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Sample records for fda proposed test

  1. New Advantage 24 contraceptive gel claims 24-hour effectiveness. But proposed FDA rule could put N-9 products to the test.

    Science.gov (United States)

    1995-04-01

    Advantage 24 is a new contraceptive gel that makes use of bioadhesive technology to offer 24 hours of protection relying on the spermicide nonoxynol-9 (N-9) in lower concentrations. If a proposed US Food and Drug Administration (FDA) rule is enforced N-9 may be examined closely. The manufacturer, Whitehall-Robins Healthcare in New Jersey, stopped production of the Today contraceptive sponge because of the costs of complying with FDA standards. The Advantage 24 gel costs twice as much as the sponge. It is made in Switzerland and distributed by an Illinois company. Any vaginal contraceptive containing N-9 would be approved by the FDA as long as it complied with guidelines laid down in an FDA monograph. However, the registration of the gel could not be confirmed. The product uses a bioadhesive technology concept that natural substances adhere to epithelial and mucosal tissues in the body. Polycarbofil is mixed with water, N-9, and mineral oil to create an emulsion that allows for a time-release mechanism, but at any given time only 2 mg of N-9 is available to kill sperm. The final formula for Advantage 24 is 52.5 mg per dose. Too much N-9 can be toxic, as demonstrated by the Today sponge, which contained 1000 mg of N-9. In Kenya prostitutes using it frequently experienced 3 times as many genital lesions as those using a placebo. A study of Advantage 24 by a Miami laboratory involved 250 women, 22-45 years old, who had had prior tubal ligations. When the gel was applied 15-30 minutes before intercourse the efficacy rate was 98%; it was 91% for those applying it 12 hours before; and it was 86% when the gel was applied 24 hours ahead of time. FDA compliance officers are intrigued about the claim that the gel lasts 24 hours. However, if the claim is held up by research data, women will have an easily available, portable, efficient, aesthetic, and highly effective contraceptive.

  2. FDA Developments: Food Code 2013 and Proposed Trans Fat Determination

    NARCIS (Netherlands)

    Grossman, M.R.

    2014-01-01

    268 Reports EFFL 4|2014 USA FDA Developments: Food Code 2013 and Proposed Trans Fat Determination Margaret Rosso Grossman* I. Food Code 2013 and Food Code Reference System Since 1993, the US Food and Drug Administration has published a Food Code, now updated every four years. In November 2013, the

  3. 75 FR 28622 - FDA Transparency Initiative: Draft Proposals for Public Comment Regarding Disclosure Policies of...

    Science.gov (United States)

    2010-05-21

    ...] FDA Transparency Initiative: Draft Proposals for Public Comment Regarding Disclosure Policies of the U...: Notice of availability; request for comments. SUMMARY: As part of the second phase of the Transparency... Transparency Initiative: Draft Proposals for Public Comment Regarding Disclosure Policies of the U.S. Food and...

  4. Price, performance, and the FDA approval process: the example of home HIV testing.

    Science.gov (United States)

    Paltiel, A David; Pollack, Harold A

    2010-01-01

    The Food and Drug Administration (FDA) is considering approval of an over-the-counter, rapid HIV test for home use. To support its decision, the FDA seeks evidence of the test's performance. It has asked the manufacturer to conduct field studies of the test's sensitivity and specificity when employed by untrained users. In this article, the authors argue that additional information should be sought to evaluate the prevalence of undetected HIV in the end-user The analytic framework produces the elementary but counterintuitive finding that the performance of the home HIV test- measured in terms of its ability to correctly detect the presence and absence of HIV infection among the people who purchase it-depends critically on the manufacturer's retail price. This finding has profound implications for the FDA's approval process.

  5. Point-Counterpoint: The FDA Has a Role in Regulation of Laboratory-Developed Tests.

    Science.gov (United States)

    Caliendo, Angela M; Hanson, Kimberly E

    2016-04-01

    Since the Food and Drug Administration (FDA) released its draft guidance on the regulation of laboratory-developed tests (LDTs) in October 2014, there has been a flurry of responses from commercial and hospital-based laboratory directors, clinicians, professional organizations, and diagnostic companies. The FDA defines an LDT as an "in vitrodiagnostic device that is intended for clinical use and is designed, manufactured, and used within a single laboratory." The draft guidance outlines a risk-based approach, with oversight of high-risk and moderate-risk tests being phased in over 9 years. High-risk tests would be regulated first and require premarket approval. Subsequently, moderate-risk tests would require a 510(k) premarket submission to the FDA and low-risk tests would need only to be registered. Oversight discretion would be exercised for LDTs focused on rare diseases (defined as fewer than 4,000 tests, not cases, per year nationally) and unmet clinical needs (defined as those tests for which there is no alternative FDA-cleared or -approved test). There was an open comment period followed by a public hearing in early January of 2015, and we are currently awaiting the final decision regarding the regulation of LDTs. Given that LDTs have been developed by many laboratories and are essential for the diagnosis and monitoring of an array of infectious diseases, changes in their regulation will have far-reaching implications for clinical microbiology laboratories. In this Point-Counterpoint, Angela Caliendo discusses the potential benefits of the FDA guidance for LDTs whereas Kim Hanson discusses the concerns associated with implementing the guidance and why these regulations may not improve clinical care. Copyright © 2016, American Society for Microbiology. All Rights Reserved.

  6. FDA Accelerates Testing and Review of Experimental Brain Cancer Drug | FNLCR

    Science.gov (United States)

    An investigational brain cancer drug made with disabled polio virus and manufactured at the Frederick National Lab has won breakthrough status from the Food and Drug Administration (FDA) to fast-track its further refinement and clinical testing.  Br

  7. FDA Accelerates Testing and Review of Experimental Brain Cancer Drug | FNLCR Staging

    Science.gov (United States)

    An investigational brain cancer drug made with disabled polio virus and manufactured at the Frederick National Lab has won breakthrough status from the Food and Drug Administration (FDA) to fast-track its further refinement and clinical testing.  Br

  8. Justification of disintegration testing beyond current FDA criteria using in vitro and in silico models.

    Science.gov (United States)

    Uebbing, Lukas; Klumpp, Lukas; Webster, Gregory K; Löbenberg, Raimar

    2017-01-01

    Drug product performance testing is an important part of quality-by-design approaches, but this process often lacks the underlying mechanistic understanding of the complex interactions between the disintegration and dissolution processes involved. Whereas a recent draft guideline by the US Food and Drug Administration (FDA) has allowed the replacement of dissolution testing with disintegration testing, the mentioned criteria are not globally accepted. This study provides scientific justification for using disintegration testing rather than dissolution testing as a quality control method for certain immediate release (IR) formulations. A mechanistic approach, which is beyond the current FDA criteria, is presented. Dissolution testing via United States Pharmacopeial Convention Apparatus II at various paddle speeds was performed for immediate and extended release formulations of metronidazole. Dissolution profile fitting via DDSolver and dissolution profile predictions via DDDPlus™ were performed. The results showed that Fickian diffusion and drug particle properties (DPP) were responsible for the dissolution of the IR tablets, and that formulation factors (eg, coning) impacted dissolution only at lower rotation speeds. Dissolution was completely formulation controlled if extended release tablets were tested and DPP were not important. To demonstrate that disintegration is the most important dosage form attribute when dissolution is DPP controlled, disintegration, intrinsic dissolution and dissolution testing were performed in conventional and disintegration impacting media (DIM). Tablet disintegration was affected by DIM and model fitting to the Korsmeyer-Peppas equation showed a growing effect of the formulation in DIM. DDDPlus was able to predict tablet dissolution and the intrinsic dissolution profiles in conventional media and DIM. The study showed that disintegration has to occur before DPP-dependent dissolution can happen. The study suggests that

  9. A hardenability test proposal

    Energy Technology Data Exchange (ETDEWEB)

    Murthy, N.V.S.N. [Ingersoll-Rand (I) Ltd., Bangalore (India)

    1996-12-31

    A new approach for hardenability evaluation and its application to heat treatable steels will be discussed. This will include an overview and deficiencies of the current methods and discussion on the necessity for a new approach. Hardenability terminology will be expanded to avoid ambiguity and over-simplification as encountered with the current system. A new hardenability definition is proposed. Hardenability specification methods are simplified and rationalized. The new hardenability evaluation system proposed here utilizes a test specimen with varying diameter as an alternative to the cylindrical Jominy hardenability test specimen and is readily applicable to the evaluation of a wide variety of steels with different cross-section sizes.

  10. Justification of disintegration testing beyond current FDA criteria using in vitro and in silico models

    Directory of Open Access Journals (Sweden)

    Uebbing L

    2017-04-01

    Full Text Available Lukas Uebbing,1,2,* Lukas Klumpp,1,3,* Gregory K Webster,4 Raimar Löbenberg1 1Faculty of Pharmacy and Pharmaceutical Sciences, Katz Group-Rexall Centre for Pharmacy and Health Research, University of Alberta, Edmonton, Canada; 2Institute of Pharmacy and Biochemistry, Johannes Gutenberg University, Mainz, 3Institute of Pharmaceutical Technology, Goethe University Frankfurt, Frankfurt, Germany; 4Global Research and Development, AbbVie Inc., North Chicago, IL, USA *These authors contributed equally to this work Abstract: Drug product performance testing is an important part of quality-by-design approaches, but this process often lacks the underlying mechanistic understanding of the complex interactions between the disintegration and dissolution processes involved. Whereas a recent draft guideline by the US Food and Drug Administration (FDA has allowed the replacement of dissolution testing with disintegration testing, the mentioned criteria are not globally accepted. This study provides scientific justification for using disintegration testing rather than dissolution testing as a quality control method for certain immediate release (IR formulations. A mechanistic approach, which is beyond the current FDA criteria, is presented. Dissolution testing via United States Pharmacopeial Convention Apparatus II at various paddle speeds was performed for immediate and extended release formulations of metronidazole. Dissolution profile fitting via DDSolver and dissolution profile predictions via DDDPlus™ were performed. The results showed that Fickian diffusion and drug particle properties (DPP were responsible for the dissolution of the IR tablets, and that formulation factors (eg, coning impacted dissolution only at lower rotation speeds. Dissolution was completely formulation controlled if extended release tablets were tested and DPP were not important. To demonstrate that disintegration is the most important dosage form attribute when dissolution is

  11. FDA-approved drugs that are spermatotoxic in animals and the utility of animal testing for human risk prediction.

    Science.gov (United States)

    Rayburn, Elizabeth R; Gao, Liang; Ding, Jiayi; Ding, Hongxia; Shao, Jun; Li, Haibo

    2018-02-01

    This study reviews FDA-approved drugs that negatively impact spermatozoa in animals, as well as how these findings reflect on observations in human male gametes. The FDA drug warning labels included in the DailyMed database and the peer-reviewed literature in the PubMed database were searched for information to identify single-ingredient, FDA-approved prescription drugs with spermatotoxic effects. A total of 235 unique, single-ingredient, FDA-approved drugs reported to be spermatotoxic in animals were identified in the drug labels. Forty-nine of these had documented negative effects on humans in either the drug label or literature, while 31 had no effect or a positive impact on human sperm. For the other 155 drugs that were spermatotoxic in animals, no human data was available. The current animal models are not very effective for predicting human spermatotoxicity, and there is limited information available about the impact of many drugs on human spermatozoa. New approaches should be designed that more accurately reflect the findings in men, including more studies on human sperm in vitro and studies using other systems (ex vivo tissue culture, xenograft models, in silico studies, etc.). In addition, the present data is often incomplete or reported in a manner that prevents interpretation of their clinical relevance. Changes should be made to the requirements for pre-clinical testing, drug surveillance, and the warning labels of drugs to ensure that the potential risks to human fertility are clearly indicated.

  12. Commercialization of genetic testing services: the FDA, market forces, and biological tarot cards.

    Science.gov (United States)

    Malinowski, M J; Blatt, R J R

    1997-03-01

    Many women fear being diagnosed with breast cancer, and rightfully so. Despite the capabilities of modern medicine, the cumulative lifetime risk of getting the disease has risen to one in eight and, despite decades of research, no cures exist. In this Article, the authors explore the commercialization of so-called breast cancer gene tests, based upon genetic alterations linked to the disease. Although the authors fully address this specific technology, they use what constitutes the seminal case of predictive genetic testing to analyze the adequacy of the existing regulatory framework. The authors conclude that the present regulatory system is inadequate and places a dangerous amount of reliance on primary care physicians. Their conclusion is grounded in the observation that most primary care physicians lack sufficient knowledge about this evolving investigative technology--which is highly subject to misinterpretation, and, though potentially helpful to some "high risk" patients, offers questionable clinical value for the general public. The authors set forth numerous proposals to promote both the quality and clinical value of predictive genetic testing so that it conforms to public health standards and can be properly integrated as a reliable component of medical care in specific situations.

  13. Drugs@FDA: FDA Approved Drug Products

    Science.gov (United States)

    ... Cosmetics Tobacco Products Home Drug Databases Drugs@FDA Drugs@FDA: FDA Approved Drug Products Share Tweet Linkedin Pin it More sharing ... Download Drugs@FDA Express for free Search by Drug Name, Active Ingredient, or Application Number Enter at ...

  14. 78 FR 60287 - Agency Information Collection Activities; Proposed Collection; Comment Request; Testing...

    Science.gov (United States)

    2013-10-01

    ... communication strategies, messages, and labels. These communications will aim to improve public understanding of... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-1164] Agency Information Collection Activities; Proposed Collection; Comment Request; Testing Communications on...

  15. 75 FR 51271 - Agency Information Collection Activities; Proposed Collection; Comment Request; Testing...

    Science.gov (United States)

    2010-08-19

    ... communication strategies, messages, and labels. These communications will aim to improve public understanding of... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0420] Agency Information Collection Activities; Proposed Collection; Comment Request; Testing Communications on...

  16. 75 FR 39952 - Agency Information Collection Activities; Proposed Collection; Comment Request; Testing...

    Science.gov (United States)

    2010-07-13

    ... communications will aim to improve public understanding of the risks and benefits of using medical devices and... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0344] Agency Information Collection Activities; Proposed Collection; Comment Request; Testing Communications on...

  17. Proposed method to calculate FRMAC intervention levels for the assessment of radiologically contaminated food and comparison of the proposed method to the U.S. FDA's method to calculate derived intervention levels

    Energy Technology Data Exchange (ETDEWEB)

    Kraus, Terrence D.; Hunt, Brian D.

    2014-02-01

    This report reviews the method recommended by the U.S. Food and Drug Administration for calculating Derived Intervention Levels (DILs) and identifies potential improvements to the DIL calculation method to support more accurate ingestion pathway analyses and protective action decisions. Further, this report proposes an alternate method for use by the Federal Emergency Radiological Assessment Center (FRMAC) to calculate FRMAC Intervention Levels (FILs). The default approach of the FRMAC during an emergency response is to use the FDA recommended methods. However, FRMAC recommends implementing the FIL method because we believe it to be more technically accurate. FRMAC will only implement the FIL method when approved by the FDA representative on the Federal Advisory Team for Environment, Food, and Health.

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

    Science.gov (United States)

    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

  19. Comparing perceived effectiveness of FDA-proposed cigarette packaging graphic health warnings between sexual and gender minorities and heterosexual adults.

    Science.gov (United States)

    Tan, Andy S L; Bigman, Cabral A; Nagler, Rebekah H; Minsky, Sara; Viswanath, Kasisomayajula

    2017-10-01

    In 2012, the U.S. Food and Drug Administration proposed nine graphic health warnings (GHWs) on cigarette packaging that were rated equally effective across racial/ethnic, education, or income groups of adult smokers. However, data on GHW effectiveness among sexual and gender minority (SGM) adults, who have higher smoking prevalence, are currently lacking. This study analyzed whether perceived effectiveness of GHWs differed by gender and sexual orientation. Data came from a randomized experiment among 1,200 adults with an oversample from low socioeconomic status groups, conducted between 2013 and 2014 in three Massachusetts communities. Participants viewed and rated the effectiveness of nine GHWs. Mixed effects regression models predicted perceived effectiveness with gender and sexual orientation, adjusting for repeated measurements, GHWs viewed, age, race, ethnicity, smoking status, and health status. Female heterosexuals rated GHWs as more effective than male heterosexual, lesbian, and transgender and other gender respondents. There was no significant difference between female and male heterosexuals versus gay, male bisexual, or female bisexual respondents. Differences by gender and sexual orientation were consistent across all nine GHWs. Significant correlates of higher perceived effectiveness included certain GHWs, older age, being African-American (vs white), being Hispanic (vs non-Hispanic), having less than high school education (vs associate degree or higher), and being current smokers (vs non-smokers). Perceived effectiveness of GHWs was lower in certain SGM groups. We recommend further studies to understand the underlying mechanisms for these findings and investments in research and policy to communicate anti-smoking messages more effectively to SGM populations.

  20. Proposed new ultrasonic test bed

    International Nuclear Information System (INIS)

    Maxfield, B.W.

    1978-01-01

    Within the last four or five years, a great deal of progress has been made both here and in a number of other laboratories in developing techniques that will enable considerably more information to be obtained from the ultrasonic examination of an object. Some of these recent developments relate to information contained within the diffracted beam which does not return along the incident path. An ultrasonic examination based upon an evaluation of diffracted energy must use at least two transducers, one for transmission and the other for reception. Current indications are that even more reliable test results will be achieved using a receiving transducer that can scan a significant portion of the diffracted field including that portion which is back-reflected. In general, this scan can be interpreted most accurately if it follows a path related to the surface shape. If more than one region within the object is to be interrogated, then the transmitting transducer must also be scanned, again along a path related to the surface shape. The large quantity of information obtained as the result of such an examination must be subjected to sophisticated computer analysis in order to be displayed in a meaningful and intelligible manner. Although one motivation for building such an instrument is to explore new ultrasonic test procedures that are evolving from current laboratory research, this is neither the sole motivation nor the only use for this instrument. Such a mechanical and electronic device would permit conventional ultrasonic tests to be performed on parts of complex geometry without the expensive and time-consuming special fixturing that is currently required. May possible test geometries could be explored in practice prior to the construction of a specialized test apparatus. Hence, it would be necessary to design much, if any, flexibility into the special test apparatus

  1. Drugs@FDA Database

    Data.gov (United States)

    U.S. Department of Health & Human Services — Information about FDA-approved brand name and generic prescription and over-the-counter human drugs and biological therapeutic products. Drugs@FDA includes most of...

  2. FDA Acronyms and Abbreviations

    Data.gov (United States)

    U.S. Department of Health & Human Services — The FDA Acronyms and Abbreviations database provides a quick reference to acronyms and abbreviations related to Food and Drug Administration (FDA) activities

  3. The first FDA marketing authorizations of next-generation sequencing technology and tests: challenges, solutions and impact for future assays.

    Science.gov (United States)

    Bijwaard, Karen; Dickey, Jennifer S; Kelm, Kellie; Težak, Živana

    2015-01-01

    The rapid emergence and clinical translation of novel high-throughput sequencing technologies created a need to clarify the regulatory pathway for the evaluation and authorization of these unique technologies. Recently, the US FDA authorized for marketing four next generation sequencing (NGS)-based diagnostic devices which consisted of two heritable disease-specific assays, library preparation reagents and a NGS platform that are intended for human germline targeted sequencing from whole blood. These first authorizations can serve as a case study in how different types of NGS-based technology are reviewed by the FDA. In this manuscript we describe challenges associated with the evaluation of these novel technologies and provide an overview of what was reviewed. Besides making validated NGS-based devices available for in vitro diagnostic use, these first authorizations create a regulatory path for similar future instruments and assays.

  4. FDA Recognized Consensus Standards

    Data.gov (United States)

    U.S. Department of Health & Human Services — This database consists of those national and international standards recognized by FDA which manufacturers can declare conformity to and is part of the information...

  5. FDA Drug Label Data

    Data.gov (United States)

    U.S. Department of Health & Human Services — This file contains the data elements used for searching the FDA Online Data Repository including proprietary name, active ingredients, marketing application number...

  6. FDA regulations for commercial food irradiation

    International Nuclear Information System (INIS)

    Takeguchi, C.A.

    1985-01-01

    The Food and Drug Administration published an Advance Notice of Proposed Rulemaking (ANPR) on food irradiation on March 27, 1981 (FDA, 1981). The next step in the rulemaking process is a proposed rule that will deal with low-dose irradiation of certain foods and high-dose irradiation of spices. The status of the proposed regulation is discussed

  7. New experimental proposals for testing Dirac equation

    International Nuclear Information System (INIS)

    Camacho, Abel; Macias, Alfredo

    2004-01-01

    The advent of phenomenological quantum gravity has ushered us in the search for experimental tests of the deviations from general relativity predicted by quantum gravity or by string theories, and as a by-product of this quest the possible modifications that some field equations, for instance, the motion equation of spin-1/2-particles, have already been considered. In the present Letter a modified Dirac equation, whose extra term embraces a second-order time derivative, is taken as mainstay, and three different experimental proposals to detect it are put forward. The novelty in these ideas is that two of them do not fall within the extant approaches in this context, to wit, red-shift, atomic interferometry, or Hughes-Drever type-like experiments

  8. EVA geen FDA

    NARCIS (Netherlands)

    Folbert, J.P.; Dagevos, J.C.

    2001-01-01

    De oprichting van een Europese Voedselautoriteit die in 2002 operationeel moet zijn. Velen zien hierin een evenbeeld van de Amerikaanse FDA (Food and Drug Administration). Deze instantie werkt echter niet zo ideaal als vaak wordt voorgesteld. Het belangrijkste verschil tussen beide instanties is de

  9. Assessing Willingness to Test for HIV among Men who have Sex with Men Using Conjoint Analysis, Evidence for Uptake of the FDA-approved at-Home HIV Test

    Science.gov (United States)

    Lee, Sung-Jae; Brooks, Ronald; Bolan, Robert K.; Flynn, Risa

    2013-01-01

    Men who have sex with men (MSM) in the United States represent a vulnerable population with lower rates of HIV testing. There are various specific attributes of HIV testing that may impact willingness to test (WTT) for HIV. Identifying specific attributes influencing patients’ decisions around WTT for HIV is critical to ensure improved HIV testing uptake. This study examined WTT for HIV by using conjoint analysis, an innovative method for systematically estimating consumer preferences across discrete attributes. WTT for HIV was assessed across eight hypothetical HIV testing scenarios varying across seven dichotomous attributes: location (home vs. clinic), price (free vs. $50), sample collection (finger prick vs. blood), timeliness of results (immediate vs. 1–2 weeks), privacy (anonymous vs. confidential), results given (by phone vs. in-person), and type of counseling (brochure vs. in-person). Seventy-five MSM were recruited from a community based organization providing HIV testing services in Los Angeles to participate in conjoint analysis. WTT for HIV score was based on a 100-point scale. Scores ranged from 32.2 to 80.3 for eight hypothetical HIV testing scenarios. Price of HIV testing (free vs. $50) had the highest impact on WTT (impact score=31.4, SD=29.2, p<.0001), followed by timeliness of results (immediate vs. 1–2 weeks) (impact score=13.9, SD=19.9, p=<.0001) and testing location (home vs. clinic) (impact score=10.3, SD=22.8, p=.0002). Impacts of other HIV testing attributes were not significant. Conjoint analysis method enabled direct assessment of HIV testing preferences and identified specific attributes that significantly impact WTT for HIV among MSM. This method provided empirical evidence to support the potential uptake of the newly FDA-approved over-the-counter HIV home-test kit with immediate results, with cautionary note on the cost of the kit. PMID:23651439

  10. Analysis of a proposed crucial test of quantum mechanics

    International Nuclear Information System (INIS)

    Collett, M.J.; Loudon, R.

    1987-01-01

    An experiment based on an extension of the Einstein-Podolsky-Rosen argument has been proposed by Popper as a crucial test of the Copenhagen interpretation of quantum mechanics. Here the authors show, by a slightly more complete version of Popper's analysis, although still at a relatively primitive level of sophistication, that the proposed experiment does not in fact provide such a test. (author)

  11. FDA Warns About Stem Cell Therapies

    Science.gov (United States)

    ... Home For Consumers Consumer Updates FDA Warns About Stem Cell Therapies Share Tweet Linkedin Pin it More sharing ... see the boxed section below for more advice. Stem Cell Uses and FDA Regulation The FDA has the ...

  12. Regulating nanomedicine - can the FDA handle it?

    Science.gov (United States)

    Bawa, Raj

    2011-05-01

    There is enormous excitement and expectation surrounding the multidisciplinary field of nanomedicine - the application of nanotechnology to healthcare - which is already influencing the pharmaceutical industry. This is especially true in the design, formulation and delivery of therapeutics. Currently, nanomedicine is poised at a critical stage. However, regulatory guidance in this area is generally lacking and critically needed to provide clarity and legal certainty to manufacturers, policymakers, healthcare providers as well as public. There are hundreds, if not thousands, of nanoproducts on the market for human use but little is known of their health risks, safety data and toxicity profiles. Less is known of nanoproducts that are released into the environment and that come in contact with humans. These nanoproducts, whether they are a drug, device, biologic or combination of any of these, are creating challenges for the Food and Drug Administration (FDA), as regulators struggle to accumulate data and formulate testing criteria to ensure development of safe and efficacious nanoproducts (products incorporating nanoscale technologies). Evidence continues to mount that many nanoproducts inherently posses novel size-based properties and toxicity profiles. Yet, this scientific fact has been generally ignored by the FDA and the agency continues to adopt a precautionary approach to the issue in hopes of countering future potential negative public opinion. As a result, the FDA has simply maintained the status quo with regard to its regulatory policies pertaining to nanomedicine. Therefore, there are no specific laws or mechanisms in place for oversight of nanomedicine and the FDA continues to treat nanoproducts as substantially equivalent ("bioequivalent") to their bulk counterparts. So, for now nanoproducts submitted for FDA review will continue to be subjected to an uncertain regulatory pathway. Such regulatory uncertainty could negatively impact venture funding, stifle

  13. Cost estimate for a proposed GDF Suez LNG testing program

    Energy Technology Data Exchange (ETDEWEB)

    Blanchat, Thomas K.; Brady, Patrick Dennis; Jernigan, Dann A.; Luketa, Anay Josephine; Nissen, Mark R.; Lopez, Carlos; Vermillion, Nancy; Hightower, Marion Michael

    2014-02-01

    At the request of GDF Suez, a Rough Order of Magnitude (ROM) cost estimate was prepared for the design, construction, testing, and data analysis for an experimental series of large-scale (Liquefied Natural Gas) LNG spills on land and water that would result in the largest pool fires and vapor dispersion events ever conducted. Due to the expected cost of this large, multi-year program, the authors utilized Sandia's structured cost estimating methodology. This methodology insures that the efforts identified can be performed for the cost proposed at a plus or minus 30 percent confidence. The scale of the LNG spill, fire, and vapor dispersion tests proposed by GDF could produce hazard distances and testing safety issues that need to be fully explored. Based on our evaluations, Sandia can utilize much of our existing fire testing infrastructure for the large fire tests and some small dispersion tests (with some modifications) in Albuquerque, but we propose to develop a new dispersion testing site at our remote test area in Nevada because of the large hazard distances. While this might impact some testing logistics, the safety aspects warrant this approach. In addition, we have included a proposal to study cryogenic liquid spills on water and subsequent vaporization in the presence of waves. Sandia is working with DOE on applications that provide infrastructure pertinent to wave production. We present an approach to conduct repeatable wave/spill interaction testing that could utilize such infrastructure.

  14. FDA regulation of tobacco: blessing or curse for FDA professionals?

    Science.gov (United States)

    O'Reilly, James T

    2009-01-01

    Upwards of 400,000 Americans will die that year from the effects of cigarettes, which FDA will now "regulate" very gently, with its hands tied by a slick statutory protection for the largest existing tobacco marketers. Career FDA professionals will be criticized as enablers of mega-marketers' continued sales, working at the margins, arranging the paperwork for protection of megafirms' market share, and sitting by as the deaths and addictive behaviors continue. "Join the Public Health Service, inspired by a public health mission," they were told, and yet they will be unable to do much regulating of the addictive and fatal products for which they now have titular responsibility. This essay observes that these fine FDA professionals are handed the sticky remains of a messy bargain, negotiated in a distracted Congress by expensive lawyers with clients who were potent contributors to political action committees. The only formula that is not secret about the 2009 law is the way in which industry purchased sufficient allegiance to gather the votes for its adoption. The remaining mystery is how FDA could be expected to do these tasks without losing its best and brightest professionals to other fields.

