Generic Verification Protocol for Verification of Online Turbidimeters

EPA Science Inventory

This protocol provides generic procedures for implementing a verification test for the performance of online turbidimeters. The verification tests described in this document will be conducted under the Environmental Technology Verification (ETV) Program. Verification tests will...

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.

Developing multiple-choices test items as tools for measuring the scientific-generic skills on solar system

NASA Astrophysics Data System (ADS)

Bhakti, Satria Seto; Samsudin, Achmad; Chandra, Didi Teguh; Siahaan, Parsaoran

2017-05-01

The aim of research is developing multiple-choices test items as tools for measuring the scientific of generic skills on solar system. To achieve the aim that the researchers used the ADDIE model consisting Of: Analyzing, Design, Development, Implementation, dan Evaluation, all of this as a method research. While The scientific of generic skills limited research to five indicator including: (1) indirect observation, (2) awareness of the scale, (3) inference logic, (4) a causal relation, and (5) mathematical modeling. The participants are 32 students at one of junior high schools in Bandung. The result shown that multiple-choices that are constructed test items have been declared valid by the expert validator, and after the tests show that the matter of developing multiple-choices test items be able to measuring the scientific of generic skills on solar system.

20 CFR 404.1519n - Informing the medical source of examination scheduling, report content, and signature requirements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... ventilatory function tests, treadmill exercise tests, or audiological tests. The medical report must be... other abnormalities or lack thereof reported or found during examination or laboratory testing; (4) The...

Stress Testing of Data-Communication Networks

NASA Technical Reports Server (NTRS)

Leucht, Kurt; Bedette, Guy

2006-01-01

NetStress is a computer program that stress-tests a data-communication network and components thereof. NetStress comprises two components running, respectively, in a transmitting system and a receiving system connected to a network under test

30 CFR 27.39 - Tests to determine resistance to vibration.

Code of Federal Regulations, 2010 CFR

2010-07-01

..., EVALUATION, AND APPROVAL OF MINING PRODUCTS METHANE-MONITORING SYSTEMS Test Requirements § 27.39 Tests to... to verify the reliability and durability of a methane-monitoring system or component(s) thereof where...

A detailed heterogeneous agent model for a single asset financial market with trading via an order book.

PubMed

Mota Navarro, Roberto; Larralde, Hernán

2017-01-01

We present an agent based model of a single asset financial market that is capable of replicating most of the non-trivial statistical properties observed in real financial markets, generically referred to as stylized facts. In our model agents employ strategies inspired on those used in real markets, and a realistic trade mechanism based on a double auction order book. We study the role of the distinct types of trader on the return statistics: specifically, correlation properties (or lack thereof), volatility clustering, heavy tails, and the degree to which the distribution can be described by a log-normal. Further, by introducing the practice of "profit taking", our model is also capable of replicating the stylized fact related to an asymmetry in the distribution of losses and gains.

A detailed heterogeneous agent model for a single asset financial market with trading via an order book

PubMed Central

2017-01-01

We present an agent based model of a single asset financial market that is capable of replicating most of the non-trivial statistical properties observed in real financial markets, generically referred to as stylized facts. In our model agents employ strategies inspired on those used in real markets, and a realistic trade mechanism based on a double auction order book. We study the role of the distinct types of trader on the return statistics: specifically, correlation properties (or lack thereof), volatility clustering, heavy tails, and the degree to which the distribution can be described by a log-normal. Further, by introducing the practice of “profit taking”, our model is also capable of replicating the stylized fact related to an asymmetry in the distribution of losses and gains. PMID:28245251

78 FR 78948 - Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-27

...In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, and as part of an effort to streamline the process to seek feedback from the public on service delivery, the Department of Defense announces a proposed generic information collection and seeks public comment on the provisions thereof. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed information collection; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.

78 FR 78947 - Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-27

...In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, and as part of an effort to streamline the process to seek feedback from the public on service delivery, the Department of Defense announces a proposed generic information collection and seeks public comment on the provisions thereof. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed information collection; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.

78 FR 78950 - Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-27

...In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, and as part of an effort to streamline the process to seek feedback from the public on service delivery, the Department of Defense announces a proposed generic information collection and seeks public comment on the provisions thereof. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed information collection; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.

78 FR 78938 - Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-27

...In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, and as part of an effort to streamline the process to seek feedback from the public on service delivery, the Department of Defense announces a proposed generic information collection and seeks public comment on the provisions thereof. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed information collection; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.

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.

Generics market in Greece: the pharmaceutical industry's beliefs.

PubMed

Geitona, Mary; Zavras, Dimitrios; Hatzikou, Magda; Kyriopoulos, John

2006-11-01

The aim of this study was to investigate the beliefs and perspectives of the pharmaceutical industry on generic medication in Greece. Questionnaires were mailed to all 58 members of the Hellenic Association of Pharmaceutical Companies from November 2002 to February 2003. The response rate was 52%, namely 30 questionnaires were completed and returned. The questionnaire requested information on companies' involvement in generics, their opinion on generics' characteristics and on public policies affecting the demand and supply of generic medication. A descriptive analysis of the outcomes, that is percentage comparison through binomial tests and Fisher tests, was performed. According to our findings, 43% of the respondents were involved in the production and distribution of generics and the mean period of their involvement was 12 years. The majority of the respondents were in favor of their companies' involvement in generics, despite the relatively small market share of generics in Greece; 9.7% of total pharmaceutical market in 2003. Bearing in mind that in Greece the promotion of generics is not encouraged, pharmaceutical companies believe that the mandatory introduction of bioequivalence studies is an indirect promotional strategy towards generics. Additionally, the majority declared that their main competitive advantages are their safety, efficacy and effectiveness as well as their economic benefit to the society. Finally, the respondents expressed their preference for the introduction of pharmacoeconomic submissions for drugs' reimbursement by social insurance funds.

76 FR 14034 - Proposed Collection; Comment Request; A Generic Submission for Formative Research, Pretesting...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-15

... Request; A Generic Submission for Formative Research, Pretesting, Stakeholder Measures and Advocate Forms... Collection: Title: A Generic Submission for Formative Research, Pre-testing, Stakeholder Measures and.... This customer satisfaction research helps ensure the relevance, utility, and appropriateness of the...

GENERIC VERIFICATION PROTOCOL FOR AQUEOUS CLEANER RECYCLING TECHNOLOGIES

EPA Science Inventory

This generic verification protocol has been structured based on a format developed for ETV-MF projects. This document describes the intended approach and explain plans for testing with respect to areas such as test methodology, procedures, parameters, and instrumentation. Also ...

75 FR 62403 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-08

... Project: 2011-2014 National Survey on Drug Use and Health: Methodological Field Tests (OMB No. 0930-0290..., SAMHSA received a three-year renewal of its generic clearance for methodological field tests. This will be a request for another renewal of the generic approval to continue methodological tests over the...

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

PubMed

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

2014-11-01

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

75 FR 25269 - Proposed Collection; Comment Request; A Generic Submission for Formative Research, Pretesting...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-07

... Request; A Generic Submission for Formative Research, Pretesting, and Stakeholder Measures at NCI SUMMARY... Generic Submission for Formative Research, Pre-testing, and Stakeholder Measures at NCI. Type of... external stakeholders with this collaboration. This customer satisfaction research helps ensure the...

A Generic Expert Scheduling System Architecture and Toolkit: GUESS (Generically Used Expert Scheduling System)

NASA Technical Reports Server (NTRS)

Liebowitz, Jay; Krishnamurthy, Vijaya; Rodens, Ira; Houston, Chapman; Liebowitz, Alisa; Baek, Seung; Radko, Joe; Zeide, Janet

1996-01-01

Scheduling has become an increasingly important element in today's society and workplace. Within the NASA environment, scheduling is one of the most frequently performed and challenging functions. Towards meeting NASA's scheduling needs, a research version of a generic expert scheduling system architecture and toolkit has been developed. This final report describes the development and testing of GUESS (Generically Used Expert Scheduling System).

76 FR 50993 - Agency Information Collection Activities: Proposed Collection; Comment Request-Generic Clearance...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-17

...: Proposed Collection; Comment Request--Generic Clearance to Conduct Methodological Testing, Surveys, Focus... proposed information collection. This information collection will conduct research by methodological... Methodological Testing, Surveys, Focus Groups, and Related Tools to Improve the Management of Federal Nutrition...

GENERIC VERIFICATION PROTOCOL: DISTRIBUTED GENERATION AND COMBINED HEAT AND POWER FIELD TESTING PROTOCOL

EPA Science Inventory

This report is a generic verification protocol by which EPA’s Environmental Technology Verification program tests newly developed equipment for distributed generation of electric power, usually micro-turbine generators and internal combustion engine generators. The protocol will ...

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.

75 FR 78720 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-16

.... Proposed Project: 2011-2014 National Survey on Drug Use and Health: Methodological Field Tests (OMB No..., SAMHSA received a 3-year renewal of its generic clearance for methodological field tests. This will be a request for another renewal of the generic approval to continue methodological tests over the next 3 years...

Charge loss (or the lack thereof) for AdS black holes

NASA Astrophysics Data System (ADS)

Ong, Yen Chin; Chen, Pisin

2014-06-01

The evolution of evaporating charged black holes is complicated to model in general, but is nevertheless important since the hints to the Information Loss Paradox and its recent firewall incarnation may lie in understanding more generic geometries than that of Schwarzschild spacetime. Fortunately, for sufficiently large asymptotically flat Reissner-Nordström black holes, the evaporation process can be modeled via a system of coupled linear ordinary differential equations, with charge loss rate governed by Schwinger pair-production process. The same model can be generalized to study the evaporation of AdS Reissner-Nordström black holes with flat horizon. It was recently found that such black holes always evolve towards extremality since charge loss is inefficient. This property is completely opposite to the asymptotically flat case in which the black hole eventually loses its charges and tends towards Schwarzschild limit. We clarify the underlying reason for this different behavior.

Systematic study of source mask optimization and verification flows

NASA Astrophysics Data System (ADS)

Ben, Yu; Latypov, Azat; Chua, Gek Soon; Zou, Yi

2012-06-01

Source mask optimization (SMO) emerged as powerful resolution enhancement technique (RET) for advanced technology nodes. However, there is a plethora of flow and verification metrics in the field, confounding the end user of the technique. Systemic study of different flows and the possible unification thereof is missing. This contribution is intended to reveal the pros and cons of different SMO approaches and verification metrics, understand the commonality and difference, and provide a generic guideline for RET selection via SMO. The paper discusses 3 different type of variations commonly arise in SMO, namely pattern preparation & selection, availability of relevant OPC recipe for freeform source and finally the metrics used in source verification. Several pattern selection algorithms are compared and advantages of systematic pattern selection algorithms are discussed. In the absence of a full resist model for SMO, alternative SMO flow without full resist model is reviewed. Preferred verification flow with quality metrics of DOF and MEEF is examined.

Interacting spin-2 fields in the Stückelberg picture

NASA Astrophysics Data System (ADS)

Noller, Johannes; Scargill, James H. C.; Ferreira, Pedro G.

2014-02-01

We revisit and extend the `Effective field theory for massive gravitons' constructed by Arkani-Hamed, Georgi and Schwartz in the light of recent progress in constructing ghost-free theories with multiple interacting spin-2 fields. We show that there exist several dual ways of restoring gauge invariance in such multi-gravity theories, find a generalised Fierz-Pauli tuning condition relevant in this context and highlight subtleties in demixing tensor and scalar modes. The generic multi-gravity feature of scalar mixing and its consequences for higher order interactions are discussed. In particular we show how the decoupling limit is qualitatively changed in theories of interacting spin-2 fields. We relate this to dRGT (de Rham, Gabadadze, Tolley) massive gravity, Hassan-Rosen bigravity and the multi-gravity constructions by Hinterbichler and Rosen. As an additional application we show that EBI (Eddington-Born-Infeld) bigravity and higher order generalisations thereof possess ghost-like instabilities.

77 FR 12089 - Proposed Generic Communication; Regulatory Issue Summary 2012-XX: Developing Inservice Testing...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-28

... NUCLEAR REGULATORY COMMISSION [NRC-2012-0048] Proposed Generic Communication; Regulatory Issue... CFR) Part 52, ``Licenses, Certifications, and Approvals for Nuclear Power Plants,'' to satisfy the... inservice testing programs during the initial 120-month program interval following nuclear power plant...

Generic Verification Protocol for Testing Pesticide Application Spray Drift Reduction Technologies for Row and Field Crops

EPA Pesticide Factsheets

This generic verification protocol provides a detailed method to conduct and report results from a verification test of pesticide application technologies that can be used to evaluate these technologies for their potential to reduce spray drift.

46 CFR 58.30-35 - Testing.

Code of Federal Regulations, 2010 CFR

2010-10-01

... components thereof shall be tested as required by this section. (b) Accumulators constructed as pressure... associated equipment components, including hydraulic steering gear, in lieu of being tested at the time of installation, may be shop tested by the manufacturer to 11/2 times the maximum allowable pressure of the system...

46 CFR 58.30-35 - Testing.

Code of Federal Regulations, 2012 CFR

2012-10-01

... components thereof shall be tested as required by this section. (b) Accumulators constructed as pressure... associated equipment components, including hydraulic steering gear, in lieu of being tested at the time of installation, may be shop tested by the manufacturer to 11/2 times the maximum allowable pressure of the system...

46 CFR 58.30-35 - Testing.

Code of Federal Regulations, 2011 CFR

2011-10-01

... components thereof shall be tested as required by this section. (b) Accumulators constructed as pressure... associated equipment components, including hydraulic steering gear, in lieu of being tested at the time of installation, may be shop tested by the manufacturer to 11/2 times the maximum allowable pressure of the system...

46 CFR 58.30-35 - Testing.

Code of Federal Regulations, 2014 CFR

2014-10-01

... components thereof shall be tested as required by this section. (b) Accumulators constructed as pressure... associated equipment components, including hydraulic steering gear, in lieu of being tested at the time of installation, may be shop tested by the manufacturer to 11/2 times the maximum allowable pressure of the system...

46 CFR 58.30-35 - Testing.

Code of Federal Regulations, 2013 CFR

2013-10-01

... components thereof shall be tested as required by this section. (b) Accumulators constructed as pressure... associated equipment components, including hydraulic steering gear, in lieu of being tested at the time of installation, may be shop tested by the manufacturer to 11/2 times the maximum allowable pressure of the system...

16 CFR 1630.31 - Reasonable and representative tests and recordkeeping requirements.

Code of Federal Regulations, 2012 CFR

2012-01-01

..., constructional units (needles, pitch, rows, shot, stitches, and weight), dye class, dyestuff, dyeing application... representative tests with respect to any quality of machine-made carpets or rugs are (1) at least one test performed upon commencement of production, importation, or other receipt thereof, (2) at least one test...

16 CFR 1630.31 - Reasonable and representative tests and recordkeeping requirements.

Code of Federal Regulations, 2014 CFR

2014-01-01

..., constructional units (needles, pitch, rows, shot, stitches, and weight), dye class, dyestuff, dyeing application... representative tests with respect to any quality of machine-made carpets or rugs are (1) at least one test performed upon commencement of production, importation, or other receipt thereof, (2) at least one test...

16 CFR 1630.31 - Reasonable and representative tests and recordkeeping requirements.

Code of Federal Regulations, 2011 CFR

2011-01-01

..., constructional units (needles, pitch, rows, shot, stitches, and weight), dye class, dyestuff, dyeing application... representative tests with respect to any quality of machine-made carpets or rugs are (1) at least one test performed upon commencement of production, importation, or other receipt thereof, (2) at least one test...

16 CFR 1631.31 - Reasonable and representative tests and recordkeeping requirements.

Code of Federal Regulations, 2014 CFR

2014-01-01

..., constructional units (needles, pitch, rows, shot, stitches, and weight), dye class, dyestuff, dyeing application... representative tests with respect to any quality of machine-made carpets or rugs are (1) at least one test performed upon commencement of production, importation, or other receipt thereof, (2) at least one test...

16 CFR 1630.31 - Reasonable and representative tests and recordkeeping requirements.

Code of Federal Regulations, 2010 CFR

2010-01-01

..., constructional units (needles, pitch, rows, shot, stitches, and weight), dye class, dyestuff, dyeing application... representative tests with respect to any quality of machine-made carpets or rugs are (1) at least one test performed upon commencement of production, importation, or other receipt thereof, (2) at least one test...

16 CFR 1631.31 - Reasonable and representative tests and recordkeeping requirements.

Code of Federal Regulations, 2011 CFR

2011-01-01

..., constructional units (needles, pitch, rows, shot, stitches, and weight), dye class, dyestuff, dyeing application... representative tests with respect to any quality of machine-made carpets or rugs are (1) at least one test performed upon commencement of production, importation, or other receipt thereof, (2) at least one test...

16 CFR 1631.31 - Reasonable and representative tests and recordkeeping requirements.

Code of Federal Regulations, 2010 CFR

2010-01-01

..., constructional units (needles, pitch, rows, shot, stitches, and weight), dye class, dyestuff, dyeing application... representative tests with respect to any quality of machine-made carpets or rugs are (1) at least one test performed upon commencement of production, importation, or other receipt thereof, (2) at least one test...

16 CFR 1631.31 - Reasonable and representative tests and recordkeeping requirements.

Code of Federal Regulations, 2012 CFR

2012-01-01

..., constructional units (needles, pitch, rows, shot, stitches, and weight), dye class, dyestuff, dyeing application... representative tests with respect to any quality of machine-made carpets or rugs are (1) at least one test performed upon commencement of production, importation, or other receipt thereof, (2) at least one test...

Perceptions of the quality of generic medicines: implications for trust in public services within the local health system in Tumkur, India.

PubMed

Aivalli, Praveen Kumar; Elias, Maya Annie; Pati, Manoj Kumar; Bhanuprakash, Srinath; Munegowda, Chikkagollahalli; Shroff, Zubin Cyrus; Srinivas, Prashanth N

2017-01-01

Generic medicines are an important policy option to reduce out-of-pocket expenditure on medicines. However, negative perceptions of their quality affect utilisation and raise issues of confidence and trust in medicines and health services. The aim of the study was to test the quality of generic and branded medicines and explain negative perceptions towards generic medicines. The study was part of a larger study on access to medicines. Information on various quality parameters was collected for branded medicines and branded and unbranded generic versions of the same medicines from government and private pharmacies in Karnataka in Southern India. To assess perceptions related to quality and drivers of preferred point of care (public vs private), focus group discussions were conducted with diabetes and hypertension patients, health workers and private pharmacists. The results of the quality tests were assessed and thematic analysis was conducted on the qualitative data to develop a conceptual framework to explain perceptions of medicine and care quality in the local health system. The generic and branded variants of the medicines tested were of comparable quality. Contrary to the quality test results, patients' and health workers' perceptions of quality were largely in favour of branded medicines. Negative perceptions of medicine quality along with other drivers contribute towards choosing more expensive medicines in the private sector. Trust in the health system emerged as an underlying central theme that explained and drove choice of medicines and providers within the local health system. Negative perceptions of generic medicines and preferential promotion of branded medicines over generics by pharmaceutical companies could influence prescriber behaviour and affect trust in healthcare provided in public services. To succeed, access to medicines programmes need to systematically invest in information on quality of medicines and develop strategies to build trust in healthcare offered in government health services.

Perceptions of the quality of generic medicines: implications for trust in public services within the local health system in Tumkur, India

PubMed Central

Aivalli, Praveen Kumar; Elias, Maya Annie; Pati, Manoj Kumar; Bhanuprakash, Srinath; Munegowda, Chikkagollahalli; Shroff, Zubin Cyrus

2017-01-01

Introduction Generic medicines are an important policy option to reduce out-of-pocket expenditure on medicines. However, negative perceptions of their quality affect utilisation and raise issues of confidence and trust in medicines and health services. The aim of the study was to test the quality of generic and branded medicines and explain negative perceptions towards generic medicines. Methods The study was part of a larger study on access to medicines. Information on various quality parameters was collected for branded medicines and branded and unbranded generic versions of the same medicines from government and private pharmacies in Karnataka in Southern India. To assess perceptions related to quality and drivers of preferred point of care (public vs private), focus group discussions were conducted with diabetes and hypertension patients, health workers and private pharmacists. The results of the quality tests were assessed and thematic analysis was conducted on the qualitative data to develop a conceptual framework to explain perceptions of medicine and care quality in the local health system. Results The generic and branded variants of the medicines tested were of comparable quality. Contrary to the quality test results, patients’ and health workers’ perceptions of quality were largely in favour of branded medicines. Negative perceptions of medicine quality along with other drivers contribute towards choosing more expensive medicines in the private sector. Trust in the health system emerged as an underlying central theme that explained and drove choice of medicines and providers within the local health system. Conclusion Negative perceptions of generic medicines and preferential promotion of branded medicines over generics by pharmaceutical companies could influence prescriber behaviour and affect trust in healthcare provided in public services. To succeed, access to medicines programmes need to systematically invest in information on quality of medicines and develop strategies to build trust in healthcare offered in government health services. PMID:29531844

50 CFR 10.12 - Definitions.

Code of Federal Regulations, 2012 CFR

2012-10-01

... any part, product, egg, or offspring thereof, or the dead body or parts thereof (excluding fossils... offspring thereof, or the dead body or parts thereof (excluding fossils), whether or not included in a... part, product, egg, or offspring thereof, or the dead body or parts thereof (excluding fossils...

50 CFR 10.12 - Definitions.

Code of Federal Regulations, 2011 CFR

2011-10-01

... any part, product, egg, or offspring thereof, or the dead body or parts thereof (excluding fossils... offspring thereof, or the dead body or parts thereof (excluding fossils), whether or not included in a... part, product, egg, or offspring thereof, or the dead body or parts thereof (excluding fossils...

50 CFR 10.12 - Definitions.

Code of Federal Regulations, 2013 CFR

2013-10-01

... any part, product, egg, or offspring thereof, or the dead body or parts thereof (excluding fossils... offspring thereof, or the dead body or parts thereof (excluding fossils), whether or not included in a... part, product, egg, or offspring thereof, or the dead body or parts thereof (excluding fossils...

50 CFR 10.12 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-10-01

... any part, product, egg, or offspring thereof, or the dead body or parts thereof (excluding fossils... offspring thereof, or the dead body or parts thereof (excluding fossils), whether or not included in a... part, product, egg, or offspring thereof, or the dead body or parts thereof (excluding fossils...

50 CFR 10.12 - Definitions.

Code of Federal Regulations, 2014 CFR

2014-10-01

... any part, product, egg, or offspring thereof, or the dead body or parts thereof (excluding fossils... offspring thereof, or the dead body or parts thereof (excluding fossils), whether or not included in a... part, product, egg, or offspring thereof, or the dead body or parts thereof (excluding fossils...

Tests Screening Reading Difficulty in Malayalam among Upper Primary School Boys

ERIC Educational Resources Information Center

Gafoor, K. Abdul

2014-01-01

Design of a screening test for identifying reading difficult students in Malayalam and validation thereof among boys is made to help schools proactively intervene with such students. A battery of tests developed based on extant literature on screening tests, reviewed difficulties in reading Malayalam, and discrimination power of the draft tests is…

76 FR 28994 - Submission for OMB Review; Comment Request; A Generic Submission for Formative Research, Pre...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-19

... quantitative (paper, phone, in-person, and web surveys) methodologies to conduct this research, allowing NCI to...; Comment Request; A Generic Submission for Formative Research, Pre-Testing, Stakeholder Measures and... Formative Research, Pre-testing, Stakeholder Measures and Advocate Forms at NCI. Type of Information...

77 FR 56866 - Agency Information Collection Activities: Proposed Collection; Comment Request, Generic Clearance...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-14

... Collection Activities: Proposed Collection; Comment Request, Generic Clearance for Cognitive, Pilot and Field... information collection clearance that will allow BJS to conduct a variety of cognitive, pilot, and field test... new or modified data collection, BJS will engage in cognitive, pilot and field test activities to...

77 FR 56867 - Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-14

... Collection Activities: Proposed Collection; Comment Request; Generic Clearance for Cognitive, Pilot and Field... information collection clearance that will allow BJS to conduct a variety of cognitive, pilot, and field test... new or modified data collection, BJS will engage in cognitive, pilot and field test activities to...

16 CFR § 1630.31 - Reasonable and representative tests and recordkeeping requirements.

Code of Federal Regulations, 2013 CFR

2013-01-01

... applicable, constructional units (needles, pitch, rows, shot, stitches, and weight), dye class, dyestuff... one test performed upon commencement of production, importation, or other receipt thereof, (2) at least one test performed after production, importation, or other receipt of the first 25,000 linear...

16 CFR § 1631.31 - Reasonable and representative tests and recordkeeping requirements.

Code of Federal Regulations, 2013 CFR

2013-01-01

... applicable, constructional units (needles, pitch, rows, shot, stitches, and weight), dye class, dyestuff... one test performed upon commencement of production, importation, or other receipt thereof, (2) at least one test performed after production, importation, or other receipt of the first 25,000 linear...

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.

Generic and oral quality of life is affected by oral mucosal diseases

PubMed Central

2012-01-01

Background The generic and oral health-related quality of life (QoL) has provided opportunity for investigation of the interrelations among generic health, oral health, and related outcomes. The purpose of this study was to identify the generic and oral QoL in the patients with oral mucosal disease (OMD). Methods Five hundred and thirty-eight OMDs were recruited in this study. The instruments applied were Chinese version of the 36-item short form health survey (SF-36) and the short-form of Oral Health Impact Profile (OHIP-14). Results The mean score of sum OHIP-14 was significantly higher in the patients with OMD (10.81 ± 9.01) compared with those in the healthy subjects (HS) (6.55 ± 6.73) (p < 0.001, Mann-Whitney U test). 56.51% of the OMD patients and 12.94% of the HS reported at least one oral negative impact (p < 0.001, Chi-square test). The overall mean score of SF-36 was significantly lower in the patients with OMD (74.54 ± 12.77) compared with those in the HS (77.97 ± 12.39) (p = 0.021, t-test). Conclusions Administration of specific and generic questionnaires of QoL can provide us a detailed picture of the impact of OMDs on patients, and both generic and oral QoL were impaired in the patients with OMD. PMID:22225834

The Great Personhole Cover Debate Revisited: A Test of the Generic "Man."

ERIC Educational Resources Information Center

Cooper, Anne Messerly

In an attempt to determine whether the generic "man" has a strong association with maleness, 307 college students (122 males and 185 females) were polled to assess their attitudes about whether people "outgrow" the limited definition of man or whether the generic still retains an exclusionary, "mostly males" coloring. In order to prevent the…

Display device for indicating the value of a parameter in a process plant

DOEpatents

Scarola, Kenneth; Jamison, David S.; Manazir, Richard M.; Rescorl, Robert L.; Harmon, Daryl L.

1993-01-01

An advanced control room complex for a nuclear power plant, including a discrete indicator and alarm system (72) which is nuclear qualified for rapid response to changes in plant parameters and a component control system (64) which together provide a discrete monitoring and control capability at a panel (14-22, 26, 28) in the control room (10). A separate data processing system (70), which need not be nuclear qualified, provides integrated and overview information to the control room and to each panel, through CRTs (84) and a large, overhead integrated process status overview board (24). The discrete indicator and alarm system (72) and the data processing system (70) receive inputs from common plant sensors and validate the sensor outputs to arrive at a representative value of the parameter for use by the operator during both normal and accident conditions, thereby avoiding the need for him to assimilate data from each sensor individually. The integrated process status board (24) is at the apex of an information hierarchy that extends through four levels and provides access at each panel to the full display hierarchy. The control room panels are preferably of a modular construction, permitting the definition of inputs and outputs, the man machine interface, and the plant specific algorithms, to proceed in parallel with the fabrication of the panels, the installation of the equipment and the generic testing thereof.

Indicator system for advanced nuclear plant control complex

DOEpatents

Scarola, Kenneth; Jamison, David S.; Manazir, Richard M.; Rescorl, Robert L.; Harmon, Daryl L.

1993-01-01

An advanced control room complex for a nuclear power plant, including a discrete indicator and alarm system (72) which is nuclear qualified for rapid response to changes in plant parameters and a component control system (64) which together provide a discrete monitoring and control capability at a panel (14-22, 26, 28) in the control room (10). A separate data processing system (70), which need not be nuclear qualified, provides integrated and overview information to the control room and to each panel, through CRTs (84) and a large, overhead integrated process status overview board (24). The discrete indicator and alarm system (72) and the data processing system (70) receive inputs from common plant sensors and validate the sensor outputs to arrive at a representative value of the parameter for use by the operator during both normal and accident conditions, thereby avoiding the need for him to assimilate data from each sensor individually. The integrated process status board (24) is at the apex of an information hierarchy that extends through four levels and provides access at each panel to the full display hierarchy. The control room panels are preferably of a modular construction, permitting the definition of inputs and outputs, the man machine interface, and the plant specific algorithms, to proceed in parallel with the fabrication of the panels, the installation of the equipment and the generic testing thereof.

Indicator system for a process plant control complex

DOEpatents

Scarola, Kenneth; Jamison, David S.; Manazir, Richard M.; Rescorl, Robert L.; Harmon, Daryl L.

1993-01-01

An advanced control room complex for a nuclear power plant, including a discrete indicator and alarm system (72) which is nuclear qualified for rapid response to changes in plant parameters and a component control system (64) which together provide a discrete monitoring and control capability at a panel (14-22, 26, 28) in the control room (10). A separate data processing system (70), which need not be nuclear qualified, provides integrated and overview information to the control room and to each panel, through CRTs (84) and a large, overhead integrated process status overview board (24). The discrete indicator and alarm system (72) and the data processing system (70) receive inputs from common plant sensors and validate the sensor outputs to arrive at a representative value of the parameter for use by the operator during both normal and accident conditions, thereby avoiding the need for him to assimilate data from each sensor individually. The integrated process status board (24) is at the apex of an information hierarchy that extends through four levels and provides access at each panel to the full display hierarchy. The control room panels are preferably of a modular construction, permitting the definition of inputs and outputs, the man machine interface, and the plant specific algorithms, to proceed in parallel with the fabrication of the panels, the installation of the equipment and the generic testing thereof.

Console for a nuclear control complex

DOEpatents

Scarola, Kenneth; Jamison, David S.; Manazir, Richard M.; Rescorl, Robert L.; Harmon, Daryl L.

1993-01-01

An advanced control room complex for a nuclear power plant, including a discrete indicator and alarm system (72) which is nuclear qualified for rapid response to changes in plant parameters and a component control system (64) which together provide a discrete monitoring and control capability at a panel (14-22, 26, 28) in the control room (10). A separate data processing system (70), which need not be nuclear qualified, provides integrated and overview information to the control room and to each panel, through CRTs (84) and a large, overhead integrated process status overview board (24). The discrete indicator and alarm system (72) and the data processing system (70) receive inputs from common plant sensors and validate the sensor outputs to arrive at a representative value of the parameter for use by the operator during both normal and accident conditions, thereby avoiding the need for him to assimilate data from each sensor individually. The integrated process status board (24) is at the apex of an information hierarchy that extends through four levels and provides access at each panel to the full display hierarchy. The control room panels are preferably of a modular construction, permitting the definition of inputs and outputs, the man machine interface, and the plant specific algorithms, to proceed in parallel with the fabrication of the panels, the installation of the equipment and the generic testing thereof.

Alarm system for a nuclear control complex

DOEpatents

Scarola, Kenneth; Jamison, David S.; Manazir, Richard M.; Rescorl, Robert L.; Harmon, Daryl L.

1994-01-01

An advanced control room complex for a nuclear power plant, including a discrete indicator and alarm system (72) which is nuclear qualified for rapid response to changes in plant parameters and a component control system (64) which together provide a discrete monitoring and control capability at a panel (14-22, 26, 28) in the control room (10). A separate data processing system (70), which need not be nuclear qualified, provides integrated and overview information to the control room and to each panel, through CRTs (84) and a large, overhead integrated process status overview board (24). The discrete indicator and alarm system (72) and the data processing system (70) receive inputs from common plant sensors and validate the sensor outputs to arrive at a representative value of the parameter for use by the operator during both normal and accident conditions, thereby avoiding the need for him to assimilate data from each sensor individually. The integrated process status board (24) is at the apex of an information hierarchy that extends through four levels and provides access at each panel to the full display hierarchy. The control room panels are preferably of a modular construction, permitting the definition of inputs and outputs, the man machine interface, and the plant specific algorithms, to proceed in parallel with the fabrication of the panels, the installation of the equipment and the generic testing thereof.

Method of installing a control room console in a nuclear power plant

DOEpatents

Scarola, Kenneth; Jamison, David S.; Manazir, Richard M.; Rescorl, Robert L.; Harmon, Daryl L.

1994-01-01

An advanced control room complex for a nuclear power plant, including a discrete indicator and alarm system (72) which is nuclear qualified for rapid response to changes in plant parameters and a component control system (64) which together provide a discrete monitoring and control capability at a panel (14-22, 26, 28) in the control room (10). A separate data processing system (70), which need not be nuclear qualified, provides integrated and overview information to the control room and to each panel, through CRTs (84) and a large, overhead integrated process status overview board (24). The discrete indicator and alarm system (72) and the data processing system (70) receive inputs from common plant sensors and validate the sensor outputs to arrive at a representative value of the parameter for use by the operator during both normal and accident conditions, thereby avoiding the need for him to assimilate data from each sensor individually. The integrated process status board (24) is at the apex of an information hierarchy that extends through four levels and provides access at each panel to the full display hierarchy. The control room panels are preferably of a modular construction, permitting the definition of inputs and outputs, the man machine interface, and the plant specific algorithms, to proceed in parallel with the fabrication of the panels, the installation of the equipment and the generic testing thereof.

Advanced nuclear plant control complex

DOEpatents

Scarola, Kenneth; Jamison, David S.; Manazir, Richard M.; Rescorl, Robert L.; Harmon, Daryl L.

1993-01-01

An advanced control room complex for a nuclear power plant, including a discrete indicator and alarm system (72) which is nuclear qualified for rapid response to changes in plant parameters and a component control system (64) which together provide a discrete monitoring and control capability at a panel (14-22, 26, 28) in the control room (10). A separate data processing system (70), which need not be nuclear qualified, provides integrated and overview information to the control room and to each panel, through CRTs (84) and a large, overhead integrated process status overview board (24). The discrete indicator and alarm system (72) and the data processing system (70) receive inputs from common plant sensors and validate the sensor outputs to arrive at a representative value of the parameter for use by the operator during both normal and accident conditions, thereby avoiding the need for him to assimilate data from each sensor individually. The integrated process status board (24) is at the apex of an information hierarchy that extends through four levels and provides access at each panel to the full display hierarchy. The control room panels are preferably of a modular construction, permitting the definition of inputs and outputs, the man machine interface, and the plant specific algorithms, to proceed in parallel with the fabrication of the panels, the installation of the equipment and the generic testing thereof.

Advanced nuclear plant control room complex

DOEpatents

Scarola, Kenneth; Jamison, David S.; Manazir, Richard M.; Rescorl, Robert L.; Harmon, Daryl L.

1993-01-01

An advanced control room complex for a nuclear power plant, including a discrete indicator and alarm system (72) which is nuclear qualified for rapid response to changes in plant parameters and a component control system (64) which together provide a discrete monitoring and control capability at a panel (14-22, 26, 28) in the control room (10). A separate data processing system (70), which need not be nuclear qualified, provides integrated and overview information to the control room and to each panel, through CRTs (84) and a large, overhead integrated process status overview board (24). The discrete indicator and alarm system (72) and the data processing system (70) receive inputs from common plant sensors and validate the sensor outputs to arrive at a representative value of the parameter for use by the operator during both normal and accident conditions, thereby avoiding the need for him to assimilate data from each sensor individually. The integrated process status board (24) is at the apex of an information hierarchy that extends through four levels and provides access at each panel to the full display hierarchy. The control room panels are preferably of a modular construction, permitting the definition of inputs and outputs, the man machine interface, and the plant specific algorithms, to proceed in parallel with the fabrication of the panels, the installation of the equipment and the generic testing thereof.

7 CFR 28.952 - Testing of samples.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 2 2010-01-01 2010-01-01 false Testing of samples. 28.952 Section 28.952 Agriculture Regulations of the Department of Agriculture AGRICULTURAL MARKETING SERVICE (Standards, Inspections, Marketing... processing tests of the properties of cotton samples and report the results thereof to the persons from whom...

15 CFR 1150.1 - Applicability.

Code of Federal Regulations, 2011 CFR

2011-01-01

... Commerce and Foreign Trade Regulations Relating to Commerce and Foreign Trade (Continued) TECHNOLOGY... combination thereof, as described in American Society for Testing and Materials standard F 589-85, Standard.... Copies may be obtained from the American Society for Testing and Materials, 1916 Race Street...

