The flexibility of a generic LC-MS/MS method for the quantitative analysis of therapeutic proteins based on human immunoglobulin G and related constructs in animal studies.

PubMed

Lanshoeft, Christian; Wolf, Thierry; Walles, Markus; Barteau, Samuel; Picard, Franck; Kretz, Olivier; Cianférani, Sarah; Heudi, Olivier

2016-11-30

An increasing demand of new analytical methods is associated with the growing number of biotherapeutic programs being prosecuted in the pharmaceutical industry. Whilst immunoassay has been the standard method for decades, a great interest in assays based on liquid chromatography tandem mass spectrometry (LC-MS/MS) is evolving. In this present work, the development of a generic method for the quantitative analysis of therapeutic proteins based on human immunoglobulin G (hIgG) in rat serum is reported. The method is based on four generic peptides GPSVFPLAPSSK (GPS), TTPPVLDSDGSFFLYSK (TTP), VVSVLTVLHQDWLNGK (VVS) and FNWYVDGVEVHNAK (FNW) originating from different parts of the fraction crystallizable (Fc) region of a reference hIgG1 (hIgG1A). A tryptic pellet digestion of rat serum spiked with hIgG1A and a stable isotope labeled protein (hIgG1B) used as internal standard (ISTD) was applied prior LC-MS/MS analysis. The upper limit of quantification was at 1000μg/mL. The lower limit of quantitation was for GPS, TTP and VVS at 1.00μg/mL whereas for FNW at 5.00μg/mL. Accuracy and precision data met acceptance over three days. The presented method was further successfully applied to the quantitative analysis of other hIgG1s (hIgG1C and hIgG1D) and hIgG4-based therapeutic proteins on spiked quality control (QC) samples in monkey and rat serum using calibration standards (Cs) prepared with hIgG1A in rat serum. In order to extend the applicability of our generic approach, a bispecific-bivalent hIgG1 (bb-hIgG1) and two lysine conjugated antibody-drug conjugates (ADC1 and ADC2) were incorporated as well. The observed values on spiked QC samples in monkey serum were satisfactory with GPS for the determination of bb-hIgG1 whereas the FNW and TTP peptides were suitable for the ADCs. Moreover, comparable mean concentration-time profiles were obtained from monkeys previously dosed intravenously with ADC2 measured against Cs samples prepared either with hIgG1A in rat serum (presented approach) or with the actual ADC2 in monkey serum (conventional approach). The results of this study highlight the great flexibility of our newly developed generic approach and that the choice of the surrogate peptide still remains critical when dealing with different matrix types or modalities. Copyright © 2016 Elsevier B.V. All rights reserved.

Smart Plasmonic Glucose Nanosensors as Generic Theranostic Agents for Targeting-Free Cancer Cell Screening and Killing.

PubMed

Chen, Limei; Li, Haijuan; He, Haili; Wu, Haoxi; Jin, Yongdong

2015-07-07

Fast and accurate identification of cancer cells from healthy normal cells in a simple, generic way is very crucial for early cancer detection and treatment. Although functional nanoparticles, like fluorescent quantum dots and plasmonic Au nanoparticles (NPs), have been successfully applied for cancer cell imaging and photothermal therapy, they suffer from the main drawback of needing time-consuming targeting preparation for specific cancer cell detection and selective ablation. The lack of a generic and effective method therefore limits their potential high-throughput cancer cell preliminary screening and theranostic applications. We report herein a generic in vitro method for fast, targeting-free (avoiding time-consuming preparations of targeting moiety for specific cancer cells) visual screening and selective killing of cancer cells from normal cells, by using glucose-responsive/-sensitive glucose oxidase-modified Ag/Au nanoshells (Ag/Au-GOx NSs) as a smart plasmonic theranostic agent. The method is generic to some extent since it is based on the distinct localized surface plasmon resonance (LSPR) responses (and colors) of the smart nanoprobe with cancer cells (typically have a higher glucose uptake level) and normal cells.

Generic particulate-monitoring system for retrofit to Hanford exhaust stacks

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

Camman, J.W.; Carbaugh, E.H.

1982-11-01

Evaluations of 72 sampling and monitoring systems were performed at Hanford as the initial phase of a program to upgrade such systems. Each evaluation included determination of theoretical sampling efficiencies for particle sizes ranging from 0.5 to 10 micrometers aerodynamic equivalent diameter, addressing anisokinetic bias, sample transport line losses, and collector device efficiency. Upgrades needed to meet current Department of Energy guidance for effluent sampling and monitoring were identified, and a cost for each upgrade was estimated. A relative priority for each system's upgrade was then established based on evaluation results, current operational status, and future plans for the facilitymore » being exhausted. Common system upgrade requirements lead to the development of a generic design for common components of an exhaust stack sampling and monitoring system for airborne radioactive particulates. The generic design consists of commercially available off-the-shelf components to the extent practical and will simplify future stack sampling and monitoring system design, fabrication, and installation efforts. Evaluation results and their significance to system upgrades are empasized. A brief discussion of the analytical models used and experience to date with the upgrade program is included. Development of the generic stack sampling and monitoring system design is outlined. Generic system design features and limitations are presented. Requirements for generic system retrofitting to existing exhaust stacks are defined and benefits derived from generic system application are discussed.« less

Sharing, samples, and generics: an antitrust framework.

PubMed

Carrier, Michael A

Rising drug prices are in the news. By increasing price, drug companies have placed vital, even life-saving, medicines out of the reach of consumers. In a recent development, brand firms have prevented generics even from entering the market. The ruse for this strategy involves risk-management programs known as Risk Evaluation and Mitigation Strategies ("REMS"). Pursuant to legislation enacted in 2007, the FDA requires REMS when a drug's risks (such as death or injury) outweigh its rewards. Brands have used this regime, intended to bring drugs to the market, to block generic competition. Regulations such as the federal Hatch-Waxman Act and state substitution laws foster widespread generic competition. But these regimes can only be effectuated through generic entry. And that entry can take place only if a generic can use a brand's sample to show that its product is equivalent. More than 100 generic firms have complained that they have not been able to access needed samples. One study of 40 drugs subject to restricted access programs found that generics' inability to enter cost more than $5 billion a year. Brand firms have contended that antitrust law does not compel them to deal with their competitors and have highlighted concerns related to safety and product liability in justifying their refusals. This Article rebuts these claims. It highlights the importance of samples in the regulatory regime and the FDA's inability to address the issue. It shows how a sharing requirement in this setting is consistent with Supreme Court caselaw. And it demonstrates that the brands' behavior fails the defendant-friendly "no economic sense" test because the conduct literally makes no sense other than by harming generics. Brands' denial of samples offers a textbook case of monopolization. In the universe of pharmaceutical antitrust behavior, other conduct--such as "pay for delay" settlements between brands and generics and "product hopping" from one drug to a slightly modified version--has received the lion's share of attention. But sample denials are overdue for antitrust scrutiny. This Article fills this gap. Given the failure of Congress and the FDA to remedy the issue, antitrust can play a crucial role in ensuring generic access to samples, affirming a linchpin of the pharmaceutical regime.

A randomized comparison of platelet reactivity in patients after treatment with various commercial clopidogrel preparations: the CLO-CLO trial.

PubMed

Oberhänsli, Markus; Lehner, Cédric; Puricel, Serban; Lehmann, Sonja; Togni, Mario; Stauffer, Jean-Christophe; Baeriswyl, Gérard; Goy, Jean-Jacques; Cook, Stéphane

2012-11-01

The salt linked to the clopidogrel molecule in generic preparations is suspected to affect its clinical efficacy. There is a lack of information about inhibition of platelet reactivity by generic preparations. To compare the effect of original clopidogrel (clopidogrel bisulphate [Plavix(®)]), generic clopidogrel preparations (clopidogrel hydrochloride [Clopidogrel-Mepha(®)]; clopidogrel besylate [Clopidogrel Sandoz(®)]) and prasugrel (Efient(®)) on platelet reactivity in patients with coronary artery disease. Patients with coronary artery disease treated with stents received, in a random sequence, original clopidogrel bisulphate, clopidogrel hydrochloride and clopidogrel besylate. Platelet function was assessed with the Multiplate analyser after an initial loading dose (600 mg) and at day 10 after each treatment period. Prasugrel was given for another 10 days. An adenosine diphosphate (ADP) test value<46 antiaggregation units (U) was defined as therapeutic platelet inhibition. Sixty patients (mean age 69 ± 10 years; 50 men) were randomized. Original clopidogrel bisulphate, clopidogrel hydrochloride and clopidogrel besylate provided similar inhibition of platelet reactivity with values of 31 ± 25, 33 ± 28 and 28 ± 23 U, respectively (P not significant). Prasugrel provided better inhibition of platelet function (10 ± 11 vs. 31 ± 25 U for clopidogrel bisulphate; P<0.001). An ADP test value>46 U was measured in 11 patients (18%) with clopidogrel bisulphate, 13 (22%) with clopidogrel besylate and 13 (22%) with clopidogrel hydrochloride compared with only one (2%) with prasugrel. Generic clopidogrel preparations provided similar inhibition of platelet reactivity to original clopidogrel bisulphate, although prasugrel was more efficient. Copyright © 2012 Elsevier Masson SAS. All rights reserved.

Generic Engineering Competencies: A Review and Modelling Approach

ERIC Educational Resources Information Center

Male, Sally A.

2010-01-01

This paper puts forward the view that engineering educators have a responsibility to prepare graduates for engineering work and careers. The current literature reveals gaps between the competencies required for engineering work and those developed in engineering education. Generic competencies feature in these competency gaps. Literature suggests…

GENERIC VERIFICATION PROTOCOL FOR THE VERIFICATION OF PESTICIDE SPRAY DRIFT REDUCTION TECHNOLOGIES FOR ROW AND FIELD CROPS

EPA Science Inventory

This ETV program generic verification protocol was prepared and reviewed for the Verification of Pesticide Drift Reduction Technologies project. The protocol provides a detailed methodology for conducting and reporting results from a verification test of pesticide drift reductio...

10 CFR 51.53 - Postconstruction environmental reports.

Code of Federal Regulations, 2011 CFR

2011-01-01

... impact statement; supplements to the final environmental impact statement, including supplements prepared at the license renewal stage; NRC staff-prepared final generic environmental impact statements; and... reflect new information in addition to that discussed in the final environmental impact statement prepared...

Long-term Stability of Vancomycin Hydrochloride in Glucose 5% Polyolefin Bags: The Brand Name Versus a Generic Product.

PubMed

Huvelle, Sophie; Godet, Marie; Hecq, Jean-Daniel; Gillet, Patricia; Jamart, Jacques; Galanti, Laurence M

2016-01-01

The objectives of this study were to determine if the preparation of vancomycin hydrochloride in advance of infusion could improve the quality of the drug, time management of drug delivery, cost savings of drug delivery, and to investigate the long-term stability of vancomycin hydrochloride (brand name Vancocin®) infusion in glucose 5% polyolefin bags versus the generic (Vancomycine®) at 5°C ± 3°C. Five bags of each infusion 1 g/100 mL vancomycin hydrochloride in 5% glucose (Vancocin ® and Vancomycine®) were stored up to 57 days at 5°C ± 3°C. A visual inspection and pH measurement were performed periodically during the storage, and the concentrations were measured by high-performance liquid chromatography-diode array detection. No color change or precipitation in the solution was observed throughout the study period. As recommended by the U.S. Food and Drug Administration, the lower confidence limit at 95% of the concentration for the solutions remained superior to 90% of the initial concentration up to 43 days for the brand vancomycin (Vancocin®) infusion (96% ± 2%) and up to 57 days for the generic (Vancomycine®) (95% ± 4%). The solutions prepared either from brand or generic vancomycin hydrochloride were chemically stable more than one month (43 days for the brand and 57 days for the generic solution) and could be prepared in advance in a centralized intravenous additive service facility. Copyright© by International Journal of Pharmaceutical Compounding, Inc.

Generic health/safety/environment cases

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

Kelland, A.N.; Primrose, M.; Pickles, J.C.

1996-12-31

A desire to implement HSE Management Systems including HSE Cases in all Shell companies operations prompted the development of a relational data base software package (THESIS) to provide a structured way of preparing an HSE Case. The software includes features which facilitate the management of {open_quotes}Keeping the Case Alive{close_quotes}, enabling the dissemination of tasks and hazard information to the workplace. During the software development it was recognized that a significant reduction could be made in the resources which would be required to prepare an HSE Case for each and every operation by the building of {open_quotes}Generic HSE Cases{close_quotes} addressing specificmore » activities which were repeated across the Company`s operations. This was recognized to be particularly valid for the smaller Single String Venture type of operations. The activities selected for the initial Generic HSE Case development include Land Drilling Operations, Land Seismic Acquisition, and Land Transport. To establish the Generic HSE Case, the THESIS data base is populated with data for a generic operation, identifying all the hazards and activities associated with that operation including all the associated controls, with established formats for the textual sections. In effect, the Generic Case defines the standards required for that type of operation. To generate an operation specific HSE Case, the Generic Case thereafter requires to be modified/adapted so that it represents the actual situation in the operation which it defines. This process includes itemization of all the operation specific details, and may involve the inclusion/deletion of any additional/existing activities or hazards together with their associated controls.« less

Nonisotopic detection of human papillomavirus DNA in clinical specimens using a consensus PCR and a generic probe mix in an enzyme-linked immunosorbent assay format.

PubMed

Kornegay, J R; Shepard, A P; Hankins, C; Franco, E; Lapointe, N; Richardson, H; Coutleé, F

2001-10-01

We assessed the value of a new digoxigenin (DIG)-labeled generic probe mix in a PCR-enzyme-linked immunosorbent assay format to screen for the presence of human papillomavirus (HPV) DNA amplified from clinical specimens. After screening with this new generic assay is performed, HPV DNA-positive samples can be directly genotyped using a reverse blotting method with product from the same PCR amplification. DNA from 287 genital specimens was amplified via PCR using biotin-labeled consensus primers directed to the L1 gene. HPV amplicons were captured on a streptavidin-coated microwell plate (MWP) and detected with a DIG-labeled HPV generic probe mix consisting of nested L1 fragments from types 11, 16, 18, and 51. Coamplification and detection of human DNA with biotinylated beta-globin primers served as a control for both sample adequacy and PCR amplification. All specimens were genotyped using a reverse line blot assay (13). Results for the generic assay using MWPs and a DIG-labeled HPV generic probe mix (DIG-MWP generic probe assay) were compared with results from a previous analysis using dot blots with a radiolabeled nested generic probe mix and type-specific probes for genotyping. The DIG-MWP generic probe assay resulted in high intralaboratory concordance in genotyping results (88% versus 73% agreement using traditional methods). There were 207 HPV-positive results using the DIG-MWP method and 196 positives using the radiolabeled generic probe technique, suggesting slightly improved sensitivity. Only one sample failed to test positive with the DIG-MWP generic probe assay in spite of a positive genotyping result. Concordance between the two laboratories was nearly 87%. Approximately 6% of samples that were positive or borderline when tested with the DIG-MWP generic probe assay were not detected with the HPV type-specific panel, perhaps representing very rare or novel HPV types. This new method is easier to perform than traditional generic probe techniques and uses more objective interpretation criteria, making it useful in studies of HPV natural history.

78 FR 74175 - Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-10

... precision requirements or power calculations that justify the proposed sample size, the expected response...: Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on... Information Collection Request (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback...

Generic tripartite Bell nonlocality sudden death under local phase noise

NASA Astrophysics Data System (ADS)

Ann, Kevin; Jaeger, Gregg

2008-11-01

We definitively show, using an explicit and broadly applicable model, that local phase noise that is capable of eliminating state coherence only in the infinite-time limit is capable of eliminating nonlocality in finite time in three two-level systems prepared in the Bell-nonlocal tripartite states of the generic entanglement class.

Focussing on Generic Skills in Training Packages.

ERIC Educational Resources Information Center

Dawe, Susan

A study assessed whether training packages gave sufficient focus to attainment of generic skills and examined approaches that can be used to enhance the delivery of these skills so students are better prepared for the new demands of the workplace. A literature review and consultations with stakeholders provided information on development of the…

Brain tissue stiffness is a sensitive marker for acidosis.

PubMed

Holtzmann, Kathrin; Gautier, Hélène O B; Christ, Andreas F; Guck, Jochen; Káradóttir, Ragnhildur Thóra; Franze, Kristian

2016-09-15

Carbon dioxide overdose is frequently used to cull rodents for tissue harvesting. However, this treatment may lead to respiratory acidosis, which potentially could change the properties of the investigated tissue. Mechanical tissue properties often change in pathological conditions and may thus offer a sensitive generic readout for changes in biological tissues with clinical relevance. In this study, we performed force-indentation measurements with an atomic force microscope on acute cerebellar slices from adult rats to test if brain tissue undergoes changes following overexposure to CO2 compared to other methods of euthanasia. The pH significantly decreased in brain tissue of animals exposed to CO2. Concomitant with the drop in pH, cerebellar grey matter significantly stiffened. Tissue stiffening was reproduced by incubation of acute cerebellar slices in acidic medium. Tissue stiffness provides an early, generic indicator for pathophysiological changes in the CNS. Atomic force microscopy offers unprecedented high spatial resolution to detect such changes. Our results indicate that the stiffness particularly of grey matter strongly correlates with changes of the pH in the cerebellum. Furthermore, the method of tissue harvesting and preparation may not only change tissue stiffness but very likely also other physiologically relevant parameters, highlighting the importance of appropriate sample preparation. Copyright © 2016 The Authors. Published by Elsevier B.V. All rights reserved.

76 FR 35069 - Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-15

... precision requirements or power calculations that justify the proposed sample size, the expected response...; Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on... (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery...

76 FR 17861 - Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-31

... requirements or power calculations that justify the proposed sample size, the expected response rate, methods...; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery... Information Collection Request (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback...

76 FR 24920 - Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-03

... precision requirements or power calculations that justify the proposed sample size, the expected response... Collection; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service... Information Collection Request (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback...

77 FR 52708 - Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-30

... calculations that justify the proposed sample size, the expected response rate, methods for assessing potential...: Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on... Information Collection request (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback...

A randomized, crossover pharmacokinetic study comparing generic tacrolimus vs. the reference formulation in subpopulations of kidney transplant patients.

PubMed

Bloom, R D; Trofe-Clark, J; Wiland, A; Alloway, R R

2013-01-01

An exploratory, post hoc analysis was performed using data from a prospective, multicenter, open-label, randomized, two-period (14 d per period), two-sequence, crossover, steady-state pharmacokinetic study comparing generic tacrolimus (Sandoz) vs. reference tacrolimus in stable renal transplant patients receiving their pre-study twice-daily dose. Pharmacokinetic parameters were compared in 68 patients according to gender, African American ethnicity, the presence or absence of diabetes, and use of steroids. The ratios of tacrolimus AUC0-12 h , Cmax , and C12 with generic vs. reference tacrolimus were calculated using the geometric mean (GM) of dose-normalized values at days 14 and 28. Mean (SD) tacrolimus dose at baseline was 5.7 (4.2) mg/d. There were no consistent differences in dose-normalized AUC0-12 h , C12 , Cmax, or tmax between the generic and reference preparations within subpopulations. The 90% confidence intervals (CI) for the ratios of dose-normalized AUC0-12 h and C12 with generic vs. reference tacrolimus were within 80-125% for all subpopulations, as were 90% CIs for Cmax other than for females, African Americans, and non-diabetics, which is not unexpected given the wide variability of tacrolimus Cmax and the small subpopulation sizes. These exploratory results suggest that this generic tacrolimus preparation would be expected to offer comparable bioavailability to the reference drug in these patient subpopulations. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

76 FR 25693 - Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-05

... requirements or power calculations that justify the proposed sample size, the expected response rate, methods... Collection; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service... Collection Request (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback on Agency...

76 FR 19826 - Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-08

... calculations that justify the proposed sample size, the expected response rate, methods for assessing potential... Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery AGENCY... (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery...

75 FR 80542 - Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-22

... calculations that justify the proposed sample size, the expected response rate, methods for assessing potential...; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery... Collection Request (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback on Agency...

76 FR 21800 - Agency Information Collection Activities: Submission for OMB Review; Comment Request; Generic...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-18

... precision requirements or power calculations that justify the proposed sample size, the expected response... Activities: Submission for OMB Review; Comment Request; Generic Clearance for the Collection of Qualitative... Request (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service...

In Vitro Stability Evaluation of Different Pharmaceutical Products Containing Meropenem

PubMed Central

Tomasello, Cristina; Leggieri, Anna; Cavalli, Roberta; Di Perri, Giovanni; D’Avolio, Antonio

2015-01-01

Background: Meropenem is a beta-lactam antibiotic for treating multidrug-resistant gram-negative bacilli infections. The expiry of the drug’s patent (Merrem) allowed the production of generics to be commercialized by a few companies, including Hospira and Hikma. The stability of these medicines after reconstitution as reported on a data sheet report is 6 hours for Merrem and 1 hour for generics. Objectives: The aim of this work was to evaluate the stability profile of 3 products in 0.9% sodium chloride until 6 hours. Methods: Six polyolefin bags (2 for each drug, stored in the light and in the dark) were prepared for every test run (n =10) at concentrations of 4 and 10 mg/mL. All solutions were stored at controlled room temperature (25°C ± 3°C) and sampled immediately after preparation and at every hour until 6 hours had passed. The concentrations, pH changes, and the visual clarity were used as stability and compatibility indicators. Results: All 3 drugs retained over 95% of the initial concentration at 3 to 4 hours. At the sixth hour, all the concentrations decayed 8% to 10%. No statistical differences were observed in the percentage deviation values of the stability profile between generics and the branded drug. Conclusion: The stability profile of the products in polyolefin bags, at 4 and 10 mg/mL, was superimposable during the period of analysis and seems to show small values of deviation (1%-2%). These data do not affect the pharmacokinetics because these variations could be attributed to the intra- and interindividual variability between patients. The products showed the same stability, and consequently they could be used interchangeably in hospital pharmacy. PMID:26448659

A generic method for the determination of acrylamide in thermally processed foods.

PubMed

Gökmen, Vural; Senyuva, Hamide Z

2006-07-07

A generic sample preparation method for the determination of acrylamide in foods was developed. The method entails extraction with methanol, purification with Carrez I and II solutions, evaporation and solvent change to water, and cleanup with Oasis HLB solid-phase extraction (SPE) cartridge. The final extract was analyzed by liquid chromatography-mass spectrometry (LC-MS) for quantitation. The chromatographic separation was performed on ODS-3 column using the isocratic mixture of 0.01 mM acetic acid in 0.2% aqueous solution of formic acid at a flow rate of 0.6 ml/min at 25 degrees C. The recoveries of acrylamide from potato chips, biscuits and coffee ranged between 92.8 and 101.5% with relative standard deviations of 4.1% or less. The limit of detection (LOD) and the limit of quantitation (LOQ) were 2 ng/g and 6 ng/g in the basis of signal to noise ratios of 3:1 and 9:1, respectively.

Determination of anti-inflammatory activities of standardised preparations of plant- and mushroom-based foods.

PubMed

Gunawardena, Dhanushka; Shanmugam, Kirubakaran; Low, Mitchell; Bennett, Louise; Govindaraghavan, Suresh; Head, Richard; Ooi, Lezanne; Münch, Gerald

2014-02-01

Chronic inflammatory processes contribute to the pathogenesis of many age-related diseases. In search of anti-inflammatory foods, we have systematically screened a variety of common dietary plants and mushrooms for their anti-inflammatory activity. A selection of 115 samples was prepared by a generic food-compatible processing method involving heating. These products were tested for their anti-inflammatory activity in murine N11 microglia and RAW 264.7 macrophages, using nitric oxide (NO) and tumour necrosis factor-α (TNF-α) as pro-inflammatory readouts. Ten food samples including lime zest, English breakfast tea, honey-brown mushroom, button mushroom, oyster mushroom, cinnamon and cloves inhibited NO production in N11 microglia, with IC50 values below 0.5 mg/ml. The most active samples were onion, oregano and red sweet potato, exhibiting IC50 values below 0.1 mg/ml. When these ten food preparations were retested in RAW 264.7 macrophages, they all inhibited NO production similar to the results obtained in N11 microglia. In addition, English breakfast tea leaves, oyster mushroom, onion, cinnamon and button mushroom preparations suppressed TNF-α production, exhibiting IC50 values below 0.5 mg/ml in RAW 264.7 macrophages. In summary, anti-inflammatory activity in these food samples survived 'cooking'. Provided that individual bioavailability allows active compounds to reach therapeutic levels in target tissues, these foods may be useful in limiting inflammation in a variety of age-related inflammatory diseases. Furthermore, these foods could be a source for the discovery of novel anti-inflammatory drugs.

Biocompatibility of metal injection molded versus wrought ASTM F562 (MP35N) and ASTM F1537 (CCM) cobalt alloys.

PubMed

Chen, Hao; Sago, Alan; West, Shari; Farina, Jeff; Eckert, John; Broadley, Mark

2011-01-01

We present a comparative analysis between biocompatibility test results of wrought and Metal Injection Molded (MIM) ASTM F562-02 UNS R30035 (MP35N) and F1537 UNS R31538 (CCM) alloy samples that have undergone the same generic orthopedic implant's mechanical, chemical surface pre-treatment, and a designed pre-testing sample preparation method. Because the biocompatibility properties resulting from this new MIM cobalt alloy process are not well understood, we conducted tests to evaluate cytotoxicity (in vitro), hemolysis (in vitro), toxicity effects (in vivo), tissue irritation level (in vivo), and pyrogenicity count (in vitro) on such samples. We show that our developed MIM MP35N and CCM materials and treatment processes are biocompatible, and that both the MIM and wrought samples, although somewhat different in microstructure and surface, do not show significant differences in biocompatibility.

Alaska IPASS database preparation manual.

Treesearch

P. McHugh; D. Olson; C. Schallau

1989-01-01

Describes the data, their sources, and the calibration procedures used in compiling a database for the Alaska IPASS (interactive policy analysis simulation system) model. Although this manual is for Alaska, it provides generic instructions for analysts preparing databases for other geographical areas.

The transition to hospital consultant and the influence of preparedness, social support, and perception: A structural equation modelling approach.

PubMed

Westerman, Michiel; Teunissen, Pim W; Fokkema, Joanne P I; van der Vleuten, Cees P M; Scherpbier, Albert J J A; Siegert, Carl E H; Scheele, Fedde

2013-04-01

Insight into the transition from specialist registrar to hospital consultant is needed to better align specialty training with starting as a consultant and to facilitate this transition. This study investigates whether preparedness regarding medical and generic competencies, perceived intensity, and social support are associated with burnout among new consultants. A population-based study among all 2643 new consultants in the Netherlands (all specialties) was conducted in June 2010. A questionnaire covering preparedness for practice, intensity of the transition, social support, and burnout was used. Structural equation modelling was used for statistical analysis. Data from a third of the population were available (32% n = 840) (43% male/57% female). Preparation in generic competencies received lower ratings than in medical competencies. A total of 10% met the criteria for burnout and 18% scored high on the emotional exhaustion subscale. Perceived lack of preparation in generic competencies correlated with burnout (r = 0.15, p < 0.001). No such relation was found for medical competencies. Furthermore, social support protected against burnout. These findings illustrate the relevance of generic competencies for new hospital consultants. Furthermore, social support facilitates this intense and stressful stage within the medical career.

Generic medications for you, but brand-name medications for me.

PubMed

Keenum, Amy J; Devoe, Jennifer E; Chisolm, Deena J; Wallace, Lorraine S

2012-01-01

Because generic medications are less expensive than brand-name medications, government and private insurers have encouraged and/or mandated the use of generics. This study aimed at evaluating perceptions about generic medications among English-speaking women of childbearing age currently enrolled in U.S. TennCare (Medicaid). We recruited a convenience sample of patients from the waiting room of a primary care/gynecology health clinic, with 80% recruitment rate among those approached. We orally administered a 25-item questionnaire to gather sociodemographic information and to assess beliefs regarding the efficacy, safety, cost, and preferences for personal use of generic medications. The average age of the women (n=172) was 28.8 ± 6.4 years, and most were white (82.0%) and currently married (58.1%). Nearly one-fifth (19.2%) had not completed high school. Most women believed that generic medications were less expensive (97.6%) and better value (60.5%) than brand-name medications, but only 45.3% preferred to take generics themselves. About a quarter (23.3%) believed that brand-name medications were more effective than generics, whereas 13.4% believed that generics caused more side effects. Few women reported that their doctor (29.7%) and/or pharmacist (35.5%) had ever talked to them about taking generics. Awareness of the benefits of generics did not equal preferences for personal use of generics among this sample of women enrolled in U.S. TennCare. Furthermore, women reported that providers-both physicians and pharmacists-infrequently discussed generic substitution with them. Copyright © 2012 Elsevier Inc. All rights reserved.

Preparing for the workplace: fostering generic attributes in allied health education programs.

PubMed

Higgs, J; Hunt, A

1999-01-01

Allied health curricula need to extend beyond the learning of discipline-specific skills to encompass broader learning goals. In particular, the acquisition of generic skills is necessary to enable graduates to function more competently and confidently within their rapidly changing work, professional, and societal environments. In health sciences education particularly, the rate of change in practice and education is rapid and unprecedented. If educators focus on components of the curriculum rather than the entire learning experience, they are likely to significantly limit the students' acquisition of such generic skills. To achieve the desired generic skills outcomes, an overarching, integrated, and consistently applied curriculum strategy is advocated. This article considers a number of such strategies relevant to allied health education.

Preparedness for practice: a systematic cross-specialty evaluation of the alignment between postgraduate medical education and independent practice.

PubMed

Dijkstra, Ids S; Pols, Jan; Remmelts, Pine; Brand, Paul L P

2015-02-01

Postgraduate medical education training programs strive to prepare their trainees optimally for independent practice. Several studies have shown, however, that new consultants feel inadequately prepared for practice, and that this increases the risk of stress and burnout. To analyze across specialties for which tasks and themes new consultants feel inadequately prepared. And, to identify themes that need improved attention in postgraduate medical education programs or after registration. 330 New consultants from all hospital specialities with accredited training programs who completed their training in the north-eastern educational region of The Netherlands between 2004 and 2010 received a questionnaire which was based on a previously validated generic task inventory. 143 respondents (43%) returned the questionnaire. They felt excellently prepared for 40 tasks, well prepared for 25 tasks, marginally sufficiently prepared for 18 tasks and insufficiently prepared for 8 tasks. Preparedness scores were lowest for tasks concerning management administration and leadership, research, end-of-life care, and patient safety-related communication. Surgical specialists felt better prepared for practice than medical specialists, which could not be explained by differences in general self-efficacy. Although new consultants felt well prepared for medical tasks, the scores of more generic tasks indicate that the alignment between the different phases of the medical education continuum and independent practice needs improvement.

A generic interface between COSMIC/NASTRAN and PATRAN (R)

NASA Technical Reports Server (NTRS)

Roschke, Paul N.; Premthamkorn, Prakit; Maxwell, James C.

1990-01-01

Despite its powerful analytical capabilities, COSMIC/NASTRAN lacks adequate post-processing adroitness. PATRAN, on the other hand is widely accepted for its graphical capabilities. A nonproprietary, public domain code mnemonically titled CPI (for COSMIC/NASTRAN-PATRAN Interface) is designed to manipulate a large number of files rapidly and efficiently between the two parent codes. In addition to PATRAN's results file preparation, CPI also prepares PATRAN's P/PLOT data files for xy plotting. The user is prompted for necessary information during an interactive session. Current implementation supports NASTRAN's displacement approach including the following rigid formats: (1) static analysis, (2) normal modal analysis, (3) direct transient response, and (4) modal transient response. A wide variety of data blocks are also supported. Error trapping is given special consideration. A sample session with CPI illustrates its simplicity and ease of use.

Microbial safety and quality of fresh herbs from Los Angeles, Orange County and Seattle farmers' markets.

PubMed

Levy, Donna J; Beck, Nicola K; Kossik, Alexandra L; Patti, Taylor; Meschke, J Scott; Calicchia, Melissa; Hellberg, Rosalee S

2015-10-01

Farmers' markets have been growing in popularity in the United States, but the microbial quality and safety of the food sold at these markets is currently unknown. The purpose of this study was to assess the microbial safety and quality of fresh basil, parsley and cilantro sold at farmers' markets in the Los Angeles, Orange County and greater Seattle areas. A total of 133 samples (52 basil, 41 cilantro and 40 parsley) were collected from 13 different farmers' markets and tested for Salmonella and generic Escherichia coli. One sample (parsley) was confirmed positive for Salmonella and 24.1% of samples were positive for generic E. coli, with a range of 0.70-3.15 log CFU g(-1) . Among the herbs tested, basil showed the highest percentage of samples with generic E. coli (26.9%), followed by cilantro (24.4%) and then parsley (20.0%). For 12% of samples, the levels of generic E. coli exceeded guidelines established by the Public Health Laboratory Service for microbiological quality of ready-to-eat foods. Overall, this study indicates the presence of Salmonella and generic E. coli in fresh herbs sold at farmers' markets; however, additional studies are needed to determine the sources and extent of contamination. © 2014 Society of Chemical Industry.

ATR-FTIR characterization of generic brand-named and counterfeit sildenafil- and tadalafil-based tablets found on the Brazilian market.

PubMed

Coelho Neto, José; Lisboa, Fernanda L C

2017-07-01

Viagra and Cialis are among the most counterfeited medicines in many parts of the world, including Brazil. Despite the many studies that have been made regarding discrimination between genuine and counterfeit samples, most published works do not contemplate generic and similar versions of these medicines and also do not explore excipients/adjuvants contributions when characterizing genuine and suspected samples. In this study, we present our findings in exploring ATR-FTIR spectral profiles for characterizing both genuine and questioned samples of several generic and brand-name sildenafil- and tadalafil-based tablets available on the Brazilian market, including Viagra and Cialis. Multi-component spectral matching (deconvolution), objective visual comparison and correlation tests were used during analysis. Besides from allowing simple and quick identification of counterfeits, results obtained evidenced the strong spectral similarities between generic and brand-named tablets employing the same active ingredient and the indistinguishability between samples produced by the same manufacturer, generic or not. For all sildenafil-based and some tadalafil-based tablets tested, differentiation between samples from different manufacturers, attributed to slight variations in excipients/adjuvants proportions, was achieved, thus allowing the possibility of tracing an unknown/unidentified tablet back to a specific manufacturer. Copyright © 2017 The Chartered Society of Forensic Sciences. Published by Elsevier B.V. All rights reserved.

Creating a Culture of Thinking in DCPS: A Generic Proposal for the District of Columbia Public Schools Board of Education

ERIC Educational Resources Information Center

Fluellen, Jerry E., Jr.

2006-01-01

Preparing students for college and work in the Knowledge Age. That is the mission of this generic proposal. A counterpoint to Industrial Age mindsets marking most initiatives in the District of Columbia Public schools and described in the "fifth discipline" works of Peter Senge, Creating a Culture of Thinking in DCPS proposes a project…

What Is the Future of Generics in Transplantation?

PubMed

van Gelder, Teun

2015-11-01

Generic immunosuppressive drugs are available in Europe, Canada, and the United States. Between countries, there are large differences in the market penetration of generic drugs in general, and for immunosuppressive drugs in particular. The registration criteria for generic immunosuppressive drugs are often criticized. However, it is unlikely that the criteria for registration of narrow therapeutic index drugs are going to change, and bioequivalence studies, performed in healthy volunteers, will remain the backbone of the registration process. It would be good if the registration authorities would demand that all generic variants of an innovator drug have the same pill appearance to reduce errors and promote drug adherence.To allow for safe substitution, a number of criteria need to be fulfilled. Generic substitution should not be taken out of the hands of the treating physicians. Generic substitution can only be done safely if initiated by the prescriber, and in well-informed and prepared patients. Payers should refrain from forcing pharmacists to dispense generic drugs in patients on maintenance treatment with innovator drug. Instead, together with transplant societies, they should design guidelines on how to implement generic immunosuppressive drugs into clinical practice. Substitutions must be followed by control visits to check if the patient is taking the medication correctly and if drug exposure remains stable. Inadvertent, uncontrolled substitutions from 1 generic to another, initiated outside the scope of the prescriber, must be avoided as they are unsafe. Repetitive subsequent generic substitutions result in minimal additional cost savings and have an inherent risk of medication errors.

Impact of generic substitution decision support on electronic prescribing behavior.

PubMed

Stenner, Shane P; Chen, Qingxia; Johnson, Kevin B

2010-01-01

To evaluate the impact of generic substitution decision support on electronic (e-) prescribing of generic medications. The authors analyzed retrospective outpatient e-prescribing data from an academic medical center and affiliated network for July 1, 2005-September 30, 2008 using an interrupted time-series design to assess the rate of generic prescribing before and after implementing generic substitution decision support. To assess background secular trends, e-prescribing was compared with a concurrent random sample of hand-generated prescriptions. Proportion of generic medications prescribed before and after the intervention, evaluated over time, and compared with a sample of prescriptions generated without e-prescribing. The proportion of generic medication prescriptions increased from 32.1% to 54.2% after the intervention (22.1% increase, 95% CI 21.9% to 22.3%), with no diminution in magnitude of improvement post-intervention. In the concurrent control group, increases in proportion of generic prescriptions (29.3% to 31.4% to 37.4% in the pre-intervention, post-intervention, and end-of-study periods, respectively) were not commensurate with the intervention. There was a larger change in generic prescribing rates among authorized prescribers (24.6%) than nurses (18.5%; adjusted OR 1.38, 95% CI 1.17 to 1.63). Two years after the intervention, the proportion of generic prescribing remained significantly higher for e-prescriptions (58.1%; 95% CI 57.5% to 58.7%) than for hand-generated prescriptions ordered at the same time (37.4%; 95% CI 34.9% to 39.9%) (p<0.0001). Generic prescribing increased significantly in every specialty. Implementation of generic substitution decision support was associated with dramatic and sustained improvements in the rate of outpatient generic e-prescribing across all specialties.

Impact of generic substitution decision support on electronic prescribing behavior

PubMed Central

Chen, Qingxia; Johnson, Kevin B

2010-01-01

Objective To evaluate the impact of generic substitution decision support on electronic (e-) prescribing of generic medications. Design The authors analyzed retrospective outpatient e-prescribing data from an academic medical center and affiliated network for July 1, 2005–September 30, 2008 using an interrupted time-series design to assess the rate of generic prescribing before and after implementing generic substitution decision support. To assess background secular trends, e-prescribing was compared with a concurrent random sample of hand-generated prescriptions. Measurements Proportion of generic medications prescribed before and after the intervention, evaluated over time, and compared with a sample of prescriptions generated without e-prescribing. Results The proportion of generic medication prescriptions increased from 32.1% to 54.2% after the intervention (22.1% increase, 95% CI 21.9% to 22.3%), with no diminution in magnitude of improvement post-intervention. In the concurrent control group, increases in proportion of generic prescriptions (29.3% to 31.4% to 37.4% in the pre-intervention, post-intervention, and end-of-study periods, respectively) were not commensurate with the intervention. There was a larger change in generic prescribing rates among authorized prescribers (24.6%) than nurses (18.5%; adjusted OR 1.38, 95% CI 1.17 to 1.63). Two years after the intervention, the proportion of generic prescribing remained significantly higher for e-prescriptions (58.1%; 95% CI 57.5% to 58.7%) than for hand-generated prescriptions ordered at the same time (37.4%; 95% CI 34.9% to 39.9%) (p<0.0001). Generic prescribing increased significantly in every specialty. Conclusion Implementation of generic substitution decision support was associated with dramatic and sustained improvements in the rate of outpatient generic e-prescribing across all specialties. PMID:20962131

76 FR 12960 - Agency Information Collection Activities: Proposed Collection; Comment Request

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... population to which generalizations will be made, the sampling frame, the sample design (including... for submission for other generic mechanisms that are designed to yield quantitative results. The... generic clearance for qualitative information will not be used for quantitative information collections...

A generic template for automated bioanalytical ligand-binding assays using modular robotic scripts in support of discovery biotherapeutic programs.

PubMed

Duo, Jia; Dong, Huijin; DeSilva, Binodh; Zhang, Yan J

2013-07-01

Sample dilution and reagent pipetting are time-consuming steps in ligand-binding assays (LBAs). Traditional automation-assisted LBAs use assay-specific scripts that require labor-intensive script writing and user training. Five major script modules were developed on Tecan Freedom EVO liquid handling software to facilitate the automated sample preparation and LBA procedure: sample dilution, sample minimum required dilution, standard/QC minimum required dilution, standard/QC/sample addition, and reagent addition. The modular design of automation scripts allowed the users to assemble an automated assay with minimal script modification. The application of the template was demonstrated in three LBAs to support discovery biotherapeutic programs. The results demonstrated that the modular scripts provided the flexibility in adapting to various LBA formats and the significant time saving in script writing and scientist training. Data generated by the automated process were comparable to those by manual process while the bioanalytical productivity was significantly improved using the modular robotic scripts.

Generic hierarchical engine for mask data preparation

NASA Astrophysics Data System (ADS)

Kalus, Christian K.; Roessl, Wolfgang; Schnitker, Uwe; Simecek, Michal

2002-07-01

Electronic layouts are usually flattened on their path from the hierarchical source downstream to the wafer. Mask data preparation has certainly been identified as a severe bottleneck since long. Data volumes are not only doubling every year along the ITRS roadmap. With the advent of optical proximity correction and phase-shifting masks data volumes are escalating up to non-manageable heights. Hierarchical treatment is one of the most powerful means to keep memory and CPU consumption in reasonable ranges. Only recently, however, has this technique acquired more public attention. Mask data preparation is the most critical area calling for a sound infrastructure to reduce the handling problem. Gaining more and more attention though, are other applications such as large area simulation and manufacturing rule checking (MRC). They all would profit from a generic engine capable to efficiently treat hierarchical data. In this paper we will present a generic engine for hierarchical treatment which solves the major problem, steady transitions along cell borders. Several alternatives exist how to walk through the hierarchy tree. They have, to date, not been thoroughly investigated. One is a bottom-up attempt to treat cells starting with the most elementary cells. The other one is a top-down approach which lends itself to creating a new hierarchy tree. In addition, since the variety, degree of hierarchy and quality of layouts extends over a wide range a generic engine has to take intelligent decisions when exploding the hierarchy tree. Several applications will be shown, in particular how far the limits can be pushed with the current hierarchical engine.

Thiolated graphene - a new platform for anchoring CdSe quantum dots for hybrid heterostructures

NASA Astrophysics Data System (ADS)

Debgupta, Joyashish; Pillai, Vijayamohanan K.

2013-04-01

Effective organization of small CdSe quantum dots on graphene sheets has been achieved by a simple solution exchange with thiol terminated graphene prepared by diazonium salt chemistry. This generic methodology of CdSe QD attachment to any graphene surface has remarkable implications in designing hybrid heterostructures.Effective organization of small CdSe quantum dots on graphene sheets has been achieved by a simple solution exchange with thiol terminated graphene prepared by diazonium salt chemistry. This generic methodology of CdSe QD attachment to any graphene surface has remarkable implications in designing hybrid heterostructures. Electronic supplementary information (ESI) available. See DOI: 10.1039/c3nr00363a

Quantitative determination of clopidogrel and its metabolites in biological samples: a mini-review.

PubMed

Elsinghorst, Paul W

2013-02-15

Clopidogrel has been applied in antiplatelet therapy since 1998 and is the thienopyridine with the largest clinical experience. By 2011, clopidogrel (Plavix(®)) was the second top-selling drug in the world. Following complete patent expiry in 2012/2013 its use is expected to grow even further from generics entering the market. Prefaced by a brief description of clopidogrel metabolism, this review analyzes analytical methods addressing the quantification of clopidogrel and its metabolites in biological samples. Techniques that have been applied to analyze human plasma or serum are predominantly LC-MS and LC-MS/MS. The lowest level of clopidogrel quantification that has been achieved is 5pg/mL, the shortest runtime is 1.5min and almost 100% recovery has been reported using solid-phase extraction for sample preparation. Copyright © 2013 Elsevier B.V. All rights reserved.

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Occurrence of foodborne bacteria in Alberta feedlots.

PubMed

Van Donkersgoed, Joyce; Bohaychuk, Valerie; Besser, Thomas; Song, Xin-Ming; Wagner, Bruce; Hancock, Dale; Renter, David; Dargatz, David

2009-02-01

The occurrence of generic Escherichia coli, E. coli O157, Salmonella, and Campylobacter in cattle manure, beef carcasses, catch basin water, and soils receiving manure application was determined in 21 Alberta feedlots. In cattle manure, generic E. coli (98%, 2069/2100) and Campylobacter (76%, 1590/2100) were frequently detected; E. coli O157 (7%, 143/2100) and Salmonella (1%, 20/2100) were less frequently detected. Samples from beef carcasses in the cooler following Hazard Analysis Critical Control Point interventions yielded only 1 isolate each of generic E. coli and Campylobacter (1/1653) and no Salmonella (0/1653). Catch basin water specimens were positive for generic E. coli in both the spring (62%, 13/21) and the fall (52%, 11/21). Other bacteria were detected only in the spring water specimens, including E. coli O157 (29%, 6/21), Salmonella (5%, 1/21), and Campylobacter (52%, 11/21). Generic E. coli was frequently isolated from soil specimens (30%, 27/88), but E. coli O157 was not found in soil samples obtained in the spring and was only occasionally detected in the fall samples (9%, 3/32). Salmonella were occasionally found in the soil specimens collected in the spring (3%, 2/56), but not in the fall season (0/32). Campylobacter jejuni was frequent in cattle manure (66%, 1070/1623), but rare in carcass and environmental samples. E. coli O157 and Salmonella were rarely detected in cattle or the environment. Generic E. coli and Salmonella were rarely detected on carcasses.

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FTIR quantification of industrial hydraulic fluids in perchloroethylene

NASA Technical Reports Server (NTRS)

Mehta, Narinder K.

1993-01-01

The purpose of this summer research project was to investigate whether perchloroethylene can be used as a solvent for the quantitative analysis of industrial hydraulic fluids by infrared spectroscopy employing Beer's law. Standard calibration curves using carbon-hydrogen stretching (generic) and ester absorption peaks were prepared for a series of standard dilutions at low ppm levels of concentration of seven hydraulic fluids in perchloroethylene. The absorbance spectras were recorded with 1.5-10 mm fixed and variable path length sample cells made of potassium bromide. The results indicate that using ester infrared spectral peak, it is possible to detect about 20 ppm of the hydraulic fluid in perchloroethylene.

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... target population to which generalizations will be made, the sampling frame, the sample design (including... for submission for other generic mechanisms that are designed to yield quantitative results. The MSPB... insights on perceptions and opinions, but are not statistical surveys that yield quantitative results that...

[HERA-QUEST: HTA evaluation of generic pharmaceutical products to improve quality, economic efficiency, patient safety and transparency in drug product changes in hospitals].

PubMed

Gyalrong-Steur, Miriam; Kellermann, Anita; Bernard, Rudolf; Berndt, Georg; Bindemann, Meike; Nusser-Rothermundt, Elfriede; Amann, Steffen; Brakebusch, Myga; Brüggmann, Jörg; Tydecks, Eva; Müller, Markus; Dörje, Frank; Kochs, Eberhard; Riedel, Rainer

2017-04-01

In view of the rising cost pressure and an increasing number of drug shortages, switches between generic drug preparations have become a daily routine in hospitals. To ensure consistently high treatment quality and best possible patient safety, the equivalence of the new and the previous drug preparation must be ensured before any change in the purchase of pharmaceutical products takes place. So far, no easily usable, transparent and standardized instrument for this kind of comparison between generic drug products has been available. A group of pharmaceutical experts has developed the drug HTA (health technology assessment) model "HERA" (HTA Evaluation of geneRic phArmaceutical products) through a multi-step process. The instrument is designed to perform both a qualitative and economic comparison of equivalent drug preparations ("aut idem" substitution) before switching products. The economic evaluation does not only consider unit prices and consumption quantity, but also the processing costs associated with a product change process. The qualitative comparison is based on the evaluation of 34 quality criteria belonging to six evaluation fields (e.g., approval status, practical handling, packaging design). The objective evaluation of the quality criteria is complemented by an assessment of special features of the individual hospital for complex drug switches, including the feedback of the physicians utilizing the drug preparation. Thus potentially problematic switches of pharmaceutical products can be avoided at the best possible rate, contributing to the improvement of patient safety. The novel drug HTA model HERA is a tool used in clinical practice that can add to an increase in quality, therapeutic safety and transparency of drug use while simultaneously contributing to the economic optimization of drug procurement in hospitals. Combining these two is essential for hospitals facing the tension between rising cost pressure and at the same time increasing demands on quality and transparency, triggered by, amongst others, current legislation (Hospital Structures Act, anti-corruption legislation). Copyright © 2017. Published by Elsevier GmbH.

Strategies That Delay Market Entry of Generic Drugs.

PubMed

Vokinger, Kerstin Noëlle; Kesselheim, Aaron S; Avorn, Jerry; Sarpatwari, Ameet

2017-11-01

Increasing prescription drug expenditures in the United States are primarily driven by high brand-name drug prices. Although generic competition helps lower drug prices, manufacturers of brand-name drugs often work to delay the availability of generic versions of their products. Strategies to forestall generic competition include patenting peripheral aspects of a drug or modified formulations that do not add clinical value, paying generic manufacturers to settle lawsuits challenging the validity of patents on brand-name drugs ("reverse payment" settlements), denying generic manufacturers access to drug samples necessary for bioequivalence testing, misusing risk evaluation and mitigation strategies, and filing citizen petitions with the US Food and Drug Administration (FDA). To address such tactics, the federal government can interpret existing patenting standards more strictly and promote certain types of patent challenges to ensure that patents are granted or upheld only for true innovations. Congress can enact pending legislation that would help discourage reverse payment settlements and compel brand-name manufacturers to share drug samples for bioequivalence testing. Finally, the FDA can provide earlier guidance on bioequivalence determinations for complex generic products and adopt the presumption that late-filed citizen petitions should be summarily rejected.

Experiential Placements: Dissemination and Stakeholder Engagement for Curriculum Planning Action to Prepare Future Pharmacy Professionals

ERIC Educational Resources Information Center

Owen, Susanne; Stupans, Ieva

2009-01-01

Preparing graduates for the professions is increasingly recognised as involving a partnership approach to curriculum design, implementation and evaluation. Experiential placements play a critical role in developing discipline-specific knowledge and skills and also generic professional dispositions including relationships, communication, problem…

Pharmaceutical Equivalence of Distributed Generic Antiretroviral (ARV) in Asian Settings: The Cross-Sectional Surveillance Study - PEDA Study.

PubMed

Sapsirisavat, Vorapot; Vongsutilers, Vorasit; Thammajaruk, Narukjaporn; Pussadee, Kanitta; Riyaten, Prakit; Kerr, Stephen; Avihingsanon, Anchalee; Phanuphak, Praphan; Ruxrungtham, Kiat

2016-01-01

Ensuring that medicines meet quality standards is mandatory for ensuring safety and efficacy. There have been occasional reports of substandard generic medicines, especially in resource-limiting settings where policies to control quality may be less rigorous. As HIV treatment in Thailand depends mostly on affordable generic antiretrovirals (ARV), we performed quality assurance testing of several generic ARV available from different sources in Thailand and a source from Vietnam. We sampled Tenofovir 300mg, Efavirenz 600mg and Lopinavir/ritonavir 200/50mg from 10 primary hospitals randomly selected from those participating in the National AIDS Program, 2 non-government organization ARV clinics, and 3 private drug stores. Quality of ARV was analyzed by blinded investigators at the Faculty of Pharmaceutical Science, Chulalongkorn University. The analysis included an identification test for drug molecules, a chemical composition assay to quantitate the active ingredients, a uniformity of mass test and a dissolution test to assess in-vitro drug release. Comparisons were made against the standards described in the WHO international pharmacopeia. A total of 42 batches of ARV from 15 sources were sampled from January-March 2015. Among those generics, 23, 17, 1, and 1 were Thai-made, Indian-made, Vietnamese-made and Chinese-made, respectively. All sampled products, regardless of manufacturers or sources, met the International Pharmacopeia standards for composition assay, mass uniformity and dissolution. Although local regulations restrict ARV supply to hospitals and clinics, samples of ARV could be bought from private drug stores even without formal prescription. Sampled generic ARVs distributed within Thailand and 1 Vietnamese pharmacy showed consistent quality. However some products were illegally supplied without prescription, highlighting the importance of dispensing ARV for treatment or prevention in facilities where continuity along the HIV treatment and care cascade is available.

Optimisation of a Generic Ionic Model of Cardiac Myocyte Electrical Activity

PubMed Central

Guo, Tianruo; Al Abed, Amr; Lovell, Nigel H.; Dokos, Socrates

2013-01-01

A generic cardiomyocyte ionic model, whose complexity lies between a simple phenomenological formulation and a biophysically detailed ionic membrane current description, is presented. The model provides a user-defined number of ionic currents, employing two-gate Hodgkin-Huxley type kinetics. Its generic nature allows accurate reconstruction of action potential waveforms recorded experimentally from a range of cardiac myocytes. Using a multiobjective optimisation approach, the generic ionic model was optimised to accurately reproduce multiple action potential waveforms recorded from central and peripheral sinoatrial nodes and right atrial and left atrial myocytes from rabbit cardiac tissue preparations, under different electrical stimulus protocols and pharmacological conditions. When fitted simultaneously to multiple datasets, the time course of several physiologically realistic ionic currents could be reconstructed. Model behaviours tend to be well identified when extra experimental information is incorporated into the optimisation. PMID:23710254

Generic drugs in Brazil: known by many, used by few.

PubMed

Bertoldi, Andréa D; Barros, Aluísio J D; Hallal, Pedro C

2005-01-01

This study evaluated knowledge and use of generic drugs in a population-based sample of adults from a southern Brazilian city. The outcomes were: the proportion of generics in total medicines used; theoretical and practical knowledge about generics; and strategies used to buy medicines on medical prescriptions. The recall period for drug utilization was 15 days. The proportion of generics in total medicines was 3.9%. While 86.0% knew that generics cost less and 70.0% that the quality is similar to brand name medicines, only 57.0% knew any packaging characteristics that distinguish generics from other medicines. The highest proportion of generic drug utilization was in the antimicrobial pharmacological group. A brand name medicine (with a brand similar to the generic name) was mistakenly classified as a generic through photos by 48.0% of the interviewees. Among subjects who bought medicines in the 15-day period, 18.9% reported buying a generic, but this result should be interpreted with caution, because the population frequently fails to differentiate between generics and other medicines.

Perceptions and utilization of generic medicines in Guatemala: a mixed-methods study with physicians and pharmacy staff.

PubMed

Flood, David; Mathieu, Irène; Chary, Anita; García, Pablo; Rohloff, Peter

2017-01-13

Access to low-cost essential generic medicines is a critical health policy goal in low-and-middle income countries (LMICs). Guatemala is an LMIC where there is both limited availability and affordability of these medications. However, attitudes of physicians and pharmacy staff regarding low-cost generics, especially generics for non-communicable diseases (NCDs), have not been fully explored in Guatemala. Semi-structured interviews with 30 pharmacy staff and 12 physicians in several highland towns in Guatemala were conducted. Interview questions related to perceptions of low-cost generic medicines, prescription and dispensing practices of generics in the treatment of two NCDs, diabetes and hypertension, and opinions about the roles of pharmacy staff and physicians in selecting medicines for patients. Pharmacy staff were recruited from a random sample of pharmacies and physicians were recruited from a convenience sample. Interview data were analyzed using a thematic approach for qualitative data as well as basic quantitative statistics. Pharmacy staff and physicians expressed doubt as to the safety and efficacy of low-cost generic medicines in Guatemala. The low cost of generic medicines was often perceived as proof of their inferior quality. In the case of diabetes and hypertension, the decision to utilize a generic medicine was based on multiple factors including the patient's financial situation, consumer preference, and, to a large extent, physician recommendations. Interventions to improve generic medication utilization in Guatemala must address the negative perceptions of physicians and pharmacy staff toward low-cost generics. Strengthening state capacity and transparency in the regulation and monitoring of the drug supply is a key goal of access-to-medicines advocacy in Guatemala.

WHO Expert Committee on Specifications for Pharmaceutical Preparations.

PubMed

2012-01-01

The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use: Development of monographs for The International Pharmacopoeia; WHO good manufacturing practices: water for pharmaceutical use; Pharmaceutical development of multisource (generic) pharmaceutical products--points to consider; Guidelines on submission of documentation for a multisource (generic) finished pharmaceutical product for the WHO Prequalification of Medicines Programme: quality part; Development of paediatric medicines: points to consider in formulation; Recommendations for quality requirements for artemisinin as a starting material in the production of antimalarial active pharmaceutical ingredients.

Impact of brand or generic labeling on medication effectiveness and side effects.

PubMed

Faasse, Kate; Martin, Leslie R; Grey, Andrew; Gamble, Greg; Petrie, Keith J

2016-02-01

Branding medication with a known pharmaceutical company name or product name bestows on the drug an added assurance of authenticity and effectiveness compared to a generic preparation. This study examined the impact of brand name and generic labeling on medication effectiveness and side effects. 87 undergraduate students with frequent headaches took part in the study. Using a within-subjects counterbalanced design, each participant took tablets labeled either as brand name "Nurofen" or "Generic Ibuprofen" to treat each of 4 headaches. In reality, half of the tablets were placebos, and half were active ibuprofen (400 mg). Participants recorded their headache pain on a verbal descriptor and visual analogue scale prior to taking the tablets, and again 1 hour afterward. Medication side effects were also reported. Pain reduction following the use of brand name labeled tablets was similar in active ibuprofen or a placebo. However, if the tablets had a generic label, placebo tablets were significantly less effective compared to active ibuprofen. Fewer side effects were attributed to placebo tablets with brand name labeling compared to the same placebo tablets with a generic label. Branding of a tablet appears to have conferred a treatment benefit in the absence of an active ingredient, while generic labeled tablets were substantially less effective if they contained no active ingredient. Branding is also associated with reduced attribution of side effects to placebo tablets. Future interventions to improve perceptions of generics may have utility in improving treatment outcomes from generic drugs. (c) 2016 APA, all rights reserved).

77 FR 51811 - Draft Guidance for Industry on Self-Identification of Generic Drug Facilities, Sites, and...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-27

... as it prepares to meet the self- identification requirement. It explains who is required to self... describing how FDA will implement the self- identification requirement contained in GDUFA. As required by... industry as it prepares to meet the self-identification requirement. The guidance explains who is required...

Preparing Content Area Teachers for Disciplinary Literacy Instruction: The Role of Literacy Teacher Educators

ERIC Educational Resources Information Center

Fang, Zhihui

2014-01-01

The recent call for secondary reading instruction to move away from a focus on generic literacy strategies to discipline-specific language and literacy practices presents new challenges for secondary teacher preparation. This column identifies some of the roles literacy teacher educators can play in helping address these challenges.

Preparation of a generic monoclonal antibody and development of a highly sensitive indirect competitive ELISA for the detection of phenothiazines in animal feed.

PubMed

Wang, Juan; Wang, Yulian; Pan, Yuanhu; Chen, Dongmei; Liu, Zhenli; Feng, Liang; Peng, Dapeng; Yuan, Zonghui

2017-04-15

In this study, a broadly specific monoclonal antibody was prepared and a sensitive monoclonal-based indirect competitive enzyme linked immunosorbent assay (ic-ELISA) was subsequently developed to determine the phenothiazines in animal feed with a simple sample preparation procedure for the first time. The obtained antibody 3A5 was of the immunoglobulin G1 (IgG1) isotype possessing a kappa light chain, which broadly cross-reacted to nine phenothiazines. The limit of detections of the method ranged from 1.1μgkg -1 to 15.3μgkg -1 in the swine feed and the fish feed. The recoveries of the phenothiazines were in the range of 78.2-116.6%. The coefficient of variations were less than 16.7%. A positive correlation (r>0.9249) between the results of the ic-ELISA and the high-performance liquid chromatography were also observed, which indicated that the developed ic-ELISA is reliable and can be used to monitor phenothiazines in animal feed. Copyright © 2016 Elsevier Ltd. All rights reserved.

Select Generic Dry-Storage Pilot Plant Design for Safeguards and Security by Design (SSBD) per Used Fuel Campaign

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

Demuth, Scott Francis; Sprinkle, James K.

As preparation to the year-end deliverable (Provide SSBD Best Practices for Generic Dry-Storage Pilot Scale Plant) for the Work Package (FT-15LA040501–Safeguards and Security by Design for Extended Dry Storage), the initial step was to select a generic dry-storage pilot plant design for SSBD. To be consistent with other DOE-NE Fuel Cycle Research and Development (FCR&D) activities, the Used Fuel Campaign was engaged for the selection of a design for this deliverable. For the work Package FT-15LA040501–“Safeguards and Security by Design for Extended Dry Storage”, SSBD will be initiated for the Generic Dry-Storage Pilot Scale Plant described by the layout ofmore » Reference 2. SSBD will consider aspects of the design that are impacted by domestic material control and accounting (MC&A), domestic security, and international safeguards.« less

Comparative analysis of the cost and effectiveness of generic and brand-name antibiotics: the case of uncomplicated urinary tract infection.

PubMed

Lin, Yu-Shiuan; Jan, I-Shiow; Cheng, Shou-Hsia

2017-03-01

Generic medications used for chronic diseases are beneficial in containing healthcare costs and improving drug accessibility. However, the effects of generic drugs in acute and severe illness remain controversial. This study aims to investigate treatment costs and outcomes of generic antibiotics prescribed for adults with a urinary tract infection in outpatient settings. The data source was the Longitudinal Health Insurance Database of Taiwan. We included outpatients aged 20 years and above with a urinary tract infection who required one oral antibiotic for which brand-name and generic products were simultaneously available. Drug cost and overall healthcare expense of the index consultation, healthcare cost during a 42-day follow-up period, and treatment failure rates were the main dependent variables. Data were compared between brand-name and generic users from the entire cohort and a propensity score-matched samples. Results from the entire cohort and propensity score-matched samples were similar. Daily antibiotic cost was significantly lower among generic users than brand-name users. Significant lower total drug claims of the index consultation only existed in patients receiving the investigated antibiotics, while the drug price between brand-name and generic versions were relatively large (e.g., >50%). The overall healthcare cost of the index consultation, healthcare expenditure during a 42-day follow-up period, and treatment failure rates were similar between the two groups. Compared with those treated with brand-name antibiotics, outpatients who received generic antibiotics had equivalent treatment outcomes with lower drug costs. Generic antibiotics are effective and worthy of adoption among outpatients with simple infections indicating oral antibiotic treatment. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Comparative cost evaluation of brand name and generic ophthalmology medications in Ontario.

PubMed

Popovic, Marko; Chan, Clara; Lattanzio, Nisha; El-Defrawy, Sherif; Schlenker, Matthew B

2018-04-01

Medication cost for the same indication can vary considerably and can affect patient compliance. In this comparative cost analysis of commonly prescribed ophthalmology medications, the differences in cost between generic and brand name medications as well as different medications within an individual drug class were evaluated. Eye preparations from the Ontario Drug Benefit Formulary were identified, and further agents commonly prescribed by ophthalmologists were included. The standardized prescription drug cost, which includes the cost of the medication, mark-up, and dispensing cost, was provided by Ontario Shoppers Drug Mart stores in July 2016 for 103 common medications using typical dosages and durations. Based on medication class, the highest and lowest cost medications were antiallergy agents (Zaditor [ketotifen], Vasocon [naphazoline]), antibiotic ophthalmic solutions (Vigamox [moxifloxacin], generic ciprofloxacin), oral antibiotics (Cipro [ciprofloxacin], generic cephalexin), antibiotic ophthalmic ointments (generic erythromycin, Tobrex [tobramycin]), antiviral treatment (Valtrex [oral valacyclovir], Viroptic [topical trifluridine]), blepharitis treatment (Zithromax [oral azithromycin], generic oral tetracycline), beta-adrenergic inhibitors (Timoptic [topical timolol], generic topical timolol), topical prostaglandin analogues (Xalatan [latanoprost], generic travoprost), oral carbonic anhydrase inhibitors (methazolamide, acetazolamide), topical carbonic anhydrase solutions (Trusopt preservative-free [dorzolamide], Azopt [brinzolamide]), topical alpha-adrenergic agonists (Alphagan [brimonidine], generic brimonidine), topical muscarinic agonists (Isopto carpine [pilocarpine], Diocarpine [pilocarpine]), topical combination glaucoma agents (Cosopt [dorzolamide-timolol], generic dorzolamide-timolol), topical lubricants (Lacri-lube, Isopto tears), topical nonsteroidal anti-inflammatory drugs (Acuvail [ketorolac], Ilevro [nepafenac]), and steroids (Durezol [difluprednate], Pred mild [prednisolone]). Substantial cost differences exist between ophthalmology medications of the same class. We encourage ophthalmologists to be aware of the associated costs of the medications they prescribe and to use this information in their decision making. Copyright © 2018 Canadian Ophthalmological Society. Published by Elsevier Inc. All rights reserved.

Building a Dangerous Outpost in the Green Mountain State: A Case Study of Educator Preparation Policymaking

ERIC Educational Resources Information Center

McGough, David J.; Bedell, Claudine; Tinkler, Barri

2018-01-01

Poised at a bifurcation, the educator preparation community in Vermont faced either the adoption of a generic product for the assessment of initial educator licensure candidates or the comprehensive revision of a longstanding state-based assessment portfolio. Using a case study approach and narrative methods, specifically the Narrative Policy…

Simulated procedure rehearsal is more effective than a preoperative generic warm-up for endovascular procedures.

PubMed

Willaert, Willem I M; Aggarwal, Rajesh; Daruwalla, Farhad; Van Herzeele, Isabelle; Darzi, Ara W; Vermassen, Frank E; Cheshire, Nicholas J

2012-06-01

Patient-specific simulated rehearsal (PsR) of a carotid artery stenting procedure (CAS) enables the interventionalist to rehearse the case before performing the procedure on the actual patient by incorporating patient-specific computed tomographic data into the simulation software. This study aimed to evaluate whether PsR of a CAS procedure can enhance the operative performance versus a virtual reality (VR) generic CAS warm-up procedure or no preparation at all. During a 10-session cognitive/technical VR course, medical residents were trained in CAS. Thereafter, in a randomized crossover study, each participant performed a patient-specific CAS case 3 times on the simulator, preceded by 3 different tasks: a PsR, a generic case, or no preparation. Technical performances were assessed using simulator-based metrics and expert-based ratings. Twenty medical residents (surgery, cardiology, radiology) were recruited. Training plateaus were observed after 10 sessions for all participants. Performances were significantly better after PsR than after a generic warm-up or no warm-up for total procedure time (16.3 ± 0.6 vs 19.7 ± 1.0 vs 20.9 ± 1.1 minutes, P = 0.001) and fluoroscopy time (9.3 ± 0.1 vs 11.2 ± 0.6 vs 11.2 ± 0.5 minutes, P = 0.022) but did not influence contrast volume or number of roadmaps used during the "real" case. PsR significantly improved the quality of performance as measured by the expert-based ratings (scores 28 vs 25 vs 25, P = 0.020). Patient-specific simulated rehearsal of a CAS procedure significantly improves operative performance, compared to a generic VR warm-up or no warm-up. This technology requires further investigation with respect to improved outcomes on patients in the clinical setting.

Generic delivery of payload of nanoparticles intracellularly via hybrid polymer capsules for bioimaging applications.

PubMed

Sami, Haider; Maparu, Auhin K; Kumar, Ashok; Sivakumar, Sri

2012-01-01

Towards the goal of development of a generic nanomaterial delivery system and delivery of the 'as prepared' nanoparticles without 'further surface modification' in a generic way, we have fabricated a hybrid polymer capsule as a delivery vehicle in which nanoparticles are loaded within their cavity. To this end, a generic approach to prepare nanomaterials-loaded polyelectrolyte multilayered (PEM) capsules has been reported, where polystyrene sulfonate (PSS)/polyallylamine hydrochloride (PAH) polymer capsules were employed as nano/microreactors to synthesize variety of nanomaterials (metal nanoparticles; lanthanide doped inorganic nanoparticles; gadolinium based nanoparticles, cadmium based nanoparticles; different shapes of nanoparticles; co-loading of two types of nanoparticles) in their hollow cavity. These nanoparticles-loaded capsules were employed to demonstrate generic delivery of payload of nanoparticles intracellularly (HeLa cells), without the need of individual nanoparticle surface modification. Validation of intracellular internalization of nanoparticles-loaded capsules by HeLa cells was ascertained by confocal laser scanning microscopy. The green emission from Tb(3+) was observed after internalization of LaF(3):Tb(3+)(5%) nanoparticles-loaded capsules by HeLa cells, which suggests that nanoparticles in hybrid capsules retain their functionality within the cells. In vitro cytotoxicity studies of these nanoparticles-loaded capsules showed less/no cytotoxicity in comparison to blank capsules or untreated cells, thus offering a way of evading direct contact of nanoparticles with cells because of the presence of biocompatible polymeric shell of capsules. The proposed hybrid delivery system can be potentially developed to avoid a series of biological barriers and deliver multiple cargoes (both simultaneous and individual delivery) without the need of individual cargo design/modification.

Human life support during interplanetary travel and domicile. VI - Generic modular flow schematic for hybrid physical/chemical-biological life support systems

NASA Technical Reports Server (NTRS)

Ganapathi, Gani B.; Seshan, P. K.; Ferrall, Joseph; Rohatgi, Naresh

1992-01-01

An extension is proposed for the NASA Space Exploration Initiative's Generic Modular Flow Schematics for physical/chemical life support systems which involves the addition of biological processes. The new system architecture includes plant, microbial, and animal habitat, as well as the human habitat subsystem. Major Feedstock Production and Food Preparation and Packaging components have also been incorporated. Inedible plant, aquaculture, microbial, and animal solids are processed for recycling.

The New Wizard War: Challenges and Opportunities for Electronic Warfare in the Information Age

DTIC Science & Technology

2007-11-06

Camp: Preparing for Conflict in the Information Age (Santa Monica, CA: RAND Corporation, 1997):175. 17. Jeffrey R . Cares, “An Information Age Combat...60. Stephen Trimble, “US Army Moves Back Into Electronic Attack Mission.” 61. Richard R . Burgess, “Jamming: The Marine Corps Refines Its Vision of...November 7, 2005), http://www.aviationweek.com/aw/generic/story_generic.jsp?channel= awst &id=news/11075p 2.xml (accessed 29 Oct 07). 74. David A

Is there a relationship between patient beliefs or communication about generic drugs and medication utilization?