  15. Proposal of world network on material testing reactors

    International Nuclear Information System (INIS)

    Takemoto, Noriyuki; Izumo, Hironobu; Hori, Naohiko; Ishitsuka, Etsuo; Ishihara, Masahiro

    2011-01-01

    Establishment of an international cooperation system of worldwide testing reactor network (world network) is proposed in order to achieve efficient facility utilization and provide high quality irradiation data by role sharing of irradiation tests with materials testing reactors in the world. As for the first step, mutual understanding among materials testing reactors is thought to be necessary. From this point, an international symposium on materials testing reactors (ISMTR) was held to construct the world network from 2008, and a common understanding of world network has begun to be shared. (author)

  16. Subarray-based FDA radar to counteract deceptive ECM signals

    Science.gov (United States)

    Abdalla, Ahmed; Wang, Wen-Qin; Yuan, Zhao; Mohamed, Suhad; Bin, Tang

    2016-12-01

    In recent years, the frequency diverse array (FDA) radar concept has attracted extensive attention, as it may benefit from a small frequency increment, compared to the carrier frequency across the array elements and thereby achieve an array factor that is a function of the angle, the time, and the range which is superior to the conventional phase array radar (PAR). However, limited effort on the subject of FDA in electronic countermeasure scenarios, especially in the presence of mainbeam deceptive jamming, has been published. Basic FDA is not desirable for anti-jamming applications, due to the range-angle coupling response of targets. In this paper, a novel method based on subarrayed FDA signal processing is proposed to counteract deceptive ECM signals. We divide the FDA array into multiple subarrays, each of which employs a distinct frequency increment. As a result, in the subarray-based FDA, the desired target can be distinguished at subarray level in joint range-angle-Doppler domain by utilizing the fact that the jammer generates false targets with the same ranges to each subarray without reparations. The performance assessment shows that the proposed solution is effective for deceptive ECM targets suppression. The effectiveness is verified by simulation results.

  17. Proposed experimental test of an alternative electrodynamic theory of superconductors

    Energy Technology Data Exchange (ETDEWEB)

    Hirsch, J.E., E-mail: jhirsch@ucsd.edu

    2015-01-15

    Highlights: • A new experimental test of electric screening in superconductors is proposed. • The electric screening length is predicted to be much larger than in normal metals. • The reason this was not seen in earlier experiments is explained. • This is not predicted by the conventional BCS theory of superconductivity. - Abstract: An alternative form of London’s electrodynamic theory of superconductors predicts that the electrostatic screening length is the same as the magnetic penetration depth. We argue that experiments performed to date do not rule out this alternative formulation and propose an experiment to test it. Experimental evidence in its favor would have fundamental implications for the understanding of superconductivity.

  18. Proposed Objective Odor Control Test Methodology for Waste Containment

    Science.gov (United States)

    Vos, Gordon

    2010-01-01

    The Orion Cockpit Working Group has requested that an odor control testing methodology be proposed to evaluate the odor containment effectiveness of waste disposal bags to be flown on the Orion Crew Exploration Vehicle. As a standardized "odor containment" test does not appear to be a matter of record for the project, a new test method is being proposed. This method is based on existing test methods used in industrial hygiene for the evaluation of respirator fit in occupational settings, and takes into consideration peer reviewed documentation of human odor thresholds for standardized contaminates, industry stardnard atmostpheric testing methodologies, and established criteria for laboratory analysis. The proposed methodology is quantitative, though it can readily be complimented with a qualitative subjective assessment. Isoamyl acetate (IAA - also known at isopentyl acetate) is commonly used in respirator fit testing, and there are documented methodologies for both measuring its quantitative airborne concentrations. IAA is a clear, colorless liquid with a banana-like odor, documented detectable smell threshold for humans of 0.025 PPM, and a 15 PPB level of quantation limit.

  19. FDA Peanut-Containing Product Recall

    Data.gov (United States)

    U.S. Department of Health & Human Services — The FDA Peanut-Containing Product Recall widget allows you to browse the Food and Drug Administration (FDA) database of peanut butter and peanut-containing products...

  20. Proposals for cold testing of the ITER TF coils

    International Nuclear Information System (INIS)

    Libeyre, P.; Ciazynski, D.; Dolgetta, N.; Duchateau, J.L.; Lyraud, C.; Kircher, F.; Schild, T.; Fietz, W.H.; Zahn, G.

    2005-01-01

    The ITER Toroidal Field (TF) magnet system will be made of 18 coils using Nb 3 Sn as superconducting material. These coils will operate at a maximum field of 11.8 T for a nominal current of 68 kA carried by a dual channel cable-in-conduit conductor cooled by a forced flow of supercritical helium at 4.5 K. In each coil, seven 760 m conductor lengths wound in double pancakes will be connected to each other by low resistance joints. As a final step of the reception tests, it is proposed to perform cold tests of these coils at liquid helium temperature after completion of their manufacture. The testing shall include high voltage tests to check the quality of the insulation, leak tests and pressure drop measurements of the hydraulic circuits as well as measurement of the joint resistances. Testing the coils up to nominal current is a discussed option, addressing on one hand measurement of the electrical performances in self field and on the other hand the mechanical behaviour of the coils. To perform these tests, a dedicated test facility has to be built, allowing possible simultaneous testing of two coils, assembled together in a twin coil configuration, similarly to their assembly in the torus. (authors)

  1. Proposals for cold testing of the ITER TF coils

    Energy Technology Data Exchange (ETDEWEB)

    Libeyre, P.; Ciazynski, D.; Dolgetta, N.; Duchateau, J.L.; Lyraud, C. [Association Euratom/CEA Cadarache, Dept. de Recherches sur la Fusion Controlee (DRFC), 13 - Saint-Paul-lez-Durance (France); Kircher, F.; Schild, T. [CEA Saclay, Dept. d' Astrophysique, de Physique des Particules, de Physique Nucleaire et de l' Instrumentation Associee, 91- Gif sur Yvette (France); Fietz, W.H.; Zahn, G. [Association Euratom-Forschungszentrum Karlsruhe, Karlsruhe (Germany)

    2005-07-01

    The ITER Toroidal Field (TF) magnet system will be made of 18 coils using Nb{sub 3}Sn as superconducting material. These coils will operate at a maximum field of 11.8 T for a nominal current of 68 kA carried by a dual channel cable-in-conduit conductor cooled by a forced flow of supercritical helium at 4.5 K. In each coil, seven 760 m conductor lengths wound in double pancakes will be connected to each other by low resistance joints. As a final step of the reception tests, it is proposed to perform cold tests of these coils at liquid helium temperature after completion of their manufacture. The testing shall include high voltage tests to check the quality of the insulation, leak tests and pressure drop measurements of the hydraulic circuits as well as measurement of the joint resistances. Testing the coils up to nominal current is a discussed option, addressing on one hand measurement of the electrical performances in self field and on the other hand the mechanical behaviour of the coils. To perform these tests, a dedicated test facility has to be built, allowing possible simultaneous testing of two coils, assembled together in a twin coil configuration, similarly to their assembly in the torus. (authors)

  2. Historical information on ORNL proposals for ECCS testing

    International Nuclear Information System (INIS)

    1976-01-01

    This document contains a compilation of the correspondence and preliminary report which the Oak Ridge National Laboratory submitted to the U.S. Atomic Energy Commission on the subject of in situ testing of emergency core cooling systems (ECCS) in pressurized water reactors. Most of the correspondence, which was prepared four to five years ago, deals with an ORNL proposal to evaluate the merits of conducting an in situ ECCS test in a full-scale commercial power plant. The end result of this work was to be a report in which the feasibility of conducting such an experiment would be discussed and a ''rough'' cost estimate provided. In support of this proposal, ORNL prepared a brief preliminary prospectus which identified some of the key questions that were to be addressed should the evaluation study be funded

  3. Spurious Seasonality Detection: A Non-Parametric Test Proposal

    Directory of Open Access Journals (Sweden)

    Aurelio F. Bariviera

    2018-01-01

    Full Text Available This paper offers a general and comprehensive definition of the day-of-the-week effect. Using symbolic dynamics, we develop a unique test based on ordinal patterns in order to detect it. This test uncovers the fact that the so-called “day-of-the-week” effect is partly an artifact of the hidden correlation structure of the data. We present simulations based on artificial time series as well. While time series generated with long memory are prone to exhibit daily seasonality, pure white noise signals exhibit no pattern preference. Since ours is a non-parametric test, it requires no assumptions about the distribution of returns, so that it could be a practical alternative to conventional econometric tests. We also made an exhaustive application of the here-proposed technique to 83 stock indexes around the world. Finally, the paper highlights the relevance of symbolic analysis in economic time series studies.

  4. Proposing and testing SOA governance process: A case study approach

    DEFF Research Database (Denmark)

    Koumaditis, Konstantinos; Themistocleous, Marinos

    2015-01-01

    Longstanding Healthcare Information Systems (HIS) integration challenges drove healthcare organisations to invest in new paradigms like Service Oriented Architecture (SOA). Yet, SOA holds challenges of its own, with SOA Governance surfacing on the top. This research depicts the development......, grounded in the normative literature and further developed to include healthcare aspects. The proposition is tested in a large Greek hospital utilising qualitative methods and the findings presented herein. This proposal aims to pinpoint attributes and guidelines for SOA Governance Process, required...

  5. A common feature pharmacophore for FDA-approved drugs inhibiting the Ebola virus.

    Science.gov (United States)

    Ekins, Sean; Freundlich, Joel S; Coffee, Megan

    2014-01-01

    We are currently faced with a global infectious disease crisis which has been anticipated for decades. While many promising biotherapeutics are being tested, the search for a small molecule has yet to deliver an approved drug or therapeutic for the Ebola or similar filoviruses that cause haemorrhagic fever. Two recent high throughput screens published in 2013 did however identify several hits that progressed to animal studies that are FDA approved drugs used for other indications. The current computational analysis uses these molecules from two different structural classes to construct a common features pharmacophore. This ligand-based pharmacophore implicates a possible common target or mechanism that could be further explored. A recent structure based design project yielded nine co-crystal structures of pyrrolidinone inhibitors bound to the viral protein 35 (VP35). When receptor-ligand pharmacophores based on the analogs of these molecules and the protein structures were constructed, the molecular features partially overlapped with the common features of solely ligand-based pharmacophore models based on FDA approved drugs. These previously identified FDA approved drugs with activity against Ebola were therefore docked into this protein. The antimalarials chloroquine and amodiaquine docked favorably in VP35. We propose that these drugs identified to date as inhibitors of the Ebola virus may be targeting VP35. These computational models may provide preliminary insights into the molecular features that are responsible for their activity against Ebola virus in vitro and in vivo and we propose that this hypothesis could be readily tested.

  6. Proposed experimental test of Bell's inequality in nuclear beta decay

    International Nuclear Information System (INIS)

    Skalsey, M.

    1986-01-01

    A β decay experiment is proposed for testing Bell's inequality, related to hidden-variables alternatives to quantum mechanics. The experiment uses Mott scattering for spin polarization analysis of internal conversion electrons. Beta-decay electrons, in cascade with the conversion electrons, are longitudinally polarized due to parity violation in the weak interaction. So simply detecting the β electron direction effectively measures the spin. A two-particle spin-spin correlation can thus be investigated and related, within certain assumptions, to Bell's inequality. The example of 203 Hg decay is used for a calculation of expected results. Specific problems related to nuclear structure and experimental inconsistencies are also discussed

  7. Proposed experimental test of the theory of hole superconductivity

    Energy Technology Data Exchange (ETDEWEB)

    Hirsch, J.E., E-mail: jhirsch@ucsd.edu

    2016-06-15

    Highlights: • The conventional theory of superconductivity predicts no charge flow when the normal-superconductor phase boundary moves. • The theory of hole superconductivity predicts flow and counterflow of charge. • An experiment to measure a voltage is proposed. • No voltage will be measured if the conventional theory is correct. • A voltage will be measured if the theory of hole superconductivity is correct. - Abstract: The theory of hole superconductivity predicts that in the reversible transition between normal and superconducting phases in the presence of a magnetic field there is charge flow in direction perpendicular to the normal-superconductor phase boundary. In contrast, the conventional BCS-London theory of superconductivity predicts no such charge flow. Here we discuss an experiment to test these predictions.

  8. Final focus test beam alignment: A draft proposal

    International Nuclear Information System (INIS)

    Fischer, G.E.; Ruland, R.E.

    1989-03-01

    The Final Focus Test Beam is a transport line designed to transmit 50 GeV electron beams of SLC emittance (3 x 10 -10 radian-meters) straight through the central arm of the Beam Switchyard (BSY C line) with a final focus point out in the Research Yard but relatively near the end of the switchyard tunnel. The hardware, methods and procedures outlined in this proposal are dedicated to measuring the placement of mechanical objects with respect to certain defined geometric axes. We wish to emphasize that the very difficult problems of locating the effective magnetic axes of focusing elements, the effective electrical center of beam position monitors and even the effective axis of the incident beam relative to mechanical reference surfaces is outside the scope of this work. Further, this proposal is restricted to the act of measurement and does not consider the vital task of on-line mechanical repositioning of elements that will, in likelihood, be called upon during operation of the system. 16 refs., 16 figs., 4 tabs

  9. Current and future state of FDA-CMS parallel reviews.

    Science.gov (United States)

    Messner, D A; Tunis, S R

    2012-03-01

    The US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) recently proposed a partial alignment of their respective review processes for new medical products. The proposed "parallel review" not only offers an opportunity for some products to reach the market with Medicare coverage more quickly but may also create new incentives for product developers to conduct studies designed to address simultaneously the information needs of regulators, payers, patients, and clinicians.

  10. Towards sensible toxicity testing for nanomaterials: proposal for the specification of test design

    International Nuclear Information System (INIS)

    Potthoff, Annegret; Meißner, Tobias; Weil, Mirco; Kühnel, Dana

    2015-01-01

    During the last decade, nanomaterials (NM) were extensively tested for potential harmful effects towards humans and environmental organisms. However, a sound hazard assessment was so far hampered by uncertainties and a low comparability of test results. The reason for the low comparability is a high variation in the (1) type of NM tested with regard to raw material, size and shape and (2) procedures before and during the toxicity testing. This calls for tailored, nanomaterial-specific protocols. Here, a structured approach is proposed, intended to lead to test protocols not only tailored to specific types of nanomaterials, but also to respective test system for toxicity testing. There are existing standards on single procedures involving nanomaterials, however, not all relevant procedures are covered by standards. Hence, our approach offers a detailed way of weighting several plausible alternatives for e.g. sample preparation, in order to decide on the procedure most meaningful for a specific nanomaterial and toxicity test. A framework of several decision trees (DT) and flow charts to support testing of NM is proposed as a basis for further refinement and in-depth elaboration. DT and flow charts were drafted for (1) general procedure—physicochemical characterisation, (2) choice of test media, (3) decision on test scenario and application of NM to liquid media, (4) application of NM to the gas phase, (5) application of NM to soil and sediments, (6) dose metrics, (S1) definition of a nanomaterial, and (S2) dissolution. The applicability of the proposed approach was surveyed by using experimental data retrieved from studies on nanoscale CuO. This survey demonstrated the DT and flow charts to be a convenient tool to systematically decide upon test procedures and processes, and hence pose an important step towards harmonisation of NM testing. (paper)

  11. Thematic Apperception Test: an original proposal for interaction analysis

    Directory of Open Access Journals (Sweden)

    Doriana Dipaola

    2015-12-01

    Full Text Available The TAT as projective technique gives the opportunity to explore the inner world and the intra-psychic functioning, as well as the objectual representations and the prevailing thinking processes. Our hypothesis is that the TAT could also be deployed as a valid tool in the analysis of inter-personal functioning, specifically within the couple. From this assumption originates our proposal for an original methodology of TAT deployment and reading, which integrates the classical individual TAT methodology with the Common Rorschach method suggested by Willi. The goal is to experiment a parallel utilisation of the test that could contribute to the understanding of personalities and of how these intertwine in couple interaction. “In the relationship with the partner, the personality takes new shapes, given personality and character traits are strengthened, while others lose importance”, (Theodore Lidz, in Willi, 1990. The couple TAT presupposes a sequence of pictures proposed following procedures identical to the Common Rorschach ones to the single individuals at first and then to the couple. From the initial individual task follows the one of building a commonly shared history starting from the stimulus. The suggested methodology shall be exemplified through the presentation of clinical cases belonging to the research sample. The comprehension of the inter-personal dynamic, in a common task, could allow to explore the ways in which conflict expresses itself, the roles and prospects for collaboration, the “generativity” of the couple and the management of affects and anxieties in the interaction and could be successfully deployed as a tool in the context of couple counselling.

  12. 78 FR 14309 - Implementation of the FDA Food Safety Modernization Act Provision Requiring FDA To Establish...

    Science.gov (United States)

    2013-03-05

    ... FDA's Product Tracing Web page at http://www.fda.gov/Food/FoodSafety/FSMA/ucm270851.htm . This... Submit a Report to Congress for the Improvement of Tracking and Tracing of Food; Request for Comments and... Institute of Food Technologists (IFT) to execute product tracing pilot projects as described in the FDA Food...

  13. The proposal of a novel software testing framework

    OpenAIRE

    Ahmad, Munib; Bajaber, Fuad; Qureshi, M. Rizwan Jameel

    2014-01-01

    Software testing is normally used to check the validity of a program. Test oracle performs an important role in software testing. The focus in this research is to perform class level test by introducing a testing framework. A technique is developed to generate test oracle for specification-based software testing using Vienna Development Method (VDM++) formal language. A three stage translation process, of VDM++ specifications of container classes to C++ test oracle classes, is described in th...

  14. Experiences of the REACH testing proposals system to reduce animal testing.

    Science.gov (United States)

    Taylor, Katy; Stengel, Wolfgang; Casalegno, Carlotta; Andrew, David

    2014-01-01

    In order to reduce animal testing, companies registering chemical substances under the EU REACH legislation must propose rather than conduct certain tests on animals. Third parties can submit 'scientifically valid information' relevant to these proposals to the Agency responsible, the European Chemicals Agency (ECHA), who are obliged to take the information into account. The European Coalition to End Animal Experiments (ECEAE) provided comments on nearly half of the 817 proposals for vertebrate tests on 480 substances published for comment for the first REACH deadline (between 1 August 2009 and 31 July 2012). The paper summarises the response by registrants and the Agency to third party comments and highlights issues with the use of read across, in vitro tests, QSAR and weight of evidence approaches. Use of existing data and evidence that testing is legally or scientifically unjustified remain the most successful comments for third parties to submit. There is a worrying conservatism within the Agency regarding the acceptance of alternative approaches and examples of where registrants have also failed to maximise opportunities to avoid testing.

  15. The effect of proposed crush tests on transport containers

    International Nuclear Information System (INIS)

    1984-09-01

    Crush tests were performed on two AECL F112 packaging specimens, two simulated AECL-CRNL 4H packaging specimens, and on empty steel drums. The 9 m drop test was carried out on two simulated AECL-CRNL 4H packaging specimens for comparison with the effects of the crush test. The tests were filmed using high speed photography and 35mm still photographs

  16. FDA Approves First Therapeutic Cancer Vaccine

    Science.gov (United States)

    Sipuleucel-T (Provenge) is a relatively nontoxic treatment option for men with hormone-resistant or castration-resistant prostate cancer. The FDA's approval of the vaccine represented the first proof of principle that immunotherapy can work in cancer.

  17. Gottlieb, the FDA and dumbing down medicine

    OpenAIRE

    Robbins RA

    2017-01-01

    No abstract available. Article truncated at 150 words. In the last few weeks several events have occurred that might impact drug approval in the US. President Donald Trump's pick for FDA commissioner, Dr. Scott Gottlieb. Gottlieb, like many of Trump’s picks for administration healthcare positions, is a physician. He also has experience as deputy FDA commissioner from 2005-7. However, his confirmation hearing before the Senate Committee on Health, Education, Labor and Pensions alarmed some wh...

  18. FDA and the Chemical Brain Drainers

    DEFF Research Database (Denmark)

    Grandjean, Philippe

    2017-01-01

    Comment to: "Anesthesia and Developing Brains — Implications of the FDA Warning." Dean B. Andropoulos, M.D., M.H.C.M., and Michael F. Greene, M.D. N Engl J Med 2017; 376:905-907......Comment to: "Anesthesia and Developing Brains — Implications of the FDA Warning." Dean B. Andropoulos, M.D., M.H.C.M., and Michael F. Greene, M.D. N Engl J Med 2017; 376:905-907...

  19. Quantum Strategies: Proposal to Experimentally Test a Quantum Economics Protocol

    Science.gov (United States)

    2009-04-09

    protocols can add security to competitive situations; and analyzing the feasibility of running multi-party quantum games over metro-distance optical... games of complete informa- tion. Physics Letters A, 272:291-303, August 2000. [21] D. A. Meyer. Quantum Communication in Games . In S. M. Barnett, E ...feasibility of quantum games , we proposed to implement a proof-of-principle quantum public goods game , and to experimentally demonstrate that the quantum

  20. Hypnotic Medications and Suicide: Risk, Mechanisms, Mitigation, and the FDA.

    Science.gov (United States)

    McCall, W Vaughn; Benca, Ruth M; Rosenquist, Peter B; Riley, Mary Anne; McCloud, Laryssa; Newman, Jill C; Case, Doug; Rumble, Meredith; Krystal, Andrew D

    2017-01-01

    Insomnia is associated with increased risk for suicide. The Food and Drug Administration (FDA) has mandated that warnings regarding suicide be included in the prescribing information for hypnotic medications. The authors conducted a review of the evidence for and against the claim that hypnotics increase the risk of suicide. This review focused on modern, FDA-approved hypnotics, beginning with the introduction of benzodiazepines, limiting its findings to adults. PubMed and Web of Science were searched, crossing the terms "suicide" and "suicidal" with each of the modern FDA-approved hypnotics. The FDA web site was searched for postmarketing safety reviews, and the FDA was contacted with requests to provide detailed case reports for hypnotic-related suicide deaths reported through its Adverse Event Reporting System. Epidemiological studies show that hypnotics are associated with an increased risk for suicide. However, none of these studies adequately controlled for depression or other psychiatric disorders that may be linked with insomnia. Suicide deaths have been reported from single-agent hypnotic overdoses. A separate concern is that benzodiazepine receptor agonist hypnotics can cause parasomnias, which in rare cases may lead to suicidal ideation or suicidal behavior in persons who were not known to be suicidal. On the other hand, ongoing research is testing whether treatment of insomnia may reduce suicidality in adults with depression. The review findings indicate that hypnotic medications are associated with suicidal ideation. Future studies should be designed to assess whether increases in suicidality result from CNS impairments from a given hypnotic medication or whether such medication decreases suicidality because of improvements in insomnia.

  1. The strong Bell inequalities: A proposed experimental test

    Science.gov (United States)

    Fry, Edward S.

    1994-01-01

    All previous experimental tests of Bell inequalities have required additional assumptions. The strong Bell inequalities (i.e. those requiring no additional assumptions) have never been tested. An experiment has been designed that can, for the first time, provide a definitive test of the strong Bell inequalities. Not only will the detector efficiency loophole be closed; but the locality condition will also be rigorously enforced. The experiment involves producing two Hg-199 atoms by a resonant Raman dissociation of a mercury dimer ((199)Hg2) that is in an electronic and nuclear spin singlet state. Bell inequalities can be tested by measuring angular momentum correlations between the spin one-half nuclei of the two Hg-199 atoms. The method used to make these latter measurements will be described.

  2. Proposed aeroelastic and flutter tests for the National Transonic Facility

    Science.gov (United States)

    Stevenson, J. R.

    1981-01-01

    Tests that can exploit the capability of the NTF and the transonic cryogenic tunnel, or lead to improvements that could enhance testing in the NTF are discussed. Shock induced oscillation, supersonic single degree control surface flutter, and transonic flutter speed as a function of the Reynolds number are considered. Honeycombs versus screens to smooth the tunnel flow and a rapid tunnel dynamic pressure reducer are recommended to improve tunnel performance.

  3. Proposed Interventions to Decrease the Frequency of Missed Test Results

    Science.gov (United States)

    Wahls, Terry L.; Cram, Peter

    2009-01-01

    Numerous studies have identified that delays in diagnosis related to the mishandling of abnormal test results are an import contributor to diagnostic errors. Factors contributing to missed results included organizational factors, provider factors and patient-related factors. At the diagnosis error conference continuing medical education conference…

  4. Proposed rf system for the fusion materials irradiation test facility

    International Nuclear Information System (INIS)

    Fazio, M.V.; Johnson, H.P.; Hoffert, W.J.; Boyd, T.J.

    1979-01-01

    Preliminary rf system design for the accelerator portion of the Fusion Materials Irradiation Test (FMIT) Facility is in progress. The 35-MeV, 100-mA, cw deuteron beam will require 6.3 MW rf power at 80 MHz. Initial testing indicates the EIMAC 8973 tetrode is the most suitable final amplifier tube for each of a series of 15 amplifier chains operating at 0.5-MW output. To satisfy the beam dynamics requirements for particle acceleration and to minimize beam spill, each amplifier output must be controlled to +-1 0 in phase and the field amplitude in the tanks must be held within a 1% tolerance. These tolerances put stringent demands on the rf phase and amplitude control system

  5. 75 FR 61492 - Agency Information Collection Activities; Proposed Collection; Comment Request; Testing...

    Science.gov (United States)

    2010-10-05

    ... understanding of target audiences that FDA needs to design effective communication strategies, messages, and labels. These communications will aim to improve public understanding of the risks and benefits of using... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0464...

  6. 78 FR 41066 - Agency Information Collection Activities; Proposed Collection; Comment Request; Testing...

    Science.gov (United States)

    2013-07-09

    ... provide the better understanding of target audiences that FDA needs to design effective communication strategies, messages, and labels. These communications will aim to improve public understanding of the risks... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0796...

  7. Proposal for testing quantum gravity in the lab

    International Nuclear Information System (INIS)

    Ali, Ahmed Farag; Das, Saurya; Vagenas, Elias C.

    2011-01-01

    Attempts to formulate a quantum theory of gravitation are collectively known as quantum gravity. Various approaches to quantum gravity such as string theory and loop quantum gravity, as well as black hole physics and doubly special relativity theories predict a minimum measurable length, or a maximum observable momentum, and related modifications of the Heisenberg Uncertainty Principle to a so-called generalized uncertainty principle (GUP). We have proposed a GUP consistent with string theory, black hole physics, and doubly special relativity theories and have showed that this modifies all quantum mechanical Hamiltonians. When applied to an elementary particle, it suggests that the space that confines it must be quantized, and in fact that all measurable lengths are quantized in units of a fundamental length (which can be the Planck length). On the one hand, this may signal the breakdown of the spacetime continuum picture near that scale, and on the other hand, it can predict an upper bound on the quantum gravity parameter in the GUP, from current observations. Furthermore, such fundamental discreteness of space may have observable consequences at length scales much larger than the Planck scale. Because this influences all the quantum Hamiltonians in an universal way, it predicts quantum gravity corrections to various quantum phenomena. Therefore, in the present work we compute these corrections to the Lamb shift, simple harmonic oscillator, Landau levels, and the tunneling current in a scanning tunneling microscope.

  8. In vitro vaccine potency testing: a proposal for reducing animal use for requalification testing.

    Science.gov (United States)

    Brown, K; Stokes, W

    2012-01-01

    This paper proposes a program under which the use of animals for requalification of in vitro potency tests could be eliminated. Standard References (USDA/CVB nomenclature) would be developed, characterized, stored and monitored by selected reference laboratories worldwide. These laboratories would employ scientists skilled in protein and glycoprotein chemistry and equipped with state-of-the-art instruments for required analyses. After Standard References are established, the reference laboratories would provide them to the animal health industry as "gold standards". Companies would then establish and validate a correlation between the Standard Reference and the company Master Reference (USDA/CVB nomenclature) using an internal in vitro assay. After this correlation is established, the company could use the Standard References for qualifying, monitoring and requalifying company Master References without the use of animals. Such a program would eliminate the need for animals for requalification of Master References and the need for each company to develop and validate a battery of Master Reference Monitoring assays. It would also provide advantages in terms of reduced costs and reduced time for requalification testing. As such it would provide a strong incentive for companies to develop and use in vitro assays for potency testing.

  9. 77 FR 14404 - Guidance for the Public, Food and Drug Administration (FDA) Advisory Committee Members, and FDA...

    Science.gov (United States)

    2012-03-09

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2002-D-0094; (formerly Docket No. 02D-0049)] Guidance for the Public, Food and Drug Administration (FDA) Advisory... Food and Drug Administration (FDA) is announcing the availability of a guidance for the public, FDA...

  10. Evaluating three proposals for testing independence in non linear spatial processes

    OpenAIRE

    López Hernández, Fernando Antonio; Mate Sánchez-Val, María Luz; Artal Tur, Andrés

    2013-01-01

    [ENG]This paper evaluates the behaviour of different families of tests when checking for spatial independence in the presence of nonlinearities. To reach this goal, we select three representative proposals. The usual parametric tests of I-Moran, the nonparametric proposal of Brett and Pinkse (1997), and the semiparametric Scan test. In order to study how they perform, we simulate different nonlinear spatial structures by Monte Carlo methods, hence conducting empirical tests on ...

  11. Proposed sealing field tests for a potential high-level radioactive waste repository in unsaturated tuff

    International Nuclear Information System (INIS)

    Fernandez, J.A.; Case, J.B.; Tyburski, J.

