvent removal as CPP. The relationship between identified CPP and particle size as CQA was described in the design space using design of experiments - one-factor response surface method. Obtained results from statistically designed experiments enabled establishment of mathematical models and equations that were used for detailed characterization of influence of identified CPP upon MDDC particle size and particle size distribution and their subsequent optimization. Copyright © 2015 Elsevier B.V. All rights reserved.

Analytical Quality by Design in pharmaceutical quality assurance: Development of a capillary electrophoresis method for the analysis of zolmitriptan and its impurities.

PubMed

Orlandini, Serena; Pasquini, Benedetta; Caprini, Claudia; Del Bubba, Massimo; Pinzauti, Sergio; Furlanetto, Sandra

2015-11-01

A fast and selective CE method for the determination of zolmitriptan (ZOL) and its five potential impurities has been developed applying the analytical Quality by Design principles. Voltage, temperature, buffer concentration, and pH were investigated as critical process parameters that can influence the critical quality attributes, represented by critical resolution values between peak pairs, analysis time, and peak efficiency of ZOL-dimer. A symmetric screening matrix was employed for investigating the knowledge space, and a Box-Behnken design was used to evaluate the main, interaction, and quadratic effects of the critical process parameters on the critical quality attributes. Contour plots were drawn highlighting important interactions between buffer concentration and pH, and the gained information was merged into the sweet spot plots. Design space (DS) was established by the combined use of response surface methodology and Monte Carlo simulations, introducing a probability concept and thus allowing the quality of the analytical performances to be assured in a defined domain. The working conditions (with the interval defining the DS) were as follows: BGE, 138 mM (115-150 mM) phosphate buffer pH 2.74 (2.54-2.94); temperature, 25°C (24-25°C); voltage, 30 kV. A control strategy was planned based on method robustness and system suitability criteria. The main advantages of applying the Quality by Design concept consisted of a great increase of knowledge of the analytical system, obtained throughout multivariate techniques, and of the achievement of analytical assurance of quality, derived by probability-based definition of DS. The developed method was finally validated and applied to the analysis of ZOL tablets. © 2015 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Implementation of "Quality by Design (QbD)" Approach for the Development of 5-Fluorouracil Loaded Thermosensitive Hydrogel.

PubMed

Dalwadi, Chintan; Patel, Gayatri

2016-01-01

The purpose of this study was to investigate Quality by Design (QbD) principle for the preparation of hydrogel products to prove both practicability and utility of executing QbD concept to hydrogel based controlled release systems. Product and process understanding will help in decreasing the variability of critical material and process parameters, which give quality product output and reduce the risk. This study includes the identification of the Quality Target Product Profiles (QTPPs) and Critical Quality Attributes (CQAs) from literature or preliminary studies. To identify and control the variability in process and material attributes, two tools of QbD was utilized, Quality Risk Management (QRM) and Experimental Design. Further, it helps to identify the effect of these attributes on CQAs. Potential risk factors were identified from fishbone diagram and screened by risk assessment and optimized by 3-level 2- factor experimental design with center points in triplicate, to analyze the precision of the target process. This optimized formulation was further characterized by gelling time, gelling temperature, rheological parameters, in-vitro biodegradation and in-vitro drug release. Design space was created using experimental design tool that gives the control space and working within this controlled space reduces all the failure modes below the risk level. In conclusion, QbD approach with QRM tool provides potent and effectual pyramid to enhance the quality into the hydrogel.

[Rapid assessment of critical quality attributes of Chinese materia medica (II): strategy of NIR assignment].

PubMed

Pei, Yan-Ling; Wu, Zhi-Sheng; Shi, Xin-Yuan; Zhou, Lu-Wei; Qiao, Yan-Jiang

2014-09-01

The present paper firstly reviewed the research progress and main methods of NIR spectral assignment coupled with our research results. Principal component analysis was focused on characteristic signal extraction to reflect spectral differences. Partial least squares method was concerned with variable selection to discover characteristic absorption band. Two-dimensional correlation spectroscopy was mainly adopted for spectral assignment. Autocorrelation peaks were obtained from spectral changes, which were disturbed by external factors, such as concentration, temperature and pressure. Density functional theory was used to calculate energy from substance structure to establish the relationship between molecular energy and spectra change. Based on the above reviewed method, taking a NIR spectral assignment of chlorogenic acid as example, a reliable spectral assignment for critical quality attributes of Chinese materia medica (CMM) was established using deuterium technology and spectral variable selection. The result demonstrated the assignment consistency according to spectral features of different concentrations of chlorogenic acid and variable selection region of online NIR model in extract process. Although spectral assignment was initial using an active pharmaceutical ingredient, it is meaningful to look forward to the futurity of the complex components in CMM. Therefore, it provided methodology for NIR spectral assignment of critical quality attributes in CMM.

A Scale-up Approach for Film Coating Process Based on Surface Roughness as the Critical Quality Attribute.

PubMed

Yoshino, Hiroyuki; Hara, Yuko; Dohi, Masafumi; Yamashita, Kazunari; Hakomori, Tadashi; Kimura, Shin-Ichiro; Iwao, Yasunori; Itai, Shigeru

2018-04-01

Scale-up approaches for film coating process have been established for each type of film coating equipment from thermodynamic and mechanical analyses for several decades. The objective of the present study was to establish a versatile scale-up approach for film coating process applicable to commercial production that is based on critical quality attribute (CQA) using the Quality by Design (QbD) approach and is independent of the equipment used. Experiments on a pilot scale using the Design of Experiment (DoE) approach were performed to find a suitable CQA from surface roughness, contact angle, color difference, and coating film properties by terahertz spectroscopy. Surface roughness was determined to be a suitable CQA from a quantitative appearance evaluation. When surface roughness was fixed as the CQA, the water content of the film-coated tablets was determined to be the critical material attribute (CMA), a parameter that does not depend on scale or equipment. Finally, to verify the scale-up approach determined from the pilot scale, experiments on a commercial scale were performed. The good correlation between the surface roughness (CQA) and the water content (CMA) identified at the pilot scale was also retained at the commercial scale, indicating that our proposed method should be useful as a scale-up approach for film coating process.

Quality by Design approach for studying the impact of formulation and process variables on product quality of oral disintegrating films.

PubMed

Mazumder, Sonal; Pavurala, Naresh; Manda, Prashanth; Xu, Xiaoming; Cruz, Celia N; Krishnaiah, Yellela S R

2017-07-15

The present investigation was carried out to understand the impact of formulation and process variables on the quality of oral disintegrating films (ODF) using Quality by Design (QbD) approach. Lamotrigine (LMT) was used as a model drug. Formulation variable was plasticizer to film former ratio and process variables were drying temperature, air flow rate in the drying chamber, drying time and wet coat thickness of the film. A Definitive Screening Design of Experiments (DoE) was used to identify and classify the critical formulation and process variables impacting critical quality attributes (CQA). A total of 14 laboratory-scale DoE formulations were prepared and evaluated for mechanical properties (%elongation at break, yield stress, Young's modulus, folding endurance) and other CQA (dry thickness, disintegration time, dissolution rate, moisture content, moisture uptake, drug assay and drug content uniformity). The main factors affecting mechanical properties were plasticizer to film former ratio and drying temperature. Dissolution rate was found to be sensitive to air flow rate during drying and plasticizer to film former ratio. Data were analyzed for elucidating interactions between different variables, rank ordering the critical materials attributes (CMA) and critical process parameters (CPP), and for providing a predictive model for the process. Results suggested that plasticizer to film former ratio and process controls on drying are critical to manufacture LMT ODF with the desired CQA. Published by Elsevier B.V.

Critical Thinking among Post-Graduate Diploma in Education Students in Higher Education: Reality or Fuss?

ERIC Educational Resources Information Center

Moeti, Bakadzi; Mgawi, Rabson Killion; Moalosi, Waitshega Tefo Smitta

2017-01-01

Critical thinking is recognised as an influential attribute to achieve quality learning and teaching in higher education institutions world over. This interpretive research study explored the critical thinking among PGDE students at the University of Botswana. The aim of the study was to identify factors contributing to the application of critical…

Process analytical technologies (PAT) in freeze-drying of parenteral products.

PubMed

Patel, Sajal Manubhai; Pikal, Michael

2009-01-01

Quality by Design (QbD), aims at assuring quality by proper design and control, utilizing appropriate Process Analytical Technologies (PAT) to monitor critical process parameters during processing to ensure that the product meets the desired quality attributes. This review provides a comprehensive list of process monitoring devices that can be used to monitor critical process parameters and will focus on a critical review of the viability of the PAT schemes proposed. R&D needs in PAT for freeze-drying have also been addressed with particular emphasis on batch techniques that can be used on all the dryers independent of the dryer scale.

Optimization and development of stable w/o/w cosmetic multiple emulsions by means of the Quality by Design approach.

PubMed

Kovács, A; Erős, I; Csóka, I

2016-04-01

The aim of our present work was to develop stable water-in-oil-in-water (w/o/w) cosmetic multiple emulsions that are proper for cosmetic use and can also be applied on the skin as pharmaceutical vehicles by means of Quality by Design (QbD) concept. This product design concept consists of a risk assessment step and also the 'predetermination' of the critical material attributes and process parameters of a stable multiple emulsion system. We have set up the hypothesis that the stability of multiple emulsions can be improved by the development based on such systematic planning - making a map of critical product parameters - so their industrial usage can be increased. The risk assessment and the determination of critical physical-chemical stability parameters of w/o/w multiple emulsions to define critical control points were performed by means of quality tools and the leanqbd(™) (QbD Works LLC, Fremont, CA, U.S.A.) software. Critical materials and process parameters: Based on the results of preformulation experiments, three factors, namely entrapped active agent, preparation methodology and shear rate, were found to be highly critical factors for critical quality attributes (CQAs) and for stability, whereas the nature of oil was found a medium level risk factor. The results of the risk assessment are the following: (i) droplet structure and size distribution should be evaluated together to be able to predict the stability issues, (ii) the presence of entrapped active agents had a great impact on droplet structure, (iii) the viscosity curves represent the structural changes during storage, if the decrease in relative viscosity is >15% the emulsion disintegrates, and (iv) it is enough to use the shear rate between 34g and 116g relative centrifugal force (RCF). CQAs: By risk assessment, we discovered that four factors should be considered to be high-risk variables as compared to others: droplet size, droplet structure, viscosity and multiple character were found to be highly critical attributes. The preformulation experiment is the part of a development plan. On the basis of these results, the control strategy can be defined and a stable multiple emulsion can be ensured that meets the relevant stakeholders' quality expectations. © 2015 Society of Cosmetic Scientists and the Société Française de Cosmétologie.

A quality by design approach using artificial intelligence techniques to control the critical quality attributes of ramipril tablets manufactured by wet granulation.

PubMed

Aksu, Buket; Paradkar, Anant; de Matas, Marcel; Özer, Özgen; Güneri, Tamer; York, Peter

2013-02-01

Quality by design (QbD) is an essential part of the modern approach to pharmaceutical quality. This study was conducted in the framework of a QbD project involving ramipril tablets. Preliminary work included identification of the critical quality attributes (CQAs) and critical process parameters (CPPs) based on the quality target product profiles (QTPPs) using the historical data and risk assessment method failure mode and effect analysis (FMEA). Compendial and in-house specifications were selected as QTPPs for ramipril tablets. CPPs that affected the product and process were used to establish an experimental design. The results thus obtained can be used to facilitate definition of the design space using tools such as design of experiments (DoE), the response surface method (RSM) and artificial neural networks (ANNs). The project was aimed at discovering hidden knowledge associated with the manufacture of ramipril tablets using a range of artificial intelligence-based software, with the intention of establishing a multi-dimensional design space that ensures consistent product quality. At the end of the study, a design space was developed based on the study data and specifications, and a new formulation was optimized. On the basis of this formulation, a new laboratory batch formulation was prepared and tested. It was confirmed that the explored formulation was within the design space.

The Top Ten Websites in Critical Care Medicine Education Today.

PubMed

Wolbrink, Traci A; Rubin, Lucy; Burns, Jeffrey P; Markovitz, Barry

2018-01-01

The number of websites for the critical care provider is rapidly growing, including websites that are part of the Free Open Access Med(ical ed)ucation (FOAM) movement. With this rapidly expanding number of websites, critical appraisal is needed to identify quality websites. The last major review of critical care websites was published in 2011, and thus a new review of the websites relevant to the critical care clinician is necessary. A new assessment tool for evaluating critical care medicine education websites, the Critical Care Medical Education Website Quality Evaluation Tool (CCMEWQET), was modified from existing tools. A PubMed and Startpage search from 2007 to 2017 was conducted to identify websites relevant to critical care medicine education. These websites were scored based on the CCMEWQET. Ninety-seven websites relevant for critical care medicine education were identified and scored, and the top ten websites were described in detail. Common types of resources available on these websites included blog posts, podcasts, videos, online journal clubs, and interactive components such as quizzes. Almost one quarter of websites (n = 22) classified themselves as FOAM websites. The top ten websites most often included an editorial process, high-quality and appropriately attributed graphics and multimedia, scored much higher for comprehensiveness and ease of access, and included opportunities for interactive learning. Many excellent online resources for critical care medicine education currently exist, and the number is likely to continue to increase. Opportunities for improvement in many websites include more active engagement of learners, upgrading navigation abilities, incorporating an editorial process, and providing appropriate attribution for graphics and media.

A quality by design approach to investigate the effect of mannitol and dicalcium phosphate qualities on roll compaction.

PubMed

Souihi, Nabil; Dumarey, Melanie; Wikström, Håkan; Tajarobi, Pirjo; Fransson, Magnus; Svensson, Olof; Josefson, Mats; Trygg, Johan

2013-04-15

Roll compaction is a continuous process for solid dosage form manufacturing increasingly popular within pharmaceutical industry. Although roll compaction has become an established technique for dry granulation, the influence of material properties is still not fully understood. In this study, a quality by design (QbD) approach was utilized, not only to understand the influence of different qualities of mannitol and dicalcium phosphate (DCP), but also to predict critical quality attributes of the drug product based solely on the material properties of that filler. By describing each filler quality in terms of several representative physical properties, orthogonal projections to latent structures (OPLS) was used to understand and predict how those properties affected drug product intermediates as well as critical quality attributes of the final drug product. These models were then validated by predicting product attributes for filler qualities not used in the model construction. The results of this study confirmed that the tensile strength reduction, known to affect plastic materials when roll compacted, is not prominent when using brittle materials. Some qualities of these fillers actually demonstrated improved compactability following roll compaction. While direct compression qualities are frequently used for roll compacted drug products because of their excellent flowability and good compaction properties, this study revealed that granules from these qualities were more poor flowing than the corresponding powder blends, which was not seen for granules from traditional qualities. The QbD approach used in this study could be extended beyond fillers. Thus any new compound/ingredient would first be characterized and then suitable formulation characteristics could be determined in silico, without running any additional experiments. Copyright © 2013 Elsevier B.V. All rights reserved.

Controlling coarse woody debris inventory quality: taper and relative size methods

Treesearch

C.W. Woodall; J.A. Westfall

2008-01-01

Accurately measuring the dimensions of coarse woody debris (CWD) is critical for ensuring the quality of CWD estimates and, hence, for accurately estimating forest ecosystem attributes (e.g., CWD carbon stocks). To improve the quality of CWD dimensional measurements, the distribution of taper (ratio of change in diameter and length) and relative size (RS; ratio of...

Microwave sensing of moisture in flowing biomass pellets

USDA-ARS?s Scientific Manuscript database

Production of pelleted biomass is a significant emerging industry in the United States. A primary quality attribute of pelleted biomass is moisture content. This parameter is critical in pricing, binding, combustion, and storage of pelleted biomass. In order to produce pellets of a high quality mois...

Impact of potassium nutrition on postharvest fruit quality: Melon (Cucumis melo L.) case study

USDA-ARS?s Scientific Manuscript database

Among the many plant minerals, potassium (K) stands out as a cation having the strongest influence on quality attributes which determines fruit marketability, consumer preference, and the concentration of critically important human-health associated phytonutrients. However, many plant, soil, and en...

If You Don't Know, Ask! Using Expert Knowledge to Determine What Content Is Needed in an Undergraduate Food Quality Management and Control Course

ERIC Educational Resources Information Center

Joyner, Helen S.; Stevenson, Clinton D.

2017-01-01

Quality management and quality control of food products are critical to producing food that is safe to consume and has consistent quality and sensory attributes. The extent to which undergraduate students are equipped with competencies in quality management/control, in theory, has a direct connection with their career potential to ensure food…

Rational Selection, Criticality Assessment, and Tiering of Quality Attributes and Test Methods for Analytical Similarity Evaluation of Biosimilars.

PubMed

Vandekerckhove, Kristof; Seidl, Andreas; Gutka, Hiten; Kumar, Manish; Gratzl, Gyöngyi; Keire, David; Coffey, Todd; Kuehne, Henriette

2018-05-10

Leading regulatory agencies recommend biosimilar assessment to proceed in a stepwise fashion, starting with a detailed analytical comparison of the structural and functional properties of the proposed biosimilar and reference product. The degree of analytical similarity determines the degree of residual uncertainty that must be addressed through downstream in vivo studies. Substantive evidence of similarity from comprehensive analytical testing may justify a targeted clinical development plan, and thus enable a shorter path to licensing. The importance of a careful design of the analytical similarity study program therefore should not be underestimated. Designing a state-of-the-art analytical similarity study meeting current regulatory requirements in regions such as the USA and EU requires a methodical approach, consisting of specific steps that far precede the work on the actual analytical study protocol. This white paper discusses scientific and methodological considerations on the process of attribute and test method selection, criticality assessment, and subsequent assignment of analytical measures to US FDA's three tiers of analytical similarity assessment. Case examples of selection of critical quality attributes and analytical methods for similarity exercises are provided to illustrate the practical implementation of the principles discussed.

Quality by design case study 1: Design of 5-fluorouracil loaded lipid nanoparticles by the W/O/W double emulsion - Solvent evaporation method.

PubMed

Amasya, Gulin; Badilli, Ulya; Aksu, Buket; Tarimci, Nilufer

2016-03-10

With Quality by Design (QbD), a systematic approach involving design and development of all production processes to achieve the final product with a predetermined quality, you work within a design space that determines the critical formulation and process parameters. Verification of the quality of the final product is no longer necessary. In the current study, the QbD approach was used in the preparation of lipid nanoparticle formulations to improve skin penetration of 5-Fluorouracil, a widely-used compound for treating non-melanoma skin cancer. 5-Fluorouracil-loaded lipid nanoparticles were prepared by the W/O/W double emulsion - solvent evaporation method. Artificial neural network software was used to evaluate the data obtained from the lipid nanoparticle formulations, to establish the design space, and to optimize the formulations. Two different artificial neural network models were developed. The limit values of the design space of the inputs and outputs obtained by both models were found to be within the knowledge space. The optimal formulations recommended by the models were prepared and the critical quality attributes belonging to those formulations were assigned. The experimental results remained within the design space limit values. Consequently, optimal formulations with the critical quality attributes determined to achieve the Quality Target Product Profile were successfully obtained within the design space by following the QbD steps. Copyright © 2016 Elsevier B.V. All rights reserved.

Critical to quality in telemedicine service management: application of DFSS (Design for Six Sigma) and SERVQUAL).

PubMed

Yun, Eun Kyoung; Chun, Kee Moon

2008-01-01

Telemedicine generally refers to the use of communications and information technologies for the delivery of health care. owever, telemedicine is not merely a simple combination of health care and technology. The researchers propose a systematic approach for assessing needs of telemedicine customers, called critical-to-quality (CTQ) in Six Sigma, with a purpose of continuous quality improvement. The combination approach using DFSS (Design for Six Sigma) and SERVQUAL (Service Quality Framework) was applied to define the critical quality attributes of telemedicine service management and to match them with the current telemedicine process. With a step-by-step procedure, telemedicine service process was reviewed and all the important CTQ candidates identified via a case study. The findings suggest that nurses need further understanding and research methods that will improve and manage the quality of health care service in various medical fields.

The identification and measurement of quality dimensions in health care: focus group interview results.

PubMed

Jun, M; Peterson, R T; Zsidisin, G A

1998-01-01

The identification and measurement of service quality are critical factors that are responsible for customer satisfaction. This article identifies 11 attributes that define quality of care and patient satisfaction and reveals various gaps among the patient, physician, and administrator groups in the perceived importance of those dimensions. Managerial implications for patient-focused health care are discussed.

Assessment Methodology for Process Validation Lifecycle Stage 3A.

PubMed

Sayeed-Desta, Naheed; Pazhayattil, Ajay Babu; Collins, Jordan; Chen, Shu; Ingram, Marzena; Spes, Jana

2017-07-01

The paper introduces evaluation methodologies and associated statistical approaches for process validation lifecycle Stage 3A. The assessment tools proposed can be applied to newly developed and launched small molecule as well as bio-pharma products, where substantial process and product knowledge has been gathered. The following elements may be included in Stage 3A: number of 3A batch determination; evaluation of critical material attributes, critical process parameters, critical quality attributes; in vivo in vitro correlation; estimation of inherent process variability (IPV) and PaCS index; process capability and quality dashboard (PCQd); and enhanced control strategy. US FDA guidance on Process Validation: General Principles and Practices, January 2011 encourages applying previous credible experience with suitably similar products and processes. A complete Stage 3A evaluation is a valuable resource for product development and future risk mitigation of similar products and processes. Elements of 3A assessment were developed to address industry and regulatory guidance requirements. The conclusions made provide sufficient information to make a scientific and risk-based decision on product robustness.

Quality By Design: Concept To Applications.

PubMed

Swain, Suryakanta; Padhy, Rabinarayan; Jena, Bikash Ranjan; Babu, Sitty Manohar

2018-03-08

Quality by Design is associated to the modern, systematic, scientific and novel approach which is concerned with pre-distinct objectives that not only focus on product, process understanding but also leads to process control. It predominantly signifies the design and product improvement and the manufacturing process in order to fulfill the predefined manufactured goods or final products quality characteristics. It is quite essential to identify desire and required product performance report such as Target Product Profile, typical Quality Target Product Profile (QTPP) and Critical Quality attributes (CQA). This review highlighted about the concepts of QbD design space, for critical material attributes (CMAs) as well as the critical process parameters that can totally affect the CQAs within which the process shall be unaffected and consistently manufacture the required product. Risk assessment tools and design of experiments are its prime components. This paper outlines the basic knowledge of QbD, the key elements; steps as well as various tools for QbD implementation in pharmaceutics field are presented briefly. In addition to this, quite a lot of applications of QbD in numerous pharmaceutical related unit operations are discussed and summarized. This article provides a complete data as well as the road map for universal implementation and application of QbD for pharmaceutical products. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Critical care nurses' decision making: sedation assessment and management in intensive care.

PubMed

Aitken, Leanne M; Marshall, Andrea P; Elliott, Rosalind; McKinley, Sharon

2009-01-01

This study was designed to examine the decision making processes that nurses use when assessing and managing sedation for a critically ill patient, specifically the attributes and concepts used to determine sedation needs and the influence of a sedation guideline on the decision making processes. Sedation management forms an integral component of the care of critical care patients. Despite this, there is little understanding of how nurses make decisions regarding assessment and management of intensive care patients' sedation requirements. Appropriate nursing assessment and management of sedation therapy is essential to quality patient care. Observational study. Nurses providing sedation management for a critically ill patient were observed and asked to think aloud during two separate occasions for two hours of care. Follow-up interviews were conducted to collect data from five expert critical care nurses pre- and postimplementation of a sedation guideline. Data from all sources were integrated, with data analysis identifying the type and number of attributes and concepts used to form decisions. Attributes and concepts most frequently used related to sedation and sedatives, anxiety and agitation, pain and comfort and neurological status. On average each participant raised 48 attributes related to sedation assessment and management in the preintervention phase and 57 attributes postintervention. These attributes related to assessment (pre, 58%; post, 65%), physiology (pre, 10%; post, 9%) and treatment (pre, 31%; post, 26%) aspects of care. Decision making in this setting is highly complex, incorporating a wide range of attributes that concentrate primarily on assessment aspects of care. Clinical guidelines should provide support for strategies known to positively influence practice. Further, the education of nurses to use such guidelines optimally must take into account the highly complex iterative process and wide range of data sources used to make decisions.

Robustness testing in pharmaceutical freeze-drying: inter-relation of process conditions and product quality attributes studied for a vaccine formulation.

PubMed

Schneid, Stefan C; Stärtzel, Peter M; Lettner, Patrick; Gieseler, Henning

2011-01-01

The recent US Food and Drug Administration (FDA) legislation has introduced the evaluation of the Design Space of critical process parameters in manufacturing processes. In freeze-drying, a "formulation" is expected to be robust when minor deviations of the product temperature do not negatively affect the final product quality attributes. To evaluate "formulation" robustness by investigating the effect of elevated product temperature on product quality using a bacterial vaccine solution. The vaccine solution was characterized by freeze-dry microscopy to determine the critical formulation temperature. A conservative cycle was developed using the SMART™ mode of a Lyostar II freeze dryer. Product temperature was elevated to imitate intermediate and aggressive cycle conditions. The final product was analyzed using X-ray powder diffraction (XRPD), scanning electron microscopy (SEM), Karl Fischer, and modulated differential scanning calorimetry (MDSC), and the life cell count (LCC) during accelerated stability testing. The cakes processed at intermediate and aggressive conditions displayed larger pores with microcollapse of walls and stronger loss in LCC than the conservatively processed product, especially during stability testing. For all process conditions, a loss of the majority of cells was observed during storage. For freeze-drying of life bacterial vaccine solutions, the product temperature profile during primary drying appeared to be inter-related to product quality attributes.

Evaluation of the structural, physicochemical, and biological characteristics of SB4, a biosimilar of etanercept

PubMed Central

Cho, Ick Hyun; Lee, Nayoung; Song, Dami; Jung, Seong Young; Bou-Assaf, George; Sosic, Zoran; Zhang, Wei; Lyubarskaya, Yelena

2016-01-01

ABSTRACT A biosimilar is a biological medicinal product that is comparable to a reference medicinal product in terms of quality, safety, and efficacy. SB4 was developed as a biosimilar to Enbrel® (etanercept) and was approved as Benepali®, the first biosimilar of etanercept licensed in the European Union (EU). The quality assessment of SB4 was performed in accordance with the ICH comparability guideline and the biosimilar guidelines of the European Medicines Agency and Food and Drug Administration. Extensive structural, physicochemical, and biological testing was performed with state-of-the-art technologies during a side-by-side comparison of the products. Similarity of critical quality attributes (CQAs) was evaluated on the basis of tolerance intervals established from quality data obtained from more than 60 lots of EU-sourced and US-sourced etanercept. Additional quality assessment was focused on a detailed investigation of immunogenicity-related quality attributes, including hydrophobic variants, high-molecular-weight (HMW) species, N-glycolylneuraminic acid (NGNA), and α-1,3-galactose. This comprehensive characterization study demonstrated that SB4 is highly similar to the reference product, Enbrel®, in structural, physicochemical, and biological quality attributes. In addition, the levels of potential immunogenicity-related quality attributes of SB4 such as hydrophobic variants, HMW aggregates, and α-1,3-galactose were less than those of the reference product. PMID:27246928

Evaluation of design parameters for TRISO-coated fuel particles to establish manufacturing critical limits using PARFUME

DOE PAGES

Skerjanc, William F.; Maki, John T.; Collin, Blaise P.; ...

2015-12-02

The success of modular high temperature gas-cooled reactors is highly dependent on the performance of the tristructural-isotopic (TRISO) coated fuel particle and the quality to which it can be manufactured. During irradiation, TRISO-coated fuel particles act as a pressure vessel to contain fission gas and mitigate the diffusion of fission products to the coolant boundary. The fuel specifications place limits on key attributes to minimize fuel particle failure under irradiation and postulated accident conditions. PARFUME (an integrated mechanistic coated particle fuel performance code developed at the Idaho National Laboratory) was used to calculate fuel particle failure probabilities. By systematically varyingmore » key TRISO-coated particle attributes, failure probability functions were developed to understand how each attribute contributes to fuel particle failure. Critical manufacturing limits were calculated for the key attributes of a low enriched TRISO-coated nuclear fuel particle with a kernel diameter of 425 μm. As a result, these critical manufacturing limits identify ranges beyond where an increase in fuel particle failure probability is expected to occur.« less

Quality by design for herbal drugs: a feedforward control strategy and an approach to define the acceptable ranges of critical quality attributes.

PubMed

Yan, Binjun; Li, Yao; Guo, Zhengtai; Qu, Haibin

2014-01-01

The concept of quality by design (QbD) has been widely accepted and applied in the pharmaceutical manufacturing industry. There are still two key issues to be addressed in the implementation of QbD for herbal drugs. The first issue is the quality variation of herbal raw materials and the second issue is the difficulty in defining the acceptable ranges of critical quality attributes (CQAs). To propose a feedforward control strategy and a method for defining the acceptable ranges of CQAs for the two issues. In the case study of the ethanol precipitation process of Danshen (Radix Salvia miltiorrhiza) injection, regression models linking input material attributes and process parameters to CQAs were built first and an optimisation model for calculating the best process parameters according to the input materials was established. Then, the feasible material space was defined and the acceptable ranges of CQAs for the previous process were determined. In the case study, satisfactory regression models were built with cross-validated regression coefficients (Q(2) ) all above 91 %. The feedforward control strategy was applied successfully to compensate the quality variation of the input materials, which was able to control the CQAs in the 90-110 % ranges of the desired values. In addition, the feasible material space for the ethanol precipitation process was built successfully, which showed the acceptable ranges of the CQAs for the concentration process. The proposed methodology can help to promote the implementation of QbD for herbal drugs. Copyright © 2013 John Wiley & Sons, Ltd.

A top-down technique to improve the solubility and bioavailability of aceclofenac: in vitro and in vivo studies.

PubMed

Narayan, Reema; Pednekar, Abhyuday; Bhuyan, Dipshikha; Gowda, Chaitra; Koteshwara, K B; Nayak, Usha Yogendra

2017-01-01

The aim of the present work was to tackle the solubility issue of a biopharmaceutics classification system (BCS)-II drug, aceclofenac. Although a number of attempts to increase the aqueous solubility have been made, none of the methods were taken up for scale-up. Hence size reduction technique by a top-down approach using wet milling process was utilized to improve the solubility and, consequently, the dissolution velocity of aceclofenac. The quality of the final product was ensured by Quality by Design approach wherein the effects of critical material attributes and critical process parameters were assessed on the critical quality attributes (CQAs) of nanocrystals. Box-Behnken design was applied to evaluate these effects on critical quality attributes. The optimized nanocrystals had a particle size of 484.7±54.12 nm with a polydispersity index (PDI) of 0.108±0.009. The solid state characterization of the formulation revealed that the crystalline nature of the drug was slightly reduced after the milling process. With the reduced particle size, the solubility of the nanocrystals was found to increase in both water and 0.1 N HCl when compared with that of unmilled pure aceclofenac. These results were further supported by in vitro release studies of nanocrystals where an appreciable dissolution velocity with 100.07%±2.38% release was observed for aceclofenac nanocrystals compared with 47.66%±4.53% release for pure unmilled aceclofenac at the end of 2 h. The in vivo pharmacokinetic data generated showed a statistically significant increase in the C max for aceclofenac nanocrystals of 3.75±0.28 µg/mL (for pure unmilled aceclofenac C max was 1.96±0.17 µg/mL). The results obtained indicated that the developed nanocrystals of aceclofenac were successful in improving the solubility, thus the absorption and bioavailability of the drug. Hence, it may be a viable and cost-effective alternative to the current therapy.

QbD-Enabled Development of Novel Stimuli-Responsive Gastroretentive Systems of Acyclovir for Improved Patient Compliance and Biopharmaceutical Performance.

PubMed

Singh, Bhupinder; Kaur, Anterpreet; Dhiman, Shashi; Garg, Babita; Khurana, Rajneet Kaur; Beg, Sarwar

2016-04-01

The current studies entail systematic quality by design (QbD)-based development of stimuli-responsive gastroretentive drug delivery systems (GRDDS) of acyclovir using polysaccharide blends for attaining controlled drug release profile and improved patient compliance. The patient-centric quality target product profile was defined and critical quality attributes (CQAs) earmarked. Risk assessment studies, carried out through Ishikawa fish bone diagram and failure mode, effect, and criticality analysis, helped in identifying the plausible risks or failure modes affecting the quality attributes of the drug product. A face-centered cubic design was employed for systematic development and optimization of the concentration of sodium alginate (X 1) and gellan (X 2) as the critical material attributes (CMAs) in the stimuli-responsive formulations, which were evaluated for CQAs viz. viscosity, gel strength, onset of floatation, and drug release characteristics. Mathematical modeling was carried out for generation of design space, and optimum formulation was embarked upon, exhibiting formulation characteristics marked by excellent floatation and bioadhesion characteristics along with promising drug release control up to 24 h. Drug-excipient compatibility studies through FTIR and DSC revealed absence of any interaction(s) among the formulation excipients. In vivo pharmacokinetic studies in Wistar rats corroborated extension in the drug absorption profile from the optimized stimuli-responsive GR formulations vis-à-vis the marketed suspension (ZOVIRAX®). Establishment of in vitro/in vivo correlation (IVIVC) revealed a high degree of correlation between the in vitro and in vivo data. In a nutshell, the present investigations report the successful development of stimuli-responsive GRDDS of acyclovir, which can be applicable as a platform approach for other drugs too.

Sound quality (SQ) of concert halls: Physical and subjective attributes

NASA Astrophysics Data System (ADS)

Beranek, Leo L.

2003-10-01

Each new concert hall has the following stated goal: ``Acoustics equal to the best in the world.'' The owner can specify the number of seats, areas of public spaces, lighting intensities, etc. But, the attributes of acoustical quality cannot as yet be specified. Most acoustical consultants seem to feel that a ``seat of the pants'' experience is the only possible specification. But the architect's goal is a monument to himself and he believes the acoustical consultant should achieve the ``best in the world'' goal without visible means. Numbers for specifications are needed. In this paper 40 years of pertinent research are described: What are the critical physical attributes of good acoustics, how do we measure them, and how can they be translated into architectural specifications? Four steps have been involved: (1) interviews of conductors and music critics to determine (a) their acoustical rank orderings of a large number of halls and (b) which acoustical characteristics do they believe are important, viz., reverberance, strength of sound, etc.; (2) a determination of which physical measures correlate with their beliefs plus others that are physiologically important; (3) measurements of those physical quantities in the rank-ordered halls; and (5) the correlation of the measured values with the subjective quality ratings.

Quality of medicines commonly used in the treatment of soil transmitted helminths and giardia in ethiopia: a nationwide survey.

PubMed

Suleman, Sultan; Zeleke, Gemechu; Deti, Habtewold; Mekonnen, Zeleke; Duchateau, Luc; Levecke, Bruno; Vercruysse, Jozef; D'Hondt, Matthias; Wynendaele, Evelien; De Spiegeleer, Bart

2014-12-01

The presence of poor quality medicines in the market is a global threat on public health, especially in developing countries. Therefore, we assessed the quality of two commonly used anthelminthic drugs [mebendazole (MEB) and albendazole (ALB)] and one antiprotozoal drug [tinidazole (TNZ)] in Ethiopia. A multilevel stratified random sampling, with as strata the different levels of supply chain system in Ethiopia, geographic areas and government/privately owned medicines outlets, was used to collect the drug samples using mystery shoppers. The three drugs (106 samples) were collected from 38 drug outlets (government/privately owned) in 7 major cities in Ethiopia between January and March 2012. All samples underwent visual and physical inspection for labeling and packaging before physico-chemical quality testing and evaluated based on individual monographs in Pharmacopoeias for identification, assay/content, dosage uniformity, dissolution, disintegration and friability. In addition, quality risk was analyzed using failure mode effect analysis (FMEA) and a risk priority number (RPN) was assigned to each quality attribute. A clinically rationalized desirability function was applied in quantification of the overall quality of each medicine. Overall, 45.3% (48/106) of the tested samples were substandard, i.e. not meeting the pharmacopoeial quality specifications claimed by their manufacturers. Assay was the quality attribute most often out-of-specification, with 29.2% (31/106) failure of the total samples. The highest failure was observed for MEB (19/42, 45.2%), followed by TNZ (10/39, 25.6%) and ALB (2/25, 8.0%). The risk analysis showed that assay (RPN = 512) is the most critical quality attribute, followed by dissolution (RPN = 336). Based on Derringer's desirability function, samples were classified into excellent (14/106,13%), good (24/106, 23%), acceptable (38/106, 36%%), low (29/106, 27%) and bad (1/106,1%) quality. This study evidenced that there is a relatively high prevalence of poor quality MEB, ALB and TNZ in Ethiopia: up to 45% if pharmacopoeial acceptance criteria are used in the traditional, dichotomous approach, and 28% if the new risk-based desirability approach was applied. The study identified assay as the most critical quality attributes. The country of origin was the most significant factor determining poor quality status of the investigated medicines in Ethiopia.

Quality of Medicines Commonly Used in the Treatment of Soil Transmitted Helminths and Giardia in Ethiopia: A Nationwide Survey

PubMed Central

Suleman, Sultan; Zeleke, Gemechu; Deti, Habtewold; Mekonnen, Zeleke; Duchateau, Luc; Levecke, Bruno; Vercruysse, Jozef; D'Hondt, Matthias; Wynendaele, Evelien; De Spiegeleer, Bart

2014-01-01

Background The presence of poor quality medicines in the market is a global threat on public health, especially in developing countries. Therefore, we assessed the quality of two commonly used anthelminthic drugs [mebendazole (MEB) and albendazole (ALB)] and one antiprotozoal drug [tinidazole (TNZ)] in Ethiopia. Methods/Principal Findings A multilevel stratified random sampling, with as strata the different levels of supply chain system in Ethiopia, geographic areas and government/privately owned medicines outlets, was used to collect the drug samples using mystery shoppers. The three drugs (106 samples) were collected from 38 drug outlets (government/privately owned) in 7 major cities in Ethiopia between January and March 2012. All samples underwent visual and physical inspection for labeling and packaging before physico-chemical quality testing and evaluated based on individual monographs in Pharmacopoeias for identification, assay/content, dosage uniformity, dissolution, disintegration and friability. In addition, quality risk was analyzed using failure mode effect analysis (FMEA) and a risk priority number (RPN) was assigned to each quality attribute. A clinically rationalized desirability function was applied in quantification of the overall quality of each medicine. Overall, 45.3% (48/106) of the tested samples were substandard, i.e. not meeting the pharmacopoeial quality specifications claimed by their manufacturers. Assay was the quality attribute most often out-of-specification, with 29.2% (31/106) failure of the total samples. The highest failure was observed for MEB (19/42, 45.2%), followed by TNZ (10/39, 25.6%) and ALB (2/25, 8.0%). The risk analysis showed that assay (RPN = 512) is the most critical quality attribute, followed by dissolution (RPN = 336). Based on Derringer's desirability function, samples were classified into excellent (14/106,13%), good (24/106, 23%), acceptable (38/106, 36%%), low (29/106, 27%) and bad (1/106,1%) quality. Conclusions/Significance This study evidenced that there is a relatively high prevalence of poor quality MEB, ALB and TNZ in Ethiopia: up to 45% if pharmacopoeial acceptance criteria are used in the traditional, dichotomous approach, and 28% if the new risk-based desirability approach was applied. The study identified assay as the most critical quality attributes. The country of origin was the most significant factor determining poor quality status of the investigated medicines in Ethiopia. PMID:25473966

Alignment issues, correlation techniques and their assessment for a visible light imaging-based 3D printer quality control system

NASA Astrophysics Data System (ADS)

Straub, Jeremy

2016-05-01

Quality control is critical to manufacturing. Frequently, techniques are used to define object conformity bounds, based on historical quality data. This paper considers techniques for bespoke and small batch jobs that are not statistical model based. These techniques also serve jobs where 100% validation is needed due to the mission or safety critical nature of particular parts. One issue with this type of system is alignment discrepancies between the generated model and the physical part. This paper discusses and evaluates techniques for characterizing and correcting alignment issues between the projected and perceived data sets to prevent errors attributable to misalignment.

Pharmaceutical quality by design: product and process development, understanding, and control.

PubMed

Yu, Lawrence X

2008-04-01

The purpose of this paper is to discuss the pharmaceutical Quality by Design (QbD) and describe how it can be used to ensure pharmaceutical quality. The QbD was described and some of its elements identified. Process parameters and quality attributes were identified for each unit operation during manufacture of solid oral dosage forms. The use of QbD was contrasted with the evaluation of product quality by testing alone. The QbD is a systemic approach to pharmaceutical development. It means designing and developing formulations and manufacturing processes to ensure predefined product quality. Some of the QbD elements include: Defining target product quality profile; Designing product and manufacturing processes; Identifying critical quality attributes, process parameters, and sources of variability; Controlling manufacturing processes to produce consistent quality over time. Using QbD, pharmaceutical quality is assured by understanding and controlling formulation and manufacturing variables. Product testing confirms the product quality. Implementation of QbD will enable transformation of the chemistry, manufacturing, and controls (CMC) review of abbreviated new drug applications (ANDAs) into a science-based pharmaceutical quality assessment.

A Quadrupole Dalton-based multi-attribute method for product characterization, process development, and quality control of therapeutic proteins.

PubMed

Xu, Weichen; Jimenez, Rod Brian; Mowery, Rachel; Luo, Haibin; Cao, Mingyan; Agarwal, Nitin; Ramos, Irina; Wang, Xiangyang; Wang, Jihong

2017-10-01

During manufacturing and storage process, therapeutic proteins are subject to various post-translational modifications (PTMs), such as isomerization, deamidation, oxidation, disulfide bond modifications and glycosylation. Certain PTMs may affect bioactivity, stability or pharmacokinetics and pharmacodynamics profile and are therefore classified as potential critical quality attributes (pCQAs). Identifying, monitoring and controlling these PTMs are usually key elements of the Quality by Design (QbD) approach. Traditionally, multiple analytical methods are utilized for these purposes, which is time consuming and costly. In recent years, multi-attribute monitoring methods have been developed in the biopharmaceutical industry. However, these methods combine high-end mass spectrometry with complicated data analysis software, which could pose difficulty when implementing in a quality control (QC) environment. Here we report a multi-attribute method (MAM) using a Quadrupole Dalton (QDa) mass detector to selectively monitor and quantitate PTMs in a therapeutic monoclonal antibody. The result output from the QDa-based MAM is straightforward and automatic. Evaluation results indicate this method provides comparable results to the traditional assays. To ensure future application in the QC environment, this method was qualified according to the International Conference on Harmonization (ICH) guideline and applied in the characterization of drug substance and stability samples. The QDa-based MAM is shown to be an extremely useful tool for product and process characterization studies that facilitates facile understanding of process impact on multiple quality attributes, while being QC friendly and cost-effective.

Characterization of a Saccharomyces cerevisiae fermentation process for production of a therapeutic recombinant protein using a multivariate Bayesian approach.

PubMed

Fu, Zhibiao; Baker, Daniel; Cheng, Aili; Leighton, Julie; Appelbaum, Edward; Aon, Juan

2016-05-01

The principle of quality by design (QbD) has been widely applied to biopharmaceutical manufacturing processes. Process characterization is an essential step to implement the QbD concept to establish the design space and to define the proven acceptable ranges (PAR) for critical process parameters (CPPs). In this study, we present characterization of a Saccharomyces cerevisiae fermentation process using risk assessment analysis, statistical design of experiments (DoE), and the multivariate Bayesian predictive approach. The critical quality attributes (CQAs) and CPPs were identified with a risk assessment. The statistical model for each attribute was established using the results from the DoE study with consideration given to interactions between CPPs. Both the conventional overlapping contour plot and the multivariate Bayesian predictive approaches were used to establish the region of process operating conditions where all attributes met their specifications simultaneously. The quantitative Bayesian predictive approach was chosen to define the PARs for the CPPs, which apply to the manufacturing control strategy. Experience from the 10,000 L manufacturing scale process validation, including 64 continued process verification batches, indicates that the CPPs remain under a state of control and within the established PARs. The end product quality attributes were within their drug substance specifications. The probability generated with the Bayesian approach was also used as a tool to assess CPP deviations. This approach can be extended to develop other production process characterization and quantify a reliable operating region. © 2016 American Institute of Chemical Engineers Biotechnol. Prog., 32:799-812, 2016. © 2016 American Institute of Chemical Engineers.

The environmental audit. I. Concepts

NASA Astrophysics Data System (ADS)

Schaeffer, David J.; Kerster, Harold W.; Perry, James A.; Cox, David K.

1985-05-01

Extensive criticism of water quality monitoring programs has developed as costs are compared with the benefits produced by monitoring efforts. Collecting water quality data while developing understanding of the functional character of the environment will improve water quality monitoring data utility in environmental management. The “environmental audit” characterizes the attributes of the natural environment (that is, attribute type, intensity, and variability), providing a theoretical as well as practical foundation for data interpretation. In the view proposed here, traditional monitoring means the very narrow activity of collecting samples and perhaps analyzing them and storing the analyses. In the environmental audit, these activities are a mechanism to systematically improve environmental monitoring and assessment by improving the design and implementation of environmental programs. Major reasons why existing programs fail to meet the needs of legislators, regulators, and conservationists are identified.

"Product on Stopper" in a Lyophilized Drug Product: Cosmetic Defect or a Product Quality Concern?

PubMed

Mehta, Shyam B; Roy, Shouvik; Yang, Han-Chang Cathy

2018-06-01

During manufacturing of a lyophilized drug product, operator errors in product handling during loading of product filled vials onto the lyophilizer can lead to a seemingly cosmetic defect which can impact certain critical quality attributes of finished product. In this study, filling of a formulated monoclonal antibody in vials was performed using a peristaltic pump filling unit, and subsequently, the product was lyophilized. After lyophilization, upon visual inspection, around 40% of vials had cosmetic defect with residual product around stopper of the vial and were categorized as "product on stopper" vials, whereas remaining 60% vials with no cosmetic defect were called "acceptable vials." Both groups of vials from 1 single batch were tested for critical quality attributes including protein concentration (ultraviolet absorbance at 280), residual moisture (Karl Fischer), sterility (membrane filtration), and container closure integrity (CCI) (blue dye ingress). Analysis of protein quality attributes such as aggregation, protein concentration, residual moisture showed no significant difference between vials with "product on stopper" and "acceptable vials." However, CCI of the "product on stopper" vials was compromised due to the presence of product around stopper of the vial. The results from this case study demonstrate the following 2 important findings: (1) that a seemingly cosmetic defect may impact product quality, compromising the integrity of the product and (2) that CCI test method can be used as an orthogonal method to sterility testing to evaluate sterility assurance of the product. The corrective action proposed to mitigate this defect is use of a larger sized vial that can potentially minimize this defect that arises because of product handling errors. Copyright © 2018 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

Unassigned MS/MS Spectra: Who Am I?

PubMed

Pathan, Mohashin; Samuel, Monisha; Keerthikumar, Shivakumar; Mathivanan, Suresh

2017-01-01

Recent advances in high resolution tandem mass spectrometry (MS) has resulted in the accumulation of high quality data. Paralleled with these advances in instrumentation, bioinformatics software have been developed to analyze such quality datasets. In spite of these advances, data analysis in mass spectrometry still remains critical for protein identification. In addition, the complexity of the generated MS/MS spectra, unpredictable nature of peptide fragmentation, sequence annotation errors, and posttranslational modifications has impeded the protein identification process. In a typical MS data analysis, about 60 % of the MS/MS spectra remains unassigned. While some of these could attribute to the low quality of the MS/MS spectra, a proportion can be classified as high quality. Further analysis may reveal how much of the unassigned MS spectra attribute to search space, sequence annotation errors, mutations, and/or posttranslational modifications. In this chapter, the tools used to identify proteins and ways to assign unassigned tandem MS spectra are discussed.

Carotenoid metabolism and regulation in horticultural crops

USDA-ARS?s Scientific Manuscript database

Carotenoids are a diverse group of pigments widely distributed in nature. The vivid yellow, orange, and red colors in many horticultural crops attribute to overaccumulation of carotenoids, which contribute to a critical agronomic trait for flowers and an important quality trait for fruits and vegeta...

Design Space Approach in Optimization of Fluid Bed Granulation and Tablets Compression Process

PubMed Central

Djuriš, Jelena; Medarević, Djordje; Krstić, Marko; Vasiljević, Ivana; Mašić, Ivana; Ibrić, Svetlana

2012-01-01

The aim of this study was to optimize fluid bed granulation and tablets compression processes using design space approach. Type of diluent, binder concentration, temperature during mixing, granulation and drying, spray rate, and atomization pressure were recognized as critical formulation and process parameters. They were varied in the first set of experiments in order to estimate their influences on critical quality attributes, that is, granules characteristics (size distribution, flowability, bulk density, tapped density, Carr's index, Hausner's ratio, and moisture content) using Plackett-Burman experimental design. Type of diluent and atomization pressure were selected as the most important parameters. In the second set of experiments, design space for process parameters (atomization pressure and compression force) and its influence on tablets characteristics was developed. Percent of paracetamol released and tablets hardness were determined as critical quality attributes. Artificial neural networks (ANNs) were applied in order to determine design space. ANNs models showed that atomization pressure influences mostly on the dissolution profile, whereas compression force affects mainly the tablets hardness. Based on the obtained ANNs models, it is possible to predict tablet hardness and paracetamol release profile for any combination of analyzed factors. PMID:22919295

Application of quality by design concepts in the development of fluidized bed granulation and tableting processes.

PubMed

Djuris, Jelena; Medarevic, Djordje; Krstic, Marko; Djuric, Zorica; Ibric, Svetlana

2013-06-01

This study illustrates the application of experimental design and multivariate data analysis in defining design space for granulation and tableting processes. According to the quality by design concepts, critical quality attributes (CQAs) of granules and tablets, as well as critical parameters of granulation and tableting processes, were identified and evaluated. Acetaminophen was used as the model drug, and one of the study aims was to investigate the possibility of the development of immediate- or extended-release acetaminophen tablets. Granulation experiments were performed in the fluid bed processor using polyethylene oxide polymer as a binder in the direct granulation method. Tablets were compressed in the laboratory excenter tablet press. The first set of experiments was organized according to Plackett-Burman design, followed by the full factorial experimental design. Principal component analysis and partial least squares regression were applied as the multivariate analysis techniques. By using these different methods, CQAs and process parameters were identified and quantified. Furthermore, an in-line method was developed to monitor the temperature during the fluidized bed granulation process, to foresee possible defects in granules CQAs. Various control strategies that are based on the process understanding and assure desired quality attributes of the product are proposed. Copyright © 2013 Wiley Periodicals, Inc.

Development of a design space and predictive statistical model for capsule filling of low-fill-weight inhalation products.

PubMed

Faulhammer, E; Llusa, M; Wahl, P R; Paudel, A; Lawrence, S; Biserni, S; Calzolari, V; Khinast, J G

2016-01-01

The objectives of this study were to develop a predictive statistical model for low-fill-weight capsule filling of inhalation products with dosator nozzles via the quality by design (QbD) approach and based on that to create refined models that include quadratic terms for significant parameters. Various controllable process parameters and uncontrolled material attributes of 12 powders were initially screened using a linear model with partial least square (PLS) regression to determine their effect on the critical quality attributes (CQA; fill weight and weight variability). After identifying critical material attributes (CMAs) and critical process parameters (CPPs) that influenced the CQA, model refinement was performed to study if interactions or quadratic terms influence the model. Based on the assessment of the effects of the CPPs and CMAs on fill weight and weight variability for low-fill-weight inhalation products, we developed an excellent linear predictive model for fill weight (R(2 )= 0.96, Q(2 )= 0.96 for powders with good flow properties and R(2 )= 0.94, Q(2 )= 0.93 for cohesive powders) and a model that provides a good approximation of the fill weight variability for each powder group. We validated the model, established a design space for the performance of different types of inhalation grade lactose on low-fill weight capsule filling and successfully used the CMAs and CPPs to predict fill weight of powders that were not included in the development set.

A Systematic Approach of Employing Quality by Design Principles: Risk Assessment and Design of Experiments to Demonstrate Process Understanding and Identify the Critical Process Parameters for Coating of the Ethylcellulose Pseudolatex Dispersion Using Non-Conventional Fluid Bed Process.

PubMed

Kothari, Bhaveshkumar H; Fahmy, Raafat; Claycamp, H Gregg; Moore, Christine M V; Chatterjee, Sharmista; Hoag, Stephen W

2017-05-01

The goal of this study was to utilize risk assessment techniques and statistical design of experiments (DoE) to gain process understanding and to identify critical process parameters for the manufacture of controlled release multiparticulate beads using a novel disk-jet fluid bed technology. The material attributes and process parameters were systematically assessed using the Ishikawa fish bone diagram and failure mode and effect analysis (FMEA) risk assessment methods. The high risk attributes identified by the FMEA analysis were further explored using resolution V fractional factorial design. To gain an understanding of the processing parameters, a resolution V fractional factorial study was conducted. Using knowledge gained from the resolution V study, a resolution IV fractional factorial study was conducted; the purpose of this IV study was to identify the critical process parameters (CPP) that impact the critical quality attributes and understand the influence of these parameters on film formation. For both studies, the microclimate, atomization pressure, inlet air volume, product temperature (during spraying and curing), curing time, and percent solids in the coating solutions were studied. The responses evaluated were percent agglomeration, percent fines, percent yield, bead aspect ratio, median particle size diameter (d50), assay, and drug release rate. Pyrobuttons® were used to record real-time temperature and humidity changes in the fluid bed. The risk assessment methods and process analytical tools helped to understand the novel disk-jet technology and to systematically develop models of the coating process parameters like process efficiency and the extent of curing during the coating process.

Application of the quality by design approach to the drug substance manufacturing process of an Fc fusion protein: towards a global multi-step design space.

PubMed

Eon-duval, Alex; Valax, Pascal; Solacroup, Thomas; Broly, Hervé; Gleixner, Ralf; Strat, Claire L E; Sutter, James

2012-10-01

The article describes how Quality by Design principles can be applied to the drug substance manufacturing process of an Fc fusion protein. First, the quality attributes of the product were evaluated for their potential impact on safety and efficacy using risk management tools. Similarly, process parameters that have a potential impact on critical quality attributes (CQAs) were also identified through a risk assessment. Critical process parameters were then evaluated for their impact on CQAs, individually and in interaction with each other, using multivariate design of experiment techniques during the process characterisation phase. The global multi-step Design Space, defining operational limits for the entire drug substance manufacturing process so as to ensure that the drug substance quality targets are met, was devised using predictive statistical models developed during the characterisation study. The validity of the global multi-step Design Space was then confirmed by performing the entire process, from cell bank thawing to final drug substance, at its limits during the robustness study: the quality of the final drug substance produced under different conditions was verified against predefined targets. An adaptive strategy was devised whereby the Design Space can be adjusted to the quality of the input material to ensure reliable drug substance quality. Finally, all the data obtained during the process described above, together with data generated during additional validation studies as well as manufacturing data, were used to define the control strategy for the drug substance manufacturing process using a risk assessment methodology. Copyright © 2012 Wiley-Liss, Inc.

Opportunities and challenges of real-time release testing in biopharmaceutical manufacturing.

PubMed

Jiang, Mo; Severson, Kristen A; Love, John Christopher; Madden, Helena; Swann, Patrick; Zang, Li; Braatz, Richard D

2017-11-01

Real-time release testing (RTRT) is defined as "the ability to evaluate and ensure the quality of in-process and/or final drug product based on process data, which typically includes a valid combination of measured material attributes and process controls" (ICH Q8[R2]). This article discusses sensors (process analytical technology, PAT) and control strategies that enable RTRT for the spectrum of critical quality attributes (CQAs) in biopharmaceutical manufacturing. Case studies from the small-molecule and biologic pharmaceutical industry are described to demonstrate how RTRT can be facilitated by integrated manufacturing and multivariable control strategies to ensure the quality of products. RTRT can enable increased assurance of product safety, efficacy, and quality-with improved productivity including faster release and potentially decreased costs-all of which improve the value to patients. To implement a complete RTRT solution, biologic drug manufacturers need to consider the special attributes of their industry, particularly sterility and the measurement of viral and microbial contamination. Continued advances in on-line and in-line sensor technologies are key for the biopharmaceutical manufacturing industry to achieve the potential of RTRT. Related article: http://onlinelibrary.wiley.com/doi/10.1002/bit.26378/full. © 2017 Wiley Periodicals, Inc.

Search engine ranking, quality, and content of webpages that are critical vs noncritical of HPV vaccine

PubMed Central

Fu, Linda Y.; Zook, Kathleen; Spoehr-Labutta, Zachary; Hu, Pamela; Joseph, Jill G.

2015-01-01

Purpose Online information can influence attitudes toward vaccination. The aim of the present study is to provide a systematic evaluation of the search engine ranking, quality, and content of webpages that are critical versus noncritical of HPV vaccination. Methods We identified HPV vaccine-related webpages with the Google search engine by entering 20 terms. We then assessed each webpage for critical versus noncritical bias as well as for the following quality indicators: authorship disclosure, source disclosure, attribution of at least one reference, currency, exclusion of testimonial accounts, and readability level less than 9th grade. We also determined webpage comprehensiveness in terms of mention of 14 HPV vaccine relevant topics. Results Twenty searches yielded 116 unique webpages. HPV vaccine-critical webpages comprised roughly a third of the top, top 5 and top 10-ranking webpages. The prevalence of HPV vaccine-critical webpages was higher for queries that included term modifiers in addition to root terms. Compared with noncritical webpages, webpages critical of HPV vaccine overall had a lower quality score than those with a noncritical bias (p<.01) and covered fewer important HPV-related topics (p<.001). Critical webpages required viewers to have higher reading skills, were less likely to include an author byline, and were more likely to include testimonial accounts. They also were more likely to raise unsubstantiated concerns about vaccination. Conclusion Webpages critical of HPV vaccine may be frequently returned and highly ranked by search engine queries despite being of lower quality and less comprehensive than noncritical webpages. PMID:26559742

Watching what widlife want and need

Treesearch

Natasha Vizcarra; Mary Rowland; Christina Vojta

2016-01-01

National forests and grasslands are home to a diverse array of wildlife. To keep tabs on the general viability and wellbeing of these inhabitants, land managers need practical, defensible monitoring protocols. Population monitoring is one method. Another is habitat monitoring, which provides critical information about the quantity and quality of key habitat attributes...

Visible and near-infrared hyperspectral imaging for cooking loss classification of fresh broiler breast fillets

USDA-ARS?s Scientific Manuscript database

Cooking loss (CL) is a critical quality attribute directly relating to meat juiciness. The potential of the hyperspectral imaging (HSI) technique was investigated for non-invasively classifying and visualizing the CL of fresh broiler breast meat. Hyperspectral images of total 75 fresh broiler breast...

Ambient assisted living healthcare frameworks, platforms, standards, and quality attributes.

PubMed

Memon, Mukhtiar; Wagner, Stefan Rahr; Pedersen, Christian Fischer; Beevi, Femina Hassan Aysha; Hansen, Finn Overgaard

2014-03-04

Ambient Assisted Living (AAL) is an emerging multi-disciplinary field aiming at exploiting information and communication technologies in personal healthcare and telehealth systems for countering the effects of growing elderly population. AAL systems are developed for personalized, adaptive, and anticipatory requirements, necessitating high quality-of-service to achieve interoperability, usability, security, and accuracy. The aim of this paper is to provide a comprehensive review of the AAL field with a focus on healthcare frameworks, platforms, standards, and quality attributes. To achieve this, we conducted a literature survey of state-of-the-art AAL frameworks, systems and platforms to identify the essential aspects of AAL systems and investigate the critical issues from the design, technology, quality-of-service, and user experience perspectives. In addition, we conducted an email-based survey for collecting usage data and current status of contemporary AAL systems. We found that most AAL systems are confined to a limited set of features ignoring many of the essential AAL system aspects. Standards and technologies are used in a limited and isolated manner, while quality attributes are often addressed insufficiently. In conclusion, we found that more inter-organizational collaboration, user-centered studies, increased standardization efforts, and a focus on open systems is needed to achieve more interoperable and synergetic AAL solutions.

Ambient Assisted Living Healthcare Frameworks, Platforms, Standards, and Quality Attributes

PubMed Central

Memon, Mukhtiar; Wagner, Stefan Rahr; Pedersen, Christian Fischer; Beevi, Femina Hassan Aysha; Hansen, Finn Overgaard

2014-01-01

Ambient Assisted Living (AAL) is an emerging multi-disciplinary field aiming at exploiting information and communication technologies in personal healthcare and telehealth systems for countering the effects of growing elderly population. AAL systems are developed for personalized, adaptive, and anticipatory requirements, necessitating high quality-of-service to achieve interoperability, usability, security, and accuracy. The aim of this paper is to provide a comprehensive review of the AAL field with a focus on healthcare frameworks, platforms, standards, and quality attributes. To achieve this, we conducted a literature survey of state-of-the-art AAL frameworks, systems and platforms to identify the essential aspects of AAL systems and investigate the critical issues from the design, technology, quality-of-service, and user experience perspectives. In addition, we conducted an email-based survey for collecting usage data and current status of contemporary AAL systems. We found that most AAL systems are confined to a limited set of features ignoring many of the essential AAL system aspects. Standards and technologies are used in a limited and isolated manner, while quality attributes are often addressed insufficiently. In conclusion, we found that more inter-organizational collaboration, user-centered studies, increased standardization efforts, and a focus on open systems is needed to achieve more interoperable and synergetic AAL solutions. PMID:24599192

Automatic MeSH term assignment and quality assessment.

PubMed Central

Kim, W.; Aronson, A. R.; Wilbur, W. J.

2001-01-01

For computational purposes documents or other objects are most often represented by a collection of individual attributes that may be strings or numbers. Such attributes are often called features and success in solving a given problem can depend critically on the nature of the features selected to represent documents. Feature selection has received considerable attention in the machine learning literature. In the area of document retrieval we refer to feature selection as indexing. Indexing has not traditionally been evaluated by the same methods used in machine learning feature selection. Here we show how indexing quality may be evaluated in a machine learning setting and apply this methodology to results of the Indexing Initiative at the National Library of Medicine. PMID:11825203

Risk management and statistical multivariate analysis approach for design and optimization of satranidazole nanoparticles.

PubMed

Dhat, Shalaka; Pund, Swati; Kokare, Chandrakant; Sharma, Pankaj; Shrivastava, Birendra

2017-01-01

Rapidly evolving technical and regulatory landscapes of the pharmaceutical product development necessitates risk management with application of multivariate analysis using Process Analytical Technology (PAT) and Quality by Design (QbD). Poorly soluble, high dose drug, Satranidazole was optimally nanoprecipitated (SAT-NP) employing principles of Formulation by Design (FbD). The potential risk factors influencing the critical quality attributes (CQA) of SAT-NP were identified using Ishikawa diagram. Plackett-Burman screening design was adopted to screen the eight critical formulation and process parameters influencing the mean particle size, zeta potential and dissolution efficiency at 30min in pH7.4 dissolution medium. Pareto charts (individual and cumulative) revealed three most critical factors influencing CQA of SAT-NP viz. aqueous stabilizer (Polyvinyl alcohol), release modifier (Eudragit® S 100) and volume of aqueous phase. The levels of these three critical formulation attributes were optimized by FbD within established design space to minimize mean particle size, poly dispersity index, and maximize encapsulation efficiency of SAT-NP. Lenth's and Bayesian analysis along with mathematical modeling of results allowed identification and quantification of critical formulation attributes significantly active on the selected CQAs. The optimized SAT-NP exhibited mean particle size; 216nm, polydispersity index; 0.250, zeta potential; -3.75mV and encapsulation efficiency; 78.3%. The product was lyophilized using mannitol to form readily redispersible powder. X-ray diffraction analysis confirmed the conversion of crystalline SAT to amorphous form. In vitro release of SAT-NP in gradually pH changing media showed <20% release in pH1.2 and pH6.8 in 5h, while, complete release (>95%) in pH7.4 in next 3h, indicative of burst release after a lag time. This investigation demonstrated effective application of risk management and QbD tools in developing site-specific release SAT-NP by nanoprecipitation. Copyright © 2016 Elsevier B.V. All rights reserved.

An integrated, quality by design (QbD) approach for design, development and optimization of orally disintegrating tablet formulation of carbamazepine.

PubMed

Mishra, Saurabh M; Rohera, Bhagwan D

2017-11-01

The objective of the present study was to design and develop a formulation for orally disintegrating tablets (ODTs) of carbamazepine using quality by design principles. The target product profile (TPP) and quality target product profile (QTPP) of ODTs were identified. Risk assessment was carried out by leveraging prior knowledge and experience to define the criticality of factors based on their impact by Ishikawa fishbone diagram and preliminary hazard analysis tool. Box-Behnken response surface methodology was used to study the effect of critical factors on various attributes of ODTs. The independent factors selected were compression pressure (X 1 ), concentration of sublimating agent (volatile material) (X 2 ), disintegrant concentration (X 3 ) and the responses were tablet crushing strength, tablet porosity, disintegration time, water absorption time, tablet friability and drug dissolution. ANOVA and lack of fit test illustrated that selected independent variables had significant effect on the response variables, and excellent correlation was observed between actual and predicted values. Optimization by desirability function indicated that compression pressure, X 1 (1534 lbs), ammonium bicarbonate concentration, X 2 (7.68%) and Kollidon ® CL-SF concentration, X 3 (6%) were optimum to prepare ODT formulation of carbamazepine of desired attributes complying with QTPP. Thus, in the present study, a high level of assurance was established for ODT product quality and performance.

Computer Optimization of Biodegradable Nanoparticles Fabricated by Dispersion Polymerization.

PubMed

Akala, Emmanuel O; Adesina, Simeon; Ogunwuyi, Oluwaseun

2015-12-22

Quality by design (QbD) in the pharmaceutical industry involves designing and developing drug formulations and manufacturing processes which ensure predefined drug product specifications. QbD helps to understand how process and formulation variables affect product characteristics and subsequent optimization of these variables vis-à-vis final specifications. Statistical design of experiments (DoE) identifies important parameters in a pharmaceutical dosage form design followed by optimizing the parameters with respect to certain specifications. DoE establishes in mathematical form the relationships between critical process parameters together with critical material attributes and critical quality attributes. We focused on the fabrication of biodegradable nanoparticles by dispersion polymerization. Aided by a statistical software, d-optimal mixture design was used to vary the components (crosslinker, initiator, stabilizer, and macromonomers) to obtain twenty nanoparticle formulations (PLLA-based nanoparticles) and thirty formulations (poly-ɛ-caprolactone-based nanoparticles). Scheffe polynomial models were generated to predict particle size (nm), zeta potential, and yield (%) as functions of the composition of the formulations. Simultaneous optimizations were carried out on the response variables. Solutions were returned from simultaneous optimization of the response variables for component combinations to (1) minimize nanoparticle size; (2) maximize the surface negative zeta potential; and (3) maximize percent yield to make the nanoparticle fabrication an economic proposition.

Using a Coupled Modelling System to Examine the Impacts of Increased Corn Production on Groundwater Quality and Human Health

EPA Science Inventory

Attributing nitrogen (N) in the environment to emissions from agricultural management practices is difficult because of the complex and inter-related chemical and biological reactions associated with N and its cascading effects across land, air and water. Such analyses are critic...

[Research advances in secondary development of Chinese patent medicines based on quality by design concept].

PubMed

Gong, Xing-Chu; Chen, Teng; Qu, Hai-Bin

2017-03-01

Quality by design (QbD) concept is an advanced pharmaceutical quality control concept. The application of QbD concept in the research and development of pharmaceutical processes of traditional Chinese medicines (TCM) mainly contains five parts, including the definition of critical processes and their evaluation criteria, the determination of critical process parameters and critical material attributes, the establishment of quantitative models, the development of design space, as well as the application and continuous improvement of control strategy. In this work, recent research advances in QbD concept implementation methods in the secondary development of Chinese patent medicines were reviewed, and five promising fields of the implementation of QbD concept were pointed out, including the research and development of TCM new drugs and Chinese medicine granules for formulation, modeling of pharmaceutical processes, development of control strategy based on industrial big data, strengthening the research of process amplification rules, and the development of new pharmaceutical equipment.. Copyright© by the Chinese Pharmaceutical Association.

Quality by Design in the development of hydrophilic interaction liquid chromatography method with gradient elution for the analysis of olanzapine.

PubMed

Tumpa, Anja; Stajić, Ana; Jančić-Stojanović, Biljana; Medenica, Mirjana

2017-02-05

This paper deals with the development of hydrophilic interaction liquid chromatography (HILIC) method with gradient elution, in accordance with Analytical Quality by Design (AQbD) methodology, for the first time. The method is developed for olanzapine and its seven related substances. Following step by step AQbD methodology, firstly as critical process parameters (CPPs) temperature, starting content of aqueous phase and duration of linear gradient are recognized, and as critical quality attributes (CQAs) separation criterion S of critical pairs of substances are investigated. Rechtschaffen design is used for the creation of models that describe the dependence between CPPs and CQAs. The design space that is obtained at the end is used for choosing the optimal conditions (set point). The method is fully validated at the end to verify the adequacy of the chosen optimal conditions and applied to real samples. Copyright © 2016 Elsevier B.V. All rights reserved.