PubMed

Shrank, William H; Cadarette, Suzanne M; Cox, Emily; Fischer, Michael A; Mehta, Jyotsna; Brookhart, Alan M; Avorn, Jerry; Choudhry, Niteesh K

2009-03-01

Insurers and policymakers strive to stimulate more cost-effective prescribing and, increasingly, are educating beneficiaries about generics. To evaluate the relationship between patient beliefs and communication about generic drugs and actual drug use. We performed a national mailed survey of a random sample of 2500 commercially-insured adults. Patient responses were linked to pharmacy claims data to assess actual generic medication use. We used factor analysis to develop 5 multi-item scales from patient survey responses that measured: (1) general preferences for generics, (2) generic safety/effectiveness, (3) generic cost/value, (4) comfort with generic substitution, and (5) communication with providers about generics. The relationship between each scale and the proportion of prescriptions filled for generics was assessed using linear regression, controlling for demographic, health, and insurance characteristics. Separate models were created for each scale and then all 5 scales were included simultaneously in a fully-adjusted model. The usable response rate was 48%. When evaluated independently, a 1 SD increase in each of the 5 scales was associated with a 3.1% to 6.3% increase in generic drug use (P < 0.05 for each). In the fully adjusted model, only 2 scales were significantly associated with generic drug use: comfort with generic substitution (P = 0.021) and communication with providers about generic drugs (P = 0.012). Generic drug use is most closely associated with the 2 actionable items we evaluated: communication with providers about generics and comfort with generic substitution. Educational campaigns that focus on these 2 domains may be most effective at influencing generic drug use.

Knowledge, perceptions and use of generic drugs: a cross sectional study

PubMed Central

de Lira, Claudio Andre Barbosa; Oliveira, Jéssica Nathalia Soares; Andrade, Marília dos Santos; Vancini-Campanharo, Cássia Regina; Vancini, Rodrigo Luiz

2014-01-01

Objective To assess the level of knowledge, perceptions and usage profile for generic drugs among laypersons. Methods A cross-sectional study was conducted with 278 volunteers (180 women and 98 men, aged 37.1±15.8 years). A questionnaire was drawn up with questions on their use, perceptions and knowledge of generic drugs. Results Most respondents (99.6%) knew that generic drugs exist, but only 48.6% were able to define them correctly, while 78.8% of the respondents had some information about generics. This information was obtained mainly through television (49.3%). In terms of generic drug characteristics, 79.1% stated that they were confident about their efficacy, 74.8% believed that generic drugs have the same effect as branded medications, 88.8% said that generics were priced lower than branded medications, and 80.2% stated that they bought generic drugs because of price. With regard to drugs prescribed by medical practitioners, 17.6% of the participants said that their doctors never prescribed generics and only 7.5% confirmed that their doctors always prescribed generics. Conclusion For the lay public, the sample in this study has sufficient knowledge of generic drugs in terms of definition, efficacy and cost. Consequently, the volunteers interviewed are very likely to use generics. Furthermore, the results of this study indicate that programs should be implemented in order to boost generic drug prescriptions by medical practitioners. PMID:25295444

Security Policy for a Generic Space Exploration Communication Network Architecture

NASA Technical Reports Server (NTRS)

Ivancic, William D.; Sheehe, Charles J.; Vaden, Karl R.

2016-01-01

This document is one of three. It describes various security mechanisms and a security policy profile for a generic space-based communication architecture. Two other documents accompany this document- an Operations Concept (OpsCon) and a communication architecture document. The OpsCon should be read first followed by the security policy profile described by this document and then the architecture document. The overall goal is to design a generic space exploration communication network architecture that is affordable, deployable, maintainable, securable, evolvable, reliable, and adaptable. The architecture should also require limited reconfiguration throughout system development and deployment. System deployment includes subsystem development in a factory setting, system integration in a laboratory setting, launch preparation, launch, and deployment and operation in space.

Generic medicines and generic substitution: contrasting perspectives of stakeholders in Ireland.

PubMed

O'Leary, A; Usher, C; Lynch, M; Hall, M; Hemeryk, L; Spillane, S; Gallagher, P; Barry, M

2015-12-15

The Health (Pricing and Supply of Medical Goods) Act 2013 passed into law in July 2013 and legislated for generic substitution in Ireland. The aim of the study was to ascertain the knowledge and perceptions of stakeholders i.e. patients, pharmacists and prescribers, of generic medicines and to generic substitution with the passing of legislation. Three stakeholder specific questionnaires were developed to assess knowledge of and perceptions to generic medicines and generic substitution. Purposive samples of patients, prescribers and pharmacists were analysed. Descriptive quantitative and qualitative analyses were undertaken. A total of 762 healthcare professionals and 353 patients were recruited. The study highlighted that over 84% of patients were familiar with generic medicines and are supportive of the concept of generic substitution. Approximately 74% of prescribers and 84% of pharmacists were supportive of generic substitution in most cases. The main areas of concern highlighted by the healthcare professionals that might impact on the successful implementation of the policy, were the issue of bioequivalence with generic medicines, the computer software systems used at present in general practitioner (GP) surgeries and the availability of branded generics. The findings from this study identify a high baseline rate of acceptance to generic medicines and generic substitution among patients, prescribers and pharmacists in the Irish setting. The concerns of the main stakeholders provide a valuable insight into the potential difficulties that may arise in its implementation, and the need for on-going reassurance and proactive dissemination of the impact of the generic substitution policy. The existing positive attitude to generic medicines and generic substitution among key stakeholders in Ireland to generic substitution, combined with appropriate support and collaboration should result in the desired increase in rates of prescribing, dispensing and use of generic medicines.

A randomized crossover study comparing the antiplatelet effect of plavix versus generic clopidogrel.

PubMed

Sambu, Nalyaka; Radhakrishnan, Ashwin; Curzen, Nick

2012-12-01

Clopidogrel exists in different salt formulations. All published data that have demonstrated its beneficial effect are based entirely on the hydrogen sulphate salt contained in the branded product Plavix, which had US sales of $6.1 billion in 2010 alone. A number of cheaper generic versions of clopidogrel are increasingly being used in Europe as an alternative to Plavix, mainly for cost reasons. However, there is insufficient evidence to show that their pharmacodynamic effect is equivalent to Plavix. This prospective study investigated whether there is any significant difference in the antiplatelet effect of Plavix versus generic clopidogrel hydrochloride in healthy male volunteers. All participants received loading and maintenance doses of both drugs, in a crossover manner, separated by a 2-week washout period. Adenosine diphosphate (ADP)-induced platelet reactivity was measured using short thrombelastography at multiple timepoints. The results showed interindividual heterogeneity in responses to clopidogrel but no significant difference in ADP-induced platelet reactivity between Plavix versus generic clopidogrel hydrochloride. Our findings suggest comparable inhibition of ADP-induced platelet reactivity with Plavix and generic clopidogrel hydrochloride. This observation is particularly pertinent at a time when the patent for Plavix is expected to expire in the near future leading to the large-scale switch to cheaper generic preparations.

Is There a Relationship Between Patient Beliefs or Communication About Generic Drugs and Medication Utilization?

PubMed Central

Shrank, William H.; Cadarette, Suzanne M.; Cox, Emily; Fischer, Michael A.; Mehta, Jyotsna; Brookhart, Alan M.; Avorn, Jerry; Choudhry, Niteesh K.

2009-01-01

Background Insurers and policymakers strive to stimulate more cost-effective prescribing and, increasingly, are educating beneficiaries about generics. Objectives To evaluate the relationship between patient beliefs and communication about generic drugs and actual drug use. Research Design and Subjects We performed a national mailed survey of a random sample of 2500 commercially-insured adults. Patient responses were linked to pharmacy claims data to assess actual generic medication use. Measures We used factor analysis to develop 5 multi-item scales from patient survey responses that measured: (1) general preferences for generics, (2) generic safety/effectiveness, (3) generic cost/value, (4) comfort with generic substitution, and (5) communication with providers about generics. The relationship between each scale and the proportion of prescriptions filled for generics was assessed using linear regression, controlling for demographic, health, and insurance characteristics. Separate models were created for each scale and then all 5 scales were included simultaneously in a fully-adjusted model. Results The usable response rate was 48%. When evaluated independently, a 1 SD increase in each of the 5 scales was associated with a 3.1% to 6.3% increase in generic drug use (P < 0.05 for each). In the fully adjusted model, only 2 scales were significantly associated with generic drug use: comfort with generic substitution (P = 0.021) and communication with providers about generic drugs (P = 0.012). Conclusions Generic drug use is most closely associated with the 2 actionable items we evaluated: communication with providers about generics and comfort with generic substitution. Educational campaigns that focus on these 2 domains may be most effective at influencing generic drug use. PMID:19194329

Generic sample preparation combined with high-resolution liquid chromatography-time-of-flight mass spectrometry for unification of urine screening in doping-control laboratories.

PubMed

Peters, R J B; Oosterink, J E; Stolker, A A M; Georgakopoulos, C; Nielen, M W F

2010-04-01

A unification of doping-control screening procedures of prohibited small molecule substances--including stimulants, narcotics, steroids, beta2-agonists and diuretics--is highly urgent in order to free resources for new classes such as banned proteins. Conceptually this may be achieved by the use of a combination of one gas chromatography-time-of-flight mass spectrometry method and one liquid chromatography-time-of-flight mass spectrometry method. In this work a quantitative screening method using high-resolution liquid chromatography in combination with accurate-mass time-of-flight mass spectrometry was developed and validated for determination of glucocorticosteroids, beta2-agonists, thiazide diuretics, and narcotics and stimulants in urine. To enable the simultaneous isolation of all the compounds of interest and the necessary purification of the resulting extracts, a generic extraction and hydrolysis procedure was combined with a solid-phase extraction modified for these groups of compounds. All 56 compounds are determined using positive electrospray ionisation with the exception of the thiazide diuretics for which the best sensitivity was obtained by using negative electrospray ionisation. The results show that, with the exception of clenhexyl, procaterol, and reproterol, all compounds can be detected below the respective minimum required performance level and the results for linearity, repeatability, within-lab reproducibility, and accuracy show that the method can be used for quantitative screening. If qualitative screening is sufficient the instrumental analysis may be limited to positive ionisation, because all analytes including the thiazides can be detected at the respective minimum required levels in the positive mode. The results show that the application of accurate-mass time-of-flight mass spectrometry in combination with generic extraction and purification procedures is suitable for unification and expansion of the window of screening methods of doping laboratories. Moreover, the full-scan accurate-mass data sets obtained still allow retrospective examination for emerging doping agents, without re-analyzing the samples.

Evaluating Site-Specific and Generic Spatial Models of Aboveground Forest Biomass Based on Landsat Time-Series and LiDAR Strip Samples in the Eastern USA

Treesearch

Ram Deo; Matthew Russell; Grant Domke; Hans-Erik Andersen; Warren Cohen; Christopher Woodall

2017-01-01

Large-area assessment of aboveground tree biomass (AGB) to inform regional or national forest monitoring programs can be efficiently carried out by combining remotely sensed data and field sample measurements through a generic statistical model, in contrast to site-specific models. We integrated forest inventory plot data with spatial predictors from Landsat time-...

A cross-sectional study examining the prevalence and risk factors for anti-microbial-resistant generic Escherichia coli in domestic dogs that frequent dog parks in three cities in south-western Ontario, Canada.

PubMed

Procter, T D; Pearl, D L; Finley, R L; Leonard, E K; Janecko, N; Reid-Smith, R J; Weese, J S; Peregrine, A S; Sargeant, J M

2014-06-01

Anti-microbial resistance can threaten health by limiting treatment options and increasing the risk of hospitalization and severity of infection. Companion animals can shed anti-microbial-resistant bacteria that may result in the exposure of other dogs and humans to anti-microbial-resistant genes. The prevalence of anti-microbial-resistant generic Escherichia coli in the faeces of dogs that visited dog parks in south-western Ontario was examined and risk factors for shedding anti-microbial-resistant generic E. coli identified. From May to August 2009, canine faecal samples were collected at ten dog parks in three cities in south-western Ontario, Canada. Owners completed a questionnaire related to pet characteristics and management factors including recent treatment with antibiotics. Faecal samples were collected from 251 dogs, and 189 surveys were completed. Generic E. coli was isolated from 237 of the faecal samples, and up to three isolates per sample were tested for anti-microbial susceptibility. Eighty-nine percent of isolates were pan-susceptible; 82.3% of dogs shed isolates that were pan-susceptible. Multiclass resistance was detected in 7.2% of the isolates from 10.1% of the dogs. Based on multilevel multivariable logistic regression, a risk factor for the shedding of generic E. coli resistant to ampicillin was attending dog day care. Risk factors for the shedding of E. coli resistant to at least one anti-microbial included attending dog day care and being a large mixed breed dog, whereas consumption of commercial dry and home cooked diets was protective factor. In a multilevel multivariable model for the shedding of multiclass-resistant E. coli, exposure to compost and being a large mixed breed dog were risk factors, while consumption of a commercial dry diet was a sparing factor. Pet dogs are a potential reservoir of anti-microbial-resistant generic E. coli; some dog characteristics and management factors are associated with the prevalence of anti-microbial-resistant generic E. coli in dogs. © 2013 Blackwell Verlag GmbH.

Operational Concepts for a Generic Space Exploration Communication Network Architecture

NASA Technical Reports Server (NTRS)

Ivancic, William D.; Vaden, Karl R.; Jones, Robert E.; Roberts, Anthony M.

2015-01-01

This document is one of three. It describes the Operational Concept (OpsCon) for a generic space exploration communication architecture. The purpose of this particular document is to identify communication flows and data types. Two other documents accompany this document, a security policy profile and a communication architecture document. The operational concepts should be read first followed by the security policy profile and then the architecture document. The overall goal is to design a generic space exploration communication network architecture that is affordable, deployable, maintainable, securable, evolvable, reliable, and adaptable. The architecture should also require limited reconfiguration throughout system development and deployment. System deployment includes: subsystem development in a factory setting, system integration in a laboratory setting, launch preparation, launch, and deployment and operation in space.

Association of authorized generic marketing with prescription drug spending on antidepressants from 2000 to 2011.

PubMed

Cheng, Ning; Banerjee, Tannista; Qian, Jingjing; Hansen, Richard A

Prior research suggests that authorized generic drugs increase competition and decrease prices, but little empirical evidence supports this conclusion. This study evaluated the impact of authorized generic marketing on brand and generic prices. Longitudinal analysis of the household component of the Medical Expenditure Panel Survey. Interview panels over 12 years, with a new panel each year. For each panel, 5 rounds of household interviews were conducted over 30 months. Nationally representative sample of the U.S. civilian noninstitutionalized population, focusing on people using 1 of 5 antidepressant drugs that became generically available between 2000 to 2011. Drugs and dose/formulations with versus without an authorized generic drug marketed. Multiple linear regression models with lagged variables evaluated the effect of an authorized generic on average inflation-adjusted brand and generic price, adjusting for payment sources, generic entry time, competitor price, and year. During 2000-2011, annual brand antidepressant utilization decreased from 51.47 to 7.52 million prescriptions, and generic antidepressant utilization increased from 0 to 88.83 million prescriptions. Over time, payment per prescription for brand prescriptions increased 25% overall, and generic payments decreased 70% for all payer types. With unadjusted data, after generic entry the average brand price decreased $0.59 per year with and $3.62 per year without an authorized generic in the market. Average generic prices decreased $10.30 per year with and $8.47 per year without an authorized generic in the market. In multiple regression models with lagged variables adjusted for heteroscedasticity, payer source, time since generic entry, competitor price, and year, authorized generics significantly reduced average payment for generic (-$3.03) and brand (-$60.64) prescriptions, and over time this price change slowly diminished. Availability of an authorized generic was associated with reduced average generic and brand price in the antidepressant market, supporting prior evidences. Copyright © 2017 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

Impact of medicare part D plan features on use of generic drugs.

PubMed

Tang, Yan; Gellad, Walid F; Men, Aiju; Donohue, Julie M

2014-06-01

Little is known about how Medicare Part D plan features influence choice of generic versus brand drugs. To examine the association between Part D plan features and generic medication use. Data from a 2009 random sample of 1.6 million fee-for-service, Part D enrollees aged 65 years and above, who were not dually eligible or receiving low-income subsidies, were used to examine the association between plan features (generic cost-sharing, difference in brand and generic copay, prior authorization, step therapy) and choice of generic antidepressants, antidiabetics, and statins. Logistic regression models accounting for plan-level clustering were adjusted for sociodemographic and health status. Generic cost-sharing ranged from $0 to $9 for antidepressants and statins, and from $0 to $8 for antidiabetics (across 5th-95th percentiles). Brand-generic cost-sharing differences were smallest for statins (5th-95th percentiles: $16-$37) and largest for antidepressants ($16-$64) across plans. Beneficiaries with higher generic cost-sharing had lower generic use [adjusted odds ratio (OR)=0.97, 95% confidence interval (CI), 0.95-0.98 for antidepressants; OR=0.97, 95% CI, 0.96-0.98 for antidiabetics; OR=0.94, 95% CI, 0.92-0.95 for statins]. Larger brand-generic cost-sharing differences and prior authorization were significantly associated with greater generic use in all categories. Plans could increase generic use by 5-12 percentage points by reducing generic cost-sharing from the 75th ($7) to 25th percentiles ($4-$5), increasing brand-generic cost-sharing differences from the 25th ($25-$26) to 75th ($32-$33) percentiles, and using prior authorization and step therapy. Cost-sharing features and utilization management tools were significantly associated with generic use in 3 commonly used medication categories.

Dissipative Quantum Control of a Spin Chain

NASA Astrophysics Data System (ADS)

Morigi, Giovanna; Eschner, Jürgen; Cormick, Cecilia; Lin, Yiheng; Leibfried, Dietrich; Wineland, David J.

2015-11-01

A protocol is discussed for preparing a spin chain in a generic many-body state in the asymptotic limit of tailored nonunitary dynamics. The dynamics require the spectral resolution of the target state, optimized coherent pulses, engineered dissipation, and feedback. As an example, we discuss the preparation of an entangled antiferromagnetic state, and argue that the procedure can be applied to chains of trapped ions or Rydberg atoms.

[General awareness and use of generic medication among citizens of Tubarão, state of Santa Catarina, Brazil].

PubMed

Blatt, Carine Raquel; Trauthman, Silvana Cristina; Schmidt, Edegar Henrique; Marchesan, Samuel; da Silva, Luana May; Martins, João Luiz

2012-01-01

Although generic medication has been introduced in the country to offer an accessible alternative to brand-name medication, it represents only 14% of sales in number of units within the pharmaceutical market. The aim of this work was to research the level of awareness and the use of generic products among residents of the municipality of Tubarão, State of Santa Catarina, Brazil. A transversal study was carried out with a sample of 234 interviewees, distributed among municipal areas. With regard to use, the majority of those interviewed had used generic medication, and half of them had at least one such product in their home. To verify awareness of different types of medication, pictures with the generic, brand name and similar packaging for paracetamol and atenolol were shown and 91% were able to identify all products correctly. To be of higher economic standing, already having used generic products, believing that the generic medication has the same effect as the brand name medication, finding generic products in drugstores easily and being accustomed to buy generic products, were factors that were positively associated with the correct identification.

Development and validation of a tool to assess knowledge and attitudes towards generic medicines among students in Greece: The ATtitude TOwards GENerics (ATTOGEN) questionnaire.

PubMed

Domeyer, Philip J; Aletras, Vassilis; Anagnostopoulos, Fotios; Katsari, Vasiliki; Niakas, Dimitris

2017-01-01

The use of generic medicines is a cost-effective policy, often dictated by fiscal restraints. To our knowledge, no fully validated tool exploring the students' knowledge and attitudes towards generic medicines exists. The aim of our study was to develop and validate a questionnaire exploring the knowledge and attitudes of M.Sc. in Health Care Management students and recent alumni's towards generic drugs in Greece. The development of the questionnaire was a result of literature review and pilot-testing of its preliminary versions to researchers and students. The final version of the questionnaire contains 18 items measuring the respondents' knowledge and attitude towards generic medicines on a 5-point Likert scale. Given the ordinal nature of the data, ordinal alpha and polychoric correlations were computed. The sample was randomly split into two halves. Exploratory factor analysis, performed in the first sample, was used for the creation of multi-item scales. Confirmatory factor analysis and Generalized Linear Latent and Mixed Model analysis (GLLAMM) with the use of the rating scale model were used in the second sample to assess goodness of fit. An assessment of internal consistency reliability, test-retest reliability, and construct validity was also performed. Among 1402 persons contacted, 986 persons completed our questionnaire (response rate = 70.3%). Overall Cronbach's alpha was 0.871. The conjoint use of exploratory and confirmatory factor analysis resulted in a six-scale model, which seemed to fit the data well. Five of the six scales, namely trust, drug quality, state audit, fiscal impact and drug substitution were found to be valid and reliable, while the knowledge scale suffered only from low inter-scale correlations and a ceiling effect. However, the subsequent confirmatory factor and GLLAMM analyses indicated a good fit of the model to the data. The ATTOGEN instrument proved to be a reliable and valid tool, suitable for assessing students' knowledge and attitudes towards generic medicines.

Generic substitution of antiretrovirals: patients' and health care providers' opinions.

PubMed

Kieran, Jennifer A; O'Reilly, Eimear; O'Dea, Siobhan; Bergin, Colm; O'Leary, Aisling

2017-10-01

There is interest in introducing generic antiretroviral drugs (ARVs) into high-income countries in order to maximise efficiency in health care budgets. Studies examining patients' and providers' knowledge and attitudes to generic substitution in HIV are few. This was a cross-sectional, observational study with a convenience sample of adult HIV-infected patients and health care providers (HCPs). Data on demographics, knowledge of generic medicine and facilitators of generic substitution were collected. Descriptive and univariate analysis was performed using SPSS V.23™. Questionnaires were completed by 66 patients. Seventy-one per cent would have no concerns with the introduction of generic ARVs. An increase in frequency of administration (61%) or pill burden (53%) would make patients less likely to accept generic ARVs. There were 30 respondents to the HCP survey. Concerns included the supply chain of generics, loss of fixed dose combinations, adherence and use of older medications. An increase in dosing frequency (76%) or an increase in pill burden (50%) would make HCPs less likely to prescribe a generic ARV. The main perceived advantage was financial. Generic substitution of ARVs would be acceptable to the majority of patients and HCPs. Reinvesting savings back into HIV services would facilitate the success of such a programme.

Exploring community pharmacists' views on generic medicines: a nationwide study from Malaysia.

PubMed

Chong, Chee Ping; Hassali, Mohamed Azmi; Bahari, Mohd Baidi; Shafie, Asrul Akmal

2011-02-01

To evaluate the Malaysian community pharmacists' views on generic medicines. A sample of 1419 Malaysian community pharmacies with resident pharmacists. A cross-sectional nationwide survey using a self-completed mailing questionnaire. Pharmacists' views on generic medicines including issues surrounding efficacy, safety, quality and bioequivalence. Responses were received from 219 pharmacies (response rate 15.4%). Only 50.2% of the surveyed pharmacists agreed that all products that are approved as generic equivalents can be considered therapeutically equivalent with the innovator medicines. Around 76% of respondents indicated that generic substitution of narrow therapeutic index medicines is inappropriate. The majority of the pharmacists understood that a generic medicine must contain the same amount of active ingredient (84.5%) and must be in the same dosage form as the innovator brand (71.7%). About 21% of respondents though that generic medicines are of inferior quality compared to innovator medicines. Most of the pharmacists (61.6%) disagreed that generic medicines produce more side-effects than innovator brand. Pharmacists graduated from Malaysian universities, twinning program and overseas universities were not differed significantly in their views on generic medicines. Additionally, the respondents appeared to have difficulty in ascertaining the bioequivalent status of the marketed generic products in Malaysia. The Malaysian pharmacists' have lack of information and/or trust in the generic manufacturing and/or approval system in Malaysia. This issue should be addressed by pharmacy educators and relevant government agencies.

Predictors of generic substitution: The role of psychological, sociodemographic, and contextual factors.

PubMed

Drozdowska, Aleksandra; Hermanowski, Tomasz

2016-01-01

Escalating pharmaceutical costs have become a global challenge for both governments and patients. Generic substitution is one way of decreasing these costs. The aim of this study was to investigate factors associated with patients' choice between generic drugs and innovator drugs. The survey was conducted in June 2013, 1000 people from across Poland were chosen as a representative population sample. The outcome (a preference for generics/a preference for innovator pharmaceuticals/no preference) was modeled by multinomial logistic regression, adjusted for several variables describing patients' sensitivity to selected generic features (price, brand, and country of origin), to third-party opinions about generics (information on generics in the mass media, opinions of health professionals (i.e. physicians, pharmacists), relatives/friends), as well as patients' personal experiences and income per household. The results supported the predictive capacity of most independent variables (except for patient sensitivity to the country of origin and to the information on generics in the mass media), denoting patients' preferences toward generic substitution. Patient sensitivity to recommendations by physicians, generic brand, and household income were the strongest predictors of the choice between generic and innovator pharmaceuticals (P < 0.001). The probability of choosing generics over innovator drugs was significantly higher among respondents with the lowest income levels, in those who were indifferent to generic brand or their physician's opinion, as well as in respondents who were sensitive to recommendations by pharmacists or attached a greater value to a past experience with generics (their own experience or that of relatives/friends). In consideration of the foregoing, awareness-raising campaigns may be recommended, supported by a variety of systemic solutions and tools to encourage generic substitution. Copyright © 2016 Elsevier Inc. All rights reserved.

Decision-Making and Problem-Solving Approaches in Pharmacy Education

PubMed Central

Martin, Lindsay C.; Holdford, David A.

2016-01-01

Domain 3 of the Center for the Advancement of Pharmacy Education (CAPE) 2013 Educational Outcomes recommends that pharmacy school curricula prepare students to be better problem solvers, but are silent on the type of problems they should be prepared to solve. We identified five basic approaches to problem solving in the curriculum at a pharmacy school: clinical, ethical, managerial, economic, and legal. These approaches were compared to determine a generic process that could be applied to all pharmacy decisions. Although there were similarities in the approaches, generic problem solving processes may not work for all problems. Successful problem solving requires identification of the problems faced and application of the right approach to the situation. We also advocate that the CAPE Outcomes make explicit the importance of different approaches to problem solving. Future pharmacists will need multiple approaches to problem solving to adapt to the complexity of health care. PMID:27170823

Decision-Making and Problem-Solving Approaches in Pharmacy Education.

PubMed

Martin, Lindsay C; Donohoe, Krista L; Holdford, David A

2016-04-25

Domain 3 of the Center for the Advancement of Pharmacy Education (CAPE) 2013 Educational Outcomes recommends that pharmacy school curricula prepare students to be better problem solvers, but are silent on the type of problems they should be prepared to solve. We identified five basic approaches to problem solving in the curriculum at a pharmacy school: clinical, ethical, managerial, economic, and legal. These approaches were compared to determine a generic process that could be applied to all pharmacy decisions. Although there were similarities in the approaches, generic problem solving processes may not work for all problems. Successful problem solving requires identification of the problems faced and application of the right approach to the situation. We also advocate that the CAPE Outcomes make explicit the importance of different approaches to problem solving. Future pharmacists will need multiple approaches to problem solving to adapt to the complexity of health care.

A new generic system for the pantropical Caesalpinia group (Leguminosae).

PubMed

Gagnon, Edeline; Bruneau, Anne; Hughes, Colin E; de Queiroz, Luciano Paganucci; Lewis, Gwilym P

2016-01-01

The Caesalpinia group is a large pantropical clade of ca. 205 species in subfamily Caesalpinioideae (Leguminosae) in which generic delimitation has been in a state of considerable flux. Here we present new phylogenetic analyses based on five plastid and one nuclear ribosomal marker, with dense taxon sampling including 172 (84%) of the species and representatives of all previously described genera in the Caesalpinia group. These analyses show that the current classification of the Caesalpinia group into 21 genera needs to be revised. Several genera ( Poincianella , Erythrostemon , Cenostigma and Caesalpinia sensu Lewis, 2005) are non-monophyletic and several previously unclassified Asian species segregate into clades that merit recognition at generic rank. In addition, the near-completeness of our taxon sampling identifies three species that do not belong in any of the main clades and these are recognised as new monospecific genera. A new generic classification of the Caesalpinia group is presented including a key for the identification of genera, full generic descriptions, illustrations (drawings and photo plates of all genera), and (for most genera) the nomenclatural transfer of species to their correct genus. We recognise 26 genera, with reinstatement of two previously described genera ( Biancaea Tod., Denisophytum R. Vig.), re-delimitation and expansion of several others ( Moullava , Cenostigma , Libidibia and Erythrostemon ), contraction of Caesalpinia s.s. and description of four new ones ( Gelrebia , Paubrasilia , Hererolandia and Hultholia ), and make 75 new nomenclatural combinations in this new generic system.

A randomized pharmacokinetic study of generic tacrolimus versus reference tacrolimus in kidney transplant recipients.

PubMed

Alloway, R R; Sadaka, B; Trofe-Clark, J; Wiland, A; Bloom, R D

2012-10-01

Pharmacokinetic analyses comparing generic tacrolimus preparations versus the reference drug in kidney transplant patients are lacking. A prospective, multicenter, open-label, randomized, two-period (14 days per period), two-sequence, crossover and steady-state pharmacokinetic study was undertaken to compare twice-daily generic tacrolimus (Sandoz) versus reference tacrolimus (Prograf®) in stable renal transplant patients. AUC(0-12h) and peak concentration (C(max) ) were calculated from 12 h pharmacokinetic profiles at the end of each period (days 14 and 28). Of 71 patients enrolled, 68 provided evaluable pharmacokinetic data. The ratios of geometric means were 1.02 (90% CI 97-108%, p = 0.486) for AUC(0-12h) and 1.09 (90% CI 101-118%, p = 0.057) for C(max) . Mean (SD) C(0) was 7.3(1.8) ng/mL for generic tacrolimus versus 7.0(2.1) ng/mL for reference tacrolimus based on data from days 14 and 28. Correlations between 12 h trough levels and AUC were r = 0.917 for generic tacrolimus and r = 0.887 for reference drug at day 28. These data indicate that generic tacrolimus (Sandoz) has a similar pharmacokinetic profile to the reference drug and is bioequivalent in kidney transplant recipients according to US Food and Drug Administration and European Medicines Agency guidelines. © Copyright 2012 The American Society of Transplantation and the American Society of Transplant Surgeons.

A Randomized Pharmacokinetic Study of Generic Tacrolimus Versus Reference Tacrolimus in Kidney Transplant Recipients

PubMed Central

Alloway, R R; Sadaka, B; Trofe-Clark, J; Wiland, A; Bloom, R D

2012-01-01

Pharmacokinetic analyses comparing generic tacrolimus preparations versus the reference drug in kidney transplant patients are lacking. A prospective, multicenter, open-label, randomized, two-period (14 days per period), two-sequence, crossover and steady-state pharmacokinetic study was undertaken to compare twice-daily generic tacrolimus (Sandoz) versus reference tacrolimus (Prograf®) in stable renal transplant patients. AUC0–12h and peak concentration (Cmax) were calculated from 12 h pharmacokinetic profiles at the end of each period (days 14 and 28). Of 71 patients enrolled, 68 provided evaluable pharmacokinetic data. The ratios of geometric means were 1.02 (90% CI 97–108%, p = 0.486) for AUC0–12h and 1.09 (90% CI 101–118%, p = 0.057) for Cmax. Mean (SD) C0 was 7.3(1.8) ng/mL for generic tacrolimus versus 7.0(2.1) ng/mL for reference tacrolimus based on data from days 14 and 28. Correlations between 12 h trough levels and AUC were r = 0.917 for generic tacrolimus and r = 0.887 for reference drug at day 28. These data indicate that generic tacrolimus (Sandoz) has a similar pharmacokinetic profile to the reference drug and is bioequivalent in kidney transplant recipients according to US Food and Drug Administration and European Medicines Agency guidelines. PMID:22759200

9 CFR 317.5 - Generically approved labeling.

Code of Federal Regulations, 2014 CFR

2014-01-01

... Section 317.5 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE..., without such labeling being submitted for approval to the Food Safety and Inspection Service in Washington... particular. (2) The Food Safety and Inspection Service shall select samples of generically approved labeling...

Generic immunosuppression in solid organ transplantation: a Canadian perspective.

PubMed

Harrison, Jennifer J; Schiff, Jeffrey R; Coursol, Christian J; Daley, Christopher J A; Dipchand, Anne I; Heywood, Norine M; Keough-Ryan, Tammy M; Keown, Paul A; Levy, Gary A; Lien, Dale C; Wichart, Jenny R; Cantarovich, Marcelo

2012-04-15

The introduction of generic immunosuppressant medications may present an opportunity for cost savings in solid organ transplantation if equivalent clinical outcomes to the branded counterparts can be achieved. An interprofessional working group of the Canadian Society of Transplantation was established to develop recommendations on the use of generic immunosuppression in solid organ transplant recipients (SOTR) based on a review of the available data. Under current Health Canada licensing requirements, a demonstration of bioequivalence with the branded formulation in healthy volunteers allows for bridging of clinical data. Cyclosporine, tacrolimus, and sirolimus are designated as "critical dose drugs" and are held to stricter criteria. However, whether this provides sufficient guarantee of therapeutic equivalence in SOTR remains controversial, and failure to maintain an appropriate balance of immunosuppression may have serious consequences, including rejection, graft loss, and death. Published evidence supporting therapeutic equivalence of generic formulations in SOTR is lacking. Moreover, in the setting of multiple generic formulations the potential for uncontrolled product switching is a major concern, since generic preparations are not required to demonstrate bioequivalence with each other. Although close monitoring is recommended with any change in formulation, drug product switches are likely to occur without prescriber knowledge and may pose a significant patient safety risk. The advent of generic immunosuppression will require new practices including more frequent therapeutic drug and clinical monitoring, and increased patient education. The additional workload placed on transplant centers without additional funding will create challenges and could ultimately jeopardize patient outcomes. Until more robust clinical data are available and adequate regulatory safeguards are instituted, caution in the use of generic immunosuppressive drugs in solid organ transplantation is warranted.

Factors influencing the preference for purchasing generic drugs in a Southern Brazilian city.

PubMed

Guttier, Marília Cruz; Silveira, Marysabel Pinto Telis; Luiza, Vera Lucia; Bertoldi, Andréa Dâmaso

2017-06-26

The objective of this study is to identify factors associated with the preference for purchasing generic drugs in a medium-sized municipality in Southern Brazil. We have analyzed data from a population-based cross-sectional study conducted in 2012 with a sample of 2,856 adults (≥ 20 years old). The preference for purchasing generic drugs was the main outcome. The explanatory variables were the demographic and socioeconomic variables. Statistical analyses included Poisson regressions. The preference for purchasing generic drugs was 63.2% (95%CI 61.4-64.9). The variables correlated with this preference in the fully adjusted models were: male (prevalence ratio [PR] = 1.08; 95%CI 1.03-1.14), age of 20-39 years (PR = 1.10; 95%CI 1.02-1.20), low socioeconomic status (PR = 1.15; 95%CI 1.03-1.28), and good knowledge about generic drugs (PR= 4.66; 95%CI 2.89-7.52). Among those who preferred to purchase generic drugs, 55.1% have reported accepting to replace the prescribed drug (if not a generic) with the equivalent generic drug. Another correlate of the preference for purchasing generic drugs was because individuals consider their quality equivalent to reference medicines (PR = 2.15; 95%CI 1.93-2.41). Knowledge about generic drugs was the main correlate of the preference for purchasing generic drugs. The greater the knowledge or positive perception about generic drugs, the greater is the preference to purchase them. Therefore, educational campaigns for healthcare professionals and consumers appear to be the best strategy for expanding the use of generic drugs in Brazil.

76 FR 61360 - Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-04

... calculations that justify the proposed sample size, the expected response rate, methods for assessing potential... Activities: Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative... Collection of Qualitative Feedback on Agency Service Delivery'' to OMB for approval under the Paperwork...

A national audit of retail lamb loin quality in Australia.

PubMed

Safari, E; Channon, H A; Hopkins, D L; Hall, D G; van de Ven, R

2002-07-01

A retail audit of lamb loin tenderness was conducted over a 12-month period to determine the variation in tenderness of Australian lamb. Tenderness was objectively measured using Warner-Bratzler (WB) shear force. Muscle pH and cooking loss were determined on all samples and colour was measured on a sub-sample of loins. A total of 909 midloins from retail butcher shops and supermarkets located in four Australian capital cities (Sydney, Canberra, Melbourne, and Perth) were evaluated at four sampling times (December 1997 and March, June, and October 1998). Overall, 20.3% of all midloins purchased had a WB shear force value above the threshold level of 5 kg. Generic samples from Melbourne butcher shops were similar for WB shear force on average to the generic samples from Canberra and Sydney, whereas those from Melbourne supermarkets had significantly (P<0.001) higher WB shear force and were in line with generic samples from Perth. In both Canberra and Perth, alliance (branded) lamb had a greater WB shear force (P<0.05) than generic lamb. No relationship was found between price per kg and shear force (r=0.02) for loins purchased in Sydney (n=220). Price per kg differed between months (P<0.001) and suburbs (P<0.001), but not between retail butcher shops and supermarkets. Of the midloins tested, 10.3% had a pH above the critical point of 5.8. Midloins from the December 1997 sampling had a lower pH (P<0.01) than those sampled at other months. Those sampled in Melbourne and Perth had a similar mean pH, which were lower (P<0.001) than Canberra and Sydney samples. The findings from this quality audit suggest that there is room to improve the tenderness of Australian lamb sold in the domestic market. A lamb eating quality assurance system, based on set protocols, is one approach that is currently being investigated in Australia to ensure the supply of consistently high eating quality lamb to consumers.

Generic medicines: Greek physicians' perceptions and prescribing practices.

PubMed

Tsiantou, V; Zavras, D; Kousoulakou, H; Geitona, M; Kyriopoulos, J

2009-10-01

The penetration of generic drugs in the Greek pharmaceutical market is placed among the weakest in the EU. The Greek regulatory framework does not systematically support the development of this subsector and physicians are not provided with incentives for prescribing generics. The aim of this study was to investigate the prescribing profile of physicians in Greece with a focus on the factors that influence their decision on generics prescribing. A structured questionnaire was sent by mail to a random national sample of 1463 physicians, stratified by sex, specialty and geographical region. The response rate was 82.3%. Greek physicians have a positive view on generics but they prefer to prescribe the original products. According to our analysis, physician's age and their opinion on generics' efficacy and effectiveness are identified as important determinants of their prescribing decision. The primary reason that could make them change their prescribing habits is the appearance of side-effects. Patients' insurance coverage and income, as well as the drug cost are also referred as factors that influence their prescribing decision. Despite the fact that they do not usually prescribe generics in their clinical practice, they are willing to substitute an original drug by a generic product. Our findings suggest that Greek physicians could be persuaded to prescribe generic medicines, if a generic promotion policy was introduced in the country. To develop such a policy, a set of supply side and demand-side measures should be implemented along with provision of information on generics to physicians during their education and clinical practice.

76 FR 36139 - Agency Information Collection Activities: Submission for OMB Review; Comment Request; Generic...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-21

... requirements or power calculations that justify the proposed sample size, the expected response rate, methods... for the Collection of Qualitative Feedback on Agency Service Delivery AGENCY: Federal Emergency...): ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery'' to the Office of...

76 FR 29763 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-23

... precision requirements or power calculations that justify the proposed sample size, the expected response... Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery AGENCY... ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery.'' Also include...

76 FR 13977 - Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-15

... requirements or power calculations that justify the proposed sample size, the expected response rate, methods... of Qualitative Feedback on Agency Service Delivery AGENCY: Office of the Secretary/Office of the...): ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery'' to OMB for...

76 FR 15027 - Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-18

... clustering), the precision requirements or power calculations that justify the proposed sample size, the...; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery... Clearance for the Collection of Qualitative Feedback on Agency Service Delivery'' to OMB for approval under...

78 FR 44099 - Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance...

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2013-07-23

... requirements or power calculations that justify the proposed sample size, the expected response rate, methods... Collection; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service... Qualitative Feedback on Agency Service Delivery'' for approval under the Paperwork Reduction Act (PRA) (44 U.S...

76 FR 31383 - Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-31

... requirements or power calculations that justify the proposed sample size, the expected response rate, methods...; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery AGENCY: Peace... Qualitative Feedback on Agency Service Delivery '' to OMB for approval under the Paperwork Reduction Act (PRA...

78 FR 23755 - Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance...

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2013-04-22

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76 FR 13019 - Agency Information Collection Activities: Comment Request; Generic Clearance for the Collection...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-09

... requirements or power calculations that justify the proposed sample size, the expected response rate, methods... Clearance for the Collection of Qualitative Feedback on Agency Service Delivery AGENCY: Department of...): ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery '' to OMB for...

76 FR 55398 - Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-07

... precision requirements or power calculations that justify the proposed sample size, the expected response... Qualitative Feedback on Agency Service Delivery AGENCY: National Institutes of Health, Eunice Kennedy Shriver...): ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery '' to OMB for...

76 FR 20967 - Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance...

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76 FR 38355 - Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance...

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2011-06-30

... calculations that justify the proposed sample size, the expected response rate, methods for assessing potential... of Qualitative Feedback on Agency Service Delivery AGENCY: Architectural and Transportation Barriers...: ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery'' to the Office of...

76 FR 22920 - Agency Information Collection Activities: Proposed Collection; Comment Request; DOL Generic...

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Generic lamotrigine versus brand-name Lamictal bioequivalence in patients with epilepsy: A field test of the FDA bioequivalence standard.

PubMed

Ting, Tricia Y; Jiang, Wenlei; Lionberger, Robert; Wong, Jessica; Jones, Jace W; Kane, Maureen A; Krumholz, Allan; Temple, Robert; Polli, James E

2015-09-01

To test the current U.S. Food and Drug Administration (FDA) bioequivalence standard in a comparison of generic and brand-name drug pharmacokinetic (PK) performance in "generic-brittle" patients with epilepsy under clinical use conditions. This randomized, double-blind, multiple-dose, steady-state, fully replicated bioequivalence study compared generic lamotrigine to brand-name Lamictal in "generic-brittle" patients with epilepsy (n = 34) who were already taking lamotrigine. Patients were repeatedly switched between masked Lamictal and generic lamotrigine. Intensive PK blood sampling at the end of each 2-week treatment period yielded two 12-h PK profiles for brand-name and generic forms for each patient. Steady-state area under the curve (AUC), peak plasma concentration (Cmax ), and minimum plasma concentration (Cmin ) data were subjected to conventional average bioequivalence (ABE) analysis, reference-scaled ABE analysis, and within-subject variability (WSV) comparisons. In addition, generic-versus-brand comparisons in individual patients were performed. Secondary clinical outcomes included seizure frequency and adverse events. Generic demonstrated bioequivalence to brand. The 90% confidence intervals of the mean for steady-state AUC, Cmax , and Cmin for generic-versus-brand were 97.2-101.6%, 98.8-104.5%, and 93.4-101.0%, respectively. The WSV of generic and brand were also similar. Individual patient PK ratios for generic-versus-brand were similar but not identical, in part because brand-versus-brand profiles were not identical, even though subjects were rechallenged with the same product. Few subjects had seizure exacerbations or tolerability issues with product switching. One subject, however, reported 267 focal motor seizures, primarily on generic, although his brand and generic PK profiles were practically identical. Some neurologists question whether bioequivalence in healthy volunteers ensures therapeutic equivalence of brand and generic antiepileptic drugs in patients with epilepsy, who may be at increased risk for problems with brand-to-generic switching. Bioequivalence results in "generic-brittle" patients with epilepsy under clinical conditions support the soundness of the FDA bioequivalence standards. Adverse events on generic were not related to the small, allowable PK differences between generic and brand. Wiley Periodicals, Inc. © 2015 International League Against Epilepsy.

Increasing productivity for the analysis of trace contaminants in food by gas chromatography-mass spectrometry using automated liner exchange, backflushing and heart-cutting.

PubMed

David, Frank; Tienpont, Bart; Devos, Christophe; Lerch, Oliver; Sandra, Pat

2013-10-25

Laboratories focusing on residue analysis in food are continuously seeking to increase sample throughput by minimizing sample preparation. Generic sample extraction methods such as QuEChERS lack selectivity and consequently extracts are not free from non-volatile material that contaminates the analytical system. Co-extracted matrix constituents interfere with target analytes, even if highly sensitive and selective GC-MS/MS is used. A number of GC approaches are described that can be used to increase laboratory productivity. These techniques include automated inlet liner exchange and column backflushing for preservation of the performance of the analytical system and heart-cutting two-dimensional GC for increasing sensitivity and selectivity. The application of these tools is illustrated by the analysis of pesticides in vegetables and fruits, PCBs in milk powder and coplanar PCBs in fish. It is demonstrated that considerable increase in productivity can be achieved by decreasing instrument down-time, while analytical performance is equal or better compared to conventional trace contaminant analysis. Copyright © 2013 Elsevier B.V. All rights reserved.

Physicochemical equivalence of generic antihypertensive medicines (EQUIMEDS): protocol for a quality of medicines assessment

PubMed Central

Redfern, Julie; Adedoyin, Rufus Adesoji; Ofori, Sandra; Anchala, Raghupathy; Ajay, Vamadevan S; De Andrade, Luciano; Zelaya, Jose; Kaur, Harparkash; Balabanova, Dina; Sani, Mahmoud U

2016-01-01

Background Prevention and optimal management of hypertension in the general population is paramount to the achievement of the World Heart Federation (WHF) goal of reducing premature cardiovascular disease (CVD) mortality by 25% by the year 2025 and widespread access to good quality antihypertensive medicines is a critical component for achieving the goal. Despite research and evidence relating to other medicines such as antimalarials and antibiotics, there is very little known about the quality of generic antihypertensive medicines in low-income and middle-income countries. The aim of this study was to determine the physicochemical equivalence (percentage of active pharmaceutical ingredient, API) of generic antihypertensive medicines available in the retail market of a developing country. Methods An observational design will be adopted, which includes literature search, landscape assessment, collection and analysis of medicine samples. To determine physicochemical equivalence, a multistage sampling process will be used, including (1) identification of the 2 most commonly prescribed classes of antihypertensive medicines prescribed in Nigeria; (2) identification of a random sample of 10 generics from within each of the 2 most commonly prescribed classes; (3) a geographical representative sampling process to identify a random sample of 24 retail outlets in Nigeria; (4) representative sample purchasing, processing to assess the quality of medicines, storage and transport; and (5) assessment of the physical and chemical equivalence of the collected samples compared to the API in the relevant class. In total, 20 samples from each of 24 pharmacies will be tested (total of 480 samples). Discussion Availability of and access to quality antihypertensive medicines globally is therefore a vital strategy needed to achieve the WHF 25×25 targets. However, there is currently a scarcity of knowledge about the quality of antihypertensive medicines available in developing countries. Such information is important for enforcing and for ensuring the quality of antihypertensive medicines. PMID:28588941

Structure and haemostatic effects of generic versions of enoxaparin available for clinical use in Brazil: similarity to the original drug.

PubMed

Glauser, Bianca F; Vairo, Bruno C; Oliveira, Stephan-Nicollas M C G; Cinelli, Leonardo P; Pereira, Mariana S; Mourão, Paulo A S

2012-02-01

Patent protection for enoxaparin has expired. Generic preparations are developed and approved for clinical use in different countries. However, there is still skepticism about the possibility of making an exact copy of the original drug due to the complex processes involved in generating low-molecular-weight heparins. We have undertaken a careful analysis of generic versions of enoxaparin available for clinical use in Brazil. Thirty-three batches of active ingredient and 70 of the final pharmaceutical product were obtained from six different suppliers. They were analysed for their chemical composition, molecular size distribution, in vitro anticoagulant activity and pharmacological effects on animal models of experimental thrombosis and bleeding. Clearly, the generic versions of enoxaparin available for clinical use in Brazil are similar to the original drug. Only three out of 33 batches of active ingredient from one supplier showed differences in molecular size distribution, resulting from a low percentage of tetrasaccharide or the presence of a minor component eluted as monosaccharide. Three out of 70 batches of the final pharmaceutical products contained lower amounts of the active ingredient than that declared by the suppliers. Our results suggest that the generic versions of enoxaparin are a viable therapeutic option, but their use requires strict regulations to ensure accurate standards.

Factors influencing the preference for purchasing generic drugs in a Southern Brazilian city

PubMed Central

Guttier, Marília Cruz; Silveira, Marysabel Pinto Telis; Luiza, Vera Lucia; Bertoldi, Andréa Dâmaso

2017-01-01

ABSTRACT OBJECTIVE The objective of this study is to identify factors associated with the preference for purchasing generic drugs in a medium-sized municipality in Southern Brazil. METHODS We have analyzed data from a population-based cross-sectional study conducted in 2012 with a sample of 2,856 adults (≥ 20 years old). The preference for purchasing generic drugs was the main outcome. The explanatory variables were the demographic and socioeconomic variables. Statistical analyses included Poisson regressions. RESULTS The preference for purchasing generic drugs was 63.2% (95%CI 61.4–64.9). The variables correlated with this preference in the fully adjusted models were: male (prevalence ratio [PR] = 1.08; 95%CI 1.03–1.14), age of 20–39 years (PR = 1.10; 95%CI 1.02–1.20), low socioeconomic status (PR = 1.15; 95%CI 1.03–1.28), and good knowledge about generic drugs (PR= 4.66; 95%CI 2.89–7.52). Among those who preferred to purchase generic drugs, 55.1% have reported accepting to replace the prescribed drug (if not a generic) with the equivalent generic drug. Another correlate of the preference for purchasing generic drugs was because individuals consider their quality equivalent to reference medicines (PR = 2.15; 95%CI 1.93–2.41). CONCLUSIONS Knowledge about generic drugs was the main correlate of the preference for purchasing generic drugs. The greater the knowledge or positive perception about generic drugs, the greater is the preference to purchase them. Therefore, educational campaigns for healthcare professionals and consumers appear to be the best strategy for expanding the use of generic drugs in Brazil. PMID:28678909

A new generic system for the pantropical Caesalpinia group (Leguminosae)

PubMed Central

Gagnon, Edeline; Bruneau, Anne; Hughes, Colin E.; de Queiroz, Luciano Paganucci; Lewis, Gwilym P.

2016-01-01

Abstract The Caesalpinia group is a large pantropical clade of ca. 205 species in subfamily Caesalpinioideae (Leguminosae) in which generic delimitation has been in a state of considerable flux. Here we present new phylogenetic analyses based on five plastid and one nuclear ribosomal marker, with dense taxon sampling including 172 (84%) of the species and representatives of all previously described genera in the Caesalpinia group. These analyses show that the current classification of the Caesalpinia group into 21 genera needs to be revised. Several genera (Poincianella, Erythrostemon, Cenostigma and Caesalpinia sensu Lewis, 2005) are non-monophyletic and several previously unclassified Asian species segregate into clades that merit recognition at generic rank. In addition, the near-completeness of our taxon sampling identifies three species that do not belong in any of the main clades and these are recognised as new monospecific genera. A new generic classification of the Caesalpinia group is presented including a key for the identification of genera, full generic descriptions, illustrations (drawings and photo plates of all genera), and (for most genera) the nomenclatural transfer of species to their correct genus. We recognise 26 genera, with reinstatement of two previously described genera (Biancaea Tod., Denisophytum R. Vig.), re-delimitation and expansion of several others (Moullava, Cenostigma, Libidibia and Erythrostemon), contraction of Caesalpinia s.s. and description of four new ones (Gelrebia, Paubrasilia, Hererolandia and Hultholia), and make 75 new nomenclatural combinations in this new generic system. PMID:28814915

Assessment of knowledge and perceptions toward generic medicines among basic science undergraduate medical students at Aruba.

PubMed

Shankar, P Ravi; Herz, Burton L; Dubey, Arun K; Hassali, Mohamed A

2016-10-01

Use of generic medicines is important to reduce rising health-care costs. Proper knowledge and perception of medical students and doctors toward generic medicines are important. Xavier University School of Medicine in Aruba admits students from the United States, Canada, and other countries to the undergraduate medical (MD) program. The present study was conducted to study the knowledge and perception about generic medicines among basic science MD students. The cross-sectional study was conducted among first to fifth semester students during February 2015. A previously developed instrument was used. Basic demographic information was collected. Respondent's agreement with a set of statements was noted using a Likert-type scale. The calculated total score was compared among subgroups of respondents. One sample Kolmogorov-Smirnov test was used to study the normality of distribution, Independent samples t -test to compare the total score for dichotomous variables, and analysis of variance for others were used for statistical analysis. Fifty-six of the 85 students (65.8%) participated. Around 55% of respondents were between 20 and 25 years of age and of American nationality. Only three respondents (5.3%) provided the correct value of the regulatory bioequivalence limits. The mean total score was 43.41 (maximum 60). There was no significant difference in scores among subgroups. There was a significant knowledge gap with regard to the regulatory bioequivalence limits for generic medicines. Respondents' level of knowledge about other aspects of generic medicines was good but could be improved. Studies among clinical students in the institution and in other Caribbean medical schools are required. Deficiencies were noted and we have strengthened learning about generic medicines during the basic science years.

Physicians' Trust in the FDA's Use of Product-Specific Pathways for Generic Drug Approval.

PubMed

Kesselheim, Aaron S; Eddings, Wesley; Raj, Tara; Campbell, Eric G; Franklin, Jessica M; Ross, Kathryn M; Fulchino, Lisa A; Avorn, Jerry; Gagne, Joshua J

2016-01-01

Generic drugs are cost-effective versions of brand-name drugs approved by the Food and Drug Administration (FDA) following proof of pharmaceutical equivalence and bioequivalence. Generic drugs are widely prescribed by physicians, although there is disagreement over the clinical comparability of generic drugs to brand-name drugs within the physician community. The objective of this survey was to assess physicians' perceptions of generic drugs and the generic drug approval process. A survey was administered to a national sample of primary care internists and specialists between August 2014 and January 2015. In total, 1,152 physicians comprising of internists with no reported specialty certification and those with specialty certification in hematology, infectious diseases, and endocrinology were surveyed. The survey assessed physicians' perceptions of the FDA's generic drug approval process, as well as their experiences prescribing six generic drugs approved between 2008 and 2012 using product-specific approval pathways and selected comparator drugs. Among 718 respondents (62% response rate), a majority were comfortable with the FDA's process in ensuring the safety and effectiveness of generic drugs overall (91%) and with letting the FDA determine which tests were necessary to determine bioequivalence in a particular drug (92%). A minority (13-26%) still reported being uncomfortable prescribing generic drugs approved using product-specific pathways. Overall, few physicians heard reports of concerns about generic versions of the study drugs or their comparators, with no differences between the two groups. Physicians tended to hear about concerns about the safety or effectiveness of generic drugs from patients, pharmacists, and physician colleagues. Physicians hold largely positive views of the FDA's generic drug approval process even when some questioned the performance of certain generic drugs in comparison to brand-name drugs. Better education about the generic drug approval process and standards may alleviate concerns among the physician community and support the delivery of cost-effective health care.

Development and validation of a tool to assess knowledge and attitudes towards generic medicines among students in Greece: The ATtitude TOwards GENerics (ATTOGEN) questionnaire

PubMed Central

Katsari, Vasiliki; Niakas, Dimitris

2017-01-01

Introduction The use of generic medicines is a cost-effective policy, often dictated by fiscal restraints. To our knowledge, no fully validated tool exploring the students’ knowledge and attitudes towards generic medicines exists. The aim of our study was to develop and validate a questionnaire exploring the knowledge and attitudes of M.Sc. in Health Care Management students and recent alumni’s towards generic drugs in Greece. Materials and methods The development of the questionnaire was a result of literature review and pilot-testing of its preliminary versions to researchers and students. The final version of the questionnaire contains 18 items measuring the respondents’ knowledge and attitude towards generic medicines on a 5-point Likert scale. Given the ordinal nature of the data, ordinal alpha and polychoric correlations were computed. The sample was randomly split into two halves. Exploratory factor analysis, performed in the first sample, was used for the creation of multi-item scales. Confirmatory factor analysis and Generalized Linear Latent and Mixed Model analysis (GLLAMM) with the use of the rating scale model were used in the second sample to assess goodness of fit. An assessment of internal consistency reliability, test-retest reliability, and construct validity was also performed. Results Among 1402 persons contacted, 986 persons completed our questionnaire (response rate = 70.3%). Overall Cronbach’s alpha was 0.871. The conjoint use of exploratory and confirmatory factor analysis resulted in a six-scale model, which seemed to fit the data well. Five of the six scales, namely trust, drug quality, state audit, fiscal impact and drug substitution were found to be valid and reliable, while the knowledge scale suffered only from low inter-scale correlations and a ceiling effect. However, the subsequent confirmatory factor and GLLAMM analyses indicated a good fit of the model to the data. Conclusions The ATTOGEN instrument proved to be a reliable and valid tool, suitable for assessing students’ knowledge and attitudes towards generic medicines. PMID:29186163

Generic Escherichia coli Contamination of Spinach at the Preharvest Stage: Effects of Farm Management and Environmental Factors

PubMed Central

Navratil, Sarah; Gregory, Ashley; Bauer, Arin; Srinath, Indumathi; Jun, Mikyoung; Szonyi, Barbara; Nightingale, Kendra; Anciso, Juan; Ivanek, Renata

2013-01-01

The objective of this study was to determine the effects of farm management and environmental factors on preharvest spinach contamination with generic Escherichia coli as an indicator of fecal contamination. A repeated cross-sectional study was conducted by visiting spinach farms up to four times per growing season over a period of 2 years (2010 to 2011). Spinach samples (n = 955) were collected from 12 spinach farms in Colorado and Texas as representative states of the Western and Southwestern United States, respectively. During each farm visit, farmers were surveyed about farm-related management and environmental factors using a questionnaire. Associations between the prevalence of generic E. coli in spinach and farm-related factors were assessed by using a multivariable logistic regression model including random effects for farm and farm visit. Overall, 6.6% of spinach samples were positive for generic E. coli. Significant risk factors for spinach contamination with generic E. coli were the proximity (within 10 miles) of a poultry farm, the use of pond water for irrigation, a >66-day period since the planting of spinach, farming on fields previously used for grazing, the production of hay before spinach planting, and the farm location in the Southwestern United States. Contamination with generic E. coli was significantly reduced with an irrigation lapse time of >5 days as well as by several factors related to field workers, including the use of portable toilets, training to use portable toilets, and the use of hand-washing stations. To our knowledge, this is the first report of an association between field workers' personal hygiene and produce contamination with generic E. coli at the preharvest level. Collectively, our findings support that practice of good personal hygiene and other good farm management practices may reduce produce contamination with generic E. coli at the preharvest level. PMID:23666336

Quality of generic medicines in South Africa: perceptions versus reality - a qualitative study.

PubMed

Patel, Aarti; Gauld, Robin; Norris, Pauline; Rades, Thomas

2012-09-03

Generic Medicines are an important policy option allowing for access to affordable, essential medicines. Quality of generic medicines must be guaranteed through the activities of national medicines regulatory authorities. Existing negative perceptions surrounding the quality of generic medicines must be addressed to ensure that people use them with confidence. Campaigns to increase the uptake of generic medicines by consumers and providers of healthcare need to be informed by local norms and practices. This study sought to compare South African consumers' and healthcare providers' perceptions of quality of generics to the actual quality of selected products. The study was conducted at the local level in three cities of South Africa: Johannesburg, Durban and Cape Town. Purposive sampling was used to recruit consumer participants (n = 73) and random sampling used to recruit healthcare providers from public and private sectors (n = 15). Data were obtained through twelve focus group discussions with consumers and semi-structured interviews (n = 15) with healthcare providers in order to gain familiarity with perceptions of quality. One hundred and thirty five products comprising paracetamol tablets (n = 47), amoxicillin capsules (n = 45) and hydrochlorothiazide tablets (n = 43) were sourced from public and private sector healthcare providers. These products were subjected to in vitro dissolution, uniformity of weight and identity (Fourier Transformed Infrared Spectroscopy) tests using prescribed methods from the British (2005) and United States Pharmacopeias (2006). Respondents described drug quality in relation to the effect on symptoms. Procurement and use behavior of healthcare providers was influenced by prior experience, manufacturers' names and consumers' ability to pay. All formulations passed the in vitro tests for quality. This study showed clear differences between perceptions of quality and actual quality of medicines suggesting deficiencies in public engagement by government regarding the implementation of generic medicines policy. Implementation of generic medicines policy requires the involvement of consumers and healthcare providers to specifically address their information gaps and needs.

Quality of generic medicines in South Africa: Perceptions versus Reality – A qualitative study

PubMed Central

2012-01-01

Background Generic Medicines are an important policy option allowing for access to affordable, essential medicines. Quality of generic medicines must be guaranteed through the activities of national medicines regulatory authorities. Existing negative perceptions surrounding the quality of generic medicines must be addressed to ensure that people use them with confidence. Campaigns to increase the uptake of generic medicines by consumers and providers of healthcare need to be informed by local norms and practices. This study sought to compare South African consumers’ and healthcare providers’ perceptions of quality of generics to the actual quality of selected products. Methods The study was conducted at the local level in three cities of South Africa: Johannesburg, Durban and Cape Town. Purposive sampling was used to recruit consumer participants (n = 73) and random sampling used to recruit healthcare providers from public and private sectors (n = 15). Data were obtained through twelve focus group discussions with consumers and semi-structured interviews (n = 15) with healthcare providers in order to gain familiarity with perceptions of quality. One hundred and thirty five products comprising paracetamol tablets (n = 47), amoxicillin capsules (n = 45) and hydrochlorothiazide tablets (n = 43) were sourced from public and private sector healthcare providers. These products were subjected to in vitro dissolution, uniformity of weight and identity (Fourier Transformed Infrared Spectroscopy) tests using prescribed methods from the British (2005) and United States Pharmacopeias (2006). Results Respondents described drug quality in relation to the effect on symptoms. Procurement and use behavior of healthcare providers was influenced by prior experience, manufacturers’ names and consumers’ ability to pay. All formulations passed the in vitro tests for quality. Conclusions This study showed clear differences between perceptions of quality and actual quality of medicines suggesting deficiencies in public engagement by government regarding the implementation of generic medicines policy. Implementation of generic medicines policy requires the involvement of consumers and healthcare providers to specifically address their information gaps and needs. PMID:22943592

Preparation for Careers--Not Jobs

ERIC Educational Resources Information Center

Worthy, James C.

1977-01-01

Sangamon State University's experimental management program has demonstrated the fundamental soundness of the generic approach. Application of common principles to a variety of organizational situations contributes to a better understanding of those principles and helps students understand the differences between organizations and how to adapt to…

Implementation of a generic SFC-MS method for the quality control of potentially counterfeited medicinal cannabis with synthetic cannabinoids.

PubMed

Jambo, Hugues; Dispas, Amandine; Avohou, Hermane T; André, Sébastien; Hubert, Cédric; Lebrun, Pierre; Ziemons, Éric; Hubert, Philippe

2018-06-05

In this study, we describe the development of a SFC-MS method for the quality control of cannabis plants that could be potentially adulterated with synthetic cannabinoids. Considering the high number of already available synthetic cannabinoids and the high rate of development of novel structures, we aimed to develop a generic method suitable for the analysis of a large panel of substances using seventeen synthetic cannabinoids from multiple classes as model compounds. Firstly, a suitable column was chosen after a screening phase. Secondly, optimal operating conditions were obtained following a robust optimization strategy based on a design of experiments and design space methodology (DoE-DS). Finally, the quantitative performances of the method were assessed with a validation according to the total error approach. The developed method has a run time of 9.4 min. It uses a simple modifier composition of methanol with 2% H 2 O and requires minimal sample preparation. It can chromatographically separate natural cannabinoids (except THC-A and CBD-A) from the synthetics assessed. Also, the use of mass spectrometry provides sensitivity and specificity. Moreover, this quality by design (QbD) approach permits the tuning of the method (within the DS) during routine analysis to achieve a desirable separation since the future compounds that should be analyzed could be unknown. The method was validated for the quantitation of a selected synthetic cannabinoid in fiber-type cannabis matrix over the range of 2.5% - 7.5% (w/w) with LOD value as low as 14.4 ng/mL. This generic method should be easy to implement in customs or QC laboratories in the context of counterfeit drugs tracking. Copyright © 2018 Elsevier B.V. All rights reserved.

Comparison of prescription drug costs in the United States and the United Kingdom, Part 1: statins.

PubMed

Jick, Hershel; Wilson, Andrew; Wiggins, Peter; Chamberlin, Douglas P

2012-01-01

To compare the annual cost of statins in the United States and in the United Kingdom. Matched-cohort cost analysis. U.K. General Practice Research Database (GPRD), and MarketScan Commercial Claims and Encounters Database, a large, U.S. self-insured medical claims database. We initially identified 1.6 million people in the GPRD who were younger than 65 years of age in 2005. These people were then matched by year of birth and sex with 1.6 million people in the U.S. database. From this matched pool, we estimated that 280,000 people aged 55-64 years from each country in 2005 were prescribed at least one drug. Of these, 91,474 (33%) in the U.S. were prescribed a statin compared with 68,217 (24%) in the U.K. After excluding those who did not receive statins continuously or who switched statins during the year, there remained 61,470 in the U.S. and 45,788 in the U.K. who were prescribed a single statin preparation continuously during 2005 (annual statin users). We estimated and compared drug costs (presented in 2005 U.S. dollars) separately in the two countries. Estimated drug costs were determined by random sampling. Estimated annual costs/patient in the U.S. ranged from $313 for generic lovastatin to $1428 for nongeneric simvastatin. In the U.K., annual costs/patient ranged from $164 for generic simvastatin to $509 for nongeneric atorvastatin. The total annual cost of the continuous receipt of statins in the U.S. was $64.9 million compared with $15.7 million in the U.K. In June 2006, after our study results were analyzed, the U.S. Food and Drug Administration approved generic simvastatin. We thus derived cost estimates for simvastatin use during 2006 and found that more than 60% of simvastatin users switched to the generic product, which reduced the cost/pill by more than 50%. The cost paid for statins in the U.S. for people younger than 65 years, who were insured by private companies, was approximately 400% higher than comparable costs paid by the government in the U.K. Available generic statins were substantially less expensive than those that were still under patent in both countries. © 2012, Pharmacotherapy Publications, Inc.

A target and nontarget strategy for identification or characterization of the chemical ingredients in Chinese herb preparation Shuang-Huang-Lian oral liquid by ultra-performance liquid chromatography-quadrupole time-of-flight mass spectrometry.

PubMed

Zhang, Feng-Xiang; Li, Min; Yao, Zhi-Hong; Li, Chang; Qiao, Li-Rui; Shen, Xiu-Yu; Yu, Kate; Dai, Yi; Yao, Xin-Sheng

2018-03-01

A target and nontarget strategy based on in-house chemical components library was developed for rapid and comprehensive analysis of complicated components from traditional Chinese medicine preparation Shuang-Huang-Lian oral liquid. The sample was analyzed by ultra-performance liquid chromatography-quadrupole time-of-flight mass spectrometry using generic acquisition parameters. Automated detection and data filtering were performed on the UNIFI™ software and the detected peaks were evaluated against an in-house library. As a result, a total of 170 chemical components (110 target compounds and 60 nontarget ones) were identified or tentatively characterized, including 54 flavonoids, 30 phenylethanoid glycosides, 16 iridoid glycosides, 14 lignans, 32 organic acids, 19 triterpenoid saponins and five other types of compounds. Among them, 44 compounds were further confirmed by comparison with reference standards. It was demonstrated that this systematical approach could be successfully applied for rapid identification of multiple compounds in traditional Chinese medicine and its preparations. Furthermore, this work established the foundation for the further investigation on the metabolic fates of multiple ingredients in Shuang-Huang-Lian oral liquid. Copyright © 2017 John Wiley & Sons, Ltd.

A Generic Wet Impregnation Method for Preparing Substrate-Supported Platinum Group Metal and Alloy Nanoparticles with Controlled Particle Morphology.

PubMed

Zhang, Changlin; Oliaee, Shirin Norooz; Hwang, Sang Youp; Kong, Xiangkai; Peng, Zhenmeng

2016-01-13

Mass production of shape-controlled platinum group metal (PGM) and alloy nanoparticles is of high importance for their many fascinating properties in catalysis, electronics, and photonics. Despite of successful demonstrations at milligram scale using wet chemistry syntheses in many fundamental studies, there is still a big gap between the current methods and their real applications due to the complex synthetic procedures, scale-up difficulty, and surface contamination problem of the made particles. Here we report a generic wet impregnation method for facile, surfactant-free, and scalable preparation of nanoparticles of PGMs and their alloys on different substrate materials with controlled particle morphology and clean surface, which bridges the outstanding properties of these nanoparticles to practical important applications. The underlying particle growth and shape formation mechanisms were investigated using a combination of ex situ and in situ characterizations and were attributed to their different interactions with the applied gas molecules.

Counselors' Experience of Providing Services to Looked-After Children in the United Kingdom: A Generic Qualitative Inquiry

ERIC Educational Resources Information Center

Ina-Egbe, Esther Funmilayo

2017-01-01

This study was conducted to examine counselors' experience of providing services to looked-after children in the United Kingdom. The generic qualitative design was used. A purposeful sample of 15 counselors was used and semi-structured interviews were conducted. Interviews were transcribed and analyzed using thematic analysis and constant…

Pharmacists' experiences and attitudes regarding generic drugs and generic substitution: two sides of the coin.

PubMed

Olsson, Erika; Kälvemark Sporrong, Sofia

2012-12-01

Generic drug substitution reduces costs for medicines, but the downsides include unintentional double medication, confusion and anxiety among patients. Information from pharmacists affects patients' experiences of substitution with generic drugs. The aim of this study was to explore experiences and attitudes to generic substitution among Swedish community pharmacists. An interview guide was developed. Semi-structured interviews with community pharmacists were conducted and transcribed verbatim. Analysis was inductive; extracts from the transcripts were compared and combined to form themes and subcategories. Pharmacists from a heterogeneous convenience sample of pharmacies were interviewed until data saturation had been achieved. Sixteen pharmacists were interviewed. Three main themes and twelve subcategories were identified, with the main themes being the role of the pharmacist, pharmacists' concerns regarding patients, and the generic drug. Pharmacists found it positive that generic substitution decreases the costs for pharmaceuticals but also emphasized that the switch can confuse and worry patients, which could result in less benefit from treatment. Respondents claimed that generic substitution has changed the focus in the pharmacist-patient meeting towards economics and regulations. According to the interviewed pharmacists generic substitution is not primarily an issue of generic versus brand-name products, but concerns above all the challenges that the switch implies for patients and pharmacists. To prevent known confusion and concerns among patients it is important that community pharmacists acquire the necessary tools and knowledge to manage this situation; pharmacists themselves as well as pharmacy owners and authorities share responsibility for this. © 2012 The Authors. IJPP © 2012 Royal Pharmaceutical Society.