    1992-01-01

    This paper contains a general description of the field tests proposed for the Yucca Mountain Site Characterization Project repository sealing program. The tests are intended to resolve various performance and emplacement concerns associated with sealing components. Ten discrete tests are proposed to address these concerns. These tests are divided into two categories -- simple and complex tests. The simple tests are: the small-scale in situ tests: the intermediate-scale borehole seal tests; the fracture grouting tests; the surface backfill tests; and the grouted rock mass tests. The complex tests are the seepage control tests; in situ backfill tests; in situ bulkhead tests; large-scale shaft seal tests; and remote borehole seal tests. These tests are proposed to be performed in welded and nonwelded tuff environments. The final selection of sealing tests will depend on the nature of the geologic and hydrologic conditions encountered during the development of the exploratory studies facility. Some tests may be performed before license application and some after license application

  12. Access to Investigational Drugs: FDA Expanded Access Programs or “Right‐to‐Try” Legislation?

    Science.gov (United States)

    Berglund, Jelena P.; Weatherwax, Kevin; Gerber, David E.; Adamo, Joan E.

    2015-01-01

    Abstract Purpose The Food and Drug Administration Expanded Access (EA) program and “Right‐to‐Try” legislation aim to provide seriously ill patients who have no other comparable treatment options to gain access to investigational drugs and biological agents. Physicians and institutions need to understand these programs to respond to questions and requests for access. Methods FDA EA programs and state and federal legislative efforts to provide investigational products to patients by circumventing FDA regulations were summarized and compared. Results The FDA EA program includes Single Patient‐Investigational New Drug (SP‐IND), Emergency SP‐IND, Intermediate Sized Population IND, and Treatment IND. Approval rates for all categories exceed 99%. Approval requires FDA and Institutional Review Board (IRB) approval, and cooperation of the pharmaceutical partner is essential. “Right‐to‐Try” legislation bypasses some of these steps, but provides no regulatory or safety oversight. Conclusion The FDA EA program is a reasonable option for patients for whom all other therapeutic interventions have failed. The SP‐IND not only provides patient access to new drugs, but also maintains a balance between immediacy and necessary patient protection. Rather than circumventing existing FDA regulations through proposed legislation, it seems more judicious to provide the knowledge and means to meet the EA requirements. PMID:25588691

  13. Access to Investigational Drugs: FDA Expanded Access Programs or "Right-to-Try" Legislation?

    Science.gov (United States)

    Holbein, M E Blair; Berglund, Jelena P; Weatherwax, Kevin; Gerber, David E; Adamo, Joan E

    2015-10-01

    The Food and Drug Administration Expanded Access (EA) program and "Right-to-Try" legislation aim to provide seriously ill patients who have no other comparable treatment options to gain access to investigational drugs and biological agents. Physicians and institutions need to understand these programs to respond to questions and requests for access. FDA EA programs and state and federal legislative efforts to provide investigational products to patients by circumventing FDA regulations were summarized and compared. The FDA EA program includes Single Patient-Investigational New Drug (SP-IND), Emergency SP-IND, Intermediate Sized Population IND, and Treatment IND. Approval rates for all categories exceed 99%. Approval requires FDA and Institutional Review Board (IRB) approval, and cooperation of the pharmaceutical partner is essential. "Right-to-Try" legislation bypasses some of these steps, but provides no regulatory or safety oversight. The FDA EA program is a reasonable option for patients for whom all other therapeutic interventions have failed. The SP-IND not only provides patient access to new drugs, but also maintains a balance between immediacy and necessary patient protection. Rather than circumventing existing FDA regulations through proposed legislation, it seems more judicious to provide the knowledge and means to meet the EA requirements. © 2015 Wiley Periodicals, Inc.

  14. Evaluating eating behavior treatments by FDA standards

    Directory of Open Access Journals (Sweden)

    A. Janet eTomiyama

    2014-01-01

    Full Text Available Behavioral treatments for obesity are not evaluated by the same criteria as pharmaceutical drugs, even though treatments such as low-calorie dieting are widely prescribed, require the patients’ time and investment, and may have risks. The Food and Drug Administration (FDA has a procedure for evaluating drugs, in which drugmakers must answer the following questions: (1 Is the treatment safe? (2 How dangerous is the condition the intervention is treating? (3 Is the treatment effective? (4 Is the treatment safe and effective for large numbers of people? We argue that using this framework to evaluate behavioral interventions could help identify unanswered research questions on their efficacy and effectiveness, and we use the example of low-calorie dieting to illustrate how FDA criteria might be applied in the context of behavioral medicine.

  15. Mining FDA drug labels for medical conditions.

    Science.gov (United States)

    Li, Qi; Deleger, Louise; Lingren, Todd; Zhai, Haijun; Kaiser, Megan; Stoutenborough, Laura; Jegga, Anil G; Cohen, Kevin Bretonnel; Solti, Imre

    2013-04-24

    Cincinnati Children's Hospital Medical Center (CCHMC) has built the initial Natural Language Processing (NLP) component to extract medications with their corresponding medical conditions (Indications, Contraindications, Overdosage, and Adverse Reactions) as triples of medication-related information ([(1) drug name]-[(2) medical condition]-[(3) LOINC section header]) for an intelligent database system, in order to improve patient safety and the quality of health care. The Food and Drug Administration's (FDA) drug labels are used to demonstrate the feasibility of building the triples as an intelligent database system task. This paper discusses a hybrid NLP system, called AutoMCExtractor, to collect medical conditions (including disease/disorder and sign/symptom) from drug labels published by the FDA. Altogether, 6,611 medical conditions in a manually-annotated gold standard were used for the system evaluation. The pre-processing step extracted the plain text from XML file and detected eight related LOINC sections (e.g. Adverse Reactions, Warnings and Precautions) for medical condition extraction. Conditional Random Fields (CRF) classifiers, trained on token, linguistic, and semantic features, were then used for medical condition extraction. Lastly, dictionary-based post-processing corrected boundary-detection errors of the CRF step. We evaluated the AutoMCExtractor on manually-annotated FDA drug labels and report the results on both token and span levels. Precision, recall, and F-measure were 0.90, 0.81, and 0.85, respectively, for the span level exact match; for the token-level evaluation, precision, recall, and F-measure were 0.92, 0.73, and 0.82, respectively. The results demonstrate that (1) medical conditions can be extracted from FDA drug labels with high performance; and (2) it is feasible to develop a framework for an intelligent database system.

  16. FDA Adverse Event Reporting System (FAERS): Latest Quartely Data Files

    Data.gov (United States)

    U.S. Department of Health & Human Services — The FDA Adverse Event Reporting System (FAERS) is a database that contains information on adverse event and medication error reports submitted to FDA. The database...

  17. 21 CFR 60.10 - FDA assistance on eligibility.

    Science.gov (United States)

    2010-04-01

    ... from the U.S. Patent and Trademark Office, FDA will assist the U.S. Patent and Trademark Office in... in FDA's Division of Dockets Management (HFA-305), 5630 Fishers Lane, rm. 1061, Rockville, MD 20852...

  18. Gottlieb, the FDA and dumbing down medicine

    Directory of Open Access Journals (Sweden)

    Robbins RA

    2017-04-01

    Full Text Available No abstract available. Article truncated at 150 words. In the last few weeks several events have occurred that might impact drug approval in the US. President Donald Trump's pick for FDA commissioner, Dr. Scott Gottlieb. Gottlieb, like many of Trump’s picks for administration healthcare positions, is a physician. He also has experience as deputy FDA commissioner from 2005-7. However, his confirmation hearing before the Senate Committee on Health, Education, Labor and Pensions alarmed some who say his deep ties to the pharmaceutical industry will cause a conflict of interest (1. Others praised Gottlieb as the right man to lead the FDA. As opposed to Trump, Gottlieb denied any connection between vaccines and autism (1,2. Dr. Gottlieb called the issue "one of the most exhaustively studied questions in medical history," before saying, "There is no plausible link between vaccines and autism. At some point, we have to accept 'no' for an answer." However, Gottlieb did not give a straight …

  19. A proposed standard round compact specimen for plane strain fracture toughness testing

    Science.gov (United States)

    Underwood, J. H.; Newman, J. C., Jr.; Seeley, R. R.

    1980-01-01

    A round, disk-shaped specimen is proposed as a standard test specimen for addition to ASTM Test for Plane-Strain Fracture Toughness of Metallic Materials (E 399-78A). The specimen is diametrically cracked, and loaded in the same way as the existing standard compact specimen. Tests and analyses were performed to verify that the proposed round compact specimen and associated stress intensity factor K solution are appropriate for a standard plane strain fracture toughness test. The use of the round compact specimen for other fracture tests is described.

  20. 21 CFR 60.34 - FDA action on petitions.

    Science.gov (United States)

    2010-04-01

    ... RESTORATION Due Diligence Petitions § 60.34 FDA action on petitions. (a) Within 90 days after FDA receives a... this section or investigate and determine under § 60.36 whether the applicant acted with due diligence during the regulatory review period. FDA will publish its due diligence determination in the Federal...

  1. A common feature pharmacophore for FDA-approved drugs inhibiting the Ebola virus [v2; ref status: indexed, http://f1000r.es/4wt

    Directory of Open Access Journals (Sweden)

    Sean Ekins

    2014-12-01

    Full Text Available We are currently faced with a global infectious disease crisis which has been anticipated for decades. While many promising biotherapeutics are being tested, the search for a small molecule has yet to deliver an approved drug or therapeutic for the Ebola or similar filoviruses that cause haemorrhagic fever. Two recent high throughput screens published in 2013 did however identify several hits that progressed to animal studies that are FDA approved drugs used for other indications. The current computational analysis uses these molecules from two different structural classes to construct a common features pharmacophore. This ligand-based pharmacophore implicates a possible common target or mechanism that could be further explored. A recent structure based design project yielded nine co-crystal structures of pyrrolidinone inhibitors bound to the viral protein 35 (VP35. When receptor-ligand pharmacophores based on the analogs of these molecules and the protein structures were constructed, the molecular features partially overlapped with the common features of solely ligand-based pharmacophore models based on FDA approved drugs. These previously identified FDA approved drugs with activity against Ebola were therefore docked into this protein. The antimalarials chloroquine and amodiaquine docked favorably in VP35. We propose that these drugs identified to date as inhibitors of the Ebola virus may be targeting VP35. These computational models may provide preliminary insights into the molecular features that are responsible for their activity against Ebola virus in vitro and in vivo and we propose that this hypothesis could be readily tested.

  2. A common feature pharmacophore for FDA-approved drugs inhibiting the Ebola virus [v1; ref status: indexed, http://f1000r.es/4qh

    Directory of Open Access Journals (Sweden)

    Sean Ekins

    2014-11-01

    Full Text Available We are currently faced with a global infectious disease crisis which has been anticipated for decades. While many promising biotherapeutics are being tested, the search for a small molecule has yet to deliver an approved drug or therapeutic for the Ebola or similar filoviruses that cause haemorrhagic fever. Two recent high throughput screens published in 2013 did however identify several hits that progressed to animal studies that are FDA approved drugs used for other indications. The current computational analysis uses these molecules from two different structural classes to construct a common features pharmacophore. This ligand-based pharmacophore implicates a possible common target or mechanism that could be further explored. A recent structure based design project yielded nine co-crystal structures of pyrrolidinone inhibitors bound to the viral protein 35 (VP35. When receptor-ligand pharmacophores based on the analogs of these molecules and the protein structures were constructed, the molecular features partially overlapped with the common features of solely ligand-based pharmacophore models based on FDA approved drugs. These previously identified FDA approved drugs with activity against Ebola were therefore docked into this protein. The antimalarials chloroquine and amodiaquine docked favorably in VP35. We propose that these drugs identified to date as inhibitors of the Ebola virus may be targeting VP35. These computational models may provide preliminary insights into the molecular features that are responsible for their activity against Ebola virus in vitro and in vivo and we propose that this hypothesis could be readily tested.

  3. 77 FR 12089 - Proposed Generic Communication; Regulatory Issue Summary 2012-XX: Developing Inservice Testing...

    Science.gov (United States)

    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...

  4. A comment on a proposed ''crucial experiment'' to test Einstein's special theory of relativity

    International Nuclear Information System (INIS)

    Rodrigues Jr, W.A.; Buonamano, V.

    1976-01-01

    A proposed ''crucial experiment'' to test Einstein's special theory of relativity is analysed and it is shown that it falls into the set of unsatisfactory proposals that attempt to make an experimental distinction between Einstein's special theory of relativity and a ''Lorentzian type'' special theory of relativity

  5. Comment on a proposed ''crucial experiment'' to test Einstein's special theory of relativity

    Energy Technology Data Exchange (ETDEWEB)

    Rodrigues, Jr, W A [Universidade Estadual de Campinas (Brazil); Buonamano, V [Universidade Estadual de Campinas (Brazil). Instituto de Matematica

    1976-08-11

    A proposed ''crucial experiment'' to test Einstein's special theory of relativity is analysed and it is shown that it falls into the set of unsatisfactory proposals that attempt to make an experimental distinction between Einstein's special theory of relativity and a ''Lorentzian type'' special theory of relativity.

  6. Environmental assessment of proposed geothermal well testing in the Tigre Lagoon Oil Field, Vermilion Parish, Louisiana

    Energy Technology Data Exchange (ETDEWEB)

    1976-03-01

    An environmental assessment is made of the proposed testing of two geopressured, geothermal aquifers in central coastal Louisiana. On the basis of an analysis of the environmental setting, subsurface characteristics, and the proposed action, potential environmental impacts are determined and evaluated together with potential conflicts with federal, state, and local programs. (LBS )

  7. Water table tests of proposed heat transfer tunnels for small turbine vanes

    Science.gov (United States)

    Meitner, P. L.

    1974-01-01

    Water-table flow tests were conducted for proposed heat-transfer tunnels which were designed to provide uniform flow into their respective test sections of a single core engine turbine vane and a full annular ring of helicopter turbine vanes. Water-table tests were also performed for the single-vane test section of the core engine tunnel. The flow in the heat-transfer tunnels was shown to be acceptable.

  8. FDA approves efavirenz. Food and Drug Administration.

    Science.gov (United States)

    Highleyman, L

    1998-10-01

    The Food and Drug Administration (FDA) approved DuPont Pharma's new non-nucleoside reverse transcriptase inhibitor (NNRTI) efavirenz (Sustiva, DMP-266). Efavirenz has shown promise in trials with over 2000 participants for up to 24 weeks, and early data suggests it may be as effective as protease inhibitors when used in a combination regimen. It is the first anti-HIV drug approved for once-daily dosing. Efavirenz is well tolerated, and the main side effects reported are dizziness, insomnia, abnormal dreams, and skin rash. Efavirenz has been approved for adults and children, but should not be used by pregnant women. Contact information is provided.

  9. Fisher, Neyman, and Bayes at FDA.

    Science.gov (United States)

    Rubin, Donald B

    2016-01-01

    The wise use of statistical ideas in practice essentially requires some Bayesian thinking, in contrast to the classical rigid frequentist dogma. This dogma too often has seemed to influence the applications of statistics, even at agencies like the FDA. Greg Campbell was one of the most important advocates there for more nuanced modes of thought, especially Bayesian statistics. Because two brilliant statisticians, Ronald Fisher and Jerzy Neyman, are often credited with instilling the traditional frequentist approach in current practice, I argue that both men were actually seeking very Bayesian answers, and neither would have endorsed the rigid application of their ideas.

  10. Proposal and validation of a clinical trunk control test in individuals with spinal cord injury.

    Science.gov (United States)

    Quinzaños, J; Villa, A R; Flores, A A; Pérez, R

    2014-06-01

    One of the problems that arise in spinal cord injury (SCI) is alteration in trunk control. Despite the need for standardized scales, these do not exist for evaluating trunk control in SCI. To propose and validate a trunk control test in individuals with SCI. National Institute of Rehabilitation, Mexico. The test was developed and later evaluated for reliability and criteria, content, and construct validity. We carried out 531 tests on 177 patients and found high inter- and intra-rater reliability. In terms of criterion validity, analysis of variance demonstrated a statistically significant difference in the test score of patients with adequate or inadequate trunk control according to the assessment of a group of experts. A receiver operating characteristic curve was plotted for optimizing the instrument's cutoff point, which was determined at 13 points, with a sensitivity of 98% and a specificity of 92.2%. With regard to construct validity, the correlation between the proposed test and the spinal cord independence measure (SCIM) was 0.873 (P=0.001) and that with the evolution time was 0.437 (P=0.001). For testing the hypothesis with qualitative variables, the Kruskal-Wallis test was performed, which resulted in a statistically significant difference between the scores in the proposed scale of each group defined by these variables. It was proven experimentally that the proposed trunk control test is valid and reliable. Furthermore, the test can be used for all patients with SCI despite the type and level of injury.

  11. FDA: polyurethane condom carries "extremely misleading" label. Federal agency allows distribution for public health's sake.

    Science.gov (United States)

    1995-02-01

    The labeling of the Avanti polyurethane condom selling in 10 Western states makes misleading claims about protection from pregnancy and sexually transmitted diseases (STDs) according to officials at the US Food and Drug Administration (FDA). Avanti is sold in a foil package printed with the claim that it is effective against pregnancy, HIV, and STDs. However, polyurethane condoms have not undergone clinical efficacy testing for contraception or STDs, according to officials. The manufacturer of the condom refuted this allegation, stating that latex condoms have the same claims on them. In early 1995 the FDA met with the manufacturer and other companies developing plastic condoms, and concluded that these condoms could not make such claims, nor any claims about slippage and breakage rates. Despite warnings in 1993 to the manufacturer of Avanti about labeling restrictions, the company printed pregnancy and STD efficacy claims on the boxes and individual packages. The FDA later worked out a compromise with the firm in which only the boxes had to be reprinted with the generic label. The FDA had to weigh the risk of the public health cost of delaying sale of the condom, which is the first impermeable condom proven safe for people with latex allergies. In 1991 the FDA was defining standards for clinical testing and labeling of polyurethane condoms under congressional mandate, but the manufacturer of Avanti began mass production based on a preliminary approval determining that the condom was equivalent to latex condoms already on the market. 7000 Avanti condoms were subsequently tested in five countries, but these user tests did not compare Avanti to latex condoms and did not test for pregnancy and STD protection. Test results submitted to the FDA by the company indicated that, although Avanti is more than 1/3 less elastic than latex condoms, it did not break more frequently in an in-use study involving 187 couples.

  12. Pilot-plant testing of materials proposed for use as NWCF feed and fuel nozzle caps

    International Nuclear Information System (INIS)

    Birrer, S.A.

    1980-12-01

    Results of a series of tests performed on materials proposed for use at New Waste Calcining Facility (NWCF) fuel and feed nozzle caps are described. Results show that Haynes Alloys 25 and 188 and Inconel Alloys 617, 625, and 690 have acceptable corrosion and erosion rates based upon the high-temperature oxidation, erosion, and corrosion tests conducted

  13. Proposed optical test of Bell's inequalities not resting upon the fair sampling assumption

    International Nuclear Information System (INIS)

    Santos, Emilio

    2004-01-01

    Arguments are given against the fair sampling assumption, used to claim an empirical disproof of local realism. New tests are proposed, able to discriminate between quantum mechanics and a restricted, but appealing, family of local hidden-variables models. Such tests require detectors with efficiencies just above 20%

  14. Lead-acid batteries in micro-hybrid applications. Part II. Test proposal

    Energy Technology Data Exchange (ETDEWEB)

    Schaeck, S.; Stoermer, A.O. [BMW Group, 80788 Muenchen (Germany); Albers, J. [Johnson Controls Power Solutions EMEA, 30419 Hannover (Germany); Weirather-Koestner, D. [ZSW Ulm, 89081 Ulm (Germany); Kabza, H. [Universitaet Ulm, Institut fuer Energiewandlung und -speicherung, 89081 Ulm (Germany)

    2011-02-01

    In the first part of this work selected key parameters for applying lead-acid (LA) batteries in micro-hybrid power systems (MHPS) were investigated. Main results are integrated in an accelerated, comprehensive test proposal presented here. The test proposal aims at a realistic representation of the pSoC operation regime, which is described in Refs. The test is designed to be sensitive with respect to dynamic charge acceptance (DCA) at partially discharged state (critical for regenerative braking) and the internal resistance at high-rate discharge (critical for idling stop applications). First results are presented for up-to-date valve-regulated LA batteries with absorbent glass mat (AGM) separators. The batteries are close to the limits of the first proposal of pass/fail-criteria. Also flooded batteries were tested; the first out of ten units failed already. (author)

  15. Proposed waste form performance criteria and testing methods for low-level mixed waste

    International Nuclear Information System (INIS)

    Franz, E.M.; Fuhrmann, M.; Bowerman, B.

    1995-01-01

    Proposed waste form performance criteria and testing methods were developed as guidance in judging the suitability of solidified waste as a physico-chemical barrier to releases of radionuclides and RCRA regulated hazardous components. The criteria follow from the assumption that release of contaminants by leaching is the single most important property for judging the effectiveness of a waste form. A two-tier regimen is proposed. The first tier consists of a leach test designed to determine the net, forward leach rate of the solidified waste and a leach test required by the Environmental Protection Agency (EPA). The second tier of tests is to determine if a set of stresses (i.e., radiation, freeze-thaw, wet-dry cycling) on the waste form adversely impacts its ability to retain contaminants and remain physically intact. In the absence of site-specific performance assessments (PA), two generic modeling exercises are described which were used to calculate proposed acceptable leachates

  16. Lead-acid batteries in micro-hybrid applications. Part II. Test proposal

    Science.gov (United States)

    Schaeck, S.; Stoermer, A. O.; Albers, J.; Weirather-Koestner, D.; Kabza, H.

    In the first part of this work [1] selected key parameters for applying lead-acid (LA) batteries in micro-hybrid power systems (MHPS) were investigated. Main results are integrated in an accelerated, comprehensive test proposal presented here. The test proposal aims at a realistic representation of the pSoC operation regime, which is described in Refs. [1,6]. The test is designed to be sensitive with respect to dynamic charge acceptance (DCA) at partially discharged state (critical for regenerative braking) and the internal resistance at high-rate discharge (critical for idling stop applications). First results are presented for up-to-date valve-regulated LA batteries with absorbent glass mat (AGM) separators. The batteries are close to the limits of the first proposal of pass/fail-criteria. Also flooded batteries were tested; the first out of ten units failed already.

  17. Right to experimental treatment: FDA new drug approval, constitutional rights, and the public's health.

    Science.gov (United States)

    Leonard, Elizabeth Weeks

    2009-01-01

    On May 2, 2006, a divided panel of the U.S. Court of Appeals for the District of Columbia, in a startling opinion, Abigail Alliance for Better Access to Developmental Drugs v. Eschenbach, held that terminally ill patients who have exhausted all other available options have a constitutional right to experimental treatment that FDA has not yet approved. Although ultimately overturned by the full court, Abigail Alliance generated considerable interest from various constituencies. Meanwhile, FDA proposed similar regulatory amendments, as have lawmakers on both sides of the aisle in Congress. But proponents of expanded access fail to consider public health and consumer safety concerns. In particular, allowing patients to try unproven treatments, outside of controlled clinical trials risks both the study's outcome and the health of patients who might benefit from the deliberate, careful process of new drug approval as it currently operates under FDA's auspices.

  18. A proposed test for the determination of the grindability of fine materials

    International Nuclear Information System (INIS)

    Levin, J.

    1984-01-01

    The grindability of ores is generally determined by the Bond standard grindability test. However, this test is not applicable to fine matetials such as sands; the grindability of fine materials must therefore be determined by a comparative grinding method, for which a reference material of known grindability is required. Suitable reference materials are not easily obtained, and a grindability test that does not depend on reference materials is needed. This report proposes such a test and records the results of some tests on the validity of the proposed method. The proposed grindability test uses the Bond standard test mill and a quantity called the 'equivalent energy per minute', which is the energy per minute that would be used by the mill if it were scaled up to a wet-grinding industrial mill of 2,44m (8 ft) diameter. The value of this quantity, denoted by E, was calculated from the results of Bond standard grindability test on various materials, and an average value of 1425X10- 6 kW.h/min was determined. It is suggested that values far removed from this figure indicate that the ores concerned do not conform to the Bond Law of Comminution. The proposed grindability test was applied to seven samples of ore from industrial secondary grinding mills and to one sample of sand, and good agreement was found between the energy consumption calculated in the laboratory tests and those reported for the operating plants. The energy consumption calculated from the results of the Bond standard grindability test agreed fairly well with the plant data for the secondary grinding circuits, but the correlation for the primary grinding circuit was erratic

  19. Proposed waste form performance criteria and testing methods for low-level mixed waste

    International Nuclear Information System (INIS)

    Franz, E.M.; Fuhrmann, M.; Bowerman, B.; Bates, S.; Peters, R.

    1994-08-01

    This document describes proposed waste form performance criteria and testing method that could be used as guidance in judging viability of a waste form as a physico-chemical barrier to releases of radionuclides and RCRA regulated hazardous components. It is assumed that release of contaminants by leaching is the single most important property by which the effectiveness of a waste form is judged. A two-tier regimen is proposed. The first tier includes a leach test required by the Environmental Protection Agency and a leach test designed to determine the net forward leach rate for a variety of materials. The second tier of tests are to determine if a set of stresses (i.e., radiation, freeze-thaw, wet-dry cycling) on the waste form adversely impact its ability to retain contaminants and remain physically intact. It is recommended that the first tier tests be performed first to determine acceptability. Only on passing the given specifications for the leach tests should other tests be performed. In the absence of site-specific performance assessments (PA), two generic modeling exercises are described which were used to calculate proposed acceptable leach rates

  20. Science, law, and politics in the Food and Drug Administration's genetically engineered foods policy: FDA's 1992 policy statement.

    Science.gov (United States)

    Pelletier, David L

    2005-05-01

    The US Food and Drug Administration's (FDA's) 1992 policy statement was developed in the context of critical gaps in scientific knowledge concerning the compositional effects of genetic transformation and severe limitations in methods for safety testing. FDA acknowledged that pleiotropy and insertional mutagenesis may cause unintended changes, but it was unknown whether this happens to a greater extent in genetic engineering compared with traditional breeding. Moreover, the agency was not able to identify methods by which producers could screen for unintended allergens and toxicants. Despite these uncertainties, FDA granted genetically engineered foods the presumption of GRAS (Generally Recognized As Safe) and recommended that producers use voluntary consultations before marketing them.

  1. A proposal on evaluation method of neutron absorption performance to substitute conventional neutron attenuation test

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Je Hyun; Shim, Chang Ho [Dept. of Nuclear Engineering, Hanyang University, Seoul (Korea, Republic of); Kim, Sung Hyun [Nuclear Fuel Cycle Waste Treatment Research Division, Research Reactor Institute, Kyoto University, Osaka (Japan); Choe, Jung Hun; Cho, In Hak; Park, Hwan Seo [Ionizing Radiation Center, Nuclear Fuel Cycle Waste Treatment Research Division, Korea Atomic Energy Research Institute, Daejeon (Korea, Republic of); Park, Hyun Seo; Kim, Jung Ho; Kim, Yoon Ho [Ionizing Radiation Center, Korea Research Institute of Standards and Science, Daejeon (Korea, Republic of)

    2016-12-15

    For a verification of newly-developed neutron absorbers, one of guidelines on the qualification and acceptance of neutron absorbers is the neutron attenuation test. However, this approach can cause a problem for the qualifications that it cannot distinguish how the neutron attenuates from materials. In this study, an estimation method of neutron absorption performances for materials is proposed to detect both direct penetration and back-scattering neutrons. For the verification of the proposed method, MCNP simulations with the experimental system designed in this study were pursued using the polyethylene, iron, normal glass and the vitrified form. The results show that it can easily test neutron absorption ability using single absorber model. Also, from simulation results of single absorber and double absorbers model, it is verified that the proposed method can evaluate not only the direct thermal neutrons passing through materials, but also the scattered neutrons reflected to the materials. Therefore, the neutron absorption performances can be accurately estimated using the proposed method comparing with the conventional neutron attenuation test. It is expected that the proposed method can contribute to increase the reliability of the performance of neutron absorbers.

  2. A proposal on evaluation method of neutron absorption performance to substitute conventional neutron attenuation test

    International Nuclear Information System (INIS)

    Kim, Je Hyun; Shim, Chang Ho; Kim, Sung Hyun; Choe, Jung Hun; Cho, In Hak; Park, Hwan Seo; Park, Hyun Seo; Kim, Jung Ho; Kim, Yoon Ho

    2016-01-01

    For a verification of newly-developed neutron absorbers, one of guidelines on the qualification and acceptance of neutron absorbers is the neutron attenuation test. However, this approach can cause a problem for the qualifications that it cannot distinguish how the neutron attenuates from materials. In this study, an estimation method of neutron absorption performances for materials is proposed to detect both direct penetration and back-scattering neutrons. For the verification of the proposed method, MCNP simulations with the experimental system designed in this study were pursued using the polyethylene, iron, normal glass and the vitrified form. The results show that it can easily test neutron absorption ability using single absorber model. Also, from simulation results of single absorber and double absorbers model, it is verified that the proposed method can evaluate not only the direct thermal neutrons passing through materials, but also the scattered neutrons reflected to the materials. Therefore, the neutron absorption performances can be accurately estimated using the proposed method comparing with the conventional neutron attenuation test. It is expected that the proposed method can contribute to increase the reliability of the performance of neutron absorbers

  3. Testing the Construct Validity of Proposed Criteria for "DSM-5" Autism Spectrum Disorder

    Science.gov (United States)

    Mandy, William P. L.; Charman, Tony; Skuse, David H.