15 CFR 1150.1 - Applicability.

Code of Federal Regulations, 2010 CFR

2010-01-01

... Commerce and Foreign Trade Regulations Relating to Commerce and Foreign Trade (Continued) TECHNOLOGY... combination thereof, as described in American Society for Testing and Materials standard F 589-85, Standard.... Copies may be obtained from the American Society for Testing and Materials, 1916 Race Street...

PHARMACEUTICAL QUALITY OF GENERIC ATORVASTATIN PRODUCTS COMPARED WITH THE INNOVATOR PRODUCT: A NEED FOR REVISING PRICING POLICY IN PALESTINE.

PubMed

Shawahna, Ramzi; Hroub, Abdel Kareem; Abed, Eliama; Jibali, Sondos; Al-Saghir, Ruba; Zaid, Abdel Naser

2016-01-01

Atorvastatin reduces morbidity and mortality due to cardiovascular events. This study was conducted to assess the prices and pharmaceutical quality of innovator atorvastatin 20 mg with its locally available generics in Palestine and to assess the suitability of their interchangeability. The prices of innovator and generic atorvastatin 20 mg were determined and compared. Innovator atorvastatin and four generic products were tested for their pharmaceutical quality. Tablets were tested for their drug contents, weight uniformity, hardness, disintegration and dissolution. Three out of four generics were less expensive than the innovator. Pharmaceutical quality assessments were satisfactory and within limits for all atorvastatin tested products. The average weight ranged from 206.6 ± 8.40 to 330 ± 3.92 mg and the %RSDs were within the permitted limits as per USP. Tablet hardness ranged from 102 ± 1.41 to 197.4 ± 6.88 kg and drug contents ranged from 92.2% to 105.3%. All products disintegrated within permitted time limits and showed very rapid dissolution. Products released more than 85% of their drug contents in less than 15 min. Our results showed that all tested innovator and generic atorvastatin products were of good pharmaceutical quality. Despite the lack of in vivo evaluation, our results indicate that these products are equivalent in vitro. Considering the in vitro release characteristics, these products might be used interchangeably. However, regulatory authorities permit the use of in vitro data in establishing similarity between immediate release oral dosage forms containing biopharmaceutical classification system class I and III drugs only.

Even apparently insignificant chemical deviations among bioequivalent generic antibiotics can lead to therapeutic nonequivalence: the case of meropenem.

PubMed

Agudelo, M; Rodriguez, C A; Pelaez, C A; Vesga, O

2014-01-01

Several studies with animal models have demonstrated that bioequivalence of generic products of antibiotics like vancomycin, as currently defined, do not guarantee therapeutic equivalence. However, the amounts and characteristics of impurities and degradation products in these formulations do not violate the requirements of the U.S. Pharmacopeia (USP). Here, we provide experimental data with three generic products of meropenem that help in understanding how these apparently insignificant chemical differences affect the in vivo efficacy. Meropenem generics were compared with the innovator in vitro by microbiological assay, susceptibility testing, and liquid chromatography/mass spectrometry (LC/MS) analysis and in vivo with the neutropenic guinea pig soleus infection model (Pseudomonas aeruginosa) and the neutropenic mouse thigh (P. aeruginosa), brain (P. aeruginosa), and lung (Klebisella pneumoniae) infection models, adding the dihydropeptidase I (DHP-I) inhibitor cilastatin in different proportions to the carbapenem. We found that the concentration and potency of the active pharmaceutical ingredient, in vitro susceptibility testing, and mouse pharmacokinetics were identical for all products; however, two generics differed significantly from the innovator in the guinea pig and mouse models, while the third generic was therapeutically equivalent under all conditions. Trisodium adducts in a bioequivalent generic made it more susceptible to DHP-I hydrolysis and less stable at room temperature, explaining its therapeutic nonequivalence. We conclude that the therapeutic nonequivalence of generic products of meropenem is due to greater susceptibility to DHP-I hydrolysis. These failing generics are compliant with USP requirements and would remain undetectable under current regulations.

Generic Verification Protocol for Testing Pesticide Application Spray Drift Reduction Technologies for Row and Field Crops (Version 1.4)

EPA Science Inventory

This generic verification protocol provides a detailed method for conducting and reporting results from verification testing of pesticide application technologies. It can be used to evaluate technologies for their potential to reduce spray drift, hence the term “drift reduction t...

77 FR 56865 - Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-14

... Collection Activities: Proposed Collection; Comment Request; Generic Clearance for Cognitive, Pilot and Field... information collection clearance that will allow BJS to conduct a variety of cognitive, pilot, and field test... each new or modified data collection, BJS will engage in cognitive, pilot and field test activities to...

Phase I Experimental Testing of a Generic Submarine Model in the DSTO Low Speed Wind Tunnel

DTIC Science & Technology

2012-07-01

used during the tests , along with the test methodology . A sub-set of the data gathered is also presented and briefly discussed. Overall, the force...total pressure probe when positioned close to the model. 4. Results Selected results from the testing of the generic submarine model in the...Appendix B summaries the test conditions. 4.3.1 Smoke Generator and Probe An Aerotech smoke generator and probe were used for visualisation of

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.

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.

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.

Differences in Preschoolers' and Adults' Use of Generics about Novel Animals and Artifacts: A Window onto a Conceptual Divide

ERIC Educational Resources Information Center

Brandone, Amanda C.; Gelman, Susan A.

2009-01-01

Children and adults commonly produce more generic noun phrases (e.g., birds fly) about animals than artifacts. This may reflect differences in participants' generic knowledge about specific animals/artifacts (e.g., dogs/chairs), or it may reflect a more general distinction. To test this, the current experiments asked adults and preschoolers to…

Using Test Data for Student Achievement: Answers to "No Child Left Behind." Second Edition

ERIC Educational Resources Information Center

Sindelar, Nancy W.

2011-01-01

Schools are drowning in test data, but many schools do little with test results other than sort students into various categories of proficiency or lack thereof. Some educators feel testing has taken the joy out of teaching. Others believe valuable instructional time has been lost as a result of testing. Yet, NCLB and other federal and state…

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.

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

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.

Differences in Peripheral Blood Lymphocytes between Brand-Name and Generic Tacrolimus Used in Stable Liver Transplant Recipients.

PubMed

Kim, Jong Man; Kwon, Choon Hyuck David; Joh, Jae-Won; Sinn, Dong Hyun; Choi, Gyu-Seong; Park, Jae Berm; Kang, Eun-Suk; Lee, Suk-Koo

2017-01-01

In this study, peripheral blood lymphocytes were compared between a brand-name and a generic tacrolimus group in stable liver transplant recipients. Sixteen patients who underwent ABO-compatible living donor liver transplants between 2012 and 2013 and had stable graft function were included in this study. Ten patients received brand-name tacrolimus and 6 patients received generic tacrolimus. CD3, CD4, CD8, γδ, CD4+FoxP3+, and CD3-CD56+ T cells were analyzed in peripheral blood obtained preoperatively and 4, 8, 12, and 24 weeks after liver transplantation. Categorical variables were compared using a χ2 test or Fisher exact test, and continuous variables were compared using the Mann-Whitney U test. Regarding the baseline and perioperative characteristics, there were no statistically significant differences between the 2 groups. Immunosuppression also was not different. Subtype analysis of T-cell populations carried out in parallel showed similar levels of CD3, CD4, CD8, and γδT cells with brand-name tacrolimus and generic tacrolimus in stable liver transplant recipients. However, the levels of CD4+Foxp3+ and CD3-CD56+ T cells were higher in the brand-name tacrolimus group than in the generic tacrolimus group 8 weeks after transplantation (p < 0.05). The level of CD4+Foxp3+ T cells was higher in the brand-name tacrolimus group than in the generic tacrolimus group after transplantation. This finding showed that brand-name tacrolimus could have more potential immunosuppressive activity than generic tacrolimus regarding the contribution of CD4+Foxp3+ T cells to graft tolerance in liver transplant recipients. © 2017 S. Karger AG, Basel.

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.

Information Learned from Generic Language Becomes Central to Children's Biological Concepts: Evidence from Their Open-Ended Explanations

ERIC Educational Resources Information Center

Cimpian, Andrei; Markman, Ellen M.

2009-01-01

Generic sentences (e.g., "Snakes have holes in their teeth") convey that a property (e.g., having holes in one's teeth) is true of a category (e.g., snakes). We test the hypothesis that, in addition to this basic aspect of their meaning, generic sentences also imply that the information they express is more conceptually central than the…

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.

Quantitative method of determining beryllium or a compound thereof in a sample

DOEpatents

McCleskey, T. Mark; Ehler, Deborah S.; John, Kevin D.; Burrell, Anthony K.; Collis, Gavin E.; Minogue, Edel M.; Warner, Benjamin P.

2006-10-31

A method of determining beryllium or a beryllium compound thereof in a sample, includes providing a sample suspected of comprising beryllium or a compound thereof, extracting beryllium or a compound thereof from the sample by dissolving in a solution, adding a fluorescent indicator to the solution to thereby bind any beryllium or a compound thereof to the fluorescent indicator, and determining the presence or amount of any beryllium or a compound thereof in the sample by measuring fluorescence.

Quantitative method of determining beryllium or a compound thereof in a sample

DOEpatents

McCleskey, T. Mark; Ehler, Deborah S.; John, Kevin D.; Burrell, Anthony K.; Collis, Gavin E.; Minogue, Edel M.; Warner, Benjamin P.

2010-08-24

A method of determining beryllium or a beryllium compound thereof in a sample, includes providing a sample suspected of comprising beryllium or a compound thereof, extracting beryllium or a compound thereof from the sample by dissolving in a solution, adding a fluorescent indicator to the solution to thereby bind any beryllium or a compound thereof to the fluorescent indicator, and determining the presence or amount of any beryllium or a compound thereof in the sample by measuring fluorescence.

In vitro disintegration studies of weekly generic and branded risedronate sodium formulations available in Canada.

PubMed

Walker, A D; Adachi, J D

2011-09-01

The aim of this study was to evaluate the in vitro disintegration of the five newly available Canadian generic risedronate 35 mg tablets compared to the innovator (branded) product, ACTONEL * *ACTONEL is a registered trade name of Warner Chilcott Company, LLC. (risedronate sodium) 35 mg. Tablets were inspected for colour and appearance. Disintegration times were determined using United States Pharmacopeia 33 (USP33-NF 28) methods. Disintegration onset time was also evaluated. The mean disintegration onset time values for the generic risedronate 35 mg tablets ranged from 2 to 29 seconds, and the mean disintegration completion times ranged from 81 to 260 seconds. The mean disintegration onset and completion time values for the ACTONEL 35 mg tablets were 23 and 43 seconds respectively. Four out of the five generic tablets tested had shorter disintegration onset times than the branded product; two of the generic tablet products had very fast disintegration onset times i.e. 2-3 seconds. Disintegration completion time for all five generic products tested was longer than that observed for the branded product; two generic products had disintegration completion time values five to six times longer than the branded product. Differences in the in vitro disintegration times were observed between the generic risedronate 35 mg tablets commercially available in Canada and the branded product, ACTONEL. The rapid disintegration onset times of two generic products may be important as this could increase the possibility of drug exposure in both the mouth and the esophagus during swallowing, resulting in unwanted localized irritation. However, it should be noted that an in vitro/in vivo correlation has not been established. Until such studies are completed it may be important to be aware of such in vitro disintegration differences when evaluating patients with newly presenting upper gastrointestinal complaints upon being switched from the branded product to generic formulations.

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.

Evaluation of zero-order controlled release preparations of nifedipine tablet on dissolution test, together with cost benefit point of view.

PubMed

Sakurai, Miyuki; Naruto, Ikue; Matsuyama, Kenji

2008-05-01

Many generic drugs have been released to decrease medical expenses, but some problems have been reported with regard to bioavailability and safety. In this study, we compared three once-a-day controlled-release preparations of nifedipine by the dissolution test (one branded and two generic preparations). Although the two generic drugs were equivalent to the branded drug according to the criteria listed in the Japanese "Guideline for Bioequivalence Studies of Generic Products", there was still a possibility of problems arising. For example, side effects could be caused by a rapid increase in the blood level of nifedipine with one generic drug, while bioavailability might be inadequate with the other due to its small area under the concentration vs. time curve. When each drug was prescribed at a dosage of 20 mg once daily for two weeks, the difference in the copayment for the patient was only 10 yen. Accordingly, it is important for doctors and pharmacists to carefully consider whether such a slight difference in price is really a benefit for the patient.

78 FR 44931 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-25

... services. The tasks of developing new questions and improving upon existing complaint questions along with... of the generic clearance process. This generic clearance will allow the Bureau to test and pilot new...

Statistical analysis of modeling error in structural dynamic systems

NASA Technical Reports Server (NTRS)

Hasselman, T. K.; Chrostowski, J. D.

1990-01-01

The paper presents a generic statistical model of the (total) modeling error for conventional space structures in their launch configuration. Modeling error is defined as the difference between analytical prediction and experimental measurement. It is represented by the differences between predicted and measured real eigenvalues and eigenvectors. Comparisons are made between pre-test and post-test models. Total modeling error is then subdivided into measurement error, experimental error and 'pure' modeling error, and comparisons made between measurement error and total modeling error. The generic statistical model presented in this paper is based on the first four global (primary structure) modes of four different structures belonging to the generic category of Conventional Space Structures (specifically excluding large truss-type space structures). As such, it may be used to evaluate the uncertainty of predicted mode shapes and frequencies, sinusoidal response, or the transient response of other structures belonging to the same generic category.

Methods, strengths, weaknesses, and limitations of bioequivalence tests with special regard to immunosuppressive drugs.

PubMed

van Gelder, Teun; Gabardi, Steven

2013-08-01

Within the field of solid organ transplantation, the patents for a number of immunosuppressive drugs have expired in the last few years. Tacrolimus, cyclosporine, and mycophenolate mofetil are now available as generic drugs. In some countries, the market penetration of these generic formulations is as high as 70%, whereas in some other countries, this figure is below 10%. Several professional societies have published position papers on the risks and benefits of generic substitution of immunosuppressive drugs. It often appears that transplant professionals are not fully aware of the requirements for registration of generic drugs. This article describes the registration requirements with a focus on bioequivalence testing, the strengths and weaknesses in this process, and the differences between Europe and the US. © 2013 The Authors Transplant International © 2013 European Society for Organ Transplantation. Published by Blackwell Publishing Ltd.

Brand loyalty, patients and limited generic medicines uptake.

PubMed

Costa-Font, Joan; Rudisill, Caroline; Tan, Stefanie

2014-06-01

The sluggish development of European generic drug markets depends heavily on demand side factors, and more specifically, patients' and doctors' loyalty to branded products. Loyalty to originator drugs, to the point where originator prices rise upon generic entry has been described as the 'generics paradox'. Originator loyalty can emerge for a plethora of reasons; including costs, perceptions about quality and physician advice. We know very little about the behavioural underpinnings of brand loyalty from the consumer or patient standpoint. This paper attempts to test the extent to which patients are brand loyal by drawing upon Spain's 2002 Health Barometer survey as it includes questions about consumer acceptance of generics in a country with exceptionally low generic uptake and substitution at the time of the study. Our findings suggest that at least 13% of the population would not accept generics as substitutes to the originator. These results confirm evidence of brand loyalty for a minority. Alongside high levels of awareness of generics, we find that low cost-sharing levels explain consumer brand loyalty but their impact on acceptance of generic substitution is very small. Higher cost-sharing and exempting fewer patients from cost-sharing have the potential to encourage generic acceptance. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Combinatorial synthesis of ceramic materials

DOEpatents

Lauf, Robert J [Oak Ridge, TN; Walls, Claudia A [Oak Ridge, TN; Boatner, Lynn A [Oak Ridge, TN

2010-02-23

A combinatorial library includes a gelcast substrate defining a plurality of cavities in at least one surface thereof; and a plurality of gelcast test materials in the cavities, at least two of the test materials differing from the substrate in at least one compositional characteristic, the two test materials differing from each other in at least one compositional characteristic.

Combinatorial synthesis of ceramic materials

DOEpatents

Lauf, Robert J.; Walls, Claudia A.; Boatner, Lynn A.

2006-11-14

A combinatorial library includes a gelcast substrate defining a plurality of cavities in at least one surface thereof; and a plurality of gelcast test materials in the cavities, at least two of the test materials differing from the substrate in at least one compositional characteristic, the two test materials differing from each other in at least one compositional characteristic.

14 CFR 141.63 - Examining authority qualification requirements.

Code of Federal Regulations, 2010 CFR

2010-01-01

... of those students passed the required practical or knowledge test, or any combination thereof, for... students in the training course for which examining authority is sought and recommended those students for...

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

Chemodynamics of aquatic metal complexes: from small ligands to colloids.

PubMed

Van Leeuwen, Herman P; Buffle, Jacques

2009-10-01

Recent progress in understanding the formation/dissociation kinetics of aquatic metal complexes with complexants in different size ranges is evaluated and put in perspective, with suggestions for further studies. The elementary steps in the Eigen mechanism, i.e., diffusion and dehydration of the metal ion, are reviewed and further developed. The (de)protonation of both the ligand and the coordinating metal ion is reconsidered in terms of the consequences for dehydration rates and stabilities of the various outer-sphere complexes. In the nanoparticulate size range, special attention is given to the case of fulvic ligands, for which the impact of electrostatic interactions is especially large. In complexation with colloidal ligands (hard, soft, and combination thereof) the diffusive transport of metal ions is generally a slower step than in the case of complexation with small ligands in a homogeneous solution. The ensuing consequences for the chemodynamics of colloidal complexes are discussed in detail and placed in a generic framework, encompassing the complete range of ligand sizes.

How do patent rights affect regulatory approvals and data exclusivity rights for pharmaceuticals in the EU?

PubMed

Bogaert, Peter; Van Keymeulen, Eveline

2012-09-01

This article sheds light on the relationship, or rather, absence of a relationship, between patent rights and regulatory approval procedures in the EU. The principle of 'patent linkage' has long been recognized and applied by regulatory authorities in the USA. The European Commission, however, opposes the idea of linking patent rights to marketing authorizations and pricing and reimbursement decisions. This position is grounded in Article 126 of Directive 2001/83 and is expected not to change anytime soon, given the clear reaffirmation thereof in the recent Sector Inquiry Report and Transparency Directive Proposal. Therefore, the European Medicines Agency or national authorities are not permitted to refuse approval and, likely, pricing and reimbursement of a generic when the innovative reference product is still protected by a patent. The authors, however, advocate that there are strong legal arguments for patent holders to challenge regulatory decisions that did not respect their patent rights before the competent national courts.

Interacting spin-2 fields in the Stückelberg picture

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

Noller, Johannes; Ferreira, Pedro G.; Scargill, James H.C., E-mail: noller@physics.ox.ac.uk, E-mail: james.scargill@physics.ox.ac.uk, E-mail: p.ferreira1@physics.ox.ac.uk

2014-02-01

We revisit and extend the 'Effective field theory for massive gravitons' constructed by Arkani-Hamed, Georgi and Schwartz in the light of recent progress in constructing ghost-free theories with multiple interacting spin-2 fields. We show that there exist several dual ways of restoring gauge invariance in such multi-gravity theories, find a generalised Fierz-Pauli tuning condition relevant in this context and highlight subtleties in demixing tensor and scalar modes. The generic multi-gravity feature of scalar mixing and its consequences for higher order interactions are discussed. In particular we show how the decoupling limit is qualitatively changed in theories of interacting spin-2 fields.more » We relate this to dRGT (de Rham, Gabadadze, Tolley) massive gravity, Hassan-Rosen bigravity and the multi-gravity constructions by Hinterbichler and Rosen. As an additional application we show that EBI (Eddington-Born-Infeld) bigravity and higher order generalisations thereof possess ghost-like instabilities.« less

Exploring the bulk in AdS /CFT : A covariant approach

NASA Astrophysics Data System (ADS)

Engelhardt, Netta

2017-03-01

I propose a general, covariant way of defining when one region is "deeper in the bulk" than another. This definition is formulated outside of an event horizon (or in the absence thereof) in generic geometries; it may be applied to both points and surfaces, and it may be used to compare the depth of bulk points or surfaces relative to a particular boundary subregion or relative to the entire boundary. Using the recently proposed "light-cone cut" formalism, the comparative depth between two bulk points can be determined from the singularity structure of Lorentzian correlators in the dual field theory. I prove that, by this definition, causal wedges of progressively larger regions probe monotonically deeper in the bulk. The definition furthermore matches expectations in pure AdS and in static AdS black holes with isotropic spatial slices, where a well-defined holographic coordinate exists. In terms of holographic renormalization group flow, this new definition of bulk depth makes contact with coarse graining over both large distances and long time scales.

GENERIC VERIFICATION PROTOCOL FOR DETERMINATION OF EMISSIONS REDUCTIONS OBTAINED BY USE OF ALTERNATIVE OR REFORMULATED LIQUID FUELS, FUEL ADDITIVES, FUEL EMULSIONS AND LUBRICANTS FOR HIGHWAY AND NONROAD USE DISEL ENGINES AND LIGHT DUTY GASOLINE ENGINES AND VEHICLES

EPA Science Inventory

This report sets standards by which the emissions reduction provided by fuel and lubricant technologies can be tested and be tested in a comparable way. It is a generic protocol under the Environmental Technology Verification program.

27 CFR 19.736 - Daily production records.

Code of Federal Regulations, 2010 CFR

2010-04-01

... removed from the premises. (7) The quantity and testing for alcoholic content of fusel oil or other chemicals removed from the production system and the disposition thereof with the name of the consignee, if...

78 FR 17940 - Certain Computerized Orthopedic Surgical Devices, Software, Implants, and Components Thereof...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-25

..., Software, Implants, and Components Thereof; Notice of Receipt of Complaint; Solicitation of Comments... Certain Computerized Orthopedic Surgical Devices, Software, Implants, and Components Thereof, DN 2945; the... importation of certain computerized orthopedic surgical devices, software, implants, and components thereof...

Comparison of cotton and acrylic socks using a generic cushion sole design for runners.

PubMed

Herring, K M; Richie, D H

1993-09-01

A longitudinal single-blind study was conducted to test the friction blister prevention properties of synthetic acrylic socks in a generic construction. This study serves as a comparison with the authors' previous work comparing acrylic and cotton socks in a patented padded construction. Twenty-seven long-distance runners provided data regarding dampness, temperature, friction blister incidence, severity, and size. Two different socks were tested; each was identical in every aspect of construction except the fiber content. One test sock was composed of 100% synthetic acrylic fibers, and the other was composed of 100% natural cotton fibers. These results were unsuccessful at demonstrating any superiority of cotton or acrylic fibers when knitting produced a generic "cushion sole" sock. The superiority of acrylic fibers has thus far been demonstrated only when sock knitting provides adequate anatomical padding [corrected].

Jordanian TEFL Graduate Students' Use of Critical Thinking Skills (as Measured by the Cornell Critical Thinking Test, Level Z)

ERIC Educational Resources Information Center

Bataineh, Ruba Fahmi; Zghoul, Lamma Hmoud

2006-01-01

This study investigates the critical thinking skills of 50 students currently enrolled in the Master's TEFL Programme at Yarmouk University, Jordan. The Cornell Critical Thinking Test, Level Z is utilised to test the students' use, or lack thereof, of the critical thinking skills of deduction, semantics, credibility, induction, definition and…

75 FR 34482 - Certain Biometric Scanning Devices, Components Thereof, Associated Software, and Products...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-17

..., Components Thereof, Associated Software, and Products Containing the Same; Notice of Investigation AGENCY: U... scanning devices, components thereof, associated software, and products containing the same by reason of... after importation of certain biometric scanning devices, components thereof, associated software, or...

Investigating the cognitive structure of stereotypes: Generic beliefs about groups predict social judgments better than statistical beliefs.

PubMed

Hammond, Matthew D; Cimpian, Andrei

2017-05-01

Stereotypes are typically defined as beliefs about groups, but this definition is underspecified. Beliefs about groups can be generic or statistical. Generic beliefs attribute features to entire groups (e.g., men are strong), whereas statistical beliefs encode the perceived prevalence of features (e.g., how common it is for men to be strong). In the present research, we sought to determine which beliefs-generic or statistical-are more central to the cognitive structure of stereotypes. Specifically, we tested whether generic or statistical beliefs are more influential in people's social judgments, on the assumption that greater functional importance indicates greater centrality in stereotype structure. Relative to statistical beliefs, generic beliefs about social groups were significantly stronger predictors of expectations (Studies 1-3) and explanations (Study 4) for unfamiliar individuals' traits. In addition, consistent with prior evidence that generic beliefs are cognitively simpler than statistical beliefs, generic beliefs were particularly predictive of social judgments for participants with more intuitive (vs. analytic) cognitive styles and for participants higher (vs. lower) in authoritarianism, who tend to view outgroups in simplistic, all-or-none terms. The present studies suggest that generic beliefs about groups are more central than statistical beliefs to the cognitive structure of stereotypes. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

China’s ASAT Test: Motivations and Implications

DTIC Science & Technology

2007-01-01

h i l l i P c . S a u n D e r S and c h a r l e S D . l u t e S Dr. Phillip C. saunders and Colonel Charles D. Lutes, UsaF, are senior Research...at <www.aviationweek.com/aw/generic/story_generic. jsp?channel= awst &id=news/aw012207p2.xml>. 11 Chris Buckley, “China confirms satellite test, says

Establishing "abuse-deterrence equivalence" for generic abuse-deterrent opioid formulations: A proposed development framework.

PubMed

Setnik, Beatrice; Cone, Edward J

2016-01-01

Abuse-deterrent formulations are one strategy for mitigating the epidemic of prescription opioid abuse. Regulatory guidance documents describe the requirements for developing abuse-deterrent formulations of novel drugs and formulations; however, they do not address "abuse-deterrence equivalence" for generic formulations. As generics may be produced with different excipients and formulations compared to reference drugs, differences in their properties may impact their abuse-deterrent features. Currently, it is unclear what specific studies are needed to support generic abuse-deterrence claims. This commentary outlines several recommendations on the in vitro and in vivo testing required, including the conditions for conducting a human abuse potential study.

External validity of a generic safety climate scale for lone workers across different industries and companies.

PubMed

Lee, Jin; Huang, Yueng-hsiang; Robertson, Michelle M; Murphy, Lauren A; Garabet, Angela; Chang, Wen-Ruey

2014-02-01

The goal of this study was to examine the external validity of a 12-item generic safety climate scale for lone workers in order to evaluate the appropriateness of generalized use of the scale in the measurement of safety climate across various lone work settings. External validity evidence was established by investigating the measurement equivalence (ME) across different industries and companies. Confirmatory factor analysis (CFA)-based and item response theory (IRT)-based perspectives were adopted to examine the ME of the generic safety climate scale for lone workers across 11 companies from the trucking, electrical utility, and cable television industries. Fairly strong evidence of ME was observed for both organization- and group-level generic safety climate sub-scales. Although significant invariance was observed in the item intercepts across the different lone work settings, absolute model fit indices remained satisfactory in the most robust step of CFA-based ME testing. IRT-based ME testing identified only one differentially functioning item from the organization-level generic safety climate sub-scale, but its impact was minimal and strong ME was supported. The generic safety climate scale for lone workers reported good external validity and supported the presence of a common feature of safety climate among lone workers. The scale can be used as an effective safety evaluation tool in various lone work situations. Copyright © 2013 Elsevier Ltd. All rights reserved.

76 FR 70164 - Certain Devices With Secure Communication Capabilities, Components Thereof, and Products...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-10

... capabilities, components thereof, and products containing the same. The complaint names Apple Inc. of Cupertino..., Components Thereof, and Products Containing the Same; Receipt of Complaint; Solicitation of Comments Relating... Certain Devices with Secure Communication Capabilities, Components Thereof, and Products Containing the...

78 FR 14357 - Certain Compact Fluorescent Reflector Lamps, Products Containing Same and Components Thereof...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-05

... Reflector Lamps, Products Containing Same and Components Thereof; Institution of Investigation AGENCY: U.S... fluorescent reflector lamps, products containing same and components thereof by reason of infringement of... compact fluorescent reflector lamps, products containing same and components thereof by reason of...

Effect of Item Arrangement, Knowledge of Arrangement, and Test Anxiety on Two Scoring Methods.

ERIC Educational Resources Information Center

Plake, Barbara S.; And Others

1981-01-01

Number right and elimination scores were analyzed on a college level mathematics exam assembled from pretest data. Anxiety measures were administered along with the experimental forms to undergraduates. Results suggest that neither test scores nor attitudes are influenced by item order knowledge thereof, or anxiety level. (Author/GK)

10 CFR Appendix C to Part 30 - Criteria Relating to Use of Financial Tests and Self Guarantees for Providing Reasonable...

Code of Federal Regulations, 2010 CFR

2010-01-01

... thereof. (3) A current rating for its most recent bond issuance of AAA, AA, or A as issued by Standard and Poors (S&P), or Aaa, Aa, or A as issued by Moodys. B. To pass the financial test, a company must meet...

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

Relevance of various animal models of human infections to establish therapeutic equivalence of a generic product of piperacillin/tazobactam.

PubMed

Agudelo, Maria; Rodriguez, Carlos A; Zuluaga, Andres F; Vesga, Omar

2015-02-01

After demonstrating with diverse intravenous antibacterials that pharmaceutical equivalence (PE) does not predict therapeutic equivalence, we tested a single generic product of piperacillin/tazobactam (TZP) in terms of PE, pharmacokinetics and in vitro/vivo pharmacodynamics against several pathogens in neutropenic mouse thigh, lung and brain infection models. A generic product was compared head-to-head against the innovator. PE was evaluated by microbiological assay. Single-dose serum pharmacokinetics were determined in infected mice, and the MIC/MBC were determined by broth microdilution. In vivo experiments were done in a blind fashion. Reproducibility was tested on different days using different infecting organisms and animal models. Neutropenic MPF mice were infected in the thighs with Staphylococcus aureus GRP-0057 or Pseudomonas aeruginosa PA01 and in the lungs or brain with Klebsiella pneumoniae ATCC 10031. Treatment started 2h (thigh and brain) or 14 h (lung) after infection and was administered every 3h over 24h (thigh and lung) or 48 h (brain). Both products exhibited the same MIC/MBC against each strain, yielded overlaid curves in the microbiological assay (P>0.21) and were bioequivalent (IC90 83-117% for AUC test/reference ratio). In vivo, the generic product and innovator were again undistinguishable in all models and against the different bacterial pathogens involved. The relevance of these neutropenic murine models of infection was established by demonstrating their accuracy to predict the biological response following simultaneous treatment with a generic product or the innovator of TZP. Therapeutic equivalence of the generic product was proved in every model and against different pathogens. Copyright © 2014 Elsevier B.V. and the International Society of Chemotherapy. All rights reserved.

75 FR 8399 - In the Matter of Certain Mobile Communications and Computer Devices and Components Thereof...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-24

... Communications and Computer Devices and Components Thereof; Notice of Investigation AGENCY: U.S. International... States after importation of certain mobile communications and computer devices and components thereof by... importation of certain mobile communications or computer devices or components thereof that infringe one or...

16 CFR 303.24 - Pile fabrics and products composed thereof.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 16 Commercial Practices 1 2010-01-01 2010-01-01 false Pile fabrics and products composed thereof... CONGRESS RULES AND REGULATIONS UNDER THE TEXTILE FIBER PRODUCTS IDENTIFICATION ACT § 303.24 Pile fabrics and products composed thereof. The fiber content of pile fabrics or products composed thereof may be...

76 FR 39896 - In the Matter of Certain GPS Navigation Products, Components Thereof, and Related Software...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-07

... Products, Components Thereof, and Related Software; Notice of Institution of Investigation; Institution of... importation of certain GPS navigation products, components thereof, and related software by reason of... importation of certain GPS navigation products, components thereof, and related software that infringe one or...

77 FR 35427 - Certain Mobile Devices, Associated Software, and Components Thereof Final Determination of...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-13

... Software, and Components Thereof Final Determination of Violation; Issuance of a Limited Exclusion Order... importation of certain mobile devices, associated software, and components thereof by reason of infringement... importation of certain mobile devices, associated software, and components thereof containing same by reason...

77 FR 4059 - Certain Electronic Devices for Capturing and Transmitting Images, and Components Thereof; Receipt...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-26

... Images, and Components Thereof; Receipt of Complaint; Solicitation of Comments Relating to the Public... Devices for Capturing and Transmitting Images, and Components Thereof, DN 2869; the Commission is... importation of certain electronic devices for capturing and transmitting images, and components thereof. The...

Criteria for a State-of-the-Art Vision Test System

DTIC Science & Technology

1985-05-01

tests are enumerated for possible inclusion in a battery of candidate vision tests to be statistically examined for validity as predictors of aircrew...derived subset thereof) of vision tests may be given to a series of individuals, and statistical tests may be used to determine which visual functions...no target. Statistical analysis of the responses would set a threshold level, which would define the smallest size - (most distant target) or least

Bioequivalence between innovator and generic tacrolimus in liver and kidney transplant recipients: A randomized, crossover clinical trial

PubMed Central

Vinks, Alexander A.; Fukuda, Tsuyoshi; King, Eileen C.; Zou, Yuanshu; Jiang, Wenlei; Klawitter, Jelena; Christians, Uwe

2017-01-01

Background Although the generic drug approval process has a long-term successful track record, concerns remain for approval of narrow therapeutic index generic immunosuppressants, such as tacrolimus, in transplant recipients. Several professional transplant societies and publications have generated skepticism of the generic approval process. Three major areas of concern are that the pharmacokinetic properties of generic products and the innovator (that is, “brand”) product in healthy volunteers may not reflect those in transplant recipients, bioequivalence between generic and innovator may not ensure bioequivalence between generics, and high-risk patients may have specific bioequivalence concerns. Such concerns have been fueled by anecdotal observations and retrospective and uncontrolled published studies, while well-designed, controlled prospective studies testing the validity of the regulatory bioequivalence testing approach for narrow therapeutic index immunosuppressants in transplant recipients have been lacking. Thus, the present study prospectively assesses bioequivalence between innovator tacrolimus and 2 generics in individuals with a kidney or liver transplant. Methods and findings From December 2013 through October 2014, a prospective, replicate dosing, partially blinded, randomized, 3-treatment, 6-period crossover bioequivalence study was conducted at the University of Cincinnati in individuals with a kidney (n = 35) or liver transplant (n = 36). Abbreviated New Drug Applications (ANDA) data that included manufacturing and healthy individual pharmacokinetic data for all generics were evaluated to select the 2 most disparate generics from innovator, and these were named Generic Hi and Generic Lo. During the 8-week study period, pharmacokinetic studies assessed the bioequivalence of Generic Hi and Generic Lo with the Innovator tacrolimus and with each other. Bioequivalence of the major tacrolimus metabolite was also assessed. All products fell within the US Food and Drug Administration (FDA) average bioequivalence (ABE) acceptance criteria of a 90% confidence interval contained within the confidence limits of 80.00% and 125.00%. Within-subject variability was similar for the area under the curve (AUC) (range 12.11–15.81) and the concentration maximum (Cmax) (range 17.96–24.72) for all products. The within-subject variability was utilized to calculate the scaled average bioequivalence (SCABE) 90% confidence interval. The calculated SCABE 90% confidence interval was 84.65%–118.13% and 80.00%–125.00% for AUC and Cmax, respectively. The more stringent SCABE acceptance criteria were met for all product comparisons for AUC and Cmax in both individuals with a kidney transplant and those with a liver transplant. European Medicines Agency (EMA) acceptance criteria for narrow therapeutic index drugs were also met, with the only exception being in the case of Brand versus Generic Lo, in which the upper limits of the 90% confidence intervals were 111.30% (kidney) and 112.12% (liver). These were only slightly above the upper EMA acceptance criteria limit for an AUC of 111.11%. SCABE criteria were also met for the major tacrolimus metabolite 13-O-desmethyl tacrolimus for AUC, but it failed the EMA criterion. No acute rejections, no differences in renal function in all individuals, and no differences in liver function were observed in individuals with a liver transplant using the Tukey honest significant difference (HSD) test for multiple comparisons. Fifty-two percent and 65% of all individuals with a kidney or liver transplant, respectively, reported an adverse event. The Exact McNemar test for paired categorical data with adjustments for multiple comparisons was used to compare adverse event rates among the products. No statistically significant differences among any pairs of products were found for any adverse event code or for adverse events overall. Limitations of this study include that the observations were made under strictly controlled conditions that did not allow for the impact of nonadherence or feeding on the possible pharmacokinetic differences. Generic Hi and Lo were selected based upon bioequivalence data in healthy volunteers because no pharmacokinetic data in recipients were available for all products. The safety data should be interpreted in light of the small number of participants and the short observation periods. Lastly, only the 1 mg tacrolimus strength was utilized in this study. Conclusions Using an innovative, controlled bioequivalence study design, we observed equivalence between tacrolimus innovator and 2 generic products as well as between 2 generic products in individuals after kidney or liver transplantation following current FDA bioequivalence metrics. These results support the position that bioequivalence for the narrow therapeutic index drug tacrolimus translates from healthy volunteers to individuals receiving a kidney or liver transplant and provides evidence that generic products that are bioequivalent with the innovator product are also bioequivalent to each other. Trial registration ClinicalTrials.gov NCT01889758. PMID:29135993

Bioequivalence between innovator and generic tacrolimus in liver and kidney transplant recipients: A randomized, crossover clinical trial.