Validation of a two-dimensional liquid chromatography method for quality control testing of pharmaceutical materials.

PubMed

Yang, Samuel H; Wang, Jenny; Zhang, Kelly

2017-04-07

Despite the advantages of 2D-LC, there is currently little to no work in demonstrating the suitability of these 2D-LC methods for use in a quality control (QC) environment for good manufacturing practice (GMP) tests. This lack of information becomes more critical as the availability of commercial 2D-LC instrumentation has significantly increased, and more testing facilities begin to acquire these 2D-LC capabilities. It is increasingly important that the transferability of developed 2D-LC methods be assessed in terms of reproducibility, robustness and performance across different laboratories worldwide. The work presented here focuses on the evaluation of a heart-cutting 2D-LC method used for the analysis of a pharmaceutical material, where a key, co-eluting impurity in the first dimension ( 1 D) is resolved from the main peak and analyzed in the second dimension ( 2 D). A design-of-experiments (DOE) approach was taken in the collection of the data, and the results were then modeled in order to evaluate method robustness using statistical modeling software. This quality by design (QBD) approach gives a deeper understanding of the impact of these 2D-LC critical method attributes (CMAs) and how they affect overall method performance. Although there are multiple parameters that may be critical from method development point of view, a special focus of this work is devoted towards evaluation of unique 2D-LC critical method attributes from method validation perspective that transcend conventional method development and validation. The 2D-LC method attributes are evaluated for their recovery, peak shape, and resolution of the two co-eluting compounds in question on the 2 D. In the method, linearity, accuracy, precision, repeatability, and sensitivity are assessed along with day-to-day, analyst-to-analyst, and lab-to-lab (instrument-to-instrument) assessments. The results of this validation study demonstrate that the 2D-LC method is accurate, sensitive, and robust and is ultimately suitable for QC testing with good method transferability. Copyright © 2017 Elsevier B.V. All rights reserved.

Search Engine Ranking, Quality, and Content of Web Pages That Are Critical Versus Noncritical of Human Papillomavirus Vaccine.

PubMed

Fu, Linda Y; Zook, Kathleen; Spoehr-Labutta, Zachary; Hu, Pamela; Joseph, Jill G

2016-01-01

Online information can influence attitudes toward vaccination. The aim of the present study was to provide a systematic evaluation of the search engine ranking, quality, and content of Web pages that are critical versus noncritical of human papillomavirus (HPV) vaccination. We identified HPV vaccine-related Web pages with the Google search engine by entering 20 terms. We then assessed each Web page for critical versus noncritical bias and for the following quality indicators: authorship disclosure, source disclosure, attribution of at least one reference, currency, exclusion of testimonial accounts, and readability level less than ninth grade. We also determined Web page comprehensiveness in terms of mention of 14 HPV vaccine-relevant topics. Twenty searches yielded 116 unique Web pages. HPV vaccine-critical Web pages comprised roughly a third of the top, top 5- and top 10-ranking Web pages. The prevalence of HPV vaccine-critical Web pages was higher for queries that included term modifiers in addition to root terms. Compared with noncritical Web pages, Web pages critical of HPV vaccine overall had a lower quality score than those with a noncritical bias (p < .01) and covered fewer important HPV-related topics (p < .001). Critical Web pages required viewers to have higher reading skills, were less likely to include an author byline, and were more likely to include testimonial accounts. They also were more likely to raise unsubstantiated concerns about vaccination. Web pages critical of HPV vaccine may be frequently returned and highly ranked by search engine queries despite being of lower quality and less comprehensive than noncritical Web pages. Copyright © 2016 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

Design of experiments (DoE) in pharmaceutical development.

PubMed

N Politis, Stavros; Colombo, Paolo; Colombo, Gaia; M Rekkas, Dimitrios

2017-06-01

At the beginning of the twentieth century, Sir Ronald Fisher introduced the concept of applying statistical analysis during the planning stages of research rather than at the end of experimentation. When statistical thinking is applied from the design phase, it enables to build quality into the product, by adopting Deming's profound knowledge approach, comprising system thinking, variation understanding, theory of knowledge, and psychology. The pharmaceutical industry was late in adopting these paradigms, compared to other sectors. It heavily focused on blockbuster drugs, while formulation development was mainly performed by One Factor At a Time (OFAT) studies, rather than implementing Quality by Design (QbD) and modern engineering-based manufacturing methodologies. Among various mathematical modeling approaches, Design of Experiments (DoE) is extensively used for the implementation of QbD in both research and industrial settings. In QbD, product and process understanding is the key enabler of assuring quality in the final product. Knowledge is achieved by establishing models correlating the inputs with the outputs of the process. The mathematical relationships of the Critical Process Parameters (CPPs) and Material Attributes (CMAs) with the Critical Quality Attributes (CQAs) define the design space. Consequently, process understanding is well assured and rationally leads to a final product meeting the Quality Target Product Profile (QTPP). This review illustrates the principles of quality theory through the work of major contributors, the evolution of the QbD approach and the statistical toolset for its implementation. As such, DoE is presented in detail since it represents the first choice for rational pharmaceutical development.

Acceptance Probability (P a) Analysis for Process Validation Lifecycle Stages.

PubMed

Alsmeyer, Daniel; Pazhayattil, Ajay; Chen, Shu; Munaretto, Francesco; Hye, Maksuda; Sanghvi, Pradeep

2016-04-01

This paper introduces an innovative statistical approach towards understanding how variation impacts the acceptance criteria of quality attributes. Because of more complex stage-wise acceptance criteria, traditional process capability measures are inadequate for general application in the pharmaceutical industry. The probability of acceptance concept provides a clear measure, derived from specific acceptance criteria for each quality attribute. In line with the 2011 FDA Guidance, this approach systematically evaluates data and scientifically establishes evidence that a process is capable of consistently delivering quality product. The probability of acceptance provides a direct and readily understandable indication of product risk. As with traditional capability indices, the acceptance probability approach assumes that underlying data distributions are normal. The computational solutions for dosage uniformity and dissolution acceptance criteria are readily applicable. For dosage uniformity, the expected AV range may be determined using the s lo and s hi values along with the worst case estimates of the mean. This approach permits a risk-based assessment of future batch performance of the critical quality attributes. The concept is also readily applicable to sterile/non sterile liquid dose products. Quality attributes such as deliverable volume and assay per spray have stage-wise acceptance that can be converted into an acceptance probability. Accepted statistical guidelines indicate processes with C pk > 1.33 as performing well within statistical control and those with C pk < 1.0 as "incapable" (1). A C pk > 1.33 is associated with a centered process that will statistically produce less than 63 defective units per million. This is equivalent to an acceptance probability of >99.99%.

Extension of quality-by-design concept to the early development phase of pharmaceutical R&D processes.

PubMed

Csóka, Ildikó; Pallagi, Edina; Paál, Tamás L

2018-03-27

Here, we propose the extension of the quality-by-design (QbD) concept to also fit the early development phases of pharmaceuticals by adding elements that are currently widely applied, but not yet included in the QbD model in a structured way. These are the introduction of a 'zero' preformulation phase (i.e., selection of drug substance, possible dosage forms and administration routes based on the evaluated therapeutic need); building in stakeholders' (industry, patient, and regulatory) requirements into the quality target product profile (QTTP); and the use of modern quality management tools during the composition and process design phase [collecting critical quality attributes (CQAs) and selection of CPPs) for (still laboratory-scale) design space (DS) development. Moreover, during industrial scale-up, CQAs (as well as critical process parameters; CPPs) can be changed; however, we recommend that the existing QbD elements are reconsidered and updated after this phase. Copyright © 2018 Elsevier Ltd. All rights reserved.

The six critical attributes of the next generation of quality management software systems.

PubMed

Clark, Kathleen

2011-07-01

Driven by both the need to meet regulatory requirements and a genuine desire to drive improved quality, quality management systems encompassing standard operating procedure, corrective and preventative actions and related processes have existed for many years, both in paper and electronic form. The impact of quality management systems on 'actual' quality, however, is often reported as far less than desired. A quality management software system that moves beyond formal forms-driven processes to include a true closed loop design, manage disparate processes across the enterprise, provide support for collaborative processes and deliver insight into the overall state of control has the potential to close the gap between simply accomplishing regulatory compliance and delivering measurable improvements in quality and efficiency.

Architecture-led Requirements and Safety Analysis of an Aircraft Survivability Situational Awareness System

DTIC Science & Technology

2015-05-01

quality attributes. Prioritization of the utility tree leafs driven by mission goals help the user ensure that critical requirements are well-specified...Methods: State of the Art and Future Directions”, ACM Computing Surveys. 1996. 10 Laitenberger, Oliver , “A Survey of Software Inspection Technologies, Handbook on Software Engineering and Knowledge Engineering”. 2002.

Developing professional attributes in critical care nurses using Team-Based Learning.

PubMed

Currey, Judy; Eustace, Paula; Oldland, Elizabeth; Glanville, David; Story, Ian

2015-05-01

Australian nurses prepare for specialty practice by undertaking postgraduate theoretical and clinical education in partnership models between universities and hospitals. In our global healthcare system, nurses require advanced critical thinking and strong communication skills to provide safe, high quality patient care. Yet, few education programs focus on developing these skills. Team-Based Learning (TBL) is a specific educational strategy that encourages and rewards students to think critically and solve clinical problems individually and in teams. The aim of this study was to investigate critical care nursing students' perceptions and experiences of TBL after it was introduced into the second half of their postgraduate specialty course. Following Ethics Committee approval, thirty-two students were invited to participate in an extended response questionnaire on their perceptions of TBL as part of a larger study. Data were analyzed thematically. Postgraduate students perceived their professional growth was accelerated due to the skills and knowledge acquired through TBL. Four themes underpinned the development and accelerated acquisition of specialty nurse attributes due to TBL: Engagement, Learning Effectiveness, Critical Thinking, and Motivation to Participate. Team-Based Learning offered deep and satisfying learning experiences for students. The early acquisition of advanced critical thinking, teamwork and communication skills, and specialty practice knowledge empowered nurses to provide safe patient care with confidence. Copyright © 2015 Elsevier Ltd. All rights reserved.

What are the roles and valued attributes of a Trial Steering Committee? Ethnographic study of eight clinical trials facing challenges.

PubMed

Daykin, Anne; Selman, Lucy E; Cramer, Helen; McCann, Sharon; Shorter, Gillian W; Sydes, Matthew R; Gamble, Carrol; Macefield, Rhiannon; Lane, J Athene; Shaw, Alison

2016-07-01

Clinical trials oversight by a Trial Steering Committee (TSC) is mandated by Good Clinical Practice. This study used qualitative methods to explore the role and valued attributes of the TSC to inform planned updates of Medical Research Council guidance and TSC terms of reference. An ethnographic study was conducted during 2013-2014. TSC and Trial Management Group meetings from eight trials were observed and audio-recorded, and semi-structured interviews conducted with purposively sampled key informants: independent and non-independent TSC members, trial sponsor representatives, funder representatives and chief investigators. The selected trials were currently recruiting and dealing with challenging scenarios. Data were analysed thematically and findings triangulated and integrated to give a multi-perspective account of the role and valued attributes of a TSC. Eight TSC meetings and six Trial Management Group meetings were observed. Sixty-five interviews were conducted with 51 informants. The two main roles played by the TSC were quality assurance and patient advocacy. Quality assurance involved being a 'critical friend' or a provider of 'tough love'. Factors influencing the ability of the TSC to fulfil this role included the TSC Chair, other independent TSC members and the model of the TSC and its fit with the trial subject. The role of the TSC as an advocate for patient well-being was perceived as paramount. Two attributes of TSC members emerged as critical: experience (of running a trial, trial oversight or in a clinical/methodological area) and independence. While independence was valued for giving impartiality, the lack of consensus about its definition and strict requirements of some funders made it difficult to operationalise. We found tensions and ambiguities in the roles expected of TSCs and the attributes valued of TSC members. In particular, the requirements of independence and experience could conflict, impacting the TSCs' quality assurance role. Concerns were raised regarding whose interests are served by funders' criteria of independence; in particular, funders' selection of TSC members was thought to potentially inhibit TSCs' ability to fulfil their patient advocacy role. These findings should be incorporated in revising guidance and terms of reference for TSCs.

Chemometrics-based process analytical technology (PAT) tools: applications and adaptation in pharmaceutical and biopharmaceutical industries.

PubMed

Challa, Shruthi; Potumarthi, Ravichandra

2013-01-01

Process analytical technology (PAT) is used to monitor and control critical process parameters in raw materials and in-process products to maintain the critical quality attributes and build quality into the product. Process analytical technology can be successfully implemented in pharmaceutical and biopharmaceutical industries not only to impart quality into the products but also to prevent out-of-specifications and improve the productivity. PAT implementation eliminates the drawbacks of traditional methods which involves excessive sampling and facilitates rapid testing through direct sampling without any destruction of sample. However, to successfully adapt PAT tools into pharmaceutical and biopharmaceutical environment, thorough understanding of the process is needed along with mathematical and statistical tools to analyze large multidimensional spectral data generated by PAT tools. Chemometrics is a chemical discipline which incorporates both statistical and mathematical methods to obtain and analyze relevant information from PAT spectral tools. Applications of commonly used PAT tools in combination with appropriate chemometric method along with their advantages and working principle are discussed. Finally, systematic application of PAT tools in biopharmaceutical environment to control critical process parameters for achieving product quality is diagrammatically represented.

Drop-on-Demand System for Manufacturing of Melt-based Solid Oral Dosage: Effect of Critical Process Parameters on Product Quality.

PubMed

Içten, Elçin; Giridhar, Arun; Nagy, Zoltan K; Reklaitis, Gintaras V

2016-04-01

The features of a drop-on-demand-based system developed for the manufacture of melt-based pharmaceuticals have been previously reported. In this paper, a supervisory control system, which is designed to ensure reproducible production of high quality of melt-based solid oral dosages, is presented. This control system enables the production of individual dosage forms with the desired critical quality attributes: amount of active ingredient and drug morphology by monitoring and controlling critical process parameters, such as drop size and product and process temperatures. The effects of these process parameters on the final product quality are investigated, and the properties of the produced dosage forms characterized using various techniques, such as Raman spectroscopy, optical microscopy, and dissolution testing. A crystallization temperature control strategy, including controlled temperature cycles, is presented to tailor the crystallization behavior of drug deposits and to achieve consistent drug morphology. This control strategy can be used to achieve the desired bioavailability of the drug by mitigating variations in the dissolution profiles. The supervisor control strategy enables the application of the drop-on-demand system to the production of individualized dosage required for personalized drug regimens.

Developing a quality by design approach to model tablet dissolution testing: an industrial case study.

PubMed

Yekpe, Ketsia; Abatzoglou, Nicolas; Bataille, Bernard; Gosselin, Ryan; Sharkawi, Tahmer; Simard, Jean-Sébastien; Cournoyer, Antoine

2018-07-01

This study applied the concept of Quality by Design (QbD) to tablet dissolution. Its goal was to propose a quality control strategy to model dissolution testing of solid oral dose products according to International Conference on Harmonization guidelines. The methodology involved the following three steps: (1) a risk analysis to identify the material- and process-related parameters impacting the critical quality attributes of dissolution testing, (2) an experimental design to evaluate the influence of design factors (attributes and parameters selected by risk analysis) on dissolution testing, and (3) an investigation of the relationship between design factors and dissolution profiles. Results show that (a) in the case studied, the two parameters impacting dissolution kinetics are active pharmaceutical ingredient particle size distributions and tablet hardness and (b) these two parameters could be monitored with PAT tools to predict dissolution profiles. Moreover, based on the results obtained, modeling dissolution is possible. The practicality and effectiveness of the QbD approach were demonstrated through this industrial case study. Implementing such an approach systematically in industrial pharmaceutical production would reduce the need for tablet dissolution testing.

Pharmaceutical product development: A quality by design approach

PubMed Central

Pramod, Kannissery; Tahir, M. Abu; Charoo, Naseem A.; Ansari, Shahid H.; Ali, Javed

2016-01-01

The application of quality by design (QbD) in pharmaceutical product development is now a thrust area for the regulatory authorities and the pharmaceutical industry. International Conference on Harmonization and United States Food and Drug Administration (USFDA) emphasized the principles and applications of QbD in pharmaceutical development in their guidance for the industry. QbD attributes are addressed in question-based review, developed by USFDA for chemistry, manufacturing, and controls section of abbreviated new drug applications. QbD principles, when implemented, lead to a successful product development, subsequent prompt regulatory approval, reduce exhaustive validation burden, and significantly reduce post-approval changes. The key elements of QbD viz., target product quality profile, critical quality attributes, risk assessments, design space, control strategy, product lifecycle management, and continual improvement are discussed to understand the performance of dosage forms within design space. Design of experiments, risk assessment tools, and process analytical technology are also discussed for their role in QbD. This review underlines the importance of QbD in inculcating science-based approach in pharmaceutical product development. PMID:27606256

Pharmaceutical product development: A quality by design approach.

PubMed

Pramod, Kannissery; Tahir, M Abu; Charoo, Naseem A; Ansari, Shahid H; Ali, Javed

2016-01-01

The application of quality by design (QbD) in pharmaceutical product development is now a thrust area for the regulatory authorities and the pharmaceutical industry. International Conference on Harmonization and United States Food and Drug Administration (USFDA) emphasized the principles and applications of QbD in pharmaceutical development in their guidance for the industry. QbD attributes are addressed in question-based review, developed by USFDA for chemistry, manufacturing, and controls section of abbreviated new drug applications. QbD principles, when implemented, lead to a successful product development, subsequent prompt regulatory approval, reduce exhaustive validation burden, and significantly reduce post-approval changes. The key elements of QbD viz., target product quality profile, critical quality attributes, risk assessments, design space, control strategy, product lifecycle management, and continual improvement are discussed to understand the performance of dosage forms within design space. Design of experiments, risk assessment tools, and process analytical technology are also discussed for their role in QbD. This review underlines the importance of QbD in inculcating science-based approach in pharmaceutical product development.

Self-Concept in Children with Down Syndrome

PubMed Central

Saha, Sayoni; Doran, Eric; Osann, Kathryn E.; Hom, Christy; Movsesyan, Nina; Rosa, Diana D.; Tournay, Anne; Lott, Ira T.

2015-01-01

Self-concept is a critical indicator of quality of life but few studies have examined this subject in children with Down syndrome (DS). In this study, we propose a novel methodology to assess the self-concept of children with DS by analyzing their responses towards two dolls, one with a “typically developing” (TD) appearance and one with the phenotypic features of DS. Fifty-four children with DS participated in play sessions with both dolls and were then interviewed to assess doll preference, resemblance, and attribution of positive qualities. We observed that children with DS: 1) exhibited a preference for the TD doll regardless of age, gender, IQ or self-awareness; 2) attributed more positive qualities to the TD doll than the DS doll; and 3) believed that they resembled the TD doll, rather than the more phenotypically accurate representation of themselves. Older participants were more likely to exhibit self-recognition by this technique. These findings contribute to current understandings of how people with DS view themselves and their disability. PMID:24838927

Helping each other grow: romantic partner support, self-improvement, and relationship quality.

PubMed

Overall, Nickola C; Fletcher, Garth J O; Simpson, Jeffry A

2010-11-01

This research tested whether and how partners' support of self-improvement efforts influences recipients' relationship evaluations and self-improvement success. Study 1 provided an initial test of predictions using self-reports (N = 150). Study 2 assessed support behavior exhibited in couples' (N = 47) discussions of self-improvement desires, and tracked relationship quality and self-improvement every 3 months for 1 year. More nurturing and action-facilitating partner support was more helpful to recipients, whereas partners who criticized and invalidated recipients were less helpful. Receiving more help from the partner, in turn, predicted greater relationship quality and more self-improvement. More negative support seeking also predicted lower self-improvement because recipients' behavior elicited less partner help. These effects were not attributable to partners' general warmth and understanding, global self or relationship evaluations, how much recipients desired or tried to change, or whether targeted attributes posed relationship problems. This research documents the powerful influence that partners' help has on recipients' personal growth.

A model to predict stream water temperature across the conterminous USA

Treesearch

Catalina Segura; Peter Caldwell; Ge Sun; Steve McNulty; Yang Zhang

2014-01-01

Stream water temperature (ts) is a critical water quality parameter for aquatic ecosystems. However, ts records are sparse or nonexistent in many river systems. In this work, we present an empirical model to predict ts at the site scale across the USA. The model, derived using data from 171 reference sites selected from the Geospatial Attributes of Gages for Evaluating...

Implementation of quality by design approach in manufacturing process optimization of dry granulated, immediate release, coated tablets - a case study.

PubMed

Teżyk, Michał; Jakubowska, Emilia; Milanowski, Bartłomiej; Lulek, Janina

2017-10-01

The aim of this study was to optimize the process of tablets compression and identification of film-coating critical process parameters (CPPs) affecting critical quality attributes (CQAs) using quality by design (QbD) approach. Design of experiment (DOE) and regression methods were employed to investigate hardness, disintegration time, and thickness of uncoated tablets depending on slugging and tableting compression force (CPPs). Plackett-Burman experimental design was applied to identify critical coating process parameters among selected ones that is: drying and preheating time, atomization air pressure, spray rate, air volume, inlet air temperature, and drum pressure that may influence the hardness and disintegration time of coated tablets. As a result of the research, design space was established to facilitate an in-depth understanding of existing relationship between CPPs and CQAs of intermediate product (uncoated tablets). Screening revealed that spray rate and inlet air temperature are two most important factors that affect the hardness of coated tablets. Simultaneously, none of the tested coating factors have influence on disintegration time. The observation was confirmed by conducting film coating of pilot size batches.

Chaotropic salts in liquid chromatographic method development for the determination of pramipexole and its impurities following quality-by-design principles.

PubMed

Vemić, Ana; Rakić, Tijana; Malenović, Anđelija; Medenica, Mirjana

2015-01-01

The aim of this paper is to present a development of liquid chromatographic method when chaotropic salts are used as mobile phase additives following the QbD principles. The effect of critical process parameters (column chemistry, salt nature and concentration, acetonitrile content and column temperature) on the critical quality attributes (retention of the first and last eluting peak and separation of the critical peak pairs) was studied applying the design of experiments-design space methodology (DoE-DS). D-optimal design is chosen in order to simultaneously examine both categorical and numerical factors in minimal number of experiments. Two ways for the achievement of quality assurance were performed and compared. Namely, the uncertainty originating from the models was assessed by Monte Carlo simulations propagating the error equal to the variance of the model residuals and propagating the error originating from the model coefficients' calculation. The baseline separation of pramipexole and its five impurities is achieved fulfilling all the required criteria while the method validation proved its reliability. Copyright © 2014 Elsevier B.V. All rights reserved.

Investigation into the Effect of Ethylcellulose Viscosity Variation on the Drug Release of Metoprolol Tartrate and Acetaminophen Extended Release Multiparticulates-Part I.

PubMed

Mehta, R; Teckoe, J; Schoener, C; Workentine, S; Ferrizzi, D; Rajabi-Siahboomi, A

2016-12-01

Ethylcellulose is one of the most commonly used polymers to develop reservoir type extended release multiparticulate dosage forms. For multiparticulate extended release dosage forms, the drug release is typically governed by the properties of the barrier membrane coating. The ICH Pharmaceutical Development Guideline (ICH Q8) requires an understanding of the influence of critical material attributes and critical process parameters on the drug release of a pharmaceutical product. Using this understanding, it is possible to develop robust formulations with consistent drug release characteristics. Critical material attributes for ethylcellulose were evaluated, and polymer molecular weight variation (viscosity) was considered to be the most critical attribute that can impact drug release. To investigate the effect of viscosity variation within the manufacturer's specifications of ethylcellulose, extended release multiparticulate formulations of two model drugs, metoprolol tartrate and acetaminophen, were developed using ETHOCEL™ as the rate controlling polymer. Quality by Design (QbD) samples of ETHOCEL Std. 10, 20, and 100 Premium grades representing the low, medium, and high molecular weight (viscosity) material were organically coated onto drug layered multiparticulates to a 15% weight gain (WG). The drug release was found to be similar (f 2  > 50) for both metoprolol tartrate and acetaminophen multiparticulates at different coating weight gains of ethylcellulose, highlighting consistent and robust drug release performance. The use of ETHOCEL QbD samples also serves as a means to develop multiparticulate dosage formulations according to regulatory guidelines.

Herbal hepatotoxicity: a critical review

PubMed Central

Teschke, Rolf; Frenzel, Christian; Glass, Xaver; Schulze, Johannes; Eickhoff, Axel

2013-01-01

This review deals with herbal hepatotoxicity, identical to herb induced liver injury (HILI), and critically summarizes the pitfalls associated with the evaluation of assumed HILI cases. Analysis of the relevant publications reveals that several dozens of different herbs and herbal products have been implicated to cause toxic liver disease, but major quality issues limit the validity of causality attribution. In most of these reports, discussions around quality specifications regarding herbal products, case data presentations and causality assessment methods prevail. Though the production of herbal drugs is under regulatory surveillance and quality aspects are normally not a matter of concern, low quality of the less regulated herbal supplements may be a critical issue considering product batch variability, impurities, adulterants and herb misidentifications. Regarding case data presentation, essential diagnostic information is often lacking, as is the use of valid and liver specific causality assessment methods that also consider alternative diseases. At present, causality is best assessed by using the Council for International Organizations of Medical Sciences scale ( CIOMS) in its original or updated form, which should primarily be applied prospectively by the treating physician when evaluating a patient rather than retrospectively by regulatory agencies. To cope with these problems, a common quality approach by manufacturers, physicians and regulatory agencies should strive for the best quality. We propose steps for improvements with impact on future cases of liver injury by herbs, herbal drugs and herbal supplements. PMID:22831551

Simultaneous monitoring of oxidation, deamidation, isomerization, and glycosylation of monoclonal antibodies by liquid chromatography-mass spectrometry method with ultrafast tryptic digestion.

PubMed

Wang, Yi; Li, Xiaojuan; Liu, Yan-Hui; Richardson, Daisy; Li, Huijuan; Shameem, Mohammed; Yang, Xiaoyu

Monoclonal antibodies are subjected to a wide variety of post-translational modifications (PTMs) that cause structural heterogeneity. Characterization and control of these modifications or quality attributes are critical to ensure antibody quality and to define any potential effects on the ultimate safety and potency of antibody therapeutics. The biopharmaceutical industry currently uses numerous tools to analyze these quality attributes individually, which requires substantial time and resources. Here, we report a simple and ultrafast bottom-up liquid chromatography-mass spectrometry (uLC-MS) method with 5 min tryptic digestion to simultaneously analyze multiple modifications, including oxidation, deamidation, isomerization, glycation, glycosylation, and N-terminal pyro-glutamate formation, which can occur during antibody production in mammalian cell culture, during purification and/or on storage. Compared to commonly used preparation procedures, this uLC-MS method eliminates assay artifacts of falsely-increased Met oxidation, Asp isomerization, and Asn deamidation, a problem associated with long digestion times in conventional LC-MS methods. This simple, low artifact multi-attribute uLC-MS method can be used to quickly and accurately analyze samples at any stage of antibody drug development, in particular for clone and media selection during cell culture development.

Integrated Application of Quality-by-Design Principles to Drug Product Development: A Case Study of Brivanib Alaninate Film-Coated Tablets.

PubMed

Badawy, Sherif I F; Narang, Ajit S; LaMarche, Keirnan R; Subramanian, Ganeshkumar A; Varia, Sailesh A; Lin, Judy; Stevens, Tim; Shah, Pankaj A

2016-01-01

Modern drug product development is expected to follow quality-by-design (QbD) paradigm. At the same time, although there are several issue-specific examples in the literature that demonstrate the application of QbD principles, a holistic demonstration of the application of QbD principles to drug product development and control strategy, is lacking. This article provides an integrated case study on the systematic application of QbD to product development and demonstrates the implementation of QbD concepts in the different aspects of product and process design for brivanib alaninate film-coated tablets. Using a risk-based approach, the strategy for development entailed identification of product critical quality attributes (CQAs), assessment of risks to the CQAs, and performing experiments to understand and mitigate identified risks. Quality risk assessments and design of experiments were performed to understand the quality of the input raw materials required for a robust formulation and the impact of manufacturing process parameters on CQAs. In addition to the material property and process parameter controls, the proposed control strategy includes use of process analytical technology and conventional analytical tests to control in-process material attributes and ensure quality of the final product. Copyright © 2016. Published by Elsevier Inc.

Real-time determination of critical quality attributes using near-infrared spectroscopy: a contribution for Process Analytical Technology (PAT).

PubMed

Rosas, Juan G; Blanco, Marcel; González, Josep M; Alcalà, Manel

2012-08-15

Process Analytical Technology (PAT) is playing a central role in current regulations on pharmaceutical production processes. Proper understanding of all operations and variables connecting the raw materials to end products is one of the keys to ensuring quality of the products and continuous improvement in their production. Near infrared spectroscopy (NIRS) has been successfully used to develop faster and non-invasive quantitative methods for real-time predicting critical quality attributes (CQA) of pharmaceutical granulates (API content, pH, moisture, flowability, angle of repose and particle size). NIR spectra have been acquired from the bin blender after granulation process in a non-classified area without the need of sample withdrawal. The methodology used for data acquisition, calibration modelling and method application in this context is relatively inexpensive and can be easily implemented by most pharmaceutical laboratories. For this purpose, Partial Least-Squares (PLS) algorithm was used to calculate multivariate calibration models, that provided acceptable Root Mean Square Error of Predictions (RMSEP) values (RMSEP(API)=1.0 mg/g; RMSEP(pH)=0.1; RMSEP(Moisture)=0.1%; RMSEP(Flowability)=0.6 g/s; RMSEP(Angle of repose)=1.7° and RMSEP(Particle size)=2.5%) that allowed the application for routine analyses of production batches. The proposed method affords quality assessment of end products and the determination of important parameters with a view to understanding production processes used by the pharmaceutical industry. As shown here, the NIRS technique is a highly suitable tool for Process Analytical Technologies. Copyright © 2012 Elsevier B.V. All rights reserved.

A quality function deployment framework for the service quality of health information websites.

PubMed

Chang, Hyejung; Kim, Dohoon

2010-03-01

This research was conducted to identify both the users' service requirements on health information websites (HIWs) and the key functional elements for running HIWs. With the quality function deployment framework, the derived service attributes (SAs) are mapped into the suppliers' functional characteristics (FCs) to derive the most critical FCs for the users' satisfaction. Using the survey data from 228 respondents, the SAs, FCs and their relationships were analyzed using various multivariate statistical methods such as principal component factor analysis, discriminant analysis, correlation analysis, etc. Simple and compound FC priorities were derived by matrix calculation. Nine factors of SAs and five key features of FCs were identified, and these served as the basis for the house of quality model. Based on the compound FC priorities, the functional elements pertaining to security and privacy, and usage support should receive top priority in the course of enhancing HIWs. The quality function deployment framework can improve the FCs of the HIWs in an effective, structured manner, and it can also be utilized for critical success factors together with their strategic implications for enhancing the service quality of HIWs. Therefore, website managers could efficiently improve website operations by considering this study's results.

Identifying critical thinking indicators and critical thinker attributes in nursing practice.

PubMed

Chao, Shu-Yuan; Liu, Hsing-Yuan; Wu, Ming-Chang; Clark, Mary Jo; Tan, Jung-Ying

2013-09-01

Critical thinking is an essential skill in the nursing process. Although several studies have evaluated the critical thinking skills of nurses, there is limited information related to the indicators of critical thinking or evaluation of critical thinking in the context of the nursing process. This study investigated the potential indicators of critical thinking and the attributes of critical thinkers in clinical nursing practice. Knowledge of these indicators can aid the development of tools to assess nursing students' critical thinking skills. The study was conducted between September 2009 and August 2010. In phase 1, a literature review and four focus groups were conducted to identify the indicators of critical thinking in the context of nursing and the attributes of critical thinkers. In phase 2, 30 nursing professionals participated in a modified Delphi research survey to establish consensus and the appropriateness of each indicator and attribute identified in phase 1. We identified 37 indicators of critical thinking and 10 attributes of critical thinkers. The indicators were categorized into five subscales within the context of the nursing process toreflect nursing clinical practice: assessment, 16 indicators of ability to apply professional knowledge and skills to analyze and interpret patient problems; diagnosis, five indicators of ability to propose preliminary suppositions; planning, five indicators of ability to develop problem-solving strategies; implementation, five indicators of ability to implement planning; and evaluation, six indicators of ability to self-assess and reflect. The study operationalized critical thinking into a practical indicator suitable for nursing contexts in which critical thinking is required for clinical problem solving. Identified indicators and attributes can assist clinical instructors to evaluate student critical thought skills and development-related teaching strategies.

Spouse Criticism/Hostility Toward Partners with Chronic Pain: The Role of Spouse Attributions for Patient Control over Pain Behaviors.

PubMed

Burns, John W; Gerhart, James; Post, Kristina M; Smith, David A; Porter, Laura S; Buvanendran, Asokumar; Fras, Anne Marie; Keefe, Francis J

2018-06-01

Spouse attributions regarding displays of pain behaviors by their partners with chronic pain may account for subsequent increases in spouse critical/hostile responses toward their partners. People with chronic low back pain (n = 105) and their pain-free spouses (n = 105) completed electronic diary measures five times per day for 14 consecutive days. Key items assessed spouse observations of patient pain behavior, attributions regarding these behaviors, and spouse critical/hostile responses toward patients. Results were: a) spouse observations of patient pain behavior at Time 1 predicted high levels of spouse critical/hostile responses toward the patient at Time 2; b) "internal" attributions (e.g., the patient was attempting to influence spouse's feelings) at Time 1 predicted high levels of spouse critical/hostile responses toward the patient at Time 2; c) internal attributions mediated links between spouse observed pain behaviors at Time 1 and levels of spouse critical/hostile responses at Time 2. Spouse observations of patient pain behavior was also related to an "external" attribution (i.e., patient pain behavior was due to pain condition), but this attribution was not a significant mediator. A vital factor linking spouse scrutiny to spouse critical/hostile responses may be the spouse's ascribed reasons for the patient's grimacing, bracing, complaining, and so forth. Results indicate that spouse internal and negative attributions for pain behaviors of their partners with chronic pain may influence subsequent spouse critical/hostile reactions to them. Findings suggest that replacing spouse internal and negative attributions with external, compassionate and accepting explanations may be useful therapeutic targets for couples coping with chronic pain. Copyright © 2018. Published by Elsevier Inc.

Influence of modified atmosphere and ethylene levels on quality attributes of fresh tomatoes (Lycopersicon esculentum Mill.).

PubMed

Domínguez, Irene; Lafuente, María T; Hernández-Muñoz, Pilar; Gavara, Rafael

2016-10-15

Controlling storage atmosphere is a key factor for delaying postharvest fruit quality loss. The objective of this study is to evaluate its influence on physico-chemical, sensorial and nutritional quality attributes of two tomato fruit cultivars (Delizia and Pitenza) that respectively have a short- and long-storage life. To that end, the effect of two types of bags with different gas permeability, combined or not with an ethylene sorbent, on tomato organoleptic and nutritional properties were compared during fruit storage at 13°C. CO2 and O2 were critical factors for controlling tomato postharvest behaviour. Weight loss, firmness, color and visual quality were only affected by bag permeability just as total sugar content and acidity for Pitenza tomatoes. (trans)-2-Hexenal also appears to be related with CO2 and O2 levels. Lycopene, total phenols (TP) and ascorbic acid (AA) contents were also affected by the packaging form and the storage length. Ethylene removal in combination with MAP led to a higher content in TP and AA in the short-life tomato cultivar. Copyright © 2016 Elsevier Ltd. All rights reserved.

Drifts in ADCC-related quality attributes of Herceptin®: Impact on development of a trastuzumab biosimilar.

PubMed

Kim, Seokkyun; Song, Jinsu; Park, Seungkyu; Ham, Sunyoung; Paek, Kyungyeol; Kang, Minjung; Chae, Yunjung; Seo, Heewon; Kim, Hyung-Chan; Flores, Michael

A biosimilar product needs to demonstrate biosimilarity to the originator reference product, and the quality profile of the latter should be monitored throughout the period of the biosimilar's development to match the quality attributes of the 2 products that relate to efficacy and safety. For the development of a biosimilar version of trastuzumab, the reference product, Herceptin®, was extensively characterized for the main physicochemical and biologic properties by standard or state-of-the-art analytical methods, using multiple lots expiring between March 2015 and December 2019. For lots with expiry dates up to July 2018, a high degree of consistency was observed for all the tested properties. However, among the lots expiring in August 2018 or later, a downward drift was observed in %afucose (G0+G1+G2). Furthermore, the upward drift of %high mannose (M5+M6) was observed in the lots with expiry dates from June 2019 to December 2019. As a result, the combination of %afucose and %high mannose showed 2 marked drifts in the lots with expiry dates from August 2018 to December 2019, which was supported by the similar trend of biologic data, such as FcγRIIIa binding and antibody-dependent cell-mediated cytotoxicity (ADCC) activity. Considering that ADCC is one of the clinically relevant mechanisms of action for trastuzumab, the levels of %afucose and %high mannose should be tightly monitored as critical quality attributes for biosimilar development of trastuzumab.

Drifts in ADCC-related quality attributes of Herceptin®: Impact on development of a trastuzumab biosimilar

PubMed Central

Kim, Seokkyun; Song, Jinsu; Park, Seungkyu; Ham, Sunyoung; Paek, Kyungyeol; Kang, Minjung; Chae, Yunjung; Seo, Heewon; Kim, Hyung-Chan; Flores, Michael

2017-01-01

ABSTRACT A biosimilar product needs to demonstrate biosimilarity to the originator reference product, and the quality profile of the latter should be monitored throughout the period of the biosimilar's development to match the quality attributes of the 2 products that relate to efficacy and safety. For the development of a biosimilar version of trastuzumab, the reference product, Herceptin®, was extensively characterized for the main physicochemical and biologic properties by standard or state-of-the-art analytical methods, using multiple lots expiring between March 2015 and December 2019. For lots with expiry dates up to July 2018, a high degree of consistency was observed for all the tested properties. However, among the lots expiring in August 2018 or later, a downward drift was observed in %afucose (G0+G1+G2). Furthermore, the upward drift of %high mannose (M5+M6) was observed in the lots with expiry dates from June 2019 to December 2019. As a result, the combination of %afucose and %high mannose showed 2 marked drifts in the lots with expiry dates from August 2018 to December 2019, which was supported by the similar trend of biologic data, such as FcγRIIIa binding and antibody-dependent cell-mediated cytotoxicity (ADCC) activity. Considering that ADCC is one of the clinically relevant mechanisms of action for trastuzumab, the levels of %afucose and %high mannose should be tightly monitored as critical quality attributes for biosimilar development of trastuzumab. PMID:28296619

Understanding effect of formulation and manufacturing variables on the critical quality attributes of warfarin sodium product.

PubMed

Rahman, Ziyaur; Korang-Yeboah, Maxwell; Siddiqui, Akhtar; Mohammad, Adil; Khan, Mansoor A

2015-11-10

Warfarin sodium (WS) is a narrow therapeutic index drug and its product quality should be thoroughly understood and monitored in order to avoid clinical performance issues. This study was focused on understanding the effect of manufacturing and formulation variables on WS product critical quality attributes (CQAs). Eight formulations were developed with lactose monohydrate (LM) or lactose anhydrous (LA), and were either wet granulated or directly compressed. Formulations were granulated either with ethanol, isopropyl alcohol (IPA) and IPA-water mixture (50:50). Formulations were characterized for IPA, water content, hardness, disintegration time (DT), assay, dissolution and drug physical forms (scanning electron microscopy (SEM), near infrared chemical imaging (NIR-CI), X-ray powder diffraction (XRPD) and solid state nuclear magnetic resonance (ssNMR)), and performed accelerated stability studies at 40°C/75% RH for three days. The DT and dissolution of directly compressed formulations were faster than wet granulated formulations. This was due to phase transformation of crystalline drug into its amorphous form as indicated by SEM, NIR-CI, XRPD and ssNMR data which itself act as a binder. Similarly, LM showed faster disintegration and dissolution than LA containing formulations. Stability results indicated an increase in hardness and DT, and a decrease in dissolution rate and extent. This was due to phase transformation of the drug and consolidation with particles' bonding. In conclusion, the CQAs of WS product were significantly affected by manufacturing and formulation variables. Published by Elsevier B.V.

Implementation of basic quality control tests for malaria medicines in Amazon Basin countries: results for the 2005–2010 period

PubMed Central

2012-01-01

Background Ensuring the quality of malaria medicines is crucial in working toward malaria control and eventual elimination. Unlike other validated tests that can assess all critical quality attributes, which is the standard for determining the quality of medicines, basic tests are significantly less expensive, faster, and require less skilled labour; yet, these tests provide reproducible data and information on several critical quality attributes, such as identity, purity, content, and disintegration. Visual and physical inspection also provides valuable information about the manufacturing and the labelling of medicines, and in many cases this inspection is sufficient to detect counterfeit medicines. The Promoting the Quality of Medicines (PQM) programme has provided technical assistance to Amazon Malaria Initiative (AMI) countries to implement the use of basic tests as a key screening mechanism to assess the quality of malaria medicines available to patients in decentralized regions. Methods Trained personnel from the National Malaria Control Programmes (NMCPs), often in collaboration with country’s Official Medicine Control Laboratory (OMCL), developed country- specific protocols that encompassed sampling methods, sample analysis, and data reporting. Sampling sites were selected based on malaria burden, accessibility, and geographical location. Convenience sampling was performed and countries were recommended to store the sampled medicines under conditions that did not compromise their quality. Basic analytical tests, such as disintegration and thin layer chromatography (TLC), were performed utilizing a portable mini-laboratory. Results Results were originally presented at regional meetings in a non-standardized format that lacked relevant medicines information. However, since 2008 information has been submitted utilizing a template specifically developed by PQM for that purpose. From 2005 to 2010, the quality of 1,663 malaria medicines from seven AMI countries was evaluated, mostly collected from the public sector, 1,445/1,663 (86.9%). Results indicate that 193/1,663 (11.6%) were found not to meet quality specifications. Most failures were reported during visual and physical inspection, 142/1663 (8.5%), and most of these were due to expired medicines, 118/142 (83.1%). Samples failing TLC accounted for 27/1,663 (1.6%) and those failing disintegration accounted for 24/1,663 (1.4%). Medicines quality failures decreased significantly during the last two years. Conclusions Basic tests revealed that the quality of medicines in the public sector improved over the years, since the implementation of this type of quality monitoring programme in 2005. However, the lack of consistent confirmatory tests in the quality control (QC) laboratory, utilizing methods that can also evaluate additional quality attributes, could still mask quality issues. In the future, AMI countries should improve coordination with their health authorities and their QC lab consistently, to provide a more complete picture of malaria medicines quality and support the implementation of corrective actions. Facilities in the private and informal sectors also should be included when these sectors constitute an important source of medicines used by malaria patients. PMID:22704680

Implementation of basic quality control tests for malaria medicines in Amazon Basin countries: results for the 2005-2010 period.

PubMed

Pribluda, Victor S; Barojas, Adrian; Añez, Arletta; López, Cecilia G; Figueroa, Ruth; Herrera, Roxana; Nakao, Gladys; Nogueira, Fernando Ha; Pianetti, Gerson A; Povoa, Marinete M; Viana, Giselle Mr; Gomes, Margarete S Mendonça; Escobar, Jose P; Sierra, Olga L Muñoz; Norena, Susana P Rendon; Veloz, Raúl; Bravo, Marcy Silva; Aldás, Martha R; Hindssemple, Alison; Collins, Marilyn; Ceron, Nicolas; Krishnalall, Karanchand; Adhin, Malti; Bretas, Gustavo; Hernandez, Nelly; Mendoza, Marjorie; Smine, Abdelkrim; Chibwe, Kennedy; Lukulay, Patrick; Evans, Lawrence

2012-06-15

Ensuring the quality of malaria medicines is crucial in working toward malaria control and eventual elimination. Unlike other validated tests that can assess all critical quality attributes, which is the standard for determining the quality of medicines, basic tests are significantly less expensive, faster, and require less skilled labour; yet, these tests provide reproducible data and information on several critical quality attributes, such as identity, purity, content, and disintegration. Visual and physical inspection also provides valuable information about the manufacturing and the labelling of medicines, and in many cases this inspection is sufficient to detect counterfeit medicines. The Promoting the Quality of Medicines (PQM) programme has provided technical assistance to Amazon Malaria Initiative (AMI) countries to implement the use of basic tests as a key screening mechanism to assess the quality of malaria medicines available to patients in decentralized regions. Trained personnel from the National Malaria Control Programmes (NMCPs), often in collaboration with country's Official Medicine Control Laboratory (OMCL), developed country- specific protocols that encompassed sampling methods, sample analysis, and data reporting. Sampling sites were selected based on malaria burden, accessibility, and geographical location. Convenience sampling was performed and countries were recommended to store the sampled medicines under conditions that did not compromise their quality. Basic analytical tests, such as disintegration and thin layer chromatography (TLC), were performed utilizing a portable mini-laboratory. Results were originally presented at regional meetings in a non-standardized format that lacked relevant medicines information. However, since 2008 information has been submitted utilizing a template specifically developed by PQM for that purpose. From 2005 to 2010, the quality of 1,663 malaria medicines from seven AMI countries was evaluated, mostly collected from the public sector, 1,445/1,663 (86.9%). Results indicate that 193/1,663 (11.6%) were found not to meet quality specifications. Most failures were reported during visual and physical inspection, 142/1663 (8.5%), and most of these were due to expired medicines, 118/142 (83.1%). Samples failing TLC accounted for 27/1,663 (1.6%) and those failing disintegration accounted for 24/1,663 (1.4%). Medicines quality failures decreased significantly during the last two years. Basic tests revealed that the quality of medicines in the public sector improved over the years, since the implementation of this type of quality monitoring programme in 2005. However, the lack of consistent confirmatory tests in the quality control (QC) laboratory, utilizing methods that can also evaluate additional quality attributes, could still mask quality issues. In the future, AMI countries should improve coordination with their health authorities and their QC lab consistently, to provide a more complete picture of malaria medicines quality and support the implementation of corrective actions. Facilities in the private and informal sectors also should be included when these sectors constitute an important source of medicines used by malaria patients.

Review of quality assessment tools for the evaluation of pharmacoepidemiological safety studies

PubMed Central

Neyarapally, George A; Hammad, Tarek A; Pinheiro, Simone P; Iyasu, Solomon

2012-01-01

Objectives Pharmacoepidemiological studies are an important hypothesis-testing tool in the evaluation of postmarketing drug safety. Despite the potential to produce robust value-added data, interpretation of findings can be hindered due to well-recognised methodological limitations of these studies. Therefore, assessment of their quality is essential to evaluating their credibility. The objective of this review was to evaluate the suitability and relevance of available tools for the assessment of pharmacoepidemiological safety studies. Design We created an a priori assessment framework consisting of reporting elements (REs) and quality assessment attributes (QAAs). A comprehensive literature search identified distinct assessment tools and the prespecified elements and attributes were evaluated. Primary and secondary outcome measures The primary outcome measure was the percentage representation of each domain, RE and QAA for the quality assessment tools. Results A total of 61 tools were reviewed. Most tools were not designed to evaluate pharmacoepidemiological safety studies. More than 50% of the reviewed tools considered REs under the research aims, analytical approach, outcome definition and ascertainment, study population and exposure definition and ascertainment domains. REs under the discussion and interpretation, results and study team domains were considered in less than 40% of the tools. Except for the data source domain, quality attributes were considered in less than 50% of the tools. Conclusions Many tools failed to include critical assessment elements relevant to observational pharmacoepidemiological safety studies and did not distinguish between REs and QAAs. Further, there is a lack of considerations on the relative weights of different domains and elements. The development of a quality assessment tool would facilitate consistent, objective and evidence-based assessments of pharmacoepidemiological safety studies. PMID:23015600

Use of mechanistic simulations as a quantitative risk-ranking tool within the quality by design framework.

PubMed

Stocker, Elena; Toschkoff, Gregor; Sacher, Stephan; Khinast, Johannes G

2014-11-20

The purpose of this study is to evaluate the use of computer simulations for generating quantitative knowledge as a basis for risk ranking and mechanistic process understanding, as required by ICH Q9 on quality risk management systems. In this specific publication, the main focus is the demonstration of a risk assessment workflow, including a computer simulation for the generation of mechanistic understanding of active tablet coating in a pan coater. Process parameter screening studies are statistically planned under consideration of impacts on a potentially critical quality attribute, i.e., coating mass uniformity. Based on computer simulation data the process failure mode and effects analysis of the risk factors is performed. This results in a quantitative criticality assessment of process parameters and the risk priority evaluation of failure modes. The factor for a quantitative reassessment of the criticality and risk priority is the coefficient of variation, which represents the coating mass uniformity. The major conclusion drawn from this work is a successful demonstration of the integration of computer simulation in the risk management workflow leading to an objective and quantitative risk assessment. Copyright © 2014. Published by Elsevier B.V.

Quality by Design approach to spray drying processing of crystalline nanosuspensions.

PubMed

Kumar, Sumit; Gokhale, Rajeev; Burgess, Diane J

2014-04-10

Quality by Design (QbD) principles were explored to understand spray drying process for the conversion of liquid nanosuspensions into solid nano-crystalline dry powders using indomethacin as a model drug. The effects of critical process variables: inlet temperature, flow and aspiration rates on critical quality attributes (CQAs): particle size, moisture content, percent yield and crystallinity were investigated employing a full factorial design. A central cubic design was employed to generate the response surface for particle size and percent yield. Multiple linear regression analysis and ANOVA were employed to identify and estimate the effect of critical parameters, establish their relationship with CQAs, create design space and model the spray drying process. Inlet temperature was identified as the only significant factor (p value <0.05) to affect dry powder particle size. Higher inlet temperatures caused drug surface melting and hence aggregation of the dried nano-crystalline powders. Aspiration and flow rates were identified as significant factors affecting yield (p value <0.05). Higher yields were obtained at higher aspiration and lower flow rates. All formulations had less than 3% (w/w) moisture content. Formulations dried at higher inlet temperatures had lower moisture compared to those dried at lower inlet temperatures. Published by Elsevier B.V.

Real-time assessment of critical quality attributes of a continuous granulation process.

PubMed

Fonteyne, Margot; Vercruysse, Jurgen; Díaz, Damián Córdoba; Gildemyn, Delphine; Vervaet, Chris; Remon, Jean Paul; De Beer, Thomas

2013-02-01

There exists the intention to shift pharmaceutical manufacturing of solid dosage forms from traditional batch production towards continuous production. The currently applied conventional quality control systems, based on sampling and time-consuming off-line analyses in analytical laboratories, would annul the advantages of continuous processing. It is clear that real-time quality assessment and control is indispensable for continuous production. This manuscript evaluates strengths and weaknesses of several complementary Process Analytical Technology (PAT) tools implemented in a continuous wet granulation process, which is part of a fully continuous from powder-to-tablet production line. The use of Raman and NIR-spectroscopy and a particle size distribution analyzer is evaluated for the real-time monitoring of critical parameters during the continuous wet agglomeration of an anhydrous theophylline- lactose blend. The solid state characteristics and particle size of the granules were analyzed in real-time and the critical process parameters influencing these granule characteristics were identified. The temperature of the granulator barrel, the amount of granulation liquid added and, to a lesser extent, the powder feed rate were the parameters influencing the solid state of the active pharmaceutical ingredient (API). A higher barrel temperature and a higher powder feed rate, resulted in larger granules.

Imaging-based logics for ornamental stone quality chart definition

NASA Astrophysics Data System (ADS)

Bonifazi, Giuseppe; Gargiulo, Aldo; Serranti, Silvia; Raspi, Costantino

2007-02-01

Ornamental stone products are commercially classified on the market according to several factors related both to intrinsic lythologic characteristics and to their visible pictorial attributes. Sometimes these latter aspects prevail in quality criteria definition and assessment. Pictorial attributes are in any case also influenced by the performed working actions and the utilized tools selected to realize the final stone manufactured product. Stone surface finishing is a critical task because it can contribute to enhance certain aesthetic features of the stone itself. The study was addressed to develop an innovative set of methodologies and techniques able to quantify the aesthetic quality level of stone products taking into account both the physical and the aesthetical characteristics of the stones. In particular, the degree of polishing of the stone surfaces and the presence of defects have been evaluated, applying digital image processing strategies. Morphological and color parameters have been extracted developing specific software architectures. Results showed as the proposed approaches allow to quantify the degree of polishing and to identify surface defects related to the intrinsic characteristics of the stone and/or the performed working actions.

Validation of feasibility and quality of chicken breast meat cooked under various water-cooking conditions.

PubMed

Chumngoen, Wanwisa; Chen, Hsin-Yi; Tan, Fa-Jui

2016-12-01

Under laboratory conditions, the qualities of boneless chicken breasts are commonly determined by placing them in a bag and cooking them in a water bath. The results are often applied as references for comparing the influences of cooking techniques. However, whether a sample cooked under this "laboratory" condition actually represents the meat cooked under the "real-life" condition in which meat is frequently cooked directly in water without packaging remains unclear. Whether the two cooking conditions lead to comparable results in meat quality should be determined. This study evaluated the influence of cooking conditions, including "placed-in-bag and cooked in a water bath (BC)" and "cooked directly in hot water (WC)" conditions, on the quality of chicken meat. The results reveal that BC samples had a longer cooking time. Deboned-and-skinless BC samples had a higher cooking loss and lower protein solubility (P < 0.01). BC samples with bone and skin had a higher lightness in both skin and muscle. No significant differences were observed in attributes, including shear force, collagen solubility, microstructures, redness, yellowness and descriptive sensory characteristics between treatments. Based on the results, considering the quality attributes that might be influenced, is critical when conducting relevant research. © 2016 Japanese Society of Animal Science.

Improving the public health sector in South Africa: eliciting public preferences using a discrete choice experiment.

PubMed

Honda, Ayako; Ryan, Mandy; van Niekerk, Robert; McIntyre, Diane

2015-06-01

The introduction of national health insurance (NHI), aimed at achieving universal coverage, is the most important issue currently on the South African health policy agenda. Improvement in public sector health-care provision is crucial for the successful implementation of NHI as, regardless of whether health-care services become more affordable and available, if the quality of the services provided is not acceptable, people will not use the services. Although there has been criticism of the quality of public sector health services, limited research is available to identify what communities regard as the greatest problems with the services. A discrete choice experiment (DCE) was undertaken to elicit public preferences on key dimensions of quality of care when selecting public health facilities in South Africa. Qualitative methods were applied to establish attributes and levels for the DCE. To elicit preferences, interviews with community members were held in two South African provinces: 491 in Western Cape and 499 in Eastern Cape. The availability of necessary medicine at health facilities has the greatest impact on the probability of attending public health facilities. Other clinical quality attributes (i.e. provision of expert advice and provision of a thorough examination) are more valued than non-clinical quality of care attributes (i.e. staff attitude, treatment by doctors or nurses, and waiting time). Treatment by a doctor was less valued than all other attributes. Communities are prepared to tolerate public sector health service characteristics such as a long waiting time, poor staff attitudes and lack of direct access to doctors if they receive the medicine they need, a thorough examination and a clear explanation of the diagnosis and prescribed treatment from health professionals. These findings prioritize issues that the South African government must address in order to meet their commitment to improve public sector health-care service provision. Published by Oxford University Press in association with The London School of Hygiene and Tropical Medicine © The Author 2014; all rights reserved.

An importance-performance analysis of hospital information system attributes: A nurses' perspective.

PubMed

Cohen, Jason F; Coleman, Emma; Kangethe, Matheri J

2016-02-01

Health workers have numerous concerns about hospital IS (HIS) usage. Addressing these concerns requires understanding the system attributes most important to their satisfaction and productivity. Following a recent HIS implementation, our objective was to identify priorities for managerial intervention based on user evaluations of the performance of the HIS attributes as well as the relative importance of these attributes to user satisfaction and productivity outcomes. We collected data along a set of attributes representing system quality, data quality, information quality, and service quality from 154 nurse users. Their quantitative responses were analysed using the partial least squares approach followed by an importance-performance analysis. Qualitative responses were analysed using thematic analysis to triangulate and supplement the quantitative findings. Two system quality attributes (responsiveness and ease of learning), one information quality attribute (detail), one service quality attribute (sufficient support), and three data quality attributes (records complete, accurate and never missing) were identified as high priorities for intervention. Our application of importance-performance analysis is unique in HIS evaluation and we have illustrated its utility for identifying those system attributes for which underperformance is not acceptable to users and therefore should be high priorities for intervention. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Inspiring the Life of the Mind: An Examination of the Roles of Residential College Environments and Motivational Attributes in Promoting Undergraduate Students' Inclination to Inquire and Capacity for Lifelong Learning

ERIC Educational Resources Information Center

Jessup-Anger, Jody E.

2009-01-01

As postsecondary education is promoted as necessary for participating in the 21st century knowledge economy, academics, policymakers, and the public have voiced concerns about the quality and coherence of undergraduate education (AAC & U, 2007; Barr and Tagg, 1995; U.S. Department of Education, 2006). Critics point to the size, scope, and multiple…

A Quality Function Deployment Framework for the Service Quality of Health Information Websites

PubMed Central

Kim, Dohoon

2010-01-01

Objectives This research was conducted to identify both the users' service requirements on health information websites (HIWs) and the key functional elements for running HIWs. With the quality function deployment framework, the derived service attributes (SAs) are mapped into the suppliers' functional characteristics (FCs) to derive the most critical FCs for the users' satisfaction. Methods Using the survey data from 228 respondents, the SAs, FCs and their relationships were analyzed using various multivariate statistical methods such as principal component factor analysis, discriminant analysis, correlation analysis, etc. Simple and compound FC priorities were derived by matrix calculation. Results Nine factors of SAs and five key features of FCs were identified, and these served as the basis for the house of quality model. Based on the compound FC priorities, the functional elements pertaining to security and privacy, and usage support should receive top priority in the course of enhancing HIWs. Conclusions The quality function deployment framework can improve the FCs of the HIWs in an effective, structured manner, and it can also be utilized for critical success factors together with their strategic implications for enhancing the service quality of HIWs. Therefore, website managers could efficiently improve website operations by considering this study's results. PMID:21818418

A quality by design study applied to an industrial pharmaceutical fluid bed granulation.

PubMed

Lourenço, Vera; Lochmann, Dirk; Reich, Gabriele; Menezes, José C; Herdling, Thorsten; Schewitz, Jens

2012-06-01

The pharmaceutical industry is encouraged within Quality by Design (QbD) to apply science-based manufacturing principles to assure quality not only of new but also of existing processes. This paper presents how QbD principles can be applied to an existing industrial pharmaceutical fluid bed granulation (FBG) process. A three-step approach is presented as follows: (1) implementation of Process Analytical Technology (PAT) monitoring tools at the industrial scale process, combined with multivariate data analysis (MVDA) of process and PAT data to increase the process knowledge; (2) execution of scaled-down designed experiments at a pilot scale, with adequate PAT monitoring tools, to investigate the process response to intended changes in Critical Process Parameters (CPPs); and finally (3) the definition of a process Design Space (DS) linking CPPs to Critical to Quality Attributes (CQAs), within which product quality is ensured by design, and after scale-up enabling its use at the industrial process scale. The proposed approach was developed for an existing industrial process. Through enhanced process knowledge established a significant reduction in product CQAs, variability already within quality specifications ranges was achieved by a better choice of CPPs values. The results of such step-wise development and implementation are described. Copyright © 2012 Elsevier B.V. All rights reserved.

Beef quality attributes: A systematic review of consumer perspectives.

PubMed

Henchion, Maeve M; McCarthy, Mary; Resconi, Virginia C

2017-06-01

Informed by quality theory, this systematic literature review seeks to determine the relative importance of beef quality attributes from a consumer perspective, considering search, experience and credence quality attributes. While little change is anticipated in consumer ranking of search and experience attributes in the future, movement is expected in terms of ranking within the credence category and also in terms of the ranking of credence attributes overall. This highlights an opportunity for quality assurance schemes (QAS) to become more consumer focused through including a wider range of credence attributes. To capitalise on this opportunity, the meat industry should actively anticipate new relevant credence attributes and researchers need to develop new or better methods to measure them. This review attempts to identify the most relevant quality attributes in beef that may be considered in future iterations of QAS, to increase consumer satisfaction and, potentially, to increase returns to industry. Copyright © 2017 Elsevier Ltd. All rights reserved.

Patient perspectives of telemedicine quality

PubMed Central

LeRouge, Cynthia M; Garfield, Monica J; Hevner, Alan R

2015-01-01

Background The purpose of this study was to explore the quality attributes required for effective telemedicine encounters from the perspective of the patient. Methods We used a multi-method (direct observation, focus groups, survey) field study to collect data from patients who had experienced telemedicine encounters. Multi-perspectives (researcher and provider) were used to interpret a rich set of data from both a research and practice perspective. Results The result of this field study is a taxonomy of quality attributes for telemedicine service encounters that prioritizes the attributes from the patient perspective. We identify opportunities to control the level of quality for each attribute (ie, who is responsible for control of each attribute and when control can be exerted in relation to the encounter process). This analysis reveals that many quality attributes are in the hands of various stakeholders, and all attributes can be addressed proactively to some degree before the encounter begins. Conclusion Identification of the quality attributes important to a telemedicine encounter from a patient perspective enables one to better design telemedicine encounters. This preliminary work not only identifies such attributes, but also ascertains who is best able to address quality issues prior to an encounter. For practitioners, explicit representation of the quality attributes of technology-based systems and processes and insight on controlling key attributes are essential to implementation, utilization, management, and common understanding. PMID:25565781

Quality risk management of top spray fluidized bed process for antihypertensive drug formulation with control strategy engendered by Box-behnken experimental design space.

PubMed

Mukharya, Amit; Patel, Paresh U; Shenoy, Dinesh; Chaudhary, Shivang

2013-01-01

Lacidipine (LCDP) is a very low soluble and highly biovariable calcium channel blocker used in the treatment of hypertension. To increase its apparent solubility and to reduce its biovariability, solid dispersion fluid bed processing technology was explored, as it produces highly dispersible granules with a characteristic porous structure that enhances dispersibility, wettability, blend uniformity (by dissolving and spraying a solution of actives), flow ability and compressibility of granules for tableting and reducing variability by uniform drug-binder solution distribution on carrier molecules. Main object of this quality risk management (QRM) study is to provide a sophisticated "robust and rugged" Fluidized Bed Process (FBP) for the preparation of LCDP tablets with desired quality (stability) and performance (dissolution) by quality by design (QbD) concept. THIS STUDY IS PRINCIPALLY FOCUSING ON THOROUGH MECHANISTIC UNDERSTANDING OF THE FBP BY WHICH IT IS DEVELOPED AND SCALED UP WITH A KNOWLEDGE OF THE CRITICAL RISKS INVOLVED IN MANUFACTURING PROCESS ANALYZED BY RISK ASSESSMENT TOOLS LIKE: Qualitative Initial Risk-based Matrix Analysis (IRMA) and Quantitative Failure Mode Effective Analysis (FMEA) to identify and rank parameters with potential to have an impact on In Process/Finished Product Critical Quality Attributes (IP/FP CQAs). These Critical Process Parameters (CPPs) were further refined by DoE and MVDA to develop design space with Real Time Release Testing (RTRT) that leads to implementation of a control strategy to achieve consistent finished product quality at lab scale itself to prevent possible product failure at larger manufacturing scale.

Quality risk management of top spray fluidized bed process for antihypertensive drug formulation with control strategy engendered by Box-behnken experimental design space

PubMed Central

Mukharya, Amit; Patel, Paresh U; Shenoy, Dinesh; Chaudhary, Shivang

2013-01-01

Introduction: Lacidipine (LCDP) is a very low soluble and highly biovariable calcium channel blocker used in the treatment of hypertension. To increase its apparent solubility and to reduce its biovariability, solid dispersion fluid bed processing technology was explored, as it produces highly dispersible granules with a characteristic porous structure that enhances dispersibility, wettability, blend uniformity (by dissolving and spraying a solution of actives), flow ability and compressibility of granules for tableting and reducing variability by uniform drug-binder solution distribution on carrier molecules. Materials and Methods: Main object of this quality risk management (QRM) study is to provide a sophisticated “robust and rugged” Fluidized Bed Process (FBP) for the preparation of LCDP tablets with desired quality (stability) and performance (dissolution) by quality by design (QbD) concept. Results and Conclusion: This study is principally focusing on thorough mechanistic understanding of the FBP by which it is developed and scaled up with a knowledge of the critical risks involved in manufacturing process analyzed by risk assessment tools like: Qualitative Initial Risk-based Matrix Analysis (IRMA) and Quantitative Failure Mode Effective Analysis (FMEA) to identify and rank parameters with potential to have an impact on In Process/Finished Product Critical Quality Attributes (IP/FP CQAs). These Critical Process Parameters (CPPs) were further refined by DoE and MVDA to develop design space with Real Time Release Testing (RTRT) that leads to implementation of a control strategy to achieve consistent finished product quality at lab scale itself to prevent possible product failure at larger manufacturing scale. PMID:23799202

Development of a validated liquid chromatographic method for quantification of sorafenib tosylate in the presence of stress-induced degradation products and in biological matrix employing analytical quality by design approach.

PubMed

Sharma, Teenu; Khurana, Rajneet Kaur; Jain, Atul; Katare, O P; Singh, Bhupinder

2018-05-01

The current research work envisages an analytical quality by design-enabled development of a simple, rapid, sensitive, specific, robust and cost-effective stability-indicating reversed-phase high-performance liquid chromatographic method for determining stress-induced forced-degradation products of sorafenib tosylate (SFN). An Ishikawa fishbone diagram was constructed to embark upon analytical target profile and critical analytical attributes, i.e. peak area, theoretical plates, retention time and peak tailing. Factor screening using Taguchi orthogonal arrays and quality risk assessment studies carried out using failure mode effect analysis aided the selection of critical method parameters, i.e. mobile phase ratio and flow rate potentially affecting the chosen critical analytical attributes. Systematic optimization using response surface methodology of the chosen critical method parameters was carried out employing a two-factor-three-level-13-run, face-centered cubic design. A method operable design region was earmarked providing optimum method performance using numerical and graphical optimization. The optimum method employed a mobile phase composition consisting of acetonitrile and water (containing orthophosphoric acid, pH 4.1) at 65:35 v/v at a flow rate of 0.8 mL/min with UV detection at 265 nm using a C 18 column. Response surface methodology validation studies confirmed good efficiency and sensitivity of the developed method for analysis of SFN in mobile phase as well as in human plasma matrix. The forced degradation studies were conducted under different recommended stress conditions as per ICH Q1A (R2). Mass spectroscopy studies showed that SFN degrades in strongly acidic, alkaline and oxidative hydrolytic conditions at elevated temperature, while the drug was per se found to be photostable. Oxidative hydrolysis using 30% H 2 O 2 showed maximum degradation with products at retention times of 3.35, 3.65, 4.20 and 5.67 min. The absence of any significant change in the retention time of SFN and degradation products, formed under different stress conditions, ratified selectivity and specificity of the systematically developed method. Copyright © 2017 John Wiley & Sons, Ltd.

A new definition of pharmaceutical quality: assembly of a risk simulation platform to investigate the impact of manufacturing/product variability on clinical performance.

PubMed

Short, Steven M; Cogdill, Robert P; D'Amico, Frank; Drennen, James K; Anderson, Carl A

2010-12-01

The absence of a unanimous, industry-specific definition of quality is, to a certain degree, impeding the progress of ongoing efforts to "modernize" the pharmaceutical industry. This work was predicated on requests by Dr. Woodcock (FDA) to re-define pharmaceutical quality in terms of risk by linking production characteristics to clinical attributes. A risk simulation platform that integrates population statistics, drug delivery system characteristics, dosing guidelines, patient compliance estimates, production metrics, and pharmacokinetic, pharmacodynamic, and in vitro-in vivo correlation models to investigate the impact of manufacturing variability on clinical performance of a model extended-release theophylline solid oral dosage system was developed. Manufacturing was characterized by inter- and intra-batch content uniformity and dissolution variability metrics, while clinical performance was described by a probabilistic pharmacodynamic model that expressed the probability of inefficacy and toxicity as a function of plasma concentrations. Least-squares regression revealed that both patient compliance variables, percent of doses taken and dosing time variability, significantly impacted efficacy and toxicity. Additionally, intra-batch content uniformity variability elicited a significant change in risk scores for the two adverse events and, therefore, was identified as a critical quality attribute. The proposed methodology demonstrates that pharmaceutical quality can be recast to explicitly reflect clinical performance. © 2010 Wiley-Liss, Inc. and the American Pharmacists Association

Integrating the Development of Graduate Attributes through Constructive Alignment

ERIC Educational Resources Information Center

Treleaven, Lesley; Voola, Ranjit

2008-01-01

The importance of graduate attributes is increasingly recognized internationally in higher education and by industry, government, and accrediting bodies. However, integrating the development of graduate attributes, such as critical thinking and critical reflection, has proved challenging in business education. This article demonstrates the value…

Hydrophobic polymers for orodispersible films: a quality by design approach.