    2012-01-01

    Objective: To use confirmatory factor analysis to test the construct validity of the proposed "DSM-5" symptom model of autism spectrum disorder (ASD), in comparison to alternative models, including that described in "DSM-IV-TR." Method: Participants were 708 verbal children and young persons (mean age, 9.5 years) with mild to severe autistic…

  4. Proposal of concentration limits for determining the hazard property HP 14 for waste using ecotoxicological tests.

    Science.gov (United States)

    Hennebert, Pierre

    2018-04-01

    Different ecotoxicological test batteries and concentration limits have been proposed to assess the hazard property (HP) HP 14 'Ecotoxic' for waste in the European Union and its member states. In test batteries, if the concentration of waste in the culture/dilution medium producing 50% of inhibitory biological effect in one or more test(s) is below the concentration limit of the test, the waste is classified as hazardous. A summarized review of the test batteries proposed since 1998 is presented. The last proposed test battery uses seven aquatic and terrestrial species with standardized methods, but with options and uniform concentration limits of 10% of waste eluate or solid waste in the culture/dilution medium. No attempt was made to match this hazard assessment with the classification made in the European List of Waste (LoW). The aim of this paper is to propose for the same test battery (reduced to 6 tests without options) concentration limits that match with the European List of Waste. This list was taken as reference (despite the fact that waste can be hazardous for other properties than the most frequent HP 14, and its partly political nature for some opinions). The concentration limits (CLs) for tests are the concentrations producing the highest ecotoxicological effects for each test observed in a non-hazardous waste set. Data from Germany, France and Belgium (from in total 5 different sources from 2009 to 2016) with the above-mentioned test battery (without options) were gathered for 81 samples, being the largest set ever published. In total, ten non-hazardous (NH) waste samples (as defined by the LoW and for most of them checked by chemical composition) were used to establish CLs. These CLs were then applied to 13 hazardous (H) waste by the LoW, and all were classified as hazardous. The matching of the resulting classification with the LoW is convincing. For the 58 'mirror entries' in the LoW (hazardous or not depending of the presence of hazardous

  5. Two-Dimensional Model Test Study of New Western Breakwater Proposal for Port of Hanstholm

    DEFF Research Database (Denmark)

    Eldrup, Mads Røge; Andersen, Thomas Lykke

    The present report presents results from a two-dimensional model test study carried out at Aalborg University in December 2016 with the proposed trunk section for the new western breakwater in Port of Hanstholm. The objectives of the model tests were to study the stability of the armour layer, toe...... erosion, overtopping and transmission. The scale used for the model tests was 1:61.5. Unless otherwise specified all values given in this report are prototype values converted from the model to prototype according to the Froude model law....

  6. Two-Dimensional Model Test Study of New Western Breakwater Proposal for Port of Hanstholm

    OpenAIRE

    Eldrup, Mads Røge; Andersen, Thomas Lykke

    2016-01-01

    The present report presents results from a two-dimensional model test study carried out at Aalborg University in December 2016 with the proposed trunk section for the new western breakwater in Port of Hanstholm. The objectives of the model tests were to study the stability of the armour layer, toe erosion, overtopping and transmission. The scale used for the model tests was 1:61.5. Unless otherwise specified all values given in this report are prototype values converted from the model to prot...

  7. 21 CFR 312.86 - Focused FDA regulatory research.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Focused FDA regulatory research. 312.86 Section 312.86 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... Severely-debilitating Illnesses § 312.86 Focused FDA regulatory research. At the discretion of the agency...

  8. 42 CFR 405.203 - FDA categorization of investigational devices.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 2 2010-10-01 2010-10-01 false FDA categorization of investigational devices. 405... Coverage Decisions That Relate to Health Care Technology § 405.203 FDA categorization of investigational.../investigational (Category A) or non-experimental/investigational (Category B). (c) CMS uses the categorization of...

  9. Changes In Growth Culture FDA Activity Under Changing Growth Conditions

    DEFF Research Database (Denmark)

    Jørgensen, Per Elberg; Eriksen, Thomas Juul; Jensen, Bjørn K.

    1992-01-01

    The FDA hydrolysis capacities and bacterial biomass concentrations (estimated by determination of ATP content) of growth cultures prepared from activated sludge and wastewater, were measured to find out whether the FDA activity would reflect bacterial biomass under different physiological states...... of the bacteria. The FDA activity/ATP ratio was calculated for different concentrations of autoclaved sludge. A faster decay rate of ATP relative to FDA hydrolysis activity was observed, thus causing changes in the ratio. Furthermore, comparison between values obtained from pure cultures and different soils...... revealed differences up to two orders of magnitude of the ratio. Based on these results it was concluded that the FDA activity should not be applied for measurements of viable biomass in environments in which different physiological conditions occur....

  10. Network-Based Real-time Integrated Fire Detection and Alarm (FDA) System with Building Automation

    Science.gov (United States)

    Anwar, F.; Boby, R. I.; Rashid, M. M.; Alam, M. M.; Shaikh, Z.

    2017-11-01

    Fire alarm systems have become increasingly an important lifesaving technology in many aspects, such as applications to detect, monitor and control any fire hazard. A large sum of money is being spent annually to install and maintain the fire alarm systems in buildings to protect property and lives from the unexpected spread of fire. Several methods are already developed and it is improving on a daily basis to reduce the cost as well as increase quality. An integrated Fire Detection and Alarm (FDA) systems with building automation was studied, to reduce cost and improve their reliability by preventing false alarm. This work proposes an improved framework for FDA system to ensure a robust intelligent network of FDA control panels in real-time. A shortest path algorithmic was chosen for series of buildings connected by fiber optic network. The framework shares information and communicates with each fire alarm panels connected in peer to peer configuration and declare the network state using network address declaration from any building connected in network. The fiber-optic connection was proposed to reduce signal noises, thus increasing large area coverage, real-time communication and long-term safety. Based on this proposed method an experimental setup was designed and a prototype system was developed to validate the performance in practice. Also, the distributed network system was proposed to connect with an optional remote monitoring terminal panel to validate proposed network performance and ensure fire survivability where the information is sequentially transmitted. The proposed FDA system is different from traditional fire alarm and detection system in terms of topology as it manages group of buildings in an optimal and efficient manner.Introduction

  11. FDA toxicity databases and real-time data entry

    International Nuclear Information System (INIS)

    Arvidson, Kirk B.

    2008-01-01

    Structure-searchable electronic databases are valuable new tools that are assisting the FDA in its mission to promptly and efficiently review incoming submissions for regulatory approval of new food additives and food contact substances. The Center for Food Safety and Applied Nutrition's Office of Food Additive Safety (CFSAN/OFAS), in collaboration with Leadscope, Inc., is consolidating genetic toxicity data submitted in food additive petitions from the 1960s to the present day. The Center for Drug Evaluation and Research, Office of Pharmaceutical Science's Informatics and Computational Safety Analysis Staff (CDER/OPS/ICSAS) is separately gathering similar information from their submissions. Presently, these data are distributed in various locations such as paper files, microfiche, and non-standardized toxicology memoranda. The organization of the data into a consistent, searchable format will reduce paperwork, expedite the toxicology review process, and provide valuable information to industry that is currently available only to the FDA. Furthermore, by combining chemical structures with genetic toxicity information, biologically active moieties can be identified and used to develop quantitative structure-activity relationship (QSAR) modeling and testing guidelines. Additionally, chemicals devoid of toxicity data can be compared to known structures, allowing for improved safety review through the identification and analysis of structural analogs. Four database frameworks have been created: bacterial mutagenesis, in vitro chromosome aberration, in vitro mammalian mutagenesis, and in vivo micronucleus. Controlled vocabularies for these databases have been established. The four separate genetic toxicity databases are compiled into a single, structurally-searchable database for easy accessibility of the toxicity information. Beyond the genetic toxicity databases described here, additional databases for subchronic, chronic, and teratogenicity studies have been prepared

  12. GENIUS-TF - a test facility for the GENIUS project. Proposal

    International Nuclear Information System (INIS)

    Klapdor-Kleingrothaus, H.V.; Dietz, A.; Heusser, G.

    2001-02-01

    GENIUS is a proposal for a large scale detector of rare events. As a first step of the experiment, a small test version, the Genius Test-Facility is proposed to be built up at the Laboratori Nazionali del Gran Sasso (LNGS). With about 40 kg of natural Ge detectors operated in liquid nitrogen, Genius-TF could exclude (or directly confirm) the DAMA annual modulation signature within about two years of measurement using both, signal and signature of the claimed WIMP Dark matter. The funding of the experiment has already been approved and four 2.5 kg germanium detectors with an extreme low treshold of 500 eV have been produced. The installation can be started immediately. No additional space in the Underground Laboratory is required. (orig.)

  13. Estimation of Viable Biomass In Wastewater And Activated Sludge By Determination of ATP, Oxygen Utilization Rate And FDA Hydrolysis

    DEFF Research Database (Denmark)

    Jørgensen, Poul-Erik; Eriksen, T.; Jensen, B.K.

    1992-01-01

    ATP content, oxygen utilization rate (OUR) and fluorescein diacetate (FDA) hydrolysis were tested for the ability to express the amount of viable biomass in wastewater and activated sludge. The relationship between biomass and these activity parameters was established in growth cultures made...... with biomass, while FDA hydrolysis in the sludge failed to show any such correlation. Conversion factors of 3 mg ATP/g dw, 300 mg O2/h g dw and 0.4 A/h (mg dw/ml) for ATP, OUR and FDA methods, respectively, were calculated. When the methods were applied for in situ determinations in four different wastewater...... plants, it was found that ATP content and respiration rate estimated viable biomass to range from 81 to 293 mg dw/g SS for raw wastewater and from 67 to 187 mg dw/g SS for activated sludge with a rather weak correlation between ATP and respiration measurements. The FDA hydrolysis estimated viable biomass...

  14. Proposed Testing to Assess the Accuracy of Glass-To-Metal Seal Stress Analyses.

    Energy Technology Data Exchange (ETDEWEB)

    Chambers, Robert S.; Emery, John M; Tandon, Rajan; Antoun, Bonnie R.; Stavig, Mark E.; Newton, Clay S.; Gibson, Cory S; Bencoe, Denise N.

    2014-09-01

    The material characterization tests conducted on 304L VAR stainless steel and Schott 8061 glass have provided higher fidelity data for calibration of material models used in Glass - T o - Metal (GTM) seal analyses. Specifically, a Thermo - Multi - Linear Elastic Plastic ( thermo - MLEP) material model has be en defined for S S304L and the Simplified Potential Energy Clock nonlinear visc oelastic model has been calibrated for the S8061 glass. To assess the accuracy of finite element stress analyses of GTM seals, a suite of tests are proposed to provide data for comparison to mo del predictions.

  15. Disintegration of sublingual tablets: proposal for a validated test method and acceptance criterion.

    Science.gov (United States)

    Weda, M; van Riet-Nales, D A; van Aalst, P; de Kaste, D; Lekkerkerker, J F F

    2006-12-01

    In the Netherlands the market share of isosorbide dinitrate 5 mg sublingual tablets is dominated by 2 products (A and B). In the last few years complaints have been received from health care professionals on product B. During patient use the disintegration of the tablet was reported to be slow and/or incomplete, and ineffectiveness was experienced. In the European Pharmacopoeia (Ph. Eur.) no requirement is present for the disintegration time of sublingual tablets. The purpose of this study was to compare the in vitro disintegration time of products A and B, and to establish a suitable test method and acceptance criterion. A and B were tested with the Ph. Eur. method described in the monograph on disintegration of tablets and capsules as well as with 3 modified tests using the same Ph. Eur. apparatus, but without movement of the basket-rack assembly. In modified test 1 and modified test 2 water was used as medium (900 ml and 50 ml respectively), whereas in modified test 3 artificial saliva was used (50 ml). In addition, disintegration was tested in Nessler tubes with 0.5 and 2 ml of water. Finally, the Ph. Eur. method was also applied to other sublingual tablets with other drug substances on the Dutch market. With modified test 3 no disintegration could be achieved within 20 min. With the Ph. Eur. method and modified tests 1 and 2 product A and B differed significantly (p disintegration times. These 3 methods were capable of discriminating between products and between batches. The time measured with the Ph. Eur. method was significantly lower compared to modified tests 1 and 2 (p tablets the disintegration time should be tested. The Ph. Eur. method is considered suitable for this test. In view of the products currently on the market and taking into consideration requirements in the United States Pharmacopeia and Japanese Pharmacopoeia, an acceptance criterion of not more than 2 min is proposed.

  16. Advancing Product Quality: a Summary of the Inaugural FDA/PQRI Conference.

    Science.gov (United States)

    Yu, Lawrence X; Baker, Jeffrey; Berlam, Susan C; Boam, Ashley; Brandreth, E J; Buhse, Lucinda; Cosgrove, Thomas; Doleski, David; Ensor, Lynne; Famulare, Joseph; Ganapathy, Mohan; Grampp, Gustavo; Hussong, David; Iser, Robert; Johnston, Gordon; Kesisoglou, Filippos; Khan, Mansoor; Kozlowski, Steven; Lacana, Emanuela; Lee, Sau L; Miller, Stephen; Miksinski, Sarah Pope; Moore, Christine M V; Mullin, Theresa; Raju, G K; Raw, Andre; Rosencrance, Susan; Rosolowsky, Mark; Stinavage, Paul; Thomas, Hayden; Wesdyk, Russell; Windisch, Joerg; Vaithiyalingam, Sivakumar

    2015-07-01

    On September 16 and 17, 2014, the Food and Drug Administration (FDA) and Product Quality Research Institute (PQRI) inaugurated their Conference on Evolving Product Quality. The Conference is conceived as an annual forum in which scientists from regulatory agencies, industry, and academia may exchange viewpoints and work together to advance pharmaceutical quality. This Conference Summary Report highlights key topics of this conference, including (1) risk-based approaches to pharmaceutical development, manufacturing, regulatory assessment, and post-approval changes; (2) FDA-proposed quality metrics for products, facilities, and quality management systems; (3) performance-based quality assessment and clinically relevant specifications; (4) recent developments and implementation of continuous manufacturing processes, question-based review, and European Medicines Agency (EMA)-FDA pilot for Quality-by-Design (QbD) applications; and (5) breakthrough therapies, biosimilars, and international harmonization, focusing on ICH M7 and Q3D guidelines. The second FDA/PQRI conference on advancing product quality is planned for October 5-7, 2015.

  17. Experimental testing on free vibration behaviour for silicone rubbers proposed within lumbar disc prosthesis

    Energy Technology Data Exchange (ETDEWEB)

    Rotaru, Iuliana, E-mail: rotaruiuliana2000@gmail.com [“Gheorghe Asachi” Technical University of Iasi, Faculty of Mechanical Engineering, Department of Mechanical Engineering, Mechatronics and Robotics, 61-63 Bd. Dimitrie Mangeron, 700050 Iasi (Romania); “Gr. T. Popa” University of Medicine and Pharmacy of Iasi, Faculty of Medical Bioengineering, Department of Biomedical Sciences, 9-13 M. Kogalniceanu Street, 700454 Iasi (Romania); Bujoreanu, Carmen [“Gheorghe Asachi” Technical University of Iasi, Faculty of Mechanical Engineering, Department of Mechanical Engineering, Mechatronics and Robotics, 61-63 Bd. Dimitrie Mangeron, 700050 Iasi (Romania); Bele, Adrian; Cazacu, Maria [“Petru Poni” Institute of Macromolecular Chemistry, Aleea Gr. Ghica Voda 41 A, 700487 Iasi (Romania); Olaru, Dumitru [“Gheorghe Asachi” Technical University of Iasi, Faculty of Mechanical Engineering, Department of Mechanical Engineering, Mechatronics and Robotics, 61-63 Bd. Dimitrie Mangeron, 700050 Iasi (Romania)

    2014-09-01

    This research was focused on the damping capacity study of two types of silicone rubbers proposed as layers within total lumbar disc prostheses of ball-and-socket model. In order to investigate the damping capacity, the two silicone rubber types mainly differing by the molecular mass of polymeric matrix and the filler content, as was emphasized by scanning electron microscopy and differential scanning calorimetry, were subjected to free vibration testing. Using an adapted experimental installation, three kinds of damping testing were realised: tests without samples and tests with three samples of each type of silicone rubber (69 ShA and 99 ShA). The free vibration tests were performed at a frequency of about 6 Hz using a weight of 11.8 kg. The relative damping coefficient was determined by measuring of two successive amplitudes on the vibrogram and calculating of the logarithmic decrement. The test results with silicone rubber samples showed a relative damping coefficient of 0.058 and respectively 0.077, whilst test results without samples showed a relative damping coefficient of 0.042. These silicone rubbers were found to have acceptable damping properties to be used as layers placed inside the prosthetic components. - Highlights: • Two types of silicone rubber were proposed within the total lumbar disc prostheses. • The filler content of elastomers was highlighted by microscopy investigation. • Damping capacity of the two elastomers was evaluated using free vibration analysis. • The logarithmic decrement and the relative damping coefficient were determined. • The silicone rubbers prepared in our work showed acceptable damping properties.

  18. Experimental testing on free vibration behaviour for silicone rubbers proposed within lumbar disc prosthesis

    International Nuclear Information System (INIS)

    Rotaru, Iuliana; Bujoreanu, Carmen; Bele, Adrian; Cazacu, Maria; Olaru, Dumitru

    2014-01-01

    This research was focused on the damping capacity study of two types of silicone rubbers proposed as layers within total lumbar disc prostheses of ball-and-socket model. In order to investigate the damping capacity, the two silicone rubber types mainly differing by the molecular mass of polymeric matrix and the filler content, as was emphasized by scanning electron microscopy and differential scanning calorimetry, were subjected to free vibration testing. Using an adapted experimental installation, three kinds of damping testing were realised: tests without samples and tests with three samples of each type of silicone rubber (69 ShA and 99 ShA). The free vibration tests were performed at a frequency of about 6 Hz using a weight of 11.8 kg. The relative damping coefficient was determined by measuring of two successive amplitudes on the vibrogram and calculating of the logarithmic decrement. The test results with silicone rubber samples showed a relative damping coefficient of 0.058 and respectively 0.077, whilst test results without samples showed a relative damping coefficient of 0.042. These silicone rubbers were found to have acceptable damping properties to be used as layers placed inside the prosthetic components. - Highlights: • Two types of silicone rubber were proposed within the total lumbar disc prostheses. • The filler content of elastomers was highlighted by microscopy investigation. • Damping capacity of the two elastomers was evaluated using free vibration analysis. • The logarithmic decrement and the relative damping coefficient were determined. • The silicone rubbers prepared in our work showed acceptable damping properties

  19. Experimental testing on free vibration behaviour for silicone rubbers proposed within lumbar disc prosthesis.

    Science.gov (United States)

    Rotaru, Iuliana; Bujoreanu, Carmen; Bele, Adrian; Cazacu, Maria; Olaru, Dumitru

    2014-09-01

    This research was focused on the damping capacity study of two types of silicone rubbers proposed as layers within total lumbar disc prostheses of ball-and-socket model. In order to investigate the damping capacity, the two silicone rubber types mainly differing by the molecular mass of polymeric matrix and the filler content, as was emphasized by scanning electron microscopy and differential scanning calorimetry, were subjected to free vibration testing. Using an adapted experimental installation, three kinds of damping testing were realised: tests without samples and tests with three samples of each type of silicone rubber (69 ShA and 99 ShA). The free vibration tests were performed at a frequency of about 6 Hz using a weight of 11.8 kg. The relative damping coefficient was determined by measuring of two successive amplitudes on the vibrogram and calculating of the logarithmic decrement. The test results with silicone rubber samples showed a relative damping coefficient of 0.058 and respectively 0.077, whilst test results without samples showed a relative damping coefficient of 0.042. These silicone rubbers were found to have acceptable damping properties to be used as layers placed inside the prosthetic components. Copyright © 2014 Elsevier B.V. All rights reserved.

  20. Real-World Evidence, Public Participation, and the FDA.

    Science.gov (United States)

    Schwartz, Jason L

    2017-11-01

    For observers of pharmaceutical regulation and the Food and Drug Administration, these are uncertain times. Events in late 2016 raised concerns that the FDA's evidentiary standards were being weakened, compromising the agency's ability to adequately perform its regulatory and public health responsibilities. Two developments most directly contributed to these fears-the approval of eteplirsen, a treatment for Duchenne muscular dystrophy, against the recommendations of both FDA staff and an advisory committee and the December 2016 signing of the 21st Century Cures Act, which encouraged greater use by the FDA of "real-world" evidence not obtained through randomized controlled trials. The arrival of the Trump administration-with its deregulatory, industry-friendly approach-has only amplified concerns over the future of the FDA. It is too early to know whether the recent developments are truly harbingers of an FDA less likely to prevent unsafe or ineffective products from reaching the market. But elements in the two events-the role of patient narratives in deliberations regarding eteplirsen and the enthusiasm for real-world evidence in the 21st Century Cures Act-raise critical issues for the future of evidence in the FDA's work. The rigorous, inclusive approach under way to consider issues related to real-world evidence provides a model for a similarly needed inquiry regarding public participation in FDA decision-making. © 2017 The Hastings Center.

  1. European experiences of the proposed ASTM test method for crack arrest toughness of ferritic materials

    International Nuclear Information System (INIS)

    Jutla, T.; Lidbury, D.P.G.; Ziebs, J.; Zimmermann, C.

    1986-01-01

    The proposed ASTM test method for measuring the crack arrest toughness of ferritic materials using wedge-loaded, side-grooved, compact specimens was applied to three steels: A514 bridge steel, A588 bridge steel, and A533B pressure vessel steel. Five sets of results from different laboratories are discussed here. Notches were prepared by spark erosion, although root radii varied from ∝0.1-1.5 mm. Although fast fractures were successfully initiated, arrest did not occur in a significant number of cases. The results showed no obvious dependence of crack arrest toughness, K a , (determined by a static analysis) on crack initiation toughness, K 0 . It was found that K a decreases markedly with increasing crack jump distance. A limited amount of further work on smaller specimens of the A533B steel showed that lower K a values tended to be recorded. It is concluded that a number of points relating to the proposed test method and notch preparation are worthy of further consideration. It is pointed out that the proposed validity criteria may screen out lower bound data. Nevertheless, for present practical purposes, K a values may be regarded as useful in providing an estimate of arrest toughness - although not necessarily a conservative estimate. (orig./HP)

  2. Test-retest reliability of the proposed DSM-5 eating disorder diagnostic criteria

    Science.gov (United States)

    Sysko, Robyn; Roberto, Christina A.; Barnes, Rachel D.; Grilo, Carlos M.; Attia, Evelyn; Walsh, B. Timothy

    2012-01-01

    The proposed DSM-5 classification scheme for eating disorders includes both major and minor changes to the existing DSM-IV diagnostic criteria. It is not known what effect these modifications will have on the ability to make reliable diagnoses. Two studies were conducted to evaluate the short-term test-retest reliability of the proposed DSM-5 eating disorder diagnoses: anorexia nervosa, bulimia nervosa, binge eating disorder, and feeding and eating conditions not elsewhere classified. Participants completed two independent telephone interviews with research assessors (n=70 Study 1; n=55 Study 2). Fair to substantial agreements (κ= 0.80 and 0.54) were observed across eating disorder diagnoses in Study 1 and Study 2, respectively. Acceptable rates of agreement were identified for the individual eating disorder diagnoses, including DSM-5 anorexia nervosa (κ’s of 0.81 to 0.97), bulimia nervosa (κ=0.84), binge eating disorder (κ’s of 0.75 and 0.61), and feeding and eating disorders not elsewhere classified (κ’s of 0.70 and 0.46). Further, improved short-term test-retest reliability was noted when using the DSM-5, in comparison to DSM-IV, criteria for binge eating disorder. Thus, these studies found that trained interviewers can reliably diagnose eating disorders using the proposed DSM-5 criteria; however, additional data from general practice settings and community samples are needed. PMID:22401974

  3. PROPOSAL FOR BUILD A TEST STAND TO THE STUDY WATER RAM BASED ON THE RECOMMENDATIONS CONSTRUCTION

    Directory of Open Access Journals (Sweden)

    Dariusz GRYGO

    2016-05-01

    Full Text Available The main aim of this article was developed of a test stand to a study physics phenomena accruing at work in a ram water based on the construction recommendations. The experience gained by a number of attempts allowed to the developed construction recommendations that allowed to adjust the test stand to perform various studies of physics phenomena occurring at the work of water ram and easy adaptions to the new requirements. The article includes: the review of the test stands on which performed the study in the history and in the present times, description of the construction recommendations of the universal test stand and the proposal of the test stand developed based on the construction recommendations. Motivation to take up this issue follows from the interest of devices that work in an unconventional way, devices used a renewable energy that can be used in household e.g. to improve their energy balance, delivery water to houses, drinking water for animals, fields irrigation, etc. Analysis of the literature of the water ram, test stands and their performance shown that it is small and typically old development in popular science form. In times of intensive search new sources of renewable energy reactivation of this type equipment may be highly probable.

  4. Gaps, tensions, and conflicts in the FDA approval process: implications for clinical practice.

    Science.gov (United States)

    Deyo, Richard A

    2004-01-01

    Despite many successes, drug approval at the Food and Drug Administration (FDA) is subject to gaps, internal tensions, and conflicts of interest. Recalls of drugs and devices and studies demonstrating advantages of older drugs over newer ones highlight the importance of these limitations. The FDA does not compare competing drugs and rarely requires tests of clinical efficacy for new devices. It does not review advertisements before use, assess cost-effectiveness, or regulate surgery (except for devices). Many believe postmarketing surveillance of drugs and devices is inadequate. A source of tension within the agency is pressure for speedy approvals. This may have resulted in "burn-out" among medical officers and has prompted criticism that safety is ignored. Others argue, however, that the agency is unnecessarily slow and bureaucratic. Recent reports identify conflicts of interest (stock ownership, consulting fees, research grants) among some members of the FDA's advisory committees. FDA review serves a critical function, but physicians should be aware that new drugs may not be as effective as old ones; that new drugs are likely to have undiscovered side effects at the time of marketing; that direct-to-consumer ads are sometimes misleading; that new devices generally have less rigorous evidence of efficacy than new drugs; and that value for money is not considered in approval.

  5. Extending FDA guidance to include consumer medication information (CMI) delivery on mobile devices.

    Science.gov (United States)

    Sage, Adam; Blalock, Susan J; Carpenter, Delesha

    This paper describes the current state of consumer-focused mobile health application use and the current U.S. Food and Drug Administration (FDA) guidance on the distribution of consumer medication information (CMI), and discusses recommendations and considerations for the FDA to expand CMI guidance to include CMI in mobile applications. Smartphone-based health interventions have been linked to increased medication adherence and improved health outcomes. Trends in smartphone ownership present opportunities to more effectively communicate and disseminate medication information; however, current FDA guidance for CMI does not outline how to effectively communicate CMI on a mobile platform, particularly in regards to user-centered design and information sourcing. As evidence supporting the potential effectiveness of mobile communication in health care continues to increase, CMI developers, regulating entities, and researchers should take note. Although mobile-based CMI offers an innovative mechanism to deliver medication information, caution should be exercised. Specifically, considerations for developing mobile CMI include consumers' digital literacy, user experience (e.g., usability), and the quality and accuracy of new widely used sources of information (e.g., crowd-sourced reviews and ratings). Recommended changes to FDA guidance for CMI include altering the language about scientific accuracy to address more novel methods of information gathering (e.g., anecdotal experiences and Google Consumer Surveys) and including guidance for usability testing of mobile health applications. Copyright © 2016 Elsevier Inc. All rights reserved.

  6. Proposal for a Universal Test Mirror for Characterization of Slope Measuring Instruments

    International Nuclear Information System (INIS)

    Yashchuk, Valeriy V.; McKinney, Wayne R.; Warwick, Tony; Noll, Tino; Siewert, Frank; Zeschke, Thomas; Geckeler, Ralf D.