PubMed

Alloway, Rita R; Vinks, Alexander A; Fukuda, Tsuyoshi; Mizuno, Tomoyuki; King, Eileen C; Zou, Yuanshu; Jiang, Wenlei; Woodle, E Steve; Tremblay, Simon; Klawitter, Jelena; Klawitter, Jost; Christians, Uwe

2017-11-01

Although the generic drug approval process has a long-term successful track record, concerns remain for approval of narrow therapeutic index generic immunosuppressants, such as tacrolimus, in transplant recipients. Several professional transplant societies and publications have generated skepticism of the generic approval process. Three major areas of concern are that the pharmacokinetic properties of generic products and the innovator (that is, "brand") product in healthy volunteers may not reflect those in transplant recipients, bioequivalence between generic and innovator may not ensure bioequivalence between generics, and high-risk patients may have specific bioequivalence concerns. Such concerns have been fueled by anecdotal observations and retrospective and uncontrolled published studies, while well-designed, controlled prospective studies testing the validity of the regulatory bioequivalence testing approach for narrow therapeutic index immunosuppressants in transplant recipients have been lacking. Thus, the present study prospectively assesses bioequivalence between innovator tacrolimus and 2 generics in individuals with a kidney or liver transplant. From December 2013 through October 2014, a prospective, replicate dosing, partially blinded, randomized, 3-treatment, 6-period crossover bioequivalence study was conducted at the University of Cincinnati in individuals with a kidney (n = 35) or liver transplant (n = 36). Abbreviated New Drug Applications (ANDA) data that included manufacturing and healthy individual pharmacokinetic data for all generics were evaluated to select the 2 most disparate generics from innovator, and these were named Generic Hi and Generic Lo. During the 8-week study period, pharmacokinetic studies assessed the bioequivalence of Generic Hi and Generic Lo with the Innovator tacrolimus and with each other. Bioequivalence of the major tacrolimus metabolite was also assessed. All products fell within the US Food and Drug Administration (FDA) average bioequivalence (ABE) acceptance criteria of a 90% confidence interval contained within the confidence limits of 80.00% and 125.00%. Within-subject variability was similar for the area under the curve (AUC) (range 12.11-15.81) and the concentration maximum (Cmax) (range 17.96-24.72) for all products. The within-subject variability was utilized to calculate the scaled average bioequivalence (SCABE) 90% confidence interval. The calculated SCABE 90% confidence interval was 84.65%-118.13% and 80.00%-125.00% for AUC and Cmax, respectively. The more stringent SCABE acceptance criteria were met for all product comparisons for AUC and Cmax in both individuals with a kidney transplant and those with a liver transplant. European Medicines Agency (EMA) acceptance criteria for narrow therapeutic index drugs were also met, with the only exception being in the case of Brand versus Generic Lo, in which the upper limits of the 90% confidence intervals were 111.30% (kidney) and 112.12% (liver). These were only slightly above the upper EMA acceptance criteria limit for an AUC of 111.11%. SCABE criteria were also met for the major tacrolimus metabolite 13-O-desmethyl tacrolimus for AUC, but it failed the EMA criterion. No acute rejections, no differences in renal function in all individuals, and no differences in liver function were observed in individuals with a liver transplant using the Tukey honest significant difference (HSD) test for multiple comparisons. Fifty-two percent and 65% of all individuals with a kidney or liver transplant, respectively, reported an adverse event. The Exact McNemar test for paired categorical data with adjustments for multiple comparisons was used to compare adverse event rates among the products. No statistically significant differences among any pairs of products were found for any adverse event code or for adverse events overall. Limitations of this study include that the observations were made under strictly controlled conditions that did not allow for the impact of nonadherence or feeding on the possible pharmacokinetic differences. Generic Hi and Lo were selected based upon bioequivalence data in healthy volunteers because no pharmacokinetic data in recipients were available for all products. The safety data should be interpreted in light of the small number of participants and the short observation periods. Lastly, only the 1 mg tacrolimus strength was utilized in this study. Using an innovative, controlled bioequivalence study design, we observed equivalence between tacrolimus innovator and 2 generic products as well as between 2 generic products in individuals after kidney or liver transplantation following current FDA bioequivalence metrics. These results support the position that bioequivalence for the narrow therapeutic index drug tacrolimus translates from healthy volunteers to individuals receiving a kidney or liver transplant and provides evidence that generic products that are bioequivalent with the innovator product are also bioequivalent to each other. ClinicalTrials.gov NCT01889758.

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.

Soft Decision Analyzer and Method

NASA Technical Reports Server (NTRS)

Zucha, Joan P. (Inventor); Schlesinger, Adam M. (Inventor); Lansdowne, Chatwin (Inventor); Steele, Glen F. (Inventor)

2015-01-01

A soft decision analyzer system is operable to interconnect soft decision communication equipment and analyze the operation thereof to detect symbol wise alignment between a test data stream and a reference data stream in a variety of operating conditions.

Soft Decision Analyzer and Method

NASA Technical Reports Server (NTRS)

Zucha, Joan P. (Inventor); Schlesinger, Adam M. (Inventor); Lansdowne, Chatwin (Inventor); Steele, Glen F. (Inventor)

2016-01-01

A soft decision analyzer system is operable to interconnect soft decision communication equipment and analyze the operation thereof to detect symbol wise alignment between a test data stream and a reference data stream in a variety of operating conditions.

Overview of NASA Lewis Research Center free-piston Stirling engine activities

NASA Technical Reports Server (NTRS)

Slaby, J. G.

1984-01-01

A generic free-piston Stirling technology project is being conducted to develop technologies generic to both space power and terrestrial heat pump applications in a cooperative, cost-shared effort. The generic technology effort includes extensive parametric testing of a 1 kW free-piston Stirling engine (RE-1000), development of a free-piston Stirling performance computer code, design and fabrication under contract of a hydraulic output modification for RE-1000 engine tests, and a 1000-hour endurance test, under contract, of a 3 kWe free-piston Stirling/alternator engine. A newly initiated space power technology feasibility demonstration effort addresses the capability of scaling a free-piston Stirling/alternator system to about 25 kWe; developing thermodynamic cycle efficiency or equal to 70 percent of Carnot at temperature ratios in the order of 1.5 to 2.0; achieving a power conversion unit specific weight of 6 kg/kWe; operating with noncontacting gas bearings; and dynamically balancing the system. Planned engine and component design and test efforts are described.

77 FR 51572 - Certain Wireless Consumer Electronics Devices and Components Thereof; Institution of...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-24

... Electronics Devices and Components Thereof; Institution of Investigation Pursuant to 19 U.S.C. 1337 AGENCY: U... importation of certain wireless consumer electronics devices and components thereof by reason of infringement... wireless consumer electronics devices and components thereof that infringe one or more of claims 1, 6, 7, 9...

16 CFR 300.26 - Pile fabrics and products composed thereof.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 16 Commercial Practices 1 2010-01-01 2010-01-01 false Pile fabrics and products composed thereof... CONGRESS RULES AND REGULATIONS UNDER THE WOOL PRODUCTS LABELING ACT OF 1939 Labeling § 300.26 Pile fabrics and products composed thereof. The fiber content of pile fabrics or products made thereof may be...

9 CFR 316.12 - Marking of equine carcasses and parts thereof.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Marking of equine carcasses and parts thereof. 316.12 Section 316.12 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT... equine carcasses and parts thereof. (a) All inspected and passed equine carcasses and parts thereof...

76 FR 585 - In the Matter of Certain Handbags, Luggage, Accessories and Packaging Thereof; Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-05

..., Accessories and Packaging Thereof; Notice of Investigation AGENCY: U.S. International Trade Commission. ACTION... packaging thereof by reason of infringement of U.S. Trademark Registration No. 297,594 (``the `594 trademark... certain handbags, luggage, accessories and packaging thereof that infringe the `594 trademark; the `625...

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...

Compositions containing borane or carborane cage compounds and related applications

DOEpatents

Bowen, III, Daniel E; Eastwood, Eric A

2013-05-28

Compositions comprising a polymer-containing matrix and a filler comprising a cage compound selected from borane cage compounds, carborane cage compounds, metal complexes thereof, residues thereof, mixtures thereof, and/or agglomerations thereof, where the cage compound is not covalently bound to the matrix polymer. Methods of making and applications for using such compositions are also disclosed.

7 CFR 1230.110 - Assessments on imported pork and pork products.

Code of Federal Regulations, 2013 CFR

2013-01-01

... Processed hams and cuts thereof, with bone in .20 .440920 0203.12.1020 Processed shoulders and cuts thereof, with bone in .20 .440920 0203.12.9010 Other hams and cuts thereof, with bone in .20 .440920 0203.12.9020 Other shoulders and cuts thereof, with bone in .20 .440920 0203.19.2010 Processed spare ribs .23...

7 CFR 1230.110 - Assessments on imported pork and pork products.

Code of Federal Regulations, 2010 CFR

2010-01-01

... Processed hams and cuts thereof, with bone in .20 .440920 0203.12.1020 Processed shoulders and cuts thereof, with bone in .20 .440920 0203.12.9010 Other hams and cuts thereof, with bone in .20 .440920 0203.12.9020 Other shoulders and cuts thereof, with bone in .20 .440920 0203.19.2010 Processed spare ribs .23...

7 CFR 1230.110 - Assessments on imported pork and pork products.

Code of Federal Regulations, 2011 CFR

2011-01-01

... Processed hams and cuts thereof, with bone in .20 .440920 0203.12.1020 Processed shoulders and cuts thereof, with bone in .20 .440920 0203.12.9010 Other hams and cuts thereof, with bone in .20 .440920 0203.12.9020 Other shoulders and cuts thereof, with bone in .20 .440920 0203.19.2010 Processed spare ribs .23...

7 CFR 1230.110 - Assessments on imported pork and pork products.

Code of Federal Regulations, 2012 CFR

2012-01-01

... Processed hams and cuts thereof, with bone in .20 .440920 0203.12.1020 Processed shoulders and cuts thereof, with bone in .20 .440920 0203.12.9010 Other hams and cuts thereof, with bone in .20 .440920 0203.12.9020 Other shoulders and cuts thereof, with bone in .20 .440920 0203.19.2010 Processed spare ribs .23...

7 CFR 1230.110 - Assessments on imported pork and pork products.

Code of Federal Regulations, 2014 CFR

2014-01-01

... Processed hams and cuts thereof, with bone in .20 .440920 0203.12.1020 Processed shoulders and cuts thereof, with bone in .20 .440920 0203.12.9010 Other hams and cuts thereof, with bone in .20 .440920 0203.12.9020 Other shoulders and cuts thereof, with bone in .20 .440920 0203.19.2010 Processed spare ribs .23...

78 FR 9674 - Ball Bearings and Parts Thereof From Germany: Preliminary Results of Antidumping Duty...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-11

... Thereof From Germany: Preliminary Results of Antidumping Duty Administrative Review and Partial Rescission... antidumping duty order on ball bearings and parts thereof from Germany. The period of review (POR) is May 1... bearings and parts thereof from Germany as the conclusion of a sunset review. See Ball Bearings and Parts...

77 FR 25136 - Hand Trucks and Certain Parts Thereof From the People's Republic of China; Extension of Time...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-27

... Parts Thereof From the People's Republic of China; Extension of Time Limit for Final Results of..., U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230... certain parts thereof from the People's Republic of China. See Hand Trucks and Certain Parts Thereof from...

76 FR 11511 - In the Matter of Certain Set-Top Boxes, and Hardware and Software Components Thereof; Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-02

... Hardware and Software Components Thereof; Notice of Investigation AGENCY: U.S. International Trade... boxes, and hardware and software components thereof by reason of infringement of certain claims of U.S... after importation of certain set-top boxes, and hardware and software components thereof that infringe...

Compositions containing borane or carborane cage compounds and related applications

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

Bowen, III, Daniel E; Eastwood, Eric A

2014-11-11

Compositions comprising a polymer-containing matrix and a filler comprising a cage compound selected from borane cage compounds, carborane cage compounds, metal complexes thereof, residues thereof, mixtures thereof, and/or agglomerations thereof, where the cage compound is not covalently bound to the matrix polymer. Methods of making and applications for using such compositions are also disclosed.

Compositions containing borane or carborane cage compounds and related applications

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

Bowen, III, Daniel E.; Eastwood, Eric A.

2015-09-15

Compositions comprising a polymer-containing matrix and a filler comprising a cage compound selected from borane cage compounds, carborane cage compounds, metal complexes thereof, residues thereof, mixtures thereof, and/or agglomerations thereof, where the cage compound is not covalently bound to the matrix polymer. Methods of making and applications for using such compositions are also disclosed.

77 FR 34063 - Certain Electronic Devices, Including Mobile Phones and Tablet Computers, and Components Thereof...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-08

... Phones and Tablet Computers, and Components Thereof Institution of Investigation AGENCY: U.S... computers, and components thereof by reason of infringement of certain claims of U.S. Patent No. 5,570,369... mobile phones and tablet computers, and components thereof that infringe one or more of claims 1-3 and 5...

75 FR 81212 - Floor-Standing Metal-Top Ironing Tables and Certain Parts Thereof from the People's Republic of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-27

... Ironing Tables and Certain Parts Thereof from the People's Republic of China: Extension of Time Limit for... parts thereof from the People's Republic of China. See Floor-Standing, Metal-Top Ironing Tables and Certain Parts Thereof From the People's Republic of China: Preliminary Results of Antidumping Duty...

77 FR 1455 - Floor-Standing, Metal-Top Ironing Tables and Certain Parts Thereof From the People's Republic of...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-10

... Ironing Tables and Certain Parts Thereof From the People's Republic of China: Extension of Time Limit for... parts thereof from the People's Republic of China. See Floor-Standing, Metal-Top Ironing Tables and Certain Parts Thereof From the People's Republic of China: Preliminary Results of Antidumping Duty...

76 FR 28731 - Hand Trucks and Certain Parts Thereof From the People's Republic of China; Extension of Time...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-18

... Parts Thereof From the People's Republic of China; Extension of Time Limit for Final Results of...- 2009 administrative review of the antidumping duty order on hand trucks and certain parts thereof from the People's Republic of China. See Hand Trucks and Certain Parts Thereof from the People's Republic...

The Impact of Acquisition Issues and Training on Test and Evaluation

DTIC Science & Technology

2000-01-01

feedback on the OT results before a milestone review and then delivering the OT report, with surprises, virtually at the review. Test Realism There...of the R3D/100 Chip Set and Simulation Heritage. MLRS WE’RE IN THE ARMY NOW TE 14(1 Video, 15 Mins) Cinematics - LTV Aerospace & Defense

Is There Evidence to Support Brand to Generic Interchange of the Mycophenolic Acid Products?

PubMed

Phillips, Karen; Reddy, Prabashni; Gabardi, Steven

2017-02-01

The uptake of generic immunosuppressants lags comparatively to other drug classes, despite that the Food and Drug Administration (FDA) uses identical bioequivalence standards for all drugs. Transplant societies acknowledge the cost savings associated with generic immunosuppressants and support their use following heart, lung, kidney, or bone marrow transplantation. Seven studies of the pharmacokinetics or clinical efficacy of generic mycophenolate mofetil compared to the innovator product are published; all studies and products were ex-United States. Three studies did not demonstrate any pharmacokinetic differences between generic and innovator products in healthy subjects, achieving FDA bioequivalence requirements. Two studies in renal allograft recipients demonstrated no difference in area under the curves between generic and innovator products, and in one, the maximum concentration (Cmax) fell outside the FDA regulatory range. Two studies revealed no difference in acute organ rejection or graft function in renal allograft recipients. Patient surveys indicate that cost is a barrier to immunosuppressant adherence. Generics present a viable method to reduce costs to payers, patients, and health care systems. Adherence to immunosuppressants is crucial to prevent graft failure. An affordable regimen potentially confers greater adherence. Concerns regarding the presumed inferiority of generic immunosuppressants should be assuaged by regulatory requirements for bioequivalency testing, transplant society position statements, and pharmacokinetic and clinical studies.

Using Bayesian Networks to Improve Knowledge Assessment

ERIC Educational Resources Information Center

Millan, Eva; Descalco, Luis; Castillo, Gladys; Oliveira, Paula; Diogo, Sandra

2013-01-01

In this paper, we describe the integration and evaluation of an existing generic Bayesian student model (GBSM) into an existing computerized testing system within the Mathematics Education Project (PmatE--Projecto Matematica Ensino) of the University of Aveiro. This generic Bayesian student model had been previously evaluated with simulated…

Environmental Technology Verification Program Materials Management and Remediation Center Generic Protocol for Verification of In Situ Chemical Oxidation

EPA Science Inventory

The protocol provides generic procedures for implementing a verification test for the performance of in situ chemical oxidation (ISCO), focused specifically to expand the application of ISCO at manufactured gas plants with polyaromatic hydrocarbon (PAH) contamination (MGP/PAH) an...

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.

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

19 CFR 12.27 - Importation or exportation of wild animals or birds, or the dead bodies thereof illegally...

Code of Federal Regulations, 2012 CFR

2012-04-01

... birds, or the dead bodies thereof illegally captured or killed, etc. 12.27 Section 12.27 Customs Duties... animals or birds, or the dead bodies thereof illegally captured or killed, etc. Customs officers shall... or exportation of wild animals or birds, or the dead bodies thereof, or the eggs of such birds...

19 CFR 12.27 - Importation or exportation of wild animals or birds, or the dead bodies thereof illegally...

Code of Federal Regulations, 2014 CFR

2014-04-01

... birds, or the dead bodies thereof illegally captured or killed, etc. 12.27 Section 12.27 Customs Duties... animals or birds, or the dead bodies thereof illegally captured or killed, etc. Customs officers shall... or exportation of wild animals or birds, or the dead bodies thereof, or the eggs of such birds...

19 CFR 12.27 - Importation or exportation of wild animals or birds, or the dead bodies thereof illegally...

Code of Federal Regulations, 2013 CFR

2013-04-01

... birds, or the dead bodies thereof illegally captured or killed, etc. 12.27 Section 12.27 Customs Duties... animals or birds, or the dead bodies thereof illegally captured or killed, etc. Customs officers shall... or exportation of wild animals or birds, or the dead bodies thereof, or the eggs of such birds...

75 FR 68379 - In the Matter of: Certain Mobile Devices, Associated Software, and Components Thereof; Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-05

..., Associated Software, and Components Thereof; Notice of Investigation AGENCY: U.S. International Trade..., associated software, and components thereof by reason of infringement of certain claims of U.S. Patent No. 5..., associated software, and components thereof that infringe one or more of claims 1-4, 22, 26, 31, and 36 of...

77 FR 16537 - Ball Bearings and Parts Thereof from France, Germany, and Italy: Extension of Time Limit for...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-21

... Bearings and Parts Thereof from France, Germany, and Italy: Extension of Time Limit for Preliminary Results... ball bearings and parts thereof from France, Germany, Italy, Japan, and the United Kingdom for the... Revocation in Part, 76 FR 37781 (June 28, 2011). See also Ball Bearings and Parts Thereof From Japan and the...

77 FR 20788 - Diamond Sawblades and Parts Thereof From the Republic of Korea and the People's Republic of China...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-06

... and Parts Thereof From the Republic of Korea and the People's Republic of China: Extension of Time... Diamond Sawblades and Parts Thereof From the People's Republic of China: Extension of Time Limit for Final... sawblades and parts thereof (diamond sawblades) from the Republic of Korea (Korea) and the People's Republic...

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.

Utilisation of real-scale renewable energy test facility for validation of generic wind turbine and wind power plant controller models

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

Zeni, Lorenzo; Hesselbæk, Bo; Bech, John

This article presents an example of application of a modern test facility conceived for experiments regarding the integration of renewable energy in the power system. The capabilities of the test facility are used to validate dynamic simulation models of wind power plants and their controllers. The models are based on standard and generic blocks. The successful validation of events related to the control of active power (control phenomena in <10 Hz range, including frequency control and power oscillation damping) is described, demonstrating the capabilities of the test facility and drawing the track for future work and improvements.

The dark side of gendered language: The masculine-generic form as a cause for self-report bias.

PubMed

Vainapel, Sigal; Shamir, Opher Y; Tenenbaum, Yulie; Gilam, Gadi

2015-12-01

Language reflects sociocultural structures, such as gender, and affects individuals' perceptions and cognitions. In gendered languages, male-inflected parts of speech are generally used for both sexes (i.e., masculine generics), thus proliferating stereotypes, inequality, and misattributions. We hypothesized that masculine-generic inflection in a questionnaire would bias women's reports compared with a gender-neutral inflection (e.g., "he or she"). We tested our prediction using an academic motivation questionnaire. We found that women reported lower task value and intrinsic goal orientation in the masculine-generic form compared with the gender-neutral form, and lower self-efficacy than men in the masculine-generic form. These findings suggest that questionnaires and surveys written in gendered languages or translated into them may contain construct-irrelevant variance that may undermine the validity of their scores' interpretations, thus risking the possibility of false conclusions. (c) 2015 APA, all rights reserved).

Regulatory Considerations of Bioequivalence Studies for Oral Solid Dosage Forms in Japan.

PubMed

Kuribayashi, Ryosuke; Takishita, Tomoko; Mikami, Kenichi

2016-08-01

Bioequivalence (BE) studies are used to infer the therapeutic equivalence of generic drug products to original drug products throughout the world. In BE studies, bioavailability (BA) should be compared between the original and generic drug products, with BA defined as the rate and extent of absorption of active pharmaceutical ingredients or active metabolites from a product into the systemic circulation. For most of BE studies conducted during generic drug development, BA comparisons are performed in single-dose studies. In Japan, the revised "Guideline for Bioequivalence Studies of Generic Products" was made available in 2012 by the Ministry of Health, Labour, and Welfare, and generic drug development is currently conducted based on this guideline. Similarly, the U.S. Food and Drug Administration and European Medicines Agency have published guidance and guideline on generic drug development. This article introduces the guideline on Japanese BE studies for oral solid dosage forms and the dissolution tests for the similarity and equivalence evaluation between the original and generic drug products. Additionally, we discuss some of the similarities and differences in guideline between Japan, the United States, and the European Union. Copyright © 2016 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

Quality Control of Direct Molecular Diagnostics for Methicillin-Resistant Staphylococcus aureus▿

PubMed Central

van Belkum, Alex; Niesters, Hubert G. M.; MacKay, William G.; van Leeuwen, Willem B.

2007-01-01

Ten samples containing various amounts of methicillin-resistant Staphylococcus aureus (MRSA), methicillin-susceptible S. aureus, methicillin-resistant Staphylococcus epidermidis (MRSE), and combinations thereof were distributed to 51 laboratories for molecular diagnostics testing. Samples containing 102 to 103 MRSA cells were frequently reported to be negative. MRSE samples were scored as negative by all commercial tests but by only two out of three in-house tests. PMID:17581936

[Pharmacoeconomic indicators of cardiovascular drug utilization in the Republic of Croatia and city of Zagreb in 2008].

PubMed

Stimac, Danijela; Stambuk, Ivanka

2010-12-01

In comparison with original drugs, generic drugs have the same efficacy but considerably lower price and should therefore be preferred to original drugs on prescribing. The aim of the present study was to assess outpatient utilization and rationality of cardiovascular drug prescribing in the City of Zagreb and Republic of Croatia based on the generic to original drug prescribing ratio. Data on the financial indicators and number of cardiovascular drug packages issued in 2008 were obtained from the Croatian Institute of Health Insurance. These data were used to calculate the number of defined daily doses (DDD) and number of DDD per 1000 inhabitants per day (DDD/1000/day). The index of generic/original drug utilization was determined for Zagreb and Croatia as a measure for assessment of prescribing rationality; the significance of difference was determined by X2-test. The rate of prescribing original cardiovascular drugs was significantly higher in Zagreb as compared with Croatia as a whole. The index of prescribing generic versus original drugs was 1.20 (249/208 DDD/1000/day) in Zagreb and 1.65 (249/151 DDD/1000/day) in Croatia. Difference in the utilization of generic drugs between Zagreb and Croatia as determined by X2-test (the level of statistical significance was set at P<0.05) was statistically significant (P=0.021). The highest differences were recorded in the most widely prescribed drug groups, i.e. ACE inhibitors with the generic/original drug index of 1.38 in Zagreb and 2.02 in Croatia; and hypolipemics with the generic/original drug index of 0.96 in Zagreb and 1.34 in Croatia. According to financial indicators, the generic/original drug index was 1.44 in Croatia and only 0.96 in Zagreb. The significantly greater influence of pharmaceutical industry marketing in Zagreb entailed the significantly higher rate of original drug prescribing, which is associated with considerably greater drug expenses. Measures to stimulate prescribing generic drugs should be launched at the national level.

Reliability and Validity of the Turkish Version of the PedsQL 3.0 Cancer Module for 2- to 7-Year-Old and the PedsQL 4.0 Generic Core Scales for 5- to 7-Year-Old: The Hacettepe University Experience.

PubMed

Yıldız Kabak, Vesile; Yakut, Yavuz; Çetin, Mualla; Düger, Tülin

2016-09-05

The aim of this study was to investigate the reliability and validity of the Turkish version of the Pediatric Quality of Life Inventory (PedsQL) 3.0 Cancer Module for 2- to 7-year-old and the PedsQL 4.0 Generic Core Scales for 5- to 7-year-old in childhood cancer. The PedsQL 3.0 Cancer Module and PedsQL 4.0 Generic Core Scales were administered to children with cancer and their parents at Hacettepe University. Internal consistency was determined by using Cronbach's alpha and test-retest reliability was determined by using the intraclass correlation coefficient (ICC). Construct validity was assessed by comparing the results of the PedsQL 3.0 Cancer Module with those of the PedsQL 4.0 Generic Core Scales. Cronbach's alpha of the PedsQL 3.0 Cancer Module varied from 0.803 to 0.873 and that of the PedsQL 4.0 Generic Core Scales from 0.665 to 0.841. Test-retest ICC values of the PedsQL 3.0 Cancer Module varied from 0.877 to 0.949 and those of the PedsQL 4.0 Generic Core Scales from 0.681 to 0.824. The correlation of the PedsQL 3.0 Cancer Module with subscale scores of the PedsQL 4.0 Generic Core Scales showed that there were excellent to fair correlations between the two scales. The relationship between parent proxy-report and child self-report of the PedsQL 3.0 Cancer Module had very good correlation (r=0.694, p<0.001), as did the PedsQL 4.0 Generic Core Scales (r=0.540, p=0.002). This study demonstrated the reliability, validity, and feasibility of the Turkish version of the PedsQL 3.0 Cancer Module in 2- to 4-year-old and 5- to 7-year-old and the PedsQL 4.0 Generic Core Scales in 5- to 7-year-old in childhood cancer.

46 CFR 67.200 - Instruments eligible for filing and recording.

Code of Federal Regulations, 2010 CFR

2010-10-01

..., satisfactions, and releases thereof; (d) Preferred mortgages and assignments, assumptions, supplements, amendments, subordinations, satisfactions, and releases thereof; (e) Interlender agreements affecting..., amendments, and satisfactions and releases thereof. ...

Improvement in Generic Problem-Solving Abilities of Students by Use of Tutor-less Problem-Based Learning in a Large Classroom Setting

PubMed Central

Klegeris, Andis; Bahniwal, Manpreet; Hurren, Heather

2013-01-01

Problem-based learning (PBL) was originally introduced in medical education programs as a form of small-group learning, but its use has now spread to large undergraduate classrooms in various other disciplines. Introduction of new teaching techniques, including PBL-based methods, needs to be justified by demonstrating the benefits of such techniques over classical teaching styles. Previously, we demonstrated that introduction of tutor-less PBL in a large third-year biochemistry undergraduate class increased student satisfaction and attendance. The current study assessed the generic problem-solving abilities of students from the same class at the beginning and end of the term, and compared student scores with similar data obtained in three classes not using PBL. Two generic problem-solving tests of equal difficulty were administered such that students took different tests at the beginning and the end of the term. Blinded marking showed a statistically significant 13% increase in the test scores of the biochemistry students exposed to PBL, while no trend toward significant change in scores was observed in any of the control groups not using PBL. Our study is among the first to demonstrate that use of tutor-less PBL in a large classroom leads to statistically significant improvement in generic problem-solving skills of students. PMID:23463230

Children's Sensitivity to the Knowledge Expressed in Pedagogical and Nonpedagogical Contexts

ERIC Educational Resources Information Center

Gelman, Susan A.; Ware, Elizabeth A.; Manczak, Erika M.; Graham, Susan A.

2013-01-01

The present studies test 2 hypotheses: (1) that pedagogical contexts especially convey generic information (Csibra & Gergely, 2009) and (2) that young children are sensitive to this aspect of pedagogy. We examined generic language (e.g., "'Elephants' live in Africa") in 3 studies, focusing on informational versus narrative children's…

State Curriculum Mandates and Student Knowledge of Personal Finance.

ERIC Educational Resources Information Center

Tennyson, Sharon; Nguyen, Chau

2001-01-01

A financial literacy test was administered to 1,643 high school students in 31 states. State mandates for generic consumer education were not associated with higher scores. Students in states requiring specific personal finance coursework scored significantly higher than those in generic-mandate or no-mandate states. (Contains 23 references.) (SK)

What's in a (role) name? Formal and conceptual aspects of comprehending personal nouns.

PubMed

Irmen, Lisa

2007-11-01

Two eye-tracking studies assessed effects of grammatical and conceptual gender cues in generic role name processing in German. Participants read passages about a social or occupational group introduced by way of a generic role name (e.g., Soldaten/soldiers, Künstler/artists). Later in the passage the gender of this group was specified by the anaphoric expression diese Männer/these men or diese Frauen/these women. Testing masculine generic role names of male, female or neutral conceptual gender (Exp. 1) showed that a gender mismatch between the role name's conceptual gender and the anaphor significantly slowed reading immediately before and after the anaphoric noun. A mismatch between the antecedent's grammatical gender and the anaphor slowed down the reading of the anaphoric noun itself. Testing grammatically gender-unmarked role names (Exp. 2) revealed a general male bias in participants' understanding, irrespective of grammatical or conceptual gender. The experiments extend previous findings on gender effects to non-referential role names and generic contexts. Theoretical aspects of gender and plural reference as well as gender information in mental models are discussed.

Microvascularized 3D Breast Cancer Constructs for Drug Testing and Development

DTIC Science & Technology

2014-10-01

cells. Therefore, both bacterial cellulose and fibrin represent promising scaffolding materials for construction of the prevascularized, 3D co-culture...group consisting of: collagen, fibrin, elastin, keratin, Matrigel™, bacterial cellulose , HuBiogel™, and combinations thereof. 7. The 3D ...AWARD NUMBER: TITLE: Microvascularized 3D Breast Cancer Constructs for Drug Testing and Development PRINCIPAL INVESTIGATOR: Joel L. Berry

Children’s Sensitivity to the Knowledge Expressed in Pedagogical and Non-Pedagogical Contexts

PubMed Central

Gelman, Susan A.; Ware, Elizabeth A.; Manczak, Erika M.; Graham, Susan A.

2013-01-01

The present studies test two hypotheses: (1) that pedagogical contexts especially convey generic information (Csibra & Gergely, 2009), and (2) that young children are sensitive to this aspect of pedagogy. We examined generic language (e.g., “Elephants live in Africa”) in three studies, focusing on: informational versus narrative children’s books (Study 1), the language of 6-year-old children and adults assuming either a pedagogical (teacher) or non-pedagogical (friend) role (Study 2), and the language of 5-year-old children and adults speaking to either an ignorant alien (pedagogical context) or a peer (non-pedagogical context; Study 3). Results suggest that generics are more frequent in informational than narrative texts. Furthermore, both adults and young children provide more generic language in pedagogical contexts and when assuming a pedagogical role. Together, the studies demonstrate that pedagogical contexts are distinctive in conveying generic information, and that children are sensitive to this aspect of the language input. We suggest that generic knowledge is more useful in making predictions about the future, and thus more highly valued during instruction. PMID:22468565

15 CFR 285.3 - Referencing NVLAP accreditation.

Code of Federal Regulations, 2014 CFR

2014-01-01

... INSTITUTE OF STANDARDS AND TECHNOLOGY, DEPARTMENT OF COMMERCE ACCREDITATION AND ASSESSMENT PROGRAMS NATIONAL... Standards and Technology and the federal government, who retain exclusive rights to control the use thereof... of announcing their accredited status, and for use on reports that describe only testing and...

15 CFR 285.3 - Referencing NVLAP accreditation.

Code of Federal Regulations, 2010 CFR

2010-01-01

... INSTITUTE OF STANDARDS AND TECHNOLOGY, DEPARTMENT OF COMMERCE ACCREDITATION AND ASSESSMENT PROGRAMS NATIONAL... Standards and Technology and the federal government, who retain exclusive rights to control the use thereof... of announcing their accredited status, and for use on reports that describe only testing and...

15 CFR 285.3 - Referencing NVLAP accreditation.

Code of Federal Regulations, 2012 CFR

2012-01-01

... INSTITUTE OF STANDARDS AND TECHNOLOGY, DEPARTMENT OF COMMERCE ACCREDITATION AND ASSESSMENT PROGRAMS NATIONAL... Standards and Technology and the federal government, who retain exclusive rights to control the use thereof... of announcing their accredited status, and for use on reports that describe only testing and...

15 CFR 285.3 - Referencing NVLAP accreditation.

Code of Federal Regulations, 2013 CFR

2013-01-01

... INSTITUTE OF STANDARDS AND TECHNOLOGY, DEPARTMENT OF COMMERCE ACCREDITATION AND ASSESSMENT PROGRAMS NATIONAL... Standards and Technology and the federal government, who retain exclusive rights to control the use thereof... of announcing their accredited status, and for use on reports that describe only testing and...

15 CFR 285.3 - Referencing NVLAP accreditation.

Code of Federal Regulations, 2011 CFR

2011-01-01

... INSTITUTE OF STANDARDS AND TECHNOLOGY, DEPARTMENT OF COMMERCE ACCREDITATION AND ASSESSMENT PROGRAMS NATIONAL... Standards and Technology and the federal government, who retain exclusive rights to control the use thereof... of announcing their accredited status, and for use on reports that describe only testing and...

7 CFR 1730.21 - Inspections and tests.

Code of Federal Regulations, 2011 CFR

2011-01-01

... implementation of, the ERP to verify the operability of the ERP. Such Exercise may be performed singly by an... and other participants or combination thereof) Tabletop execution or actual full implementation of the... which participants will identify the policy, communication, resources, data, coordination, and...

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.

Assessment of behavioral mechanisms maintaining encopresis: Virginia Encopresis-Constipation Apperception Test.

PubMed

Cox, Daniel J; Ritterband, Lee M; Quillian, Warren; Kovatchev, Boris; Morris, James; Sutphen, James; Borowitz, Stephen

2003-09-01

To develop and test a scale for parent and child, evaluating theoretical and clinical parameters relevant to children with encopresis. Encopretic children were hypothesized to have more bowel-specific, but not more generic, psychological problems, as compared with nonsymptomatic control children. In addition, mothers were also believed to be more discerning than children. The Virginia Encopresis-Constipation Apperception Test (VECAT) consists of 9 pairs of bowel-specific and 9 parallel generic drawings. Respondents selected the picture in each pair that best described them/their child. It was administered to encopretic children (N = 87), nonsymptomatic siblings (N = 27), and nonsymptomatic nonsiblings (N = 35). The mothers of all the participants also completed the VECAT. Encopretic children were retested 6 and 12 months posttreatment with Enhanced Toilet Training. The VECAT demonstrated good test-retest reliability and internal consistency. Encopretic children and their mothers reported more bowel-specific, but not more generic, problems. Bowel-specific scores improved significantly posttreatment only for those patients who demonstrated significant symptom improvement. Mothers were significantly more discerning than children. The VECAT is a reliable, valid, discriminating, and sensitive test. Bowel-specific problems appear to best differentiate children with and without encopresis.

Bioequivalence of generic and branded amoxicillin capsules in healthy human volunteers

PubMed Central

Pathak, Priyanka; Pandit, Vijaya A.; Dhande, Priti P.