PubMed

Borges, Ana Filipa; Silva, Branca M A; Silva, Cláudia; Coelho, Jorge F J; Simões, Sérgio

2016-10-01

To develop orodispersible films (ODF) based on hydrophobic polymers with higher stability to ordinary environmental humidity conditions without compromising their fast disintegration time. A quality by design approach was applied to screen three different formulations each one based on a different hydrophobic polymer: polyvinyl acetate, methacrylate-based copolymer and shellac. The screening formulations were characterized regarding their mechanical properties, residual water content, disintegration time and appearance, in order to find a suitable ODF formulation according to established critical quality attributes. The selected critical process parameters for the selection of appropriate ODF formulations were the percentage of the different excipients and the plasticizer type. Three hydrophobic-based matrices with fast disintegration were developed. These were generically composed by a hydrophobic polymer, a stabilizer, a disintegrant and a plasticizer. It verified that the common components within the three different formulations behave differently depending on the system/chemical environment that they were included. It was shown that it is possible to develop oral films based on hydrophobic polymers with fast disintegration time, good texture and appearance, breaking a paradigm of the ODF research field.

Dried fruits quality assessment by hyperspectral imaging

NASA Astrophysics Data System (ADS)

Serranti, Silvia; Gargiulo, Aldo; Bonifazi, Giuseppe

2012-05-01

Dried fruits products present different market values according to their quality. Such a quality is usually quantified in terms of freshness of the products, as well as presence of contaminants (pieces of shell, husk, and small stones), defects, mould and decays. The combination of these parameters, in terms of relative presence, represent a fundamental set of attributes conditioning dried fruits humans-senses-detectable-attributes (visual appearance, organolectic properties, etc.) and their overall quality in terms of marketable products. Sorting-selection strategies exist but sometimes they fail when a higher degree of detection is required especially if addressed to discriminate between dried fruits of relatively small dimensions and when aiming to perform an "early detection" of pathogen agents responsible of future moulds and decays development. Surface characteristics of dried fruits can be investigated by hyperspectral imaging (HSI). In this paper, specific and "ad hoc" applications addressed to propose quality detection logics, adopting a hyperspectral imaging (HSI) based approach, are described, compared and critically evaluated. Reflectance spectra of selected dried fruits (hazelnuts) of different quality and characterized by the presence of different contaminants and defects have been acquired by a laboratory device equipped with two HSI systems working in two different spectral ranges: visible-near infrared field (400-1000 nm) and near infrared field (1000-1700 nm). The spectra have been processed and results evaluated adopting both a simple and fast wavelength band ratio approach and a more sophisticated classification logic based on principal component (PCA) analysis.

Evaluation of the visual performance of image processing pipes: information value of subjective image attributes

NASA Astrophysics Data System (ADS)

Nyman, G.; Häkkinen, J.; Koivisto, E.-M.; Leisti, T.; Lindroos, P.; Orenius, O.; Virtanen, T.; Vuori, T.

2010-01-01

Subjective image quality data for 9 image processing pipes and 8 image contents (taken with mobile phone camera, 72 natural scene test images altogether) from 14 test subjects were collected. A triplet comparison setup and a hybrid qualitative/quantitative methodology were applied. MOS data and spontaneous, subjective image quality attributes to each test image were recorded. The use of positive and negative image quality attributes by the experimental subjects suggested a significant difference between the subjective spaces of low and high image quality. The robustness of the attribute data was shown by correlating DMOS data of the test images against their corresponding, average subjective attribute vector length data. The findings demonstrate the information value of spontaneous, subjective image quality attributes in evaluating image quality at variable quality levels. We discuss the implications of these findings for the development of sensitive performance measures and methods in profiling image processing systems and their components, especially at high image quality levels.

Empirical research on Kano’s model and customer satisfaction

PubMed Central

Lin, Feng-Han; Tsai, Sang-Bing; Lee, Yu-Cheng; Hsiao, Cheng-Fu; Zhou, Jie; Wang, Jiangtao; Shang, Zhiwen

2017-01-01

Products are now developed based on what customers desire, and thus attractive quality creation has become crucial. In studies on customer satisfaction, methods for analyzing quality attributes and enhancing customer satisfaction have been proposed to facilitate product development. Although substantial studies have performed to assess the impact of the attributes on customer satisfaction, little research has been conducted that quantitatively calculate the odds of customer satisfaction for the Kano classification, fitting a nonlinear relationship between attribute-level performance and customer satisfaction. In the present study, the odds of customer satisfaction were determined to identify the classification of quality attributes, and took customer psychology into account to suggest how decision-makers should prioritize the allocation of resources. A novel method for quantitatively assessing quality attributes was proposed to determine classification criteria and fit the nonlinear relationship between quality attributes and customer satisfaction. Subsequently, a case study was conducted on bicycle user satisfaction to verify the novel method. The concept of customer satisfaction odds was integrated with the value function from prospect theory to understand quality attributes. The results of this study can serve as a reference for product designers to create attractive quality attributes in their products and thus enhance customer satisfaction. PMID:28873418

Empirical research on Kano's model and customer satisfaction.

PubMed

Lin, Feng-Han; Tsai, Sang-Bing; Lee, Yu-Cheng; Hsiao, Cheng-Fu; Zhou, Jie; Wang, Jiangtao; Shang, Zhiwen

2017-01-01

Products are now developed based on what customers desire, and thus attractive quality creation has become crucial. In studies on customer satisfaction, methods for analyzing quality attributes and enhancing customer satisfaction have been proposed to facilitate product development. Although substantial studies have performed to assess the impact of the attributes on customer satisfaction, little research has been conducted that quantitatively calculate the odds of customer satisfaction for the Kano classification, fitting a nonlinear relationship between attribute-level performance and customer satisfaction. In the present study, the odds of customer satisfaction were determined to identify the classification of quality attributes, and took customer psychology into account to suggest how decision-makers should prioritize the allocation of resources. A novel method for quantitatively assessing quality attributes was proposed to determine classification criteria and fit the nonlinear relationship between quality attributes and customer satisfaction. Subsequently, a case study was conducted on bicycle user satisfaction to verify the novel method. The concept of customer satisfaction odds was integrated with the value function from prospect theory to understand quality attributes. The results of this study can serve as a reference for product designers to create attractive quality attributes in their products and thus enhance customer satisfaction.

Biopharmaceutical Evaluation and CMC Aspects of Oral Modified Release Formulations.

PubMed

Chang, Rong-Kun; Mathias, Neil; Hussain, Munir A

2017-09-01

This article discusses the range of outcomes from biopharmaceutical studies of specific modified release (MR) product examples in preclinical models and humans. It touches upon five major biopharmaceutical areas for MR drug products: (1) evidence for regional permeability throughout the GI tract, (2) susceptibility to food-effect, (3) susceptibility to pH-effect, (4) impact of chronopharmacology in designing MR products, and (5) implications to narrow therapeutic index products. Robust bioperformance requires that product quality is met through a thorough understanding of the appropriate critical quality attributes that ensure reliable and robust manufacture of a MR dosage form. The quality-by-design (QbD) aspects of MR dosage form design and development are discussed with the emphasis on the regulatory view of the data required to support dosage form development.

Main Quality Attributes of Monoclonal Antibodies and Effect of Cell Culture Components

PubMed

Torkashvand, Fatemeh; Vaziri, Behrouz

2017-05-01

The culture media optimization is an inevitable part of upstream process development in therapeutic monoclonal antibodies (mAbs) production. The quality by design (QbD) approach defines the assured quality of the final product through the development stage. An important step in QbD is determination of the main quality attributes. During the media optimization, some of the main quality attributes such as glycosylation pattern, charge variants, aggregates, and low-molecular-weight species, could be significantly altered. Here, we provide an overview of how cell culture medium components affects the main quality attributes of the mAbs. Knowing the relationship between the culture media components and the main quality attributes could be successfully utilized for a rational optimization of mammalian cell culture media for industrial mAbs production.

Quality by design approach in the development of an ultra-high-performance liquid chromatography method for Bexsero meningococcal group B vaccine.

PubMed

Nompari, Luca; Orlandini, Serena; Pasquini, Benedetta; Campa, Cristiana; Rovini, Michele; Del Bubba, Massimo; Furlanetto, Sandra

2018-02-01

Bexsero is the first approved vaccine for active immunization of individuals from 2 months of age and older to prevent invasive disease caused by Neisseria meningitidis serogroup B. The active components of the vaccine are Neisseria Heparin Binding Antigen, factor H binding protein, Neisseria adhesin A, produced in Escherichia coli cells by recombinant DNA technology, and Outer Membrane Vesicles (expressing Porin A and Porin B), produced by fermentation of Neisseria meningitidis strain NZ98/254. All the Bexsero active components are adsorbed on aluminum hydroxide and the unadsorbed antigens content is a product critical quality attribute. In this paper the development of a fast, selective and sensitive ultra-high-performance liquid chromatography (UHPLC) method for the determination of the Bexsero antigens in the vaccine supernatant is presented. For the first time in the literature, the Quality by Design (QbD) principles were applied to the development of an analytical method aimed to the quality control of a vaccine product. The UHPLC method was fully developed within the QbD framework, the new paradigm of quality outlined in International Conference on Harmonisation guidelines. Critical method attributes (CMAs) were identified with the capacity factor of Neisseria Heparin Binding Antigen, antigens resolution and peak areas. After a scouting phase, aimed at selecting a suitable and fast UHPLC operative mode for the vaccine antigens separation, risk assessment tools were employed to define the critical method parameters to be considered in the screening phase. Screening designs were applied for investigating at first the effects of vial type and sample concentration, and then the effects of injection volume, column type, organic phase starting concentration, ramp time and temperature. Response Surface Methodology pointed out the presence of several significant interaction effects, and with the support of Monte-Carlo simulations led to map out the design space, at a selected probability level, for the desired CMAs. The selected working conditions gave a complete separation of the antigens in about 5min. Robustness testing was carried out by a multivariate approach and a control strategy was implemented by defining system suitability tests. The method was qualified for the analysis of the Bexsero vaccine. Copyright © 2017 Elsevier B.V. All rights reserved.

Process design and control of a twin screw hot melt extrusion for continuous pharmaceutical tamper-resistant tablet production.

PubMed

Baronsky-Probst, J; Möltgen, C-V; Kessler, W; Kessler, R W

2016-05-25

Hot melt extrusion (HME) is a well-known process within the plastic and food industries that has been utilized for the past several decades and is increasingly accepted by the pharmaceutical industry for continuous manufacturing. For tamper-resistant formulations of e.g. opioids, HME is the most efficient production technique. The focus of this study is thus to evaluate the manufacturability of the HME process for tamper-resistant formulations. Parameters such as the specific mechanical energy (SME), as well as the melt pressure and its standard deviation, are important and will be discussed in this study. In the first step, the existing process data are analyzed by means of multivariate data analysis. Key critical process parameters such as feed rate, screw speed, and the concentration of the API in the polymers are identified, and critical quality parameters of the tablet are defined. In the second step, a relationship between the critical material, product and process quality attributes are established by means of Design of Experiments (DoEs). The resulting SME and the temperature at the die are essential data points needed to indirectly qualify the degradation of the API, which should be minimal. NIR-spectroscopy is used to monitor the material during the extrusion process. In contrast to most applications in which the probe is directly integrated into the die, the optical sensor is integrated into the cooling line of the strands. This saves costs in the probe design and maintenance and increases the robustness of the chemometric models. Finally, a process measurement system is installed to monitor and control all of the critical attributes in real-time by means of first principles, DoE models, soft sensor models, and spectroscopic information. Overall, the process is very robust as long as the screw speed is kept low. Copyright © 2015 Elsevier B.V. All rights reserved.

Developing critical consciousness or justifying the system? A qualitative analysis of attributions for poverty and wealth among low-income racial/ethnic minority and immigrant women

PubMed Central

Godfrey, Erin B.; Wolf, Sharon

2015-01-01

Objectives Economic inequality is a growing concern in the United States and globally. The current study uses qualitative techniques to (1) explore the attributions low-income racial/ethnic minority and immigrant women make for poverty and wealth in the U.S., and (2) clarify important links between attributions, critical consciousness development and system justification theory. Methods In-depth interview transcripts from 19 low-income immigrant Dominican and Mexican and native African-American mothers in a large Northeastern city were analyzed using open coding techniques. Interview topics included perceptions of current economic inequality and mobility and experiences of daily economic hardships. Results Almost all respondents attributed economic inequality to individual factors (character flaws, lack of hard work). Structural explanations for poverty and wealth were expressed by less than half the sample and almost always paired with individual explanations. Moreover, individual attributions included system-justifying beliefs such as the belief in meritocracy and equality of opportunity and structural attributions represented varying levels of critical consciousness. Conclusions Our analysis sheds new light on how and why individuals simultaneously hold individual and structural attributions and highlights key links between system justification and critical consciousness. It shows that critical consciousness and system justification do not represent opposite stances along a single underlying continuum, but are distinct belief systems and motivations. It also suggests that the motive to justify the system is a key psychological process impeding the development of critical consciousness. Implications for scholarship and intervention are discussed. PMID:25915116

Developing critical consciousness or justifying the system? A qualitative analysis of attributions for poverty and wealth among low-income racial/ethnic minority and immigrant women.

PubMed

Godfrey, Erin B; Wolf, Sharon

2016-01-01

Economic inequality is a growing concern in the United States and globally. The current study uses qualitative techniques to (a) explore the attributions low-income racial/ethnic minority and immigrant women make for poverty and wealth in the U.S., and (b) clarify important links between attributions, critical consciousness development, and system justification theory. In-depth interview transcripts from 19 low-income immigrant Dominican and Mexican and native African American mothers in a large Northeastern city were analyzed using open coding techniques. Interview topics included perceptions of current economic inequality and mobility and experiences of daily economic hardships. Almost all respondents attributed economic inequality to individual factors (character flaws, lack of hard work). Structural explanations for poverty and wealth were expressed by fewer than half the sample and almost always paired with individual explanations. Moreover, individual attributions included system-justifying beliefs such as the belief in meritocracy and equality of opportunity and structural attributions represented varying levels of critical consciousness. Our analysis sheds new light on how and why individuals simultaneously hold individual and structural attributions and highlights key links between system justification and critical consciousness. It shows that critical consciousness and system justification do not represent opposite stances along a single underlying continuum, but are distinct belief systems and motivations. It also suggests that the motive to justify the system is a key psychological process impeding the development of critical consciousness. Implications for scholarship and intervention are discussed. (c) 2016 APA, all rights reserved).

Quality index of radiological devices: results of one year of use.

PubMed

Tofani, Alessandro; Imbordino, Patrizia; Lecci, Antonio; Bonannini, Claudia; Del Corona, Alberto; Pizzi, Stefano

2003-01-01

The physical quality index (QI) of radiological devices summarises in a single numerical value between 0 and 1 the results of constancy tests. The aim of this paper is to illustrate the results of the use of such an index on all public radiological devices in the Livorno province over one year. The quality index was calculated for 82 radiological devices of a wide range of types by implementing its algorithm in a spreadsheet-based software for the automatic handling of quality control data. The distribution of quality index values was computed together with the associated statistical quantities. This distribution is strongly asymmetrical, with a sharp peak near the highest QI values. The mean quality index values for the different types of device show some inhomogeneity: in particular, mammography and panoramic dental radiography devices show far lower quality than other devices. In addition, our analysis has identified the parameters that most frequently do not pass the quality tests for each type of device. Finally, we sought some correlation between quality and age of the device, but this was poorly significant. The quality index proved to be a useful tool providing an overview of the physical conditions of radiological devices. By selecting adequate QI threshold values for, it also helps to decide whether a given device should be upgraded or replaced. The identification of critical parameters for each type of device may be used to improve the definition of the QI by attributing greater weights to critical parameters, so as to better address the maintenance of radiological devices.

Critical Thinking as a Leadership Attribute.

PubMed

Werner, Stacy H; Bleich, Michael R

2017-01-01

Leaders are tasked with making decisions that have substantial impact on an organization's well-being. Decision making requires critical thinking and requisite action taking. The nature of critical thinking and how professional development educators can strengthen this attribute are presented. J Contin Educ Nurs. 2017;48(1):9-11. Copyright 2017, SLACK Incorporated.

An approach to detecting deliberately introduced defects and micro-defects in 3D printed objects

NASA Astrophysics Data System (ADS)

Straub, Jeremy

2017-05-01

In prior work, Zeltmann, et al. demonstrated the negative impact that can be created by defects of various sizes in 3D printed objects. These defects may make the object unsuitable for its application or even present a hazard, if the object is being used for a safety-critical application. With the uses of 3D printing proliferating and consumer access to printers increasing, the desire of a nefarious individual or group to subvert the desired printing quality and safety attributes of a printer or printed object must be considered. Several different approaches to subversion may exist. Attackers may physically impair the functionality of the printer or launch a cyber-attack. Detecting introduced defects, from either attack, is critical to maintaining public trust in 3D printed objects and the technology. This paper presents an alternate approach. It applies a quality assurance technology based on visible light sensing to this challenge and assesses its capability for detecting introduced defects of multiple sizes.

A quality by design approach to optimization of emulsions for electrospinning using factorial and D-optimal designs.

PubMed

Badawi, Mariam A; El-Khordagui, Labiba K

2014-07-16

Emulsion electrospinning is a multifactorial process used to generate nanofibers loaded with hydrophilic drugs or macromolecules for diverse biomedical applications. Emulsion electrospinnability is greatly impacted by the emulsion pharmaceutical attributes. The aim of this study was to apply a quality by design (QbD) approach based on design of experiments as a risk-based proactive approach to achieve predictable critical quality attributes (CQAs) in w/o emulsions for electrospinning. Polycaprolactone (PCL)-thickened w/o emulsions containing doxycycline HCl were formulated using a Span 60/sodium lauryl sulfate (SLS) emulsifier blend. The identified emulsion CQAs (stability, viscosity and conductivity) were linked with electrospinnability using a 3(3) factorial design to optimize emulsion composition for phase stability and a D-optimal design to optimize stable emulsions for viscosity and conductivity after shifting the design space. The three independent variables, emulsifier blend composition, organic:aqueous phase ratio and polymer concentration, had a significant effect (p<0.05) on emulsion CQAs, the emulsifier blend composition exerting prominent main and interaction effects. Scanning electron microscopy (SEM) of emulsion-electrospun NFs and desirability functions allowed modeling of emulsion CQAs to predict electrospinnable formulations. A QbD approach successfully built quality in electrospinnable emulsions, allowing development of hydrophilic drug-loaded nanofibers with desired morphological characteristics. Copyright © 2014 Elsevier B.V. All rights reserved.

Training the eye care team: principles and practice.

PubMed

Garg, Prashant; Reddy, Snigdha; Nelluri, Chaitanya

2014-01-01

One of the crucial factors to make high quality eye care services available, accessible and affordable to all is the availability of appropriately trained human resources. Providing health through a health care team is a better and cost effective alternative. The concept of the team approach is based on the principles of working together; task shifting; and ensuring continuity of care. Composition of a team varies based on the community needs, population characteristics and disease burden. But for it to be effective, a team must possess four attributes - availability, competency, productivity, and responsiveness. Therefore, training of all team members and training the team to work together as a unit are crucial components in the success of this concept. Some of the critical attributes include: Training across the health spectrum through quality and responsive curricula administered by motivated teachers; accreditation of programs or institutions by national or international bodies; certification and recertification of team members; and training in working together as a team through inter- and intra- disciplinary workshops both during training and as a part of the job activity.

Training the Eye Care Team: Principles and Practice

PubMed Central

Garg, Prashant; Reddy, Snigdha; Nelluri, Chaitanya

2014-01-01

One of the crucial factors to make high quality eye care services available, accessible and affordable to all is the availability of appropriately trained human resources. Providing health through a health care team is a better and cost effective alternative. The concept of the team approach is based on the principles of working together; task shifting; and ensuring continuity of care. Composition of a team varies based on the community needs, population characteristics and disease burden. But for it to be effective, a team must possess four attributes - availability, competency, productivity, and responsiveness. Therefore, training of all team members and training the team to work together as a unit are crucial components in the success of this concept. Some of the critical attributes include: Training across the health spectrum through quality and responsive curricula administered by motivated teachers; accreditation of programs or institutions by national or international bodies; certification and recertification of team members; and training in working together as a team through inter- and intra- disciplinary workshops both during training and as a part of the job activity. PMID:24791103

A Concept Analysis of Systems Thinking.

PubMed

Stalter, Ann M; Phillips, Janet M; Ruggiero, Jeanne S; Scardaville, Debra L; Merriam, Deborah; Dolansky, Mary A; Goldschmidt, Karen A; Wiggs, Carol M; Winegardner, Sherri

2017-10-01

This concept analysis, written by the National Quality and Safety Education for Nurses (QSEN) RN-BSN Task Force, defines systems thinking in relation to healthcare delivery. A review of the literature was conducted using five databases with the keywords "systems thinking" as well as "nursing education," "nursing curriculum," "online," "capstone," "practicum," "RN-BSN/RN to BSN," "healthcare organizations," "hospitals," and "clinical agencies." Only articles that focused on systems thinking in health care were used. The authors identified defining attributes, antecedents, consequences, and empirical referents of systems thinking. Systems thinking was defined as a process applied to individuals, teams, and organizations to impact cause and effect where solutions to complex problems are accomplished through collaborative effort according to personal ability with respect to improving components and the greater whole. Four primary attributes characterized systems thinking: dynamic system, holistic perspective, pattern identification, and transformation. Using the platform provided in this concept analysis, interprofessional practice has the ability to embrace planned efforts to improve critically needed quality and safety initiatives across patients' lifespans and all healthcare settings. © 2016 Wiley Periodicals, Inc.

Visualizing desirable patient healthcare experiences.

PubMed

Liu, Sandra S; Kim, Hyung T; Chen, Jie; An, Lingling

2010-01-01

High healthcare cost has drawn much attention and healthcare service providers (HSPs) are expected to deliver high-quality and consistent care. Therefore, an intimate understanding of the most desirable experience from a patient's and/or family's perspective as well as effective mapping and communication of such findings should facilitate HSPs' efforts in attaining sustainable competitive advantage in an increasingly discerning environment. This study describes (a) the critical quality attributes (CQAs) of the experience desired by patients and (b) the application of two visualization tools that are relatively new to the healthcare sector, namely the "spider-web diagram" and "promotion and detraction matrix." The visualization tools are tested with primary data collected from telephone surveys of 1,800 patients who had received care during calendar year 2005 at 6 of 61 hospitals within St. Louis, Missouri-based, Ascension Health. Five CQAs were found by factor analysis. The spider-web diagram illustrates that communication and empowerment and compassionate and respectful care are the most important CQAs, and accordingly, the promotion and detraction matrix shows those attributes that have the greatest effect for creating promoters, preventing detractors, and improving consumer's likelihood to recommend the healthcare provider.

The effect of sucrose addition at dosage stage on the foam attributes of a bottle-fermented English sparkling wine.

PubMed

Crumpton, Mark; Rice, Christopher J; Atkinson, Andrew; Taylor, Geoff; Marangon, Matteo

2018-02-01

Approximately two-thirds of wine produced in the UK is bottle-fermented sparkling wine. Effervescence and foamability are key features used to assess English sparkling wine (ESW) quality. A critical, yet understudied, area of research is the potential for dosage to influence foam behaviour via associated changes in wine viscosity. In this study, dosage treatments of five increasing levels of sucrose (from 0 to 31 g L -1 ) were added to an ESW. After storage, the foamability attributes of the wines were analysed via an adapted Mosalux method and a novel image analysis method combined with free pour of the wine. Results indicate that increasing sucrose concentration improved foam formation, but reduced foam stability, likely due to the sucrose added causing a modification in wine viscosity. These results highlight the impact that dosage treatments can have on the quality of foam produced upon pouring, and therefore have the potential to inform future sparkling winemaking practices. © 2017 Society of Chemical Industry. © 2017 Society of Chemical Industry.

Application of Analytical Quality by Design concept for bilastine and its degradation impurities determination by hydrophilic interaction liquid chromatographic method.

PubMed

Terzić, Jelena; Popović, Igor; Stajić, Ana; Tumpa, Anja; Jančić-Stojanović, Biljana

2016-06-05

This paper deals with the development of hydrophilic interaction liquid chromatographic (HILIC) method for the analysis of bilastine and its degradation impurities following Analytical Quality by Design approach. It is the first time that the method for bilastine and its impurities is proposed. The main objective was to identify the conditions where an adequate separation in minimal analysis duration could be achieved within a robust region. Critical process parameters which have the most influence on method performance were defined as acetonitrile content in the mobile phase, pH of the aqueous phase and ammonium acetate concentration in the aqueous phase. Box-Behnken design was applied for establishing a relationship between critical process parameters and critical quality attributes. The defined mathematical models and Monte Carlo simulations were used to identify the design space. Fractional factorial design was applied for experimental robustness testing and the method is validated to verify the adequacy of selected optimal conditions: the analytical column Luna(®) HILIC (100mm×4.6mm, 5μm particle size); mobile phase consisted of acetonitrile-aqueous phase (50mM ammonium acetate, pH adjusted to 5.3 with glacial acetic acid) (90.5:9.5, v/v); column temperature 30°C, mobile phase flow rate 1mLmin(-1), wavelength of detection 275nm. Copyright © 2016 Elsevier B.V. All rights reserved.

Design of experiments-based monitoring of critical quality attributes for the spray-drying process of insulin by NIR spectroscopy.

PubMed

Maltesen, Morten Jonas; van de Weert, Marco; Grohganz, Holger

2012-09-01

Moisture content and aerodynamic particle size are critical quality attributes for spray-dried protein formulations. In this study, spray-dried insulin powders intended for pulmonary delivery were produced applying design of experiments methodology. Near infrared spectroscopy (NIR) in combination with preprocessing and multivariate analysis in the form of partial least squares projections to latent structures (PLS) were used to correlate the spectral data with moisture content and aerodynamic particle size measured by a time of flight principle. PLS models predicting the moisture content were based on the chemical information of the water molecules in the NIR spectrum. Models yielded prediction errors (RMSEP) between 0.39% and 0.48% with thermal gravimetric analysis used as reference method. The PLS models predicting the aerodynamic particle size were based on baseline offset in the NIR spectra and yielded prediction errors between 0.27 and 0.48 μm. The morphology of the spray-dried particles had a significant impact on the predictive ability of the models. Good predictive models could be obtained for spherical particles with a calibration error (RMSECV) of 0.22 μm, whereas wrinkled particles resulted in much less robust models with a Q (2) of 0.69. Based on the results in this study, NIR is a suitable tool for process analysis of the spray-drying process and for control of moisture content and particle size, in particular for smooth and spherical particles.

The influence of direct compression powder blend transfer method from the container to the tablet press on product critical quality attributes: a case study.

PubMed

Teżyk, Michał; Jakubowska, Emilia; Milczewska, Kasylda; Milanowski, Bartłomiej; Voelkel, Adam; Lulek, Janina

2017-06-01

The aim of this article is to compare the gravitational powder blend loading method to the tablet press and manual loading in terms of their influence on tablets' critical quality attributes (CQA). The results of the study can be of practical relevance to the pharmaceutical industry in the area of direct compression of low-dose formulations, which could be prone to content uniformity (CU) issues. In the preliminary study, particle size distribution (PSD) and surface energy of raw materials were determined using laser diffraction method and inverse gas chromatography, respectively. For trials purpose, a formulation containing two pharmaceutical ingredients (APIs) was used. Tablet samples were collected during the compression progress to analyze their CQAs, namely assay and CU. Results obtained during trials indicate that tested direct compression powder blend is sensitive to applied powder handling method. Mild increase in both APIs content was observed during manual scooping. Gravitational approach (based on discharge into the drum) resulted in a decrease in CU, which is connected to a more pronounced assay increase at the end of tableting than in the case of manual loading. The correct design of blend transfer over single unit processes is an important issue and should be investigated during the development phase since it may influence the final product CQAs. The manual scooping method, although simplistic, can be a temporary solution to improve the results of API's content and uniformity when compared to industrial gravitational transfer.

Critical quality attributes, in vitro release and correlated in vitro skin permeation-in vivo tape stripping collective data for demonstrating therapeutic (non)equivalence of topical semisolids: A case study of "ready-to-use" vehicles.

PubMed

Ilić, Tanja; Pantelić, Ivana; Lunter, Dominique; Đorđević, Sanela; Marković, Bojan; Ranković, Dragana; Daniels, Rolf; Savić, Snežana

2017-08-07

This work aimed to prove the ability of "ready-to-use" topical vehicles based on alkyl polyglucoside-mixed emulsifier (with/without co-solvent modifications) to replace the conventionally used pharmacopoeial bases (e.g., non-ionic hydrophilic cream) in compounding practice. For this purpose, considering the regulatory efforts to establish alternative, scientifically valid methods for evaluating therapeutic equivalence of topical semisolids, we performed a comparative assessment of microstructure, selected critical quality attributes (CQAs) and in vitro/in vivo product performances, by utilizing aceclofenac as a model drug. The differences in composition between investigated samples have imposed remarkable variances in monitored CQAs (particularly in the amount of aceclofenac dissolved, rheological properties and water distribution mode), reflecting the distinct differences in microstructure formed, as partially observed by polarization microscopy and confocal Raman spectral imaging. Although not fully indicative of the in vivo performances, in vitro release data (vertical diffusion vs. immersion cells) proved the microstructure peculiarities, asserting the rheological properties as decisive factor for obtained liberation profiles. Contrary, in vitro permeation results obtained using pig ear epidermis correlated well with in vivo dermatopharmacokinetic data and distinguished unequivocally between tested formulations, emphasizing the importance of skin/vehicle interactions. In summary, suggested multi-faceted approach can provide adequate proof on topical semisolids therapeutic equivalence or lack thereof. Copyright © 2017 Elsevier B.V. All rights reserved.

Editors’ Perspectives on Enhancing Manuscript Quality and Editorial Decisions Through Peer Review and Reviewer Development

PubMed Central

Janke, Kristin K.; Traynor, Andrew P.

2017-01-01

Objectives. To identify peer reviewer and peer review characteristics that enhance manuscript quality and editorial decisions, and to identify valuable elements of peer reviewer training programs. Methods. A three-school, 15-year review of pharmacy practice and pharmacy administration faculty’s publications was conducted to identify high-publication volume journals for inclusion. Editors-in-chief identified all editors managing manuscripts for participation. A three-round modified Delphi process was used. Rounds advanced from open-ended questions regarding actions and attributes of good reviewers to consensus-seeking and clarifying questions related to quality, importance, value, and priority. Results. Nineteen editors representing eight pharmacy journals participated. Three characteristics of reviews were rated required or helpful in enhancing manuscript quality by all respondents: includes a critical analysis of the manuscript (88% required, 12% helpful), includes feedback that contains both strengths and areas of improvement (53% required, 47% helpful), and speaks to the manuscript’s utility in the literature (41% required, 59% helpful). Hands-on experience with review activities (88%) and exposure to good and bad reviews (88%) were identified as very valuable to peer reviewer development. Conclusion. Reviewers, individuals involved in faculty development, and journals should work to assist new reviewers in defining focused areas of expertise, building knowledge in these areas, and developing critical analysis skills. PMID:28630514

Formulation and development of ophthalmic in situ gel for the treatment ocular inflammation and infection using application of quality by design concept.

PubMed

Patel, Nirav; Thakkar, Vaishali; Metalia, Viral; Baldaniya, Lalji; Gandhi, Tejal; Gohel, Mukesh

2016-09-01

The conventional liquid ophthalmic delivery systems exhibit short pre-corneal residence time and the relative impermeability to the cornea which leads to poor ocular bioavailability. The aim of this study was to apply quality by design (QbD) for development of dexamethasone sodium phosphate (DSP) and tobramycin sulfate (TS)-loaded thermoresponsive ophthalmic in situ gel containing Poloxamer 407 and hydroxyl propyl methyl cellulose (HPMC) K4M for prolonging the pre-corneal residence time, ocular bioavability and decreases the frequency of administration of dosage form. The material attributes and the critical quality attributes (CQA) of the in situ gel were identified. Central composite design (CCD) was adopted to optimize the formulation. The ophthalmic in situ forming gels were prepared by cold method. Materials attributes were the amount of Poloxamer 407 and HPMC and CQA identified were Gel strength, mucoadhesive index, gelation temperature and % of drug release of both drug. Optimized batch (F*) containing 16.75% poloxamer 407 and 0.54% HPMC K4M were exhibited all results in acceptable limits. Compared with the marketed formulation, optimized in situ gel showed delayed Tmax, improved Cmax and AUC in rabbit aqueous humor, suggesting the sustained drug release and better corneal penetration and absorption. According to the study, it could be concluded that DSP and TS would be successfully formulated as in situ gelling mucoadhesive system for the treatment of steroid responsive eye infections with the properties of sustained drug release, prolonged ocular retention and improved corneal penetration.

Quality by design approach for optimizing the formulation and physical properties of extemporaneously prepared orodispersible films.

PubMed

Visser, J Carolina; Dohmen, Willem M C; Hinrichs, Wouter L J; Breitkreutz, Jörg; Frijlink, Henderik W; Woerdenbag, Herman J

2015-05-15

The quality by design (QbD) approach was applied for optimizing the formulation of extemporaneously prepared orodispersible films (ODFs) using Design-Expert® Software. The starting formulation was based on earlier experiments and contained the film forming agents hypromellose and carbomer 974P and the plasticizer glycerol (Visser et al., 2015). Trometamol and disodium EDTA were added to stabilize the solution. To optimize this formulation a quality target product profile was established in which critical quality attributes (CQAs) such as mechanical properties and disintegration time were defined and quantified. As critical process parameters (CPP) that were evaluated for their effect on the CQAs the percentage of hypromellose and the percentage of glycerol as well as the drying time were chosen. Response surface methodology (RMS) was used to evaluate the effects of the CPPs on the CQAs of the final product. The main factor affecting tensile strength and Young's modulus was the percentage of glycerol. Elongation at break was mainly influenced by the drying temperature. Disintegration time was found to be sensitive to the percentage of hypromellose. From the results a design space could be created. As long as the formulation and process variables remain within this design space, a product is obtained with desired characteristics and that meets all set quality requirements. Copyright © 2015 Elsevier B.V. All rights reserved.

Adaptation of the quality by design concept in early pharmaceutical development of an intranasal nanosized formulation.

PubMed

Pallagi, Edina; Ambrus, Rita; Szabó-Révész, Piroska; Csóka, Ildikó

2015-08-01

Regulatory science based pharmaceutical development and product manufacturing is highly recommended by the authorities nowadays. The aim of this study was to adapt regulatory science even in the nano-pharmaceutical early development. Authors applied the quality by design (QbD) concept in the early development phase of nano-systems, where the illustration material was meloxicam. The meloxicam nanoparticles produced by co-grinding method for nasal administration were studied according to the QbD policy and the QbD based risk assessment (RA) was performed. The steps were implemented according to the relevant regulatory guidelines (quality target product profile (QTPP) determination, selection of critical quality attributes (CQAs) and critical process parameters (CPPs)) and a special software (Lean QbD Software(®)) was used for the RA, which represents a novelty in this field. The RA was able to predict and identify theoretically the factors (e.g. sample composition, production method parameters, etc.) which have the highest impact on the desired meloxicam-product quality. The results of the practical research justified the theoretical prediction. This method can improve pharmaceutical nano-developments by achieving shorter development time, lower cost, saving human resource efforts and more effective target-orientation. It makes possible focusing the resources on the selected parameters and area during the practical product development. Copyright © 2015 Elsevier B.V. All rights reserved.

Emerging technologies for the non-invasive characterization of physical-mechanical properties of tablets.

PubMed

Dave, Vivek S; Shahin, Hend I; Youngren-Ortiz, Susanne R; Chougule, Mahavir B; Haware, Rahul V

2017-10-30

The density, porosity, breaking force, viscoelastic properties, and the presence or absence of any structural defects or irregularities are important physical-mechanical quality attributes of popular solid dosage forms like tablets. The irregularities associated with these attributes may influence the drug product functionality. Thus, an accurate and efficient characterization of these properties is critical for successful development and manufacturing of a robust tablets. These properties are mainly analyzed and monitored with traditional pharmacopeial and non-pharmacopeial methods. Such methods are associated with several challenges such as lack of spatial resolution, efficiency, or sample-sparing attributes. Recent advances in technology, design, instrumentation, and software have led to the emergence of newer techniques for non-invasive characterization of physical-mechanical properties of tablets. These techniques include near infrared spectroscopy, Raman spectroscopy, X-ray microtomography, nuclear magnetic resonance (NMR) imaging, terahertz pulsed imaging, laser-induced breakdown spectroscopy, and various acoustic- and thermal-based techniques. Such state-of-the-art techniques are currently applied at various stages of development and manufacturing of tablets at industrial scale. Each technique has specific advantages or challenges with respect to operational efficiency and cost, compared to traditional analytical methods. Currently, most of these techniques are used as secondary analytical tools to support the traditional methods in characterizing or monitoring tablet quality attributes. Therefore, further development in the instrumentation and software, and studies on the applications are necessary for their adoption in routine analysis and monitoring of tablet physical-mechanical properties. Copyright © 2017 Elsevier B.V. All rights reserved.

Using an innovative combination of quality-by-design and green analytical chemistry approaches for the development of a stability indicating UHPLC method in pharmaceutical products.

PubMed

Boussès, Christine; Ferey, Ludivine; Vedrines, Elodie; Gaudin, Karen

2015-11-10

An innovative combination of green chemistry and quality by design (QbD) approach is presented through the development of an UHPLC method for the analysis of the main degradation products of dextromethorphan hydrobromide. QbD strategy was integrated to the field of green analytical chemistry to improve method understanding while assuring quality and minimizing environmental impacts, and analyst exposure. This analytical method was thoroughly evaluated by applying risk assessment and multivariate analysis tools. After a scouting phase aimed at selecting a suitable stationary phase and an organic solvent in accordance with green chemistry principles, quality risk assessment tools were applied to determine the critical process parameters (CPPs). The effects of the CPPs on critical quality attributes (CQAs), i.e., resolutions, efficiencies, and solvent consumption were further evaluated by means of a screening design. A response surface methodology was then carried out to model CQAs as function of the selected CPPs and the optimal separation conditions were determined through a desirability analysis. Resulting contour plots enabled to establish the design space (DS) (method operable design region) where all CQAs fulfilled the requirements. An experimental validation of the DS proved that quality within the DS was guaranteed; therefore no more robustness study was required before the validation. Finally, this UHPLC method was validated using the concept of total error and was used to analyze a pharmaceutical drug product. Copyright © 2015 Elsevier B.V. All rights reserved.

Exploring the attributes of critical thinking: a conceptual basis.

PubMed

Forneris, Susan G

2004-01-01

Many teaching methods used in nursing education to enhance critical thinking focus on teaching students how to directly apply knowledge; a technically rational approach. While seemingly effective at enhancing students' critical thinking abilities in structured learning situations, these methods don't prepare students to operationalize critical thinking to manage the complexities that actually exist in practice. The work of contemporary educational theorists Paulo Freire, Donald Schon, Chris Argyris, Jack Mezirow, Stephen Brookfield, and Robert Tennyson all share similar perspectives on thinking in practice and the use of reflection to achieve a coherence of understanding. Their perspectives provide insight on how educators can shift from a means-end approach to operationalizing thinking in practice. The author identifies four attributes of critical thinking in practice evidenced in these views, followed by a discussion of specific educational strategies that reflect these attributes, and operationalize a critical thinking process in nursing practice to achieve a coherence of understanding.

[Application of quality by design in granulation process for Ginkgo leaf tablet (Ⅲ)： process control strategy based on design space].

PubMed

Cui, Xiang-Long; Xu, Bing; Sun, Fei; Dai, Sheng-Yun; Shi, Xin-Yuan; Qiao, Yan-Jiang

2017-03-01

In this paper, under the guidance of quality by design (QbD) concept, the control strategy of the high shear wet granulation process of the ginkgo leaf tablet based on the design space was established to improve the process controllability and product quality consistency. The median granule size (D50) and bulk density (Da) of granules were identified as critical quality attributes (CQAs) and potential critical process parameters (pCPPs) were determined by the failure modes and effect analysis (FMEA). The Plackeet-Burmann experimental design was used to screen pCPPs and the results demonstrated that the binder amount, the wet massing time and the wet mixing impeller speed were critical process parameters (CPPs). The design space of the high shear wet granulation process was developed within pCPPs range based on the Box-Behnken design and quadratic polynomial regression models. ANOVA analysis showed that the P-values of model were less than 0.05 and the values of lack of fit test were more than 0.1, indicating that the relationship between CQAs and CPPs could be well described by the mathematical models. D₅₀ could be controlled within 170 to 500 μm, and the bulk density could be controlled within 0.30 to 0.44 g•cm⁻³ by using any CPPs combination within the scope of design space. Besides, granules produced by process parameters within the design space region could also meet the requirement of tensile strength of the ginkgo leaf tablet.. Copyright© by the Chinese Pharmaceutical Association.

SOA: A Quality Attribute Perspective

DTIC Science & Technology

2011-06-23

in software engineering from CMU. 6June 2011 Twitter #seiwebinar © 2011 Carnegie Mellon University Agenda Service -Oriented Architecture and... Software Architecture: Review Service -Orientation and Quality Attributes Summary and Future Challenges 7June 2011 Twitter #seiwebinar © 2011...Architecture and Software Architecture: Review Service -Orientation and Quality Attributes Summary and Future Challenges Review 10June 2011 Twitter

Recent progress in the development of ISO 19751

NASA Astrophysics Data System (ADS)

Farnand, Susan P.; Dalal, Edul N.; Ng, Yee S.

2006-01-01

A small number of general visual attributes have been recognized as essential in describing image quality. These include micro-uniformity, macro-uniformity, colour rendition, text and line quality, gloss, sharpness, and spatial adjacency or temporal adjacency attributes. The multiple-part International Standard discussed here was initiated by the INCITS W1 committee on the standardization of office equipment to address the need for unambiguously documented procedures and methods, which are widely applicable over the multiple printing technologies employed in office applications, for the appearance-based evaluation of these visually significant image quality attributes of printed image quality. 1,2 The resulting proposed International Standard, for which ISO/IEC WD 19751-1 3 presents an overview and an outline of the overall procedure and common methods, is based on a proposal that was predicated on the idea that image quality could be described by a small set of broad-based attributes. 4 Five ad hoc teams were established (now six since a sharpness team is in the process of being formed) to generate standards for one or more of these image quality attributes. Updates on the colour rendition, text and line quality, and gloss attributes are provided.

[Continual improvement of quantitative analytical method development of Panax notogineng saponins based on quality by design].

PubMed

Dai, Sheng-Yun; Xu, Bing; Shi, Xin-Yuan; Xu, Xiang; Sun, Ying-Qiang; Qiao, Yan-Jiang

2017-03-01

This study is aimed to propose a continual improvement strategy based on quality by design (QbD). An ultra high performance liquid chromatography (UPLC) method was developed to accomplish the method transformation from HPLC to UPLC of Panax notogineng saponins (PNS) and achieve the continual improvement of PNS based on QbD, for example. Plackett-Burman screening design and Box-Behnken optimization design were employed to further understand the relationship between the critical method parameters (CMPs) and critical method attributes (CMAs). And then the Bayesian design space was built. The separation degree of the critical peaks (ginsenoside Rg₁ and ginsenoside Re) was over 2.0 and the analysis time was less than 17 min by a method chosen from the design space with 20% of the initial concentration of the acetonitrile, 10 min of the isocratic time and 6%•min⁻¹ of the gradient slope. At last, the optimum method was validated by accuracy profile. Based on the same analytical target profile (ATP), the comparison of HPLC and UPLC including chromatograph method, CMA identification, CMP-CMA model and system suitability test (SST) indicated that the UPLC method could shorten the analysis time, improve the critical separation and satisfy the requirement of the SST. In all, HPLC method could be replaced by UPLC for the quantity analysis of PNS. Copyright© by the Chinese Pharmaceutical Association.

The protective role of self-compassion in relation to psychopathology symptoms and quality of life in chronic and in cancer patients.

PubMed

Pinto-Gouveia, José; Duarte, Cristiana; Matos, Marcela; Fráguas, Sofia

2014-01-01

The importance of self-compassion in the context of medical problems has been highlighted in previous research. Its role in the psychological adjustment of cancer patients, however, has remained unexplored. The current study aimed at examining whether self-compassion and self-critical judgement would distinctively predict general psychopathological symptoms and quality of life in three distinct groups: a mixed sample of cancer patients (n = 63), patients with chronic illnesses (n = 68) and healthy subjects (n = 71). Correlation analyses revealed significant associations between lower self-compassion and increased depressive and stress symptoms, and lower scores in quality of life dimensions in the patients' samples. The opposite correlational pattern was found regarding self-critical judgement. In the case of healthy subjects, these correlations were weaker or nonsignificant. Regression analyses revealed that in patients with chronic illnesses, self-critical judgement emerged as the best predictor of depressive and stress symptoms, and quality of life dimensions. In patients with cancer, however, it was the affiliate dimension of self-compassion that was found to significantly predict lower levels of depressive and stress symptoms, and increased quality of life. These findings have important clinical implications by suggesting the relevance of nurturing a caring and kind relation with oneself in the face of challenging medical conditions, particularly in patients with cancer. The link between self-compassion and psychopathology and quality of life was examined in a mixed sample of cancer patients, in chronic patients, and in healthy subjects. Self-compassion is associated with decreased psychopathological symptoms of stress and depression, and better quality of life in patients with chronic illnesses, and especially in patients with cancer. Psychological supportive interventions targeting the development of self-compassionate attributes and skills may have beneficial effects in the psychological adjustment of medically ill patients, namely patients with cancer. Copyright © 2013 John Wiley & Sons, Ltd.

Impact of service attributes on customer satisfaction and loyalty in a healthcare context.

PubMed

Lonial, Subash; Raju, P S

2015-01-01

The purpose of this paper is to examine the role of perceived service attributes in the development of overall customer satisfaction (OCS) and customer loyalty (CL) in a health-care setting. This paper also sheds light on the role of hospitalist physicians (HPs) and offers suggestions to improve patient satisfaction and loyalty. A telephone survey was used to collect data from recently hospitalized patients with respect to their HP. Structural equations modeling (SEM) was used to confirm the overall relationships between perceived service quality (PSQ), OCS and CL. The sample was then divided into customer relationship groups (CRGs) based on satisfaction and loyalty measures. Discriminant analysis was used to determine which attributes differentiated most between high and low satisfaction and loyalty groups. Overall relationships among PSQ, OCS and CL were in conformity with the conceptual model. Findings also revealed that service attributes played an important role in distinguishing between high and low satisfaction and loyalty groups, although some attributes were more important than others and different attributes emerged as being key influencers for satisfaction and loyalty. The conceptual model used is a fairly straight forward model, and we have not considered the impact of individual factors such as expectations and value perceptions or involvement levels and demographic characteristics on service quality and overall satisfaction. The data for this study were provided by a major health maintenance organization (HMO), and there is room for improvement in the manner in which certain constructs were measured. For example, OCS, recommendation and retention all used single item measures, and it might have been preferable to use multiple item measures for these constructs. The study shows that organizations can benefit by identifying and focusing on critical attributes as part of their customer relationship management program. The SEM results provide strong support for the overall model linking service quality, OCS and CL in a health-care setting. As one would expect, PSQ has a strong impact on OCS, which, in turn, has a fairly strong impact on CL. However, there is also a significant direct linkage between PSQ and CL. This linkage shows that at least a certain portion of CL could evolve independent of the satisfaction level with the HP. This shows that, in addition to trying to improve satisfaction, organizations should also explore influencing loyalty directly, perhaps by the strategic use of service attribute perceptions. The study shows that customer perceptions at the service attribute level can often be the key to the generation and management of customer satisfaction and loyalty. It also has significance for how satisfaction and loyalty with HPs can be improved in a hospital setting.

Role of pressure-sensitive adhesives in transdermal drug delivery systems.

PubMed

Lobo, Shabbir; Sachdeva, Sameer; Goswami, Tarun

2016-01-01

Transdermal drug delivery systems (TDDS) are employed for the delivery of drugs across skin into the systemic circulation. Pressure-sensitive adhesive (PSA) is one of the most critical components used in a TDDS. The primary function of PSA is to help in adhesion of patch to skin, but more importantly it acts as a matrix for the drug and other excipients. Hence, apart from adhesion of the patch, PSA also affects other critical quality attributes of the TDDS such as drug delivery, flux through skin and physical and chemical stability of the finished product. This review article provides a summary of the adhesives used in various types of TDDS. In particular, this review will cover the design types of TDDS, categories of PSAs and their evaluation and regulatory aspects.

Prediction of quality attributes of chicken breast fillets by using Vis/NIR spectroscopy combined with factor analysis method

USDA-ARS?s Scientific Manuscript database

Visible/near-infrared (Vis/NIR) spectroscopy with wavelength range between 400 and 2500 nm combined with factor analysis method was tested to predict quality attributes of chicken breast fillets. Quality attributes, including color (L*, a*, b*), pH, and drip loss were analyzed using factor analysis ...

The sweet tooth of biopharmaceuticals: importance of recombinant protein glycosylation analysis.

PubMed

Lingg, Nico; Zhang, Peiqing; Song, Zhiwei; Bardor, Muriel

2012-12-01

Biopharmaceuticals currently represent the fastest growing sector of the pharmaceutical industry, mainly driven by a rapid expansion in the manufacture of recombinant protein-based drugs. Glycosylation is the most prominent post-translational modification occurring on these protein drugs. It constitutes one of the critical quality attributes that requires thorough analysis for optimal efficacy and safety. This review examines the functional importance of glycosylation of recombinant protein drugs, illustrated using three examples of protein biopharmaceuticals: IgG antibodies, erythropoietin and glucocerebrosidase. Current analytical methods are reviewed as solutions for qualitative and quantitative measurements of glycosylation to monitor quality target product profiles of recombinant glycoprotein drugs. Finally, we propose a framework for designing the quality target product profile of recombinant glycoproteins and planning workflow for glycosylation analysis with the selection of available analytical methods and tools. Copyright © 2012 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Approaches to Quality Risk Management When Using Single-Use Systems in the Manufacture of Biologics.

PubMed

Ishii-Watabe, Akiko; Hirose, Akihiko; Katori, Noriko; Hashii, Norikata; Arai, Susumu; Awatsu, Hirotoshi; Eiza, Akira; Hara, Yoshiaki; Hattori, Hideshi; Inoue, Tomomi; Isono, Tetsuya; Iwakura, Masahiro; Kajihara, Daisuke; Kasahara, Nobuo; Matsuda, Hiroyuki; Murakami, Sei; Nakagawa, Taishiro; Okumura, Takehiro; Omasa, Takeshi; Takuma, Shinya; Terashima, Iyo; Tsukahara, Masayoshi; Tsutsui, Maiko; Yano, Takahiro; Kawasaki, Nana

2015-10-01

Biologics manufacturing technology has made great progress in the last decade. One of the most promising new technologies is the single-use system, which has improved the efficiency of biologics manufacturing processes. To ensure safety of biologics when employing such single-use systems in the manufacturing process, various issues need to be considered including possible extractables/leachables and particles arising from the components used in single-use systems. Japanese pharmaceutical manufacturers, together with single-use suppliers, members of the academia and regulatory authorities have discussed the risks of using single-use systems and established control strategies for the quality assurance of biologics. In this study, we describe approaches for quality risk management when employing single-use systems in the manufacturing of biologics. We consider the potential impact of impurities related to single-use components on drug safety and the potential impact of the single-use system on other critical quality attributes as well as the stable supply of biologics. We also suggest a risk-mitigating strategy combining multiple control methods which includes the selection of appropriate single-use components, their inspections upon receipt and before releasing for use and qualification of single-use systems. Communication between suppliers of single-use systems and the users, as well as change controls in the facilities both of suppliers and users, are also important in risk-mitigating strategies. Implementing these control strategies can mitigate the risks attributed to the use of single-use systems. This study will be useful in promoting the development of biologics as well as in ensuring their safety, quality and stable supply.

The unbiasedness of a generalized mirage boundary correction method for Monte Carlo integration estimators of volume

Treesearch

Thomas B. Lynch; Jeffrey H. Gove

2014-01-01

The typical "double counting" application of the mirage method of boundary correction cannot be applied to sampling systems such as critical height sampling (CHS) that are based on a Monte Carlo sample of a tree (or debris) attribute because the critical height (or other random attribute) sampled from a mirage point is generally not equal to the critical...

Effects of Patient-Centered Medical Home Attributes on Patients’ Perceptions of Quality in Federally Supported Health Centers

PubMed Central

Lebrun-Harris, Lydie A.; Shi, Leiyu; Zhu, Jinsheng; Burke, Matthew T.; Sripipatana, Alek; Ngo-Metzger, Quyen

2013-01-01

PURPOSE We sought to assess patients’ ratings of patient-centered medical home (PCMH) attributes and overall quality of care within federally supported health centers. METHODS Data were collected through the 2009 Health Center Patient Survey (n = 4,562), which consisted of in-person interviews and included a nationally representative sample of patients seen in health centers. Quality measures included patients’ perceptions of overall quality of services, perceptions of quality of clinician advice/treatment, and likelihood of referring friends and relatives to the health center. PCMH attributes included (1) access to care getting to health center, (2) access to care during visit, (3) patient-centered communication with health care clinicians, (4) patient-centered communication with support staff, (5) self-management support for chronic conditions, (6) self-management support for behavioral risks, and (7) comprehensive preventive care. Bivariate analysis and logistic regressions were used to examine associations between patients’ perceptions of PCMH attributes and patient-reported quality of care. RESULTS Eighty-four percent of patients reported excellent/very good overall quality of services, 81% reported excellent/very good quality of clinician care, and 84% were very likely to refer friends and relatives. Higher patient ratings on the access to care and patient-centered communication attributes were associated with higher odds of patient-reported high quality of care on the 3 outcome measures. CONCLUSIONS More than 80% of patients perceived high quality of care in health centers. PCMH attributes related to access to care and communication were associated with greater likelihood of patients reporting high-quality care. PMID:24218374

Analysis of information quality attribute for SME towards adoption of research result

NASA Astrophysics Data System (ADS)

Febriani, E.; Dewobroto, W. S.; Anggraini, R. D.

2017-12-01

Small and Medium Enterprises (SME) holds significant role in fostering Indonesian economy. However, the research that is supposed to support the development of SMEs business has not yet fully adopted or utilized. Information attributes may be used as the benchmark to find the intention of SMEs from a research result and develop the strategy of quality information for all organizations both SMEs and the researcher. Therefore, because of the importance of information quality attribute required by SMEs, the research aims to analyses the information quality required by SMEs to clarify the information quality into the dimension of information quality. The research was started by distributing online questionnaire to SMEs. The questionnaire result showed that the content dimension is the most aspect required by SMEs, followed by time and form dimension, respectively. Quality information attribute required by SMEs from a research is that the result may be applied to the business.

Attributes of quality in audiovisual materials for health professionals.

PubMed

Suter, E; Waddell, W H

1981-07-01

Utilizing a series of meetings and incorporating individual efforts of producers, evaluators, and users of audiovisual materials; an attempt has been made to define the quality of an instructional item. Attributes of quality in content, instructional design, technical production, and packaging of audiovisual materials are addressed through questions about general criteria that permit expression of individual dictates off creativity and taste. These attributes of quality are intended for use by the producers and evaluators of audiovisual instruction.

Evaluating the Properties of Poly(lactic-co-glycolic acid) Nanoparticle Formulations Encapsulating a Hydrophobic Drug by Using the Quality by Design Approach.

PubMed

Kozaki, Masato; Kobayashi, Shin-Ichiro; Goda, Yukihiro; Okuda, Haruhiro; Sakai-Kato, Kumiko

2017-01-01

We applied the Quality by Design (QbD) approach to the development of poly(lactic-co-glycolic acid) (PLGA) nanoparticle formulations encapsulating triamcinolone acetonide, and the critical process parameters (CPPs) were identified to clarify the correlations between critical quality attributes and CPPs. Quality risk management was performed by using an Ishikawa diagram and experiments with a fractional factorial design (ANOVA). The CPPs for particle size were PLGA concentration and rotation speed, and the CPP for relative drug loading efficiency was the poor solvent to good solvent volume ratio. By assessing the mutually related factors in the form of ratios, many factors could be efficiently considered in the risk assessment. We found a two-factor interaction between rotation speed and rate of addition of good solvent by using a fractional factorial design with resolution V. The system was then extended by using a central composite design, and the results obtained were visualized by using the response surface method to construct a design space. Our research represents a case study of the application of the QbD approach to pharmaceutical development, including formulation screening, by taking actual production factors into consideration. Our findings support the feasibility of using a similar approach to nanoparticle formulations under development. We could establish an efficient method of analyzing the CPPs of PLGA nanoparticles by using a QbD approach.

Advanced qualification of pharmaceutical excipient suppliers by multiple analytics and multivariate analysis combined.

PubMed

Hertrampf, A; Müller, H; Menezes, J C; Herdling, T

2015-11-10

Pharmaceutical excipients have different functions within a drug formulation, consequently they can influence the manufacturability and/or performance of medicinal products. Therefore, critical to quality attributes should be kept constant. Sometimes it may be necessary to qualify a second supplier, but its product will not be completely equal to the first supplier product. To minimize risks of not detecting small non-similarities between suppliers and to detect lot-to-lot variability for each supplier, multivariate data analysis (MVA) can be used as a more powerful alternative to classical quality control that uses one-parameter-at-a-time monitoring. Such approach is capable of supporting the requirements of a new guideline by the European Parliament and Council (2015/C-95/02) demanding appropriate quality control strategies for excipients based on their criticality and supplier risks in ensuring quality, safety and function. This study compares calcium hydrogen phosphate from two suppliers. It can be assumed that both suppliers use different manufacturing processes. Therefore, possible chemical and physical differences were investigated by using Raman spectroscopy, laser diffraction and X-ray powder diffraction. Afterwards MVA was used to extract relevant information from each analytical technique. Both CaHPO4 could be discriminated by their supplier. The gained knowledge allowed to specify an enhanced strategy for second supplier qualification. Copyright © 2015 Elsevier B.V. All rights reserved.

Towards quality by design in pharmaceutical manufacturing: modelling and control of air jet mills

NASA Astrophysics Data System (ADS)

Bhonsale, Satyajeet; Telen, Dries; Stokbroekx, Bard; Van Impe, Jan

2017-06-01

Milling is an important step in pharmaceutical manufacturing as it not only determines the final formulation of the drug product, but also influences the bioavailability and dissolution rate of the active pharmaceutical ingredient (API). In this respect, the air jet mill (AJM) is most commonly used in the pharmaceutical industry as it is a non-contaminating and non-degrading self-classifying process capable of delivering narrow particle size distributions (PSD). Keeping the principles of Quality by Design in mind, the Critical Process Parameters (CPPs) of the AJM have been identified to be the pressures at the grinding nozzles, and the feed rate which affect the PSD, surface charge and the morphology of the product (i.e. the Critical Material Attributes (CMAs)). For the purpose of this research, the PSD is considered to be the only relevant CMA. A population balance based model is proposed to simulate the dynamics milling operation by utilizing the concept of breakage functions. This model agrees qualitatively with experimental observations of the air jet mill unit present at Janssen Pharmaceutica but further steps for model validation need to be carried out.

Sensor Technologies for Particulate Detection and Characterization

NASA Technical Reports Server (NTRS)

Greenberg, Paul S.

2008-01-01

Planned Lunar missions have resulted in renewed attention to problems attributable to fine particulates. While the difficulties experienced during the sequence of Apollo missions did not prove critical in all cases, the comparatively long duration of impending missions may present a different situation. This situation creates the need for a spectrum of particulate sensing technologies. From a fundamental perspective, an improved understanding of the properties of the dust fraction is required. Described here is laboratory-based reference instrumentation for the measurement of fundamental particle size distribution (PSD) functions from 2.5 nanometers to 20 micrometers. Concomitant efforts for separating samples into fractional size bins are also presented. A requirement also exists for developing mission compatible sensors. Examples include provisions for air quality monitoring in spacecraft and remote habitation modules. Required sensor attributes such as low mass, volume, and power consumption, autonomy of operation, and extended reliability cannot be accommodated by existing technologies.

Development of Process Analytical Technology (PAT) methods for controlled release pellet coating.

PubMed

Avalle, P; Pollitt, M J; Bradley, K; Cooper, B; Pearce, G; Djemai, A; Fitzpatrick, S

2014-07-01

This work focused on the control of the manufacturing process for a controlled release (CR) pellet product, within a Quality by Design (QbD) framework. The manufacturing process was Wurster coating: firstly layering active pharmaceutical ingredient (API) onto sugar pellet cores and secondly a controlled release (CR) coating. For each of these two steps, development of a Process Analytical Technology (PAT) method is discussed and also a novel application of automated microscopy as the reference method. Ultimately, PAT methods should link to product performance and the two key Critical Quality Attributes (CQAs) for this CR product are assay and release rate, linked to the API and CR coating steps respectively. In this work, the link between near infra-red (NIR) spectra and those attributes was explored by chemometrics over the course of the coating process in a pilot scale industrial environment. Correlations were built between the NIR spectra and coating weight (for API amount), CR coating thickness and dissolution performance. These correlations allow the coating process to be monitored at-line and so better control of the product performance in line with QbD requirements. Copyright © 2014 Elsevier B.V. All rights reserved.

Bayesian framework inspired no-reference region-of-interest quality measure for brain MRI images

PubMed Central

Osadebey, Michael; Pedersen, Marius; Arnold, Douglas; Wendel-Mitoraj, Katrina

2017-01-01

Abstract. We describe a postacquisition, attribute-based quality assessment method for brain magnetic resonance imaging (MRI) images. It is based on the application of Bayes theory to the relationship between entropy and image quality attributes. The entropy feature image of a slice is segmented into low- and high-entropy regions. For each entropy region, there are three separate observations of contrast, standard deviation, and sharpness quality attributes. A quality index for a quality attribute is the posterior probability of an entropy region given any corresponding region in a feature image where quality attribute is observed. Prior belief in each entropy region is determined from normalized total clique potential (TCP) energy of the slice. For TCP below the predefined threshold, the prior probability for a region is determined by deviation of its percentage composition in the slice from a standard normal distribution built from 250 MRI volume data provided by Alzheimer’s Disease Neuroimaging Initiative. For TCP above the threshold, the prior is computed using a mathematical model that describes the TCP–noise level relationship in brain MRI images. Our proposed method assesses the image quality of each entropy region and the global image. Experimental results demonstrate good correlation with subjective opinions of radiologists for different types and levels of quality distortions. PMID:28630885

Media milling process optimization for manufacture of drug nanoparticles using design of experiments (DOE).

PubMed

Nekkanti, Vijaykumar; Marwah, Ashwani; Pillai, Raviraj

2015-01-01

Design of experiments (DOE), a component of Quality by Design (QbD), is systematic and simultaneous evaluation of process variables to develop a product with predetermined quality attributes. This article presents a case study to understand the effects of process variables in a bead milling process used for manufacture of drug nanoparticles. Experiments were designed and results were computed according to a 3-factor, 3-level face-centered central composite design (CCD). The factors investigated were motor speed, pump speed and bead volume. Responses analyzed for evaluating these effects and interactions were milling time, particle size and process yield. Process validation batches were executed using the optimum process conditions obtained from software Design-Expert® to evaluate both the repeatability and reproducibility of bead milling technique. Milling time was optimized to <5 h to obtain the desired particle size (d90 < 400 nm). The desirability function used to optimize the response variables and observed responses were in agreement with experimental values. These results demonstrated the reliability of selected model for manufacture of drug nanoparticles with predictable quality attributes. The optimization of bead milling process variables by applying DOE resulted in considerable decrease in milling time to achieve the desired particle size. The study indicates the applicability of DOE approach to optimize critical process parameters in the manufacture of drug nanoparticles.

Quality risk management in pharmaceutical development.

PubMed

Charoo, Naseem Ahmad; Ali, Areeg Anwer

2013-07-01

The objective of ICH Q8, Q9 and Q10 documents is application of systemic and science based approach to formulation development for building quality into product. There is always some uncertainty in new product development. Good risk management practice is essential for success of new product development in decreasing this uncertainty. In quality by design paradigm, the product performance properties relevant to the patient are predefined in target product profile (TPP). Together with prior knowledge and experience, TPP helps in identification of critical quality attributes (CQA's). Initial risk assessment which identifies risks to these CQA's provides impetus for product development. Product and process are designed to gain knowledge about these risks, devise strategies to eliminate or mitigate these risks and meet objectives set in TPP. By laying more emphasis on high risk events the protection level of patient is increased. The process being scientifically driven improves the transparency and reliability of the manufacturer. The focus on risk to the patient together with flexible development approach saves invaluable resources, increases confidence on quality and reduces compliance risk. The knowledge acquired in analysing risks to CQA's permits construction of meaningful design space. Within the boundaries of the design space, variation in critical material characteristics and process parameters must be managed in order to yield a product having the desired characteristics. Specifications based on product and process understanding are established such that product will meet the specifications if tested. In this way, the product is amenable to real time release, since specifications only confirm quality but they do not serve as a means of effective process control.

Relative Importance of Intercultural, Interpersonal, and Psychopathogical Attributions in Judging Critical Incidents by Multicultural Counselors.

ERIC Educational Resources Information Center

Mwaba, Kelvin; Pedersen, Paul

1990-01-01

Investigated the relative importance of multicultural counselors' experience or training in their choice of intercultural, interpersonal, or psychopathological attributions when interpreting 20 brief multicultural critical incidents. An inverse correlation was found between experience or training and emphasis on intercultural, as opposed to…

Application of quality-by-design approach to optimize diallyl disulfide-loaded solid lipid nanoparticles.

PubMed

Talluri, Siddhartha Venkata; Kuppusamy, Gowthamarajan; Karri, Veera Venkata Satyanarayana Reddy; Yamjala, Karthik; Wadhwani, Ashish; Madhunapantula, SubbaRao V; Pindiprolu, Saikiran S S

2017-05-01

The current work was carried out by the principles of quality-by-design approach to develop an optimized solid lipid nanoparticles (SLNs) formulation of diallyl disulfide (DADS) through systematic statistical study. And its antitumor activity of DADS was also evaluated on breast cancer cell lines. To understand the effect of formulation variables (critical parameters) on the responses (critical quality attributes) of SLN, a 3-factor, 3-level Box-Behnken design, was explored to predict the responses such as particle size (Y1) and % entrapment efficiency (EE) (Y2) when concentration of surfactant (X1), amount of lipid (X2), and volume of solvent (X3) were selected as independent variables. Particle size analysis revealed that all the batches were within the nanometer range. DADS was released from the SLN much more rapidly at pH 4.5 than at pH 7.4, which is a desirable characteristic for tumor-targeted drug delivery. The cytotoxicity, reactive oxygen species (ROS), determination revealed that the antitumor activity of DADS is enhanced with SLN compared to DADS-free drug, and apoptosis is the mechanism underlying the cytotoxicity. The present study indicated the remarkable potential of DADS-SLN in enhancing the anticancer effect of DADS in breast cancer cells in vitro.

Academic provenance: Investigation of pathways that lead students into the geosciences

NASA Astrophysics Data System (ADS)

Houlton, Heather R.

Pathways that lead students into the geosciences as a college major have not been fully explored in the current literature, despite the recent studies on the "geoscience pipeline model." Anecdotal evidence suggests low quality geoscience curriculum in K-12 education, lack of visibility of the discipline and lack of knowledge about geoscience careers contribute to low geoscience enrollments at universities. This study investigated the reasons why college students decided to major in the geosciences. Students' interests, experiences, motivations and desired future careers were examined to develop a pathway model. In addition, self-efficacy was used to inform pathway analyses, as it is an influential factor in academic major and career choice. These results and interpretations have strong implications for recruitment and retention in academia and industry. A semi-structured interview protocol was developed, which was informed by John Flanagan's critical incident theory. The responses to this interview were used to identify common experiences that diverse students shared for reasons they became geoscience majors. Researchers used self-efficacy theory by Alfred Bandura to assess students' pathways. Seventeen undergraduate geoscience majors from two U.S. Midwest research universities were sampled for cross-comparison and analysis. Qualitative analyses led to the development of six categorical steps for the geoscience pathway. The six pathway steps are: innate attributes/interest sources, pre-college critical incidents, college critical incidents, current/near future goals, expected career attributes and desired future careers. Although, how students traversed through each step was unique for individuals, similar patterns were identified between different populations in our participants: Natives, Immigrants and Refugees. In addition, critical incidents were found to act on behavior in two different ways: to support and confirm decision-making behavior (supportive critical incidents) or to alter behavior as to change or make an initial decision (behavior altering critical incidents). Comparing and contrasting populations' distinct pathways resulted in valuable discussion for recruitment and retention initiatives for the geoscience.