Knowledge, attitudes, and practices of community pharmacists on generic medicines in Qatar.

PubMed

Awaisu, Ahmed; Kheir, Nadir; Ibrahim, Mohamed Izham Mohamed; El-Hajj, Maguy; Hazi, Huda; Khudair, Nada; Barazi, Raja

2014-04-01

The practice of generic medicines prescribing, dispensing and substitution in developing countries has been controversial among healthcare professionals, particularly due to issues on quality, safety and efficacy. These controversies are as a result of inter-country differences in policies and laws as well as individualized knowledge and attitudes of pharmacists pertaining to generic medicines. This study primarily aims to assess the knowledge, attitudes, and practices of community pharmacists in Qatar towards generic medicines. Community pharmacy settings throughout the State of Qatar. A cross-sectional study using a pretested paper-based survey was conducted among a random sample of community pharmacists in Qatar. The data were analyzed using IBM-SPSS(®) version 20. Both descriptive and inferential statistical analyses were applied. Knowledge, attitudes, and practices of generic medicines pertaining to regulatory standards, safety, efficacy, quality, and future policies. Results A total of 160 surveys were distributed to community pharmacists of which 118 were returned (response rate, 74 %). The mean total score of generic medicines knowledge among the pharmacists was 6.8 ± 1.6 (maximum possible score was 10). Years of practice as well as place of obtaining academic degree did not influence knowledge score. Approximately 72 % of the pharmacists supported generic substitution for brand name drugs in all cases where a generic medicine is available and the majority (93 %) agreed that pharmacists should be given generic substitution right. Nearly 61 % of the pharmacists considered lack of proven bioequivalence to original brands as an important barrier for selecting generic medicines and 55 % rated "lack of policy for directing the practice of generic medicine" as an important barrier. In order to enhance the quality use of and to promote the practice of generic medicines in Qatar, an educational program should be implemented. A national generic medicine policy and guidelines are warranted in the State of Qatar.

Requirements analysis notebook for the flight data systems definition in the Real-Time Systems Engineering Laboratory (RSEL)

NASA Astrophysics Data System (ADS)

Wray, Richard B.

1991-12-01

A hybrid requirements analysis methodology was developed, based on the practices actually used in developing a Space Generic Open Avionics Architecture. During the development of this avionics architecture, a method of analysis able to effectively define the requirements for this space avionics architecture was developed. In this methodology, external interfaces and relationships are defined, a static analysis resulting in a static avionics model was developed, operating concepts for simulating the requirements were put together, and a dynamic analysis of the execution needs for the dynamic model operation was planned. The systems engineering approach was used to perform a top down modified structured analysis of a generic space avionics system and to convert actual program results into generic requirements. CASE tools were used to model the analyzed system and automatically generate specifications describing the model's requirements. Lessons learned in the use of CASE tools, the architecture, and the design of the Space Generic Avionics model were established, and a methodology notebook was prepared for NASA. The weaknesses of standard real-time methodologies for practicing systems engineering, such as Structured Analysis and Object Oriented Analysis, were identified.

Requirements analysis notebook for the flight data systems definition in the Real-Time Systems Engineering Laboratory (RSEL)

NASA Technical Reports Server (NTRS)

Wray, Richard B.

1991-01-01

A hybrid requirements analysis methodology was developed, based on the practices actually used in developing a Space Generic Open Avionics Architecture. During the development of this avionics architecture, a method of analysis able to effectively define the requirements for this space avionics architecture was developed. In this methodology, external interfaces and relationships are defined, a static analysis resulting in a static avionics model was developed, operating concepts for simulating the requirements were put together, and a dynamic analysis of the execution needs for the dynamic model operation was planned. The systems engineering approach was used to perform a top down modified structured analysis of a generic space avionics system and to convert actual program results into generic requirements. CASE tools were used to model the analyzed system and automatically generate specifications describing the model's requirements. Lessons learned in the use of CASE tools, the architecture, and the design of the Space Generic Avionics model were established, and a methodology notebook was prepared for NASA. The weaknesses of standard real-time methodologies for practicing systems engineering, such as Structured Analysis and Object Oriented Analysis, were identified.

Exploring factors underlying the attitude of community pharmacists to generic substitution: a nationwide study from Poland.

PubMed

Drozdowska, Aleksandra; Hermanowski, Tomasz

2016-02-01

Generic uptake will increasingly be promoted by governments in the face of increasing healthcare costs and global economic uncertainties. The purpose of this study was to investigate attitudes towards generic substitution among community pharmacists, with a focus on the perception of the efficacy, knowledge of the generics characteristics, as well as the willingness to recommend generic substitution. Community pharmacies in Poland. The survey was conducted in 2013 by telephone interviews with 802 holders of an MSc degree in pharmacy working as community pharmacists. Stratified sampling was implemented to make the study representative in geographic terms. Pharmacists' attitudes towards generics drugs. The study showed that only 40 % of pharmacists always inform patients about their right to choose a generic substitute. It was also shown that the less time a pharmacist has been practising, the less likely they are to invite consumers to choose between generic and innovator products. The likelihood of informing was not affected by pharmacist's sex or age, or by pharmacy location or status (chain vs. independent pharmacy) (p > 0.05). Pharmacists varied in their approach to their statutory obligation to inform about a generic; a more or less equal share of respondents were either in favour or against it. Approximately 60 % pharmacists were shown to be familiar with the definition of a generic medicine. Pharmacists with shorter time of practice proved to know more about generics. However, more than 30 % respondents failed to choose the correct statement on generic versus reference medicine dosage. The majority of respondents (67 %) believed there are no differences in efficacy between generics and innovator drugs, whereas 31 % claimed that original brands could be more effective. A significant correlation was demonstrated between the views of pharmacists on the therapeutic efficacy and their willingness to substitute for generics whenever permitted by a physician. It is important to address all concerns pharmacists may have over generics, for example by implementing comprehensive awareness-raising campaigns. Also, pharmacotherapy monitoring systems (i.e. provided in a framework of pharmaceutical care) could be considered to identify any safety or quality concerns that may arise.

Exploring pharmacists' opinions regarding PHARMAC's interventions in promoting brand changes.

PubMed

Babar, Z U; Polwin, A; Kan, S W; Amerasinghe, N; McCarthy, S; Rasheed, F; Stewart, J; Lessing, C; Ragupathy, R; Scahill, S L

2015-01-01

In New Zealand, the use of generic medicines is advocated by the Pharmaceutical Management Agency of New Zealand (PHARMAC). Among other interventions, PHARMAC uses educational awareness campaigns to educate pharmacists to promote the uptake of generic medicines. However, the opinion of pharmacists regarding these interventions has not yet been evaluated. The objective of this study was to explore pharmacists' opinions regarding PHARMAC's interventions in promoting medicine brand changes. A cross-sectional study design was employed to explore pharmacists' opinions regarding brand changes. A questionnaire was sent to 500 randomly selected pharmacists in New Zealand. In second component of the study, five community pharmacies in the Auckland region were selected through convenience sampling, and a semi-structured interview was conducted with a pharmacist in each site. One-hundred and eighty seven questionnaires were returned and analyzed (response rate of 37.4%). Sixty-eight percent of pharmacists supported brand changes and 98.4% mentioned that PHARMAC is responsible for informing them of brand changes. Over half (51.3%) of pharmacists found the current interventions effective, and 39.6% were satisfied with the current brand change information provided by PHARMAC. The majority (94.7%) of pharmacists currently receive faxed information but many indicated (70.8%) that they prefer email notifications. Cilazapril was considered the least difficult medicine to substitute in the past 10 years and omeprazole the most difficult. Patient acceptance and claims about effectiveness were the main factors in determining the difficulty of brand substitution. Fewer than half of the respondents felt that interventions were implemented with enough preparation time for a brand change. The ideal lead-in time was in the range of three to six months. Pharmacists expressed a number of concerns about brand changes such as the frequency at which they occur and the lack of generic stock availability when a brand change occurs. Over one-third of respondents were satisfied with brand change information provided by PHARMAC. Cilazapril was the least difficult medicine to substitute, while omeprazole and salbutamol changes were the most difficult. Claims about effectiveness, quality and side effects were the main factors identified as barriers to generic substitution. Copyright © 2015 Elsevier Inc. All rights reserved.

Undergraduate Accounting Students: Prepared for the Workplace?

ERIC Educational Resources Information Center

Towers-Clark, Jane

2015-01-01

Purpose: This paper aims to explore and investigate student perceptions as to what generic skills they considered were important for accountants and to what extent these skills were developed by their programme of study. Design/methodology/approach: Data gathered from 357 UK undergraduate accounting degree graduates were used to develop insights…

Online Collaborative Communities of Learning for Pre-Service Teachers of Languages

ERIC Educational Resources Information Center

Morgan, Anne-Marie

2015-01-01

University programs for preparing preservice teachers of languages for teaching in schools generally involve generic pedagogy, methodology, curriculum, programming and issues foci, that provide a bridge between the study of languages (or recognition of existing language proficiency) and the teaching of languages. There is much territory to cover…

Generic products of antiepileptic drugs: a perspective on bioequivalence, bioavailability, and formulation switches using Monte Carlo simulations.

PubMed

Karalis, Vangelis; Macheras, Panos; Bialer, Meir

2014-01-01

Generic products of antiepileptic drugs (AEDs) are currently a controversial topic as neurologists and patients are reluctant to switch from brand products to generics and to switch between generics. The aim of this study was to provide enlightenment on issues of bioequivalence (BE) and interchangeability of AED products. Monte Carlo simulations of the classic 2 × 2 BE studies were performed to study the effect of sample size, within-subject variability, and the true difference in pharmacokinetic values of the products under comparison on BE acceptance of generic AED products. Simulations were extended to study the comparative performance of two generic AED products against the same innovative product. The simulated results are compared with literature data on AEDs. The question with regard to bioavailability (BA) is whether two formulations are different, while for BE the question is whether two formulations are sufficiently similar in terms of extent and rate of absorption. Therefore, the criteria for BA and BE and the statistical analysis involved in their analysis are different. Two generic formulations that meet regulatory approval requirements for generics by being bioequivalent to the same innovative AED may not be bioequivalent to one another and therefore should not be regarded as equal or as therapeutically equivalent products. A switch from a standard or an immediate-release formulation to a modified-release product, which comprises extended-release or delayed-release formulations, should not be regarded as a switch between generics, but rather as a switch between different formulation types. Switches between bioequivalent generic AED products could potentially lead to larger changes in plasma levels and exposure than the brand-to-generic switch. The simulation work verified the clinical findings that not all generic AED products bioequivalent to the same innovative product are bioequivalent to one another. Two generic formulations that meet regulatory approval requirements for generics, by being bioequivalent to the innovative AED, may not be bioequivalent to one another. Additional BE criteria are needed for a formulation switch, particularly in epilepsy, where a breakthrough seizure may change a patient's status from seizure-free to refractory.

Knowledge, attitudes and practices of community pharmacists on generic medicines in Palestine: a cross-sectional study.

PubMed

Shraim, Naser Y; Al Taha, Tasneem A; Qawasmeh, Rawan F; Jarrar, Hiba N; Shtaya, Maram A N; Shayeb, Lama A; Sweileh, Waleed M

2017-12-28

Generic substitution in several countries has become a common practice. Besides, it is considered as a major cost minimizing strategy meant to contain pharmaceutical expenditure without compromising healthcare quality. However, the safety and quality issues of generic products are of top concerns of general practitioners and health work professionals. This study aimed to investigate community pharmacist's knowledge, attitudes and practices toward generic medicines in Palestine. This study was a cross-sectional observational study employing a self-administered questionnaire. The questionnaire was of four main sections: demographic and practice details of the participants, knowledge, attitudes and the influencing factors related to selection and dispensing of generic medicines. A convenience sampling technique was implemented in this study in which the data collection form was distributed in West Bank- Palestine among a set of practicing pharmacists. Mann-Whitney-U or Kruskal-Wallis tests were used to comparison of different issues as appropriate. P-values of <0.05 were considered significant. A total of 302 community pharmacists were interviewed, slightly more than half were males (52.3%). The mean knowledge score of participants regarding generic medicines was (5.91 ± 1.27) where the highest score was 8 of 10. Knowledge score was not significantly influenced by any of the socio-demographic characteristics. Our data showed that most of included pharmacists in the study (95.4%) agreed that health authorities should implement bioequivalence policies prior to marketing approval of generics, while 87.4% of participants agreed that they should be given the right to substitute generics and the majority (62.3%) support generic substitution for brand name drugs in all cases when a generic is available The main two factors affect pharmacists' selection and dispensing of generic medicines are personal faith in the product (86.1%) and cost effectiveness of generic medicines (84.1%). Generic medicines substitution among pharmacists is widespread and prevalent. Our data found that participant pharmacists in Palestine had basic knowledge with regards to generic medicine. However, their knowledge score pertaining the technical and regulatory aspects of bioequivalence and pharmacokinetic parameters in particular was insufficient.

Disclosure of industry payments to prescribers: industry payments might be a factor impacting generic drug prescribing.

PubMed

Qian, Jingjing; Hansen, Richard A; Surry, Daniel; Howard, Jennifer; Kiptanui, Zippora; Harris, Ilene

2017-07-01

Pharmaceutical companies paid at least $3.91bn to prescribers in 2013, yet evidence indicating whether industry payments shift prescribing away from generics is limited. This study examined the association between amount of industry payments to prescribers and generic drug prescribing rates among Medicare Part D prescribers. A cross-sectional analysis was conducted among 770 095 Medicare Part D prescribers after linking the 2013 national Open Payments data with 2013 Medicare Provider Utilization and Payment data. The exposure variable was the categorized amount of total industry payments to prescribers (i.e., meals, travel, research, and ownership). The outcome was prescriber's annual generic drug prescribing rate. Multivariable generalized linear regression models were used to examine the association between the amount of industry payments and prescriber's annual generic drug prescribing rates, controlling for prescriber's demographic and practice characteristics. In this sample, over one-third (38.0%) of Medicare Part D prescribers received industry payments in 2013. The mean annual generic drug prescribing rate was highest among prescribers receiving no payments and lowest among those receiving more than $500 of industry payments (77.5% vs. 71.3%, respectively; p < 0.001). The receipt of industry payments was independently associated with prescribers' generic drug prescribing rate; higher payments corresponded with lower generic drug prescribing rates. Other prescriber characteristics associated with higher annual generic drug prescribing rate included male sex, non-northeast region, specialty, and patient volume. Receipt of industry payments was associated with a decreased rate of generic drug prescribing. How this affects patient care and total medical costs warrants further study. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

Impact of alternative interventions on changes in generic dispensing rates.

PubMed

O'Malley, A James; Frank, Richard G; Kaddis, Atheer; Rothenberg, Barbara M; McNeil, Barbara J

2006-10-01

To evaluate the effectiveness of four alternative interventions (member mailings, advertising campaigns, free generic drug samples to physicians, and physician financial incentives) used by a major health insurer to encourage its members to switch to generic drugs. Using claim-level data from Blue Cross Blue Shield of Michigan, we evaluated the success of four interventions implemented during 2000-2003 designed to increase the use of generic drugs among its members. Around 13 million claims involving seven important classes of drugs were used to assess the effectiveness of the interventions. For each intervention a control group was developed that most closely resembled the corresponding intervention group. Logistic regression models with interaction effects between the treatment group (intervention versus control) and the status of the intervention (active versus not active) were used to evaluate if the interventions had an effect on the generic dispensing rate (GDR). Because the mail order pharmacy was considered more aggressive at converting prescriptions to generics, separate generic purchasing models were fitted to retail and mail order claims. In secondary analyses separate models were also fitted to claims involving a new condition and claims refilled for preexisting conditions. The interventions did not appear to increase the market penetration of generic drugs for either retail or mail order claims, or for claims involving new or preexisting conditions. In addition, we found that the ratio of copayments for brand name to generic drugs had a large positive effect on the GDR. The interventions did not appear to directly influence the GDR. Financial incentives expressed to consumers through benefit designs have a large influence on their switching to generic drugs and on the less-costly mail-order mode of purchase.

Transforming RN education: clinical learning and clinical knowledge development.

PubMed

Benner, P

1993-04-01

Transforming RN education has the potential for transforming clinical teaching and learning for all students. The returning RN student offers possibilities for clinical learning that the generic student does not have, but this should not cause us to limit the returning RN student to the generic level. Where possible innovative programs should be developed to move the RN student from baccalaureate level to the Master's level. As educators, we should take the opportunity to increase the numbers of nurses who are educationally prepared to move into advanced levels of practice. The returning RN student offers a rich human resource for the profession, and a rich resource for improving our clinical teaching as well as our practice.

Acute toxicity of two generic drilling fluids and six additives, alone and combined, to mysids (Mysidopsis bahia)

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

Parrish, P.R.; Macauley, J.M.; Montgomery, R.M.

1988-01-01

Toxicity tests were conducted with two laboratory-prepared generic drilling fluids (muds) and six commonly used drilling-fluid additives to determine their toxicity, alone and combined, to mysids (Mysidopsis bahia). In 25 tests, the acute toxicity of combinations of one, two, or three of the drilling-fluid additives mixed with either drilling fluid was less than the toxicity predicted from the empirical 96-h LC50s for drilling fluid additive(s) and/or drilling fluid alone; the observed 96-h LC50s of the mixtures were from 1.3 to 23.6 times the values predicted from the presumption of additive toxicity.

Rocketdyne/Westinghouse nuclear thermal rocket engine modeling

NASA Technical Reports Server (NTRS)

Glass, James F.

1993-01-01

The topics are presented in viewgraph form and include the following: systems approach needed for nuclear thermal rocket (NTR) design optimization; generic NTR engine power balance codes; rocketdyne nuclear thermal system code; software capabilities; steady state model; NTR engine optimizer code-logic; reactor power calculation logic; sample multi-component configuration; NTR design code output; generic NTR code at Rocketdyne; Rocketdyne NTR model; and nuclear thermal rocket modeling directions.

A Generic Qualitative Study of the Experiences of International Students Participating in the Cultural Connections Program at the University of Mississippi

ERIC Educational Resources Information Center

Kholomeydik, Nadezda

2012-01-01

The purpose of this research was to explore the experiences of international students participating in the Cultural Connections Program at The University of Mississippi. A generic qualitative design was utilized using purposeful criterion sampling. The data was collected from two focus group interviews with 11 participants in focus group 1 and 10…

Purification of complex samples: Implementation of a modular and reconfigurable droplet-based microfluidic platform with cascaded deterministic lateral displacement separation modules

PubMed Central

Pudda, Catherine; Boizot, François; Verplanck, Nicolas; Revol-Cavalier, Frédéric; Berthier, Jean; Thuaire, Aurélie

2018-01-01

Particle separation in microfluidic devices is a common problematic for sample preparation in biology. Deterministic lateral displacement (DLD) is efficiently implemented as a size-based fractionation technique to separate two populations of particles around a specific size. However, real biological samples contain components of many different sizes and a single DLD separation step is not sufficient to purify these complex samples. When connecting several DLD modules in series, pressure balancing at the DLD outlets of each step becomes critical to ensure an optimal separation efficiency. A generic microfluidic platform is presented in this paper to optimize pressure balancing, when DLD separation is connected either to another DLD module or to a different microfluidic function. This is made possible by generating droplets at T-junctions connected to the DLD outlets. Droplets act as pressure controllers, which perform at the same time the encapsulation of DLD sorted particles and the balance of output pressures. The optimized pressures to apply on DLD modules and on T-junctions are determined by a general model that ensures the equilibrium of the entire platform. The proposed separation platform is completely modular and reconfigurable since the same predictive model applies to any cascaded DLD modules of the droplet-based cartridge. PMID:29768490

Tapered Optical Fiber Probe Assembled with Plasmonic Nanostructures for Surface-Enhanced Raman Scattering Application.

PubMed

Huang, Zhulin; Lei, Xing; Liu, Ye; Wang, Zhiwei; Wang, Xiujuan; Wang, Zhaoming; Mao, Qinghe; Meng, Guowen

2015-08-12

Optical fiber-Raman devices integrated with plasmonic nanostructures have promising potentials for in situ probing remote liquid samples and biological samples. In this system, the fiber probe is required to simultaneously demonstrate stable surface enhanced Raman scattering (SERS) signals and high sensitivity toward the target species. Here we demonstrate a generic approach to integrate presynthesized plasmonic nanostructures with tapered fiber probes that are prepared by a dipping-etching method, through reversed electrostatic attraction between the silane couple agent modified silica fiber probe and the nanostructures. Using this approach, both negatively and positively charged plasmonic nanostructures with various morphologies (such as Au nanosphere, Ag nanocube, Au nanorod, Au@Ag core-shell nanorod) can be stably assembled on the tapered silica fiber probes. Attributed to the electrostatic force between the plasmonic units and the fiber surface, the nanostructures do not disperse in liquid samples easily, making the relative standard deviation of SERS signals as low as 2% in analyte solution. Importantly, the detection sensitivity of the system can be optimized by adjusting the cone angle (from 3.6° to 22°) and the morphology of nanostructures assembled on the fiber. Thus, the nanostructures-sensitized optical fiber-Raman probes show great potentials in the applications of SERS-based environmental detection of liquid samples.

77 FR 67777 - National Oil and Hazardous Substance Pollution Contingency Plan; National Priorities List...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-14

... subsequent soil samples showed levels of metals at or below generic residential criteria or background values... 1994- 1996 and additional sampling between 1998 and 2007. Area A--Site Entrance: Soil boring samples... verification samples. Additional soil samples were collected from the same location as the previous collection...

Pharmaceutical quality of seven generic Levodopa/Benserazide products compared with original Madopar® / Prolopa®.

PubMed

Gasser, Urs E; Fischer, Anton; Timmermans, Jan P; Arnet, Isabelle

2013-04-23

By definition, a generic product is considered interchangeable with the innovator brand product. Controversy exists about interchangeability, and attention is predominantly directed to contaminants. In particular for chronic, degenerative conditions such as in Parkinson's disease (PD) generic substitution remains debated among physicians, patients and pharmacists. The objective of this study was to compare the pharmaceutical quality of seven generic levodopa/benserazide hydrochloride combination products marketed in Germany with the original product (Madopar® / Prolopa® 125, Roche, Switzerland) in order to evaluate the potential impact of Madopar® generics versus branded products for PD patients and clinicians. Madopar® / Prolopa® 125 tablets and capsules were used as reference material. The generic products tested (all 100 mg/25 mg formulations) included four tablet and three capsule formulations. Colour, appearance of powder (capsules), disintegration and dissolution, mass of tablets and fill mass of capsules, content, identity and amounts of impurities were assessed along with standard physical and chemical laboratory tests developed and routinely practiced at Roche facilities. Results were compared to the original "shelf-life" specifications in use by Roche. Each of the seven generic products had one or two parameters outside the specifications. Deviations for the active ingredients ranged from +8.4% (benserazide) to -7.6% (levodopa) in two tablet formulations. Degradation products were measured in marked excess (+26.5%) in one capsule formulation. Disintegration time and dissolution for levodopa and benserazide hydrochloride at 30 min were within specifications for all seven generic samples analysed, however with some outliers. Deviations for the active ingredients may go unnoticed by a new user of the generic product, but may entail clinical consequences when switching from original to generic during a long-term therapy. Degradation products may pose a safety concern. Our results should prompt caution when prescribing a generic of Madopar®/Prolopa®, and also invite to further investigations in view of a more comprehensive approach, both pharmaceutical and clinical.

Attitudes of Slovene general practitioners towards generic drug prescribing and comparison with international studies.

PubMed

Kersnik, J; Peklar, J

2006-12-01

Over the recent years there has been a steady 7% yearly increase in prescribing costs, which accounts for 17% of the Slovene national health care budget. Substitution of branded products by generic equivalents can offer savings. General practitioners (GPs) are often concerned about the quality of generic products and possible legal liabilities associated with their use. We wanted to examine the attitudes of GPs in Slovenia towards generic drug prescribing. We conducted a postal survey of a random sample of 200 out of 800 GPs in Slovenia from the National Health Insurance Institute database. GPs were asked 21 questions regarding their knowledge on generic drugs, awareness of prescribing costs, prices of generic drugs relative to brand name drugs and their attitude towards use of generic drugs. The 117 (58.5%) replies we received represent 15% of the GP population in Slovenia. 66.1% of GPs considered rising costs of medicines to be a serious problem for the health care budget. Each week, over 50% of GPs experienced demands from patients for specific drugs and the majority of GPs usually met their patients' demands or requests from hospital consultants for branded products. 38.3% of GPs did not take price into consideration when prescribing drugs. The majority of GPs (88.9%) perceived generics to have the same effectiveness as branded drugs. One quarter of GPs would prescribe more generics if additional clinical trials were presented. 37.3% would follow advice of academic detailers and 30.3% expected the generics to be even cheaper than they were. Independent detailing was welcomed by 63.8% of GPs because of the big influence of the pharmaceutical industry on the prescribing habits. 15.5% thought that the industry had a tremendous impact on their prescribing patterns. Slovene GPs are aware of the cost of prescribed drugs. They are willing to accept independent academic detailing to improve their prescribing and are willing to increase generic drugs under certain conditions.

76 FR 23609 - New Proposed Collection; Comment Request; Biospecimen and Physical Measures Formative Research...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-27

... has obtained an OMB generic clearance to conduct survey and instrument design and administration... conduct the detailed preparation needed for a study of this size and complexity, the NCS was designed to... methodological studies conducted during the Vanguard phase will inform the implementation and analysis plan for...

Rural Special Education Quarterly, Volume 5, Nos. 1-4, Spring-Fall 1984, Winter 1985.

ERIC Educational Resources Information Center

Rural Special Education Quarterly, 1985

1985-01-01

Four newsletter issues examine aspects of rural special education. Issue number one considers the generic problems or solutions in rural special education leadership, the need for innovative preservice preparation for rural educators, preservice training for Native American professionals and paraprofessionals, a model for rural early intervention,…

Requirements Higher Education Graduates Meet on the Labor Market

ERIC Educational Resources Information Center

Braun, Edith M. P.; Brachem, Julia-Carolin

2015-01-01

In Europe and all over the world, higher education systems face the challenge of preparing an increasing number of students for the labor market and teaching them discipline-related knowledge and competences as well as generic competences. But what requirements do higher education graduates actually meet on the labor market? To identify higher…

Optimal Weighting for Exam Composition

ERIC Educational Resources Information Center

Ganzfried, Sam; Yusuf, Farzana

2018-01-01

A problem faced by many instructors is that of designing exams that accurately assess the abilities of the students. Typically, these exams are prepared several days in advance, and generic question scores are used based on rough approximation of the question difficulty and length. For example, for a recent class taught by the author, there were…

Quality Assurance Toolkit for Distance Higher Education Institutions and Programmes

ERIC Educational Resources Information Center

Rama, Kondapalli, Ed.; Hope, Andrea, Ed.

2009-01-01

The Commonwealth of Learning is proud to partner with the Sri Lankan Ministry of Higher Education and UNESCO to produce this "Quality Assurance Toolkit for Distance Higher Education Institutions and Programmes". The Toolkit has been prepared with three features. First, it is a generic document on quality assurance, complete with a…

78 FR 37324 - Preparation of Environmental Reports for Nuclear Power Plant License Renewal Applications

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-20

... Commission's 1996 findings on the environmental impacts of renewing the operating license of a nuclear power.... Specifically, the final rule amends Table B-1 by redefining the number and scope of the environmental impact... is publishing Revision 1 to NUREG-1437, ``Generic Environmental Impact Statement for License Renewal...

WHO Expert Committee on Specifications for Pharmaceutical Preparations. Forty-ninth report.

PubMed

2015-01-01

The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use. Revised procedure for the development of monographs and other texts for The International Pharmacopoeia; Revised updating mechanism for the section on radiopharmaceuticals in The International Pharmacopoeia; Revision of the supplementary guidelines on good manufacturing practices: validation, Appendix 7: non-sterile process validation; General guidance for inspectors on hold-time studies; 16 technical supplements to Model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products; Recommendations for quality requirements when plant-derived artemisinin is used as a starting material in the production of antimalarial active pharmaceutical ingredients; Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability: revision; Guidance on the selection of comparator pharmaceutical products for equivalence assessment of interchangeable multisource (generic) products: revision; and Good review practices: guidelines for national and regional regulatory authorities.

Laser-induced breakdown spectroscopy in industrial and security applications

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

Bol'shakov, Alexander A.; Yoo, Jong H.; Liu Chunyi

2010-05-01

Laser-induced breakdown spectroscopy (LIBS) offers rapid, localized chemical analysis of solid or liquid materials with high spatial resolution in lateral and depth profiling, without the need for sample preparation. Principal component analysis and partial least squares algorithms were applied to identify a variety of complex organic and inorganic samples. This work illustrates how LIBS analyzers can answer a multitude of real-world needs for rapid analysis, such as determination of lead in paint and children's toys, analysis of electronic and solder materials, quality control of fiberglass panels, discrimination of coffee beans from different vendors, and identification of generic versus brand-name drugs.more » Lateral and depth profiling was performed on children's toys and paint layers. Traditional one-element calibration or multivariate chemometric procedures were applied for elemental quantification, from single laser shot determination of metal traces at {approx}10 {mu}g/g to determination of halogens at 90 {mu}g/g using 50-shot spectral accumulation. The effectiveness of LIBS for security applications was demonstrated in the field by testing the 50-m standoff LIBS rasterizing detector.« less

Validated multiclass targeted determination of antibiotics in fish with high performance liquid chromatography-benchtop quadrupole orbitrap hybrid mass spectrometry.

PubMed

Chiesa, Luca; Panseri, Sara; Pasquale, Elisa; Malandra, Renato; Pavlovic, Radmila; Arioli, Francesco

2018-08-30

High performance liquid chromatography, coupled with a benchtop Q-Exactive Orbitrap high-resolution mass spectrometer, was successfully applied for the determination of 24 target antibiotics (selected beta-lactams, tetracyclines, fluoroquinolones, sulfonamids, phenicols, macrolides, cephalosporins, lincosamides, diaminopyrimidine) in fish matrices. The Q-Exactive parameters were carefully studied to accomplish the best compromise between a suitable scan speed and selectivity, considering the restrictions associated with generic sample preparation methodology. Retention time, an exact mass with tolerance of 2 ppm and data-dependent MS 2 spectra were the main identifiers. The method was validated through specificity, linearity, recovery, intra- and inter-day repeatability, decision limit (CCα) and detection capability (CCβ), according to 2002/657/EC. The values of CCα and CCβ ranged from 29.2 to 36.8 and 32.5 to 48.9, respectively, while overall recovery ranged from 91.1 to 105.6%. Fifty fish samples were analysed, showing the sporadic incidence of enrofloxacin, chlortetracycline, oxytetracycline, amoxicillin and trimethoprim, albeit below the maximum residual levels. Copyright © 2018 Elsevier Ltd. All rights reserved.

How to save money on infant formula

MedlinePlus

... from now, and those coupons will save you money. Sign up for newsletters, special programs, and deals on formula company websites. They often send out coupons and free samples. Ask your pediatrician for samples. Consider generic ...

Patient socioeconomic determinants of the choice of generic versus brand name drugs in the context of a reference price system: evidence from Belgian prescription data.

PubMed

Farfan-Portet, Maria-Isabel; Van de Voorde, Carine; Vrijens, France; Vander Stichele, Robert

2012-06-01

The generic reference price system (RPS) can impose a financial penalty for patients using a brand name drug instead of its generic alternative. Previous studies on the impact of the RPS have not considered the potentially differential effect of using generic alternatives for individuals with a different socioeconomic background. However, patients' characteristics might determine their overall knowledge of the existence of the system and thus of the financial burden to which they may be confronted. The association between patients' characteristics and the use of generic drugs versus brand name drugs was analyzed for ten highly prescribed pharmaceutical molecules included in the Belgian generic reference price system. Prescriptions were obtained from a 10% sample of all general practitioners in 2008 (corresponding to 120,670 adult patients and 368,101 prescriptions). For each pharmaceutical molecule, logistic regression models were performed, with independent variables for patient socioeconomic background at the individual level (work status, having a guaranteed income and being entitled to increased reimbursement of co-payments) and at the level of the neighborhood (education). The percentage of generic prescriptions ranged from 24.7 to 76.4%, and the mean reference supplement in 2008 ranged from €4.3 to €37.8. For seven molecules, higher use of a generic alternative was associated with either having a guaranteed income, with receiving increased reimbursement of co-payments or with living in areas with the lowest levels of education. Globally, results provided evidence that the generic RPS in Belgium does not lead to a higher financial burden on individuals from a low socioeconomic background.

Is generic rifaximin still a poorly absorbed antibiotic? A comparison of branded and generic formulations in healthy volunteers.

PubMed

Blandizzi, Corrado; Viscomi, Giuseppe Claudio; Marzo, Antonio; Scarpignato, Carmelo

2014-07-01

Rifaximin is an antibiotic, locally acting in the gastrointestinal tract, which may exist in different crystal as well as amorphous forms. The branded rifaximin formulation contains the polymorph rifaximin-α, whose systemic bioavailability is very limited. This study was performed to compare the pharmacokinetics of this formulation with that of a generic product, whose composition in terms of solid state forms of the active pharmaceutical ingredient was found to be different. Two tablets (2×200mg) of branded and generic formulations were given to 24 healthy volunteers of either sex, according to a single-blind, randomized, two-treatment, single-dose, two-period, cross-over design. Plasma and urinary samples were collected at preset times (for 24h or 48h, respectively) after dosing, and assayed for rifaximin concentrations by high-performance liquid chromatography-mass spectrometry. Rifaximin plasma and urine concentration-time profiles showed relevant differences when generic and branded rifaximin were compared. Most pharmacokinetic parameters were significantly higher after administration of generic rifaximin than after rifaximin-α. In particular, the differences for Cmax, AUC and cumulative urinary excretion between the generic formulation and the branded product ranged from 165% to 345%. The few adverse events recorded were not serious and not related to study medications. The results of the present investigation demonstrate different systemic bioavailability of generic and branded formulations of rifaximin. As a consequence, the therapeutic results obtained with rifaximin-α should not be translated sic et simpliciter to the generic formulations of rifaximin, which do not claim containing only rifaximin-α and will display significantly higher systemic absorption in both health and disease. Copyright © 2014 Elsevier Ltd. All rights reserved.

Are private physicians more likely to veto generic substitution of prescribed pharmaceuticals?

PubMed

Granlund, David

2009-12-01

Physicians' decisions whether or not to veto generic substitution were analyzed using a sample of 350,000 pharmaceutical prescriptions from the county of Västerbotten, Sweden. Although generic substitution reforms have been introduced in many European countries and American states, this is to my knowledge the first study on this topic. The topic is important since physicians' decisions regarding generic substitution not only directly affect patients' and insurers' costs for pharmaceuticals, but also indirectly since more bans against substitution reduces price-competition between pharmaceutical firms. The primary purpose was to test if physicians working at private practices were more likely to oppose substitution than county-employed physicians working on salary. It was found that private physicians were 50-80% more likely to veto substitution. Also, the probability of a veto was found to increase as patients' copayments decreased. This might indicate moral hazard in insurance, though other explanations are plausible.

A comparison of generic drug prices in seven European countries: a methodological analysis.

PubMed

Wouters, Olivier J; Kanavos, Panos G

2017-03-31

Policymakers and researchers frequently compare the prices of medicines between countries. Such comparisons often serve as barometers of how pricing and reimbursement policies are performing. The aim of this study was to examine methodological challenges to comparing generic drug prices. We calculated all commonly used price indices based on 2013 IMS Health data on sales of 3156 generic drugs in seven European countries. There were large differences in generic drug prices between countries. However, the results varied depending on the choice of index, base country, unit of volume, method of currency conversion, and therapeutic category. The results also differed depending on whether one looked at the prices charged by manufacturers or those charged by pharmacists. Price indices are a useful statistical approach for comparing drug prices across countries, but researchers and policymakers should interpret price indices with caution given their limitations. Price-index results are highly sensitive to the choice of method and sample. More research is needed to determine the drivers of price differences between countries. The data suggest that some governments should aim to reduce distribution costs for generic drugs.

Method development in high-performance liquid chromatography for high-throughput profiling and metabonomic studies of biofluid samples.

PubMed

Pham-Tuan, Hai; Kaskavelis, Lefteris; Daykin, Clare A; Janssen, Hans-Gerd

2003-06-15

"Metabonomics" has in the past decade demonstrated enormous potential in furthering the understanding of, for example, disease processes, toxicological mechanisms, and biomarker discovery. The same principles can also provide a systematic and comprehensive approach to the study of food ingredient impact on consumer health. However, "metabonomic" methodology requires the development of rapid, advanced analytical tools to comprehensively profile biofluid metabolites within consumers. Until now, NMR spectroscopy has been used for this purpose almost exclusively. Chromatographic techniques and in particular HPLC, have not been exploited accordingly. The main drawbacks of chromatography are the long analysis time, instabilities in the sample fingerprint and the rigorous sample preparation required. This contribution addresses these problems in the quest to develop generic methods for high-throughput profiling using HPLC. After a careful optimization process, stable fingerprints of biofluid samples can be obtained using standard HPLC equipment. A method using a short monolithic column and a rapid gradient with a high flow-rate has been developed that allowed rapid and detailed profiling of larger numbers of urine samples. The method can be easily translated into a slow, shallow-gradient high-resolution method for identification of interesting peaks by LC-MS/NMR. A similar approach has been applied for cell culture media samples. Due to the much higher protein content of such samples non-porous polymer-based small particle columns yielded the best results. The study clearly shows that HPLC can be used in metabonomic fingerprinting studies.

The Resilience Questionnaire for Bipolar Disorder: Development and validation.

PubMed

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

2017-08-01

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

Presence of Multidrug-Resistant Shiga Toxin-Producing Escherichia coli, Enteropathogenic E. coli and Enterotoxigenic E. coli, on Raw Nopalitos (Opuntia ficus-indica L.) and in Nopalitos Salads from Local Retail Markets in Mexico.

PubMed

Gómez-Aldapa, Carlos A; Cerna-Cortes, Jorge F; Rangel-Vargas, Esmeralda; Torres-Vitela, Mdel Refugio; Villarruel-López, Angelica; Gutiérrez-Alcántara, Eduardo J; Castro-Rosas, Javier

2016-05-01

The presence of multidrug-resistant pathogenic bacteria in food is a significant public health concern. Diarrheagenic Escherichia coli pathotypes (DEPs) are foodborne bacteria. In Mexico, DEPs have been associated with diarrheal illness. There is no information about the presence of multidrug-resistant DEPs on fresh vegetables and in cooked vegetable salads in Mexico. "Nopalitos" (Opuntia ficus-indica L.) is a Cactacea extensively used as a fresh green vegetable throughout Mexico. The presence of generic E. coli and multidrug-resistant DEPs on raw whole and cut nopalitos and in nopalitos salad samples was determined. One hundred raw whole nopalitos (without prickles) samples, 100 raw nopalitos cut into small square samples, and 100 cooked nopalitos salad samples were collected from markets. Generic E. coli was determined using the most probable number procedures. DEPs were identified using two multiplex polymerase chain reaction procedures. Susceptibility to 16 antibiotics was tested for the isolated DEP strains by standard test. Of the 100 whole nopalitos samples, 100 cut nopalitos samples, and 100 nopalitos salad samples, generic E. coli and DEPs were identified, respectively, in 80% and 10%, 74% and 10%, and 64% and 8%. Eighty-two DEP strains were isolated from positive nopalitos samples. The identified DEPs included Shiga toxin-producing E. coli (STEC), enteropathogenic E. coli (EPEC), and enterotoxigenic E. coli (ETEC). All isolated strains exhibited resistance to at least six antibiotics. To the best of our knowledge, this is the first report of the presence of multidrug-resistant and antibiotic resistance profiles of STEC, ETEC, and EPEC on raw nopalitos and in nopalitos salads in Mexico.

A sample implementation for parallelizing Divide-and-Conquer algorithms on the GPU.

PubMed

Mei, Gang; Zhang, Jiayin; Xu, Nengxiong; Zhao, Kunyang

2018-01-01

The strategy of Divide-and-Conquer (D&C) is one of the frequently used programming patterns to design efficient algorithms in computer science, which has been parallelized on shared memory systems and distributed memory systems. Tzeng and Owens specifically developed a generic paradigm for parallelizing D&C algorithms on modern Graphics Processing Units (GPUs). In this paper, by following the generic paradigm proposed by Tzeng and Owens, we provide a new and publicly available GPU implementation of the famous D&C algorithm, QuickHull, to give a sample and guide for parallelizing D&C algorithms on the GPU. The experimental results demonstrate the practicality of our sample GPU implementation. Our research objective in this paper is to present a sample GPU implementation of a classical D&C algorithm to help interested readers to develop their own efficient GPU implementations with fewer efforts.

75 FR 54384 - Notice of Intent To Prepare an Environmental Impact Statement for the Gas Hills Uranium Project...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-07

..., the reader is referred to the Nuclear Regulatory Commission's Generic EIS of In-Situ Leach Uranium.... SUMMARY: Pursuant to the National Environmental Policy Act of 1969, as amended, (NEPA) and in response to... to solicit public comments regarding issues and resource information for the proposed Gas Hills in...

Generic Learning-Based Ensemble Framework for Small Sample Size Face Recognition in Multi-Camera Networks.

PubMed

Zhang, Cuicui; Liang, Xuefeng; Matsuyama, Takashi

2014-12-08

Multi-camera networks have gained great interest in video-based surveillance systems for security monitoring, access control, etc. Person re-identification is an essential and challenging task in multi-camera networks, which aims to determine if a given individual has already appeared over the camera network. Individual recognition often uses faces as a trial and requires a large number of samples during the training phrase. This is difficult to fulfill due to the limitation of the camera hardware system and the unconstrained image capturing conditions. Conventional face recognition algorithms often encounter the "small sample size" (SSS) problem arising from the small number of training samples compared to the high dimensionality of the sample space. To overcome this problem, interest in the combination of multiple base classifiers has sparked research efforts in ensemble methods. However, existing ensemble methods still open two questions: (1) how to define diverse base classifiers from the small data; (2) how to avoid the diversity/accuracy dilemma occurring during ensemble. To address these problems, this paper proposes a novel generic learning-based ensemble framework, which augments the small data by generating new samples based on a generic distribution and introduces a tailored 0-1 knapsack algorithm to alleviate the diversity/accuracy dilemma. More diverse base classifiers can be generated from the expanded face space, and more appropriate base classifiers are selected for ensemble. Extensive experimental results on four benchmarks demonstrate the higher ability of our system to cope with the SSS problem compared to the state-of-the-art system.

Generic Learning-Based Ensemble Framework for Small Sample Size Face Recognition in Multi-Camera Networks

PubMed Central

Zhang, Cuicui; Liang, Xuefeng; Matsuyama, Takashi

2014-01-01

Multi-camera networks have gained great interest in video-based surveillance systems for security monitoring, access control, etc. Person re-identification is an essential and challenging task in multi-camera networks, which aims to determine if a given individual has already appeared over the camera network. Individual recognition often uses faces as a trial and requires a large number of samples during the training phrase. This is difficult to fulfill due to the limitation of the camera hardware system and the unconstrained image capturing conditions. Conventional face recognition algorithms often encounter the “small sample size” (SSS) problem arising from the small number of training samples compared to the high dimensionality of the sample space. To overcome this problem, interest in the combination of multiple base classifiers has sparked research efforts in ensemble methods. However, existing ensemble methods still open two questions: (1) how to define diverse base classifiers from the small data; (2) how to avoid the diversity/accuracy dilemma occurring during ensemble. To address these problems, this paper proposes a novel generic learning-based ensemble framework, which augments the small data by generating new samples based on a generic distribution and introduces a tailored 0–1 knapsack algorithm to alleviate the diversity/accuracy dilemma. More diverse base classifiers can be generated from the expanded face space, and more appropriate base classifiers are selected for ensemble. Extensive experimental results on four benchmarks demonstrate the higher ability of our system to cope with the SSS problem compared to the state-of-the-art system. PMID:25494350

Comparing a generic and individualized information decision support intervention for men newly diagnosed with localized prostate cancer.

PubMed

Davison, B Joyce; Goldenberg, S Larry; Wiens, Kristin P; Gleave, Martin E

2007-01-01

A randomized study was conducted to compare a generic and individualized approach to providing decisional support to men newly diagnosed with localized prostate cancer. Patients (N = 324) were referred by community urologists to a patient education center where they were randomly assigned to receive either an individualized or generic information intervention. Men assigned to the generic group viewed a video on the various treatments available for localized prostate cancer. Men in the individualized information group used a computer program to identify their information preferences. Computer printouts on top information preferences were individualized according to patient's specific disease characteristics, followed by a discussion of the pros and cons of each recommended treatment option. Both groups received a standardized package of written information. Men completed measures of decision control, satisfaction, and decision conflict at baseline and after a definitive treatment decision was made. Results demonstrated that overall both groups reported increased levels of decision control and lower levels of decision conflict after their treatment decision. All men reported being satisfied with their preparation to make a treatment decision. Compared to the generic information group, men who received the individualized information were more satisfied with the type, amount and method of providing information, and role played in treatment decision making with their physician (P < .002). Both information interventions seem to be similar in providing decisional support to this group of men at the time of diagnosis. Further research is required to determine how to identify men who may benefit from a more individualized approach.

A generic implementation of replica exchange with solute tempering (REST2) algorithm in NAMD for complex biophysical simulations

NASA Astrophysics Data System (ADS)

Jo, Sunhwan; Jiang, Wei

2015-12-01

Replica Exchange with Solute Tempering (REST2) is a powerful sampling enhancement algorithm of molecular dynamics (MD) in that it needs significantly smaller number of replicas but achieves higher sampling efficiency relative to standard temperature exchange algorithm. In this paper, we extend the applicability of REST2 for quantitative biophysical simulations through a robust and generic implementation in greatly scalable MD software NAMD. The rescaling procedure of force field parameters controlling REST2 "hot region" is implemented into NAMD at the source code level. A user can conveniently select hot region through VMD and write the selection information into a PDB file. The rescaling keyword/parameter is written in NAMD Tcl script interface that enables an on-the-fly simulation parameter change. Our implementation of REST2 is within communication-enabled Tcl script built on top of Charm++, thus communication overhead of an exchange attempt is vanishingly small. Such a generic implementation facilitates seamless cooperation between REST2 and other modules of NAMD to provide enhanced sampling for complex biomolecular simulations. Three challenging applications including native REST2 simulation for peptide folding-unfolding transition, free energy perturbation/REST2 for absolute binding affinity of protein-ligand complex and umbrella sampling/REST2 Hamiltonian exchange for free energy landscape calculation were carried out on IBM Blue Gene/Q supercomputer to demonstrate efficacy of REST2 based on the present implementation.

Genetic structure and inter-generic relationship of closed colony of laboratory rodents based on RAPD markers.

PubMed

Kumar, Mahadeo; Kumar, Sharad

2014-11-01

Molecular genetic analysis was performed using random amplified polymorphic DNA (RAPD) on three commonly used laboratory bred rodent genera viz. mouse (Mus musculus), rat (Rattus norvegicus) and guinea pig (Cavia porcellus) as sampled from the breeding colony maintained at the Animal Facility, CSIR-Indian Institute of Toxicology Research, Lucknow. In this study, 60 samples, 20 from each genus, were analyzed for evaluation of genetic structure of rodent stocks based on polymorphic bands using RAPD markers. Thirty five random primers were assessed for RAPD analysis. Out of 35, only 20 primers generated a total of 56.88% polymorphic bands among mice, rats and guinea pigs. The results revealed significantly variant and distinct fingerprint patterns specific to each of the genus. Within-genera analysis, the highest (89.0%) amount of genetic homogeneity was observed in mice samples and the least (79.3%) were observed in guinea pig samples. The amount of genetic homogeneity was observed very high within all genera. The average genetic diversity index observed was low (0.045) for mice and high (0.094) for guinea pigs. The inter-generic distances were maximum (0.8775) between mice and guinea pigs; and the minimum (0.5143) between rats and mice. The study proved that the RAPD markers are useful as genetic markers for assessment of genetic structure as well as inter-generic variability assessments.

Microbiological baseline study of beef and pork carcasses from provincially inspected abattoirs in Alberta, Canada

PubMed Central

Bohaychuk, Valerie M.; Gensler, Gary E.; Barrios, Pablo Romero

2011-01-01

In 2006 and 2007 beef and pork carcass swabs from provincially inspected abattoirs in Alberta, Canada were tested to determine the levels of total aerobic bacteria, coliform bacteria, and generic Escherichia coli, and the prevalence of Salmonella spp., Campylobacter spp., and Shiga toxin-producing E. coli (STEC). Swabs from beef and pork carcasses from 48 and 34 facilities, respectively, were analyzed. All samples tested were positive for aerobic bacteria with 99.8% of beef and 96.0% of pork samples, having total counts of ≤ 100 000 CFU/cm2. Coliform bacteria were isolated from 22.4% and 42.0% of beef and pork carcass samples, respectively. Generic E. coli were recovered from 14.6% of beef and 33.7% of pork carcass samples. For beef carcasses, positive tests were obtained for 0.1% of 1036 samples tested for Salmonella spp., 1.5% of 1022 samples tested for Campylobacter spp. and 5.4% of 1018 samples tested for STEC. For pork carcasses, positive tests were obtained for 1.6 % of 1076 samples tested for Salmonella spp., 8.8% of 1070 samples tested for Campylobacter spp. and 4.8% of 1067 samples tested for STEC. PMID:22467964

[Early achievements of the Danish pharmaceutical industry-7].

PubMed

Grevsen, Jørgen V; Kirkegaard, Hanne; Kruse, Edith; Kruse, Poul R

2014-01-01

A/S GEA Farmaceutisk Fabrik was established as a family business in 1927 by the pharmacist Knud L. Gad Andresen who until then had been employed in the pharmaceutical industry. Gad Andresen wanted to run a company focusing on the development of generics, and he wanted this development to take place in a close cooperation with Danish physicians. This has indeed been achieved with success. In 1995 GEA was purchase'd by the American pharmaceutical company Bristol-Myers Squibb who in a press release characterized GEA as Denmark's second largest manufacturer of generics. Immediately after this takeover GEA's R&D department ceased the research in innovative products and from now on exclusively focused on the development of generics. Three years later GEA was sold to the German generic company Hexal who later on resold GEA to the Swiss generic company Sandoz. GEA changed ownership another couple of times until the last owner went bankrupt in 2011. GEA is yet again a model example of an early Danish pharmaceutical company which was established as an individual company, and which had a long commercial success with the production and marketing of generics. GEA's earliest products, the organotherapeutics, were not innovations. The innovative products were developed already in the 1890s in Denmark by Alfred Benzon, and later on copies followed a.o. from Medicinalco and from foreign companies before GEA marketed their generics. Therefore GEA had to promote their preparations as especially qualified medicinal products and to intimate that the products of the competitors were less "active'". At the end of the 1920s the Ministry of Health became aware of the fact that there might be health problems related to the none-existing control of both the or- ganotherapeutic preparations and actually also the other medicinal products of the pharmaceutical industry. Therefore the Ministry had requested the National Board of Health for a statement regarding this problem. The National Board of Health was, however, at that time of the opinion that there were no serious problems with organotherapeutics from those companies marketing such products. It requires studies in the unprinted journals of the Ministry of Health and the National Board of Health to find the background for and the causes of the request from the Ministry at this point concerning the control of the organotherapeutic products of the pharmaceutical industry. Neither were GEA's barbiturates innovative products. The "Gad Andresen Case" is interesting for two reasons. Firstly, it illustrates that the development of generics at this stage could not always take place exclusively in a pharmaceutical-chemical laboratory, but also required a certain minimum of clinical trials including human beings. Secondly, it shows that the industrial products had now slowly, but surely gained market shares and displaced the pharmacy-produced medicinal products to such an extent that it did not only worry the pharmacy owners and their trade orga- nization. Now this concern had also resulted in a counteract so that the pharmacies in the manufacture of their products had to copy the industrial products, however, in certain cases with a dubious result. Gealgica tablets and especially their content of fenacetine is not only a model example of how the opinion of the positive and negative properties of a medicinal product changes over time. It also shows how long time could pass before the health authorities took measures against a substance with problematic side effects in spite of the fact that less damaging substances had been available for a long time, in this case paracetamol. Medicinal products containing fenacetine were on the market for almost 100 years. On the contrary meprobamat is a model example of a drug substance where the opinion of its positive and negative properties changed essentially over a relatively short period. In spite of this it remained on the market for a little less than 40 years. Restenil and Trihistan are mentioned on Knud & Dagny Gad Andresen's homepage (in 2014) as new medicinal products developed by GEA. This is not quite correct. Both drug substances in these preparations had been developed in the USA. In Denmark GEA had the possibility to market these substances under GEA's own brand names along with corresponding foreign brand names. It can be concluded that GEA's own research on the whole was confined to the development of own patentable syntheses of already known drug substances. During the later marketing of generics GEA appealed to the national feeling of the Danish population in the same way as a.o. Pharmacia did in the 1920s. From the very start GEA specialized in the manufacture of generics, and GEA was able to follow this way with commercial success--as a Danish alternative--for almost 90 years.

Electron paramagnetic resonance method for the quantitative assay of ketoconazole in pharmaceutical preparations.

PubMed

Morsy, Mohamed A; Sultan, Salah M; Dafalla, Hatim

2009-08-15

In this study, electron paramagnetic resonance (EPR) is used, for the first time, as an analytical tool for the quantitative assay of ketoconazole (KTZ) in drug formulations. The drug was successfully characterized by the prominent signals by two radical species produced as a result of its oxidation with 400 microg/mL cerium(IV) in 0.10 mol dm(-3) sulfuric acid. The EPR signal of the reaction mixture was measured in eight capillary tubes housed in a 4 mm EPR sample tube. The radical stability was investigated by obtaining multi-EPR scans of each KTZ sample solution at time intervals of 2.5 min of the reaction mixing time. The plot of the disappearance of the radical species show that the disappearance is apparently of zero order. The zero-time intercept of the EPR signal amplitude, which should be proportional to the initial radical concentration, is linear in the sample concentration in the range between 100 and 400 microg/mL, with a correlation coefficient, r, of 0.999. The detection limit was determined to be 11.7 +/- 2.5 microg/mL. The method newly adopted was fully validated following the United States Pharmacopeia (USP) monograph protocol in both the generic and the proprietary forms. The method is very accurate, such that we were able to measure the concentration at confidence levels of 99.9%. The method was also found to be suitable for the assay of KTZ in its tablet and cream pharmaceutical preparations, as no interferences were encountered from excipients of the proprietary drugs. High specificity, simplicity, and rapidity are the merits of the present method compared to the previously reported methods.

Pharmaceutical quality of seven generic Levodopa/Benserazide products compared with original Madopar® / Prolopa®

PubMed Central

2013-01-01

Background By definition, a generic product is considered interchangeable with the innovator brand product. Controversy exists about interchangeability, and attention is predominantly directed to contaminants. In particular for chronic, degenerative conditions such as in Parkinson’s disease (PD) generic substitution remains debated among physicians, patients and pharmacists. The objective of this study was to compare the pharmaceutical quality of seven generic levodopa/benserazide hydrochloride combination products marketed in Germany with the original product (Madopar® / Prolopa® 125, Roche, Switzerland) in order to evaluate the potential impact of Madopar® generics versus branded products for PD patients and clinicians. Methods Madopar® / Prolopa® 125 tablets and capsules were used as reference material. The generic products tested (all 100 mg/25 mg formulations) included four tablet and three capsule formulations. Colour, appearance of powder (capsules), disintegration and dissolution, mass of tablets and fill mass of capsules, content, identity and amounts of impurities were assessed along with standard physical and chemical laboratory tests developed and routinely practiced at Roche facilities. Results were compared to the original “shelf-life” specifications in use by Roche. Results Each of the seven generic products had one or two parameters outside the specifications. Deviations for the active ingredients ranged from +8.4% (benserazide) to −7.6% (levodopa) in two tablet formulations. Degradation products were measured in marked excess (+26.5%) in one capsule formulation. Disintegration time and dissolution for levodopa and benserazide hydrochloride at 30 min were within specifications for all seven generic samples analysed, however with some outliers. Conclusions Deviations for the active ingredients may go unnoticed by a new user of the generic product, but may entail clinical consequences when switching from original to generic during a long-term therapy. Degradation products may pose a safety concern. Our results should prompt caution when prescribing a generic of Madopar®/Prolopa®, and also invite to further investigations in view of a more comprehensive approach, both pharmaceutical and clinical. PMID:23617953

Comparison of the effectiveness of brand-name and generic antipsychotic drugs for treating patients with schizophrenia in Taiwan.

PubMed

Hsu, Chih-Wei; Lee, Sheng-Yu; Wang, Liang-Jen

2018-03-01

The purpose of this nationwide population-based study is to compare the long-term effectiveness of brand-name antipsychotics with generic antipsychotics for treating schizophrenia. We identified patients with schizophrenia who were prescribed antipsychotics from a random sample of one million records from Taiwan's National Health Insurance database, observed between January 1, 2000 and December 31, 2012. Only those with no prior use of antipsychotics for at least 180days were included. We selected patients who were prescribed brand-name risperidone (N=404), generic risperidone (N=145), brand-name sulpiride (N=334), or generic sulpiride (N=991). The effectiveness of the treatments researched in this study consisted of average daily doses, rates of treatment discontinuation, augmentation therapy, and psychiatric hospitalization. We found that compared to patients treated with generic risperidone, those treated with brand-name risperidone required lower daily doses (2.14mg vs. 2.61mg). However, the two groups demonstrated similar rates of treatment discontinuation, augmentation, and psychiatric hospitalization. On the other hand, in comparison with patients prescribed generic sulpiride, those treated with brand-name sulpiride not only required lower daily doses (302.72mg vs. 340.71mg) but also had lower psychiatric admission rates (adjusted hazard ratio: 0.24, 95% confidence interval: 0.10-0.56). In conclusion, for both risperidone and sulpiride, higher daily doses of the respective generic drugs were prescribed than with brand-name drugs in clinical settings. Furthermore, the brand-name sulpiride is more effective at preventing patients from hospitalization than generic sulpiride. These findings can serve as an important reference for clinical practices and healthcare economics for treating schizophrenic patients. Copyright © 2017 Elsevier B.V. All rights reserved.

Evaluating community pharmacists' perspectives and practices concerning generic medicines substitution in Saudi Arabia: A cross-sectional study.

PubMed

Alkhuzaee, Fahad S; Almalki, Hamdan M; Attar, Ammar Y; Althubiani, Shoeab I; Almuallim, Wassam Ali; Cheema, Ejaz; Hadi, Muhammad Abdul

2016-12-01

To assess the community pharmacists' knowledge, attitude, perception and current practices towards generic medicines substitution in Saudi Arabia. A cross-sectional study was conducted between February and March 2016 in the Makkah region, Saudi Arabia. A 25-item, structured, validated, pilot-tested and self-completed questionnaire was used to achieve study objectives. A 4-step systematic sampling technique was used to recruit community pharmacists. Data were analysed using SPSS version 20. Of 128 community pharmacists approached, 121 participated in the study (response rate=95%). Majority of the participants (n=108; 89.3%) had graduated from Egypt, were working as staff pharmacists (n=85; 70%) and had BPharm degree (97; 80.2%). Only 26 (22%) of the participants correctly answered all knowledge questions accurately. No statistically significant difference in total knowledge score was observed across different sociodemographic characteristics of participants (all P>0.05).Two-thirds of the respondents (83; 68.2%) supported the use of generic substitution. Medicines cost and patients' request were the most commonly cited reasons for performing generic substitution. Country of graduation (P=0.01) and number of years of practicing in Saudi Arabia (P=0.02) was associated with the pharmacists' support towards generic substitution. The community pharmacists had clear knowledge deficits about generic medicines and their substitution which may partly explain low consumption of generic medicines in Saudi Arabia. Healthcare policy makers need to improve awareness about the safety and efficacy of generic medicines and promote their use in order to cut down cost of medicines and overall healthcare expenditure. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Brand versus generic dispensing trend for ciprofloxacin 500 mg, levofloxacin 500 mg, and moxifloxacin 400 mg (oral dosage forms) among pharmacies of Karachi, Pakistan.

PubMed

Zehra, Fatima; Naqvi, Atta Abbas; Tasneem, Sumbul; Ahmad, Rizwan; Ahmad, Niyaz; Shamsi, Adnan Zia; Asghar, Naqiya Ali; Khan, Ghufran Ullah

2017-01-01

Pakistan spends 0.7% of its gross domestic product on health. The public sector health-care system provides services to 22% of population thus paving the way for a dominant private sector. Patients in Pakistan mostly pay their medical expenses directly, and 64% of the health expenditures are borne by the household. Expenditure on medicine constitutes 43% of the total household expenditure. A quantitative cross-sectional study was conducted in Karachi, Pakistan, for a month. It was aimed at gathering response from different pharmacies to understand the brand versus generic dispensing trend of ciprofloxacin 500 mg, levofloxacin 500 mg, and moxifloxacin 400 mg oral dosage forms. The study employed convenience sampling and used a survey checklist. The data gathered was entered in SPSS version 22. The mean price per tablet for ciprofloxacin brand and generic was reported at Pakistani Rupees (PKR) 48.44 and PKR 26.85, respectively. The trend for dispensing ciprofloxacin highlighted a split in the market between brand (51%) and generic (49%). For levofloxacin brand and generic, the price per tablet was reported at PKR 36.50 and PKR 36.15 respectively, and despite same price, the market was dominated by generic levofloxacin (92%). Due to a price difference between brand and generic moxifloxacin, i.e., PKR 129.44 and PKR 71.91, respectively, the market was mostly occupied by the generic form (75%). Pricing mechanism must be revisited, and the authorities should take stern actions against any illegitimate price hike. The surging burden of drug expenditure on poorer sections of the society must be addressed by the government on an urgent basis.

Intrinsically Disordered Protein Specific Force Field CHARMM36IDPSFF.

PubMed

Liu, Hao; Song, Dong; Lu, Hui; Luo, Ray; Chen, Hai-Feng

2018-05-28

Intrinsically disordered proteins (IDPs) are closely related to various human diseases. Because IDPs lack certain tertiary structure, it is difficult to use X-ray and NMR methods to measure their structures. Therefore, molecular dynamics simulation is a useful tool to study the conformer distribution of IDPs. However, most generic protein force fields were found to be insufficient in simulations of IDPs. Here we report our development for the CHARMM community. Our residue-specific IDP force field (CHARMM36IDPSFF) was developed based on the base generic force field with CMAP corrections of for all 20 naturally occurring amino acids. Multiple tests show that the simulated chemical shifts with the newly developed force field are in quantitative agreement with NMR experiment and are more accurate than the base generic force field. Comparison of J-couplings with previous work shows that CHARMM36IDPSFF and its corresponding base generic force field have their own advantages. In addition, CHARMM36IDPSFF simulations also agree with experiment for SAXS profiles and radii of gyration of IDPs. Detailed analysis shows that CHARMM36IDPSFF can sample more diverse and disordered conformers. These findings confirm that the newly developed force field can improve the balance of accuracy and efficiency for the conformer sampling of IDPs. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

The Effects of Mineral Matrices and Extraction Method on Quantification of Bacterial Phospholipid Fatty Acids.

NASA Astrophysics Data System (ADS)

Ford, S. E.; McKelvie, J. R. M.; Sherwood Lollar, B.; Slater, G. F.

2017-12-01

Understanding the distribution, abundances and metabolic activities of microbial life in the subsurface is fundamental to our understanding of biogeochemical cycling on Earth. Given that the most likely environments for life to still exist, or be preserved, on other planets and moons in the solar system are in the subsurface, a better understanding of subsurface life on Earth is also a key factor in our ability to search for life beyond the Earth. While we have made progress in investigating life in the continental subsurface in recent years, significant challenges remain. In particular, the low biomass abundance, heterogeneous distribution of biomass, and the potential for matrix effects during sampling and analysis mean that further development and optimization of methods to study subsurface life are needed. Phospholipid fatty acids (PLFA) are a useful biosignature of extant, viable microbial communities that are applied in a wide range of environments. Here we test the sensitivity of two methods of PLFA analysis (modified Bligh and Dyer, Microwave Assisted Extraction) to detect known numbers of cells doped into two distinct matrices (bentonite, crushed granite). Samples were prepared by adding known cellular concentrations of Basciullus subtilis subtilis (ATCC 6051) to crushed bentonite, or to granite, respectively, to create dilution series. Samples were extracted for PLFA using a dichloromethane-methanol modified Bligh & Dyer (mBD) or Microwave Assisted Extraction (MAE) and then quantified using GC - MS and GC - FID. Pure culture extractions yielded a linearly decreasing trend to the level of the process blank. The ratio of cells to PLFA for this trend was 2.4x104 +/- 1.9x104 cells/pmol at the lower end of the generic range of 2 to 6 x105 cells/pmol. For bentonite the PLFA results were lower than for the pure culture. PLFA results for bentonite followed a linear trend at higher concentrations, but departed from this at low concentrations indicating the potential for interference for low biomass samples. The ratio of cells to PLFA for the bentonite was to 6.2x104 +/- 4.5x104 cells/pmol, at the upper end of generic range. Ongoing comparison of the efficiency of microwave extraction and the effect of different matrices (e.g. granite) aims to optimize detection of PLFA for low biomass samples relevant to subsurface systems.

Right ventricular outflow tract tachycardia due to a somatic cell mutation in G protein subunitalphai2.

PubMed Central

Lerman, B B; Dong, B; Stein, K M; Markowitz, S M; Linden, J; Catanzaro, D F

1998-01-01

Idiopathic ventricular tachycardia is a generic term that describes the various forms of ventricular arrhythmias that occur in patients without structural heart disease and in the absence of the long QT syndrome. Many of these tachycardias are focal in origin, localize to the right ventricular outflow tract (RVOT), terminate in response to beta blockers, verapamil, vagal maneuvers, and adenosine, and are thought to result from cAMP-mediated triggered activity. DNA was prepared from biopsy samples obtained from myocardial tissue from a patient with adenosine-insensitive idiopathic ventricular tachycardia arising from the RVOT. Genomic sequences of the inhibitory G protein Galphai2 were determined after amplification by PCR and subcloning. A point mutation (F200L) in the GTP binding domain of the inhibitory G protein Galphai2 was identified in a biopsy sample from the arrhythmogenic focus. This mutation was shown to increase intracellular cAMP concentration and inhibit suppression of cAMP by adenosine. No mutations were detected in Galphai2 sequences from myocardial tissue sampled from regions remote from the origin of tachycardia, or from peripheral lymphocytes. These findings suggest that somatic cell mutations in the cAMP-dependent signal transduction pathway occurring during myocardial development may be responsible for some forms of idiopathic ventricular tachycardia. PMID:9637720

Selective Transfer Machine for Personalized Facial Action Unit Detection

PubMed Central

Chu, Wen-Sheng; De la Torre, Fernando; Cohn, Jeffery F.

2014-01-01

Automatic facial action unit (AFA) detection from video is a long-standing problem in facial expression analysis. Most approaches emphasize choices of features and classifiers. They neglect individual differences in target persons. People vary markedly in facial morphology (e.g., heavy versus delicate brows, smooth versus deeply etched wrinkles) and behavior. Individual differences can dramatically influence how well generic classifiers generalize to previously unseen persons. While a possible solution would be to train person-specific classifiers, that often is neither feasible nor theoretically compelling. The alternative that we propose is to personalize a generic classifier in an unsupervised manner (no additional labels for the test subjects are required). We introduce a transductive learning method, which we refer to Selective Transfer Machine (STM), to personalize a generic classifier by attenuating person-specific biases. STM achieves this effect by simultaneously learning a classifier and re-weighting the training samples that are most relevant to the test subject. To evaluate the effectiveness of STM, we compared STM to generic classifiers and to cross-domain learning methods in three major databases: CK+ [20], GEMEP-FERA [32] and RU-FACS [2]. STM outperformed generic classifiers in all. PMID:25242877

76 FR 66021 - Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Generic Annual Catch Limits...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-25

..., Shrimp, and Coral and Coral Reefs Fishery Management Plans for the Gulf of Mexico (FMPs) as prepared and... fisheries for reef fish, red drum, shrimp, and coral and coral reefs of the Gulf of Mexico (Gulf) are... remove octocorals from the Coral and Coral Reefs FMP. Most octocorals are harvested in waters under the...

Raster Metafile And Raster Metafile Translator Programs

NASA Technical Reports Server (NTRS)

Randall, Donald P.; Gates, Raymond L.; Skeens, Kristi M.

1994-01-01

Raster Metafile (RM) computer program is generic raster-image-format program, and Raster Metafile Translator (RMT) program is assortment of software tools for processing images prepared in this format. Processing includes reading, writing, and displaying RM images. Such other image-manipulation features as minimal compositing operator and resizing option available under RMT command structure. RMT written in FORTRAN 77 and C language.