2017-01-01

CONTEXT: The Medical Council of India urges doctors to prescribe generic drugs as far as possible. The Indian Medical Association had responded earlier saying that it requires guarantees on the quality of generic forms of drugs. Although no published scientific reports are available on the issue of therapeutic inequivalence, unconfirmed clinician accounts and newspaper reports of therapeutic inequivalence exist. AIM: This study was planned to ascertain whether bioequivalence of branded and generic amoxicillin capsule is comparable. SETTINGS AND DESIGN: An open-label, randomized, single-dose, two-treatment, two-sequence, two-period crossover oral bioequivalence study was conducted in 12 healthy, adult human subjects under fasting condition. MATERIALS AND METHODS: Serum samples, collected at 8 time points, were analyzed by a validated ultraviolet spectrophotometer method. Pharmacokinetic (PK) parameters such as area under the curve (AUC)0–t, AUC0–∞, Cmax, and Tmax were determined along with time above minimum inhibitory concentration (MIC). STATISTICAL ANALYSIS USED: The log-transformed PK parameters (Cmax, AUC0–t, AUC0–∞) were analyzed using a Two One-Sided Test ANOVA in SAS for each parameter. Tmax and MIC were analyzed by Wilcoxon rank-sum test in GraphPad Prism. RESULTS: Geometric mean ratio of Cmax fell within bioequivalence criteria. The upper and lower confidence limits of both AUC0–t and AUC0–∞ geometric mean ratio fell below bioequivalence criteria. Time above MIC of generic preparation was significantly lower than that of branded version. CONCLUSIONS: The generic capsule was not bioequivalent to the branded amoxicillin capsule. PMID:28706331

Method of bonding metals to ceramics

DOEpatents

Maroni, Victor A.

1991-01-01

A ceramic or glass having a thin layer of silver, gold or alloys thereof at the surface thereof. A first metal is bonded to the thin layer and a second metal is bonded to the first metal. The first metal is selected from the class consisting of In, Ga, Sn, Bi, Zn, Cd, Pb, Tl and alloys thereof, and the second metal is selected from the class consisting of Cu, Al, Pb, An and alloys thereof.

Use of Li.sub.2[B.sub.12H.sub.12] salt to absorb water into polymers

DOEpatents

Eastwood, Eric A.; Bowen, III, Daniel E.

2016-08-30

Methods of adjusting the properties of a composition are provided. The compositions comprise a polymer-containing matrix and a filler comprising a hygroscopic salt. Preferred such salts comprise a cage compound selected from the group consisting of borane cage compounds, carborane cage compounds, metal complexes thereof, residues thereof, mixtures thereof, and/or agglomerations thereof, where the cage compound is not covalently bound to the matrix polymer.

Switching between phenytoin generics in patients with epilepsy may lead to increased risk of breakthrough seizure: chart analysis and practice recommendations.

PubMed

Shin, Jung-Won; Chu, Kon; Jung, Keun-Hwa; Lee, Soon-Tae; Moon, Jangsup; Lee, Sang Kun

2014-12-01

The Food and Drug Administration (FDA) only requires bioequivalence testing of generic substitutions in order for them to be deemed equivalen to the original product. There may be a large difference of bioavailability among the generic drugs that especially have a narrow therapeutic index, and this may affect clinical outcomes. We aimed to determine whether switching from generic-to-generic equivalent anti-epileptic drugs (AEDs) in patients with epilepsy is associated with clinical outcomes. We performed a retrospective study using the electronic medical records of a tertiary hospital. Adults with a history of epilepsy who used a generic phenytoin and whose therapy was switched to another generic phenytoin between January 2012 and June 2013 were included (n = 80). We compared the drug concentration of phenytoin and seizure events before and after the switch. After switching their generic phenytoin, 33 out of 80 patients (41%) suffered from increasing seizure events (pre-interchange period, 0.44 ± 0.97; post-interchange period, 1.24 ± 2.05; p < 0.0001). The number of medical visits for acute seizure significantly increased in the post-interchange period. The phenytoin serum concentration of all the patients was lesser in the post-interchange period than in the pre-interchange period. (pre-interchange period, 12.79 μg/mL; post-interchange period, 6.36 μg/mL; p < 0.0001). Among the patients with drug resistant epilepsy (DRE), 17 patients (84.2%) had increasing seizure events in the post-interchange period. We confirmed that there was a significant difference in bioavailability between generic phenytoin. Therefore, when using or switching generic anti-epileptic drugs, therapeutic drug monitoring must be done, and the patients' condition must be considered.

Diagnosis of asthma: diagnostic testing.

PubMed

Brigham, Emily P; West, Natalie E

2015-09-01

Asthma is a heterogeneous disease, encompassing both atopic and non-atopic phenotypes. Diagnosis of asthma is based on the combined presence of typical symptoms and objective tests of lung function. Objective diagnostic testing consists of 2 components: (1) demonstration of airway obstruction, and (2) documentation of variability in degree of obstruction. A review of current guidelines and literature was performed regarding diagnostic testing for asthma. Spirometry with bronchodilator reversibility testing remains the mainstay of asthma diagnostic testing for children and adults. Repetition of the test over several time points may be necessary to confirm airway obstruction and variability thereof. Repeated peak flow measurement is relatively simple to implement in a clinical and home setting. Bronchial challenge testing is reserved for patients in whom the aforementioned testing has been unrevealing but clinical suspicion remains, though is associated with low specificity. Demonstration of eosinophilic inflammation, via fractional exhaled nitric oxide measurement, or atopy, may be supportive of atopic asthma, though diagnostic utility is limited particularly in nonatopic asthma. All efforts should be made to confirm the diagnosis of asthma in those who are being presumptively treated but have not had objective measurements of variability in the degree of obstruction. Multiple testing modalities are available for objective confirmation of airway obstruction and variability thereof, consistent with a diagnosis of asthma in the appropriate clinical context. Providers should be aware that both these characteristics may be present in other disease states, and may not be specific to a diagnosis of asthma. © 2015 ARS-AAOA, LLC.

Delineating parameter unidentifiabilities in complex models

NASA Astrophysics Data System (ADS)

Raman, Dhruva V.; Anderson, James; Papachristodoulou, Antonis

2017-03-01

Scientists use mathematical modeling as a tool for understanding and predicting the properties of complex physical systems. In highly parametrized models there often exist relationships between parameters over which model predictions are identical, or nearly identical. These are known as structural or practical unidentifiabilities, respectively. They are hard to diagnose and make reliable parameter estimation from data impossible. They furthermore imply the existence of an underlying model simplification. We describe a scalable method for detecting unidentifiabilities, as well as the functional relations defining them, for generic models. This allows for model simplification, and appreciation of which parameters (or functions thereof) cannot be estimated from data. Our algorithm can identify features such as redundant mechanisms and fast time-scale subsystems, as well as the regimes in parameter space over which such approximations are valid. We base our algorithm on a quantification of regional parametric sensitivity that we call `multiscale sloppiness'. Traditionally, the link between parametric sensitivity and the conditioning of the parameter estimation problem is made locally, through the Fisher information matrix. This is valid in the regime of infinitesimal measurement uncertainty. We demonstrate the duality between multiscale sloppiness and the geometry of confidence regions surrounding parameter estimates made where measurement uncertainty is non-negligible. Further theoretical relationships are provided linking multiscale sloppiness to the likelihood-ratio test. From this, we show that a local sensitivity analysis (as typically done) is insufficient for determining the reliability of parameter estimation, even with simple (non)linear systems. Our algorithm can provide a tractable alternative. We finally apply our methods to a large-scale, benchmark systems biology model of necrosis factor (NF)-κ B , uncovering unidentifiabilities.

GenoGAM: genome-wide generalized additive models for ChIP-Seq analysis.

PubMed

Stricker, Georg; Engelhardt, Alexander; Schulz, Daniel; Schmid, Matthias; Tresch, Achim; Gagneur, Julien

2017-08-01

Chromatin immunoprecipitation followed by deep sequencing (ChIP-Seq) is a widely used approach to study protein-DNA interactions. Often, the quantities of interest are the differential occupancies relative to controls, between genetic backgrounds, treatments, or combinations thereof. Current methods for differential occupancy of ChIP-Seq data rely however on binning or sliding window techniques, for which the choice of the window and bin sizes are subjective. Here, we present GenoGAM (Genome-wide Generalized Additive Model), which brings the well-established and flexible generalized additive models framework to genomic applications using a data parallelism strategy. We model ChIP-Seq read count frequencies as products of smooth functions along chromosomes. Smoothing parameters are objectively estimated from the data by cross-validation, eliminating ad hoc binning and windowing needed by current approaches. GenoGAM provides base-level and region-level significance testing for full factorial designs. Application to a ChIP-Seq dataset in yeast showed increased sensitivity over existing differential occupancy methods while controlling for type I error rate. By analyzing a set of DNA methylation data and illustrating an extension to a peak caller, we further demonstrate the potential of GenoGAM as a generic statistical modeling tool for genome-wide assays. Software is available from Bioconductor: https://www.bioconductor.org/packages/release/bioc/html/GenoGAM.html . gagneur@in.tum.de. Supplementary information is available at Bioinformatics online. © The Author (2017). Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com

Leveraging consumer's behaviour to promote generic drugs in Italy.

PubMed

Zerbini, Cristina; Luceri, Beatrice; Vergura, Donata Tania

2017-04-01

The aim of this study was to fill the lack of knowledge regarding a more grounded exploration of the consumer's decision-making process in the context of generic drugs. In this perspective, a model, within the theoretical framework of the Theory of Planned Behaviour (TPB), for studying the consumers' purchase intention of generic drugs was developed. An online survey on 2,222 Italian people who bought drugs in the past was conducted. The proposed model was tested through structural equation modelling (SEM). Almost all the constructs considered in the model, except the perceived behavioural control, contribute to explain the consumer's purchase intention of generic drugs, after controlling for demographic variables (age, income, education). Specifically, attitude, subjective norm, past behaviour, self-identity and trust in the pharmacist have a positive influence on the intention to buy generic drugs. On the contrary, perceived risk towards products and brand sensitivity act negatively. The results of the present study could be useful to public policy makers in developing effective policies and educational campaigns aimed at promoting generic drugs. Specifically, marketing efforts should be directed to inform consumers about the generic drugs' characteristics to mitigate the perceived risk towards these products and to raise awareness during their decision-making process. Copyright © 2017 Elsevier B.V. All rights reserved.

Revised Reynolds Stress and Triple Product Models

NASA Technical Reports Server (NTRS)

Olsen, Michael E.; Lillard, Randolph P.

2017-01-01

Revised versions of Lag methodology Reynolds-stress and triple product models are applied to accepted test cases to assess the improvement, or lack thereof, in the prediction capability of the models. The Bachalo-Johnson bump flow is shown as an example for this abstract submission.

Financial incentives and physicians' prescription decisions on the choice between brand-name and generic drugs: evidence from Taiwan.

PubMed

Liu, Ya-Ming; Yang, Yea-Huei Kao; Hsieh, Chee-Ruey

2009-03-01

This paper tests the hypothesis of whether or not financial incentives affect a physician's prescription decision on the choice of generic versus brand-name drugs within a system in which physicians prescribe and dispense drugs. By using data obtained from Taiwan and focusing on diabetic patients, our empirical results provide several consistent findings in support of the hypothesis that profit incentives do affect the physician's prescribing decision, suggesting that physicians act as imperfect agents. An important implication of our findings is that rent seeking for profit margin between the reimbursement and the acquisition price instead of reducing costs is the major driving force behind generic substitution. As a result, the providers instead of the payers or consumers reap the financial benefits of generic substitution.

Cultural transmission of social essentialism

PubMed Central

Rhodes, Marjorie; Leslie, Sarah-Jane; Tworek, Christina M.

2012-01-01

Social essentialism entails the belief that certain social categories (e.g., gender, race) mark fundamentally distinct kinds of people. Essentialist beliefs have pernicious consequences, supporting social stereotyping and contributing to prejudice. How does social essentialism develop? In the studies reported here, we tested the hypothesis that generic language facilitates the cultural transmission of social essentialism. Two studies found that hearing generic language about a novel social category diverse for race, ethnicity, age, and sex led 4-y-olds and adults to develop essentialist beliefs about that social category. A third study documented that experimentally inducing parents to hold essentialist beliefs about a novel social category led them to produce more generic language when discussing the category with their children. Thus, generic language facilitates the transmission of essentialist beliefs about social categories from parents to children. PMID:22869722

Method of bonding metals to ceramics

DOEpatents

Maroni, V.A.

1991-04-23

A ceramic or glass having a thin layer of silver, gold or alloys thereof at the surface thereof is disclosed. A first metal is bonded to the thin layer and a second metal is bonded to the first metal. The first metal is selected from the class consisting of In, Ga, Sn, Bi, Zn, Cd, Pb, Tl and alloys thereof, and the second metal is selected from the class consisting of Cu, Al, Pb, Au and alloys thereof. 3 figures.

Method for forming nuclear fuel containers of a composite construction and the product thereof

DOEpatents

Cheng, Bo-Ching; Rosenbaum, Herman S.; Armijo, Joseph S.

1984-01-01

An improved method for producing nuclear fuel containers of a composite construction having components providing therein a barrier system for resisting destructive action by volatile fission products or impurities and also interdiffusion of metal constituents, and the product thereof. The composite nuclear fuel containers of the method comprise a casing of zirconium or alloy thereof with a layer of copper overlying an oxidized surface portion of the zirconium or alloy thereof.

Low-Speed Dynamic Wind Tunnel Test Analysis of a Generic 53 Degree Swept UCAV Configuration With Controls

NASA Technical Reports Server (NTRS)

Vicroy, Dan D.; Huber, Kerstin C.; Rohlf, Detlef; Loser, Thomas

2014-01-01

Several static and dynamic forced-motion wind tunnel tests have been conducted on a generic unmanned combat air vehicle (UCAV) configuration with a 53deg swept leading edge. These tests are part of an international research effort to assess and advance the state-of-art of computational fluid dynamics (CFD) methods to predict the static and dynamic stability and control characteristics for this type of configuration. This paper describes the dynamic forced motion data collected from two different models of this UCAV configuration as well as analysis of the control surface deflections on the dynamic forces and moments.

Push plate, mounting assembly, circuit board, and method of assembling thereof for ball grid array packages

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

Vaughn, Mark R.; Montague, Stephen

A push plate that includes springs in the form of cantilever flexures and an inspection window is disclosed. The push plate provides a known, uniform, down force and minimal torque to a package to be tested. The cantilevers have a known, calculable down force producing stiffness. The window provides for viewing of the package during testing.

On the stabilizability of multivariable systems by minimum order compensation

NASA Technical Reports Server (NTRS)

Byrnes, C. I.; Anderson, B. D. O.

1983-01-01

In this paper, a derivation is provided of the necessary condition, mp equal to or greater than n, for stabilizability by constant gain feedback of the generic degree n, p x m system. This follows from another of the main results, which asserts that generic stabilizability is equivalent to generic solvability of a deadbeat control problem, provided mp equal to or less than n. Taken together, these conclusions make it possible to make some sharp statements concerning minimum order stabilization. The techniques are primarily drawn from decision algebra and classical algebraic geometry and have additional consequences for problems of stabilizability and pole-assignability. Among these are the decidability (by a Sturm test) of the equivalence of generic pole-assignability and generic stabilizability, the semi-algebraic nature of the minimum order, q, of a stabilizing compensator, and the nonexistence of formulae involving rational operations and extraction of square roots for pole-assigning gains when they exist, answering in the negative a question raised by Anderson, Bose, and Jury (1975).

76 FR 57019 - Ball Bearings and Parts Thereof From France, Germany and Italy: Final Results of Sunset Reviews...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-15

... with integral shafts, ball bearings (including radial ball bearings) and parts thereof, and housed or... thereof (inner race, outer race, cage, rollers, balls, seals, shields, etc.) outlined above with certain...

Pressurization and expulsion of cryogenic liquids: Generic requirements for a low gravity experiment

NASA Technical Reports Server (NTRS)

Vandresar, Neil T.; Stochl, Robert J.

1991-01-01

Requirements are presented for an experiment designed to obtain data for the pressurization and expulsion of a cryogenic supply tank in a low gravity environment. These requirements are of a generic nature and applicable to any cryogenic fluid of interest, condensible or non-condensible pressurants, and various low gravity test platforms such as the Space Shuttle or a free-flyer. Background information, the thermophysical process, preliminary analytical modeling, and experimental requirements are discussed. Key parameters, measurements, hardware requirements, procedures, a test matrix, and data analysis are outlined.

77 FR 32996 - Certain Handheld Electronic Computing Devices, Related Software, and Components Thereof...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-04

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-769] Certain Handheld Electronic Computing Devices, Related Software, and Components Thereof; Termination of the Investigation Based on... electronic computing devices, related software, and components thereof by reason of infringement of certain...

Fibrous microcapsules and methods of assembly and use thereof

DOEpatents

Stupp, Samuel; Rozkiewicz, Dorota

2015-01-27

The present invention relates to assembly of peptide amphiphiles and biopolymers into fibrous microcapsules, and uses thereof. In particular, the present invention provides devices, compositions, and methods for interfacial self-assembly of peptide amphiphiles and biopolyments into fibrous microcapsules, and uses thereof.

76 FR 54252 - In the Matter of Certain Wireless Devices With 3G Capabilities and Components Thereof; Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-31

... With 3G Capabilities and Components Thereof; Notice of Institution of Investigation Institution of... States after importation of certain wireless devices with 3G capabilities and components thereof by... after [[Page 54253

Reliability and Validity of the Turkish Version of the PedsQL 3.0 Cancer Module for 2- to 7-Year-Old and the PedsQL 4.0 Generic Core Scales for 5- to 7-Year-Old: The Hacettepe University Experience

PubMed Central

Yıldız Kabak, Vesile; Yakut, Yavuz; Çetin, Mualla; Düger, Tülin

2016-01-01

Objective: The aim of this study was to investigate the reliability and validity of the Turkish version of the Pediatric Quality of Life Inventory (PedsQL) 3.0 Cancer Module for 2- to 7-year-old and the PedsQL 4.0 Generic Core Scales for 5- to 7-year-old in childhood cancer. Materials and Methods: The PedsQL 3.0 Cancer Module and PedsQL 4.0 Generic Core Scales were administered to children with cancer and their parents at Hacettepe University. Internal consistency was determined by using Cronbach’s alpha and test-retest reliability was determined by using the intraclass correlation coefficient (ICC). Construct validity was assessed by comparing the results of the PedsQL 3.0 Cancer Module with those of the PedsQL 4.0 Generic Core Scales. Results: Cronbach’s alpha of the PedsQL 3.0 Cancer Module varied from 0.803 to 0.873 and that of the PedsQL 4.0 Generic Core Scales from 0.665 to 0.841. Test-retest ICC values of the PedsQL 3.0 Cancer Module varied from 0.877 to 0.949 and those of the PedsQL 4.0 Generic Core Scales from 0.681 to 0.824. The correlation of the PedsQL 3.0 Cancer Module with subscale scores of the PedsQL 4.0 Generic Core Scales showed that there were excellent to fair correlations between the two scales. The relationship between parent proxy-report and child self-report of the PedsQL 3.0 Cancer Module had very good correlation (r=0.694, p<0.001), as did the PedsQL 4.0 Generic Core Scales (r=0.540, p=0.002). Conclusion: This study demonstrated the reliability, validity, and feasibility of the Turkish version of the PedsQL 3.0 Cancer Module in 2- to 4-year-old and 5- to 7-year-old and the PedsQL 4.0 Generic Core Scales in 5- to 7-year-old in childhood cancer. PMID:27095607

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.

27 CFR 1.61 - Use of wine.

Code of Federal Regulations, 2013 CFR

2013-04-01

... for experimental or research purposes by any scientific university, college of learning, or institution of scientific research; or (c) Free of tax for use by the United States or any agency thereof, and for use for analysis, testing, research, or experimentation by the governments of the several States...

27 CFR 1.61 - Use of wine.

Code of Federal Regulations, 2014 CFR

2014-04-01

... for experimental or research purposes by any scientific university, college of learning, or institution of scientific research; or (c) Free of tax for use by the United States or any agency thereof, and for use for analysis, testing, research, or experimentation by the governments of the several States...

27 CFR 1.61 - Use of wine.

Code of Federal Regulations, 2012 CFR

2012-04-01

... for experimental or research purposes by any scientific university, college of learning, or institution of scientific research; or (c) Free of tax for use by the United States or any agency thereof, and for use for analysis, testing, research, or experimentation by the governments of the several States...

7 CFR 58.1 - Meaning of words.

Code of Federal Regulations, 2013 CFR

2013-01-01

..., GENERAL SPECIFICATIONS FOR APPROVED PLANTS AND STANDARDS FOR GRADES OF DAIRY PRODUCTS 1 Regulations... official tests in accordance with this part. Approved plant means one or more adjacent buildings, or parts thereof, comprising a single plant at one location in which the facilities and methods of operation...

7 CFR 58.1 - Meaning of words.

Code of Federal Regulations, 2012 CFR

2012-01-01

..., GENERAL SPECIFICATIONS FOR APPROVED PLANTS AND STANDARDS FOR GRADES OF DAIRY PRODUCTS 1 Regulations... official tests in accordance with this part. Approved plant means one or more adjacent buildings, or parts thereof, comprising a single plant at one location in which the facilities and methods of operation...

7 CFR 58.1 - Meaning of words.

Code of Federal Regulations, 2014 CFR

2014-01-01

..., GENERAL SPECIFICATIONS FOR APPROVED PLANTS AND STANDARDS FOR GRADES OF DAIRY PRODUCTS 1 Regulations... official tests in accordance with this part. Approved plant means one or more adjacent buildings, or parts thereof, comprising a single plant at one location in which the facilities and methods of operation...

27 CFR 1.61 - Use of wine.

Code of Federal Regulations, 2011 CFR

2011-04-01

... for experimental or research purposes by any scientific university, college of learning, or institution of scientific research; or (c) Free of tax for use by the United States or any agency thereof, and for use for analysis, testing, research, or experimentation by the governments of the several States...

27 CFR 1.61 - Use of wine.

Code of Federal Regulations, 2010 CFR

2010-04-01

... for experimental or research purposes by any scientific university, college of learning, or institution of scientific research; or (c) Free of tax for use by the United States or any agency thereof, and for use for analysis, testing, research, or experimentation by the governments of the several States...

12 CFR 9.18 - Collective investment funds.

Code of Federal Regulations, 2014 CFR

2014-01-01

... participating accounts. (2) Fund management. A bank administering a collective investment fund shall have exclusive management thereof, except as a prudent person might delegate responsibilities to others. 3 3 If a... other unfair results to participating accounts in the STIF; (H) Adopt procedures for stress testing the...

12 CFR 9.18 - Collective investment funds.

Code of Federal Regulations, 2013 CFR

2013-01-01

... adverse stress testing results to the bank's senior risk management that is independent from the STIF's... participating accounts. (2) Fund management. A bank administering a collective investment fund shall have exclusive management thereof, except as a prudent person might delegate responsibilities to others. 3 3 If a...

20 CFR 410.472 - Consultative examinations.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false Consultative examinations. 410.472 Section... Consultative examinations. Upon reasonable notice of the time and place thereof, any individual filing a claim... physical examinations or tests, at the expense of the Administration, by a physician or other professional...

Test evaluation of shock buffering concept for hydrodynamic ram induced by yawing projectile impacting a simulated integral fuel tank

NASA Technical Reports Server (NTRS)

Zabel, P. H.

1979-01-01

A concept for containing the shock inputs due to hydrodynamic ram caused by an impacting projectile within a fuel cell is discussed. This is to provide a buffering layer of foam, flexible, rigid or a combination thereof, which is sealed from the liquid. A program is described in which this buffering concept was tested. The effectiveness of a novel muzzle-mounted, 'tumble', test device is shown.

77 FR 16562 - Certain Navigation Products, Components Thereof, and Related Software; Determination Not To...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-21

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-810] Certain Navigation Products, Components Thereof, and Related Software; Determination Not To Review an Initial Determination Granting a... United States after importation of certain navigation products, components thereof, and related software...

78 FR 52563 - Certain Sleep-Disordered Breathing Treatment Systems and Components Thereof; Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-23

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-890] Certain Sleep-Disordered Breathing... certain sleep- disordered breathing treatment systems and components thereof by reason of infringement of... after importation of certain sleep- disordered breathing treatment systems and components thereof that...

77 FR 13350 - Certain Automotive GPS Navigation Systems, Components Thereof, and Products Containing Same...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-06

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-814] Certain Automotive GPS Navigation Systems, Components Thereof, and Products Containing Same; Determination Not To Review Initial... importation of certain automotive GPS navigation systems, components thereof, and products containing the same...

78 FR 16531 - Certain Electronic Devices for Capturing and Transmitting Images, and Components Thereof...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-15

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-831] Certain Electronic Devices for Capturing and Transmitting Images, and Components Thereof; Commission Determination Not To Review an Initial... certain electronic devices for capturing and transmitting images, and components thereof. The complaint...

Biopharmaceutic Risk Assessment of Brand and Generic Lamotrigine Tablets.

PubMed

Vaithianathan, Soundarya; Raman, Siddarth; Jiang, Wenlei; Ting, Tricia Y; Kane, Maureen A; Polli, James E

2015-07-06

The therapeutic equivalence of generic and brand name antiepileptic drugs has been questioned by neurologists and the epilepsy community. A potential contributor to such concerns is pharmaceutical quality. The objective was to assess the biopharmaceutic risk of brand name Lamictal 100 mg tablets and generic lamotrigine 100 mg tablets from several manufacturers. Lamotrigine was characterized in terms of the Biopharmaceutics Classification System (BCS), including aqueous solubility and Caco-2 permeability. A panel of pharmaceutical quality tests was also performed on three batches of Lamictal, three batches of Teva generic, and one batch of each of four other generics: appearance, identity, assay, impurity, uniformity of dosage units, disintegration, dissolution, friability, and loss on drying. These market surveillance results indicate that all brand name and generic lamotrigine 100 mg tablets passed all tests and showed acceptable pharmaceutical quality and low biopharmaceutic risk. Lamotrigine was classified as a BCS class IIb drug, exhibiting pH-dependent aqueous solubility and dissolution. At pH 1.2 and 4.5, lamotrigine exhibited high solubility, whereas lamotrigine exhibited low solubility at pH 6.8, including non-sink dissolution. Lamotrigine showed high Caco-2 permeability. The apparent permeability (Papp) of lamotrigine was (73.7 ± 8.7) × 10(-6) cm/s in the apical-to-basolateral (AP-BL) direction and (41.4 ± 1.6) × 10(-6) cm/s in the BL-AP direction, which were higher than metoprolol's AP-BL Papp of (21.2 ± 0.9) × 10(-6) cm/s and BL-AP Papp of (34.6 ± 4.6) × 10(-6) cm/s. Overall, lamotrigine's favorable biopharmaceutics from a drug substance perspective and favorable quality characteristics from a tablet formulation perspective suggest that multisource lamotrigine tablets exhibit a low biopharmaceutic risk.

Draft Test Guideline: Generic Freshwater Microcosm Test, Laboratory

EPA Pesticide Factsheets

The following draft test guideline is part of a series of test guidelines that have been developed by EPA for use in the testing of pesticides and toxic substances, and the development of test data for submission to the Agency for review.

Working at the Nexus of Generic and Content-Specific Teaching Practices: An Exploratory Study Based on TIMSS Secondary Analyses

ERIC Educational Resources Information Center

Charalambous, Charalambos Y.; Kyriakides, Ermis

2017-01-01

For years scholars have attended to either generic or content-specific teaching practices attempting to understand instructional quality and its effects on student learning. Drawing on the TIMSS 2007 and 2011 databases, this exploratory study empirically tests the hypothesis that attending to both types of practices can help better explain student…

Critical Thinking as a Predictor and Outcome Measure in a Large Undergraduate Educational Psychology Course.

ERIC Educational Resources Information Center

Williams, Robert L.

This study first determined how well two types of critical thinking measures, generic and subject-specific, predicted performance on course tests. Secondly, the study examined the extent to which critical thinking changed from the beginning to the end of the course. Two generic and one subject-specific measure of critical thinking were used in the…

The Impact of Generic Language about Ability on Children's Achievement Motivation

ERIC Educational Resources Information Center

Cimpian, Andrei

2010-01-01

Nuances in how adults talk about ability may have important consequences for children's sustained involvement and success in an activity. In this study, I tested the hypothesis that children would be less motivated while performing a novel activity if they were told that boys or girls in general are good at this activity (generic language) than if…

Therapy Processes and Outcomes of Psychological Interventions for Women Diagnosed with Gynecological Cancers: A Test of the Generic Process Model of Psychotherapy

ERIC Educational Resources Information Center

Manne, Sharon; Winkel, Gary; Zaider, Talia; Rubin, Stephen; Hernandez, Enrique; Bergman, Cynthia

2010-01-01

Objective: Little attention has been paid to the role of nonspecific therapy processes in the efficacy of psychological interventions for individuals diagnosed with cancer. The goal of the current study was to examine the three constructs from the generic model of psychotherapy (GMP): therapeutic alliance, therapeutic realizations, and therapeutic…

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

Eucapnic voluntary hyperventilation in diagnosing exercise-induced laryngeal obstructions.

PubMed

Christensen, Pernille M; Rasmussen, Niels

2013-11-01

Exercise-induced laryngeal obstructions (EILOs) cause exercise-related respiratory symptoms (ERRS) and are important differential diagnoses to exercise-induced asthma. The diagnostic method for EILOs includes provocation to induce the obstruction followed by a verification of the obstruction and the degree thereof. The objective of the present study was to examine if a eucapnic voluntary hyperventilation (EVH) test could induce laryngeal obstructions laryngoscopically identical in subtypes and development as seen during an exercise test. EVH and exercise testing with continuous laryngoscopy were performed during a screening of two national athletic teams (n = 67). The laryngoscopic recordings were examined for usability, abnormalities and maximal supraglottic and glottic obstruction using two currently available methods (Eilomea and CLE-score). The participants were asked questions on ERRS, and whether the symptoms experienced during each provocation matched those experienced during regular training. A total of 39 completed both tests. There were no significant differences in subtypes and development thereof, the experience of symptoms, and specificity and sensitivity between the methods. Significantly more recordings obtained during the exercise test were usable for evaluation primarily due to resilient mucus on the tip of the fiber-laryngoscope in the EVH test. Only recordings of six athletes from both provocation methods were usable for evaluation using the Eilomea method (high-quality demand). Amongst these, a linear correlation was found for the glottic obstruction. EVH tests can induce EILOs. However, the present test protocol needs adjustments to secure better visualisation of the larynx during provocation.

77 FR 24738 - Certain Wireless Communication Devices and Systems, Components Thereof, and Products Containing...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-25

... Devices and Systems, Components Thereof, and Products Containing Same; Notice of Commission Determination... certain wireless communication devices and systems, components thereof, and products containing the same..., California; Apple Inc. of Cupertino, California; Aruba Networks, Inc. of Sunnyvale, California; Meru Networks...

76 FR 69285 - Certain Game Devices, Components Thereof, and Products Containing the Same; Determination Not To...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-08

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-757] Certain Game Devices, Components Thereof, and Products Containing the Same; Determination Not To Review An Initial Determination Granting... the United States after importation of certain game devices, components thereof, and products...

78 FR 32689 - Certain Portable Electronic Communications Devices, Including Mobile Phones and Components...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-31

..., Including Mobile Phones and Components Thereof Notice of Receipt of Complaint; Solicitation of Comments... Certain Portable Electronic Communications Devices, Including Mobile Phones and Components Thereof, DN... mobile phones and components thereof. The complaint names as respondents HTC Corporation of China and HTC...

75 FR 43205 - Enforcement Proceeding: In the Matter of: Certain Voltage Regulators, Components Thereof and...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-23

... INTERNATIONAL TRADE COMMISSION [Inv. No. 337-TA-564] Enforcement Proceeding: In the Matter of: Certain Voltage Regulators, Components Thereof and Products Containing Same; Notice of Final Determination... the United States after importation of certain voltage regulators, components thereof and products...

78 FR 19311 - Certain Radio Frequency Identification (“RFID”) Products And Components Thereof; Institution of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-29

... Identification (``RFID'') Products And Components Thereof; Institution of Investigation Pursuant to 19 U.S.C... sale within the United States after importation of certain radio frequency identification (``RFID... after importation of certain radio frequency identification (``RFID'') products and components thereof...

77 FR 22802 - Certain Handbags, Luggage, Accessories, and Packaging Thereof; Determination Not To Review an...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-17

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-754] Certain Handbags, Luggage, Accessories, and Packaging Thereof; Determination Not To Review an Initial Determination Granting Complainant... importation of certain handbags, luggage, accessories, and packaging thereof by reason of infringement of U.S...

77 FR 26041 - Certain Computers and Computer Peripheral Devices and Components Thereof and Products Containing...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-02

... INTERNATIONAL TRADE COMMISSION [Inv. No. 337-TA-841] Certain Computers and Computer Peripheral... after importation of certain computers and computer peripheral devices and components thereof and... computers and computer peripheral devices and components thereof and products containing the same that...

The influence of nozzle type, operating pressure, and tank-mixture components on droplet characteristics and the EPA's drift reduction rating

USDA-ARS?s Scientific Manuscript database

The introduction of drift reduction technology (DRT) guidelines by the U. S. Environmental Protection Agency (EPA) has established testing protocols for nozzles, agrochemicals, application parameters, and combinations thereof for applying agrochemicals by certified individuals in the United States....

Apparatus and method for pressure testing closure disks

DOEpatents

Merten, Jr., Charles W.

1992-01-21

A method and device for testing the burst pressure of closure disks which provides high pressure to both sides of a disk and rapidly releases pressure from one side thereof causing a high rate of change of pressure. A hollow notched plug allows the rapid release of pressure upon rupturing. A tensile load is transmitted by a piston in combination with fluid pressure to the hollow notched plug.

Complex Parts, Complex Data: Why You Need to Understand What Radiation Single Event Testing Data Does and Doesn't Show and the Implications Thereof

NASA Technical Reports Server (NTRS)

LaBel, Kenneth A.; Berg, Melanie D.

2015-01-01

Electronic parts (integrated circuits) have grown in complexity such that determining all failure modes and risks from single particle event testing is impossible. In this presentation, the authors will present why this is so and provide some realism on what this means. Its all about understanding actual risks and not making assumptions.

Hazards of high altitude decompression sickness during falls in barometric pressure from 1 atm to a fraction thereof

NASA Technical Reports Server (NTRS)

Genin, A. M.

1980-01-01

Various tests related to studies concerning the effects of decompression sicknesses at varying pressure levels and physical activity are described. The tests indicate that there are no guarantees of freedom from decompression sicknesses when man transitions from a normally oxygenated normobaric nitrogen-oxygen atmosphere into an environment having a 0.4 atm or lower pressure and he is performing physical work.

77 FR 58577 - Certain Video Game Systems and Wireless Controllers and Components Thereof; Notice of Request for...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-21

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-770] Certain Video Game Systems and Wireless Controllers and Components Thereof; Notice of Request for Statements on the Public Interest AGENCY... desist order against certain video game systems and wireless controllers and components thereof, imported...

78 FR 68091 - Certain Marine Sonar Imaging Devices, Products Containing the Same, and Components Thereof...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-13

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-898] Certain Marine Sonar Imaging Devices... importation of certain marine sonar imaging devices, products containing the same, and components thereof by... marine sonar imaging devices, products containing the same, and components thereof by reason of...

75 FR 3444 - Ball Bearings and Parts Thereof From Germany: Initiation of Antidumping Duty Changed...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-21

... Thereof From Germany: Initiation of Antidumping Duty Changed-Circumstances Review AGENCY: Import... bearings and parts thereof from Germany with respect to myonic GmbH. DATES: Effective Date: January 21... Germany on May 15, 1989. See Antidumping Duty Orders: Ball Bearings, Cylindrical Roller Bearings, and...

77 FR 27078 - Certain Electronic Devices, Including Mobile Phones and Tablet Computers, and Components Thereof...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-08

... Phones and Tablet Computers, and Components Thereof; Notice of Receipt of Complaint; Solicitation of... entitled Certain Electronic Devices, Including Mobile Phones and Tablet Computers, and Components Thereof... the United States after importation of certain electronic devices, including mobile phones and tablet...

76 FR 12994 - In the Matter of Certain Digital Televisions and Components Thereof, and Certain Electronic...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-09

... INTERNATIONAL TRADE COMMISSION [Inv. No. 337-TA-764] In the Matter of Certain Digital Televisions and Components Thereof, and Certain Electronic Devices Having a Blu-Ray Disc Player and Components Thereof; Notice of Investigation AGENCY: U.S. International Trade Commission. ACTION: Institution of...

77 FR 14423 - Certain Food Containers, Cups, Plates, Cutlery, and Related Items, and Packaging Thereof; Notice...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-09

... INTERNATIONAL TRADE COMMISSION [DN 2883] Certain Food Containers, Cups, Plates, Cutlery, and... Containers, Cups, Plates, Cutlery, and Related Items, and Packaging Thereof, DN 2883; the Commission is... importation of certain food containers, cups, plates, cutlery, and related items, and packaging thereof. The...