    2007-01-01

    The development of third generation light sources like the Advanced Light Source (ALS) or BESSY II brought to a focus the need for high performance synchrotron optics with unprecedented tolerances for slope error and micro roughness. Proposed beam lines at Free Electron Lasers (FEL) require optical elements up to a length of one meter, characterized by a residual slope error in the range of 0.1mu rad (rms),and rms values of 0.1 nm for micro roughness. These optical elements must be inspected by highly accurate measuring instruments, providing a measurement uncertainty lower than the specified accuracy of the surface under test. It is essential that metrology devices in use at synchrotron laboratories be precisely characterized and calibrated to achieve this target. In this paper we discuss a proposal for a Universal Test Mirror (UTM) as a realization of a high performance calibration instrument. The instrument would provide an ideal calibration surface to replicate a redundant surface under test of redundant figure. The application of a sophisticated calibration instrument will allow the elimination of the majority of the systematic error from the error budget of an individual measurement of a particular optical element. We present the limitations of existing methods, initial UTM design considerations, possible calibration algorithms, and an estimation of the expected accuracy

  7. Proposal of a critical test of the Navier-Stokes-Fourier paradigm for compressible fluid continua

    Science.gov (United States)

    Brenner, Howard

    2013-01-01

    A critical, albeit simple experimental and/or molecular-dynamic (MD) simulation test is proposed whose outcome would, in principle, establish the viability of the Navier-Stokes-Fourier (NSF) equations for compressible fluid continua. The latter equation set, despite its longevity as constituting the fundamental paradigm of continuum fluid mechanics, has recently been criticized on the basis of its failure to properly incorporate volume transport phenomena—as embodied in the proposed bivelocity paradigm [H. Brenner, Int. J. Eng. Sci.IJESAN0020-722510.1016/j.ijengsci.2012.01.006 54, 67 (2012)]—into its formulation. Were the experimental or simulation results found to accord, even only qualitatively, with bivelocity predictions, the temperature distribution in a gas-filled, thermodynamically and mechanically isolated circular cylinder undergoing steady rigid-body rotation in an inertial reference frame would not be uniform; rather, the temperature would be higher at the cylinder wall than along the axis of rotation. This radial temperature nonuniformity contrasts with the uniformity of the temperature predicted by the NSF paradigm for these same circumstances. Easily attainable rates of rotation in centrifuges and readily available tools for measuring the expected temperature differences render experimental execution of the proposed scheme straightforward in principle. As such, measurement—via experiment or MD simulation—of, say, the temperature difference ΔT between the gas at the wall and along the axis of rotation would provide quantitative tests of both the NSF and bivelocity hydrodynamic models, whose respective solutions for the stated set of circumstances are derived in this paper. Independently of the correctness of the bivelocity model, any temperature difference observed during the proposed experiment or simulation, irrespective of magnitude, would preclude the possibility of the NSF paradigm being correct for fluid continua, except for

  8. Proposal of a critical test of the Navier-Stokes-Fourier paradigm for compressible fluid continua.

    Science.gov (United States)

    Brenner, Howard

    2013-01-01

    A critical, albeit simple experimental and/or molecular-dynamic (MD) simulation test is proposed whose outcome would, in principle, establish the viability of the Navier-Stokes-Fourier (NSF) equations for compressible fluid continua. The latter equation set, despite its longevity as constituting the fundamental paradigm of continuum fluid mechanics, has recently been criticized on the basis of its failure to properly incorporate volume transport phenomena-as embodied in the proposed bivelocity paradigm [H. Brenner, Int. J. Eng. Sci. 54, 67 (2012)]-into its formulation. Were the experimental or simulation results found to accord, even only qualitatively, with bivelocity predictions, the temperature distribution in a gas-filled, thermodynamically and mechanically isolated circular cylinder undergoing steady rigid-body rotation in an inertial reference frame would not be uniform; rather, the temperature would be higher at the cylinder wall than along the axis of rotation. This radial temperature nonuniformity contrasts with the uniformity of the temperature predicted by the NSF paradigm for these same circumstances. Easily attainable rates of rotation in centrifuges and readily available tools for measuring the expected temperature differences render experimental execution of the proposed scheme straightforward in principle. As such, measurement-via experiment or MD simulation-of, say, the temperature difference ΔT between the gas at the wall and along the axis of rotation would provide quantitative tests of both the NSF and bivelocity hydrodynamic models, whose respective solutions for the stated set of circumstances are derived in this paper. Independently of the correctness of the bivelocity model, any temperature difference observed during the proposed experiment or simulation, irrespective of magnitude, would preclude the possibility of the NSF paradigm being correct for fluid continua, except for incompressible flows.

  9. 76 FR 1180 - FDA Transparency Initiative: Improving Transparency to Regulated Industry

    Science.gov (United States)

    2011-01-07

    ...] FDA Transparency Initiative: Improving Transparency to Regulated Industry AGENCY: Food and Drug... the Transparency Initiative, the Food and Drug Administration (FDA) is announcing the availability of a report entitled ``FDA Transparency Initiative: Improving Transparency to Regulated Industry.'' The...

  10. The proposed alignment system for the Final Focus Test Beam at SLAC

    International Nuclear Information System (INIS)

    Ruland, R.E.; Fischer, G.E.

    1990-09-01

    This report describes the current state of work in progress with respect to the geometry, alignment requirements, scenarios, and hardware for meeting the tolerances of the Final Focus Test Beam (FFTB) at SLAC. The methods and systems proposed acknowledge that component motion at the micron level, from whatever cause (ground motion, thermal effects, etc.) must be measured on-line and compensated for on relatively short time scales. To provide an integrated alignment/positioning package, some unique designs for reference systems, calibration of effect electric and magnetic centers, and component movers are introduced. 24 refs., 28 figs

  11. General Electric Company proposed test and evaluation plan, commercial buildings. National Solar Demonstration Program

    Energy Technology Data Exchange (ETDEWEB)

    None

    1976-04-01

    The general requirements and methods for instrumenting, testing, and evaluating solar HVAC systems forming a part of ERDA's ''Commercial Demonstration Program'' commensurate with ERDA 23A and the Proposed Management Plan 75SDS4270 are defined. Design requirements are specified for the performance of components and subsystems comprising the instrumentation and data gathering system, as well as the support functions required to perform the diagnostic measurements, collection and processing of data, and documentation of reports on solar HVAC system performance, including economic and societal evaluations.

  12. The US FDA and animal cloning: risk and regulatory approach.

    Science.gov (United States)

    Rudenko, Larisa; Matheson, John C

    2007-01-01

    The Food and Drug Administration's (FDA's) Center for Veterinary Medicine issued a voluntary request to producers of livestock clones not to introduce food from clones or their progeny into commerce until the agency had assessed whether production of cattle, swine, sheep, or goats by somatic cell nuclear transfer (SCNT) posed any unique risks to the animal(s) involved in the process, humans, or other animals by consuming food from those animals, compared with any other assisted reproductive technology (ART) currently in use. Following a comprehensive review, no anomalies were observed in animals produced by cloning that have not also been observed in animals produced by other ARTs and natural mating. Further systematic review on the health of, and composition of meat and milk from, cattle, swine, and goat clones and the progeny of cattle and sheep did not result in the identification of any food-consumption hazards. The agency therefore concluded that food from cattle, swine, and goat clones was as safe to eat as food from animals of those species derived by conventional means. The agency also concluded that food from the progeny of the clone of any species normally consumed for food is as safe to eat as those animals. The article also describes the methodology used by the agency to analyze data and draw these conclusions, the plans the agency has proposed to manage any identified risks, and the risk communication approaches the agency has used.

  13. Dose Matters: FDA's Guidance on Children's X-rays

    Science.gov (United States)

    ... Consumer Updates Dose Matters: FDA's Guidance on Children's X-rays Share Tweet Linkedin Pin it More sharing options ... exposure during medical procedures. The level of ionizing radiation from X-ray imaging is generally very low, but can ...

  14. The ecological sustainability trigon - A proposed conceptual framework for creating and testing management scenarios

    International Nuclear Information System (INIS)

    Marques, J.C.; Basset, A.; Brey, T.; Elliott, M.

    2009-01-01

    The ability to achieve ecological sustainability and the sustainable development of marine and estuarine ecosystems constitutes a complex major challenge and depends on many driving forces, often conflicting with each other. In particular, there are three major drivers: (a) the search for human well-being, health and safety, (b) the maintenance of ecological sustainability and environmental equilibrium, and (c) the tolerance of an increasing human population pressure and demand for wealth creation. We propose here the use of a conceptual guidance tool - the ecological sustainability trigon (EST) - as a means of building and testing environmental management scenarios. Although it requires further testing, the EST allows us to (a) address those three major drivers using human society view as a common currency, and (b) describe our behaviour, energetics (economy) and dynamics through ecological theory. Moreover, the EST appears promising for gap analysis and the means to address new research questions.

  15. Teste de figuras para discriminação fonêmica: uma proposta Phoneme Discrimination Picture Test: a proposal

    Directory of Open Access Journals (Sweden)

    Beatriz dos Santos-Carvalho

    2008-01-01

    Full Text Available OBJETIVOS: Propor um teste que avaliasse a discriminação fonêmica por meio de pares mínimos, abrangendo todos os fonemas do Português Brasileiro e utilizando-os em palavras que possam ser facilmente representadas por figuras. Buscou-se que este teste contribua para o diagnóstico de alterações fonoaudiológicas e para a pesquisa científica. Procurou-se fazer um teste que fosse de fácil aplicação, podendo ser utilizado em qualquer local de trabalho dos fonoaudiólogos. MÉTODOS: Selecionou-se pares mínimos que opusessem fonemas em relação ao valor binário de cada traço distintivo e às combinações possíveis entre os traços de lugar ([labial], [coronal], [dorsal] bem como pelas oposições de estruturas silábicas. Criou-se figuras que representam as palavras dos pares. RESULTADOS: Elaborou-se o Teste de Figuras para Discriminação Fonêmica, que avalia a habilidade de discriminação fonêmica em crianças de quatro a oito anos. Este teste contém 40 apresentações, das quais 30 são pares mínimos e dez pares de palavras iguais. Nestas 30 apresentações, opôs-se os traços distintivos [+/- soante], [+/- aproximante], [+/- contínuo], [+/- voz], [coronal+/-ant], [labial] x [coronal], [dorsal] x [coronal] e [labial] x [dorsal]. Igualmente foram opostas as seguintes estruturas silábicas: V x CV, CV x CCV, CV x CVC. CONCLUSÃO: Conclui-se que os objetivos deste trabalho foram alcançados com êxito, pois o Teste de Figura para Discriminação Fonêmica contempla tudo a que se propôs. Acredita-se que o teste deva ser aplicado em um estudo piloto para averiguar se as palavras e as figuras estão adequadas para a faixa etária. Posteriormente, deve ser aplicado em diversas regiões do país para ser devidamente padronizado.PURPOSE: To propose a test to evaluate phonemic discrimination using minimum pairs, comprising all Brazilian Portuguese phonemes and using them in words which can be easily represented by pictures. The

  16. A proposal for refining the forced swim test in Swiss mice.

    Science.gov (United States)

    Costa, Ana Paula Ramos; Vieira, Cintia; Bohner, Lauren O L; Silva, Cristiane Felisbino; Santos, Evelyn Cristina da Silva; De Lima, Thereza Christina Monteiro; Lino-de-Oliveira, Cilene

    2013-08-01

    The forced swim test (FST) is a preclinical test to the screening of antidepressants based on rats or mice behaviours, which is also sensitive to stimulants of motor activity. This work standardised and validated a method to register the active and passive behaviours of Swiss mice during the FST in order to strength the specificity of the test. Adult male Swiss mice were subjected to the FST for 6 min without any treatment or after intraperitoneal injection of saline (0.1 ml/10 g), antidepressants (imipramine, desipramine, or fluoxetine, 30 mg/kg) or stimulants (caffeine, 30 mg/kg or apomorphine, 10mg/kg). The latency, frequency and duration of behaviours (immobility, swimming, and climbing) were scored and summarised in bins of 6, 4, 2 or 1 min. Parameters were first analysed using Principal Components Analysis generating components putatively related to antidepressant (first and second) or to stimulant effects (third). Antidepressants and stimulants affected similarly the parameters grouped into all components. Effects of stimulants on climbing were better distinguished of antidepressants when analysed during the last 4 min of the FST. Surprisingly, the effects of antidepressants on immobility were better distinguished from saline when parameters were scored in the first 2 min. The method proposed here is able to distinguish antidepressants from stimulants of motor activity using Swiss mice in the FST. This refinement should reduce the number of mice used in preclinical evaluation of antidepressants. Copyright © 2013 Elsevier Inc. All rights reserved.

  17. Testing a SEA methodology for the energy sector: a waste incineration tax proposal

    International Nuclear Information System (INIS)

    Nilsson, Maans; Bjoerklund, Anna; Finnveden, Goeran; Johansson, Jessica

    2005-01-01

    Most Strategic Environmental Assessment (SEA) research has been preoccupied with SEA as a procedure and there are relatively few developments and tests of analytical methodologies. This paper applies and tests an analytical framework for an energy sector SEA. In a case study on a policy proposal for waste-to-energy taxation in Sweden, it studies changes in the energy system as a result of implementing the suggested tax by testing three analytical pathways: an LCA pathway, a site-dependent pathway, and a qualitative pathway. In addition, several valuation methods are applied. The assessment indicates that there are some overall environmental benefits to introducing a tax, but that benefits are modest compared to the potential. The methods are discussed in relation to characteristics for effective policy learning and knowledge uptake. The application shows that in many ways they complement each other rather than substitute for each other. The qualitative pathway is useful for raising awareness and getting a comprehensive view of environmental issues, but has limited potential for decision support. The precision increased as we went to LCA and to site-dependent analysis, and a hierarchy emerged in which the qualitative pathway filled rudimentary functions whereas the site-dependent analysis gave more advanced decision support. All methods had limited potential in supporting a choice between alternatives unless data was aggregated through a valuation exercise

  18. Global dose to man from proposed NNTRP high altitude nuclear tests

    International Nuclear Information System (INIS)

    Peterson, K.R.

    1975-05-01

    Radionuclide measurements from past high altitude nuclear testing have enabled development of a model to estimate surface deposition and doses from 400 kt of fission products injected in winter within the Pacific Test Area at altitudes in excess of 50 km. The largest 30-year average dose to man is about 10 millirem and occurs at 30 0 to 50 0 N latitude. The principal contributor to this dose is external gamma radiation from gross fission products. Individual doses from 90 Sr via the forage-cow-milk pathway and 137 Cs via the pasture-meat pathway are about 1/5 the gross fission product doses. The global 30-year population dose is 3 x 10 7 person-rem, which compares with a 30-year natural background population dose of 1 X 10 10 person-rem. Due in large part to the global distribution of population, over 98 percent of the global person-rem from the proposed high altitude tests is received in the Northern Hemisphere, while about 75 percent of the total population dose occurs within the 30 0 --50 0 N latitude belt. Detonations in summer would decrease the global dose by about a factor of three. (U.S.)

  19. Environmental assessment report: Nuclear Test Technology Complex. [Construction and operation of proposed facility

    Energy Technology Data Exchange (ETDEWEB)

    Tonnessen, K.; Tewes, H.A.

    1982-08-01

    The US Department of Energy (USDOE) is planning to construct and operate a structure, designated the Nuclear Test Technology Complex (NTTC), on a site located west of and adjacent to the Lawrence Livermore National Laboratory. The NTTC is designed to house 350 nuclear test program personnel, and will accommodate the needs of the entire staff of the continuing Nuclear Test Program (NTP). The project has three phases: land acquisition, facility construction and facility operation. The purpose of this environmental assessment report is to describe the activities associated with the three phases of the NTTC project and to evaluate potential environmental disruptions. The project site is located in a rural area of southeastern Alameda County, California, where the primary land use is agriculture; however, the County has zoned the area for industrial development. The environmental impacts of the project include surface disturbance, high noise levels, possible increases in site erosion, and decreased air quality. These impacts will occur primarily during the construction phase of the NTTC project and can be mitigated in part by measures proposed in this report.

  20. Proposed particle-beam characterizations for the APS undulator test line

    Energy Technology Data Exchange (ETDEWEB)

    Lumpkin, A.H.; Borland, M.; Milton, S.

    1993-09-01

    A research and development effort is underway at the Advanced Photon Source (APS) to use an rf gun as a low-emittance electron source for injection into the 100- to 650-MeV linac subsystem and subsequently to an undulator test area. This configuration would combine the acceleration capability of the 200-MeV S-band electron linac and the in-line 450-MeV positron linac that normally provide positrons to the positron accumulator ring (PAR). A transport line that bypasses the PAR will bring the electrons to the undulator test area. Characterization techniques will be discussed for the electron beam with a normalized, rms emittance of <10 {pi} mm mrad (1{sigma}) at micropulse charges of up to 350 pC and micropulse durations of {approximately}5 ps (FWHM). Tests proposed include measurement of particle beam transport effects (at one-tenth the storage ring beam rigidity) caused by small undulator field errors as well as operations intended to produce coherent, short wavelength radiation (<200 nm).

  1. An evaluation of the proposed tests with radioactive waste at WIPP

    International Nuclear Information System (INIS)

    Chaturvedi, L.; Silva, M.

    1992-01-01

    This paper discusses the Waste Isolation Pilot Plant (WIPP) a planned repository for permanent disposal of transuranic (TRU) radiative waste that has resulted from the defense activities of the U.S. Government over the past 50 years. Only the waste that is currently stored in an easily retrievable mode at ten U.S. Department of Energy (DOE) laboratories around the country will be shipped to WIPP. The waste consists of various kinds of trash including paper, rubber, rags and metal that is contaminated with radionuclides with very long half-lives. The decision to dispose of the waste permanently will be made based on projections of the behavior of the waste and the repository of 10,000 years or more. DOE has proposed shipping a limited amount of waste to WIPP for a five year Test Phase to demonstrating compliance with the U.S. Environmental Protection Agency (EPA) Standard for long-term isolation

  2. Intertechnology Corporation proposed test and evaluation plan, commercial buildings. National Solar Demonstration Program

    Energy Technology Data Exchange (ETDEWEB)

    None

    1976-09-01

    This report has three major parts. The first of these derives the requirements for the Test and Evaluation plan from the System Level Plan which is summarized in Section II. The second part contains the proposed plan to fill these requirements and includes hardware and software recommendations as well as procedures and management considerations. Primary emphasis has been given to the remote site because this is the area in which the commercial part of the demonstration is most unique. Finally, some pre-demonstration activities are described. The pilot program is intended to resolve a number of issues which arose in the course of the T and E plan. These relate to choice of scan frequencies, compression algorithms, etc. It is also intended to confirm performance and cost effectiveness of the site data collection package. The base line measurements of attitudes, etc. provide a reference mark against which one can measure the non-technical effectiveness of the demonstration program. (WDM)

  3. Determination of Natural Levels of Radionuclides in Proposed Mushroom Reference Material (A Proficiency Test Exercise)

    International Nuclear Information System (INIS)

    Waheed, S.; Rahman, A.; Siddique, N.; Ahmad, S.; Zaidi, J.H.

    2006-08-01

    A proficiency test (PT) was organized within the framework of international Atomic Energy Agency (IAEA) project INT/1/054, entitled 'Preparation' of Reference Materials and Organization of Proficiency Test Rounds'. This exercise served to estimate the proficiency of the analytical laboratories from participating countries. This report presents the results of the proficiency test exercise on the proposed Mushroom Reference Material for the determination of natural levels of radionuclides. Laboratories from 6 different countries submitted data on the following three radionuclides: /sup 134/Cs, /sup 137/Cs, /sup 40/K. Results for /sup 134/Cs, 137/sup 137/Cs, and /sup 40/K in the mushroom reference material were reported by three or more participating laboratories and could be subjected to statistical evaluation. The original data of these raionuclides was subjected to a computer program 'Histo Vession 2.1' provided by IAEA. The four outlier tests i.e. Dixon, Grubbs, Skewness and Kurtosis were applied to the data sets. All values for these three radionuclides were accepted by the software. Consensus (overall) mean value, absolute standard deviation, relative standard deviation, standard error, median and range of values for these three radionuclides have been are obtained (at significance level 0.05). the consensus mean values and confidence intervals are given./sup 134/Cs: 4.4 Bq/kg (3.4-5.3 Bq/kg) /sup 137/Cs: 2899 Bq/kg (2740-3058 Bq/kg) /sup 40/K: 1136 Bq/kg (1046-1226 Bq/kg). (author)

  4. Pure- and Mixed-Gas Permeation Properties of Highly Selective and Plasticization Resistant Hydroxyl-Diamine-Based 6FDA Polyimides for CO2/CH4 Separation

    KAUST Repository

    Alaslai, Nasser Y.; Ghanem, Bader; Alghunaimi, Fahd; Litwiller, Eric; Pinnau, Ingo

    2016-01-01

    The effect of hydroxyl functionalization on the m-phenylene diamine moiety of 6FDA dianhydride-based polyimides was investigated for gas separation applications. Pure-gas permeability coefficients of He, H2, N2, O2, CH4, and CO2 were measured at 35 °C and 2 atm. The introduction of hydroxyl groups in the diamine moiety of 6FDA-diaminophenol (DAP) and 6FDA-diamino resorcinol (DAR) polyimides tightened the overall polymer structure due to increased charge transfer complex formation compared to unfunctionalized 6FDA-m-phenylene diamine (mPDA). The BET surface areas based on nitrogen adsorption of 6FDA-DAP (54 m2g−1) and of 6FDA-DAR (45 m2g−1) were ~18% and 32% lower than that of 6FDA-mPDA (66 m2g−1). 6FDA-mPDA had a pure-gas CO2 permeability of 14 Barrer and CO2/CH4 selectivity of 70. The hydroxyl-functionalized polyimides 6FDA-DAP and 6FDA-DAR exhibited very high pure-gas CO2/CH4 selectivities of 92 and 94 with moderate CO2 permeability of 11 and 8 Barrer, respectively. It was demonstrated that hydroxyl-containing polyimide membranes maintained very high CO2/CH4 selectivity (~ 75 at CO2 partial pressure of 10 atm) due to CO2 plasticization resistance when tested under high-pressure mixed-gas conditions. Functionalization with hydroxyl groups may thus be a promising strategy towards attaining highly selective polyimides for economical membrane-based natural gas sweetening.

  5. Pure- and Mixed-Gas Permeation Properties of Highly Selective and Plasticization Resistant Hydroxyl-Diamine-Based 6FDA Polyimides for CO2/CH4 Separation

    KAUST Repository

    Alaslai, Nasser Y.

    2016-01-05

    The effect of hydroxyl functionalization on the m-phenylene diamine moiety of 6FDA dianhydride-based polyimides was investigated for gas separation applications. Pure-gas permeability coefficients of He, H2, N2, O2, CH4, and CO2 were measured at 35 °C and 2 atm. The introduction of hydroxyl groups in the diamine moiety of 6FDA-diaminophenol (DAP) and 6FDA-diamino resorcinol (DAR) polyimides tightened the overall polymer structure due to increased charge transfer complex formation compared to unfunctionalized 6FDA-m-phenylene diamine (mPDA). The BET surface areas based on nitrogen adsorption of 6FDA-DAP (54 m2g−1) and of 6FDA-DAR (45 m2g−1) were ~18% and 32% lower than that of 6FDA-mPDA (66 m2g−1). 6FDA-mPDA had a pure-gas CO2 permeability of 14 Barrer and CO2/CH4 selectivity of 70. The hydroxyl-functionalized polyimides 6FDA-DAP and 6FDA-DAR exhibited very high pure-gas CO2/CH4 selectivities of 92 and 94 with moderate CO2 permeability of 11 and 8 Barrer, respectively. It was demonstrated that hydroxyl-containing polyimide membranes maintained very high CO2/CH4 selectivity (~ 75 at CO2 partial pressure of 10 atm) due to CO2 plasticization resistance when tested under high-pressure mixed-gas conditions. Functionalization with hydroxyl groups may thus be a promising strategy towards attaining highly selective polyimides for economical membrane-based natural gas sweetening.

  6. Healthy public relations: the FDA's 1930s legislative campaign.

    Science.gov (United States)

    Kay, G

    2001-01-01

    In this article, I argue that the Food and Drug Administration (FDA) is an oft-overlooked government agency that acts to preserve and secure the public's health. From its early years as an agency charged with enforcement of the 1906 Pure Food and Drugs Act, the FDA not only protected the public's health but also made the public aware of its mission, using methods as diverse as displays at county fairs and at the 1933 Chicago World's Fair, radio programming, and active correspondence. The agency encouraged the public to protect itself, particularly in those arenas in which the FDA had no regulatory authority. In addition, it may have overstepped its boundaries when it actively solicited public support for a bill submitted to Congress in the early 1930s. In the dark days of the Great Depression, the FDA contended not only with limited resources and its own feelings of inadequacy in terms of what could and could not be done to protect the populace, but also with "guinea pig" books that horrified and angered many readers. By 1938, when the agency prevailed and the revisions to the 1906 Act passed Congress and were signed into law by President Franklin D. Roosevelt, the FDA had done all that a responsible public health agency should do, and more.

  7. A proposed holistic approach to on-chip, off-chip, test, and package interconnections

    Science.gov (United States)

    Bartelink, Dirk J.

    1998-11-01

    recognize—test is also performed using IC's. A system interconnection is proposed using multiple chips fabricated with conventional silicon processes, including MEMS technology. The system resembles an MCM that can be joined without committing to final assembly to perform at-speed testing. 50-Ohm test probes never load the circuit; only intended neighboring chips are ever connected. A `back-plane' chip provides the connection layers for both inter- and intra-chip signals and also serves as the probe card, in analogy with membrane probes now used for single-chip testing. Intra-chip connections, which require complicated connections during test that exactly match the product, are then properly made and all waveforms and loading conditions under test will be identical to those of the product. The major benefit is that all front-end chip technologies can be merged—logic, memory, RF, even passives. ESD protection is required only on external system connections. Manufacturing test information will accurately characterize process faults and thus avoid the Known-Good-Die problem that has slowed the arrival of conventional MCM's.

  8. FDA regulations regarding iodine addition to foods and labeling of foods containing added iodine12

    Science.gov (United States)

    Trumbo, Paula R

    2016-01-01

    The US Food and Drug Administration (FDA) regulates the addition of iodine to infant formulas, the iodization of salt, and the addition of salt and iodine to foods. The required amount of iodine in infant formulas is based on caloric content, and the label must provide the iodine content per 100 kcal. Cuprous iodide and potassium iodide may be added to table salt as a source of dietary iodine at a maximum amount of 0.01%; if added, the label must indicate that the salt is iodized. Table salt to which iodine has not been added must bear the statement, “This salt does not supply iodide, a necessary nutrient.” If a nutrient is to be appropriately added to a food for the purpose of correcting a dietary insufficiency, there should be sufficient scientific information available to demonstrate a nutritional deficiency and/or identify a public health problem. Furthermore, the population groups that would benefit from the proposed fortification should be identified. If iodine is added to a food, the percent Daily Value of iodine must be listed. There are no FDA regulations governing ingredient standards for dietary supplements. As a result, some dietary supplements include iodine and others do not. If a supplement contains iodine, the Supplement Facts label must list iodine as a nutrient ingredient. If iodine is not listed on the Supplement Facts label, then it has not been added. There are similarities between the FDA, which establishes US food regulations and policies, and the Codex Alimentarius (Codex), which develops international food standards and guidelines under the aegis of the FAO and the WHO. Both the FDA and Codex call for the labeling of table salt to indicate fortification with iodine, voluntary labeling of iodine on foods, and a Daily Value (called a Nutrient Reference Value by Codex) of 150 μg for iodine. PMID:27534626

  9. Testing Proposed Correlations Between Olduvai Gorge and Laetoli, Tanzania Using Tephra Composition

    Science.gov (United States)

    McHenry, L. J.

    2006-12-01

    Olduvai Gorge and Laetoli are well-known Plio-Pleistocene archaeological sites located 30 km apart in Tanzania. Both received volcanic input from the nearby Ngorongoro Volcanic Highlands (NVH), and together provide a sedimentary and volcanic record from about 4.3 Ma to the Holocene. Previous researchers have proposed likely temporal correlations between the two sites, using both faunal and volcanic evidence. Direct tephra correlation between these sites could create a regional stratigraphic framework for their fossil and paleoecological records. Here, one of the proposed correlations is tested using geochemical fingerprinting. The fossiliferous Laetolil and Ndolanya beds of Laetoli predate the deposition of the Olduvai Beds, however recent 39Ar/40Ar SCLF age dating has shown potential temporal overlap between the Naibadad (2.23-1.93 +/- 0.02; Mangea, 1993) and Olpiro Beds (2.06-2.01 +/- 0.03; Manega 1993) at Laetoli with the Naabi Ignimbrite (2.029 +/- 0.005 Ma, Walter et al. 1992) and lower Bed I at Olduvai. Both the Naibadad bed and lower Bed I also contain fresh quartz-bearing tephra, which can be used for geochemical correlation. Three Naibadad tuffs and five lower Bed I tuffs (Naabi Ignimbrite, coarse feldspar crystal tuff (CFCT), Tuff IA, and two ignimbrites near Ngorongoro) were analyzed by electron microprobe for phenocryst and glass composition and compared to test for possible correlations. Certain mineralogical features made such a correlation unlikely. None of the lower Bed I tuffs analyzed contain significant plagioclase, which is present in all of the Naibadad tuffs analyzed. One Naibadad tuff has a bimodal glass composition indistinguishable from the CFCT, however the CFCT is rich in hornblende, while this Naibadad tuff contains none. This mineralogical difference highlights the need for mineralogical in addition to glass geochemical data for tephra correlation. Ngorongoro crater is the likely source for the Naibadad and lower Bed I tuffs because it

  10. FDA approved drugs as potential Ebola treatments [v2; ref status: indexed, http://f1000r.es/554

    Directory of Open Access Journals (Sweden)

    Sean Ekins

    2015-03-01

    Full Text Available In the search for treatments for the Ebola Virus, multiple screens of FDA drugs have led to the identification of several with promising in vitro activity. These compounds were not originally developed as antivirals and some have been further tested in mouse in vivo models. We put forward the opinion that some of these drugs could be evaluated further and move into the clinic as they are already FDA approved and in many cases readily available. This may be important if there is a further outbreak in future and no other therapeutic is available.