Generic immunosuppression in solid organ transplantation: systematic review and meta-analysis

PubMed Central

Molnar, Amber O; Fergusson, Dean; Tsampalieros, Anne K; Bennett, Alexandria; Fergusson, Nicholas; Ramsay, Timothy

2015-01-01

Objective To compare the clinical efficacy and bioequivalence of generic immunosuppressive drugs in patients with solid organ transplants. Design Systematic review and meta-analysis of all studies comparing generic with innovator immunosuppressive drugs. Data sources Medline and Embase from 1980 to September 2014. Review methods A literature search was performed for all studies comparing a generic to an innovator immunosuppressive drug in solid organ transplantation. Two reviewers independently extracted data and assessed quality of studies. Meta-analyses of prespecified outcomes were performed when deemed appropriate. Outcomes included patient survival, allograft survival, acute rejection, adverse events and bioequivalence. Results 1679 citations were screened, of which 50 studies met eligibility criteria (17 randomized trials, 15 non-randomized interventional studies, and 18 observational studies). Generics were compared with Neoral (cyclosporine) (32 studies), Prograf (tacrolimus) (12 studies), and Cellcept (mycophenolate mofetil) (six studies). Pooled analysis of randomized controlled trials in patients with kidney transplants that reported bioequivalence criteria showed that Neoral (two studies) and Prograf (three studies) were not bioequivalent with generic preparations according to criteria of the European Medicines Agency. The single Cellcept trial also did not meet bioequivalence. Acute rejection was rare but did not differ between groups. For Neoral, the pooled Peto odds ratio was 1.23 (95% confidence interval 0.64 to 2.36) for kidney randomized controlled trials and 0.66 (0.40 to 1.08) for observational studies. For kidney observational studies, the pooled Peto odds ratios were 0.98 (0.37 to 2.60) for Prograf and 0.49 (0.09 to 2.56) for Cellcept. Meta-analyses for non-renal solid organ transplants were not performed because of a lack of data.There were insufficient data reported on patient or graft survival. Pooling of results was limited by inconsistent study methods and reporting of outcomes. Many studies did not report standard criteria used to determine bioequivalence. While rates of acute rejection seemed similar and were relatively rare, few studies were designed to properly compare clinical outcomes. Most studies had short follow-up times and included stable patients without a history of rejection. Conclusions High quality data showing bioequivalence and clinical efficacy of generic immunosuppressive drugs in patients with transplants are lacking. Given the serious consequences of rejection and allograft failure, well designed studies on bioequivalence and safety of generic immunosuppression in transplant recipients are needed. PMID:26101226

Generic and Brand-Name l-Thyroxine Are Not Bioequivalent for Children With Severe Congenital Hypothyroidism

PubMed Central

Carswell, Jeremi M.; Gordon, Joshua H.; Popovsky, Erica; Hale, Andrea

2013-01-01

Context: In the United States, generic substitution of levothyroxine (l-T4) by pharmacists is permitted if the formulations are deemed to be bioequivalent by the Federal Drug Administration, but there is widespread concern that the pharmacokinetic standard used is too insensitive. Objective: We aimed to evaluate the bioequivalence of a brand-name l-T4 (Synthroid) and an AB-rated generic formulation (Sandoz, Princeton, NJ) in children with severe hypothyroidism. Design: This was a prospective randomized crossover study in which patients received 8 weeks of one l-T4 formulation followed by 8 weeks of the other. Setting: The setting was an academic medical center. Patients: Of 31 children with an initial serum TSH concentration >100 mU/L, 20 had congenital hypothyroidism (CH), and 11 had autoimmune thyroiditis. Main Outcome Measures: The primary endpoint was the serum TSH concentration. Secondary endpoints were the free T4 and total T3 concentrations. Results: The serum TSH concentration was significantly lower after 8 weeks of Synthroid than after generic drug (P = .002), but thyroid hormone levels did not differ significantly. Subgroup analysis revealed that the difference in TSH was restricted to patients with CH (P = .0005). Patients with CH required a higher l-T4 dose (P < .0004) and were younger (P = .003) but were not resistant to thyroid hormone; 15 of 16 CH patients had severe thyroid dysgenesis or agenesis on imaging. The response to generic vs brand-name preparation remained significant when adjusted for age. Conclusions: Synthroid and an AB-rated generic l-T4 are not bioequivalent for patients with severe hypothyroidism due to CH, probably because of diminished thyroid reserve. It would therefore seem prudent not to substitute l-T4 formulations in patients with severe CH, particularly in those <3 yr of age. Our results may have important implications for other severely hypothyroid patients in whom precise titration of l-T4 is necessary. PMID:23264396

Physicians’ generic drug prescribing behavior in district hospitals: a case of Phitsanulok, Thailand

PubMed Central

Plianbangchang, Pinyupa; Jetiyanon, Kanchalee; Suttaloung, Charawee; Khumchuen, Lalida

2010-01-01

Generic prescribing is a sound approach to contain health care costs. However, little is known about physicians’ prescribing patterns in the Thai context. Objective: To explore physicians’ generic prescription patterns in district hospitals. Methods: Data was collected from three of the eight district hospitals between January and December 2008 (final response rate 37.5%). All participating hospitals were between 30 and 60-bed capacity. The researchers reviewed 10% of total outpatient prescriptions in each hospital. Results: A total of 14,500 prescriptions were evaluated. The majority of patients were under universal health coverage (4,367; 30.1%), followed by senior citizens’ health insurance (2,734; 18.9%), and civil servant medical benefit schemes (2,419; 16.7%). Ten thousand six hundred and seventy-one prescriptions (73.6% of total prescriptions) had at least one medication. Among these, each prescription contained 2.85 (SD=1.69) items. The majority of prescriptions (7,886; 73.9%) were prescribed by generic name only. Drugs prescribed by brand names varied in their pharmacological actions. They represented both innovator and branded-generic items. Interestingly, a large number of them were fixed-dose combination drugs. All brand name prescriptions were off patented. In addition, none of the brand-name drugs prescribed were categorized as narrow therapeutic range or any other drug that had been reported to have had problems with generic substitution. Conclusion: The majority of prescriptions in this sample were written by generic names. There is room for improvement in brand name prescribing patterns. PMID:25126136

Crewmember in the middeck with Commercial Generic Bioprocessing experiment.

NASA Image and Video Library

1993-01-19

STS054-30-009 (13 Jan 1993) --- Astronaut Susan J. Helms communicates with ground controllers about the Commercial Generic Bioprocessing Apparatus (CGBA) on Endeavour's middeck. The mission specialist holds samples from the CGBA in her left hand. Sleep restraints can be seen in their temporary stow position in the left part of the frame, near the airlock hatch. Also onboard the spacecraft for the six-day mission were astronauts John H. Casper, Donald R. McMonagle, Gregory J. Harbaugh and Mario Runco Jr.

Generic Delivery of Payload of Nanoparticles Intracellularly via Hybrid Polymer Capsules for Bioimaging Applications

PubMed Central

Sami, Haider; Maparu, Auhin K.; Kumar, Ashok; Sivakumar, Sri

2012-01-01

Towards the goal of development of a generic nanomaterial delivery system and delivery of the ‘as prepared’ nanoparticles without ‘further surface modification’ in a generic way, we have fabricated a hybrid polymer capsule as a delivery vehicle in which nanoparticles are loaded within their cavity. To this end, a generic approach to prepare nanomaterials-loaded polyelectrolyte multilayered (PEM) capsules has been reported, where polystyrene sulfonate (PSS)/polyallylamine hydrochloride (PAH) polymer capsules were employed as nano/microreactors to synthesize variety of nanomaterials (metal nanoparticles; lanthanide doped inorganic nanoparticles; gadolinium based nanoparticles, cadmium based nanoparticles; different shapes of nanoparticles; co-loading of two types of nanoparticles) in their hollow cavity. These nanoparticles-loaded capsules were employed to demonstrate generic delivery of payload of nanoparticles intracellularly (HeLa cells), without the need of individual nanoparticle surface modification. Validation of intracellular internalization of nanoparticles-loaded capsules by HeLa cells was ascertained by confocal laser scanning microscopy. The green emission from Tb3+ was observed after internalization of LaF3:Tb3+(5%) nanoparticles-loaded capsules by HeLa cells, which suggests that nanoparticles in hybrid capsules retain their functionality within the cells. In vitro cytotoxicity studies of these nanoparticles-loaded capsules showed less/no cytotoxicity in comparison to blank capsules or untreated cells, thus offering a way of evading direct contact of nanoparticles with cells because of the presence of biocompatible polymeric shell of capsules. The proposed hybrid delivery system can be potentially developed to avoid a series of biological barriers and deliver multiple cargoes (both simultaneous and individual delivery) without the need of individual cargo design/modification. PMID:22649489

Low Concentration of Salmonella enterica and Generic Escherichia coli in Farm Ponds and Irrigation Distribution Systems Used for Mixed Produce Production in Southern Georgia.

PubMed

Antaki, Elizabeth M; Vellidis, George; Harris, Casey; Aminabadi, Peiman; Levy, Karen; Jay-Russell, Michele T

2016-10-01

Studies have shown that irrigation water can be a vector for pathogenic bacteria. Due to this, the Food Safety Modernization Act's (FSMA) produce safety rule requires that agricultural water directly applied to produce be safe and of adequate sanitary quality for use, which may pose a challenge for some farmers. The purpose of this research was to assess the presence and concentration of Salmonella and generic Escherichia coli in irrigation water from distribution systems in a mixed produce production region of southern Georgia. Water samples were collected during three growing seasons at three farms irrigating crops with surface water (Pond 1, Pond 2) or groundwater (Well) during 2012-2013. Salmonella and generic E. coli populations were monitored by culture and Most Probable Number (MPN). Confirmed isolates were characterized by pulsed-field gel electrophoresis and serotyping. In Pond 1, Salmonella was detected in 2/21 surface, 5/26 subsurface, 10/50 center pivot, and 0/16 solid set sprinkler head water samples. In Pond 2, Salmonella was detected in 2/18 surface, 1/18 subsurface, 6/36 drip line start, and 8/36 drip line end water samples. Twenty-six well pumps and 64 associated drip line water samples were negative. The overall mean Salmonella concentration for positive water samples was 0.03 MPN/100 mL (range <0.0011-1.8 MPN/100 mL). Nine Salmonella serovars comprising 22 pulsotypes were identified. Identical serovars and subtypes were found three times on the same day and location: Pond 1-Pivot-Cantaloupe (serovar Rubislaw), Pond 1-Pivot-Peanut (serovar Saintpaul), and Pond 2-Drip Line Start-Drip Line End-Yellow Squash (serovar III_16z10:e,n,x,z15). Generic E. coli was detected in water from both farm ponds and irrigation distribution systems, but the concentrations met FSMA microbial water quality criteria. The results from this study will allow producers in southern Georgia to better understand how potential pathogens move through irrigation distribution systems.

Comparsion of an immunochromatographic strip with ELISA for simultaneous detection of thiamphenicol, florfenicol and chloramphenicol in food samples.

PubMed

Guo, Lingling; Song, Shanshan; Liu, Liqiang; Peng, Juan; Kuang, Hua; Xu, Chuanlai

2015-09-01

Rapid and sensitive indirect competitive enzyme-linked immunosorbent assays (ic-ELISA) and gold nanoparticle immunochromatographic strip tests were developed to detect thiamphenicol (TAP), florfenicol (FF) and chloramphenicol (CAP) in milk and honey samples. The generic monoclonal antibody for TAP, FF and CAP was prepared based on a hapten [D-threo-1-(4-aminophenyl)-2- dichloroacetylamino-1,3-propanediol], and the haptenwas linked to a carrier protein using the diazotization method. After the optimization of several parameters (coating, pH, sodium chloride content and methanol content), the ic-ELISA was established. The quantitative working range for TAP was 0.11-1.36 ng/mL, with an IC50 of 0.39 ng/mL. The optimized ELISA showed cross-reactivity to CAP (300%) and FF (15.6%), with IC50 values of 0.13 and 2.5 ng/mL, respectively. The analytical recovery of TAP, FF and CAP in milk and honey samples in the ic-ELISA ranged from 81.2 to 112.9%. Based on this monoclonal antibody, a rapid and sensitive immunochromatographic test strip was also developed. This strip had a detection limit of 1 ng/mL for TAP, FF and CAP in milk and honey samples. Moreover, the test was completed within 10 min. Our results showed that the proposed ic-ELISA and immunochromatographic test strip method are highly useful screening tools for TAP, FF and CAP detection in milk and honey samples. Copyright © 2015 John Wiley & Sons, Ltd.

Thermal processing of a poorly water-soluble drug substance exhibiting a high melting point: the utility of KinetiSol® Dispersing.

PubMed

Hughey, Justin R; Keen, Justin M; Brough, Chris; Saeger, Sophie; McGinity, James W

2011-10-31

Poorly water-soluble drug substances that exhibit high melting points are often difficult to successfully process by fusion-based techniques. The purpose of this study was to identify a suitable polymer system for meloxicam (MLX), a high melting point class II BCS compound, and investigate thermal processing techniques for the preparation of chemically stable single phase solid dispersions. Thermal and solution based screening techniques were utilized to screen hydrophilic polymers suitable for immediate release formulations. Results of the screening studies demonstrated that Soluplus(®)(SOL) provided the highest degree of miscibility and solubility enhancement. A hot-melt extrusion feasibility study demonstrated that high temperatures and extended residence times were required in order to render compositions amorphous, causing significant degradation of MLX. A design of experiments (DOE) was conducted on the KinetiSol(®) Dispersing (KSD) process to evaluate the effect of processing conditions on the chemical stability and amorphous character of MLX. The study demonstrated that ejection temperature significantly impacted MLX stability. All samples prepared by KSD were substantially amorphous. Dissolution analysis of the KSD processed solid dispersions showed increased dissolution rates and extent of supersaturation over the marketed generic MLX tablets. Copyright © 2011 Elsevier B.V. All rights reserved.

Microfluidic Biochip Design

NASA Technical Reports Server (NTRS)

Panzarella, Charles

2004-01-01

As humans prepare for the exploration of our solar system, there is a growing need for miniaturized medical and environmental diagnostic devices for use on spacecrafts, especially during long-duration space missions where size and power requirements are critical. In recent years, the biochip (or Lab-on-a-Chip) has emerged as a technology that might be able to satisfy this need. In generic terms, a biochip is a miniaturized microfluidic device analogous to the electronic microchip that ushered in the digital age. It consists of tiny microfluidic channels, pumps and valves that transport small amounts of sample fluids to biosensors that can perform a variety of tests on those fluids in near real time. It has the obvious advantages of being small, lightweight, requiring less sample fluids and reagents and being more sensitive and efficient than larger devices currently in use. Some of the desired space-based applications would be to provide smaller, more robust devices for analyzing blood, saliva and urine and for testing water and food supplies for the presence of harmful contaminants and microorganisms. Our group has undertaken the goal of adapting as well as improving upon current biochip technology for use in long-duration microgravity environments.

Simultaneous Time-concentration Analysis of Soman and VX Adducts to Butyrylcholinesterase and Albumin by LC-MS-MS.

PubMed

Lee, Jin Young; Kim, Changhwan; Lee, Yong Han

2018-06-01

A sensitive method for the purification and determination of two protein adducts, organophosphorus (OP)-BChE and OP-albumin adducts, in a single sample using a simultaneous sample preparation method was developed and validated using liquid chromatography-tandem mass spectrometry. First, we isolated O-ethyl S-2-diisopropylaminoethyl methyl phosphonothiolate (VX) and O-pinacolyl methylphosphonofluoridate (soman, GD)-BChE adducts using an immunomagnetic separation (IMS) method and the HiTrap™ Blue affinity column was subsequently used to isolate and purify VX and GD-albumin adducts from the plasma of rhesus monkeys exposed to nerve agents. Additionally, we examined the time-concentration profiles of two biomarkers, VX and GD-nonapeptides and VX and GD-tyrosines, derived from OP-BChE and OP-albumin adducts up to 8 weeks after exposure. Based on the results, we determined that VX and GD-tyrosine is more suitable than VX and GD-nonapeptide as a biomarker owing to its longevity. This integrated approach is expected to be applicable for the quantification of other OP-BChE and OP-albumin adducts in human plasma, thus serving as a potential generic assay for exposure to nerve agents.

Quantum Metropolis sampling.

PubMed

Temme, K; Osborne, T J; Vollbrecht, K G; Poulin, D; Verstraete, F

2011-03-03

The original motivation to build a quantum computer came from Feynman, who imagined a machine capable of simulating generic quantum mechanical systems--a task that is believed to be intractable for classical computers. Such a machine could have far-reaching applications in the simulation of many-body quantum physics in condensed-matter, chemical and high-energy systems. Part of Feynman's challenge was met by Lloyd, who showed how to approximately decompose the time evolution operator of interacting quantum particles into a short sequence of elementary gates, suitable for operation on a quantum computer. However, this left open the problem of how to simulate the equilibrium and static properties of quantum systems. This requires the preparation of ground and Gibbs states on a quantum computer. For classical systems, this problem is solved by the ubiquitous Metropolis algorithm, a method that has basically acquired a monopoly on the simulation of interacting particles. Here we demonstrate how to implement a quantum version of the Metropolis algorithm. This algorithm permits sampling directly from the eigenstates of the Hamiltonian, and thus evades the sign problem present in classical simulations. A small-scale implementation of this algorithm should be achievable with today's technology.

SPECIATION OF ARSENIC IN DIETARY AND DIETARY COMPOSITE SAMPLES TO PROVIDE A MORE COMPLETE ASSESSMENT OF ARSENIC EXPOSURE FROM DIETARY SOURCES

EPA Science Inventory

The FDA's market basket study reports total arsenic concentrations from composite diet samples. The use of composite diets, based on market basket sampling, is the most cost effective means of obtaining a generic arsenic exposure estimate for a population. For example, the tota...

Comparison of response rates and cost-effectiveness for a community-based survey: postal, internet and telephone modes with generic or personalised recruitment approaches

PubMed Central

2012-01-01

Background Epidemiological research often requires collection of data from a representative sample of the community or recruitment of specific groups through broad community approaches. The population coverage of traditional survey methods such as mail-outs to residential addresses, and telephone contact via public directories or random-digit-dialing is declining and survey response rates are falling. There is a need to explore new sampling frames and consider multiple response modes including those offered by changes in telecommunications and internet technology. Methods We evaluated response rates and cost-effectiveness for three modes of survey administration (postal invitation/postal survey, postal invitation/internet survey and postal invitation/telephone survey) and two styles of contact approach (personalised and generic) in a community survey of greywater use. Potential respondents were contacted only once, with no follow up of non-responders. Results The telephone survey produced the highest adjusted response rate (30.2%), followed by the personalised postal survey (10.5%), generic postal survey (7.5%) and then the internet survey (4.7% for the personalised approach and 2.2% for the generic approach). There were some differences in household characteristics and greywater use rates between respondents to different survey modes, and between respondents to personalised and generic approaches. These may be attributable to the differing levels of motivations needed for a response, and varying levels of interest in the survey topic among greywater users and non-users. The generic postal survey had the lowest costs per valid survey received (Australian $22.93), followed by the personalised postal survey ($24.75). Conclusions Our findings suggest that postal surveys currently remain the most economic option for population-based studies, with similar costs for personalised and generic approaches. Internet surveys may be effective for specialised groups where email lists are available for initial contact, but barriers other than household internet access still exist for community-based surveys. Given the increasing recruitment challenges facing community-based studies, there is an imperative to gather contemporary comparative data on different survey modes and recruitment approaches in order to determine their strengths, limitations and costs. Researchers also need to document and report on the potential biases in the target and respondent populations and how this may affect the data collected. PMID:22938205

Treatment of Tinea Pedis in Elderly Patients Using External Preparations.

PubMed

Otani, Michiteru

2017-01-01

Infection rate of tinea pedis is high in the elderly, wherein treatment by a dermatologist should be considered to prevent infecting their family members. About 90 percent of cases with tinea pedis is treated only using external preparations. In treating the elderly with tinea pedis using external preparation, we should take into consideration that the elderly have thinner and weaker skin compared to younger people. There are many kinds of dosage form (cream, ointments, lotion, spray, and so on) for external preparations to treat tinea pedis. Generally, liquid forms such as lotions and sprays cause stronger irritation compared to ointments and creams, thus, caution should be taken for side effects when applying them to the elderly. Contact dermatitis is the most frequent side effect of external preparations. Caution should also be taken for the type of additives used. The composition of the preparation should be checked when changing dosage forms, or when switching brand-name drugs to generic drugs. Since the adherence rate of external preparations is low, it is preferable to use those with strong antibacterial activity and only have to be applied once a day.

Sample Handling Considerations for a Europa Sample Return Mission: An Overview

NASA Technical Reports Server (NTRS)

Fries, M. D.; Calaway, M. L.; Evans, C. A.; McCubbin, F. M.

2015-01-01

The intent of this abstract is to provide a basic overview of mission requirements for a generic Europan plume sample return mission, based on NASA Curation experience in NASA sample return missions ranging from Apollo to OSIRIS-REx. This should be useful for mission conception and early stage planning. We will break the mission down into Outbound and Return legs and discuss them separately.

Gas engine heat pump cycle analysis. Volume 1: Model description and generic analysis

NASA Astrophysics Data System (ADS)

Fischer, R. D.

1986-10-01

The task has prepared performance and cost information to assist in evaluating the selection of high voltage alternating current components, values for component design variables, and system configurations and operating strategy. A steady-state computer model for performance simulation of engine-driven and electrically driven heat pumps was prepared and effectively used for parametric and seasonal performance analyses. Parametric analysis showed the effect of variables associated with design of recuperators, brine coils, domestic hot water heat exchanger, compressor size, engine efficiency, insulation on exhaust and brine piping. Seasonal performance data were prepared for residential and commercial units in six cities with system configurations closely related to existing or contemplated hardware of the five GRI engine contractors. Similar data were prepared for an advanced variable-speed electric unit for comparison purposes. The effect of domestic hot water production on operating costs was determined. Four fan-operating strategies and two brine loop configurations were explored.

Reflective Writing as a Tool for Assessing Teamwork in Bioscience: Insights into Student Performance and Understanding of Teamwork

ERIC Educational Resources Information Center

Mayne, Lynne

2012-01-01

To ensure a modern bioscience curriculum that responds to the current needs of stakeholders, there is a need to embed a range of generic capabilities that enables graduates to succeed in and contribute to a rapidly changing world, as well as building strong bioscience skills and knowledge. The curriculum must also prepare students for a rapidly…

Coal gasification systems engineering and analysis, volume 2

NASA Technical Reports Server (NTRS)

1980-01-01

The major design related features of each generic plant system were characterized in a catalog. Based on the catalog and requirements data, approximately 17 designs and cost estimates were developed for MBG and alternate products. A series of generic trade studies was conducted to support all of the design studies. A set of cost and programmatic analyses were conducted to supplement the designs. The cost methodology employed for the design and sensitivity studies was documented and implemented in a computer program. Plant design and construction schedules were developed for the K-T, Texaco, and B&W MBG plant designs. A generic work breakdown structure was prepared, based on the K-T design, to coincide with TVA's planned management approach. An extensive set of cost sensitivity analyses was completed for K-T, Texaco, and B&W design. Product price competitiveness was evaluated for MBG and the alternate products. A draft management policy and procedures manual was evaluated. A supporting technology development plan was developed to address high technology risk issues. The issues were identified and ranked in terms of importance and tractability, and a plan developed for obtaining data or developing technology required to mitigate the risk.

Dynamic competition in pharmaceuticals. Patent expiry, generic penetration, and industry structure.

PubMed

Magazzini, Laura; Pammolli, Fabio; Riccaboni, Massimo

2004-06-01

This paper investigates patterns of industrial dynamics and competition in the pharmaceutical industry, with particular reference to the consequences of patent expiry in different countries. We focus on the competition at the level of single chemical entities, distinguishing between original brands and generic products. Quarterly data, spanning from July 1987 to December 1998, on sales of pharmaceutical products in four countries (USA, UK, Germany, and France) constitute the basis of our analysis. All the products containing major molecules whose patent expiration date lies between 1986 and 1996 are included in our sample. We show how diffusion of generics is linked to the characteristics of the market and investigate how price dynamics of original products are affected by generic competition. Our empirical investigation shows that the dynamics of drug prices and the competition by generic drugs vary significantly across countries. This heterogeneity notwithstanding, a clear distinction seems to emerge. On the one hand, systems that rely on market-based competition in pharmaceuticals promote a clear distinction between firms that act as innovators and firms that act as imitators after patent expiry. Here, original products enjoy premium prices and exclusivity profits under patent protection, and face fierce price competition after patent expiry. On the other hand, in systems that rely on administered prices, penetration by generic drugs tends to be rather limited. Its descriptive and preliminary nature notwithstanding, our analysis seems to have relevant implications at different levels of generality, especially for Europe.

Validation of the Korean version of the pediatric quality of life inventory 4.0 (PedsQL) generic core scales in school children and adolescents using the Rasch model.

PubMed

Kook, Seung Hee; Varni, James W

2008-06-02

The Pediatric Quality of Life Inventory (PedsQL) is a child self-report and parent proxy-report instrument designed to assess health-related quality of life (HRQOL) in healthy and ill children and adolescents. It has been translated into over 70 international languages and proposed as a valid and reliable pediatric HRQOL measure. This study aimed to assess the psychometric properties of the Korean translation of the PedsQL 4.0 Generic Core Scales. Following the guidelines for linguistic validation, the original US English scales were translated into Korean and cognitive interviews were administered. The field testing responses of 1425 school children and adolescents and 1431 parents to the Korean version of PedsQL 4.0 Generic Core Scales were analyzed utilizing confirmatory factor analysis and the Rasch model. Consistent with studies using the US English instrument and other translation studies, score distributions were skewed toward higher HRQOL in a predominantly healthy population. Confirmatory factor analysis supported a four-factor and a second order-factor model. The analysis using the Rasch model showed that person reliabilities are low, item reliabilities are high, and the majority of items fit the model's expectation. The Rasch rating scale diagnostics showed that PedsQL 4.0 Generic Core Scales in general have the optimal number of response categories, but category 4 (almost always a problem) is somewhat problematic for the healthy school sample. The agreements between child self-report and parent proxy-report were moderate. The results demonstrate the feasibility, validity, item reliability, item fit, and agreement between child self-report and parent proxy-report of the Korean version of PedsQL 4.0 Generic Core Scales for school population health research in Korea. However, the utilization of the Korean version of the PedsQL 4.0 Generic Core Scales for healthy school populations needs to consider low person reliability, ceiling effects and cultural differences, and further validation studies on Korean clinical samples are required.

Generic Amplicon Deep Sequencing to Determine Ilarvirus Species Diversity in Australian Prunus

PubMed Central

Kinoti, Wycliff M.; Constable, Fiona E.; Nancarrow, Narelle; Plummer, Kim M.; Rodoni, Brendan

2017-01-01

The distribution of Ilarvirus species populations amongst 61 Australian Prunus trees was determined by next generation sequencing (NGS) of amplicons generated using a genus-based generic RT-PCR targeting a conserved region of the Ilarvirus RNA2 component that encodes the RNA dependent RNA polymerase (RdRp) gene. Presence of Ilarvirus sequences in each positive sample was further validated by Sanger sequencing of cloned amplicons of regions of each of RNA1, RNA2 and/or RNA3 that were generated by species specific PCRs and by metagenomic NGS. Prunus necrotic ringspot virus (PNRSV) was the most frequently detected Ilarvirus, occurring in 48 of the 61 Ilarvirus-positive trees and Prune dwarf virus (PDV) and Apple mosaic virus (ApMV) were detected in three trees and one tree, respectively. American plum line pattern virus (APLPV) was detected in three trees and represents the first report of APLPV detection in Australia. Two novel and distinct groups of Ilarvirus-like RNA2 amplicon sequences were also identified in several trees by the generic amplicon NGS approach. The high read depth from the amplicon NGS of the generic PCR products allowed the detection of distinct RNA2 RdRp sequence variant populations of PNRSV, PDV, ApMV, APLPV and the two novel Ilarvirus-like sequences. Mixed infections of ilarviruses were also detected in seven Prunus trees. Sanger sequencing of specific RNA1, RNA2, and/or RNA3 genome segments of each virus and total nucleic acid metagenomics NGS confirmed the presence of PNRSV, PDV, ApMV and APLPV detected by RNA2 generic amplicon NGS. However, the two novel groups of Ilarvirus-like RNA2 amplicon sequences detected by the generic amplicon NGS could not be associated to the presence of sequence from RNA1 or RNA3 genome segments or full Ilarvirus genomes, and their origin is unclear. This work highlights the sensitivity of genus-specific amplicon NGS in detection of virus sequences and their distinct populations in multiple samples, and the need for a standardized approach to accurately determine what constitutes an active, viable virus infection after detection by molecular based methods. PMID:28713347

Generic Amplicon Deep Sequencing to Determine Ilarvirus Species Diversity in Australian Prunus.

PubMed

Kinoti, Wycliff M; Constable, Fiona E; Nancarrow, Narelle; Plummer, Kim M; Rodoni, Brendan

2017-01-01

The distribution of Ilarvirus species populations amongst 61 Australian Prunus trees was determined by next generation sequencing (NGS) of amplicons generated using a genus-based generic RT-PCR targeting a conserved region of the Ilarvirus RNA2 component that encodes the RNA dependent RNA polymerase (RdRp) gene. Presence of Ilarvirus sequences in each positive sample was further validated by Sanger sequencing of cloned amplicons of regions of each of RNA1, RNA2 and/or RNA3 that were generated by species specific PCRs and by metagenomic NGS. Prunus necrotic ringspot virus (PNRSV) was the most frequently detected Ilarvirus , occurring in 48 of the 61 Ilarvirus -positive trees and Prune dwarf virus (PDV) and Apple mosaic virus (ApMV) were detected in three trees and one tree, respectively. American plum line pattern virus (APLPV) was detected in three trees and represents the first report of APLPV detection in Australia. Two novel and distinct groups of Ilarvirus -like RNA2 amplicon sequences were also identified in several trees by the generic amplicon NGS approach. The high read depth from the amplicon NGS of the generic PCR products allowed the detection of distinct RNA2 RdRp sequence variant populations of PNRSV, PDV, ApMV, APLPV and the two novel Ilarvirus -like sequences. Mixed infections of ilarviruses were also detected in seven Prunus trees. Sanger sequencing of specific RNA1, RNA2, and/or RNA3 genome segments of each virus and total nucleic acid metagenomics NGS confirmed the presence of PNRSV, PDV, ApMV and APLPV detected by RNA2 generic amplicon NGS. However, the two novel groups of Ilarvirus -like RNA2 amplicon sequences detected by the generic amplicon NGS could not be associated to the presence of sequence from RNA1 or RNA3 genome segments or full Ilarvirus genomes, and their origin is unclear. This work highlights the sensitivity of genus-specific amplicon NGS in detection of virus sequences and their distinct populations in multiple samples, and the need for a standardized approach to accurately determine what constitutes an active, viable virus infection after detection by molecular based methods.

Choice of generic versus brand-name antidepressants in a regulated prescription drug market: evidence from Taiwan.

PubMed

Liu, Ya-Ming; Ou, Huang-Tz; Yang, Yen-Kuang

2014-12-01

A health care system in which there is no separation between prescription and dispensation, combined with a regulated prescription drug market, leads to various generic substitution mechanisms for antidepressants. We investigated the determinants of generic versus brand-name antidepressant choices in a regulated prescription market where physicians both prescribe and dispense drugs. Using data from a sample of one million individuals selected randomly from the registry of National Health Insurance beneficiaries in 2010, and all claims for these one million enrollees between January 1997 and December 2011, we employed logistic regression to examine the choice of generic versus brand-name antidepressants in the Taiwanese prescription drug market. Access to various antidepressant brands varies according to the accreditation level and type of ownership of the healthcare provider. Private healthcare providers and those with lower accreditation levels were more likely to prescribe generic antidepressants compared to their brand-name counterparts. The diversity of products and competition in the molecule market was positively associated with the probability of prescribing generic antidepressants. In a regulated prescription drug market with no separation between prescription and dispensation, the substitution of generic antidepressant prescriptions in place of brand-name prescriptions is likely driven by drug and provider market characteristics, rather than by lowering costs. The allocation of different types of ownership and accreditation levels of healthcare providers may lead to unequal access to various brands of antidepressants. Policies for improving the treatment of depression should take into account the structure of molecule and provider markets as important factors in determining the choice and utilization of antidepressants, in a healthcare system where physicians both prescribe and dispense drugs. Other psychotropic drug classes should be investigated to explore the effect of molecule and provider characteristics on the utilization of various classes of medication.

The WHO/PEPFAR collaboration to prepare an operations manual for HIV prevention, care, and treatment at primary health centers in high-prevalence, resource-constrained settings: defining laboratory services.

PubMed

Spira, Thomas; Lindegren, Mary Lou; Ferris, Robert; Habiyambere, Vincent; Ellerbrock, Tedd

2009-06-01

The expansion of HIV/AIDS care and treatment in resource-constrained countries, especially in sub-Saharan Africa, has generally developed in a top-down manner. Further expansion will involve primary health centers where human and other resources are limited. This article describes the World Health Organization/President's Emergency Plan for AIDS Relief collaboration formed to help scale up HIV services in primary health centers in high-prevalence, resource-constrained settings. It reviews the contents of the Operations Manual developed, with emphasis on the Laboratory Services chapter, which discusses essential laboratory services, both at the center and the district hospital level, laboratory safety, laboratory testing, specimen transport, how to set up a laboratory, human resources, equipment maintenance, training materials, and references. The chapter provides specific information on essential tests and generic job aids for them. It also includes annexes containing a list of laboratory supplies for the health center and sample forms.

X-Ray Fluorescence Spectroscopy for Analysis of Explosive-Related Materials and Unknowns

DTIC Science & Technology

2017-08-01

locally sourced baking soda) were added for further investigation. 3.2.5 Sample Cups and Film The samples cups used for this work were Chemplex...from Na and Cl; photograph was taken after irradiation, which induced the tan coloring Sodium bicarbonate Generic, store-brand baking soda

Characterization of a dielectric phantom for high-field magnetic resonance imaging applications

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

Duan, Qi, E-mail: Qi.Duan@nih.gov; Duyn, Jeff H.; Gudino, Natalia

2014-10-15

Purpose: In this work, a generic recipe for an inexpensive and nontoxic phantom was developed within a range of biologically relevant dielectric properties from 150 MHz to 4.5 GHz. Methods: The recipe includes deionized water as the solvent, NaCl to primarily control conductivity, sucrose to primarily control permittivity, agar–agar to gel the solution and reduce heat diffusivity, and benzoic acid to preserve the gel. Two hundred and seventeen samples were prepared to cover the feasible range of NaCl and sucrose concentrations. Their dielectric properties were measured using a commercial dielectric probe and were fitted to a 3D polynomial to generatemore » a recipe describing the properties as a function of NaCl concentration, sucrose concentration, and frequency. Results: Results indicated that the intuitive linear and independent relationships between NaCl and conductivity and between sucrose and permittivity are not valid. A generic polynomial recipe was developed to characterize the complex relationship between the solutes and the resulting dielectric values and has been made publicly available as a web application. In representative mixtures developed to mimic brain and muscle tissue, less than 2% difference was observed between the predicted and measured conductivity and permittivity values. Conclusions: It is expected that the recipe will be useful for generating dielectric phantoms for general magnetic resonance imaging (MRI) coil development at high magnetic field strength, including coil safety evaluation as well as pulse sequence evaluation (including B{sub 1}{sup +} mapping, B{sub 1}{sup +} shimming, and selective excitation pulse design), and other non-MRI applications which require biologically equivalent dielectric properties.« less

Urine testing for designer steroids by liquid chromatography with androgen bioassay detection and electrospray quadrupole time-of-flight mass spectrometry identification.

PubMed

Nielen, Michel W F; Bovee, Toine F H; van Engelen, Marcel C; Rutgers, Paula; Hamers, Astrid R M; van Rhijn, J Hans A; Hoogenboom, L Ron A P

2006-01-15

New anabolic steroids show up occasionally in sports doping and in veterinary control. The discovery of these designer steroids is facilitated by findings of illicit preparations, thus allowing bioactivity testing, structure elucidation using NMR and mass spectrometry, and final incorporation in urine testing. However, as long as these preparations remain undiscovered, new designer steroids are not screened for in routine sports doping or veterinary control urine tests since the established GC/MS and LC/MS/MS methods are set up for the monitoring of a few selected ions or MS/MS transitions of known substances only. In this study, the feasibility of androgen bioactivity testing and mass spectrometric identification is being investigated for trace analysis of designer steroids in urine. Following enzymatic deconjugation and a generic solid-phase extraction, the samples are analyzed by gradient LC with effluent splitting toward two identical 96-well fraction collectors. One well plate is used for androgen bioactivity detection using a novel robust yeast reporter gene bioassay yielding a biogram featuring a 20-s time resolution. The bioactive wells direct the identification efforts to the corresponding well numbers in the duplicate plate. These are subjected to high-resolution LC using a short column packed with 1.7-microm C18 material and coupled with electrospray quadrupole time-of-flight mass spectrometry (LC/QTOFMS) with accurate mass measurement. Element compositions are calculated and used to interrogate electronic substance databases. The feasibility of this approach for doping control is demonstrated via the screening of human urine samples spiked with the designer anabolic steroid tetrahydrogestrinone. Application of the proposed methodology, complementary to the established targeted urine screening for known anabolics, will increase the chance of finding unknown emerging designer steroids, rather then being solely dependent on findings of the illicit preparations themselves.

Microbiological baseline study of poultry slaughtered in provincially inspected abattoirs in Alberta, Canada

PubMed Central

Bohaychuk, Valerie M.; Checkley, Sylvia L.; Gensler, Gary E.; Barrios, Pablo Romero

2009-01-01

Studies to determine baseline levels of microbial contaminants and foodborne bacterial pathogens are needed to evaluate the effectiveness of Hazard Analysis Critical Control Point (HACCP) programs, Good Manufacturing/Production Practices, and various interventions. In 2004 and 2005 poultry carcass rinses from provincially inspected abattoirs in Alberta, Canada, were tested to determine the levels of aerobic plate count bacteria, coliform bacteria, and generic Escherichia coli, the prevalence and levels of Campylobacter spp., and the prevalence of Salmonella spp. and Shiga toxin-producing E. coli (STEC). Samples were collected from 3 high volume and 62 low volume abbatoirs. All samples (1296) were positive for aerobic plate count bacteria, with 98.8% of samples having counts of 100 000 or less colony forming units (CFU)/cm2. Coliform bacteria were isolated from 99.7% of the 1296 carcasses and were recovered at levels of ≤ 1000 CFU/cm2 for 98.3% of the samples. Generic E. coli were recovered from 99.1% of the 1296 carcasses at levels of ≤ 1000 CFU/cm2 for 98.6% of the samples. Seventy five percent of 1234 samples that were tested for Campylobacter were positive; 37.5% of 1295 samples that were tested for Salmonella were positive; and only 2 of 1296 samples tested for STEC were positive (0.15%). PMID:19412397

Generic framework for the secure Yuen 2000 quantum-encryption protocol employing the wire-tap channel approach

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

Mihaljevic, Miodrag J.

2007-05-15

It is shown that the security, against known-plaintext attacks, of the Yuen 2000 (Y00) quantum-encryption protocol can be considered via the wire-tap channel model assuming that the heterodyne measurement yields the sample for security evaluation. Employing the results reported on the wire-tap channel, a generic framework is proposed for developing secure Y00 instantiations. The proposed framework employs a dedicated encoding which together with inherent quantum noise at the attacker's side provides Y00 security.

Energy use in the marine transportation industry. Task II. Efficiency improvements. Draft report

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

Not Available

1977-06-02

Research and development areas that hold promise for maritime energy conservation are identified and evaluated. The methodology used in the evaluation of potential research areas and results, conclusions, and recommendations are presented. Fifteen programs are identified in four generic technologies and these are discussed in detail in appendices A-D. The areas are: main propulsion plants, propulsors, hydrodynamics, and vessel operations. Fuels are discussed briefly in appendix E. Additional information is presented on the generic US flag baseline operational and cost parameters; a sample output model is presented. (MCW)

Developing Coping Typologies of Minority Adolescents: A Latent Profile Analysis

PubMed Central

Aldridge, Arianna A.; Roesch, Scott C.

2008-01-01

Latent profile analysis (LPA) was used to develop a coping typology of minority adolescents (M = 15.5 yrs). A multiethnic sample (n = 354) was recruited from a program aimed at serving low-income students. LPA revealed three distinct coping profiles. The first comprised adolescents who used a number of specific coping strategies at a low level (Low Generic Copers). The second comprised adolescents who emphasized active/approach strategies (e.g., planning; Active Copers). The third comprised adolescents who emphasized avoidant/passive strategies (e.g., substance abuse; Avoidant Copers). Active Copers experienced significantly less depression and more stress-related growth than Low Generic Copers. Low Generic Copers experienced significantly less depression than Avoidant Copers but also significantly less stress-related growth than Active Copers. Discussion focuses on integrating the current typology with traditional coping taxomonies. PMID:17904631

21 CFR 870.1200 - Diagnostic intravascular catheter.

Code of Federal Regulations, 2010 CFR

2010-04-01

... intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among...

21 CFR 870.1200 - Diagnostic intravascular catheter.

Code of Federal Regulations, 2012 CFR

2012-04-01

... intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among...

21 CFR 870.1200 - Diagnostic intravascular catheter.

Code of Federal Regulations, 2011 CFR

2011-04-01

... intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among...

21 CFR 870.1200 - Diagnostic intravascular catheter.

Code of Federal Regulations, 2013 CFR

2013-04-01

... intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among...

21 CFR 870.1200 - Diagnostic intravascular catheter.

Code of Federal Regulations, 2014 CFR

2014-04-01

... intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among...

Effects of electronic prescribing on formulary compliance and generic drug utilization in the ambulatory care setting: a retrospective analysis of administrative claims data.

PubMed

Ross, S Michael; Papshev, Diana; Murphy, Erin L; Sternberg, David J; Taylor, Jeffrey; Barg, Ronald

2005-06-01

Electronic prescribing (e-prescribing) provides formulary information at the point of care. The objective of this study was to assess the effects of e-prescribing on formulary compliance and generic utilization. This was a retrospective analysis of pharmacy claims data from a large national managed care organization. A sample of 95 providers using predominantly e-prescribing was randomly selected (e-prescriber group). A matched sample of 95 traditional prescribers was selected (traditional prescriber group), matched to the e-prescriber group by zip code and medical specialty. A total of 110,975 paid pharmacy claims, for the 12 months from August 1, 2001, through July 31, 2002, were analyzed to assess the effect of e-prescribing on formulary compliance and generic utilization. All paid pharmacy claims were examined for each group; for the e-prescriber group, this included all claims, not just those prescribed using an e-prescribing device. A written qualitative survey was distributed to physicians and office managers to assess e-prescribing usage, sources of formulary information, and effects of e-prescribing on office resources. Both predominantly e-prescribers and traditional prescribers demonstrated high levels of formulary compliance, 83.2% versus 82.8%, respectively (P=0.32). Formulary compliance for these groups did not differ from the overall prescriber population (82.0%). There was not a difference in generic drug utilization rates between e-prescribers and traditional prescribers (absolute rates 37.3% versus 36.9%, P=0.18). Qualitative survey responses supported previously reported research indicating reductions in calls both to and from pharmacies for prescription orders. An examination of paid pharmacy claims from a large, national managed care organization demonstrated no differences between predominantly e-prescribers and traditional prescribers in measures of formulary compliance or generic drug utilization. Future studies should examine keystroke data at the point of care to observe more detail about drug selection methods.

A prospective, observational study comparing the PK/PD relationships of generic Meropenem (Mercide®) to the innovator brand in critically ill patients.

PubMed

Mer, Mervyn; Snyman, Jacques Rene; van Rensburg, Constance Elizabeth Jansen; van Tonder, Jacob John; Laurens, Ilze

2016-01-01

Clinicians' skepticism, fueled by evidence of inferiority of some multisource generic antimicrobial products, results in the underutilization of more cost-effective generics, especially in critically ill patients. The aim of this observational study was to demonstrate equivalence between the generic or comparator brand of meropenem (Mercide ® ) and the leading innovator brand (Meronem ® ) by means of an ex vivo technique whereby antimicrobial activity is used to estimate plasma concentration of the active moiety. Patients from different high care and intensive care units were recruited for observation when prescribed either of the meropenem brands under investigation. Blood samples were collected over 6 hours after a 30 minute infusion of the different brands. Meropenem concentration curves were established against United States Pharmacopeia standard meropenem (Sigma-Aldrich) by using standard laboratory techniques for culture of Klebsiella pneumoniae. Patients' plasma samples were tested ex vivo, using a disc diffusion assay, to confirm antimicrobial activity and estimate plasma concentrations of the two brands. Both brands of meropenem demonstrated similar curves in donor plasma when concentrations in vials were confirmed. Patient-specific serum concentrations were determined from zones of inhibition against a standard laboratory Klebsiella strain ex vivo, confirming at least similar in vivo concentrations as the concentration curves (90% confidence interval) overlapped; however, the upper limit of the area under the curve for the ratio comparator/innovator exceeded the 1.25-point estimate, i.e., 4% higher for comparator meropenem. This observational, in-practice study demonstrates similar ex vivo activity and in vivo plasma concentration time curves for the products under observation. Assay sensitivity is also confirmed. Current registration status of generic small molecules is in place. The products are therefore clinically interchangeable based on registration status as well as bioassay results, demonstrating sufficient overlap for clinical comfort. The slightly higher observed comparator meropenem concentration (4%) is still clinically acceptable due to the large therapeutic index and should ally fears of inferiority.

Tuning the dispersion of multiwall carbon nanotubes in co-continuous polymer blends: a generic approach

NASA Astrophysics Data System (ADS)

Bose, Suryasarathi; Bhattacharyya, Arup R.; Khare, Rupesh A.; Kulkarni, Ajit R.; Umasankar Patro, T.; Sivaraman, P.

2008-08-01

Melt-mixed blends of polyamide 6 and acrylonitrile-butadiene-styrene (PA6/ABS) with multiwall carbon nanotubes (MWNTs) were prepared with the intention to develop conducting composites. A generic strategy, namely specific interactions combined with reactive coupling, was adopted to facilitate and to retain the 'network-like' structure of MWNTs during melt-mixing. This was facilitated by the sodium salt of 6-amino hexanoic acid (Na-AHA) and certain phosphonium based modifiers, where it was envisaged that these modifiers would establish specific interactions (either 'cation-π' or 'π-π' ) with the 'π-electron' clouds of MWNTs, as well as restricting them in the PA6 phase of the blends via reactive coupling. This route eventually led to a remarkable increase in the electrical conductivity and dielectric constant in the blends with MWNTs. Raman, FTIR and TEM investigations further supported these observations.

Instrumental texture profile analysis of gelatin gel extracted from grouper skin and commercial (bovine and porcine) gelatin gels.

PubMed

Rahman, Mohammad Shafiur; Al-Mahrouqi, Abdullah Issa

2009-01-01

Mechanical compression was used to study the gelling characteristics of gelatin gels. Texture profile analysis (TPA) showed that the hardness of fish and mammalian gelatin increased significantly as the concentrations of gels increased. TPA attributes of 10% fish skin gel showed significant differences from those obtained from 20% and 30% gels. In bovine and porcine cases, such generic trends were not observed. Mechanical characteristics of 10% gels of gelatin from fish skin, determined from one cycle compression, were significantly lower than other sources of gelatin gels, while bovine and porcine gels did not show any significant differences. In the case of TPA, hardness of bovine gelatin gel was highest at 41 N for 10% gel, followed by porcine (30 N) then fish skin (5 N) gelatin gels. The gels prepared from different sources did not show any generic trends when all other mechanical attributes were considered.

Society already achieves economic benefits from generic substitution but fails to do the same for therapeutic substitution.

PubMed

Gumbs, Pearl D; Verschuren, W M Monique; Souverein, Patrick C; Mantel-Teeuwisse, Aukje K; de Wit, G Ardine; de Boer, Anthonius; Klungel, Olaf H

2007-11-01

To assess the potential annual savings due to generic and therapeutic substitution of statin therapy for the general Dutch population, taking the patients medical history into account. We conducted a population-based costing study using the PHARMO Record Linkage System (RLS). PHARMO RLS contains drug dispensing records from a representative sample of pharmacies located in more than 50 regions in the Netherlands. We selected all statin users in the database since 2003. The cost-savings of generic substitution of statin therapy for all simvastatin and pravastatin users, and of therapeutic substitution of statin therapy for other statin users were calculated. Substituting current users and new users of statins were considered separately. Therapeutic substitution was based on the medical history of the individual patient. Patients were only substituted if there was an appropriate substitute available. The appropriateness of substitution was based on drug-drug interactions between statins and possible comedication and the availability of an equipotent alternative. Substituting (generic and therapeutic) statin therapy for all current users would lead to potential annual savings of approximately 87 million euros. Substituting (generic and therapeutic) all starters on statin therapy would lead to potential annual savings of around 51 million euros. In the case of generic substitution only, the potential annual savings for all current simvastatin and pravastatin users would be 2.4 million euros and for the new users about 1.8 million euros. From an economic point of view, society could gain a lot from substituting statin therapy, especially from therapeutic substitution.

Field Evaluation of Dried Blood Spots for Routine HIV-1 Viral Load and Drug Resistance Monitoring in Patients Receiving Antiretroviral Therapy in Africa and Asia

PubMed Central

Monleau, Marjorie; Eymard-Duvernay, Sabrina; Dagnra, Anoumou; Kania, Dramane; Ngo-Giang-Huong, Nicole; Touré-Kane, Coumba; Truong, Lien X. T.; Chaix, Marie-Laure; Delaporte, Eric; Ayouba, Ahidjo; Peeters, Martine

2014-01-01

Dried blood spots (DBS) can be used in developing countries to alleviate the logistic constraints of using blood plasma specimens for viral load (VL) and HIV drug resistance (HIVDR) testing, but they should be assessed under field conditions. Between 2009 and 2011, we collected paired plasma-DBS samples from treatment-experienced HIV-1-infected adults in Burkina Faso, Cameroon, Senegal, Togo, Thailand, and Vietnam. The DBS were stored at an ambient temperature for 2 to 4 weeks and subsequently at −20°C before testing. VL testing was performed on the plasma samples and DBS using locally available methods: the Abbott m2000rt HIV-1 test, generic G2 real-time PCR, or the NucliSENS EasyQ version 1.2 test. In the case of virological failure (VF), i.e., a plasma VL of ≥1,000 copies/ml, HIVDR genotyping was performed on paired plasma-DBS samples. Overall, we compared 382 plasma-DBS sample pairs for DBS VL testing accuracy. The sensitivities of the different assays in different laboratories for detecting VF using DBS varied from 75% to 100% for the m2000rt test in labs B, C, and D, 91% to 93% for generic G2 real-time PCR in labs A and F, and 85% for the NucliSENS test in lab E. The specificities varied from 82% to 97% for the m2000rt and NucliSENS tests and reached only 60% for the generic G2 test. The NucliSENS test showed good agreement between plasma and DBS VL but underestimated the DBS VL. The lowest agreement was observed for the generic G2 test. Genotyping was successful for 96/124 (77%) DBS tested, and 75/96 (78%) plasma-DBS pairs had identical HIVDR mutations. Significant discrepancies in resistance interpretations were observed in 9 cases, 6 of which were from the same laboratory. DBS can be successfully used as an alternative to blood plasma samples for routine VL and HIVDR monitoring in African and Asian settings. However, the selection of an adequate VL measurement method and the definition of the VF threshold should be considered, and laboratory performance should be monitored. PMID:24478491

A highly sensitive monoclonal antibody based biosensor for quantifying 3-5 ring polycyclic aromatic hydrocarbons (PAHs) in aqueous environmental samples.

PubMed

Li, Xin; Kaattari, Stephen L; Vogelbein, Mary A; Vadas, George G; Unger, Michael A

2016-03-01

Immunoassays based on monoclonal antibodies (mAbs) are highly sensitive for the detection of polycyclic aromatic hydrocarbons (PAHs) and can be employed to determine concentrations in near real-time. A sensitive generic mAb against PAHs, named as 2G8, was developed by a three-step screening procedure. It exhibited nearly uniformly high sensitivity against 3-ring to 5-ring unsubstituted PAHs and their common environmental methylated PAHs, with IC 50 values between 1.68-31 μg/L (ppb). 2G8 has been successfully applied on the KinExA Inline Biosensor system for quantifying 3-5 ring PAHs in aqueous environmental samples. PAHs were detected at a concentration as low as 0.2 μg/L. Furthermore, the analyses only required 10 min for each sample. To evaluate the accuracy of the 2G8-based biosensor, the total PAH concentrations in a series of environmental samples analyzed by biosensor and GC-MS were compared. In most cases, the results yielded a good correlation between methods. This indicates that generic antibody 2G8 based biosensor possesses significant promise for a low cost, rapid method for PAH determination in aqueous samples.

Why do generic drugs fail to achieve an adequate market share in Greece? Empirical findings and policy suggestions.

PubMed

Balasopoulos, T; Charonis, A; Athanasakis, K; Kyriopoulos, J; Pavi, E

2017-03-01

Since 2010, the memoranda of understanding were implemented in Greece as a measure of fiscal adjustment. Public pharmaceutical expenditure was one of the main focuses of this implementation. Numerous policies, targeted on pharma spending, reduced the pharmaceutical budget by 60.5%. Yet, generics' penetration in Greece remained among the lowest among OECD countries. This study aims to highlight the factors that affect the perceptions of the population on generic drugs and to suggest effective policy measures. The empirical analysis is based on a national cross-sectional survey that was conducted through a sample of 2003 individuals, representative of the general population. Two ordinal logistic regression models were constructed in order to identify the determinants that affect the respondents' beliefs on the safety and the effectiveness of generic drugs. The empirical findings presented a positive and statistically significant correlation with income, bill payment difficulties, safety and effectiveness of drugs, prescription and dispensing preferences and the views toward pharmaceutical companies. Also, age and trust toward medical community have a positive and statistically significant correlation with the perception on the safety of generic drugs. Policy interventions are suggested on the bases of the empirical results on 3 major categories; (a) information campaigns, (b) incentives to doctors and pharmacists and (c) to strengthen the bioequivalence control framework and the dissemination of results. Copyright © 2017 Elsevier B.V. All rights reserved.

Measuring health-related quality of life in population-based studies of coronary heart disease: comparing six generic indexes and a disease-specific proxy score.

PubMed

Garster, Noelle C; Palta, Mari; Sweitzer, Nancy K; Kaplan, Robert M; Fryback, Dennis G

2009-11-01

To compare HRQoL differences with CHD in generic indexes and a proxy CVD-specific score in a nationally representative sample of U.S. adults. The National Health Measurement Study, a cross-sectional random-digit-dialed telephone survey of adults aged 35-89, administered the EQ-5D, QWB-SA, HUI2, HUI3, SF-36v2 (yielding PCS, MCS, and SF-6D), and HALex. Analyses compared 3,350 without CHD (group 1), 265 with CHD not taking chest pain medication (group 2), and 218 with CHD currently taking chest pain medication (group 3), with and without adjustment for demographic variables and comorbidities. Data on 154 patients from heart failure clinics were used to construct a proxy score utilizing generic items probing CVD symptoms. Mean scores differed between CHD groups for all indexes with and without adjustment (P < 0.0001 for all except MCS P = 0.018). Unadjusted group 3 versus 1 differences were about three times larger than for group 2 versus 1. Standardized differences for the proxy score were similar to those for generic indexes, and were about 1.0 for all except MCS for group 3 versus 1. Generic indexes capture differences in HRQoL in population-based studies of CHD similarly to a score constructed from questions probing CVD-specific symptoms.

21 CFR 884.1660 - Transcervical endoscope (amnioscope) and accessories.

Code of Federal Regulations, 2010 CFR

2010-04-01

... visualize the fetus or amniotic fluid and to sample fetal blood or amniotic fluid. This generic type of device may include obturators, instruments used through an operating channel, light sources and cables...

A generic, cost-effective, and scalable cell lineage analysis platform

PubMed Central

Biezuner, Tamir; Spiro, Adam; Raz, Ofir; Amir, Shiran; Milo, Lilach; Adar, Rivka; Chapal-Ilani, Noa; Berman, Veronika; Fried, Yael; Ainbinder, Elena; Cohen, Galit; Barr, Haim M.; Halaban, Ruth; Shapiro, Ehud

2016-01-01

Advances in single-cell genomics enable commensurate improvements in methods for uncovering lineage relations among individual cells. Current sequencing-based methods for cell lineage analysis depend on low-resolution bulk analysis or rely on extensive single-cell sequencing, which is not scalable and could be biased by functional dependencies. Here we show an integrated biochemical-computational platform for generic single-cell lineage analysis that is retrospective, cost-effective, and scalable. It consists of a biochemical-computational pipeline that inputs individual cells, produces targeted single-cell sequencing data, and uses it to generate a lineage tree of the input cells. We validated the platform by applying it to cells sampled from an ex vivo grown tree and analyzed its feasibility landscape by computer simulations. We conclude that the platform may serve as a generic tool for lineage analysis and thus pave the way toward large-scale human cell lineage discovery. PMID:27558250

"Hi Mommy": Parental Preferences of Greetings by Medical Staff.

PubMed

Wilks-Gallo, Lisa; Aron, Chaim Zev; Messina, Catherine R

2018-04-01

The therapeutic alliance between pediatricians and parents begins at the initial encounter. The manner in which pediatricians greet family members influences this relationship. This study evaluated whether parents are addressed using generic titles and investigated perceptions of parents regarding how they are addressed by medical staff. Written surveys of 137 parents of pediatric inpatients collected opinions about greetings during medical encounters. Parents were asked if they have been addressed as Mom/Dad/Mommy/Daddy during past medical encounters and which generic titles they would prefer. Using a Likert-type scale, the parents' perceptions of various salutations were assessed and compared. In this sample, 86% of parents were previously called Mom/Dad/Mommy/Daddy. Parents preferred to be addressed as Mom or Dad over other generic titles. Many disliked being addressed as Mommy/Daddy, Ma'am/Sir, or without a name, suggesting that providers should avoid the use of these salutations.

Knowledge Data Base for Amorphous Metals

DTIC Science & Technology

2007-07-26

not programmatic, updates. Over 100 custom SQL statements that maintain the domain specific data are attached to the workflow entries in a generic...for the form by populating the SQL and run generation tables. Application data may be prepared in different ways for two steps that invoke the same form...run generation mode). There is a single table of SQL commands. Each record has a user-definable ID, the SQL code, and a comment. The run generation

Advanced Software Development Workstation Project, phase 3

NASA Technical Reports Server (NTRS)

1991-01-01

ACCESS provides a generic capability to develop software information system applications which are explicitly intended to facilitate software reuse. In addition, it provides the capability to retrofit existing large applications with a user friendly front end for preparation of input streams in a way that will reduce required training time, improve the productivity even of experienced users, and increase accuracy. Current and past work shows that ACCESS will be scalable to much larger object bases.

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

Hichwa, B.P.; Pun, D.D.; Wang, D.

A multielemental analysis to determine the trace metal content of generic and name-brand aspirins and name-brand lipsticks was done via proton induced x-ray (PIXE) measurements. The Hope College PIXE system is described as well as the target preparation methods. The trace metal content of twelve brands of aspirin and aspirin substitutes and fourteen brands of lipstick are reported. Detection limits for most elements are in the range of 100 parts per billion (ppb) to 10 parts per million (ppm).

Systematic conversion to generic tacrolimus in stable kidney transplant recipients.

PubMed

Rosenborg, Staffan; Nordström, Annica; Almquist, Tora; Wennberg, Lars; Bárány, Peter

2014-04-01

Tacrolimus (Prograf ® ) is a key drug in the immunosuppressive treatment of renal transplant patients. Since the expiration of the patent for Prograf ® , generic preparations have been approved in Europe as bioequivalence has been shown in healthy volunteers. However, few studies have investigated whether patients can be successfully converted from Prograf ® to generic tacrolimus. Tacrolimus drug costs are by far the largest single item in the total drug expenditure for patients with renal disease in the Stockholm area. Considerable reductions in drug costs could be achieved if generic tacrolimus were to be used. The aim of this quality assurance study was to evaluate whether a switch from Prograf ® to generic tacrolimus (Tacrolimus Sandoz ® ) could be safely performed in renal transplant patients. It further aimed to investigate changes of renal function (measured in estimated glomerular filtration rate, eGFR), need for dose changes and to calculate potential drug cost savings as a result of the conversion. We planned to recruit at least 50 patients. Plasma creatinine levels and trough concentrations of tacrolimus were collected from patients with renal transplants at three occasions during treatment with Prograf ® and three times after conversion to Tacrolimus Sandoz ® . The eGFR was calculated before and after the conversion. Sixty-three of 67 enrolled patients (69% males, age 28-80 years) are included in this analysis. The ratio of mean trough concentrations of tacrolimus after comparison with before conversion was 1.02 (90% confidence interval 0.95-1.09). Fourteen patients experienced a change in tacrolimus levels >20% compared with baseline, no patients changed >20% in eGFR. The drug cost saving per daily dose was 33.40 SEK (∼€3.60, -23%). Stable kidney transplant patients treated with Prograf ® can be converted to Tacrolimus Sandoz ® if trough concentrations of tacrolimus and plasma creatinine levels are closely monitored. The conversion brought savings, despite costs for extra monitoring.

Systematic conversion to generic tacrolimus in stable kidney transplant recipients

PubMed Central

Rosenborg, Staffan; Nordström, Annica; Almquist, Tora; Wennberg, Lars; Bárány, Peter

2014-01-01

Background Tacrolimus (Prograf®) is a key drug in the immunosuppressive treatment of renal transplant patients. Since the expiration of the patent for Prograf®, generic preparations have been approved in Europe as bioequivalence has been shown in healthy volunteers. However, few studies have investigated whether patients can be successfully converted from Prograf® to generic tacrolimus. Tacrolimus drug costs are by far the largest single item in the total drug expenditure for patients with renal disease in the Stockholm area. Considerable reductions in drug costs could be achieved if generic tacrolimus were to be used. The aim of this quality assurance study was to evaluate whether a switch from Prograf® to generic tacrolimus (Tacrolimus Sandoz®) could be safely performed in renal transplant patients. It further aimed to investigate changes of renal function (measured in estimated glomerular filtration rate, eGFR), need for dose changes and to calculate potential drug cost savings as a result of the conversion. Methods We planned to recruit at least 50 patients. Plasma creatinine levels and trough concentrations of tacrolimus were collected from patients with renal transplants at three occasions during treatment with Prograf® and three times after conversion to Tacrolimus Sandoz®. The eGFR was calculated before and after the conversion. Results Sixty-three of 67 enrolled patients (69% males, age 28–80 years) are included in this analysis. The ratio of mean trough concentrations of tacrolimus after comparison with before conversion was 1.02 (90% confidence interval 0.95–1.09). Fourteen patients experienced a change in tacrolimus levels >20% compared with baseline, no patients changed >20% in eGFR. The drug cost saving per daily dose was 33.40 SEK (∼€3.60, −23%). Conclusions Stable kidney transplant patients treated with Prograf® can be converted to Tacrolimus Sandoz® if trough concentrations of tacrolimus and plasma creatinine levels are closely monitored. The conversion brought savings, despite costs for extra monitoring. PMID:24944783

A Study of Shrinkage Stress Reduction and Mechanical Properties of Nanogel-Modified Resin Systems

PubMed Central

Liu, JianCheng; Howard, Gregory D.; Lewis, Steven H.; Barros, Matthew D.; Stansbury, Jeffrey W.

2012-01-01

A series of nanogel compositions were prepared from urethane dimethacrylate (UDMA) and isobornyl methacrylate (IBMA) in the presence of a thiol chain transfer agent. The linear oligomer of IBMA was synthesized by a similar solution polymerization technique. The nanogels were prepared with different crosslinker concentrations to achieve varied branching densities and molecular weights. The prepolymers were dispersed in triethylene glycol dimethacrylate at loading levels ranging from 10 wt% to 50 wt%. Photopolymerization reaction kinetics of all prepolymer modified systems were enhanced relative to the nanogel-free control during early stage polymerization while limiting conversion was similar for most samples. Volumetric polymerization shrinkage was reduced proportionally with the prepolymer content while the corresponding decrease in polymerization stress was potentially greater than an additive linear behavior. Flexural strength for inert linear polymer-modified systems decreased significantly with the increase in the prepolymer content; however, with an increase in the crosslinker concentration within the nanogel additives, and an increase in the concentration of residual pendant reactive sites, flexural strength was maintained or improved regardless of the nanogel loading level. This demonstrates that covalent attachment rather than just physical entanglement with the polymer matrix is important for effective polymer mechanical reinforcement by nanogel additives. Reactive nanogel additives can be considered as a practical, generic means to achieve substantial reductions in polymerization shrinkage and shrinkage stress in common polymers. PMID:23109731

Communication: An efficient approach to compute state-specific nuclear gradients for a generic state-averaged multi-configuration self consistent field wavefunction.

PubMed

Granovsky, Alexander A

2015-12-21

We present a new, very efficient semi-numerical approach for the computation of state-specific nuclear gradients of a generic state-averaged multi-configuration self consistent field wavefunction. Our approach eliminates the costly coupled-perturbed multi-configuration Hartree-Fock step as well as the associated integral transformation stage. The details of the implementation within the Firefly quantum chemistry package are discussed and several sample applications are given. The new approach is routinely applicable to geometry optimization of molecular systems with 1000+ basis functions using a standalone multi-core workstation.

Communication: An efficient approach to compute state-specific nuclear gradients for a generic state-averaged multi-configuration self consistent field wavefunction

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

Granovsky, Alexander A., E-mail: alex.granovsky@gmail.com

We present a new, very efficient semi-numerical approach for the computation of state-specific nuclear gradients of a generic state-averaged multi-configuration self consistent field wavefunction. Our approach eliminates the costly coupled-perturbed multi-configuration Hartree-Fock step as well as the associated integral transformation stage. The details of the implementation within the Firefly quantum chemistry package are discussed and several sample applications are given. The new approach is routinely applicable to geometry optimization of molecular systems with 1000+ basis functions using a standalone multi-core workstation.

Development of performance matrix for generic product equivalence of acyclovir topical creams.

PubMed

Krishnaiah, Yellela S R; Xu, Xiaoming; Rahman, Ziyaur; Yang, Yang; Katragadda, Usha; Lionberger, Robert; Peters, John R; Uhl, Kathleen; Khan, Mansoor A

2014-11-20

The effect of process variability on physicochemical characteristics and in vitro performance of qualitatively (Q1) and quantitatively (Q2) equivalent generic acyclovir topical dermatological creams was investigated to develop a matrix of standards for determining their in vitro bioequivalence with reference listed drug (RLD) product (Zovirax®). A fractional factorial design of experiment (DOE) with triplicate center point was used to create 11 acyclovir cream formulations with manufacturing variables such as pH of aqueous phase, emulsification time, homogenization speed, and emulsification temperature. Three more formulations (F-12-F-14) with drug particle size representing RLD were also prepared where the pH of the final product was adjusted. The formulations were subjected to physicochemical characterization (drug particle size, spreadability, viscosity, pH, and drug concentration in aqueous phase) and in vitro drug release studies against RLD. The results demonstrated that DOE formulations were structurally and functionally (e.g., drug release) similar (Q3) to RLD. Moreover, in vitro drug permeation studies showed that extent of drug bioavailability/retention in human epidermis from F-12-F-14 were similar to RLD, although differed in rate of permeation. The results suggested generic acyclovir creams can be manufactured to obtain identical performance as that of RLD with Q1/Q2/Q3. Published by Elsevier B.V.

Sampling and Analysis Plan for Supplemental Environmental Project: Aquatic Life Surveys

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

Berryhill, Jesse Tobias; Gaukler, Shannon Marie

As part of a settlement agreement for nuclear waste incidents in 2014, several supplemental environment projects (SEPs) were initiated at Los Alamos National Laboratory (LANL or the Laboratory) between the U.S. Department of Energy and the state of New Mexico. One SEP from this agreement consists of performing aquatic life surveys and will be used to assess the applicability of using generic ambient water-quality criteria (AWQC) for aquatic life. AWQC are generic criteria developed by the U.S. Environmental Protection Agency (EPA) to cover a broad range of aquatic species and are not unique to a specific region or state. AWQCmore » are established by a composition of toxicity data, called species sensitivity distributions (SSDs), and are determined by LC50 (lethal concentration of 50% of the organisms studied) acute toxicity experiments for chemicals of interest. It is of interest to determine whether aquatic species inhabiting waters on the Pajarito Plateau are adequately protected using the current generic AWQC. The focus of this study will determine which aquatic species are present in ephemeral, intermittent, and perennial waters within LANL boundaries and from reference waters adjacent to LANL. If the species identified from these waters do not generally represent species used in the SSDs, then SSDs may need to be modified and AWQC may need to be updated. This sampling and analysis plan details the sampling methodology, surveillance locations, temporal scheduling, and analytical approaches that will be used to complete aquatic life surveys. A significant portion of this sampling and analysis plan was formalized by referring to Appendix E: SEP Aquatic Life Surveys DQO (Data Quality Objectives).« less

Single-cell high resolution melting analysis: A novel, generic, pre-implantation genetic diagnosis (PGD) method applied to cystic fibrosis (HRMA CF-PGD).

PubMed

Destouni, A; Poulou, M; Kakourou, G; Vrettou, C; Tzetis, M; Traeger-Synodinos, J; Kitsiou-Tzeli, S

2016-03-01

Institutions offering CF-PGD face the challenge of developing and optimizing single cell genotyping protocols that should cover for the extremely heterogeneous CF mutation spectrum. Here we report the development and successful clinical application of a generic CF-PGD protocol to facilitate direct detection of any CFTR nucleotide variation(s) by HRMA and simultaneous confirmation of diagnosis through haplotype analysis. A multiplex PCR was optimized supporting co-amplification of any CFTR exon-region, along with 6 closely linked STRs. Single cell genotypes were established through HRM analysis following melting of the 2nd round PCR products and were confirmed by STR haplotype analysis of the 1st PCR products. The protocol was validated pre-clinically, by testing 208 single lymphocytes, isolated from whole blood samples from 4 validation family trios. Fifteen PGD cycles were performed and 103 embryos were biopsied. In 15 clinical PGD cycles, genotypes were achieved in 88/93 (94.6%) embryo biopsy samples, of which 57/88 (64.8%) were deemed genetically suitable for embryo transfer. Amplification failed at all loci for 10/103 blastomeres biopsied from poor quality embryos. Six clinical pregnancies were achieved (2 twin, 4 singletons). PGD genotypes were confirmed following conventional amniocentesis or chorionic villus sampling in all achieved pregnancies. The single cell HRMA CF-PGD protocol described herein is a flexible, generic, low cost and robust genotyping method, which facilitates the analysis of any CFTR genotype combination. Single-cell HRMA can be beneficial to other clinical settings, for example the detection of single nucleotide variants in single cells derived from clinical tumor samples. Copyright © 2015 European Cystic Fibrosis Society. Published by Elsevier B.V. All rights reserved.