GIS measured environmental correlates of active school transport: A systematic review of 14 studies

PubMed Central

2011-01-01

Background Emerging frameworks to examine active school transportation (AST) commonly emphasize the built environment (BE) as having an influence on travel mode decisions. Objective measures of BE attributes have been recommended for advancing knowledge about the influence of the BE on school travel mode choice. An updated systematic review on the relationships between GIS-measured BE attributes and AST is required to inform future research in this area. The objectives of this review are: i) to examine and summarize the relationships between objectively measured BE features and AST in children and adolescents and ii) to critically discuss GIS methodologies used in this context. Methods Six electronic databases, and websites were systematically searched, and reference lists were searched and screened to identify studies examining AST in students aged five to 18 and reporting GIS as an environmental measurement tool. Fourteen cross-sectional studies were identified. The analyses were classified in terms of density, diversity, and design and further differentiated by the measures used or environmental condition examined. Results Only distance was consistently found to be negatively associated with AST. Consistent findings of positive or negative associations were not found for land use mix, residential density, and intersection density. Potential modifiers of any relationship between these attributes and AST included age, school travel mode, route direction (e.g., to/from school), and trip-end (home or school). Methodological limitations included inconsistencies in geocoding, selection of study sites, buffer methods and the shape of zones (Modifiable Areal Unit Problem [MAUP]), the quality of road and pedestrian infrastructure data, and school route estimation. Conclusions The inconsistent use of spatial concepts limits the ability to draw conclusions about the relationship between objectively measured environmental attributes and AST. Future research should explore standardizing buffer size, assess the quality of street network datasets and, if necessary, customize existing datasets, and explore further attributes linked to safety. PMID:21545750

Thermal pasteurization of ready-to-eat foods and vegetables: Critical factors for process design and effects on quality.

PubMed

Peng, Jing; Tang, Juming; Barrett, Diane M; Sablani, Shyam S; Anderson, Nathan; Powers, Joseph R

2017-09-22

Increasing consumer desire for high quality ready-to-eat foods makes thermal pasteurization important to both food producers and researchers. To be in compliance with the Food Safety Modernization Act (FSMA), food companies seek regulatory and scientific guidelines to ensure that their products are safe. Clearly understanding the regulations for chilled or frozen foods is of fundamental importance to the design of thermal pasteurization processes for vegetables that meet food safety requirements. This article provides an overview of the current regulations and guidelines for pasteurization in the U.S. and in Europe for control of bacterial pathogens. Poorly understood viral pathogens, in terms of their survival in thermal treatments, are an increasing concern for both food safety regulators and scientists. New data on heat resistance of viruses in different foods are summarized. Food quality attributes are sensitive to thermal degradation. A review of thermal kinetics of inactivation of quality-related enzymes in vegetables and the effects of thermal pasteurization on vegetable quality is presented. The review also discusses shelf-life of thermally pasteurized vegetables.

High adherence is necessary to realize health gains from water quality interventions.

PubMed

Brown, Joe; Clasen, Thomas

2012-01-01

Safe drinking water is critical for health. Household water treatment (HWT) has been recommended for improving access to potable water where existing sources are unsafe. Reports of low adherence to HWT may limit the usefulness of this approach, however. We constructed a quantitative microbial risk model to predict gains in health attributable to water quality interventions based on a range of assumptions about pre-treatment water quality; treatment effectiveness in reducing bacteria, viruses, and protozoan parasites; adherence to treatment interventions; volume of water consumed per person per day; and other variables. According to mean estimates, greater than 500 DALYs may be averted per 100,000 person-years with increased access to safe water, assuming moderately poor pre-treatment water quality that is a source of risk and high treatment adherence (>90% of water consumed is treated). A decline in adherence from 100% to 90% reduces predicted health gains by up to 96%, with sharpest declines when pre-treatment water quality is of higher risk. Results suggest that high adherence is essential in order to realize potential health gains from HWT.

Application of Quality by Design to the characterization of the cell culture process of an Fc-Fusion protein.

PubMed

Rouiller, Yolande; Solacroup, Thomas; Deparis, Véronique; Barbafieri, Marco; Gleixner, Ralf; Broly, Hervé; Eon-Duval, Alex

2012-06-01

The production bioreactor step of an Fc-Fusion protein manufacturing cell culture process was characterized following Quality by Design principles. Using scientific knowledge derived from the literature and process knowledge gathered during development studies and manufacturing to support clinical trials, potential critical and key process parameters with a possible impact on product quality and process performance, respectively, were determined during a risk assessment exercise. The identified process parameters were evaluated using a design of experiment approach. The regression models generated from the data allowed characterizing the impact of the identified process parameters on quality attributes. The main parameters having an impact on product titer were pH and dissolved oxygen, while those having the highest impact on process- and product-related impurities and variants were pH and culture duration. The models derived from characterization studies were used to define the cell culture process design space. The design space limits were set in such a way as to ensure that the drug substance material would consistently have the desired quality. Copyright © 2012 Elsevier B.V. All rights reserved.

High Adherence Is Necessary to Realize Health Gains from Water Quality Interventions

PubMed Central

Brown, Joe; Clasen, Thomas

2012-01-01

Background Safe drinking water is critical for health. Household water treatment (HWT) has been recommended for improving access to potable water where existing sources are unsafe. Reports of low adherence to HWT may limit the usefulness of this approach, however. Methods and Findings We constructed a quantitative microbial risk model to predict gains in health attributable to water quality interventions based on a range of assumptions about pre-treatment water quality; treatment effectiveness in reducing bacteria, viruses, and protozoan parasites; adherence to treatment interventions; volume of water consumed per person per day; and other variables. According to mean estimates, greater than 500 DALYs may be averted per 100,000 person-years with increased access to safe water, assuming moderately poor pre-treatment water quality that is a source of risk and high treatment adherence (>90% of water consumed is treated). A decline in adherence from 100% to 90% reduces predicted health gains by up to 96%, with sharpest declines when pre-treatment water quality is of higher risk. Conclusions Results suggest that high adherence is essential in order to realize potential health gains from HWT. PMID:22586491

Options for reducing food waste by quality-controlled logistics using intelligent packaging along the supply chain.

PubMed

Heising, Jenneke K; Claassen, G D H; Dekker, Matthijs

2017-10-01

Optimising supply chain management can help to reduce food waste. This paper describes how intelligent packaging can be used to reduce food waste when used in supply chain management based on quality-controlled logistics (QCL). Intelligent packaging senses compounds in the package that correlate with the critical quality attribute of a food product. The information on the quality of each individual packaged food item that is provided by the intelligent packaging can be used for QCL. In a conceptual approach it is explained that monitoring food quality by intelligent packaging sensors makes it possible to obtain information about the variation in the quality of foods and to use a dynamic expiration date (IP-DED) on a food package. The conceptual approach is supported by quantitative data from simulations on the effect of using the information of intelligent packaging in supply chain management with the goal to reduce food waste. This simulation shows that by using the information on the quality of products that is provided by intelligent packaging, QCL can substantially reduce food waste. When QCL is combined with dynamic pricing based on the predicted expiry dates, a further waste reduction is envisaged.

Viewpoint: methanol poisoning outbreak in Libya: a need for policy reforms.

PubMed

Taleb, Ziyad Ben; Bahelah, Raed

2014-11-01

We address the controversies surrounding a 2013 outbreak of methanol poisoning in Tripoli, Libya. We critically examine and systematically analyze the outbreak to highlight the lessons learned from this disaster and how to act properly to prevent similar outbreaks in future. Many health problems have been directly attributed to drinking alcohol; the type and quality of alcohol determines the detrimental effects. An unregulated and flourishing black market in alcohol is among the factors behind the Libyan tragedy, where approximately 90 deaths and about 1000 hospital admissions were reported. We reviewed gaps in local and regional alcohol policy, and highlighted the issue of illegally produced and home-made alcohol. Collaboration between countries in the region plus critical health and policy reforms in Libya, with emphasis on public health preparedness, can dramatically decrease morbidity and mortality associated with such outbreaks.

The Attributive Theory of Quality: A Model for Quality Measurement in Higher Education.

ERIC Educational Resources Information Center

Afshar, Arash

A theoretical basis for defining and measuring the quality of institutions of higher education, namely for accreditation purposes, is developed. The theory, the Attributive Theory of Quality, is illustrated using a calculation model that is based on general systems theory. The theory postulates that quality only exists in relation to the…

Relatives' expressed emotion, distress and attributions in clinical high-risk and recent onset of psychosis.

PubMed

Domínguez-Martínez, Tecelli; Medina-Pradas, Cristina; Kwapil, Thomas R; Barrantes-Vidal, Neus

2017-01-01

It has been well-demonstrated that Expressed Emotion (EE) in caregivers of schizophrenia patients is related to their illness attributions, but little is known about relatives' cognitive and emotional appraisals at early stages of psychosis. This study examined differences on the relationships of EE with distress and illness attributions in 78 relatives of At-Risk Mental States (ARMS) and First-Episode of Psychosis (FEP) patients, and which of those variables better predicted EE. Criticism and Emotional Over-Involvement (EOI) were associated with distress and with several illness attributions in both groups. Anxiety was more strongly associated with criticism in ARMS than in FEP-relatives, and it was associated with EOI in the ARMS but not in the FEP-group. No differences on the relationships of EE with depression or attributions were found. Furthermore, distress and attributions of blame toward the patients predicted criticism. Attributions of control by the patient and emotional negative representation about the disorder predicted EOI. Findings highlight the need to focus on early family interventions that provide proper information and psychological support in accordance with the illness stage, to help relatives improve their understanding of the disorder, handle difficult thoughts and emotions, reduce negative appraisals, and prevent high-EE over the psychotic process. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Attributing Illness to Food

PubMed Central

Doyle, Michael P.; Morris, J. Glenn; Painter, John; Singh, Ruby; Tauxe, Robert V.; Taylor, Michael R.; Wong, Danilo M.A. Lo Fo

2005-01-01

Identification and prioritization of effective food safety interventions require an understanding of the relationship between food and pathogen from farm to consumption. Critical to this cause is food attribution, the capacity to attribute cases of foodborne disease to the food vehicle or other source responsible for illness. A wide variety of food attribution approaches and data are used around the world, including the analysis of outbreak data, case-control studies, microbial subtyping and source tracking methods, and expert judgment, among others. The Food Safety Research Consortium sponsored the Food Attribution Data Workshop in October 2003 to discuss the virtues and limitations of these approaches and to identify future options for collecting food attribution data in the United States. We summarize workshop discussions and identify challenges that affect progress in this critical component of a risk-based approach to improving food safety. PMID:16022770

Engineering Quality Software: 10 Recommendations for Improved Software Quality Management

DTIC Science & Technology

2010-04-27

lack of user involvement • Inadequate Software Process Management & Control By Contractors • No “Team” of Vendors and users; little SME participation...1990 Quality Perspectives • Process Quality ( CMMI ) • Product Quality (ISO/IEC 2500x) – Internal Quality Attributes – External Quality Attributes... CMMI /ISO 9000 Assessments – Capture organizational knowledge • Identify best practices, lessons learned Know where you are, and where you need to be

Parents' Criticisms and Attributions about Their Adult Children with High Functioning Autism or Schizophrenia

ERIC Educational Resources Information Center

Wasserman, Stephanie; Weisman de Mamani, Amy; Mundy, Peter

2010-01-01

The current study examined the criticism component of expressed emotion (EE) and attributions in parents of adults diagnosed with schizophrenia/schizoaffective disorder (S/SA) or high functioning autism/Asperger's. Consistent with study hypotheses, parents of adults diagnosed with autism/Asperger's disorder exhibited lower levels of high…

Attributes of quality programs in universities in developing countries: Case studies of two private universities in Ecuador and beyond

NASA Astrophysics Data System (ADS)

Uriguen, Monica I.

This study sought to identify the key attributes of high-quality programs with an eye toward helping developing countries such as Ecuador advance program quality. The dissertation is divided into five chapters: (1) introduction to high-quality programs; (2) literature review of attributes of high-quality programs; (3) grounded theory method (including interviews with 60 individuals) used to identify program attributes that enhance student learning; (4) findings; and (5) conclusions and recommendations. Following are the five clusters and thirteen attributes of high-quality programs that I identified: Cluster One: Highly Qualified Participants: (1) Highly Qualified Faculty, and (2) Highly Qualified Students; Cluster Two: Learning-Centered Cultures: (3) Shared Program Direction Focused on Learning, (4) Real-World Learning Experiences, (5) Reading-Centered Culture, and (6) Supportive and Risk-Taking Environment; Cluster Three: Interactive Teaching and Learning: (7) Integrative learning: Theory with Practice, Self with Subject, and (8) Exclusive Tutoring and Mentoring; Cluster Four: Connected Program Requirements: (9) Planned Breadth and Depth Course Work, and (10) Tangible Products; and Cluster Five: Adequate Resources: (11) Support for Students, (12) Support for Faculty, and (13) Support for Campus Infrastructure. The study was guided by Haworth and Conrad's (1997) "Engagement Theory of High-Quality Programs." Eleven of the attributes of high-quality programs are closely connected to Haworth and Conrad's theory and the other two attributes---real-world learning experiences and a reading-centered culture---make the signature theoretical contributions of the study. Real-world learning experiences encourage the active involvement of stakeholders in designing curricula with real-world learning experiences. The second attribute---a reading-centered culture---has never before been identified in the literature. There are four key differences between Haworth and Conrad's theory and the theory developed in this study. This study identified four attributes that are highly important in Ecuador and, possibly, other developing countries: highly-qualified faculty, highly-qualified students, reading-centered cultures, and real-world learning experiences. If Latin American universities implement the recommendations proposed in the study, particularly Ecuadorian universities, there is a foundation for envisioning a better future for Ecuadorian universities.

Cancer patients' perceptions of quality-of-care attributes-Associations with age, perceived health status, gender and education.

PubMed

Suhonen, Riitta; Stolt, Minna; Berg, Agneta; Katajisto, Jouko; Lemonidou, Chryssoula; Patiraki, Elisabeth; Sjövall, Katarina; Charalambous, Andreas

2018-01-01

The aim of this study was to explore the associations between patients' gender, education, health status in relation to assessments of patient-centred quality and individuality in care and trust in nurses for those <65 (working age) and ≥65 years (older people). Patients' assessments of the quality of care they receive are essential for the development of the provision of patient care and services. Previous studies have revealed age of the patient is associated with their assessment of care quality attributes. The study employed a cross-sectional, multicultural comparative survey design. The data were collected using questionnaires among hospitalised cancer patients (N = 876, n = 599, 68%) in four European countries: Greece, Cyprus, Sweden and Finland. The data were divided into two subgroups based on age (cut point 65 years) and were analysed statistically. Cancer patients' age, gender and level of education were not related to their assessments of care quality attributes: person-centred care quality, individuality in care and trust in nurses. Subgroup analysis of the older adults and those of working age showed clear associations with patients' assessments of quality-of-care attributes and perceived health status. The lower the perceived health status, the lower the assessment of care quality attributes. The results suggest that the cancer itself is the strongest determinant of the care delivered, rather than any patient characteristics, such as age, education or gender. Perceived health status, in association with cancer patient assessments of care quality attributes, may be useful in the development of patient-centred, individualised care strategies alongside a stronger focus on people instead of cancer-care-related processes and duties. Health status was the only factor associated with cancer patients' assessments of care quality attributes. Cancer itself may be the strongest determinant of the care quality perceptions, rather than any patient characteristics. The findings of this study have implications for cancer care professionals in terms of patient assessment and care planning. The measures may be useful in assessing quality of cancer nursing care. © 2017 John Wiley & Sons Ltd.

A Hearing-Based, Frequency Domain Sound Quality Model for Combined Aerodynamic and Power Transmission Response with Application to Rotorcraft Interior Noise

NASA Astrophysics Data System (ADS)

Sondkar, Pravin B.

The severity of combined aerodynamics and power transmission response in high-speed, high power density systems such as a rotorcraft is still a major cause of annoyance in spite of recent advancement in passive, semi-active and active control. With further increase in the capacity and power of this class of machinery systems, the acoustic noise levels are expected to increase even more. To achieve further improvements in sound quality, a more refined understanding of the factors and attributes controlling human perception is needed. In the case of rotorcraft systems, the perceived quality of the interior sound field is a major determining factor of passenger comfort. Traditionally, this sound quality factor is determined by measuring the response of a chosen set of juries who are asked to compare their qualitative reactions to two or more sounds based on their subjective impressions. This type of testing is very time-consuming, costly, often inconsistent, and not useful for practical design purposes. Furthermore, there is no known universal model for sound quality. The primary aim of this research is to achieve significant improvements in quantifying the sound quality of combined aerodynamic and power transmission response in high-speed, high power density machinery systems such as a rotorcraft by applying relevant objective measures related to the spectral characteristics of the sound field. Two models have been proposed in this dissertation research. First, a classical multivariate regression analysis model based on currently known sound quality metrics as well some new metrics derived in this study is presented. Even though the analysis resulted in the best possible multivariate model as a measure of the acoustic noise quality, it lacks incorporation of human judgment mechanism. The regression model can change depending on specific application, nature of the sounds and types of juries used in the study. Also, it predicts only the averaged preference scores and does not explain why two jury members differ in their judgment. To address the above shortcoming of applying regression analysis, a new human judgment model is proposed to further improve the ability to predict the degree of subjective annoyance. The human judgment model involves extraction of subjective attributes and their values using a proposed artificial jury processor. In this approach, a set of ear transfer functions are employed to compute the characteristics of sound pressure waves as perceived subjectively by human. The resulting basilar membrane displacement data from this proposed model is then applied to analyze the attribute values. Using this proposed human judgment model, the human judgment mechanism, which is highly sophisticated, will be examined. Since the human judgment model is essentially based on jury attributes that are not expected to change significantly with application or nature of the sound field, it gives a more common basis to evaluate sound quality. This model also attempts to explain the inter-juror differences in opinion, which is critical in understanding the variability in human response.

Quality Improvement in Virtual Higher Education: A Grounded Theory Approach

ERIC Educational Resources Information Center

Mahdiuon, Rouhollah; Masoumi, Davoud; Farasatkhah, Maghsoud

2017-01-01

The article aims to explore the attributes of quality and quality improvement including the process and specific actions associated with these attributes--that contribute enhancing quality in Iranian Virtual Higher Education (VHE) institutions. A total of 16 interviews were conducted with experts and key actors in Iranian virtual higher education.…

A review of data quality assessment methods for public health information systems.

PubMed

Chen, Hong; Hailey, David; Wang, Ning; Yu, Ping

2014-05-14

High quality data and effective data quality assessment are required for accurately evaluating the impact of public health interventions and measuring public health outcomes. Data, data use, and data collection process, as the three dimensions of data quality, all need to be assessed for overall data quality assessment. We reviewed current data quality assessment methods. The relevant study was identified in major databases and well-known institutional websites. We found the dimension of data was most frequently assessed. Completeness, accuracy, and timeliness were the three most-used attributes among a total of 49 attributes of data quality. The major quantitative assessment methods were descriptive surveys and data audits, whereas the common qualitative assessment methods were interview and documentation review. The limitations of the reviewed studies included inattentiveness to data use and data collection process, inconsistency in the definition of attributes of data quality, failure to address data users' concerns and a lack of systematic procedures in data quality assessment. This review study is limited by the coverage of the databases and the breadth of public health information systems. Further research could develop consistent data quality definitions and attributes. More research efforts should be given to assess the quality of data use and the quality of data collection process.

A Review of Data Quality Assessment Methods for Public Health Information Systems

PubMed Central

Chen, Hong; Hailey, David; Wang, Ning; Yu, Ping

2014-01-01

High quality data and effective data quality assessment are required for accurately evaluating the impact of public health interventions and measuring public health outcomes. Data, data use, and data collection process, as the three dimensions of data quality, all need to be assessed for overall data quality assessment. We reviewed current data quality assessment methods. The relevant study was identified in major databases and well-known institutional websites. We found the dimension of data was most frequently assessed. Completeness, accuracy, and timeliness were the three most-used attributes among a total of 49 attributes of data quality. The major quantitative assessment methods were descriptive surveys and data audits, whereas the common qualitative assessment methods were interview and documentation review. The limitations of the reviewed studies included inattentiveness to data use and data collection process, inconsistency in the definition of attributes of data quality, failure to address data users’ concerns and a lack of systematic procedures in data quality assessment. This review study is limited by the coverage of the databases and the breadth of public health information systems. Further research could develop consistent data quality definitions and attributes. More research efforts should be given to assess the quality of data use and the quality of data collection process. PMID:24830450

Relationship between Quality of Life, Relationship Beliefs and Attribution Style in Infertile Couples.

PubMed

Navid, Behnaz; Mohammadi, Maryam; Maroufizadeh, Saman; Amini, Payam; Shirin, Zahra; Omani-Saman, Reza

2018-07-01

Many infertile couples experience psychological distress and suffer from impaired quality of life. Generally, when couples are dealing with uncontrolled events such as infertility, it is important to manage it well and to use the suitable coping style; so this can represent an example of attribution style. The purpose of this study is to investigate the quality of life, relationship beliefs and attribution style in infertile couples. This cross-sectional study consisted of 50 infertile couples, who were at least 18 years of age and could read and write in Persian. Participants provided demographic and general characteristics and completed the quality of life (SF-12), relationship belief inventory (RBI) and attribution style (ASQ) forms. Data was analyzed by the paired t test, Pearson correlation tests and multiple linear regression analysis, using SPSS version 22 statistical software. Overall, 50 infertile couples participated in our study. The males had a significantly higher score for quality of life compared to the females (P=0.019). In RBI subscales except "Disagreement is Destructive" all others significantly higher in wives than husbands. All subscales of RBI had a negative correlation with the quality of life. The quality of life had a significant correlation with positive internal (r=0.213, P=0.033). The adjusted regression model showed that the quality of life for males was higher than in females (β=-3.098, P=0.024). The current data indicate that in infertile couples, the husbands have a higher quality of life in comparison to their wives. Also, all subscales of relationship beliefs have a negative correlation with the quality of life, but in attribution style, just internal attribution style for positive events is associated with the quality of life. In general, there is a correlation between relationship beliefs and the quality of life in infertile couples. Copyright© by Royan Institute. All rights reserved.

Impact of data base structure in a successful in vitro-in vivo correlation for pharmaceutical products.

PubMed

Roudier, B; Davit, B; Schütz, H; Cardot, J-M

2015-01-01

The in vitro-in vivo correlation (IVIVC) (Food and Drug Administration 1997) aims to predict performances in vivo of a pharmaceutical formulation based on its in vitro characteristics. It is a complex process that (i) incorporates in a gradual and incremental way a large amount of information and (ii) requires information from different properties (formulation, analytical, clinical) and associated dedicated treatments (statistics, modeling, simulation). These results in many studies that are initiated and integrated into the specifications (quality target product profile, QTPP). This latter defines the appropriate experimental designs (quality by design, QbD) (Food and Drug Administration 2011, 2012) whose main objectives are determination (i) of key factors of development and manufacturing (critical process parameters, CPPs) and (ii) of critical points of physicochemical nature relating to active ingredients (API) and critical quality attribute (CQA) which may have implications in terms of efficiency, safety, and inoffensiveness for the patient, due to their non-inclusion. These processes generate a very large amount of data that is necessary to structure. In this context, the storage of information in a database (DB) and the management of this database (database management system, DBMS) become an important issue for the management of projects and IVIVC and more generally for development of new pharmaceutical forms. This article describes the implementation of a prototype object-oriented database (OODB) considered as a tool, which is helpful for decision taking, responding in a structured and consistent way to the issues of project management of IVIVC (including bioequivalence and bioavailability) (Food and Drug Administration 2003) necessary for the implementation of QTPP.

Fermentanomics: Relating quality attributes of a monoclonal antibody to cell culture process variables and raw materials using multivariate data analysis.

PubMed

Rathore, Anurag S; Kumar Singh, Sumit; Pathak, Mili; Read, Erik K; Brorson, Kurt A; Agarabi, Cyrus D; Khan, Mansoor

2015-01-01

Fermentanomics is an emerging field of research and involves understanding the underlying controlled process variables and their effect on process yield and product quality. Although major advancements have occurred in process analytics over the past two decades, accurate real-time measurement of significant quality attributes for a biotech product during production culture is still not feasible. Researchers have used an amalgam of process models and analytical measurements for monitoring and process control during production. This article focuses on using multivariate data analysis as a tool for monitoring the internal bioreactor dynamics, the metabolic state of the cell, and interactions among them during culture. Quality attributes of the monoclonal antibody product that were monitored include glycosylation profile of the final product along with process attributes, such as viable cell density and level of antibody expression. These were related to process variables, raw materials components of the chemically defined hybridoma media, concentration of metabolites formed during the course of the culture, aeration-related parameters, and supplemented raw materials such as glucose, methionine, threonine, tryptophan, and tyrosine. This article demonstrates the utility of multivariate data analysis for correlating the product quality attributes (especially glycosylation) to process variables and raw materials (especially amino acid supplements in cell culture media). The proposed approach can be applied for process optimization to increase product expression, improve consistency of product quality, and target the desired quality attribute profile. © 2015 American Institute of Chemical Engineers.

Water Quality Assessment in the Harbin Reach of the Songhuajiang River (China) Based on a Fuzzy Rough Set and an Attribute Recognition Theoretical Model

PubMed Central

An, Yan; Zou, Zhihong; Li, Ranran

2014-01-01

A large number of parameters are acquired during practical water quality monitoring. If all the parameters are used in water quality assessment, the computational complexity will definitely increase. In order to reduce the input space dimensions, a fuzzy rough set was introduced to perform attribute reduction. Then, an attribute recognition theoretical model and entropy method were combined to assess water quality in the Harbin reach of the Songhuajiang River in China. A dataset consisting of ten parameters was collected from January to October in 2012. Fuzzy rough set was applied to reduce the ten parameters to four parameters: BOD5, NH3-N, TP, and F. coli (Reduct A). Considering that DO is a usual parameter in water quality assessment, another reduct, including DO, BOD5, NH3-N, TP, TN, F, and F. coli (Reduct B), was obtained. The assessment results of Reduct B show a good consistency with those of Reduct A, and this means that DO is not always necessary to assess water quality. The results with attribute reduction are not exactly the same as those without attribute reduction, which can be attributed to the α value decided by subjective experience. The assessment results gained by the fuzzy rough set obviously reduce computational complexity, and are acceptable and reliable. The model proposed in this paper enhances the water quality assessment system. PMID:24675643

Associative false consumer memory: effects of need for cognition and encoding task.

PubMed

Parker, Andrew; Dagnall, Neil

2018-04-01

Two experiments investigated the effects of product-attribute associations on false consumer memory. In both experiments, subjects were presented with sets of related product attributes under incidental encoding conditions. Later, recognition memory was tested with studied attributes, non-studied but associated attributes (critical lures) and non-studied unrelated attributes. In Experiment 1, the effect of Need for Cognition (NFC) was assessed. It was found that individuals high in NFC recognised more presented attributes and falsely recognised more associative critical lures. The increase in both true and associative false memory was accompanied by a greater number of responses that index the retrieval of detailed episodic-like information. Experiment 2, replicated the main findings through an experimental manipulation of the encoding task that required subjects to consider purchase likelihood. Explanations for these findings are considered from the perspective of activation processes and knowledge structures in the form of gist-based representations.

New gentle-wing high-shear granulator: impact of processing variables on granules and tablets characteristics of high-drug loading formulation using design of experiment approach.

PubMed

Fayed, Mohamed H; Abdel-Rahman, Sayed I; Alanazi, Fars K; Ahmed, Mahrous O; Tawfeek, Hesham M; Al-Shdefat, Ramadan I

2017-10-01

The aim of this work was to study the application of design of experiment (DoE) approach in defining design space for granulation and tableting processes using a novel gentle-wing high-shear granulator. According to quality-by-design (QbD) prospective, critical attributes of granules, and tablets should be ensured by manufacturing process design. A face-centered central composite design has been employed in order to investigate the effect of water amount (X 1 ), impeller speed (X 2 ), wet massing time (X 3 ), and water addition rate (X 4 ) as independent process variables on granules and tablets characteristics. Acetaminophen was used as a model drug and granulation experiments were carried out using dry addition of povidone k30. The dried granules have been analyzed for their size distribution, density, and flow pattern. Additionally, the produced tablets have been investigated for; weight uniformity, breaking force, friability and percent capping, disintegration time, and drug dissolution. Results of regression analysis showed that water amount, impeller speed and wet massing time have significant (p < .05) effect on granules and tablets characteristics. However, the water amount had the most pronounced effect as indicated by its higher parameter estimate. On the other hand, water addition rate showed a minimal impact on granules and tablets properties. In conclusion, water amount, impeller speed, and wet massing time could be considered as critical process variables. Thus, understanding the relationship between these variables and quality attributes of granules and corresponding tablets provides the basis for adjusting granulation variables in order to optimize product performance.

Explication of Interspousal Criticality Bias

PubMed Central

Peterson, Kristina M.; Smith, David A.; Windle, Chaunce R.

2009-01-01

Although bias towards perceiving spousal criticism is related to dysphoria and marital discord (Smith & Peterson, 2008), the bias construct has received insufficient elaboration. We explicated the criticality bias construct by exploring its correlates and incremental validity relative to perceived criticism, marital attributions, and negative affect. 118 couples completed self-report measures and undertook a videotaped discussion task. Signal detection analyses of both spouses’ and outside observers’ ratings of discussions produced bias indices. Criticality bias evidenced a pattern of convergent and discriminant validity mirroring perceived criticism’s (Renshaw, 2008). Bias also provided incremental validity beyond perceived criticism, marital attributions, and negative affect to the prediction of behavior. Bias may be a dysfunctional way to view marital events and a stress generation process. PMID:19286167

Feeling safe during an inpatient hospitalization: a concept analysis.

PubMed

Mollon, Deene

2014-08-01

This paper aims to explore the critical attributes of the concept feeling safe. The safe delivery of care is a high priority; however; it is not really known what it means to the patient to 'feel safe' during an inpatient hospitalization. This analysis explores the topic of safety from the patient's perspective. Concept analysis. The data bases of CINAHL, Medline, PsychInfo and Google Scholar for the years 1995-2012 were searched using the terms safe and feeling safe. The eight-step concept analysis method of Walker and Avant was used to analyse the concept of feeling safe. Uses and defining attributes, as well as identified antecedents, consequences and empirical referents, are presented. Case examples are provided to assist in the understanding of defining attributes. Feeling safe is defined as an emotional state where perceptions of care contribute to a sense of security and freedom from harm. Four attributes were identified: trust, cared for, presence and knowledge. Relationship, environment and suffering are the antecedents of feeling safe, while control, hope and relaxed or calm are the consequences. Empirical referents and early development of a theory of feeling safe are explored. This analysis begins the work of synthesizing qualitative research already completed around the concept of feeling safe by defining the key attributes of the concept. Support for the importance of developing patient-centred models of care and creating positive environments where patients receive high-quality care and feel safe is provided. © 2014 John Wiley & Sons Ltd.

Non-linear assessment and deficiency of linear relationship for healthcare industry

NASA Astrophysics Data System (ADS)

Nordin, N.; Abdullah, M. M. A. B.; Razak, R. C.

2017-09-01

This paper presents the development of the non-linear service satisfaction model that assumes patients are not necessarily satisfied or dissatisfied with good or poor service delivery. With that, compliment and compliant assessment is considered, simultaneously. Non-linear service satisfaction instrument called Kano-Q and Kano-SS is developed based on Kano model and Theory of Quality Attributes (TQA) to define the unexpected, hidden and unspoken patient satisfaction and dissatisfaction into service quality attribute. A new Kano-Q and Kano-SS algorithm for quality attribute assessment is developed based satisfaction impact theories and found instrumentally fit the reliability and validity test. The results were also validated based on standard Kano model procedure before Kano model and Quality Function Deployment (QFD) is integrated for patient attribute and service attribute prioritization. An algorithm of Kano-QFD matrix operation is developed to compose the prioritized complaint and compliment indexes. Finally, the results of prioritized service attributes are mapped to service delivery category to determine the most prioritized service delivery that need to be improved at the first place by healthcare service provider.

[Application of risk-based approach for determination of critical factors in technology transfer of production of medicinal products].

PubMed

Beregovykh, V V; Spitskiy, O R

2014-01-01

Risk-based approach is used for examination of impact of different factors on quality of medicinal products in technology transfer. A general diagram is offered for risk analysis execution in technology transfer from pharmaceutical development to production. When transferring technology to full- scale commercial production it is necessary to investigate and simulate production process application beforehand in new real conditions. The manufacturing process is the core factorfor risk analysis having the most impact on quality attributes of a medicinal product. Further importantfactors are linked to materials and products to be handled and manufacturing environmental conditions such as premises, equipment and personnel. Usage of risk-based approach in designing of multipurpose production facility of medicinal products is shown where quantitative risk analysis tool RAMM (Risk Analysis and Mitigation Matrix) was applied.

Quality by Design approach in the development of hydrophilic interaction liquid chromatographic method for the analysis of iohexol and its impurities.

PubMed

Jovanović, Marko; Rakić, Tijana; Tumpa, Anja; Jančić Stojanović, Biljana

2015-06-10

This study presents the development of hydrophilic interaction liquid chromatographic method for the analysis of iohexol, its endo-isomer and three impurities following Quality by Design (QbD) approach. The main objective of the method was to identify the conditions where adequate separation quality in minimal analysis duration could be achieved within a robust region that guarantees the stability of method performance. The relationship between critical process parameters (acetonitrile content in the mobile phase, pH of the water phase and ammonium acetate concentration in the water phase) and critical quality attributes is created applying design of experiments methodology. The defined mathematical models and Monte Carlo simulation are used to evaluate the risk of uncertainty in models prediction and incertitude in adjusting the process parameters and to identify the design space. The borders of the design space are experimentally verified and confirmed that the quality of the method is preserved in this region. Moreover, Plackett-Burman design is applied for experimental robustness testing and method is fully validated to verify the adequacy of selected optimal conditions: the analytical column ZIC HILIC (100 mm × 4.6 mm, 5 μm particle size); mobile phase consisted of acetonitrile-water phase (72 mM ammonium acetate, pH adjusted to 6.5 with glacial acetic acid) (86.7:13.3) v/v; column temperature 25 °C, mobile phase flow rate 1 mL min(-1), wavelength of detection 254 nm. Copyright © 2015 Elsevier B.V. All rights reserved.

Tailoring recombinant protein quality by rational media design.

PubMed

Brühlmann, David; Jordan, Martin; Hemberger, Jürgen; Sauer, Markus; Stettler, Matthieu; Broly, Hervé

2015-01-01

Clinical efficacy and safety of recombinant proteins are closely associated with their structural characteristics. The major quality attributes comprise glycosylation, charge variants (oxidation, deamidation, and C- & N-terminal modifications), aggregates, low-molecular-weight species (LMW), and misincorporation of amino acids in the protein backbone. Cell culture media design has a great potential to modulate these quality attributes due to the vital role of medium in mammalian cell culture. The purpose of this review is to provide an overview of the way both classical cell culture medium components and novel supplements affect the quality attributes of recombinant therapeutic proteins expressed in mammalian hosts, allowing rational and high-throughput optimization of mammalian cell culture media. A selection of specific and/or potent inhibitors and activators of oligosaccharide processing as well as components affecting multiple quality attributes are presented. Extensive research efforts in this field show the feasibility of quality engineering through media design, allowing to significantly modulate the protein function. © 2015 American Institute of Chemical Engineers.

[Challenges and barriers in the promotion of quality in health care services].

PubMed

Brezis, Mayer; Cohen, Matan J; Frankel, Meir; Chinitz, David

2012-03-01

The promotion of quality and safety in health care faces many challenges and barriers including lack of cooperation by physicians. Complexity and uncertainty in measuring quality raise methodological difficulties. Lack of sufficient awareness about these limitations, also among those who measure quality, contributes to physicians lack of interest, suspicion and mistrust. Strategic issues associated with quality assessment in the Israeli health care system derive from lack of regulation and evasiveness about the accountability of executives and governing bodies regarding the quality of the services provided to patients in hospitals and clinics. Some of these challenges relate to the intrusion of market forces into the world of medicine without needed adaptations, so that reimbursement is often conveniently linked to the quantity of services and not to their quality. Efficiency, which characterizes competitive markets, is not easily translated in the clinical world where empathy, listening skills, and capability of explaining are critical physician attributes. This clinical world values giving beyond monetary compensation, and cooperation between institutions--rather than competition--all crucial for the continuity of patient's care. The interface between economics and health care calls for creative thinking, with a novel definition for the social value of medical and nursing care according to their quality and not their quantity.

INCITS W1.1 development update: appearance-based image quality standards for printers

NASA Astrophysics Data System (ADS)

Zeise, Eric K.; Rasmussen, D. René; Ng, Yee S.; Dalal, Edul; McCarthy, Ann; Williams, Don

2008-01-01

In September 2000, INCITS W1 (the U.S. representative of ISO/IEC JTC1/SC28, the standardization committee for office equipment) was chartered to develop an appearance-based image quality standard. (1),(2) The resulting W1.1 project is based on a proposal (3) that perceived image quality can be described by a small set of broad-based attributes. There are currently six ad hoc teams, each working towards the development of standards for evaluation of perceptual image quality of color printers for one or more of these image quality attributes. This paper summarizes the work in progress of the teams addressing the attributes of Macro-Uniformity, Colour Rendition, Gloss & Gloss Uniformity, Text & Line Quality and Effective Resolution.

ATTRIBUTES OF AESTHETIC QUALITY USED BY TEXTILE CONSERVATORS IN EVALUATING CONSERVATION INTERVENTIONS ON MUSEUM COSTUMES.

PubMed

Nilsson, Johanna; Axelsson, Östen

2015-08-01

Aesthetic quality is central to textile conservators when evaluating a conservation method. However, the literature on textile conservation chiefly focuses on physical properties, and little is known about what factors determine aesthetic quality according to textile conservators. The latter was explored through two experiments. Experiment 1 explored the underlying attributes of aesthetic quality of textile conservation interventions. Experiment 2 explored the relationships between these attributes and how well they predicted aesthetic quality. Rank-order correlation analyses revealed two latent factors called Coherence and Completeness. Ordinal regression analysis revealed that Coherence was the most important predictor of aesthetic quality. This means that a successful conservation intervention is visually well-integrated with the textile item in terms of the material and method.

Critical thinking of nurse managers related to staff RNs' perceptions of the practice environment.

PubMed

Zori, Susan; Nosek, Laura J; Musil, Carol M

2010-09-01

BACKGROUND INFORMATION AND SIGNIFICANCE: Critical thinking (CT) skills and the inclination to engage in critical thinking are essential for nurse managers to function as transformational leaders capable of influencing staff to align with organizational goals. In an extensive literature review, numerous studies were found examining the concept of CT in students and no studies were found exploring CT in nurse managers. Identifying the attributes, such as CT, that lead to success in the nurse manager role is useful when preparing nurse managers to lead effectively in the current healthcare climate. Is there a difference between nurse managers' CT dispositions and their respective staff nurses' perceptions of the practice environment? A convenience sample of 12 nurse managers and a random sample of 132 of their respective staff registered nurses (RNs) participated in this descriptive study. CT in nurse managers was measured by the California Critical Thinking Disposition Inventory (CCTDI). Staff RNs' perceptions of the practice environment were measured by the Practice Environment Scale (PES). The research question was answered using a t test. Significant (p < .001) differences were found between specific nurse managers' CCTDI scores for open-mindedness, analyticity, and critical thinking confidence, and significant differences (p < .01) were found for systematicity when compared with their respective staff RNs' mean subscale and overall PES scores. Results of the study support the positive relationship between strength in critical thinking dispositions of nurse managers and their respective staff RNs' perceptions of the practice environment. Nurse managers with stronger CT dispositions may be better able to create positive practice environments that are conducive to job satisfaction and thus the retention of staff RNs. Inclusion of strategies to support the development and use of CT in nurse managers is recommended. CT and other leadership attributes and skills including emotional and social intelligence and management of change through an appreciative inquiry process may provide opportunities to improve leadership effectiveness in nurse managers. Enhancing critical thinking skills and dispositions of nurse managers may help to create positive work environments for staff RNs. Staff RNs who work in an environment perceived to be positive may be in a better position to deliver high quality, safe patient care.

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.

Impact of fill-level in twin-screw granulation on critical quality attributes of granules and tablets.

PubMed

Meier, Robin; Moll, Klaus-Peter; Krumme, Markus; Kleinebudde, Peter

2017-06-01

In a previous study a change of the fill-level in the barrel exerted a huge influence on the twin-screw granulation (TSG) process of a high drug loaded, simplified formulation. The present work investigated this influence systematically. The specific feed load (SFL) indicating the mass per revolution as surrogate parameter for the fill-level was applied and the correlation to the real volumetric fill level of an extruder could be demonstrated by a newly developed method. A design of experiments was conducted to examine the combined influence of SFL and screw speed on the process and on critical quality attributes of granules and tablets. The same formulation was granulated at constant liquid level with the same screw configuration and led to distinctively different results by only changing the fill-level and the screw speed. The power consumption of the extruder increased at higher SFLs with hardly any influence of screw speed. At low SFL the median residence time was mainly fill-level dependent and at higher SFL mainly screw speed dependent. Optimal values for the product characteristics were found at medium values for the SFL. Granule size distributions shifted from mono-modal and narrow shape to broader and even bimodal distributions of larger median granule sizes, when exceeding or falling below a certain fill-level. Deviating from the optimum fill-level, tensile strength of tablets decreased by about 25% and disintegration times of tablets increased for more than one third. At low fill-levels, material accumulation in front of the kneading zone was detected by pressure measurements and was assumed to be responsible for the unfavored product performance. At high fill-levels, granule consolidation due to higher propensity of contact with the result of higher material temperature was accounted for inferior product performance. The fill-level was found to be an important factor in assessment and development of twin-screw granulation processes as it impacted process and product attributes enormously. Copyright © 2017 Elsevier B.V. All rights reserved.

Edible films and coatings in seafood preservation: A review.

PubMed

Dehghani, Samira; Hosseini, Seyed Vali; Regenstein, Joe M

2018-02-01

Seafood is highly perishable and has a short shelf-life. During storage many reactions occur leading to changes in quality such as endogenous chemical and enzymatic reactions. The safety and shelf-life are related to the presence of food spoilage and pathogenic microorganisms. Despite improved manufacturing facilities and implementation of effective process control procedures such as the Hazard Analysis Critical Control Point system by seafood companies, the number of seafood-related foodborne illnesses has increased. Edible coatings can improve the quality of fresh and frozen products by retarding microbial growth, reducing lipid oxidation and moisture loss, and functioning as a carrier of food additives such as antimicrobial and antioxidant agents. Biodegradable edible coatings have various advantages over synthetic coatings such as being edible and generally being more environmentally friendly. This paper reviews the application of various types of natural bio-polymer and different active ingredients incorporated into the films and their effects on seafood quality attributes. Copyright © 2017 Elsevier Ltd. All rights reserved.

Variation in the health and biochemical condition of the coral Acropora tenuis along two water quality gradients on the Great Barrier Reef, Australia.

PubMed

Rocker, Melissa M; Francis, David S; Fabricius, Katharina E; Willis, Bette L; Bay, Line K

2017-06-30

This study explores how plasticity in biochemical attributes, used as indicators of health and condition, enables the coral Acropora tenuis to respond to differing water quality regimes in inshore regions of the Great Barrier Reef. Health attributes were monitored along a strong and weak water quality gradient, each with three reefs at increasing distances from a major river source. Attributes differed significantly only along the strong gradient; corals grew fastest, had the least dense skeletons, highest symbiont densities and highest lipid concentrations closest to the river mouth, where water quality was poorest. High nutrient and particulate loads were only detrimental to skeletal density, which decreased as linear extension increased, highlighting a trade-off. Our study underscores the importance of assessing multiple health attributes in coral reef monitoring. For example, autotrophic indices are poor indicators of coral health and condition, but improve when combined with attributes like lipid content and biomass. Copyright © 2017 Elsevier Ltd. All rights reserved.

Undergraduate nursing students' perceptions of the effectiveness of clinical teaching behaviours in Malaysia: A cross-sectional, correlational survey.

PubMed

Ludin, Salizar Mohamed; Fathullah, Nik Mohamed Nik

2016-09-01

Clinical teachers are a critical determinant of the quality of nursing students' clinical learning experiences. Understanding students' perceptions of clinical teachers' behaviours can provide the basis for recommendations that will help improve the quality of clinical education in clinical settings by developing better clinical teachers. To understand clinical teaching behaviours and their influence on students' learning from the perspective of undergraduate nursing students. A cross-sectional, correlational survey. A nursing faculty in Kuantan, Pahang, Malaysia. A sample of 120/154 (78%) students from Year 2-Year 4 were recruited according to set criteria. A self-administered questionnaire was employed to collect demographic data, and students' perceptions of clinical teaching behaviours and their impact on learning using the Nursing Clinical Teaching Effectiveness Inventory (NCTEI). Year 3 and 4 students perceived faculty clinical teaching behaviours positively. There was a significant association between clinical teaching behaviours and their influence on students' clinical learning. Teachers' competence rated as the most significant influential factor, while teachers' personality rated as least influential. Participants were able to identify the attributes of good clinical teachers and which attributes had the most influence on their learning. Overall, they perceived their teachers as providing good clinical teaching resulting in good clinical learning. Novice clinical teachers and nursing students can use this positive association between teaching behaviours and quality of clinical learning as a guide to clinical teaching and learning. Copyright © 2016 Elsevier Ltd. All rights reserved.

Quality-by-Design II: Application of Quantitative Risk Analysis to the Formulation of Ciprofloxacin Tablets.

PubMed

Claycamp, H Gregg; Kona, Ravikanth; Fahmy, Raafat; Hoag, Stephen W

2016-04-01

Qualitative risk assessment methods are often used as the first step to determining design space boundaries; however, quantitative assessments of risk with respect to the design space, i.e., calculating the probability of failure for a given severity, are needed to fully characterize design space boundaries. Quantitative risk assessment methods in design and operational spaces are a significant aid to evaluating proposed design space boundaries. The goal of this paper is to demonstrate a relatively simple strategy for design space definition using a simplified Bayesian Monte Carlo simulation. This paper builds on a previous paper that used failure mode and effects analysis (FMEA) qualitative risk assessment and Plackett-Burman design of experiments to identity the critical quality attributes. The results show that the sequential use of qualitative and quantitative risk assessments can focus the design of experiments on a reduced set of critical material and process parameters that determine a robust design space under conditions of limited laboratory experimentation. This approach provides a strategy by which the degree of risk associated with each known parameter can be calculated and allocates resources in a manner that manages risk to an acceptable level.

Measuring Environmental Quality in the Southern Appalachian Mountains

Treesearch

Linwood Pendleton; Brent Sohngen; Robert Mendelsohn; Thomas Holmes

1998-01-01

This study presents a method for valuing recreational environmental quality in the forests of the southeastern United States. The paper offers a method for choosing, measuring, and valuing forest attributes. Surveys and popular recreation literature are used to identify forest attributes that contribute to recreational quality. Standard ecological techniques are...

Dyadic Processes in Early Marriage: Attributions, Behavior, and Marital Quality

ERIC Educational Resources Information Center

Durtschi, Jared A.; Fincham, Frank D.; Cui, Ming; Lorenz, Frederick O.; Conger, Rand D.

2011-01-01

Marital processes in early marriage are important for understanding couples' future marital quality. Spouses' attributions about a partner's behavior have been linked to marital quality, yet the mechanisms underlying this association remain largely unknown. When we used couple data from the Family Transitions Project (N = 280 couples) across the…

Strategic deployment of CHO expression platforms to deliver Pfizer's Monoclonal Antibody Portfolio.

PubMed

Scarcelli, John J; Shang, Tanya Q; Iskra, Tim; Allen, Martin J; Zhang, Lin

2017-11-01

Development of stable cell lines for expression of large-molecule therapeutics represents a significant portion of the time and effort required to advance a molecule to enabling regulatory toxicology studies and clinical evaluation. Our development strategy employs two different approaches for cell line development based on the needs of a particular project: a random integration approach for projects where high-level expression is critical, and a site-specific integration approach for projects in which speed and reduced employee time spend is a necessity. Here we describe both our random integration and site-specific integration platforms and their applications in support of monoclonal antibody development and production. We also compare product quality attributes of monoclonal antibodies produced with a nonclonal cell pool or clonal cell lines derived from the two platforms. Our data suggests that material source (pools vs. clones) does not significantly alter the examined product quality attributes. Our current practice is to leverage this observation with our site-specific integration platform, where material generated from cell pools is used for an early molecular assessment of a given candidate to make informed decisions around development strategy. © 2017 American Institute of Chemical Engineers Biotechnol. Prog., 33:1463-1467, 2017. © 2017 American Institute of Chemical Engineers.

Box-Behnken study design for optimization of bicalutamide-loaded nanostructured lipid carrier: stability assessment.

PubMed

Kudarha, Ritu; Dhas, Namdev L; Pandey, Abhijeet; Belgamwar, Veena S; Ige, Pradum P

2015-01-01

Bicalutamide (BCM) is an anti-androgen drug used to treat prostate cancer. In this study, nanostructured lipid carriers (NLCs) were chosen as a carrier for delivery of BCM using Box-Behnken (BB) design for optimizing various quality attributes such as particle size and entrapment efficiency which is very critical for efficient drug delivery and high therapeutic efficacy. Stability of formulated NLCs was assessed with respect to storage stability, pH stability, hemolysis, protein stability, serum protein stability and accelerated stability. Hot high-pressure homogenizer was utilized for formulation of BCM-loaded NLCs. In BB response surface methodology, total lipid, % liquid lipid and % soya lecithin was selected as independent variable and particle size and %EE as dependent variables. Scanning electron microscopy (SEM) was done for morphological study of NLCs. Differential scanning calorimeter and X-ray diffraction study were used to study crystalline and amorphous behavior. Analysis of design space showed that process was robust with the particle size less than 200 nm and EE up to 78%. Results of stability studies showed stability of carrier in various storage conditions and in different pH condition. From all the above study, it can be concluded that NLCs may be suitable carrier for the delivery of BCM with respect to stability and quality attributes.

The process defines the product: what really matters in biosimilar design and production?

PubMed

Vulto, Arnold G; Jaquez, Orlando A

2017-08-01

Biologic drugs are highly complex molecules produced by living cells through a multistep manufacturing process. The key characteristics of these molecules, known as critical quality attributes (CQAs), can vary based on post-translational modifications that occur in the cellular environment or during the manufacturing process. The extent of the variation in each of the CQAs must be characterized for the originator molecule and systematically matched as closely as possible by the biosimilar developer to ensure bio-similarity. The close matching of the originator fingerprint is the foundation of the biosimilarity exercise, as the analytical tools designed to measure differences at the molecular level are far more sensitive and specific than tools available to physicians during clinical trials. Biosimilar development, therefore, has a greater focus on preclinical attributes compared with the development of an original biological agent. As changes in CQAs can occur at different stages of the manufacturing process, even small modifications to the process can alter biosimilar attributes beyond the point of similarity and impact clinical effectiveness and safety. The manufacturer's ability to provide consistent production and quality control will greatly influence the acceptance of biosimilars. To this end, preventing drift from the required specifications over time and avoiding the various implications brought by product shortage will enhance biosimilar integration into daily practice. As most prescribers are not familiar with this new drug development paradigm, educational programmes will be needed so that prescribers see biosimilars as fully equivalent, efficacious and safe medicines when compared with originator products. © The Author 2017. Published by Oxford University Press on behalf of the British Society for Rheumatology.

The process defines the product: what really matters in biosimilar design and production?

PubMed Central

Jaquez, Orlando A.

2017-01-01

Abstract Biologic drugs are highly complex molecules produced by living cells through a multistep manufacturing process. The key characteristics of these molecules, known as critical quality attributes (CQAs), can vary based on post-translational modifications that occur in the cellular environment or during the manufacturing process. The extent of the variation in each of the CQAs must be characterized for the originator molecule and systematically matched as closely as possible by the biosimilar developer to ensure bio-similarity. The close matching of the originator fingerprint is the foundation of the biosimilarity exercise, as the analytical tools designed to measure differences at the molecular level are far more sensitive and specific than tools available to physicians during clinical trials. Biosimilar development, therefore, has a greater focus on preclinical attributes compared with the development of an original biological agent. As changes in CQAs can occur at different stages of the manufacturing process, even small modifications to the process can alter biosimilar attributes beyond the point of similarity and impact clinical effectiveness and safety. The manufacturer’s ability to provide consistent production and quality control will greatly influence the acceptance of biosimilars. To this end, preventing drift from the required specifications over time and avoiding the various implications brought by product shortage will enhance biosimilar integration into daily practice. As most prescribers are not familiar with this new drug development paradigm, educational programmes will be needed so that prescribers see biosimilars as fully equivalent, efficacious and safe medicines when compared with originator products. PMID:28903544

Maternal sensitivity: a concept analysis.

PubMed

Shin, Hyunjeong; Park, Young-Joo; Ryu, Hosihn; Seomun, Gyeong-Ae

2008-11-01

The aim of this paper is to report a concept analysis of maternal sensitivity. Maternal sensitivity is a broad concept encompassing a variety of interrelated affective and behavioural caregiving attributes. It is used interchangeably with the terms maternal responsiveness or maternal competency, with no consistency of use. There is a need to clarify the concept of maternal sensitivity for research and practice. A search was performed on the CINAHL and Ovid MEDLINE databases using 'maternal sensitivity', 'maternal responsiveness' and 'sensitive mothering' as key words. The searches yielded 54 records for the years 1981-2007. Rodgers' method of evolutionary concept analysis was used to analyse the material. Four critical attributes of maternal sensitivity were identified: (a) dynamic process involving maternal abilities; (b) reciprocal give-and-take with the infant; (c) contingency on the infant's behaviour and (d) quality of maternal behaviours. Maternal identity and infant's needs and cues are antecedents for these attributes. The consequences are infant's comfort, mother-infant attachment and infant development. In addition, three positive affecting factors (social support, maternal-foetal attachment and high self-esteem) and three negative affecting factors (maternal depression, maternal stress and maternal anxiety) were identified. A clear understanding of the concept of maternal sensitivity could be useful for developing ways to enhance maternal sensitivity and to maximize the developmental potential of infants. Knowledge of the attributes of maternal sensitivity identified in this concept analysis may be helpful for constructing measuring items or dimensions.

[Studying on purification technology of Resina Draconis phenol extracts based on design space method].

PubMed

Zhang, Jian; Zhang, Xin; Bi, Yu-An; Xu, Gui-Hong; Huang, Wen-Zhe; Wang, Zhen-Zhong; Xiao, Wei

2017-09-01

The "design space" method was used to optimize the purification process of Resina Draconis phenol extracts by using the concept of "quality derived from design" (QbD). The content and transfer rate of laurin B and 7,4'-dihydroxyflavone and yield of extract were selected as the critical quality attributes (CQA). Plackett-Burman design showed that the critical process parameters (CPP) were concentration of alkali, the amount of alkali and the temperature of alkali dissolution. Then the Box-Behnken design was used to establish the mathematical model between CQA and CPP. The variance analysis results showed that the P values of the five models were less than 0.05 and the mismatch values were all greater than 0.05, indicating that the model could well describe the relationship between CQA and CPP. Finally, the control limits of the above 5 indicators (content and transfer rate of laurine B and 7,4'-dihydroxyflavone, as well as the extract yield) were set, and then the probability-based design space was calculated by Monte Carlo simulation and verified. The results of the design space validation showed that the optimized purification method can ensure the stability of the Resina Draconis phenol extracts refining process, which would help to improve the quality uniformity between batches of phenol extracts and provide data support for production automation control. Copyright© by the Chinese Pharmaceutical Association.

A quality by design approach to understand formulation and process variability in pharmaceutical melt extrusion processes.

PubMed

Patwardhan, Ketaki; Asgarzadeh, Firouz; Dassinger, Thomas; Albers, Jessica; Repka, Michael A

2015-05-01

In this study, the principles of quality by design (QbD) have been uniquely applied to a pharmaceutical melt extrusion process for an immediate release formulation with a low melting model drug, ibuprofen. Two qualitative risk assessment tools - Fishbone diagram and failure mode effect analysis - were utilized to strategically narrow down the most influential parameters. Selected variables were further assessed using a Plackett-Burman screening study, which was upgraded to a response surface design consisting of the critical factors to study the interactions between the study variables. In process torque, glass transition temperature (Tg ) of the extrudates, assay, dissolution and phase change were measured as responses to evaluate the critical quality attributes (CQAs) of the extrudates. The effect of each study variable on the measured responses was analysed using multiple regression for the screening design and partial least squares for the optimization design. Experimental limits for formulation and process parameters to attain optimum processing have been outlined. A design space plot describing the domain of experimental variables within which the CQAs remained unchanged was developed. A comprehensive approach for melt extrusion product development based on the QbD methodology has been demonstrated. Drug loading concentrations between 40- 48%w/w and extrusion temperature in the range of 90-130°C were found to be the most optimum. © 2015 Royal Pharmaceutical Society.

Development and evaluation of paclitaxel nanoparticles using a quality-by-design approach.

PubMed

Yerlikaya, Firat; Ozgen, Aysegul; Vural, Imran; Guven, Olgun; Karaagaoglu, Ergun; Khan, Mansoor A; Capan, Yilmaz

2013-10-01

The aims of this study were to develop and characterize paclitaxel nanoparticles, to identify and control critical sources of variability in the process, and to understand the impact of formulation and process parameters on the critical quality attributes (CQAs) using a quality-by-design (QbD) approach. For this, a risk assessment study was performed with various formulation and process parameters to determine their impact on CQAs of nanoparticles, which were determined to be average particle size, zeta potential, and encapsulation efficiency. Potential risk factors were identified using an Ishikawa diagram and screened by Plackett-Burman design and finally nanoparticles were optimized using Box-Behnken design. The optimized formulation was further characterized by Fourier transform infrared spectroscopy, X-ray diffractometry, differential scanning calorimetry, scanning electron microscopy, atomic force microscopy, and gas chromatography. It was observed that paclitaxel transformed from crystalline state to amorphous state while totally encapsulating into the nanoparticles. The nanoparticles were spherical, smooth, and homogenous with no dichloromethane residue. In vitro cytotoxicity test showed that the developed nanoparticles are more efficient than free paclitaxel in terms of antitumor activity (more than 25%). In conclusion, this study demonstrated that understanding formulation and process parameters with the philosophy of QbD is useful for the optimization of complex drug delivery systems. © 2013 Wiley Periodicals, Inc. and the American Pharmacists Association.

Lessons learned from successful human vaccines: Delineating key epitopes by dissecting the capsid proteins

PubMed Central

Zhang, Xiao; Xin, Lu; Li, Shaowei; Fang, Mujin; Zhang, Jun; Xia, Ningshao; Zhao, Qinjian

2015-01-01

Recombinant VLP-based vaccines have been successfully used against 3 diseases caused by viral infections: Hepatitis B, cervical cancer and hepatitis E. The VLP approach is attracting increasing attention in vaccine design and development for human and veterinary use. This review summarizes the clinically relevant epitopes on the VLP antigens in successful human vaccines. These virion-like epitopes, which can be delineated with molecular biology, cryo-electron microscopy and x-ray crystallographic methods, are the prerequisites for these efficacious vaccines to elicit functional antibodies. The critical epitopes and key factors influencing these epitopes are discussed for the HEV, HPV and HBV vaccines. A pentamer (for HPV) or a dimer (for HEV and HBV), rather than a monomer, is the basic building block harboring critical epitopes for the assembly of VLP antigen. The processing and formulation of VLP-based vaccines need to be developed to promote the formation and stabilization of these epitopes in the recombinant antigens. Delineating the critical epitopes is essential for antigen design in the early phase of vaccine development and for critical quality attribute analysis in the commercial phase of vaccine manufacturing. PMID:25751641

A Conceptual Framework for Quality of Care

PubMed Central

Mosadeghrad, Ali Mohammad

2012-01-01

Despite extensive research on defining and measuring health care quality, little attention has been given to different stakeholders’ perspectives of high-quality health care services. The main purpose of this study was to explore the attributes of quality healthcare in the Iranian context. Exploratory in-depth individual and focus group interviews were conducted with key healthcare stakeholders including clients, providers, managers, policy makers, payers, suppliers and accreditation panel members to identify the healthcare service quality attributes and dimensions. Data analysis was carried out by content analysis, with the constant comparative method. Over 100 attributes of quality healthcare service were elicited and grouped into five categories. The dimensions were: efficacy, effectiveness, efficiency, empathy, and environment. Consequently, a comprehensive model of service quality was developed for health care context. The findings of the current study led to a conceptual framework of healthcare quality. This model leads to a better understanding of the different aspects of quality in health care and provides a better basis for defining, measuring and controlling quality of health care services. PMID:23922534

Effects of technology on nursing care and caring attributes of a sample of Iranian critical care nurses.

PubMed

Bagherian, Behnaz; Sabzevari, Sakineh; Mirzaei, Tayebeh; Ravari, Ali

2017-04-01

To examine the association between attitudes of critical care nurses about influences of technology and their caring attributes. In a cross-sectional study, firstly the psychometric properties of caring attributes questionnaire, which was developed to examine caring attributes of a sample of international nurses, was refined in a sample of 200 critical care nurses working in educational hospitals of a city in the southwest of Iran. Results of factor analysis with Varimax rotation decreased 60 items of caring attributes to 47 items which loaded under five subscales of caring negation, caring compassionate, caring advocacy, caring essence and caring communication. Secondly, attitudes of these nurses toward influences of technology on nursing care were assessed using a 22-item questionnaire, developed by the study researchers. Finally, the association between scores of caring attributes and attitudes toward influences of technology of this sample was determined. There was a positive association between caring attributes and influences of technology among our study nurses. Caring attributes scores were higher in female single nurses. Although caring attributes' scores had decreased along with age and work experience, caring commitment was higher in older more experienced nurses. Furthermore, female nurses had a better attitude toward influences of technology on their care. In contrast, younger and less experienced nurses had negative views on the effects of technology on nursing care. Continuing education and life-long learning on application of new technological equipment in nursing care and harmonising their use with caring values are necessary for nursing students and registered nurses to ensure delivering a patient-centred care, in a technologically driven environment. Copyright © 2016 Elsevier Ltd. All rights reserved.

Application of quality by design (QbD) to formulation and processing of naproxen pellets by extrusion-spheronization.

PubMed

Wang, Junlin; Kan, Shuling; Chen, Tong; Liu, Jianping

2015-03-01

The aim of this research was to apply quality by design (QbD) to the development of naproxen loaded core pellets which can be used as the potential core for colon-specific pellets. In the early stages of this study, prior knowledge and preliminary studies were systematically incorporated into the risk assessment using failure mode and effect analysis (FMEA) and fishbone diagram. Then Plackett-Burman design was used to screen eight potential high risk factors (spheronization speed, spheronization time, extrusion speed, drying method, CCMC-Na concentration, lactose concentration, water concentration and Tween 80 concentration) obtained from the above risk assessment. It was discovered that out of the eight potential high risk factors only three factors (spheronization speed, extrusion speed and CCMC-Na concentration) had significant effects on the quality of the pellets. This allowed the use of Box-Behnken design (BBD) to fully elucidate the relationship between the variables and critical quality attribute (CQA). Finally, the final control space was established within which the quality of the pellets can meet the requirement of colon-specific drug delivery system. This study demonstrated that naproxen loaded core pellets were successfully designed using QbD principle.

Attributions, criticism and warmth in mothers of children with intellectual disability and challenging behaviour: a pilot study.

PubMed

Lancaster, R L; Balling, K; Hastings, R; Lloyd, T J

2014-11-01

Associations between parental expressed emotion (EE) or parental attributions and the problem behaviours of children with intellectual disability (ID) have been explored in ID research. However, a more detailed examination of the attributional model of EE has not been reported. In the present study, we partially replicated and extended research focused on mothers of typically developing children with behaviour problems. Twenty-seven mothers of children with ID and behaviour problems aged 4-9 years were interviewed about their most problematic behaviours exhibited by their child, and completed a Five Minute Speech Sample. Interview transcripts and speech samples were coded for maternal EE and spontaneous causal attributions regarding the child's behaviour problems. Data were also collected on maternal well-being, and the child's behaviour problems. Mothers typically made attributions that were internal to the child, controllable by the child, personal to the child and stable for the child. Maternal attributions of being able to control the child's behaviour were associated with high maternal criticism and low warmth. Maternal depression was more strongly associated with the child's behaviour problems when mothers were coded as high in criticism or low in warmth. Patterns of maternal attributions about their child's behaviour problems and their consequences for maternal well-being and maternal-child relationships require more research attention. Implications for practice are discussed, including the potential for maternal attributions to be incompatible with the focus of positive behaviour supports offered to families. © 2013 The Authors. Journal of Intellectual Disability Research © 2013 John Wiley & Sons Ltd, MENCAP & IASSIDD.

Correlating wine quality indicators to chemical and sensory measurements.

PubMed

Hopfer, Helene; Nelson, Jenny; Ebeler, Susan E; Heymann, Hildegarde

2015-05-12

Twenty-seven commercial Californian Cabernet Sauvignon wines of different quality categories were analyzed with sensory and chemical methods. Correlations between five quality proxies-points awarded during a wine competition, wine expert scores, retail price, vintage, and wine region-were correlated to sensory attributes, volatile compounds, and elemental composition. Wine quality is a multi-faceted construct, incorporating many different layers. Depending on the quality proxy studied, significant correlations between quality and attributes, volatiles and elements were found, some of them previously reported in the literature.

Research on manufacturing service behavior modeling based on block chain theory

NASA Astrophysics Data System (ADS)

Zhao, Gang; Zhang, Guangli; Liu, Ming; Yu, Shuqin; Liu, Yali; Zhang, Xu

2018-04-01

According to the attribute characteristics of processing craft, the manufacturing service behavior is divided into service attribute, basic attribute, process attribute, resource attribute. The attribute information model of manufacturing service is established. The manufacturing service behavior information is successfully divided into public and private domain. Additionally, the block chain technology is introduced, and the information model of manufacturing service based on block chain principle is established, which solves the problem of sharing and secreting information of processing behavior, and ensures that data is not tampered with. Based on the key pairing verification relationship, the selective publishing mechanism for manufacturing information is established, achieving the traceability of product data, guarantying the quality of processing quality.

The Interplay between Teacher-Centredness and Self-Critical Tendency among Malaysian ESL Learners: New Insights for the Asian Context

ERIC Educational Resources Information Center

Thang, Siew Ming; Jaafar, Nurjanah Mohd

2017-01-01

Over the last decade, issues regarding attributions for success and failure in the learning of English have garnered much interest among Asian researchers. Of particular interest is the tendency of Asian learners to be self-critical when it comes to attributions for failure in the learning of English. This tendency has commonly been linked to the…

Risk as an attribute in discrete choice experiments: a systematic review of the literature.

PubMed

Harrison, Mark; Rigby, Dan; Vass, Caroline; Flynn, Terry; Louviere, Jordan; Payne, Katherine

2014-01-01

Discrete choice experiments (DCEs) are used to elicit preferences of current and future patients and healthcare professionals about how they value different aspects of healthcare. Risk is an integral part of most healthcare decisions. Despite the use of risk attributes in DCEs consistently being highlighted as an area for further research, current methods of incorporating risk attributes in DCEs have not been reviewed explicitly. This study aimed to systematically identify published healthcare DCEs that incorporated a risk attribute, summarise and appraise methods used to present and analyse risk attributes, and recommend best practice regarding including, analysing and transparently reporting the methodology supporting risk attributes in future DCEs. The Web of Science, MEDLINE, EMBASE, PsycINFO and Econlit databases were searched on 18 April 2013 for DCEs that included a risk attribute published since 1995, and on 23 April 2013 to identify studies assessing risk communication in the general (non-DCE) health literature. Healthcare-related DCEs with a risk attribute mentioned or suggested in the title/abstract were obtained and retained in the final review if a risk attribute meeting our definition was included. Extracted data were tabulated and critically appraised to summarise the quality of reporting, and the format, presentation and interpretation of the risk attribute were summarised. This review identified 117 healthcare DCEs that incorporated at least one risk attribute. Whilst there was some evidence of good practice incorporated into the presentation of risk attributes, little evidence was found that developing methods and recommendations from other disciplines about effective methods and validation of risk communication were systematically applied to DCEs. In general, the reviewed DCE studies did not thoroughly report the methodology supporting the explanation of risk in training materials, the impact of framing risk, or exploring the validity of risk communication. The primary limitation of this review was that the methods underlying presentation, format and analysis of risk attributes could only be appraised to the extent that they were reported. Improvements in reporting and transparency of risk presentation from conception to the analysis of DCEs are needed. To define best practice, further research is needed to test how the process of communicating risk affects the way in which people value risk attributes in DCEs.

Describing Quality and Sensory Attributes of 3 Mango (Mangifera indica L.) Cultivars at 3 Ripeness Stages Based on Firmness.