25 CFR 307.12 - Certificates, dating, and signing thereof.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 25 Indians 2 2010-04-01 2010-04-01 false Certificates, dating, and signing thereof. 307.12 Section 307.12 Indians INDIAN ARTS AND CRAFTS BOARD, DEPARTMENT OF THE INTERIOR NAVAJO ALL-WOOL WOVEN FABRICS; USE OF GOVERNMENT CERTIFICATE OF GENUINENESS § 307.12 Certificates, dating, and signing thereof. When...

78 FR 36572 - Certain Crawler Cranes and Components Thereof Notice of Receipt of Complaint; Solicitation of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-18

... INTERNATIONAL TRADE COMMISSION [Docket No. 2960] Certain Crawler Cranes and Components Thereof... Trade Commission has received a complaint entitled Certain Crawler Cranes and Components Thereof, DN...) of the Commission's Rules of Practice and Procedure filed on behalf of Manitowoc Cranes, LLC on June...

76 FR 69284 - Certain Integrated Solar Power Systems and Components Thereof: Notice of Institution of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-08

... the United States after importation of certain integrated solar power systems and components thereof... certain integrated solar power systems and components thereof that infringe one or more of claims 6 and 10... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-811] Certain Integrated Solar Power...

77 FR 39736 - Certain Integrated Solar Power Systems and Components Thereof; Notice of Termination of the...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-05

... certain integrated solar power systems and components thereof by reason of infringement of certain claims... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-811] Certain Integrated Solar Power Systems and Components Thereof; Notice of Termination of the Investigation Based on Settlement AGENCY: U.S...

77 FR 26041 - Certain Cameras and Mobile Devices, Related Software and Firmware, and Components Thereof and...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-02

... Software and Firmware, and Components Thereof and Products Containing the Same; Institution of..., related software and firmware, and components thereof and products containing the same by reason of... after importation of certain cameras and mobile devices, related software and firmware, and components...

77 FR 22611 - Certain Set-Top Boxes, and Hardware and Software Components Thereof; Determination Not To Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-16

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-761] Certain Set-Top Boxes, and Hardware and Software Components Thereof; Determination Not To Review Initial Determination Terminating... certain set-top boxes, and hardware and software components thereof by reason of infringement of various...

77 FR 20417 - Certain Cameras and Mobile Devices, Related Software and Firmware, and Components Thereof and...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-04

... INTERNATIONAL TRADE COMMISSION [DN 2891] Certain Cameras and Mobile Devices, Related Software and... complaint entitled Certain Cameras and Mobile Devices, Related Software and Firmware, and Components Thereof... cameras and mobile devices, related software and firmware, and components thereof and products containing...

77 FR 16860 - Certain GPS Navigation Products, Components Thereof, and Related Software; Termination of...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-22

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-783] Certain GPS Navigation Products, Components Thereof, and Related Software; Termination of Investigation on the Basis of Settlement AGENCY: U.S... GPS navigation products, components thereof, and related software, by reason of the infringement of...

76 FR 39895 - In the Matter of Certain Microprocessors, Components Thereof, and Products Containing Same...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-07

... INTERNATIONAL TRADE COMMISSION [Inv. No. 337-TA-781] In the Matter of Certain Microprocessors... importation of certain microprocessors, components thereof, and products containing same by reason of... microprocessors, components thereof, and products containing same that infringe one or more of claims 11-16, 41...

76 FR 55944 - In the Matter of Certain Electronic Devices With Image Processing Systems, Components Thereof...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-09

... With Image Processing Systems, Components Thereof, and Associated Software; Notice of Commission... importation of certain electronic devices with image processing systems, components thereof, and associated... direct infringement is asserted and the accused article does not meet every limitation of the asserted...

Synthetic substrates for enzyme analysis

DOEpatents

Bissell, Eugene R.; Mitchell, Alexander R.; Pearson, Karen W.; Smith, Robert E.

1983-01-01

Synthetic substrates are provided which may be represented as A-D. The A moiety thereof includes an amino acid, polypeptide, or derivative thereof. The D moiety thereof includes 7-amino coumarin derivatives having an electron withdrawing substituent group at the 3 position carbon or fused between the 3 and 4 position carbons.

21 CFR 501.22 - Animal foods; labeling of spices, flavorings, colorings, and chemical preservatives.

Code of Federal Regulations, 2010 CFR

2010-04-01

..., meat, fish, poultry, eggs, dairy products, or fermentation products thereof. Artificial flavor includes... products, or fermentation products thereof, whose significant function in food is flavoring rather than... or retard deterioration thereof, but does not include common salt, sugars, vinegars, spices, or oils...

75 FR 65656 - In the Matter of: Certain Notebook Computer Products and Components Thereof; Notice of Commission...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-26

... States after importation of certain notebook computer products and components thereof by reason of... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-705] In the Matter of: Certain Notebook Computer Products and Components Thereof; Notice of Commission Determination Not To Review an Initial...

78 FR 55294 - Certain Wireless Devices With 3G Capabilities and Components Thereof Commission Determination To...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-10

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-800] Certain Wireless Devices With 3G Capabilities and Components Thereof Commission Determination To Review the Final Initial Determination Finding... importation of certain wireless devices with 3G capabilities and components thereof by reason of infringement...

CVD apparatus and process for the preparation of fiber-reinforced ceramic composites

DOEpatents

Caputo, A.J.; Devore, C.E.; Lowden, R.A.; Moeller, H.H.

1990-01-23

An apparatus and process for the chemical vapor deposition of a matrix into a preform having circumferentially wound ceramic fibers, comprises heating one surface of the preform while cooling the other surface thereof. The resulting product may have fibers that are wound on radial planes or at an angle from the radial planes. The fibers can also be precoated with pyrolytic carbon before application of the matrix. The matrix is applied by passing reactant gas through the preform thereof to the other side thereof for the initial deposition of matrix near such other surface of the preform. The matrix fills in the preform from the other side surface thereof to the surface of the side of application thereof until a desired amount of matrix has been deposited. 6 figs.

CVD apparatus and process for the preparation of fiber-reinforced ceramic composites

DOEpatents

Caputo, Anthony J.; Devore, Charles E.; Lowden, Richard A.; Moeller, Helen H.

1990-01-01

An apparatus and process for the chemical vapor deposition of a matrix into a preform having circumferentially wound ceramic fibers, comprises heating one surface of the preform while cooling the other surface thereof. The resulting product may have fibers that are wound on radial planes or at an angle from the radial planes. The fibers can also be precoated with pyrolytic carbon before application of the matrix. The matrix is applied by passing reactant gas through the preform thereof to the other side thereof for the initial deposition of matrix near such other surface of the preform. The matrix fills in the preform from the other side surface thereof to the surface of the side of application thereof until a desired amount of matrix has been deposited.

Common Cause Failure Modeling: Aerospace Versus Nuclear

NASA Technical Reports Server (NTRS)

Stott, James E.; Britton, Paul; Ring, Robert W.; Hark, Frank; Hatfield, G. Spencer

2010-01-01

Aggregate nuclear plant failure data is used to produce generic common-cause factors that are specifically for use in the common-cause failure models of NUREG/CR-5485. Furthermore, the models presented in NUREG/CR-5485 are specifically designed to incorporate two significantly distinct assumptions about the methods of surveillance testing from whence this aggregate failure data came. What are the implications of using these NUREG generic factors to model the common-cause failures of aerospace systems? Herein, the implications of using the NUREG generic factors in the modeling of aerospace systems are investigated in detail and strong recommendations for modeling the common-cause failures of aerospace systems are given.

Physicochemical Characterization of Iron Carbohydrate Colloid Drug Products.

PubMed

Zou, Peng; Tyner, Katherine; Raw, Andre; Lee, Sau

2017-09-01

Iron carbohydrate colloid drug products are intravenously administered to patients with chronic kidney disease for the treatment of iron deficiency anemia. Physicochemical characterization of iron colloids is critical to establish pharmaceutical equivalence between an innovator iron colloid product and generic version. The purpose of this review is to summarize literature-reported techniques for physicochemical characterization of iron carbohydrate colloid drug products. The mechanisms, reported testing results, and common technical pitfalls for individual characterization test are discussed. A better understanding of the physicochemical characterization techniques will facilitate generic iron carbohydrate colloid product development, accelerate products to market, and ensure iron carbohydrate colloid product quality.

75 FR 36677 - In the Matter of Certain Inkjet Ink Cartridges With Printheads and Components Thereof; Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-28

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-711] In the Matter of Certain Inkjet Ink Cartridges With Printheads and Components Thereof; Notice of a Commission Determination Not To Review an... importation of certain inkjet ink cartridges with printheads and components thereof by reason of infringement...

76 FR 51055 - In the Matter of Certain Inkjet Ink Cartridges with Printheads and Components Thereof; Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-17

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-723] In the Matter of Certain Inkjet Ink... importation of certain inkjet ink cartridges with printheads and components thereof by reason of infringement... importation of the accused inkjet ink cartridges with printheads and components thereof. Regarding...

78 FR 56245 - Certain Wireless Consumer Electronics Devices and Components Thereof; Notice of Request for...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-12

... Electronics Devices and Components Thereof; Notice of Request for Statements on the Public Interest AGENCY: U... wireless consumer electronics devices and components thereof imported by respondents Acer, Inc. of Taipei... Communications, Inc. of San Diego, California; LG Electronics, Inc. of Seoul, Korea; LG Electronics U.S.A., Inc...

76 FR 41523 - In the Matter of Certain Mobile Communications and Computer Devices and Components Thereof...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-14

... Communications and Computer Devices and Components Thereof; Notice of Commission Determination Not To Review an... in its entirety Inv. No. 337-TA-704, Certain Mobile Communications and Computer Devices and... importation of certain mobile communications and computer devices and components thereof by reason of...

76 FR 5206 - In the Matter of Certain Game Devices, Components Thereof, and Products Containing the Same...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-28

... INTERNATIONAL TRADE COMMISSION [Inv. No. 337-TA-757] In the Matter of Certain Game Devices... importation of certain game devices, components thereof, and products containing the same by reason of... certain game devices, components thereof, and products containing the same that infringe one or more of...

77 FR 5275 - Certain Ink Application Devices and Components Thereof and Methods of Using the Same; Receipt of...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-02

... INTERNATIONAL TRADE COMMISSION [DN 2874] Certain Ink Application Devices and Components Thereof... the U.S. International Trade Commission has received a complaint entitled In Re Certain Ink... United States after importation of certain ink application devices and components thereof and methods of...

76 FR 68504 - Advisory Opinion Proceeding; Certain Coaxial Cable Connectors and Components Thereof and Products...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-04

... Coaxial Cable Connectors and Components Thereof and Products Containing Same; Determination To Institute... coaxial cable connectors and components thereof and products containing the same by reason of infringement... under Commission Rule 210.79 (19 CFR 210.79) that would declare that its coaxial cable connectors...

75 FR 20861 - Certain Digital Set-Top Boxes and Components Thereof; Notice of Investigation

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-21

... INTERNATIONAL TRADE COMMISSION [Inv. No. 337-TA-712] Certain Digital Set-Top Boxes and Components... the United States after importation of certain digital set-top boxes and components thereof that... after importation of certain digital set- top boxes and components thereof that infringe one or more of...

77 FR 14043 - Certain Mobile Devices, Associated Software, and Components Thereof; Determination To Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-08

... Software, and Components Thereof; Determination To Review Final Initial Determination AGENCY: U.S..., and the sale within the United States after importation of certain mobile devices, associated software... software, and components thereof containing same by reason of infringement of one or more of claims 1, 2, 5...

75 FR 38118 - In the Matter of Certain Electronic Devices With Image Processing Systems, Components Thereof...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-01

... With Image Processing Systems, Components Thereof, and Associated Software; Notice of Investigation..., and associated software by reason of infringement of certain claims of U.S. Patent Nos. 7,043,087... processing systems, components thereof, and associated software that infringe one or more of claims 1, 6, and...

75 FR 80843 - In the Matter of Certain Gaming and Entertainment Consoles, Related Software, and Components...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-23

... Entertainment Consoles, Related Software, and Components Thereof; Notice of Investigation AGENCY: U.S..., related software, and components thereof by reason of infringement of certain claims of U.S. Patent No. 5... gaming and entertainment consoles, related software, and components thereof that infringe one or more of...

75 FR 36632 - Diamond Sawblades and Parts Thereof from the People's Republic of China: Initiation of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-28

... Thereof from the People's Republic of China: Initiation of Antidumping Duty New Shipper Review AGENCY... new shipper review (``NSR'') of the antidumping duty order on diamond sawblades and parts thereof... statutory and regulatory requirements for initiation. The period of review (``POR'') for the NSR is January...

76 FR 775 - Diamond Sawblades and Parts Thereof From the People's Republic of China: Initiation of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-06

... Thereof From the People's Republic of China: Initiation of Antidumping Duty New Shipper Review AGENCY... new shipper review (``NSR'') of the antidumping duty order on diamond sawblades and parts thereof... the statutory and regulatory requirements for initiation. The period of review (``POR'') for this NSR...

9 CFR 319.703 - Rendered animal fat or mixture thereof.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Rendered animal fat or mixture thereof... INSPECTION AND CERTIFICATION DEFINITIONS AND STANDARDS OF IDENTITY OR COMPOSITION Fats, Oils, Shortenings § 319.703 Rendered animal fat or mixture thereof. “Rendered Animal Fat,” or any mixture of fats...

9 CFR 319.703 - Rendered animal fat or mixture thereof.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Rendered animal fat or mixture thereof... INSPECTION AND CERTIFICATION DEFINITIONS AND STANDARDS OF IDENTITY OR COMPOSITION Fats, Oils, Shortenings § 319.703 Rendered animal fat or mixture thereof. “Rendered Animal Fat,” or any mixture of fats...

9 CFR 319.703 - Rendered animal fat or mixture thereof.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Rendered animal fat or mixture thereof... INSPECTION AND CERTIFICATION DEFINITIONS AND STANDARDS OF IDENTITY OR COMPOSITION Fats, Oils, Shortenings § 319.703 Rendered animal fat or mixture thereof. “Rendered Animal Fat,” or any mixture of fats...

49 CFR 510.3 - Compulsory process, the service thereof, claims for confidential treatment, and terms of compliance.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 6 2010-10-01 2010-10-01 false Compulsory process, the service thereof, claims... OF TRANSPORTATION INFORMATION GATHERING POWERS § 510.3 Compulsory process, the service thereof... description of the documents or things to be produced. (c) Service of the compulsory processes specified in...

16 CFR 1605.3 - Compulsory processes and the service thereof.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Compulsory processes and the service thereof... Investigations, Inspections and Inquiries § 1605.3 Compulsory processes and the service thereof. (a) In addition... inquired of. (c) The date of service of any form of compulsory process shall be the date on which the...

76 FR 41761 - Ball Bearings and Parts Thereof From Japan and the United Kingdom: Revocation of Antidumping Duty...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-15

... Parts Thereof From Japan and the United Kingdom: Revocation of Antidumping Duty Orders AGENCY... Japan and the United Kingdom. DATES: Effective Date: July 16, 2011. FOR FURTHER INFORMATION CONTACT... thereof from Japan and the United Kingdom (collectively, the orders) in the Federal Register. See...

40 CFR 80.1403 - Which fuels are not subject to the 20% GHG thresholds?

Code of Federal Regulations, 2010 CFR

2010-07-01

... construction after December 19, 2007, and are fired with natural gas, biomass, or a combination thereof, the... are fired with natural gas, biomass, or a combination thereof at all times the facility operated... produced through processes fired with natural gas, biomass, or any combination thereof. (e) The annual...

75 FR 47027 - In the Matter of: Certain Devices Having Elastomeric Gel and Components Thereof; Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-04

... Elastomeric Gel and Components Thereof; Notice of Investigation AGENCY: U.S. International Trade Commission... importation, and the sale within the United States after importation of certain devices having elastomeric gel... after importation of certain devices having elastomeric gel and components thereof that infringe one or...

76 FR 59737 - In the Matter of Certain Digital Photo Frames and Image Display Devices and Components Thereof...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-27

... Frames and Image Display Devices and Components Thereof; Notice of Institution of Investigation... United States after importation of certain digital photo frames and image display devices and components... certain digital photo frames and image display devices and components thereof that infringe one or more of...

75 FR 17437 - In the Matter of Certain Notebook Computer Products and Components Thereof; Notice of Commission...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-06

... importation of certain notebook computer products and components thereof by reason of infringement of the '693... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-705] In the Matter of Certain Notebook Computer Products and Components Thereof; Notice of Commission Decision Not To Review an Initial...

75 FR 8400 - In the Matter of Certain Notebook Computer Products and Components Thereof; Notice of Investigation

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-24

... INTERNATIONAL TRADE COMMISSION [Inv. No. 337-TA-705] In the Matter of Certain Notebook Computer... United States after importation of certain notebook computer products and components thereof by reason of... after importation of certain notebook computer products or components thereof that infringe one or more...

76 FR 64896 - Diamond Sawblades and Parts Thereof From the People's Republic of China: Extension of Time Limit...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-19

... DEPARTMENT OF COMMERCE International Trade Administration [A-570-900] Diamond Sawblades and Parts Thereof From the People's Republic of China: Extension of Time Limit for Preliminary Results of... sawblades and parts thereof from the People's Republic of China for the period January 23, 2009, through...

76 FR 41759 - Diamond Sawblades and Parts Thereof From the People's Republic of China: Extension of Time Limit...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-15

... DEPARTMENT OF COMMERCE International Trade Administration [A-570-900] Diamond Sawblades and Parts Thereof From the People's Republic of China: Extension of Time Limit for Preliminary Results of... sawblades and parts thereof from the People's Republic of China for the period January 23, 2009, through...

77 FR 26788 - Certain Wireless Devices With 3G Capabilities and Components Thereof Determination Not To Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-07

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-800] Certain Wireless Devices With 3G Capabilities and Components Thereof Determination Not To Review Initial Determination To Amend the Notice of... importation of certain wireless devices with 3G capabilities and components thereof by reason of infringement...

Stress-strain analysis of a (0/90)sub 2 symmetric titanium matrix laminate subjected to a generic hypersonic flight profile

NASA Technical Reports Server (NTRS)

Mirdamadi, Massoud; Johnson, W. Steven

1992-01-01

Cross ply laminate behavior of Ti-15V-3Cr-3Al-3Sn (Ti-15-3) matrix reinforced with continuous silicon carbide fibers (SCS-6) subjected to a generic hypersonic flight profile was evaluated experimentally and analytically. Thermomechanical fatigue test techniques were developed to conduct a simulation of a generic hypersonic flight profile. A micromechanical analysis was used. The analysis predicts the stress-strain response of the laminate and of the constituents in each ply during thermal and mechanical cycling by using only constituent properties as input. The fiber was modeled using a thermo-viscoplastic constitutive relation. The fiber transverse modulus was reduced in the analysis to simulate the fiber matrix interface failure. Excellent correlation was found between measured and predicted laminate stress-strain response due to generic hypersonic flight profile when fiber debonding was modeled.

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.

System and method for detecting cells or components thereof

DOEpatents

Porter, Marc D [Ames, IA; Lipert, Robert J [Ames, IA; Doyle, Robert T [Ames, IA; Grubisha, Desiree S [Corona, CA; Rahman, Salma [Ames, IA

2009-01-06

A system and method for detecting a detectably labeled cell or component thereof in a sample comprising one or more cells or components thereof, at least one cell or component thereof of which is detectably labeled with at least two detectable labels. In one embodiment, the method comprises: (i) introducing the sample into one or more flow cells of a flow cytometer, (ii) irradiating the sample with one or more light sources that are absorbed by the at least two detectable labels, the absorption of which is to be detected, and (iii) detecting simultaneously the absorption of light by the at least two detectable labels on the detectably labeled cell or component thereof with an array of photomultiplier tubes, which are operably linked to two or more filters that selectively transmit detectable emissions from the at least two detectable labels.

Ecological Risk Assessment Framework for Low-Altitude Overflights by Fixed-Wing and Rotary-Wing Military Aircraft

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

Efroymson, R.A.

2001-01-12

This is a companion report to the risk assessment framework proposed by Suter et al. (1998): ''A Framework for Assessment of Risks of Military Training and Testing to Natural Resources,'' hereafter referred to as the ''generic framework.'' The generic framework is an ecological risk assessment methodology for use in environmental assessments on Department of Defense (DoD) installations. In the generic framework, the ecological risk assessment framework of the US Environmental Protection Agency (EPA 1998) is modified for use in the context of (1) multiple and diverse stressors and activities at a military installation and (2) risks resulting from causal chains,more » e.g., effects on habitat that indirectly impact wildlife. Both modifications are important if the EPA framework is to be used on military installations. In order for the generic risk assessment framework to be useful to DoD environmental staff and contractors, the framework must be applied to specific training and testing activities. Three activity-specific ecological risk assessment frameworks have been written (1) to aid environmental staff in conducting risk assessments that involve these activities and (2) to guide staff in the development of analogous frameworks for other DoD activities. The three activities are: (1) low-altitude overflights by fixed-wing and rotary-wing aircraft (this volume), (2) firing at targets on land, and (3) ocean explosions. The activities were selected as priority training and testing activities by the advisory committee for this project.« less

[Evaluation of Gastric Mucosal Injury Model Animals of Rebamipide Formulation--Study of Therapeutic Equivalence].

PubMed

Abe, Noriaki; Funato, Hiroki; Hirata, Ayumu; Nakai, Megumi; Iizuka, Michiro; Shiraishi, Hisashi; Jobu, Kohei; Yagi, Yusuke; Kadota, Aki; Ogi, Kyoko; Yokota, Junko; Miyamura, Mitsuhiko

2016-01-01

The introduction of generic drugs is promoted from the perspective of medical economics. In this context, we need to understand not only the bioequivalence of generic drugs specified in "the Guidelines for Bioequivalence Studies of Generic Products", but also formulation properties to consider their effect on pharmacological therapy. We evaluated the pharmaceutical characteristics of rebamipide formulations, a brand-name drug and two generic drugs, and their clinical functionality by using rat models of gastric mucosal injury induced by non-steroidal anti-inflammatory drugs (NSAIDs). Pharmaceutical evaluation showed significant differences in hardness. The inter-lot variation was small in all rebamipide formulations. In the clinical functionality study, biochemistry test values 7 d after the administration of rebamipide showed no differences among formulations. Higher levels of mucosal fluid secretion and antioxidative enzymes were observed in the groups administered rebamipide than in the control group. The levels of lipid peroxide were lower in the groups administered rebamipide than the control group. Multivariate analysis showed slight divergence between the brand-name and generic drugs. In future, it will be necessary to select generic drugs after careful consideration of bioequivalence, clinical functionality, and therapeutic equivalence by reviewing scientific evidence such as indication and formulation design, not to mention stable provision.

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

Comparison of Code Predictions to Test Measurements for Two Orifice Compensated Hydrostatic Bearings at High Reynolds Numbers

NASA Technical Reports Server (NTRS)

Keba, John E.

1996-01-01

Rotordynamic coefficients obtained from testing two different hydrostatic bearings are compared to values predicted by two different computer programs. The first set of test data is from a relatively long (L/D=1) orifice compensated hydrostatic bearing tested in water by Texas A&M University (TAMU Bearing No.9). The second bearing is a shorter (L/D=.37) bearing and was tested in a lower viscosity fluid by Rocketdyne Division of Rockwell (Rocketdyne 'Generic' Bearing) at similar rotating speeds and pressures. Computed predictions of bearing rotordynamic coefficients were obtained from the cylindrical seal code 'ICYL', one of the industrial seal codes developed for NASA-LeRC by Mechanical Technology Inc., and from the hydrodynamic bearing code 'HYDROPAD'. The comparison highlights the difference the bearing has on the accuracy of the predictions. The TAMU Bearing No. 9 test data is closely matched by the predictions obtained for the HYDROPAD code (except for added mass terms) whereas significant differences exist between the data from the Rocketdyne 'Generic' bearing the code predictions. The results suggest that some aspects of the fluid behavior in the shorter, higher Reynolds Number 'Generic' bearing may not be modeled accurately in the codes. The ICYL code predictions for flowrate and direct stiffness approximately equal those of HYDROPAD. Significant differences in cross-coupled stiffness and the damping terms were obtained relative to HYDROPAD and both sets of test data. Several observations are included concerning application of the ICYL code.

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.

78 FR 34985 - Tapered Roller Bearings and Parts Thereof, Finished and Unfinished From the People's Republic of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-11

... Parts Thereof, Finished and Unfinished From the People's Republic of China: Rescission, in Part, of... parts thereof, finished and unfinished (TRBs) from the People's Republic of China (PRC) covering the... section 771(9)(A) of the Act, as amended, Dana Off Highway Products, LLC, for the company Timken de Mexico...

26 CFR 1.1335-1 - Elective method; time and manner of making election and effect thereof.

Code of Federal Regulations, 2010 CFR

2010-04-01

... Elective method; time and manner of making election and effect thereof. (a) In general. If the taxpayer... election and effect thereof. 1.1335-1 Section 1.1335-1 Internal Revenue INTERNAL REVENUE SERVICE... election to all taxable years of the taxpayer beginning after December 31, 1941. Thus, the taxpayer need...

76 FR 36083 - Hand Trucks and Certain Parts Thereof From the People's Republic of China: Final Results and...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-21

... DEPARTMENT OF COMMERCE International Trade Administration [A-570-891] Hand Trucks and Certain... review of the antidumping duty order on hand trucks and certain parts thereof from the People's Republic of China (PRC). See Hand Trucks and Certain Parts Thereof from the People's Republic of China...

77 FR 41744 - Hand Trucks and Certain Parts Thereof From the People's Republic of China: Final Results of...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-16

... DEPARTMENT OF COMMERCE International Trade Administration [A-570-891] Hand Trucks and Certain... order on hand trucks and certain parts thereof from the People's Republic of China (PRC).\\1\\ Based upon...\\ See Hand Trucks and Certain Parts Thereof from the People's Republic of China: Preliminary Results of...

76 FR 60871 - Ball Bearings and Parts Thereof From France, Germany, and Italy; Termination of Five-Year Reviews

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-30

... INTERNATIONAL TRADE COMMISSION [Investigation Nos. 731-TA-391A-393A (Third Review)] Ball Bearings and Parts Thereof From France, Germany, and Italy; Termination of Five-Year Reviews AGENCY: United... parts thereof from France, Germany, and Italy would be likely to lead to continuation or recurrence of...

77 FR 2031 - Tapered Roller Bearings and Parts Thereof, Finished and Unfinished From the People's Republic of...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-13

... Parts Thereof, Finished and Unfinished From the People's Republic of China: Extension of the Time Limit..., International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW..., finished and unfinished from the People's Republic of China. See Tapered Roller Bearings and Parts Thereof...

75 FR 60480 - In the Matter of Certain Bulk Welding Wire Containers and Components Thereof and Welding Wire...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-30

... Welding Wire Containers and Components Thereof and Welding Wire; Notice of Commission Determination To... within the United States after importation of certain bulk welding wire containers, components thereof, and welding wire by reason of infringement of certain claims of United States Patent Nos. 6,260,781; 6...

76 FR 22918 - In the Matter of Certain Handheld Electronic Computing Devices, Related Software, and Components...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-25

... Computing Devices, Related Software, and Components Thereof; Notice of Investigation AGENCY: U.S... devices, related software, and components thereof by reason of infringement of certain claims of U.S... devices, related software, and components thereof that infringe one or more of claims 1 and 5 of the '372...

76 FR 68209 - Certain Navigation Products, Components Thereof, and Related Software; Institution of Investigation

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-03

..., Components Thereof, and Related Software; Institution of Investigation AGENCY: U.S. International Trade... navigation products, components thereof, and related software by reason of infringement of certain claims of... related software that infringe one or more of claims 1, 2, 11, and 16 of the '565 patent; claim 1 of the...

78 FR 36573 - Certain Digital Media Devices, Including Televisions, Blu-Ray Disc Players, Home Theater Systems...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-18

... Thereof and Associated Software AGENCY: U.S. International Trade Commission. ACTION: Notice, Institution... thereof and associated software, by reason of infringement of U.S. Patent No. 8,028,323 (``the `323 patent... mobile phones, components thereof and associated software by reason of infringement of one or more of...

7 CFR 160.87 - Prohibited use of word “turpentine” or derivatives thereof.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 3 2010-01-01 2010-01-01 false Prohibited use of word âturpentineâ or derivatives... use of word “turpentine” or derivatives thereof. It shall be deemed unlawful to use in commerce the word “turpentine” or a compound, derivative or imitation thereof, or any word or combination of words...

76 FR 4634 - Diamond Sawblades and Parts Thereof From the People's Republic of China (PRC): Rescission of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-26

... Thereof From the People's Republic of China (PRC): Rescission of Antidumping Duty New-Shipper Review... (the Department) initiated a new-shipper review of the antidumping duty order on diamond sawblades and parts thereof from the People's Republic of China (PRC) covering the period January 23, 2009, through...

77 FR 53844 - Ball Bearings and Parts Thereof From France and Italy: Rescission of Antidumping Duty...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-04

... DEPARTMENT OF COMMERCE International Trade Administration [A-475-801, A-427-801] Ball Bearings and... antidumping duty orders on ball bearings and parts thereof from France and Italy. The period of review is May... the antidumping duty orders on ball bearings and parts thereof from France and Italy in accordance...

78 FR 16707 - Certain Digital Photo Frames and Image Display Devices and Components Thereof; Issuance of a...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-18

... Image Display Devices and Components Thereof; Issuance of a Limited Exclusion Order and Cease and Desist... within the United States after importation of certain digital photo frames and image display devices and...: (1) The unlicensed entry of digital photo frames and image display devices and components thereof...

78 FR 11818 - Diamond Sawblades and Parts Thereof From the Republic of Korea: Final Results of Antidumping Duty...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-20

..., 2010. For the final results, we continue to find that the companies covered by the review made sales of... Thereof From the Republic of Korea: Final Results of Antidumping Duty Administrative Review, 2009-2010... administrative review of the antidumping duty order on diamond sawblades and parts thereof (diamond sawblades...

78 FR 36524 - Diamond Sawblades and Parts Thereof From the Republic of Korea: Final Results of Antidumping Duty...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-18

..., we were unable to conduct a sales below cost investigation for Hyosung. Final Results of the Review... Thereof From the Republic of Korea: Final Results of Antidumping Duty Administrative Review, 2010-2011... administrative review of the antidumping duty order on diamond sawblades and parts thereof (diamond sawblades...

75 FR 51980 - Hand Trucks and Certain Parts Thereof from the People's Republic of China; Extension of Time...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-24

... Parts Thereof from the People's Republic of China; Extension of Time Limit for Preliminary Results of... review of the antidumping duty order on hand trucks and certain parts thereof from the People's Republic... Antidumping and Countervailing Duty Administrative Reviews and Request for Revocation in Part, and Deferral of...

75 FR 2108 - Ball Bearings and Parts Thereof from France, Germany, Italy, Japan, and the United Kingdom...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-14

...-804, A-412-801] Ball Bearings and Parts Thereof from France, Germany, Italy, Japan, and the United Kingdom: Extension of Time Limit for Preliminary Results of Antidumping Duty Administrative Reviews AGENCY... reviews of the antidumping duty orders on ball bearings and parts thereof from France, Germany, Italy...

77 FR 14733 - Diamond Sawblades and Parts Thereof From the People's Republic of China: Extension of Time Limit...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-13

... DEPARTMENT OF COMMERCE International Trade Administration [A-570-900] Diamond Sawblades and Parts Thereof From the People's Republic of China: Extension of Time Limit for Final Results of Antidumping Duty... order on diamond sawblades and parts thereof from the People's Republic of China for the period January...

77 FR 2511 - Ball Bearings and Parts Thereof From France, Germany, and Italy: Extension of Time Limit for...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-18

... Bearings and Parts Thereof From France, Germany, and Italy: Extension of Time Limit for Preliminary Results... ball bearings and parts thereof from France, Germany, Italy, Japan, and the United Kingdom for the... Administrative Reviews and Request for Revocation in Part, 76 FR 37781 (June 28, 2011).\\1\\ The preliminary...

76 FR 50455 - Diamond Sawblades and Parts Thereof From the People's Republic of China: Extension of Time Limit...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-15

... DEPARTMENT OF COMMERCE International Trade Administration [A-570-900] Diamond Sawblades and Parts Thereof From the People's Republic of China: Extension of Time Limit for Final Results of the Antidumping... parts thereof from the People's Republic of China.\\1\\ Subsequent to the publication of the Preliminary...

76 FR 2647 - Ball Bearings and Parts Thereof From France, Germany, Italy, Japan, and the United Kingdom...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-14

...-804, A-412-801] Ball Bearings and Parts Thereof From France, Germany, Italy, Japan, and the United Kingdom: Extension of Time Limit for Preliminary Results of Antidumping Duty Administrative Reviews AGENCY... administrative reviews of the antidumping duty orders on ball bearings and parts thereof from France, Germany...

76 FR 59111 - Diamond Sawblades and Parts Thereof From the People's Republic of China: Extension of Time Limit...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-23

... Sawblades and Parts Thereof From the People's Republic of China: Extension of Time Limit for Final Results... DEPARTMENT OF COMMERCE International Trade Administration [A-570-900] Diamond Sawblades and Parts Thereof From the People's Republic of China: Extension of Time Limit for Final Results of the Antidumping...

76 FR 69241 - Tapered Roller Bearings and Parts Thereof, Finished or Unfinished, From the People's Republic of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-08

... Parts Thereof, Finished or Unfinished, From the People's Republic of China: Extension of Time Limit for... and parts thereof, finished or unfinished, (``TRBs'') from the People's Republic of China (``PRC... Revocation in Part, 75 FR 44224 (July 28, 2010). On July 13, 2011, the Department published the preliminary...

76 FR 40324 - Diamond Sawblades and Parts Thereof From the Republic of Korea: Extension of Time Limit for the...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-08

... DEPARTMENT OF COMMERCE International Trade Administration [A-580-855] Diamond Sawblades and Parts Thereof From the Republic of Korea: Extension of Time Limit for the Preliminary Results of the Antidumping... antidumping duty order on diamond sawblades and parts thereof from the Republic of Korea, covering the period...

Educators and the Boundaryless Career Model: An Approach to Subjective Career Success

ERIC Educational Resources Information Center

Hamilton, Sharron

2017-01-01

This quantitative study examines the correlation between measures of subjective career success using an independent samples t test with the possession of or lack thereof of a boundaryless career attitude with a sample of secondary educators. The shift from traditional, organizational careers has grown tremendously over the last decade. Research…

26 CFR 25.2522(a)-1 - Charitable and similar gifts; citizens or residents.

Code of Federal Regulations, 2012 CFR

2012-04-01

... purposes. (2) Any corporation, trust, community chest, fund, or foundation organized and operated... war veterans or auxiliary unit or society thereof, if organized in the United States or any of its... foundation unless the organization or trust meets the following four tests: (1) It must be organized and...

16 CFR 1115.13 - Content and form of reports; delegations of authority.

Code of Federal Regulations, 2010 CFR

2010-01-01

... (or a summary thereof) shall be attached. Give a chronological account of facts or events leading to... changes (e.g., designs, adjustments, and additional parts, quality control, testing) that have been or... such changes and steps. (11) Information that has been or will be given to purchasers, including...

The Impact of Generic Substitution on Health and Economic Outcomes: A Systematic Review.

PubMed

Gothe, H; Schall, I; Saverno, K; Mitrovic, M; Luzak, A; Brixner, D; Siebert, U

2015-08-01

Generic drugs are considered therapeutically equivalent to their original counterparts and lower in acquisition costs. However, the overall impact of generic substitution (GS) on global clinical and economic outcomes has not been conclusively evaluated. To test whether (1) generics and original products yield the same health outcomes, and (2) generic therapies save economic resources versus original therapies. We performed a systematic literature review in Medline, Embase, and the Cochrane Database of Systematic Reviews to identify original studies that examine clinical or economic outcomes of GS. After standardized data extraction, reported outcomes were categorized as supporting or rejecting the hypotheses. Each reported outcome was assessed and accounted for supporting and opposing GS. One publication could provide multiple outcome comparisons. We included 40 studies across ten therapeutic areas. Fourteen studies examined patients on de novo therapy; 24 studies investigated maintenance drug therapy, and two studies considered both settings. Overall, 119 outcome comparisons were examined. Of 97 clinical outcome comparisons, 67% reported no significant difference between generic drugs and their off-patent counterparts. Of 22 economic comparisons, 64% suggested that GS increased costs. Consequently, hypothesis (1) was supported but hypothesis (2) was not. We found no major differences among studies that investigated clinical outcomes with de novo or maintenance therapy. The review suggests that clinical effects are similar after GS. However, economic savings are not guaranteed. More systematic research comparing clinical and economic outcomes with or without GS is needed to inform policy on the use of generic substitution.

Cermet electrode

DOEpatents

Maskalick, Nicholas J.