Publications - GMC 351 | Alaska Division of Geological & Geophysical

Science.gov Websites

DGGS GMC 351 Publication Details Title: Geochemical analysis of Alaska North Slope NPR-A oil samples at Reservoir, and North Slope Borough US Navy South Barrow #12 - Sag River Reservoir Authors: Organic analysis of Alaska North Slope NPR-A oil samples at the Alaska GMC from: Umiat (generic) Nanushuk Reservoir

Gerst and Swanson perform blood draw in Columbus module

NASA Image and Video Library

2014-06-04

Astronaut Alexander Gerst,Expedition 40 flight engineer (background),and Expedition 40 Commander Steve Swanson are photographed performing blood sample collection in the Columbus module as part of HRF Generic Frozen Blood Collection Operations.

Comparison of bioavailability between the most available generic tablet formulation containing artemether and lumefantrine on the Tanzanian market and the innovator's product.

PubMed

Minzi, Omary M S; Marealle, Ignace A; Shekalaghe, Seif; Juma, Omar; Ngaimisi, Eliford; Chemba, Mwajuma; Rutaihwa, Mastidia; Abdulla, Salim; Sasi, Philip

2013-05-30

Existence of anti-malarial generic drugs with low bioavailability marketed on sub-Saharan Africa raises a concern on patients achieving therapeutic concentrations after intake of such products. This work compared bioavailability of one generic tablet formulation with innovator's product. Both were fixed dose combination tablet formulations containing artemether and lumefantrine. The study was conducted in Dar Es Salaam, Tanzania, in which a survey of the most abundant generic containing artemether-lumefantrine tablet formulation was carried out in retail pharmacies. The most widely available generic (Artefan®, Ajanta Pharma Ltd, Maharashtra, India) was sampled for bioavailability comparison with Coartem® (Novartis Pharma, Basel, Switzerland)--the innovator's product. A randomized, two-treatment cross-over study was conducted in 18 healthy Tanzanian black male volunteers. Each volunteer received Artefan® (test) and Coartem® (as reference) formulation separated by 42 days of drug-free washout period. Serial blood samples were collected up to 168 hours after oral administration of a single dose of each treatment. Quantitation of lumefantrine plasma levels was done using HPLC with UV detection. Bioequivalence of the two products was assessed in accordance with the US Food and Drug Authority (FDA) guidelines. The most widely available generic in pharmacies was Artefan® from India. All eighteen enrolled volunteers completed the study and both test and reference tablet formulations were well tolerated. It was possible to quantify lumefantrine alone, therefore, the pharmacokinetic parameters reported herein are for lumefantrine. The geometric mean ratios for Cmax, AUC0-t and AUC0-∞ were 84% in all cases and within FDA recommended bioequivalence limits of 80%-125%, but the 90% confidence intervals were outside FDA recommended limits (CI 49-143%, 53-137%, 52-135% respectively). There were no statistical significant differences between the two formulations with regard to PK parameters (P > 0.05). Although the ratios of AUCs and Cmax were within the acceptable FDA range, bioequivalence between Artefan® and Coartem® tablet formulations was not demonstrated due to failure to comply with the FDA 90% confidence interval criteria. Based on the observed total drug exposure (AUCs), Artefan® is likely to produce a similar therapeutic response as Coartem®.

Selective Transfer Machine for Personalized Facial Expression Analysis

PubMed Central

Chu, Wen-Sheng; De la Torre, Fernando; Cohn, Jeffrey F.

2017-01-01

Automatic facial action unit (AU) and expression detection from videos is a long-standing problem. The problem is challenging in part because classifiers must generalize to previously unknown subjects that differ markedly in behavior and facial morphology (e.g., heavy versus delicate brows, smooth versus deeply etched wrinkles) from those on which the classifiers are trained. While some progress has been achieved through improvements in choices of features and classifiers, the challenge occasioned by individual differences among people remains. Person-specific classifiers would be a possible solution but for a paucity of training data. Sufficient training data for person-specific classifiers typically is unavailable. This paper addresses the problem of how to personalize a generic classifier without additional labels from the test subject. We propose a transductive learning method, which we refer as a Selective Transfer Machine (STM), to personalize a generic classifier by attenuating person-specific mismatches. STM achieves this effect by simultaneously learning a classifier and re-weighting the training samples that are most relevant to the test subject. We compared STM to both generic classifiers and cross-domain learning methods on four benchmarks: CK+ [44], GEMEP-FERA [67], RU-FACS [4] and GFT [57]. STM outperformed generic classifiers in all. PMID:28113267

Psychometric properties of the self-report Malay version of the Pediatric Quality of Life (PedsQLTM) 4.0 Generic Core Scales among multiethnic Malaysian adolescents.

PubMed

Ainuddin, Husna A; Loh, Siew Yim; Chinna, Karuthan; Low, Wah Yun; Roslani, April Camilla

2015-06-01

Adolescence is the potential period for growth and optimal functioning, but developmental issues like time of transition from childhood to adulthood will create stress and affect the adolescent's quality of life (QOL). However, there is a lack of research tool for measuring adolescent's QOL in Malaysia. The aim of the study was to determine the validity and reliability of the self-report Malay version of the pediatric QOL (PedsQL™) 4.0 Generic Core Scales in assessing the QOL of Malaysian adolescents. A cross-sectional study design using the 23-item self-report Malay version of the PedsQL 4.0 Generic Core Scales was administered on a convenient cluster sampling (n = 297 adolescent) from a secondary school. The internal consistency reliability had Cronbach's α values ranging from .70 to .89. Factor analysis reported a six-factor structure via principal axis factor analysis. In conclusion, the self-report Malay version of the pediatric QOL 4.0 Generic Core Scales is a reliable and valid tool to measure the QOL of multiethnic Malaysian adolescents. © The Author(s) 2013.

Summary Report of Cable Aging and Performance Data for Fiscal Year 2014.

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

Celina, Mathias C.; Celina, Mathias C.; Redline, Erica Marie

2014-09-01

As part of the Light Water Reactor Sustainability Program, science - based engineering approaches were employed to address cable degradation behavior under a range of exposure environments. Experiments were conducted with the goal to provide best guidance for aged material states, remaining life and expected performance under specific conditions for a range of cable materials. Generic engineering tests , which focus on rapid accelerated aging and tensile elongation , were combined with complementar y methods from polymer degradation science. Sandia's approach, building on previous years' efforts, enabled the generation of some of the necessary data supporting the development of improvedmore » lifetime predictions models, which incorporate known material b ehaviors and feedback from field - returned 'aged' cable materials. Oxidation rate measurements have provided access to material behavior under low dose rate thermal conditions, where slow degradation is not apparent in mechanical property changes. Such da ta have shown aging kinetics consistent with established radiati on - thermal degradation models. ACKNOWLEDGEMENTS We gratefully acknowledge ongoing technical support at the LICA facility and extensive sample handling provided by Maryla Wasiolek and Don Hans on. Sam Durbin and Patrick Mattie are recognized for valuable guidance throughout the year and assistance in the preparation of the final report. Doug Brunson is appreciated for sample analysis, compilation and plotting of experimental data.« less

Evaluation of the clinical and economic impact of a brand name-to-generic warfarin sodium conversion program.

PubMed

Witt, Daniel M; Tillman, Donald J; Evans, Christy M; Plotkin, Tatyana V; Sadler, Melanie A

2003-03-01

Substitution of generic warfarin initially was discouraged because of concerns regarding therapeutic failure or toxicity. Although subsequent research with AB-rated (i.e., bioequivalent) warfarin did not confirm initial concerns, the issue is not settled for all clinicians. We sought to provide additional information regarding the clinical and economic impact of warfarin conversion by analyzing a real-life sample of patients receiving long-term anticoagulation therapy who were switched from brand name to generic warfarin. Patients who had been taking warfarin for at least 180 days and had received uninterrupted oral anticoagulation 90 days before and 90 days after switching to generic warfarin were included. The switch date was based on the first time generic warfarin was dispensed from our pharmacies. The primary end point was the calculated amount of time each patient's international normalized ratio (INR) values were within the patient-specific target INR range in the 90 days before and after the switch. Data regarding adverse events and medical resource utilization were also collected. Pharmacoeconomic analyses were performed. The analysis included 2299 patients. The overall difference in calculated time INR values were below (22.6% before vs 26.1% after switch, p<0.0001) and within (65.9% before vs 63.3% after switch, p=0.0002) the therapeutic INR range was statistically but not clinically significant. Only 28.0% of patients experienced a change in therapeutic INR control of 10% or less, 33.1% experienced INR control that improved by greater than 10%, and 38.9% experienced INR control that worsened by more than 10%. The difference in total treatment costs associated with brand name and generic warfarin was 3128 dollars/100 patient-years in favor of the generic product. Sensitivity analyses revealed that cost savings associated with warfarin conversion in this health care system were highly dependent on the difference between warfarin costs and cost of treating anticoagulation-related adverse events. Most of these patients were successfully switched from brand name to generic warfarin. However, supplemental INR monitoring is warranted when one warfarin product is substituted for another to allow timely detection of those patients who experience significant changes in anticoagulation response.

Brand-to-generic levetiracetam switch in patients with epilepsy in a routine clinical setting.

PubMed

Markoula, Sofia; Chatzistefanidis, Dimitrios; Gatzonis, Stylianos; Siatouni, Anna; Siarava, Eleftheria; Verentzioti, Anastasia; Kyritsis, Athanassios P; Patsalos, Philip N

2017-05-01

The therapeutic equivalence of generic and brand antiepileptic drugs, based on studies performed on healthy volunteers, has been questioned. We compare, in a routine clinical setting, brand versus generic levetiracetam (LEV) bioequivalence in patients with epilepsy and also the clinical efficacy and tolerability of the substitution. A prospective, open-label, non-randomized, steady-state, multiple-dose, bioequivalence study was conducted in 12 patients with epilepsy (5 females), with a mean age of 38.4±16.2 years. Patients treated with the brand LEV (Keppra; UCB Pharma) were closely followed for a four-week period and subsequently switched to a generic LEV (Pharmaten) and followed for another four-week period. Blood samples were collected at the end of each 4-week period, during a dose interval for each formulation, for LEV concentration measurements by liquid chromatography mass spectrometry. Steady-state area under the curve (AUC) and peak plasma concentration (Cmax) data were subjected to conventional average bioequivalence analysis. Secondary clinical outcomes, including seizure frequency and adverse events, were recorded. Patients had epilepsy for a mean period of 14.1±10.6years and the mean daily LEV dose was 2583.3±763.7mg. The mean AUC±SD and Cmax±SD was 288.4±86.3(mg/L)h and 37.8±10.4mg/L respectively for brand LEV and 319.2±104.7(mg/L)h and 41.6±12.3mg/L respectively for the generic LEV. Statistic analysis showed no statistical significant difference in bioequivalence. Also, no change in seizures frequency and/or adverse events was recorded. In our clinical setting, generic LEV was determined to be bioequivalent to brand LEV. Furthermore, seizures frequency or/and adverse events were not affected upon switching from brand to generic LEV. Copyright © 2017 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.

Steady State Bioequivalence of Generic and Innovator Formulations of Stavudine, Lamivudine, and Nevirapine in HIV-Infected Ugandan Adults

PubMed Central

Byakika-Tusiime, Jayne; Chinn, Leslie W.; Oyugi, Jessica H.; Obua, Celestino; Bangsberg, David R.; Kroetz, Deanna L.

2008-01-01

Background Generic antiretroviral therapy is the mainstay of HIV treatment in resource-limited settings, yet there is little evidence confirming the bioequivalence of generic and brand name formulations. We compared the steady-state pharmacokinetics of lamivudine, stavudine and nevirapine in HIV-infected subjects who were receiving a generic formulation (Triomune®) or the corresponding brand formulations (Epivir®, Zerit®, and Viramune®). Methodology/Principal Findings An open-label, randomized, crossover study was carried out in 18 HIV-infected Ugandan subjects stabilized on Triomune-40. Subjects received lamivudine (150 mg), stavudine (40 mg), and nevirapine (200 mg) in either the generic or brand formulation twice a day for 30 days, before switching to the other formulation. At the end of each treatment period, blood samples were collected over 12 h for pharmacokinetic analysis. The main outcome measures were the mean AUC0–12h and Cmax. Bioequivalence was defined as a geometric mean ratio between the generic and brand name within the 90% confidence interval of 0.8–1.25. The geometric mean ratios and the 90% confidence intervals were: stavudine Cmax, 1.3 (0.99–1.71) and AUC0–12h, 1.1 (0.87–1.38); lamivudine Cmax, 0.8 (0.63–0.98) and AUC0–12h, 0.8 (0.65–0.99); and nevirapine Cmax, 1.1 (0.95–1.23) and AUC0–12h, 1.1 (0.95–1.31). The generic formulation was not statistically bioequivalent to the brand formulations during steady state, although exposures were comparable. A mixed random effects model identified about 50% intersubject variability in the pharmacokinetic parameters. Conclusions/Significant Findings These findings provide support for the use of Triomune in resource-limited settings, although identification of the sources of intersubject variability in these populations is critical. PMID:19096711

Generic entry, reformulations and promotion of SSRIs in the US.

PubMed

Huskamp, Haiden A; Donohue, Julie M; Koss, Catherine; Berndt, Ernst R; Frank, Richard G

2008-01-01

Previous research has shown that a manufacturer's promotional strategy for a brand name drug is typically affected by generic entry. However, little is known about how newer strategies to extend patent life, including product reformulation introduction or obtaining approval to market for additional clinical indications, influence promotion. To examine the relationships among promotional expenditures, generic entry, reformulation entry and new indication approval. We used quarterly data on national product-level promotional spending (including expenditures for physician detailing and direct-to-consumer advertising [DTCA], and the retail value of free samples distributed in physician offices) for selective serotonin reuptake inhibitors (SSRIs) over the period 1997-2004. We estimated econometric models of detailing, DTCA and total quarterly promotional expenditures as a function of the timing of generic entry, entry of new product formulations and US FDA approval for new clinical indications for existing medications in the SSRI class. Expenditures by pharmaceutical manufacturers for promotion of antidepressant medications was the main outcome measure. Over the period 1997-2004, there was considerable variation in the composition of promotional expenditures across the SSRIs. Promotional expenditures for the original brand molecule decreased dramatically when a reformulation of the molecule was introduced. Promotional spending (both total and detailing alone) for a specific molecule was generally lower after generic entry than before, although the effect of generic entry on promotional spending appears to be closely linked with the choice of product reformulation strategy pursued by the manufacturer. Detailing expenditures for Paxil were increased after the manufacturer received FDA approval to market the drug for generalized anxiety disorder (GAD), while the likelihood of DTCA outlays for the drug was not changed. In contrast, FDA approval to market Paxil and Zoloft for social anxiety disorder (SAD) did not affect the manufacturers' detailing expenditures but did result in a greater likelihood of DTCA outlays. The introduction of new product formulations appears to be a common strategy for attempting to extend market exclusivity for medications facing impending generic entry. Manufacturers who introduced a reformulation before generic entry shifted most promotion dollars from the original brand to the reformulation long before generic entry, and in some cases manufacturers appeared to target a particular promotion type for a given indication. Given the significant impact that pharmaceutical promotion has on demand for prescription drugs in the US, these findings have important implications for prescription drug spending and public health.

Physical and chemical stability of reconstituted and diluted dexrazoxane infusion solutions.

PubMed

Zhang, Yan-Ping; Myers, Alan L; Trinh, Van A; Kawedia, Jitesh D; Kramer, Mark A; Benjamin, Robert S; Tran, Hai T

2014-02-01

Dexrazoxane is used clinically to prevent anthracycline-associated cardiotoxicity. Hydrolysis of dexrazoxane prior to reaching the cardiac membranes severely hampers its mode of action; therefore, degradation during the preparation and administration of intravenous dexrazoxane admixtures demands special attention. Moreover, the ongoing national shortage of one dexrazoxane formulation in the United States has forced pharmacies to dispense other commercially available dexrazoxane products. However, the manufacturers' limited stability data restrict the flexibility of dexrazoxane usage in clinical practice. The aims of this study are to determine the physical and chemical stability of reconstituted and diluted solutions of two commercially available dexrazoxane formulations. The stability of two dexrazoxane products, brand and generic name, in reconstituted and intravenous solutions stored at room temperature without light protection in polyvinyl chloride bags was determined. The concentrations of dexrazoxane were measured at predetermined time points up to 24 h using a validated reversed phase high-performance liquid chromatography with ultraviolet detection assay. Brand (B-) and generic (G-) dexrazoxane products, reconstituted in either sterile water or 0.167 M sodium lactate (final concentration of 10 mg/mL), were found stable for at least to 8 h. Infusion solutions of B-dexrazoxane, prepared according to each manufacturer's directions, were stable for at least 24 h and 8 h at 1 mg/mL and 3 mg/mL, respectively. Infusion solutions of G-dexrazoxane, prepared in either 5% dextrose or 0.9% sodium chloride following the manufacturer's guidelines, were also stable for at least 24 h and 8 h at 1 mg/mL and 3 mg/mL, respectively. All tested solutions were found physically stable up to 24 h at room temperature. The stability of dexrazoxane infusion solutions reported herein permits advance preparation of dexrazoxane intravenous admixtures, facilitating pharmacy workflow and clinical operations. However, due to the potential risks of fluid overload when these intravenous solutions are administered to patients, caution is advised to ensure patient safety.

Long-term stability of acyclovir in 0.9% NaCl infusion polyolefin bags at 5±3°C after freeze-thaw treatment: a generic product versus the brand name.

PubMed

Dewulf, J; Galanti, L; Godet, M; Gillet, P; Jamart, J; Hecq, J-D

2015-03-01

The aim of the study was to investigate the long-term stability of acyclovir 5 mg/mL (a generic product versus the brand name) in NaCl 0.9% after storage at 5±3°C and to evaluate the influence of initial freezing and microwave thawing on this stability. Five bags of Acyclovir® Hospira 5 mg/mL (A) and five bags of Zovirax® GSK 5 mg/mL (B) were prepared under aseptic conditions and stored 3 months at -20°C, then thawed and stored 30 days at 4°C. Five bags of Acyclovir® 5 mg/mL (C) and five bags of Zovirax® 5 mg/mL (D) were also prepared under aseptic conditions and stored 30 days at 5±3°C. Optic density measurement at different wavelengths, pH measurement and optic microscope observations were performed periodically during the storage. A forced degradation test with HCl 12 M and NaOH 5 M before and after heating at 100°C was also performed. The concentrations were measured by HPLC-PDA. The only one forced degradation test that yielded chromatograms with degradation products peak was the test with the acid solution heated at 100°C without interference with the native product. No significant change in pH values or optic densities were seen during the study for both products. No crystals were seen with the optic microscope during the study. Acyclovir® and Zovirax® solutions were stable for at least 21 days according to the FDA recommendations. Moreover, there was no statistical difference between regression lines of those two products and two storage conditions. Under the conditions of this study, Acyclovir® 5 mg/mL in 100 mL of NaCl 0.9% infusion remains stable at least for 21 days at 5±3°C with or without freezing at -20°C during the three previous months. There is no statistical difference between the brand name and a generic product. Acyclovir may be prepared in advanced by a centralized intravenous additive service, frozen in polyolefin bags and microwave thawed before storage under refrigeration until 21 days. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

Consumer choice between common generic and brand medicines in a country with a small generic market.

PubMed

Fraeyman, Jessica; Peeters, Lies; Van Hal, Guido; Beutels, Philippe; De Meyer, Guido R Y; De Loof, Hans

2015-04-01

Generic medicines offer an opportunity for governments to contain pharmaceutical expenditures, since generics are generally 10%-80% lower in price than brand medicines. Belgium has a small generic market that takes up 15% of the total pharmaceutical market in packages sold. To determine the knowledge of consumers about the different available packages of a common over-the-counter medicine (acetaminophen) with regard to price advantage, quality, and effectiveness in a country with a small generic market. We conducted an online survey in the general Flemish population using a questionnaire with 25 statements. The questionnaire also contained 2 informative interventions. First, we showed the price per package and per tablet that the patient would pay in the pharmacy. Second, we provided the respondent with general information about generic medication (equivalence, effectiveness, price, and recognition). Before and after the interventions, we probed for preferences and knowledge about the different packages. Multivariate logistic models were used to examine the independent effects of consumer characteristics on responses to the survey statements. We obtained a sample of 1,636 respondents. The general attitude towards generic medication was positive-only 5% would rather not use a generic. Nevertheless, only 17% of the respondents were able to recognize a generic medicine. Older consumers (aged 60 years and above) were more often confused about the different packages (OR = 2.59, 95% CI = 1.76-3.80, P ≤ 0.001). Consumers without a higher education degree tended to be more doubtful about the difference in effectiveness and quality between the different brands (OR = 0.59, 95% CI = 0.44-0.79, P ≤ 0.001). Consumer recognition of the name of the active substance of acetaminophen was poor. When different brands were displayed, possible price advantage seemed to be an important motive to switch to a cheaper brand. Consumers generally found medicines to be too expensive; however, consumers with medical or paramedical training had a different opinion. Two main recommendations can be made to increase the knowledge and enhance the trust in cheaper equivalent medicines. First, highlighting the name of the active substance on the label of medicine packages can reduce confusion and avoid health risks, especially among older consumers. Second, new investments or reallocation of budgets should be considered in order to provide consumers with authoritative information on the bioequivalence and price differences between the different available brands. This would be a cost-effective and potentially cost-saving investment for health care payers.

Multimodal analysis of pretreated biomass species highlights generic markers of lignocellulose recalcitrance.

PubMed

Herbaut, Mickaël; Zoghlami, Aya; Habrant, Anouck; Falourd, Xavier; Foucat, Loïc; Chabbert, Brigitte; Paës, Gabriel

2018-01-01

Biomass recalcitrance to enzymatic hydrolysis has been assigned to several structural and chemical factors. However, their relative importance remains challenging to evaluate. Three representative biomass species (wheat straw, poplar and miscanthus) were submitted to four standard pretreatments (dilute acid, hot water, ionic liquid and sodium chlorite) in order to generate a set of contrasted samples. A large array of techniques, including wet chemistry analysis, porosity measurements using NMR spectroscopy, electron and fluorescence microscopy, were used in order to determine possible generic factors of biomass recalcitrance. The pretreatment conditions selected allowed obtaining samples displaying different susceptibility to enzymatic hydrolysis (from 3 up to 98% of the initial glucose content released after 96 h of saccharification). Generic correlation coefficients were calculated between the measured chemical and structural features and the final saccharification rates. Increases in porosity displayed overall strong positive correlations with saccharification efficiency, but different porosity ranges were concerned depending on the considered biomass. Lignin-related factors displayed highly negative coefficients for all biomasses. Lignin content, which is likely involved in the correlations observed for porosity, was less detrimental to enzymatic hydrolysis than lignin composition. Lignin influence was highlighted by the strong negative correlation with fluorescence intensity which mainly originates from monolignols in mature tissues. Our results provide a better understanding of the factors responsible for biomass recalcitrance that can reasonably be considered as generic. The correlations with specific porosity ranges are biomass species-dependent, meaning that enzymes cocktails with fitted enzyme size are likely to be needed to optimise saccharification depending on the biomass origin. Lignin composition, which probably influences its structure, is the most important parameter to overcome to enhance enzymes access to the polysaccharides. Accordingly, fluorescence intensity was found to be a rapid and simple method to assess recalcitrance after pretreatment.

Generic and sequence-variant specific molecular assays for the detection of the highly variable Grapevine leafroll-associated virus 3.

PubMed

Chooi, Kar Mun; Cohen, Daniel; Pearson, Michael N

2013-04-01

Grapevine leafroll-associated virus 3 (GLRaV-3) is an economically important virus, which is found in all grapevine growing regions worldwide. Its accurate detection in nursery and field samples is of high importance for certification schemes and disease management programmes. To reduce false negatives that can be caused by sequence variability, a new universal primer pair was designed against a divergent sequence data set, targeting the open reading frame 4 (heat shock protein 70 homologue gene), and optimised for conventional one-step RT-PCR and one-step SYBR Green real-time RT-PCR assays. In addition, primer pairs for the simultaneous detection of specific GLRaV-3 variants from groups 1, 2, 6 (specifically NZ-1) and the outlier NZ2 variant, and the generic detection of variants from groups 1 to 5 were designed and optimised as a conventional one-step multiplex RT-PCR assay using the plant nad5 gene as an internal control (i.e. one-step hexaplex RT-PCR). Results showed that the generic and variant specific assays detected in vitro RNA transcripts from a range of 1×10(1)-1×10(8) copies of amplicon per μl diluted in healthy total RNA from Vitis vinifera cv. Cabernet Sauvignon. Furthermore, the assays were employed effectively to screen 157 germplasm and 159 commercial field samples. Thus results demonstrate that the GLRaV-3 generic and variant-specific assays are prospective tools that will be beneficial for certification schemes and disease management programmes, as well as biological and epidemiological studies of the divergent GLRaV-3 populations. Copyright © 2013 Elsevier B.V. All rights reserved.

Testing of complementarity of PDA and MS detectors using chromatographic fingerprinting of genuine and counterfeit samples containing sildenafil citrate.

PubMed

Custers, Deborah; Krakowska, Barbara; De Beer, Jacques O; Courselle, Patricia; Daszykowski, Michal; Apers, Sandra; Deconinck, Eric

2016-02-01

Counterfeit medicines are a global threat to public health. High amounts enter the European market, which is why characterization of these products is a very important issue. In this study, a high-performance liquid chromatography-photodiode array (HPLC-PDA) and high-performance liquid chromatography-mass spectrometry (HPLC-MS) method were developed for the analysis of genuine Viagra®, generic products of Viagra®, and counterfeit samples in order to obtain different types of fingerprints. These data were included in the chemometric data analysis, aiming to test whether PDA and MS are complementary detection techniques. The MS data comprise both MS1 and MS2 fingerprints; the PDA data consist of fingerprints measured at three different wavelengths, i.e., 254, 270, and 290 nm, and all possible combinations of these wavelengths. First, it was verified if both groups of fingerprints can discriminate between genuine, generic, and counterfeit medicines separately; next, it was studied if the obtained results could be ameliorated by combining both fingerprint types. This data analysis showed that MS1 does not provide suitable classification models since several genuines and generics are classified as counterfeits and vice versa. However, when analyzing the MS1_MS2 data in combination with partial least squares-discriminant analysis (PLS-DA), a perfect discrimination was obtained. When only using data measured at 254 nm, good classification models can be obtained by k nearest neighbors (kNN) and soft independent modelling of class analogy (SIMCA), which might be interesting for the characterization of counterfeit drugs in developing countries. However, in general, the combination of PDA and MS data (254 nm_MS1) is preferred due to less classification errors between the genuines/generics and counterfeits compared to PDA and MS data separately.

Quantification of active pharmaceutical ingredient and impurities in sildenafil citrate obtained from the Internet.

PubMed

Veronin, Michael A; Nutan, Mohammad T; Dodla, Uday Krishna Reddy

2014-10-01

The accessibility of prescription drugs produced outside of the United States, most notably sildenafil citrate (innovator product, Viagra®), has been made much easier by the Internet. Of greatest concern to clinicians and policymakers is product quality and patient safety. The US Food and Drug Administration (FDA) has issued warnings to potential buyers that the safety of drugs purchased from the Internet cannot be guaranteed, and may present a health risk to consumers from substandard products. The objective of this study was to determine whether generic sildenafil citrate tablets from international markets obtained via the Internet are equivalent to the US innovator product regarding major aspects of pharmaceutical quality: potency, accuracy of labeling, and presence and level of impurities. This will help identify aspects of drug quality that may impact public health risks. A total of 15 sildenafil citrate tablets were obtained for pharmaceutical analysis: 14 generic samples from international Internet pharmacy websites and the US innovator product. According to US Pharmacopeial guidelines, tablet samples were tested using high-performance liquid chromatography for potency of active pharmaceutical ingredient (API) and levels of impurities (impurities A, B, C, and D). Impurity levels were compared with International Conference on Harmonisation (ICH) limits. Among the 15 samples, 4 samples possessed higher impurity B levels than the ICH qualification threshold, 8 samples possessed higher impurity C levels than the ICH qualification threshold, and 4 samples possessed more than 1% impurity quantity of maximum daily dose (MDD). For API, 6 of the samples failed to fall within the 5% assay limit. Quality assurance tests are often used to detect formulation defects of drug products during the manufacturing and/or storage process. Results suggest that manufacturing standards for sildenafil citrate generic drug products compared with the US innovator product are not equivalent with regards to potency and levels of impurities. These findings have implications for safety and effectiveness that should be addressed by clinicians to safeguard consumers who choose to purchase sildenafil citrate and foreign-manufactured drugs, in general, via the Internet.

Quantification of active pharmaceutical ingredient and impurities in sildenafil citrate obtained from the Internet

PubMed Central

Nutan, Mohammad T.; Dodla, Uday Krishna Reddy

2014-01-01

Background: The accessibility of prescription drugs produced outside of the United States, most notably sildenafil citrate (innovator product, Viagra®), has been made much easier by the Internet. Of greatest concern to clinicians and policymakers is product quality and patient safety. The US Food and Drug Administration (FDA) has issued warnings to potential buyers that the safety of drugs purchased from the Internet cannot be guaranteed, and may present a health risk to consumers from substandard products. Objective: The objective of this study was to determine whether generic sildenafil citrate tablets from international markets obtained via the Internet are equivalent to the US innovator product regarding major aspects of pharmaceutical quality: potency, accuracy of labeling, and presence and level of impurities. This will help identify aspects of drug quality that may impact public health risks. Methods: A total of 15 sildenafil citrate tablets were obtained for pharmaceutical analysis: 14 generic samples from international Internet pharmacy websites and the US innovator product. According to US Pharmacopeial guidelines, tablet samples were tested using high-performance liquid chromatography for potency of active pharmaceutical ingredient (API) and levels of impurities (impurities A, B, C, and D). Impurity levels were compared with International Conference on Harmonisation (ICH) limits. Results: Among the 15 samples, 4 samples possessed higher impurity B levels than the ICH qualification threshold, 8 samples possessed higher impurity C levels than the ICH qualification threshold, and 4 samples possessed more than 1% impurity quantity of maximum daily dose (MDD). For API, 6 of the samples failed to fall within the 5% assay limit. Conclusions: Quality assurance tests are often used to detect formulation defects of drug products during the manufacturing and/or storage process. Results suggest that manufacturing standards for sildenafil citrate generic drug products compared with the US innovator product are not equivalent with regards to potency and levels of impurities. These findings have implications for safety and effectiveness that should be addressed by clinicians to safeguard consumers who choose to purchase sildenafil citrate and foreign-manufactured drugs, in general, via the Internet. PMID:25360239

Solid-state characterization and impurities determination of fluconazol generic products marketed in Morocco

PubMed Central

Bourichi, Houda; Brik, Youness; Hubert, Philipe; Cherrah, Yahia; Bouklouze, Abdelaziz

2012-01-01

In this paper, we report the results of quality control based in physicochemical characterization and impurities determination of three samples of fluconazole drug substances marketed in Morocco. These samples were supplied by different pharmaceuticals companies. The sample A, as the discovered product, was supplied by Pfizer, while samples B and C (generics), were manufactured by two different Indian industries. Solid-state characterization of the three samples was realized with different physicochemical methods as: X-ray powder diffraction, Fourier-transformation infrared spectroscopy, differential scanning calorimetry. High performance liquid chromatography was used to quantify the impurities in the different samples. The results from the physicochemical methods cited above, showed difference in polymorph structure of the three drug substances. Sample A consisted in pure polymorph III, sample B consisted in pure polymorph II, sample C consisted in a mixture of fluconazole Form III, form II and the monohydrate. This result was confirmed by differential scanning calorimetry. Also it was demonstrated that solvents used during the re-crystallization step were among the origins of these differences in the structure form. On the other hand, the result of the stability study under humidity and temperature showed that fluconazole polymorphic transformation could be owed to the no compliance with the conditions of storage. The HPLC analysis of these compounds showed the presence of specific impurities for each polymorphic form, and a possible relationship could be exist between impurities and crystalline form of fluconazole. PMID:29403776

Seeking to understand: using generic qualitative research to explore access to medicines and pharmacy services among resettled refugees.

PubMed

Bellamy, Kim; Ostini, Remo; Martini, Nataly; Kairuz, Therese

2016-06-01

Introduction There are challenges associated with selecting a qualitative research approach. In a field abundant with terminology and theories, it may be difficult for a pharmacist to know where and how to begin a qualitative research journey. The purpose of this paper is to provide insight into generic qualitative research and to describe the journey of data collection of a novice qualitative researcher in the quest to answer her research question: 'What are the barriers to accessing medicines and pharmacy services for resettled refugees in Queensland, Australia?' Methodology Generic qualitative research draws on the strengths of one or more qualitative approaches. The aim is to draw out participants' ideas about things that are 'outside themselves'; rather than focussing on their inner feelings the research seeks to understand a phenomenon, a process, or the perspectives of participants. Sampling is designed to obtain a broad range of opinions about events and experiences and data collection includes interviews, questionnaires or surveys; thematic analysis is often used to analyse data. When to use Generic qualitative research provides an opportunity to develop research designs that fit researchers' epistemological stance and discipline, with research choices, including methodology and methods, being informed by the research question. Limitations Generic qualitative research is one of many methodologies that may be used to answer a research question and there is a paucity of literature about how to do it well. There is also debate about its validity as a qualitative methodology.

Infused chemotherapy use in the elderly after patent expiration.

PubMed

Conti, Rena M; Rosenthal, Meredith B; Polite, Blase N; Bach, Peter B; Shih, Ya-Chen Tina

2012-05-01

The use of anticancer drugs (chemotherapies) is an important determinant of national spending trends. Recent policies have aimed to accelerate generic entry among chemotherapies to generate cost savings. We examined the effects of generic entry on the choice of chemotherapy for the treatment of metastatic colorectal cancer (MCRC) between 2006 and 2009 using autoregressive-moving average modeling with case control. A nationally representative sample of oncologists and patients with cancer (age ≥ 65 years) was employed to estimate the magnitude and significance of the impact of the generic entry of irinotecan in February 2008 on the number of administrations of irinotecan compared with oxaliplatin. The generic entry of irinotecan resulted in a 17% to 19% decrease (P < .001) in use among elderly patients with MCRC compared with oxaliplatin. The results were robust to multiple sensitivity checks. This study provides novel and robust estimates of the decline in use of a chemotherapy to treat a common cancer in the elderly after patent expiration. The results suggest estimates from a previous Office of the Inspector General report of the potential savings derived from the generic entry of irinotecan for public payers are an overestimate, likely confounded by oncologists' response to financial incentives, changes in scientific evidence, and promotional activities. As calls for improving the quality and cost efficiency of oncology increase, future empirical work is needed to examine the responsiveness of oncologists' treatment decision making to incentives among patients of all ages and insurance types.

Infused chemotherapy use in the elderly after patent expiration.

PubMed

Conti, Rena M; Rosenthal, Meredith B; Polite, Blase N; Bach, Peter B; Shih, Ya-Chen Tina

2012-05-01

The use of anticancer drugs (chemotherapies) is an important determinant of national spending trends. Recent policies have aimed to accelerate generic entry among chemotherapies to generate cost savings. We examined the effects of generic entry on the choice of chemotherapy for the treatment of metastatic colorectal cancer (MCRC) between 2006 and 2009 using autoregressivemoving average modeling with case control. A nationally representative sample of oncologists and patients with cancer (aged ≥65 years) was employed to estimate the magnitude and significance of the impact of the generic entry of irinotecan in February 2008 on the number of administrations of irinotecan compared with oxaliplatin. The generic entry of irinotecan resulted in a 17% to 19% decrease (P <.001) in use among elderly patients with MCRC compared with oxaliplatin. The results were robust to multiple sensitivity checks. This study provides novel and robust estimates of the decline in use of a chemotherapy to treat a common cancer in the elderly after patent expiration. The results suggest estimates from a previous Office of the Inspector General report of the potential savings derived from the generic entry of irinotecan for public payers are an overestimate, likely confounded by oncologists' response to financial incentives, changes in scientific evidence, and promotional activities. As calls for improving the quality and cost efficiency of oncology increase, future empirical work is needed to examine the responsiveness of oncologists' treatment decision making to incentives among patients of all ages and insurance types.

The Effects of Text Message Content on the Use of an Internet-Based Physical Activity Intervention in Hong Kong Chinese Adolescents.

PubMed

Lau, Erica Y; Lau, Patrick W C; Cai, Bo; Archer, Edward

2015-01-01

This study examined the effects of text message content (generic vs. culturally tailored) on the login rate of an Internet physical activity program in Hong Kong Chinese adolescent school children. A convenience sample of 252 Hong Kong secondary school adolescents (51% female, 49% male; M age = 13.17 years, SD = 1.28 years) were assigned to one of 3 treatments for 8 weeks. The control group consisted of an Internet physical activity program. The Internet plus generic text message group consisted of the same Internet physical activity program and included daily generic text messages. The Internet plus culturally tailored text message group consisted of the Internet physical activity program and included daily culturally tailored text messages. Zero-inflated Poisson mixed models showed that the overall effect of the treatment group on the login rates varied significantly across individuals. The login rates over time were significantly higher in the Internet plus culturally tailored text message group than the control group (β = 46.06, 95% CI 13.60, 156.02; p = .002) and the Internet plus generic text message group (β = 15.80, 95% CI 4.81, 51.9; p = .021) after adjusting for covariates. These findings suggest that culturally tailored text messages may be more advantageous than generic text messages on improving adolescents' website login rate, but effects varied significantly across individuals. Our results support the inclusion of culturally tailored messaging in future online physical activity interventions.

Quality of phenobarbital solid-dosage forms in the urban community of Nouakchott (Mauritania).

PubMed

Laroche, Marie-Laure; Traore, Hamidou; Merle, Louis; Gaulier, Jean-Michel; Viana, Marylene; Preux, Pierre-Marie

2005-08-01

Epilepsy is a major public-health problem in Africa. The quality of available drugs is a limiting factor for an adequate management. The aim of this study was to describe the proportion of poor-quality phenobarbital (PB) solid-dosage forms and evaluate the factors associated with its quality in Nouakchott (Mauritania). A cross-sectional study was carried out within pharmacies, hospitals, and on the parallel market in March 2003. PB samples were bought by a native person and then assayed by a liquid chromatography method. A package was considered to be of good quality if the active-substance average content was between 85 and 115% of the stated content printed on the packet. Forty-five pharmaceutical stores were visited, enabling us to collect 146 samples of PB. Three brand names were available in Nouakchott. They originated from France, Morocco, Senegal, and Egypt. Results: A prevalence of 13.7%[95% confidence interval (CI), 8.8-20.0] of poor-quality PB was found. All samples from Morocco were underdosed. The generic active content was satisfactory, but saccharose, an excipient with a potential side effects, was identified. Two factors associated with the good quality of PB have been put forward: tablets manufactured in France and loose packaging as generics conditioned in such a way were of good quality. This study shows that the quality of antiepileptic drugs in Africa is still worrying. The setting up of medicine quality control in Mauritania is legitimate. Considering the good quality of generic PB and its lower cost, this type of medicine should be promoted in this region.

Biologically Inspired Synthesis Route to Three-Dimensionally Structured Inorganic Thin Films

DOE PAGES

Schwenzer, Birgit; Morse, Daniel E.

2008-01-01

Inorganic thin films (hydroxide, oxide, and phosphate materials) that are textured on a submicron scale have been prepared from aqueous metal salt solutions at room temperature using vapor-diffusion catalysis. This generic synthesis approach mimics the essential advantages of the catalytic and structure-directing mechanisms observed for the formation of silica skeletons of marine sponges. Chemical composition, crystallinity, and the three-dimensional morphology of films prepared by this method are extremely sensitive to changes in the synthesis conditions, such as concentrations, reaction times, and the presence and nature of substrate materials. Focusing on different materials systems, the reaction mechanism for the formation ofmore » these thin films and the influence of different reaction parameters on the product are explained.« less

A highly sensitive monoclonal antibody based biosensor for quantifying 3-5 ring polycyclic aromatic hydrocarbons (PAHs) in aqueous environmental samples

PubMed Central

Li, Xin; Kaattari, Stephen L.; Vogelbein, Mary A.; Vadas, George G.; Unger, Michael A.

2016-01-01

Immunoassays based on monoclonal antibodies (mAbs) are highly sensitive for the detection of polycyclic aromatic hydrocarbons (PAHs) and can be employed to determine concentrations in near real-time. A sensitive generic mAb against PAHs, named as 2G8, was developed by a three-step screening procedure. It exhibited nearly uniformly high sensitivity against 3-ring to 5-ring unsubstituted PAHs and their common environmental methylated PAHs, with IC50 values between 1.68–31 μg/L (ppb). 2G8 has been successfully applied on the KinExA Inline Biosensor system for quantifying 3-5 ring PAHs in aqueous environmental samples. PAHs were detected at a concentration as low as 0.2 μg/L. Furthermore, the analyses only required 10 min for each sample. To evaluate the accuracy of the 2G8-based biosensor, the total PAH concentrations in a series of environmental samples analyzed by biosensor and GC-MS were compared. In most cases, the results yielded a good correlation between methods. This indicates that generic antibody 2G8 based biosensor possesses significant promise for a low cost, rapid method for PAH determination in aqueous samples. PMID:26925369

STORMWATER FILTRATION USING MULCH AND JUTE

EPA Science Inventory

This study evaluated the feasibility of using readily available, low-cost natural filter naterials for stormwater (SW) treatment. Generic (hardwood) mulch and processed jute fiber were evaluated for the removal of metallic and organic pollutants from urban SW runoff samples colle...

A generic nuclei detection method for histopathological breast images

NASA Astrophysics Data System (ADS)

Kost, Henning; Homeyer, André; Bult, Peter; Balkenhol, Maschenka C. A.; van der Laak, Jeroen A. W. M.; Hahn, Horst K.

2016-03-01

The detection of cell nuclei plays a key role in various histopathological image analysis problems. Considering the high variability of its applications, we propose a novel generic and trainable detection approach. Adaption to specific nuclei detection tasks is done by providing training samples. A trainable deconvolution and classification algorithm is used to generate a probability map indicating the presence of a nucleus. The map is processed by an extended watershed segmentation step to identify the nuclei positions. We have tested our method on data sets with different stains and target nuclear types. We obtained F1-measures between 0.83 and 0.93.

A prospective, observational study comparing the PK/PD relationships of generic Meropenem (Mercide®) to the innovator brand in critically ill patients

PubMed Central

Mer, Mervyn; Snyman, Jacques Rene; van Rensburg, Constance Elizabeth Jansen; van Tonder, Jacob John; Laurens, Ilze

2016-01-01

Introduction Clinicians’ skepticism, fueled by evidence of inferiority of some multisource generic antimicrobial products, results in the underutilization of more cost-effective generics, especially in critically ill patients. The aim of this observational study was to demonstrate equivalence between the generic or comparator brand of meropenem (Mercide®) and the leading innovator brand (Meronem®) by means of an ex vivo technique whereby antimicrobial activity is used to estimate plasma concentration of the active moiety. Methods Patients from different high care and intensive care units were recruited for observation when prescribed either of the meropenem brands under investigation. Blood samples were collected over 6 hours after a 30 minute infusion of the different brands. Meropenem concentration curves were established against United States Pharmacopeia standard meropenem (Sigma-Aldrich) by using standard laboratory techniques for culture of Klebsiella pneumoniae. Patients’ plasma samples were tested ex vivo, using a disc diffusion assay, to confirm antimicrobial activity and estimate plasma concentrations of the two brands. Results Both brands of meropenem demonstrated similar curves in donor plasma when concentrations in vials were confirmed. Patient-specific serum concentrations were determined from zones of inhibition against a standard laboratory Klebsiella strain ex vivo, confirming at least similar in vivo concentrations as the concentration curves (90% confidence interval) overlapped; however, the upper limit of the area under the curve for the ratio comparator/innovator exceeded the 1.25-point estimate, i.e., 4% higher for comparator meropenem. Conclusion This observational, in-practice study demonstrates similar ex vivo activity and in vivo plasma concentration time curves for the products under observation. Assay sensitivity is also confirmed. Current registration status of generic small molecules is in place. The products are therefore clinically interchangeable based on registration status as well as bioassay results, demonstrating sufficient overlap for clinical comfort. The slightly higher observed comparator meropenem concentration (4%) is still clinically acceptable due to the large therapeutic index and should ally fears of inferiority. PMID:27895516

Risk Factors for Salmonella, Shiga Toxin-Producing Escherichia coli and Campylobacter Occurrence in Primary Production of Leafy Greens and Strawberries

PubMed Central

Ceuppens, Siele; Johannessen, Gro S.; Allende, Ana; Tondo, Eduardo César; El-Tahan, Fouad; Sampers, Imca; Jacxsens, Liesbeth; Uyttendaele, Mieke

2015-01-01

The microbiological sanitary quality and safety of leafy greens and strawberries were assessed in the primary production in Belgium, Brazil, Egypt, Norway and Spain by enumeration of Escherichia coli and detection of Salmonella, Shiga toxin-producing E. coli (STEC) and Campylobacter. Water samples were more prone to containing pathogens (54 positives out of 950 analyses) than soil (16/1186) and produce on the field (18/977 for leafy greens and 5/402 for strawberries). The prevalence of pathogens also varied markedly according to the sampling region. Flooding of fields increased the risk considerably, with odds ratio (OR) 10.9 for Salmonella and 7.0 for STEC. A significant association between elevated numbers of generic E. coli and detection of pathogens (OR of 2.3 for STEC and 2.7 for Salmonella) was established. Generic E. coli was found to be a suitable index organism for Salmonella and STEC, but to a lesser extent for Campylobacter. Guidelines on frequency of sampling and threshold values for E. coli in irrigation water may differ from region to region. PMID:26295251

Quantification of polychlorinated dibenzo-p-dioxins and dibenzofurans by direct injection of sample extract into the comprehensive multidimensional gas chromatograph/high-resolution time-of-flight mass spectrometer.

PubMed

Shunji, Hashimoto; Yoshikatsu, Takazawa; Akihiro, Fushimi; Hiroyasu, Ito; Kiyoshi, Tanabe; Yasuyuki, Shibata; Masa-aki, Ubukata; Akihiko, Kusai; Kazuo, Tanaka; Hideyuki, Otsuka; Katsunori, Anezaki

2008-01-18

Polychlorinated dibenzo-p-dioxins and dibenzofurans in crude extracts of fly ash and flue gas from municipal waste incinerators were quantified using a comprehensive multidimensional gas chromatograph (GC x GC) coupled to a high-resolution time-of-flight mass spectrometer (HR-TOFMS). For identification and quantification, we developed our own program to prepare 3D chromatograms of selected mass numbers from the data of the GC x GC/HR-TOFMS. Isolation of all congeners with a TCDD toxic equivalency factor from the other isomers by only one injection was confirmed. The instrumental detection limit of TCDD on the GC x GC/HR-TOFMS was 0.9 pg by the relative calibration method. Quantification of these substances in the crude extracts was achieved by direct injection to the GC x GC/HR-TOFMS. The results agree with the values obtained using a generic gas chromatography/high-resolution mass spectrometry (GC/HRMS) system. It was confirmed that measurement by high-resolution TOFMS and GC x GC effectively reduces interference from other chemicals.

An experiment to fly on mission STS-93 is prepared at Life Sciences Building, CCAS

NASA Technical Reports Server (NTRS)

1999-01-01

In the KSC Life Sciences Building, Hangar L, Cape Canaveral Air Station, Mark Rupert, with BioServe Space Technologies, checks the canisters, or incubators, that will hold an experiment to fly on mission STS-93. The incubators will hold a mix of fruit fly embryos and larvae to examine the effects of microgravity and space flight on the development of neural connections between specific motor neurons and their targets in muscle fibers. The incubators are part of a Commercial Generic Bioprocessing Apparatus (CGBA), which can start bioprocessing reactions by mixing or heating a sample and can also initiate multiple-step, sequential reactions in a technique called phased processing. The primary payload of mission STS-93 is the Chandra X-ray Observatory, which will allow scientists from around the world to see previously invisible black holes and high-temperature gas clouds, giving the observatory the potential to rewrite the books on the structure and evolution of our universe. The target launch date for STS-93 is July 9, aboard Space Shuttle Columbia, from Launch Pad 39B.

An experiment to fly on mission STS-93 is prepared at Life Sciences Building, CCAS

NASA Technical Reports Server (NTRS)

1999-01-01

In the KSC Life Sciences Building, Hangar L, Cape Canaveral Air Station, Jake Freeman and Mark Rupert, with BioServe Space Technologies, check canisters, or incubators, that will hold fruit fly embryos and larvae for an experiment to fly on mission STS-93. The experiment will examine the effects of microgravity and space flight on the development of neural connections between specific motor neurons and their targets in muscle fibers. The incubators are part of the Commercial Generic Bioprocessing Apparatus (CGBA), which can start bioprocessing reactions by mixing or heating a sample and can also initiate multiple-step, sequential reactions in a technique called phased processing. The primary payload of mission STS-93 is the Chandra X-ray Observatory, which will allow scientists from around the world to see previously invisible black holes and high-temperature gas clouds, giving the observatory the potential to rewrite the books on the structure and evolution of our universe. The target launch date for STS-93 is July 9, aboard Space Shuttle Columbia, from Launch Pad 39B.

High Resolution Transmission Electron Microscopy (HRTEM) of nanophase ferric oxides

NASA Technical Reports Server (NTRS)

Golden, D. C.; Morris, R. V.; Ming, D. W.; Lauer, H. V., Jr.

1994-01-01

Iron oxide minerals are the prime candidates for Fe(III) signatures in remotely sensed Martian surface spectra. Magnetic, Mossbauer, and reflectance spectroscopy have been carried out in the laboratory in order to understand the mineralogical nature of Martian analog ferric oxide minerals of submicron or nanometer size range. Out of the iron oxide minerals studied, nanometer sized ferric oxides are promising candidates for possible Martian spectral analogs. 'Nanophase ferric oxide (np-Ox)' is a generic term for ferric oxide/oxihydroxide particles having nanoscale (less than 10 nm) particle dimensions. Ferrihydrite, superparamagnetic particles of hematite, maghemite and goethite, and nanometer sized particles of inherently paramagnetic lepidocrocite are all examples of nanophase ferric oxides. np-Ox particles in general do not give X-ray diffraction (XRD) patterns with well defined peaks and would often be classified as X-ray amorphous. Therefore, different np-Oxs preparations should be characterized using a more sensitive technique e.g., high resolution transmission electron microscopy (HRTEM). The purpose of this study is to report the particle size, morphology and crystalline order, of five np-Ox samples by HRTEM imaging and electron diffraction (ED).

Quantum Interferometry

NASA Technical Reports Server (NTRS)

Dowling, Jonathan P.

2000-01-01

Recently, several researchers, including yours truly, have been able to demonstrate theoretically that quantum photon entanglement has the potential to also revolutionize the entire field of optical interferometry, by providing many orders of magnitude improvement in interferometer sensitivity. The quantum entangled photon interferometer approach is very general and applies to many types of interferometers. In particular, without nonlocal entanglement, a generic classical interferometer has a statistical-sampling shot-noise limited sensitivity that scales like 1/Sqrt[N], where N is the number of particles (photons, electrons, atoms, neutrons) passing through the interferometer per unit time. However, if carefully prepared quantum correlations are engineered between the particles, then the interferometer sensitivity improves by a factor of Sqrt[N] (square root of N) to scale like 1/N, which is the limit imposed by the Heisenberg Uncertainty Principle. For optical (laser) interferometers operating at milliwatts of optical power, this quantum sensitivity boost corresponds to an eight-order-of-magnitude improvement of signal to noise. Applications are to tests of General Relativity such as ground and orbiting optical interferometers for gravity wave detection, Laser Interferometer Gravity Observatory (LIGO) and the European Laser Interferometer Space Antenna (LISA), respectively.

Addition of generic medication vouchers to a pharmacist academic detailing program: effects on the generic dispensing ratio in a physician-hospital organization.

PubMed

Bhargava, Vinay; Greg, Mark E; Shields, Mark C

2010-01-01

Generic dispensing ratio (GDR) is an important measure of efficiency in pharmacy benefit management. A few studies have examined the effects of academic detailing or generic drug samples on GDR. On July 1, 2007, a physician-hospital organization (PHO) with a pay-for-performance incentive for generic utilization initiated a pilot generic medication voucher program that augmented its existing pharmacist-led academic detailing efforts. No published studies have examined the role of generic medication vouchers in promoting generic drug utilization. To determine if supplementing an existing academic detailing initiative in a PHO with a generic medication voucher program would be more effective in increasing the GDR compared with academic detailing alone. The intervention took place over the 9-month period from July 1, 2007, through March 31, 2008. Vouchers provided patients with the first fill of a 30-day supply of a generic drug at no cost to the patient for 8 specific generic medications obtained through a national community pharmacy chain. The study was conducted in a PHO composed of 7 hospitals and approximately 2,900 physicians (900 primary care providers [PCPs] and 2,000 specialists). Of the approximately 300 PCP practices, 21 practices with at least 2 physicians each were selected on the basis of high prescription volume (more than 500 pharmacy claims for the practice over a 12-month pre-baseline period) and low GDR (practice GDR less than 55% in the 12-month pre-baseline period). These 21 practices were then randomized to a control group of academic detailing alone or the intervention group that received academic detailing plus generic medication vouchers. One of 10 intervention groups declined to participate, and 2 of 11 control groups dropped out of the PHO. GDR was calculated monthly for all pharmacy claims including the 8 voucher medications. GDR was defined as the ratio of the total number of paid generic pharmacy claims divided by the total number of paid pharmacy claims for 108 prescriber identification numbers (Drug Enforcement Administration [DEA] or National Provider Identifier [NPI]) for 9 intervention groups [n = 53 PCPs] and 9 control groups [n = 55 PCPs]). For both intervention and control arms, the GDR for each month from July 2007 (start of 2007 Q3, intervention start date) through September 2008 (end of 2008 Q3, 6 months after intervention end date) was compared with the same month in the previous year. A descriptive analysis compared a 9-month baseline period from 2006 Q3 through 2007 Q1 with a 9-month voucher period from 2007 Q3 to 2008 Q1. A panel data regression analysis assessed GDR for 18 practices over 27 months (12 months pre-intervention and 15 months post-intervention). A total of 656 vouchers were redeemed over the 9-month voucher period from July 1, 2007, through March 31, 2008, for an average of about 12 vouchers per participating physician; approximately one-third of the redeemed vouchers were for generic simvastatin. The GDR increase for all drugs, including the 8 voucher drugs, was 7.4 points for the 9 PCP group practices with access to generic medication vouchers, from 53.4% in the 9-month baseline period to 60.8% in the 9-month voucher period, compared with a 6.2 point increase for the control group from 55.9% during baseline to 62.1% during the voucher period. The panel data regression model estimated that the medication voucher program was associated with a 1.77-point increase in overall GDR compared with academic detailing alone (P = 0.047). Compared with academic detailing alone, a generic medication voucher program providing a 30-day supply of 8 specific medications in addition to academic detailing in PCP groups with low GDR and high prescribing volume in an outpatient setting was associated with a small but statistically significant increase in adjusted overall GDR.

Place-based social contact and mixing: a typology of generic meeting places of relevance for infectious disease transmission.

PubMed

Strömgren, M; Holm, E; Dahlström, Ö; Ekberg, J; Eriksson, H; Spreco, A; Timpka, T

2017-09-01

This study aims to develop a typology of generic meeting places based on social contact and mixing of relevance for infectious disease transmission. Data were collected by means of a contact diary survey conducted on a representative sample of the Swedish population. The typology is derived from a cluster analysis accounting for four dimensions associated with transmission risk: visit propensity and its characteristics in terms of duration, number of other persons present and likelihood of physical contact. In the analysis, we also study demographic, socio-economic and geographical differences in the propensity of visiting meeting places. The typology identifies the family venue, the fixed activity site, the family vehicle, the trading plaza and the social network hub as generic meeting places. The meeting place typology represents a spatially explicit account of social contact and mixing relevant to infectious disease modelling, where the social context of the outbreak can be highlighted in light of the actual infectious disease.

Comparison of Outcomes Following a Switch From a Brand to an Authorized Versus Independent Generic Drug.

PubMed

Hansen, R A; Qian, J; Berg, R L; Linneman, J G; Seoane-Vazquez, E; Dutcher, S; Raofi, S; Page, C D; Peissig, P L

2018-02-01

Authorized generics are identical in formulation to brand drugs, manufactured by the brand company but marketed as a generic. Generics, marketed by generic manufacturers, are required to demonstrate pharmaceutical and bioequivalence to the brand drug, but repetition of clinical trials is not required. This retrospective cohort study compared outcomes for generics and authorized generics, which serves as a generic vs. brand proxy that minimizes bias against generics. For the seven drugs studied between 1999 and 2014, 5,234 unique patients were on brand drugs prior to generic entry and 4,900 (93.6%) switched to a generic. During the 12 months following the brand-to-generic switch, patients using generics vs. authorized generics were similar in terms of outpatient visits, urgent care visits, hospitalizations, and medication discontinuation. The likelihood of emergency department (ED) visits was slightly higher for authorized generics compared with generics. These data suggest that generics were clinically no worse than their proxy brand comparators. © 2017 American Society for Clinical Pharmacology and Therapeutics.

Synthesis and identification of three-dimensional faces from image(s) and three-dimensional generic models

NASA Astrophysics Data System (ADS)

Liu, Zexi; Cohen, Fernand

2017-11-01

We describe an approach for synthesizing a three-dimensional (3-D) face structure from an image or images of a human face taken at a priori unknown poses using gender and ethnicity specific 3-D generic models. The synthesis process starts with a generic model, which is personalized as images of the person become available using preselected landmark points that are tessellated to form a high-resolution triangular mesh. From a single image, two of the three coordinates of the model are reconstructed in accordance with the given image of the person, while the third coordinate is sampled from the generic model, and the appearance is made in accordance with the image. With multiple images, all coordinates and appearance are reconstructed in accordance with the observed images. This method allows for accurate pose estimation as well as face identification in 3-D rendering of a difficult two-dimensional (2-D) face recognition problem into a much simpler 3-D surface matching problem. The estimation of the unknown pose is achieved using the Levenberg-Marquardt optimization process. Encouraging experimental results are obtained in a controlled environment with high-resolution images under a good illumination condition, as well as for images taken in an uncontrolled environment under arbitrary illumination with low-resolution cameras.

Geometric analysis characterizes molecular rigidity in generic and non-generic protein configurations

PubMed Central

Budday, Dominik; Leyendecker, Sigrid; van den Bedem, Henry

2015-01-01

Proteins operate and interact with partners by dynamically exchanging between functional substates of a conformational ensemble on a rugged free energy landscape. Understanding how these substates are linked by coordinated, collective motions requires exploring a high-dimensional space, which remains a tremendous challenge. While molecular dynamics simulations can provide atomically detailed insight into the dynamics, computational demands to adequately sample conformational ensembles of large biomolecules and their complexes often require tremendous resources. Kinematic models can provide high-level insights into conformational ensembles and molecular rigidity beyond the reach of molecular dynamics by reducing the dimensionality of the search space. Here, we model a protein as a kinematic linkage and present a new geometric method to characterize molecular rigidity from the constraint manifold Q and its tangent space Q at the current configuration q. In contrast to methods based on combinatorial constraint counting, our method is valid for both generic and non-generic, e.g., singular configurations. Importantly, our geometric approach provides an explicit basis for collective motions along floppy modes, resulting in an efficient procedure to probe conformational space. An atomically detailed structural characterization of coordinated, collective motions would allow us to engineer or allosterically modulate biomolecules by selectively stabilizing conformations that enhance or inhibit function with broad implications for human health. PMID:26213417

Geometric analysis characterizes molecular rigidity in generic and non-generic protein configurations

NASA Astrophysics Data System (ADS)

Budday, Dominik; Leyendecker, Sigrid; van den Bedem, Henry

2015-10-01

Proteins operate and interact with partners by dynamically exchanging between functional substates of a conformational ensemble on a rugged free energy landscape. Understanding how these substates are linked by coordinated, collective motions requires exploring a high-dimensional space, which remains a tremendous challenge. While molecular dynamics simulations can provide atomically detailed insight into the dynamics, computational demands to adequately sample conformational ensembles of large biomolecules and their complexes often require tremendous resources. Kinematic models can provide high-level insights into conformational ensembles and molecular rigidity beyond the reach of molecular dynamics by reducing the dimensionality of the search space. Here, we model a protein as a kinematic linkage and present a new geometric method to characterize molecular rigidity from the constraint manifold Q and its tangent space Tq Q at the current configuration q. In contrast to methods based on combinatorial constraint counting, our method is valid for both generic and non-generic, e.g., singular configurations. Importantly, our geometric approach provides an explicit basis for collective motions along floppy modes, resulting in an efficient procedure to probe conformational space. An atomically detailed structural characterization of coordinated, collective motions would allow us to engineer or allosterically modulate biomolecules by selectively stabilizing conformations that enhance or inhibit function with broad implications for human health.

The PedsQL in pediatric cerebral palsy: reliability and validity of the Chinese version pediatric quality of life inventory 4.0 generic core scales and 3.0 cerebral palsy module.

PubMed

Yang, Xue; Xiao, Nong; Yan, Jianying

2011-03-01

This investigation examines the reliability, validity, and sensitivity of the Chinese version Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales and 3.0 cerebral palsy (CP) Module in pediatric CP. The study sample was comprised of 126 parents of children with CP between the ages of 2 and 12 years including 18 child respondents 5-12 years of age. Mean age of the 87 boys (69.0%) and 39 girls (31.0%) was 4 years 1 month (SD 2 years 2 month). Reliability was demonstrated for the PedsQL 4.0 (α = 0.86 child, 0.89 parent) and CP Module (α = 0.91 child, 0.96 parent). The PedsQL 4.0 distinguished between healthy children and children with CP. Construct validity of the CP Module was supported through an analysis of the intercorrelations between the Generic Core Scale scores and the CP Module Scale scores and exploratory factor analysis of PedsQL items. The findings provide support for the measurement properties of the Chinese version PedsQL 4.0 Generic Core Scales and 3.0 CP Module in pediatric CP.

Development of an On-Demand, Generic, Drug-Delivery System

DTIC Science & Technology

1985-08-06

systems Two systems were evaluated for CO2 evolution. The first of these was an enzymatic system based on urea and urease . The second system was based...PHM 84 Research pH Meter was used te monitor pH. Solutions of various buffer concen- trations and pHs were prepared for each buffer system. One urease ...Measurement of carbon dio~ide production was accomplished using the apparatus shown in Figure 2. Carbon dioxide was generated by putting a urease tablet in the

SPHERES Vertigo

NASA Image and Video Library

2014-07-25

ISS040-E-079083 (25 July 2014) --- In the International Space Station?s Kibo laboratory, NASA astronaut Steve Swanson, Expedition 40 commander, enters data in a computer in preparation for a session with a trio of soccer-ball-sized robots known as the Synchronized Position Hold, Engage, Reorient, Experimental Satellites, or SPHERES. The free-flying robots were equipped with stereoscopic goggles called the Visual Estimation and Relative Tracking for Inspection of Generic Objects, or VERTIGO, to enable the SPHERES to perform relative navigation based on a 3D model of a target object.

Doing accelerator physics using SDDS, UNIX, and EPICS

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

Borland, M.; Emery, L.; Sereno, N.

1995-12-31

The use of the SDDS (Self-Describing Data Sets) file protocol, together with the UNIX operating system and EPICS (Experimental Physics and Industrial Controls System), has proved powerful during the commissioning of the APS (Advanced Photon Source) accelerator complex. The SDDS file protocol has permitted a tool-oriented approach to developing applications, wherein generic programs axe written that function as part of multiple applications. While EPICS-specific tools were written for data collection, automated experiment execution, closed-loop control, and so forth, data processing and display axe done with the SDDS Toolkit. Experiments and data reduction axe implemented as UNIX shell scripts that coordinatemore » the execution of EPICS specific tools and SDDS tools. Because of the power and generic nature of the individual tools and of the UNIX shell environment, automated experiments can be prepared and executed rapidly in response to unanticipated needs or new ideas. Examples are given of application of this methodology to beam motion characterization, beam-position-monitor offset measurements, and klystron characterization.« less

The ssWavelets package

Treesearch

Jeffrey H. Gove

2017-01-01

This package adds several classes, generics and associated methods as well as a few various functions to help with wavelet decomposition of sampling surfaces generated using sampSurf. As such, it can be thought of as an extension to sampSurf for wavelet analysis.

New engineering: from knowledge to competences

NASA Astrophysics Data System (ADS)

Cartagena, M. C.; Tarquis, A. M.; Arce, A.

2009-04-01

One of the main innovations of Bologna system has been to link learning outcomes, ECTS workload based credits and competences. Competences represent a dynamic combination of knowledge, understanding, skills and abilities. Competences can be distinguished in subject specific and generic ones (instrumental, interpersonal and systemic competences). Actually in Spain Engineering degrees are changing to the new University educational system and should aim to satisfy the real needs of European society. This change has been long and complex, particularly. on the issue that have influenced curricular change Consultation with "actors" and "stakeholders", the definition of academic and professionals profiles and the translation of these into desired learning outcomes. Generic competences or transferable skills are relevant for preparing students well for their future role in society in terms of employability and citizenship. The criteria used by the companies to select their engineers are based in a good background and capacity to adapt and to acquire new knowledge, better than specific education, even postgraduate. It was interesting to note the great importance of generic competences However, Spanish government has regulated conditions of core curriculum need for to guarantee the acquisition of the competences needs to exercise the correspondent professional activities. The new degrees should comply with the core curriculum if the graduates want maintain the legal attributions guaranteed actually by the Spanish Professional Associations. After these degrees, students can access to professional master with actually horizontal attributions of regulated professions.

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

Rao, N.S.V.

The classical Nadaraya-Watson estimator is shown to solve a generic sensor fusion problem where the underlying sensor error densities are not known but a sample is available. By employing Haar kernels this estimator is shown to yield finite sample guarantees and also to be efficiently computable. Two simulation examples, and a robotics example involving the detection of a door using arrays of ultrasonic and infrared sensors, are presented to illustrate the performance.

Generic Entry, Reformulations, and Promotion of SSRIs

PubMed Central

Donohue, Julie M.; Koss, Catherine; Berndt, Ernst R.; Frank, Richard G.

2009-01-01

Background Previous research has shown that a manufacturer’s promotional strategy for a brand-name drug is typically affected by generic entry. However, little is known about how newer strategies to extend patent life, including product reformulation introduction or obtaining approval to market for additional clinical indications, influence promotion. Objective To examine the relationship between promotional expenditures, generic entry, reformulation entry, and new indication approval. Study Design/Setting We used quarterly data on national product-level promotional spending (including expenditures for physician detailing and direct-to-consumer advertising (DTCA), and the retail value of free samples distributed in physician offices) for selective serotonin reuptake inhibitors (SSRIs) over the period 1997 through 2004. We estimated econometric models of detailing, DTCA, and total quarterly promotional expenditures as a function of the timing of generic entry, entry of new product formulations, and Food and Drug Administration (FDA) approval for new clinical indications for existing medications in the SSRI class. Main Outcome Measure Expenditures by pharmaceutical manufacturers for promotion of antidepressant medications. Results Over the period 1997–2004, there was considerable variation in the composition of promotional expenditures across the SSRIs. Promotional expenditures for the original brand molecule decreased dramatically when a reformulation of the molecule was introduced. Promotional spending (both total and detailing alone) for a specific molecule was generally lower after generic entry than before, although the effect of generic entry on promotional spending appears to be closely linked with the choice of product reformulation strategy pursued by the manufacturer. Detailing expenditures for Paxil were increased after the manufacturer received FDA approval to market the drug for generalized anxiety disorder (GAD), while the likelihood of DTCA outlays for the drug was not changed. In contrast, FDA approval to market Paxil and Zoloft for social anxiety disorder (SAD) did not affect the manufacturers’ detailing expenditures but did result in a greater likelihood of DTCA outlays. Conclusion The introduction of new product formulations appears to be a common strategy for attempting to extend market exclusivity for medications facing impending generic entry. Manufacturers that introduced a reformulation before generic entry shifted most promotion dollars from the original brand to the reformulation long before generic entry, and in some cases manufacturers appeared to target a particular promotion type for a given indication. Given the significant impact pharmaceutical promotion has on demand for prescription drugs, these findings have important implications for prescription drug spending and public health. PMID:18563951

Perception and attitude of general practitioners regarding generic medicines in Karachi, Pakistan: A questionnaire based study

PubMed Central

Jamshed, Shazia Qasim; Ibrahim, Mohamed Izham Mohamed; Hassali, Mohamed Azmi Ahmad; Masood, Imran; Low, Bee Yean; Shafie, Asrul Akmal; Babar, Zaheer-ud-din

2012-01-01

Objectives: In developing countries out-of-pocket payments (OOP) are as high as 80% of healthcare spending. Generic medicines can be instrumental in reducing this expenditure. The current study is aimed to explore the knowledge, perception, and attitude of general practitioners towards generic medicines in Karachi, Pakistan. Methods: This exploratory, descriptive study was conducted on a sample of 289 randomly selected general practitioners who were dispensing at their private clinics in Karachi, Pakistan. The questionnaires were distributed and collected by hand. Data was entered to SPSS version 17. Fischer’s exact test was applied to see the association between variables. Results: A total of 206 questionnaires were included in the study. A response rate of 71.3% was achieved. Out of 206 respondents, 139 (67.5%) were male while 67 (32.5%) respondents were female. Close to three quaters of the respondents (n= 148; 71.8%) showed correct knowledge about generic medicines being a ‘copy of the brand name medicines’ and ‘interchangeable with brand name medicines’ (n= 148; 71.8%). In terms of safety, the majority of respondents (n=85; 41.26%) incorrectly understood that the generic medicines are less safe than brand name medicines. The total percentage of correct responses was seen in 53% of the respondents. More than half of the respondents agreed that locally manufactured medicines are of the same effectiveness as brand name medicines (n=114; 55.4%). Male practitioners with practice experience of 11-15 years showed positive perception towards the quality of multinational products. The Majority of respondents believed that their prescribing decision is influenced by medical representatives (n=117; 56.8%). More than three-quarters of the respondents expressed their wish to prescribe low cost medicines in their practice (n=157; 76.2%). More than one third of the respondents expressed their uneasiness to prescribe products from all local manufacturers (n=72; 35%). Conclusion: There were gaps identified in the knowledge of respondents. Although good perception and attitude were noted among the respondents, dissemination of information regarding generic medicines may perhaps strengthen generic prescribing. There is a need to introduce ‘Quality by Design’ concept in local manufacturing units. This, in turn, can inculcate confidence in prescribers towards locally manufactured generic medicines. PMID:23093896

Tank 241-C-112 vapor sampling and analysis tank characterization report. Revision 1

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

Huckaby, J.L.