PubMed

Nassur, Rita de Cássia Mirela Resende; González-Moscoso, Sara; Crisosto, Gayle M; Lima, Luiz Carlos de Oliveira; Vilas Boas, Eduardo Valério de Barros; Crisosto, Carlos H

2015-09-01

To determine the ideal ripening stage for consumption of the mango cultivars, "Ataulfo," "Haden," and "Tommy Atkins"; fruits at 3 flesh firmness levels (ripeness stages) were evaluated by a trained panel using descriptive analysis after instrumental measurements were made. After harvest, all fruits were ripened to allow softening and quality and sensory attribute changes. Ripening changes during softening of Ataulfo mangos were expressed by a characteristic increase in the perception of "tropical fruit" and "peach" aromas, an increase in "juiciness," "sweetness," and "tropical fruit" flavor, while "fibrousness," "chewiness," and "sourness" decreased. Similar desirable sensory changes were also detected during softening of Haden mangos; an increase in tropical fruit and peach aromas, sweetness and tropical fruit flavor, and a decrease in chewiness, sourness, and bitterness. Softening of Tommy Atkins mangos was followed by reduced chewiness and sourness and increased peach aroma. Softening of all cultivars was followed by decreased sourness and titratable acidity (TA) and increased soluble solids concentration (SSC) and SSC:TA ratio. The results indicate that mango ripening leads to increased expression of sensory attributes such as tropical fruit and peach aromas, tropical flavor, and sweetness that have been related to improved eating quality and these final changes in sensory quality attributes are specific for each cultivar. For example, Ataulfo and Haden mangos had greater improvement in quality and sensory attributes related to fruit eating quality during ripening-softening than Tommy Atkins. In our consumer test, these quality-sensory attributes expressed during ripening that were perceived by the trained panel were also validated, supporting the need for a controlled ripening protocol in mangos. © 2015 Institute of Food Technologists®

Preparing national health systems to cope with the impending tsunami of ageing and its associated complexities: Towards more sustainable health care.

PubMed

Amalberti, René; Nicklin, Wendy; Braithwaite, Jeffrey

2016-06-01

Healthcare systems across the world are experiencing increased financial, organizational and social pressures attributable to a range of critical issues including the challenge of ageing populations. Health systems need to adapt, in order to sustainably provide quality care to the widest range of patients, particularly those with chronic and complex diseases, and especially those in vulnerable and low-income groups. We report on a workshop designed to tackle such issues under the auspices of ISQua, with representatives from Argentina, Australia, Canada, Columbia, Denmark, Emirates, France, Ireland, Jordan, Qatar, Malaysia, Norway, Oman, UK, South Africa and Switzerland. We discuss some of the challenges facing healthcare systems in countries ageing rapidly, to those less so, and touch on current and future reform options. © The Author 2016. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

Reducing the risk of contamination of sterile parenteral products via ready-to-use closure components.

PubMed

Curry, Wayne; Conway, Samuel; Goodfield, Clara; Miller, Kimberly; Mueller, Ronald L; Polini, Eugene

2010-12-01

The preparation of sterile parenteral products requires careful control of all ingredients, materials, and processes to ensure the final product has the identity and strength, and meets the quality and purity characteristics that it purports to possess. Contamination affecting these critical properties of parenteral products can occur in many ways and from many sources. The use of closures supplied by manufacturers in a ready-to-use state can be an effective method for reducing the risk of contamination and improving the quality of the drug product. This article will address contamination attributable to elastomeric container closure components and the regulatory requirements associated with container closure systems. Possible contaminants, including microorganisms, endotoxins, and chemicals, along with the methods by which these contaminants can enter the product will be reviewed. Such methods include inappropriate material selection, improper closure preparation processes, compromised container closure integrity, degradation of closures, and leaching of compounds from the closures.

Analysis of potential genotoxic impurities in rabeprazole active pharmaceutical ingredient via Liquid Chromatography-tandem Mass Spectrometry, following quality-by-design principles for method development.

PubMed

Iliou, Katerina; Malenović, Anđelija; Loukas, Yannis L; Dotsikas, Yannis

2018-02-05

A novel Liquid Chromatography-tandem mass spectrometry (LC-MS/MS) method is presented for the quantitative determination of two potential genotoxic impurities (PGIs) in rabeprazole active pharmaceutical ingredient (API). In order to overcome the analytical challenges in the trace analysis of PGIs, a development procedure supported by Quality-by-Design (QbD) principles was evaluated. The efficient separation between rabeprazole and the two PGIs in the shortest analysis time was set as the defined analytical target profile (ATP) and to this purpose utilization of a switching valve allowed the flow to be sent to waste when rabeprazole was eluted. The selected critical quality attributes (CQAs) were the separation criterion s between the critical peak pair and the capacity factor k of the last eluted compound. The effect of the following critical process parameters (CPPs) on the CQAs was studied: %ACN content, the pH and the concentration of the buffer salt in the mobile phase, as well as the stationary phase of the analytical column. D-Optimal design was implemented to set the plan of experiments with UV detector. In order to define the design space, Monte Carlo simulations with 5000 iterations were performed. Acceptance criteria were met for C 8 column (50×4mm, 5μm) , and the region having probability π≥95% to achieve satisfactory values of all defined CQAs was computed. The working point was selected with the mobile phase consisting ‎of ACN, ammonium formate 11mM at a ratio 31/69v/v with pH=6,8 for the water phase. The LC protocol was transferred to LC-MS/MS and validated according to ICH guidelines. Copyright © 2017 Elsevier B.V. All rights reserved.

Resource distributions among habitats determine solitary bee offspring production in a mosaic landscape.

PubMed

Williams, Neal M; Kremen, Claire

2007-04-01

Within mosaic landscapes, many organisms depend on attributes of the environment that operate over scales ranging from a single habitat patch to the entire landscape. One such attribute is resource distribution. Organisms' reliance on resources from within a local patch vs. those found among habitats throughout the landscape will depend on local habitat quality, patch quality, and landscape composition. The ability of individuals to move among complementary habitat types to obtain various resources may be a critical mechanism underlying the dynamics of animal populations and ultimately the level of biodiversity at different spatial scales. We examined the effects that local habitat type and landscape composition had on offspring production and survival of the solitary bee Osmia lignaria in an agri-natural landscape in California (U.S.A.). Female bees were placed on farms that did not use pesticides (organic farms), on farms that did use pesticides (conventional farms), or in seminatural riparian habitats. We identified pollens collected by bees nesting in different habitat types and matched these to pollens of flowering plants from throughout the landscape. These data enabled us to determine the importance of different plant species and habitat types in providing food for offspring, and how this importance changed with landscape and local nesting-site characteristics. We found that increasing isolation from natural habitat significantly decreased offspring production and survival for bees nesting at conventional farms, had weaker effects on bees in patches of seminatural habitat, and had little impact on those at organic farm sites. Pollen sampled from nests showed that females nesting in both farm and seminatural habitats relied on pollen from principally native plant species growing in seminatural habitat. Thus connectivity among habitats was critical for offspring production. Females nesting on organic farms were buffered to isolation effects by switching to floral resources growing at the farm site when seminatural areas were too distant. Overall local habitat conditions (farm management practices) can help bolster pollinators, but maintaining functional connectivity among habitats will likely be critical for persistence of pollinator populations as natural habitats are increasingly fragmented by human activities.

Gluten-Free Sources of Fermentable Extract: Effect of Temperature and Germination Time on Quality Attributes of Teff [Eragrostis tef (zucc.) Trotter] Malt and Wort.

PubMed

Di Ghionno, Lidia; Marconi, Ombretta; Lee, Eung Gwan; Rice, Christopher J; Sileoni, Valeria; Perretti, Giuseppe

2017-06-14

This study was conducted to evaluate the behavior of a white teff variety called Witkop during malting by using different parameters (germination temperature and duration) and to identify the best malting program. Samples were evaluated for standard quality malt and wort attributes, pasting characteristics, β-glucan and arabinoxylan content, and sugar profile. It was concluded that malting teff at 24 °C for 6 days produced acceptable malt in terms of quality attributes and sugar profile for brewing. The main attributes were 80.4% extract, 80.9% fermentability, 1.53 mPa s viscosity, 7.4 EBC-U color, 129 mg/L FAN, and 72.1 g/L of total fermentable sugars. Statistical analysis showed that pasting characteristics of teff malt were negatively correlated with some malt quality attributes, such as extract and fermentability. Witkop teff appeared to be a promising raw material for malting and brewing. However, the small grain size may lead to difficulties in handling malting process, and a bespoke brewhouse plant should be developed for the production at industrial scale.

Evaluation of the chemical quality traits of soybean seeds, as related to sensory attributes of soymilk.

PubMed

Ma, Lei; Li, Bin; Han, Fenxia; Yan, Shurong; Wang, Lianzheng; Sun, Junming

2015-04-15

The soybean seed chemical quality traits (including protein content, oil content, fatty acid composition, isoflavone content, and protein subunits), soymilk chemical character (soluble solid), and soymilk sensory attributes were evaluated among 70 genotypes to determine the correlation between seed chemical quality traits and soymilk sensory attributes. Six sensory parameters (i.e., soymilk aroma, smoothness in the mouth, thickness in the mouth, sweetness, colour and appearance, and overall acceptability) and a seven-point hedonic scale for each parameter were developed. Significant positive correlations were observed between overall acceptability and the other five evaluation parameters, suggesting that overall acceptability is an ideal parameter for evaluating soymilk flavour. The soymilk sensory attributes were significantly positively correlated with the characteristics of the glycinin (11S)/beta-conglycinin (7S) protein ratio, soluble solid, and oil content but negatively correlated with glycitein and protein content. Our results indicated that soymilk sensory attributes could be improved by selecting the desirable seed chemical quality traits in practical soybean breeding programs. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

A qualitative evaluation of the crucial attributes of contextual information necessary in EHR design to support patient-centered medical home care.

PubMed

Weir, Charlene R; Staggers, Nancy; Gibson, Bryan; Doing-Harris, Kristina; Barrus, Robyn; Dunlea, Robert

2015-04-16

Effective implementation of a Primary Care Medical Home model of care (PCMH) requires integration of patients' contextual information (physical, mental, social and financial status) into an easily retrievable information source for the healthcare team and clinical decision-making. This project explored clinicians' perceptions about important attributes of contextual information for clinical decision-making, how contextual information is expressed in CPRS clinical documentation as well as how clinicians in a highly computerized environment manage information flow related to these areas. A qualitative design using Cognitive Task Analyses and a modified Critical Incident Technique were used. The study was conducted in a large VA with a fully implemented EHR located in the western United States. Seventeen providers working in a PCMH model of care in Primary Care, Home Based Care and Geriatrics reported on a recent difficult transition requiring contextual information for decision-making. The transcribed interviews were qualitatively analyzed for thematic development related to contextual information using an iterative process and multiple reviewers with ATLAS@ti software. Six overarching themes emerged as attributes of contextual information: Informativeness, goal language, temporality, source attribution, retrieval effort, and information quality. These results indicate that specific attributes are needed to in order for contextual information to fully support clinical decision-making in a Medical Home care delivery environment. Improved EHR designs are needed for ease of contextual information access, displaying linkages across time and settings, and explicit linkages to both clinician and patient goals. Implications relevant to providers' information needs, team functioning and EHR design are discussed.

Real time monitoring of powder blend bulk density for coupled feed-forward/feed-back control of a continuous direct compaction tablet manufacturing process.

PubMed

Singh, Ravendra; Román-Ospino, Andrés D; Romañach, Rodolfo J; Ierapetritou, Marianthi; Ramachandran, Rohit

2015-11-10

The pharmaceutical industry is strictly regulated, where precise and accurate control of the end product quality is necessary to ensure the effectiveness of the drug products. For such control, the process and raw materials variability ideally need to be fed-forward in real time into an automatic control system so that a proactive action can be taken before it can affect the end product quality. Variations in raw material properties (e.g., particle size), feeder hopper level, amount of lubrication, milling and blending action, applied shear in different processing stages can affect the blend density significantly and thereby tablet weight, hardness and dissolution. Therefore, real time monitoring of powder bulk density variability and its incorporation into the automatic control system so that its effect can be mitigated proactively and efficiently is highly desired. However, real time monitoring of powder bulk density is still a challenging task because of different level of complexities. In this work, powder bulk density which has a significant effect on the critical quality attributes (CQA's) has been monitored in real time in a pilot-plant facility, using a NIR sensor. The sensitivity of the powder bulk density on critical process parameters (CPP's) and CQA's has been analyzed and thereby feed-forward controller has been designed. The measured signal can be used for feed-forward control so that the corrective actions on the density variations can be taken before they can influence the product quality. The coupled feed-forward/feed-back control system demonstrates improved control performance and improvements in the final product quality in the presence of process and raw material variations. Copyright © 2015 Elsevier B.V. All rights reserved.

Determination of Appropriate Service Delivery Level for Quantitative Attributes of Household Toilets in Rural Settlements of India from Users' Perspective

NASA Astrophysics Data System (ADS)

Rashid, Mohammad; Pandit, Debapratim

2018-04-01

Improvement of quality of sanitation services in rural settlements is an important development goal in developing countries including India and accordingly several strategies are adopted which promote the demand and use of household toilets through creating awareness and providing subsidies to poor people for construction of household toilets with service-level standards specified from experts' perspective. In many cases, users are unsatisfied with the quality of toilets constructed using subsidies and the same remain unused. Users' satisfaction depends on their perceptions of service quality of individual attributes and overall service quality of the household toilets, which is an important determinant of sustainability and sustained use of toilets. This study aims to assess and benchmark the appropriate service delivery level for quantitative attributes of rural household toilets based on user perception. The service quality is determined with the help of level of service (LOS) scales developed using successive interval scaling technique, the zone of tolerance (ZOT), and users satisfaction level (USL) which relates service delivery levels with user satisfaction directly. The study finds that the service quality of most of the attributes of household toilets constructed using subsidies is perceived as poor. The results also suggest that most of the users expect to have a toilet with the service level of attributes ranging between LOS A and LOS B.

Determination of Appropriate Service Delivery Level for Quantitative Attributes of Household Toilets in Rural Settlements of India from Users' Perspective.

PubMed

Rashid, Mohammad; Pandit, Debapratim

2018-04-01

Improvement of quality of sanitation services in rural settlements is an important development goal in developing countries including India and accordingly several strategies are adopted which promote the demand and use of household toilets through creating awareness and providing subsidies to poor people for construction of household toilets with service-level standards specified from experts' perspective. In many cases, users are unsatisfied with the quality of toilets constructed using subsidies and the same remain unused. Users' satisfaction depends on their perceptions of service quality of individual attributes and overall service quality of the household toilets, which is an important determinant of sustainability and sustained use of toilets. This study aims to assess and benchmark the appropriate service delivery level for quantitative attributes of rural household toilets based on user perception. The service quality is determined with the help of level of service (LOS) scales developed using successive interval scaling technique, the zone of tolerance (ZOT), and users satisfaction level (USL) which relates service delivery levels with user satisfaction directly. The study finds that the service quality of most of the attributes of household toilets constructed using subsidies is perceived as poor. The results also suggest that most of the users expect to have a toilet with the service level of attributes ranging between LOS A and LOS B.

Disciplinary Epistemologies, Generic Attributes and Undergraduate Academic Writing in Nursing and Midwifery

ERIC Educational Resources Information Center

Gimenez, Julio

2012-01-01

Generic attributes such as "holding a critical stance", "using evidence to support claims", and "projecting an impersonal voice" are central to disciplinary academic writing in higher education. These attributes, also referred to as "skills", have for a long time been conceptualised as transferable in that…

Integrating Written Communication Skills: Working towards a Whole of Course Approach

ERIC Educational Resources Information Center

Harris, Anne

2016-01-01

Australian universities, through their graduate attributes, claim that graduates have the ability to communicate, an attribute encompassing, at the least, written and oral literacies. Despite this claim, Australian universities have been criticised over the past decade for their lack of rigour in assessing this attribute; a criticism generally…

Quality of life and ethics.

PubMed

Fumincelli, Laís; Mazzo, Alessandra; Martins, José Carlos Amado; Mendes, Isabel Amélia Costa

2017-01-01

In health, ethics is an essential aspect of practice and care and guarantees a better quality of life for patients and their caregivers. To outline a conceptual analysis of quality of life and ethics, identifying attributes, contexts and magnitudes for health. A qualitative design about quality of life and ethics in health, considering the evolutionary approach in order to analyse the concept. To collect the data, a search was done using the keywords ethic*, quality of life and health. After, in total, 152 studies were found, finalizing seven relevant studies for the proposed concept analysis. Of seven studies analysed, their main results were shown by means of antecedents, consequences and attributes of the concepts. The three final attributes that synthesize the concept of quality of life and ethics in health were highlighted: Ethics dilemmas and quality of life; Human ethics and quality of life; and Ethics of care and quality of life. In fact, the attributes and context clearly reveal that ethics and quality of life influence the ability to solve ethical dilemmas, guarantee human ethics in healthcare and impact ethics in healthcare for the production of effective health policies and care that encompasses professional quality of life as well. The magnitude of ethical knowledge in each professional discipline permits cultivating a solidary attitude and developing the willingness to improve healthcare. The right to access, dignity and respect in care delivery are rooted in behaviours and are spontaneously applied in practice to the extent that they play an ethical role.

Engineering of an inhalable DDA/TDB liposomal adjuvant: a quality-by-design approach towards optimization of the spray drying process.

PubMed

Ingvarsson, Pall Thor; Yang, Mingshi; Mulvad, Helle; Nielsen, Hanne Mørck; Rantanen, Jukka; Foged, Camilla

2013-11-01

The purpose of this study was to identify and optimize spray drying parameters of importance for the design of an inhalable powder formulation of a cationic liposomal adjuvant composed of dimethyldioctadecylammonium (DDA) bromide and trehalose-6,6'-dibehenate (TDB). A quality by design (QbD) approach was applied to identify and link critical process parameters (CPPs) of the spray drying process to critical quality attributes (CQAs) using risk assessment and design of experiments (DoE), followed by identification of an optimal operating space (OOS). A central composite face-centered design was carried out followed by multiple linear regression analysis. Four CQAs were identified; the mass median aerodynamic diameter (MMAD), the liposome stability (size) during processing, the moisture content and the yield. Five CPPs (drying airflow, feed flow rate, feedstock concentration, atomizing airflow and outlet temperature) were identified and tested in a systematic way. The MMAD and the yield were successfully modeled. For the liposome size stability, the ratio between the size after and before spray drying was modeled successfully. The model for the residual moisture content was poor, although, the moisture content was below 3% in the entire design space. Finally, the OOS was drafted from the constructed models for the spray drying of trehalose stabilized DDA/TDB liposomes. The QbD approach for the spray drying process should include a careful consideration of the quality target product profile. This approach implementing risk assessment and DoE was successfully applied to optimize the spray drying of an inhalable DDA/TDB liposomal adjuvant designed for pulmonary vaccination.

Modeling relationships between catchment attributes and river water quality in southern catchments of the Caspian Sea.

PubMed

Hasani Sangani, Mohammad; Jabbarian Amiri, Bahman; Alizadeh Shabani, Afshin; Sakieh, Yousef; Ashrafi, Sohrab

2015-04-01

Increasing land utilization through diverse forms of human activities, such as agriculture, forestry, urban growth, and industrial development, has led to negative impacts on the water quality of rivers. To find out how catchment attributes, such as land use, hydrologic soil groups, and lithology, can affect water quality variables (Ca(2+), Mg(2+), Na(+), Cl(-), HCO 3 (-) , pH, TDS, EC, SAR), a spatio-statistical approach was applied to 23 catchments in southern basins of the Caspian Sea. All input data layers (digital maps of land use, soil, and lithology) were prepared using geographic information system (GIS) and spatial analysis. Relationships between water quality variables and catchment attributes were then examined by Spearman rank correlation tests and multiple linear regression. Stepwise approach-based multiple linear regressions were developed to examine the relationship between catchment attributes and water quality variables. The areas (%) of marl, tuff, or diorite, as well as those of good-quality rangeland and bare land had negative effects on all water quality variables, while those of basalt, forest land cover were found to contribute to improved river water quality. Moreover, lithological variables showed the greatest most potential for predicting the mean concentration values of water quality variables, and noting that measure of EC and TDS have inversely associated with area (%) of urban land use.

The effect of source credibility on consumers' perceptions of the quality of health information on the Internet.

PubMed

Bates, Benjamin R; Romina, Sharon; Ahmed, Rukhsana; Hopson, Danielle

2006-03-01

Recent use of the Internet as a source of health information has raised concerns about consumers' ability to tell 'good' information from 'bad' information. Although consumers report that they use source credibility to judge information quality, several observational studies suggest that consumers make little use of source credibility. This study examines consumer evaluations of web pages attributed to a credible source as compared to generic web pages on measures of message quality. In spring 2005, a community-wide convenience survey was distributed in a regional hub city in Ohio, USA. 519 participants were randomly assigned one of six messages discussing lung cancer prevention: three messages each attributed to a highly credible national organization and three identical messages each attributed to a generic web page. Independent sample t-tests were conducted to compare each attributed message to its counterpart attributed to a generic web page on measures of trustworthiness, truthfulness, readability, and completeness. The results demonstrated that differences in attribution to a source did not have a significant effect on consumers' evaluations of the quality of the information.Conclusions. The authors offer suggestions for national organizations to promote credibility to consumers as a heuristic for choosing better online health information through the use of media co-channels to emphasize credibility.

Client expectations and satisfaction of quality in home care services. A consumer perspective.

PubMed

Samuelsson, G; Wister, A

2000-12-01

This study examines clients' expectations of quality in home care services and their perceived satisfaction with services among a random sample of 76 home care recipients in Vancouver, Canada. The researchers conducted face-to-face interviews that applied Multiattribute Utility Technology, a procedure that organizes several quality attributes of "ideal" home care into a tree structure to compare their relative importance and ranking from the clients' perspective. Participants also were asked to state their satisfaction or dissatisfaction with the services received in these domains. Among the five main quality attributes identified, the subjects ranked suitability of the home helper and its subset, personal competence, as the most important indicators of quality, followed by continuity in service. In addition, clients tended to have a high level of satisfaction with regard to the attributes of overall home care services. The highest level of satisfaction was reported for elements of personal dispositions of home care staff. The lowest level of satisfaction involved the time/availability components of the service. Finally, comparisons between client expectations and satisfaction of received home care services showed the highest discrepancy for the attributes of influence and time/availability and the greatest congruence for personal attributes of the staff. The results are discussed in terms of their implications for the delivery of home care services.

Attribute importance segmentation of Norwegian seafood consumers: The inclusion of salient packaging attributes.

PubMed

Olsen, Svein Ottar; Tuu, Ho Huu; Grunert, Klaus G

2017-10-01

The main purpose of this study is to identify consumer segments based on the importance of product attributes when buying seafood for homemade meals on weekdays. There is a particular focus on the relative importance of the packaging attributes of fresh seafood. The results are based on a representative survey of 840 Norwegian consumers between 18 and 80 years of age. This study found that taste, freshness, nutritional value and naturalness are the most important attributes for the home consumption of seafood. Except for the high importance of information about expiration date, most other packaging attributes have only medium importance. Three consumer segments are identified based on the importance of 33 attributes associated with seafood: Perfectionists, Quality Conscious and Careless Consumers. The Quality Conscious consumers feel more self-confident in their evaluation of quality, and are less concerned with packaging, branding, convenience and emotional benefits compared to the Perfectionists. Careless Consumers are important as regular consumers of convenient and pre-packed seafood products and value recipe information on the packaging. The seafood industry may use the results provided in this study to strengthen their positioning of seafood across three different consumer segments. Copyright © 2017 Elsevier Ltd. All rights reserved.

Product design enhancement using apparent usability and affective quality.

PubMed

Seva, Rosemary R; Gosiaco, Katherine Grace T; Santos, Ma Crea Eurice D; Pangilinan, Denise Mae L

2011-03-01

In this study, apparent usability and affective quality were integrated in a design framework called the Usability Perception and Emotion Enhancement Model (UPEEM). The UPEEM was validated using structural equation modeling (SEM). The methodology consists of four phases namely product selection, attribute identification, design alternative generation, and design alternative evaluation. The first stage involved the selection of a product that highly involves the consumer. In the attribute identification stage, design elements of the product were identified. The possible values of these elements were also determined for use in the experimentation process. Design of experiments was used to identify how the attributes will be varied in the design alternative stage and which of the attributes significantly contribute to affective quality, apparent usability, and desirability in the design evaluation stage. Results suggest that product attributes related to form are relevant in eliciting intense affect and perception of usability in mobile phones especially those directly related to functionality and aesthetics. This study considered only four product attributes among so many due to the constraints of the research design employed. Attributes related to aesthetic perception of a product enhance apparent usability such as those related to dimensional ratios. Copyright © 2010 Elsevier Ltd and The Ergonomics Society. All rights reserved.

Spatiotemporal patterns and source attribution of nitrogen pollution in a typical headwater agricultural watershed in Southeastern China.

PubMed

Chen, Wenjun; He, Bin; Nover, Daniel; Duan, Weili; Luo, Chuan; Zhao, Kaiyan; Chen, Wen

2018-01-01

Excessive nitrogen (N) discharge from agriculture causes widespread problems in aquatic ecosystems. Knowledge of spatiotemporal patterns and source attribution of N pollution is critical for nutrient management programs but is poorly studied in headwaters with various small water bodies and mini-point pollution sources. Taking a typical small watershed in the low mountains of Southeastern China as an example, N pollution and source attribution were studied for a multipond system around a village using the Hydrological Simulation Program-Fortran (HSPF) model. The results exhibited distinctive spatio-seasonal variations with an overall seriousness rank for the three indicators: total nitrogen (TN) > nitrate/nitrite nitrogen (NO x - -N) > ammonia nitrogen (NH 3 -N), according to the Chinese Surface Water Quality Standard. TN pollution was severe for the entire watershed, while NO x - -N pollution was significant for ponds and ditches far from the village, and the NH 3 -N concentrations were acceptable except for the ponds near the village in summer. Although food and cash crop production accounted for the largest source of N loads, we discovered that mini-point pollution sources, including animal feeding operations, rural residential sewage, and waste, together contributed as high as 47% of the TN and NH 3 -N loads in ponds and ditches. So, apart from eco-fertilizer programs and concentrated animal feeding operations, the importance of environmental awareness building for resource management is highlighted for small farmers in headwater agricultural watersheds. As a first attempt to incorporate multipond systems into the process-based modeling of nonpoint source (NPS) pollution, this work can inform other hydro-environmental studies on scattered and small water bodies. The results are also useful to water quality improvement for entire river basins.

Identification of sensory attributes, instrumental and chemical measurements important for consumer acceptability of grilled lamb Longissimus lumborum.

PubMed

Oltra, O R; Farmer, L J; Gordon, A W; Moss, B W; Birnie, J; Devlin, D J; Tolland, E L C; Tollerton, I J; Beattie, A M; Kennedy, J T; Farrell, D

2015-02-01

In this study, important eating quality attributes that influence consumer liking for grilled lamb loin have been identified using preference mapping techniques. The eating quality attributes identified as driving the consumer liking of lamb loin steaks were “tenderness”, “sweet flavour”, “meaty aftertaste”, “roast lamb flavour” and “roast lamb aftertaste”. In contrast, the texture attribute “rubbery” and the flavour attributes “bitter flavour” and "bitter aftertaste" had a negative influence on consumer perceptions. Associations were observed between eating quality and a number of instrumental and chemical measurements. Warner Bratzler Shear Force showed an association with “rubbery” texture and a negative association with “tenderness” and consumer liking scores. The compounds, glucose, glucose-6-phosphate, inosine, inosine monophosphate and adenosine monophosphate were associated with the attributes, “sweet flavour”,“meaty aftertaste”, “roast lamb flavour”, “roast lamb aftertaste” and with consumer scores for liking of lamb which is probably caused by the role some of these compounds play as precursors of flavour and as taste compounds.

A system identification approach for developing model predictive controllers of antibody quality attributes in cell culture processes

PubMed Central

Schmitt, John; Beller, Justin; Russell, Brian; Quach, Anthony; Hermann, Elizabeth; Lyon, David; Breit, Jeffrey

2017-01-01

As the biopharmaceutical industry evolves to include more diverse protein formats and processes, more robust control of Critical Quality Attributes (CQAs) is needed to maintain processing flexibility without compromising quality. Active control of CQAs has been demonstrated using model predictive control techniques, which allow development of processes which are robust against disturbances associated with raw material variability and other potentially flexible operating conditions. Wide adoption of model predictive control in biopharmaceutical cell culture processes has been hampered, however, in part due to the large amount of data and expertise required to make a predictive model of controlled CQAs, a requirement for model predictive control. Here we developed a highly automated, perfusion apparatus to systematically and efficiently generate predictive models using application of system identification approaches. We successfully created a predictive model of %galactosylation using data obtained by manipulating galactose concentration in the perfusion apparatus in serialized step change experiments. We then demonstrated the use of the model in a model predictive controller in a simulated control scenario to successfully achieve a %galactosylation set point in a simulated fed‐batch culture. The automated model identification approach demonstrated here can potentially be generalized to many CQAs, and could be a more efficient, faster, and highly automated alternative to batch experiments for developing predictive models in cell culture processes, and allow the wider adoption of model predictive control in biopharmaceutical processes. © 2017 The Authors Biotechnology Progress published by Wiley Periodicals, Inc. on behalf of American Institute of Chemical Engineers Biotechnol. Prog., 33:1647–1661, 2017 PMID:28786215

Physicochemical and biological characterization of SB2, a biosimilar of Remicade® (infliximab)

PubMed Central

Hong, Juyong; Lee, Yuhwa; Lee, Changsoo; Eo, Suhyeon; Kim, Soyeon; Park, Seungkyu; Seo, Donghyuck; Lee, Youngji; Yeon, Soojeong; Bou-Assaf, George; Sosic, Zoran; Zhang, Wei

2017-01-01

ABSTRACT A biosimilar is a biological medicinal product that contains a version of the active substance of an already authorized original biological medicinal product. Biosimilarity to the reference product (RP) in terms of quality characteristics, such as physicochemical and biological properties, safety, and efficacy, based on a comprehensive comparability exercise needs to be established. SB2 (Flixabi® and Renflexis®) is a biosimilar to Remicade® (infliximab). The development of SB2 was performed in accordance with relevant guidelines of the International Conference on Harmonisation, the European Medicines Agency, and the United States Food and Drug Administration. To determine whether critical quality attributes meet quality standards, an extensive characterization test was performed with more than 80 lots of EU- and US-sourced RP. The physicochemical characterization study results revealed that SB2 was similar to the RP. Although a few differences in physicochemical attributes were observed, the evidence from the related literature, structure-activity relationship studies, and comparative biological assays showed that these differences were unlikely to be clinically meaningful. The biological characterization results showed that SB2 was similar to the RP in terms of tumor necrosis factor–α (TNF-α) binding and TNF-α neutralization activities as a main mode of action. SB2 was also similar in Fc-related biological activities including antibody-dependent cell-mediated cytotoxicity, complement-dependent cytotoxicity, neonatal Fc receptor binding, C1q binding, and Fc gamma receptor binding activities. These analytical findings support that SB2 is similar to the RP and also provide confidence of biosimilarity in terms of clinical safety and efficacy. PMID:28005456

A self-assessment of the propensity to obtain future employment: a case of final-year engineering students at the University of Botswana

NASA Astrophysics Data System (ADS)

Ssegawa, Joseph K.; Kasule, Daniel

2017-09-01

The article provides a self-assessment by final-year engineering students at the University of Botswana regarding the propensity to get employment. Students rated which employability attributes are important, the level of attainment and the sources that have facilitated the development of the attributes. Results indicated that students identified the most important attributes as management of time; possessing a high level of technical skills, meeting deadlines and creating viable solutions for solving a problem. They also indicated that they have weaknesses in managing time, meeting deadlines and creating viable solutions (attributes critical to the engineering profession). Students reported that their strengths were in having a positive attitude, orderly physical presentation, adaptation to new environments and willingness to learn new ideas. Students further noted that they developed the attributes from the university academic system followed by their own private activities. The study concludes that students lacked some of the critical attributes of engineering. They therefore, need to be explicitly and holistically sensitised as to how the attributes relate to their profession, employment and career development. As part of the review of the engineering programmes, sensitisation could be included in the induction process at enrolment.

Manufacturing Cell Therapies Using Engineered Biomaterials.

PubMed

Abdeen, Amr A; Saha, Krishanu

2017-10-01

Emerging manufacturing processes to generate regenerative advanced therapies can involve extensive genomic and/or epigenomic manipulation of autologous or allogeneic cells. These cell engineering processes need to be carefully controlled and standardized to maximize safety and efficacy in clinical trials. Engineered biomaterials with smart and tunable properties offer an intriguing tool to provide or deliver cues to retain stemness, direct differentiation, promote reprogramming, manipulate the genome, or select functional phenotypes. This review discusses the use of engineered biomaterials to control human cell manufacturing. Future work exploiting engineered biomaterials has the potential to generate manufacturing processes that produce standardized cells with well-defined critical quality attributes appropriate for clinical testing. Copyright © 2017 Elsevier Ltd. All rights reserved.

Broadening our understanding of clinical quality: from attribution error to situated cognition.

PubMed

Artino, A R; Durning, S J; Waechter, D M; Leary, K L; Gilliland, W R

2012-02-01

The tendency to overestimate the influence of personal characteristics on outcomes, and to underestimate the influence of situational factors, is known as the fundamental attribution error. We argue that medical-education researchers and policy makers may be guilty of this error in their quest to understand clinical quality. We suggest that to truly understand clinical quality, they must examine situational factors, which often have a strong influence on the quality of clinical encounters.

Analysis of consumers' preferences and behavior with regard to horse meat using a structured survey questionnaire.

PubMed

Oh, Woon Yong; Lee, Ji Woong; Lee, Chong Eon; Ko, Moon Seok; Jeong, Jae Hong

2009-12-01

In this study, a structured survey questionnaire was used to determine consumers' preferences and behavior with regard to horse meat at a horse meat restaurant located in Jeju, Korea, from October 1 to December 24, 2005. The questionnaire employed in this study consisted of 20 questions designed to characterize six general attributes: horse meat sensory property, physical appearance, health condition, origin, price, and other attributes. Of the 1370 questionnaires distributed, 1126 completed questionnaires were retained based on the completeness of the answers, representing an 82.2% response rate. Two issues were investigated that might facilitate the search for ways to improve horse meat production and marketing programs in Korea. The first step was to determine certain important factors, called principal components, which enabled the researchers to understand the needs of horse meat consumers via principal component analysis. The second step was to define consumer segments with regard to their preferences for horse meat, which was accomplished via cluster analysis. The results of the current study showed that health condition, price, origin, and leanness were the most critical physical attributes affecting the preferences of horse meat consumers. Four segments of consumers, with different demands for horse meat attributes, were identified: origin-sensitive consumers, price-sensitive consumers, quality and safety-sensitive consumers, and non-specific consumers. Significant differences existed among segments of consumers in terms of age, nature of work, frequency of consumption, and general level of acceptability of horse meat.

Profiles of innovators in a semi-arid smallholder agricultural environment in south west Zimbabwe

NASA Astrophysics Data System (ADS)

Mutsvangwa-Sammie, Eness P.; Manzungu, Emmanuel; Siziba, Shephard

2017-08-01

Innovations are regarded as critical to improving the efficiency, productivity and effectiveness of African agriculture. However, few efforts have been directed at understanding 'agricultural innovators', especially among smallholder farmers in sub-Saharan Africa who face low agricultural productivity and widespread food insecurity. This paper investigates the profile of innovators from a local perspective in a semi-arid smallholder farming area in south-west Zimbabwe. The paper is based on data collected from key informant interviews and a household questionnaire survey administered to 239 households from Gwanda and Insiza districts between 2013 and 2014. Qualities or attributes of an innovator (which constitute the profile of an innovator) identified by key informants included: resource endowment; social networks; education; and enthusiasm (passionate and hardworking). The attributes were used in a logit regression model to estimate the probability of the 239 households exhibiting the attributes of an innovator. Social networks and resource endowment, as depicted by amount of land cultivated, were found to significantly influence the probability of an individual being an innovator. Interestingly, the common attributes of education or belonging to an innovation platform used by extension and development agents, were found not to influence the probability of one being an innovator. The paper concludes that understanding local perceptions of innovators, which is based on appreciation of the socio-economic and biophysical circumstances, should be used to identify a 'basket' of context specific innovations that have potential to address the diverse needs of rural households farming households.

Development of a Conceptual Model of Disease Progression for Use in Economic Modeling of Chronic Obstructive Pulmonary Disease.

PubMed

Tabberer, Maggie; Gonzalez-McQuire, Sebastian; Muellerova, Hana; Briggs, Andrew H; Rutten-van Mölken, Maureen P M H; Chambers, Mike; Lomas, David A

2017-05-01

To develop and validate a new conceptual model (CM) of chronic obstructive pulmonary disease (COPD) for use in disease progression and economic modeling. The CM identifies and describes qualitative associations between disease attributes, progression and outcomes. A literature review was performed to identify any published CMs or literature reporting the impact and association of COPD disease attributes with outcomes. After critical analysis of the literature, a Steering Group of experts from the disciplines of health economics, epidemiology and clinical medicine was convened to develop a draft CM, which was refined using a Delphi process. The refined CM was validated by testing for associations between attributes using data from the Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE). Disease progression attributes included in the final CM were history and occurrence of exacerbations, lung function, exercise capacity, signs and symptoms (cough, sputum, dyspnea), cardiovascular disease comorbidities, 'other' comorbidities (including depression), body composition (body mass index), fibrinogen as a biomarker, smoking and demographic characteristics (age, gender). Mortality and health-related quality of life were determined to be the most relevant final outcome measures for this model, intended to be the foundation of an economic model of COPD. The CM is being used as the foundation for developing a new COPD model of disease progression and to provide a framework for the analysis of patient-level data. The CM is available as a reference for the implementation of further disease progression and economic models.

Physical Quality Indicators and Mechanical Behavior of Agricultural Soils of Argentina.

PubMed

Imhoff, Silvia; da Silva, Alvaro Pires; Ghiberto, Pablo J; Tormena, Cássio A; Pilatti, Miguel A; Libardi, Paulo L

2016-01-01

Mollisols of Santa Fe have different tilth and load support capacity. Despite the importance of these attributes to achieve a sustainable crop production, few information is available. The objectives of this study are i) to assess soil physical indicators related to plant growth and to soil mechanical behavior; and ii) to establish relationships to estimate the impact of soil loading on the soil quality to plant growth. The study was carried out on Argiudolls and Hapludolls of Santa Fe. Soil samples were collected to determine texture, organic matter content, bulk density, water retention curve, soil resistance to penetration, least limiting water range, critical bulk density for plant growth, compression index, pre-consolidation pressure and soil compressibility. Water retention curve and soil resistance to penetration were linearly and significantly related to clay and organic matter (R2 = 0.91 and R2 = 0.84). The pedotransfer functions of water retention curve and soil resistance to penetration allowed the estimation of the least limiting water range and critical bulk density for plant growth. A significant nonlinear relationship was found between critical bulk density for plant growth and clay content (R2 = 0.98). Compression index was significantly related to bulk density, water content, organic matter and clay plus silt content (R2 = 0.77). Pre-consolidation pressure was significantly related to organic matter, clay and water content (R2 = 0.77). Soil compressibility was significantly related to initial soil bulk density, clay and water content. A nonlinear and significantly pedotransfer function (R2 = 0.88) was developed to predict the maximum acceptable pressure to be applied during tillage operations by introducing critical bulk density for plant growth in the compression model. The developed pedotransfer function provides a useful tool to link the mechanical behavior and tilth of the soils studied.

Physical Quality Indicators and Mechanical Behavior of Agricultural Soils of Argentina

PubMed Central

Pires da Silva, Alvaro; Ghiberto, Pablo J.; Tormena, Cássio A.; Pilatti, Miguel A.; Libardi, Paulo L.

2016-01-01

Mollisols of Santa Fe have different tilth and load support capacity. Despite the importance of these attributes to achieve a sustainable crop production, few information is available. The objectives of this study are i) to assess soil physical indicators related to plant growth and to soil mechanical behavior; and ii) to establish relationships to estimate the impact of soil loading on the soil quality to plant growth. The study was carried out on Argiudolls and Hapludolls of Santa Fe. Soil samples were collected to determine texture, organic matter content, bulk density, water retention curve, soil resistance to penetration, least limiting water range, critical bulk density for plant growth, compression index, pre-consolidation pressure and soil compressibility. Water retention curve and soil resistance to penetration were linearly and significantly related to clay and organic matter (R2 = 0.91 and R2 = 0.84). The pedotransfer functions of water retention curve and soil resistance to penetration allowed the estimation of the least limiting water range and critical bulk density for plant growth. A significant nonlinear relationship was found between critical bulk density for plant growth and clay content (R2 = 0.98). Compression index was significantly related to bulk density, water content, organic matter and clay plus silt content (R2 = 0.77). Pre-consolidation pressure was significantly related to organic matter, clay and water content (R2 = 0.77). Soil compressibility was significantly related to initial soil bulk density, clay and water content. A nonlinear and significantly pedotransfer function (R2 = 0.88) was developed to predict the maximum acceptable pressure to be applied during tillage operations by introducing critical bulk density for plant growth in the compression model. The developed pedotransfer function provides a useful tool to link the mechanical behavior and tilth of the soils studied. PMID:27099925

Reducing false asystole alarms in intensive care.

PubMed

Dekimpe, Remi; Heldt, Thomas

2017-07-01

High rates of false monitoring alarms in intensive care can desensitize staff and therefore pose a significant risk to patient safety. Like other critical arrhythmia alarms, asystole alarms require immediate attention by the care providers as a true asystole event can be acutely life threatening. Here, it is illustrated that most false asystole alarms can be attributed to poor signal quality, and we propose and evaluate an algorithm to identify data windows of poor signal quality and thereby help suppress false asystole alarms. The algorithm combines intuitive signal-quality features (degree of signal saturation and baseline wander) and information from other physiological signals that might be available. Algorithm training and testing was performed on the MIMIC II and 2015 PhysioNet/Computing in Cardiology Challenge databases, respectively. The algorithm achieved an alarm specificity of 81.0% and sensitivity of 95.4%, missing only one out of 22 true asystole alarms. On a separate neonatal data set, the algorithm was able to reject 89.7% (890 out of 992) of false asystole alarms while keeping all 22 true events. The results show that the false asystole alarm rate can be significantly reduced through basic signal quality evaluation.

Social cognition interventions for people with schizophrenia: a systematic review focussing on methodological quality and intervention modality.

PubMed

Grant, Nina; Lawrence, Megan; Preti, Antonio; Wykes, Til; Cella, Matteo

2017-08-01

People with a diagnosis of schizophrenia have significant social and functional difficulties. Social cognition was found to influences these outcomes and in recent years interventions targeting this domain were developed. This paper reviews the existing literature on social cognition interventions for people with a diagnosis of schizophrenia focussing on: i) comparing focussed (i.e. targeting only one social cognitive domain) and global interventions and ii) studies methodological quality. Systematic search was conducted on PubMed and PsycInfo. Studies were included if they were randomised control trials, participants had a diagnosis of schizophrenia or schizoaffective disorder, and the intervention targeted at least one out of four social cognition domains (i.e. theory of mind, affect recognition, social perception and attribution bias). All papers were assessed for methodological quality. Information on the intervention, control condition, study methodology and the main findings from each study were extracted and critically summarised. Data from 32 studies fulfilled the inclusion criteria, considering a total of 1440 participants. Taking part in social cognition interventions produced significant improvements in theory of mind and affect recognition compared to both passive and active control conditions. Results were less clear for social perception and attributional bias. Focussed and global interventions had similar results on outcomes. Overall study methodological quality was modest. There was very limited evidence showing that social cognitive intervention result in functional outcome improvement. The evidence considered suggests that social cognition interventions may be a valuable approach for people with a diagnosis of schizophrenia. However, evidence quality is limited by measure heterogeneity, modest study methodology and short follow-up periods. The findings point to a number of recommendations for future research, including measurement standardisation, appropriately powered studies and investigation of the impact of social cognition improvements on functioning problems. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

Transcriptomic analysis of apple fruit ripening and texture attributes

USDA-ARS?s Scientific Manuscript database

Molecular events regulating cultivar-specific apple fruit ripening and sensory quality are largely unknown. Such knowledge is essential for genomic-assisted apple breeding and postharvest quality management. The ripening behavior and texture attributes of two apple cultivars, ‘Pink Lady’ and ‘Honey...

Using ArchE in the Classroom: One Experience

DTIC Science & Technology

2007-09-01

The Architecture Expert (ArchE) tool serves as a software architecture design assistant. It embodies knowledge of quality attributes and the relation...between the achievement of quality attribute requirements and architecture design . This technical note describes the use of a pre-alpha release of

Formulation characteristics and in vitro release testing of cyclosporine ophthalmic ointments.

PubMed

Dong, Yixuan; Qu, Haiou; Pavurala, Naresh; Wang, Jiang; Sekar, Vasanthakumar; Martinez, Marilyn N; Fahmy, Raafat; Ashraf, Muhammad; Cruz, Celia N; Xu, Xiaoming

2018-06-10

The aim of the present study was to investigate the relationship between formulation/process variables versus the critical quality attributes (CQAs) of cyclosporine ophthalmic ointments and to explore the feasibility of using an in vitro approach to assess product sameness. A definitive screening design (DSD) was used to evaluate the impact of formulation and process variables. The formulation variables included drug percentage, percentage of corn oil and lanolin alcohol. The process variables studied were mixing temperature, mixing time and the method of mixing. The quality and performance attributes examined included drug assay, content uniformity, image analysis, rheology (storage modulus, shear viscosity) and in vitro drug release. Of the formulation variables evaluated, the percentage of the drug substance and the percentage of corn oil in the matrix were the most influential factors with respect to in vitro drug release. Conversely, the process parameters tested were observed to have minimal impact. An evaluation of the release mechanism of cyclosporine from the ointment revealed an interplay between formulation (e.g. physicochemical properties of the drug and ointment matrix type) and the release medium. These data provide a scientific basis to guide method development for in vitro drug release testing of ointment dosage forms. These results demonstrate that the in vitro methods used in this investigation were fit-for-purpose for detecting formulation and process changes and therefore amenable to assessment of product sameness. Published by Elsevier B.V.

Close relationships and attributions for peer victimization among late adolescents.

PubMed

Chen, Xiaochen; Graham, Sandra

2012-12-01

This study examined the effect of close relationships (best friendship and romantic relationship) on late adolescents' casual attributions for peer victimization. A total of 1106 twelfth grade students completed self-report measures of perceived peer victimization, self-blame attribution, psychological maladjustment (loneliness and social anxiety), and quality of close peer relationships. Results indicated that self-blame partly mediated the link between peer victimization and psychological maladjustment. Relationship quality moderated the victimization-self-blame relation. Participants were more likely to endorse self-blame attributions for peer victimization when they had a negative relationship with a best friend or romantic partner. The moderated effect of negative best friendship quality was only significant for girls, whereas the moderated effect of negative romantic relationship quality was only significant for boys. Implications of these findings for future research on close relations during adolescence and for interventions to reduce the effects of peer victimization were discussed. Copyright © 2012 The Foundation for Professionals in Services for Adolescents. Published by Elsevier Ltd. All rights reserved.

Automated statistical experimental design approach for rapid separation of coenzyme Q10 and identification of its biotechnological process related impurities using UHPLC and UHPLC-APCI-MS.

PubMed

Talluri, Murali V N Kumar; Kalariya, Pradipbhai D; Dharavath, Shireesha; Shaikh, Naeem; Garg, Prabha; Ramisetti, Nageswara Rao; Ragampeta, Srinivas

2016-09-01

A novel ultra high performance liquid chromatography method development strategy was ameliorated by applying quality by design approach. The developed systematic approach was divided into five steps (i) Analytical Target Profile, (ii) Critical Quality Attributes, (iii) Risk Assessments of Critical parameters using design of experiments (screening and optimization phases), (iv) Generation of design space, and (v) Process Capability Analysis (Cp) for robustness study using Monte Carlo simulation. The complete quality-by-design-based method development was made automated and expedited by employing sub-2 μm particles column with an ultra high performance liquid chromatography system. Successful chromatographic separation of the Coenzyme Q10 from its biotechnological process related impurities was achieved on a Waters Acquity phenyl hexyl (100 mm × 2.1 mm, 1.7 μm) column with gradient elution of 10 mM ammonium acetate buffer (pH 4.0) and a mixture of acetonitrile/2-propanol (1:1) as the mobile phase. Through this study, fast and organized method development workflow was developed and robustness of the method was also demonstrated. The method was validated for specificity, linearity, accuracy, precision, and robustness in compliance to the International Conference on Harmonization, Q2 (R1) guidelines. The impurities were identified by atmospheric pressure chemical ionization-mass spectrometry technique. Further, the in silico toxicity of impurities was analyzed using TOPKAT and DEREK software. © 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Bridging the gap between PAT concepts and implementation: An integrated software platform for fermentation.

PubMed

Chopda, Viki R; Gomes, James; Rathore, Anurag S

2016-01-01

Bioreactor control significantly impacts both the amount and quality of the product being manufactured. The complexity of the control strategy that is implemented increases with reactor size, which may vary from thousands to tens of thousands of litres in commercial manufacturing. The Process Analytical Technology (PAT) initiative has highlighted the need for having robust monitoring tools and effective control schemes that are capable of taking real time information about the critical quality attributes (CQA) and the critical process parameters (CPP) and executing immediate response as soon as a deviation occurs. However, the limited flexibility that present commercial software packages offer creates a hurdle. Visual programming environments have gradually emerged as potential alternatives to the available text based languages. This paper showcases development of an integrated programme using a visual programming environment for a Sartorius BIOSTAT® B Plus 5L bioreactor through which various peripheral devices are interfaced. The proposed programme facilitates real-time access to data and allows for execution of control actions to follow the desired trajectory. Major benefits of such integrated software system include: (i) improved real time monitoring and control; (ii) reduced variability; (iii) improved performance; (iv) reduced operator-training time; (v) enhanced knowledge management; and (vi) easier PAT implementation. © 2015 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

In situ monitoring of cocrystals in formulation development using low-frequency Raman spectroscopy.

PubMed

Otaki, Takashi; Tanabe, Yuta; Kojima, Takashi; Miura, Masaru; Ikeda, Yukihiro; Koide, Tatsuo; Fukami, Toshiro

2018-05-05

In recent years, to guarantee a quality-by-design approach to the development of pharmaceutical products, it is important to identify properties of raw materials and excipients in order to determine critical process parameters and critical quality attributes. Feedback obtained from real-time analyses using various process analytical technology (PAT) tools has been actively investigated. In this study, in situ monitoring using low-frequency (LF) Raman spectroscopy (10-200 cm -1 ), which may have higher discriminative ability among polymorphs than near-infrared spectroscopy and conventional Raman spectroscopy (200-1800 cm -1 ), was investigated as a possible application to PAT. This is because LF-Raman spectroscopy obtains information about intermolecular and/or lattice vibrations in the solid state. The monitoring results obtained from Furosemide/Nicotinamide cocrystal indicate that LF-Raman spectroscopy is applicable to in situ monitoring of suspension and fluidized bed granulation processes, and is an effective technique as a PAT tool to detect the conversion risk of cocrystals. LF-Raman spectroscopy is also used as a PAT tool to monitor reactions, crystallizations, and manufacturing processes of drug substances and products. In addition, a sequence of conversion behaviors of Furosemide/Nicotinamide cocrystals was determined by performing in situ monitoring for the first time. Copyright © 2018 Elsevier B.V. All rights reserved.

Factors Affecting Quality and Health Promoting Compounds during Growth and Postharvest Life of Sweet Cherry (Prunus avium L.)

PubMed Central

Correia, Sofia; Schouten, Rob; Silva, Ana P.; Gonçalves, Berta

2017-01-01

Sweet cherries are attractive fruits due to their taste, color, nutritional value, and beneficial health effects. Sweet cherry is a highly perishable fruit and all quality attributes and the level of health promoting compounds are affected by growth conditions, picking, packing, transport, and storage. During production, the correct combination of scion × rootstock will produce fruits with higher firmness, weight, sugars, vitamins, and phenolic compounds that boost the fruit antioxidant activity. Orchard management, such as applying drip irrigation and summer pruning, will increase fruit sugar levels and total phenolic content, while application of growth regulators can result in improved storability, increased red coloring, increased fruit size, and reduced cracking. Salicylic acid, oxalic acid, acetylsalicylic acid, and methyl salicylate are promising growth regulators as they also increase total phenolics, anthocyanins, and induce higher activity of antioxidant enzymes. These growth regulators are now also applied as fruit coatings that improve shelf-life with higher antioxidant enzyme activities and total phenolics. Optimizing storage and transport conditions, such as hydro cooling with added CaCl2, chain temperature and relative humidity control, are crucial for slowing down decay of quality attributes and increasing the antioxidant capacity. Application of controlled atmosphere during storage is successful in delaying quality attributes, but lowers ascorbic acid levels. The combination of low temperature storage in combination with modified atmosphere packaging (MAP) is successful in reducing the incidence of fruit decay, while preserving taste attributes and stem color with a higher antioxidant capacity. A new trend in MAP is the use of biodegradable films such as micro-perforated polylactic acid film that combine significant retention of quality attributes, high consumer acceptability, and a reduced environmental footprint. Another trend is to replace MAP with fruit edible coatings. Edible coatings, such as various lipid composite coatings, have advantages in retaining quality attributes and increasing the antioxidant activity (chitosan) and are regarded as approved food additives, although studies regarding consumer acceptance are needed. The recent publication of the sweet cherry genome will likely increase the identification of more candidate genes involved in growing and maintaining health related compounds and quality attributes. PMID:29312407

Quality by design (QbD), Process Analytical Technology (PAT), and design of experiment applied to the development of multifunctional sunscreens.

PubMed

Peres, Daniela D'Almeida; Ariede, Maira Bueno; Candido, Thalita Marcilio; de Almeida, Tania Santos; Lourenço, Felipe Rebello; Consiglieri, Vladi Olga; Kaneko, Telma Mary; Velasco, Maria Valéria Robles; Baby, André Rolim

2017-02-01

Multifunctional formulations are of great importance to ensure better skin protection from harm caused by ultraviolet radiation (UV). Despite the advantages of Quality by Design and Process Analytical Technology approaches to the development and optimization of new products, we found in the literature only a few studies concerning their applications in cosmetic product industry. Thus, in this research work, we applied the QbD and PAT approaches to the development of multifunctional sunscreens containing bemotrizinol, ethylhexyl triazone, and ferulic acid. In addition, UV transmittance method was applied to assess qualitative and quantitative critical quality attributes of sunscreens using chemometrics analyses. Linear discriminant analysis allowed classifying unknown formulations, which is useful for investigation of counterfeit and adulteration. Simultaneous quantification of ethylhexyl triazone, bemotrizinol, and ferulic acid presented at the formulations was performed using PLS regression. This design allowed us to verify the compounds in isolation and in combination and to prove that the antioxidant action of ferulic acid as well as the sunscreen actions, since the presence of this component increased 90% of antioxidant activity in vitro.

Exploring the critical quality attributes and models of smart homes.

PubMed

Ted Luor, Tainyi; Lu, Hsi-Peng; Yu, Hueiju; Lu, Yinshiu

2015-12-01

Research on smart homes has significantly increased in recent years owing to their considerably improved affordability and simplicity. However, the challenge is that people have different needs (or attitudes toward smart homes), and provision should be tailored to individuals. A few studies have classified the functions of smart homes. Therefore, the Kano model is first adopted as a theoretical base to explore whether the functional classifications of smart homes are attractive or necessary, or both. Second, three models and test user attitudes toward three function types of smart homes are proposed. Based on the Kano model, the principal results, namely, two "Attractive Quality" and nine "Indifferent Quality" items, are found. Verification of the hypotheses also indicates that the entertainment, security, and automation functions are significantly correlated with the variables "perceive useful" and "attitude." Cost consideration is negatively correlated with attitudes toward entertainment and automation. Results suggest that smart home providers should survey user needs for their product instead of merely producing smart homes based on the design of the builder or engineer. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

A Consideration of Quality-Attribute-Property for Interoperability of Quality Data

NASA Astrophysics Data System (ADS)

Tarumi, Shinya; Kozaki, Kouji; Kitamura, Yoshinobu; Mizoguchi, Riichiro

Descriptions of attribute and quality are essential elements in ontology developments. Needless to say, science data are description of attributes of target things and it is an important role of ontology to support the validity of and interoperability between the description. Although some upper ontologies such as DOLCE, BFO, etc. are already developed and extensively used, a careful examination reveals some rooms for improvement of them. While each ontology covers quality and quantity, the mutual interchangeability among these ontologies is not considered because each has been designed intended to develop a ``correct'' ontology of quality and quantity. Furthermore, due to variety of ways of data description, no single ontology can cover all the existing scientific data. In this paper, we investigate ``quality'' and ``value'' from an ontological viewpoint and propose a conceptual framework to deal with attribute, property and quality appearing in existing data descriptions in the nanotechnology domain. This framework can be considered as a reference ontology for describing quality with existing upper ontology. Furthermore, on the basis of the results of the consideration, we evaluate and refine a conceptual hierarchy of materials functions which has been built by nanomaterials researchers. Through the evaluation process, we discuss an effect of the definition of a conceptual framework for building/refining ontology. Such conceptual consideration about quality and value is not only the problem in nanomaterials domain but also a first step toward advancement of an intelligent sharing of scientific data in e-Science.

Genetic and cultural management solutions to improve potato storage quality

USDA-ARS?s Scientific Manuscript database

Potato storage quality is most easily described in terms of tuber attributes that maintain the value of the harvested crop. Among these attributes are attractive appearance, low shrink, low incidence of bruising and, for chip and fry processing varieties, specific gravity and reducing sugars appropr...

Measuring Website Quality: Asymmetric Effect of User Satisfaction

ERIC Educational Resources Information Center

Kincl, Tomas; Strach, Pavel

2012-01-01

Website quality measurement tools have been largely static and have struggled to determine relevant attributes of user satisfaction. This study compares and contrasts attributes of user satisfaction based on usability guidelines seeking to identify practical easy-to-administer measurement tools. The website users assessed business school homepages…

Textural, nutritional and functional attributes in tomato genotypes for breeding better quality varieties.

PubMed

Saha, Supradip; Hedau, Nirmal K; Mahajan, Vinay; Singh, Gyanendra; Gupta, Hari S; Gahalain, Anita

2010-01-30

Screening of natural biodiversity for their better quality attributes is of prime importance for quality breeding programmes. A set of 53 tomato genotypes was measured for their textural [skin firmness, pericarp thickness, total soluble solids (TSS)], nutritional [phosphorus (P), potassium (K), iron (Fe), zinc (Zn), copper (Cu), manganese (Mn) and titrable acidity (TA)] and functional (beta-carotene, lycopene and ascorbic acid) quality attributes. Three sets of data (textural, nutritional and functional attributes) were obtained and analysed for their mutual relationships. Wide variations were observed in most of the measurements, e.g. skin firmness (coefficient of variability (CV) 269-612 g), pericarp thickness (CV 1.4-4.9 mm), potassium (CV 229-371 mg 100 g(-1)), iron (CV 611-1772 mg 100 g(-1)), ascorbic acid (CV 12-86 mg 100 g(-1)), suggesting that there are considerable levels of genetic diversity. Significant correlations (P < 0.05, 0.01) were also detected among different attributes of tomato genotypes, such as phosphorus and zinc with a correlation coefficient of 0.74, ascorbic acid and copper of 0.57, pericarp thickness and lycopene of - 0.52. However, there were no correlations between textural and nutritional attributes. Five factors were computed by principal component analysis that explained 66% of the variation in the attributes, among which all micronutrients other than iron, TSS, firmness and beta-carotene were most important. Functional attributes except beta-carotene played a less important role in explaining total variation. This knowledge could aid in the efficient conservation of important parts of the agricultural biodiversity of India. These results are also potentially useful for tomato breeders working on the development of new varieties. (c) 2009 Society of Chemical Industry.

Academic Expectations, Attributed Responsibility, and Teachers' Reinforcement Behavior: A Comment on Cooper and Baron, with Some Additional Data.

ERIC Educational Resources Information Center

Meyer, Wulf-Uwe

1979-01-01

Cooper and Baron's conclusions (EJ 174 719) that teachers' performance expectations were more potent predictors of their reinforcement behavior in class than were their attributions of responsibility is criticized on the basis of methodological flaws in the study. Evidence associations between teachers' attributions of responsibility and their…

Empowerment in critical care - a concept analysis.

PubMed

Wåhlin, Ingrid

2017-03-01

The purpose of this paper was to analyse how the concept of empowerment is defined in the scientific literature in relation to critical care. As empowerment is a mutual process affecting all individuals involved, the perspectives of not only patients and next of kin but also staff were sought. A literature review and a concept analysis based on Walker and Avant's analysis procedure were used to identify the basic elements of empowerment in critical care. Twenty-two articles with a focus on critical care were discovered and included in the investigation. A mutual and supportive relationship, knowledge, skills, power within oneself and self-determination were found to be the common attributes of empowerment in critical care. The results could be adapted and used for all parties involved in critical care - whether patients, next of kin or staff - as these defining attributes are assumed to be universal to all three groups, even if the more specific content of each attribute varies between groups and individuals. Even if empowerment is only sparsely used in relation to critical care, it appears to be a very useful concept in this context. The benefits of improving empowerment are extensive: decreased levels of distress and strain, increased sense of coherence and control over situation, and personal and/or professional development and growth, together with increased comfort and inner satisfaction. © 2016 The Authors. Scandinavian Journal of Caring Sciences published by John Wiley & Sons Ltd on behalf of Nordic College.

Applying image quality in cell phone cameras: lens distortion

NASA Astrophysics Data System (ADS)

Baxter, Donald; Goma, Sergio R.; Aleksic, Milivoje

2009-01-01

This paper describes the framework used in one of the pilot studies run under the I3A CPIQ initiative to quantify overall image quality in cell-phone cameras. The framework is based on a multivariate formalism which tries to predict overall image quality from individual image quality attributes and was validated in a CPIQ pilot program. The pilot study focuses on image quality distortions introduced in the optical path of a cell-phone camera, which may or may not be corrected in the image processing path. The assumption is that the captured image used is JPEG compressed and the cellphone camera is set to 'auto' mode. As the used framework requires that the individual attributes to be relatively perceptually orthogonal, in the pilot study, the attributes used are lens geometric distortion (LGD) and lateral chromatic aberrations (LCA). The goal of this paper is to present the framework of this pilot project starting with the definition of the individual attributes, up to their quantification in JNDs of quality, a requirement of the multivariate formalism, therefore both objective and subjective evaluations were used. A major distinction in the objective part from the 'DSC imaging world' is that the LCA/LGD distortions found in cell-phone cameras, rarely exhibit radial behavior, therefore a radial mapping/modeling cannot be used in this case.

Defining Hardwood Veneer Log Quality Attributes

Treesearch

Jan Wiedenbeck; Michael Wiemann; Delton Alderman; John Baumgras; William Luppold

2004-01-01

This publication provides a broad spectrum of information on the hardwood veneer industry in North America. Veneer manufacturers and their customers impose guidelines in specifying wood quality attributes that are very discriminating but poorly defined (e.g., exceptional color, texture, and/or figure characteristics). To better understand and begin to define the most...

Biases in Quality Attribution to Mother-Child and Caregiver-Child Interaction.

ERIC Educational Resources Information Center

Shpancer, Noam; Britner, Preston A.

1995-01-01

Examined the possible existence, direction, and nature of subconscious, cognitive biases in participants' quality attributions to maternal and nonmaternal child-care interactions, the relationship of such biases to subject's background, and their attitudes toward child care and maternal employment. Potential explanations for the biases and the…

Monsters, Lovers and Former Friends: Exploring Relationships with Mathematics via Personification

ERIC Educational Resources Information Center

Zazkis, Dov

2015-01-01

Personification is the attribution of human qualities to non-human entities. The method of eliciting personification, which requires participants to attribute human qualities to non-human entities, takes advantage of a naturally occurring means through which (some) people discuss the emotional relationship they have with those entities. Eliciting…

Characterizing CO and NOy Sources and Relative Ambient Ratios in the Baltimore Area Using Ambient Measurements and Source Attribution Modeling

EPA Science Inventory

Modeled source attribution information from the Community Multiscale Air Quality model was coupled with ambient data from the 2011 Deriving Information on Surface conditions from Column and Vertically Resolved Observations Relevant to Air Quality Baltimore field study. We assess ...

The Role of Negative Affect in the Assessment of Quality of Life among Women with Type 1 Diabetes Mellitus

PubMed Central

Gawlik, Nicola R.

2018-01-01

Background The purpose of this study is to determine the impact of negative affect (defined in terms of lack of optimism, depressogenic attributional style, and hopelessness depression) on the quality of life of women with type 1 diabetes mellitus. Methods Participants (n=177) completed either an online or paper questionnaire made available to members of Australian diabetes support groups. Measures of optimism, attributional style, hopelessness depression, disease-specific data, and diabetes-related quality of life were sought. Bivariate correlations informed the construction of a structural equation model. Results Participants were 36.3±11.3 years old, with a disease duration of 18.4±11.2 years. Age and recent glycosylated hemoglobin readings were significant contextual variables in the model. All bivariate associations involving the components of negative affect were as hypothesized. That is, poorer quality of life was associated with a greater depressogenic attributional style, higher hopelessness depression, and lower optimism. The structural equation model demonstrated significant direct effects of depressogenic attributional style and hopelessness depression on quality of life, while (lack of) optimism contributed to quality of life indirectly by way of these variables. Conclusion The recognition of negative affect presentations among patients, and an understanding of its relevance to diabetes-related quality of life, is a valuable tool for the practitioner. PMID:29199406

Comprehensive model for predicting perceptual image quality of smart mobile devices.

PubMed

Gong, Rui; Xu, Haisong; Luo, M R; Li, Haifeng

2015-01-01

An image quality model for smart mobile devices was proposed based on visual assessments of several image quality attributes. A series of psychophysical experiments were carried out on two kinds of smart mobile devices, i.e., smart phones and tablet computers, in which naturalness, colorfulness, brightness, contrast, sharpness, clearness, and overall image quality were visually evaluated under three lighting environments via categorical judgment method for various application types of test images. On the basis of Pearson correlation coefficients and factor analysis, the overall image quality could first be predicted by its two constituent attributes with multiple linear regression functions for different types of images, respectively, and then the mathematical expressions were built to link the constituent image quality attributes with the physical parameters of smart mobile devices and image appearance factors. The procedure and algorithms were applicable to various smart mobile devices, different lighting conditions, and multiple types of images, and performance was verified by the visual data.

Near infrared and Raman spectroscopy as Process Analytical Technology tools for the manufacturing of silicone-based drug reservoirs.

PubMed

Mantanus, J; Rozet, E; Van Butsele, K; De Bleye, C; Ceccato, A; Evrard, B; Hubert, Ph; Ziémons, E

2011-08-05

Using near infrared (NIR) and Raman spectroscopy as PAT tools, 3 critical quality attributes of a silicone-based drug reservoir were studied. First, the Active Pharmaceutical Ingredient (API) homogeneity in the reservoir was evaluated using Raman spectroscopy (mapping): the API distribution within the industrial drug reservoirs was found to be homogeneous while API aggregates were detected in laboratory scale samples manufactured with a non optimal mixing process. Second, the crosslinking process of the reservoirs was monitored at different temperatures with NIR spectroscopy. Conformity tests and Principal Component Analysis (PCA) were performed on the collected data to find out the relation between the temperature and the time necessary to reach the crosslinking endpoints. An agreement was found between the conformity test results and the PCA results. Compared to the conformity test method, PCA had the advantage to discriminate the heating effect from the crosslinking effect occurring together during the monitored process. Therefore the 2 approaches were found to be complementary. Third, based on the HPLC reference method, a NIR model able to quantify the API in the drug reservoir was developed and thoroughly validated. Partial Least Squares (PLS) regression on the calibration set was performed to build prediction models of which the ability to quantify accurately was tested with the external validation set. The 1.2% Root Mean Squared Error of Prediction (RMSEP) of the NIR model indicated the global accuracy of the model. The accuracy profile based on tolerance intervals was used to generate a complete validation report. The 95% tolerance interval calculated on the validation results indicated that each future result will have a relative error below ±5% with a probability of at least 95%. In conclusion, 3 critical quality attributes of silicone-based drug reservoirs were quickly and efficiently evaluated by NIR and Raman spectroscopy. Copyright © 2011 Elsevier B.V. All rights reserved.

Effect of Frozen Storage Temperature on the Quality of Premium Ice Cream.

PubMed

Park, Sung Hee; Jo, Yeon-Ji; Chun, Ji-Yeon; Hong, Geun-Pyo; Davaatseren, Munkhtugs; Choi, Mi-Jung

2015-01-01

The market sales of premium ice cream have paralleled the growth in consumer desire for rich flavor and taste. Storage temperature is a major consideration in preserving the quality attributes of premium ice cream products for both the manufacturer and retailers during prolonged storage. We investigated the effect of storage temperature (-18℃, -30℃, -50℃, and -70℃) and storage times, up to 52 wk, on the quality attributes of premium ice cream. Quality attributes tested included ice crystal size, air cell size, melting resistance, and color. Ice crystal size increased from 40.3 μm to 100.1 μm after 52 wk of storage at -18℃. When ice cream samples were stored at -50℃ or -70℃, ice crystal size slightly increased from 40.3 μm to 57-58 μm. Initial air cell size increased from 37.1 μm to 87.7 μm after storage at -18℃ for 52 wk. However, for storage temperatures of -50℃ and -70℃, air cell size increased only slightly from 37.1 μm to 46-47 μm. Low storage temperature (-50℃ and -70℃) resulted in better melt resistance and minimized color changes in comparison to high temperature storage (-18℃ and -30℃). In our study, quality changes in premium ice cream were gradually minimized according to decrease in storage temperature up to-50℃. No significant beneficial effect of -70℃ storage was found in quality attributes. In the scope of our experiment, we recommend a storage temperature of -50℃ to preserve the quality attributes of premium ice cream.