  11. FDA-approved small-molecule kinase inhibitors

    DEFF Research Database (Denmark)

    Wu, Peng; Nielsen, Thomas E.; Clausen, Mads Hartvig

    2015-01-01

    Kinases have emerged as one of the most intensivelypursued targets in current pharmacological research,especially for cancer, due to their critical roles in cellularsignaling. To date, the US FDA has approved 28 smallmoleculekinase inhibitors, half of which were approvedin the past 3 years. While...

  12. 21 CFR 5.1110 - FDA public information offices.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false FDA public information offices. 5.1110 Section 5.1110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL...) Press Relations Staff. Press offices are located in White Oak Bldg. 1, 10903 New Hampshire Ave., Silver...

  13. Malaria transmission dynamics at a site in northern Ghana proposed for testing malaria vaccines.

    Science.gov (United States)

    Appawu, Maxwell; Owusu-Agyei, Seth; Dadzie, Samuel; Asoala, Victor; Anto, Francis; Koram, Kwadwo; Rogers, William; Nkrumah, Francis; Hoffman, Stephen L; Fryauff, David J

    2004-01-01

    We studied the malaria transmission dynamics in Kassena Nankana district (KND), a site in northern Ghana proposed for testing malaria vaccines. Intensive mosquito sampling for 1 year using human landing catches in three micro-ecological sites (irrigated, lowland and rocky highland) yielded 18 228 mosquitoes. Anopheles gambiae s.l. and Anopheles funestus constituted 94.3% of the total collection with 76.8% captured from the irrigated communities. Other species collected but in relatively few numbers were Anopheles pharoensis (5.4%) and Anopheles rufipes (0.3%). Molecular analysis of 728 An. gambiae.s.l. identified Anopheles gambiae s.s. as the most dominant sibling species (97.7%) of the An. gambiae complex from the three ecological sites. Biting rates of the vectors (36.7 bites per man per night) were significantly higher (P<0.05) in the irrigated area than in the non-irrigated lowland (5.2) and rocky highlands (5.9). Plasmodium falciparum sporozoite rates of 7.2% (295/4075) and 7.1% (269/3773) were estimated for An. gambiae s.s. and An. funestus, respectively. Transmission was highly seasonal, and the heaviest transmission occurred from June to October. The intensity of transmission was higher for people in the irrigated communities than the non-irrigated ones. An overall annual entomological inoculation rate (EIR) of 418 infective bites was estimated in KND. There were micro-ecological variations in the EIRs, with values of 228 infective bites in the rocky highlands, 360 in the lowlands and 630 in the irrigated area. Approximately 60% of malaria transmission in KND occurred indoors during the second half of the night, peaking at daybreak between 04.00 and 06.00 hours. Vaccine trials could be conducted in this district, with timing dependent on the seasonal patterns and intensity of transmission taking into consideration the micro-geographical differences and vaccine trial objectives.

  14. Proposed quality control guidelines for National Committee for Clinical Laboratory Standards Susceptibility Tests using the veterinary antimicrobial agent tiamulin.

    Science.gov (United States)

    Pfaller, M A; Jones, R N; Walter, D H

    2001-01-01

    Quality control guidelines for standardized antimicrobial susceptibility test methods are critical for the continuing accuracy of these clinical tests. In this report, quality control limits were proposed for the veterinary antimicrobial agent tiamulin with minimum inhibitory concentration (MIC) ranges of three or four log(2) dilution steps in two different medium formulations. Disk diffusion zone diameter ranges were proposed for tiamulin tested against Actinobacillus pleuropneumoniae ATCC 27090 (12-18 mm) and Staphylococcus aureus ATCC 25923 (25-32 mm). The data from eight participating laboratories produced 100% of results within proposed MIC limits (8-32 microg/mL), and 95.8-97.0% of zones were found within suggested zone diameter QC guidelines. These proposed QC ranges should be validated by in-use results from veterinary clinical laboratories.

  15. Effects of 31 FDA approved small-molecule kinase inhibitors on isolated rat liver mitochondria.

    Science.gov (United States)

    Zhang, Jun; Salminen, Alec; Yang, Xi; Luo, Yong; Wu, Qiangen; White, Matthew; Greenhaw, James; Ren, Lijun; Bryant, Matthew; Salminen, William; Papoian, Thomas; Mattes, William; Shi, Qiang

    2017-08-01

    The FDA has approved 31 small-molecule kinase inhibitors (KIs) for human use as of November 2016, with six having black box warnings for hepatotoxicity (BBW-H) in product labeling. The precise mechanisms and risk factors for KI-induced hepatotoxicity are poorly understood. Here, the 31 KIs were tested in isolated rat liver mitochondria, an in vitro system recently proposed to be a useful tool to predict drug-induced hepatotoxicity in humans. The KIs were incubated with mitochondria or submitochondrial particles at concentrations ranging from therapeutic maximal blood concentrations (Cmax) levels to 100-fold Cmax levels. Ten endpoints were measured, including oxygen consumption rate, inner membrane potential, cytochrome c release, swelling, reactive oxygen species, and individual respiratory chain complex (I-V) activities. Of the 31 KIs examined only three including sorafenib, regorafenib and pazopanib, all of which are hepatotoxic, caused significant mitochondrial toxicity at concentrations equal to the Cmax, indicating that mitochondrial toxicity likely contributes to the pathogenesis of hepatotoxicity associated with these KIs. At concentrations equal to 100-fold Cmax, 18 KIs were found to be toxic to mitochondria, and among six KIs with BBW-H, mitochondrial injury was induced by regorafenib, lapatinib, idelalisib, and pazopanib, but not ponatinib, or sunitinib. Mitochondrial liability at 100-fold Cmax had a positive predictive power (PPV) of 72% and negative predictive power (NPV) of 33% in predicting human KI hepatotoxicity as defined by product labeling, with the sensitivity and specificity being 62% and 44%, respectively. Similar predictive power was obtained using the criterion of Cmax ≥1.1 µM or daily dose ≥100 mg. Mitochondrial liability at 1-2.5-fold Cmax showed a 100% PPV and specificity, though the NPV and sensitivity were 32% and 14%, respectively. These data provide novel mechanistic insights into KI hepatotoxicity and indicate that

  16. 78 FR 16681 - International Conference on Harmonisation; Proposed Change to Rodent Carcinogenicity Testing of...

    Science.gov (United States)

    2013-03-18

    ...-evidence (WOE) factors proposed for inclusion in CADs. II. Past Experience With Carcinogenicity Assessment... Medicines Agency; and the Japanese Ministry of Health, Labour and Welfare. We would request that CADs be... WOE factors proposed for inclusion in carcinogenicity assessment documents. Submit either electronic...

  17. FDA advisory committees meet January 26 on Salk HIV-1 immunogen.

    Science.gov (United States)

    1995-01-06

    Two advisory committees of the Food and Drug Administration (FDA) will meet to consider future trials of the HIV-1 immunogen developed by Dr. Jonas Salk. The Immune Response Corporation has already conducted several studies of the immunogen, and has found improvement in various immunological and other blood tests, and no adverse effects. However, the studies have not been large enough to show conclusively that the treatment has clinical benefit in delaying disease progression. The new, larger trials are intended to demonstrate a delay in disease progression and validate the use of blood-test markers of disease progression for studying an immune-based treatment.

  18. FDA's Activities Supporting Regulatory Application of "Next Gen" Sequencing Technologies.

    Science.gov (United States)

    Wilson, Carolyn A; Simonyan, Vahan

    2014-01-01

    Applications of next-generation sequencing (NGS) technologies require availability and access to an information technology (IT) infrastructure and bioinformatics tools for large amounts of data storage and analyses. The U.S. Food and Drug Administration (FDA) anticipates that the use of NGS data to support regulatory submissions will continue to increase as the scientific and clinical communities become more familiar with the technologies and identify more ways to apply these advanced methods to support development and evaluation of new biomedical products. FDA laboratories are conducting research on different NGS platforms and developing the IT infrastructure and bioinformatics tools needed to enable regulatory evaluation of the technologies and the data sponsors will submit. A High-performance Integrated Virtual Environment, or HIVE, has been launched, and development and refinement continues as a collaborative effort between the FDA and George Washington University to provide the tools to support these needs. The use of a highly parallelized environment facilitated by use of distributed cloud storage and computation has resulted in a platform that is both rapid and responsive to changing scientific needs. The FDA plans to further develop in-house capacity in this area, while also supporting engagement by the external community, by sponsoring an open, public workshop to discuss NGS technologies and data formats standardization, and to promote the adoption of interoperability protocols in September 2014. Next-generation sequencing (NGS) technologies are enabling breakthroughs in how the biomedical community is developing and evaluating medical products. One example is the potential application of this method to the detection and identification of microbial contaminants in biologic products. In order for the U.S. Food and Drug Administration (FDA) to be able to evaluate the utility of this technology, we need to have the information technology infrastructure and

  19. Mining association patterns of drug-interactions using post marketing FDA's spontaneous reporting data.

    Science.gov (United States)

    Ibrahim, Heba; Saad, Amr; Abdo, Amany; Sharaf Eldin, A

    2016-04-01

    Pharmacovigilance (PhV) is an important clinical activity with strong implications for population health and clinical research. The main goal of PhV is the timely detection of adverse drug events (ADEs) that are novel in their clinical nature, severity and/or frequency. Drug interactions (DI) pose an important problem in the development of new drugs and post marketing PhV that contribute to 6-30% of all unexpected ADEs. Therefore, the early detection of DI is vital. Spontaneous reporting systems (SRS) have served as the core data collection system for post marketing PhV since the 1960s. The main objective of our study was to particularly identify signals of DI from SRS. In addition, we are presenting an optimized tailored mining algorithm called "hybrid Apriori". The proposed algorithm is based on an optimized and modified association rule mining (ARM) approach. A hybrid Apriori algorithm has been applied to the SRS of the United States Food and Drug Administration's (U.S. FDA) adverse events reporting system (FAERS) in order to extract significant association patterns of drug interaction-adverse event (DIAE). We have assessed the resulting DIAEs qualitatively and quantitatively using two different triage features: a three-element taxonomy and three performance metrics. These features were applied on two random samples of 100 interacting and 100 non-interacting DIAE patterns. Additionally, we have employed logistic regression (LR) statistic method to quantify the magnitude and direction of interactions in order to test for confounding by co-medication in unknown interacting DIAE patterns. Hybrid Apriori extracted 2933 interacting DIAE patterns (including 1256 serious ones) and 530 non-interacting DIAE patterns. Referring to the current knowledge using four different reliable resources of DI, the results showed that the proposed method can extract signals of serious interacting DIAEs. Various association patterns could be identified based on the relationships among

  20. No 3025. Proposal of law aiming at the acknowledgement and indemnification of the people victim of nuclear tests or accidents

    International Nuclear Information System (INIS)

    Taubira, Ch.; Giacobbi, P.; Ayrault, J.M.; Lurel, V.; Montebourg, A.; Dosiere, R.; Floch, J.; Adam, P.; Andrieux, S.; Aubron, J.M.; Bacquet, J.P.; Bapt, G.; Bascou, J.; Beauchaud, J.C.; Blazy, J.P.; Blisko, S.; Bloche, P.; Bois, J.C.; Boisserie, D.; Bourguignon, P.; Bousquet, D.; Carcenac, Th.; Carrillon-Couvreur, M.; Charzat, M.; Claeys, A.; Cohen, P.; Darciaux, C.; Dasseux, M.; David, M.; Dehoux, M.; Derosier, B.; Dolez, M.; Dose, F.; Ducout, P.; Dufau, J.P.; Dumas, W.; Dumont, J.L.; Dupre, J.P.; Durand, Y.; Duriez, O.; Emmanuelli, H.; Facon, A.; Francaix, M.; Gaillard, G.; Gautier, N.; Genisson, C.; Giraud, J.; Guinchard, P.; Habib, D.; Hoffman-Rispal, D.; Imbert, F.; Jalton, E.; Janquin, S.; Kucheida, J.P.; Lacuey, C.; Lambert, J.; Lamy, F.; Lang, J.; Le Bouillonnec, J.Y.; Le Bris, G.; Le Garrec, J.; Le Roux, B.; Lebranchu, M.; Lemasle, P.; Lepetit, A.; Leroy, J.C.; Liebgott, M.; Lignieres-Cassou, M.; Loncle, F.; Madrelle, B.; Masse, Ch.; Mathus, D.; Migaud, D.; Mignon, H.; Nayrou, H.; Neri, A.; Oget, M.R.; Paul, Ch.; Perez, J.C.; Perol-Dumont, M.F.

    2006-04-01

    This proposal of law aims at establishing the presumption of a relation between nuclear tests or accidents with the pathologies developed later on by the people present at that time in the contaminated areas. The proposal aims also at establishing an equality among the victims and at making up the juridical framework necessary for the government to proceed to the compensation of victims damages. (J.S.)

  1. THPdb: Database of FDA-approved peptide and protein therapeutics.

    Directory of Open Access Journals (Sweden)

    Salman Sadullah Usmani

    Full Text Available THPdb (http://crdd.osdd.net/raghava/thpdb/ is a manually curated repository of Food and Drug Administration (FDA approved therapeutic peptides and proteins. The information in THPdb has been compiled from 985 research publications, 70 patents and other resources like DrugBank. The current version of the database holds a total of 852 entries, providing comprehensive information on 239 US-FDA approved therapeutic peptides and proteins and their 380 drug variants. The information on each peptide and protein includes their sequences, chemical properties, composition, disease area, mode of activity, physical appearance, category or pharmacological class, pharmacodynamics, route of administration, toxicity, target of activity, etc. In addition, we have annotated the structure of most of the protein and peptides. A number of user-friendly tools have been integrated to facilitate easy browsing and data analysis. To assist scientific community, a web interface and mobile App have also been developed.

  2. Validation of Proposed Metrics for Two-Body Abrasion Scratch Test Analysis Standards

    Science.gov (United States)

    Street, Kenneth W., Jr.; Kobrick, Ryan L.; Klaus, David M.

    2013-01-01

    Abrasion of mechanical components and fabrics by soil on Earth is typically minimized by the effects of atmosphere and water. Potentially abrasive particles lose sharp and pointed geometrical features through erosion. In environments where such erosion does not exist, such as the vacuum of the Moon, particles retain sharp geometries associated with fracturing of their parent particles by micrometeorite impacts. The relationship between hardness of the abrasive and that of the material being abraded is well understood, such that the abrasive ability of a material can be estimated as a function of the ratio of the hardness of the two interacting materials. Knowing the abrasive nature of an environment (abrasive)/construction material is crucial to designing durable equipment for use in such surroundings. The objective of this work was to evaluate a set of standardized metrics proposed for characterizing a surface that has been scratched from a two-body abrasion test. This is achieved by defining a new abrasion region termed Zone of Interaction (ZOI). The ZOI describes the full surface profile of all peaks and valleys, rather than just measuring a scratch width. The ZOI has been found to be at least twice the size of a standard width measurement; in some cases, considerably greater, indicating that at least half of the disturbed surface area would be neglected without this insight. The ZOI is used to calculate a more robust data set of volume measurements that can be used to computationally reconstruct a resultant profile for de tailed analysis. Documenting additional changes to various surface roughness par ameters also allows key material attributes of importance to ultimate design applications to be quantified, such as depth of penetration and final abraded surface roughness. Further - more, by investigating the use of custom scratch tips for specific needs, the usefulness of having an abrasion metric that can measure the displaced volume in this standardized

  3. FDA actions against health economic promotions, 2002-2011.

    Science.gov (United States)

    Neumann, Peter J; Bliss, Sarah K

    2012-01-01

    To investigate Food and Drug Administration (FDA) regulatory actions against drug companies' health economic promotions from 2002 through 2011 to understand how frequently and in what circumstances the agency has considered such promotions false or misleading. We reviewed all warning letters and notices of violation ("untitled letters") issued by the FDA's Division of Drug Marketing, Advertising and Communications (DDMAC) to pharmaceutical companies from January 2002 through December 2011. We analyzed letters containing a violation related to "health economic promotion," defined according to one of several categories (e.g., implied claims of cost savings due to work productivity or economic claims containing unsupported statements about effectiveness or safety). We also collected information on factors such as the indication and type of media involved and whether the letter referenced Section 114 of the Food and Drug Administration Modernization Act. Of 291 DDMAC letters sent to pharmaceutical companies during the study period, 35 (12%) cited a health economic violation. The most common type of violation cited was an implied claim of cost savings due to work productivity or functioning (found in 20 letters) and economic claims containing unsubstantiated comparative claims of effectiveness, safety, or interchangeability (7 letters). The violations covered various indications, mostly commonly psychiatric disorders (6 letters) and pain (6 letters). No DDMAC letter pertained to Food and Drug Administration Modernization Act Section 114. The FDA has cited inappropriate health economic promotions in roughly 12% of the letters issued by the DDMAC. The letters highlight drug companies' interest in promoting the value of their products and the FDA's concerns in certain cases about the lack of supporting evidence. Copyright © 2012 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  4. Three Drugs Approved for Urothelial Carcinoma by FDA.

    Science.gov (United States)

    2017-07-01

    The FDA has approved one PD-1 checkpoint inhibitor, pembrolizumab, and two PD-L1 checkpoint inhibitors, avelumab and durvalumab, to treat metastatic urothelial carcinoma in patients whose disease continues to progress despite platinum-based chemotherapy. This brings the total number of checkpoint inhibitors for the disease to five, prompting questions about how best to use them. ©2017 American Association for Cancer Research.

  5. Which factors predict proposal and uptake of psychological counselling after BRCA1/2 test result disclosure?

    Science.gov (United States)

    Maheu, Christine; Bouhnik, Anne-Deborah; Nogues, Catherine; Mouret-Fourme, Emmanuelle; Stoppa-Lyonnet, Dominique; Lasset, Christine; Berthet, Pascaline; Fricker, Jean-Pierre; Caron, Olivier; Luporsi, Elizabeth; Gladieff, Laurence; Julian-Reynier, Claire

    2014-04-01

    The aim of this study is to prospectively determine the factors contributing to whether unaffected women from BRCA1/2 families reported that clinicians proposed psychological consultations and that they had attended these consultations during the genetic testing process. A prospective study was performed on a national cohort, using self-administered questionnaires to determine the rates of proposal and use of psychological services at the time of BRCA1/2 test result disclosure (N = 533) and during the first year after disclosure (N = 478) among unaffected French women from BRCA1/2 families who had undergone genetic testing for BRCA1/2. Multivariate adjustment was carried out using logistic regression models fitted using generalized estimation equations, with the genetic testing centre as the clustering variable. At the time of BRCA1/2 test result disclosure, a psychological consultation was proposed by cancer geneticists to 72% and 32% of the carriers (N = 232) and noncarriers (N = 301), respectively (p disclosure, 21% of the carriers had consulted a psychologist, versus 9% of the noncarriers (p distress they experienced about their genetic test results (proposal AOR: 1.02; 95% CI 1.01-1.03; uptake AOR: 1.04; 95% CI 1.02-1.06) CONCLUSIONS: Determinants of the proposal/uptake of psychological consultations in the BRCA1/2 testing process highlight the need for inventive strategies to reach the different types of women's profiles. Copyright © 2013 John Wiley & Sons, Ltd.

  6. Changes in the utilization of osteoporosis drugs after the 2010 FDA bisphosphonate drug safety communication

    Directory of Open Access Journals (Sweden)

    Bander Balkhi

    2018-02-01

    Conclusions: The 2010 FDA bisphosphonates safety communication appeared to have influenced Osteoporosis utilization in Medicaid recipients. The 2010 FDA bisphosphonates safety communication was associated with a significant reduction in the utilization of bisphosphonates in the Medicaid program.

  7. Dimensions of Oppositionality in a Brazilian Community Sample: Testing the "DSM-5" Proposal and Etiological Links

    Science.gov (United States)

    Krieger, Fernanda Valle.; Polanczyk, Guilherme Vanoni; Goodman, Robert; Rohde, Luis Augusto; Graeff-Martins, Ana Soledade; Salum, Giovanni; Gadelha, Ary; Pan, Pedro; Stahl, Daniel; Stringaris, Argyris

    2013-01-01

    Objective: Investigating dimensions of oppositional symptoms may help to explain heterogeneity of etiology and outcomes for mental disorders across development and provide further empirical justification for the "DSM-5"-proposed modifications of oppositional defiant disorder (ODD). However, dimensions of oppositionality have not…

  8. Testing Report: Littleford-Day Dryer Operation: Dryer Operation Impacts of Proposed MIS Mitigation Changes

    Energy Technology Data Exchange (ETDEWEB)

    Shimskey, Rick W. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Buchmiller, William C. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Elmore, Monte R. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States)

    2007-06-01

    Pacific Northwest National Laboratory performed a series of tests using the Littleford Day 22-liter dryer during investigations that evaluated changes in the melter-feed composition for the Demonstration Bulk Vitrification System. During testing, a new melter-feed formulation was developed that improved dryer performance while improving the retention of waste salts in the melter feed during vitrification.

  9. Use of the FDA nozzle model to illustrate validation techniques in computational fluid dynamics (CFD) simulations.

    Science.gov (United States)

    Hariharan, Prasanna; D'Souza, Gavin A; Horner, Marc; Morrison, Tina M; Malinauskas, Richard A; Myers, Matthew R

    2017-01-01

    A "credible" computational fluid dynamics (CFD) model has the potential to provide a meaningful evaluation of safety in medical devices. One major challenge in establishing "model credibility" is to determine the required degree of similarity between the model and experimental results for the model to be considered sufficiently validated. This study proposes a "threshold-based" validation approach that provides a well-defined acceptance criteria, which is a function of how close the simulation and experimental results are to the safety threshold, for establishing the model validity. The validation criteria developed following the threshold approach is not only a function of Comparison Error, E (which is the difference between experiments and simulations) but also takes in to account the risk to patient safety because of E. The method is applicable for scenarios in which a safety threshold can be clearly defined (e.g., the viscous shear-stress threshold for hemolysis in blood contacting devices). The applicability of the new validation approach was tested on the FDA nozzle geometry. The context of use (COU) was to evaluate if the instantaneous viscous shear stress in the nozzle geometry at Reynolds numbers (Re) of 3500 and 6500 was below the commonly accepted threshold for hemolysis. The CFD results ("S") of velocity and viscous shear stress were compared with inter-laboratory experimental measurements ("D"). The uncertainties in the CFD and experimental results due to input parameter uncertainties were quantified following the ASME V&V 20 standard. The CFD models for both Re = 3500 and 6500 could not be sufficiently validated by performing a direct comparison between CFD and experimental results using the Student's t-test. However, following the threshold-based approach, a Student's t-test comparing |S-D| and |Threshold-S| showed that relative to the threshold, the CFD and experimental datasets for Re = 3500 were statistically similar and the model could be

  10. Dose Uniformity of Scored and Unscored Tablets: Application of the FDA Tablet Scoring Guidance for Industry.

    Science.gov (United States)

    Ciavarella, Anthony B; Khan, Mansoor A; Gupta, Abhay; Faustino, Patrick J

    This U.S. Food and Drug Administration (FDA) laboratory study examines the impact of tablet splitting, the effect of tablet splitters, and the presence of a tablet score on the dose uniformity of two model drugs. Whole tablets were purchased from five manufacturers for amlodipine and six for gabapentin. Two splitters were used for each drug product, and the gabapentin tablets were also split by hand. Whole and split amlodipine tablets were tested for content uniformity following the general chapter of the United States Pharmacopeia (USP) Uniformity of Dosage Units , which is a requirement of the new FDA Guidance for Industry on tablet scoring. The USP weight variation method was used for gabapentin split tablets based on the recommendation of the guidance. All whole tablets met the USP acceptance criteria for the Uniformity of Dosage Units. Variation in whole tablet content ranged from 0.5 to 2.1 standard deviation (SD) of the percent label claim. Splitting the unscored amlodipine tablets resulted in a significant increase in dose variability of 6.5-25.4 SD when compared to whole tablets. Split tablets from all amlodipine drug products did not meet the USP acceptance criteria for content uniformity. Variation in the weight for gabapentin split tablets was greater than the whole tablets, ranging from 1.3 to 9.3 SD. All fully scored gabapentin products met the USP acceptance criteria for weight variation. Size, shape, and the presence or absence of a tablet score can affect the content uniformity and weight variation of amlodipine and gabapentin tablets. Tablet splitting produced higher variability. Differences in dose variability and fragmentation were observed between tablet splitters and hand splitting. These results are consistent with the FDA's concerns that tablet splitting can have an effect on the amount of drug present in a split tablet and available for absorption. Tablet splitting has become a very common practice in the United States and throughout the

  11. No sisyphean task: how the FDA can regulate electronic cigarettes.

    Science.gov (United States)

    Paradise, Jordan

    2013-01-01

    The adverse effects of smoking have fostered a natural market for smoking cessation and smoking reduction products. Smokers attempting to quit or reduce consumption have tried everything: "low" or "light" cigarettes; nicotine-infused chewing gum, lozenges, and lollipops; dermal patches; and even hypnosis. The latest craze in the quest to find a safer source of nicotine is the electronic cigarette. Electronic cigarettes (e-cigarettes) have swept the market, reaching a rapidly expanding international consumer base. Boasting nicotine delivery and the tactile feel of a traditional cigarette without the dozens of other chemical constituents that contribute to carcinogenicity, e-cigarettes are often portrayed as less risky, as a smoking reduction or even a complete smoking cessation product, and perhaps most troubling for its appeal to youth, as a flavorful, trendy, and convenient accessory. The sensationalism associated with e-cigarettes has spurred outcry from health and medical professional groups, as well as the Food and Drug Administration (FDA), because of the unknown effects on public health. Inhabiting a realm of products deemed "tobacco products" under recent 2009 legislation, e-cigarettes pose new challenges to FDA regulation because of their novel method of nicotine delivery, various mechanical and electrical parts, and nearly nonexistent safety data. Consumer use, marketing and promotional claims, and technological characteristics of e-cigarettes have also raised decades old questions of when the FDA can assert authority over products as drugs or medical devices. Recent case law restricting FDA enforcement efforts against e-cigarettes further confounds the distinction among drugs and medical devices, emerging e-cigarette products, and traditional tobacco products such as cigarettes, cigars, and smokeless tobacco. This Article investigates the e-cigarette phenomenon in the wake of the recently enacted Family Smoking Prevention and Tobacco Control Act of 2009

  12. Formation of defect-free 6FDA-DAM asymmetric hollow fiber membranes for gas separations

    KAUST Repository

    Xu, Liren; Zhang, Chen; Rungta, Meha; Qiu, Wulin; Liu, Junqiang; Koros, William J.

    2014-01-01

    This paper reports the formation of defect-free 6FDA-DAM asymmetric hollow fiber membranes. 6FDA-polyimides are of great interest for advanced gas separation membranes, and 6FDA-DAM polyimide is a representative polymer in this family

  13. 76 FR 30175 - Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by...

    Science.gov (United States)

    2011-05-24

    ... consider public release of financial disclosure information related to an approved marketing application...] (Formerly FDA-1999-D-0792) Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial... entitled ``Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical...

  14. 78 FR 47217 - Proposed Supervisory Guidance on Implementing Dodd-Frank Act Company-Run Stress Tests for Banking...

    Science.gov (United States)

    2013-08-05

    ... 10-50. More advanced portfolio segmentation can take several forms, such as by product (construction... CORPORATION 12 CFR Part 325 Proposed Supervisory Guidance on Implementing Dodd-Frank Act Company-Run Stress... 165(i)(2) of the Dodd-Frank Act Wall Street Reform and Consumer Protection Act (``DFA'') stress tests...

  15. Proposal for a test using aquatic mosses for the radioecological control of the environment

    International Nuclear Information System (INIS)

    Baudin-Jaulent, Y.; Descamps, B.

    1985-01-01

    Field experiments demonstrated that a test using aquatic mosses (bags made of plastic netting and containing a small amount of moss) could be considered for the radioecological monitoring of a uranium mining complex. This test has the required qualities: easy operation, reliability and low cost. It also makes it possible to assess inorganic pollution due, for instance, to heavy metals, or organic pollution by products such as chlorinated compounds [fr

  16. Reliability of core test – Critical assessment and proposed new approach

    OpenAIRE

    Shafik Khoury; Ali Abdel-Hakam Aliabdo; Ahmed Ghazy

    2014-01-01

    Core test is commonly required in the area of concrete industry to evaluate the concrete strength and sometimes it becomes the unique tool for safety assessment of existing concrete structures. Core test is therefore introduced in most codes. An extensive literature survey on different international codes’ provisions; including the Egyptian, British, European and ACI Codes, for core analysis is presented. All studied codes’ provisions seem to be unreliable for predicting the in-situ concrete ...