1995-05-31

Tank 241-C-112 headspace gas and vapor samples were collected and analyzed to help determine the potential risks to tank farm workers due to fugitive emissions from the tank. The drivers and objectives of waste tank headspace sampling and analysis are discussed in {open_quotes}Program Plan for the Resolution of Tank Vapor Issues.{close_quotes} Tank 241-C-112 was vapor sampled in accordance with {open_quotes}Data Quality Objectives for Generic In-Tank Health and Safety Issue Resolution.{close_quotes}

How Low-Income Subsidy Recipients Respond to Medicare Part D Cost Sharing.

PubMed

Stuart, Bruce; Hendrick, Franklin B; Xu, Jing; Dougherty, J Samantha

2017-06-01

To determine the magnitude and mechanisms of response to Medicare Part D cost sharing by low-income subsidy (LIS) recipients using oral hypoglycemic agents (OHAs) and statins. Medicare data for a 5 percent random sample of beneficiaries with diabetes enrolled in fee-for-service Part D drug plans in 2008. We evaluated the impact of differences between generic and brand cost sharing rates among cohorts of LIS and non-LIS recipients to determine if wider price spreads increased the generic dispensing rate (GDR) and reduced total drug use and cost. We found little association between cost sharing and aggregate OHA and statin use. In adjusted analyses, non-LIS beneficiaries who paid 46 percent of total OHA costs had 2.5 percent fewer OHA days supply than full benefit dual eligibles who paid just 5 percent of their therapy costs. For statins, the difference in days supply between those facing the lowest and highest cost sharing was 4.6 percent. Higher cost sharing was associated with filling fewer but larger prescriptions for both generics and brands. Higher generic and brand copays had little association with OHA and statin use among LIS recipients. This implies that modest changes in required cost sharing for these medicines would have very little substantive impact on generic dispensing or utilization patterns among LIS recipients and thus would have little effect on total program spending. At the same time, any increases in out-of-pocket costs would be expected to shift costs and place greater financial burden on low-income beneficiaries, particularly those in poor health. © Health Research and Educational Trust.

Generic pure quantum states as steady states of quasi-local dissipative dynamics

NASA Astrophysics Data System (ADS)

Karuvade, Salini; Johnson, Peter D.; Ticozzi, Francesco; Viola, Lorenza

2018-04-01

We investigate whether a generic pure state on a multipartite quantum system can be the unique asymptotic steady state of locality-constrained purely dissipative Markovian dynamics. In the tripartite setting, we show that the problem is equivalent to characterizing the solution space of a set of linear equations and establish that the set of pure states obeying the above property has either measure zero or measure one, solely depending on the subsystems’ dimension. A complete analytical characterization is given when the central subsystem is a qubit. In the N-partite case, we provide conditions on the subsystems’ size and the nature of the locality constraint, under which random pure states cannot be quasi-locally stabilized generically. Also, allowing for the possibility to approximately stabilize entangled pure states that cannot be exact steady states in settings where stabilizability is generic, our results offer insights into the extent to which random pure states may arise as unique ground states of frustration-free parent Hamiltonians. We further argue that, to a high probability, pure quantum states sampled from a t-design enjoy the same stabilizability properties of Haar-random ones as long as suitable dimension constraints are obeyed and t is sufficiently large. Lastly, we demonstrate a connection between the tasks of quasi-local state stabilization and unique state reconstruction from local tomographic information, and provide a constructive procedure for determining a generic N-partite pure state based only on knowledge of the support of any two of the reduced density matrices of about half the parties, improving over existing results.

Comparison of generic-to-brand switchback patterns for generic and authorized generic drugs

PubMed Central

Hansen, Richard A.; Qian, Jingjing; Berg, Richard; Linneman, James; Seoane-Vazquez, Enrique; Dutcher, Sarah K.; Raofi, Saeid; Page, C. David; Peissig, Peggy

2018-01-01

Background While generic drugs are therapeutically equivalent to brand drugs, some patients and healthcare providers remain uncertain about whether they produce identical outcomes. Authorized generics, which are identical in formulation to corresponding brand drugs but marketed as a generic, provide a unique post-marketing opportunity to study whether utilization patterns are influenced by perceptions of generic drugs. Objectives To compare generic-to-brand switchback rates between generics and authorized generics. Methods A retrospective cohort study was conducted using claims and electronic health records data from a regional U.S. healthcare system. Ten drugs with authorized generics and generics marketed between 1999 and 2014 were evaluated. Eligible adult patients received a brand drug during the 6 months preceding generic entry, and then switched to a generic or authorized generic. Patients in this cohort were followed for up to 30 months from the index switch date to evaluate occurrence of generic-to-brand switchbacks. Switchback rates were compared between patients on authorized generics versus generics using Kaplan-Meier curves and Cox proportional hazards models, controlling for individual drug effects, age, sex, Charlson comorbidity score, pre-index drug use characteristics, and pre-index healthcare utilization. Results Among 5,542 unique patients that switched from brand-to-generic or brand-to-authorized generic, 264 (4.8%) switched back to the brand drug. Overall switchback rates were similar for authorized generics compared with generics (HR=0.86; 95% CI 0.65-1.15). The likelihood of switchback was higher for alendronate (HR=1.64; 95% CI 1.20-2.23) and simvastatin (HR=1.81; 95% CI 1.30-2.54) and lower for amlodipine (HR=0.27; 95% CI 0.17-0.42) compared with other drugs in the cohort. Conclusions Overall switchback rates were similar between authorized generic and generic drug users, indirectly supporting similar efficacy and tolerability profiles for brand and generic drugs. Reasons for differences in switchback rates among specific products need to be further explored. PMID:28152215

TREATMENT OF STORMWATER BY NATURAL ORGANIC MATERIALS

EPA Science Inventory

The overall objective of this study was to evaluate the feasibility of using low-cost natural filter materials for stormwater (SW) treatment. Generic mulch, pine bark mulch, and processed jute were evaluated for metal and organic pollutant removal from actual SW samples collected...

USE OF NATURAL FILTER MEDIA FOR STORMWATER TREATMENT

EPA Science Inventory

The overall objective of this study was to evaluate the feasibility of using low-cost natural filter materials for stormwater (SW) treatment. Generic mulch, pine bark mulch, and processed jute were evaluated for metal and organic pollutant removal from actual SW samples collected...

Immunological techniques for detection of fungal and dinoflagellate toxins. Annual report, 1 May 1987-30 April 1988

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

Chu, F.S.

1988-05-12

1) A new direct ELISA, which involves the use of a generic type antibody for T-2 toxin and 3-acetyl-neosolaniol-hemisuccinate (3-Ac-NEOS-HS) conjugated to horseradish peroxidase for the analysis of T-2 toxin metabolites, was established. 2) Analysis of 5 metabolites, i.e., T-2 toxin, HT-2, T-2-4ol, 3'-OH-HT-2, NEOS and a mixture of these five toxins, added at toxin concentrations of 50 and 200 ng/mL of urine, revealed that 87% of the added toxins were recovered analytically at both concentrations in the ELISA, and 69% in RIA and the 200 ppb level. 3) A series of monkey urine samples obtained from a metabolic studymore » was subjected to the new ELISA protocol was as well as to RIA. 4) An extensive study to evaluate a fluorometric method, i.e., hit-and-run assay was made. 5) A direct ELISA for deoxynivalenol (DON) was established. 6) Further improvements for the ELISA for saxitoxin were made. 7) New approaches to produce antibody against nivalenol and saxitoxin were made, but the antibody titers were low. 8) Antibody against microcystin (MCS) was obtained from rabbits after immunizing the animals with MCS-BSA conjugate. 9) A chemical method for the preparation of different monoacetoxyscirpenol (MAS) was established. 10) Routine preparation of different immunochemical reagents continued. Phytotoxins Biological warfare agents; Dinoflagellates. (AW)« less

A high-throughput assay of membrane protein stability.

PubMed

Postis, Vincent L G; Deacon, Sarah E; Roach, Peter C J; Wright, Gareth S A; Xia, Xiaobing; Ingram, Jean C; Hadden, Jonathan M; Henderson, Peter J F; Phillips, Simon E V; McPherson, Michael J; Baldwin, Stephen A

2008-12-01

The preparation of purified, detergent-solubilized membrane proteins in a monodisperse and stable form is usually a prerequisite for investigation not only of their function but also for structural studies by X-ray crystallography and other approaches. Typically, it is necessary to explore a wide range of conditions, including detergent type, buffer pH, and the presence of additives such as glycerol, in order to identify those optimal for stability. Given the difficulty of expressing and purifying membrane proteins in large amounts, such explorations must ideally be performed on as small a scale as practicable. To achieve this objective in the UK Membrane Protein Structure Initiative, we have developed a rapid, economical, light-scattering assay of membrane protein aggregation that allows the testing of 48 buffer conditions in parallel on 6 protein targets, requiring less than 2 mg protein for each target. Testing of the assay on a number of unrelated membrane transporters has shown that it is of generic applicability. Proteins of sufficient purity for this plate-based assay are first rapidly prepared using simple affinity purification procedures performed in batch mode. Samples are then transferred by microdialysis into each of the conditions to be tested. Finally, attenuance at 340 nm is monitored in a 384-well plate using a plate reader. Optimal conditions for protein stability identified in the assay can then be exploited for the tailored purification of individual targets in as stable a form as possible.

Relative toxicity of pyrolysis products of some synthetic polymers

NASA Technical Reports Server (NTRS)

Hilado, C. J.; Slattengren, C. L.; Furst, A.; Kourtides, D. A.; Parker, J. A.

1976-01-01

Nineteen samples of synthetic polymers were evaluated for relative toxicity in the course of characterizing materials intended for aircraft interior applications. The generic polymers included ABS, chlorinated PVC, polycarbonate, polyphenylene oxide, polyphenylene sulfide, polysulfone, polyaryl sulfone, polyether sulfone, polybismaleimide, and polyvinyl fluoride. Test results are presented, and compared in relative rankings with similar results on cellulosic materials and other synthetic polymers. Under these test conditions, the samples of synthetic polymers were either comparable to or significantly less toxic than the samples of commercial cellulosic materials.

Incorporating a Generic Model of Subcutaneous Insulin Absorption into the AIDA v4 Diabetes Simulator 3. Early Plasma Insulin Determinations

PubMed Central

Lehmann, Eldon D.; Tarín, Cristina; Bondia, Jorge; Teufel, Edgar; Deutsch, Tibor

2009-01-01

Introduction AIDA is an interactive educational diabetes simulator that has been available without charge via the Internet for over 12 years. Recent articles have described the incorporation of a novel generic model of insulin absorption into AIDA as a way of enhancing its capabilities. The basic model components to be integrated have been overviewed, with the aim being to provide simulations of regimens utilizing insulin analogues, as well as insulin doses greater than 40 IU (the current upper limit within the latest release of AIDA [v4.3a]). Some preliminary calculated insulin absorption results have also recently been described. Methods This article presents the first simulated plasma insulin profiles from the integration of the generic subcutaneous insulin absorption model, and the currently implemented model in AIDA for insulin disposition. Insulin absorption has been described by the physiologically based model of Tarín and colleagues. A single compartment modeling approach has been used to specify how absorbed insulin is distributed in, and eliminated from, the human body. To enable a numerical solution of the absorption model, a spherical subcutaneous depot for the injected insulin dose has been assumed and spatially discretized into shell compartments with homogeneous concentrations, having as its center the injection site. The number of these compartments will depend on the dose and type of insulin. Insulin inflow arises as the sum of contributions to the different shells. For this report the first bench testing of plasma insulin determinations has been done. Results Simulated plasma insulin profiles are provided for currently available insulin preparations, including a rapidly acting insulin analogue (e.g., lispro/Humalog or aspart/Novolog), a short-acting (regular) insulin preparation (e.g., Actrapid), intermediate-acting insulins (both Semilente and neutral protamine Hagedorn types), and a very long-acting insulin analogue (e.g., glargine/Lantus), as well as for insulin doses up to 50 IU. Discussion The methodology to be adopted for implementing the generic absorption model within AIDA has been overviewed, and the first plasma insulin profiles based on this approach have been demonstrated. Ideas for future work and development are discussed. It is expected that an updated release of AIDA (v4.5), based on this collaborative approach, will become available for free—in due course—via the www.2aida.org Web site. Readers who wish to be informed when the new software is launched can join the very low volume AIDA announcement list by sending a blank email note to subscribe@2aida.org. PMID:20046665

Validation of Persian Version of PedsQL™ 4.0™ Generic Core Scales in Toddlers and Children

PubMed Central

Gheissari, Alaleh; Farajzadegan, Ziba; Heidary, Maryam; Salehi, Fatemeh; Masaeli, Ali; Mazrooei, Amin; Varni, James W; Fallah, Zahra; Zandieh, Fariborz

2012-01-01

Introduction: To evaluate the reliability, validity and feasibility of the Persian version of the Pediatric Quality of Life inventory (PedsQL™ 4.0™ 4.0) Generic Core Scales in Iranian healthy students ages 7-15 and chronically ill children ages 2-18. Methods: We followed the translation methodology proposed by developer to validate Persian version of PedsQL™ 4.0™ 4.0 Generic Core Scales for children. Six hundred and sixty children and adolescents and their parents were enrolled. Sample of 160 healthy students were chosen by random cluster method between 4 regions of Isfahan education offices and 60 chronically ill children were recruited from St. Alzahra hospital private clinics. The questionnaires were fulfilled by the participants. Results: The Persian version of PedsQL™ 4.0™ 4.0 Generic Core Scales discriminated between healthy and chronically ill children (healthy students mean score was 12.3 better than chronically ill children, P<0.001). Cronbachs’ alpha internal consistency values exceeded 0.7 for children self reports and proxy reports of children 5-7 years old and 13-18 years old. Reliability of proxy reports for 2-4 years old was much lower than 0.7. Although, proxy reports for chronically ill children 8-12 years old was more than 0.7, these reports for healthy children with same age group was slightly lower than 0.7. Constructive, criterion face and content validity were acceptable. In addition, the Persian version of PedsQL™ 4.0™ 4.0 Generic Core Scales was feasible and easy to complete. Conclusion: Results showed that Persian version of PedsQL™ 4.0™ 4.0 Generic Core Scales is valid and acceptable for pediatric health researches. It is necessary to alternate scoring for 2-4 years old questionnaire and to find a way to increase reliability for healthy children aged 8-12 years especially, according to Iranian culture. PMID:22701775

Generic versus brand-name drugs used in cardiovascular diseases.

PubMed

Manzoli, Lamberto; Flacco, Maria Elena; Boccia, Stefania; D'Andrea, Elvira; Panic, Nikola; Marzuillo, Carolina; Siliquini, Roberta; Ricciardi, Walter; Villari, Paolo; Ioannidis, John P A

2016-04-01

This meta-analysis aimed to compare the efficacy and adverse events, either serious or mild/moderate, of all generic versus brand-name cardiovascular medicines. We searched randomized trials in MEDLINE, Scopus, EMBASE, Cochrane Controlled Clinical Trial Register, and ClinicalTrials.gov (last update December 1, 2014). Attempts were made to contact the investigators of all potentially eligible trials. Two investigators independently extracted and analyzed soft (including systolic blood pressure, LDL cholesterol, and others) and hard efficacy outcomes (including major cardiovascular adverse events and death), minor/moderate and serious adverse events. We included 74 randomized trials; 53 reported ≥1 efficacy outcome (overall sample 3051), 32 measured mild/moderate adverse events (n = 2407), and 51 evaluated serious adverse events (n = 2892). We included trials assessing ACE inhibitors (n = 12), anticoagulants (n = 5), antiplatelet agents (n = 17), beta-blockers (n = 11), calcium channel blockers (n = 7); diuretics (n = 13); statins (n = 6); and others (n = 3). For both soft and hard efficacy outcomes, 100 % of the trials showed non-significant differences between generic and brand-name drugs. The aggregate effect size was 0.01 (95 % CI -0.05; 0.08) for soft outcomes; -0.06 (-0.71; 0.59) for hard outcomes. All but two trials showed non-significant differences in mild/moderate adverse events, and aggregate effect size was 0.07 (-0.06; 0.20). Comparable results were observed for each drug class and in each stratified meta-analysis. Overall, 8 serious possibly drug-related adverse events were reported: 5/2074 subjects on generics; 3/2076 subjects on brand-name drugs (OR 1.69; 95 % CI 0.40-7.20). This meta-analysis strengthens the evidence for clinical equivalence between brand-name and generic cardiovascular drugs. Physicians could be reassured about prescribing generic cardiovascular drugs, and health care organization about endorsing their wider use.

Affordability of adult HIV/AIDS treatment in developing countries: modelling price determinants for a better insight of the market functioning.

PubMed

Sagaon-Teyssier, Luis; Singh, Sauman; Dongmo-Nguimfack, Boniface; Moatti, Jean-Paul

2016-01-01

This study aims to provide a landscape of the global antiretroviral (ARV) market by analyzing the transactional data on donor-funded ARV procurement between 2003 and 2015, and the ARV price determinants. The data were obtained from the Global Price Reporting Mechanism (GPRM) managed by the AIDS Medicines and Diagnostics Service of the WHO, and it consists of information that covers approximately 80% of the total donor-funded adult ARV transactions procurement. ExWorks prices and procured quantities were standardized according to the guidelines in terms of yearly doses. Descriptive statistics on quantities and prices show the main trends of the ARV market. Ordinary least squares estimation was carried out for the whole sample, then stratified according to the type of supplier (originator and generic) and controlled for time and geographical fixed-effects. Given that analyses were carried out on a public dataset on ARV transactional prices from the GPRM, ethics are respected and consent was not necessary. Originator medicines are on average the least expensive in the sub-Saharan Africa region, where at the same time, generic medicines are on average the most expensive. By contrast, originator medicines are the most expensive in Europe and Central Asia, and generic medicines are the least expensive. In fact, the data suggest mixed strategies by ARV suppliers to exploit opportunities for profit maximization and to adapt to the specific conditions of market competition in each region. Our results also suggest that the expiration of patents is not sufficient to boost additional developments in generic competition (at least in the ARV market) and that formal or informal agreements between generic firms may de facto slow down or even reverse long-term trends towards price decreases. Our findings provide an improved understanding of the ARV market that can help countries strengthen policy measures to increase their bargaining power in price negotiations and the use of TRIPS flexibilities, with a special emphasis on negotiations with generic manufacturers.

Perceived health status and cardiometabolic risk among a sample of youth in Mexico

PubMed Central

Flores, Yvonne N.; Shaibi, Gabriel Q.; Morales, Leo S.; Salmerón, Jorge; Skalicky, Anne M.; Edwards, Todd C.; Gallegos-Carrillo, Katia; Patrick, Donald L.

2015-01-01

Purpose To examine differences in self-reported perceived mental and physical health status (PHS), as well as known cardiometabolic risk factors in a sample of normal weight, overweight, and obese Mexican youths. Methods Cross-sectional analysis of 164 youths aged 11-18 years recruited in Cuernavaca, Mexico. Participants completed a self-administered questionnaire that included measures of generic and weight-specific quality of life (QoL), perceived health, physical function, depressive symptoms, and body shape satisfaction. Height, weight and waist circumference were measured and body mass index (BMI) was determined. Fasting blood samples from participants yielded levels of glucose, triglycerides, and cholesterol (total, HDL and LDL). Results Nearly 50% of participants were female, 21% had a normal BMI, 39% were overweight, and 40% were obese. Obese youths reported significantly lower measures of PHS and showed an increase in cardiometabolic risk, compared to normal weight youths. Physical functioning, generic and weight-specific QoL were inversely associated with BMI, waist circumference and glucose. Depressive symptoms were positively correlated with BMI, waist circumference, glucose levels and HDL cholesterol. No correlation was found between PHS and cardiometabolic risk measures after controlling for BMI. Conclusions In this sample of Mexican youths, obesity was associated with a significantly lower PHS and increased cardiometabolic risk. PMID:25648756

Comprehensive identification and structural characterization of target components from Gelsemium elegans by high-performance liquid chromatography coupled with quadrupole time-of-flight mass spectrometry based on accurate mass databases combined with MS/MS spectra.

PubMed

Liu, Yan-Chun; Xiao, Sa; Yang, Kun; Ling, Li; Sun, Zhi-Liang; Liu, Zhao-Ying

2017-06-01

This study reports an applicable analytical strategy of comprehensive identification and structure characterization of target components from Gelsemium elegans by using high-performance liquid chromatography quadrupole time-of-flight mass spectrometry (LC-QqTOF MS) based on the use of accurate mass databases combined with MS/MS spectra. The databases created included accurate masses and elemental compositions of 204 components from Gelsemium and their structural data. The accurate MS and MS/MS spectra were acquired through data-dependent auto MS/MS mode followed by an extraction of the potential compounds from the LC-QqTOF MS raw data of the sample. The same was matched using the databases to search for targeted components in the sample. The structures for detected components were tentatively characterized by manually interpreting the accurate MS/MS spectra for the first time. A total of 57 components have been successfully detected and structurally characterized from the crude extracts of G. elegans, but has failed to differentiate some isomers. This analytical strategy is generic and efficient, avoids isolation and purification procedures, enables a comprehensive structure characterization of target components of Gelsemium and would be widely applicable for complicated mixtures that are derived from Gelsemium preparations. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

Generic, Extensible, Configurable Push-Pull Framework for Large-Scale Science Missions

NASA Technical Reports Server (NTRS)

Foster, Brian M.; Chang, Albert Y.; Freeborn, Dana J.; Crichton, Daniel J.; Woollard, David M.; Mattmann, Chris A.

2011-01-01

The push-pull framework was developed in hopes that an infrastructure would be created that could literally connect to any given remote site, and (given a set of restrictions) download files from that remote site based on those restrictions. The Cataloging and Archiving Service (CAS) has recently been re-architected and re-factored in its canonical services, including file management, workflow management, and resource management. Additionally, a generic CAS Crawling Framework was built based on motivation from Apache s open-source search engine project called Nutch. Nutch is an Apache effort to provide search engine services (akin to Google), including crawling, parsing, content analysis, and indexing. It has produced several stable software releases, and is currently used in production services at companies such as Yahoo, and at NASA's Planetary Data System. The CAS Crawling Framework supports many of the Nutch Crawler's generic services, including metadata extraction, crawling, and ingestion. However, one service that was not ported over from Nutch is a generic protocol layer service that allows the Nutch crawler to obtain content using protocol plug-ins that download content using implementations of remote protocols, such as HTTP, FTP, WinNT file system, HTTPS, etc. Such a generic protocol layer would greatly aid in the CAS Crawling Framework, as the layer would allow the framework to generically obtain content (i.e., data products) from remote sites using protocols such as FTP and others. Augmented with this capability, the Orbiting Carbon Observatory (OCO) and NPP (NPOESS Preparatory Project) Sounder PEATE (Product Evaluation and Analysis Tools Elements) would be provided with an infrastructure to support generic FTP-based pull access to remote data products, obviating the need for any specialized software outside of the context of their existing process control systems. This extensible configurable framework was created in Java, and allows the use of different underlying communication middleware (at present, both XMLRPC, and RMI). In addition, the framework is entirely suitable in a multi-mission environment and is supporting both NPP Sounder PEATE and the OCO Mission. Both systems involve tasks such as high-throughput job processing, terabyte-scale data management, and science computing facilities. NPP Sounder PEATE is already using the push-pull framework to accept hundreds of gigabytes of IASI (infrared atmospheric sounding interferometer) data, and is in preparation to accept CRIMS (Cross-track Infrared Microwave Sounding Suite) data. OCO will leverage the framework to download MODIS, CloudSat, and other ancillary data products for use in the high-performance Level 2 Science Algorithm. The National Cancer Institute is also evaluating the framework for use in sharing and disseminating cancer research data through its Early Detection Research Network (EDRN).

Numerical methods for comparing fresh and weathered oils by their FTIR spectra.

PubMed

Li, Jianfeng; Hibbert, D Brynn; Fuller, Stephen

2007-08-01

Four comparison statistics ('similarity indices') for the identification of the source of a petroleum oil spill based on the ASTM standard test method D3414 were investigated. Namely, (1) first difference correlation coefficient squared and (2) correlation coefficient squared, (3) first difference Euclidean cosine squared and (4) Euclidean cosine squared. For numerical comparison, an FTIR spectrum is divided into three regions, described as: fingerprint (900-700 cm(-1)), generic (1350-900 cm(-1)) and supplementary (1770-1685 cm(-1)), which are the same as the three major regions recommended by the ASTM standard. For fresh oil samples, each similarity index was able to distinguish between replicate independent spectra of the same sample and between different samples. In general, the two first difference-based indices worked better than their parent indices. To provide samples to reveal relationships between weathered and fresh oils, a simple artificial weathering procedure was carried out. Euclidean cosine and correlation coefficients both worked well to maintain identification of a match in the fingerprint region and the two first difference indices were better in the generic region. Receiver operating characteristic curves (true positive rate versus false positive rate) for decisions on matching using the fingerprint region showed two samples could be matched when the difference in weathering time was up to 7 days. Beyond this time the true positive rate falls and samples cannot be reliably matched. However, artificial weathering of a fresh source sample can aid the matching of a weathered sample to its real source from a pool of very similar candidates.

A generic standard additions based method to determine endogenous analyte concentrations by immunoassays to overcome complex biological matrix interference.

PubMed

Pang, Susan; Cowen, Simon

2017-12-13

We describe a novel generic method to derive the unknown endogenous concentrations of analyte within complex biological matrices (e.g. serum or plasma) based upon the relationship between the immunoassay signal response of a biological test sample spiked with known analyte concentrations and the log transformed estimated total concentration. If the estimated total analyte concentration is correct, a portion of the sigmoid on a log-log plot is very close to linear, allowing the unknown endogenous concentration to be estimated using a numerical method. This approach obviates conventional relative quantification using an internal standard curve and need for calibrant diluent, and takes into account the individual matrix interference on the immunoassay by spiking the test sample itself. This technique is based on standard additions for chemical analytes. Unknown endogenous analyte concentrations within even 2-fold diluted human plasma may be determined reliably using as few as four reaction wells.

Authorized generic drugs, price competition, and consumers' welfare.

PubMed

Berndt, Ernst R; Mortimer, Richard; Bhattacharjya, Ashoke; Parece, Andrew; Tuttle, Edward

2007-01-01

The growing frequency of authorized generics has important implications for the welfare of prescription drug consumers. Authorized generic entry could affect the timing of generic entry, brand-name and generic prices, and generic penetration. We reviewed 1999-2003 data and found that generic entry in the absence of short-run exclusivity restrictions benefits consumers through lower short-run prices. We suggest that these benefits likely also result from authorized generics. We posit that long-run prices and shares are likely essentially unaffected by authorized generics and that potential costs to consumers from any delayed generic entry are likely small.

Effect of preparation methods and doping on the structural and tunable emissions of CdS

NASA Astrophysics Data System (ADS)

Mohamed, Mohamed Bakr; Abdel-Kader, M. H.; Alhazime, Ali A.; Almarashi, Jamal Q. M.

2018-03-01

Fe, Mn and Mg doped CdS samples were prepared by thermolysis method in air and under flow of nitrogen. Structural, compositional and optical properties of the prepared samples were investigated using x-ray powder diffraction (XRD), scanning electron microscope (SEM/EDS mapping), Fourier transform infrared red (FTIR), UV-vis absorption and photoluminescence (PL) spectroscopes. Rietveld refinement of x-ray data showed that all the undoped and doped CdS samples prepared in air and under flow of nitrogen have both cubic and hexagonal structures. The percentages of hexagonal and cubic phases for all prepared samples were determined. The crystallite size increased for CdS prepared under flow of N2 compared with the sample prepared in air. The energy gap of all the samples was calculated using UV data. The intensity of PL emission changed according to the method of preparation and the kind of doping elements. PL emission revealed a blue shift for CdS prepared in air compared with CdS prepared under flow of nitrogen; also all doped samples showed a red shift of PL spectra compared with undoped samples. Undoped and doped CdS with Fe and Mg samples emitted violet and blue sub-spectra. Mn doped CdS prepared in air revealed violet, blue and yellow sub-spectra, while the sample prepared under flow of N2 emitted violet, blue and green sub-spectra.

Educational approaches aimed at preparing students for professional veterinary practice.

PubMed

Jaarsma, A D C; Dolmans, D H J M; Scherpbier, A J J A; van Beukelen, P

2009-08-01

Changes in society and dissatisfaction with current educational practices have led to changes in undergraduate veterinary curricula. New approaches that are thought to better prepare students for future professional veterinary practice are being introduced. One such change is a transition from conventional teacher-centred curricula to student-centred curricula. In student-centred curricula, students are actively involved in learning and teachers not only transmit knowledge but help students to obtain a deep understanding. Furthermore, learning within these curricula takes place in a multi-disciplinary context which is more relevant for the future of the profession. Another change is that more emphasis is put on training in academic skills, for instance, by establishing research internships. Finally, a new emphasis is being placed on training in more generic competencies, such as communication and business skills. These changes are assumed to better suit the profile of veterinary students today and in the future and to better prepare them for future veterinary practice.

The experiences of implementing generic medicine policy in eight countries: A review and recommendations for a successful promotion of generic medicine use

PubMed Central

Hassali, Mohamed Azmi; Alrasheedy, Alian A.; McLachlan, Andrew; Nguyen, Tuan Anh; AL-Tamimi, Saleh Karamah; Ibrahim, Mohamed Izham Mohamed; Aljadhey, Hisham

2013-01-01

Generic medicines are clinically interchangeable with original brand medicines and have the same quality, efficacy and safety profiles. They are, nevertheless, much cheaper in price. Thus, while providing the same therapeutic outcomes, generic medicines lead to substantial savings for healthcare systems. Therefore, the quality use of generic medicines is promoted in many countries. In this paper, we reviewed the role of generic medicines in healthcare systems and the experiences of promoting the use of generic medicines in eight selected countries, namely the United States (US), the United Kingdom (UK), Sweden, Finland, Australia, Japan, Malaysia and Thailand. The review showed that there are different main policies adopted to promote generic medicines such as generic substitution in the US, generic prescribing in the UK and mandatory generic substitution in Sweden and Finland. To effectively and successfully implement the main policy, different complementary policies and initiatives were necessarily introduced. Barriers to generic medicine use varied between countries from negative perceptions about generic medicines to lack of a coherent generic medicine policy, while facilitators included availability of information about generic medicines to both healthcare professionals and patients, brand interchangeability guidelines, regulations that support generic substitution by pharmacists, and incentives to both healthcare professionals and patients. PMID:25561861

Measuring Belief in Conspiracy Theories: The Generic Conspiracist Beliefs Scale

PubMed Central

Brotherton, Robert; French, Christopher C.; Pickering, Alan D.

2013-01-01

The psychology of conspiracy theory beliefs is not yet well understood, although research indicates that there are stable individual differences in conspiracist ideation – individuals’ general tendency to engage with conspiracy theories. Researchers have created several short self-report measures of conspiracist ideation. These measures largely consist of items referring to an assortment of prominent conspiracy theories regarding specific real-world events. However, these instruments have not been psychometrically validated, and this assessment approach suffers from practical and theoretical limitations. Therefore, we present the Generic Conspiracist Beliefs (GCB) scale: a novel measure of individual differences in generic conspiracist ideation. The scale was developed and validated across four studies. In Study 1, exploratory factor analysis of a novel 75-item measure of non-event-based conspiracist beliefs identified five conspiracist facets. The 15-item GCB scale was developed to sample from each of these themes. Studies 2, 3, and 4 examined the structure and validity of the GCB, demonstrating internal reliability, content, criterion-related, convergent and discriminant validity, and good test-retest reliability. In sum, this research indicates that the GCB is a psychometrically sound and practically useful measure of conspiracist ideation, and the findings add to our theoretical understanding of conspiracist ideation as a monological belief system unpinned by a relatively small number of generic assumptions about the typicality of conspiratorial activity in the world. PMID:23734136

Physician Experiences With High Value Care in Internal Medicine Residency: Mixed-Methods Study of 2003-2013 Residency Graduates.

PubMed

Ryskina, Kira L; Holmboe, Eric S; Shea, Judy A; Kim, Esther; Long, Judith A

2018-01-01

Phenomenon: High healthcare costs and relatively poor health outcomes in the United States have led to calls to improve the teaching of high value care (defined as care that balances potential benefits of interventions with their harms including costs) to physicians-in-training. Numerous interventions to increase high value care in graduate medical education were implemented at the national and local levels over the past decade. However, there has been little evaluation of their impact on physician experiences during training and perceived preparedness for practice. We aimed to assess trends in U.S. physician experiences with high value care during residency over the past decade. This mixed-methods study used a cross-sectional survey mailed July 2014 to January 2015 to 902 internists who completed residency in 2003-2013, randomly selected from the American Medical Association Masterfile. Quantitative analyses of survey responses and content analysis of free-text comments submitted by respondents were performed. A total of 456 physicians (50.6%) responded. Fewer than one fourth reported being exposed to teaching about high value care at least frequently (23.6%, 106/450). Only 43.8% of respondents (193/446) felt prepared to use overtreatment guidelines in conversations with patients, whereas 85.8% (379/447) felt prepared to participate in shared decision making with patients at the conclusion of their training, and 84.4% (380/450) reported practicing generic prescribing. Physicians who completed residency more recently were more likely to report practicing generic prescribing and feeling well prepared to use overtreatment guidelines in conversations with patients (p < .01 for both). Insights: In a national survey, recent U.S. internal medicine residency graduates were more likely to experience high value care during training, which may reflect increased national and local efforts in this area. However, being exposed to high value care as a trainee may not translate into specific tools for practice. In fact, many U.S. internists reported inadequate exposure to prepare them for patient discussions about costs and the use of overtreatment guidelines in practice.

77 FR 70780 - Agency Forms Undergoing Paperwork Reduction Act Review

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-27

... requirements or power calculations that justify the proposed sample size, the expected response rate, methods... notice. Proposed Project Generic Clearance for the Collection of Qualitative Feedback on Agency Service... Collection of Qualitative Feedback on Agency Service Delivery'' to OMB for approval under the Paperwork...

Genie Inference Engine Rule Writer’s Guide.

DTIC Science & Technology

1987-08-01

33 APPENDIX D. Animal Bootstrap File.............................................................. 39...APPENDIX E. Sample Run of Animal Identification Expert System.......................... 43 APPENDIX F. Numeric Test Knowledge Base...and other data s.tructures stored in the knowledge base (KB), queries the user for input, and draws conclusions. Genie (GENeric Inference Engine) is

Cross-cultural adaptation, reliability and validity of the Spanish version of the Quality of Life in Adult Cancer Survivors (QLACS) questionnaire: application in a sample of short-term survivors.

PubMed

Escobar, Antonio; Trujillo-Martín, Maria del Mar; Rueda, Antonio; Pérez-Ruiz, Elisabeth; Avis, Nancy E; Bilbao, Amaia

2015-11-16

The aim of this study was to validate the Quality of Life in Adult Cancer Survivors (QLACS) in short-term Spanish cancer survivor's patients. Patients with breast, colorectal or prostate cancer that had finished their initial cancer treatment 3 years before the beginning of this study completed QLACS, WHOQOL, Short Form-36, Hospital Anxiety and Depression Scale, EORTC-QLQ-BR23 and EQ-5D. Cultural adaptation was made based on established guidelines. Reliability was evaluated using internal consistency and test-retest. Convergent validity was studied by mean of Pearson's correlation coefficient. Structural validity was determined by a second-order confirmatory factor analysis (CFA) and Rasch analysis was used to assess the unidimensionality of the Generic and Cancer-specific scales. Cronbach's alpha were above 0.7 in all domains and summary scales. Test-retest coefficients were 0.88 for Generic and 0.82 for Cancer-specific summary scales. QLACS generic summary scale was correlated with other generic criterion measures, SF-36 MCS (r = - 0.74) and EQ-VAS (r = - 0.63). QLACS cancer-specific scale had lower values with the same constructs. CFA provided satisfactory fit indices in all cases. The RMSEA value was 0.061 and CFI and TLI values were 0.929 and 0.925, respectively. All factor loadings were higher than 0.40 and statistically significant (P < 0.001). Generic summary scale had eight misfitting items. In the remaining 20 items, the unidimensionality was supported. Cancer Specific summary scale showed four misfitting items, the remaining showed unidimensionality. The findings support the validity and reliability of QLACS questionnaire to be used in short-term cancer survivors.

Patient-reported Pediatric Quality of Life Inventory™ 4.0 Generic Core Scales in pediatric patients with attention-deficit/hyperactivity disorder and comorbid psychiatric disorders: feasibility, reliability, and validity.

PubMed

Limbers, Christine A; Ripperger-Suhler, Jane; Heffer, Robert W; Varni, James W

2011-06-01

The primary objective of the study was to evaluate the feasibility, reliability, and validity of the Pediatric Quality of Life Inventory™ (PedsQL) 4.0 Generic Core Scales as a patient self-reported health-related quality of life measurement instrument in pediatric patients with attention-deficit/hyperactivity disorder (ADHD) and physician-diagnosed comorbid psychiatric disorders being seen in a pediatric psychiatric clinic. The secondary objective was to evaluate parent proxy-reported PedsQL in this population. One hundred seventy-nine children with ADHD and comorbid psychiatric disorders ages 5 to 18 years and 181 parents completed the PedsQL 4.0 Generic Core Scales and parents also completed the Vanderbilt ADHD Diagnostic Rating Scales. Known-groups discriminant validity comparisons were made between the sample of pediatric patients with ADHD and comorbid psychiatric disorders and healthy, cancer, and type 1 diabetes samples. The PedsQL evidenced minimal missing responses for patient self-report and parent proxy-report (0.2% and 0.5%, respectively), demonstrated no significant floor or ceiling effects, and achieved excellent reliability for the Total Scale Score (α = 0.85 patient self-report, 0.92 parent proxy-report). Pediatric patients with ADHD and comorbid psychiatric disorders and their parents reported statistically significantly worse PedsQL scores than healthy children, with large effect sizes across all domains, supporting known-groups discriminant validity. Pediatric patients with ADHD and comorbid psychiatric disorders and their parents reported worse PedsQL scores compared to pediatric patients with cancer and diabetes with the exception of physical health, in which pediatric cancer patients manifested lower physical health, indicating the relative severe impact of ADHD and comorbid psychiatric disorders. More severe ADHD symptoms were generally associated with more impaired PedsQL scores, supporting construct validity. These data demonstrate the feasibility, reliability, and validity of patient self-reported PedsQL 4.0 Generic Core Scales in this high risk population of pediatric patients and highlight the profound negative impact of ADHD and comorbid psychiatric disorders on generic health-related quality of life, comparable to or worse than serious pediatric chronic physical diseases. Copyright © 2011 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Differences in In Vitro Disintegration Time among Canadian Brand and Generic Bisphosphonates

PubMed Central

Olszynski, Wojciech P.; Adachi, Jonathan D.; Davison, K. Shawn

2014-01-01

The objective of this study was to compare the disintegration times among Canadian-marketed brand (alendronate 70 mg, alendronate 70 mg plus vitamin D 5600 IU, and risedronate 35 mg) and generic (Novo-alendronate 70 mg and Apo-alendronate 70 mg) once-weekly dosed bisphosphonates. All disintegration tests were performed with a Vanderkamp Disintegration Tester. Disintegration was deemed to have occurred when no residue of the tablet, except fragments of insoluble coating or capsule shell, was visible. Eighteen to 20 samples were tested for each bisphosphonate group. The mean (±standard deviation) disintegration times were significantly (P < 0.05) faster for Apo-alendronate (26 ± 5.6 seconds) and Novo-alendronate (13 ± 1.1 seconds) as compared to brand alendronate (147 ± 50.5 seconds), brand alendronate plus vitamin D (378 ± 60.5 seconds), or brand risedronate (101 ± 20.6 seconds). The significantly faster disintegration of the generic tablets as compared to the brand bisphosphonates may have concerning safety and effectiveness implications for patients administering these therapies. PMID:25349772

Differences in In Vitro Disintegration Time among Canadian Brand and Generic Bisphosphonates.

PubMed

Olszynski, Wojciech P; Adachi, Jonathan D; Davison, K Shawn

2014-01-01

The objective of this study was to compare the disintegration times among Canadian-marketed brand (alendronate 70 mg, alendronate 70 mg plus vitamin D 5600 IU, and risedronate 35 mg) and generic (Novo-alendronate 70 mg and Apo-alendronate 70 mg) once-weekly dosed bisphosphonates. All disintegration tests were performed with a Vanderkamp Disintegration Tester. Disintegration was deemed to have occurred when no residue of the tablet, except fragments of insoluble coating or capsule shell, was visible. Eighteen to 20 samples were tested for each bisphosphonate group. The mean (±standard deviation) disintegration times were significantly (P < 0.05) faster for Apo-alendronate (26 ± 5.6 seconds) and Novo-alendronate (13 ± 1.1 seconds) as compared to brand alendronate (147 ± 50.5 seconds), brand alendronate plus vitamin D (378 ± 60.5 seconds), or brand risedronate (101 ± 20.6 seconds). The significantly faster disintegration of the generic tablets as compared to the brand bisphosphonates may have concerning safety and effectiveness implications for patients administering these therapies.

Advances and Challenges in Super-Resolution

DTIC Science & Technology

2004-03-15

resolution in video. In: Proc. European Conf on Computer Vision (ECCV), May 2002, pp. 331–336. N. Sochen, R . Kimmel, R . Malladi . 1998. A general...2004a). 48 Vol. 14, 47–57 (2004) distinguish between a generic down-sampling operation (or CCD decimation by a factor r ) and the sampling...factor r often depends on the number of available low-resolution frames, the computational limitations (exponential in r ), and the accuracy of motion

7 CFR 27.21 - Preparation of samples of cotton.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 7 Agriculture 2 2012-01-01 2012-01-01 false Preparation of samples of cotton. 27.21 Section 27.21... REGULATIONS COTTON CLASSIFICATION UNDER COTTON FUTURES LEGISLATION Regulations Inspection and Samples § 27.21 Preparation of samples of cotton. The samples from each bale shall be prepared as specified in this section...

7 CFR 27.21 - Preparation of samples of cotton.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 2 2010-01-01 2010-01-01 false Preparation of samples of cotton. 27.21 Section 27.21... REGULATIONS COTTON CLASSIFICATION UNDER COTTON FUTURES LEGISLATION Regulations Inspection and Samples § 27.21 Preparation of samples of cotton. The samples from each bale shall be prepared as specified in this section...

7 CFR 27.21 - Preparation of samples of cotton.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 2 2011-01-01 2011-01-01 false Preparation of samples of cotton. 27.21 Section 27.21... REGULATIONS COTTON CLASSIFICATION UNDER COTTON FUTURES LEGISLATION Regulations Inspection and Samples § 27.21 Preparation of samples of cotton. The samples from each bale shall be prepared as specified in this section...

Nuclear Criticality Safety Data Book

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

Hollenbach, D. F.

The objective of this document is to support the revision of criticality safety process studies (CSPSs) for the Uranium Processing Facility (UPF) at the Y-12 National Security Complex (Y-12). This design analysis and calculation (DAC) document contains development and justification for generic inputs typically used in Nuclear Criticality Safety (NCS) DACs to model both normal and abnormal conditions of processes at UPF to support CSPSs. This will provide consistency between NCS DACs and efficiency in preparation and review of DACs, as frequently used data are provided in one reference source.

A Generic Metallographic Preparation Method for Magnesium Alloys

DTIC Science & Technology

2013-05-01

treated castings or wrought alloys. Stains solid solution, leaves compound white. 9: 100-ml water 0.2–2-g oxalic acid For pure Mg and most alloys. Swab...water 2-g oxalic acid Pure Mg Mg-Mn Mg-Al, Mg-Al-Zn (Al+Znɝ%) Mg-Al, Mg-Al-Zn (Al+Zn>5%) Mg-Zn-Zr Mg-Th-Zr Swab...using a 100-ml ethanol, 10-ml distilled water, 10-ml acetic acid , and 5-g picric acid etchant. Immersed and using gentle agitation 5–20 s. Though not

A device-oriented optimizer for solving ground state problems on an approximate quantum computer, Part II: Experiments for interacting spin and molecular systems

NASA Astrophysics Data System (ADS)

Kandala, Abhinav; Mezzacapo, Antonio; Temme, Kristan; Bravyi, Sergey; Takita, Maika; Chavez-Garcia, Jose; Córcoles, Antonio; Smolin, John; Chow, Jerry; Gambetta, Jay

Hybrid quantum-classical algorithms can be used to find variational solutions to generic quantum problems. Here, we present an experimental implementation of a device-oriented optimizer that uses superconducting quantum hardware. The experiment relies on feedback between the quantum device and classical optimization software which is robust to measurement noise. Our device-oriented approach uses naturally available interactions for the preparation of trial states. We demonstrate the application of this technique for solving interacting spin and molecular structure problems.

Raster Metafile and Raster Metafile Translator

NASA Technical Reports Server (NTRS)

Taylor, Nancy L.; Everton, Eric L.; Randall, Donald P.; Gates, Raymond L.; Skeens, Kristi M.

1989-01-01

The intent is to present an effort undertaken at NASA Langley Research Center to design a generic raster image format and to develop tools for processing images prepared in this format. Both the Raster Metafile (RM) format and the Raster Metafile Translator (RMT) are addressed. This document is intended to serve a varied audience including: users wishing to display and manipulate raster image data, programmers responsible for either interfacing the RM format with other raster formats or for developing new RMT device drivers, and programmers charged with installing the software on a host platform.

77 FR 24221 - Agency Information Collection Activities: Proposed Collection; Comments Requested; Research To...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-23

... collection: Extension of the time frame required to complete approved and ongoing methodological research on... methodological research on the National Crime Victimization Survey. (2) Title of the Form/Collection: National.... This generic clearance will cover methodological research that will use existing or new sampled...

The Rewards of Human Capital Competences for Young European Higher Education Graduates

ERIC Educational Resources Information Center

Garcia-Aracil, Adela; Mora, Jose-Gines; Vila, Luis E.

2004-01-01

The labour market rewards for a number of required human capital competences are analysed using a sample of young European higher education graduates. Factor analysis is applied to classify competences by jobs into eight orthogonal groups, namely participative, methodological, specialised, organisational, applying rules, physical, generic and…

49 CFR 172.101 - Purpose and use of hazardous materials table.

Code of Federal Regulations, 2010 CFR

2010-10-01

... paragraph (c)(11): For the transportation of samples of self-reactive materials, organic peroxides... hazard class, the material is not a hazardous material. (13) Self-reactive materials and organic peroxides. A generic proper shipping name for a self-reactive material or an organic peroxide, as listed in...

77 FR 63798 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-17

... requirements or power calculations that justify the proposed sample size, the expected response rate, methods... Clearance for the Collection of Qualitative Feedback on the Service Delivery of the Consumer Financial... title, ``Generic Clearance for the Collection of Qualitative Feedback on the Service Delivery of the...

76 FR 23536 - Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-27

... requirements or power calculations that justify the proposed sample size, the expected response rate, methods... Qualitative Feedback on Agency Service Delivery April 22, 2011. AGENCY: Department of Agriculture (USDA... Qualitative Feedback on Agency Service Delivery'' to OMB for approval under the Paperwork Reduction Act (PRA...

77 FR 28893 - Intent To Request Approval From OMB of One New Public Collection of Information: Generic...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-16

... that justify the proposed sample size, the expected response rate, methods for assessing potential non... Qualitative Feedback on Agency Service Delivery AGENCY: Transportation Security Administration, DHS. ACTION... collection activity provides a means to gather qualitative customer and stakeholder feedback in an efficient...

76 FR 10939 - Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-28

... requirements or power calculations that justify the proposed sample size, the expected response rate, methods... of Qualitative Feedback on Agency Service Delivery AGENCY: Federal Railroad Administration (FRA... Qualitative Feedback on Agency Service Delivery'' to OMB for approval under the Paperwork Reduction Act (PRA...

ANALYSIS OF THE ENANTIOMERS OF CHIRAL PESTICIDES AND OTHER POLLUTANTS IN ENVIRONMENTAL SAMPLES BY CAPILLARY ELECTROPHORESIS

EPA Science Inventory

The generic method described here involves typical capillary electrophoresis (CE) techniques, with the addition of cyclodextrin chiral selectors to the electrolyte for enantiomer separation and also, in the case of neutral analytes, the further addition of a micelle forming comp...

WHO Expert Committee on Specifications for Pharmaceutical Preparations.

PubMed

2014-01-01

The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use, in addition to 20 monographs and general texts for inclusion in The International Pharmacopoeia and 11 new International Chemical Reference Substances. The International Pharmacopoeia--updating mechanism for the section on radiopharmaceuticals; WHO good manufacturing practices for pharmaceutical products: main principles; Model quality assurance system for procurement agencies; Assessment tool based on the model quality assurance system for procurement agencies: aide-memoire for inspection; Guidelines on submission of documentation for prequalification of finished pharmaceutical products approved by stringent regulatory authorities; and Guidelines on submission of documentation for a multisource (generic) finished pharmaceutical product: quality part.

Economic aspects of the new Spanish laws on pharmaceutical preparations.

PubMed

Antoñanzas, Fernando; Oliva, Juan; Pinillos, Mariola; Juàrez, Carmelo

2007-09-01

In this article, we provide readers with a summary of the main economic features of the recently approved Spanish law regarding pharmaceutical preparations entitled the Law of Guarantees and Rational Use of Pharmaceuticals and Health Products (Law 29/2006 of July 26th). We review information on pricing, reference pricing, promotion of generic drugs, public reimbursement, patients' contributions, and penalties. Other aspects of minor economic relevance such as the information on prices shown in the packs and the transparency on the results of clinical trials irrespective of whether these are positive or not, are not addressed in this paper. We conclude with some observations on the new horizons opened up by this new legal framework. We have not included any detailed references to the new law; we merely wish to comment on certain aspects of its application.

The Market Dynamics of Generic Medicines in the Private Sector of 19 Low and Middle Income Countries between 2001 and 2011: A Descriptive Time Series Analysis

PubMed Central

Kaplan, Warren A.; Wirtz, Veronika J.; Stephens, Peter

2013-01-01

This observational study investigates the private sector, retail pharmaceutical market of 19 low and middle income countries (LMICs) in Latin America, Asia and the Middle East/South Africa analyzing the relationships between volume market share of generic and originator medicines over a time series from 2001 to 2011. Over 5000 individual pharmaceutical substances were divided into generic (unbranded generic, branded generic medicines) and originator categories for each country, including the United States as a comparator. In 9 selected LMICs, the market share of those originator substances with the largest decrease over time was compared to the market share of their counterpart generic versions. Generic medicines (branded generic plus unbranded generic) represent between 70 and 80% of market share in the private sector of these LMICs which exceeds that of most European countries. Branded generic medicine market share is higher than that of unbranded generics in all three regions and this is in contrast to the U.S. Although switching from an originator to its generic counterpart can save money, this narrative in reality is complex at the level of individual medicines. In some countries, the market behavior of some originator medicines that showed the most temporal decrease, showed switching to their generic counterpart. In other countries such as in the Middle East/South Africa and Asia, the loss of these originators was not accompanied by any change at all in market share of the equivalent generic version. For those countries with a significant increase in generic medicines market share and/or with evidence of comprehensive “switching” to generic versions, notably in Latin America, it would be worthwhile to establish cause-effect relationships between pharmaceutical policies and uptake of generic medicines. The absence of change in the generic medicines market share in other countries suggests that, at a minimum, generic medicines have not been strongly promoted. PMID:24098644

The market dynamics of generic medicines in the private sector of 19 low and middle income countries between 2001 and 2011: a descriptive time series analysis.

PubMed

Kaplan, Warren A; Wirtz, Veronika J; Stephens, Peter

2013-01-01

This observational study investigates the private sector, retail pharmaceutical market of 19 low and middle income countries (LMICs) in Latin America, Asia and the Middle East/South Africa analyzing the relationships between volume market share of generic and originator medicines over a time series from 2001 to 2011. Over 5000 individual pharmaceutical substances were divided into generic (unbranded generic, branded generic medicines) and originator categories for each country, including the United States as a comparator. In 9 selected LMICs, the market share of those originator substances with the largest decrease over time was compared to the market share of their counterpart generic versions. Generic medicines (branded generic plus unbranded generic) represent between 70 and 80% of market share in the private sector of these LMICs which exceeds that of most European countries. Branded generic medicine market share is higher than that of unbranded generics in all three regions and this is in contrast to the U.S. Although switching from an originator to its generic counterpart can save money, this narrative in reality is complex at the level of individual medicines. In some countries, the market behavior of some originator medicines that showed the most temporal decrease, showed switching to their generic counterpart. In other countries such as in the Middle East/South Africa and Asia, the loss of these originators was not accompanied by any change at all in market share of the equivalent generic version. For those countries with a significant increase in generic medicines market share and/or with evidence of comprehensive "switching" to generic versions, notably in Latin America, it would be worthwhile to establish cause-effect relationships between pharmaceutical policies and uptake of generic medicines. The absence of change in the generic medicines market share in other countries suggests that, at a minimum, generic medicines have not been strongly promoted.

Testing REACH draft technical guidance notes for conducting chemical safety assessments-the experience of a downstream user of a preparation.

PubMed

Gade, Anne Lill; Ovrebø, Steinar; Hylland, Ketil

2008-07-01

The goal of REACH is the safe use of chemicals. This study examines the efficiency and usefulness of two draft technical guidance notes in the REACH Interim Project 3.2-2 for the development of the chemical safety report and exposure scenarios. A case study was carried out for a paint system for protection of structural steel. The focuses of the study were risk assessment of preparations based on Derived No Effect Level (DNEL) and Predicted No Effect Concentrations (PNEC) and on effective and accurate communication in the supply chain. Exposure scenarios and generic descriptions of uses, risk management measures, and exposure determinants were developed. The study showed that communication formats, software tools, and guidelines for chemical risk assessment need further adjustment to preparations and real-life situations. Web platforms may simplify such communication. The downstream formulator needs basic substance data from the substance manufacturer during the pre-registration phase to develop exposure scenarios for preparations. Default values need to be communicated in the supply chain because these were critical for the derivation of applicable risk management demands. The current guidelines which rely on the available toxicological knowledge are insufficient to advise downstream users on how to develop exposure scenarios for preparations.

Generics, Supergenerics and Patent Strategies--SMi's 13th Annual Meeting.

PubMed

Edwards, Catherine

2010-07-01

SMi's 13th Annual Meeting on Generics, Supergenerics and Patent Strategies, held in London, included topics covering new trends in the generics field, the difficulties faced by companies in entering the generics market and recent developments in IP. This conference report highlights selected presentations on generics in India, protecting pharmaceutical products in China, changes in generics law and litigation in the US and Europe, challenges for market selection and entry for generics companies, the influence of changes in the healthcare market on the generics industry, supergenerics, and biosimilars.

Towards a phylogenetic generic classification of Thelypteridaceae: Additional sampling suggests alterations of neotropical taxa and further study of paleotropical genera.

PubMed

Almeida, Thaís Elias; Hennequin, Sabine; Schneider, Harald; Smith, Alan R; Batista, João Aguiar Nogueira; Ramalho, Aline Joseph; Proite, Karina; Salino, Alexandre

2016-01-01

Thelypteridaceae is one of the largest fern families, having about 950 species and a cosmopolitan distribution but with most species occurring in tropical and subtropical regions. Its generic classification remains controversial, with different authors recognizing from one up to 32 genera. Phylogenetic relationships within the family have not been exhaustively studied, but previous studies have confirmed the monophyly of the lineage. Thus far, sampling has been inadequate for establishing a robust hypothesis of infrafamilial relationships within the family. In order to understand phylogenetic relationships within Thelypteridaceae and thus to improve generic reclassification, we expand the molecular sampling, including new samples of Old World taxa and, especially, many additional neotropical representatives. We also explore the monophyly of exclusively or mostly neotropical genera Amauropelta, Goniopteris, Meniscium, and Steiropteris. Our sampling includes 68 taxa and 134 newly generated sequences from two plastid genomic regions (rps4-trnS and trnL-trnF), plus 73 rps4 and 72 trnL-trnF sequences from GenBank. These data resulted in a concatenated matrix of 1980 molecular characters for 149 taxa. The combined data set was analyzed using maximum parsimony and bayesian inference of phylogeny. Our results are consistent with the general topological structure found in previous studies, including two main lineages within the family: phegopteroid and thelypteroid. The thelypteroid lineage comprises two clades; one of these included the segregates Metathelypteris, Coryphopteris, and Amauropelta (including part of Parathelypteris), whereas the other comprises all segregates of Cyclosorus s.l., such as Goniopteris, Meniscium, and Steiropteris (including Thelypteris polypodioides, previously incertae sedis). The three mainly neotropical segregates were found to be monophyletic but nested in a broadly defined Cyclosorus. The fourth mainly neotropical segregate, Amauropelta, was found to include species considered to be part of Parathelypteris. In Old World thelypteroids, which correspond to nearly half the diversity in the family, an increase in sampling is still needed to resolve relationships and circumscription of genera, particularly in the christelloid clade (i.e., Amphineuron, Chingia, Christella, Pneumatopteris, Pronephrium, and Sphaerostephanos). Based on currently available knowledge, we propose the recognition of 16 genera in the family. Copyright © 2015 Elsevier Inc. All rights reserved.

A Generic Framework for Real-Time Multi-Channel Neuronal Signal Analysis, Telemetry Control, and Sub-Millisecond Latency Feedback Generation

PubMed Central

Zrenner, Christoph; Eytan, Danny; Wallach, Avner; Thier, Peter; Marom, Shimon

2010-01-01

Distinct modules of the neural circuitry interact with each other and (through the motor-sensory loop) with the environment, forming a complex dynamic system. Neuro-prosthetic devices seeking to modulate or restore CNS function need to interact with the information flow at the level of neural modules electrically, bi-directionally and in real-time. A set of freely available generic tools is presented that allow computationally demanding multi-channel short-latency bi-directional interactions to be realized in in vivo and in vitro preparations using standard PC data acquisition and processing hardware and software (Mathworks Matlab and Simulink). A commercially available 60-channel extracellular multi-electrode recording and stimulation set-up connected to an ex vivo developing cortical neuronal culture is used as a model system to validate the method. We demonstrate how complex high-bandwidth (>10 MBit/s) neural recording data can be analyzed in real-time while simultaneously generating specific complex electrical stimulation feedback with deterministically timed responses at sub-millisecond resolution. PMID:21060803

Safeguarding the process of drug administration with an emphasis on electronic support tools

PubMed Central

Seidling, Hanna M; Lampert, Anette; Lohmann, Kristina; Schiele, Julia T; Send, Alexander J F; Witticke, Diana; Haefeli, Walter E

2013-01-01

Aims The aim of this work is to understand the process of drug administration and identify points in the workflow that resulted in interventions by clinical information systems in order to improve patient safety. Methods To identify a generic way to structure the drug administration process we performed peer-group discussions and supplemented these discussions with a literature search for studies reporting errors in drug administration and strategies for their prevention. Results We concluded that the drug administration process might consist of up to 11 sub-steps, which can be grouped into the four sub-processes of preparation, personalization, application and follow-up. Errors in drug handling and administration are diverse and frequent and in many cases not caused by the patient him/herself, but by family members or nurses. Accordingly, different prevention strategies have been set in place with relatively few approaches involving e-health technology. Conclusions A generic structuring of the administration process and particular error-prone sub-steps may facilitate the allocation of prevention strategies and help to identify research gaps. PMID:24007450

Bioequivalence of generic alendronate sodium tablets (70 mg) to Fosamax® tablets (70 mg) in fasting, healthy volunteers: a randomized, open-label, three-way, reference-replicated crossover study

PubMed Central

Zhang, Yifan; Chen, Xiaoyan; Tang, Yunbiao; Lu, Youming; Guo, Lixia; Zhong, Dafang

2017-01-01

Purpose The aim of this study was to evaluate the bioequivalence of a generic product 70 mg alendronate sodium tablets with the reference product Fosamax® 70 mg tablet. Materials and methods A single-center, open-label, randomized, three-period, three-sequence, reference-replicated crossover study was performed in 36 healthy Chinese male volunteers under fasting conditions. In each study period, the volunteers received a single oral dose of the generic or reference product (70 mg). Blood samples were collected at pre-dose and up to 8 h after administration. The bioequivalence of the generic product to the reference product was assessed using the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) reference-scaled average bioequivalence (RSABE) methods. Results The average maximum concentrations (Cmax) of alendronic acid were 64.78±43.76, 56.62±31.95, and 60.15±37.12 ng/mL after the single dose of the generic product and the first and second doses of the reference product, respectively. The areas under the plasma concentration–time curves from time 0 to the last timepoint (AUC0–t) were 150.36±82.90, 148.15±85.97, and 167.11±110.87 h⋅ng/mL, respectively. Reference scaling was used because the within-subject standard deviations of the reference product (sWR) for Cmax and AUC0–t were all higher than the cutoff value of 0.294. The 95% upper confidence bounds were −0.16 and −0.17 for Cmax and AUC0–t, respectively, and the point estimates for the generic/reference product ratio were 1.08 and 1.00, which satisfied the RSABE acceptance criteria of the FDA. The 90% CIs for Cmax and AUC0–t were 90.35%–129.04% and 85.31%–117.15%, respectively, which were within the limits of the EMA for the bioequivalence of 69.84%–143.19% and 80.00%–125.00%. Conclusion The generic product was bioequivalent to the reference product in terms of the rate and extent of alendronate absorption after a single 70 mg oral dose under fasting conditions. PMID:28744102

Brand vs generic adverse event reporting patterns: An authorized generic-controlled evaluation of cardiovascular medications.

PubMed

Alatawi, Y; Rahman, Md M; Cheng, N; Qian, J; Peissig, P L; Berg, R L; Page, C D; Hansen, R A

2018-06-01

Some public scepticism exists about generics in terms of whether brand and generic drugs produce identical outcomes. This study explores whether adverse event (AE) reporting patterns are similar between brand and generic drugs, using authorized generics (AGs) as a control for possible generic drug perception biases. Events reported to the FDA Adverse Event Reporting System from the years 2004-2015 were analysed. Drugs were classified as brand, AG or generic based on drug and manufacturer names. Reports were included if amlodipine, losartan, metoprolol extended release (ER) or simvastatin were listed as primary or secondary suspect drugs. Disproportionality analyses using the reporting odds ratio (ROR) assessed the relative rate of reporting labelled AEs compared to reporting these AEs with all other drugs. The Breslow-Day test compared RORs across brand, AG and generic. Interrupted time series analysis evaluated the impact of generic entry on reporting trends. Generics accounted for significant percentages of total U.S. reports, but AGs accounted for smaller percentages of reports, including for amlodipine (14.26%), losartan (1.48%), metoprolol ER (0.35%) and simvastatin (0.70%). Whereas the RORs were significantly different for multiple brand vs generic comparisons, the AG vs generic comparisons yielded fewer statistically significant findings. Namely, only the ROR for AG differed from generic for amlodipine with peripheral oedema (P < .01). Inconsistent reporting patterns were observed more between brand and generic compared with AG and generic. Use of AGs as a control for perception biases against generics is useful, but this approach can be limited by small AG report numbers. Requiring the manufacturer name to be printed on the prescription bottle or packaging could improve the accuracy of assignment for products being reported. © 2017 John Wiley & Sons Ltd.

Comparison of Generic-to-Brand Switchback Rates Between Generic and Authorized Generic Drugs.

PubMed

Hansen, Richard A; Qian, Jingjing; Berg, Richard; Linneman, James; Seoane-Vazquez, Enrique; Dutcher, Sarah K; Raofi, Saeid; Page, C David; Peissig, Peggy

2017-04-01

Generic drugs contain identical active ingredients as their corresponding brand drugs and are pharmaceutically equivalent and bioequivalent, whereas authorized generic drugs (AGs) contain both identical active and inactive ingredients as their corresponding brand drugs but are marketed as generics. This study compares generic-to-brand switchback rates between generic and AGs. Retrospective cohort study. Claims and electronic health record data from a regional U.S. health care system. The full cohort consisted of 5542 unique patients who received select branded drugs during the 6 months prior to their generic drug market availability (between 1999 and 2014) and then were switched to an AG or generic drug within 30 months of generic drug entry. For these patients, 5929 unique patient-drug combinations (867 with AGs and 5062 with generic drugs) were evaluated. Ten drugs with AGs and generics marketed between 1999 and 2014 were evaluated. The date of the first generic prescription was considered the index date for each drug, and it marked the beginning of follow-up to evaluate the occurrence of generic-to-brand switchback patterns over the subsequent 30 months. Switchback rates were compared between patients receiving AGs versus those receiving generics using multivariable Cox proportional hazards models, controlling for individual drug effects, age, sex, Charlson Comorbidity Score, pre-index drug use characteristics, and pre-index health care utilization. Among the 5542 unique patients who switched from brand to generic or brand to AG, 264 (4.8%) switched back to the brand drug. Overall switchback rates were similar for AGs compared with generics (hazard ratio [HR] 0.86, 95% confidence interval [CI] 0.65-1.15). The likelihood of switchback was higher for alendronate (HR 1.64, 95% CI 1.20-2.23) and simvastatin (HR 1.81, 95% CI 1.30-2.54) and lower for amlodipine (HR 0.27, 95% CI 0.17-0.42) compared with the other drugs evaluated. Overall switchback rates were similar between AG and generic drug users, indirectly supporting similar efficacy and tolerability profiles for brand and generic drugs. Reasons for differences in switchback rates among specific products need to be explored further. © 2017 Pharmacotherapy Publications, Inc.

An experiment to fly on mission STS-93 is prepared at Life Sciences Building, CCAS

NASA Technical Reports Server (NTRS)

1999-01-01

In the KSC Life Sciences Building, Hangar L, Cape Canaveral Air Station, Shawn Bengtson, with Lockheed Martin, checks population cages containing fruit flies. The larvae of the flies are part of an experiment that is a secondary payload on mission STS-93. The experiment will examine the effects of microgravity and space flight on the development of neural connections between specific motor neurons and their targets in muscle fibers. That information could lead to understanding the effect of microgravity on human nervous system connectivity. The larvae will be contained in incubators that are part of a Commercial Generic Bioprocessing Apparatus (CGBA), which can start bioprocessing reactions by mixing or heating a sample and can also initiate multiple-step, sequential reactions in a technique called phased processing. The primary payload of mission STS-93 is the Chandra X-ray Observatory, which will allow scientists from around the world to see previously invisible black holes and high-temperature gas clouds, giving the observatory the potential to rewrite the books on the structure and evolution of our universe. The target launch date for STS-93 is July 9, aboard Space Shuttle Columbia, from Launch Pad 39B.

Synthesis cathode material LiNi0.80Co0.15Al0.05O2 with two step solid-state method under air stream

NASA Astrophysics Data System (ADS)

Xia, Shubiao; Zhang, Yingjie; Dong, Peng; Zhang, Yannan

2014-01-01

A facile generic strategy of solid-state reaction under air atmosphere is employed to prepare LiNi0.8Co0.15Al0.05O2 layer structure micro-sphere as cathodes for Li-ion batteries. The impurity phase has been eliminated wholly without changing the R-3m space group of LiNi0.8Co0.15Al0.05O2. The electrochemical performance of LiNi0.8Co0.15Al0.05O2 cathodes depend on the sintering step, temperature, particle size and uniformity. The sample pre-sintered at 540 °C for 12 h and then sintered at 720 °C for 28 h exhibits the best electrochemical performance, which delivers a reversible capacity of 180.4, 165.8, 154.7 and 135.6 mAhg-1 at 0.2 C, 1 C, 2 C and 5 C, respectively. The capacity retention keeps over 87% after 76 cycles at 1 C. This method is simple, cheap and mass-productive, and thus suitable to large scale production of NCA cathodes directly used for lithium ion batteries.

An experiment to fly on mission STS-93 is prepared at Life Sciences Building, CCAS

NASA Technical Reports Server (NTRS)

1999-01-01

In the KSC Life Sciences Building, Hangar L, Cape Canaveral Air Station, Dr. Haig Keshishian checks fruit fly larvae in a petri dish. The larvae are part of an experiment that is a secondary payload on mission STS-93. The experiment will examine the effects of microgravity and space flight on the development of neural connections between specific motor neurons and their targets in muscle fibers. Dr. Keshishian, from Yale University, is the principle investigator for the experiment. The larvae will be contained in incubators that are part of a Commercial Generic Bioprocessing Apparatus (CGBA), which can start bioprocessing reactions by mixing or heating a sample and can also initiate multiple-step, sequential reactions in a technique called phased processing. The primary payload of mission STS-93 is the Chandra X-ray Observatory, which will allow scientists from around the world to see previously invisible black holes and high- temperature gas clouds, giving the observatory the potential to rewrite the books on the structure and evolution of our universe. The target launch date for STS-93 is July 9, aboard Space Shuttle Columbia, from Launch Pad 39B.

Encouraging generic use can yield significant savings.

PubMed

Zimmerman, Christina

2012-11-01

Key findings. (1) Zero copayment for generic drugs is the greatest influencer of generic statin utilization. (2) Both higher copayments for generic drugs and lower copayments for competing brands are associated with a decreased probability of using generic statins. (3) Prior authorization and step therapy requirements for brand-name statins are associated with an increased use of generic drugs. (4) Greater use of generic statins should reduce costs for patients, plans, and Medicare.

Improved Dielectric Properties via Mechano-Chemical Activation in Ba0.80Pb0.20TiO3 Ceramics

NASA Astrophysics Data System (ADS)

Kumar, Parveen; Rani, Renu; Singh, Sangeeta; Juneja, J. K.; Prakash, Chandra; Raina, K. K.

2011-12-01

The present report is about the preparation and dielectric properties of commonly used Ba0.80Pb0.20TiO3 (BPT) ferroelectric ceramic via Mechano-Chemical Activation (MCA). Results were compared by the BPT sample prepared by conventional solid state method. The BPT sample prepared via MCA technique was found to have decreased tetragonality, dielectric constant value (ɛRT = 450 and ɛmax = 6170) approximately double the value for sample prepared by conventional method (ɛRT = 260 and ɛmax = 3275). Also, the sample prepared by MCA was found to be less frequency dependent. Thus, the BPT sample prepared via MCA is more suitable for capacitor applications requiring lesser frequency dependency than the conventionally prepared BPT sample.