1988-08-30

Disclosed is a cermet electrode consisting of metal particles of nickel, cobalt, iron, or alloys or mixtures thereof immobilized by zirconia stabilized in cubic form which contains discrete deposits of about 0.1 to about 5% by weight of praseodymium, dysprosium, terbium, or a mixture thereof. The solid oxide electrode can be made by covering a substrate with particles of nickel, cobalt, iron, or mixtures thereof, growing a stabilized zirconia solid oxide skeleton around the particles thereby immobilizing them, contacting the skeleton with a compound of praseodymium, dysprosium, terbium, or a mixture thereof, and heating the skeleton to a temperature of at least 500.degree. C. The electrode can also be made by preparing a slurry of nickel, cobalt, iron, or mixture and a compound of praseodymium, dysprosium, terbium, or a mixture thereof, depositing the slurry on a substrate, heating the slurry to dryness, and growing a stabilized zirconia skeleton around the metal particles.

Data Applicability of Heritage and New Hardware For Launch Vehicle Reliability Models

NASA Technical Reports Server (NTRS)

Al Hassan, Mohammad; Novack, Steven

2015-01-01

Bayesian reliability requires the development of a prior distribution to represent degree of belief about the value of a parameter (such as a component's failure rate) before system specific data become available from testing or operations. Generic failure data are often provided in reliability databases as point estimates (mean or median). A component's failure rate is considered a random variable where all possible values are represented by a probability distribution. The applicability of the generic data source is a significant source of uncertainty that affects the spread of the distribution. This presentation discusses heuristic guidelines for quantifying uncertainty due to generic data applicability when developing prior distributions mainly from reliability predictions.

The Generic Resolution Advisor and Conflict Evaluator (GRACE) for Detect-And-Avoid (DAA) Systems

NASA Technical Reports Server (NTRS)

Abramson, Michael; Refai, Mohamad; Santiago, Confesor

2017-01-01

The paper describes the Generic Resolution Advisor and Conflict Evaluator (GRACE), a novel alerting and guidance algorithm that combines flexibility, robustness, and computational efficiency. GRACE is "generic" in that it makes no assumptions regarding temporal or spatial scales, aircraft performance, or its sensor and communication systems. Accordingly, GRACE is well suited to research applications where alerting and guidance is a central feature and requirements are fluid involving a wide range of aviation technologies. GRACE has been used at NASA in a number of real-time and fast-time experiments supporting evolving requirements of DAA research, including parametric studies, NAS-wide simulations, human-in-the-loop experiments, and live flight tests.

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

Evaluation of a single cell and candidate materials with high water content hydrogen in a generic solid oxide fuel cell stack test fixture, Part II: materials and interface characterization

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

Chou, Y. S.; Stevenson, Jeffry W.; Choi, Jung-Pyung

2013-01-01

A generic solid oxide fuel cell (SOFC) test fixture was developed to evaluate candidate materials under realistic conditions. A commerical 50 mm x 50 mm NiO-YSZ anode supported thin YSZ electrolyte cell with lanthanum strontium manganite (LSM) cathode was tested to evaluate the stability of candidate materials. The cell was tested in two stages at 800oC: stage I of low (~3% H2O) humidity and stage II of high (~30% H2O) humidity hydrogen fuel at constant voltage or constant current mode. Part I of the work was published earlier with information of the generic test fixture design, materials, cell performance, andmore » optical post-mortem analysis. In part II, detailed microstructure and interfacial characterizations are reported regarding the SOFC candidate materials: (Mn,Co)-spinel conductive coating, alumina coating for sealing area, ferritic stainless steel interconnect, refractory sealing glass, and their interactions with each other. Overall, the (Mn,Co)-spinel coating was very effective in minimizing Cr migration. No Cr was identified in the cathode after 1720h at 800oC. Aluminization of metallic interconnect also proved to be chemically compatible with alkaline-earth silicate sealing glass. The details of interfacial reaction and microstructure development are discussed.« less

The impact of generic language about ability on children's achievement motivation.

PubMed

Cimpian, Andrei

2010-09-01

Nuances in how adults talk about ability may have important consequences for children's sustained involvement and success in an activity. In this study, I tested the hypothesis that children would be less motivated while performing a novel activity if they were told that boys or girls in general are good at this activity (generic language) than if they were told that a particular boy or girl is good at it (non-generic language). Generic language may be detrimental because it expresses normative societal expectations regarding performance. If these expectations are negative, they may cause children to worry about confirming them; if positive, they may cause worries about failing to meet them. Moreover, generic statements may be threatening because they imply that performance is the result of stable traits rather than effort. Ninety-seven 4- to 7-year-olds were asked to play a game in which they succeeded at first but then made a few mistakes. Since young children remain optimistic in achievement situations until the possibility of failure is made clear, I hypothesized that 4- and 5-year-olds would not be affected by the implications of generic language until after they made mistakes; 6- and 7-year-olds, however, may be susceptible earlier. As expected, the older children who heard that boys or girls are good at this game displayed lower motivation (e.g., more negative emotions, lower perceived competence) from the start, while they were still succeeding and receiving praise. Four- and 5-year-olds who heard these generic statements had a similar reaction, but only after they made mistakes. These findings demonstrate that exposure to generic language about ability can be an obstacle to children's motivation and, potentially, their success.

The effect of an apparent change to a branded or generic medication on drug effectiveness and side effects.

PubMed

Faasse, Kate; Cundy, Tim; Gamble, Greg; Petrie, Keith J

2013-01-01

Generic medications are associated with reduced perceived effectiveness, increased perceived adverse effects, and increased rates of nonadherence compared with brand-name medications. This study examined the effect of an apparent medication formulation change on subjective and objective measures of medication effectiveness and medication side effects. Sixty-two university students participated in a study purportedly testing the effectiveness of fast-acting β-blocker medications in reducing preexamination anxiety. All tablets were placebos. In session 1, all participants received a yellow tablet ("Betaprol"). In session 2, participants were randomly allocated to receive Betaprol (no change condition) or a white tablet labeled either as "Novaprol" (branded change condition) or "Generic" (generic change condition). Blood pressure and state anxiety were measured before and after tablet ingestion. Side effects attributed to medication were assessed. The no change group showed significantly greater decreases in systolic blood pressure (mean [M] [standard deviation] = -7.72 mm Hg, standard error [SE] = 1.45) than the branded change (M = -2.75 mm Hg, SE = 1.44, p = .02) and generic change (M = -3.26 mm Hg, SE = 1.45, p = .03) groups. The no-change group showed significantly greater decreases in state anxiety (M = -1.53, SE = 0.33) than the branded change (M = -0.50, SE = 0.33, p = .03) and generic change (M = -0.52, SE = 0.33, p = .04) groups. Significantly more side effects were attributed to the medication in the generic change (M = 1.83, SE = 0.23) (but not the branded change) condition when compared with the no change condition (M = 0.87, SE = 0.31, p = .03). Medication formulation change, particularly to generic medication, seems to be associated with reduced subjective and objective measures of medication effectiveness and increased side effects.

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.

An Electronic Patient-Reported Outcome Measures System in UK Chiropractic Practices: A Feasibility Study of Routine Collection of Outcomes and Costs.

PubMed

Newell, Dave; Diment, Emily; Bolton, Jenni E

2016-01-01

The purpose of this study was to test the feasibility of collecting valid and widely used health outcomes, including information concerning cost of care, using a Web-based patient-driven patient-reported outcome measure (PROM) collection process within a cohort of UK chiropractic practices. A Web-based PROM system (Care Response) was used. Patients with low back and neck pain were recruited from a group of chiropractic practices located in the United Kingdom. Information collected included demographic data, generic and condition-specific PROMs at the initial consultation and 90 days later, patient-reported experience measures, and additional health seeking to estimate costs of care. A group of 33 clinics provided information from a total of 1895 patients who completed baseline questionnaires with 844 (45%) completing the measures at 90-day follow-up. Subsequent outcomes suggest that more than 70% of patients improved over the course of treatment regardless of the outcome used. Using the baseline as a virtual counterfactual with respect to follow-up, we calculated quality-adjusted life years and the cost thereof resulting in a mean quality-adjusted life years gained of 0.8 with an average cost of £895 per quality-adjusted life year. Routine collection of PROMs, including information about cost, is feasible and can be achieved using an online system within a clinical practice environment. We describe a Web-based collection system and discuss the choice of measures leading to a comprehensive understanding of outcomes and costs in routine practice. Copyright © 2016 National University of Health Sciences. Published by Elsevier Inc. All rights reserved.

7 CFR 160.87 - Prohibited use of word “turpentine” or derivatives thereof.

Code of Federal Regulations, 2014 CFR

2014-01-01

... use of word “turpentine” or derivatives thereof. It shall be deemed unlawful to use in commerce the word “turpentine” or a compound, derivative or imitation thereof, or any word or combination of words which are a part of a United States Standard for any kind of spirits of turpentine, to describe in any...

7 CFR 160.87 - Prohibited use of word “turpentine” or derivatives thereof.

Code of Federal Regulations, 2013 CFR

2013-01-01

... use of word “turpentine” or derivatives thereof. It shall be deemed unlawful to use in commerce the word “turpentine” or a compound, derivative or imitation thereof, or any word or combination of words which are a part of a United States Standard for any kind of spirits of turpentine, to describe in any...

7 CFR 160.87 - Prohibited use of word “turpentine” or derivatives thereof.

Code of Federal Regulations, 2011 CFR

2011-01-01

... use of word “turpentine” or derivatives thereof. It shall be deemed unlawful to use in commerce the word “turpentine” or a compound, derivative or imitation thereof, or any word or combination of words which are a part of a United States Standard for any kind of spirits of turpentine, to describe in any...

7 CFR 160.87 - Prohibited use of word “turpentine” or derivatives thereof.

Code of Federal Regulations, 2012 CFR

2012-01-01

... use of word “turpentine” or derivatives thereof. It shall be deemed unlawful to use in commerce the word “turpentine” or a compound, derivative or imitation thereof, or any word or combination of words which are a part of a United States Standard for any kind of spirits of turpentine, to describe in any...

78 FR 28801 - Hand Trucks and Certain Parts Thereof From the People's Republic of China: Final Results of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-16

... Parts Thereof From the People's Republic of China: Final Results of Antidumping Duty Administrative... of China (PRC).\\2\\ The period of review (POR) is December 1, 2010, through November 30, 2011. We gave... China, 69 FR 70122 (December 2, 2004). \\2\\ See Hand Trucks and Certain Parts Thereof From the People's...

19 CFR 12.27 - Importation or exportation of wild animals or birds, or the dead bodies thereof illegally...

Code of Federal Regulations, 2011 CFR

2011-04-01

... birds, or the dead bodies thereof illegally captured or killed, etc. 12.27 Section 12.27 Customs Duties... SPECIAL CLASSES OF MERCHANDISE Wild Animals, Birds, and Insects § 12.27 Importation or exportation of wild animals or birds, or the dead bodies thereof illegally captured or killed, etc. Customs officers shall...

19 CFR 12.27 - Importation or exportation of wild animals or birds, or the dead bodies thereof illegally...

Code of Federal Regulations, 2010 CFR

2010-04-01

... birds, or the dead bodies thereof illegally captured or killed, etc. 12.27 Section 12.27 Customs Duties... SPECIAL CLASSES OF MERCHANDISE Wild Animals, Birds, and Insects § 12.27 Importation or exportation of wild animals or birds, or the dead bodies thereof illegally captured or killed, etc. Customs officers shall...

75 FR 9391 - Tapered Roller Bearings and Parts Thereof, Finished or Unfinished, from the People's Republic of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-02

... Parts Thereof, Finished or Unfinished, from the People's Republic of China: Extension of Time Limit for... review of the antidumping duty order on tapered roller bearings and parts thereof, finished or unfinished... March 9, 2010. Statutory Time Limits Section 751(a)(3)(A) of the Tariff Act of 1930, as amended (``the...

L(sub 1) Adaptive Control Design for NASA AirSTAR Flight Test Vehicle

NASA Technical Reports Server (NTRS)

Gregory, Irene M.; Cao, Chengyu; Hovakimyan, Naira; Zou, Xiaotian

2009-01-01

In this paper we present a new L(sub 1) adaptive control architecture that directly compensates for matched as well as unmatched system uncertainty. To evaluate the L(sub 1) adaptive controller, we take advantage of the flexible research environment with rapid prototyping and testing of control laws in the Airborne Subscale Transport Aircraft Research system at the NASA Langley Research Center. We apply the L(sub 1) adaptive control laws to the subscale turbine powered Generic Transport Model. The presented results are from a full nonlinear simulation of the Generic Transport Model and some preliminary pilot evaluations of the L(sub 1) adaptive control law.

Viewpoint: observations on scaled average bioequivalence.

PubMed

Patterson, Scott D; Jones, Byron

2012-01-01

The two one-sided test procedure (TOST) has been used for average bioequivalence testing since 1992 and is required when marketing new formulations of an approved drug. TOST is known to require comparatively large numbers of subjects to demonstrate bioequivalence for highly variable drugs, defined as those drugs having intra-subject coefficients of variation greater than 30%. However, TOST has been shown to protect public health when multiple generic formulations enter the marketplace following patent expiration. Recently, scaled average bioequivalence (SABE) has been proposed as an alternative statistical analysis procedure for such products by multiple regulatory agencies. SABE testing requires that a three-period partial replicate cross-over or full replicate cross-over design be used. Following a brief summary of SABE analysis methods applied to existing data, we will consider three statistical ramifications of the proposed additional decision rules and the potential impact of implementation of scaled average bioequivalence in the marketplace using simulation. It is found that a constraint being applied is biased, that bias may also result from the common problem of missing data and that the SABE methods allow for much greater changes in exposure when generic-generic switching occurs in the marketplace. Copyright © 2011 John Wiley & Sons, Ltd.

Pressurization System Modeling for a Generic Bimese Two- Stage-to-Orbit Reusable Launch Vehicle

NASA Technical Reports Server (NTRS)

Mazurkivich, Pete; Chandler, Frank; Nguyen, Han

2005-01-01

A pressurization system model was developed for a generic bimese Two-Stage-to-orbit Reusable Launch Vehicle using a cross-feed system and operating with densified propellants. The model was based on the pressurization system model for a crossfeed subscale water test article and was validated with test data obtained from the test article. The model consists of the liquid oxygen and liquid hydrogen pressurization models, each made up of two submodels, Booster and Orbiter tank pressurization models. The tanks are controlled within a 0.2-psi band and pressurized on the ground with ambient helium and autogenously in flight with gaseous oxygen and gaseous hydrogen. A 15-psi pressure difference is maintained between the Booster and Orbiter tanks to ensure crossfeed check valve closure before Booster separation. The analysis uses an ascent trajectory generated for a generic bimese vehicle and a tank configuration based on the Space Shuttle External Tank. It determines the flow rates required to pressurize the tanks on the ground and in flight, and demonstrates the model's capability to analyze the pressurization system performance of a full-scale bimese vehicle with densified propellants.

Generic reclassification and species boundaries in the rediscovered freshwater mussel ‘Quadrula’ mitchelli (Simpson in Dall, 1896)

USGS Publications Warehouse

Pfeiffer, John M.; Johnson, Nathan A.; Randklev, Charles R.; Howells, Robert G.; Williams, James D.

2016-01-01

The Central Texas endemic freshwater mussel, Quadrula mitchelli (Simpson in Dall, 1896), had been presumed extinct until relict populations were recently rediscovered. To help guide ongoing and future conservation efforts focused on Q. mitchelli we set out to resolve several uncertainties regarding its evolutionary history, specifically its unknown generic position and untested species boundaries. We designed a molecular matrix consisting of two loci (cytochrome c oxidase subunit I and internal transcribed spacer I) and 57 terminal taxa to test the generic position of Q. mitchelli using Bayesian inference and maximum likelihood phylogenetic reconstruction. We also employed two Bayesian species validation methods to test five a priori species models (i.e. hypotheses of species delimitation). Our study is the first to test the generic position of Q.mitchelli and we found robust support for its inclusion in the genusFusconaia. Accordingly, we introduce the binomial, Fusconaia mitchelli comb. nov., to accurately represent the systematic position of the species. We resolved F. mitchelli individuals in two well supported and divergent clades that were generally distinguished as distinct species using Bayesian species validation methods, although alternative hypotheses of species delineation were also supported. Despite strong evidence of genetic isolation within F. mitchelli, we do not advocate for species-level status of the two clades as they are allopatrically distributed and no morphological, behavioral, or ecological characters are known to distinguish them. These results are discussed in the context of the systematics, distribution, and conservation ofF. mitchelli.

Performance degradation of a model helicopter rotor with a generic ice shape

NASA Technical Reports Server (NTRS)

Korkan, K. D.; Cross, E. J., Jr.; Miller, T. L.

1984-01-01

An experimental program using a commercially available remotely controlled model helicopter in the Texas A&M University (TAMU) subsonic wind tunnel has been conducted to investigate the performance degradation resulting from the simulated formation of ice on the leading edge of the main rotor blades in both hover and forward flight. The rotor blades utilized a NACA 0012 airfoil with a 2.5-in. constant chord. A generic ice shape derived from a predetermined natural ice condition was applied to the 53.375-in.-diameter main rotor, and thrust and torque coefficients were measured for the main rotor as functions of velocity, main rotor rpm, fuselage angle of incidence, collective pitch angle, and spanwise extent of icing. The model helicopter test exhibited significant performance degradation of the main rotor when generic ice was added. An increase of approximately 150 percent in torque coefficient to maintain a constant thrust coefficient was noted when generic ice had been applied to the 85 percent rotor radial location. Also, considerable additional degradation occurred when generic ice was applied to the 100 percent rotor radial location, as compared with the 85 percent simulated ice performance values, indicating the sensitivity of the rotor tip region.

Recognizing Severe Adverse Drug Reactions: Two Case Reports After Switching Therapies to the Same Generic Company.

PubMed

Gallelli, Luca; Gallelli, Giuseppe; Codamo, Giuseppe; Argentieri, Angela; Michniewicz, Andzelika; Siniscalchi, Antonio; Stefanelli, Roberta; Cione, Erika; Caroleo, Maria C; Longo, Paola; De Sarro, Giovambattista

2016-01-01

Generic formulations represent a way to reduce the costs of brand compounds when their patent is expired. While, the bio-equivalence in generic drugs is guaranteed, some excipients as well as dyes could be different and this could reduce the drug safety. Herein, we report the development of Adverse Drug Reactions (ADRs) in two patients after the switch from brand to generic formulations. We have tested cytochrome P450 enzymes expression as well as drug serum levels. None of these markers were altered. Checking deeply into both patient's medical history, they harbored poly-sensitivity or allergy to pollen and graminacea and used different active ingredients for different health problems coming from the same generic company Almus(®). This company used different dyes and excipients compared to the branded drugs made by distinguished companies. In conclusion, we strongly suggest to both pharmacists and physicians to be careful in giving the advice to change the drug, thinking to reduce health sanitary costs without considering the personal clinical history of each one. Paradoxically this behavior is causing other health issues, bringing to an increase of the overall costs for patients as well as for National Health System.

"Righting" the Writing Problem.

ERIC Educational Resources Information Center

Shaughnessy, Michael F.; Eastham, Nicholas

The problem of college students' writing skills or lack thereof is generally agreed upon in academia. One cause is the inordinate amount of multiple choice/true false/fill in the blank type of tests that students take in high school and college. Not only is there is a dearth of actual classes in writing available, few students recognize the need…

Interviewing Child Witnesses: The Effect of Forced Confabulation on Event Memory

ERIC Educational Resources Information Center

Stolzenberg, Stacia; Pezdek, Kathy

2013-01-01

Age differences in rates of forced confabulation and memory consequences thereof were assessed using a recall task similar to real forensic interview procedures. Children viewed a target video and were tested with the same 18 questions immediately afterward and 1 week later. Of the 18 questions, 12 were answerable; the 6 unanswerable questions…

19 CFR 10.91 - Prototypes used exclusively for product development and testing.

Code of Federal Regulations, 2014 CFR

2014-04-01

... prototypes or any part(s) of the prototypes may be sold as scrap, waste, or for recycling, as prescribed in..., or for recycling. This includes a prototype or any part thereof that is incorporated into another product, as scrap, waste, or recycled material. If sold as scrap, waste, or for recycling, applicable duty...

19 CFR 10.91 - Prototypes used exclusively for product development and testing.

Code of Federal Regulations, 2011 CFR

2011-04-01

... prototypes or any part(s) of the prototypes may be sold as scrap, waste, or for recycling, as prescribed in..., or for recycling. This includes a prototype or any part thereof that is incorporated into another product, as scrap, waste, or recycled material. If sold as scrap, waste, or for recycling, applicable duty...

19 CFR 10.91 - Prototypes used exclusively for product development and testing.

Code of Federal Regulations, 2010 CFR

2010-04-01

... prototypes or any part(s) of the prototypes may be sold as scrap, waste, or for recycling, as prescribed in..., or for recycling. This includes a prototype or any part thereof that is incorporated into another product, as scrap, waste, or recycled material. If sold as scrap, waste, or for recycling, applicable duty...

19 CFR 10.91 - Prototypes used exclusively for product development and testing.

Code of Federal Regulations, 2012 CFR

2012-04-01

... prototypes or any part(s) of the prototypes may be sold as scrap, waste, or for recycling, as prescribed in..., or for recycling. This includes a prototype or any part thereof that is incorporated into another product, as scrap, waste, or recycled material. If sold as scrap, waste, or for recycling, applicable duty...

19 CFR 10.91 - Prototypes used exclusively for product development and testing.

Code of Federal Regulations, 2013 CFR

2013-04-01

... prototypes or any part(s) of the prototypes may be sold as scrap, waste, or for recycling, as prescribed in..., or for recycling. This includes a prototype or any part thereof that is incorporated into another product, as scrap, waste, or recycled material. If sold as scrap, waste, or for recycling, applicable duty...

APA's Guidelines for Test User Qualifications: An Executive Summary.

ERIC Educational Resources Information Center

Turner, Samuel M.; DeMers, Stephen T.; Fox, Heather Roberts; Reed, Geoffrey M.

2001-01-01

Describes the American Psychological Association's (APA's) development of the Task Force on Test User Qualifications, explaining the APA's purpose in developing guidelines for the use of psychological tests. Highlights the historical background, the scope of the guidelines, generic knowledge and skills considered important for good test use, and…

77 FR 55217 - Submission for OMB Review; Comment Request: Cognitive Testing of Instrumentation and Materials...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-07

...; Comment Request: Cognitive Testing of Instrumentation and Materials for the Population Assessment of..., unless it displays a currently valid OMB control number. Proposed Collection: Title: Cognitive Testing of... Administration (FDA). NIDA is requesting generic approval from OMB for cognitive testing of the PATH study's...

Wind turbine with automatic pitch and yaw control

DOEpatents

Cheney, Jr., Marvin Chapin; Spierings, Petrus A. M.

1978-01-01

A wind turbine having a flexible central beam member supporting aerodynamic blades at opposite ends thereof and fabricated of uni-directional high tensile strength material bonded together into beam form so that the beam is lightweight, and has high tensile strength to carry the blade centrifugal loads, low shear modulus to permit torsional twisting thereof for turbine speed control purposes, and adequate bending stiffness to permit out-of-plane deflection thereof for turbine yard control purposes. A selectively off-set weighted pendulum member is pivotally connected to the turbine and connected to the beam or blade so as to cause torsional twisting thereof in response to centrifugal loading of the pendulum member for turbine speed control purposes.

Uses of monoclonal antibody 8H9

DOEpatents

Cheung, Nai-Kong V

2013-08-06

This invention provides a composition comprising an effective amount of monoclonal antibody 8H9 or a derivative thereof and a suitable carrier. This invention provides a pharmaceutical composition comprising an effective amount of monoclonal antibody 8H9 or a derivative thereof and a pharmaceutically acceptable carrier. This invention also provides an antibody other than the monoclonal antibody 8H9 comprising the complementary determining regions of monoclonal antibody 8H9 or a derivative thereof, capable of binding to the same antigen as the monoclonal antibody 8H9. This invention provides a substance capable of competitively inhibiting the binding of monoclonal antibody 8H9. This invention also provides an isolated scFv of monoclonal antibody 8H9 or a derivative thereof. This invention also provides the 8H9 antigen. This invention also provides a method of inhibiting the growth of tumor cells comprising contacting said tumor cells with an appropriate amount of monoclonal antibody 8H9 or a derivative thereof.

Uses of monoclonal antibody 8H9

DOEpatents

Cheung, Nai-Kong V.

2010-06-15

This invention provides a composition comprising an effective amount of monoclonal antibody 8H9 or a derivative thereof and a suitable carrier. This invention provides a pharmaceutical composition comprising an effective amount of monoclonal antibody 8H9 or a derivative thereof and a pharmaceutically acceptable carrier. This invention also provides an antibody other than the monoclonal antibody 8H9 comprising the complementary determining regions of monoclonal antibody 8H9 or a derivative thereof, capable of binding to the same antigen as the monoclonal antibody 8H9. This invention provides a substance capable of competitively inhibiting the binding of monoclonal antibody 8H9. This invention also provides an isolated scFv of monoclonal antibody 8H9 or a derivative thereof. This invention also provides the 8H9 antigen. This invention also provides a method of inhibiting the growth of tumor cells comprising contacting said tumor cells with an appropriate amount of monoclonal antibody 8H9 or a derivative thereof.

Uses of monoclonal antibody 8H9

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

Cheung, Nai-Kong V.

This invention provides a composition comprising an effective amount of monoclonal antibody 8H9 or a derivative thereof and a suitable carrier. This invention provides a pharmaceutical composition comprising an effective amount of monoclonal antibody 8H9 or a derivative thereof and a pharmaceutically acceptable carrier. This invention also provides an antibody other than the monoclonal antibody 8H9 comprising the complementary determining regions of monoclonal antibody 8H9 or a derivative thereof, capable of binding to the same antigen as the monoclonal antibody 8H9. This invention provides a substance capable of competitively inhibiting the binding of monoclonal antibody 8H9. This invention also providesmore » an isolated scFv of monoclonal antibody 8H9 or a derivative thereof. This invention also provides the 8H9 antigen. This invention also provides a method of inhibiting the growth of tumor cells comprising contacting said tumor cells with an appropriate amount of monoclonal antibody 8H9 or a derivative thereof.« less

Experiment of Enzyme Kinetics Using Guided Inquiry Model for Enhancing Generic Science Skills

NASA Astrophysics Data System (ADS)

Amida, N.; Supriyanti, F. M. T.; Liliasari

2017-02-01

This study aims to enhance generic science skills of students using guided inquiry model through experiments of enzyme kinetics. This study used quasi-experimental methods, with pretest-posttestnonequivalent control group design. Subjects of this study were chemistry students enrolled in biochemistry lab course, consisted of 18 students in experimental class and 19 students in control class. Instrument in this study were essay test that involves 5 indicators of generic science skills (i.e. direct observation, causality, symbolic language, mathematical modeling, and concepts formation) and also student worksheets. The results showed that the experiments of kinetics enzyme using guided inquiry model have been enhance generic science skills in high category with a value of average of 0.77. Four indicators classified in the high category are direct observation, causality, symbolic language, and mathematical modeling with the value of 0,73 0,70; 0,96; dan 0,85. Meanwhile, indicator of concepts formation in the medium category with a value of 0.62

Creating New Economic Incentives for Repurposing Generic Drugs for Unsolved Diseases Using Social Finance.

PubMed

Bloom, Bruce E

2015-12-01

Repurposing research improves patient lives by taking drugs approved for one disease and clinically testing them to create a treatment for a different disease. Repurposing drugs that are generic, inexpensive, and widely available and that can be taken in their current dosage and formulation in the new indication provide a quick, affordable, and effective way to create "new" treatments. However, generic drug repurposing often provides no profit potential, and so there is no economic incentive for industry to pursue this, and philanthropy and government funds are often insufficient. One way to create new economic incentive for the repurposing of generic drugs is through social finance. This perspective describes how social finance can create a new economic incentive by using a social impact bond, or similar financial structure, to repay for-profit investors who fund the repurposing research from the proceeds of healthcare cost reductions generated when these affordable, effective, and widely available repurposed therapies improve healthcare outcomes.

Generic Airplane Model Concept and Four Specific Models Developed for Use in Piloted Simulation Studies

NASA Technical Reports Server (NTRS)

Hoffler, Keith D.; Fears, Scott P.; Carzoo, Susan W.

1997-01-01

A generic airplane model concept was developed to allow configurations with various agility, performance, handling qualities, and pilot vehicle interface to be generated rapidly for piloted simulation studies. The simple concept allows stick shaping and various stick command types or modes to drive an airplane with both linear and nonlinear components. Output from the stick shaping goes to linear models or a series of linear models that can represent an entire flight envelope. The generic model also has provisions for control power limitations, a nonlinear feature. Therefore, departures from controlled flight are possible. Note that only loss of control is modeled, the generic airplane does not accurately model post departure phenomenon. The model concept is presented herein, along with four example airplanes. Agility was varied across the four example airplanes without altering specific excess energy or significantly altering handling qualities. A new feedback scheme to provide angle-of-attack cueing to the pilot, while using a pitch rate command system, was implemented and tested.

78 FR 45558 - Western Gulf of Mexico Planning Area (WPA) Outer Continental Shelf (OCS) Oil and Gas Lease Sale...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-29

... meters Initial period 0 to $25.00 per acre or fraction thereof for blocks in water depths less than 400 meters $100.00 per acre or fraction thereof for blocks in water depths of 400 meters or deeper BOEM will... specified minimum bid of $25.00 per acre or fraction thereof for blocks in water depths less than 400 meters...

Nonlinear Optical Acrylic Polymers and Use Thereof in Optical and Electro-Optic Devices

DTIC Science & Technology

1992-01-07

COVERED 4. TITLE AND SUBTITLE Nonlinear Optical Acrylic Polymers and Use Thereof in Optical and Electro - Optic Devices 5a. CONTRACT NUMBER 5b. GRANT...generators, computational devices and the like. 15. SUBJECT TERMS optical devices, electro - optical devices, optical signal processing...THEREOF IN OPTICAL AND ELECTRO - OPTIC DEVICES [75] Inventors: Le*lie H. Sperling, Bethlehem; Clarence J. Murphy, Stroudsburg; Warren A. Rosen

Water-soluble luminescent quantum dots and biomolecular conjugates thereof and related compositions and methods of use

DOEpatents

Nie, Shuming; Chan, Warren C. W.; Emory, Stephen

2007-03-20

The present invention provides a water-soluble luminescent quantum dot, a biomolecular conjugate thereof and a composition comprising such a quantum dot or conjugate. Additionally, the present invention provides a method of obtaining a luminescent quantum dot, a method of making a biomolecular conjugate thereof, and methods of using a biomolecular conjugate for ultrasensitive nonisotopic detection in vitro and in vivo.

Compounds, compositions, pharmaceutical compositions, and methods of use

DOEpatents

Hammond, Gerald B.; Jin, Zhuang; Bates, Paula J.; Reyes-Reyes, Elsa Merit

2016-11-15

Certain embodiments of the invention include compositions comprising a compound of Formula (I), and salts, isomers, and derivatives thereof. Pharmaceutical compositions of some embodiments of the present invention comprise a compound of Formula (I), and salts, isomers, and derivatives thereof. Other embodiments of this invention include methods for treating disease (e.g., cancer) and methods for administering a compound of Formula (I), and salts, isomers, and derivatives thereof.

Water-soluble luminescent quantum dots and biomolecular conjugates thereof and related compositions and method of use

DOEpatents

Nie, Shuming; Chan, Warren C. W.; Emory, Steven R.

2002-01-01

The present invention provides a water-soluble luminescent quantum dot, a biomolecular conjugate thereof and a composition comprising such a quantum dot or conjugate. Additionally, the present invention provides a method of obtaining a luminescent quantum dot, a method of making a biomolecular conjugate thereof, and methods of using a biomolecular conjugate for ultrasensitive nonisotopic detection in vitro and in vivo.

Composite construction for nuclear fuel containers

DOEpatents

Cheng, Bo-Ching [Fremont, CA; Rosenbaum, Herman S [Fremont, CA; Armijo, Joseph S [Saratoga, CA

1987-01-01

An improved method for producing nuclear fuel containers of a composite construction having components providing therein a barrier system for resisting destructive action by volatile fission products or impurities and also interdiffusion of metal constituents, and the product thereof. The composite nuclear fuel containers of the method comprise a casing of zirconium or alloy thereof with a layer of copper overlying an oxidized surface portion of the zirconium or alloy thereof.

The relationship between perceived stigma, disclosure patterns, support and distress in new attendees at an infertility clinic.

PubMed

Slade, P; O'Neill, C; Simpson, A J; Lashen, H

2007-08-01

A model suggesting that high perception of stigma is associated with reduced disclosure to others, leading to lower social support and higher distress in new attendees at an infertility clinic is tested. Questionnaires measuring stigmatization (Stigma consciousness questionnaire), disclosure of fertility difficulties (Disclosure questionnaire), social support (Duke-UNC Functional Social Support Questionnaire) and fertility-related [Fertility Problem Inventory (FPI)] and generic distress [Hospital Anxiety and Depression Scale (HADS)] were completed by 87 women and 64 men. Data were analysed by gender comparisons, correlations and path analysis. Women reported higher stigma and disclosure than men. For women, stigma and disclosure were unrelated but in men higher stigma was associated with lower disclosure. Perceptions of stigma were related to low social support for both genders. Social support was negatively related to anxiety, depression and overall infertility distress and showed greater predictive capacity than satisfaction with partner relationship. Testing the model showed that, for men, stigma was linked to lower disclosure and support and higher fertility-related and generic distress. Disclosure itself did not link to support. For women, greater disclosure linked only to higher generic distress. Stigma was directly linked to fertility-related distress and to low perceived support which mediated a relationship with generic distress. Stigma and the wider social context should be considered when supporting people with fertility problems. Greater disclosure may be associated with higher distress in women.

Key Technical Aspects Influencing the Accuracy of Tablet Subdivision.

PubMed

Teixeira, Maíra T; Sá-Barreto, Lívia C L; Gratieri, Taís; Gelfuso, Guilherme M; Silva, Izabel C R; Cunha-Filho, Marcílio S S

2017-05-01

Tablet subdivision is a common practice used mainly for dose adjustment. The aim of this study was to investigate how the technical aspects of production as well as the method of tablets subdivision (employing a tablet splitter or a kitchen knife) influence the accuracy of this practice. Five drugs commonly used as subdivided tablets were selected. For each drug, the innovator drug product, a scored-generic and a non-scored generic were investigated totalizing fifteen drug products. Mechanical and physical tests, including image analysis, were performed. Additionally, comparisons were made between tablet subdivision method, score, shape, diluent composition and coating. Image analysis based on surface area was a useful tool as an alternative assay to evaluate the accuracy of tablet subdivision. The tablet splitter demonstrates an advantage relative to a knife as it showed better results in weight loss and friability tests. Oblong, coated and scored tablets had better results after subdivision than round, uncoated and non-scored tablets. The presence of elastic diluents such as starch and dibasic phosphate dehydrate conferred a more appropriate behaviour for the subdivision process than plastic materials such as microcrystalline cellulose and lactose. Finally, differences were observed between generics and their innovator products in all selected drugs with regard the quality control assays in divided tablet, which highlights the necessity of health regulations to consider subdivision performance at least in marketing authorization of generic products.

A generic method for evaluating crowding in the emergency department.

PubMed

Eiset, Andreas Halgreen; Erlandsen, Mogens; Møllekær, Anders Brøns; Mackenhauer, Julie; Kirkegaard, Hans

2016-06-14

Crowding in the emergency department (ED) has been studied intensively using complicated non-generic methods that may prove difficult to implement in a clinical setting. This study sought to develop a generic method to describe and analyse crowding from measurements readily available in the ED and to test the developed method empirically in a clinical setting. We conceptualised a model with ED patient flow divided into separate queues identified by timestamps for predetermined events. With temporal resolution of 30 min, queue lengths were computed as Q(t + 1) = Q(t) + A(t) - D(t), with A(t) = number of arrivals, D(t) = number of departures and t = time interval. Maximum queue lengths for each shift of each day were found and risks of crowding computed. All tests were performed using non-parametric methods. The method was applied in the ED of Aarhus University Hospital, Denmark utilising an open cohort design with prospectively collected data from a one-year observation period. By employing the timestamps already assigned to the patients while in the ED, a generic queuing model can be computed from which crowding can be described and analysed in detail. Depending on availability of data, the model can be extended to include several queues increasing the level of information. When applying the method empirically, 41,693 patients were included. The studied ED had a high risk of bed occupancy rising above 100 % during day and evening shift, especially on weekdays. Further, a 'carry over' effect was shown between shifts and days. The presented method offers an easy and generic way to get detailed insight into the dynamics of crowding in an ED.

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.