  17. Proposal for health effects studies related to nuclear weapon testing at Semipalatinsk, Kazakhstan

    International Nuclear Information System (INIS)

    Peterson, L.E.; Weinberg, A.D.

    1997-01-01

    Populations that resided and who now resid in and the Semipalatinsk Test Site have emained there for decades and experienced little in and out migration. Semipalatinsk City was literally a secret city until the dissolution of the USSR. The urban population of the city of Semipalatinsk has steadily grown from several hundred thousand to about 1 million people in the area. Although current urban and rural levels of exposure from environmental radiocontamination are not markedly increased beyond natural background, there are many villagers who resided near the Semipalatinsk Test Site whose cumulative lifetime doses are on the order of 0.8-2 Sv. Over the course of 40 years, more than 470 nuclear weapons were tested at the Semipalatinsk Test Site (STS) in the Semipalatinsk region of Kazakhstan. From 1949 to 1963, 38 detonations occured on the ground and 128 in the air. Radionuclides emanating from there tests resulted in atmospheric and enviromental contamination leading to varios levels of acute and chronic radiation exposure. The medical, scientific and social ramifications of the nuclear testing pose serius challenges to the Kazakhstan Repubic and its scientific and health care systems. The release of radionuclides over a long period of time and their spread in the enveronment posed major problems to the Kazakhstan authorities. Efforts to study the association between fallout radiation and radiation-induced health effects were prevented by official decree until 1980. Initially, efforts to address the medical and scientific challenges of the radioactive contamination which was classified in the FSU. After the dissolution of the FSU, efforts to study populations aroud STS were hampered and further encumbered by the political and social changes that increased sharply in the FSU soon after test suspension

  18. Proposed diagnostic thresholds for gestational diabetes mellitus according to a 75-g oral glucose tolerance test

    DEFF Research Database (Denmark)

    Jensen, Dorte Møller; Damm, P; Sørensen, B

    2003-01-01

    AIMS: To study if established diagnostic threshold values for gestational diabetes based on a 75-g, 2-h oral glucose tolerance test can be supported by maternal and perinatal outcomes. METHODS: Historical cohort study of 3260 pregnant women examined for gestational diabetes on the basis of risk...... indicators. Information on oral glucose tolerance test results and clinical outcomes were collected from medical records. RESULTS: There was an increased risk of delivering a macrosomic infant in women with 2-h capillary blood glucose of 7.8-8.9 mmol/l compared with women with 2-h glucose ... mellitus. Until these results are available, a 2-h threshold level of 9.0 mmol/l after a 75-g oral glucose tolerance test seems acceptable....

  19. An Architecture Proposal for the ILC Test Beam Silicon Telescope at Fermilab

    Energy Technology Data Exchange (ETDEWEB)

    Turqueti, M.A.; /Fermilab

    2007-04-01

    The requirements for an ILC Test Beam silicon telescope system are foreseen to be very stringent. Resolution, noise, and throughput must be carefully managed in order to provide a useful instrument for the high energy physics community to develop detector technologies for the ILC. Since the ILC Test Beam is meant to test a wide variety of different detectors, it must employ universally accepted software techniques, hardware standards and protocols as well as easy integration of hardware and software with the various clients using the system. In this paper, we describe an open modular architecture to achieve these goals, including an analysis of the entire chain of software and hardware needed to meet the requirements.

  20. U.S.: proposed federal legislation to allow condom distribution and HIV testing in prison.

    Science.gov (United States)

    Dolinsky, Anna

    2007-05-01

    Representative Barbara Lee (D-CA) is reintroducing legislation in the U.S. House of Representatives that would require federal correctional facilities to allow community organizations to distribute condoms and provide voluntary counselling and testing for HIV and STDs for inmates. The bill has been referred to the House Judiciary Committee's Subcommittee on Crime, Terrorism, and Homeland Security.

  1. 77 FR 809 - Request for Proposals for Certification and Testing Expertise for the Ballistic Resistance of...

    Science.gov (United States)

    2012-01-06

    ... for Certification and Testing Expertise for the Ballistic Resistance of Personal Body Armor (2008... revising its Ballistic Resistance of Personal Body Armor (2008) Standard and corresponding certification... laboratories with experience in programs for similar types of ballistic-resistant personal protective equipment...

  2. Interpreting Statistical Significance Test Results: A Proposed New "What If" Method.

    Science.gov (United States)

    Kieffer, Kevin M.; Thompson, Bruce

    As the 1994 publication manual of the American Psychological Association emphasized, "p" values are affected by sample size. As a result, it can be helpful to interpret the results of statistical significant tests in a sample size context by conducting so-called "what if" analyses. However, these methods can be inaccurate…

  3. A Proposal for Testing Local Realism Without Using Assumptions Related to Hidden Variable States

    Science.gov (United States)

    Ryff, Luiz Carlos

    1996-01-01

    A feasible experiment is discussed which allows us to prove a Bell's theorem for two particles without using an inequality. The experiment could be used to test local realism against quantum mechanics without the introduction of additional assumptions related to hidden variables states. Only assumptions based on direct experimental observation are needed.

  4. Evaluation of a Proposed Drift Reduction Technology High-Speed Wind Tunnel Testing Protocol

    Science.gov (United States)

    2009-03-01

    05: “Standard Test Method for Determining Liquid Drop Size Characteristics in a Spray Using Optical Nonimaging Light- Scattering Instruments” 15...Method for Determining Liquid Drop Size Characteris- tics in a Spray Using Optical Nonimaging Light-Scattering Instruments,” Annual Book of ASTM Standards

  5. Stroop test software. The Tastiva proposal (Software para pruebas Stroop. La propuesta de Tastiva

    Directory of Open Access Journals (Sweden)

    María Claudia Scurtu

    2016-08-01

    Full Text Available There has been a great deal of research on emotional information processing within the field of clinical psychology. Many tests have been developed and the emotional Stroop test is one of the most used. However, some versions of the Stroop test have methodological issues when used to study word-colour interferences, especially when the words are emotionally charged. We present a computer-assisted version of the emotional Stroop test called Tastiva, which is highly versatile, useful, and accessible, in addition to being easy to use and widely applicable. The Tastiva software and User Manual is available on the University of Seville website: http://grupo.us.es/recursos/Tastiva/index.htm. We also present a case study using neutral and sexual content words, in which the program calculates the word exposure time by analysing the behaviour of the respondent. One of its novel contributions is the graphic presentation of measures: response time, errors, and non-response to stimuli.

  6. 77 FR 10509 - Agency Information Collection Activities; Proposed Collection; Comment Request; Drug Testing for...

    Science.gov (United States)

    2012-02-22

    ... that may potentially affect communities and the surrounding environment. Releases may be accidental... may be responsible for testing their employees for the use of marijuana, cocaine, opiates.... Respondents/Affected Entities: EPA contractor employees who work at sensitive sites. Estimated Number of...

  7. 78 FR 77646 - Proposed Information Collection; Comment Request; 2014 Census Site Test

    Science.gov (United States)

    2013-12-24

    ... improve self- response, the Census Bureau plans to test new contact and notification strategies such as... physical location, and provide a preference for a contact strategy of either email or text. Furthermore... will be a communications and promotional campaign designed to increase awareness and encourage...

  8. 78 FR 694 - Proposed Extension of Approval of Information Collection; Comment Request-Testing and...

    Science.gov (United States)

    2013-01-04

    ... ignition of mattresses, 16 CFR part 1632. The Open- Flame standard is intended to reduce unreasonable risks... may be introduced into commerce. The Office of Management and Budget (OMB) previously approved the... suppliers, and confirmation test records, if establishments choose to pool a prototype. This documentation...

  9. Experimental testing and theoretical analysis of samples of a divertor plate proposed for NET

    International Nuclear Information System (INIS)

    Brossa, F.; Federici, G.; Renda, V.; Papa, L.

    1986-01-01

    This paper presents the JRC-Ispra effort to support the design of a divertor concept for future reactors. The reference frame used in this work, i.e. divertor geometry and wall loading, is that of the NET (Next European Torus) reactor, which constitutes the European collaboration in the fusion reactor technology Program. Because of its main function of plasma impurity control, the divertor is submitted to high thermal fluxes, severe sputtering rates and electromagnetic forces. The present proposal for the divertor plate is the following: 1) W-5Re for the armour; 2) Cu for the heat sink. This choice is due to the low sputtering rate and favourable high temperature mechanical properties of the W-5Re, and the high thermal conductivity of copper

  10. FDA cigarette warning labels lower craving and elicit frontoinsular activation in adolescent smokers

    Science.gov (United States)

    Do, Kathy T.

    2015-01-01

    Cigarette smoking is an economically and epidemiologically expensive public health concern. Most adult smokers become addicted during adolescence, rendering it a crucial period for prevention and intervention. Although litigation claims have delayed implementation, graphic warning labels proposed by the U.S. Food and Drug Administration (FDA) may be a promising way to achieve this goal. We aimed to determine the efficacy of the labels in reducing in-scanner craving and to characterize the neurobiological responses in adolescent and adult smokers and non-smokers. While undergoing functional magnetic resonance imaging, thirty-nine 13- to 18-year-old adolescent and forty-one 25- to 30-year-old adult smokers and non-smokers rated their desire to smoke when presented with emotionally graphic warning labels and comparison non-graphic labels. Compared with adult smokers, adolescent smokers exhibited greater craving reduction in response to the warning labels. Although smokers evinced overall blunted recruitment of insula and dorsolateral prefrontal cortex (DLPFC) relative to non-smokers, an effect that was stronger in adolescent smokers, parametrically increasing activation of these regions was associated with greater craving reduction. Functional connectivity analyses suggest that greater DLPFC regulation of limbic regions predicted cigarette craving. These data underscore a prominent role of frontoinsular circuitry in predicting the efficacy of FDA graphic warning labels in craving reduction in adult and adolescent smokers. PMID:25887154

  11. Waste Package and Material Testing for the Proposed Yucca Mountain High Level Waste Repository

    International Nuclear Information System (INIS)

    Doering, Thomas; Pasupathi, V.

    2002-01-01

    Over the repository lifetime, the waste package containment barriers will perform various functions that will change with time. During the operational period, the barriers will function as vessels for handling, emplacement, and waste retrieval (if necessary). During the years following repository closure, the containment barriers will be relied upon to provide substantially complete containment, through 10,000 years and beyond. Following the substantially complete containment phase, the barriers and the waste package internal structures help minimize release of radionuclides by aqueous- and gaseous-phase transport. These requirements have lead to a defense-in-depth design philosophy. A multi-barrier design will result in a lower breach rate distributed over a longer period of time, thereby ensuring the regulatory requirements are met. The design of the Engineered Barrier System (EBS) has evolved. The initial waste package design was a thin walled package, 3/8 inch of stainless steel 304, that had very limited capacity, (3 PWR and 4 BWR assemblies) and performance characteristics, 300 to 1,000 years. This design required over 35,000 waste packages compared to today's design of just over 10,000 waste packages. The waste package designs are now based on a defense-in-depth/multi-barrier philosophy and have a capacity similar to the standard storage and rail transported spent nuclear fuel casks. Concurrent with the development of the design of the waste packages, a comprehensive waste package materials testing program has been undertaken to support the selection of containment barrier materials and to develop predictive models for the long-term behavior of these materials under expected repository conditions. The testing program includes both long-term and short-term tests and the results from these tests combination with the data published in the open literature are being used to develop models for predicting performance of the waste packages

  12. Environmental Assessment (EA): Proposed Missile Storage Improvements, Utah Test and Training Range

    Science.gov (United States)

    2013-06-11

    801) 451 -7872 Standard Form 298 (Rev. 8-98) Prescribed by ANSI Std. Z39.18 Hill Air Force Base, Utah Final Environmental Assessment...motors were monitored to determine their functional capability when stored in prescribed temperatures varying between -65 degrees Fahrenheit to 200...degrees Fahrenheit . One of these structures (Building 30260) was used for cryogenic or deep-freeze testing. They were hardened structures meant to

  13. Detection of Misconceptions about Colour and an Experimentally Tested Proposal to Combat them

    Science.gov (United States)

    Martinez-Borreguero, Guadalupe; Pérez-Rodríguez, Ángel Luis; Suero-López, María Isabel; José Pardo-Fernández, Pedro

    2013-06-01

    We study the misconceptions about colour that most people hold, determining the general phenomenological laws that govern them. Concept mapping was used to combat the misconceptions which were found in the application of a test specifically designed to determine these misconceptions, while avoiding the possible misleading inductions that could have arisen from the use of everyday language. In particular, care was taken to avoid the distorting effect that the use of the verb 'to be' applied to coloured objects could have on the responses. The misconceptions found were shown to have an internal consistency in the form of authentic mini-theories (implicit theories). We compared experimentally the results of two different teaching methods applied to combat these misconceptions. This study was conducted with 470 undergraduates of the University of Extremadura. We analysed the persistence over time of their learning made to overcome those misconceptions. The students were divided randomly into an experimental group (EG) and a control group (CG). To combat their misconceptions, EG were taught following a method based on the use of concept maps, and CG were taught following traditional teaching methods. The results of a pre-test and a post-test were compared for the two groups, finding statistically significant differences. The results allowed the principal working hypothesis to be accepted-concept maps are learning tools which foster conceptual change and allow misconceptions to be eradicated via meaningful learning maintained over time, i.e. EG acquired a relative long-lasting gain in learning that was superior to that acquired by CG.

  14. Testing the Deployment Repeatability of a Precision Deployable Boom Prototype for the Proposed SWOT Karin Instrument

    Science.gov (United States)

    Agnes, Gregory S.; Waldman, Jeff; Hughes, Richard; Peterson, Lee D.

    2015-01-01

    NASA's proposed Surface Water Ocean Topography (SWOT) mission, scheduled to launch in 2020, would provide critical information about Earth's oceans, ocean circulation, fresh water storage, and river discharge. The mission concept calls for a dual-antenna Ka-band radar interferometer instrument, known as KaRIn, that would map the height of water globally along two 50 km wide swaths. The KaRIn antennas, which would be separated by 10 meters on either side of the spacecraft, would need to be precisely deployable in order to meet demanding pointing requirements. Consequently, an effort was undertaken to design build and prototype a precision deployable Mast for the KaRIn instrument. Each mast was 4.5-m long with a required dilitation stability of 2.5 microns over 3 minutes. It required a minimum first mode of 7 Hz. Deployment repeatability was less than +/- 7 arcsec in all three rotation directions. Overall mass could not exceed 41.5 Kg including any actuators and thermal blanketing. This set of requirements meant the boom had to be three times lighter and two orders of magnitude more precise than the existing state of the art for deployable booms.

  15. Collaborative Proposal. Development of an Isotope-Enabled CESM for Testing Abrupt Climate Changes

    Energy Technology Data Exchange (ETDEWEB)

    Otto-Bliesner, Bette [National Center for Atmospheric Research, Boulder, CO (United States)

    2015-12-10

    We have made significant landmarks in our proposed work in the last 4 years (3 years plus 1 year of no cost extension). We have developed the simulation capability of the major isotopes in CESM. In particular, we have completed the implementation of the stable water isotopes (δ18O, δD) into the components for the atmosphere, ocean, land surface, runoff transport, sea ice, and coupler. In addition, the carbon isotopes (abiotic and biotic radiocarbon, δ13 C) have been implemented into the CESM ocean and land models, and long spinup simulations have been completed (Jahn et al., 2015). Furthermore, we have added abiotic Neodymium to the CESM ocean model as a tracer of ocean circulation, also measured by the proxy data community. Fullycoupled simulations with the stable water isotopes and ocean radiocarbon are currently being run for the preindustrial and also the Last Glacial Maximum. We have secured 19 million core-hours on the NWSC Yellowstone supercomputer for 12 months. Together with some CESM Paleoclimate Working Group CSL Yellowstone core hours, we are guaranteed sufficient computing for the spin-up experiments and deglaciation simulations for 21 to 15ka.

  16. In-pile experiments and test facilities proposed for fast reactor safety

    International Nuclear Information System (INIS)

    Grolmes, M.A.; Avery, R.; Goldman, A.J.; Fauske, H.K.; Marchaterre, J.F.; Rose, D.; Wright, A.E.

    1976-01-01

    The role of in-pile experiments in support of the resolution of fast breeder reactor safety and licensing issues has been re-examined, with emphasis on key safety issues. Experiment needs have been related to the specific characteristics of these safety issues and to realistic requirements for additional test facility capabilities which can be achieved and utilized within the next ten years. It is found that those safety issues related to the energetics of core disruptive accidents have the largest impact on new facility requirements. However, utilization of existing facilities with modifications can provide for a continuing increase in experiment capability and experiment results on a timely bases. Emphasis has been placed upon maximum utilization of existing facilities and minimum requirements for new facilities. This evaluation has concluded that a new Safety Test Facility, STF, along with major modifications to the EBR II facility, improvement in TREAT capabilities, the existing Sodium Loop Safety Facility and corresponding Support Facilities provide the essential elements of the Safety Research Experiment Facilities (SAREF) required for resolution of key issues

  17. A Descriptive Longitudinal Study of Changes in Vape Shop Characteristics and Store Policies in Anticipation of the 2016 FDA Regulations of Tobacco Products, Including E-Cigarettes.

    Science.gov (United States)

    Yu, Sheila; Escobedo, Patricia; Garcia, Robert; Cruz, Tess Boley; Unger, Jennifer B; Baezconde-Garbanati, Lourdes; Meza, Leah; Sussman, Steve

    2018-02-11

    After proposing the "Deeming Rule" in 2014, the U.S. Food and Drug Administration (FDA) began regulating the manufacturing, marketing, and sales of electronic cigarette (e-cigarette) products as tobacco products in 2016. The current study conducted vape shop store observations and surveyed Los Angeles-area shop employees (assessing their beliefs, awareness, and perceptions of e-cigarettes and related FDA regulations) at two time points one year apart to better understand what vape shop retailers would do given FDA's soon-to-be-enacted Deeming Rule. The study also compared retailer beliefs/awareness/actions and store characteristics immediately after the Deeming Rule proposal versus a year after the Rule had been proposed, right before its enactment. Two data collection waves occurred before the Deeming Rule enactment, with Year 1 surveying 77 shops (2014) and Year 2 surveying 61 shops (2015-2016). Between the data collection points, 16 shops had closed. Among the shops that were open at both time points, the majority (95% in Year 1; 74% in Year 2) were aware of some FDA regulations or other policies applying to vape shops. However, overall awareness of FDA regulations and state/local policies governing e-cigarettes significantly decreased from Year 1 to Year 2. At both time points, all shops offered customers free puffs of nicotine-containing e-liquids (prohibited by the then upcoming Deeming Rule). Perceptions of e-cigarette safety also significantly decreased between the years. Exploring vape shop retailer perceptions and store policies (i.e., free puffs/samples displays, perceptions of e-cigarette safety, etc.) over time will help the FDA assess the needs of the vape shop community and develop more effective retailer education campaigns and materials targeted to increase compliance with the newly enacted regulations.

  18. Proposal for testing lepton universality in upsilon decays at a B factory running at Υ(3S)

    International Nuclear Information System (INIS)

    Sanchis-Lozano, Miguel-Angel

    2007-01-01

    A proposal is presented for detecting new physics at a B factory running at the Υ(3S) resonance by testing lepton universality to the few percent level in the leptonic decays of the Υ(1S) and Υ(2S) resonances tagged by the dipion in the chain decay: Υ(3S) → π + π - Υ(1S,2S); Υ(1S,2S) → l + l - , l=e,μ,τ. (author)

  19. Implementation and test of proposals to integrate human factors in reporting and causal analysis in nuclear power plants

    International Nuclear Information System (INIS)

    Wilpert; Maimer, H.; Miller, R.; Fahlbruch, B.; Leiber, I.; Szameitat, S.; Baggen, R.; Gans, A.; Becker, G.

    1998-01-01

    The research project 'Implementation and Test of Proposals to integrate Human Factors in Reporting and Causal Analysis in Nuclear Power Plants' ('Implementation and Test', SR 2039/8) is based on two antecedent projects: 'Reporting System' (SR 2039/1) and 'Causal Analysis' (SR 2039/2). The project 'Implementation and Test' conducted various tests and introductory programs in cooperation with different target groups concerning the event analysis methodology 'SOL - Safety through Organizational Learning': Regulators, consultant organizations, union/works councillors and utilities. Thus, SOL was concurrently optimized and [apted for the practice in the German nuclear power industry. SOL was also validated in a German nuclear power plant using a concrete event. Results of the 'Implementation and Test' project demonstrate that SOL is fit to conduct event analyses practicably and economically with appropriate comprehensiveness and depth. SOL facilitates the identification of relevant contributing factors of events. This report concludes with various concrete proposals for the further development of the Program of the Federal Ministry of Environment, Nature Protection and Reactor Safety (BMU) and the Federal Agency of R[iation Protection (BfS) concerning 'The Contribution of Humans to Safety of Nuclear Power Plants'. (orig.) [de

  20. Application of a recently proposed test to the hypernettedchain approximation for the electric double layer

    Directory of Open Access Journals (Sweden)

    D.Henderson

    2007-09-01

    Full Text Available Bhuiyan, Outhwaite, and Henderson, J. Electroanal. Chem., 2007, 607, 54, have studied the electric double layer formed by a symmetric electrolyte in the restricted primitive model and suggested that an examination of the product of the coion and counter ion profiles, normalized to the one when the distance of an ion from the electrode is large, is an interesting and useful test of a theory. This product is identically one in the Poisson-Boltzmann theory but simulation results show that, at contact, this product can be greater or smaller than one at small electrode charge but always seems to tend to zero at large electrode charge. In this study we report the results of the hypernetted chain approximation (HNC/MSA version for this product and find that, at contact, for this theory this product is always greater than the one at small electrode charge but tends to zero at large electrode charge.

  1. Proposed Guidelines for Selection of Methods for Erosion-corrosion Testing in Flowing Liquids

    International Nuclear Information System (INIS)

    Matsumura, Masanobu

    2007-01-01

    The corrosion of metals and alloys in flowing liquids can be classified into uniform corrosion and localized corrosion which may be categorized as follows. (1) Localized corrosion of the erosion-corrosion type: the protective oxide layer is assumed to be removed from the metal surface by shear stress or turbulence of the fluid flow. A macro-cell may be defined as a situation in which the bare surface is the macro-anode and the other surface covered with the oxide layer is the macro-cathode. (2) Localized corrosion of the differential flow-velocity corrosion type: at a location of lower fluid velocity, a thin and coarse oxide layer with poor protective qualities may be produced because of an insufficient supply of oxygen. A macro-cell may be defined as a situation in which this surface is the macro-anode and the other surface covered witha dense and stable oxide layer is the macro-cathode. (3) Localized corrosion of the active/passive-cell type: on a metal surface a macro-cell may be defined as a situation in which a part of it is in a passivation state and another in an active dissolution state. This situation may arise from differences in temperature as well as in the supply of the dissolved oxygen. Compared to uniform corrosion, localized corrosion tends to involve a higher wall thinning rate (corrosion rate) due to the macro-cell current as well as to the ratio of the surface area of the macro-anode to that of the macro-cathode, which may be rationalized using potential vs. current density diagrams. The three types of localized corrosion described above can be reproduced in a Jet-in-slit test by changing the flow direction of the test liquid and arranging environmental conditions in an appropriate manner

  2. Communicating safe sun practices to farm youth: a model and field test of a proposed curriculum

    International Nuclear Information System (INIS)

    Turk, D.R.; Parrott, R.; Martin, M.; Steiner, C.; Lewis, D.

    1997-01-01

    This project was designed to identify the barriers and motivators to farm youths' performance of skin cancer prevention and detection behavior in order to design curricula which could directly address both. The curriculum as developed was pilot tested in 1994 at the Georgia Healthy Farmers ''Farm Kids'' Safety Camp. The 82 participants, aged 8 to 15 years, were children of Georgia farmers. Eight Sun Safety classes were held over the course of two days. Participants were seated in a large conference room and were given a research questionnaire packet consisting of a skin cancer prevention/detection knowledge measure, three skin cancer related fact sheets, and a workbook to be used to rate various skin cancer prevention/detection materials and behaviors staged at centers around the room. A brief presentation about the dangers of sun exposure and skin cancer prevention behaviors was given after which subjects participated in three activities: a sun protection hat station, a sun block station, and skin self exam station. Student t- tests were conducted comparing the outcome expectancy scores for individuals who reported that they would wear the particular hat or sunscreen with the outcome expectancy scores for individuals who reported that they would not wear the particular hat or sunscreen. Participants who reported that they would wear the hat had significantly higher positive outcome expectancy scores than those who said that they would not wear those hats. For four out of five sun blocks, participants who reported that they would wear these blocks had significantly higher positive outcome expectancies than those reporting that they would not wear them. The authors conclude that health education curricula to promote sun safety to youth must focus on building positive outcome expectancies in relation to the most efficacious practices, and in drawing clear distinctions for youth among their options, so that they are able to make decisions for themselves. (author)

  3. Integration of new technology into clinical practice after FDA approval.

    Science.gov (United States)

    Govil, Ashul; Hao, Steven C

    2016-10-01

    Development of new medical technology is a crucial part of the advancement of medicine and our ability to better treat patients and their diseases. This process of development is long and arduous and requires a significant investment of human, financial and material capital. However, technology development can be rewarded richly by its impact on patient outcomes and successful sale of the product. One of the major regulatory hurdles to technology development is the Food and Drug Administration (FDA) approval process, which is necessary before a technology can be marketed and sold in the USA. Many businesses, medical providers and consumers believe that the FDA approval process is the only hurdle prior to use of the technology in day-to-day care. In order for the technology to be adopted into clinical use, reimbursement for both the device as well as the associated work performed by physicians and medical staff must be in place. Work and coverage decisions require Current Procedural Terminology (CPT) code development and Relative Value Scale Update Committee (RUC) valuation determination. Understanding these processes is crucial to the timely availability of new technology to patients and providers. Continued and better partnerships between physicians, industry, regulatory bodies and payers will facilitate bringing technology to market sooner and ensure appropriate utilization.

  4. Timelines of translational science: From technology initiation to FDA approval.

    Directory of Open Access Journals (Sweden)

    Laura M McNamee

    Full Text Available While timelines for clinical development have been extensively studied, there is little data on the broader path from initiation of research on novel drug targets, to approval of drugs based on this research. We examined timelines of translational science for 138 drugs and biologicals approved by the FDA from 2010-2014 using an analytical model of technology maturation. Research on targets for 102 products exhibited a characteristic (S-curve maturation pattern with exponential growth between statistically defined technology initiation and established points. The median initiation was 1974, with a median of 25 years to the established point, 28 years to first clinical trials, and 36 years to FDA approval. No products were approved before the established point, and development timelines were significantly longer when the clinical trials began before this point (11.5 vs 8.5 years, p<0.0005. Technological maturation represents the longest stage of translation, and significantly impacts the efficiency of drug development.

  5. Automatic extraction of drug indications from FDA drug labels.

    Science.gov (United States)

    Khare, Ritu; Wei, Chih-Hsuan; Lu, Zhiyong

    2014-01-01

    Extracting computable indications, i.e. drug-disease treatment relationships, from narrative drug resources is the key for building a gold standard drug indication repository. The two steps to the extraction problem are disease named-entity recognition (NER) to identify disease mentions from a free-text description and disease classification to distinguish indications from other disease mentions in the description. While there exist many tools for disease NER, disease classification is mostly achieved through human annotations. For example, we recently resorted to human annotations to prepare a corpus, LabeledIn, capturing structured indications from the drug labels submitted to FDA by pharmaceutical companies. In this study, we present an automatic end-to-end framework to extract structured and normalized indications from FDA drug labels. In addition to automatic disease NER, a key component of our framework is a machine learning method that is trained on the LabeledIn corpus to classify the NER-computed disease mentions as "indication vs. non-indication." Through experiments with 500 drug labels, our end-to-end system delivered 86.3% F1-measure in drug indication extraction, with 17% improvement over baseline. Further analysis shows that the indication classifier delivers a performance comparable to human experts and that the remaining errors are mostly due to disease NER (more than 50%). Given its performance, we conclude that our end-to-end approach has the potential to significantly reduce human annotation costs.