27 CFR 4.24 - Generic, semi-generic, and non-generic designations of geographic significance.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Generic, semi-generic, and non-generic designations of geographic significance. 4.24 Section 4.24 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU, DEPARTMENT OF THE TREASURY LIQUORS LABELING AND...

Parts on Demand: Evaluation of Approaches to Achieve Flexible Manufacturing Systems for Navy Partson Demand. Volume 1

DTIC Science & Technology

1984-02-01

measurable impact if changed. The following items were included in the sample: * Mark Zero Items -Low demand insurance items which represent about three...R&D efforts reviewed. The resulting assessment highlighted the generic enabling technologies and cross- cutting R&D projects required to focus current...supplied by spot buys, and which may generate Navy Inventory Control Numbers (NICN). Random samples of data were extracted from the Master Data File ( MDF

Comparison of brand versus generic antiepileptic drug adverse event reporting rates in the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS).

PubMed

Rahman, Md Motiur; Alatawi, Yasser; Cheng, Ning; Qian, Jingjing; Plotkina, Annya V; Peissig, Peggy L; Berg, Richard L; Page, David; Hansen, Richard A

2017-09-01

Despite the cost saving role of generic anti-epileptic drugs (AEDs), debate exists as to whether generic substitution of branded AEDs may lead to therapeutic failure and increased toxicity. This study compared adverse event (AE) reporting rates for brand vs. authorized generic (AG) vs. generic AEDs. Since AGs are pharmaceutically identical to brand but perceived as generics, the generic vs. AG comparison minimized potential bias against generics. Events reported to the U.S. Food and Drug Administration Adverse Event Reporting System between January 2004 to March 2015 with lamotrigine, carbamazepine, and oxcarbazepine listed as primary or secondary suspect were classified as brand, generic, or AG based on the manufacturer. Disproportionality analyses using the reporting odds ratio (ROR) assessed the relative rate of reporting of labeled AEs compared to reporting these events with all other drugs. The Breslow-Day statistic compared RORs across brand, AG, and other generics using a Bonferroni-corrected P<0.01. A total of 27,150 events with lamotrigine, 13,950 events with carbamazepine, and 5077 events with oxcarbazepine were reported, with generics accounting for 27%, 41%, and 32% of reports, respectively. Although RORs for the majority of known AEs were different between brand and generics for all three drugs of interest (Breslow-Day P<0.001), RORs generally were similar for AG and generic comparisons. Generic lamotrigine and carbamazepine were more commonly involved in reports of suicide or suicidal ideation compared with the respective AGs based on a multiple comparison-adjusted P<0.01. Similar AED reporting rates were observed for the AG and generic comparisons for most outcomes and drugs, suggesting that brands and generics have similar reporting rates after accounting for generic perception biases. Disproportional suicide reporting was observed for generics compared with AGs and brand, although this finding needs further study. Copyright © 2017 Elsevier B.V. All rights reserved.

Recent advances in applications of nanomaterials for sample preparation.

PubMed

Xu, Linnan; Qi, Xiaoyue; Li, Xianjiang; Bai, Yu; Liu, Huwei

2016-01-01

Sample preparation is a key step for qualitative and quantitative analysis of trace analytes in complicated matrix. Along with the rapid development of nanotechnology in material science, numerous nanomaterials have been developed with particularly useful applications in analytical chemistry. Benefitting from their high specific areas, increased surface activities, and unprecedented physical/chemical properties, the potentials of nanomaterials for rapid and efficient sample preparation have been exploited extensively. In this review, recent progress of novel nanomaterials applied in sample preparation has been summarized and discussed. Both nanoparticles and nanoporous materials are evaluated for their unusual performance in sample preparation. Various compositions and functionalizations extended the applications of nanomaterials in sample preparations, and distinct size and shape selectivity was generated from the diversified pore structures of nanoporous materials. Such great variety make nanomaterials a kind of versatile tools in sample preparation for almost all categories of analytes. Copyright © 2015 Elsevier B.V. All rights reserved.

The Recent Developments in Sample Preparation for Mass Spectrometry-Based Metabolomics.

PubMed

Gong, Zhi-Gang; Hu, Jing; Wu, Xi; Xu, Yong-Jiang

2017-07-04

Metabolomics is a critical member in systems biology. Although great progress has been achieved in metabolomics, there are still some problems in sample preparation, data processing and data interpretation. In this review, we intend to explore the roles, challenges and trends in sample preparation for mass spectrometry- (MS-) based metabolomics. The newly emerged sample preparation methods were also critically examined, including laser microdissection, in vivo sampling, dried blood spot, microwave, ultrasound and enzyme-assisted extraction, as well as microextraction techniques. Finally, we provide some conclusions and perspectives for sample preparation in MS-based metabolomics.

Microbiological analysis of pre-packed sweet basil (Ocimum basilicum) and coriander (Coriandrum sativum) leaves for the presence of Salmonella spp. and Shiga toxin-producing E. coli.

PubMed

Delbeke, Stefanie; Ceuppens, Siele; Jacxsens, Liesbeth; Uyttendaele, Mieke

2015-09-02

Enteric pathogens, such as Salmonella spp. and pathogenic Escherichia coli, have been detected and associated with food borne outbreaks from (imported) fresh leafy herbs. Screening on imported herbs from South East Asian countries has been described. However, limited information on prevalence of these pathogens is available from other sourcing regions. Therefore, fresh pre-packed basil and coriander leaves from a Belgian trading company were investigated for the presence of Salmonella spp., Shiga toxin-producing E. coli (STEC), generic E. coli and coliforms. In total 592 samples were collected originating from Belgium, Israel and Cyprus during 2013-2014. Multiplex PCR followed by further culture confirmation was used for the detection of Salmonella spp. and STEC, whereas the Petrifilm Select E. coli and VRBL-agar were used, respectively, for the enumeration of E. coli and coliforms. Salmonella was detected in 10 out of 592 samples (25g) (1.7%; 5 from basil and 5 from coriander), of which two samples were sourced from Israel and eight from Cyprus. The presence of STEC was suspected in 11 out of 592 samples (25g) (1.9%; 3 basil and 8 coriander), due to the detection of stx and eae genes, of which one sample originated from Belgium, four from Israel and six from Cyprus. No STEC was isolated by culture techniques, but in three samples a serotype (O26, O103 or O111) with its most likely associated eae-variant (β or θ) was detected by PCR. Generic E. coli was enumerated in 108 out of 592 samples, whereby 55, 32 and 13 samples respectively between 10-100, 100-1000 and 1000-10,000cfu/g and 8 samples exceeding 10,000cfu/g. Coliforms were enumerated in all herb samples at variable levels ranging from 1.6 to 7.5logcfu/g. Further statistics indicate that the E. coli class (categorized by level) was significantly correlated with the presence of Salmonella (p<0.001) or STEC (p=0.019), while coliform counts were significant correlated with Salmonella (p<0.001), but not with STEC (p=0.405). Generic E. coli class is a better indicator for the presence of enteric pathogens than coliforms on fresh herbs, but the relationship between E. coli and Salmonella or STEC was not strong enough to provide a threshold value for E. coli to assure food safety (i.e. no pathogens present). Results indicate that fresh leafy herbs like basil and coriander sourced from different cultivation regions, may contain enteric pathogens and potentially pose a risk for human health. Copyright © 2015 Elsevier B.V. All rights reserved.

Neophyte facilitator experiences of interprofessional education: implications for faculty development.

PubMed

Egan-Lee, Eileen; Baker, Lindsay; Tobin, Stasey; Hollenberg, Elisa; Dematteo, Dale; Reeves, Scott

2011-09-01

The facilitation of learners from different professional groups requires a range of interprofessional knowledge and skills (e.g. an understanding of possible sources of tension between professions) in addition to those that are more generic, such as how to manage a small group of learners. The development and delivery of interprofessional education (IPE) programs tends to rely on a small cohort of facilitators who have typically gained expertise through 'hands-on' involvement in facilitating IPE and through mentorship from more experienced colleagues. To avoid burn-out and to meet a growing demand for IPE, a larger number of facilitators are needed. However, empirical evidence regarding effective approaches to prepare for this type of work is limited. This article draws on data from a multiple case study of four IPE programs based in an urban setting in North America with a sample of neophyte facilitators and provides insight into their perceptions and experiences in preparing for and delivering IPE. Forty-one semi-structured interviews were conducted before (n = 20) and after (n = 21) program delivery with 21 facilitators. Findings indicated that despite participating in a three-fold faculty development strategy designed to support them in their IPE facilitation work, many felt unprepared and continued to have a poor conceptual understanding of core IPE and interprofessional collaboration principles, resulting in problematic implications (e.g. 'missed teachable moments') within their IPE programs. Findings from this study are discussed in relation to the IPE, faculty development and wider educational literature before implications are offered for the future delivery of interprofessional faculty development activities.

Do higher-priced generic medicines enjoy a competitive advantage under reference pricing?

PubMed

Puig-Junoy, Jaume

2012-11-01

In many countries with generic reference pricing, generic producers and distributors compete by means of undisclosed discounts offered to pharmacies in order to reduce acquisition costs and to induce them to dispense their generic to patients in preference over others. The objective of this article is to test the hypothesis that under prevailing reference pricing systems for generic medicines, those medicines sold at a higher consumer price may enjoy a competitive advantage. Real transaction prices for 179 generic medicines acquired by pharmacies in Spain have been used to calculate the discount rate on acquisition versus reimbursed costs to pharmacies. Two empirical hypotheses are tested: the discount rate at which pharmacies acquire generic medicines is higher for those pharmaceutical presentations for which there are more generic competitors; and, the discount rate at which pharmacies acquire generic medicines is higher for those pharmaceutical forms for which the consumer price has declined less in relation to the consumer price of the brand drug before generic entry (higher-priced generic medicines). An average discount rate of 39.3% on acquisition versus reimbursed costs to pharmacies has been observed. The magnitude of the discount positively depends on the number of competitors in the market. The higher the ratio of the consumer price of the generic to that of the brand drug prior to generic entry (i.e. the smaller the price reduction of the generic in relation to the brand drug), the larger the discount rate. Under reference pricing there is intense price competition among generic firms in the form of unusually high discounts to pharmacies on official ex-factory prices reimbursed to pharmacies. However, this effect is highly distorting because it favours those medicines with a higher relative price in relation to the brand price before generic entry.

Questionnaire on the awareness of generic drugs among outpatients and medical staff.

PubMed

Hoshi, S; Kimura, H

2008-06-01

Generic drugs are not as widely used in Japan as they are in the West. The objective of this study was to survey the awareness of generic drugs among outpatients and medical staff and propose methods of promoting the use of generic drugs. Our survey showed that 86.7% of respondents were aware of generic drugs. This is a higher awareness rate than that in a survey of other groups conducted last year. One reason to explain this higher awareness is the recent increase in generic drug advertisements both in newspapers and on television. However, a point of note is that generic drug usage has not increased. Our survey also showed that generic drug awareness was differed widely among age groups, as younger respondents were much more aware of generic drugs than older respondents. Still, about 40% of respondents who were aware of generic drugs did not realize that they were less expensive than name-brand drugs ? including 30% of medical staff. In addition to continuing advertisement of generic drugs in the media, medical doctors and pharmacists should also be encouraged to endorse the use of generic drugs. Furthermore a new system allowing for substitution prescriptions started in April 2008 and consequently pharmacists can now play an important role in promoting the use of generic drugs.

Assessment of the physical properties and stability of mixtures of tetracycline hydrochloride ointment and acyclovir cream.

PubMed

Inoue, Yutaka; Furuya, Kayoko; Maeda, Rikimaru; Murata, Isamu; Kanamoto, Ikuo

2013-04-15

In dermatology, ointments are often mixed as part of drug therapy, but mixing often leads to incompatibility. Three combinations of tetracycline ointment (TC-o) and acyclovir cream (ACV-cr) were prepared at a TC-o:ACV-cr ratio of 1:1 using a brand-name ACV-cr and two generic ACV-cr (samples TC-o+ACV-A, TC-o+ACV-B, and TC-o+ACV-C). Microscopic examination revealed separation in TC-o+ACV-C. Viscosity and elasticity measurement indicated that the storage modulus (G') and loss modulus (G″) of each of the TC-o+ACV-cr mixtures behaved similarly to those of an ACV-cr and the loss tangent (tanδ) behaved similarly to that of a TC ointment. In addition, differences in the storage modulus (G') and loss modulus (G″) of the TC-o+ACV-cr mixtures were noted. To assess stability, each TC-o+ACV-cr mixture was stored away from direct sunlight at 25 °C and an RH of 84% and at 4 °C (in a refrigerator). HPLC revealed that the ACV content in each TC-o+ACV-cr mixture remained at 95-105% for up to 14 days under both sets of storage conditions. A decline in TC content in each TC-o+ACV-cr mixture was not noted with storage at 4 °C but was noted over time with storage at 25 °C and an RH of 84%. In addition, significant differences in the percent decline in TC content in each TC-o+ACV-cr mixture occurred with storage at 25 °C and an RH of 84%. Thus, differences in physical properties and stability may occur when combining brand-name and generic drugs, and temperature and humidity may be the cause of the TC-o's incompatibility. Crown Copyright © 2013. Published by Elsevier B.V. All rights reserved.

Analysis of French generic medicines retail market: why the use of generic medicines is limited.

PubMed

Dylst, Pieter; Vulto, Arnold; Simoens, Steven

2014-12-01

The market share of generic medicines in France is low compared to other European countries. This perspective paper provides an overview of the generic medicines retail market in France and how the current policy environment may affect the long-term sustainability. Looking at the French generic medicines retail market and the surrounding regulatory framework, all conditions seem to be in place to create a healthy generic medicines market: the country has well-respected regulatory authorities, generic medicines enter the market in a timely manner and prices of generic medicines are competitive compared with other European countries. Despite the success of the demand-side policies targeted at pharmacists and patients, those targeted at physicians were less successful due to a lack of enforcement and a lack of trust in generic medicines by French physicians. Recommendations to increase the use of generic medicines in France round off this perspective paper.

Comparison of the antiplatelet effect of two clopidogrel bisulfate formulations: Plavix and generic-Egitromb.

PubMed

Komosa, A; Siller-Matula, J M; Kowal, J; Lesiak, M; Siniawski, A; Mączyński, M; Michalak, M; Mularek-Kubzdela, T; Grajek, S

2015-01-01

Due to expansion of the pharmaceutical market it seems necessary to prove the efficacy of the generic drugs. The aim of this study is to compare the effects of two clopidogrel formulations: brand-name-Plavix and generic drug - Egitromb. This is a prospective, randomized study comparing two groups of patients treated with two clopidogrel: brand-name Plavix and generic drug- Egitromb. The 53 consecutive patients with stable coronary artery disease qualifying for coronary angiography and PCI were enrolled in this trial. They were randomized into two groups. In the group A (n = 28) patients received Egitromb 300 mg at admission followed by 8 days of 75 mg Egitromb daily. In the group B (n = 25) patients received Plavix 300 mg on the admission followed by 8 days of 75 mg Plavix maintenance therapy. Blood samples for multiple electrode aggregometry testing were drawn at baseline, 5 hours and 8 days after taking the loading dose. Median values of platelet aggregation inhibition did not differ between the Plavix and Egitromb groups when assessed at baseline: 239AU/min (IQR:329) vs. 209 (IQR:406; p = 0.894), 5 hours after loading: 183 AU/min (IQR:107) vs. 165 (IQR:171; p = 0.831) or at day 8: 174 AU/min (IQR:133) vs. 211 (IQR:133; p = 0.332. The study showed no difference in the therapeutic effect of two clopidogrel formulations (Egitromb and Plavix).

Reference pricing system and competition: case study from Portugal.

PubMed

Portela, Conceiçăo

2009-10-01

To characterize the patterns of competition for a sample of drugs in the Portuguese pharmaceutical market before (January 2002-March 2003) and after (April 2003-June 2003) the introduction of the reference pricing system (RPS). We performed a descriptive, retrospective, longitudinal analysis, with monthly observations from January 2002 until June 2003 of 15 homogeneous groups. The groups represented the upper limit of public pharmaceutical expenditure in the RPS segment in 2003 (n=270). Measures of competition were: 1) number of presentations; 2) prescriptions' concentration in the generic and originator (brand) segments, using Herfindahl-Hirschman Index (HHI); and 3) dominant positions of market leader in the homogeneous group. A correlation analysis between the number of presentations, the HHI, and the dominant position of the market leader was performed using Pearson coefficient of correlation. The structure of the market changed with the introduction of RPS. We found an increasing number of generic presentations (from 4+/-3 to 7+/-4; mean+/-standard deviation) and a decrease in the HHI for the generics market segment (from 0.7+/-0.2 to 0.6+/-0.3). There was a negative correlation between those variables that increased after the introduction of RPS (from -0.6 to -0.8). The HHI for brands and the dominant positions remained unchanged. After the implementation of RPS, the increased competition was mainly driven by economic and social agents in the generics market segment but not in the brands market segment.

Perception of Generic Prescription Drugs and Utilization of Generic Drug Discount Programs

PubMed Central

Omojasola, Anthony; Hernandez, Mike; Sansgiry, Sujit; Jones, Lovell

2012-01-01

Objective Our study aimed to assess patient’s perceptions of generic drugs and utilization of generic drug discount programs. Design, Setting and Participants A survey was administered to adult participants at community health centers and community-based organizations in Houston, Texas, USA (n=525). Main Outcome Measures Multivariate logistic regression was used to quantify the strength of association between generic drug perception and utilization of generic drug discount programs. Results Respondents who agreed that “Generic prescription drugs are as effective as brand name prescription drugs,” were 3 times as likely to utilize generic drug discount programs (AOR: 3.0, 95% CI: 1.8–4.8, P<.001). Compared to non-Hispanic Whites, African Americans (OR: 10.2; 95% CI: 1.4–76.4) and Hispanics (OR: 10.3; 95% CI: 1.3–79.4) were 10 times as likely to agree that generic drugs have more side effects than brand name drugs. Conclusion Race/ethnicity had no impact in utilization of generic drug discount programs, despite racial disparities in perception toward generic drugs’ side effects and generic drugs being inferior to brand name drugs. PMID:23140080

How much could be saved in Chinese hospitals in procurement of anti-hypertensives and anti-diabetics?

PubMed

Sun, Jing; Ren, Luo; Wirtz, Veronika

2016-09-01

Efficient use of government funding has been increasingly relevant for the success and sustainability of ongoing health-system reform in China; however, as there is no generic substitution policy, patients and basic health-insurance programs pay more for public-preferred brand originators. Such phenomenon is especially typical in public hospitals. The objective of this study is to estimate the potential cost savings in procurement by Chinese public hospitals when switching from brand originators of anti-hypertensive and anti-diabetic medications to their generic equivalents between 2012-2014. IMS Health volume and value consumption data (IMS China Hospitals Audit system 2012-2014) were used, which covered all Chinese hospitals with 100 beds and above. The top 60% IMS volume consumption of respective anti-hypertensive and anti-diabetic medication with unique dosage form and strength were included. The potential cost savings were calculated from a switch of brand originators with their generic equivalents on the Chinese and international market. An independent sample t-test was conducted to compare the difference of proportion of cost savings in value between the Chinese and international market. An average of 44% (US$44 million) and 87% (US$90 million) and a total of US$1.4 and 2.8 billion (2014 US$) could be saved from a switch from originator brand anti-hypertensives and anti-diabetics to domestically and internationally available generic equivalents, respectively. The differences of cost savings (in proportion) between domestic and international market were statistically significant (α = 0.005, p = 0.003, p = 0.002, p = 0.000). Expensive brand originators dominated the anti-hypertensive and anti-diabetic market in Chinese hospitals between 2012-2014. Preference of brand originators wastes a huge amount of health resources in China and these limited resources could have been used more efficiently. As one of the world's key generic suppliers, if China wants to use its health resource more efficiently on medicines, comprehensive measures are needed to address both demand-side (consumers' low trust in the quality of local generics) and supply-side barriers (health professionals' preference of brand originators).

Affordability of adult HIV/AIDS treatment in developing countries: modelling price determinants for a better insight of the market functioning

PubMed Central

Sagaon-Teyssier, Luis; Singh, Sauman; Dongmo-Nguimfack, Boniface; Moatti, Jean-Paul

2016-01-01

Introduction This study aims to provide a landscape of the global antiretroviral (ARV) market by analyzing the transactional data on donor-funded ARV procurement between 2003 and 2015, and the ARV price determinants. Design The data were obtained from the Global Price Reporting Mechanism (GPRM) managed by the AIDS Medicines and Diagnostics Service of the WHO, and it consists of information that covers approximately 80% of the total donor-funded adult ARV transactions procurement. Methods ExWorks prices and procured quantities were standardized according to the guidelines in terms of yearly doses. Descriptive statistics on quantities and prices show the main trends of the ARV market. Ordinary least squares estimation was carried out for the whole sample, then stratified according to the type of supplier (originator and generic) and controlled for time and geographical fixed-effects. Given that analyses were carried out on a public dataset on ARV transactional prices from the GPRM, ethics are respected and consent was not necessary. Results Originator medicines are on average the least expensive in the sub-Saharan Africa region, where at the same time, generic medicines are on average the most expensive. By contrast, originator medicines are the most expensive in Europe and Central Asia, and generic medicines are the least expensive. In fact, the data suggest mixed strategies by ARV suppliers to exploit opportunities for profit maximization and to adapt to the specific conditions of market competition in each region. Our results also suggest that the expiration of patents is not sufficient to boost additional developments in generic competition (at least in the ARV market) and that formal or informal agreements between generic firms may de facto slow down or even reverse long-term trends towards price decreases. Conclusions Our findings provide an improved understanding of the ARV market that can help countries strengthen policy measures to increase their bargaining power in price negotiations and the use of TRIPS flexibilities, with a special emphasis on negotiations with generic manufacturers. PMID:27765142

Perceived Use of Inquiry Teaching by a Sample of Malaysian Biology Teachers.

ERIC Educational Resources Information Center

Ismail, Nor Asma; Rubba, Peter A.

1981-01-01

Determined degree to which Malaysian biology teachers (N=26) perceived they understood and used inquiry teaching. Data indicated that these teachers perceived they had a moderate amount of knowledge about inquiry and occasionally used the 21 inquiry-related behaviors assessed by "A Generic Problem Solving (Inquiry) Model" (Hungerford,…

78 FR 17210 - Agency Information Collection Activities; Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-20

... questions, the Bureau of the Census, at AHRQ's direction, conducted a pretest of these questions on a sampled set of 2012 MEPS-IC survey respondents. A telephone pretest was conducted in the spring and summer of 2012. The results of this pretest, conducted under the Census Bureau's generic pretest clearance...

77 FR 76043 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-26

... a pretest of these questions on a sampled set of 2012 MEPS-IC survey respondents. A telephone pretest was conducted in the spring and summer of 2012. The results of this pretest, conducted under the Census Bureau's generic pretest clearance process, led to AHRQ recommending that a subset of the tested...

On the use of ultracentrifugal devices for routine sample preparation in biomolecular magic-angle-spinning NMR

PubMed Central

Mandal, Abhishek; Boatz, Jennifer C.; Wheeler, Travis; van der Wel, Patrick C. A.

2017-01-01

A number of recent advances in the field of magic-angle-spinning (MAS) solid-state NMR have enabled its application to a range of biological systems of ever increasing complexity. To retain biological relevance, these samples are increasingly studied in a hydrated state. At the same time, experimental feasibility requires the sample preparation process to attain a high sample concentration within the final MAS rotor. We discuss these considerations, and how they have led to a number of different approaches to MAS NMR sample preparation. We describe our experience of how custom-made (or commercially available) ultracentrifugal devices can facilitate a simple, fast and reliable sample preparation process. A number of groups have since adopted such tools, in some cases to prepare samples for sedimentation-style MAS NMR experiments. Here we argue for a more widespread adoption of their use for routine MAS NMR sample preparation. PMID:28229262

Similarities and differences in dream content at the cross-cultural, gender, and individual levels.

PubMed

William Domhoff, G; Schneider, Adam

2008-12-01

The similarities and differences in dream content at the cross-cultural, gender, and individual levels provide one starting point for carrying out studies that attempt to discover correspondences between dream content and various types of waking cognition. Hobson and Kahn's (Hobson, J. A., & Kahn, D. (2007). Dream content: Individual and generic aspects. Consciousness and Cognition, 16, 850-858.) conclusion that dream content may be more generic than most researchers realize, and that individual differences are less salient than usually thought, provides the occasion for a review of findings based on the Hall and Van de Castle (Hall, C., & Van de Castle, R. (1966). The content analysis of dreams. New York: Appleton-Century-Crofts.) coding system for the study of dream content. Then new findings based on a computationally intensive randomization strategy are presented to show the minimum sample sizes needed to detect gender and individual differences in dream content. Generally speaking, sample sizes of 100-125 dream reports are needed because most dream elements appear in less than 50% of dream reports and the magnitude of the differences usually is not large.

The Portuguese generic medicines market: a policy analysis

PubMed Central

Simoens, Steven

2008-01-01

Objectives: This study aims to conduct a descriptive analysis of the policy environment surrounding the generic medicines retail market in Portugal. The policy analysis focuses on supply-side measures (i.e. market access, pricing, reference-pricing and reimbursement of generic medicines) and demand-side measures (i.e. incentives for physicians to prescribe, for pharmacists to dispense and for patients to use generic medicines). Methods: The policy analysis was based on an international literature review. Also, a simulation exercise was carried out to compute potential savings from substituting generic for originator medicines in Portugal using IMS Health data. Results: Portugal has developed a successful generic medicines market by increasing reimbursement of generic medicines (until October 2005), by introducing a reference-pricing system, by encouraging physicians to prescribe by international non-proprietary name (INN), and by allowing generic substitution by pharmacists. However, the development of the generic medicines market has been hindered by the existence of copies, pricing regulation, certain features of the reference-pricing system, weak incentives for physicians to prescribe generic medicines and a financial disincentive for pharmacists to dispense generic medicines. Increased generic substitution would be expected to reduce public expenditure on originator medicines by 45%. Conclusions: The development of the Portuguese generic medicines market has mainly been fuelled by supply-side measures. To support the further expansion of the market, policy makers need to strengthen demand-side measures inciting physicians to prescribe, pharmacists to dispense and patients to use generic medicines. PMID:25152781

RT-PCR for detection of all seven genotypes of Lyssavirus genus.

PubMed

Vázquez-Morón, S; Avellón, A; Echevarría, J E

2006-08-01

The Lyssavirus genus includes seven species or genotypes named 1-7. Rabies genotypes correlate with geographical distribution and specific hosts. Co-circulation of different lyssaviruses, imported cases, and the presence of unknown viruses, such as Aravan, Khujand, Irkut and West Caucasian Bat Virus, make it necessary to use generic methods able to detect all lyssaviruses. Primer sequences were chosen from conserved regions in all genotypes in order to optimise a generic RT-PCR. Serial dilutions of 12 RNA extracts from all seven Lyssavirus genotypes were examined to compare the sensitivity of the RT-PCR standardised in this study with a published RT-PCR optimised for EBLV1 detection and capable of amplifying RNA from all seven lyssaviruses. All seven genotypes were detected by both RT-PCRs, however, the sensitivity was higher with the new version of the test. Twenty samples submitted for rabies diagnosis were tested by the new RT-PCR. Eight out of 20 samples from six dogs, one horse and one bat were found positive, in agreement with immunofluorescence results. Seven samples from terrestrial mammals were genotype 1 and one from a bat was genotype 5. In conclusion, this method can be used to complement immunofluorescence for the diagnosis of rabies, enabling the detection of unexpected lyssaviruses during rabies surveillance.

Measuring performance in off-patent drug markets: a methodological framework and empirical evidence from twelve EU Member States.

PubMed

Kanavos, Panos

2014-11-01

This paper develops a methodological framework to help evaluate the performance of generic pharmaceutical policies post-patent expiry or after loss of exclusivity in non-tendering settings, comprising five indicators (generic availability, time delay to and speed of generic entry, number of generic competitors, price developments, and generic volume share evolution) and proposes a series of metrics to evaluate performance. The paper subsequently tests this framework across twelve EU Member States (MS) by using IMS data on 101 patent expired molecules over the 1998-2010 period. Results indicate that significant variation exists in generic market entry, price competition and generic penetration across the study countries. Size of a geographical market is not a predictor of generic market entry intensity or price decline. Regardless of geographic or product market size, many off patent molecules lack generic competitors two years after loss of exclusivity. The ranges in each of the five proposed indicators suggest, first, that there are numerous factors--including institutional ones--contributing to the success of generic entry, price decline and market penetration and, second, MS should seek a combination of supply and demand-side policies in order to maximise cost-savings from generics. Overall, there seems to be considerable potential for faster generic entry, uptake and greater generic competition, particularly for molecules at the lower end of the market. Copyright © 2014. Published by Elsevier Ireland Ltd.

Gas chromatographic quadrupole time-of-flight full scan high resolution mass spectrometric screening of human urine in antidoping analysis.

PubMed

Abushareeda, Wadha; Lyris, Emmanouil; Kraiem, Suhail; Wahaibi, Aisha Al; Alyazidi, Sameera; Dbes, Najib; Lommen, Arjen; Nielen, Michel; Horvatovich, Peter L; Alsayrafi, Mohammed; Georgakopoulos, Costas

2017-09-15

This paper presents the development and validation of a high-resolution full scan (FS) electron impact ionization (EI) gas chromatography coupled to quadrupole Time-of-Flight mass spectrometry (GC/QTOF) platform for screening anabolic androgenic steroids (AAS) in human urine samples. The World Antidoping Agency (WADA) enlists AAS as prohibited doping agents in sports, and our method has been developed to comply with the qualitative specifications of WADA to be applied for the detection of sports antidoping prohibited substances, mainly for AAS. The method also comprises of the quantitative analysis of the WADA's Athlete Biological Passport (ABP) endogenous steroidal parameters. The applied preparation of urine samples includes enzymatic hydrolysis for the cleavage of the Phase II glucuronide conjugates, generic liquid-liquid extraction and trimethylsilyl (TMS) derivatization steps. Tandem mass spectrometry (MS/MS) acquisition was applied on few selected ions to enhance the specificity and sensitivity of GC/TOF signal of few compounds. The full scan high resolution acquisition of analytical signal, for known and unknown TMS derivatives of AAS provides the antidoping system with a new analytical tool for the detection designer drugs and novel metabolites, which prolongs the AAS detection, after electronic data files' reprocessing. The current method is complementary to the respective liquid chromatography coupled to mass spectrometry (LC/MS) methodology widely used to detect prohibited molecules in sport, which cannot be efficiently ionized with atmospheric pressure ionization interface. Copyright © 2017 Elsevier B.V. All rights reserved.

GOST: A generic ordinal sequential trial design for a treatment trial in an emerging pandemic.

PubMed

Whitehead, John; Horby, Peter

2017-03-01

Conducting clinical trials to assess experimental treatments for potentially pandemic infectious diseases is challenging. Since many outbreaks of infectious diseases last only six to eight weeks, there is a need for trial designs that can be implemented rapidly in the face of uncertainty. Outbreaks are sudden and unpredictable and so it is essential that as much planning as possible takes place in advance. Statistical aspects of such trial designs should be evaluated and discussed in readiness for implementation. This paper proposes a generic ordinal sequential trial design (GOST) for a randomised clinical trial comparing an experimental treatment for an emerging infectious disease with standard care. The design is intended as an off-the-shelf, ready-to-use robust and flexible option. The primary endpoint is a categorisation of patient outcome according to an ordinal scale. A sequential approach is adopted, stopping as soon as it is clear that the experimental treatment has an advantage or that sufficient advantage is unlikely to be detected. The properties of the design are evaluated using large-sample theory and verified for moderate sized samples using simulation. The trial is powered to detect a generic clinically relevant difference: namely an odds ratio of 2 for better rather than worse outcomes. Total sample sizes (across both treatments) of between 150 and 300 patients prove to be adequate in many cases, but the precise value depends on both the magnitude of the treatment advantage and the nature of the ordinal scale. An advantage of the approach is that any erroneous assumptions made at the design stage about the proportion of patients falling into each outcome category have little effect on the error probabilities of the study, although they can lead to inaccurate forecasts of sample size. It is important and feasible to pre-determine many of the statistical aspects of an efficient trial design in advance of a disease outbreak. The design can then be tailored to the specific disease under study once its nature is better understood.

A study of psychrophilic organisms isolated from the manufacture and assembly areas of spacecraft to be used in the Viking mission, 1 January - 30 June 1973

NASA Technical Reports Server (NTRS)

Foster, T. L.; Winans, L., Jr.

1973-01-01

Soil samples from the areas associated with the Viking spacecraft were analyzed for major generic groups of microorganisms and the percentage of obligate psychrophiles. Results are presented which show the distribution of organisms isolated at low temperatures and the methods employed for subjecting samples to simulated Martian conditions. Emphasis is placed on application of these results to the objectives of the quarantine program.

[Generic drugs: good or bad? Physician's knowledge of generic drugs and prescribing habits].

PubMed

García, A J; Martos, F; Leiva, F; Sánchez de la Cuesta, F

2003-01-01

In this article we analyze the responses of 1220 Spanish physicians who participated in a survery about generic drugs. A previously validated questionnaire was sent to physicians through the Spanish Medical Councils of the different provinces. Four items were analyzed: what doctors know about generic drugs (knowledge); physicians' prescribing habits concerning these drugs (attitude and professional competence); how prescription of generic drugs effects pharmaceutical costs amd, finally, what doctors believe a generic drug should be. The influence of physician-related variables (age, type of contract, specialty, workload, etc.) on prescribing of generic drugs was also analyzed. In view of the results, we believe that to rationalize expenditure through and appropriate policy on generic drugs Spanish health authorities should offer more and better training and information (clear and independent) about what generic drugs are.

Anaplasma phagocytophilum, Bartonella spp., haemoplasma species and Hepatozoon spp. in ticks infesting cats: a large-scale survey.

PubMed

Duplan, Florent; Davies, Saran; Filler, Serina; Abdullah, Swaid; Keyte, Sophie; Newbury, Hannah; Helps, Chris R; Wall, Richard; Tasker, Séverine

2018-03-20

Ticks derived from cats have rarely been evaluated for the presence of pathogens. The aim of this study was to determine the prevalence of Anaplasma phagocytophilum, Bartonella spp., haemoplasma species and Hepatozoon spp. in ticks collected from cats in the UK. Five hundred and forty DNA samples extracted from 540 ticks collected from cats presenting to veterinarians in UK practices were used. Samples underwent a conventional generic PCR assay for detection of Hepatozoon spp. and real-time quantitative PCR assays for detection of Anaplasma phagocytophilum and three feline haemoplasma species and a generic qPCR for detection of Bartonella spp. Feline 28S rDNA served as an endogenous internal PCR control and was assessed within the haemoplasma qPCR assays. Samples positive on the conventional and quantitative generic PCRs were submitted for DNA sequencing for species identification. Feline 28S rDNA was amplified from 475 of the 540 (88.0%) ticks. No evidence of PCR inhibition was found using an internal amplification control. Of 540 ticks, 19 (3.5%) contained DNA from one of the tick-borne pathogens evaluated. Pathogens detected were: A. phagocytophilum (n = 5; 0.9%), Bartonella spp. (n = 7; 1.3%) [including Bartonella henselae (n = 3; 0.6%) and Bartonella clarridgeiae (n = 1; 0.2%)], haemoplasma species (n = 5; 0.9%), "Candidatus Mycoplasma haemominutum" (n = 3; 0.6%), Mycoplasma haemofelis (n = 1; 0.2%), "Candidatus Mycoplasma turicensis" (n = 1; 0.2%), Hepatozoon spp. (n = 2; 0.4%), Hepatozoon felis (n = 1; 0.2%) and Hepatozoon silvestris (n = 1; 0.2%). These data provide important information on the prevalence of tick-borne pathogens in ticks infesting cats, with the identification of haemoplasma species, A. phagocytophilum, H. felis and Bartonella spp. (including B. henselae and B. clarridgeiae). This study also documents the first report of H. silvestris in ticks collected from domestic cats.

76 FR 17182 - Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-28

... Activities: Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative... Request (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service...: Title: Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery. Abstract...

Generic Example Proving Criteria for All

ERIC Educational Resources Information Center

Yopp, David; Ely, Rob; Johnson­-Leung, Jennifer

2015-01-01

We review literature that discusses generic example proving and highlight ambiguities that pervade our research community's discourse about generic example arguments. We distinguish between pedagogical advice for choosing good examples that can serve as generic examples when teaching and advice for developing generic example arguments. We provide…

Production and Purification of Recombinant Filamentous Bacteriophages Displaying Immunogenic Heterologous Epitopes.

PubMed

Deng, Lei; Linero, Florencia; Saelens, Xavier

2016-01-01

Viruslike particles often combine high physical stability with robust immunogenicity. Furthermore, when such particles are based on bacteriophages, they can be produced in high amounts at minimal cost and typically will require only standard biologically contained facilities. We provide protocols for the characterization and purification of recombinant viruslike particles derived from filamentous bacteriophages. As an example, we focus on filamentous Escherichia coli fd phage displaying a conserved influenza A virus epitope that is fused genetically to the N-terminus of the major coat protein of this phage. A step-by-step procedure to obtain a high-titer, pure recombinant phage preparation is provided. We also describe a quality control experiment based on a biological readout of the purified fd phage preparation. These protocols together with the highlighted critical steps may facilitate generic implementation of the provided procedures for the display of other epitopes by recombinant fd phages.

Deceleration, precooling, and multi-pass stopping of highly charged ions in Be{sup +} Coulomb crystals

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

Schmöger, L., E-mail: lisa.schmoeger@mpi-hd.mpg.de; Schwarz, M.; Versolato, O. O.

2015-10-15

Preparing highly charged ions (HCIs) in a cold and strongly localized state is of particular interest for frequency metrology and tests of possible spatial and temporal variations of the fine structure constant. Our versatile preparation technique is based on the generic modular combination of a pulsed ion source with a cryogenic linear Paul trap. Both instruments are connected by a compact beamline with deceleration and precooling properties. We present its design and commissioning experiments regarding these two functionalities. A pulsed buncher tube allows for the deceleration and longitudinal phase-space compression of the ion pulses. External injection of slow HCIs, specificallymore » Ar{sup 13+}, into the linear Paul trap and their subsequent retrapping in the absence of sympathetic cooling is demonstrated. The latter proved to be a necessary prerequisite for the multi-pass stopping of HCIs in continuously laser-cooled Be{sup +} Coulomb crystals.« less

Perspectives of physicians practicing in low and middle income countries towards generic medicines: a narrative review.

PubMed

Hassali, Mohamed Azmi; Wong, Zhi Yen; Alrasheedy, Alian A; Saleem, Fahad; Mohamad Yahaya, Abdul Haniff; Aljadhey, Hisham

2014-09-01

This review was conducted to document published literature related to physicians' knowledge, attitudes, and perceptions of generic medicines in low- and middle-income countries (LMICs) and to compare the findings with high-income countries. A systematic search of articles published in peer-reviewed journals from January 2001 to February 2013 was performed. The search comprised nine electronic databases. The search strategy involved using Boolean operators for combinations of the following terms: generic medicines, generic medications, generic drugs, generic, generic substitution, generic prescribing, international non-proprietary, prescribers, doctors, general practitioners, physicians, and specialists. Sixteen articles were included in this review. The majority (n=11) were from high income countries and five from LMICs. The main difference between high income countries and LMICs is that physicians from high income countries generally have positive views whereas those from LMICs tend to have mixed views regarding generic medicines. Few similarities were identified among different country income groups namely low level of physicians' knowledge of the basis of bioequivalence testing, cost of generic medicines as an encouraging factor for generic medicine prescribing, physicians' concerns towards safety and quality of generic medicines and effect of pharmaceutical sales representative on generic medicine prescribing. The present literature review revealed that physicians from LMICs tend to have mixed views regarding generic medicines. This may be due to differences in the health care system and pharmaceutical funding system, medicine policies, the level of educational interventions, and drug information sources in countries of different income levels. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Assessing bioequivalence of generic antiepilepsy drugs.

PubMed

Krauss, Gregory L; Caffo, Brian; Chang, Yi-Ting; Hendrix, Craig W; Chuang, Kelly

2011-08-01

Patients with epilepsy are often concerned that switching between brand-name and generic formulations of antiepilepsy drugs (AEDs) may cause clinically significant changes in plasma drug concentrations. We assessed bioequivalence (BE) studies for approved generic AEDs to evaluate US Food and Drug Administration claims that: (1) generic AEDs are accurate copies of reference formulations; (2) delivery of reference formulations may be as variable as generic AEDs and so provide no increased benefit; and (3) switches between generic AED formulations are safe and effective. We determined differences in 90% confidence interval limits for total drug exposure (AUC(0-t) ) and peak concentration (Cmax) ratios of generic and reference formulations during fasting and fed BE studies. We simulated BE between generic formulations after adjusting for reference values. AUC(0-t) values of approved reference and generic formulations differed by <15% in 99% of BE studies; Cmax differed by <15% in 89% of studies. Food affected variability of Cmax but not AUC(0-t) . Intersubject variability in Cmax and AUC(0-t) was small and similar for reference and generic products. In simulated switches between 595 pairs of generic AED formulations, estimated AUC(0-t) differed by >15% for 17% of pairs; estimated Cmax differed by >15% for 39%. AEDs with low bioavailability and solubility (eg, oxcarbazepine) had the greatest variability in BE. Most generic AED products provide total drug delivery (AUC) similar to reference products; differences in peak concentrations between formulations are more common. Switches between generic AED products may cause greater changes in plasma drug concentrations than generic substitutions of reference products. Copyright © 2011 American Neurological Association.

Incorporating a Generic Model of Subcutaneous Insulin Absorption into the AIDA v4 Diabetes Simulator: 1. A Prospective Collaborative Development Plan

PubMed Central

Lehmann, Eldon D.; Tarín, Cristina; Bondia, Jorge; Teufel, Edgar; Deutsch, Tibor

2007-01-01

Introduction AIDA v4 is an interactive educational diabetes simulator that has been made available, for over a decade, without charge via the Internet. The software is currently freely accessible at http://www.2aida.org. This report sets out a collaborative development plan to enhance the program with a new model of subcutaneous insulin absorption, which permits the simulation of rapidly acting and very long-acting insulin analogues, as well as insulin injection doses larger than 40 units. Methods A novel, generic, physiological subcutaneous insulin absorption model is overviewed and a methodology is proposed by which this can be substituted in place of the previously adopted insulin absorption model utilized within AIDA v4.3a. Apart from this substitution it is proposed to retain the existing model of the glucoregulatory system currently used in AIDA v4.3a. Results Initial simulation results based on bench testing of this approach using MATLAB are presented for the exogenous insulin flow profile (Iex) following subcutaneous injections of a rapidly acting insulin analogue, a short-acting (regular) insulin preparation, intermediate-acting insulins (both Semilente and neutral protamine Hagedorn types), and a very long-acting insulin analogue. Discussion It is proposed to implement this collaborative development plan—first by bench testing the approach in MATLAB and then by integrating the generic subcutaneous insulin absorption Iex model into the AIDA simulator in Pascal. The aim is to provide enhanced functionality and educational simulations of regimens utilizing novel insulin analogues, as well as injections larger than 40 units of insulin. PMID:19885100

A single-centre comparison of the clinical outcomes at 6 months of renal transplant recipients administered Adoport® or Prograf® preparations of tacrolimus

PubMed Central

Connor, Andrew; Prowse, Andrew; Newell, Paul; Rowe, Peter A.

2013-01-01

Background The use of generic formulations of immunosuppressive drugs in place of brand name drugs offers considerable cost savings. Brand name tacrolimus (Prograf®) came off patent in April 2008. However, published evidence supporting therapeutic equivalence of generic formulations of tacrolimus in solid organ transplantation is lacking. The South West Transplant Centre switched from administering Prograf® to a generic formulation (Adoport®) for de novo transplant recipients in November 2010. This study sought to compare the clinical outcomes of renal transplant recipients administered Prograf® with those receiving Adoport®. Methods Data regarding patient characteristics and clinical outcomes were collected retrospectively for all patients undergoing renal transplantation at the South West Transplant Centre between 8 November 2009 and 8 November 2011 to whom tacrolimus was prescribed. Results A total of 48 patients received Prograf® and 51 received Adoport®. At 6 months, no statistically significant differences were identified in the rates of patient survival, graft survival, acute allograft rejection, delayed graft function, calcineurin inhibitor toxicity or cytomegalovirus infection occurring within the two groups. Conclusions This is the first study to compare the clinical outcomes of patients receiving Adoport® with those receiving brand name tacrolimus. We report comparable clinical outcomes at 6 months in patients receiving either Prograf® or Adoport® from the time of renal transplantation. These early outcome data therefore support the use of Adoport® in place of Prograf® as a potential cost-saving measure. PMID:27818747

A comparison of two brands of clopidogrel in patients with drug-eluting stent implantation.

PubMed

Park, Yae Min; Ahn, Taehoon; Lee, Kyounghoon; Shin, Kwen-Chul; Jung, Eul Sik; Shin, Dong Su; Kim, Myeong Gun; Kang, Woong Chol; Han, Seung Hwan; Choi, In Suck; Shin, Eak Kyun

2012-07-01

Although generic clopidogrel is widely used, clinical efficacy and safety between generic and original clopidogrel had not been well evaluated. The aim of this study was to evaluate the clinical outcomes of 2 oral formulations of clopidogrel 75 mg tablets in patients with coronary artery disease (CAD) undergoing drug-eluting stent (DES) implantation. Between July 2006 and February 2009, 428 patients that underwent implantation with DES for CAD and completed >1 year of clinical follow-up were enrolled in this study. Patients were divided into the following 2 groups based on treatment formulation, Platless® (test formulation, n=211) or Plavix® (reference formulation, n=217). The incidence of 1-year major adverse cardiovascular and cerebrovascular event (MACCE) and stent thrombosis (ST) were retrospectively reviewed. The baseline demographic and procedural characteristics were not significantly different between two treatment groups. The incidence of 1-year MACCEs was 8.5% {19/211, 2 deaths, 4 myocardial infarctions (MIs), 2 strokes, and 11 target vessel revascularizations (TVRs)} in Platless® group vs. 7.4% (16/217, 4 deaths, 1 MI, 2 strokes, and 9 TVRs) in Plavix® group (p=0.66). The incidence of 1-year ST was 0.5% (1 definite and subacute ST) in Platless® group vs. 0% in Plavix® group (p=0.49). In this study, the 2 tablet preparations of clopidogrel showed similar rates of MACCEs, but additional prospective randomized studies with pharmacodynamics and platelet reactivity are needed to conclude whether generic clopidgrel may replace original clopidogrel.

MilQuant: a free, generic software tool for isobaric tagging-based quantitation.

PubMed

Zou, Xiao; Zhao, Minzhi; Shen, Hongyan; Zhao, Xuyang; Tong, Yuanpeng; Wang, Qingsong; Wei, Shicheng; Ji, Jianguo

2012-09-18

Isobaric tagging techniques such as iTRAQ and TMT are widely used in quantitative proteomics and especially useful for samples that demand in vitro labeling. Due to diversity in choices of MS acquisition approaches, identification algorithms, and relative abundance deduction strategies, researchers are faced with a plethora of possibilities when it comes to data analysis. However, the lack of generic and flexible software tool often makes it cumbersome for researchers to perform the analysis entirely as desired. In this paper, we present MilQuant, mzXML-based isobaric labeling quantitator, a pipeline of freely available programs that supports native acquisition files produced by all mass spectrometer types and collection approaches currently used in isobaric tagging based MS data collection. Moreover, aside from effective normalization and abundance ratio deduction algorithms, MilQuant exports various intermediate results along each step of the pipeline, making it easy for researchers to customize the analysis. The functionality of MilQuant was demonstrated by four distinct datasets from different laboratories. The compatibility and extendibility of MilQuant makes it a generic and flexible tool that can serve as a full solution to data analysis of isobaric tagging-based quantitation. Copyright © 2012 Elsevier B.V. All rights reserved.

Generic element processor (application to nonlinear analysis)

NASA Technical Reports Server (NTRS)

Stanley, Gary

1989-01-01

The focus here is on one aspect of the Computational Structural Mechanics (CSM) Testbed: finite element technology. The approach involves a Generic Element Processor: a command-driven, database-oriented software shell that facilitates introduction of new elements into the testbed. This shell features an element-independent corotational capability that upgrades linear elements to geometrically nonlinear analysis, and corrects the rigid-body errors that plague many contemporary plate and shell elements. Specific elements that have been implemented in the Testbed via this mechanism include the Assumed Natural-Coordinate Strain (ANS) shell elements, developed with Professor K. C. Park (University of Colorado, Boulder), a new class of curved hybrid shell elements, developed by Dr. David Kang of LPARL (formerly a student of Professor T. Pian), other shell and solid hybrid elements developed by NASA personnel, and recently a repackaged version of the workhorse shell element used in the traditional STAGS nonlinear shell analysis code. The presentation covers: (1) user and developer interfaces to the generic element processor, (2) an explanation of the built-in corotational option, (3) a description of some of the shell-elements currently implemented, and (4) application to sample nonlinear shell postbuckling problems.

The risks and costs of multiple-generic substitution of topiramate.

PubMed

Duh, M S; Paradis, P E; Latrémouille-Viau, D; Greenberg, P E; Lee, S P; Durkin, M B; Wan, G J; Rupnow, M F T; LeLorier, J

2009-06-16

To investigate clinical and economic consequences following generic substitution of one vs multiple generics of topiramate (Topamax; Ortho-McNeil Neurologics, Titusville, NJ). Medical and pharmacy claims data of Régie de l'Assurance-Maladie du Québec from January 2006 to October 2007 were used. Patients with epilepsy treated with topiramate were selected. An open-cohort design was used to classify the observation period into periods of brand, single-generic, and multiple-generic use. One-year generic-switch and switchback-to-brand rates were estimated using Kaplan-Meier methodology. Medical resource utilization and costs were compared among the three periods using multivariate regression analysis. In total, 948 patients were observed during 1,105 person-years of brand use, 233 person-years of single-generic use, and 92 person-years of multiple-generic use. A total of 23% of generic users received at least two different generic versions. Compared to brand use, multiple-generic use was associated with higher utilization of other prescription drugs (incidence rate ratio [IRR] = 1.27, 95% confidence interval [CI] = 1.24-1.31), higher hospitalization rates (0.48 vs 0.83 visit/person-year, IRR = 1.65, 95% CI = 1.28-2.13), and longer hospital stays (2.6 vs 3.9 days/person-year, IRR = 1.43, 95% CI = 1.27-1.60), but the effect was less pronounced in single-generic use (hospitalization: IRR = 1.08, 95% CI = 0.88-1.34, length of stay: IRR = 1.12, 95% CI = 1.03-1.23). The risk of head injury or fracture was nearly three times higher (hazard ratio = 2.84, 95% CI = 1.24-6.48) following a generic-to-generic switch compared to brand use. The total annualized health care cost per patient was higher in the multiple-generic than brand periods by C$1,716 (cost ratio = 1.21, p = 0.0420). Multiple-generic substitution of topiramate was significantly associated with negative outcomes, such as hospitalizations and injuries, and increased health care costs.

76 FR 39893 - Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-07

...; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery... (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery.... SUPPLEMENTARY INFORMATION: Title: Generic Clearance for the Collection of Qualitative Feedback on Agency Service...

76 FR 19359 - Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-07

... Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery AGENCY... Information Collection Request (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback...: Title: Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery. Abstract...

A "three-in-one" sample preparation method for simultaneous determination of B-group water-soluble vitamins in infant formula using VitaFast(®) kits.

PubMed

Zhang, Heng; Lan, Fang; Shi, Yupeng; Wan, Zhi-Gang; Yue, Zhen-Feng; Fan, Fang; Lin, Yan-Kui; Tang, Mu-Jin; Lv, Jing-Zhang; Xiao, Tan; Yi, Changqing

2014-06-15

VitaFast(®) test kits designed for the microbiological assay in microtiter plate format can be applied to quantitative determination of B-group water-soluble vitamins such as vitamin B12, folic acid and biotin, et al. Compared to traditional microbiological methods, VitaFast(®) kits significantly reduce sample processing time and provide greater reliability, higher productivity and better accuracy. Recently, simultaneous determination of vitamin B12, folic acid and biotin in one sample is urgently required when evaluating the quality of infant formulae in our practical work. However, the present sample preparation protocols which are developed for individual test systems, are incompatible with simultaneous determination of several analytes. To solve this problem, a novel "three-in-one" sample preparation method is herein developed for simultaneous determination of B-group water-soluble vitamins using VitaFast(®) kits. The performance of this novel "three-in-one" sample preparation method was systematically evaluated through comparing with individual sample preparation protocols. The experimental results of the assays which employed "three-in-one" sample preparation method were in good agreement with those obtained from conventional VitaFast(®) extraction methods, indicating that the proposed "three-in-one" sample preparation method is applicable to the present three VitaFast(®) vitamin test systems, thus offering a promising alternative for the three independent sample preparation methods. The proposed new sample preparation method will significantly improve the efficiency of infant formulae inspection. Copyright © 2013 Elsevier Ltd. All rights reserved.

[Medical education in the digital era; opportunities for the Netherlands].

PubMed

Broeders, Ivo A M J

2015-01-01

The next generation of physicians enters a job market of high-tech medicine; detailed technical knowledge of this technology is therefore a prerequisite. However, teaching on technology does not currently form an integral part of the medicine degree curriculum. We should consider if a generic medicine degree is still a valid framework, or whether students should be offered to move into different specialties at an earlier stage. By applying the latter approach, we can produce a generation of physicians prepared for the challenges thrown at them in a constantly changing, high-tech, professional environment.

Hyperinflation of Isoproterenol.

PubMed

D'Ambrosi, Julie; Amin, Nilesh

2018-01-01

The hyperinflation of isoproterenol, a 75-year-old drug, in early 2015 was unbelievable. The attention of health-care professionals, health system administrators, legislators, and the general public was quickly focused on Valeant Pharmaceuticals, purchaser of several generics solely to raise their price. With isoproterenol easily launched toward the top of drug expenditures, pharmacists in many hospitals were forced to engage stakeholders in the investigation and implementation of alternatives, explore utilization and optimize inventory, reduce cost through sterile product preparation, where possible, restrict use to settings that were beneficial to their budget, and become legislative advocates. The alternatives drugs and strategies will be reviewed.

A generic high-dose rate {sup 192}Ir brachytherapy source for evaluation of model-based dose calculations beyond the TG-43 formalism

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

Ballester, Facundo, E-mail: Facundo.Ballester@uv.es; Carlsson Tedgren, Åsa; Granero, Domingo

Purpose: In order to facilitate a smooth transition for brachytherapy dose calculations from the American Association of Physicists in Medicine (AAPM) Task Group No. 43 (TG-43) formalism to model-based dose calculation algorithms (MBDCAs), treatment planning systems (TPSs) using a MBDCA require a set of well-defined test case plans characterized by Monte Carlo (MC) methods. This also permits direct dose comparison to TG-43 reference data. Such test case plans should be made available for use in the software commissioning process performed by clinical end users. To this end, a hypothetical, generic high-dose rate (HDR) {sup 192}Ir source and a virtual watermore » phantom were designed, which can be imported into a TPS. Methods: A hypothetical, generic HDR {sup 192}Ir source was designed based on commercially available sources as well as a virtual, cubic water phantom that can be imported into any TPS in DICOM format. The dose distribution of the generic {sup 192}Ir source when placed at the center of the cubic phantom, and away from the center under altered scatter conditions, was evaluated using two commercial MBDCAs [Oncentra{sup ®} Brachy with advanced collapsed-cone engine (ACE) and BrachyVision ACUROS{sup TM}]. Dose comparisons were performed using state-of-the-art MC codes for radiation transport, including ALGEBRA, BrachyDose, GEANT4, MCNP5, MCNP6, and PENELOPE2008. The methodologies adhered to recommendations in the AAPM TG-229 report on high-energy brachytherapy source dosimetry. TG-43 dosimetry parameters, an along-away dose-rate table, and primary and scatter separated (PSS) data were obtained. The virtual water phantom of (201){sup 3} voxels (1 mm sides) was used to evaluate the calculated dose distributions. Two test case plans involving a single position of the generic HDR {sup 192}Ir source in this phantom were prepared: (i) source centered in the phantom and (ii) source displaced 7 cm laterally from the center. Datasets were independently produced by different investigators. MC results were then compared against dose calculated using TG-43 and MBDCA methods. Results: TG-43 and PSS datasets were generated for the generic source, the PSS data for use with the ACE algorithm. The dose-rate constant values obtained from seven MC simulations, performed independently using different codes, were in excellent agreement, yielding an average of 1.1109 ± 0.0004 cGy/(h U) (k = 1, Type A uncertainty). MC calculated dose-rate distributions for the two plans were also found to be in excellent agreement, with differences within type A uncertainties. Differences between commercial MBDCA and MC results were test, position, and calculation parameter dependent. On average, however, these differences were within 1% for ACUROS and 2% for ACE at clinically relevant distances. Conclusions: A hypothetical, generic HDR {sup 192}Ir source was designed and implemented in two commercially available TPSs employing different MBDCAs. Reference dose distributions for this source were benchmarked and used for the evaluation of MBDCA calculations employing a virtual, cubic water phantom in the form of a CT DICOM image series. The implementation of a generic source of identical design in all TPSs using MBDCAs is an important step toward supporting univocal commissioning procedures and direct comparisons between TPSs.« less

Standardized Sample Preparation Using a Drop-on-Demand Printing Platform

DTIC Science & Technology

2013-05-07

successful and robust methodology for energetic sample preparation. Keywords: drop-on-demand; inkjet printing; sample preparation OPEN ACCESS...on a similar length scale. Recently, drop-on-demand inkjet printing technology has emerged as an effective approach to produce test materials to...which most of the material is concentrated along the edges, samples prepared using drop-on-demand inkjet technology demonstrate excellent uniform

76 FR 57767 - Proposed Generic Communication; Draft NRC Generic Letter 2011-XX: Seismic Risk Evaluations for...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-16

... NUCLEAR REGULATORY COMMISSION [NRC-2011-0204] Proposed Generic Communication; Draft NRC Generic Letter 2011-XX: Seismic Risk Evaluations for Operating Reactors AGENCY: Nuclear Regulatory Commission... FR 54507), that requested public comment on Draft NRC Generic Letter 2011- XX: Seismic Risk...

42 CFR 447.506 - Authorized generic drugs.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 4 2014-10-01 2014-10-01 false Authorized generic drugs. 447.506 Section 447.506... (CONTINUED) MEDICAL ASSISTANCE PROGRAMS PAYMENTS FOR SERVICES Payment for Drugs § 447.506 Authorized generic drugs. (a) Authorized generic drug defined. For the purposes of this subpart, an authorized generic drug...

42 CFR 447.506 - Authorized generic drugs.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 4 2011-10-01 2011-10-01 false Authorized generic drugs. 447.506 Section 447.506... (CONTINUED) MEDICAL ASSISTANCE PROGRAMS PAYMENTS FOR SERVICES Payment for Drugs § 447.506 Authorized generic drugs. (a) Authorized generic drug defined. For the purposes of this subpart, an authorized generic drug...

42 CFR 447.506 - Authorized generic drugs.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 4 2012-10-01 2012-10-01 false Authorized generic drugs. 447.506 Section 447.506... (CONTINUED) MEDICAL ASSISTANCE PROGRAMS PAYMENTS FOR SERVICES Payment for Drugs § 447.506 Authorized generic drugs. (a) Authorized generic drug defined. For the purposes of this subpart, an authorized generic drug...

42 CFR 447.506 - Authorized generic drugs.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 4 2010-10-01 2010-10-01 false Authorized generic drugs. 447.506 Section 447.506... (CONTINUED) MEDICAL ASSISTANCE PROGRAMS PAYMENTS FOR SERVICES Payment for Drugs § 447.506 Authorized generic drugs. (a) Authorized generic drug defined. For the purposes of this subpart, an authorized generic drug...

42 CFR 447.506 - Authorized generic drugs.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 4 2013-10-01 2013-10-01 false Authorized generic drugs. 447.506 Section 447.506... (CONTINUED) MEDICAL ASSISTANCE PROGRAMS PAYMENTS FOR SERVICES Payment for Drugs § 447.506 Authorized generic drugs. (a) Authorized generic drug defined. For the purposes of this subpart, an authorized generic drug...

Cognitive and affective determinants of generic drug acceptance and use: cross-sectional and experimental findings

PubMed Central

Dohle, Simone; Siegrist, Michael

2013-01-01

An increase in generic substitution could be a viable approach to reduce global healthcare expenditures. In many countries, however, generic drug use is rather low. This study examines cognitive predictors (knowledge and beliefs) and affective predictors (general affect and sacred values) to explain generic drug acceptance and use. Data for the study come from a random postal survey conducted in Switzerland (N = 668). A detailed knowledge scale about generic drugs was developed. In addition, an experimental choice task was constructed in which respondents chose between branded and generic drugs. Generic drug acceptance as well as drug choices were influenced by knowledge, beliefs, and affect. It was also found that generic substitution is chosen less frequently for a more severe illness. Key insights could be used for developing information material or interventions aimed at increasing the substitution of generic drugs in order to make health care more affordable. PMID:25632372

Two-year-olds use the generic/non-generic distinction to guide their inferences about novel kinds

PubMed Central

Graham, Susan A.; Nayer, Samantha L.; Gelman, Susan A.

2011-01-01

These studies investigated 24- and 30-month-olds’ sensitivity to generic versus nongeneric language when acquiring knowledge about novel kinds. Toddlers were administered an inductive inference task, during which they heard a generic noun-phrase (e.g., “Blicks drink milk”) or a non-generic noun-phrase (e.g., “This blick drinks milk”) paired with an action (e.g., drinking) modeled on an object. They were then provided with the model and a non-model exemplar and asked to imitate the action. After hearing non-generic phrases, 30-month-olds, but not 24-month-olds, imitated more often with the model than with the non-model exemplar. In contrast, after hearing generic phrases, 30-month-olds imitated equally often with both exemplars. These results suggest that 30-month-olds use the generic/non-generic distinction to guide their inferences about novel kinds. PMID:21410928

Methodological Considerations for Comparison of Brand Versus Generic Versus Authorized Generic Adverse Event Reports in the US Food and Drug Administration Adverse Event Reporting System (FAERS).

PubMed

Rahman, Md Motiur; Alatawi, Yasser; Cheng, Ning; Qian, Jingjing; Peissig, Peggy L; Berg, Richard L; Page, David C; Hansen, Richard A

2017-12-01

The US Food and Drug Administration Adverse Event Reporting System (FAERS), a post-marketing safety database, can be used to differentiate brand versus generic safety signals. To explore the methods for identifying and analyzing brand versus generic adverse event (AE) reports. Public release FAERS data from January 2004 to March 2015 were analyzed using alendronate and carbamazepine as examples. Reports were classified as brand, generic, and authorized generic (AG). Disproportionality analyses compared reporting odds ratios (RORs) of selected known labeled serious adverse events stratifying by brand, generic, and AG. The homogeneity of these RORs was compared using the Breslow-Day test. The AG versus generic was the primary focus since the AG is identical to brand but marketed as a generic, therefore minimizing generic perception bias. Sensitivity analyses explored how methodological approach influenced results. Based on 17,521 US event reports involving alendronate and 3733 US event reports involving carbamazepine (immediate and extended release), no consistently significant differences were observed across RORs for the AGs versus generics. Similar results were obtained when comparing reporting patterns over all time and just after generic entry. The most restrictive approach for classifying AE reports yielded smaller report counts but similar results. Differentiation of FAERS reports as brand versus generic requires careful attention to risk of product misclassification, but the relative stability of findings across varying assumptions supports the utility of these approaches for potential signal detection.

The effect of generic competition on the price of brand-name drugs.

PubMed

Lexchin, Joel

2004-04-01

Literature from the US has shown that brand-name manufacturers do not compete on price once generic competitors become available. This study was undertaken to investigate if this is also true in Canada. Editions of the Ontario Drug Benefit Formulary were used to identify brand-name drugs that lacked generic competition in July 1990 but had acquired one or more generic competitors by December 1998. Prices of the brand-name drugs were compared before generic competition, at the point when generic competition started and subsequent to the initiation of competition. Price changes for 81 different products in 144 separate presentations were analysed. There was no statistically significant change in brand-name prices when generic competition started. The movement of brand-name prices was not influenced by whether the generic was made by the company producing the brand-name product or price freezes imposed by the Ontario government. When generics first became available having four or more generics was associated with a rise in the price of the brand-name drugs compared to having one, two or three generic competitor(s). The lack of price competition may lead to increased costs in the private market. Private insurance companies generally do not require generic substitution and some provinces do not require generic substitution for cash-paying customers. Maintaining higher prices on brand-name drugs impacts on the prices of new patented medications coming onto the Canadian market under the current pricing guidelines of the Patented Medicine Prices Review Board.

Improving the assessment of prescribing: use of a 'substitution index'.

PubMed

Kunisawa, Susumu; Otsubo, Tetsuya; Lee, Jason; Imanaka, Yuichi

2013-07-01

To analyse the current and potential utilization of generic drugs in Japan, to examine the maximum possible cost savings from generic drug use and to develop a fairer measure to assess the level of generic drug substitution. We conducted a cross-sectional retrospective analysis of nine million dispensing records during January to March 2010 in Kyoto Prefecture. Maximum potential quantity-based shares were defined as the quantity of generic drugs used plus the quantity of branded drugs that could have been replaced by generic drugs divided by the quantity of all drugs dispensed. We developed a 'substitution index', defined as the proportion of generic drugs out of the total drugs substitutable with generic drugs (based on quantity rather than cost). Generic drugs had a quantity-based share of 17.9%, a cost-based share of 8.9% and a maximum potential quantity-based share of 50.1%, which is lower than the actual generic drug shares of some other countries. The maximum possible cost savings as a result of generic drug substitution was 16.5%. We also observed wide variations in maximum potential quantity-based shares between health care sectors and health care institutions. Simple comparisons based on quantity-based shares may misrepresent the actual generic drug use. A substitution index that takes into account the maximum potential quantity-based share of generic drugs as a fairer measure may promote more realistic goals and encourage generic drug usage.

A developmental analysis of generic nouns in Southern Peruvian Quechua.

PubMed

Mannheim, Bruce; Gelman, Susan A; Escalante, Carmen; Huayhua, Margarita; Puma, Rosalía

2010-01-01

Generic noun phrases (e.g., "Cats like to drink milk") are a primary means by which adults express generalizations to children, yet they pose a challenging induction puzzle for learners. Although prior research has established that English speakers understand and produce generic noun phrases by preschool age, little is known regarding the cross-cultural generality of generic acquisition. Southern Peruvian Quechua provides a valuable comparison because, unlike English, it is a highly inflected language in which generics are marked by the absence rather than the presence of any linguistic markers. Moreover, Quechua is spoken in a cultural context that differs markedly from the highly educated, middle-class contexts within which earlier research on generics was conducted. We presented participants from 5 age groups (3-6, 7-9, 10-12, 14-35, and 36-90 years of age) with two tasks that examined the ability to distinguish generic from non-generic utterances. In Study 1, even the youngest children understood generics as applying broadly to a category (like "all") and distinct from indefinite reference ("some"). However, there was a developmental lag before children understood that generics, unlike "all", can include exceptions. Study 2 revealed that generic interpretations are more frequent for utterances that (a) lack specifying markers and (b) are animate. Altogether, generic interpretations are found among the youngest participants, and may be a default mode of quantification. These data demonstrate the cross-cultural importance of generic information in linguistic expression.

A developmental analysis of generic nouns in Southern Peruvian Quechua

PubMed Central

Mannheim, Bruce; Gelman, Susan A.; Escalante, Carmen; Huayhua, Margarita; Puma, Rosalía

2010-01-01

Generic noun phrases (e.g., “Cats like to drink milk”) are a primary means by which adults express generalizations to children, yet they pose a challenging induction puzzle for learners. Although prior research has established that English speakers understand and produce generic noun phrases by preschool age, little is known regarding the cross-cultural generality of generic acquisition. Southern Peruvian Quechua provides a valuable comparison because, unlike English, it is a highly inflected language in which generics are marked by the absence rather than the presence of any linguistic markers. Moreover, Quechua is spoken in a cultural context that differs markedly from the highly educated, middle-class contexts within which earlier research on generics was conducted. We presented participants from 5 age groups (3-6, 7-9, 10-12, 14-35, and 36-90 years of age) with two tasks that examined the ability to distinguish generic from non-generic utterances. In Study 1, even the youngest children understood generics as applying broadly to a category (like “all”) and distinct from indefinite reference (“some”). However, there was a developmental lag before children understood that generics, unlike “all”, can include exceptions. Study 2 revealed that generic interpretations are more frequent for utterances that (a) lack specifying markers and (b) are animate. Altogether, generic interpretations are found among the youngest participants, and may be a default mode of quantification. These data demonstrate the cross-cultural importance of generic information in linguistic expression. PMID:21779154

Comparing Generic Drug Markets in Europe and the United States: Prices, Volumes, and Spending.

PubMed

Wouters, Olivier J; Kanavos, Panos G; McKEE, Martin

2017-09-01

Policy Points: Our study indicates that there are opportunities for cost savings in generic drug markets in Europe and the United States. Regulators should make it easier for generic drugs to reach the market. Regulators and payers should apply measures to stimulate price competition among generic drugmakers and to increase generic drug use. To meaningfully evaluate policy options, it is important to analyze historical context and understand why similar initiatives failed previously. Rising drug prices are putting pressure on health care budgets. Policymakers are assessing how they can save money through generic drugs. We compared generic drug prices and market shares in 13 European countries, using data from 2013, to assess the amount of variation that exists between countries. To place these results in context, we reviewed evidence from recent studies on the prices and use of generics in Europe and the United States. We also surveyed peer-reviewed studies, gray literature, and books published since 2000 to (1) outline existing generic drug policies in European countries and the United States; (2) identify ways to increase generic drug use and to promote price competition among generic drug companies; and (3) explore barriers to implementing reform of generic drug policies, using a historical example from the United States as a case study. The prices and market shares of generics vary widely across Europe. For example, prices charged by manufacturers in Switzerland are, on average, more than 2.5 times those in Germany and more than 6 times those in the United Kingdom, based on the results of a commonly used price index. The proportion of prescriptions filled with generics ranges from 17% in Switzerland to 83% in the United Kingdom. By comparison, the United States has historically had low generic drug prices and high rates of generic drug use (84% in 2013), but has in recent years experienced sharp price increases for some off-patent products. There are policy solutions to address issues in Europe and the United States, such as streamlining the generic drug approval process and requiring generic prescribing and substitution where such policies are not yet in place. The history of substitution laws in the United States provides insights into the economic, political, and cultural issues influencing the adoption of generic drug policies. Governments should apply coherent supply- and demand-side policies in generic drug markets. An immediate priority is to convince more physicians, pharmacists, and patients that generic drugs are bioequivalent to branded products. Special-interest groups continue to obstruct reform in Europe and the United States. © 2017 The Authors The Milbank Quarterly published by Wiley Periodicals, Inc. on behalf of The Millbank Memorial Fund.