Effect of Frozen Storage Temperature on the Quality of Premium Ice Cream

PubMed Central

Park, Sung Hee; Jo, Yeon-Ji; Chun, Ji-Yeon; Hong, Geun-Pyo

2015-01-01

The market sales of premium ice cream have paralleled the growth in consumer desire for rich flavor and taste. Storage temperature is a major consideration in preserving the quality attributes of premium ice cream products for both the manufacturer and retailers during prolonged storage. We investigated the effect of storage temperature (−18℃, −30℃, −50℃, and −70℃) and storage times, up to 52 wk, on the quality attributes of premium ice cream. Quality attributes tested included ice crystal size, air cell size, melting resistance, and color. Ice crystal size increased from 40.3 μm to 100.1 μm after 52 wk of storage at −18℃. When ice cream samples were stored at −50℃ or −70℃, ice crystal size slightly increased from 40.3 μm to 57-58 μm. Initial air cell size increased from 37.1 μm to 87.7 μm after storage at −18℃ for 52 wk. However, for storage temperatures of −50℃ and −70℃, air cell size increased only slightly from 37.1 μm to 46-47 μm. Low storage temperature (−50℃ and −70℃) resulted in better melt resistance and minimized color changes in comparison to high temperature storage (−18℃ and −30℃). In our study, quality changes in premium ice cream were gradually minimized according to decrease in storage temperature up to−50℃. No significant beneficial effect of −70℃ storage was found in quality attributes. In the scope of our experiment, we recommend a storage temperature of −50℃ to preserve the quality attributes of premium ice cream. PMID:26877639

Probing concept of critical thinking in nursing education in Iran: a concept analysis.

PubMed

Tajvidi, Mansooreh; Ghiyasvandian, Shahrzad; Salsali, Mahvash

2014-06-01

Given the wide disagreement over the definition of critical thinking in different disciplines, defining and standardizing the concept according to the discipline of nursing is essential. Moreover, there is limited scientific evidence regarding critical thinking in the context of nursing in Iran. The aim of this study was to analyze and clarify the concept of critical thinking in nursing education in Iran. We employed the hybrid model to define the concept of critical thinking. The hybrid model has three interconnected phases--the theoretical phase, the fieldwork phase, and the final analytic phase. In the theoretical phase, we searched the online scientific databases (such as Elsevier, Wiley, CINAHL, Proquest, Ovid, and Springer as well as Iranian databases such as SID, Magiran, and Iranmedex). In the fieldwork phase, a purposive sample of 17 nursing faculties, PhD students, clinical instructors, and clinical nurses was recruited. Participants were interviewed by using an interview guide. In the analytical phase we compared the data from the theoretical and the fieldwork phases. The concept of critical thinking had many different antecedents, attributes, and consequences. Antecedents, attributes, and consequences of critical thinking concept identified in the theoretical phase were in some ways different and in some way similar to antecedents, attributes, and consequences identified in the fieldwork phase. Finally critical thinking in nursing education in Iran was clarified. Critical thinking is a logical, situational, purposive, and outcome-oriented thinking process. It is an acquired and evolving ability which develops individually. Such thinking process could lead to the professional accountability, personal development, God's consent, conscience appeasement, and personality development. Copyright © 2014. Published by Elsevier B.V.

A critical evaluation of the enhancement of mechanical properties of epoxy modified using CNTs

NASA Astrophysics Data System (ADS)

Bedsole, Robert W.; Park, Cheol; Bogert, Philip B.; Tippur, Hareesh V.

2015-09-01

Carbon nanotubes (CNTs) have been widely shown in the literature to improve mechanical properties of epoxy, such as tensile strength, elastic modulus, strain to failure, and fracture toughness. These improvements in nanocomposite properties have been attributed to the extraordinary properties of the nanotubes, as well as the quality of their dispersion within and adhesion to the epoxy matrix. However, many authors have also struggled to show significant mechanical improvements using similar methodologies and despite, in some cases, showing qualitative improvements in dispersion with optical microscopy. These authors have frequently resorted to other methods for improving the mechanical properties of CNT/epoxy, such as electrically aligning CNTs, using different types of CNTs, or modifying the stoichiometry. The current work examines many different dispersion techniques, types of CNTs, types of epoxies, curing cycles, and other variables in an attempt to improve the mechanical properties of neat epoxy with CNTs. Despite seeing significant changes in the microscopy, no significant improvements in tensile or fracture properties have been attributed to CNTs in this work.

Relational interaction in occupational therapy: Conversation analysis of positive feedback.

PubMed

Weiste, Elina

2018-01-01

The therapeutic relationship is an important factor for good therapy outcomes. The primary mediator of a beneficial therapy relationship is clinician-client interaction. However, few studies identify the observable interactional attributes of good quality relational interactions, e.g. offering the client positive feedback. The present paper aims to expand current understanding of relational interaction by analyzing the real-time interactional practices therapists use for offering positive feedback, an important value in occupational therapy. The analysis is based on the conversation analysis of 15 video-recorded occupational therapy encounters in psychiatric outpatient clinics. Two types of positive feedback were identified. In aligning feedback, therapists encouraged and complimented clients' positive perspectives on their own achievements in adopting certain behaviour, encouraging and supporting their progress. In redirecting feedback, therapists shifted the perspective from clients' negative experiences to their positive experiences. This shift was interactionally successful if they laid the foundation for the shift in perspective and attuned their expressions to the clients' emotional states. Occupational therapists routinely provide their clients with positive feedback. Awareness of the interactional attributes related to positive feedback is critically important for successful relational interaction.

Important and Critical Psychological Attributes of USAF MQ-1 Predator and MQ-9 Reaper Pilots According to Subject Matter Experts

DTIC Science & Technology

2011-05-01

and skills required for military-specific RPAs such as the Pioneer (e.g., Ref 20,21) and Global Hawk (Nagy JE, Muse K , Eaton G , Phillips A, U.S. Air...Analyses, Predator Pilot Front End Analysis (FEA) Report, SURVIAC-TR-06-203, Feb 2006 ; available through the Defense Technical Information Center to U.S...assessing the critical attributes (e.g., subscales of verbal and performance intelligence quotients ) prior to entering the training pipeline. Aeromedical

Critical attributes of transdermal drug delivery system (TDDS)--a generic product development review.

PubMed

Ruby, P K; Pathak, Shriram M; Aggarwal, Deepika

2014-11-01

Bioequivalence testing of transdermal drug delivery systems (TDDS) has always been a subject of high concern for generic companies due to the formulation complexity and the fact that they are subtle to even minor manufacturing differences and hence should be clearly qualified in terms of quality, safety and efficacy. In recent times bioequivalence testing of transdermal patches has gained a global attention and many regulatory authorities worldwide have issued recommendations to set specific framework for demonstrating equivalence between two products. These current regulatory procedures demand a complete characterization of the generic formulation in terms of its physicochemical sameness, pharmacokinetics disposition, residual content and/or skin irritation/sensitization testing with respect to the reference formulation. This paper intends to highlight critical in vitro tests in assessing the therapeutic equivalence of products and also outlines their valuable applications in generic product success. Understanding these critical in vitro parameters can probably help to decode the complex bioequivalence outcomes, directing the generic companies to optimize the formulation design in reduced time intervals. It is difficult to summarize a common platform which covers all possible transdermal products; hence few case studies based on this approach has been presented in this review.

Latent variable modeling to analyze the effects of process parameters on the dissolution of paracetamol tablet

PubMed Central

Sun, Fei; Xu, Bing; Zhang, Yi; Dai, Shengyun; Shi, Xinyuan; Qiao, Yanjiang

2017-01-01

ABSTRACT The dissolution is one of the critical quality attributes (CQAs) of oral solid dosage forms because it relates to the absorption of drug. In this paper, the influence of raw materials, granules and process parameters on the dissolution of paracetamol tablet was analyzed using latent variable modeling methods. The variability in raw materials and granules was understood based on the principle component analysis (PCA), respectively. A multi-block partial least squares (MBPLS) model was used to determine the critical factors affecting the dissolution. The results showed that the binder amount, the post granulation time, the API content in granule, the fill depth and the punch tip separation distance were the critical factors with variable importance in the projection (VIP) values larger than 1. The importance of each unit of the whole process was also ranked using the block importance in the projection (BIP) index. It was concluded that latent variable models (LVMs) were very useful tools to extract information from the available data and improve the understanding on dissolution behavior of paracetamol tablet. The obtained LVMs were also helpful to propose the process design space and to design control strategies in the further research. PMID:27689242

Towards the implementation of quality by design to the production of therapeutic monoclonal antibodies with desired glycosylation patterns.

PubMed

del Val, Ioscani Jimenez; Kontoravdi, Cleo; Nagy, Judit M

2010-01-01

Quality by design (QbD) is a scheme for the development, manufacture, and approval of pharmaceutical products. The end goal of QbD is to ensure product quality by building it into the manufacturing process. The main regulatory bodies are encouraging its implementation to the manufacture of all new pharmaceuticals including biological products. Monoclonal antibodies (mAbs) are currently the leading products of the biopharmaceutical industry. It has been widely reported that glycosylation directly influences the therapeutic mechanisms by which mAbs function in vivo. In addition, glycosylation has been identified as one of the main sources of monoclonal antibody heterogeneity, and thus, a critical parameter to follow during mAb manufacture. This article reviews the research on glycosylation of mAbs over the past 2 decades under the QbD scope. The categories presented under this scope are: (a) definition of the desired clinical effects of mAbs, (b) definition of the glycosylation-associated critical quality attributes (glycCQAs) of mAbs, (c) assessment of process parameters that pose a risk for mAb glycCQAs, and (d) methods for accurately quantifying glycCQAs of mAbs. The information available in all four areas leads us to conclude that implementation of QbD to the manufacture of mAbs with specific glycosylation patterns will be a reality in the near future. We also foresee that the implementation of QbD will lead to the development of more robust and efficient manufacturing processes and to a new generation of mAbs with increased clinical efficacy. Copyright © 2010 American Institute of Chemical Engineers (AIChE).

Where Would You Go for Your Next Hospitalization?

PubMed Central

Jung, Kyoungrae; Feldman, Roger; Scanlon, Dennis

2014-01-01

We examine the effects of diverse dimensions of hospital quality – including consumers’ perceptions of unobserved attributes – on future hospital choice. We utilize consumers’ stated preference weights to obtain hospital-specific estimates of perceptions about unmeasured attributes such as reputation. We report three findings. First, consumers’ perceptions of reputation and medical services contribute substantially to utility for a hospital choice. Second, consumers tend to select hospitals with high clinical quality scores even before the scores are publicized. However, the effect of clinical quality on hospital choice is relatively small. Third, satisfaction with a prior hospital admission has a large impact on future hospital choice. Our findings suggest that including measures of consumers’ experience in report cards may increase their responsiveness to publicized information, but other strategies are needed to overcome the large effects of consumers’ beliefs about other quality attributes. PMID:21665300

Global mortality attributable to aircraft cruise emissions.

PubMed

Barrett, Steven R H; Britter, Rex E; Waitz, Ian A

2010-10-01

Aircraft emissions impact human health though degradation of air quality. The majority of previous analyses of air quality impacts from aviation have considered only landing and takeoff emissions. We show that aircraft cruise emissions impact human health over a hemispheric scale and provide the first estimate of premature mortalities attributable to aircraft emissions globally. We estimate ∼8000 premature mortalities per year are attributable to aircraft cruise emissions. This represents ∼80% of the total impact of aviation (where the total includes the effects of landing and takeoff emissions), and ∼1% of air quality-related premature mortalities from all sources. However, we note that the impact of landing and takeoff emissions is likely to be under-resolved. Secondary H(2)SO(4)-HNO(3)-NH(3) aerosols are found to dominate mortality impacts. Due to the altitude and region of the atmosphere at which aircraft emissions are deposited, the extent of transboundary air pollution is particularly strong. For example, we describe how strong zonal westerly winds aloft, the mean meridional circulation around 30-60°N, interaction of aircraft-attributable aerosol precursors with background ammonia, and high population densities in combination give rise to an estimated ∼3500 premature mortalities per year in China and India combined, despite their relatively small current share of aircraft emissions. Subsidence of aviation-attributable aerosol and aerosol precursors occurs predominantly around the dry subtropical ridge, which results in reduced wet removal of aviation-attributable aerosol. It is also found that aircraft NO(x) emissions serve to increase oxidation of nonaviation SO(2), thereby further increasing the air quality impacts of aviation. We recommend that cruise emissions be explicitly considered in the development of policies, technologies and operational procedures designed to mitigate the air quality impacts of air transportation.

The Incorporation of Quality Attributes into Online Course Design in Higher Education

ERIC Educational Resources Information Center

Lenert, Kathleen Anne; Diane P. Janes

2017-01-01

A survey was designed incorporating questions on 28 attributes (compiled through a literature review) and considered to be quality features in online academic courses in higher education. This study sought to investigate the ongoing practice of instructional designers and instructors in the United States with respect to their incorporation of…

Hydrodynamic pressure processing: Impact on the quality attributes of fresh and further-processed meat products

USDA-ARS?s Scientific Manuscript database

This book chapter reviews hydrodynamic pressure processing (HDP) as an innovative, postharvest technology for enhancing the quality attributes of fresh and further-processed meat products. A variety of meat products have been tested for their response to the high pressure shockwaves of HDP. The st...

Evaluation of Communication about Groups: The Hydra Phenomenon.

ERIC Educational Resources Information Center

Desmond, Roger Jon; Bezzini, John

A study investigated how the attribution of a problem solution to an individual or group affects the consumer's perception of the solution's quality. Based on the tendency to support group decision-making (Hydra phenomenon) it was predicted that decisions attributed to groups would be perceived as higher in quality than those made by individuals,…

Reliability and Validity of a Measure of Preschool Teachers' Attributions for Disruptive Behavior

ERIC Educational Resources Information Center

Carter, Lauren M.; Williford, Amanda P.; LoCasale-Crouch, Jennifer

2014-01-01

Research Findings: This study examined the quality of teacher attributions for child disruptive behavior using a new measure, the Preschool Teaching Attributions measure. A sample of 153 early childhood teachers and 432 children participated. All teachers completed the behavior attributions measure, as well as measures regarding demographics,…

Temperature affects long-term productivity and quality attributes of day-neutral strawberry for a space life-support system

NASA Astrophysics Data System (ADS)

Massa, Gioia D.; Chase, Elaine; Santini, Judith B.; Mitchell, Cary A.

2015-04-01

Strawberry (Fragaria x ananassa L.) is a promising candidate crop for space life-support systems with desirable sensory quality and health attributes. Day-neutral cultivars such as 'Seascape' are adaptable to a range of photoperiods, including short days that would save considerable energy for crop lighting without reductions in productivity or yield. Since photoperiod and temperature interact to affect strawberry growth and development, several diurnal temperature regimes were tested under a short photoperiod of 10 h per day for effects on yield and quality attributes of 'Seascape' strawberry during production cycles longer than 270 days. The coolest day/night temperature regime, 16°/8 °C, tended to produce smaller numbers of larger fruit than did the intermediate temperature range of 18°/10 °C or the warmest regime, 20°/12 °C, both of which produced similar larger numbers of smaller fruit. The intermediate temperature regime produced the highest total fresh mass of berries over an entire production cycle. Independent experiments examined either organoleptic or physicochemical quality attributes. Organoleptic evaluation indicated that fruit grown under the coolest temperature regime tended to score the highest for both hedonic preference and descriptive evaluation of sensory attributes related to sweetness, texture, aftertaste, and overall approval. The physicochemical quality attributes Brix, pH, and sugar/acid ratio were highest for fruits harvested from the coolest temperature regime and lower for those from the warmer temperature regimes. The cool-regime fruits also were lowest in titratable acidity. The yield parameters fruit number and size oscillated over the course of a production cycle, with a gradual decline in fruit size under all three temperature regimes. Brix and titratable acidity both decreased over time for all three temperature treatments, but sugar/acid ratio remained highest for the cool temperature regime over the entire production period. Periodic rejuvenation or replacement of strawberry propagules may be needed to maintain both quality and quantity of strawberry yield in space.

The health care and life sciences community profile for dataset descriptions

PubMed Central

Alexiev, Vladimir; Ansell, Peter; Bader, Gary; Baran, Joachim; Bolleman, Jerven T.; Callahan, Alison; Cruz-Toledo, José; Gaudet, Pascale; Gombocz, Erich A.; Gonzalez-Beltran, Alejandra N.; Groth, Paul; Haendel, Melissa; Ito, Maori; Jupp, Simon; Juty, Nick; Katayama, Toshiaki; Kobayashi, Norio; Krishnaswami, Kalpana; Laibe, Camille; Le Novère, Nicolas; Lin, Simon; Malone, James; Miller, Michael; Mungall, Christopher J.; Rietveld, Laurens; Wimalaratne, Sarala M.; Yamaguchi, Atsuko

2016-01-01

Access to consistent, high-quality metadata is critical to finding, understanding, and reusing scientific data. However, while there are many relevant vocabularies for the annotation of a dataset, none sufficiently captures all the necessary metadata. This prevents uniform indexing and querying of dataset repositories. Towards providing a practical guide for producing a high quality description of biomedical datasets, the W3C Semantic Web for Health Care and the Life Sciences Interest Group (HCLSIG) identified Resource Description Framework (RDF) vocabularies that could be used to specify common metadata elements and their value sets. The resulting guideline covers elements of description, identification, attribution, versioning, provenance, and content summarization. This guideline reuses existing vocabularies, and is intended to meet key functional requirements including indexing, discovery, exchange, query, and retrieval of datasets, thereby enabling the publication of FAIR data. The resulting metadata profile is generic and could be used by other domains with an interest in providing machine readable descriptions of versioned datasets. PMID:27602295

Improving lactate metabolism in an intensified CHO culture process: productivity and product quality considerations.

PubMed

Xu, Sen; Hoshan, Linda; Chen, Hao

2016-11-01

In this study, we discussed the development and optimization of an intensified CHO culture process, highlighting medium and control strategies to improve lactate metabolism. A few strategies, including supplementing glucose with other sugars (fructose, maltose, and galactose), controlling glucose level at <0.2 mM, and supplementing medium with copper sulfate, were found to be effective in reducing lactate accumulation. Among them, copper sulfate supplementation was found to be critical for process optimization when glucose was in excess. When copper sulfate was supplemented in the new process, two-fold increase in cell density (66.5 ± 8.4 × 10(6) cells/mL) and titer (11.9 ± 0.6 g/L) was achieved. Productivity and product quality attributes differences between batch, fed-batch, and concentrated fed-batch cultures were discussed. The importance of process and cell metabolism understanding when adapting the existing process to a new operational mode was demonstrated in the study.

Integrated Biorefining: Coproduction of Renewable Resol Biopolymer for Aqueous Stream Valorization

DOE PAGES

Wilson, A. Nolan; Price, Mariel J.; Mukarakate, Calvin; ...

2017-07-13

Phenol-formaldehyde resins are major material classes that are used in a range of applications including composites, adhesives, foams, electronics, and insulation. While efforts have been made to produce renewable resins, there has yet to be an approach that offers potential for economic viability and meets all critical quality metrics. This failure can be attributed largely to the use of phenol and cresol homologues and to high separation costs. In this work, the use of phenol, cresol, and alkyl phenols derived from the aqueous phase generated from catalytic fast pyrolysis of biomass to produce a high-quality biobased resin is demonstrated. Production,more » through catalytic fast pyrolysis (CFP), separation, through distillation and adsorption unit operations, and synthesis, through typical resol chemistry, produced a resin with properties, such as curing kinetics and molecular weight, competitive with petroleum-derived resin. In conclusion, this work explores a pathway to value-added coproducts from a CFP waste stream, which has the potential to improve the economic viability of biofuels production.« less

Integrated Biorefining: Coproduction of Renewable Resol Biopolymer for Aqueous Stream Valorization

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

Wilson, A. Nolan; Price, Mariel J.; Mukarakate, Calvin

Phenol-formaldehyde resins are major material classes that are used in a range of applications including composites, adhesives, foams, electronics, and insulation. While efforts have been made to produce renewable resins, there has yet to be an approach that offers potential for economic viability and meets all critical quality metrics. This failure can be attributed largely to the use of phenol and cresol homologues and to high separation costs. In this work, the use of phenol, cresol, and alkyl phenols derived from the aqueous phase generated from catalytic fast pyrolysis of biomass to produce a high-quality biobased resin is demonstrated. Production,more » through catalytic fast pyrolysis (CFP), separation, through distillation and adsorption unit operations, and synthesis, through typical resol chemistry, produced a resin with properties, such as curing kinetics and molecular weight, competitive with petroleum-derived resin. In conclusion, this work explores a pathway to value-added coproducts from a CFP waste stream, which has the potential to improve the economic viability of biofuels production.« less

Physician Burnout: Improving Treatment Efficacy with Virtual Reality.

PubMed

Wiederhold, Brenda K; Riva, Giuseppe; Gaggioli, Andrea; Wiederhold, Mark D

2016-01-01

Creating a significant negative impact on both their quality of life and the quality of patient care with an evident economical burden for the healthcare system, there is a growing concern over physician burnout. The range of interventions and treatments that have been used to address this problem, however, appear quite fragmented and lack compelling efficacy. We describe the main factors known to contribute to the development of physician burnout as well as currently available treatments. Studies seem to indicate that both specialisation area as well as personality traits may contribute to the manifestation. The highest risk specialties appear to be critical care physicians, emergency physicians, oncologists and internal medicine physicians, while the highest risk personality attributes are high neuroticism, low agreeableness, introversion, and negative affectivity. In addition, being exceedingly enthusiastic about one's work and having high aspirations at work, with an idealistic approach, also serve as factors which contribute to increased risk of burnout, and in particular for those who are new to the occupation.

Evaluation of an attributive measurement system in the automotive industry

NASA Astrophysics Data System (ADS)

Simion, C.

2016-08-01

Measurement System Analysis (MSA) is a critical component for any quality improvement process. MSA is defined as an experimental and mathematical method of determining how much the variation within the measurement process contributes to overall process variability and it falls into two categories: attribute and variable. Most problematic measurement system issues come from measuring attribute data, which are usually the result of human judgment (visual inspection). Because attributive measurement systems are often used in some manufacturing processes, their assessment is important to obtain the confidence in the inspection process, to see where are the problems in order to eliminate them and to guide the process improvement. It was the aim of this paper to address such a issue presenting a case study made in a local company from the Sibiu region supplying products for the automotive industry, specifically the bag (a technical textile component, i.e. the fabric) for the airbag module. Because defects are inherent in every manufacturing process and in the field of airbag systems a minor defect can influence their performance and lives depend on the safety feature, there is a stringent visual inspection required on the defects of the bag material. The purpose of this attribute MSA was: to determine if all inspectors use the same criteria to determine “pass” from “fail” product (i.e. the fabric); to assess company inspection standards against customer's requirements; to determine how well inspectors are conforming to themselves; to identify how inspectors are conforming to a “known master,” which includes: how often operators ship defective product, how often operators dispose of acceptable product; to discover areas where training is required, procedures must be developed and standards are not available. The results were analyzed using MINITAB software with its module called Attribute Agreement Analysis. The conclusion was that the inspection process must be improved by operator training, developing visual aids/boundary samples, establishing standards and set-up procedures.

A system identification approach for developing model predictive controllers of antibody quality attributes in cell culture processes.

PubMed

Downey, Brandon; Schmitt, John; Beller, Justin; Russell, Brian; Quach, Anthony; Hermann, Elizabeth; Lyon, David; Breit, Jeffrey

2017-11-01

As the biopharmaceutical industry evolves to include more diverse protein formats and processes, more robust control of Critical Quality Attributes (CQAs) is needed to maintain processing flexibility without compromising quality. Active control of CQAs has been demonstrated using model predictive control techniques, which allow development of processes which are robust against disturbances associated with raw material variability and other potentially flexible operating conditions. Wide adoption of model predictive control in biopharmaceutical cell culture processes has been hampered, however, in part due to the large amount of data and expertise required to make a predictive model of controlled CQAs, a requirement for model predictive control. Here we developed a highly automated, perfusion apparatus to systematically and efficiently generate predictive models using application of system identification approaches. We successfully created a predictive model of %galactosylation using data obtained by manipulating galactose concentration in the perfusion apparatus in serialized step change experiments. We then demonstrated the use of the model in a model predictive controller in a simulated control scenario to successfully achieve a %galactosylation set point in a simulated fed-batch culture. The automated model identification approach demonstrated here can potentially be generalized to many CQAs, and could be a more efficient, faster, and highly automated alternative to batch experiments for developing predictive models in cell culture processes, and allow the wider adoption of model predictive control in biopharmaceutical processes. © 2017 The Authors Biotechnology Progress published by Wiley Periodicals, Inc. on behalf of American Institute of Chemical Engineers Biotechnol. Prog., 33:1647-1661, 2017. © 2017 The Authors Biotechnology Progress published by Wiley Periodicals, Inc. on behalf of American Institute of Chemical Engineers.

Effects of vegetable juice powder concentration and storage time on some chemical and sensory quality attributes of uncured, emulsified cooked sausages.

PubMed

Sindelar, J J; Cordray, J C; Sebranek, J G; Love, J A; Ahn, D U

2007-06-01

Uncured, no-nitrate/nitrite-added meat products can be manufactured with vegetable juice powder (VJP) and a starter culture containing Staphylococcus carnosus, resulting in quality and sensory attributes similar to traditional cured products. The 1st objective of this study was to determine the effects of varying concentrations of VJP and incubation times (MIN-HOLD) on quality characteristics, including lipid oxidation, color, and cured meat pigment concentrations, of emulsified-frankfurter-style-cooked (EFSC) sausages over a 90-d storage period. The 2nd objective was to compare residual nitrate and nitrite content resulting from different processing treatments and the 3rd objective was to assess sensory properties of finished products. Four EFSC sausage treatments (TRT) (TRT 1: 0.20% VJP, 30 MIN-HOLD; TRT 2: 0.20% VJP, 120 MIN-HOLD; TRT 3: 0.40% VJP, 30 MIN-HOLD; TRT 4: 0.40% VJP, 120 MIN-HOLD) and a sodium nitrite-added control (C) were used for this study. No differences for lipid oxidation (TBARS) between any TRTs and C or over time were observed. No differences (P > 0.05) for CIE L* values were found between TRTs. CIE a* and reflectance ratio values revealed that TRTs 2, 4, and C were redder than TRTs 1 and 3 at day 0. Trained sensory intensity ratings for cured aroma, cured color, cured flavor, uniform color, and firmness determined that all but TRT 1 were similar to C. These results indicate a longer incubation time (120 compared with 30 min) was found more critical than VJP level (0.20% or 0.40%) to result in products comparable to a sodium nitrite-added control.

Impact of storage on dark chocolate: texture and polymorphic changes.

PubMed

Nightingale, Lia M; Lee, Soo-Yeun; Engeseth, Nicki J

2011-01-01

Chocolate storage is critical to final product quality. Inadequate storage, especially with temperature fluctuations, may lead to rearrangement of triglycerides that make up the bulk of the chocolate matrix; this rearrangement may lead to fat bloom. Bloom is the main cause of quality loss in the chocolate industry. The effect of storage conditions leading to bloom formation on texture and flavor attributes by human and instrumental measures has yet to be reported. Therefore, the impact of storage conditions on the quality of dark chocolate by sensory and instrumental measurements was determined. Dark chocolate was kept under various conditions and analyzed at 0, 4, and 8 wk of storage. Ten members of a descriptive panel analyzed texture and flavor. Instrumental methods included texture analysis, color measurement, lipid polymorphism by X-ray diffraction and differential scanning calorimetry, triglyceride concentration by gas chromatography, and surface properties by atomic force microscopy. Results were treated by analysis of variance, cluster analysis, principal component analysis, and linear partial least squares regression analysis. Chocolate stored 8 wk at high temperature without fluctuations and 4 wk with fluctuations transitioned from form V to VI. Chocolates stored at high temperature with and without fluctuations were harder, more fracturable, more toothpacking, had longer melt time, were less sweet, and had less cream flavor. These samples had rougher surfaces, fewer but larger grains, and a heterogeneous surface. Overall, all stored dark chocolate experienced instrumental or perceptual changes attributed to storage condition. Chocolates stored at high temperature with and without fluctuations were most visually and texturally compromised. Practical Application: Many large chocolate companies do their own "in-house" unpublished research and smaller confectionery facilities do not have the means to conduct their own research. Therefore, this study relating sensory and instrumental data provides published evidence available for application throughout the confectionery industry.

Application of Optical Coherence Tomography Freeze-Drying Microscopy for Designing Lyophilization Process and Its Impact on Process Efficiency and Product Quality.

PubMed

Korang-Yeboah, Maxwell; Srinivasan, Charudharshini; Siddiqui, Akhtar; Awotwe-Otoo, David; Cruz, Celia N; Muhammad, Ashraf

2018-01-01

Optical coherence tomography freeze-drying microscopy (OCT-FDM) is a novel technique that allows the three-dimensional imaging of a drug product during the entire lyophilization process. OCT-FDM consists of a single-vial freeze dryer (SVFD) affixed with an optical coherence tomography (OCT) imaging system. Unlike the conventional techniques, such as modulated differential scanning calorimetry (mDSC) and light transmission freeze-drying microscopy, used for predicting the product collapse temperature (Tc), the OCT-FDM approach seeks to mimic the actual product and process conditions during the lyophilization process. However, there is limited understanding on the application of this emerging technique to the design of the lyophilization process. In this study, we investigated the suitability of OCT-FDM technique in designing a lyophilization process. Moreover, we compared the product quality attributes of the resulting lyophilized product manufactured using Tc, a critical process control parameter, as determined by OCT-FDM versus as estimated by mDSC. OCT-FDM analysis revealed the absence of collapse even for the low protein concentration (5 mg/ml) and low solid content formulation (1%w/v) studied. This was confirmed by lab scale lyophilization. In addition, lyophilization cycles designed using Tc values obtained from OCT-FDM were more efficient with higher sublimation rate and mass flux than the conventional cycles, since drying was conducted at higher shelf temperature. Finally, the quality attributes of the products lyophilized using Tc determined by OCT-FDM and mDSC were similar, and product shrinkage and cracks were observed in all the batches of freeze-dried products irrespective of the technique employed in predicting Tc.

Modernization of software quality assurance

NASA Technical Reports Server (NTRS)

Bhaumik, Gokul

1988-01-01

The customers satisfaction depends not only on functional performance, it also depends on the quality characteristics of the software products. An examination of this quality aspect of software products will provide a clear, well defined framework for quality assurance functions, which improve the life-cycle activities of software development. Software developers must be aware of the following aspects which have been expressed by many quality experts: quality cannot be added on; the level of quality built into a program is a function of the quality attributes employed during the development process; and finally, quality must be managed. These concepts have guided our development of the following definition for a Software Quality Assurance function: Software Quality Assurance is a formal, planned approach of actions designed to evaluate the degree of an identifiable set of quality attributes present in all software systems and their products. This paper is an explanation of how this definition was developed and how it is used.

Probiotic supplementation and fast freezing to improve quality attributes and oxidation stability of frozen chicken breast muscle

USDA-ARS?s Scientific Manuscript database

The objective of this study was to determine the effects of probiotic supplementation and fast freezing on quality attributes and oxidation stability of frozen/thawed chicken breast meat. Broilers were fed with a basal diet or the basal diet plus 250 ppm Sporulin (three strains of Bacillus subtilis)...

Comparison of optimal wavelengths selection methods for visible/near-infrared prediction of apple firmness and soluble solids content

USDA-ARS?s Scientific Manuscript database

Visible and near-infrared (Vis-NIR) spectroscopy is now being used for nondestructive quality measurement of fruits and other food products. To implement the technology, it is necessary to develop an effective calibration model relating the acquired spectral data to the quality attribute(s) of inter...

Song and Male Quality in Prairie Warblers

Treesearch

Bruce E. Byers; Michael E. Akresh; David I. King; W. Koenig

2016-01-01

To determine if the songs of male prairie warblers could potentially reveal to female listeners information about the quality of singers, we compared various aspects of prairie warbler song structure and performance to attributes that might reflect a male singer's potential to enhance the fitness of his mate. We found that all the tested male attributes—arrival...

Quality Management: An "Essential Attributes" Approach. A Case Study towards a Sustainable Model of Course Effectiveness Evaluation

ERIC Educational Resources Information Center

Murphy, Francis S.

2005-01-01

Education of potential professional engineers should take account of the type of employment that they will eventually obtain. The quality of an engineering degree course can be judged by assessing whether the correct balance of "essential attributes" has been effectively obtained. This case study is concerned with assessing the balance…

Emerging markets for imported beef in China: Results from a consumer choice experiment in Beijing.

PubMed

Ortega, David L; Hong, Soo Jeong; Wang, H Holly; Wu, Laping

2016-11-01

The purpose of this study is to explore emerging markets for imported beef in China by assessing Beijing consumer demand for quality attributes. This study utilizes data from an in-store choice experiment to evaluate consumer willingness-to-pay for select food quality attributes (food safety, animal welfare, Green Food and Organic certification) taking into account country-of-origin information. Our results show that Beijing consumers value food safety information the most, and are willing to pay more for Australian beef products than for US or domestic (Chinese) beef. We explore the various relationships between the quality attributes, find evidence of preference heterogeneity and discuss agribusiness and marketing implications of our findings. Copyright © 2016 Elsevier Ltd. All rights reserved.

Exploratory sensory profiling of three culinary preparations of potatoes (Solanum tuberosum L.).

PubMed

Seefeldt, Helene F; Tønning, Erik; Thybo, Anette K

2011-01-15

A consumer-oriented description of potato quality with regard to culinary preparation could increase potato consumption. The aim of this study was to investigate the sensory attributes in 11 potato varieties grown at two locations and used for three culinary preparations. Sensory evaluation of the potatoes served either as boiled, oven-fried or mashed were performed using 15-19 descriptors for appearance, flavour and texture attributes. A principal component analysis revealed that 45% of the variation in the sensory data was related to variety differences, which was ascribed to variation in appearance, dry matter content and texture. Growing location also significantly affected appearance and texture. The sensory panel judged the sensory attributes 'yellowness', 'hardness', 'adhesiveness' and 'moistness' to be important quality descriptors in all three culinary preparations. Internal references showed the high reproducibility of the sensory evaluations. The potatoes grown in a sandy location had higher content of dry matter compared to those grown in a clay location, affecting the quality. This study showed that it was possible to do reliable and reproducible sensory profiles in a potato material with a large span in quality. Sensory information based on few attributes can be used to describe culinary quality of potato varieties. Copyright © 2010 Society of Chemical Industry.

Evaluation of variability and quality control procedures for a receptor-binding assay for paralytic shellfish poisoning toxins.

PubMed

Ruberu, S R; Langlois, G W; Masuda, M; Perera, S Kusum

2012-01-01

The receptor-binding assay (RBA) method for determining saxatoxin (STX) and its numerous analogues, which cause paralytic shellfish poisoning (PSP) in humans, was evaluated in a single laboratory study. Each step of the assay preparation procedure including the performance of the multi-detector TopCount® instrument was evaluated for its contribution to method variability. The overall inherent RBA variability was determined to be 17%. Variability within the 12 detectors was observed; however, there was no reproducible pattern in detector performance. This observed variability among detectors could be attributed to other factors, such as pipetting errors. In an attempt to reduce the number of plates rejected due to excessive variability in the method's quality control parameters, a statistical approach was evaluated using either Grubbs' test or the Student's t-test for rejecting outliers in the measurement of triplicate wells. This approach improved the ratio of accepted versus rejected plates, saving cost and time for rerunning the assay. However, the potential reduction in accuracy and the lack of improvement in precision suggests caution when using this approach. The current study has recommended an alternate quality control procedure for accepting or rejecting plates in place of the criteria currently used in the published assay, or the alternative of outlier testing. The recommended procedure involves the development of control charts to monitor the critical parameters identified in the published method (QC sample, EC₅₀, slope of calibration curve), with the addition of a fourth critical parameter which is the top value (100% binding) of the calibration curve.

Critical appraisal of questionnaires to assess functional impairment in individuals with mild cognitive impairment.

PubMed

Kaur, Navaldeep; Belchior, Patricia; Gelinas, Isabelle; Bier, Nathalie

2016-09-01

Mild deficits in instrumental activities of daily living (IADLs) have consistently been reported in the individuals with mild cognitive impairment (MCI). A variety of functional assessment tools, including self-and informant report questionnaires and performance-based measures, have been employed in MCI. Previously, a limited focus has been directed at appraising the quality of questionnaires. The goal of this study was to identify the questionnaires that have been validated in the MCI population. Additionally, the quality of validation studies and psychometric attributes of these questionnaires were appraised. Relevant articles were systematically searched in PsychINFO, Ovid MEDLINE, and CINAHL against specific eligibility criteria. To evaluate the methodology of the psychometric studies, the COSMIN checklist was employed. Also, the psychometric properties of the assessment tools were evaluated based upon Terwee's criteria. A total of five psychometric studies and questionnaires were critically evaluated. Varying psychometric properties were available for the chosen tools. None of the studies received the best possible rating for their methodological quality. It was found that questionnaires with high discriminative ability to distinguish MCI from other diagnostic groups were: Disability Assessment in Dementia-6 (DAD-6), Functional Activity Questionnaire (FAQ), and Alzheimer's Disease Cooperative Study/Activities of Daily Living scale adapted for MCI patients (ADCS-MCI-ADL-24). Psychometric studies with strong methodological rigor are required in the future. Considering the fact that IADL decline has been associated with dementia, early detection of functional difficulties in MCI needs to be encouraged as it will allow suitable and timely interventions to prolong functional independence of affected individuals.

Unit operation optimization for the manufacturing of botanical injections using a design space approach: a case study of water precipitation.

PubMed

Gong, Xingchu; Chen, Huali; Chen, Teng; Qu, Haibin

2014-01-01

Quality by design (QbD) concept is a paradigm for the improvement of botanical injection quality control. In this work, water precipitation process for the manufacturing of Xueshuantong injection, a botanical injection made from Notoginseng Radix et Rhizoma, was optimized using a design space approach as a sample. Saponin recovery and total saponin purity (TSP) in supernatant were identified as the critical quality attributes (CQAs) of water precipitation using a risk assessment for all the processes of Xueshuantong injection. An Ishikawa diagram and experiments of fractional factorial design were applied to determine critical process parameters (CPPs). Dry matter content of concentrated extract (DMCC), amount of water added (AWA), and stirring speed (SS) were identified as CPPs. Box-Behnken designed experiments were carried out to develop models between CPPs and process CQAs. Determination coefficients were higher than 0.86 for all the models. High TSP in supernatant can be obtained when DMCC is low and SS is high. Saponin recoveries decreased as DMCC increased. Incomplete collection of supernatant was the main reason for the loss of saponins. Design space was calculated using a Monte-Carlo simulation method with acceptable probability of 0.90. Recommended normal operation region are located in DMCC of 0.38-0.41 g/g, AWA of 3.7-4.9 g/g, and SS of 280-350 rpm, with a probability more than 0.919 to attain CQA criteria. Verification experiment results showed that operating DMCC, SS, and AWA within design space can attain CQA criteria with high probability.

Valuing river characteristics using combined site choice and participation travel cost models.

PubMed

Johnstone, C; Markandya, A

2006-08-01

This paper presents new welfare measures for marginal changes in river quality in selected English rivers. The river quality indicators used include chemical, biological and habitat-level attributes. Economic values for recreational use of three types of river-upland, lowland and chalk-are presented. A survey of anglers was carried out and using these data, two travel cost models were estimated, one to predict the numbers of trips and the other to predict angling site choice. These models were then linked to estimate the welfare associated with marginal changes in river quality using the participation levels as estimated in the trip prediction model. The model results showed that higher flow rates, biological quality and nutrient pollution levels affect site choice and influence the likelihood of a fishing trip. Consumer surplus values per trip for a 10% change in river attributes range from pound 0.04 to pound 3.93 ( pound 2001) depending on the attribute.

Application of analytical quality by design principles for the determination of alkyl p-toluenesulfonates impurities in Aprepitant by HPLC. Validation using total-error concept.

PubMed

Zacharis, Constantinos K; Vastardi, Elli

2018-02-20

In the research presented we report the development of a simple and robust liquid chromatographic method for the quantification of two genotoxic alkyl sulphonate impurities (namely methyl p-toluenesulfonate and isopropyl p-toluenesulfonate) in Aprepitant API substances using the Analytical Quality by Design (AQbD) approach. Following the steps of AQbD protocol, the selected critical method attributes (CMAs) were the separation criterions between the critical peak pairs, the analysis time and the peak efficiencies of the analytes. The critical method parameters (CMPs) included the flow rate, the gradient slope and the acetonitrile content at the first step of the gradient elution program. Multivariate experimental designs namely Plackett-Burman and Box-Behnken designs were conducted sequentially for factor screening and optimization of the method parameters. The optimal separation conditions were estimated using the desirability function. The method was fully validated in the range of 10-200% of the target concentration limit of the analytes using the "total error" approach. Accuracy profiles - a graphical decision making tool - were constructed using the results of the validation procedures. The β-expectation tolerance intervals did not exceed the acceptance criteria of±10%, meaning that 95% of future results will be included in the defined bias limits. The relative bias ranged between - 1.3-3.8% for both analytes, while the RSD values for repeatability and intermediate precision were less than 1.9% in all cases. The achieved limit of detection (LOD) and the limit of quantification (LOQ) were adequate for the specific purpose and found to be 0.02% (corresponding to 48μgg -1 in sample) for both methyl and isopropyl p-toluenesulfonate. As proof-of-concept, the validated method was successfully applied in the analysis of several Aprepitant batches indicating that this methodology could be used for routine quality control analyses. Copyright © 2017 Elsevier B.V. All rights reserved.

Quality Attribute Techniques Framework

NASA Astrophysics Data System (ADS)

Chiam, Yin Kia; Zhu, Liming; Staples, Mark

The quality of software is achieved during its development. Development teams use various techniques to investigate, evaluate and control potential quality problems in their systems. These “Quality Attribute Techniques” target specific product qualities such as safety or security. This paper proposes a framework to capture important characteristics of these techniques. The framework is intended to support process tailoring, by facilitating the selection of techniques for inclusion into process models that target specific product qualities. We use risk management as a theory to accommodate techniques for many product qualities and lifecycle phases. Safety techniques have motivated the framework, and safety and performance techniques have been used to evaluate the framework. The evaluation demonstrates the ability of quality risk management to cover the development lifecycle and to accommodate two different product qualities. We identify advantages and limitations of the framework, and discuss future research on the framework.

Quality-by-design approach for the development of telmisartan potassium tablets.

PubMed

Oh, Ga-Hui; Park, Jin-Hyun; Shin, Hye-Won; Kim, Joo-Eun; Park, Young-Joon

2018-05-01

A quality-by-design approach was adopted to develop telmisartan potassium (TP) tablets, which were bioequivalent with the commercially available Micardis ® (telmisartan free base) tablets. The dissolution pattern and impurity profile of TP tablets differed from those of Micardis ® tablets because telmisartan free base is poorly soluble in water. After identifying the quality target product profile and critical quality attributes (CQAs), drug dissolution, and impurities were predicted to be risky CQAs. To determine the exact range and cause of risks, we used the risk assessment (RA) tools, preliminary hazard analysis and failure mode and effect analysis to determine the parameters affecting drug dissolution, impurities, and formulation. The range of the design space was optimized using the face-centered central composite design among the design of experiment (DOE) methods. The binder, disintegrant, and kneading time in the wet granulation were identified as X values affecting Y values (disintegration, hardness, friability, dissolution, and impurities). After determining the design space with the desired Y values, the TP tablets were formulated and their dissolution pattern was compared with that of the reference tablet. The selected TP tablet formulated using design space showed a similar dissolution to that of Micardis ® tablets at pH 7.5. The QbD approach TP tablet was bioequivalent to Micardis ® tablets in beagle dogs.

Freshness indices of roasted coffee: monitoring the loss of freshness for single serve capsules and roasted whole beans in different packaging.

PubMed

Glöss, Alexia N; Schönbächler, Barbara; Rast, Markus; Deuber, Louis; Yeretzian, Chahan

2014-01-01

With the growing demand for high-quality coffee, it is becoming increasingly important to establish quantitative measures of the freshness of coffee, or the loss thereof, over time. Indeed, freshness has become a critical quality criterion in the specialty coffee scene, where the aim is to deliver the most pleasant flavor in the cup, from highest quality beans. A series of intensity ratios of selected volatile organic compounds (VOC) in the headspace of coffee (by gas chromatography-mass spectrometry) were revisited, with the aim to establish robust indicators of freshness of coffee - called freshness indices. Roasted whole beans in four different packaging materials and four commercial capsule systems from the Swiss market were investigated over a period of up to one year of storage time. These measurements revealed three types of insight. First, a clear link between barrier properties of the packaging material and the evolution of selected freshness indices was observed. Packaging materials that contain an aluminum layer offer better protection. Second, processing steps prior to packaging are reflected in the absolute values of freshness indices. Third, differences in the standard deviations of freshness-indices for single serve coffee capsule systems are indicative of differences in the consistency among systems, consistency being an important quality attribute of capsules.

Research and application of a novel hybrid air quality early-warning system: A case study in China.

PubMed

Li, Chen; Zhu, Zhijie

2018-06-01

As one of the most serious meteorological disasters in modern society, air pollution has received extensive attention from both citizens and decision-makers. With the complexity of pollution components and the uncertainty of prediction, it is both critical and challenging to construct an effective and practical early-warning system. In this paper, a novel hybrid air quality early-warning system for pollution contaminant monitoring and analysis was proposed. To improve the efficiency of the system, an advanced attribute selection method based on fuzzy evaluation and rough set theory was developed to select the main pollution contaminants for cities. Moreover, a hybrid model composed of the theory of "decomposition and ensemble", an extreme learning machine and an advanced heuristic algorithm was developed for pollution contaminant prediction; it provides deterministic and interval forecasting for tackling the uncertainty of future air quality. Daily pollution contaminants of six major cities in China were selected as a dataset to evaluate the practicality and effectiveness of the developed air quality early-warning system. The superior experimental performance determined by the values of several error indexes illustrated that the proposed early-warning system was of great effectiveness and efficiency. Copyright © 2018 Elsevier B.V. All rights reserved.

Bioreactor process parameter screening utilizing a Plackett-Burman design for a model monoclonal antibody.

PubMed

Agarabi, Cyrus D; Schiel, John E; Lute, Scott C; Chavez, Brittany K; Boyne, Michael T; Brorson, Kurt A; Khan, Mansoora; Read, Erik K

2015-06-01

Consistent high-quality antibody yield is a key goal for cell culture bioprocessing. This endpoint is typically achieved in commercial settings through product and process engineering of bioreactor parameters during development. When the process is complex and not optimized, small changes in composition and control may yield a finished product of less desirable quality. Therefore, changes proposed to currently validated processes usually require justification and are reported to the US FDA for approval. Recently, design-of-experiments-based approaches have been explored to rapidly and efficiently achieve this goal of optimized yield with a better understanding of product and process variables that affect a product's critical quality attributes. Here, we present a laboratory-scale model culture where we apply a Plackett-Burman screening design to parallel cultures to study the main effects of 11 process variables. This exercise allowed us to determine the relative importance of these variables and identify the most important factors to be further optimized in order to control both desirable and undesirable glycan profiles. We found engineering changes relating to culture temperature and nonessential amino acid supplementation significantly impacted glycan profiles associated with fucosylation, β-galactosylation, and sialylation. All of these are important for monoclonal antibody product quality. © 2015 Wiley Periodicals, Inc. and the American Pharmacists Association.

Taking the pulse of Internet pharmacies.

PubMed

Yang, Z; Peterson, R T; Huang, L

2001-01-01

Like most businesses, online pharmacy companies will only be successful if they make sure customers are satisfied with the service they receive. But what attributes of service quality lead to satisfaction and dissatisfaction? This study identified 19 Internet pharmacy service quality dimensions in three categories: (1) product cost and availability, (2) customer service, and (3) the online information system. Our analysis uncovered attributes that tend to determine consumer satisfaction and points out ways to improve overall service quality in the Internet pharmacy arena.

A software quality model and metrics for risk assessment

NASA Technical Reports Server (NTRS)

Hyatt, L.; Rosenberg, L.

1996-01-01

A software quality model and its associated attributes are defined and used as the model for the basis for a discussion on risk. Specific quality goals and attributes are selected based on their importance to a software development project and their ability to be quantified. Risks that can be determined by the model's metrics are identified. A core set of metrics relating to the software development process and its products is defined. Measurements for each metric and their usability and applicability are discussed.

An integrated quality by design and mixture-process variable approach in the development of a capillary electrophoresis method for the analysis of almotriptan and its impurities.

PubMed

Orlandini, S; Pasquini, B; Stocchero, M; Pinzauti, S; Furlanetto, S

2014-04-25

The development of a capillary electrophoresis (CE) method for the assay of almotriptan (ALM) and its main impurities using an integrated Quality by Design and mixture-process variable (MPV) approach is described. A scouting phase was initially carried out by evaluating different CE operative modes, including the addition of pseudostationary phases and additives to the background electrolyte, in order to approach the analytical target profile. This step made it possible to select normal polarity microemulsion electrokinetic chromatography (MEEKC) as operative mode, which allowed a good selectivity to be achieved in a low analysis time. On the basis of a general Ishikawa diagram for MEEKC methods, a screening asymmetric matrix was applied in order to screen the effects of the process variables (PVs) voltage, temperature, buffer concentration and buffer pH, on critical quality attributes (CQAs), represented by critical separation values and analysis time. A response surface study was then carried out considering all the critical process parameters, including both the PVs and the mixture components (MCs) of the microemulsion (borate buffer, n-heptane as oil, sodium dodecyl sulphate/n-butanol as surfactant/cosurfactant). The values of PVs and MCs were simultaneously changed in a MPV study, making it possible to find significant interaction effects. The design space (DS) was defined as the multidimensional combination of PVs and MCs where the probability for the different considered CQAs to be acceptable was higher than a quality level π=90%. DS was identified by risk of failure maps, which were drawn on the basis of Monte-Carlo simulations, and verification points spanning the design space were tested. Robustness testing of the method, performed by a D-optimal design, and system suitability criteria allowed a control strategy to be designed. The optimized method was validated following ICH Guideline Q2(R1) and was applied to a real sample of ALM coated tablets. Copyright © 2014 Elsevier B.V. All rights reserved.

Quantification of BMPs Selection and Spatial Placement Impact on Water Quality Controlling Plans in Lower Bear River Watershed, Utah

NASA Astrophysics Data System (ADS)

Salha, A. A.; Stevens, D. K.

2016-12-01

The aim of the watershed-management program in Box Elder County, Utah set by Utah Division of Water Quality (UDEQ) is to evaluate the effectiveness and spatial placement of the implemented best-management practices (BMP) for controlling nonpoint-source contamination at watershed scale. The need to evaluate the performance of BMPs would help future policy and program decisions making as desired end results. The environmental and costs benefits of BMPs in Lower Bear River watershed have seldom been measured beyond field experiments. Yet, implemented practices have rarely been evaluated at the watershed scale where the combined effects of variable soils, climatic conditions, topography and land use/covers and management conditions may significantly change anticipated results and reductions loads. Such evaluation requires distributed watershed models that are necessary for quantifying and reproducing the movement of water, sediments and nutrients. Soil and Water Assessment Tool (SWAT) model is selected as a watershed level tool to identify contaminant nonpoint sources (critical zones) and areas of high pollution risks. Water quality concerns have been documented and are primarily attributed to high phosphorus and total suspended sediment concentrations caused by agricultural and farming practices (required load is 460 kg/day of total phosphorus based on 0.075 mg/l and an average of total suspended solids of 90 mg/l). Input data such as digital elevation model (DEM), land use/Land cover (LULC), soils, and climate data for 10 years (2000-2010) is utilized along with observed water quality at the watershed outlet (USGS) and some discrete monitoring points within the watershed. Statistical and spatial analysis of scenarios of management practices (BMP's) are not implemented (before implementation), during implementation, and after BMP's have been studied to determine whether water quality of the two main water bodies has improved as required by the LBMR watershed's TMDL and if the BMPs are cost-effectively targeting the critical zones.

Contribution of stimulus attributes to errors in duration and distance judgments--a developmental study.

PubMed

Matsuda, F; Lan, W C; Tanimura, R

1999-02-01

In Matsuda's 1996 study, 4- to 11-yr.-old children (N = 133) watched two cars running on two parallel tracks on a CRT display and judged whether their durations and distances were equal and, if not, which was larger. In the present paper, the relative contributions of the four critical stimulus attributes (whether temporal starting points, temporal stopping points, spatial starting points, and spatial stopping points were the same or different between two cars) to the production of errors were quantitatively estimated based on the data for rates of errors obtained by Matsuda. The present analyses made it possible not only to understand numerically the findings about qualitative characteristics of the critical attributes described by Matsuda, but also to add more detailed findings about them.

Application of terahertz pulse imaging as PAT tool for non-destructive evaluation of film-coated tablets under different manufacturing conditions.

PubMed

Dohi, Masafumi; Momose, Wataru; Yoshino, Hiroyuki; Hara, Yuko; Yamashita, Kazunari; Hakomori, Tadashi; Sato, Shusaku; Terada, Katsuhide

2016-02-05

Film-coated tablets (FCTs) are a popular solid dosage form in pharmaceutical industry. Manufacturing conditions during the film-coating process affect the properties of the film layer, which might result in critical quality problems. Here, we analyzed the properties of the film layer using a non-destructive approach with terahertz pulsed imaging (TPI). Hydrophilic tablets that become distended upon water absorption were used as core tablets and coated with film under different manufacturing conditions. TPI-derived parameters such as film thickness (FT), film surface reflectance (FSR), and interface density difference (IDD) between the film layer and core tablet were affected by manufacturing conditions and influenced critical quality attributes of FCTs. Relative standard deviation of FSR within tablets correlated well with surface roughness. Tensile strength could be predicted in a non-destructive manner using the multivariate regression equation to estimate the core tablet density by film layer density and IDD. The absolute value of IDD (Lateral) correlated with the risk of cracking on the lateral film layer when stored in a high-humidity environment. Further, in-process control was proposed for this value during the film-coating process, which will enable a feedback control system to be applied to process parameters and reduced risk of cracking without a stability test. Copyright © 2015 Elsevier B.V. All rights reserved.

A novel quality by design approach for developing an HPLC method to analyze herbal extracts: A case study of sugar content analysis.

PubMed

Shao, Jingyuan; Cao, Wen; Qu, Haibin; Pan, Jianyang; Gong, Xingchu

2018-01-01

The aim of this study was to present a novel analytical quality by design (AQbD) approach for developing an HPLC method to analyze herbal extracts. In this approach, critical method attributes (CMAs) and critical method parameters (CMPs) of the analytical method were determined using the same data collected from screening experiments. The HPLC-ELSD method for separation and quantification of sugars in Codonopsis Radix extract (CRE) samples and Astragali Radix extract (ARE) samples was developed as an example method with a novel AQbD approach. Potential CMAs and potential CMPs were found with Analytical Target Profile. After the screening experiments, the retention time of the D-glucose peak of CRE samples, the signal-to-noise ratio of the D-glucose peak of CRE samples, and retention time of the sucrose peak in ARE samples were considered CMAs. The initial and final composition of the mobile phase, flow rate, and column temperature were found to be CMPs using a standard partial regression coefficient method. The probability-based design space was calculated using a Monte-Carlo simulation method and verified by experiments. The optimized method was validated to be accurate and precise, and then it was applied in the analysis of CRE and ARE samples. The present AQbD approach is efficient and suitable for analysis objects with complex compositions.

Systematic Development and Validation of a Thin-Layer Densitometric Bioanalytical Method for Estimation of Mangiferin Employing Analytical Quality by Design (AQbD) Approach

PubMed Central

Khurana, Rajneet Kaur; Rao, Satish; Beg, Sarwar; Katare, O.P.; Singh, Bhupinder

2016-01-01

The present work aims at the systematic development of a simple, rapid and highly sensitive densitometry-based thin-layer chromatographic method for the quantification of mangiferin in bioanalytical samples. Initially, the quality target method profile was defined and critical analytical attributes (CAAs) earmarked, namely, retardation factor (Rf), peak height, capacity factor, theoretical plates and separation number. Face-centered cubic design was selected for optimization of volume loaded and plate dimensions as the critical method parameters selected from screening studies employing D-optimal and Plackett–Burman design studies, followed by evaluating their effect on the CAAs. The mobile phase containing a mixture of ethyl acetate : acetic acid : formic acid : water in a 7 : 1 : 1 : 1 (v/v/v/v) ratio was finally selected as the optimized solvent for apt chromatographic separation of mangiferin at 262 nm with Rf 0.68 ± 0.02 and all other parameters within the acceptance limits. Method validation studies revealed high linearity in the concentration range of 50–800 ng/band for mangiferin. The developed method showed high accuracy, precision, ruggedness, robustness, specificity, sensitivity, selectivity and recovery. In a nutshell, the bioanalytical method for analysis of mangiferin in plasma revealed the presence of well-resolved peaks and high recovery of mangiferin. PMID:26912808

QbD for pediatric oral lyophilisates development: risk assessment followed by screening and optimization.

PubMed

Casian, Tibor; Iurian, Sonia; Bogdan, Catalina; Rus, Lucia; Moldovan, Mirela; Tomuta, Ioan

2017-12-01

This study proposed the development of oral lyophilisates with respect to pediatric medicine development guidelines, by applying risk management strategies and DoE as an integrated QbD approach. Product critical quality attributes were overviewed by generating Ishikawa diagrams for risk assessment purposes, considering process, formulation and methodology related parameters. Failure Mode Effect Analysis was applied to highlight critical formulation and process parameters with an increased probability of occurrence and with a high impact on the product performance. To investigate the effect of qualitative and quantitative formulation variables D-optimal designs were used for screening and optimization purposes. Process parameters related to suspension preparation and lyophilization were classified as significant factors, and were controlled by implementing risk mitigation strategies. Both quantitative and qualitative formulation variables introduced in the experimental design influenced the product's disintegration time, mechanical resistance and dissolution properties selected as CQAs. The optimum formulation selected through Design Space presented ultra-fast disintegration time (5 seconds), a good dissolution rate (above 90%) combined with a high mechanical resistance (above 600 g load). Combining FMEA and DoE allowed the science based development of a product with respect to the defined quality target profile by providing better insights on the relevant parameters throughout development process. The utility of risk management tools in pharmaceutical development was demonstrated.

Users' demographic profile and quality attributes of bus services: The perspectives of users, operators and local authorities

NASA Astrophysics Data System (ADS)

Noh, Nur'Amirah Mhd.; Hamid, Ahmad Hilmy Abd

2017-10-01

Bus services that can help meet almost every bus user's needs are the goals of bus operators. Despite such an idealistic view, the operators themselves, users and even the local authorities have been found to hold different views about the quality of service that the bus should deliver. As the users i.e., customers are considered as important stakeholders, understanding their characteristics, profile and pattern is very crucial. To this end, the present study has attempted to gauge the perspectives of all the above-mentioned stakeholders. For the users, a customer satisfaction survey was employed to look into the relative influence of service attributes. In addition, surveys were also administered to bus operators and local authorities to study their perspectives in relation to this matter. 450 randomly selected respondents were surveyed. Identification of the service level was analyzed through the Likert scale whereas the perspectives of the operators and authorities were dealt with through mean value Analysis. Specifically, this study aims to identify the crucial attributes in determining the quality of the bus services. Findings of the study indicated that different attributes were selected by users, operators and authorities, which clearly enlightened the variations of the important attributes in determining the level of bus service quality. In its attempt to compare the service level attributes from three perspectives, this study has helped advance better improvement and strategies for the urban public bus operators and planners, in addition to the authorities in delivering user-friendly bus services by taking into account the local context, user profile and demographic characteristics.

Inline UV/Vis spectroscopy as PAT tool for hot-melt extrusion.

PubMed

Wesholowski, Jens; Prill, Sebastian; Berghaus, Andreas; Thommes, Markus

2018-01-11

Hot-melt extrusion on co-rotating twin screw extruders is a focused technology for the production of pharmaceuticals in the context of Quality by Design. Since it is a continuous process, the potential for minimizing product quality fluctuation is enhanced. A typical application of hot-melt extrusion is the production of solid dispersions, where an active pharmaceutical ingredient (API) is distributed within a polymer matrix carrier. For this dosage form, the product quality is related amongst others to the drug content. This can be monitored on- or inline as critical quality attribute by a process analytical technology (PAT) in order to meet the specific requirements of Quality by Design. In this study, an inline UV/Vis spectrometer from ColVisTec was implemented in an early development twin screw extruder and the performance tested in accordance to the ICH Q2 guideline. Therefore, two API (carbamazepine and theophylline) and one polymer matrix (copovidone) were considered with the main focus on the quantification of the drug load. The obtained results revealed the suitability of the implemented PAT tool to quantify the drug load in a typical range for pharmaceutical applications. The effort for data evaluation was minimal due to univariate data analysis, and in combination with a measurement frequency of 1 Hz, the system is sufficient for real-time data acquisition.

The effect of cryogenic grinding and hammer milling on the flavour quality of ground pepper (Piper nigrum L.).

PubMed

Liu, Hong; Zeng, Fankui; Wang, Qinghuang; Ou, Shiyi; Tan, Lehe; Gu, Fenglin

2013-12-15

In this study, we compared the effects of cryogenic grinding and hammer milling on the flavour attributes of black, white, and green pepper. The flavour attributes were analysed using headspace solid-phase micro-extraction (HS-SPME) and gas chromatography-mass spectrometry (GC/MS), sensory evaluation and electronic nose (e-nose) analysis. Cryogenic grinding resulted in minimal damage to the colour, flavour, and sensory attributes of the spices. Cryogenic grinding was also better than hammer milling at preserving the main potent aroma constituents, but the concentrations of the main aroma constituents were dramatically reduced after storing the samples at 4 °C for 6 months. Pattern matching performed by the e-nose further supported our sensory and instrumental findings. Overall, cryogenic grinding was superior to hammer milling for preserving the sensory properties and flavour attributes of pepper without significantly affecting its quality. However, we found that the flavour quality of ground pepper was reduced during storage. Copyright © 2013 Elsevier Ltd. All rights reserved.

Effect of node attributes on the temporal dynamics of network structure

NASA Astrophysics Data System (ADS)

Momeni, Naghmeh; Fotouhi, Babak

2017-03-01

Many natural and social networks evolve in time and their structures are dynamic. In most networks, nodes are heterogeneous, and their roles in the evolution of structure differ. This paper focuses on the role of individual attributes on the temporal dynamics of network structure. We focus on a basic model for growing networks that incorporates node attributes (which we call "quality"), and we focus on the problem of forecasting the structural properties of the network in arbitrary times for an arbitrary initial network. That is, we address the following question: If we are given a certain initial network with given arbitrary structure and known node attributes, then how does the structure change in time as new nodes with given distribution of attributes join the network? We solve the model analytically and obtain the quality-degree joint distribution and degree correlations. We characterize the role of individual attributes in the position of individual nodes in the hierarchy of connections. We confirm the theoretical findings with Monte Carlo simulations.

Consumer preferences for food product quality attributes from Swedish agriculture.

PubMed

Carlsson, Fredrik; Frykblom, Peter; Lagerkvist, Carl Johan

2005-06-01

This paper employs a choice experiment to obtain consumer preferences and willingness to pay for food product quality attributes currently not available in Sweden. Data were obtained from a large mail survey and estimated with a random parameter logit model. We found evidence for intraproduct differences in consumer preferences for identical attributes, as well as interproduct discrepancies in ranking of attributes. Furthermore, we found evidence of a market failure relating to the potential use of genetically modified animal fodder. Finally, we found support for the idea that a cheap-talk script can alleviate problems of external validity of choice experiments. Our results are useful in forming product differentiation strategies within the food industry, as well as for the formation of food policy.

Quality assurance and reliability in the Japanese electronics industry

NASA Astrophysics Data System (ADS)

Pecht, Michael; Boulton, William R.

1995-02-01

Quality and reliability are two attributes required for all Japanese products, although the JTEC panel found these attributes to be secondary to customer cost requirements. While our Japanese hosts gave presentations on the challenges of technology, cost, and miniaturization, quality and reliability were infrequently the focus of our discussions. Quality and reliability were assumed to be sufficient to meet customer needs. Fujitsu's slogan, 'quality built-in, with cost and performance as prime consideration,' illustrates this point. Sony's definition of a next-generation product is 'one that is going to be half the size and half the price at the same performance of the existing one'. Quality and reliability are so integral to Japan's electronics industry that they need no new emphasis.

Quality assurance and reliability in the Japanese electronics industry

NASA Technical Reports Server (NTRS)

Pecht, Michael; Boulton, William R.

1995-01-01

Quality and reliability are two attributes required for all Japanese products, although the JTEC panel found these attributes to be secondary to customer cost requirements. While our Japanese hosts gave presentations on the challenges of technology, cost, and miniaturization, quality and reliability were infrequently the focus of our discussions. Quality and reliability were assumed to be sufficient to meet customer needs. Fujitsu's slogan, 'quality built-in, with cost and performance as prime consideration,' illustrates this point. Sony's definition of a next-generation product is 'one that is going to be half the size and half the price at the same performance of the existing one'. Quality and reliability are so integral to Japan's electronics industry that they need no new emphasis.

Work-Family Conflict within the Family: Crossover Effects, Perceived Parent-Child Interaction Quality, Parental Self-Efficacy, and Life Role Attributions

ERIC Educational Resources Information Center

Cinamon, Rachel Gali; Weisel, Amatzia; Tzuk, Kineret

2007-01-01

To better understand the work-family interface within the family domain, this study investigated crossover effects of two types of work-family conflict among 120 participants (60 married couples), these conflicts' relations with parental self-efficacy and perceived quality of parent-child interaction, and the contribution of attributions of…

Creating Enabling Environment for Student Engagement: Faculty Practices of Critical Thinking

ERIC Educational Resources Information Center

Cassum, Shanaz Hussein; Gul, Raisa Begum

2017-01-01

Critical thinking (CT) is considered an important attribute in practice disciplines and faculty members in nursing, medicine, and education are expected to facilitate the development of CT in their graduates so that these individuals can be critical, reflective, competent, and caring professionals and service providers. When students are actively…

The Nature and Development of Critical-Analytic Thinking

ERIC Educational Resources Information Center

Byrnes, James P.; Dunbar, Kevin N.

2014-01-01

In this article, we attempt to provide an overview of the features of the abilities, aptitudes, and frames of minds that are attributed to critical thinking and provide the broad outlines of the development of critical-analytic thinking (CAT) abilities. In addition, we evaluate the potential viability of three main hypotheses regarding the reasons…

Assessing Critical Thinking Performance of Postgraduate Students in Threaded Discussions

ERIC Educational Resources Information Center

Tan, Cheng Lee; Ng, Lee Luan

2014-01-01

Critical thinking has increasingly been seen as one of the important attributes where human capital is concerned and in line with this recognition, the tertiary educational institutions worldwide are putting more effort into designing courses that produce university leavers who are critical thinkers. This study aims to investigate the critical…

Investigating Contingency in School History: An Aid to Rich, Meaningfully Critical Citizenship?

ERIC Educational Resources Information Center

Billingham, Luke

2016-01-01

A common charge levelled at English and Welsh citizenship education, whether taught as a separate subject or incorporated into other disciplines, is that it encourages compliance more than it inspires critical thought. There is room within the compulsory citizenship framework, however, for teachers to advance genuinely critical attributes in…

Factors affecting the water holding capacity of red meat products: a review of recent research advances.

PubMed

Cheng, Qiaofen; Sun, Da-Wen

2008-02-01

The water holding capacity of meat products is a very important quality attribute which has an influence on product yield, which in turn has economic implications, but is also important in terms of eating quality. A number of pre-and post-mortem factors influence the water holding capacity (WHC) of meat. During the growth and development of meat animals, genotype and animal diet are important due to their direct influence on muscle characteristics. In the immediate pre-slaughter period, stresses on the animal such as fasting, and different stunning methods are likely to influence meat WHC. In the post-slaughter period chilling, ageing, injecting non-meat ingredients, as well as tumbling have important influences on WHC. Furthermore, cooking and cooling procedures for the final meat products can also affect the WHC of the product, in particular the cooking and the cooling methods, the heating and the cooling rate, the cooking temperature, and the endpoint temperature. This paper provides an overview of recent research on important intrinsic and extrinsic factors that affect the WHC of beef, pork, and lamb products, and reveals explanations and solutions to some of the critical problems related to WHC and product quality.

The quality of the maternal health system in Eritrea.