Investigation of Reynolds Number Effects on a Generic Fighter Configuration in the National Transonic Facility

NASA Technical Reports Server (NTRS)

Tomek, W. G.; Hall, R. M.; Wahls, R. A.; Luckring, J. M.; Owens, L. R.

2002-01-01

A wind tunnel test of a generic fighter configuration was tested in the National Transonic Facility through a cooperative agreement between NASA Langley Research Center and McDonnell Douglas. The primary purpose of the test was to assess Reynolds number scale effects on a thin-wing, fighter-type configuration up to full-scale flight conditions (that is, Reynolds numbers of the order of 60 million). The test included longitudinal and lateral/directional studies at subsonic and transonic conditions across a range of Reynolds numbers from that available in conventional wind tunnels to flight conditions. Results are presented for three Mach numbers (0.6, 0.8, and 0.9) and three configurations: (1) Fuselage/Wing; (2) Fuselage/Wing/Centerline Vertical Tail/Horizontal Tail; and (3) Fuselage/Wing/Trailing-Edge Extension/Twin Vertical Tails. Reynolds number effects on the longitudinal aerodynamic characteristics are presented herein.

Critical outlook and trends for environmental reference materials at the Measurements & Testing Generic Activity (European Commission).

PubMed

Quevauviller, P; Bennink, D; Bøwadt, S

2001-05-01

It is now well recognised that the quality control (QC) of all types of analyses, including environmental analyses depends on the appropriate use of reference materials. One of the ways to check the accuracy of methods is based on the use of Certified Reference Materials (CRMs), whereas other types of (not certified) Reference Materials (RMs) are used for routine quality control (establishment of control charts) and interlaboratory testing (e.g. proficiency testing). The perception of these materials, in particular with respect to their production and use, differs widely according to various perspectives (e.g. RM producers, routine laboratories, researchers). This review discusses some critical aspects of RM use and production for the QC of environmental analyses and describes the new approach followed by the Measurements & Testing Generic Activity (European Commission) to tackle new research and production needs.

Low-speed static and dynamic force tests of a generic supersonic cruise fighter configuration

NASA Technical Reports Server (NTRS)

Hahne, David E.

1989-01-01

Static and dynamic force tests of a generic fighter configuration designed for sustained supersonic flight were conducted in the Langley 30- by 60-foot tunnel. The baseline configuration had a 65 deg arrow wing, twin wing mounted vertical tails and a canard. Results showed that control was available up to C sub L,max (maximum lift coefficient) from aerodynamic controls about all axes but control in the pitch and yaw axes decreased rapidly in the post-stall angle-of-attack region. The baseline configuration showed stable lateral-directional characteristics at low angles of attack but directional stability occurred near alpha = 25 deg as the wing shielded the vertical tails. The configuration showed positive effective dihedral throughout the test angle-of-attack range. Forced oscillation tests indicated that the baseline configuration had stable damping characteristics about the lateral-directional axes.

Passenger comfort during terminal-area flight maneuvers. M.S. Thesis.

NASA Technical Reports Server (NTRS)

Schoonover, W. E., Jr.

1976-01-01

A series of flight experiments was conducted to obtain passenger subjective responses to closely controlled and repeatable flight maneuvers. In 8 test flights, reactions were obtained from 30 passenger subjects to a wide range of terminal-area maneuvers, including descents, turns, decelerations, and combinations thereof. Analysis of the passenger rating variance indicated that the objective of a repeatable flight passenger environment was achieved. Multiple linear regression models developed from the test data were used to define maneuver motion boundaries for specified degrees of passenger acceptance.

Device for testing closure disks at high rates of change of pressure

DOEpatents

Merten, Jr., Charles W.

1993-11-09

A device for testing the burst pressure of closure disks which provides high pressure to both sides of a disk and rapidly releases pressure from one side thereof causing a high rate of change of pressure. A hollow notched plug allows the rapid release of pressure upon rupturing. A means is also disclosed for transmitting a tensile load from a piston to a hollow notched plug and for sealing the means for transmitting load within a hole in a piston.

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.

Composite construction for nuclear fuel containers

DOEpatents

Cheng, B. C.; Rosenbaum, H. S.; Armijo, J. S.

1987-04-21

Disclosed is an improved method for producing nuclear fuel containers of a composite construction having components providing therein a barrier system for resisting destructive action by volatile fission products or impurities and also interdiffusion of metal constituents, and the product thereof. The composite nuclear fuel containers of the method comprise a casing of zirconium or alloy thereof with a layer of copper overlying an oxidized surface portion of the zirconium or alloy thereof. 1 fig.

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

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.

Reliability and validity of the PedsQL™ Generic Core Scales 4.0 for Chinese children with epilepsy.

PubMed

Duan, Xiaoling; Zhang, Shuqing; Xiao, Nong

2012-04-01

This investigation examines the reliability and validity of the Chinese version of the PedsQL 4.0 Generic Core Scales for prognostic measures of pediatric epilepsy. The study comprised 163 parents whose children, between the ages of 2 and 18 years, were diagnosed with epilepsy. The parents were given a questionnaire to be completed on behalf of the child. Reliability was assessed by Cronbach's alpha analysis. Validity was assessed by the exploratory factor analysis and intercorrelation analysis between the four subscales as well as Student's t-test. The internal consistency reliability for Total Scale Score was 0.94 by Cronbach's alpha test. Four major factors were extracted by factor analysis. The scores from all sub-scales derived from healthy children were significantly higher than children with epilepsy (P<0.001). The reliability and validity of the parent proxy-report scales from the Chinese version of the PedsQL™ 4.0 Generic Core Scales effectively matched the original version and could be used to evaluate the health-related quality of life of children with epilepsy. Copyright © 2012 Elsevier Inc. All rights reserved.

Antibacterial Effect of Cysteine-Nitrosothiol and Possible Percursors Thereof

PubMed Central

Incze, K.; Farkas, J.; Mihályi, Vilma; Zukál, E.

1974-01-01

The postulated intermediate of nitrite-myoglobin reaction, cysteine-nitrosothiol, was prepared and its antibacterial effect was tested on Salmonella strains, Streptococcus faecium, and spores and vegetative cells of Clostridium sporogenes. Cysteine-nitrosothiol showed a higher inhibitory effect than nitrite. Preliminary results on the effect of simultaneous use of nitrite and cysteine on Clostridium sporogenes spores were also presented. PMID:4589130

Driver compliance to take-over requests with different auditory outputs in conditional automation.

PubMed

Forster, Yannick; Naujoks, Frederik; Neukum, Alexandra; Huestegge, Lynn

2017-12-01

Conditionally automated driving (CAD) systems are expected to improve traffic safety. Whenever the CAD system exceeds its limit of operation, designers of the system need to ensure a safe and timely enough transition from automated to manual mode. An existing visual Human-Machine Interface (HMI) was supplemented by different auditory outputs. The present work compares the effects of different auditory outputs in form of (1) a generic warning tone and (2) additional semantic speech output on driver behavior for the announcement of an upcoming take-over request (TOR). We expect the information carried by means of speech output to lead to faster reactions and better subjective evaluations by the drivers compared to generic auditory output. To test this assumption, N=17 drivers completed two simulator drives, once with a generic warning tone ('Generic') and once with additional speech output ('Speech+generic'), while they were working on a non-driving related task (NDRT; i.e., reading a magazine). Each drive incorporated one transition from automated to manual mode when yellow secondary lanes emerged. Different reaction time measures, relevant for the take-over process, were assessed. Furthermore, drivers evaluated the complete HMI regarding usefulness, ease of use and perceived visual workload just after experiencing the take-over. They gave comparative ratings on usability and acceptance at the end of the experiment. Results revealed that reaction times, reflecting information processing time (i.e., hands on the steering wheel, termination of NDRT), were shorter for 'Speech+generic' compared to 'Generic' while reaction time, reflecting allocation of attention (i.e., first glance ahead), did not show this difference. Subjective ratings were in favor of the system with additional speech output. Copyright © 2017 Elsevier Ltd. All rights reserved.

Comparing recurrent antibiotic prescriptions in children treated with a brand name or a generic formulation.

PubMed

Piovani, Daniele; Clavenna, Antonio; Cartabia, Massimo; Bortolotti, Angela; Fortino, Ida; Merlino, Luca; Bonati, Maurizio

2015-02-01

The aim of this study was to investigate the rate of recurrent prescriptions and hospital admissions in children receiving a brand name or generic antibiotic prescription. The data source was a database of reimbursed prescriptions. Outpatient children/adolescents <18 years old (Lombardy Region, Italy) were included. The observational period was February-April 2010. A recurrence was defined as an antibiotic prescription occurring within 28 days after an index prescription. The rate of recurrent prescriptions and hospital admissions was calculated for generic/brand name formulations and for each age strata (0-5, 6-11, and 12-17 years old) for four antibiotics: amoxicillin, amoxicillin clavulanate, clarithromycin, and cefaclor. The percentage of therapy switches was calculated. Cochran-Mantel-Haenszel test was used to compare the age-adjusted outcomes. In all, 17.5% (57 346) of children received at least one recurrent prescription. The rate of recurrent prescriptions was slightly lower in children receiving any generic (OR 0.96; 95%CI 0.93-0.98), compared with any brand name, antibiotic. The percentage of hospital admissions occurring in children initially treated with a brand name (1.01%; 95%CI 0.98-1.08) or generic (1.03%; 0.96-1.06) antibiotic was not different (p = 0.43). For children receiving amoxicillin clavulanate, the hospital admission rate was slightly higher in the brand name group (p = 0.002), while no differences were found for the other active substances. Children treated with generic antibiotics had no worse safety and effectiveness outcomes when compared with those receiving brand name ones. These results provide additional evidence on the safety of generic antibiotics. Copyright © 2014 John Wiley & Sons, Ltd.

Can genetic risk information for age-related macular degeneration influence motivation to stop smoking? A pilot study

PubMed Central

Rennie, C A; Stinge, A; King, E A; Sothirachagan, S; Osmond, C; Lotery, A J

2012-01-01

Aims Smoking can increase the risk of macular degeneration and this is more than additive if a person also has a genetic risk. The purpose of this study was to examine whether knowledge of genetic risk for age-related macular degeneration (AMD) could influence motivation to quit smoking. Methods A questionnaire-based study of hypothetical case scenarios given to 49 smokers without AMD. Participants were randomly allocated to a generic risk, high genetic risk, or low genetic risk of developing AMD scenario. Results Forty-seven percent knew of the link between smoking and eye disease. In all, 76%, 67%, and 46% for the high risk, generic, and low risk groups, respectively, would rethink quitting (Pfor trend=0.082). In all, 67%, 40%, and 38.5%, respectively, would be likely, very likely, or would definitely quit in the following month (Pfor trend=0.023). Few participants (<16% of any group) were very likely to or would definitely attend a quit smoking session with no difference across groups. In all, 75.5% of participants would consider taking a genetic test for AMD. Conclusion In this pilot study, a trend was seen for the group given high genetic risk information to be more likely to quit than the generic or low genetic risk groups. Participants were willing to take a genetic test but further work is needed to address the cost benefits of routine genetic testing for risk of AMD. More generic risk information should be given to the public, and health warnings on cigarette packets that ‘smoking causes blindness' is a good way to achieve this. PMID:22037055

Descriptive Model of Generic WAMS

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

Hauer, John F.; DeSteese, John G.

The Department of Energy’s (DOE) Transmission Reliability Program is supporting the research, deployment, and demonstration of various wide area measurement system (WAMS) technologies to enhance the reliability of the Nation’s electrical power grid. Pacific Northwest National Laboratory (PNNL) was tasked by the DOE National SCADA Test Bed Program to conduct a study of WAMS security. This report represents achievement of the milestone to develop a generic WAMS model description that will provide a basis for the security analysis planned in the next phase of this study.

Composite structural materials

NASA Technical Reports Server (NTRS)

Loewy, R.; Wiberley, S. E.

1986-01-01

Overall emphasis is on basic long-term research in the following categories: constituent materials, composite materials, generic structural elements, processing science technology; and maintaining long-term structural integrity. Research in basic composition, characteristics, and processing science of composite materials and their constituents is balanced against the mechanics, conceptual design, fabrication, and testing of generic structural elements typical of aerospace vehicles so as to encourage the discovery of unusual solutions to present and future problems. Detailed descriptions of the progress achieved in the various component parts of this comprehensive program are presented.

The Generic Resolution Advisor and Conflict Evaluator (GRACE) for Unmanned Aircraft Detect-And-Avoid Systems

NASA Technical Reports Server (NTRS)

Abramson, Michael; Refai, Mohamad; Santiago, Confesor

2017-01-01

The paper describes the Generic Resolution Advisor and Conflict Evaluator (GRACE), a novel alerting and guidance algorithm that combines flexibility, robustness, and computational efficiency. GRACE is generic since it was designed without any assumptions regarding temporal or spatial scales, aircraft performance, or its sensor and communication systems. Therefore, GRACE was adopted as a core component of the Java Architecture for Detect-And-Avoid (DAA) Extensibility and Modeling, developed by NASA as a research and modeling tool for Unmanned Aerial Systems Integration in the National Airspace System (NAS). GRACE has been used in a number of real-time and fast-time experiments supporting evolving requirements of DAA research, including parametric studies, NAS-wide simulations, human-in-the-loop experiments, and live flight tests.

Generic icing effects on forward flight performance of a model helicopter rotor

NASA Technical Reports Server (NTRS)

Tinetti, Ana F.; Korkan, Kenneth D.

1989-01-01

An experimental program using a commercially available model helicopter has been conducted in the TAMU 7 ft x 10 ft Subsonic Wind Tunnel to investigate main rotor performance degradation due to generic ice adhesion. Base and iced performance data were gathered as functions of fuselage incidence, blade collective pitch, main rotor rotational velocity, and freestream velocity. The experimental values have shown that, in general, the presence of generic ice introduces decrements in performance caused by leading edge separation regions and increased surface roughness. In addition to the expected changes in aerodynamic forces caused by variations in test Reynolds number, forward flight data seemed to be influenced by changes in freestream and rotational velocity. The dependence of the data upon such velocity variations was apparently enhanced by increases in blade chord.

Thermal fluctuations of dark matter in bouncing cosmology

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

Li, Changhong, E-mail: changhongli@ynu.edu.cn

We investigate the statistical nature of the dark matter particles produced in bouncing cosmology, especially, the evolution of its thermal fluctuations. By explicitly deriving and solving the equation of motion of super-horizon mode, we fully determine the evolution of thermal perturbation of dark matter in a generic bouncing background. And we also show that the evolution of super-horizon modes is stable and will not ruin the background evolution of a generic bouncing universe till the Planck scale. Given no super-horizon thermal perturbation of dark matter appears in standard inflation scenario such as WIMP(-less) miracles, such super-horizon thermal perturbation of darkmore » matter generated during the generic bouncing universe scenario may be significant for testing and distinguishing these two scenario in near future.« less

Heat flux limiting sleeves

DOEpatents

Harris, William G.

1985-01-01

A heat limiting tubular sleeve extending over only a portion of a tube having a generally uniform outside diameter, the sleeve being open on both ends, having one end thereof larger in diameter than the other end thereof and having a wall thickness which decreases in the same direction as the diameter of the sleeve decreases so that the heat transfer through the sleeve and tube is less adjacent the large diameter end of the sleeve than adjacent the other end thereof.

Best Practices: Power Quality and Integrated Testing at JSC

NASA Technical Reports Server (NTRS)

Davis, Lydia

2018-01-01

This presentation discusses Best Practices for Power Quality and Integrated Testing at JSC in regards to electrical systems. These high-level charts include mostly generic information; however, a specific issue is discussed involving flight hardware that could have been discovered prior to flight with an integrated test.

Artificial intelligence in a mission operations and satellite test environment

NASA Technical Reports Server (NTRS)

Busse, Carl

1988-01-01

A Generic Mission Operations System using Expert System technology to demonstrate the potential of Artificial Intelligence (AI) automated monitor and control functions in a Mission Operations and Satellite Test environment will be developed at the National Aeronautics and Space Administration (NASA) Jet Propulsion Laboratory (JPL). Expert system techniques in a real time operation environment are being studied and applied to science and engineering data processing. Advanced decommutation schemes and intelligent display technology will be examined to develop imaginative improvements in rapid interpretation and distribution of information. The Generic Payload Operations Control Center (GPOCC) will demonstrate improved data handling accuracy, flexibility, and responsiveness in a complex mission environment. The ultimate goal is to automate repetitious mission operations, instrument, and satellite test functions by the applications of expert system technology and artificial intelligence resources and to enhance the level of man-machine sophistication.

Preharvest quarantine treatments of chlorantraniliprole, clothianidin, and imidacloprid-based insecticides for control of Japanese beetle (Coleoptera: Scarabaeidae) and other scarab larvae in the root zone of field-grown nursery trees.

PubMed

Oliver, Jason B; Ranger, Christopher M; Reding, Michael E; Moyseenko, James J; Youssef, Nadeer N; Bray, Alicia M

2013-06-01

Japanese beetle, Popillia japonica Newman (Coleoptera: Scarabaeidae), is an important quarantine pest of nurseries. Nursery plant movement from P. japonica-infested regions is regulated by the U.S. Domestic Japanese Beetle Harmonization Plan (DJHP), which classifies states by risk categories. Treatments for category 2 states include preharvest soil surface treatment of nursery plants grown in field soil using Discus SC, Marathon (1G or 60 WP), or Flagship (0.22G or 25 WG). In this study, Discus, Marathon 60 WP, or Flagship 0.22G DJHP standards were compared with labeled rates of non-DJHP-approved insecticides, including neonicotinoids clothianidin (Arena 50WDG), generic imidacloprid (Quali-Pro Imidacloprid 2 F T&O Insecticide, Mallet 2 F T&O Insecticide, and Lada 2 F Insecticide), and imidacloprid + bifenthrin (Allectus SC), as well as the anthranilic diamide, chlorantraniliprole (Acelepryn Insecticide). Arena provided 100% P. japonica control in May, June, and July over four test years, but had one larva recovered during August in two of those 4 yr. Acelepryn did not provide DJHP-acceptable P. japonica control. During July, Allectus provided 100% P. japonica control in three of four test years, but had four larvae in one test year. Other treatments tested only during July, which provided 100% P. japonica control, included Discus (five tests); Marathon, Quali-Pro, and Mallet (two tests); and Lada and Flagship (one test). Generic imidacloprid 2 F formulations were equivalent in P. japonica control to DJHP-approved insecticides. Insecticides generally performed poorly on other scarabs or curculionid larvae. The study supports Arena, Allectus, and generic imidacloprid 2 F products as suitable candidates for the DJHP.

CMC thermal protection system for future reusable launch vehicles: Generic shingle technological maturation and tests

NASA Astrophysics Data System (ADS)

Pichon, T.; Barreteau, R.; Soyris, P.; Foucault, A.; Parenteau, J. M.; Prel, Y.; Guedron, S.

2009-07-01

Experimental re-entry demonstrators are currently being developed in Europe, with the objective of increasing the technology readiness level (TRL) of technologies applicable to future reusable launch vehicles. Among these are the Pre-X programme, currently funded by CNES, the French Space Agency, and which is about to enter into development phase B, and the IXV, within the future launcher preparatory programme (FLPP) funded by ESA. One of the major technologies necessary for such vehicles is the thermal protection system (TPS), and in particular the ceramic matrix composites (CMC) based windward TPS. In support of this goal, technology maturation activities named "generic shingle" were initiated beginning of 2003 by SPS, under a CNES contract, with the objective of performing a test campaign of a complete shingle of generic design, in preparation of the development of a re-entry experimental vehicle decided in Europe. The activities performed to date include: the design, manufacturing of two C/SiC panels, finite element model (FEM) calculation of the design, testing of technological samples extracted from a dedicated panel, mechanical pressure testing of a panel, and a complete study of the attachment system. Additional testing is currently under preparation on the panel equipped with its insulation, seal, attachment device, and representative portion of cold structure, to further assess its behaviour in environments relevant to its application The paper will present the activities that will have been performed in 2006 on the prediction and preparation of these modal characterization, dynamic, acoustic as well as thermal and thermo-mechanical tests. Results of these tests will be presented and the lessons learned will be discussed.

Predicting of biomass in Brazilian tropical dry forest: a statistical evaluation of generic equations.

PubMed

Lima, Robson B DE; Alves, Francisco T; Oliveira, Cinthia P DE; Silva, José A A DA; Ferreira, Rinaldo L C

2017-01-01

Dry tropical forests are a key component in the global carbon cycle and their biomass estimates depend almost exclusively of fitted equations for multi-species or individual species data. Therefore, a systematic evaluation of statistical models through validation of estimates of aboveground biomass stocks is justifiable. In this study was analyzed the capacity of generic and specific equations obtained from different locations in Mexico and Brazil, to estimate aboveground biomass at multi-species levels and for four different species. Generic equations developed in Mexico and Brazil performed better in estimating tree biomass for multi-species data. For Poincianella bracteosa and Mimosa ophthalmocentra, only the Sampaio and Silva (2005) generic equation was the most recommended. These equations indicate lower tendency and lower bias, and biomass estimates for these equations are similar. For the species Mimosa tenuiflora, Aspidosperma pyrifolium and for the genus Croton the specific regional equations are more recommended, although the generic equation of Sampaio and Silva (2005) is not discarded for biomass estimates. Models considering gender, families, successional groups, climatic variables and wood specific gravity should be adjusted, tested and the resulting equations should be validated at both local and regional levels as well as on the scales of tropics with dry forest dominance.

Design and rationale for the WARFA trial: a randomized controlled cross-over trial testing the therapeutic equivalence of branded and generic warfarin in atrial fibrillation patients in Brazil.

PubMed

Freitas, Carolina Gomes; Walsh, Michael; Atallah, Álvaro Nagib

2017-06-07

Warfarin is a commonly used anticoagulant. Whether a given dose of the different formulations of Brazilian warfarin will result in the same effect on the international normalized ratio (INR) is uncertain. The aim of the WARFA trial is to determine whether the branded and two generic warfarins available in Brazil differ in their effect on the INR. WARFA is a cross-over RCT comparing three warfarins. The formulations tested are the branded Marevan® (Uniao Quimica/Farmoquimica) and two generic warfarin (manufactured respectively by Uniao Quimica Farmaceutica Nacional and Laboratorio Teuto Brasileiro). All of them were manufactured in Brazil, are available in all settings of the Brazilian healthcare system and were purchased from retail drugstores. Eligible participants had atrial fibrillation or flutter, had been using warfarin for at least 2 months with a therapeutic range of 2.0-3.0 and had low variability in INR results during the 1st period of the trial. Our primary outcome, for which we have an equality hypothesis, is the difference between warfarins in the mean absolute difference between two INR results, obtained after three and 4 weeks with each drug. Our secondary outcomes, that will be tested for inequality (except for the mean INR, which will be tested for equality), include the difference in the warfarin dose, and time in therapeutic range. Clinical events and adherence were also recorded and will be reported. To our knowledge, WARFA will be the first comparison of the more readily applicable INR results between branded and generic warfarins in Brazil. WARFA is important because warfarins are commonly switched between in the course of a chronic treatment in Brazil. Final results of WARFA are expected in May 2017. ClinicalTrials.gov NCT02017197 . Registered 11 December 2013.

Generic atorvastatin is as effective as the brand-name drug (LIPITOR®) in lowering cholesterol levels: a cross-sectional retrospective cohort study.

PubMed

Loch, Alexander; Bewersdorf, Jan Philipp; Kofink, Daniel; Ismail, Dzafir; Abidin, Imran Zainal; Veriah, Ramesh Singh

2017-07-17

In a world of ever increasing health care costs, generic drugs represent a major opportunity to ensure access to essential medicines for people who otherwise would be unable to afford them. However, some clinicians and patients are still questioning the safety and effectiveness of generic formulations compared to the proprietary drugs necessitating further systematic research analyzing the generic drugs' efficacy. Our objective was to compare the lipid lowering effects of generic and branded atorvastatin. This cross-sectional, retrospective cohort study was conducted at the University of Malaya Medical Centre from 1 May 2013 until 30 May 2013. We analyzed the lipid profiles (total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides) of 629 patients before and at least 3 months after switching them from proprietary atorvastatin (Lipitor ® ) to generic atorvastatin (atorvastatin calcium from Ranbaxy Laboratories, Inc.). We also investigated if there was any difference in the effectiveness of both atorvastatin formulations in various ethnic groups. 266 patients were included in this study. When comparing the median values we found no statistically significant differences (Wilcoxon signed-rank test; p < 0.05) between proprietary and generic atorvastatin in lowering total cholesterol (4.60 mmol/l pre-transition vs. 4.50 mmol/l post-transition; p = 0.583), LDL-cholesterol (2.42 mmol/l vs. 2.41 mmol/l; p = 0.923) and triglycerides (1.50 mmol/l vs. 1.50 mmol/l; p = 0.513). While there was a statistically significant (p = 0.009) difference in HDL-cholesterol levels favouring proprietary atorvastatin, the extent of this change (1.26 mmol/l vs. 1.25 mmol/l) was deemed not to be clinically relevant. There was no statistically significant difference when analyzing the effects on various ethnic groups. Substituting proprietary atorvastatin for its generic formulation atorvastatin calcium does not result in a less effective management of hyperlipidemia. Our findings lend support to the approach of lowering health care costs by switching patients from branded drugs to their less expensive generic analogues.

The replacement of dry heat in generic reliability assurance requirements for passive optical components

NASA Astrophysics Data System (ADS)

Ren, Xusheng; Qian, Longsheng; Zhang, Guiyan

2005-12-01

According to Generic Reliability Assurance Requirements for Passive Optical Components GR-1221-CORE (Issue 2, January 1999), reliability determination test of different kinds of passive optical components which using in uncontrolled environments is taken. The test condition of High Temperature Storage Test (Dry Test) and Damp Test is in below sheet. Except for humidity condition, all is same. In order to save test time and cost, after a sires of contrast tests, the replacement of Dry Heat is discussed. Controlling the Failure mechanism of dry heat and damp heat of passive optical components, the contrast test of dry heat and damp heat for passive optical components (include DWDM, CWDM, Coupler, Isolator, mini Isolator) is taken. The test result of isolator is listed. Telcordia test not only test the reliability of the passive optical components, but also test the patience of the experimenter. The cost of Telcordia test in money, manpower and material resources, especially in time is heavy burden for the company. After a series of tests, we can find that Damp heat could factually test the reliability of passive optical components, and equipment manufacturer in accord with component manufacture could omit the dry heat test if damp heat test is taken first and passed.

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

Devices and methods of operation thereof for providing stable flow for centrifugal compressors

NASA Technical Reports Server (NTRS)

Skoch, Gary J. (Inventor); Stevens, Mark A. (Inventor); Jett, Thomas A. (Inventor)

2008-01-01

Centrifugal compressor flow stabilizing devices and methods of operation thereof are disclosed that act upon the flow field discharging from the impeller of a centrifugal compressor and modify the flow field ahead of the diffuser vanes such that flow conditions contributing to rotating stall and surge are reduced or even eliminated. In some embodiments, shaped rods and methods of operation thereof are disclosed, whereas in other embodiments reverse-tangent air injection devices and methods are disclosed.

Host cells and methods for producing 1-deoxyxylulose 5-phosphate (DXP) and/or a DXP derived compound

DOEpatents

Kirby, James; Fortman, Jeffrey L.; Nishimoto, Minobu; Keasling, Jay D.

2017-05-02

The present invention provides for a genetically modified host cell capable of producing 1-deoxyxylulose 5-phosphate or 1-deoxy-D-xylulose 5-phosphate (DXP) (12), and optionally one or more DXP derived compounds, comprising: (a) a mutant RibB, or functional variant thereof, capable of catalyzing xylulose 5-phoshpate and/or ribulose 5-phospate to DXP, or (b) a YajO, or functional variant thereof, and a XylB, or functional variant thereof.

Host cells and methods for producing 1-deoxyxylulose 5-phosphate (DXP) and/or a DXP derived compound

DOEpatents

Kirby, James; Fortman, Jeffrey L.; Nishimoto, Minobu; Keasling, Jay D.

2016-07-05

The present invention provides for a genetically modified host cell capable of producing 1-deoxyxylulose 5-phosphate or 1-deoxy-D-xylulose 5-phosphate (DXP) (12), and optionally one or more DXP derived compounds, comprising: (a) a mutant RibB, or functional variant thereof, capable of catalyzing xylulose 5-phosphate and/or ribulose 5-phosphate to DXP, or (b) a YajO, or functional variant thereof, and a XylB, or functional variant thereof.

Switchgrass ubiquitin promoter (PVUBI2) and uses thereof

DOEpatents

Stewart, C. Neal; Mann, David George James

2013-12-10

The subject application provides polynucleotides, compositions thereof and methods for regulating gene expression in a plant. Polynucleotides disclosed herein comprise novel sequences for a promoter isolated from Panicum virgatum (switchgrass) that initiates transcription of an operably linked nucleotide sequence. Thus, various embodiments of the invention comprise the nucleotide sequence of SEQ ID NO: 2 or fragments thereof comprising nucleotides 1 to 692 of SEQ ID NO: 2 that are capable of driving the expression of an operably linked nucleic acid sequence.

7 CFR 301.52-5 - Compliance agreements; and cancellation thereof.

Code of Federal Regulations, 2010 CFR

2010-01-01

... PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE DOMESTIC QUARANTINE NOTICES Pink Bollworm Quarantine and Regulations § 301.52-5 Compliance agreements; and cancellation thereof. (a) Any person engaged...

7 CFR 301.52-5 - Compliance agreements; and cancellation thereof.

Code of Federal Regulations, 2012 CFR

2012-01-01

... PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE DOMESTIC QUARANTINE NOTICES Pink Bollworm Quarantine and Regulations § 301.52-5 Compliance agreements; and cancellation thereof. (a) Any person engaged...

50 CFR 14.24 - Scientific specimens.

Code of Federal Regulations, 2011 CFR

2011-10-01

... or 23 of this subchapter, dead, preserved, dried, or embedded scientific specimens or parts thereof... international mail system. Provided, that this exception will not apply to any specimens or parts thereof taken...

50 CFR 14.24 - Scientific specimens.

Code of Federal Regulations, 2012 CFR

2012-10-01

... or 23 of this subchapter, dead, preserved, dried, or embedded scientific specimens or parts thereof... international mail system. Provided, that this exception will not apply to any specimens or parts thereof taken...

50 CFR 14.24 - Scientific specimens.

Code of Federal Regulations, 2013 CFR

2013-10-01

... or 23 of this subchapter, dead, preserved, dried, or embedded scientific specimens or parts thereof... international mail system. Provided, that this exception will not apply to any specimens or parts thereof taken...

50 CFR 14.24 - Scientific specimens.

Code of Federal Regulations, 2014 CFR

2014-10-01

... or 23 of this subchapter, dead, preserved, dried, or embedded scientific specimens or parts thereof... international mail system. Provided, that this exception will not apply to any specimens or parts thereof taken...

Thermal Modeling and Analysis of a Cryogenic Tank Design Exposed to Extreme Heating Profiles

NASA Technical Reports Server (NTRS)

Stephens, Craig A.; Hanna, Gregory J.

1991-01-01

A cryogenic test article, the Generic Research Cryogenic Tank, was designed to qualitatively simulate the thermal response of transatmospheric vehicle fuel tanks exposed to the environment of hypersonic flight. One-dimensional and two-dimensional finite-difference thermal models were developed to simulate the thermal response and assist in the design of the Generic Research Cryogenic Tank. The one-dimensional thermal analysis determined the required insulation thickness to meet the thermal design criteria and located the purge jacket to eliminate the liquefaction of air. The two-dimensional thermal analysis predicted the temperature gradients developed within the pressure-vessel wall, estimated the cryogen boiloff, and showed the effects the ullage condition has on pressure-vessel temperatures. The degree of ullage mixing, location of the applied high-temperature profile, and the purge gas influence on insulation thermal conductivity had significant effects on the thermal behavior of the Generic Research Cryogenic Tank. In addition to analysis results, a description of the Generic Research Cryogenic Tank and the role it will play in future thermal structures and transatmospheric vehicle research at the NASA Dryden Flight Research Facility is presented.

Acquisition of generic memory in amnesia.

PubMed

Verfaellie, M; Cermak, L S

1994-06-01

Amnesic patients' ability to acquire generic, semantic information was assessed relative to their own level of episodic memory. Patients studied a list of words in which some items were presented twice and others once. Upon each presentation, the words were tagged episodically by presenting them in a unique color. Recall of the colors in which words were presented suggested that individual presentations of repeated items were less likely to be recalled than presentations of nonrepeated items; however, actual recall of repeated items exceeded that of nonrepeated items. This outcome demonstrated that amnesics can recall some items generically without recalling either of their individual presentations. However, amnesics' recall of twice-presented items remained far below that of the control group, even when their recall of once-presented items was matched by testing the control group after a delay. This finding suggests that amnesic patients can acquire new generic knowledge but do so much less efficiently than do normal individuals. Furthermore, this deficit occurs independently of the amnesics' episodic memory impairments, reflecting instead a disruption in semantic learning per se.

The development of a post-test diagnostic system for rocket engines

NASA Technical Reports Server (NTRS)

Zakrajsek, June F.

1991-01-01

An effort was undertaken by NASA to develop an automated post-test, post-flight diagnostic system for rocket engines. The automated system is designed to be generic and to automate the rocket engine data review process. A modular, distributed architecture with a generic software core was chosen to meet the design requirements. The diagnostic system is initially being applied to the Space Shuttle Main Engine data review process. The system modules currently under development are the session/message manager, and portions of the applications section, the component analysis section, and the intelligent knowledge server. An overview is presented of a rocket engine data review process, the design requirements and guidelines, the architecture and modules, and the projected benefits of the automated diagnostic system.

Steady and Periodic Pressure Measurements on a Generic Helicopter Fuselage Model in the Presence of a Rotor

NASA Technical Reports Server (NTRS)

Mineck, Raymond E.; Gorton, Susan A.

2000-01-01

A wind tunnel test of a generic helicopter fuselage model with an independently mounted rotor has been conducted to obtain steady and periodic pressure data on the helicopter body. The model was tested at four advance ratios and three thrust coefficients. The periodic unsteady pressure coefficients are marked by four peaks associated with the passage of the four rotor blades. Blade passage effects are largest on the nose and tail boom of the model. The magnitude of the pulse increases with rotor thrust coefficient. Tabular listings of the unsteady pressure data are included to permit independent analysis. A CD-rom containing the steady and unsteady pressure data presented in the report is available from the authors.

Terrestrial photovoltaic cell process testing

NASA Technical Reports Server (NTRS)

Burger, D. R.

1985-01-01

The paper examines critical test parameters, criteria for selecting appropriate tests, and the use of statistical controls and test patterns to enhance PV-cell process test results. The coverage of critical test parameters is evaluated by examining available test methods and then screening these methods by considering the ability to measure those critical parameters which are most affected by the generic process, the cost of the test equipment and test performance, and the feasibility for process testing.

Terrestrial photovoltaic cell process testing

NASA Astrophysics Data System (ADS)

Burger, D. R.

The paper examines critical test parameters, criteria for selecting appropriate tests, and the use of statistical controls and test patterns to enhance PV-cell process test results. The coverage of critical test parameters is evaluated by examining available test methods and then screening these methods by considering the ability to measure those critical parameters which are most affected by the generic process, the cost of the test equipment and test performance, and the feasibility for process testing.

Keto-isovalerate decarboxylase enzymes and methods of use thereof

DOEpatents

McElvain, Jessica; O'Keefe, Daniel P.; Paul, Brian James; Payne, Mark S.; Rothman, Steven Cary; He, Hongxian

2016-01-19

Provided herein are polypeptides and polynucleotides encoding such polypeptides which have ketoisovalerate decarboxylase activity. Also provided are recombinant host cells comprising such polypeptides and polynucleotides and methods of use thereof.

Patient-specific model of a scoliotic torso for surgical planning

NASA Astrophysics Data System (ADS)

Harmouche, Rola; Cheriet, Farida; Labelle, Hubert; Dansereau, Jean

2013-03-01

A method for the construction of a patient-specific model of a scoliotic torso for surgical planning via inter-patient registration is presented. Magnetic Resonance Images (MRI) of a generic model are registered to surface topography (TP) and X-ray data of a test patient. A partial model is first obtained via thin-plate spline registration between TP and X-ray data of the test patient. The MRIs from the generic model are then fit into the test patient using articulated model registration between the vertebrae of the generic model's MRIs in prone position and the test patient's X-rays in standing position. A non-rigid deformation of the soft tissues is performed using a modified thin-plate spline constrained to maintain bone rigidity and to fit in the space between the vertebrae and the surface of the torso. Results show average Dice values of 0:975 +/- 0:012 between the MRIs following inter-patient registration and the surface topography of the test patient, which is comparable to the average value of 0:976 +/- 0:009 previously obtained following intra-patient registration. The results also show a significant improvement compared to rigid inter-patient registration. Future work includes validating the method on a larger cohort of patients and incorporating soft tissue stiffness constraints. The method developed can be used to obtain a geometric model of a patient including bone structures, soft tissues and the surface of the torso which can be incorporated in a surgical simulator in order to better predict the outcome of scoliosis surgery, even if MRI data cannot be acquired for the patient.