Stable Isotope Profiling of Internet-Sourced Viagra® and 'generic- Viagra' Tablets

NASA Astrophysics Data System (ADS)

Kemp, Helen; Meier-Augenstein, Wolfram

2013-04-01

Viagra® manufactured by Pfizer was the first prescription drug for the treatment of erectile dysfunction (ED), a condition that is estimated to affect 1 in 10 men at some stage in their lives (1). Viagra® contains the active pharmaceutical ingredient (API) sildenafil, as the citrate salt. Sildenafil, along with Tadalafil and Vardenafil belong to a class of drugs known as phosphodiesterase type 5 (PDE5) inhibitors. Since its first production in 1998, Viagra® has generated well in excess of 10 billion US dollars in sales (2) and with Pfizers' patent extended to April 2020 (3) it still remains the only sildenafil-based treatment option for sufferers of ED in the US. There are no legal 'generic-Viagra' formulations available in the US. However, formulations containing sildenafil citrate as API are widely available over the internet and often sold as 'generic Viagra'. These cheaper alternatives are often manufactured under less than ideal conditions with little or no QA/QC procedures in place. The World Health Organisation recognised the scale of the problem in its 2010 bulletin "Growing threat from counterfeit medicines" (4) and quotes a Dutch study cited in the International Journal of Clinical Practice in which from a cohort of 370 seized Viagra® samples, only 10 were genuine. We sourced a variety of tablets sold for the treatment of ED which claimed to have sildenafil citrate as API. Viagra®, 'generic-Viagra', Kamagra, Silagra and Filagra tablets were ordered via the internet and supplied from both UK-based pharmacies as well as overseas suppliers (Hong Kong, India, Vanuata). In this small-scale pilot study, we present results from bulk 2H/18O and 13C/15N stable isotope analysis performed on crushed tablets from 23 samples of internet-sourced tablets sold for the treatment of ED and purported to contain sildenafil citrate as API. References 1. www.healthcare.org.uk 2. www.moneynews.com 3. US Patent & trademark office (www.uspto.gov) 4. WHO bulletin 2010; 88:247-248

Patient, physician, pharmacy, and pharmacy benefit design factors related to generic medication use.

PubMed

Shrank, William H; Stedman, Margaret; Ettner, Susan L; DeLapp, Dee; Dirstine, June; Brookhart, M Alan; Fischer, Michael A; Avorn, Jerry; Asch, Steven M

2007-09-01

Increased use of generic medications conserves insurer and patient financial resources and may increase patient adherence. The objective of the study is to evaluate whether physician, patient, pharmacy benefit design, or pharmacy characteristics influence the likelihood that patients will use generic drugs Observational analysis of 2001-2003 pharmacy claims from a large health plan in the Western United States. We evaluated claims for 5,399 patients who filled a new prescription in at least 1 of 5 classes of chronic medications with generic alternatives. We identified patients initiated on generic drugs and those started on branded medications who switched to generic drugs in the subsequent year. We used generalized estimating equations to perform separate analyses assessing the relationship between independent variables and the probability that patients were initiated on or switched to generic drugs. Of the 5,399 new prescriptions filled, 1,262 (23.4%) were generics. Of those initiated on branded medications, 606 (14.9%) switched to a generic drug in the same class in the subsequent year. After regression adjustment, patients residing in high-income zip codes were more likely to initiate treatment with a generic than patients in low-income regions (RR = 1.29; 95% C.I. 1.04-1.60); medical subspecialists (RR = 0.82; 0.69-0.95) and obstetrician/gynecologists (RR = 0.81; 0.69-0.98) were less likely than generalist physicians to initiate generics. Pharmacy benefit design and pharmacy type were not associated with initiation of generic medications. However, patients were over 2.5 times more likely to switch from branded to generic medications if they were enrolled in 3-tier pharmacy plans (95% C.I. 1.12-6.09), and patients who used mail-order pharmacies were 60% more likely to switch to a generic (95% C.I. 1.18-2.30) after initiating treatment with a branded drug. Physician and patient factors have an important influence on generic drug initiation, with the patients who live in the poorest zip codes paradoxically receiving generic drugs least often. While tiered pharmacy benefit designs and mail-order pharmacies helped steer patients towards generic medications once the first prescription has been filled, they had little effect on initial prescriptions. Providing patients and physicians with information about generic alternatives may reduce costs and lead to more equitable care.

Sequence-Based Genotyping for Marker Discovery and Co-Dominant Scoring in Germplasm and Populations

PubMed Central

Truong, Hoa T.; Ramos, A. Marcos; Yalcin, Feyruz; de Ruiter, Marjo; van der Poel, Hein J. A.; Huvenaars, Koen H. J.; Hogers, René C. J.; van Enckevort, Leonora. J. G.; Janssen, Antoine; van Orsouw, Nathalie J.; van Eijk, Michiel J. T.

2012-01-01

Conventional marker-based genotyping platforms are widely available, but not without their limitations. In this context, we developed Sequence-Based Genotyping (SBG), a technology for simultaneous marker discovery and co-dominant scoring, using next-generation sequencing. SBG offers users several advantages including a generic sample preparation method, a highly robust genome complexity reduction strategy to facilitate de novo marker discovery across entire genomes, and a uniform bioinformatics workflow strategy to achieve genotyping goals tailored to individual species, regardless of the availability of a reference sequence. The most distinguishing features of this technology are the ability to genotype any population structure, regardless whether parental data is included, and the ability to co-dominantly score SNP markers segregating in populations. To demonstrate the capabilities of SBG, we performed marker discovery and genotyping in Arabidopsis thaliana and lettuce, two plant species of diverse genetic complexity and backgrounds. Initially we obtained 1,409 SNPs for arabidopsis, and 5,583 SNPs for lettuce. Further filtering of the SNP dataset produced over 1,000 high quality SNP markers for each species. We obtained a genotyping rate of 201.2 genotypes/SNP and 58.3 genotypes/SNP for arabidopsis (n = 222 samples) and lettuce (n = 87 samples), respectively. Linkage mapping using these SNPs resulted in stable map configurations. We have therefore shown that the SBG approach presented provides users with the utmost flexibility in garnering high quality markers that can be directly used for genotyping and downstream applications. Until advances and costs will allow for routine whole-genome sequencing of populations, we expect that sequence-based genotyping technologies such as SBG will be essential for genotyping of model and non-model genomes alike. PMID:22662172

A solid-phase microextraction GC/MS/MS method for rapid quantitative analysis of food and beverages for the presence of legally restricted biologically active flavorings.

PubMed

Bousova, Katerina; Mittendorf, Klaus; Senyuva, Hamide

2011-01-01

A method was developed using automated headspace solid-phase microextraction coupled with GC/MS/MS to simultaneously determine the presence of seven biologically active flavoring substances whose levels of use in processed foods is controlled by statutory limits. The method can be applied to identify and quantify the presence of 1,2-benzopyrone (coumarin), beta-asarone, 1-allyl-4-methoxybenzene (estragole), menthofuran, 4-allyl-1 ,2-dimethoxybenzene (methyl eugenol), pulegone, and thujone at levels ranging from 0.5 to 3000 mg/kg. The method has been optimized and validated for three different generic food types categorized on the basis of composition and anticipated use levels of flavorings and food ingredients. The food categories are alcoholic and nonalcoholic beverages; semisolid processed foods (e.g., soups, sauces, confectionary, etc.); and solid foods (muesli, bakery products, etc.). The method is simple, inexpensive, and rapid, and eliminates the use of flammable and toxic solvents. There is no sample preparation, and using MSIMS, unequivocal confirmation of identification is achieved even in highly complex matrixes containing many potential interfering volatiles. The method precision for spiked samples ranged from 2 to 21%, with the greatest variability associated with solid matrixes. The LOD and LOQ values were well below 0.1 and 0.5 mg/kg, respectively, in all cases for individual substances, fulfilling requirements for enforcement purposes. The robustness of the method was demonstrated in a small survey of retail samples of four spirits, five flavored milks, three energy drinks, five liqueurs, five soups, 10 sauces, five herbal teas, and three breakfast cereals.

The effect of introducing rebate contracts to promote generic drug substitution, on doctors' prescribing practices.

PubMed

Hoffmann, Falk; Glaeske, Gerd; Pfannkuche, Matthias S

2009-11-01

As of 1 April 2007, pharmacists in Germany filling prescriptions covered by the statutory health insurance system (Gesetzliche Krankenversicherung, GKV) are required, whenever possible, to dispense a preparation that contains the same active substance and for which a rebate contract is in effect. The physician can block drug substitution by crossing out "aut idem" ("or the like") on the prescription form. The latter option has existed since 2002. We studied the possible effect of the introduction of rebate contracts on the use of the no-substitution option. Three independent random samples were taken from the routine data of the Gmünder ErsatzKasse (GEK, a statutory health insurance carrier). The samples consisted of 0.5% of the insured adult population in the month of October in the years 2006, 2007, and 2008 (n = 6195; n = 6300; n = 6845). Within these sample groups, all medication orders in which the physician could potentially have exercised a no-substitution option were selected, and the corresponding prescriptions were examined. The percentage of no-substitution prescriptions rose from October 2006 to October 2007, and then rose still further to October 2008 (14.4%, 18.4%, 19.0%; p for trend < 0.0001). Considerable differences were seen between physicians belonging to different regional Associations of Statutory Health Insurance Physicians (Kassenärztliche Vereinigungen). In about one-quarter of the no-substitution prescriptions for 2007 and 2008 (25.1%, 25.7%), the prescribed medication was itself included in a rebate contract. The use of the no-substitution option is not uniform across Germany at present. Rebate contracts and the no-substitution option require further evaluation. Moreover, the dispensing of medications urgently needs a more stable regulatory framework.

Societal value of generic medicines beyond cost-saving through reduced prices.

PubMed

Dylst, Pieter; Vulto, Arnold; Simoens, Steven

2015-01-01

This paper aims to provide an overview of the added societal value of generic medicines beyond their cost-saving potential through reduced prices. In addition, an observational case study will document the impact of generic entry on access to pharmacotherapy in The Netherlands and an illustrative exercise was carried out to highlight the budget impact of generic entry. A narrative literature review was carried out to explore the impact of generic medicines on access to pharmacotherapy, innovation and medication adherence. Data from the Medicines and Medical Devices Information Project database in The Netherlands were used for the case study in which the impact of generic medicine entrance on the budget and the number of users was calculated as an illustrative exercise. Generic medicines have an additional societal value beyond their cost-saving potential through reduced prices. Generic medicines increase access to pharmacotherapy, provide a stimulus for innovation by both originator companies and generic companies and, under the right circumstances, have a positive impact on medication adherence. Generic medicines offer more to society than just their cost-saving potential through reduced prices. As such, governments must not focus only on the prices of generic medicines as this will threaten their long-term sustainability. Governments must therefore act appropriately and implement a coherent set of policies to increase the use of generic medicines.

A survey to determine the views of renal transplant patients on generic substitution in the UK.

PubMed

Al Ameri, Mubarak N; Whittaker, Clare; Tucker, Arthur; Yaqoob, Magdi; Johnston, Atholl

2011-08-01

Rising healthcare costs promote the generic substitution among patients because it is identifiable costs. A key concern is that patients should be involved in the decision of switching. The aim of this study was to examine renal transplant patients' views on generic substitution in the UK. A total of 163 renal patients were surveyed using 36 multiple-choice questions at Barts and The London Renal Transplant Clinic, in the UK. Transplant recipients over 18 years, able to read and write English and willing to fill in the questionnaire were targeted; 84% of patients were conscious of the availability of generic medicines, 70% understood the terms "generic" and "branded" in relation to medicines and 54% were aware of generic substitution practice. However, 75% did not know if they were taking generics and 84% felt that generics are not equivalent or only equivalent sometimes and they were uncertain that generics had the same quality as branded medicines. Moreover, many patients admitted that they would not accept the generic substitution of ciclosporin when become available in the UK. A number of factors such as patients' education, knowledge, severity of the disease, efficacy of generic medicines and patients' involvement in decisions regarding their health appear to drive patients' attitudes towards generic substitution. © 2011 The Authors. Transplant International © 2011 European Society for Organ Transplantation.

Generic drug prices and policy in Australia: room for improvement? a comparative analysis with England.

PubMed

Mansfield, Sarah J

2014-02-01

To assess the degree to which reimbursement prices in Australia and England differ for a range of generic drugs, and to analyse the supply- and demand-side factors that may contribute to these differences. Australian and English reimbursement prices were compared for a range of generic drugs using pricing information obtained from government websites. Next, a literature review was conducted to identify supply- and demand-side factors that could affect generic prices in Australia and England. Various search topics were identified addressing potential supply-side (e.g. market approval, intellectual property protection of patented drugs, generic pricing policy, market size, generic supply chain and discounting practices) and demand-side (consumers, prescribers and pharmacists) factors. Related terms were searched in academic databases, official government websites, national statistical databases and internet search engines. Analysis of drug reimbursement prices for 15 generic molecules (representing 45 different drug presentations) demonstrated that Australian prices were on average over 7-fold higher than in England. Significant supply-side differences included aspects of pricing policy, the relative size of the generics markets and the use of clawback policies. Major differences in demand-side policies related to generic prescribing, pharmacist substitution and consumer incentives. Despite recent reforms, the Australian Government continues to pay higher prices than its English counterpart for many generic medications. The results suggest that particular policy areas may benefit from review in Australia, including the length of the price-setting process, the frequency of subsequent price adjustments, the extent of price competition between originators and generics, medical professionals' knowledge about generic medicines and incentives for generic prescribing. WHAT IS KNOWN ABOUT THE TOPIC? Prices of generic drugs have been the subject of much scrutiny over recent years. From 2005 to 2010 the Australian Government responded to observations that Pharmaceutical Benefits Scheme prices for many generics were higher than in numerous comparable countries by instituting several reforms aimed at reducing the prices of generics. Despite this, several studies have demonstrated that prices for generic statins (one class of cholesterol-lowering drug) are higher in Australia compared with England and many other developed countries, and prices of numerous other generics remain higher than in the USA and New Zealand. Recently there has been increasing interest in why these differences exist. WHAT DOES THIS PAPER ADD? By including a much larger range of commonly used and costly generic drugs, this paper builds significantly on the limited previous investigations of generic drug prices in Australia and England. Additionally, this is the first comprehensive investigation of multiple supply- and, in particular, demand-side factors that may explain any price differences between these countries. WHAT ARE THE IMPLICATIONS FOR PRACTITIONERS? Practitioners may contribute to the higher prices of generic medications in Australia compared with England through relatively low rates of generic prescribing. There are also significant implications for health policy makers, as this paper demonstrates that if Australia achieved the same prices as England for many generic drugs there could be substantial savings for the Pharmaceutical Benefits Scheme.

Size Controllable, Transparent, and Flexible 2D Silver Meshes Using Recrystallized Ice Crystals as Templates.

PubMed

Wu, Shuwang; Li, Linhai; Xue, Han; Liu, Kai; Fan, Qingrui; Bai, Guoying; Wang, Jianjun

2017-10-24

Ice templates have been widely utilized for the preparation of porous materials due to the obvious advantages, such as environmentally benign and applicable to a wide range of materials. However, it remains a challenge to have controlled pore size as well as dimension of the prepared porous materials with the conventional ice template, since it often employs the kinetically not-stable growing ice crystals as the template. For example, there is no report so far for the preparation of 2D metal meshes with tunable pore size based on the ice template, although facile and eco-friendly prepared metal meshes are highly desirable for wearable electronics. Here, we report the preparation of 2D silver meshes with tunable mesh size employing recrystallized ice crystals as templates. Ice recrystallization is a kinetically stable process; therefore, the grain size of recrystallized ice crystals can be easily tuned, e.g., by adding different salts and changing the annealing temperature. Consequently, the size and line width of silver meshes obtained after freeze-drying can be easily adjusted, which in turn varied the conductivity of the obtained 2D silver film. Moreover, the silver meshes are transparent and display stable conductivity after the repeated stretching and bending. It can be envisioned that this approach for the preparation of 2D conducting films is of practical importance for wearable electronics. Moreover, this study provides a generic approach for the fabrication of 2D meshes with a controllable pore size.

A Cross-Linguistic Comparison of Generic Noun Phrases in English and Mandarin.

ERIC Educational Resources Information Center

Gelman, Susan A.; Tardif, Twila

1998-01-01

Three studies examined adults' generic noun phrases in English and Mandarin Chinese from child-directed speech of caregivers interacting with their toddlers. Found that generic noun phrases were reliably identified in both languages. Generic noun phrases most frequently referred to animals. Non-generic noun phrases were used most frequently for…

Generic Language and Judgements about Category Membership: Can Generics Highlight Properties as Central?

ERIC Educational Resources Information Center

Hollander, Michelle A.; Gelman, Susan A.; Raman, Lakshmi

2009-01-01

Many languages distinguish generic utterances (e.g., "Tigers are ferocious") from non-generic utterances (e.g., "Those tigers are ferocious"). Two studies examined how generic language specially links properties and categories. We used a novel-word extension task to ask if 4- to 5-year-old children and adults distinguish…

On assessing bioequivalence and interchangeability between generics based on indirect comparisons.

PubMed

Zheng, Jiayin; Chow, Shein-Chung; Yuan, Mengdie

2017-08-30

As more and more generics become available in the market place, the safety/efficacy concerns may arise as the result of interchangeably use of approved generics. However, bioequivalence assessment for regulatory approval among generics of the innovative drug product is not required. In practice, approved generics are often used interchangeably without any mechanism of safety monitoring. In this article, based on indirect comparisons, we proposed several methods to assessing bioequivalence and interchangeability between generics. The applicability of the methods and the similarity assumptions were discussed, as well as the inappropriateness of directly adopting adjusted indirect comparison to the field of generics' comparison. Besides, some extensions were given to take into consideration the important topics in clinical trials for bioequivalence assessments, for example, multiple comparisons and simultaneously testing bioequivalence among three generics. Extensive simulation studies were conducted to investigate the performances of the proposed methods. The studies of malaria generics and HIV/AIDS generics prequalified by the WHO were used as real examples to demonstrate the use of the methods. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

Acquisition of Generic Noun Phrases in Chinese: Learning about lions without an ‘-s’

PubMed Central

Tardif, Twila; Gelman, Susan A.; Fu, Xiaolan; Zhu, Liqi

2013-01-01

English-speaking children understand and produce generic expressions in the preschool years, but there are cross-linguistic differences in how generics are expressed. Three studies examined interpretation of generic noun phrases in 3- to 7-year-old child (N = 192) and adult speakers (N = 163) of Mandarin Chinese. Contrary to suggestions by A. Bloom (1981), Chinese-speaking adults honor a clear distinction between generics (expressed as bare NPs) and other quantified expressions (‘all’/suo3you3 and ‘some’/you3de). Furthermore, Mandarin-speaking children begin to distinguish generics from ‘all’ or ‘some’ as early as 5 years, as shown in both confirmation (Study 2) and property-generation (Study 3) tasks. Nonetheless, the developmental trajectory for Chinese appears prolonged relative to English and this seems to reflect difficulty with ‘all’ and ‘some’ rather than difficulty with generics. Altogether these results suggest that generics are primary, and that the consistency of markings affects the rate at which non-generic NPs are distinguished from generics. PMID:21849102

"This body does not want free medicines": South African consumer perceptions of drug quality.

PubMed

Patel, Aarti; Gauld, Robin; Norris, Pauline; Rades, Thomas

2010-01-01

OBJECTIVES Like many other developing countries, South Africa provides free medicines through its public health care facilities. Recent policies encourage generic substitution in the private sector. This study explored South African consumer perceptions of drug quality and whether these perceptions influenced how people procured and used their medicines. METHODS The study was undertaken in Durban, Cape Town and Johannesburg in South Africa between December 2005 and January 2006. A combination of purposive and snowball sampling was used to recruit participants from low and middle socio-economic groups as well as the elderly and teenagers. Data were collected through 12 focus group discussions involving a total of 73 participants. Interviews were tape-recorded. Thematic analysis was performed on the transcripts. RESULTS Irrespective of socio-economic status, respondents described medicine quality in terms of the effect the medicine produced on felt symptoms. Generic medicines, as well as medicines supplied without charge by the state, were considered to be poor quality and treated with suspicion. Respondents obtained medicines from three sources: public sector hospitals and/or clinics, dispensing doctors and community pharmacies. Cost, avoidance of feeling 'second-class', receiving individualized care and choice in drug selection were the main determinants influencing their procurement behaviour. Selection of over-the-counter medicines was influenced by prior knowledge of products, through advertising and previous use. Participants perceived that they had limited influence on selection of prescription medicines. Generic substitution would be supported if the doctor, rather than the pharmacist, recommended it. CONCLUSIONS Our findings emphasize the importance of meaningful consumer involvement in the development of national medicines policies, and strategic campaigns targeting consumers and prescribers regarding the quality of generic and essential medicines. Where consumers perceive free or generic medicines as inferior, this could significantly undermine attempts to implement national medicines policies aimed to improve access to medicines.

Does the market share of generic medicines influence the price level?: a European analysis.

PubMed

Dylst, Pieter; Simoens, Steven

2011-10-01

After the expiry of patents for originator medicines, generic medicines can enter the market, and price competition may occur. This process generates savings to the healthcare payer and to patients, but knowledge about the factors affecting price competition in the pharmaceutical market following patent expiry is still limited. This study aimed to investigate the relationship between the market share of generic medicines and the change of the medicine price level in European off-patent markets. Data on medicine volumes and values for 35 active substances were purchased from IMS Health. Ex-manufacturer prices were used, and the analysis was limited to medicines in immediate-release, oral, solid dosage forms. Countries included were Austria, Belgium, Denmark, Germany, France, Italy, the Netherlands, Spain, Sweden and the UK, which constitute a mix of countries with low and high generic medicines market shares. Data were available from June 2002 until March 2007. Market volume has risen in both high and low generic market share countries (+29.27% and +27.40%, respectively), but the cause of the rise is different for the two markets. In low generic market share countries, the rise was caused by the increased use of generic medicines, while in high market share countries, the rise was driven by the increased use of generic medicines and a shift of use from originator to generic medicines. Market value was substantially decreased in high generic market share countries (-26.6%), while the decrease in low generic market share countries was limited (-0.06%). In high generic market share countries, medicine prices dropped by -43.18% versus -21.56% in low market share countries. The extent to which price competition from generic medicines leads to price reductions appears to vary according to the market share of generic medicines. High generic market share countries have seen a larger decrease in medicine prices than low market share countries.

Economic savings versus health losses: The cost-effectiveness of generic antiretroviral therapy in the United States

PubMed Central

Walensky, Rochelle P.; Sax, Paul E.; Nakamura, Yoriko M.; Weinstein, Milton C.; Pei, Pamela P.; Freedberg, Kenneth A.; Paltiel, A. David; Schackman, Bruce R.

2013-01-01

Background US HIV treatment guidelines recommend branded once-daily, one-pill efavirenz/emtricitabine/tenofovir as preferred first-line antiretroviral treatment (ART). With the anticipated approval of generic efavirenz in 2012 in the US, the cost of a once-daily, three-pill alternative (generic efavirenz, generic lamivudine, tenofovir) will decrease, but adherence and virologic suppression may be reduced. Objectives To assess the clinical impact, costs, and cost-effectiveness of the generic-based three-pill regimen compared to the branded, co-formulated regimen. To project the potential national savings in the first year of a switch to generic-based ART. Design Mathematical simulation of HIV disease. Data Sources Published data from US clinical trials and observational cohorts. Target Population HIV-infected patients eligible to start on or switch to an efavirenz-based generic ART regimen. Time Horizon Lifetime, One-year Perspective US health system Interventions No ART (for comparison), Three-pill Generic ART, and Branded ART Outcome Measures Quality-adjusted life expectancy, costs, and incremental cost-effectiveness ratios (ICER, $/quality-adjusted life expectancy [QALY]). Results of Base-Case Analysis Compared to No ART, Generic ART has an ICER of $21,100/QALY. Compared to Generic ART, Branded ART increases lifetime costs by $42,500, and per-person survival gains by 0.37 QALYs, for an ICER of $114,800/QALY. Estimated first-year savings, if all eligible US patients start on or switch to Generic ART, are $920 million. Results of Sensitivity Analysis Most plausible assumptions about Generic ART efficacy and costs lead to Branded ART ICERs >$100,000/QALY. Limitations The efficacy and price reduction associated with generics are unknown; estimates are intended to be conservative. Conclusions Compared to a slightly less effective generic-based regimen, the cost-effectiveness of first-line Branded ART exceeds $100,000/QALY. Generic-based ART in the US could yield substantial budgetary savings to HIV programs. PMID:23318310

Lack of latex allergen contamination of solutions withdrawn from vials with natural rubber stoppers.

PubMed

Thomsen, D J; Burke, T G

2000-01-01

The effect on latex allergen contamination and microbial growth of a latex-allergy precaution technique for preparing injectable products was studied. The study consisted of three parts: (1) preparation of 20 samples from vials with latex-containing stoppers in accordance with conventional guidelines, (2) preparation of 20 samples in accordance with latex-allergy precaution guidelines, and (3) preparation of 5 latex-free samples and 1 latex-contaminated sample as negative and positive controls, respectively. The conventional method involved swabbing a vial top with an alcohol prep pad, puncturing the dry natural rubber stopper with an 18-gauge needle attached to a latex-free syringe, and withdrawing the contents of the vial into the syringe. The latex-allergy precaution preparation technique was similar, except that the stopper was removed before the vial contents were withdrawn. There was essentially no difference in latex allergen concentrations between the two drug preparation methods. None of the samples prepared with the standard method supported any microbial growth. One sample prepared with the latex-allergy precaution method grew bacteria. Removal of the dry rubber stopper from vials did not yield solutions with less latex allergen than solutions prepared according to conventional guidelines.

[It is not only about cost ... when it comes to generic medication].

PubMed

Piguet, Valérie; D'Incau, Stéphanie; Besson, Marie; Desmeules, Jules; Cedraschi, Christine

2016-06-22

The aim of this qualitative study was to explore patients' representations regarding generics in patients suffering from non-specific disabling chronic musculoskeletal pain, as these patients are confronted with the issue of the prescription and/or substitution of original formulations with generics. Patients' representations suggest that they might be confident in taking a generic medication: when the generic medication is prescribed by the physician and each prescription is discussed, i.e., the patient is prescribed the generic version of a given medication and not a generic medication. Economic arguments are not sufficient to accept substitution. Negative representations require attention and need be considered.

Scenario tree model for animal disease freedom framed in the OIE context using the example of a generic swine model for Aujeszky's disease in commercial swine in Canada.

PubMed

Christensen, Jette; Vallières, André

2016-01-01

"Freedom from animal disease" is an ambiguous concept that may have a different meaning in trade and science. For trade alone, there are different levels of freedom from OIE listed diseases. A country can: be recognized by OIE to be "officially free"; self-declare freedom, with no official recognition by the OIE; or report animal disease as absent (no occurrence) in six-monthly reports. In science, we apply scenario tree models to calculate the probability of a population being free from disease at a given prevalence to provide evidence of freedom from animal disease. Here, we link science with application by describing how a scenario tree model may contribute to a country's claim of freedom from animal disease. We combine the idea of a standardized presentation of scenario tree models for disease freedom and having a similar model for two different animal diseases to suggest that a simple generic model may help veterinary authorities to build and evaluate scenario tree models for disease freedom. Here, we aim to develop a generic scenario tree model for disease freedom that is: animal species specific, population specific, and has a simple structure. The specific objectives were: to explore the levels of freedom described in the OIE Terrestrial Animal Health Code; to describe how scenario tree models may contribute to a country's claim of freedom from animal disease; and to present a generic swine scenario tree model for disease freedom in Canada's domestic (commercial) swine applied to Aujeszky's disease (AD). In particular, to explore how historical survey data, and data mining may affect the probability of freedom and to explore different sampling strategies. Finally, to frame the generic scenario tree model in the context of Canada's claim of freedom from AD. We found that scenario tree models are useful to support a country's claim of freedom either as "recognized officially free" or as part of a self-declaration but the models should not stand alone in a claim. The generic AD scenario tree model demonstrated the benefit of combining three sources of surveillance data and helped to design the surveillance for the next year. The generic AD scenario model is one piece in Canada's self-declaration of freedom from AD. The model is strongly supported by the fact that AD has never been detected in Canada. Crown Copyright © 2015. Published by Elsevier B.V. All rights reserved.

Measuring health-related quality of life in Hungarian children with heart disease: psychometric properties of the Hungarian version of the Pediatric Quality of Life Inventory 4.0 Generic Core Scales and the Cardiac Module.

PubMed

Berkes, Andrea; Pataki, István; Kiss, Mariann; Kemény, Csilla; Kardos, László; Varni, James W; Mogyorósy, Gábor

2010-01-28

The aim of the study was to investigate the psychometric properties of the Hungarian version of the Pediatric Quality of Life Inventory (PedsQL) Generic Core Scales and Cardiac Module. The PedsQL 4.0 Generic Core Scales and the PedsQL 3.0 Cardiac Module was administered to 254 caregivers of children (aged 2-18 years) and to 195 children (aged 5-18 years) at a pediatric cardiology outpatient unit. A postal survey on a demographically group-matched sample of the general population with 525 caregivers of children (aged 2-18 years) and 373 children (aged 5-18 years) was conducted with the PedsQL 4.0 Generic Core Scale. Responses were described, compared over subgroups of subjects, and were used to assess practical utility, distributional coverage, construct validity, internal consistency, and inter-reporter agreement of the instrument. The moderate scale-level mean percentage of missing item responses (range 1.8-2.3%) supported the feasibility of the Generic Core Scales for general Hungarian children. Minimal to moderate ceiling effects and no floor effects were found on the Generic Core Scales. We observed stronger ceiling than floor effects in the Cardiac Module. Most of the scales showed satisfactory reliability with Cronbach's alpha estimates exceeding 0.70. Generally, moderate to good agreement was found between self- and parent proxy-reports in the patient and in the comparison group (intraclass correlation coefficient range 0.52-0.77), but remarkably low agreement in the perceived physical appearance subscale in the age group 5-7 years (0.18) and for the treatment II scale (problems on taking heart medicine) scale of the Cardiac Module in children aged 8-12 years (0.39). Assessing the construct validity of the questionnaires, statistically significant difference was found between the patient group and the comparison group only in the Physical Functioning Scale scores (p = 0.003) of the child self-report component, and in Physical (p = 0.022), Emotional, (p = 0.017), Psychosocial Summary (p = 0.019) scores and in the total HRQoL (health-related quality of life) scale score (p = 0.034) for parent proxy-report. The findings generally support the feasibility, reliability and validity of the Hungarian translation of the PedsQL 4.0 Generic Core Scales and the PedsQL 3.0 Cardiac Module in Hungarian children with heart disease.

Files in /noaa/dhs

Science.gov Websites

noaa_20110510_wbg.gif 10-May-2011 20:58 31K generic file noaa_20110510_wbg.pdf 10-May-2011 20:58 128K generic file noaa_20110513_wbg.gif 13-May-2011 20:10 27K generic file noaa_20110513_wbg.pdf 13-May-2011 20:10 122K generic file noaa_20110518_wbg.gif 18-May-2011 21:10 33K generic file noaa_20110518_wbg.pdf 18-May-2011 21:10 128K generic file

[Sample preparation and bioanalysis in mass spectrometry].

PubMed

Bourgogne, Emmanuel; Wagner, Michel

2015-01-01

The quantitative analysis of compounds of clinical interest of low molecular weight (<1000 Da) in biological fluids is currently in most cases performed by liquid chromatography-mass spectrometry (LC-MS). Analysis of these compounds in biological fluids (plasma, urine, saliva, hair...) is a difficult task requiring a sample preparation. Sample preparation is a crucial part of chemical/biological analysis and in a sense is considered the bottleneck of the whole analytical process. The main objectives of sample preparation are the removal of potential interferences, analyte preconcentration, and converting (if needed) the analyte into a more suitable form for detection or separation. Without chromatographic separation, endogenous compounds, co-eluted products may affect a quantitative method in mass spectrometry performance. This work focuses on three distinct parts. First, quantitative bioanalysis will be defined, different matrices and sample preparation techniques currently used in bioanalysis by mass spectrometry of/for small molecules of clinical interest in biological fluids. In a second step the goals of sample preparation will be described. Finally, in a third step, sample preparation strategies will be made either directly ("dilute and shoot") or after precipitation.

The differences between the branded and generic medicines using solid dosage forms: In-vitro dissolution testing

PubMed Central

Al Ameri, Mubarak Nasser; Nayuni, Nanda; Anil Kumar, K.G.; Perrett, David; Tucker, Arthur; Johnston, Atholl

2011-01-01

Introduction Dissolution is the amount of substance that goes into solution per unit time under standardised conditions of liquid/solid interface, solvent composition and temperature. Dissolution is one of the most important tools to predict the in-vivo bioavailability and in some cases to determine bioequivalence and assure interchangeability. Aim To compare the differences in dissolution behaviour of solid dosage forms between innovators (reference products) and their generic counterparts (tested products). Methods Four replicates for each batch of 37 tested medicines was carried out using A PT-DT70 dissolution tester from Pharma Test. A total of 13 branded medicines and 24 generic counterparts were obtained locally and internationally to detect any differences in their dissolution behaviour. They were tested according to the British Pharmacopeia, European Pharmacopeia and the US Pharmacopeia with the rate of dissolution determined by ultra-violet Spectrophotometery. Results Most tested medicines complied with the pharmacopoeial specifications and achieved 85% dissolution in 60 min. However, some generic medicines showed significant differences in dissolution rate at 60 and 120 min. Many generic medicines showed a slower dissolution rate than their branded counterparts such as the generic forms of omeprazole 20 mg. Some showed an incomplete dissolution such as the generic form of nifedipine 10 mg. Other generics showed faster dissolution rate than their branded counterpart such as the generic forms of meloxicam 15 mg. Moreover, some generics from different batches of the same manufacturer showed significant differences in their dissolution rate such as the generic forms of meloxicam 7.5 mg. Nevertheless, some generic medicines violated the EMA and the FDA guidelines for industry when they failed to achieve 85% dissolution at 60 min, such as the generic form of diclofenac sodium 50 mg. Conclusion Most medicines in this study complied with the pharmacopeial limits. However, some generics dissolved differently than their branded counterparts. This can clearly question the interchangeability between the branded and its generic counterpart or even among generics. PMID:25755988

Elastic moduli in nano-size samples of amorphous solids: System size dependence

NASA Astrophysics Data System (ADS)

Cohen, Yossi; Procaccia, Itamar

2012-08-01

This letter is motivated by some recent experiments on pan-cake-shaped nano-samples of metallic glass that indicate a decline in the measured shear modulus upon decreasing the sample radius. Similar measurements on crystalline samples of the same dimensions showed a much more modest change. In this letter we offer a theory of this phenomenon; we argue that such results are generically expected for any amorphous solid, with the main effect being related to the increased contribution of surfaces with respect to the bulk when the samples get smaller. We employ exact relations between the shear modulus and the eigenvalues of the system's Hessian matrix to explore the role of surface modes in affecting the elastic moduli.

Is bioavailability altered in generic versus brand anticonvulsants?

PubMed

Jankovic, Slobodan M; Ignjatovic Ristic, Dragana

2015-03-01

Therapeutic window of anticonvulsants is not a wide one, with phenytoin being one extreme, which can be classified as a narrow therapeutic index drug, since its ratio between the least toxic and the least effective concentration is less than twofold. In order to obtain marketing authorization, a generic anticonvulsant should demonstrate relative bioequivalence with its brand-name counterpart. However, although bioequivalent, generic anticonvulsants still do not have the same bioavailability as brand-name drugs, which may lead to larger fluctuations of steady-state plasma concentrations, and sometimes to loss of seizure control if a patient is switched from brand-name to generic or from generic to generic anticonvulsant. Generic anticonvulsants are effective, safe and affordable drugs for treatment of epilepsy, and patients could be successfully treated with them from the very beginning. It is switching from brand-name to generic anticonvulsant or from one generic anticonvulsant to another that should be avoided in clinical practice, since subtle differences in bioavailability may disturb optimal degree of seizure control to which the patient was previously successfully titrated.

Generic medicines: solutions for a sustainable drug market?

PubMed

Dylst, Pieter; Vulto, Arnold; Godman, Brian; Simoens, Steven

2013-10-01

Generic medicines offer equally high-quality treatment as originator medicines do at much lower prices. As such, they represent a considerable opportunity for authorities to obtain substantial savings. At the moment, the pharmaceutical landscape is changing and many pharmaceutical companies have altered their development and commercial strategies, combining both originator and generic divisions. In spite of this, the generic medicines industry is currently facing a number of challenges: delayed market access; the limited price differential with originator medicines; the continuous downwards pressure on prices; and the negative perception regarding generic medicines held by some key stakeholder groups. This could jeopardize the long-term sustainability of the generic manufacturing industry. Therefore, governments must focus on demand-side policies, alongside policies to accelerate market access, as the generic medicines industry will only be able to deliver competitive and sustainable prices if they are ensured a high volume. In the future, the generic medicines industry will increasingly look to biosimilars and generic versions of orphan drugs to expand their business.

Analysis of the Italian generic medicines retail market: recommendations to enhance long-term sustainability.

PubMed

Dylst, Pieter; Vulto, Arnold; Simoens, Steven

2015-02-01

Italy is among the European countries with the lowest uptake of generic medicines. This paper provides a perspective on the Italian generic medicines retail market. Fast market entrance of generic medicines in Italy is hindered by several factors: the existence of Complementary Protection Certificates in the past, the large market for copies and multiple cases of patent linkage. Prices of generic medicines in Italy are low compared to other European countries. To contain pharmaceutical expenditure, pharmaceutical companies are currently forced to pay back in case of overspending, which disproportionally penalizes small and fast growing companies, to which most generic companies belong to. Current demand-side policies do not successfully stimulate the use of generic medicines. The current market environment surrounding the Italian generic medicines retail market (i.e., low prices, low volumes) threatens its long-term sustainability. Recommendations to enhance the long-term sustainability of the Italian generic medicines retail market round off this perspective paper.

Small RNA Library Preparation Method for Next-Generation Sequencing Using Chemical Modifications to Prevent Adapter Dimer Formation.

PubMed

Shore, Sabrina; Henderson, Jordana M; Lebedev, Alexandre; Salcedo, Michelle P; Zon, Gerald; McCaffrey, Anton P; Paul, Natasha; Hogrefe, Richard I

2016-01-01

For most sample types, the automation of RNA and DNA sample preparation workflows enables high throughput next-generation sequencing (NGS) library preparation. Greater adoption of small RNA (sRNA) sequencing has been hindered by high sample input requirements and inherent ligation side products formed during library preparation. These side products, known as adapter dimer, are very similar in size to the tagged library. Most sRNA library preparation strategies thus employ a gel purification step to isolate tagged library from adapter dimer contaminants. At very low sample inputs, adapter dimer side products dominate the reaction and limit the sensitivity of this technique. Here we address the need for improved specificity of sRNA library preparation workflows with a novel library preparation approach that uses modified adapters to suppress adapter dimer formation. This workflow allows for lower sample inputs and elimination of the gel purification step, which in turn allows for an automatable sRNA library preparation protocol.

Patients' perceptions of generic drugs in Greece.

PubMed

Skaltsas, Leonora N; Vasileiou, Konstantinos Z

2015-11-01

The use of generic drugs is growing increasingly around the world and in Greece, in particular, in order to reduce pharmaceutical expenditure. However, patients' perceptions and attitudes about generics have only partially been studied so far in Greece. This study aimed to examine the factors that influence the attitude of patients and consumers regarding generic drugs. A questionnaire survey of 364 patients visiting a pharmacy was conducted. The questionnaire consisted of 29 questions, including questions regarding their knowledge about generics, the reasons for using them, their previous experience, their willingness for generic substitution, and the factors behind these choices. Nearly half of the participants in the survey know the term 'generic' and that it has a lower price compared to the brand name drug. Their views on safety and efficacy vary significantly and the main source of information on generics is the media and the internet. The lack of knowledge is the main barrier for attitudes of doctors. Health professionals play the most influential role for the substitution of a branded drug by a generic, followed by the cost of the generic. Almost half of the patients know about generic drugs, with their lower price being the most popular feature which most patients are familiar with. It seems that primarily the doctor and, subsequently the pharmacist play the most important role in a patient's decision to replace his/her medicine with a generic. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Biomimetic Silica Nanoparticles Prepared by a Combination of Solid-Phase Imprinting and Ostwald Ripening.

PubMed

Piletska, Elena; Yawer, Heersh; Canfarotta, Francesco; Moczko, Ewa; Smolinska-Kempisty, Katarzyna; Piletsky, Stanislav S; Guerreiro, Antonio; Whitcombe, Michael J; Piletsky, Sergey A

2017-09-14

Herein we describe the preparation of molecularly imprinted silica nanoparticles by Ostwald ripening in the presence of molecular templates immobilised on glass beads (the solid-phase). To achieve this, a seed material (12 nm diameter silica nanoparticles) was incubated in phosphate buffer in the presence of the solid-phase. Phosphate ions act as a catalyst in the ripening process which is driven by differences in surface energy between particles of different size, leading to the preferential growth of larger particles. Material deposited in the vicinity of template molecules results in the formation of sol-gel molecular imprints after around 2 hours. Selective washing and elution allows the higher affinity nanoparticles to be isolated. Unlike other strategies commonly used to prepare imprinted silica nanoparticles this approach is extremely simple in nature and can be performed under physiological conditions, making it suitable for imprinting whole proteins and other biomacromolecules in their native conformations. We have demonstrated the generic nature of this method by preparing imprinted silica nanoparticles against targets of varying molecular mass (melamine, vancomycin and trypsin). Binding to the imprinted particles was demonstrated in an immunoassay (ELISA) format in buffer and complex media (milk or blood plasma) with sub-nM detection ability.

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

Not Available

This volume contains the interim change notice for sample preparation methods. Covered are: acid digestion for metals analysis, fusion of Hanford tank waste solids, water leach of sludges/soils/other solids, extraction procedure toxicity (simulate leach in landfill), sample preparation for gamma spectroscopy, acid digestion for radiochemical analysis, leach preparation of solids for free cyanide analysis, aqueous leach of solids for anion analysis, microwave digestion of glasses and slurries for ICP/MS, toxicity characteristic leaching extraction for inorganics, leach/dissolution of activated metal for radiochemical analysis, extraction of single-shell tank (SST) samples for semi-VOC analysis, preparation and cleanup of hydrocarbon- containing samples for VOCmore » and semi-VOC analysis, receiving of waste tank samples in onsite transfer cask, receipt and inspection of SST samples, receipt and extrusion of core samples at 325A shielded facility, cleaning and shipping of waste tank samplers, homogenization of solutions/slurries/sludges, and test sample preparation for bioassay quality control program.« less

Effects of Sample Preparation on the Infrared Reflectance Spectra of Powders

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

Brauer, Carolyn S.; Johnson, Timothy J.; Myers, Tanya L.

2015-05-22

While reflectance spectroscopy is a useful tool in identifying molecular compounds, laboratory measurement of solid (particularly powder) samples often is confounded by sample preparation methods. For example, both the packing density and surface roughness can have an effect on the quantitative reflectance spectra of powdered samples. Recent efforts in our group have focused on developing standard methods for measuring reflectance spectra that accounts for sample preparation, as well as other factors such as particle size and provenance. In this work, the effect of preparation method on sample reflectivity was investigated by measuring the directional-hemispherical spectra of samples that were hand-packedmore » as well as pressed into pellets using an integrating sphere attached to a Fourier transform infrared spectrometer. The results show that the methods used to prepare the sample have a substantial effect on the measured reflectance spectra, as do other factors such as particle size.« less

Effects of sample preparation on the infrared reflectance spectra of powders

NASA Astrophysics Data System (ADS)

Brauer, Carolyn S.; Johnson, Timothy J.; Myers, Tanya L.; Su, Yin-Fong; Blake, Thomas A.; Forland, Brenda M.

2015-05-01

While reflectance spectroscopy is a useful tool for identifying molecular compounds, laboratory measurement of solid (particularly powder) samples often is confounded by sample preparation methods. For example, both the packing density and surface roughness can have an effect on the quantitative reflectance spectra of powdered samples. Recent efforts in our group have focused on developing standard methods for measuring reflectance spectra that accounts for sample preparation, as well as other factors such as particle size and provenance. In this work, the effect of preparation method on sample reflectivity was investigated by measuring the directional-hemispherical spectra of samples that were hand-loaded as well as pressed into pellets using an integrating sphere attached to a Fourier transform infrared spectrometer. The results show that the methods used to prepare the sample can have a substantial effect on the measured reflectance spectra, as do other factors such as particle size.

On the possibility of using polycrystalline material in the development of structure-based generic assays

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

Allaire, Marc, E-mail: allaire@bnl.gov; Moiseeva, Natalia; Botez, Cristian E.

The correlation coefficients calculated between raw powder diffraction profiles can be used to identify ligand-bound/unbound states of lysozyme. The discovery of ligands that bind specifically to a targeted protein benefits from the development of generic assays for high-throughput screening of a library of chemicals. Protein powder diffraction (PPD) has been proposed as a potential method for use as a structure-based assay for high-throughput screening applications. Building on this effort, powder samples of bound/unbound states of soluble hen-egg white lysozyme precipitated with sodium chloride were compared. The correlation coefficients calculated between the raw diffraction profiles were consistent with the known bindingmore » properties of the ligands and suggested that the PPD approach can be used even prior to a full description using stereochemically restrained Rietveld refinement.« less

The importance of being first: evidence from Canadian generic pharmaceuticals.

PubMed

Hollis, Aidan

2002-12-01

This paper uses pooled cross-section data on Canadian ethical drug sales to examine the effect of entry timing on sales of generic drugs. The data is for all drugs for which the first generic competitor entered during the years 1994-1997. It is found that the first generic entrant has a lasting competitive advantage: being first into the market appears to lead to an increase of around 30% in market share (among generics) over a period of at least 4 years. This finding has considerable implications for the current policy of allowing brandname drug companies to issue pseudo-generic equivalents as a preemptive strike against true generic competitors. Copyright 2002 John Wiley & Sons, Ltd.

Generic penetration in the retail antidepressant market.

PubMed

Ventimiglia, Jeffrey; Kalali, Amir H

2010-06-01

In this article, we explore the accelerated penetration of generic antidepressants in the United States market following the availability of generic citalopram and sertraline. Analysis suggests that overall, generic penetration into the antidepressant market has grown from approximately 41 percent in January 2004 to over 73 percent in January 2010. Similar trends are uncovered when branded and generic prescriptions are analyzed by specialty.

A review of the differences and similarities between generic drugs and their originator counterparts, including economic benefits associated with usage of generic medicines, using Ireland as a case study.

PubMed

Dunne, Suzanne; Shannon, Bill; Dunne, Colum; Cullen, Walter

2013-01-05

Generic medicines are those where patent protection has expired, and which may be produced by manufacturers other than the innovator company. Use of generic medicines has been increasing in recent years, primarily as a cost saving measure in healthcare provision. Generic medicines are typically 20 to 90% cheaper than originator equivalents. Our objective is to provide a high-level description of what generic medicines are and how they differ, at a regulatory and legislative level, from originator medicines. We describe the current and historical regulation of medicines in the world's two main pharmaceutical markets, in addition to the similarities, as well as the differences, between generics and their originator equivalents including the reasons for the cost differences seen between originator and generic medicines. Ireland is currently poised to introduce generic substitution and reference pricing. This article refers to this situation as an exemplar of a national system on the cusp of significant health policy change, and specifically details Ireland's history with usage of generic medicines and how the proposed changes could affect healthcare provision.

Effects of generic versus non-generic feedback on motor learning in children.

PubMed

Chiviacowsky, Suzete; Drews, Ricardo

2014-01-01

Non-generic feedback refers to a specific event and implies that performance is malleable, while generic feedback implies that task performance reflects an inherent ability. The present study examined the influences of generic versus non-generic feedback on motor performance and learning in 10-year-old children. In the first experiment, using soccer ball kicking at a target as a task, providing participants with generic feedback resulted in worse performance than providing non-generic feedback, after both groups received negative feedback. The second experiment measured more permanent effects. Results of a retention test, performed one day after practicing a throwing task, showed that participants who received non-generic feedback during practice outperformed the generic feedback group, after receiving a negative feedback statement. The findings demonstrate the importance of the wording of feedback. Even though different positive feedback statements may not have an immediate influence on performance, they can affect performance, and presumably individuals' motivation, when performance is (purportedly) poor. Feedback implying that performance is malleable, rather than due to an inherent ability, seems to have the potential to inoculate learners against setbacks--a situation frequently encountered in the context of motor performance and learning.

Generic medicine pricing in Europe: current issues and future perspective.

PubMed

Simoens, Steven

2008-01-01

This editorial discusses a number of trends affecting the pricing of generic medicines in Europe. With respect to pricing, recent evidence has emerged that European generic medicine manufacturers face competition from Indian manufacturers; that the price level of generic medicines varies substantially between European countries; and that generic medicine manufacturers engage in competition by discount rather than price competition in France, The Netherlands and the UK. These trends suggest that there may be scope for further reducing the prices of generic medicines in several countries. In relation to reference pricing, most European countries have incorporated market incentives within reference pricing systems with a view to promoting price competition. The European experience indicates that the generic medicines industry delivers competitive prices under a reference pricing system if demand-side policies are in place that stimulate physicians, pharmacists and patients to use generic medicines. Finally, caution needs to be exercised when focusing on the drivers of generic medicine pricing as these drivers not only vary between countries, but may also vary within a country. Manufacturers of originator and generic medicines do not take a single pricing approach following patent expiry, but vary their pricing strategy from molecule to molecule.

Effects of Generic versus Non-Generic Feedback on Motor Learning in Children

PubMed Central

Chiviacowsky, Suzete; Drews, Ricardo

2014-01-01

Non-generic feedback refers to a specific event and implies that performance is malleable, while generic feedback implies that task performance reflects an inherent ability. The present study examined the influences of generic versus non-generic feedback on motor performance and learning in 10-year-old children. In the first experiment, using soccer ball kicking at a target as a task, providing participants with generic feedback resulted in worse performance than providing non-generic feedback, after both groups received negative feedback. The second experiment measured more permanent effects. Results of a retention test, performed one day after practicing a throwing task, showed that participants who received non-generic feedback during practice outperformed the generic feedback group, after receiving a negative feedback statement. The findings demonstrate the importance of the wording of feedback. Even though different positive feedback statements may not have an immediate influence on performance, they can affect performance, and presumably individuals' motivation, when performance is (purportedly) poor. Feedback implying that performance is malleable, rather than due to an inherent ability, seems to have the potential to inoculate learners against setbacks – a situation frequently encountered in the context of motor performance and learning. PMID:24523947

A review of the differences and similarities between generic drugs and their originator counterparts, including economic benefits associated with usage of generic medicines, using Ireland as a case study

PubMed Central

2013-01-01

Generic medicines are those where patent protection has expired, and which may be produced by manufacturers other than the innovator company. Use of generic medicines has been increasing in recent years, primarily as a cost saving measure in healthcare provision. Generic medicines are typically 20 to 90% cheaper than originator equivalents. Our objective is to provide a high-level description of what generic medicines are and how they differ, at a regulatory and legislative level, from originator medicines. We describe the current and historical regulation of medicines in the world’s two main pharmaceutical markets, in addition to the similarities, as well as the differences, between generics and their originator equivalents including the reasons for the cost differences seen between originator and generic medicines. Ireland is currently poised to introduce generic substitution and reference pricing. This article refers to this situation as an exemplar of a national system on the cusp of significant health policy change, and specifically details Ireland’s history with usage of generic medicines and how the proposed changes could affect healthcare provision. PMID:23289757

Inhalation devices: from basic science to practical use, innovative vs generic products.

PubMed

Pirozynski, Michal; Sosnowski, Tomasz R

2016-11-01

Inhalation therapy is a convenient method of treating respiratory diseases. The key factors required for inhalation are the preparation of drug carriers (aerosol particles) allowing reproducible dosing during administration. These technical challenges are accomplished with a variety of inhalation devices (inhalers) and medicinal formulations, which are optimized to be easily converted into inhalable aerosols. Areas covered: This review is focused on the most important, but often overlooked, effects, which are required for the reliable and reproducible inhalable drug administration. The effects of patient-related issues that influence inhalation therapy, such as proper selection of inhalers for specific cases is discussed. We also discuss factors that are the most essential if generic inhalation product should be considered equivalent to the drugs with the clinically confirmed efficacy. Expert opinion: Proper device selection is crucial in clinical results of inhalation therapy. The patients' ability to coordinate inhalation with actuation, generation of optimal flow through the device, use of optimal inspiratory volume, all produces crucial effects on disease control. Also the severity of the disease process effects proper use of inhalers. Interchanging of inhalers can produce potentially conflicting problem regarding efficacy and safety of inhalation therapy.

[The introduction of generic pharmaceutical products into Galicia].

PubMed

Verdejo González, A; López-Lázaro, L; Rodríguez Moreno, C; Piñeiro Lago, B; Pereira Martínez, M L

1999-11-30

To know the evolution of the introduction of generic drugs (GDs) in Galicia. Secondarily, to evaluate its potential impact on pharmaceutical expenditure. Descriptive study of GDs utilization. Cost-minimization analysis. Galician autonomous region, year 1998. Using data from the prescription billing registry of Social Security we have selected the active ingredients corresponding to GDs with prescriptions in Galicia in 1997. We have analyzed the data for their oral single substance preparations by quarters. Consumption in DHDs of allopurinol, atenolol, captopril, naproxen and ranitidine remained stable during 1998. The market share for their GDs in quantitative terms relative to both total consumption of the active ingredients and to their pharmaceutical equivalents, showed an overall growing trend. The maximum observed value was seen for ranitidine at last quarter. Total expenditure (in final customer prices) during 1998 on the selected active substances was higher than 1864 million pesetas. Potential savings afforded by substitution for the lowest price GD prescribed in Galicia would reach 427 million pesetas. GDs market penetration in Galicia during 1998 was limited but increasing. Its utilization may afford estimated savings of 21-28% of the cost for the selected drugs. However, the expenditure on the above drugs was just 2.7% of total pharmaceutical expenditure.

Determinants of generic drug substitution in Switzerland.

PubMed

Decollogny, Anne; Eggli, Yves; Halfon, Patricia; Lufkin, Thomas M

2011-01-26

Since generic drugs have the same therapeutic effect as the original formulation but at generally lower costs, their use should be more heavily promoted. However, a considerable number of barriers to their wider use have been observed in many countries. The present study examines the influence of patients, physicians and certain characteristics of the generics' market on generic substitution in Switzerland. We used reimbursement claims' data submitted to a large health insurer by insured individuals living in one of Switzerland's three linguistic regions during 2003. All dispensed drugs studied here were substitutable. The outcome (use of a generic or not) was modelled by logistic regression, adjusted for patients' characteristics (gender, age, treatment complexity, substitution groups) and with several variables describing reimbursement incentives (deductible, co-payments) and the generics' market (prices, packaging, co-branded original, number of available generics, etc.). The overall generics' substitution rate for 173,212 dispensed prescriptions was 31%, though this varied considerably across cantons. Poor health status (older patients, complex treatments) was associated with lower generic use. Higher rates were associated with higher out-of-pocket costs, greater price differences between the original and the generic, and with the number of generics on the market, while reformulation and repackaging were associated with lower rates. The substitution rate was 13% lower among hospital physicians. The adoption of the prescribing practices of the canton with the highest substitution rate would increase substitution in other cantons to as much as 26%. Patient health status explained a part of the reluctance to substitute an original formulation by a generic. Economic incentives were efficient, but with a moderate global effect. The huge interregional differences indicated that prescribing behaviours and beliefs are probably the main determinant of generic substitution.

Farm Management, Environment, and Weather Factors Jointly Affect the Probability of Spinach Contamination by Generic Escherichia coli at the Preharvest Stage

PubMed Central

Navratil, Sarah; Gregory, Ashley; Bauer, Arin; Srinath, Indumathi; Szonyi, Barbara; Nightingale, Kendra; Anciso, Juan; Jun, Mikyoung; Han, Daikwon; Lawhon, Sara; Ivanek, Renata

2014-01-01

The National Resources Information (NRI) databases provide underutilized information on the local farm conditions that may predict microbial contamination of leafy greens at preharvest. Our objective was to identify NRI weather and landscape factors affecting spinach contamination with generic Escherichia coli individually and jointly with farm management and environmental factors. For each of the 955 georeferenced spinach samples (including 63 positive samples) collected between 2010 and 2012 on 12 farms in Colorado and Texas, we extracted variables describing the local weather (ambient temperature, precipitation, and wind speed) and landscape (soil characteristics and proximity to roads and water bodies) from NRI databases. Variables describing farm management and environment were obtained from a survey of the enrolled farms. The variables were evaluated using a mixed-effect logistic regression model with random effects for farm and date. The model identified precipitation as a single NRI predictor of spinach contamination with generic E. coli, indicating that the contamination probability increases with an increasing mean amount of rain (mm) in the past 29 days (odds ratio [OR] = 3.5). The model also identified the farm's hygiene practices as a protective factor (OR = 0.06) and manure application (OR = 52.2) and state (OR = 108.1) as risk factors. In cross-validation, the model showed a solid predictive performance, with an area under the receiver operating characteristic (ROC) curve of 81%. Overall, the findings highlighted the utility of NRI precipitation data in predicting contamination and demonstrated that farm management, environment, and weather factors should be considered jointly in development of good agricultural practices and measures to reduce produce contamination. PMID:24509926

Measuring Individual Differences in Generic Beliefs in Conspiracy Theories Across Cultures: Conspiracy Mentality Questionnaire

PubMed Central

Bruder, Martin; Haffke, Peter; Neave, Nick; Nouripanah, Nina; Imhoff, Roland

2013-01-01

Conspiracy theories are ubiquitous when it comes to explaining political events and societal phenomena. Individuals differ not only in the degree to which they believe in specific conspiracy theories, but also in their general susceptibility to explanations based on such theories, that is, their conspiracy mentality. We present the Conspiracy Mentality Questionnaire (CMQ), an instrument designed to efficiently assess differences in the generic tendency to engage in conspiracist ideation within and across cultures. The CMQ is available in English, German, and Turkish. In four studies, we examined the CMQ’s factorial structure, reliability, measurement equivalence across cultures, and its convergent, discriminant, and predictive validity. Analyses based on a cross-cultural sample (Study 1a; N = 7,766) supported the conceptualization of conspiracy mentality as a one-dimensional construct across the three language versions of the CMQ that is stable across time (Study 1b; N = 141). Multi-group confirmatory factor analysis demonstrated cross-cultural measurement equivalence of the CMQ items. The instrument could therefore be used to examine differences in conspiracy mentality between European, North American, and Middle Eastern cultures. In Studies 2–4 (total N = 476), we report (re-)analyses of three datasets demonstrating the validity of the CMQ in student and working population samples in the UK and Germany. First, attesting to its convergent validity, the CMQ was highly correlated with another measure of generic conspiracy belief. Second, the CMQ showed patterns of meaningful associations with personality measures (e.g., Big Five dimensions, schizotypy), other generalized political attitudes (e.g., social dominance orientation and right-wing authoritarianism), and further individual differences (e.g., paranormal belief, lack of socio-political control). Finally, the CMQ predicted beliefs in specific conspiracy theories over and above other individual difference measures. PMID:23641227

Phylogeny of palaeotropic Derris-like taxa (Fabaceae) based on chloroplast and nuclear DNA sequences shows reorganization of (infra)generic classifications is needed.

PubMed

Sirichamorn, Yotsawate; Adema, Frits A C B; Gravendeel, Barbara; van Welzen, Peter C

2012-11-01

Palaeotropic Derris-like taxa (family Fabaceae, tribe Millettieae) comprise 6-9 genera. They are well known as important sources of rotenone toxin, which are used as organic insecticide and fish poison. However, their phylogenetic relationships and classification are still problematic due to insufficient sampling and high morphological variability. Fifty species of palaeotropic Derris-like taxa were sampled, which is more than in former studies. Three chloroplast genes (trnK-matK, trnL-F IGS, and psbA-trnH IGS) and nuclear ribosomal ITS /5.8S were analyzed using parsimony and Bayesian methods. Parsimony and Bayesian analyses of individual and combined markers show more or less similar tree topologies (only varying in terminal branches). The old-world monophyletic genera Aganope, Brachypterum, and Leptoderris are distinct from Derris s.s., and their generic status is here confirmed. Aganope may be classified into two or three subgeneric taxa. Paraderris has to be included in Derris s.s. to form a monophyletic group. The genera Philenoptera, Deguelia, and Lonchocarpus are monophyletic and distinct from each other and clearly separate from Derris s.s. Morphologically highly similar species of Derris s.s. are shown to be unrelated. Our study shows that previous infrageneric classifications of Derris are incorrect. Paraderris elliptica may contain several cryptic lineages that need further investigation. The concept of the genus Derris s.s. should be reorganized with a new generic circumscription by including Paraderris but excluding Brachypterum. Synapomorphic morphological features will be examined in future studies, and the status of the newly defined Derris and its closely related taxa will be formalized.

Potential artifacts associated with historical preparation of joint compound samples and reported airborne asbestos concentrations.

PubMed

Brorby, G P; Sheehan, P J; Berman, D W; Bogen, K T; Holm, S E

2011-05-01

Airborne samples collected in the 1970s for drywall workers using asbestos-containing joint compounds were likely prepared and analyzed according to National Institute of Occupational Safety and Health Method P&CAM 239, the historical precursor to current Method 7400. Experimentation with a re-created, chrysotile-containing, carbonate-based joint compound suggested that analysis following sample preparation by the historical vs. current method produces different fiber counts, likely because of an interaction between the different clearing and mounting chemicals used and the carbonate-based joint compound matrix. Differences were also observed during analysis using Method 7402, depending on whether acetic acid/dimethylformamide or acetone was used during preparation to collapse the filter. Specifically, air samples of sanded chrysotile-containing joint compound prepared by the historical method yielded fiber counts significantly greater (average of 1.7-fold, 95% confidence interval: 1.5- to 2.0-fold) than those obtained by the current method. In addition, air samples prepared by Method 7402 using acetic acid/dimethylformamide yielded fiber counts that were greater (2.8-fold, 95% confidence interval: 2.5- to 3.2-fold) than those prepared by this method using acetone. These results indicated (1) there is an interaction between Method P&CAM 239 preparation chemicals and the carbonate-based joint compound matrix that reveals fibers that were previously bound in the matrix, and (2) the same appeared to be true for Method 7402 preparation chemicals acetic acid/dimethylformamide. This difference in fiber counts is the opposite of what has been reported historically for samples of relatively pure chrysotile dusts prepared using the same chemicals. This preparation artifact should be considered when interpreting historical air samples for drywall workers prepared by Method P&CAM 239. Copyright © 2011 JOEH, LLC

Sample Preparation of Corn Seed Tissue to Prevent Analyte Relocations for Mass Spectrometry Imaging

NASA Astrophysics Data System (ADS)

Kim, Shin Hye; Kim, Jeongkwon; Lee, Young Jin; Lee, Tae Geol; Yoon, Sohee

2017-08-01

Corn seed tissue sections were prepared by the tape support method using an adhesive tape, and mass spectrometry imaging (MSI) was performed. The effect of heat generated during sample preparation was investigated by time-of-flight secondary mass spectrometry (TOF-SIMS) imaging of corn seed tissue prepared by the tape support and the thaw-mounted methods. Unlike thaw-mounted sample preparation, the tape support method does not cause imaging distortion because of the absence of heat, which can cause migration of the analytes on the sample. By applying the tape-support method, the corn seed tissue was prepared without structural damage and MSI with accurate spatial information of analytes was successfully performed.

MARS: bringing the automation of small-molecule bioanalytical sample preparations to a new frontier.

PubMed

Li, Ming; Chou, Judy; Jing, Jing; Xu, Hui; Costa, Aldo; Caputo, Robin; Mikkilineni, Rajesh; Flannelly-King, Shane; Rohde, Ellen; Gan, Lawrence; Klunk, Lewis; Yang, Liyu

2012-06-01

In recent years, there has been a growing interest in automating small-molecule bioanalytical sample preparations specifically using the Hamilton MicroLab(®) STAR liquid-handling platform. In the most extensive work reported thus far, multiple small-molecule sample preparation assay types (protein precipitation extraction, SPE and liquid-liquid extraction) have been integrated into a suite that is composed of graphical user interfaces and Hamilton scripts. Using that suite, bioanalytical scientists have been able to automate various sample preparation methods to a great extent. However, there are still areas that could benefit from further automation, specifically, the full integration of analytical standard and QC sample preparation with study sample extraction in one continuous run, real-time 2D barcode scanning on the Hamilton deck and direct Laboratory Information Management System database connectivity. We developed a new small-molecule sample-preparation automation system that improves in all of the aforementioned areas. The improved system presented herein further streamlines the bioanalytical workflow, simplifies batch run design, reduces analyst intervention and eliminates sample-handling error.

Patients’ beliefs about generic medicines in Malaysia

PubMed Central

Wong, Zhi Y.; Hassali, Mohamed A.; Alrasheedy, Alian A.; Saleem, Fahad; Yahaya, Abdul H.; Aljadhey, Hisham

2014-01-01

Background: Acceptance of generic medicines by patients is an essential factor given that they are the end users of these medicines. In fact, adequate knowledge and positive perceptions are prerequisite to patients’ acceptance and use of generic medicines. Objective: To assess the current belief and views of patients about generic medicines in Malaysia. Method: This was a self-administered questionnaire-based study. The study was conducted with patients visiting outpatient pharmacy department at a tertiary care hospital in Malaysia. The Malaysian version of Generic Medicines Scale (GMS) was used. The GMS consists of two subscales: efficacy and similarity of generic medicines to original brand medicines. The efficacy subscale consists of 10 items while the similarity subscale consists of 6 items. The responses to the items were framed as a five-point Likert scale (1=strongly disagree to 5=strongly agree). Results: A total of 202 out of 300 patients participated in the study, giving a response rate of 67.3%. In this study, only 49% of them (n=99) knew the term ‘generic medicine’. Moreover, only 53.5% of the respondents (n=108) believed that the efficacy of generic medicines was the same as original brand medicines. In terms of quality, only 44% of the respondents (n=89) disagreed that generic medicines were of a lower quality. About one third (n=65, 32.2%) believed that generic medicines were cheaper because they were less efficacious. In terms of side effects, 44.5% of the respondents (n=90) believed that generic medicines had the same side effect profile as original brand medicines. Conclusions: The study finding showed that almost half of the respondents had negative belief in generic medicines. Similarly, many patients were not aware of the similarities and differences between generic and original brand medicines. Therefore, there is a need to provide patients with adequate information about generic medicines. PMID:25580171

A Systematic Review of Physicians' and Pharmacists' Perspectives on Generic Drug Use: What are the Global Challenges?

PubMed

Toverud, Else-Lydia; Hartmann, Katrin; Håkonsen, Helle

2015-08-01

Generic substitution has been introduced in most countries in order to reduce costs and improve access to drugs. However, regulations and the generic drugs available vary between countries. It is the prescriber or dispenser of the drug who is the final decision maker. Nevertheless, physicians' and pharmacists' perceptions of generic drug use are not well documented to date. This study presents a systematic review of physicians' and pharmacists' perspectives on generic drug use worldwide. A systematic literature search was performed to retrieve all articles published between 2002 and 2012 regarding physicians' and/or pharmacists' experiences with generic drugs and generic substitution. Of 1322 publications initially identified, 24 were eligible for inclusion. Overall, the studies revealed that physicians and pharmacists were aware of the cost-saving function of generic drugs and their role in improving global access to drugs. Nevertheless, marked differences were observed between countries when studying physicians' and pharmacists' perceptions of the available generic drugs. In less mature healthcare systems, large variations regarding, for example, control routines, bioequivalence requirements, and manufacturer standards were reported. A lack of reliable information and mistrust in the efficacy and quality were also mentioned by these participants. In the most developed healthcare systems, the participants trusted the quality of the generic drugs and did not hesitate to offer them to all patients regardless of socioeconomic status. In general, pharmacists seemed to have better knowledge of the concept of bioequivalence and generic drug aspects than physicians. The present study indicates that physicians and pharmacists are aware of the role of generic drugs in the improvement of global access to drugs. However, there are marked differences regarding how these health professionals view the quality of generic drugs depending on the maturity of their country's healthcare system. This can be attributed to the fact that developed healthcare systems have more reliable public control routines for drugs in general as well as better bioequivalence requirements concerning generics in particular.

A price and use comparison of generic versus originator cardiovascular medicines: a hospital study in Chongqing, China

PubMed Central

2013-01-01

Background Developed countries use generic competition to contain pharmaceutical expenditure. China, as a developing and transitional country, has not yet deemed an increase in the use of generic products as important; otherwise, much effort has been made to decrease the drug prices. This paper aims to explore dynamically the price and use comparison of generic and originator drugs in China, and estimate the potential savings of patients from switching originator drugs to generics. Methods A typical hospital in Chongqing, China, was selected to examine the price and use comparisons of 12 cardiovascular drugs from 2006 to 2011. Results The market share of the 12 generic medicines studied in this paper was 34.37% for volume and 31.33% for value in the second half of 2011. The price ratio of generic to originator drugs was between 0.34 and 0.98, and the volume price index of originators to generics was 1.63. The potential savings of patients from switching originator drugs to generics is 65%. Conclusion The market share of the generics was lowering and the weighted mean price kept increasing in face of the strict price control. Under the background of hospitals both prescribing and dispensing medicines, China’s comprehensive healthcare policy makers should take measures from supply and demand sides to promote the consumption of generic medicines. PMID:24093493