PubMed

Sharan, Mona; Ahmed, Saifuddin; Ghebrehiwet, Mismay; Rogo, Khama

2011-12-01

To examine the quality of the maternal health system in Eritrea to understand system deficiencies and its relevance to maternal mortality within the context of Millennium Development Goal (MDG) 5. A sample of 118 health facilities was surveyed. Data were collected on 5 dimensions of health system quality: availability; accessibility; management; infrastructure; and process indicators. Data on the causes of hospital admissions for obstetric patients and maternal deaths were extracted from medical records. Eritrea has only 11 comprehensive emergency obstetric care (CEmOC) facilities, all of which are grossly understaffed. There is considerable pressure on the infrastructure and health providers at hospitals. Compliance with clinical care standards and availability of supplies were optimal. As a result, the case fatality rate of 0.65% was low. In total, 45.6% of obstetric admissions and 19.5% of maternal deaths were attributed to abortion complications. In Eritrea, critical gaps in the health system-especially those related to human resources-will impede progress toward MDG 5, and it will not be possible to reduce maternal mortality without addressing the high burden of abortion. Copyright © 2011 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

The effect of texture granularity on texture synthesis quality

NASA Astrophysics Data System (ADS)

Golestaneh, S. Alireza; Subedar, Mahesh M.; Karam, Lina J.

2015-09-01

Natural and artificial textures occur frequently in images and in video sequences. Image/video coding systems based on texture synthesis can make use of a reliable texture synthesis quality assessment method in order to improve the compression performance in terms of perceived quality and bit-rate. Existing objective visual quality assessment methods do not perform satisfactorily when predicting the synthesized texture quality. In our previous work, we showed that texture regularity can be used as an attribute for estimating the quality of synthesized textures. In this paper, we study the effect of another texture attribute, namely texture granularity, on the quality of synthesized textures. For this purpose, subjective studies are conducted to assess the quality of synthesized textures with different levels (low, medium, high) of perceived texture granularity using different types of texture synthesis methods.

Physician Service Attribution Methods for Examining Provision of Low-Value Care

PubMed Central

Chang, Eva; Buist, Diana SM; Handley, Matthew; Pardee, Roy; Gundersen, Gabrielle; Reid, Robert J.

2016-01-01

Objectives: There has been significant research on provider attribution for quality and cost. Low-value care is an area of heightened focus, with little of the focus being on measurement; a key methodological decision is how to attribute delivered services and procedures. We illustrate the difference in relative and absolute physician- and panel-attributed services and procedures using overuse in cervical cancer screening. Study Design: A retrospective, cross-sectional study in an integrated health care system. Methods: We used 2013 physician-level data from Group Health Cooperative to calculate two utilization attributions: (1) panel attribution with the procedure assigned to the physician’s predetermined panel, regardless of who performed the procedure; and (2) physician attribution with the procedure assigned to the performing physician. We calculated the percentage of low-value cervical cancer screening tests and ranked physicians within the clinic using the two utilization attribution methods. Results: The percentage of low-value cervical cancer screening varied substantially between physician and panel attributions. Across the whole delivery system, median panel- and physician-attributed percentages were 15 percent and 10 percent, respectively. Among sampled clinics, panel-attributed percentages ranged between 10 percent and 17 percent, and physician-attributed percentages ranged between 9 percent and 13 percent. Within a clinic, median panel-attributed screening percentage was 17 percent (range 0 percent–27 percent) and physician-attributed percentage was 11 percent (range 0 percent–24 percent); physician rank varied by attribution method. Conclusions: The attribution method is an important methodological decision when developing low-value care measures since measures may ultimately have an impact on national benchmarking and quality scores. Cross-organizational dialogue and transparency in low-value care measurement will become increasingly important for all stakeholders. PMID:28203612

Physician Service Attribution Methods for Examining Provision of Low-Value Care.

PubMed

Chang, Eva; Buist, Diana Sm; Handley, Matthew; Pardee, Roy; Gundersen, Gabrielle; Reid, Robert J

2016-01-01

There has been significant research on provider attribution for quality and cost. Low-value care is an area of heightened focus, with little of the focus being on measurement; a key methodological decision is how to attribute delivered services and procedures. We illustrate the difference in relative and absolute physician- and panel-attributed services and procedures using overuse in cervical cancer screening. A retrospective, cross-sectional study in an integrated health care system. We used 2013 physician-level data from Group Health Cooperative to calculate two utilization attributions: (1) panel attribution with the procedure assigned to the physician's predetermined panel, regardless of who performed the procedure; and (2) physician attribution with the procedure assigned to the performing physician. We calculated the percentage of low-value cervical cancer screening tests and ranked physicians within the clinic using the two utilization attribution methods. The percentage of low-value cervical cancer screening varied substantially between physician and panel attributions. Across the whole delivery system, median panel- and physician-attributed percentages were 15 percent and 10 percent, respectively. Among sampled clinics, panel-attributed percentages ranged between 10 percent and 17 percent, and physician-attributed percentages ranged between 9 percent and 13 percent. Within a clinic, median panel-attributed screening percentage was 17 percent (range 0 percent-27 percent) and physician-attributed percentage was 11 percent (range 0 percent-24 percent); physician rank varied by attribution method. The attribution method is an important methodological decision when developing low-value care measures since measures may ultimately have an impact on national benchmarking and quality scores. Cross-organizational dialogue and transparency in low-value care measurement will become increasingly important for all stakeholders.

Algal Attributes: An Autecological Classification of Algal Taxa Collected by the National Water-Quality Assessment Program

USGS Publications Warehouse

Porter, Stephen D.

2008-01-01

Algae are excellent indicators of water-quality conditions, notably nutrient and organic enrichment, and also are indicators of major ion, dissolved oxygen, and pH concentrations and stream microhabitat conditions. The autecology, or physiological optima and tolerance, of algal species for various water-quality contaminants and conditions is relatively well understood for certain groups of freshwater algae, notably diatoms. However, applications of autecological information for water-quality assessments have been limited because of challenges associated with compiling autecological literature from disparate sources, tracking name changes for a large number of algal species, and creating an autecological data base from which algal-indicator metrics can be calculated. A comprehensive summary of algal autecological attributes for North American streams and rivers does not exist. This report describes a large, digital data file containing 28,182 records for 5,939 algal taxa, generally species or variety, collected by the U.S. Geological Survey?s National Water-Quality Assessment (NAWQA) Program. The data file includes 37 algal attributes classified by over 100 algal-indicator codes or metrics that can be calculated easily with readily available software. Algal attributes include qualitative classifications based on European and North American autecological literature, and semi-quantitative, weighted-average regression approaches for estimating optima using regional and national NAWQA data. Applications of algal metrics in water-quality assessments are discussed and national quartile distributions of metric scores are shown for selected indicator metrics.

Measuring Software Product Quality: The ISO 25000 Series and CMMI

DTIC Science & Technology

2004-06-14

performance objectives” covers objectives and requirements for product quality, service quality , and process performance. Process performance objectives...such that product quality, service quality , and process performance attributes are measurable and controlled throughout the project (internal and

Talent identification and recruitment in youth soccer: Recruiter's perceptions of the key attributes for player recruitment.

PubMed

Larkin, Paul; O'Connor, Donna

2017-01-01

Using the modified Delphi method, we aimed to understand the attributes youth coaches and recruiters perceive as important when identifying skilled youth performance at the entry level of representative soccer in Australia (i.e., Under 13 years). Furthermore, we also aimed to describe the current methods youth coaches and recruiters use to assess and identify these attributes in youth players. Australian regional youth technical directors and coaches (n = 20) completed a three stage process, including an initial interview and two subsequent questionnaires, whereby attributes and qualities associated with talent identification were rated and justified according to the importance for youth player performance and talent identification. Results indicate a hierarchy of attributes recruiters perceive as important for Under 13 soccer performance, including technical (i.e., first touch, striking the ball, one-versus-one ability, and technical ability under pressure), tactical (i.e., decision-making ability) and psychological attributes (i.e., coachability and positive attitude). In addition, the findings indicated attributes and qualities not emphasised within the talent identification process including, physiological, anthropometrical, sociological and several psychological attributes. It is suggested talent recruiters apply a holistic multidisciplinary approach to talent identification, with the current findings potentially providing initial evidence to suggest recruiters do consider numerous attributes when selecting and identifying youth players.

Talent identification and recruitment in youth soccer: Recruiter’s perceptions of the key attributes for player recruitment

PubMed Central

2017-01-01

Using the modified Delphi method, we aimed to understand the attributes youth coaches and recruiters perceive as important when identifying skilled youth performance at the entry level of representative soccer in Australia (i.e., Under 13 years). Furthermore, we also aimed to describe the current methods youth coaches and recruiters use to assess and identify these attributes in youth players. Australian regional youth technical directors and coaches (n = 20) completed a three stage process, including an initial interview and two subsequent questionnaires, whereby attributes and qualities associated with talent identification were rated and justified according to the importance for youth player performance and talent identification. Results indicate a hierarchy of attributes recruiters perceive as important for Under 13 soccer performance, including technical (i.e., first touch, striking the ball, one-versus-one ability, and technical ability under pressure), tactical (i.e., decision-making ability) and psychological attributes (i.e., coachability and positive attitude). In addition, the findings indicated attributes and qualities not emphasised within the talent identification process including, physiological, anthropometrical, sociological and several psychological attributes. It is suggested talent recruiters apply a holistic multidisciplinary approach to talent identification, with the current findings potentially providing initial evidence to suggest recruiters do consider numerous attributes when selecting and identifying youth players. PMID:28419175

Self-Handicapping Behavior: A Critical Review of Empirical Research.

ERIC Educational Resources Information Center

Carsrud, Robert Steven

Since the identification of self-handicapping strategies in 1978, considerable attention has been paid to this phenomenon. Self-handicapping is a strategy for discounting ability attributions for probable failure while augmenting ability attributions for possible success. Behavioral self-handicaps are conceptually distinct from self-reported…

[Study on the optimization of monitoring indicators of drinking water quality during health supervision].

PubMed

Ye, Bixiong; E, Xueli; Zhang, Lan

2015-01-01

To optimize non-regular drinking water quality indices (except Giardia and Cryptosporidium) of urban drinking water. Several methods including drinking water quality exceed the standard, the risk of exceeding standard, the frequency of detecting concentrations below the detection limit, water quality comprehensive index evaluation method, and attribute reduction algorithm of rough set theory were applied, redundancy factor of water quality indicators were eliminated, control factors that play a leading role in drinking water safety were found. Optimization results showed in 62 unconventional water quality monitoring indicators of urban drinking water, 42 water quality indicators could be optimized reduction by comprehensively evaluation combined with attribute reduction of rough set. Optimization of the water quality monitoring indicators and reduction of monitoring indicators and monitoring frequency could ensure the safety of drinking water quality while lowering monitoring costs and reducing monitoring pressure of the sanitation supervision departments.

Establishing a Quality Control System for Stem Cell-Based Medicinal Products in China

PubMed Central

2015-01-01

Stem cell-based medicinal products (SCMPs) are emerging as novel therapeutic products. The success of its development depends on the existence of an effective quality control system, which is constituted by quality control technologies, standards, reference materials, guidelines, and the associated management system in accordance with regulatory requirements along product lifespan. However, a worldwide, effective quality control system specific for SCMPs is still far from established partially due to the limited understanding of stem cell sciences and lack of quality control technologies for accurately assessing the safety and biological effectiveness of SCMPs before clinical use. Even though, based on the existing regulations and current stem cell sciences and technologies, initial actions toward the goal of establishing such a system have been taken as exemplified by recent development of new “interim guidelines” for governing quality control along development of SCMPs and new development of the associated quality control technologies in China. In this review, we first briefly introduced the major institutions involved in the regulation of cell substrates and therapeutic cell products in China and the existing regulatory documents and technical guidelines used as critical references for developing the new interim guidelines. With focus only on nonhematopoietic stem cells, we then discussed the principal quality attributes of SCMPs as well as our thinking of proper testing approaches to be established with relevant evaluation technologies to ensure all quality requirements of SCMPs along different manufacturing processes and development stages. At the end, some regulatory and technical challenges were also discussed with the conclusion that combined efforts should be taken to promote stem cell regulatory sciences to establish the effective quality control system for SCMPs. PMID:25471126

Mapping by sequencing in cotton (Gossypium hirsutum) line MD52ne identified candidate genes for fiber strength and its related quality attributes.

PubMed

Islam, Md S; Zeng, Linghe; Thyssen, Gregory N; Delhom, Christopher D; Kim, Hee Jin; Li, Ping; Fang, David D

2016-06-01

Three QTL regions controlling three fiber quality traits were validated and further fine-mapped with 27 new single nucleotide polymorphism (SNP) markers. Transcriptome analysis suggests that receptor-like kinases found within the validated QTLs are potential candidate genes responsible for superior fiber strength in cotton line MD52ne. Fiber strength, length, maturity and fineness determine the market value of cotton fibers and the quality of spun yarn. Cotton fiber strength has been recognized as a critical quality attribute in the modern textile industry. Fine mapping along with quantitative trait loci (QTL) validation and candidate gene prediction can uncover the genetic and molecular basis of fiber quality traits. Four previously-identified QTLs (qFBS-c3, qSFI-c14, qUHML-c14 and qUHML-c24) related to fiber bundle strength, short fiber index and fiber length, respectively, were validated using an F3 population that originated from a cross of MD90ne × MD52ne. A group of 27 new SNP markers generated from mapping-by-sequencing (MBS) were placed in QTL regions to improve and validate earlier maps. Our refined QTL regions spanned 4.4, 1.8 and 3.7 Mb of physical distance in the Gossypium raimondii reference genome. We performed RNA sequencing (RNA-seq) of 15 and 20 days post-anthesis fiber cells from MD52ne and MD90ne and aligned reads to the G. raimondii genome. The QTL regions contained 21 significantly differentially expressed genes (DEGs) between the two near-isogenic parental lines. SNPs that result in non-synonymous substitutions to amino acid sequences of annotated genes were identified within these DEGs, and mapped. Taken together, transcriptome and amino acid mutation analysis indicate that receptor-like kinase pathway genes are likely candidates for superior fiber strength and length in MD52ne. MBS along with RNA-seq demonstrated a powerful strategy to elucidate candidate genes for the QTLs that control complex traits in a complex genome like tetraploid upland cotton.

Efficacy of Sweet Potato Powder and Added Water as Fat Replacer on the Quality Attributes of Low-fat Pork Patties.

PubMed

Verma, Akhilesh K; Chatli, Manish Kumar; Kumar, Devendra; Kumar, Pavan; Mehta, Nitin

2015-02-01

The present study was conducted to investigate the efficacy of sweet potato powder (SPP) and water as a fat replacer in low-fat pork patties. Low-fat pork patties were developed by replacing the added fat with combinations of SPP and chilled water. Three different levels of SPP/chilled water viz. 0.5/9.5% (T-1), 1.0/9.0% (T-2), and 1.5/8.5% (T-3) were compared with a control containing 10% animal fat. The quality of low-fat pork patties was evaluated for physico-chemical (pH, emulsion stability, cooking yield, aw), proximate, instrumental colour and textural profile, and sensory attributes. The cooking yield and emulsion stability improved (p<0.05) in all treatments over the control and were highest in T-2. Instrumental texture profile attributes and hardness decreased, whereas cohesiveness increased compared with control, irrespective of SPP level. Dimensional parameters (% gain in height and % decrease in diameter) were better maintained during cooking in the low-fat product than control. The sensory quality attributes juiciness, texture and overall acceptability of T-2 and T-3 were (p<0.05) higher than control. Results concluded that low-fat pork patties with acceptable sensory attributes, improved cooking yield and textural attributes can be successfully developed with the incorporation of a combination of 1.0% SPP and 9.0% chilled water.

Efficacy of Sweet Potato Powder and Added Water as Fat Replacer on the Quality Attributes of Low-fat Pork Patties

PubMed Central

Verma, Akhilesh K.; Chatli, Manish Kumar; Kumar, Devendra; Kumar, Pavan; Mehta, Nitin

2015-01-01

The present study was conducted to investigate the efficacy of sweet potato powder (SPP) and water as a fat replacer in low-fat pork patties. Low-fat pork patties were developed by replacing the added fat with combinations of SPP and chilled water. Three different levels of SPP/chilled water viz. 0.5/9.5% (T-1), 1.0/9.0% (T-2), and 1.5/8.5% (T-3) were compared with a control containing 10% animal fat. The quality of low-fat pork patties was evaluated for physico-chemical (pH, emulsion stability, cooking yield, aw), proximate, instrumental colour and textural profile, and sensory attributes. The cooking yield and emulsion stability improved (p<0.05) in all treatments over the control and were highest in T-2. Instrumental texture profile attributes and hardness decreased, whereas cohesiveness increased compared with control, irrespective of SPP level. Dimensional parameters (% gain in height and % decrease in diameter) were better maintained during cooking in the low-fat product than control. The sensory quality attributes juiciness, texture and overall acceptability of T-2 and T-3 were (p<0.05) higher than control. Results concluded that low-fat pork patties with acceptable sensory attributes, improved cooking yield and textural attributes can be successfully developed with the incorporation of a combination of 1.0% SPP and 9.0% chilled water. PMID:25557822

Antibody performance in ChIP-sequencing assays: From quality scores of public data sets to quantitative certification.

PubMed

Mendoza-Parra, Marco-Antonio; Saravaki, Vincent; Cholley, Pierre-Etienne; Blum, Matthias; Billoré, Benjamin; Gronemeyer, Hinrich

2016-01-01

We have established a certification system for antibodies to be used in chromatin immunoprecipitation assays coupled to massive parallel sequencing (ChIP-seq). This certification comprises a standardized ChIP procedure and the attribution of a numerical quality control indicator (QCi) to biological replicate experiments. The QCi computation is based on a universally applicable quality assessment that quantitates the global deviation of randomly sampled subsets of ChIP-seq dataset with the original genome-aligned sequence reads. Comparison with a QCi database for >28,000 ChIP-seq assays were used to attribute quality grades (ranging from 'AAA' to 'DDD') to a given dataset. In the present report we used the numerical QC system to assess the factors influencing the quality of ChIP-seq assays, including the nature of the target, the sequencing depth and the commercial source of the antibody.  We have used this approach specifically to certify mono and polyclonal antibodies obtained from Active Motif directed against the histone modification marks H3K4me3, H3K27ac and H3K9ac for ChIP-seq. The antibodies received the grades AAA to BBC ( www.ngs-qc.org). We propose to attribute such quantitative grading of all antibodies attributed with the label "ChIP-seq grade".

Determining consumer purchase intentions: the importance of dry matter, size, and price of kiwifruit.

PubMed

Jaeger, Sara R; Harker, Roger; Triggs, Chris M; Gunson, Anne; Campbell, Rachel L; Jackman, Richard; Requejo-Jackman, Cecilia

2011-04-01

Knowledge of the relative importance of food quality attributes in determining consumer purchase intention is critical for robust assessment of economic opportunities for industry growth. The aim of this study is to demonstrate how conjoint analysis methodology that incorporates tasting of fruit can be used to collect such information. Three hundred Japanese consumers took part in research designed to measure the importance of dry matter (DM), size, and price of kiwifruit (Actinidia deliciosa "Hayward" and Actinidia chinensis "Hort16A") for purchase intention. Measurement of consumer liking for kiwifruit of different DM content was a key first step. Liking increased as DM increased and was accompanied by increased purchase likelihood/choice probability for kiwifruit. The size of kiwifruit presented to consumers varied from "small" to "extra large." Consumers liked "mid-sized" kiwifruit over "small" or "extra-large" kiwifruit. Despite these differences in liking, size was of little importance in determining purchase likelihood/choice probability for kiwifruit. Price was a very important factor in determining purchase likelihood/choice probability but was less important than DM content. As price increased, purchase likelihood/choice probability decreased. Beneath these general findings, heterogeneity existed. Some consumers placed more/less importance on the focal purchase drivers than suggested by the aggregate model. Overall, the results suggest that incentive schemes already implemented by industry should consider rewarding high-DM fruit more than fruit size.   This research has contributed to the New Zealand kiwifruit industry gaining a better understanding of the relative importance consumers place on DM, size, and price of kiwifruit and has resulted in changes to grower incentive schemes. The research approach presented forces consumer to tradeoff attributes of kiwifruit against each other and decide on how important two key quality attributes-DM and size-are relative to each other and relative to price. The application of conjoint analysis in this article can be transferred to other fruits, food, and beverages and help guide consumer-led innovation.

Multiscale predictions of aviation-attributable PM2.5 for U.S. airports modeled using CMAQ with plume-in-grid and an aircraft-specific 1-D emission model

EPA Science Inventory

Aviation activities represent an important and unique mode of transportation, but also impact air quality. In this study, we aim to quantify the impact of aircraft on air quality, focusing on aviation-attributable PM2.5 at scales ranging from local (a few kilometers) to continent...

Mental Toughness

ERIC Educational Resources Information Center

Quinn, Tori; Cavanaugh, Lauren

2017-01-01

Mental toughness (MT) is defined as a set of attributes that allow an individual to persevere through difficult circumstances that ultimately can lead to successful outcomes. It is also a critical component of maximizing the performance of an athlete. These attributes assist with and promote a state of mind that enhances performance. A negative…

Is Teaching Neoclassical Economics as "the" Science of Economics Moral?

ERIC Educational Resources Information Center

Parvin, Manoucher

1992-01-01

Discusses the morality of teaching neoclassical theory as the only science of economics. Argues that the teaching of neoclassical theory violates moral principles unless each and every attribute of neoclassical theory is proven superior to corresponding attributes of competing theories. Criticizes neoclassical economics for teaching what rather…

Teaching Effectiveness Attributes in Business Schools

ERIC Educational Resources Information Center

Simendinger, Earl; El-Kassar, Abdul-Nasser; Gonzalez-Perez, Maria Alejandra; Crawford, John; Thomason, Stephanie; Reynet, Philippe; Kjellander, Björn; Edwards, Judson

2017-01-01

Purpose: Determining the attributes of effective business teachers is critical to schools as they strive to attract and retain students, assure learning, obtain and maintain reputation and accreditations, and place their alumni in the competitive job market. The purpose of this paper is to examine students and faculty perceptions of teaching…

Rice Grain Quality and Consumer Preferences: A Case Study of Two Rural Towns in the Philippines

PubMed Central

Velarde, Orlee; Demont, Matty

2016-01-01

Hedonic pricing analysis is conducted to determine the implicit values of various attributes in the market value of a good. In this study, hedonic pricing analysis was applied to measure the contribution of grain quality search and experience attributes to the price of rice in two rural towns in the Philippines. Rice samples from respondents underwent quantitative routine assessments of grain quality. In particular, gelatinization temperature and chalkiness, two parameters that are normally assessed through visual scores, were evaluated by purely quantitative means (differential scanning calorimetry and by digital image analysis). Results indicate that rice consumed by respondents had mainly similar physical and chemical grain quality attributes. The respondents’ revealed preferences were typical of what has been previously reported for Filipino rice consumers. Hedonic regression analyses showed that grain quality characteristics that affected price varied by income class. Some of the traits or socioeconomic factors that affected price were percent broken grains, gel consistency, and household per capita rice consumption. There is an income effect on rice price and the characteristics that affect price vary between income classes. PMID:26982587

Rice Grain Quality and Consumer Preferences: A Case Study of Two Rural Towns in the Philippines.

PubMed

Cuevas, Rosa Paula; Pede, Valerien O; McKinley, Justin; Velarde, Orlee; Demont, Matty

2016-01-01

Hedonic pricing analysis is conducted to determine the implicit values of various attributes in the market value of a good. In this study, hedonic pricing analysis was applied to measure the contribution of grain quality search and experience attributes to the price of rice in two rural towns in the Philippines. Rice samples from respondents underwent quantitative routine assessments of grain quality. In particular, gelatinization temperature and chalkiness, two parameters that are normally assessed through visual scores, were evaluated by purely quantitative means (differential scanning calorimetry and by digital image analysis). Results indicate that rice consumed by respondents had mainly similar physical and chemical grain quality attributes. The respondents' revealed preferences were typical of what has been previously reported for Filipino rice consumers. Hedonic regression analyses showed that grain quality characteristics that affected price varied by income class. Some of the traits or socioeconomic factors that affected price were percent broken grains, gel consistency, and household per capita rice consumption. There is an income effect on rice price and the characteristics that affect price vary between income classes.

Integrated Process Modeling-A Process Validation Life Cycle Companion.

PubMed

Zahel, Thomas; Hauer, Stefan; Mueller, Eric M; Murphy, Patrick; Abad, Sandra; Vasilieva, Elena; Maurer, Daniel; Brocard, Cécile; Reinisch, Daniela; Sagmeister, Patrick; Herwig, Christoph

2017-10-17

During the regulatory requested process validation of pharmaceutical manufacturing processes, companies aim to identify, control, and continuously monitor process variation and its impact on critical quality attributes (CQAs) of the final product. It is difficult to directly connect the impact of single process parameters (PPs) to final product CQAs, especially in biopharmaceutical process development and production, where multiple unit operations are stacked together and interact with each other. Therefore, we want to present the application of Monte Carlo (MC) simulation using an integrated process model (IPM) that enables estimation of process capability even in early stages of process validation. Once the IPM is established, its capability in risk and criticality assessment is furthermore demonstrated. IPMs can be used to enable holistic production control strategies that take interactions of process parameters of multiple unit operations into account. Moreover, IPMs can be trained with development data, refined with qualification runs, and maintained with routine manufacturing data which underlines the lifecycle concept. These applications will be shown by means of a process characterization study recently conducted at a world-leading contract manufacturing organization (CMO). The new IPM methodology therefore allows anticipation of out of specification (OOS) events, identify critical process parameters, and take risk-based decisions on counteractions that increase process robustness and decrease the likelihood of OOS events.

A proposed profile of the effective leader in human spaceflight based on findings from analog environments.

PubMed

Nicholas, J M; Penwell, L W

1995-01-01

This paper presents a literature review of leader characteristics and associated outcomes from four environments considered as analogs to long-duration spaceflight: aviation, submersibles, polar stations, and expeditions. Evidence from 23 sources indicates that, despite differences in the analog settings, effective leaders share a common core of personal traits and leadership-style attributes. The general profile that emerges is a person who works hard to achieve mission objectives, is optimistic, holds the respect of the crew, ordinarily uses participative decision-making but takes charge during critical situations, is sensitive to and makes crew members feel valued for their expertise and their personal qualities, and maintains group harmony and cohesion. Results have implications for selecting leaders for future long-duration space missions.

Carotenoid metabolism and regulation in horticultural crops

PubMed Central

Yuan, Hui; Zhang, Junxiang; Nageswaran, Divyashree; Li, Li

2015-01-01

Carotenoids are a diverse group of pigments widely distributed in nature. The vivid yellow, orange, and red colors of many horticultural crops are attributed to the overaccumulation of carotenoids, which contribute to a critical agronomic trait for flowers and an important quality trait for fruits and vegetables. Not only do carotenoids give horticultural crops their visual appeal, they also enhance nutritional value and health benefits for humans. As a result, carotenoid research in horticultural crops has grown exponentially over the last decade. These investigations have advanced our fundamental understanding of carotenoid metabolism and regulation in plants. In this review, we provide an overview of carotenoid biosynthesis, degradation, and accumulation in horticultural crops and highlight recent achievements in our understanding of carotenoid metabolic regulation in vegetables, fruits, and flowers. PMID:26504578

Emissions of CO2 and criteria air pollutants from mobile sources: Insights from integrating real-time traffic data into local air quality models

NASA Astrophysics Data System (ADS)

Gately, Conor; Hutyra, Lucy

2016-04-01

In 2013, on-road mobile sources were responsible for over 26% of U.S. fossil fuel carbon dioxide (ffCO2) emissions, and over 34% of both CO and NOx emissions. However, accurate representations of these emissions at the scale of urban areas remains a difficult challenge. Quantifying emissions at the scale of local streets and highways is critical to provide policymakers with the information needed to develop appropriate mitigation strategies and to guide research into the underlying process that drive mobile emissions. Quantification of vehicle ffCO2 emissions at high spatial and temporal resolutions requires a detailed synthesis of data on traffic activity, roadway attributes, fleet characteristics and vehicle speeds. To accurately characterize criteria air pollutant emissions, information on local meteorology is also critical, as the temperature and relative humidity can affect emissions rates of these pollutants by as much as 400%. As the health impacts of air pollutants are more severe for residents living in close proximity (<500m) to road sources, it is critical that inventories of these emissions rely on highly resolved source data to locate potential hot-spots of exposure. In this study we utilize real-time GPS estimates of vehicle speeds to estimate ffCO2 and criteria air pollutant emissions at multiple spatial and temporal scales across a large metropolitan area. We observe large variations in emissions associated with diurnal activity patterns, congestion, sporting and civic events, and weather anomalies. We discuss the advantages and challenges of using highly-resolved source data to quantify emissions at a roadway scale, and the potential of this methodology for forecasting the air quality impacts of changes in infrastructure, urban planning policies, and regional climate.

Emissions of CO2 and criteria air pollutants from mobile sources: Insights from integrating real-time traffic data into local air quality models

NASA Astrophysics Data System (ADS)

Gately, C.; Hutyra, L.; Sue Wing, I.; Peterson, S.; Janetos, A.

2015-12-01

In 2013, on-road mobile sources were responsible for over 26% of U.S. fossil fuel carbon dioxide (ffCO2) emissions, and over 34% of both CO and NOx emissions. However, accurate representations of these emissions at the scale of urban areas remains a difficult challenge. Quantifying emissions at the scale of local streets and highways is critical to provide policymakers with the information needed to develop appropriate mitigation strategies and to guide research into the underlying process that drive mobile emissions. Quantification of vehicle ffCO2 emissions at high spatial and temporal resolutions requires a detailed synthesis of data on traffic activity, roadway attributes, fleet characteristics and vehicle speeds. To accurately characterize criteria air pollutant emissions, information on local meteorology is also critical, as the temperature and relative humidity can affect emissions rates of these pollutants by as much as 400%. As the health impacts of air pollutants are more severe for residents living in close proximity (<500m) to road sources, it is critical that inventories of these emissions rely on highly resolved source data to locate potential hot-spots of exposure. In this study we utilize real-time GPS estimates of vehicle speeds to estimate ffCO2 and criteria air pollutant emissions at multiple spatial and temporal scales across a large metropolitan area. We observe large variations in emissions associated with diurnal activity patterns, congestion, sporting and civic events, and weather anomalies. We discuss the advantages and challenges of using highly-resolved source data to quantify emissions at a roadway scale, and the potential of this methodology for forecasting the air quality impacts of changes in infrastructure, urban planning policies, and regional climate.

The Correlation of Critical Thinking Disposition and Approaches to Learning among Baccalaureate Nursing Students

ERIC Educational Resources Information Center

Kabeel, Abeer Refaat; Eisa, Sahar Abd El-Mohsen Mosa

2016-01-01

Background: Part of the 21st century skills is critical thinking and learning approaches of students. A part of that resurgence can be attributable to several studies on critical thinking, logic, and thinking skills. Health care professionals are challenged by the complexities of the health care environment. The practice of nursing requires…

Naturalness and interestingness of test images for visual quality evaluation

NASA Astrophysics Data System (ADS)

Halonen, Raisa; Westman, Stina; Oittinen, Pirkko

2011-01-01

Balanced and representative test images are needed to study perceived visual quality in various application domains. This study investigates naturalness and interestingness as image quality attributes in the context of test images. Taking a top-down approach we aim to find the dimensions which constitute naturalness and interestingness in test images and the relationship between these high-level quality attributes. We compare existing collections of test images (e.g. Sony sRGB images, ISO 12640 images, Kodak images, Nokia images and test images developed within our group) in an experiment combining quality sorting and structured interviews. Based on the data gathered we analyze the viewer-supplied criteria for naturalness and interestingness across image types, quality levels and judges. This study advances our understanding of subjective image quality criteria and enables the validation of current test images, furthering their development.

Downstream processing from melt granulation towards tablets: In-depth analysis of a continuous twin-screw melt granulation process using polymeric binders.

PubMed

Grymonpré, W; Verstraete, G; Vanhoorne, V; Remon, J P; De Beer, T; Vervaet, C

2018-03-01

The concept of twin-screw melt granulation (TSMG) has steadily (re)-gained interest in pharmaceutical formulation development as an intermediate step during tablet manufacturing. However, to be considered as a viable processing option for solid oral dosage forms there is a need to understand all critical sources of variability which could affect this granulation technique. The purpose of this study was to provide an in-depth analysis of the continuous TSMG process in order to expose the critical process parameters (CPP) and elucidate the impact of process and formulation parameters on the critical quality attributes (CQA) of granules and tablets during continuous TSMG. A first part of the study dealt with the screening of various amorphous polymers as binder for producing high-dosed melt granules of two model drug (i.e. acetaminophen and hydrochlorothiazide). The second part of this study described a quality-by-design (QbD) approach for melt granulation of hydrochlorothiazide in order to thoroughly evaluate TSMG, milling and tableting stage of the continuous TSMG line. Using amorphous polymeric binders resulted in melt granules with high milling efficiency due to their brittle behaviour without producing excessive amounts of fines, providing high granule yields with low friability. Therefore, it makes them extremely suitable for further downstream processing. One of the most important CPP during TSMG with polymeric binders was the granulation-torque, which - in case of polymers with high T g - increased during longer granulation runs to critical levels endangering the continuous process flow. However, by optimizing both screw speed and throughput or changing to polymeric binders with lower T g it was possible to significantly reduce this risk. This research paper highlighted that TSMG must be considered as a viable option during formulation development of solid oral dosage forms based on the robustness of the CQA of both melt granules and tablets. Copyright © 2017 Elsevier B.V. All rights reserved.

Experiences From Developing and Upgrading a Web-Based Surveillance System for Malaria Elimination in Cambodia

PubMed Central

Mellor, Steve; Aryal, Siddhi; Sovannaroth, Siv; Roca-Feltrer, Arantxa

2017-01-01

Strengthening the surveillance component is key toward achieving country-wide malaria elimination in Cambodia. A Web-based upgraded malaria information system (MIS) was deemed to essentially act as the central component for surveillance strengthening. New functionality (eg, data visualization) and operational (eg, data quality) attributes of the system received particular attention. However, building from the lessons learned in previous systems’ developments, other aspects unique to Cambodia were considered to be equally important; for instance, feasibility issues, particularly at the field level (eg, user acceptability at various health levels), and sustainability needs (eg, long-term system flexibility). The Cambodian process of identifying the essential changes and critical attributes for this new information system can provide a model for other countries at various stages of the disease control and elimination continuum. Sharing these experiences not only facilitates the establishment of “best practices” but also accelerates global and regional malaria elimination efforts. In this article, Cambodia’s experience in developing and upgrading its MIS to remain responsive to country-specific needs demonstrates the necessity for considering functionality, operationalization, feasibility, and sustainability of an information system in the context of malaria elimination. PMID:28615155

A food-predictive cue attributed with incentive salience engages subcortical afferents and efferents of the paraventricular nucleus of the thalamus.

PubMed

Haight, Joshua L; Fuller, Zachary L; Fraser, Kurt M; Flagel, Shelly B

2017-01-06

The paraventricular nucleus of the thalamus (PVT) has been implicated in behavioral responses to reward-associated cues. However, the precise role of the PVT in these behaviors has been difficult to ascertain since Pavlovian-conditioned cues can act as both predictive and incentive stimuli. The "sign-tracker/goal-tracker" rat model has allowed us to further elucidate the role of the PVT in cue-motivated behaviors, identifying this structure as a critical component of the neural circuitry underlying individual variation in the propensity to attribute incentive salience to reward cues. The current study assessed differences in the engagement of specific PVT afferents and efferents in response to presentation of a food-cue that had been attributed with only predictive value or with both predictive and incentive value. The retrograde tracer fluorogold (FG) was injected into the PVT or the nucleus accumbens (NAc) of rats, and cue-induced c-Fos in FG-labeled cells was quantified. Presentation of a predictive stimulus that had been attributed with incentive value elicited c-Fos in PVT afferents from the lateral hypothalamus, medial amygdala (MeA), and the prelimbic cortex (PrL), as well as posterior PVT efferents to the NAc. PVT afferents from the PrL also showed elevated c-Fos levels following presentation of a predictive stimulus alone. Thus, presentation of an incentive stimulus results in engagement of subcortical brain regions; supporting a role for the hypothalamic-thalamic-striatal axis, as well as the MeA, in mediating responses to incentive stimuli; whereas activity in the PrL to PVT pathway appears to play a role in processing the predictive qualities of reward-paired stimuli. Copyright © 2016 IBRO. Published by Elsevier Ltd. All rights reserved.

Multiattribute selection of acute stroke imaging software platform for Extending the Time for Thrombolysis in Emergency Neurological Deficits (EXTEND) clinical trial.

PubMed

Churilov, Leonid; Liu, Daniel; Ma, Henry; Christensen, Soren; Nagakane, Yoshinari; Campbell, Bruce; Parsons, Mark W; Levi, Christopher R; Davis, Stephen M; Donnan, Geoffrey A

2013-04-01

The appropriateness of a software platform for rapid MRI assessment of the amount of salvageable brain tissue after stroke is critical for both the validity of the Extending the Time for Thrombolysis in Emergency Neurological Deficits (EXTEND) Clinical Trial of stroke thrombolysis beyond 4.5 hours and for stroke patient care outcomes. The objective of this research is to develop and implement a methodology for selecting the acute stroke imaging software platform most appropriate for the setting of a multi-centre clinical trial. A multi-disciplinary decision making panel formulated the set of preferentially independent evaluation attributes. Alternative Multi-Attribute Value Measurement methods were used to identify the best imaging software platform followed by sensitivity analysis to ensure the validity and robustness of the proposed solution. Four alternative imaging software platforms were identified. RApid processing of PerfusIon and Diffusion (RAPID) software was selected as the most appropriate for the needs of the EXTEND trial. A theoretically grounded generic multi-attribute selection methodology for imaging software was developed and implemented. The developed methodology assured both a high quality decision outcome and a rational and transparent decision process. This development contributes to stroke literature in the area of comprehensive evaluation of MRI clinical software. At the time of evaluation, RAPID software presented the most appropriate imaging software platform for use in the EXTEND clinical trial. The proposed multi-attribute imaging software evaluation methodology is based on sound theoretical foundations of multiple criteria decision analysis and can be successfully used for choosing the most appropriate imaging software while ensuring both robust decision process and outcomes. © 2012 The Authors. International Journal of Stroke © 2012 World Stroke Organization.

A food-predictive cue attributed with incentive salience engages subcortical afferents and efferents of the paraventricular nucleus of the thalamus

PubMed Central

Haight, Joshua L.; Fuller, Zachary L.; Fraser, Kurt M.; Flagel, Shelly B.

2016-01-01

The paraventricular nucleus of the thalamus (PVT) has been implicated in behavioral responses to reward-associated cues. However, the precise role of the PVT in these behaviors has been difficult to ascertain since Pavlovian-conditioned cues can act as both predictive and incentive stimuli. The “sign-tracker/goal-tracker” animal model has allowed us to further elucidate the role of the PVT in cue-motivated behaviors, identifying this structure as a critical component of the neural circuitry underlying individual variation in the propensity to attribute incentive salience to reward cues. The current study assessed differences in the engagement of specific PVT afferents and efferents in response to presentation of a food-cue that had been attributed with only predictive value or with both predictive and incentive value. The retrograde tracer fluorogold (FG) was injected into the PVT or the nucleus accumbens (NAc), and cue-induced c-Fos in FG-labeled cells was quantified. Presentation of a predictive stimulus that had been attributed with incentive value elicited c-Fos in PVT afferents from the lateral hypothalamus, medial amygdala (MeA), and the prelimbic cortex (PrL), as well as posterior PVT efferents to the NAc. PVT afferents from the PrL also showed elevated c-Fos levels following presentation of a predictive stimulus alone. Thus, presentation of an incentive stimulus results in engagement of subcortical brain regions; supporting a role for the hypothalamic-thalamic-striatal axis, as well as the MeA, in mediating responses to incentive stimuli; whereas activity in the PrL to PVT pathway appears to play a role in processing the predictive qualities of reward-paired stimuli. PMID:27793779

Quality attributes of pistachio nuts as affected by rootstock and deficit irrigation.

PubMed

Carbonell-Barrachina, Ángel A; Memmi, Houssem; Noguera-Artiaga, Luis; Gijón-López, María del Carmen; Ciapa, Rafał; Pérez-López, David

2015-11-01

In this work, the influence of two regulated deficit irrigation (RDI) treatments and three different rootstocks on the quality of pistachios was evaluated by analyzing different parameters: morphological analysis, physicochemical analysis and sensory analysis. The results obtained in terms of the choice of rootstock revealed that Pistacia atlantica had increased production yields, nut weight, mineral content, higher intensities of characteristic sensory attributes and a higher degree of consumer satisfaction, than the other rootstocks studied. Moreover, the results established that the application of RDI on pistachio cultivation had no significant influence on production yield, weight, size, colour, water activity or mineral composition. Furthermore, T1 treatment (stem water potential < -1.3 MPa) resulted in higher intensities of characteristic sensory attributes and a greater level of satisfaction among international consumers. These results confirm that the application of deficit irrigation (T1) contributes to an increase in overall product quality. Furthermore, Pistacia atlantica rootstock provided better yield and quality than the other rootstocks studied. © 2014 Society of Chemical Industry.

Proclaimed Graduate Attributes of Australian Universities: Patterns, Problems and Prospects

ERIC Educational Resources Information Center

Donleavy, Gabriel

2012-01-01

Purpose: Graduate attributes are about to be policed by the Tertiary Education Quality and Standards Agency (TEQSA) in Australia. All universities proclaim them on their public web sites. The aim of this paper is to determine whether distinct patterns or clusters are apparent in the declared graduate attributes declared by Australian universities…

Enabling Incremental Iterative Development at Scale: Quality Attribute Refinement and Allocation in Practice

DTIC Science & Technology

2015-06-01

abstract constraints along six dimen- sions for expansion: user, actions, data , business rules, interfaces, and quality attributes [Gottesdiener 2010...relevant open source systems. For example, the CONNECT and HADOOP Distributed File System (HDFS) projects have many user stories that deal with...Iteration Zero involves architecture planning before writing any code. An overly long Iteration Zero is equivalent to the dysfunctional “ Big Up-Front

Cultural competence in healthcare in the community: A concept analysis.

PubMed

Henderson, Saras; Horne, Maria; Hills, Ruth; Kendall, Elizabeth

2018-03-07

This study aims to conduct a concept analysis on cultural competence in community healthcare. Clarification of the concept of cultural competence is needed to enable clarity in the definition and operation, research and theory development to assist healthcare providers to better understand this evolving concept. Rodgers' evolutionary concept analysis method was used to clarify the concept's context, surrogate terms, antecedents, attributes and consequences and to determine implications for further research. Articles from 2004 to 2015 were sought from Medline, PubMed, CINAHL and Scopus using the terms "cultural competency" AND "health," "cultural competence" OR "cultural safety" OR "cultural knowledge" OR "cultural awareness" OR cultural sensitivity OR "cultural skill" AND "Health." Articles with antecedents, attributes and consequences of cultural competence in community health were included. The 26 articles selected included nursing (n = 8), health (n = 8), psychology (n = 2), social work (n = 1), mental health (n = 3), medicine (n = 3) and occupational therapy (n = 1). Findings identify cultural openness, awareness, desire, knowledge and sensitivity and encounter as antecedents of cultural competence. Defining attributes are respecting and tailoring care aligned with clients' values, needs, practices and expectations, providing equitable and ethical care, and understanding. Consequences of cultural competence are satisfaction with care, the perception of quality healthcare, better adherence to treatments, effective interaction and improved health outcomes. An interesting finding is that the antecedents and attributes of cultural competence appear to represent a superficial level of understanding, sometimes only manifested through the need for social desirability. What is reported as critical in sustaining competence is the carers' capacity for a higher level of moral reasoning attainable through formal education in cultural and ethics knowledge. Our conceptual analysis incorporates moral reasoning in the definition of cultural competence. Further research to underpin moral reasoning with antecedents, attributes and consequences could enhance its clarity and promote a sustainable enactment of cultural competence. © 2018 John Wiley & Sons Ltd.

Quality of Public Open Spaces and Recreational Walking

PubMed Central

Gunn, Lucy D.; Christian, Hayley; Francis, Jacinta; Foster, Sarah; Hooper, Paula; Owen, Neville; Giles-Corti, Billie

2015-01-01

Objectives. We examined associations between specific public open space (POS) attributes and recreational walking to local POS. Methods. Between October 2004 and December 2006, 1465 adults of the RESIDential Environments Project, conducted in Perth, Australia, reported whether they walk to a POS for recreation. For each participant, we identified all open spaces larger than 0.8 hectares within 1.6 kilometers from home. On the basis of field audit data, we created 3 scores (presence, count, size-weighted presence) for 19 specific open space attributes. Results. With logistic regression analyses, we found that walking to a POS was associated with the presence of gardens, grassed areas, walking paths, water features, wildlife, amenities, dog-related facilities, and off-leash areas for dogs. It was also associated with the highest number of these attributes in a single open space, but not with the total number of attributes in all POSs within 1.6 kilometers of home. Conclusions. Building 1 high-quality local park may be more effective in promoting recreational walking than is providing many average-quality parks. PMID:26469676

Statistical Approaches to Assess Biosimilarity from Analytical Data.

PubMed

Burdick, Richard; Coffey, Todd; Gutka, Hiten; Gratzl, Gyöngyi; Conlon, Hugh D; Huang, Chi-Ting; Boyne, Michael; Kuehne, Henriette

2017-01-01

Protein therapeutics have unique critical quality attributes (CQAs) that define their purity, potency, and safety. The analytical methods used to assess CQAs must be able to distinguish clinically meaningful differences in comparator products, and the most important CQAs should be evaluated with the most statistical rigor. High-risk CQA measurements assess the most important attributes that directly impact the clinical mechanism of action or have known implications for safety, while the moderate- to low-risk characteristics may have a lower direct impact and thereby may have a broader range to establish similarity. Statistical equivalence testing is applied for high-risk CQA measurements to establish the degree of similarity (e.g., highly similar fingerprint, highly similar, or similar) of selected attributes. Notably, some high-risk CQAs (e.g., primary sequence or disulfide bonding) are qualitative (e.g., the same as the originator or not the same) and therefore not amenable to equivalence testing. For biosimilars, an important step is the acquisition of a sufficient number of unique originator drug product lots to measure the variability in the originator drug manufacturing process and provide sufficient statistical power for the analytical data comparisons. Together, these analytical evaluations, along with PK/PD and safety data (immunogenicity), provide the data necessary to determine if the totality of the evidence warrants a designation of biosimilarity and subsequent licensure for marketing in the USA. In this paper, a case study approach is used to provide examples of analytical similarity exercises and the appropriateness of statistical approaches for the example data.

Using Cluster Analysis to Compartmentalize a Large Managed Wetland Based on Physical, Biological, and Climatic Geospatial Attributes.

PubMed

Hahus, Ian; Migliaccio, Kati; Douglas-Mankin, Kyle; Klarenberg, Geraldine; Muñoz-Carpena, Rafael

2018-04-27

Hierarchical and partitional cluster analyses were used to compartmentalize Water Conservation Area 1, a managed wetland within the Arthur R. Marshall Loxahatchee National Wildlife Refuge in southeast Florida, USA, based on physical, biological, and climatic geospatial attributes. Single, complete, average, and Ward's linkages were tested during the hierarchical cluster analyses, with average linkage providing the best results. In general, the partitional method, partitioning around medoids, found clusters that were more evenly sized and more spatially aggregated than those resulting from the hierarchical analyses. However, hierarchical analysis appeared to be better suited to identify outlier regions that were significantly different from other areas. The clusters identified by geospatial attributes were similar to clusters developed for the interior marsh in a separate study using water quality attributes, suggesting that similar factors have influenced variations in both the set of physical, biological, and climatic attributes selected in this study and water quality parameters. However, geospatial data allowed further subdivision of several interior marsh clusters identified from the water quality data, potentially indicating zones with important differences in function. Identification of these zones can be useful to managers and modelers by informing the distribution of monitoring equipment and personnel as well as delineating regions that may respond similarly to future changes in management or climate.

Determinant Product and Supplier Attributes in Domestic Markets for Hardwood Lumber

Treesearch

Robert J. Bush; Steven A. Sinclair; Philip A. Araman

1991-01-01

Product and supplier attributes that are critical in hardwood lumber purchase decisions (i.e., determinant) were investigated in four segments of the domestic market for hardwood lumber: millwork producers (Standard Industrial Classification (SIC) 2431), hardwood dimension and flooring producers (SIC 2426), wood household furniture producers (SIC 2511), and wood...

Sex, Attribution, and Severity Influence Intervention Decisions of Informal Helpers in Domestic Violence

ERIC Educational Resources Information Center

Chabot, Heather Frasier; Tracy, Tracy L.; Manning, Christine A.; Poisson, Chelsea A.

2009-01-01

Most domestic violence (DV) researchers examine professional intervention (e.g., police and nurses), but informal helpers (e.g., friends and bystanders) are critical. The authors measure undergraduates' intervention likelihood, type of involvement (i.e., contact with abuser), and the influence of attribution decisions in DV situations where the…

The Art of Athlete Leadership: Identifying High-Quality Athlete Leadership at the Individual and Team Level Through Social Network Analysis.

PubMed

Fransen, Katrien; Van Puyenbroeck, Stef; Loughead, Todd M; Vanbeselaere, Norbert; De Cuyper, Bert; Vande Broek, Gert; Boen, Filip

2015-06-01

This research aimed to introduce social network analysis as a novel technique in sports teams to identify the attributes of high-quality athlete leadership, both at the individual and at the team level. Study 1 included 25 sports teams (N = 308 athletes) and focused on athletes' general leadership quality. Study 2 comprised 21 sports teams (N = 267 athletes) and focused on athletes' specific leadership quality as a task, motivational, social, and external leader. The extent to which athletes felt connected with their leader proved to be most predictive for athletes' perceptions of that leader's quality on each leadership role. Also at the team level, teams with higher athlete leadership quality were more strongly connected. We conclude that social network analysis constitutes a valuable tool to provide more insight in the attributes of high-quality leadership both at the individual and at the team level.

Non-destructive Determination of Disintegration Time and Dissolution in Immediate Release Tablets by Terahertz Transmission Measurements.

PubMed

Markl, Daniel; Sauerwein, Johanna; Goodwin, Daniel J; van den Ban, Sander; Zeitler, J Axel

2017-05-01

The aim of this study was to establish the suitability of terahertz (THz) transmission measurements to accurately measure and predict the critical quality attributes of disintegration time and the amount of active pharmaceutical ingredient (API) dissolved after 15, 20 and 25 min for commercial tablets processed at production scale. Samples of 18 batches of biconvex tablets from a production-scale design of experiments study into exploring the design space of a commercial tablet manufacturing process were used. The tablet production involved the process steps of high-shear wet granulation, fluid-bed drying and subsequent compaction. The 18 batches were produced using a 4 factor split plot design to study the effects of process changes on the disintegration time. Non-destructive and contactless terahertz transmission measurements of the whole tablets without prior sample preparation were performed to measure the effective refractive index and absorption coefficient of 6 tablets per batch. The disintegration time (R 2  = 0.86) and API dissolved after 15 min (R 2  = 0.96) linearly correlates with the effective refractive index, n eff , measured at terahertz frequencies. In contrast, no such correlation could be established from conventional hardness measurements. The magnitude of n eff represents the optical density of the sample and thus it reflects both changes in tablet porosity as well as granule density. For the absorption coefficient, α eff , we observed a better correlation with dissolution after 20 min (R 2  = 0.96) and a weaker correlation with disintegration (R 2  = 0.83) compared to n eff . The measurements of n eff and α eff provide promising predictors for the disintegration and dissolution time of tablets. The high penetration power of terahertz radiation makes it possible to sample a significant volume proportion of a tablet without any prior sample preparation. Together with the short measurement time (seconds), the potential to measure content uniformity and the fact that the method requires no chemometric models this technology shows clear promise to be established as a process analyser to non-destructively predict critical quality attributes of tablets.

Towards a model for the measurement of data quality in websites

NASA Astrophysics Data System (ADS)

Leite, Patrícia; Gonçalves, Joaquim; Teixeira, Paulo; Rocha, Álvaro

2014-10-01

Websites are, nowadays, the face of institutions, but they are often neglected, especially when it comes to contents. In the present paper, we put forth an investigation work whose final goal is the development of a model for the measurement of data quality in institutional websites for health units. To that end, we have carried out a bibliographic review of the available approaches for the evaluation of website content quality, in order to identify the most recurrent dimensions and the attributes, and we are currently carrying out a Delphi Method process, presently in its second stage, with the purpose of reaching an adequate set of attributes for the measurement of content quality.

Lean leadership attributes: a systematic review of the literature.

PubMed

Aij, Kjeld Harald; Teunissen, Maurits

2017-10-09

Purpose Emphasis on quality and reducing costs has led many health-care organizations to reconfigure their management, process, and quality control infrastructures. Many are lean, a management philosophy with roots in manufacturing industries that emphasizes elimination of waste. Successful lean implementation requires systemic change and strong leadership. Despite the importance of leadership to successful lean implementation, few researchers have probed the question of ideal leadership attributes to achieve lean thinking in health care. The purpose of this paper is to provide insight into applicable attributes for lean leaders in health care. Design/methodology/approach The authors systematically reviewed the literature on principles of leadership and, using Dombrowski and Mielke's (2013) conceptual model of lean leadership, developed a parallel theoretical model for lean leadership in health care. Findings This work contributes to the development of a new framework for describing leadership attributes within lean management of health care. Originality/value The summary of attributes can provide a model for health-care leaders to apply lean in their organizations.

Examining extrinsic factors that influence product acceptance: a review.

PubMed

Li, X E; Jervis, S M; Drake, M A

2015-05-01

Drivers of liking (DOL) studies are useful for product development to formulate acceptable products; however, DOL alone are insufficient for understanding why a product is purchased and repurchased, which is ultimately the indication of a successful product. Ultimately sensory attributes drive product success (that is, repeat and continued purchase). However, ignoring the importance of extrinsic factors may neglect the vital product attributes responsible for the initial purchase, which may in turn, affect repeat purchase. The perception of sensory attributes assessed by DOL is mitigated by external perceptions of quality. If the sensory attributes do not deliver based upon the quality cues, the product will not be acceptable. Four key extrinsic factors that affect DOL are the perceived satiety, brand and labeling, price, and the emotional impact to decision making. In order to more thoroughly understand what the DOL for a product is, these 4 product cues should be considered in conjunction with sensory attribute perception to gain a holistic understanding of product acceptance. © 2015 Institute of Food Technologists®

Uncertainty of OpenStreetMap data for the road network in Cyprus

NASA Astrophysics Data System (ADS)

Demetriou, Demetris

2016-08-01

Volunteered geographic information (VGI) refers to the geographic data compiled and created by individuals which are rendered on the Internet through specific web-based tools for diverse areas of interest. One of the most well-known VGI projects is the OpenStreetMap (OSM) that provides worldwide free geospatial data representing a variety of features. A critical issue for all VGI initiatives is the quality of the information offered. Thus, this report looks into the uncertainty of the OSM dataset for the main road network in Cyprus. The evaluation is based on three basic quality standards, namely positional accuracy, completeness and attribute accuracy. The work has been carried out by employing the Model Builder of ArcGIS which facilitated the comparison between the OSM data and the authoritative data provided by the Public Works Department (PWD). Findings showed that the positional accuracy increases with the hierarchical level of a road, it varies per administrative District and around 70% of the roads have a positional accuracy within 6m compared to the reference dataset. Completeness in terms of road length difference is around 25% for three out of four road categories examined and road name completeness is 100% and around 40% for higher and lower level roads, respectively. Attribute accuracy focusing on road name is very high for all levels of roads. These outputs indicate that OSM data are good enough if they fit for the purpose of use. Furthermore, the study revealed some weaknesses of the methods used for calculating the positional accuracy, suggesting the need for methodological improvements.

Supplementary effects of higher levels of various disaccharides on processing yield, quality properties and sensory attributes of Chinese - style pork jerky.

PubMed

Chen, Chih-Ming; Lin, Hsien-Tang

2017-12-01

This study evaluated the supplementary effect of higher concentrations of various disaccharides on processing yield, major physicochemical properties, and sensory attributes of Chinese-style pork jerky (CSPJ). CSPJ samples were prepared by marinating sliced ham (4 mm) with three dissaccharides, including sucrose, lactose, and maltose, at 0%, 15%, 18%, 21%, and 24%. Subsequently, the CSPJ samples were dried and roasted. The moisture content, water activity, crude protein, moisture-to-protein ratio, pH, processing yield, shear force, color, and sensory attributes of the CSPJ samples were evaluated. The quality characteristics of CSPJ samples prepared with sucrose were more acceptable. By contrast, CSPJ samples prepared with lactose showed the lowest scores. However, the processing yield and moisture content were the highest for CSPJ samples prepared with lactose, which may be associated with improved benefits for cost reduction. Furthermore, sucrose and lactose supplementation resulted in contrasting quality characteristics; for example, CSPJ samples with sucrose and maltose supplementation had higher sensory scores for color than samples with lactose supplementation. Additionally, most quality characteristics of CSPJ samples with sucrose supplementation contrasted with those of the samples with lactose supplementation; for example, the samples with sucrose supplementation had higher scores for sensory attributes than those with lactose supplementation. Sucrose supplementation up to 21% to 24% was associated with the highest overall acceptability scores (5.19 to 5.80), enhanced quality characteristics, increased processing yield, and reduced production cost.

Systematic synthesis of barriers and facilitators to service user-led care planning.

PubMed

Bee, Penny; Price, Owen; Baker, John; Lovell, Karina

2015-08-01

Service user (patient) involvement in care planning is a principle enshrined by mental health policy yet often attracts criticism from patients and carers in practice. To examine how user-involved care planning is operationalised within mental health services and to establish where, how and why challenges to service user involvement occur. Systematic evidence synthesis. Synthesis of data from 117 studies suggests that service user involvement fails because the patients' frame of reference diverges from that of providers. Service users and carers attributed highest value to the relational aspects of care planning. Health professionals inconsistently acknowledged the quality of the care planning process, tending instead to define service user involvement in terms of quantifiable service-led outcomes. Service user-involved care planning is typically operationalised as a series of practice-based activities compliant with auditor standards. Meaningful involvement demands new patient-centred definitions of care planning quality. New organisational initiatives should validate time spent with service users and display more tangible and flexible commitments to meeting their needs. © The Royal College of Psychiatrists 2015.

Systematic synthesis of barriers and facilitators to service user-led care planning

PubMed Central

Bee, Penny; Price, Owen; Baker, John; Lovell, Karina

2015-01-01

Background Service user (patient) involvement in care planning is a principle enshrined by mental health policy yet often attracts criticism from patients and carers in practice. Aims To examine how user-involved care planning is operationalised within mental health services and to establish where, how and why challenges to service user involvement occur. Method Systematic evidence synthesis. Results Synthesis of data from 117 studies suggests that service user involvement fails because the patients' frame of reference diverges from that of providers. Service users and carers attributed highest value to the relational aspects of care planning. Health professionals inconsistently acknowledged the quality of the care planning process, tending instead to define service user involvement in terms of quantifiable service-led outcomes. Conclusions Service user-involved care planning is typically operationalised as a series of practice-based activities compliant with auditor standards. Meaningful involvement demands new patient-centred definitions of care planning quality. New organisational initiatives should validate time spent with service users and display more tangible and flexible commitments to meeting their needs. PMID:26243762

Application of a quality by design approach to the cell culture process of monoclonal antibody production, resulting in the establishment of a design space.

PubMed

Nagashima, Hiroaki; Watari, Akiko; Shinoda, Yasuharu; Okamoto, Hiroshi; Takuma, Shinya

2013-12-01

This case study describes the application of Quality by Design elements to the process of culturing Chinese hamster ovary cells in the production of a monoclonal antibody. All steps in the cell culture process and all process parameters in each step were identified by using a cause-and-effect diagram. Prospective risk assessment using failure mode and effects analysis identified the following four potential critical process parameters in the production culture step: initial viable cell density, culture duration, pH, and temperature. These parameters and lot-to-lot variability in raw material were then evaluated by process characterization utilizing a design of experiments approach consisting of a face-centered central composite design integrated with a full factorial design. Process characterization was conducted using a scaled down model that had been qualified by comparison with large-scale production data. Multivariate regression analysis was used to establish statistical prediction models for performance indicators and quality attributes; with these, we constructed contour plots and conducted Monte Carlo simulation to clarify the design space. The statistical analyses, especially for raw materials, identified set point values, which were most robust with respect to the lot-to-lot variability of raw materials while keeping the product quality within the acceptance criteria. © 2013 Wiley Periodicals, Inc. and the American Pharmacists Association.

Quality by design approach of a pharmaceutical gel manufacturing process, part 1: determination of the design space.

PubMed

Rosas, Juan G; Blanco, Marcel; González, Josep M; Alcalá, Manel

2011-10-01

This work was conducted in the framework of a quality by design project involving the production of a pharmaceutical gel. Preliminary work included the identification of the quality target product profiles (QTPPs) from historical values for previously manufactured batches, as well as the critical quality attributes for the process (viscosity and pH), which were used to construct a D-optimal experimental design. The experimental design comprised 13 gel batches, three of which were replicates at the domain center intended to assess the reproducibility of the target process. The viscosity and pH models established exhibited very high linearity and negligible lack of fit (LOF). Thus, R(2) was 0.996 for viscosity and 0.975 for pH, and LOF was 0.53 for the former parameter and 0.84 for the latter. The process proved reproducible at the domain center. Water content and temperature were the most influential factors for viscosity, and water content and acid neutralized fraction were the most influential factors for pH. A desirability function was used to find the best compromise to optimize the QTPPs. The body of information was used to identify and define the design space for the process. A model capable of combining the two response variables into a single one was constructed to facilitate monitoring of the process. Copyright © 2011 Wiley-Liss, Inc.

Liposomal Drug Product Development and Quality: Current US Experience and Perspective.

PubMed

Kapoor, Mamta; Lee, Sau L; Tyner, Katherine M

2017-05-01

Research in the area of liposomes has grown substantially in the past few decades. Liposomes are lipid bilayer structures that can incorporate drug substances to modify the drug's pharmacokinetic profile thereby improving drug delivery. The agency has received over 400 liposomal drug product submissions (excluding combination therapies), and there are currently eight approved liposomal drug products on the US market. In order to identify the pain points in development and manufacturing of liposomal drug products, a retrospective analysis was performed from a quality perspective on submissions for new and generic liposomal drug products. General analysis on liposomal drug product submissions was also performed. Results indicated that 96% of the submissions were Investigational New Drug (IND) applications, 3% were New Drug Applications (NDAs), and the remaining 1% was Abbreviated New Drug Applications (ANDAs). Doxorubicin hydrochloride was the most commonly used drug substance incorporated into the liposomes (31%). The majority of the liposomal products were administered via intravenous route (84%) with cancer (various types) being the most common indication (63%). From a quality perspective, major challenges during the development of liposomal drug products included identification and (appropriate) characterization of critical quality attributes of liposomal drug products and suitable control strategies during product development. By focusing on these areas, a faster and more efficient development of liposomal drug products may be achieved. Additionally, in this way, the drug review process for such products can be streamlined.

Hospitalization stay and costs attributable to Clostridium difficile infection: a critical review.

PubMed

Gabriel, L; Beriot-Mathiot, A

2014-09-01

In most healthcare systems, third-party payers fund the costs for patients admitted to hospital for Clostridium difficile infection (CDI) whereas, for CDI cases arising as complications of hospitalization, not all related costs are refundable to the hospital. We therefore aimed to critically review and categorize hospital costs and length of hospital stay (LOS) attributable to Clostridium difficile infection and to investigate the economic burden associated with it. A comprehensive literature review selected papers describing the costs and LOS for hospitalized patients as outcomes of CDI, following the use of statistics to identify costs and LOS solely attributable to CDI. Twenty-four studies were selected. Estimated attributable costs, all ranges expressed in US dollars, were $6,774-$10,212 for CDI requiring admission, $2,992-$29,000 for hospital-acquired CDI, and $2,454-$12,850 where no categorization was made. The ranges for LOS values were 5-13.6, 2.7-21.3, and 2.8-17.9 days, respectively. The categorization of CDI attributable costs allows budget holders to anticipate the cost per CDI case, a perspective that should enrich the design of appropriate incentives for the various budget holders to invest in prevention so that CDI prevention is optimized globally. Copyright © 2014 The Healthcare Infection Society. Published by Elsevier Ltd. All rights reserved.

Transforming nanomedicine manufacturing toward Quality by Design and microfluidics.

PubMed

Colombo, Stefano; Beck-Broichsitter, Moritz; Bøtker, Johan Peter; Malmsten, Martin; Rantanen, Jukka; Bohr, Adam

2018-04-05

Nanopharmaceuticals aim at translating the unique features of nano-scale materials into therapeutic products and consequently their development relies critically on the progression in manufacturing technology to allow scalable processes complying with process economy and quality assurance. The relatively high failure rate in translational nanopharmaceutical research and development, with respect to new products on the market, is at least partly due to immature bottom-up manufacturing development and resulting sub-optimal control of quality attributes in nanopharmaceuticals. Recently, quality-oriented manufacturing of pharmaceuticals has undergone an unprecedented change toward process and product development interaction. In this context, Quality by Design (QbD) aims to integrate product and process development resulting in an increased number of product applications to regulatory agencies and stronger proprietary defense strategies of process-based products. Although QbD can be applied to essentially any production approach, microfluidic production offers particular opportunities for QbD-based manufacturing of nanopharmaceuticals. Microfluidics provides unique design flexibility, process control and parameter predictability, and also offers ample opportunities for modular production setups, allowing process feedback for continuously operating production and process control. The present review aims at outlining emerging opportunities in the synergistic implementation of QbD strategies and microfluidic production in contemporary development and manufacturing of nanopharmaceuticals. In doing so, aspects of design and development, but also technology management, are reviewed, as is the strategic role of these tools for aligning nanopharmaceutical innovation, development, and advanced industrialization in the broader pharmaceutical field. Copyright © 2018 Elsevier B.V. All rights reserved.

Performance Effects of Measurement and Analysis: Perspectives from CMMI High Maturity Organizations and Appraisers

DTIC Science & Technology

2010-06-01

models 13 The Chi-Square test fails to reject the null hypothesis that there is no difference between 2008 and 2009 data (p-value = 0.601). This...attributed to process performance modeling 53 Table 4: Relationships between data quality and integrity activities and overall value attributed to... data quality and integrity; staffing and resources devoted to the work; pertinent training and coaching; and the alignment of the models with

The Relationship Between Professional Quality of Life and Caring Ability in Critical Care Nurses.

PubMed

Mohammadi, Marzieh; Peyrovi, Hamid; Mahmoodi, Mahmood

Critical care nursing has some features that may affect the ability of critical care nurses to provide care. Professionals as critical care nurses who deal with peoples' health and life often experience some levels of stress that affects their quality of life. This study examined the relationship between professional quality of life and caring ability of critical care nurses. In this descriptive correlational study, 253 critical care nurses working in the medical and surgical intensive care units of Tehran University of Medical Sciences were recruited by convenience sampling method. The data collection tools included demographic data form, Caring Ability Inventory, and questionnaire for professional quality of life version 5. There was a statistically significant positive relationship between the professional quality of life and the caring ability (P < .0001). A significant inverse relationship was found between burn-out subscale of compassion fatigue as one aspect of professional life quality with all 3 aspects of caring ability (knowledge, courage, and patience). Secondary traumatic stress, as another subscale of compassion fatigue (as one aspect of professional quality of life), had no statistically significant correlation with caring ability aspects of knowledge and patience. However, there was a significant inverse correlation between the secondary traumatic stress and courage aspect of caring ability (P < .0001). There was a statistically significant positive relationship between compassion satisfaction aspect of professional life quality with knowledge and patience aspects of caring ability, but there was not any relationship between the compassion satisfaction aspect of professional life quality and the courage aspect of caring ability. Improvement of critical care nurses' professional quality of life may increase their caring ability, thereby leading to better and more effective nursing care. Increased awareness by critical care nurse managers of the compassion fatigue phenomenon (secondary traumatic stress and burnout) and its effect on quality of critical care would be helpful in planning more specific strategies and preventing the onset and progression of these symptoms.

A network extension of species occupancy models in a patchy environment applied to the Yosemite toad (Anaxyrus canorus)

USGS Publications Warehouse

Berlow, Eric L.; Knapp, Roland A.; Ostoja, Steven M.; Williams, Richard J.; McKenny, Heather; Matchett, John R.; Guo, Qinghau; Fellers, Gary M.; Kleeman, Patrick; Brooks, Matthew L.; Joppa, Lucas

2013-01-01

A central challenge of conservation biology is using limited data to predict rare species occurrence and identify conservation areas that play a disproportionate role in regional persistence. Where species occupy discrete patches in a landscape, such predictions require data about environmental quality of individual patches and the connectivity among high quality patches. We present a novel extension to species occupancy modeling that blends traditionalpredictions of individual patch environmental quality with network analysis to estimate connectivity characteristics using limited survey data. We demonstrate this approach using environmental and geospatial attributes to predict observed occupancy patterns of the Yosemite toad (Anaxyrus (= Bufo) canorus) across >2,500 meadows in Yosemite National Park (USA). A. canorus, a Federal Proposed Species, breeds in shallow water associated with meadows. Our generalized linear model (GLM) accurately predicted ~84% of true presence-absence data on a subset of data withheld for testing. The predicted environmental quality of each meadow was iteratively ‘boosted’ by the quality of neighbors within dispersal distance. We used this park-wide meadow connectivity network to estimate the relative influence of an individual Meadow’s ‘environmental quality’ versus its ‘network quality’ to predict: a) clusters of high quality breeding meadows potentially linked by dispersal, b) breeding meadows with high environmental quality that are isolated from other such meadows, c) breeding meadows with lower environmental quality where long-term persistence may critically depend on the network neighborhood, and d) breeding meadows with the biggest impact on park-wide breeding patterns. Combined with targeted data on dispersal, genetics, disease, and other potential stressors, these results can guide designation of core conservation areas for A. canorus in Yosemite National Park.