Generic anthropometric and performance characteristics among elite adolescent boys in nine different sports.

PubMed

Pion, Johan; Segers, Veerle; Fransen, Job; Debuyck, Gijs; Deprez, Dieter; Haerens, Leen; Vaeyens, Roel; Philippaerts, Renaat; Lenoir, Matthieu

2015-01-01

The aim of the present study was to evaluate the Flemish Sports Compass (FSC), a non-sport-specific generic testing battery. It was hypothesised that a set of 22 tests would have sufficient discriminant power to allocate athletes to their own sport based on a unique combination of test scores. First, discriminant analyses were applied to the 22 tests of anthropometry, physical fitness and motor coordination in 141 boys under age 18 (16.1 ± 0.8 years) and post age at peak height velocity (maturity offset = 2.674 ± 0.926) from Flemish Top Sport Academies for badminton, basketball, gymnastics, handball, judo, soccer, table tennis, triathlon and volleyball. Second, nine sequential discriminant analyses were used to assess the ability of a set of relevant performance characteristics classifying participants and non-participants for the respective sports. Discriminant analyses resulted in a 96.4% correct classification of all participants for the nine different sports. When focusing on relevant performance characteristics, 80.1% to 97.2% of the total test sample was classified correctly within their respective disciplines. The discriminating characteristics were briefly the following: flexibility in gymnastics, explosive lower-limb strength in badminton and volleyball, speed and agility in badminton, judo, soccer and volleyball, upper-body strength in badminton, basketball and gymnastics, cardiorespiratory endurance in triathletes, dribbling skills in handball, basketball and soccer and overhead-throwing skills in badminton and volleyball. The generic talent characteristics of the FSC enable the distinction of adolescent boys according to their particular sport. Implications for talent programmes are discussed.

An Analysis of Task-Scheduling for a Generic Avionics Mission Computer

DTIC Science & Technology

2006-04-01

3 3. 1. 3 Response Time Analysis........................................................................... 8 3. 2 Non - Preemptive ...Fixed Priority Scheduling ...................................................... 10 3. 2. 1 Simple Non - Preemptive Response Time Test...10 3. 2. 2 Non - Preemptive Response Time Test .................................................. 12 3. 3 Asynchronous Fixed

Mind the Gap: 20 Years of Progress and Retrenchment in School Funding and Achievement Gaps. Policy Information Report. ETS RR-16-15

ERIC Educational Resources Information Center

Baker, Bruce D.; Farrie, Danielle; Sciarra, David G.

2016-01-01

Although there has been significant progress in the long term, achievement gaps among the nation's students persist.Many factors have contributed to the disparities in outcomes, and societal changes can explain progress, or lack thereof, over the past few decades.This is well documented in the 2010 Educational Testing Service (ETS) report…

Liquid Crystals for Nondestructive Evaluation

DTIC Science & Technology

1978-09-01

Information Analysis Center (NTIAC), Southwest Resarc Istiut. 620Culebra Road, San Antonio, Texas 78254. NTIAC is a full service information analy-AlI sis...document. or parns thereof, may not be reproduced in ay form without witnpr mission of the Nondestructive Testing Information Analysis Center. J...NUMBER OF PAGES Reserch ente 15a40__Alexandria, VYA 22314 014. MONITORING AGENCY NAME & ADDRESS 15. SECURITY CLASS. (of thireport) fif different from

Report on Development and Evaluation of a Self-Study Course for Adult Four-H Leaders.

ERIC Educational Resources Information Center

Neidt, Charles O.

This programed instruction project for adult Four-H leaders was undertaken to develop a ten unit manuscript covering basic Four H concepts; to prepare four versions thereof differing in response mode; to field test all four on a national sample of leaders; and to prepare a final research edition of the course based on the response mode proving…

Revision and Experimental Verification of the Hazard Assessment Computer System Models for Spreading, Movement, Dissolution, and Dissipation of Insoluble Chemicals Spilled Onto Water. Volume 2. Test Data.

DTIC Science & Technology

1983-06-01

and they do not constitute a standard, specification, or regulation. This report, or portions thereof may not be used for advertising or sales ... promotion purposes. Citation of trade names and manufacturers does not constitute endorsement or approval of such products. Y5. Ji I I .- "r

Flight Test of Composite Model Reference Adaptive Control (CMRAC) Augmentation Using NASA AirSTAR Infrastructure

NASA Technical Reports Server (NTRS)

Gregory, Irene M.; Gadient, ROss; Lavretsky, Eugene

2011-01-01

This paper presents flight test results of a robust linear baseline controller with and without composite adaptive control augmentation. The flight testing was conducted using the NASA Generic Transport Model as part of the Airborne Subscale Transport Aircraft Research system at NASA Langley Research Center.

A Guide to Computer Adaptive Testing Systems

ERIC Educational Resources Information Center

Davey, Tim

2011-01-01

Some brand names are used generically to describe an entire class of products that perform the same function. "Kleenex," "Xerox," "Thermos," and "Band-Aid" are good examples. The term "computerized adaptive testing" (CAT) is similar in that it is often applied uniformly across a diverse family of testing methods. Although the various members of…

Software and System Warranty Issues and Generic Warranty Clause.

DTIC Science & Technology

1987-06-01

communications networks and other government-furnished equipment. Special attention . must also be paid to software packages, such as operating...34 :- ’.-’".,:., ",’., . .’.’ . ’ -.’ -. ., .- . 0;/ .’.. ,; .’ ’.’...’. • . .. . * Phose A - Devekpment Test and Evaluation conducted at a test facility. * Phaie - Devopment Test and

TRANSURANIC METAL HALIDES AND A PROCESS FOR THE PRODUCTION THEREOF

DOEpatents

Fried, S.

1951-03-20

Halides of transuranic elements are prepared by contacting with aluminum and a halogen, or with an aluminum halide, a transuranic metal oxide, oxyhalide, halide, or mixture thereof at an elevated temperature.

Flow-through biological conversion of lignocellulosic biomass

DOEpatents

Herring, Christopher D.; Liu, Chaogang; Bardsley, John

2014-07-01

The present invention is directed to a process for biologically converting carbohydrates from lignocellulosic biomass comprising the steps of: suspending lignocellulosic biomass in a flow-through reactor, passing a reaction solution into the reactor, wherein the solution is absorbed into the biomass substrate and at least a portion of the solution migrates through said biomass substrate to a liquid reservoir, recirculating the reaction solution in the liquid reservoir at least once to be absorbed into and migrate through the biomass substrate again. The biological converting of the may involve hydrolyzing cellulose, hemicellulose, or a combination thereof to form oligosaccharides, monomelic sugars, or a combination thereof; fermenting oligosaccharides, monomelic sugars, or a combination thereof to produce ethanol, or a combination thereof. The process can further comprise removing the reaction solution and processing the solution to separate the ethanol produced from non-fermented solids.

Psychometric properties of the Chinese version of the Pediatric Quality Of Life Inventory 4.0 Generic Core scales among pediatric cancer patients.

PubMed

Yeung, Nelson C Y; Lau, Joseph T F; Yu, Xiao-nan; Chu, Yvonne; Shing, Matthew M K; Leung, Ting Fan; Li, Chi Kong; Fok, Tai Fai; Mak, Winnie W S

2013-01-01

The Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales are commonly used to assess health-related quality of life of healthy children and pediatric patients. Validation of the Generic Core Scales among Chinese pediatric cancer patients has not been reported in the literature. The scales can serve to measure different quality-of-life domains that are not captured by the PedsQL Cancer Module. Psychometric properties of the Chinese version of the PedsQL 4.0 among pediatric cancer patients and their caretakers were examined. The Generic Core Scales were administered to 335 pairs of pediatric cancer patients (aged 8-18 years) and their caretakers in Hong Kong. A 5-factor structure (physical, emotional, social, school-related cognitive function, and missed school) was identified in the patient and proxy versions of the scales using confirmatory factor analysis. Both versions of the total scale reported Cronbach α's of .90 or greater, with almost all subscales reporting α's of .70 or greater. Test-retest reliability at 2 weeks was acceptable (intraclass correlations ≥0.60) for a majority of subscales. Agreement between patients' and caretakers' ratings was medium. The scales demonstrated acceptable psychometric properties and construct validity. This study validated the Chinese version of the Generic Core Scales among pediatric cancer patients and their caretakers, which supports the future use of the scales in clinical settings. The Generic Core Scales can also be supplementary to the PedsQL Cancer Module for measuring multiple domains of quality of life in cancer population.

Molybdenum-99 Isotope Production Preparation at Sandia National Laboratories

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

Carson, S.D.; Longley, S.W.; McDonald, M.J.

`Q&c M. J. McDonald, S. D. Carson, S. W. Longley, E. J. Parma, M. E. Vern `~ I@ .,., Sandia National Laboratories*, P. .0. Box 5800, Albuquerque, NM, 8 W? 1$ tl?;:q `f. (3 . 8 /'~ Abstract This report was prepared as an account of work sponsored byanagency of the United States Government. Neither the United States Government nor any agency thereof, nor any of their employees, make any warranty, express or implied, or assumes any legal liability or responsibility for the accuracy, completeness, or usefulness of any information, apparatus, product, or process disclosed, or represents that its usemore » would not infringe privately owned rights. Reference herein to any specific commercial product, process, or service by trade name, trademark, manufacturer, or otherwise does not necessarily constitute or imply its endorsement, recommendation, or favoring by the United States Government or any agency thereof. The views and opinions of authors expressed herein do not necessarily state or reflect those of the United States Government or any agency thereof. loading on the Cintichem targets. These tests were designed to gain process knowledge prior to processing an irradiated target. The chemical separation tests were performed in a fime hood During cold testing, several tests were performed on individual components of the process to complete, a series of `hot' tests was designed to process irradiated targets. These were designed to optimize the process, identify problems prior to processing higher inventory targets, and to the shielded containment box (SCB). Table 1 is a summary of the tests performed prior to the Test Target Power Post irradiation Total inventory 99M0 inventory (kW)/ Irradiation decay (hrs) (TBq*) /decay (TBq)/decay Time (hrs) inventory (TBq) inventory(TBq) in the processing boxes as color comparisons. Product quality control testing was conducted for all the tests and the results were compared to The production process generates a high activity acidic liquid waste. Several waste stabilization processing box. The cement, in addition to stabilizing the waste, neutralized the waste resulting The processing hardware and fixtures were developed in parallel to the cold tests and tested in a that expected during processing. During processing, precautions will be taken to minimize the Island incident. The facility consisted of shielded glove boxes, unshielded glove box lines and the the facility for production operations; the glove box lines and shielded glove boxes, all the new configuration will have six windows, four extraction boxes and a waste packaging box on the shielding. The walls and windows of the processing boxes will have the equivalent 150 of the purification box will be considerably less than the processing boxes with dose being from only `gMo. The increased wall thickness will reduce the dose levels to boxes will have under the box transport systems to move material into and out of the boxes. prior to FDA requiring process validation and, consequently, had not pertlormed a process« less

Device for testing closure disks at high rates of change of pressure

DOEpatents

Merten, C.W. Jr.

1993-11-09

A device is described for testing the burst pressure of closure disks which provides high pressure to both sides of a disk and rapidly releases pressure from one side thereof causing a high rate of change of pressure. A hollow notched plug allows the rapid release of pressure upon rupturing. A means is also disclosed for transmitting a tensile load from a piston to a hollow notched plug and for sealing the means for transmitting load within a hole in a piston. 5 figures.

43 CFR 4.808 - Participation by a party.

Code of Federal Regulations, 2010 CFR

2010-10-01

... Department of the Interior-Effectuation of Title VI of the Civil Rights Act of 1964 Appearance and Practice... thereof, a political subdivision of the State or instrumentality thereof, or a corporation may appear by...

37 CFR 1.81 - Drawings required in patent application.

Code of Federal Regulations, 2011 CFR

2011-07-01

... to be patented; this drawing, or a high quality copy thereof, must be filed with the application... the original disclosure thereof for the purpose of interpretation of the scope of any claim. [43 FR...

Toughened and corrosion- and wear-resistant composite structures and fabrication methods thereof

DOEpatents

Seals, Roland D.; Ripley, Edward B.; Hallman, Russell L.

2017-06-20

Composite structures having a reinforced material interjoined with a substrate, wherein the reinforced material comprises a compound selected from the group consisting of titanium monoboride, titanium diboride, and combinations thereof.

Before the Transplant

MedlinePlus

... effects Other medications Generic and brand name drugs Post-transplant tests Infections and immunity Lifestyle changes Health concerns Back ... certain window of time. Be ready for medical tests and possibly a long wait for ... 6: Care Your medical team manages your post-transplant care. They will help you understand the ...

Experimental Stage Separation Tool Development in NASA Langley's Aerothermodynamics Laboratory

NASA Technical Reports Server (NTRS)

Murphy, Kelly J.; Scallion, William I.

2005-01-01

As part of the research effort at NASA in support of the stage separation and ascent aerothermodynamics research program, proximity testing of a generic bimese wing-body configuration was conducted in NASA Langley's Aerothermodynamics Laboratory in the 20-Inch Mach 6 Air Tunnel. The objective of this work is the development of experimental tools and testing methodologies to apply to hypersonic stage separation problems for future multi-stage launch vehicle systems. Aerodynamic force and moment proximity data were generated at a nominal Mach number of 6 over a small range of angles of attack. The generic bimese configuration was tested in a belly-to-belly and back-to-belly orientation at 86 relative proximity locations. Over 800 aerodynamic proximity data points were taken to serve as a database for code validation. Longitudinal aerodynamic data generated in this test program show very good agreement with viscous computational predictions. Thus a framework has been established to study separation problems in the hypersonic regime using coordinated experimental and computational tools.

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.

Bimetallic catalysts for CO.sub.2 hydrogenation and H.sub.2 generation from formic acid and/or salts thereof

DOEpatents

Hull, Jonathan F.; Himeda, Yuichiro; Fujita, Etsuko; Muckeman, James T.

2015-08-04

The invention relates to a ligand that may be used to create a catalyst including a coordination complex is formed by the addition of two metals; Cp, Cp* or an unsubstituted or substituted .pi.-arene; and two coordinating solvent species or solvent molecules. The bimetallic catalyst may be used in the hydrogenation of CO.sub.2 to form formic acid and/or salts thereof, and in the dehydrogenation of formic acid and/or salts thereof to form H.sub.2 and CO.sub.2.

SEPARATION OF POLONIUM, PROTACTINIUM OR MIXTURES THEREOF IN AQUEOUS SOLUTION FROM BISMUTH, LEAD, ZIRCONIUM AND/OR COLUMBIUM VALUES

DOEpatents

Van Winkle, Q.; Kraus, K.A.

1959-10-27

A process is presented for separating polonium, protactinium, or mixtures thereof in aqueous solution from bismuth, zirconium, lead, and niobium values contained in the solution. The method comprises providing hydrochloric acid in the solution in a concentration of at least 5N. contacting the aqueous solution with a substantially waterimmiscible organic solvent such as diisopropyl ketone, and separating the aqueous phase containing the bismuth, zirconium, lead, and niobium from the organic extract phase containing the polonium, protactinium, or mixture thereof.

Computerized tomography calibrator

NASA Technical Reports Server (NTRS)

Engel, Herbert P. (Inventor)

1991-01-01

A set of interchangeable pieces comprising a computerized tomography calibrator, and a method of use thereof, permits focusing of a computerized tomographic (CT) system. The interchangeable pieces include a plurality of nestable, generally planar mother rings, adapted for the receipt of planar inserts of predetermined sizes, and of predetermined material densities. The inserts further define openings therein for receipt of plural sub-inserts. All pieces are of known sizes and densities, permitting the assembling of different configurations of materials of known sizes and combinations of densities, for calibration (i.e., focusing) of a computerized tomographic system through variation of operating variables thereof. Rather than serving as a phanton, which is intended to be representative of a particular workpiece to be tested, the set of interchangeable pieces permits simple and easy standardized calibration of a CT system. The calibrator and its related method of use further includes use of air or of particular fluids for filling various openings, as part of a selected configuration of the set of pieces.

[Lack of bioavailability of generic lopinavir/ritonavir not prequalified by WHO marketed in Africa (Congo Brazzaville)].

PubMed

Camara, S; Zucman, D; Vasse, M; Goudjo, A; Guillard, E; Peytavin, G

2015-02-01

Although second-line generic antiretroviral drugs are of great value in developing countries there are concerns regarding their quality and safety. This study is a case report and pharmacological study in healthy volunteers. A French subject of sub-saharan origin who visited Republic of Congo received a post-exposure treatment with AZT+3TC and LPV/r (200/50 mg, Arga-L®, India) following unprotected sexual intercourse. Two days later, in France, tests showed that plasma concentrations of lopinavir and ritonavir were undetectable. The WHO prequalification list showed Arga-L® was not prequalified. A pharmacological study in healthy volunteers evaluated oral bioavailability: plasma concentrations of generic LPV/r Arga-L® and LPV/r Kaletra® (400/100 mg) were measured after one single dose at 7 days apart in four healthy volunteers. Concentrations of Arga-L® at 12 h after intake were considerably lower than those of Kaletra®, revealing very low oral bioavailability of generic lopinavir and ritonavir (<10%) compared to the brand-name drug. We found that Arga-L®, despite having adequate qualitative and quantitative drug contents, had very poor bio availability compared to Kaletra®. In order to avoid the selection and the spread of drug-resistant HIV strains, rigorous pharmacological monitoring of generic antiretroviral drugs that are not pre-qualified by WHO, but are marketed in Africa, must be a priority for health authorities.

Complement activation as a bioequivalence issue relevant to the development of generic liposomes and other nanoparticulate drugs

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

Szebeni, Janos, E-mail: jszebeni2@gmail.com; Storm, Gert

Liposomes are known to activate the complement (C) system, which can lead in vivo to a hypersensitivity syndrome called C activation-related pseudoallergy (CARPA). CARPA has been getting increasing attention as a safety risk of i.v. therapy with liposomes, whose testing is now recommended in bioequivalence evaluations of generic liposomal drug candidates. This review highlights the adverse consequences of C activation, the unique symptoms of CARPA triggered by essentially all i.v. administered liposomal drugs, and the various features of vesicles influencing this adverse immune effect. For the case of Doxil, we also address the mechanism of C activation and the opsonization vs.more » long circulation (stealth) paradox. In reviewing the methods of assessing C activation and CARPA, we delineate the most sensitive porcine model and an algorithm for stepwise evaluation of the CARPA risk of i.v. liposomes, which are proposed for standardization for preclinical toxicology evaluation of liposomal and other nanoparticulate drug candidates. - Highlights: • Outlining of difficulties in generic development of liposomal drugs. • New regulatory requirements to evaluate CARPA in preclinical studies. • Review of complement activation by liposomes and its adverse consequences (CARPA). • Assays of C activation in vitro and CARPA in vivo, with the porcine test in focus. • Decision tree how to handle the risk of CARPA assessed by a battery of tests.« less

Comparative study of quality and efficacy of originator's and generic ABZ for the mass treatment of soil-transmitted nematode infections in Nepal

PubMed Central

Albonico, Marco; Mathema P., Pragya; Montresor, Antonio; Khakurel, Balkrishna; Reggi, Valerio; Pandey, Sharada; Savioli, Lorenzo

2017-01-01

Quality and efficacy of two locally-manufactured generic albendazole (ABZ) products (Curex and Royal Drug) used for de-worming children in Nepal since 1999 were tested against the originator product (GSK). The study conducted disintegration and dissolution testing and a randomised controlled clinical trial comparing cure rates (CR) and egg reduction rates (ERR) for Ascaris lumbricoides, Trichuris trichiura and hookworm infections. Stool samples from 1277 children were examined before and 21 days after treatment. For A. lumbricoides GSK's (97.0%) and Royal Drug's (95.0 %) product provided significantly higher CR than Curex's (82.6%); however, all products provided ERR higher than 90%. For T. trichiura Curex's product showed significantly lower ERR (63.2%). For hookworm, GSK's product performed significantly better (CR 74.3%, ERR 87.1%) than Royal Drug's (CR 53.3%, ERR 80.8%) and Curex's (CR 50.7%, ERR 73.1%). Only GSK's product passed both disintegration and dissolution. Both generic products failed dissolution. Curex's product showed poor disintegration. Despite its lower efficacy the cheaper Curex's product achieved good results in controlling morbidity due to soil-transmitted helminth (STH) infections. This study shows that cost-effectiveness of drugs used in mass de-worming campaigns should not be inferred on the basis of one single quality testing parameter. PMID:17129592

Psychometric properties of the Swedish PedsQL, Pediatric Quality of Life Inventory 4.0 generic core scales.

PubMed

Petersen, Solveig; Hägglöf, Bruno; Stenlund, Hans; Bergström, Erik

2009-09-01

To study the psychometric performance of the Swedish version of the Pediatric Quality of Life Inventory (PedsQL) 4.0 generic core scales in a general child population in Sweden. PedsQL forms were distributed to 2403 schoolchildren and 888 parents in two different school settings. Reliability and validity was studied for self-reports and proxy reports, full forms and short forms. Confirmatory factor analysis tested the factor structure and multigroup confirmatory factor analysis tested measurement invariance between boys and girls. Test-retest reliability was demonstrated for all scales and internal consistency reliability was shown with alpha value exceeding 0.70 for all scales but one (self-report short form: social functioning). Child-parent agreement was low to moderate. The four-factor structure of the PedsQL and factorial invariance across sex subgroups were confirmed for the self-report forms and for the proxy short form, while model fit indices suggested improvement of several proxy full-form scales. The Swedish PedsQL 4.0 generic core scales are a reliable and valid tool for health-related quality of life (HRQoL) assessment in Swedish child populations. The proxy full form, however, should be used with caution. The study also support continued use of the PedsQL as a four-factor model, capable of revealing meaningful HRQoL differences between boys and girls.

75 FR 34688 - Ball Bearings and Parts Thereof from France: Final Results of Changed-Circumstances Review

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-18

...: antifriction balls, ball bearings with integral shafts, ball bearings (including radial ball bearings) and... thereof (inner race, outer race, cage, rollers, balls, seals, shields, etc.) outlined above with certain...

78 FR 29702 - Ball Bearings and Parts Thereof From Germany: Final Results of Antidumping Duty Administrative...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-21

... balls, ball bearings with integral shafts, ball bearings (including radial ball bearings) and parts... all the subject bearings and parts thereof (inner race, outer race, cage, rollers, balls, seals...

75 FR 82410 - Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public Interest

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-30

... Certain Game Devices, Components Thereof, and Products Containing the Same, DN 2776; the Commission is... United States after importation of certain game devices, components thereof, and products containing the...

Metal-polymer composites comprising nanostructures and applications thereof

DOEpatents

Wang, Hsing-Lin [Los Alamos, NM; Jeon, Sea Ho [Dracut, MA; Mack, Nathan H [Los Alamos, NM

2011-08-02

Metal-polymer composites, and methods of making and use thereof, said composites comprising a thermally-cured dense polyaniline substrate; an acid dopant; and, metal nanostructure deposits wherein the deposits have a morphology dependent upon the acid dopant.

Metal-polymer composites comprising nanostructures and applications thereof

DOEpatents

Wang, Hsing-Lin [Los Alamos, NM; Jeon, Sea Ho [Dracut, MA; Mack, Nathan H [Los Alamos, NM

2012-04-03

Metal-polymer composites, and methods of making and use thereof, said composites comprising a thermally-cured dense polyaniline substrate; an acid dopant; and, metal nanostructure deposits wherein the deposits have a morphology dependent upon the acid dopant.

7 CFR 52.3761 - Defects.

Code of Federal Regulations, 2010 CFR

2010-01-01

... PROCESSED FRUITS AND VEGETABLES, PROCESSED PRODUCTS THEREOF, AND CERTAIN OTHER PROCESSED FOOD PRODUCTS 1... harmless extraneous vegetable material, stems, and portions thereof, blemishes, wrinkles, mutilated olives... these two axes exceeds 45 degrees. (5) Harmless extraneous vegetable material. Harmless extraneous...

76 FR 34100 - Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public Interest

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-10

... Certain GPS Navigation Products, Components Thereof, and Related Software, DN 2814; the Commission is... importation of certain GPS navigation products, components thereof, and related software. The complaint names...

45 CFR 509.3 - Exhibits and documents in support of claim.

Code of Federal Regulations, 2010 CFR

2010-10-01

... translation thereof duly verified under oath by its translator to be a true and accurate translation thereof, together with the name and address of the translator. (c) Preparation of papers. All claims, briefs, and...

Seal assembly with anti-rotation pin for high pressure supercritical fluids

DOEpatents

Wright, Steven A.; Fuller, Robert L.

2014-08-05

A seal assembly for sealing a machine with a first chamber and a second chamber is provided. A rotating shaft extends through the first and second chambers, and rotates therein. The seal assembly has a seal housing, a seal ring and a seal pin. The seal housing is positionable in the machine housing. The seal housing has a seal pocket extending into a fluid side thereof, and a housing receptacle extending into an inner diameter thereof at the seal pocket. The seal ring is positionable in the seal pocket of the seal housing for forming a seal therewith. The seal ring has a ring receptacle extending into an outer diameter thereof. The ring receptacle is positionable adjacent to the housing receptacle for defining a pin hole therebetween. The seal pin is loosely positionable in the pin hole whereby movement about the seal ring is accommodated while preventing rotation thereof.

Flow-through biological conversion of lignocellulosic biomass

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

Herring, Christopher D.; Liu, Chaogang; Bardsley, John

2014-07-01

The present invention is directed to a process for biologically converting carbohydrates from lignocellulosic biomass comprising the steps of: suspending lignocellulosic biomass in a flow-through reactor, passing a reaction solution into the reactor, wherein the solution is absorbed into the biomass substrate and at least a portion of the solution migrates through said biomass substrate to a liquid reservoir, recirculating the reaction solution in the liquid reservoir at least once to be absorbed into and migrate through the biomass substrate again. The biological converting of the may involve hydrolyzing cellulose, hemicellulose, or a combination thereof to form oligosaccharides, monomelic sugars,more » or a combination thereof; fermenting oligosaccharides, monomelic sugars, or a combination thereof to produce ethanol, or a combination thereof. The process can further comprise removing the reaction solution and processing the solution to separate the ethanol produced from non-fermented solids.« less

Uses of monoclonal antibody 8H9

DOEpatents

Cheung, Nai-Kong V.

2013-04-09

This invention provides a composition comprising an effective amount of monoclonal antibody 8H9 or a derivative thereof and a suitable carrier. This invention provides a pharmaceutical composition comprising an effective amount of monoclonal antibody 8H9 or a derivative thereof and a pharmaceutically acceptable carrier. This invention also provides an antibody other than the monoclonal antibody 8H9 comprising the complementary determining regions of monoclonal antibody 8H9 or a derivative thereof, capable of binding to the same antigen as the monoclonal antibody 8H9. This invention provides a substance capable of competitively inhibiting the binding of monoclonal antibody 8H9. This invention also provides an isolated scFv of monoclonal antibody 8H9 or a derivative thereof. This invention also provides the 8H9 antigen. This invention also provides different uses of the monoclonal antibody 8H9 or its derivative.

Uses of monoclonal antibody 8H9

DOEpatents

Cheung, Nai-Kong V.

2010-06-22

This invention provides a composition comprising an effective amount of monoclonal antibody 8H9 or a derivative thereof and a suitable carrier. This invention provides a pharmaceutical composition comprising an effective amount of monoclonal antibody 8H9 or a derivative thereof and a pharmaceutically acceptable carrier. This invention also provides an antibody other than the monoclonal antibody 8H9 comprising the complementary determining regions of monoclonal antibody 8H9 or a derivative thereof, capable of binding to the same antigen as the monoclonal antibody 8H9. This invention provides a substance capable of competitively inhibiting the binding of monoclonal antibody 8H9. This invention also provides an isolated scFv of monoclonal antibody 8H9 or a derivative thereof. This invention also provides the 8H9 antigen. This invention also provides different uses of the monoclonal antibody 8H9 or its derivative.

Nickel cobalt phosphorous low stress electroplating

NASA Technical Reports Server (NTRS)

Engelhaupt, Darell E. (Inventor); Ramsey, Brian D. (Inventor)

2002-01-01

An electrolytic plating process is provided for electrodepositing a nickel or nickel cobalt alloy which contains at least about 2% to 25% by atomic volume of phosphorous. The process solutions contains nickel and optionally cobalt sulfate, hypophosphorous acid or a salt thereof, boric acid or a salt thereof, a monodentate organic acid or a salt thereof, and a multidentate organic acid or a salt thereof. The pH of the plating bath is from about 3.0 to about 4.5. An electroplating process is also provided which includes electroplating from the bath a nickel or nickel cobalt phosphorous alloy. This process can achieve a deposit with high microyield of at least about 84 kg/mm.sup.2 (120 ksi) and a density lower than pure nickel of about 8.0 gm/cc. This process can be used to plate a deposit of essentially zero stress at plating temperatures from ambient to 70.degree. C.

Radius of curvature controlled mirror

DOEpatents

Neil, George R.; Rathke, John Wickham; Schultheiss, Thomas John; Shinn, Michelle D.; Dillon-Townes, Lawrence A.

2006-01-17

A controlled radius of curvature mirror assembly comprising: a distortable mirror having a reflective surface and a rear surface; and in descending order from the rear surface; a counter-distortion plate; a flow diverter having a flow diverter aperture at the center thereof; a flow return plate having a flow return aperture at the center thereof; a thermal isolation plate having a thermal isolation plate aperture at the center thereof and a flexible heater having a rear surface and a flexible heater aperture at the center thereof; a double walled tube defining a coolant feed chamber and a coolant return chamber; said coolant feed chamber extending to and through the flow diverter aperture and terminating at the counter-distortion plate and the coolant return chamber extending to and through the thermal isolation backplate and terminating at the flow diverter; and a coolant feed and a coolant return exit at the rear of said flexible heater.

TEST-HOLE CONSTRUCTION FOR A NEUTRONIC REACTOR

DOEpatents

Ohlinger, L.A.; Seitz, F.; Young, G.J.

1959-02-17

Test-hole construction is described for a reactor which provides safe and ready access to the neutron flux region for specimen materials which are to be irradiated therein. An elongated tubular thimble adapted to be inserted in the access hole through the wall of the reactor is constructed of aluminum and is provided with a plurality of holes parallel to the axis of the thimble for conveying the test specimens into position for irradiation, and a conduit for the circulation of coolant. A laminated shield formed of alternate layers of steel and pressed wood fiber is disposed lengthwise of the thimble near the outer end thereof.

Method of measuring metal coating adhesion

DOEpatents

Roper, J.R.

A method for measuring metal coating adhesion to a substrate material comprising the steps of preparing a test coupon of substrate material having the metal coating applied to one surface thereof, applying a second metal coating of gold or silver to opposite surfaces of the test coupon by hot hollow cathode process, applying a coating to one end of each of two pulling rod members, joining the coated ends of the pulling rod members to said opposite coated surfaces of the test coupon by a solid state bonding technique and finally applying instrumented static tensile loading to the pulling rod members until fracture of the metal coating adhesion to the substrate material occurs.

Method of measuring metal coating adhesion

DOEpatents

Roper, John R.

1985-01-01

A method for measuring metal coating adhesion to a substrate material comprising the steps of preparing a test coupon of substrate material having the metal coating applied to one surface thereof, applying a second metal coating of gold or silver to opposite surfaces of the test coupon by hot hollow cathode process, applying a coating to one end of each of two pulling rod members, joining the coated ends of the pulling rod members to said opposite coated surfaces of the test coupon by a solid state bonding technique and finally applying instrumented static tensile loading to the pulling rod members until fracture of the metal coating adhesion to the substrate material occurs.

76 FR 60498 - Agency Forms Undergoing Paperwork Reduction Act Review

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-29

... in all instances, the same kinds of questions are asked in most message testing. This package includes generic questions and formats that can used to develop health message testing data collection instruments. These include a list of screening questions, comprised of demographic and introductory questions...

Environmental Technology Verification: Supplement to Test/QA Plan for Biological and Aerosol Testing of General Ventilation Air Cleaners; Bioaerosol Inactivation Efficiency by HVAC In-Duct Ultraviolet Light Air Cleaners

EPA Science Inventory

The Air Pollution Control Technology Verification Center has selected general ventilation air cleaners as a technology area. The Generic Verification Protocol for Biological and Aerosol Testing of General Ventilation Air Cleaners is on the Environmental Technology Verification we...

Test/QA plan for the validation of the verification protocol for high speed pesticide spray drift reduction technologies for row and field crops

EPA Science Inventory

This test/QA plan for evaluation the generic test protocol for high speed wind tunnel, representing aerial application, pesticide spray drift reduction technologies (DRT) for row and field crops is in conformance with EPA Requirements for Quality Assurance Project Plans (EPA QA/R...

Test/QA plan for the validation of the verification protocol for low speed pesticide spray drift reduction technologies for row and field crops

EPA Science Inventory

This test/QA plan for evaluation the generic test protocol for high speed wind tunnel, representing aerial application, pesticide spray drift reduction technologies (DRT) for row and field crops is in conformance with EPA Requirements for Quality Assurance Project Plans (EPA QA/R...

Generic Kalman Filter Software

NASA Technical Reports Server (NTRS)

Lisano, Michael E., II; Crues, Edwin Z.

2005-01-01

The Generic Kalman Filter (GKF) software provides a standard basis for the development of application-specific Kalman-filter programs. Historically, Kalman filters have been implemented by customized programs that must be written, coded, and debugged anew for each unique application, then tested and tuned with simulated or actual measurement data. Total development times for typical Kalman-filter application programs have ranged from months to weeks. The GKF software can simplify the development process and reduce the development time by eliminating the need to re-create the fundamental implementation of the Kalman filter for each new application. The GKF software is written in the ANSI C programming language. It contains a generic Kalman-filter-development directory that, in turn, contains a code for a generic Kalman filter function; more specifically, it contains a generically designed and generically coded implementation of linear, linearized, and extended Kalman filtering algorithms, including algorithms for state- and covariance-update and -propagation functions. The mathematical theory that underlies the algorithms is well known and has been reported extensively in the open technical literature. Also contained in the directory are a header file that defines generic Kalman-filter data structures and prototype functions and template versions of application-specific subfunction and calling navigation/estimation routine code and headers. Once the user has provided a calling routine and the required application-specific subfunctions, the application-specific Kalman-filter software can be compiled and executed immediately. During execution, the generic Kalman-filter function is called from a higher-level navigation or estimation routine that preprocesses measurement data and post-processes output data. The generic Kalman-filter function uses the aforementioned data structures and five implementation- specific subfunctions, which have been developed by the user on the basis of the aforementioned templates. The GKF software can be used to develop many different types of unfactorized Kalman filters. A developer can choose to implement either a linearized or an extended Kalman filter algorithm, without having to modify the GKF software. Control dynamics can be taken into account or neglected in the filter-dynamics model. Filter programs developed by use of the GKF software can be made to propagate equations of motion for linear or nonlinear dynamical systems that are deterministic or stochastic. In addition, filter programs can be made to operate in user-selectable "covariance analysis" and "propagation-only" modes that are useful in design and development stages.

Atomization methods for forming magnet powders

DOEpatents

Sellers, Charles H.; Branagan, Daniel J.; Hyde, Timothy A.

2000-01-01

The invention encompasses methods of utilizing atomization, methods for forming magnet powders, methods for forming magnets, and methods for forming bonded magnets. The invention further encompasses methods for simulating atomization conditions. In one aspect, the invention includes an atomization method for forming a magnet powder comprising: a) forming a melt comprising R.sub.2.1 Q.sub.13.9 B.sub.1, Z and X, wherein R is a rare earth element; X is an element selected from the group consisting of carbon, nitrogen, oxygen and mixtures thereof; Q is an element selected from the group consisting of Fe, Co and mixtures thereof; and Z is an element selected from the group consisting of Ti, Zr, Hf and mixtures thereof; b) atomizing the melt to form generally spherical alloy powder granules having an internal structure comprising at least one of a substantially amorphous phase or a substantially nanocrystalline phase; and c) heat treating the alloy powder to increase an energy product of the alloy powder; after the heat treatment, the alloy powder comprising an energy product of at least 10 MGOe. In another aspect, the invention includes a magnet comprising R, Q, B, Z and X, wherein R is a rare earth element; X is an element selected from the group consisting of carbon, nitrogen, oxygen and mixtures thereof; Q is an element selected from the group consisting of Fe, Co and mixtures thereof; and Z is an element selected from the group consisting of Ti, Zr, Hf and mixtures thereof; the magnet comprising an internal structure comprising R.sub.2.1 Q.sub.13.9 B.sub.1.