Are extreme hydro-meteorological events a prerequisite for extreme water quality impacts? Exploring climate impacts on inland and coastal waters

NASA Astrophysics Data System (ADS)

Michalak, A. M.; Balaji, V.; Del Giudice, D.; Sinha, E.; Zhou, Y.; Ho, J. C.

2017-12-01

Questions surrounding water sustainability, climate change, and extreme events are often framed around water quantity - whether too much or too little. The massive impacts of extreme water quality impairments are equally compelling, however. Recent years have provided a host of compelling examples, with unprecedented harmful algal blooms developing along the West coast, in Utah Lake, in Lake Erie, and off the Florida coast, and huge hypoxic dead zones continuing to form in regions such as Lake Erie, the Chesapeake Bay, and the Gulf of Mexico. Linkages between climate change, extreme events, and water quality impacts are not well understood, however. Several factors explain this lack of understanding, including the relative complexity of underlying processes, the spatial and temporal scale mismatch between hydrologists and climatologists, and observational uncertainty leading to ambiguities in the historical record. Here, we draw on a number of recent studies that aim to quantitatively link meteorological variability and water quality impacts to test the hypothesis that extreme water quality impairments are the result of extreme hydro-meteorological events. We find that extreme hydro-meteorological events are neither always a necessary nor a sufficient condition for the occurrence of extreme water quality impacts. Rather, extreme water quality impairments often occur in situations where multiple contributing factors compound, which complicates both attribution of historical events and the ability to predict the future incidence of such events. Given the critical societal importance of water quality projections, a concerted program of uncertainty reduction encompassing observational and modeling components will be needed to examine situations where extreme weather plays an important, but not solitary, role in the chain of cause and effect.

Optimizing the dermal accumulation of a tazarotene microemulsion using skin deposition modeling.

PubMed

Nasr, Maha; Abdel-Hamid, Sameh

2016-01-01

It is well known that microemulsions are mainly utilized for their transdermal rather than their dermal drug delivery potential due to their low viscosity, and the presence of penetration enhancing surfactants and co-surfactants. Applying quality by design (QbD) principles, a tazarotene microemulsion formulation for local skin delivery was optimized by creating a control space. Critical formulation factors (CFF) were oil, surfactant/co-surfactant (SAA/CoS), and water percentages. Critical quality attributes (CQA) were globular size, microemulsion viscosity, tazarotene skin deposition, permeation, and local accumulation efficiency index. Increasing oil percentage increased globular size, while the opposite occurred regarding SAA/CoS, (p = 0.001). Microemulsion viscosity was reduced by increasing oil and water percentages (p < 0.05), due to the inherent high viscosity of the utilized SAA/CoS. Drug deposition in the skin was reduced by increasing SAA/CoS due to the increased hydrophilicity and viscosity of the system, but increased by increasing water due to hydration effect (p = 0.009). Models with very good fit were generated, predicting the effect of CFF on globular size, microemulsion viscosity, and drug deposition. A combination of 40% oil and 45% SAA/CoS showed the maximum drug deposition of 75.1%. Clinical skin irritation study showed that the aforementioned formula was safe for topical use. This article suggests that applying QbD tools such as experimental design is an efficient tool for drug product design.

Systematic Development and Validation of a Thin-Layer Densitometric Bioanalytical Method for Estimation of Mangiferin Employing Analytical Quality by Design (AQbD) Approach.

PubMed

Khurana, Rajneet Kaur; Rao, Satish; Beg, Sarwar; Katare, O P; Singh, Bhupinder

2016-01-01

The present work aims at the systematic development of a simple, rapid and highly sensitive densitometry-based thin-layer chromatographic method for the quantification of mangiferin in bioanalytical samples. Initially, the quality target method profile was defined and critical analytical attributes (CAAs) earmarked, namely, retardation factor (Rf), peak height, capacity factor, theoretical plates and separation number. Face-centered cubic design was selected for optimization of volume loaded and plate dimensions as the critical method parameters selected from screening studies employing D-optimal and Plackett-Burman design studies, followed by evaluating their effect on the CAAs. The mobile phase containing a mixture of ethyl acetate : acetic acid : formic acid : water in a 7 : 1 : 1 : 1 (v/v/v/v) ratio was finally selected as the optimized solvent for apt chromatographic separation of mangiferin at 262 nm withRf 0.68 ± 0.02 and all other parameters within the acceptance limits. Method validation studies revealed high linearity in the concentration range of 50-800 ng/band for mangiferin. The developed method showed high accuracy, precision, ruggedness, robustness, specificity, sensitivity, selectivity and recovery. In a nutshell, the bioanalytical method for analysis of mangiferin in plasma revealed the presence of well-resolved peaks and high recovery of mangiferin. © The Author 2016. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

7 CFR 29.2601 - Elements of quality and degrees of each element.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 2 2011-01-01 2011-01-01 false Elements of quality and degrees of each element. 29... STANDARD CONTAINER REGULATIONS TOBACCO INSPECTION Standards Elements of Quality § 29.2601 Elements of quality and degrees of each element. Tobacco attributes or characteristics which constitute quality are...

7 CFR 29.2351 - Elements of quality and degrees of each element.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 2 2011-01-01 2011-01-01 false Elements of quality and degrees of each element. 29... STANDARD CONTAINER REGULATIONS TOBACCO INSPECTION Standards Elements of Quality § 29.2351 Elements of quality and degrees of each element. Tobacco attributes or characteristics which constitute quality are...

7 CFR 29.2601 - Elements of quality and degrees of each element.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 7 Agriculture 2 2012-01-01 2012-01-01 false Elements of quality and degrees of each element. 29... STANDARD CONTAINER REGULATIONS TOBACCO INSPECTION Standards Elements of Quality § 29.2601 Elements of quality and degrees of each element. Tobacco attributes or characteristics which constitute quality are...

7 CFR 29.2601 - Elements of quality and degrees of each element.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 7 Agriculture 2 2014-01-01 2014-01-01 false Elements of quality and degrees of each element. 29... STANDARD CONTAINER REGULATIONS TOBACCO INSPECTION Standards Elements of Quality § 29.2601 Elements of quality and degrees of each element. Tobacco attributes or characteristics which constitute quality are...

7 CFR 29.2351 - Elements of quality and degrees of each element.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 7 Agriculture 2 2014-01-01 2014-01-01 false Elements of quality and degrees of each element. 29... STANDARD CONTAINER REGULATIONS TOBACCO INSPECTION Standards Elements of Quality § 29.2351 Elements of quality and degrees of each element. Tobacco attributes or characteristics which constitute quality are...

7 CFR 29.2351 - Elements of quality and degrees of each element.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 7 Agriculture 2 2012-01-01 2012-01-01 false Elements of quality and degrees of each element. 29... STANDARD CONTAINER REGULATIONS TOBACCO INSPECTION Standards Elements of Quality § 29.2351 Elements of quality and degrees of each element. Tobacco attributes or characteristics which constitute quality are...

7 CFR 29.2351 - Elements of quality and degrees of each element.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 7 Agriculture 2 2013-01-01 2013-01-01 false Elements of quality and degrees of each element. 29... STANDARD CONTAINER REGULATIONS TOBACCO INSPECTION Standards Elements of Quality § 29.2351 Elements of quality and degrees of each element. Tobacco attributes or characteristics which constitute quality are...

7 CFR 29.2601 - Elements of quality and degrees of each element.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 7 Agriculture 2 2013-01-01 2013-01-01 false Elements of quality and degrees of each element. 29... STANDARD CONTAINER REGULATIONS TOBACCO INSPECTION Standards Elements of Quality § 29.2601 Elements of quality and degrees of each element. Tobacco attributes or characteristics which constitute quality are...

Exemplary Chinese University Professors: Qualities and Impact on Students

ERIC Educational Resources Information Center

Kim, Eugene P.; Olson, Mathias

2016-01-01

This study focuses on the qualities of Chinese university professors as perceived by their students and the effects of those qualities on student learning and motivation. Specifically, what qualities and personal characteristics do Chinese university students attribute to their favorite and least favorite professors, and how do those qualities and…

Quality: from imperatives to innovations.

PubMed

Dunbar, S

1987-05-01

I have outlined the quality issues facing critical care nurses today and have also presented some challenges for the future. Critical care nurses must now enter a new era characterized by unification, collaboration and involvement, increased professional autonomy, and caring to meet the customer's expectations for quality in fact and quality in perception. Through innovation, critical care nurses can control the pace of change and influence quality in critical care. Recall the kaleidoscope and remember that its intent is to make the whole seem more than the sum of its parts. The image on the horizon is a dynamic and powerful nursing profession as a whole, with critical care nurses assuming an essential and more important role. In fact, the image on the horizon looks bright to me.

Nondestructive detection of pork quality based on dual-band VIS/NIR spectroscopy

NASA Astrophysics Data System (ADS)

Wang, Wenxiu; Peng, Yankun; Li, Yongyu; Tang, Xiuying; Liu, Yuanyuan

2015-05-01

With the continuous development of living standards and the relative change of dietary structure, consumers' rising and persistent demand for better quality of meat is emphasized. Colour, pH value, and cooking loss are important quality attributes when evaluating meat. To realize nondestructive detection of multi-parameter of meat quality simultaneously is popular in production and processing of meat and meat products. The objectives of this research were to compare the effectiveness of two bands for rapid nondestructive and simultaneous detection of pork quality attributes. Reflectance spectra of 60 chilled pork samples were collected from a dual-band visible/near-infrared spectroscopy system which covered 350-1100 nm and 1000-2600 nm. Then colour, pH value and cooking loss were determined by standard methods as reference values. Standard normal variables transform (SNVT) was employed to eliminate the spectral noise. A spectrum connection method was put forward for effective integration of the dual-band spectrum to make full use of the whole efficient information. Partial least squares regression (PLSR) and Principal component analysis (PCA) were applied to establish prediction models using based on single-band spectrum and dual-band spectrum, respectively. The experimental results showed that the PLSR model based on dual-band spectral information was superior to the models based on single band spectral information with lower root means quare error (RMSE) and higher accuracy. The PLSR model based on dual-band (use the overlapping part of first band) yielded the best prediction result with correlation coefficient of validation (Rv) of 0.9469, 0.9495, 0.9180, 0.9054 and 0.8789 for L*, a*, b*, pH value and cooking loss, respectively. This mainly because dual-band spectrum can provide sufficient and comprehensive information which reflected the quality attributes. Data fusion from dual-band spectrum could significantly improve pork quality parameters prediction performance. The research also indicated that multi-band spectral information fusion has potential to comprehensively evaluate other quality and safety attributes of pork.

An integrative review of health-related quality of life in patients with critical limb ischaemia.

PubMed

Monaro, Susan; West, Sandra; Gullick, Janice

2017-10-01

To examine the domains and the domain-specific characteristics within a peripheral arterial disease health-related quality of life framework for their usefulness in defining critical limb ischaemia health-related quality of life. Critical Limb Ischaemia presents a highly individualised set of personal and health circumstances. Treatment options include conservative management, revascularisation or amputation. However, the links between treatment decisions and quality of life require further investigation. The framework for this integrative review was the peripheral arterial disease-specific health-related quality of life domains identified by Treat-Jacobson et al. The literature expanded and refined Treat-Jacobson's framework by modifying the characteristics to better describe health-related quality of life in critical limb ischaemia. Given that critical limb ischaemia is a highly individualised situation with powerful health-related quality of life implications, further research focusing on patient and family-centred decision-making relating to therapeutic options and advanced care planning is required. A critical limb ischaemia-specific, health-related quality of life tool is required to capture both the unique characteristics of this disorder, and the outcomes for active or conservative care among this complex group of patients. © 2016 John Wiley & Sons Ltd.

APPLICATION OF OAT, WHEAT AND RYE BRAN TO MODIFY NUTRITIONAL PROPERTIES, PHYSICAL AND SENSORY CHARACTERISTICS OF EXTRUDED CORN SNACKS.

PubMed

Makowska, Agnieszka; Polcyn, Anna; Chudy, Sylwia; Michniewicz, Jan

2015-01-01

Cereal products constitute the basis of the diet pyramid. While the consumption of such products as bread decreases, the group of food which popularity increase is cereal snacks. Unfortunately, the dietary value of this group of foodstuffs is limited. Thus, different types of cereal bran may be added to the produced snacks to enhance their nutritive value. However, an addition of bran may have an adverse effect on quality attributes of products. Corn grits enriched with 20 and 40% oat, wheat and rye bran was extruded. Basic parameters determining the nutritive value, physical characteristics and sensory attributes of the six produced types of extrudates were measured and compared. Moreover, the effect of additives applied on viscosity of aqueous suspensions of the raw materials and extrudates under controlled conditions was measured using RVA. The dietary value of snacks containing bran depends on the type and quantitative shares of the additives. The content of dietary fibre in produced extrudates ranged from 6.5 to 15.8%, including soluble dietary fibre at 2.1 to 3.7%. With an increase of bran content in extrudates, their expansion decreased, density increased and the colour of extrudates changed (reduced brightness, increased a*, decreased b*). In sensory evaluation the highest acceptability was given to extrudates with a 20% addition of oat bran, while the lowest was given for those with 40% wheat bran. Based on PCA results positive correlations were found between overall desirability and crispiness, porosity, taste, colour and expansion. Negative correlations between desirability and hardness and density of extrudates were observed. The additives and their level also had an effect on changes in viscosity of aqueous suspensions measured using RVA. However, no correlation was found between quality features of extrudates and values of attributes measured in the analysis of viscosity. In the production of corn extruded snacks an addition of oat, wheat and rye bran may be applied up to 20%. Such products have adequate sensory and dietary quality. The Critical Paste Test (Whalen et al., 1996) is not applicable in the evaluation of suitability of the corn raw material with an addition of oat, wheat and rye bran to produce extrudates.

An Evaluation of Attributes Sought by Prospective Business Majors at Private Colleges.

ERIC Educational Resources Information Center

Massad, Victor J.; Tucker, Joanne M.

2000-01-01

Discusses how much of the criticism toward the use of marketing theory in strategic planning for higher education is predicated on the idea that students are unqualified to evaluate the complex and long-term nuances of educational services. A survey of 157 high school seniors finds that students ranked academically related attributes higher in…

Developing a customised approach for strengthening tuberculosis laboratory quality management systems toward accreditation

PubMed Central

Trollip, Andre; Erni, Donatelle; Kao, Kekeletso

2017-01-01

Background Quality-assured tuberculosis laboratory services are critical to achieve global and national goals for tuberculosis prevention and care. Implementation of a quality management system (QMS) in laboratories leads to improved quality of diagnostic tests and better patient care. The Strengthening Laboratory Management Toward Accreditation (SLMTA) programme has led to measurable improvements in the QMS of clinical laboratories. However, progress in tuberculosis laboratories has been slower, which may be attributed to the need for a structured tuberculosis-specific approach to implementing QMS. We describe the development and early implementation of the Strengthening Tuberculosis Laboratory Management Toward Accreditation (TB SLMTA) programme. Development The TB SLMTA curriculum was developed by customizing the SLMTA curriculum to include specific tools, job aids and supplementary materials specific to the tuberculosis laboratory. The TB SLMTA Harmonized Checklist was developed from the World Health Organisation Regional Office for Africa Stepwise Laboratory Quality Improvement Process Towards Accreditation checklist, and incorporated tuberculosis-specific requirements from the Global Laboratory Initiative Stepwise Process Towards Tuberculosis Laboratory Accreditation online tool. Implementation Four regional training-of-trainers workshops have been conducted since 2013. The TB SLMTA programme has been rolled out in 37 tuberculosis laboratories in 10 countries using the Workshop approach in 32 laboratories in five countries and the Facility-based approach in five tuberculosis laboratories in five countries. Conclusion Lessons learnt from early implementation of TB SLMTA suggest that a structured training and mentoring programme can build a foundation towards further quality improvement in tuberculosis laboratories. Structured mentoring, and institutionalisation of QMS into country programmes, is needed to support tuberculosis laboratories to achieve accreditation. PMID:28879165

Quality by Design (QbD) Approach for Development of Co-Processed Excipient Pellets (MOMLETS) By Extrusion-Spheronization Technique.

PubMed

Patel, Hetal; Patel, Kishan; Tiwari, Sanjay; Pandey, Sonia; Shah, Shailesh; Gohel, Mukesh

2016-01-01

Microcrystalline cellulose (MCC) is an excellent excipient for the production of pellets by extrusion spheronization. However, it causes slow release rate of poorly water soluble drugs from pellets. Co-processed excipient prepared by spray drying (US4744987; US5686107; WO2003051338) and coprecipitation technique (WO9517831) are patented. The objective of present study was to develop co-processed MCC pellets (MOMLETS) by extrusion-spheronization technique using the principle of Quality by Design (QbD). Co-processed excipient core pellets (MOMLETS) were developed by extrusion spheronization technique using Quality by Design (QbD) approach. BCS class II drug (telmisartan) was layered onto it in a fluidized bed processor. Quality Target Product Profile (QTPP) and Critical Quality Attributes (CQA) for pellets were identified. Risk assessment was reported using Ishikawa diagram. Plackett Burman design was used to check the effect of seven independent variables; superdisintegrant, extruder speed, ethanol: water, spheronizer speed, extruder screen, pore former and MCC: lactose; on percentage drug release at 30 min. Pareto chart and normal probability plot was constructed to identify the significant factors. Box-Behnken design (BBD) using three most significant factors (Extruder screen size, type of superdisintegrant and type of pore former) was used as an optimization design. The control space was identified in which desired quality of the pellets can be obtained. Co-processed excipient core pellets (MOMLETS) were successfully developed by QbD approach. Versatility, Industrial scalability and simplicity are the main features of the proposed research. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

The Concepts of Quality, Quality Assurance and Quality Enhancement

ERIC Educational Resources Information Center

Elassy, Noha

2015-01-01

Purpose: This paper aims to critically review and discuss different definitions of the concepts of quality, quality assurance (QA) and quality enhancement (QE) in higher education (HE) with presenting critical perspectives of the literature. Design/methodology/approach: The paper looks at literature concerns with the meaning of quality, QA and QE,…

Organizational Attributes Associated With Medicare ACO Quality Performance.

PubMed

Zhu, Xi; Mueller, Keith; Huang, Huang; Ullrich, Fred; Vaughn, Thomas; MacKinney, A Clinton

2018-05-08

To evaluate associations between geographic, structural, and service-provision attributes of Accountable Care Organizations (ACOs) participating in the Medicare Shared Savings Program (MSSP) and the ACOs' quality performance. We conducted cross-sectional and longitudinal analyses of ACO quality performance using data from the Centers for Medicare and Medicaid Services and additional sources. The sample included 322 and 385 MSSP ACOs that had successfully reported quality measures in 2014 and 2015, respectively. Results show that after adjusting for other organizational factors, rural ACOs' average quality score was comparable to that of ACOs serving other geographic categories. ACOs with hospital-system sponsorship, larger beneficiary panels, and higher posthospitalization follow-up rates achieved better quality performance. There is no significant difference in average quality performance between rural ACOs and other ACOs after adjusting for structural and service-provision factors. MSSP ACO quality performance is positively associated with hospital-system sponsorship, beneficiary panel size, and posthospitalization follow-up rate. © 2018 National Rural Health Association.

The biopharmaceutics risk assessment roadmap for optimizing clinical drug product performance.

PubMed

Selen, Arzu; Dickinson, Paul A; Müllertz, Anette; Crison, John R; Mistry, Hitesh B; Cruañes, Maria T; Martinez, Marilyn N; Lennernäs, Hans; Wigal, Tim L; Swinney, David C; Polli, James E; Serajuddin, Abu T M; Cook, Jack A; Dressman, Jennifer B

2014-11-01

The biopharmaceutics risk assessment roadmap (BioRAM) optimizes drug product development and performance by using therapy-driven target drug delivery profiles as a framework to achieve the desired therapeutic outcome. Hence, clinical relevance is directly built into early formulation development. Biopharmaceutics tools are used to identify and address potential challenges to optimize the drug product for patient benefit. For illustration, BioRAM is applied to four relatively common therapy-driven drug delivery scenarios: rapid therapeutic onset, multiphasic delivery, delayed therapeutic onset, and maintenance of target exposure. BioRAM considers the therapeutic target with the drug substance characteristics and enables collection of critical knowledge for development of a dosage form that can perform consistently for meeting the patient's needs. Accordingly, the key factors are identified and in vitro, in vivo, and in silico modeling and simulation techniques are used to elucidate the optimal drug delivery rate and pattern. BioRAM enables (1) feasibility assessment for the dosage form, (2) development and conduct of appropriate "learning and confirming" studies, (3) transparency in decision-making, (4) assurance of drug product quality during lifecycle management, and (5) development of robust linkages between the desired clinical outcome and the necessary product quality attributes for inclusion in the quality target product profile. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

Organizational coherence in health care organizations: conceptual guidance to facilitate quality improvement and organizational change.

PubMed

McAlearney, Ann Scheck; Terris, Darcey; Hardacre, Jeanne; Spurgeon, Peter; Brown, Claire; Baumgart, Andre; Nyström, Monica E

2013-01-01

We sought to improve our understanding of how health care quality improvement (QI) methods and innovations could be efficiently and effectively translated between settings to reduce persistent gaps in health care quality both within and across countries. We aimed to examine whether we could identify a core set of organizational cultural attributes, independent of context and setting, which might be associated with success in implementing and sustaining QI systems in health care organizations. We convened an international group of investigators to explore the issues of organizational culture and QI in different health care contexts and settings. This group met in person 3 times and held a series of conference calls to discuss emerging ideas over 2 years. Investigators also conducted pilot studies in their home countries to examine the applicability of our conceptual model. We suggest that organizational coherence may be a critical element of QI efforts in health care organizations and propose that there are 3 key components of organizational coherence: (1) people, (2) processes, and (3) perspectives. Our work suggests that the concept of organizational coherence embraces both culture and context and can thus help guide both researchers and practitioners in efforts to enhance health care QI efforts, regardless of organizational type, location, or context.

Organizational coherence in health care organizations: conceptual guidance to facilitate quality improvement and organizational change.

PubMed

McAlearney, Ann Scheck; Terris, Darcey; Hardacre, Jeanne; Spurgeon, Peter; Brown, Claire; Baumgart, Andre; Nyström, Monica E

2014-01-01

We sought to improve our understanding of how health care quality improvement (QI) methods and innovations could be efficiently and effectively translated between settings to reduce persistent gaps in health care quality both within and across countries. We aimed to examine whether we could identify a core set of organizational cultural attributes, independent of context and setting, which might be associated with success in implementing and sustaining QI systems in health care organizations. We convened an international group of investigators to explore the issues of organizational culture and QI in different health care contexts and settings. This group met in person 3 times and held a series of conference calls to discuss emerging ideas over 2 years. Investigators also conducted pilot studies in their home countries to examine the applicability of our conceptual model. We suggest that organizational coherence may be a critical element of QI efforts in health care organizations and propose that there are 3 key components of organizational coherence: (1) people, (2) processes, and (3) perspectives. Our work suggests that the concept of organizational coherence embraces both culture and context and can thus help guide both researchers and practitioners in efforts to enhance health care QI efforts, regardless of organizational type, location, or context.

EFFECTS OF Au ON THE GROWTH OF ZnO NANOSTRUCTURES ON Si BY MOCVD

NASA Astrophysics Data System (ADS)

Cong, Chen; Fan, Lu Yang; Ping, He Hai; Wei, Wu Ke; Zhen, Ye Zhi

2013-06-01

The effects of Au on the growth of ZnO nanostructures on Si by metal organic chemical vapor deposition (MOCVD) at a relatively low temperature (450°C) were investigated. The experimental results showed that Au nanoparticles played a critical role during the growth of the ZnO nanostructures and affected their morphology and optical properties. It was found that Au nanoparticles particularly affected the nucleation of ZnO nanostructures during the growth process and the Au-assisted growth mechanism of ZnO nanostructures should be ascribed to the vapor-solid (VS) mechanism. The formation of a nanoneedle may be attributed to a more reactive interface between Au and ZnO, which leads to more zinc gaseous species absorbed near the interface. Different nucleation sites on ZnO nuclei resulted in the disorder of ZnO nanoneedles. Moreover, the crystalline quality of nano-ZnO was improved due to the presence of Au, according to the smaller full width at half maximum (FWHM) of the low-temperature exciton emission. We confirmed that ZnO nanoneedles showed better crystalline quality than ZnO nanorods through the HRTEM images and the SAED patterns. The reason for the improvement of the crystalline quality of nano-ZnO may be due to the less lattice mismatch.

Interface-Induced Zeeman-Protected Superconductivity in Ultrathin Crystalline Lead Films

NASA Astrophysics Data System (ADS)

Liu, Yi; Wang, Ziqiao; Zhang, Xuefeng; Liu, Chaofei; Liu, Yongjie; Zhou, Zhimou; Wang, Junfeng; Wang, Qingyan; Liu, Yanzhao; Xi, Chuanying; Tian, Mingliang; Liu, Haiwen; Feng, Ji; Xie, X. C.; Wang, Jian

2018-04-01

Two-dimensional (2D) superconducting systems are of great importance for exploring exotic quantum physics. The recent development of fabrication techniques has stimulated studies of high-quality single-crystalline 2D superconductors, where intrinsic properties give rise to unprecedented physical phenomena. Here, we report the observation of Zeeman-type spin-orbit interaction protected superconductivity (Zeeman-protected superconductivity) in 4-monolayer (ML) to 6-ML crystalline Pb films grown on striped incommensurate Pb layers on Si(111) substrates by molecular beam epitaxy. An anomalously large in-plane critical field far beyond the Pauli limit is detected, which can be attributed to the Zeeman-protected superconductivity due to the in-plane inversion symmetry breaking at the interface. Our work demonstrates that, in superconducting heterostructures, the interface can induce Zeeman-type spin-orbit interactions and modulate the superconductivity.

Second International Conference on Accelerating Biopharmaceutical Development

PubMed Central

2009-01-01

The Second International Conference on Accelerating Biopharmaceutical Development was held in Coronado, California. The meeting was organized by the Society for Biological Engineering (SBE) and the American Institute of Chemical Engineers (AIChE); SBE is a technological community of the AIChE. Bob Adamson (Wyeth) and Chuck Goochee (Centocor) were co-chairs of the event, which had the theme “Delivering cost-effective, robust processes and methods quickly and efficiently.” The first day focused on emerging disruptive technologies and cutting-edge analytical techniques. Day two featured presentations on accelerated cell culture process development, critical quality attributes, specifications and comparability, and high throughput protein formulation development. The final day was dedicated to discussion of technology options and new analysis methods provided by emerging disruptive technologies; functional interaction, integration and synergy in platform development; and rapid and economic purification process development. PMID:20065637

An official American Thoracic Society/American Association of Critical-Care Nurses/American College of Chest Physicians/Society of Critical Care Medicine policy statement: the Choosing Wisely® Top 5 list in Critical Care Medicine.

PubMed

Halpern, Scott D; Becker, Deborah; Curtis, J Randall; Fowler, Robert; Hyzy, Robert; Kaplan, Lewis J; Rawat, Nishi; Sessler, Curtis N; Wunsch, Hannah; Kahn, Jeremy M

2014-10-01

The high costs of health care in the United States and other developed nations are attributable, in part, to overuse of tests, treatments, and procedures that provide little to no benefit for patients. To improve the quality of care while also combating this problem of cost, the American Board of Internal Medicine Foundation developed the Choosing Wisely Campaign, tasking professional societies to develop lists of the top five medical services that patients and physicians should question. To present the Critical Care Societies Collaborative's Top 5 list in Critical Care Medicine and describe its development. Each professional society in the Collaborative nominated members to the Choosing Wisely task force, which established explicit criteria for evaluating candidate items, generated lists of items, performed literature reviews on each, and sought external input from content experts. Task force members narrowed the list to the Top 5 items using a standardized scoring system based on each item's likely overall impact and merits on the five explicit criteria. From an initial list of 58 unique recommendations, the task force proposed a Top 5 list that was ultimately endorsed by each Society within the Collaborative. The five recommendations are: (1) do not order diagnostic tests at regular intervals (such as every day), but rather in response to specific clinical questions; (2) do not transfuse red blood cells in hemodynamically stable, nonbleeding ICU patients with an Hb concentration greater than 7 g/dl; (3) do not use parenteral nutrition in adequately nourished critically ill patients within the first 7 days of an ICU stay; (4) do not deeply sedate mechanically ventilated patients without a specific indication and without daily attempts to lighten sedation; and (5) do not continue life support for patients at high risk for death or severely impaired functional recovery without offering patients and their families the alternative of care focused entirely on comfort. These five recommendations provide a starting point for clinicians and patients to make decisions leading to higher-quality, lower-cost care. Future work is needed to promote adherence to these recommendations and to develop additional ways for intensive care clinicians to take leadership in reining in health-care costs.

Changes in sensory quality characteristics of coffee during storage

PubMed Central

Kreuml, Michaela T L; Majchrzak, Dorota; Ploederl, Bettina; Koenig, Juergen

2013-01-01

How long can roasted coffee beans be stored, without reducing the typical coffee flavor which is mainly responsible for consumers’ enjoyment? In Austria, most coffee packages have a best-before date between 12 and 24 months, but it is not regulated by law. Therefore, there is the need to evaluate changes in sensory qualities of coffee beverages prepared from stored coffee beans. For preparation of the coffee beverages, the paper filter method was used. In the quantitative descriptive analysis (QDA) 10 trained assessors evaluated the intensity of 30 coffee attributes after roasting at the 9th and 18th month of storage, respectively. The sensory evaluation results showed reduction in the sensory qualities of coffee beverages after 9 months storage of roasted coffee beans. The positive associated odor and flavor attributes decreased in their intensity, whereas the negative associated odor and flavor attributes increased significantly (P < 0.05). After 18 months of storage, the rancid odor and flavor which indicate oxidation processes were even considerably perceivable. Consequently, we can assume that changes in sensory quality characteristics of roasted and vacuum-packed coffee beans during storage are possible. PMID:24804030

Reduced Fat Food Emulsions: Physicochemical, Sensory, and Biological Aspects.

PubMed

Chung, Cheryl; Smith, Gordon; Degner, Brian; McClements, David Julian

2016-01-01

Fat plays multiple important roles in imparting desirable sensory attributes to emulsion-based food products, such as sauces, dressings, soups, beverages, and desserts. However, there is concern that over consumption of fats leads to increased incidences of chronic diseases, such as obesity, coronary heart disease, and diabetes. Consequently, there is a need to develop reduced fat products with desirable sensory profiles that match those of their full-fat counterparts. The successful design of high quality reduced-fat products requires an understanding of the many roles that fat plays in determining the sensory attributes of food emulsions, and of appropriate strategies to replace some or all of these attributes. This paper reviews our current understanding of the influence of fat on the physicochemical and physiological attributes of food emulsions, and highlights some of the main approaches that can be used to create high quality emulsion-based food products with reduced fat contents.

On the quality of commercial boneless skinless broiler breast meat.

PubMed

Lee, Y S; Owens, C M; Meullenet, J F

2008-08-01

This study was conducted to assess the overall quality of commercial broiler breast meat products representing several brands and various industry practices (that is, chilling or enhancement procedures). Six different broiler breast products were evaluated by 75 consumers for 11 attributes related to appearance, flavor, tenderness, and juiciness, including overall acceptance. Twenty-three sensory attributes representing basic taste, flavor, texture, and appearance were evaluated by 11 trained descriptive panelists. Tenderness of cooked meat was instrumentally predicted by the Meullenet-Owens razor shear (MORS). Water holding capacity (cook loss) of cooked meat was also evaluated, and color and pH of raw meat were determined. Significant variations in quality among products tested were reported, indicating a broad range of product quality in the marketplace. One air-chilled and 1 water-chilled/enhanced product were found to be most liked by consumers. Tenderness of products tested was rated in average between "neither tough nor tender" and "very tender" by consumers. Cook loss of the 2 air-chilled products (13.5% to 19.1%, respectively) was significantly lower than that of water-chilled products (18.7% to 24.1%). Partial least squares regression revealed that 4 sensory texture attributes (hardness, hardness of mass, cohesiveness of mass, and tooth pack) and 1 basic taste (sour) were the major attributes driving consumer overall liking of commercial broiler breast meat products.

Impacts on quality of life related to dental caries in a national representative sample of Thai 12- and 15-year-olds.

PubMed

Krisdapong, S; Prasertsom, P; Rattanarangsima, K; Sheiham, A

2013-01-01

Dental caries is generally given the highest priority in national oral health services for school-aged populations. Yet, there is no study exploring the impacts on quality of life specifically related to dental caries in national samples of school-aged children. This study assessed prevalence and characteristics of oral impacts attributed to dental caries on quality of life and compared them with overall oral health impacts. In addition, associations of oral impacts attributed to dental caries and dental caries status were investigated. A national representative sample of 1,063 12- and 811 15-year-olds completed a sociodemographic and behavioural questionnaire, and were orally examined and interviewed about oral health-related quality of life using the Child-OIDP or OIDP indexes, respectively. Associations of condition-specific impacts (CS impacts) attributed to dental caries with components of DMF were investigated using χ(2) tests and multivariate logistic regressions. CS impacts attributed to dental caries were reported by nearly half the children and such impacts accounted for half of overall oral impacts from all oral conditions. The majority of impacts were of little intensity and affected only 1-2 daily performances, particularly performances on Eating, Emotional stability and Cleaning teeth. CS impacts were significantly positively associated with number of decayed teeth, and strongly associated with severe decay. Copyright © 2012 S. Karger AG, Basel.

The combined effect of wet granulation process parameters and dried granule moisture content on tablet quality attributes.

PubMed

Gabbott, Ian P; Al Husban, Farhan; Reynolds, Gavin K

2016-09-01

A pharmaceutical compound was used to study the effect of batch wet granulation process parameters in combination with the residual moisture content remaining after drying on granule and tablet quality attributes. The effect of three batch wet granulation process parameters was evaluated using a multivariate experimental design, with a novel constrained design space. Batches were characterised for moisture content, granule density, crushing strength, porosity, disintegration time and dissolution. Mechanisms of the effect of the process parameters on the granule and tablet quality attributes are proposed. Water quantity added during granulation showed a significant effect on granule density and tablet dissolution rate. Mixing time showed a significant effect on tablet crushing strength, and mixing speed showed a significant effect on the distribution of tablet crushing strengths obtained. The residual moisture content remaining after granule drying showed a significant effect on tablet crushing strength. The effect of moisture on tablet tensile strength has been reported before, but not in combination with granulation parameters and granule properties, and the impact on tablet dissolution was not assessed. Correlations between the energy input during granulation, the density of granules produced, and the quality attributes of the final tablets were also identified. Understanding the impact of the granulation and drying process parameters on granule and tablet properties provides a basis for process optimisation and scaling. Copyright © 2016 Elsevier B.V. All rights reserved.

The Development of a Situational Judgement Test of Personal Attributes for Quality Teaching in Rural and Remote Australia

ERIC Educational Resources Information Center

Durksen, Tracy L.; Klassen, Robert M.

2018-01-01

Education authorities in Australia are calling for valid tools to help assess prospective teachers' non-academic attributes, with a particular need for identifying those attributes necessary for effective teaching in specific contexts. With the New South Wales (NSW) Department of Education, we aimed to develop a scenario-based tool to help assess…

Achieving graduate outcomes in undergraduate nursing education: following the Yellow Brick Road.

PubMed

Baldwin, Adele; Bentley, Karyn; Langtree, Tanya; Mills, Jane

2014-01-01

Nursing practice is a dynamic and constantly changing field within healthcare, with well-documented challenges to maintaining a suitably skilled workforce to meet the needs of the community it serves. Undergraduate nursing education provides the mandatory minimum requirements for professional registration. Each nursing program has clearly stated graduate attributes, qualities that their graduates will possess on graduation. The aim of this paper is to stimulate discussion about graduate attributes for nurses, a transferrable set of specific attributes that make nursing graduates work ready. This paper focuses on identifying specific attributes, the embedding of those attributes in nursing education, particularly through role modelling, with the aim of producing a future workforce that is knowledgeable, compassionate and confident. The graduate attributes are likened to the qualities sought by the characters in 'The Wizard of Oz'; brains, heart and courage and the learning process as the 'Yellow Brick Road'. There is a relative lack of discussion about role modelling by nurse educators for nursing students, a potentially undervalued learning experience that we believe must be brought to the forefront of discussions pertaining to undergraduate nursing education and achieving graduate outcomes. Copyright © 2013 Elsevier Ltd. All rights reserved.

Nursing Faculty Perceptions on Teaching Critical Thinking

ERIC Educational Resources Information Center

Clark, Doris A.

2010-01-01

The perceptions of nursing faculty teaching critical thinking (CT) affective attributes and cognitive skills are described in this quantitative, descriptive study. The study sample consisted of nurse educators from the National League of Nursing database. The purpose of the study was to gain nursing faculty perception of which teaching strategies…

What Do Feminist Critics Want? Or a Postcard from the Volcano.

ERIC Educational Resources Information Center

Gilbert, Sandra

1980-01-01

Explores the task of revising Western culture, particularly in the study of literature, that feminist critics encounter. Discusses the male-oriented attitudes towards feminist studies in academia, as well as the attributes of and need for the study of literature from a feminist perspective. (HTH)

Preparing "Professional" Science Teachers: Critical Goals.

ERIC Educational Resources Information Center

Dass, Pradeep Maxwell

This paper focuses on pre-service teacher education and elaborates on the critical importance of three attributes to the development of professional science teachers: (1) science teachers must be reflective practitioners of their profession; (2) all instructional practice and decisions of science teachers must be backed by a research-based…

Quality-related enzymes in fruit and vegetable products: effects of novel food processing technologies, part 1: high-pressure processing.

PubMed

Terefe, Netsanet Shiferaw; Buckow, Roman; Versteeg, Cornelis

2014-01-01

The activity of endogenous deteriorative enzymes together with microbial growth (with associated enzymatic activity) and/or other non-enzymatic (usually oxidative) reactions considerably shorten the shelf life of fruits and vegetable products. Thermal processing is commonly used by the food industry for enzyme and microbial inactivation and is generally effective in this regard. However, thermal processing may cause undesirable changes in product's sensory as well as nutritional attributes. Over the last 20 years, there has been a great deal of interest shown by both the food industry and academia in exploring alternative food processing technologies that use minimal heat and/or preservatives. One of the technologies that have been investigated in this context is high-pressure processing (HPP). This review deals with HPP focusing on its effectiveness for controlling quality-degrading enzymes in horticultural products. The scientific literature on the effects of HPP on plant enzymes, mechanism of action, and intrinsic and extrinsic factors that influence the effectiveness of HPP for controlling plant enzymes is critically reviewed. HPP inactivates vegetative microbial cells at ambient temperature conditions, resulting in a very high retention of the nutritional and sensory characteristics of the fresh product. Enzymes such as polyphenol oxidase (PPO), peroxidase (POD), and pectin methylesterase (PME) are highly resistant to HPP and are at most partially inactivated under commercially feasible conditions, although their sensitivity towards pressure depends on their origin as well as their environment. Polygalacturonase (PG) and lipoxygenase (LOX) on the other hand are relatively more pressure sensitive and can be substantially inactivated by HPP at commercially feasible conditions. The retention and activation of enzymes such as PME by HPP can be beneficially used for improving the texture and other quality attributes of processed horticultural products as well as for creating novel structures that are not feasible with thermal processing.

Risk Assessment Integrated QbD Approach for Development of Optimized Bicontinuous Mucoadhesive Limicubes for Oral Delivery of Rosuvastatin.

PubMed

Javed, Md Noushad; Kohli, Kanchan; Amin, Saima

2018-04-01

Statins are widely prescribed for hyperlipidemia, cancer, and Alzheimer's disease but are facing some inherent challenges such as low solubility and drug loading, higher hepatic metabolism, as well as instability at gastric pH. So, relatively higher circulating dose, required for exerting the therapeutic benefits, leads to dose-mediated severe toxicity. Furthermore, due to low biocompatibility, high toxicity, and other regulatory caveats such as product conformity, reproducibility, and stability of conventional formulations as well as preferentially higher bioabsorption of lipids in their favorable cuboidal geometry, enhancement in in vivo biopharmaceutical performance of Rosuvastatin could be well manifested in Quality by Design (QbD) integrated cuboidal-shaped mucoadhesive microcrystalline delivery systems (Limicubes). Here, quality-target-product-profile (QTPPs), critical quality attributes (CQAs), Ishikawa fishbone diagram, and integration of risk management through risk assessment matrix for failure mode and effects analysis (FMEA) followed by processing of Plackett-Burman design matrix using different statistical test for the first time established an approach to substantiate the claims that controlling levels of only these three screened out independent process variables, i.e., Monoolein (B = 800-1100 μL), Poloxamer (C = 150-200 mg), and stirring speed (F = 700-1000 rpm) were statistically significant to modulate and improve the biopharmaceutical performance affecting key attributes, viz., average particle size (Y 1  = 1.40-2.70 μ), entrapment efficiency (Y 2  = 62.60-88.80%), and drug loading (Y 3  = 0.817-1.15%), in QbD-enabled process. The optimal performance of developed Limicubes exhibited an average particle size of 1.8 ± 0.2 μ, entrapment efficiency 80.32 ± 2.88%, and drug loading 0.93 ± 0.08% at the level of 1100 μL (+ 1), 200 mg (+ 1), and 700 rpm (- 1) for Monoolein, Poloxamer, and stirring speed, respectively.

Quality of Care Attributions to Employed Versus Stay-at-Home Mothers

ERIC Educational Resources Information Center

Shpancer, Noam; Melick, Katherine M.; Sayre, Pamela S.; Spivey, Aria T.

2006-01-01

The present study was designed to find whether evaluations of maternal competence are linked to mothers' employment status and the quality of maternal care. Participants rated videotaped vignettes, depicting either high-quality or low-quality mother-infant interactions, on various dimensions of care quality. The videotaped mothers were described…

On Regional Modeling to Support Air Quality Policies

EPA Science Inventory

We examine the use of the Community Multiscale Air Quality (CMAQ) model in simulating the changes in the extreme values of air quality that are of interest to the regulatory agencies. Year-to-year changes in ozone air quality are attributable to variations in the prevailing mete...

Measuring, evaluating and improving hospital quality parameters/dimensions--an integrated healthcare quality approach.

PubMed

Zineldin, Mosad; Camgöz-Akdağ, Hatice; Vasicheva, Valiantsina

2011-01-01

This paper aims to examine the major factors affecting cumulative summation, to empirically examine the major factors affecting satisfaction and to address the question whether patients in Kazakhstan evaluate healthcare similarly or differently from patients in Egypt and Jordan. A questionnaire, adapted from previous research, was distributed to Kazakhstan inpatients. The questionnaire contained 39 attributes about five newly-developed quality dimensions (5Qs), which were identified to be the most relevant attributes for hospitals. The questionnaire was translated into Russian to increase the response rate and improve data quality. Almost 200 usable questionnaires were returned. Frequency distribution, factor analysis and reliability checks were used to analyze the data. The three biggest concerns for Kazakhstan patients are: infrastructure; atmosphere; and interaction. Hospital staffs concern for patients' needs, parking facilities for visitors, waiting time and food temperature were all common specific attributes, which were perceived as concerns. These were shortcomings in all three countries. Improving health service quality by applying total relationship management and the 5Qs model together with a customer-orientation strategy is recommended. Results can be used by hospital staff to reengineer and redesign creatively their quality management processes and help move towards more effective healthcare quality strategies. Patients in three countries have similar concerns and quality perceptions. The paper describes a new instrument and method. The study assures relevance, validity and reliability, while being explicitly change-oriented. The authors argue that patient satisfaction is a cumulative construct, summing satisfaction as five different qualities (5Qs): object; processes; infrastructure; interaction and atmosphere.

Stakeholder analysis: theAndalusian Agency For Healthcare Quality case.

PubMed

Reyes-Alcázar, Víctor; Casas-Delgado, Marta; Herrera-Usagre, Manuel; Torres-Olivera, Antonio

2012-01-01

The aim of this study was to identify the different groups that can affect or be affected by an agency charged with the promoting and guaranteeing of health care quality in Andalusian region (Spain) and to provide a framework with the stakeholders included in different categories. The study adopted a cross-sectional research design. A case study with structured interviews among Andalusian Agency for Healthcare Quality Steering Committee members was carried out in 2010 to define stakeholders' categories and map the interest groups using 5 attributes: influence, importance, legitimacy, power, and urgency. After identification and categorization, stakeholders were weighted qualitatively according to the attributes of importance and influence using 4 possible levels. A matrix was made with the collected data relating both attributes. Furthermore, 8 different types of stakeholders were identified according to attributes power, legitimacy, and urgency. The study concludes that identifying and classifying stakeholders are fundamental to ensuring the success of an organization that must respond to needs and expectations, especially those of its clients. Moreover, knowing stakeholder linkages can contribute to increase organizational worth. This is essential for organizations basically directed to the provision of services in the scope of health care.

Identification, summary and comparison of tools used to measure organizational attributes associated with chronic disease management within primary care settings

PubMed Central

Lukewich, Julia; Corbin, Renée; VanDenKerkhof, Elizabeth G; Edge, Dana S; Williamson, Tyler; Tranmer, Joan E

2014-01-01

Rationale, aims and objectives Given the increasing emphasis being placed on managing patients with chronic diseases within primary care, there is a need to better understand which primary care organizational attributes affect the quality of care that patients with chronic diseases receive. This study aimed to identify, summarize and compare data collection tools that describe and measure organizational attributes used within the primary care setting worldwide. Methods Systematic search and review methodology consisting of a comprehensive and exhaustive search that is based on a broad question to identify the best available evidence was employed. Results A total of 30 organizational attribute data collection tools that have been used within the primary care setting were identified. The tools varied with respect to overall focus and level of organizational detail captured, theoretical foundations, administration and completion methods, types of questions asked, and the extent to which psychometric property testing had been performed. The tools utilized within the Quality and Costs of Primary Care in Europe study and the Canadian Primary Health Care Practice-Based Surveys were the most recently developed tools. Furthermore, of the 30 tools reviewed, the Canadian Primary Health Care Practice-Based Surveys collected the most information on organizational attributes. Conclusions There is a need to collect primary care organizational attribute information at a national level to better understand factors affecting the quality of chronic disease prevention and management across a given country. The data collection tools identified in this review can be used to establish data collection strategies to collect this important information. PMID:24840066

Indicators of ocean health and human health: developing a research and monitoring framework.

PubMed Central

Knap, Anthony; Dewailly, Eric; Furgal, Chris; Galvin, Jennifer; Baden, Dan; Bowen, Robert E; Depledge, Michael; Duguay, Linda; Fleming, Lora E; Ford, Tim; Moser, Fredricka; Owen, Richard; Suk, William A; Unluata, Umit

2002-01-01

We need to critically assess the present quality of the marine ecosystem, especially the connection between ecosystem change and threats to human health. In this article we review the current state of indicators to link changes in marine organisms with eventual effects to human health, identify research opportunities in the use of indicators of ocean and human health, and discuss how to establish collaborations between national and international governmental and private sector groups. We present a synthesis of the present state of understanding of the connection between ocean health and human health, a discussion of areas where resources are required, and a discussion of critical research needs and a template for future work in this field. To understand fully the interactions between ocean health and human health, programs should be organized around a "models-based" approach focusing on critical themes and attributes of marine environmental and public health risks. Given the extent and complex nature of ocean and human health issues, a program networking across geographic and disciplinary boundaries is essential. The overall goal of this approach would be the early detection of potential marine-based contaminants, the protection of marine ecosystems, the prevention of associated human illness, and by implication, the development of products to enhance human well-being. The tight connection between research and monitoring is essential to develop such an indicator-based effort. PMID:12204815

Application of process analytical technology for monitoring freeze-drying of an amorphous protein formulation: use of complementary tools for real-time product temperature measurements and endpoint detection.

PubMed

Schneid, Stefan C; Johnson, Robert E; Lewis, Lavinia M; Stärtzel, Peter; Gieseler, Henning

2015-05-01

Process analytical technology (PAT) and quality by design have gained importance in all areas of pharmaceutical development and manufacturing. One important method for monitoring of critical product attributes and process optimization in laboratory scale freeze-drying is manometric temperature measurement (MTM). A drawback of this innovative technology is that problems are encountered when processing high-concentrated amorphous materials, particularly protein formulations. In this study, a model solution of bovine serum albumin and sucrose was lyophilized at both conservative and aggressive primary drying conditions. Different temperature sensors were employed to monitor product temperatures. The residual moisture content at primary drying endpoints as indicated by temperature sensors and batch PAT methods was quantified from extracted sample vials. The data from temperature probes were then used to recalculate critical product parameters, and the results were compared with MTM data. The drying endpoints indicated by the temperature sensors were not suitable for endpoint indication, in contrast to the batch methods endpoints. The accuracy of MTM Pice data was found to be influenced by water reabsorption. Recalculation of Rp and Pice values based on data from temperature sensors and weighed vials was possible. Overall, extensive information about critical product parameters could be obtained using data from complementary PAT tools. © 2015 Wiley Periodicals, Inc. and the American Pharmacists Association.

Perceptions of staff attributes in substance abuse treatment.

PubMed

Grosenick, J K; Hatmaker, C M

2000-10-01

Qualified professional staff contribute significantly to successful health-care service delivery. Organizations view six categories of staff attributes as valued qualities of competent personnel: knowledge and experience, organizational citizenship, interpersonal skills, service orientation, personal attributes, and leadership skills. This study presents the perceptions regarding these and other staff attributes held by female clients and staff from a substance abuse treatment facility. Results indicated that four attributes were perceived as particularly influential in assisting women to reach treatment goals. These included knowledge and experience, supportiveness, nonthreatening behaviors, and availability. Attention to these variables may prove useful as treatment programs strive to improve client outcomes.

Selection and Evaluation of Media for Behavioral Health Interventions Employing Critical Media Analysis.

PubMed

Wilson, Patrick A; Cherenack, Emily M; Jadwin-Cakmak, Laura; Harper, Gary W

2018-01-01

Although a growing number of psychosocial health promotion interventions use the critical analysis of media to facilitate behavior change, no specific guidelines exist to assist researchers and practitioners in the selection and evaluation of culturally relevant media stimuli for intervention development. Mobilizing Our Voices for Empowerment is a critical consciousness-based health enhancement intervention for HIV-positive Black young gay/bisexual men that employs the critical analysis of popular media. In the process of developing and testing this intervention, feedback on media stimuli was collected from youth advisory board members (n = 8), focus group participants (n = 19), intervention participants (n = 40), and intervention facilitators (n = 6). A thematic analysis of qualitative data resulted in the identification of four key attributes of media stimuli and participants' responses to media stimuli that are important to consider when selecting and evaluating media stimuli for use in behavioral health interventions employing the critical analysis of media: comprehension, relevance, emotionality, and action. These four attributes are defined and presented as a framework for evaluating media, and adaptable tools are provided based on this framework to guide researchers and practitioners in the selection and evaluation of media for similar interventions.

Identifying Cognitive and Interpersonal Predictors of Adolescent Depression

PubMed Central

Auerbach, Randy P.; Ho, Moon Ho-Ringo; Kim, Judy C.

2014-01-01

Emerging research has begun to examine cognitive and interpersonal predictors of stress and subsequent depression in adolescents. This research is critical as cognitive and interpersonal vulnerability factors likely shape expectations, perspectives, and interpretations of a given situation prior to the onset of a stressor. In the current study, adolescents (n=157; boys=64, girls=93), ages 12 to 18, participated in a 6-month, multi-wave longitudinal study examining the impact of negative cognitive style, self-criticism, and dependency on stress and depression. Results of time-lagged, idiographic multilevel analyses indicate that depressogenic attributional styles (i.e., composite score and weakest link approach) and self-criticism predict dependent interpersonal, but not noninterpersonal stress. Moreover, the occurrence of stress mediates the relationship between cognitive vulnerability and depressive symptoms over time. At the same time, self-criticism predicts above and beyond depressogenic attributional styles (i.e., composite and weakest link approach). In contrast to our hypotheses, dependency does not contribute to the occurrence of stress, and additionally, no gender differences emerge. Taken together, the findings suggest that self-criticism may be a particularly damaging vulnerability factor in adolescence, and moreover, it may warrant greater attention in the context of psychotherapeutic interventions. PMID:24398789

To what do firms attribute success? An application of attribution theory to the secondary woodworking industry

Treesearch

Matthew Bumgardner; Urs Buehlmann

2015-01-01

Small firms are a critical component of the secondary woodworking industry and are important to hardwood lumber demand in the US. Understanding managers' perceptions of competitiveness in these firms is important to those working with the industry to help maintain a viable wood manufacturing base. One area of interest relative to the overall business environment...

Attribution of net carbon change by disturbance type across forest lands of the conterminous United States

Treesearch

N. L. Harris; S. C. Hagen; S. S. Saatchi; T. R. H. Pearson; Christopher W. Woodall; Grant M. Domke; B. H. Braswell; Brian F. Walters; S. Brown; W. Salas; A. Fore; Y. Yu

2016-01-01

Background: Locating terrestrial sources and sinks of carbon (C) will be critical to developing strategies that contribute to the climate change mitigation goals of the Paris Agreement. Here we present spatially resolved estimates of net C change across United States (US) forest lands between 2006 and 2010 and attribute them to natural and anthropogenic processes....

On Regional Modeling to Support Air Quality Policies (book chapter)

EPA Science Inventory

We examine the use of the Community Multiscale Air Quality (CMAQ) model in simulating the changes in the extreme values of air quality that are of interest to the regulatory agencies. Year-to-year changes in ozone air quality are attributable to variations in the prevailing meteo...

Evaluation of beef eating quality by Irish consumers.

PubMed

McCarthy, S N; Henchion, M; White, A; Brandon, K; Allen, P

2017-10-01

A consumer's decision to purchase beef is strongly linked to its sensory properties and consistent eating quality is one of the most important attributes. Consumer taste panels were held according to the Meat Standards Australia guidelines and consumers scored beef according to its palatability attributes and completed a socio-demographic questionnaire. Consumers were able to distinguish between beef quality on a scale from unsatisfactory to premium with high accuracy. Premium cuts of beef scored significantly higher on all of the scales compared to poorer quality cuts. Men rated grilled beef higher on juiciness and flavour scales compared to women. Being the main purchaser of beef had no impact on rating scores. Overall the results show that consumers can judge eating quality with high accuracy. Further research is needed to determine how best to communicate inherent benefits that are not visible into extrinsic eating quality indicators, to provide the consumer with consistent indications of quality at the point of purchase. Copyright © 2017 Elsevier Ltd. All rights reserved.

The Influence of Race/Ethnicity and Education on Family Ratings of the Quality of Dying in the ICU.

PubMed

Lee, Janet J; Long, Ann C; Curtis, J Randall; Engelberg, Ruth A

2016-01-01

Racial and ethnic differences in end-of-life care may be attributable to both patient preferences and health-care disparities. Identifying factors that differentiate preferences from disparities may enhance end-of-life care for critically ill patients and their families. To understand the association of minority race/ethnicity and education with family ratings of the quality of dying and death, taking into consideration possible markers of patient and family preferences for end-of-life care as mediators of this association. Data were obtained from 15 intensive care units participating in a cluster-randomized trial of a palliative care intervention. Family members of decedents completed self-report surveys evaluating quality of dying. We used regression analyses to identify associations between race/ethnicity, education, and quality of dying ratings. We then used path analyses to investigate whether advance directives and life-sustaining treatment acted as mediators between patient characteristics and ratings of quality of dying. Family members returned 1290 surveys for 2850 decedents. Patient and family minority race/ethnicity were both associated with lower ratings of quality of dying. Presence of a living will and dying in the setting of full support mediated the relationship between patient race and family ratings; patient race exerted an indirect, rather than direct, effect on quality of dying. Family minority race had a direct effect on lower ratings of quality of dying. Neither patient nor family education was associated with quality of dying. Minority race/ethnicity was associated with lower family ratings of quality of dying. This association was mediated by factors that may be markers of patient and family preferences (living will, death in the setting of full support); family member minority race/ethnicity was directly associated with lower ratings of quality of dying. Our findings generate hypothesized pathways that require future evaluation. Copyright © 2016 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

Consumer palatability scores, sensory descriptive attributes, and volatile compounds of grilled beef steaks from three USDA Quality Grades.

PubMed

Legako, J F; Dinh, T T N; Miller, M F; Adhikari, K; Brooks, J C

2016-02-01

Consumer palatability scores, sensory descriptive attributes, and volatile compounds were assessed for beef Longissimus lumborum steaks of USDA Prime, Low Choice, and Standard grades. Overall and flavor liking was greater (P<0.05) for Prime and Low Choice. Initial flavor impact and fat-like attributes were greater (P<0.05) among Prime and Low Choice. Prime had greater (P<0.05) brown/roasted, beef identity, overall sweetness, and umami. Cardboard was greater (P<0.05) in Standard. Volatile compounds representing flavor development pathways were varied with quality grade. Standard had greater (P<0.05) abundances of n-aldehydes. Phenylacetaldehyde was greater (P<0.05) in Prime and Low Choice. Both 2,3-butanedione and 3-hydroxy-2-butanone were greatest (P<0.05) in Prime. Overall liking was positively correlated with many descriptive attributes, 3-hydroxy-2-butanone, and phenylacetaldehyde, and negatively correlated with cardboard, green, and n-aldehydes. While the measured attributes and volatiles may not be causative of flavor, this data indicates potential for prediction of flavor through their measurement. Copyright © 2015 Elsevier Ltd. All rights reserved.

The effects of food irradiation on quality of pine nut kernels

NASA Astrophysics Data System (ADS)

Gölge, Evren; Ova, Gülden

2008-03-01

Pine nuts ( Pinus pinae) undergo gamma irradiation process with the doses 0.5, 1.0, 3.0, and 5.0 kGy. The changes in chemical, physical and sensory attributes were observed in the following 3 months of storage period. The data obtained from the experiments showed the peroxide values of the pine nut kernels increased proportionally to the dose. On contrary, irradiation process has no effect on the physical quality such as texture and color, fatty acid composition and sensory attributes.

Overall quality and shelf life of minimally processed and modified atmosphere packaged 'ready-to-eat' pomegranate arils.

PubMed

Ayhan, Zehra; Eştürk, Okan

2009-06-01

Minimally processed ready-to-eat pomegranate arils have become popular due to their convenience, high value, unique sensory characteristics, and health benefits. The objective of this study was to monitor quality parameters and to extend the shelf life of ready-to-eat pomegranate arils packaged with modified atmospheres. Minimally processed pomegranate arils were packed in PP trays sealed with BOPP film under 4 atmospheres including low and super atmospheric oxygen. Packaged arils were stored at 5 degrees C for 18 d and monitored for internal atmosphere and quality attributes. Atmosphere equilibrium was reached for all MAP applications except for high oxygen. As a general trend, slight or no significant change was detected in chemical and physical attributes of pomegranate arils during cold storage. The aerobic mesophilic bacteria were in the range of 2.30 to 4.51 log CFU/g at the end of the storage, which did not affect the sensory quality. Overall, the pomegranate arils packed with air, nitrogen, and enriched oxygen kept quality attributes and were acceptable to sensory panelists on day 18; however, marketability period was limited to 15 d for the low oxygen atmosphere. PP trays sealed with BOPP film combined with either passive or active modified atmospheres and storage at 5 degrees C provided commercially acceptable arils for 18 d with high quality and convenience.

Comparison of beer quality attributes between beers brewed with 100% barley malt and 100% barley raw material.

PubMed

Steiner, Elisabeth; Auer, Andrea; Becker, Thomas; Gastl, Martina

2012-03-15

Brewing with 100% barley using the Ondea® Pro exogenous brewing enzyme product was compared to brewing with 100% barley. The use of barley, rather than malt, in the brewing process and the consequences for selected beer quality attributes (foam formation, colloidal stability and filterability, sensory differences, protein content and composition) was considered. The quality attributes of barley, malt, kettle-full-wort, cold wort, unfiltered beer and filtered beer were assessed. A particular focus was given to monitoring changes in the barley protein composition during the brewing process and how the exogenous OndeaPro® enzymes influenced wort protein composition. All analyses were based on standard brewing methods described in ASBC, EBC or MEBAK. To monitor the protein changes two-dimensional polyacrylamide gel electrophoresis was used. It was shown that by brewing beer with 100% barley and an appropriate addition of exogenous Ondea® Pro enzymes it was possible to efficiently brew beer of a satisfactory quality. The production of beers brewed with 100% barley resulted in good process efficiency (lautering and filtration) and to a final product whose sensory quality was described as light, with little body and mouthfeel, very good foam stability and similar organoleptic qualities compared to conventional malt beer. In spite of the sensory evaluation differences could still be seen in protein content and composition. Copyright © 2011 Society of Chemical Industry.

How Deep is the Critical Zone: A Scientific Question with Potential Impact For Decision-makers in Areas of Shale-Gas Development and Hydraulic Fracturing

NASA Astrophysics Data System (ADS)

Brantley, S. L.

2014-12-01

Citizens living in areas of shale-gas development such as the Marcellus gas play in Pennsylvania and surrounding states are cognizant of the possibility that drilling and production of natural gas -- including hydraulic fracturing -- may have environmental impacts on their water. The Critical Zone is defined as the zone from vegetation canopy to the lower limits of groundwater. This definition is nebulous in terms of the lower limit, and yet, defining the bottom of the Critical Zone is important if citizens are to embrace shale-gas development. This is because, although no peer-reviewed study has been presented that documents a case where hydraulic fracturing or formation fluids have migrated upwards from fracturing depths to drinking water resources, a few cases of such leakage have been alleged. On the other hand, many cases of methane migration into aquifers have been documented to occur and some have been attributed to shale-gas development. The Critical Zone science community has a role to play in understanding such contamination problems, how they unfold, and how they should be ameliorated. For example, one big effort of the Critical Zone science community is to promote sharing of data describing the environment. This data effort has been extended to provide data for citizens to understand water quality by a team known as the Shale Network. As scientists learn to publish data online, these efforts must also be made accessible to non-scientists. As citizens access the data, the demand for data will grow and all branches of government will eventually respond by providing more accessible data that will help the public and policy-makers make decisions.

Evaluating the process parameters of the dry coating process using a 2(5-1) factorial design.

PubMed

Kablitz, Caroline Désirée; Urbanetz, Nora Anne

2013-02-01

A recent development of coating technology is dry coating, where polymer powder and liquid plasticizer are layered on the cores without using organic solvents or water. Several studies evaluating the process were introduced in literature, however, little information about the critical process parameters (CPPs) is given. Aim of the study was the investigation and optimization of CPPs with respect to one of the critical quality attributes (CQAs), the coating efficiency of the dry coating process in a rotary fluid bed. Theophylline pellets were coated with hydroxypropyl methylcellulose acetate succinate as enteric film former and triethyl citrate and acetylated monoglyceride as plasticizer. A 2(5-1) design of experiments (DOEs) was created investigating five independent process parameters namely coating temperature, curing temperature, feeding/spraying rate, air flow and rotor speed. The results were evaluated by multilinear regression using the software Modde(®) 7. It is shown, that generally, low feeding/spraying rates and low rotor speeds increase coating efficiency. High coating temperatures enhance coating efficiency, whereas medium curing temperatures have been found to be optimum in terms of coating efficiency. This study provides a scientific base for the design of efficient dry coating processes with respect to coating efficiency.

Quality of Life for Diverse Older Adults in Assisted Living: The Centrality of Control.

PubMed

Koehn, Sharon D; Mahmood, Atiya N; Stott-Eveneshen, Sarah

This pilot project asked: How do ethnically diverse older adult residents of assisted living (AL) facilities in British Columbia (BC) experience quality of life? And, what role, if any, do organizational and physical environmental features play in influencing how quality of life is experienced? The study was conducted at three AL sites in BC: two ethnoculturally targeted and one nontargeted. Environmental audits at each site captured descriptive data on policies, fees, rules, staffing, meals, and activities, and the built environment of the AL building and neighborhood. Using a framework that understands the quality of life of older adults to be contingent on their capability to pursue 5 conceptual attributes-attachment, role, enjoyment, security, and control-we conducted 3 focus groups with residents (1 per site) and 6 interviews with staff (2 per site). Attributes were linked to the environmental features captured in the audits. All dimensions of the environment, especially organizational, influence tenants' capability to attain the attributes of quality of life, most importantly control. Although many tenants accept the trade-off between increased safety and diminished control that accompanies a move into AL, more could be done to minimize that loss. Social workers can advocate for the necessary multi-sectoral changes.

Cell culture media supplementation of uncommonly used sugars sucrose and tagatose for the targeted shifting of protein glycosylation profiles of recombinant protein therapeutics.

PubMed

Hossler, Patrick; McDermott, Sean; Racicot, Christopher; Chumsae, Christopher; Raharimampionona, Haly; Zhou, Yu; Ouellette, David; Matuck, Joseph; Correia, Ivan; Fann, John; Li, Jianmin

2014-01-01

Protein glycosylation is an important post-translational modification toward the structure and function of recombinant therapeutics. The addition of oligosaccharides to recombinant proteins has been shown to greatly influence the overall physiochemical attributes of many proteins. It is for this reason that protein glycosylation is monitored by the developer of a recombinant protein therapeutic, and why protein glycosylation is typically considered a critical quality attribute. In this work, we highlight a systematic study toward the supplementation of sucrose and tagatose into cell culture media for the targeted modulation of protein glycosylation profiles on recombinant proteins. Both sugars were found to affect oligosaccharide maturation resulting in an increase in the percentage of high mannose N-glycan species, as well as a concomitant reduction in fucosylation. The latter effect was demonstrated to increase antibody-dependent cell-mediated cytotoxicity for a recombinant antibody. These aforementioned results were found to be reproducible at different scales, and across different Chinese hamster ovary cell lines. Through the selective supplementation of these described sugars, the targeted modulation of protein glycosylation profiles is demonstrated, as well as yet another tool in the cell culture toolbox for ensuring product comparability. © 2014 American Institute of Chemical Engineers.

Detection of cretaceous incised-valley shale for resource play, Miano gas field, SW Pakistan: Spectral decomposition using continuous wavelet transform

NASA Astrophysics Data System (ADS)

Naseer, Muhammad Tayyab; Asim, Shazia

2017-10-01

Unconventional resource shales can play a critical role in economic growth throughout the world. The hydrocarbon potential of faults/fractured shales is the most significant challenge for unconventional prospect generation. The continuous wavelet transforms (CWT) of spectral decomposition (SD) technology is applied for shale gas prospects on high-resolution 3D seismic data from the Miano area in the Indus platform, SW Pakistan. Schmoker' technique reveals high-quality shales with total organic carbon (TOC) of 9.2% distributed in the western regions. The seismic amplitude, root-mean-square (RMS), and most positive curvature attributes show limited ability to resolve the prospective fractured shale components. The CWT is used to identify the hydrocarbon-bearing faulted/fractured compartments encased within the non-hydrocarbon bearing shale units. The hydrocarbon-bearing shales experience higher amplitudes (4694 dB and 3439 dB) than the non-reservoir shales (3290 dB). Cross plots between sweetness, 22 Hz spectral decomposition, and the seismic amplitudes are found more effective tools than the conventional seismic attribute mapping for discriminating the seal and reservoir elements within the incised-valley petroleum system. Rock physics distinguish the productive sediments from the non-productive sediments, suggesting the potential for future shale play exploration.

Milestones of critical thinking: a developmental model for medicine and nursing.

PubMed

Papp, Klara K; Huang, Grace C; Lauzon Clabo, Laurie M; Delva, Dianne; Fischer, Melissa; Konopasek, Lyuba; Schwartzstein, Richard M; Gusic, Maryellen

2014-05-01

Critical thinking is essential to a health professional's competence to assess, diagnose, and care for patients. Defined as the ability to apply higher-order cognitive skills (conceptualization, analysis, evaluation) and the disposition to be deliberate about thinking (being open-minded or intellectually honest) that lead to action that is logical and appropriate, critical thinking represents a "meta-competency" that transcends other knowledge, skills, abilities, and behaviors required in health care professions. Despite its importance, the developmental stages of critical thinking have not been delineated for nurses and physicians. As part of a task force of educators who considered different developmental stage theories, the authors have iteratively refined and proposed milestones in critical thinking. The attributes associated with unreflective, beginning, practicing, advanced, accomplished, and challenged critical thinkers are conceived as independent of an individual's level of training. Depending on circumstances and environmental factors, even the most experienced clinician may demonstrate attributes associated with a challenged thinker. The authors use the illustrative case of a patient with abdominal pain to demonstrate how critical thinking may manifest in learners at different stages of development, analyzing how the learner at each stage applies information obtained in the patient interaction to arrive at a differential diagnosis and plan for evaluation. The authors share important considerations and provide this work as a foundation for the development of effective approaches to teaching and promoting critical thinking and to establishing expectations for learners in this essential meta-competency.