  6. Proposal for the modernization of CDTN's Air-Water CCFL experimental test circuit

    International Nuclear Information System (INIS)

    Pessoa, Marcio Araujo; Mesquita, Amir Zacarias; Navarro, Moyses A.; Santos, Andre A. Campagnole dos

    2015-01-01

    The Counter Current Flow Limitation (CCFL) phenomenon, specifically the control that the gas exerts in a liquid flow in the opposite direction, is of real importance in the study of design and operation of various industrial sectors, particularly the nuclear industry. In nuclear engineering, such a phenomenon can occur in a loss of coolant accident (LOCA) of a Pressurized Water Reactor (PWR) when there is the need to re-flood the reactor core during an emergency cooling process. The CCFL phenomenon is being investigated at the Nuclear Technology Development Center (CDTN) thermo-hydraulics laboratory in order to better understand the flow and its limitations and thereby contribute to the improvement of its modeling for analysis of severe accidents. For this, a series of experiments were performed in CDTN in a reduced scale acrylic test section of the 'hot leg' of a PWR. In these tests, the countercurrent flow was established through the water injection by the upper end of the inclined pipe and the air addition at the end opposite to the entry of liquid flow. With the gradual increase of the air flow for predetermined water levels, the onset of the limitation of flow to the full blockage was determined. After full blockage, a gradual reduction of air flow was performed to evaluate the deflooding of the hot leg. The trials also evaluated CCFL behavior for various lengths of the horizontal section, the inclined duct slope influence and the dependence of the pipe's diameter. The infrastructure for CCFL analysis was built 14 years ago and has not been updated since. This paper describes the updates that are being performed to the existing setup. Hydraulic circuit and instrumentation upgrades and the implementation of modern control systems will allow new data to be collected and a new range of experiments to be performed with lower uncertainty. It is intended that the new data be used to validate CFD models that are also being developed by the research

  7. Testing of parameters of proposed robotic wrist based on the precision modules

    Directory of Open Access Journals (Sweden)

    Jan Semjon

    2016-10-01

    Full Text Available The use of precision actuators in robotic arm comes from the need to ensure the resulting accuracy of the robot at the maximum speed of movement. The replacement of actuators by means of electrical module allows the use of carrier body of the module for gripping flanges or other modules. Development of new modules is based on the requirement of providing a complete solution for the customer’s needs. After the development of new modules, the producer checks the parameters, receives feedback, and uses the authentication options in the independent workplaces, which can provide impartial results. Based on this data, manufacturers can optimize their solutions and deliver the products to market, complying with not only their vision but mainly the needs of customers. This article describes how to verify the characteristics of the modules used in the construction of robotic wrist. It primarily focuses on verification of the accuracy of results and repeatability of position of the wrist on output flange end module. In addition, it presents the design of the testing stand and selection methodologies of measurement. The declared values are compared with the values measured during verification.

  8. Systematic review and proposal of a field-based physical fitness-test battery in preschool children: the PREFIT battery.

    Science.gov (United States)

    Ortega, Francisco B; Cadenas-Sánchez, Cristina; Sánchez-Delgado, Guillermo; Mora-González, José; Martínez-Téllez, Borja; Artero, Enrique G; Castro-Piñero, Jose; Labayen, Idoia; Chillón, Palma; Löf, Marie; Ruiz, Jonatan R

    2015-04-01

    Physical fitness is a powerful health marker in childhood and adolescence, and it is reasonable to think that it might be just as important in younger children, i.e. preschoolers. At the moment, researchers, clinicians and sport practitioners do not have enough information about which fitness tests are more reliable, valid and informative from the health point of view to be implemented in preschool children. Our aim was to systematically review the studies conducted in preschool children using field-based fitness tests, and examine their (1) reliability, (2) validity, and (3) relationship with health outcomes. Our ultimate goal was to propose a field-based physical fitness-test battery to be used in preschool children. PubMed and Web of Science. Studies conducted in healthy preschool children that included field-based fitness tests. When using PubMed, we included Medical Subject Heading (MeSH) terms to enhance the power of the search. A set of fitness-related terms were combined with 'child, preschool' [MeSH]. The same strategy and terms were used for Web of Science (except for the MeSH option). Since no previous reviews with a similar aim were identified, we searched for all articles published up to 1 April 2014 (no starting date). A total of 2,109 articles were identified, of which 22 articles were finally selected for this review. Most studies focused on reliability of the fitness tests (n = 21, 96%), while very few focused on validity (0 criterion-related validity and 4 (18%) convergent validity) or relationship with health outcomes (0 longitudinal and 1 (5%) cross-sectional study). Motor fitness, particularly balance, was the most studied fitness component, while cardiorespiratory fitness was the least studied. After analyzing the information retrieved in the current systematic review about fitness testing in preschool children, we propose the PREFIT battery, field-based FITness testing in PREschool children. The PREFIT battery is composed of the following

  9. Proposal of abolition of the skin sensitivity test before equine rabies immune globulin application

    Directory of Open Access Journals (Sweden)

    CUPO Palmira

    2001-01-01

    Full Text Available An epizootic outbreak of rabies occurred in 1995 in Ribeirão Preto, SP, with 58 cases of animal rabies (54 dogs, 3 cats and 1 bat confirmed by the Pasteur Institute of São Paulo, and one human death. The need to provide care to a large number of people for the application of equine rabies immune globulin (ERIG prevented the execution of the skin sensitivity test (SST and often also the execution of desensitization, procedures routinely used up to that time at the Emergency Unit of the University Hospital of the Faculty of Medicine of Ribeirão Preto, University of São Paulo (EU-UHFMRP-USP, a reference hospital for the application of heterologous sera. In view of our positive experience of several years with the abolition of SST and of the use of premedication before the application of antivenom sera, we used a similar schedule for ERIG application. Of the 1489 victims of animal bites, 1054 (71% received ERIG; no patient was submitted to SST and all received intravenously anti-histamines (anti-H1 + anti-H2 and corticosteroids before the procedure. The patients were kept under observation for 60 to 180 minutes and no adverse reaction was observed. On the basis of these results, since December 1995 ERIG application has been decentralized in Ribeirão Preto and has become the responsibility of the Emergency Unit of the University Hospital and the Central Basic Health Unit, where the same routine is used. Since then, 4216 patients have received ERIG (1818 at the Basic Health Unit and 2398 at the EU-UHFMRP, with no problems. The ideal would be the routine use of human rabies immune globulin (HRIG in public health programs, but this is problematic, because of their high cost. However, while this does not occur, the use of SST is no longer justified at the time of application of ERIG, in view of the clinical evidence of low predictive value and low sensitivity of SST involving the application of heterologous sera. It is very important to point out

  10. Identifying and Synchronizing Health Information Technology (HIT) Events from FDA Medical Device Reports.

    Science.gov (United States)

    Kang, Hong; Wang, Frank; Zhou, Sicheng; Miao, Qi; Gong, Yang

    2017-01-01

    Health information technology (HIT) events, a subtype of patient safety events, pose a major threat and barrier toward a safer healthcare system. It is crucial to gain a better understanding of the nature of the errors and adverse events caused by current HIT systems. The scarcity of HIT event-exclusive databases and event reporting systems indicates the challenge of identifying the HIT events from existing resources. FDA Manufacturer and User Facility Device Experience (MAUDE) database is a potential resource for HIT events. However, the low proportion and the rapid evolvement of HIT-related events present challenges for distinguishing them from other equipment failures and hazards. We proposed a strategy to identify and synchronize HIT events from MAUDE by using a filter based on structured features and classifiers based on unstructured features. The strategy will help us develop and grow an HIT event-exclusive database, keeping pace with updates to MAUDE toward shared learning.

  11. 76 FR 38184 - Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Recall...

    Science.gov (United States)

    2011-06-29

    ... 2008 to 2010. The resulting number of total recalls (9,303) and terminations (2,858) from this database... per Total annual burden per Total hours respondents respondent responses response Recall strategy (Sec...)......... Termination of a recall (Sec. 953 1 953 10 9,530 7.55(b)) Total 443,820 \\1\\ There are no capital costs or...

  12. FDA Proposes New Safety Measures for Indoor Tanning Devices: The Facts

    Science.gov (United States)

    ... Related Consumer Updates Indoor Tanning: The Risks of Ultraviolet Rays 5 Tips for a Healthy Vacation More in Consumer Updates Animal & Veterinary Children's Health Cosmetics Dietary Supplements Drugs Food Medical Devices Nutrition Radiation-Emitting Products Tobacco Products ...

  13. Clinical relevance of the proposed sexual addiction diagnostic criteria: relation to the Sexual Addiction Screening Test-Revised.

    Science.gov (United States)

    Carnes, Patrick J; Hopkins, Tiffany A; Green, Bradley A

    2014-01-01

    The present article examines and compares the various diagnostic rubrics proposed to codify symptoms of sexual addiction, and then briefly summarizes the ongoing controversy on whether sexual addiction is a valid construct. Using the diagnostic criteria proposed by , the prevalence rate of each criterion is examined in terms of scores on the Sexual Addiction Screening Test-Revised scales (). Differences in diagnostic criteria endorsement associated with sex, sexual orientation, and setting were also explored. Results from a clinical sample of men and women seeking treatment for sexual addiction demonstrated clinical relevance of the criteria, in that all but 3 criteria are endorsed at more than 50% of participants screening positive for sexual addiction on the Sexual Addiction Screening Test-Revised. Sex differences were also noted for endorsement rates of several of the criteria. Finally, several proposed criteria may pose a higher clinical threshold and thus be utilized by clinicians to identify patients with increased pathology. Results are discussed in the context of existing diagnostic frameworks across etiological perspectives.

  14. Ecological evaluation of proposed dredged material from the John F. Baldwin Ship Channel: Phase 3 -- biological testing

    Energy Technology Data Exchange (ETDEWEB)

    Kohn, N.P.; Karle, L.M.; Pinza, M.R.; Mayhew, H.L.; White, P.J.; Gruendell, B.D.; Word, J.Q. [Battelle/Marine Sciences Lab., Sequim, WA (United States)

    1993-10-01

    The John F. Baldwin Ship Channel is a 28-mile-long portion of the San Francisco Bay to Stockton Ship Channel, the primary shipping lane through San Francisco Bay and Delta. The San Francisco District of the US Army Corps of Engineers (USACE) is responsible for construction of the John F. Baldwin Ship Channel, which is authorized to be deepened to a project depth of {minus}45 ft relative to mean lower low water (MLLW). Approximately 8.5 million cubic yards (mcy) of sediment will be removed from the channel to reach this project depth. The USACE requested Battelle/Marine Sciences Laboratory (MSL) to conduct testing for ocean disposal under the guidelines in Evaluation of Dredged Material Proposed for Ocean Disposal-Testing Manual (EPA/USACE 1991). This testing manual contains a tiered evaluation approach developed specifically for ocean disposal of dredged material at a selected site. In this study, John F. Baldwin Ship Channel sediments were evaluated under the Tier III (biological) testing guidance, which is considered to be highly stringent and protective of the environment. The Tier III guidance for ocean disposal testing requires tests of water column effects, (following dredged material disposal), deposited sediment toxicity, and bioaccumulation of contaminants from deposited sediment (dredged material).

  15. Proposed research on class I components to test a general approach to accelerated aging under combined stress environments

    International Nuclear Information System (INIS)

    Gillen, K.T.; Salazar, E.A.; Frank, C.W.

    1977-04-01

    This report summarizes research on the aging of Class I components in environments representative of nuclear power plants. It discusses Class IE equipment used in nuclear power plants, typical environments encountered by Class IE components, and aging techniques used to qualify this equipment. General discussions of radiation chemistry of polymers and accelerated aging techniques are also included. Based on the inadequacies of present aging techniques for Class IE equipment, a proposal for an experimental program on electrical cables is presented. One of the main purposes of the proposed work is to obtain relevant data in two areas of particular concern--the effect of radiation dose rate on polymer degradation, and the importance of synergism for combined thermal and radiation environments. A new model that allows combined environment accelerated aging to be carried out is introduced, and it is shown how the experimental data to be generated can be used to test this model

  16. A proposed structural, risk-informed approach to the periodicity of CANDU-6 nuclear containment integrated leak rate testing

    Energy Technology Data Exchange (ETDEWEB)

    Saliba, N. [McGill Univ., Dept. of Civil Engineering and Applied Mechanics, Montreal, Quebec (Canada); Komljenovic, D. [Hydro-Quebec, Gentilly-2 Nuclear Power Plant, Becancour, Quebec (Canada); Chouinard, L. [McGill Univ., Dept. of Civil Engineering and Applied Mechanics, Montreal, Quebec (Canada); Vaillancourt, R.; Chretien, G. [Hydro-Quebec, Gentilly-2 Nuclear Power Plant, Becancour, Quebec (Canada); Gocevski, V. [Hydro-Quebec Equipements, Montreal, Quebec (Canada)

    2010-07-01

    As ultimate lines of defense against leakage of large amounts of radioactive material to the environment in case of major reactor accidents, containments have been monitored through well designed periodic tests to ensure their proper performance. Regulatory organizations have imposed types and frequencies of containment tests based on highly-conservative deterministic approaches, and judgments of knowledgeable experts. Recent developments in the perception and methods of risk evaluation have been applied to rationalize the leakage-rate testing frequencies while maintaining risks within acceptable levels, preserving the integrity of containments, and respecting the defense-in-depth philosophy. The objective of this paper is to introduce a proposed risk-informed decision making framework on the periodicity of nuclear containment ILRTs for CANDU-6 nuclear power plants based on five main decision criteria, namely: 1) the containment structural integrity; 2) inputs from PSA Level-2; 3) the requirements of deterministic safety analyses and defense-in-depth concepts; 4- the obligations under regulatory and standard requirements; and 5) the return of experience from nuclear containments historic performance. The concepts of dormant reliability and structural fragility will guide the assessment of the containment structural integrity, within the general context of a global containment life cycle management program. This study is oriented towards the requirements of CANDU-6 reactors, in general, and Hydro-Quebec's Gentilly-2 nuclear power plant, in particular. The present article is the first part in a series of papers that will comprehensively detail the proposed research. (author)

  17. An analysis of pharmaceutical experience with decades of rat carcinogenicity testing: support for a proposal to modify current regulatory guidelines.

    Science.gov (United States)

    Sistare, Frank D; Morton, Daniel; Alden, Carl; Christensen, Joel; Keller, Douglas; Jonghe, Sandra De; Storer, Richard D; Reddy, M Vijayaraj; Kraynak, Andrew; Trela, Bruce; Bienvenu, Jean-Guy; Bjurström, Sivert; Bosmans, Vanessa; Brewster, David; Colman, Karyn; Dominick, Mark; Evans, John; Hailey, James R; Kinter, Lewis; Liu, Matt; Mahrt, Charles; Marien, Dirk; Myer, James; Perry, Richard; Potenta, Daniel; Roth, Arthur; Sherratt, Philip; Singer, Thomas; Slim, Rabih; Soper, Keith; Fransson-Steen, Ronny; Stoltz, James; Turner, Oliver; Turnquist, Susan; van Heerden, Marjolein; Woicke, Jochen; DeGeorge, Joseph J

    2011-06-01

    Data collected from 182 marketed and nonmarketed pharmaceuticals demonstrate that there is little value gained in conducting a rat two-year carcinogenicity study for compounds that lack: (1) histopathologic risk factors for rat neoplasia in chronic toxicology studies, (2) evidence of hormonal perturbation, and (3) positive genetic toxicology results. Using a single positive result among these three criteria as a test for outcome in the two-year study, fifty-two of sixty-six rat tumorigens were correctly identified, yielding 79% test sensitivity. When all three criteria were negative, sixty-two of seventy-six pharmaceuticals (82%) were correctly predicted to be rat noncarcinogens. The fourteen rat false negatives had two-year study findings of questionable human relevance. Applying these criteria to eighty-six additional chemicals identified by the International Agency for Research on Cancer as likely human carcinogens and to drugs withdrawn from the market for carcinogenicity concerns confirmed their sensitivity for predicting rat carcinogenicity outcome. These analyses support a proposal to refine regulatory criteria for conducting a two-year rat study to be based on assessment of histopathologic findings from a rat six-month study, evidence of hormonal perturbation, genetic toxicology results, and the findings of a six-month transgenic mouse carcinogenicity study. This proposed decision paradigm has the potential to eliminate over 40% of rat two-year testing on new pharmaceuticals without compromise to patient safety.

  18. PROPOSAL FOR A MEASUREMENT MODEL FOR SOFTWARE TESTS WITH A FOCUS ON THE MANAGEMENT OF OUTSOURCED SERVICES

    Directory of Open Access Journals (Sweden)

    Angelica Toffano Seidel Calazans

    2012-08-01

    Full Text Available The need for outsourcing IT services has shown a significant growth over the past few years. This article presents a proposal for a measurement model for Software Tests with a focus on the management of these outsourced services by governmental organizations. The following specific goals were defined: to identify and analyze the test process; to identify and analyze the existing standards that govern the hiring of IT services and to propose a Measurement Model for outsourced services of this type. As to the analysis of the data collected (documentary research and semi-structured interviews, content analysis was adopted, and in order to prepare the metrics, the GQM – Goal, Questions, Metrics – approach was used. The result was confirmed by semi-structured interviews. Here is what the research identifies as possible: to establish objective and measurable criteria for a measurement size as the input to evaluate the efforts and deadlines involved; to follow up the test sub-processes and to evaluate the service quality. Therefore, the management of this type of service hiring can be done more efficiently.

  19. A proposed structural, risk-informed approach to the periodicity of CANDU-6 nuclear containment integrated leak rate testing

    International Nuclear Information System (INIS)

    Saliba, N.; Komljenovic, D.; Chouinard, L.; Vaillancourt, R.; Chretien, G.; Gocevski, V.

    2010-01-01

    As ultimate lines of defense against leakage of large amounts of radioactive material to the environment in case of major reactor accidents, containments have been monitored through well designed periodic tests to ensure their proper performance. Regulatory organizations have imposed types and frequencies of containment tests based on highly-conservative deterministic approaches, and judgments of knowledgeable experts. Recent developments in the perception and methods of risk evaluation have been applied to rationalize the leakage-rate testing frequencies while maintaining risks within acceptable levels, preserving the integrity of containments, and respecting the defense-in-depth philosophy. The objective of this paper is to introduce a proposed risk-informed decision making framework on the periodicity of nuclear containment ILRTs for CANDU-6 nuclear power plants based on five main decision criteria, namely: 1) the containment structural integrity; 2) inputs from PSA Level-2; 3) the requirements of deterministic safety analyses and defense-in-depth concepts; 4- the obligations under regulatory and standard requirements; and 5) the return of experience from nuclear containments historic performance. The concepts of dormant reliability and structural fragility will guide the assessment of the containment structural integrity, within the general context of a global containment life cycle management program. This study is oriented towards the requirements of CANDU-6 reactors, in general, and Hydro-Quebec's Gentilly-2 nuclear power plant, in particular. The present article is the first part in a series of papers that will comprehensively detail the proposed research. (author)

  20. Stem-cell-derived products: an FDA update.

    Science.gov (United States)

    Moos, Malcolm

    2008-12-01

    The therapeutic potential of products derived from stem cells of various types has prompted increasing research and development and public attention. Initiation of human clinical trials in the not-too-distant future is now a realistic possibility. It is, therefore, important to weigh the potential benefits against known, theoretical and totally unsuspected risks in light of current knowledge to ensure that subjects participating in these trials are afforded the most reasonable balance possible between potential risks and potential benefits. There are no apparent differences in fundamental, qualitative biological characteristics between stem-cell-derived products and other cellular therapies regulated by the United States Food and Drug Administration (FDA). Existing authorities can, therefore, be applied. Nevertheless, these products do have properties that require careful evaluation.

  1. 2016 in review: FDA approvals of new molecular entities.

    Science.gov (United States)

    Griesenauer, Rebekah H; Kinch, Michael S

    2017-11-01

    An overview of drugs approved by FDA in 2016 reveals dramatic disruptions in long-term trends. The number of new molecular entities (NMEs) dropped, reflecting the lowest rate of small-molecule approvals observed in almost five decades. In addition, the pace of industry consolidation slowed substantially. The impact of mergers and acquisitions decreased the total number of organizations with past approval experience and continued research and development (R&D) activities to 102, divided evenly between more established pharmaceutical and newer biotechnology companies. Despite these substantial differences, the industry continued to pursue regulatory incentives, as evidenced by a continued increase in the fraction of NMEs approved using an orphan or priority designation, and almost all oncology drugs approved in 2016 utilized these mechanisms. Copyright © 2017 Elsevier Ltd. All rights reserved.

  2. What Factors Lead Companies to Adopt Social Media in their processes: Proposal and Test of a Measurement Model

    Directory of Open Access Journals (Sweden)

    Jozé Braz de Araújo

    2016-01-01

    Full Text Available The objective of this study was to understand which factors lead companies to use social media to achieve results. For that, a theoretical model was proposed and tested. Data was collected using a survey of 237 companies. In the analysis we analysis used the structural eq uation modeling technique. The results show that the social media relative advantage and its observability were important factors to social media organizational adoption. We also found that big companies with more formalized organizational structure (OS t end to adopt social media more than small ones with no formal OS. The companies studied showed strong organizational disposition for innovation adoption.

  3. Comment on "Proposal of a critical test of the Navier-Stokes-Fourier paradigm for compressible fluid continua".

    Science.gov (United States)

    Felderhof, B U

    2013-08-01

    Recently, a critical test of the Navier-Stokes-Fourier equations for compressible fluid continua was proposed [H. Brenner, Phys. Rev. E 87, 013014 (2013)]. It was shown that the equations of bivelocity hydrodynamics imply that a compressible fluid in an isolated rotating circular cylinder attains a nonequilibrium steady state with a nonuniform temperature increasing radially with distance from the axis. We demonstrate that statistical mechanical arguments, involving Hamiltonian dynamics and ergodicity due to irregularity of the wall, lead instead to a thermal equilibrium state with uniform temperature. This is the situation to be expected in experiment.

  4. Understanding Laboratory Tests

    Science.gov (United States)

    ... and Drug Administration (FDA) regulates the development and marketing of all laboratory tests that use test kits ... Cancer.gov en español Multimedia Publications Site Map Digital Standards for NCI Websites POLICIES Accessibility Comment Policy ...

  5. Maintaining Life-saving Testing for Patients With Infectious Diseases: Infectious Diseases Society of America, American Society for Microbiology, and Pan American Society for Clinical Virology Recommendations on the Regulation of Laboratory-developed Tests.

    Science.gov (United States)

    Caliendo, Angela M; Couturier, Marc R; Ginocchio, Christine C; Hanson, Kimberly E; Miller, Melissa B; Walker, Kimberly E; Frank, Gregory M

    2016-07-15

    In 2014, the US Food and Drug Administration (FDA) proposed to regulate laboratory-developed tests (LDTs)-diagnostics designed, manufactured, and used within a single laboratory. The Infectious Diseases Society of America, the American Society for Microbiology, and the Pan American Society for Clinical Virology recognize that the FDA is committed to protecting patients. However, our societies are concerned that the proposed regulations will limit access to testing and negatively impact infectious diseases (ID) LDTs. In this joint commentary, our societies discuss why LDTs are critical for ID patient care, hospital infection control, and public health responses. We also highlight how the FDA's proposed regulation of LDTs could impair patient access to life-saving tests and stifle innovation in ID diagnostics. Finally, our societies make specific recommendations for the FDA's consideration to reduce the burden of the proposed new rules on clinical laboratories and protect patients' access to state-of-the art, quality LDTs. © The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com.

  6. Proposal for an Accelerator R&D User Facility at Fermilab's Advanced Superconducting Test Accelerator (ASTA)

    Energy Technology Data Exchange (ETDEWEB)

    Church, M. [Fermi National Accelerator Lab. (FNAL), Batavia, IL (United States); Edwards, H. [Fermi National Accelerator Lab. (FNAL), Batavia, IL (United States); Harms, E. [Fermi National Accelerator Lab. (FNAL), Batavia, IL (United States); Henderson, S. [Fermi National Accelerator Lab. (FNAL), Batavia, IL (United States); Holmes, S. [Fermi National Accelerator Lab. (FNAL), Batavia, IL (United States); Lumpkin, A. [Fermi National Accelerator Lab. (FNAL), Batavia, IL (United States); Kephart, R. [Fermi National Accelerator Lab. (FNAL), Batavia, IL (United States); Levedev, V. [Fermi National Accelerator Lab. (FNAL), Batavia, IL (United States); Leibfritz, J. [Fermi National Accelerator Lab. (FNAL), Batavia, IL (United States); Nagaitsev, S. [Fermi National Accelerator Lab. (FNAL), Batavia, IL (United States); Piot, P. [Fermi National Accelerator Lab. (FNAL), Batavia, IL (United States); Northern Illinois Univ., DeKalb, IL (United States); Prokop, C. [Northern Illinois Univ., DeKalb, IL (United States); Shiltsev, V. [Fermi National Accelerator Lab. (FNAL), Batavia, IL (United States); Sun, Y. E. [Argonne National Lab. (ANL), Argonne, IL (United States); Valishev, A. [Fermi National Accelerator Lab. (FNAL), Batavia, IL (United States)

    2013-10-01

    Fermilab is the nation’s particle physics laboratory, supported by the DOE Office of High Energy Physics (OHEP). Fermilab is a world leader in accelerators, with a demonstrated track-record— spanning four decades—of excellence in accelerator science and technology. We describe the significant opportunity to complete, in a highly leveraged manner, a unique accelerator research facility that supports the broad strategic goals in accelerator science and technology within the OHEP. While the US accelerator-based HEP program is oriented toward the Intensity Frontier, which requires modern superconducting linear accelerators and advanced highintensity storage rings, there are no accelerator test facilities that support the accelerator science of the Intensity Frontier. Further, nearly all proposed future accelerators for Discovery Science will rely on superconducting radiofrequency (SRF) acceleration, yet there are no dedicated test facilities to study SRF capabilities for beam acceleration and manipulation in prototypic conditions. Finally, there are a wide range of experiments and research programs beyond particle physics that require the unique beam parameters that will only be available at Fermilab’s Advanced Superconducting Test Accelerator (ASTA). To address these needs we submit this proposal for an Accelerator R&D User Facility at ASTA. The ASTA program is based on the capability provided by an SRF linac (which provides electron beams from 50 MeV to nearly 1 GeV) and a small storage ring (with the ability to store either electrons or protons) to enable a broad range of beam-based experiments to study fundamental limitations to beam intensity and to develop transformative approaches to particle-beam generation, acceleration and manipulation which cannot be done elsewhere. It will also establish a unique resource for R&D towards Energy Frontier facilities and a test-bed for SRF accelerators and high brightness beam applications in support of the OHEP

  7. A proposal of ITER vacuum vessel fabrication specification and results of the full-scale partial mock-up test

    Energy Technology Data Exchange (ETDEWEB)

    Nakahira, Masataka; Takeda, Nobukazu; Onozuka, Masanori [Japan Atomic Energy Agency (Japan); Kakudate, Satoshi [Mitsubishi Heavy Industries, Ltd. (Japan)

    2007-07-01

    The structure and fabrication methods of the ITER vacuum vessel have been investigated and defined by the ITER international team. However, some of the current specifications are very difficult to be achieved from the manufacturing point of view and will lead to cost increase. In the mock-up fabrication, it is planned to conduct the following items: 1. Feasibility of the Japanese proposed VV structure and fabrication methods and the applicability to the ITER are to be confirmed; 2. Assembly procedure and inspection procedure are to be confirmed; 3. Manufacturing tolerances are to be assessed; 4. Manufacturing schedule is to be assessed. This report summarizes the Japanese proposed specification of the VV mock-up describing differences between the ITER supplied design. General scope of the mock-up fabrication and the detailed dimensions are also shown. In the VV fabrication, several types of weld joint configuration will be used. This report shows the joint configurations proposed by Japan to be used for the inner shell connection, the rib-to-shell connection and outer shell connection, and the housing-to-shell connection, respectively. Non-destructive testing considered to be applied to each joint configuration is also presented. A series of the fabrication and assembly procedures for the mock-up are presented in this report, together with candidates of welding configurations. Finally, the report summarizes the results of mock-up fabrication, including results of nondestructive examination of weld lines, obtained welding deformation and issues revealed from the fabrication experience. (orig.)

  8. Testing the ability of a proposed geotechnical based method to evaluate the liquefaction potential analysis subjected to earthquake vibrations

    Science.gov (United States)

    Abbaszadeh Shahri, A.; Behzadafshar, K.; Esfandiyari, B.; Rajablou, R.

    2010-12-01

    During the earthquakes a number of earth dams have had severe damages or suffered major displacements as a result of liquefaction, thus modeling by computer codes can provide a reliable tool to predict the response of the dam foundation against earthquakes. These modeling can be used in the design of new dams or safety assessments of existing ones. In this paper, on base of the field and laboratory tests and by combination of several software packages a seismic geotechnical based analysis procedure is proposed and verified by comparison with computer model tests, field and laboratory experiences. Verification or validation of the analyses relies to ability of the applied computer codes. By use of Silakhor earthquake (2006, Ms 6.1) and in order to check the efficiency of the proposed framework, the procedure is applied to the Korzan earth dam of Iran which is located in Hamedan Province to analyze and estimate the liquefaction and safety factor. Design and development of a computer code by authors which named as “Abbas Converter” with graphical user interface which operates as logic connecter function that can computes and models the soil profiles is the critical point of this study and the results are confirm and proved the ability of the generated computer code on evaluation of soil behavior under the earthquake excitations. Also this code can make and render facilitate this study more than previous have done, and take over the encountered problem.

  9. Chloroquine, a FDA-approved Drug, Prevents Zika Virus Infection and its Associated Congenital Microcephaly in Mice.

    Science.gov (United States)

    Li, Chunfeng; Zhu, Xingliang; Ji, Xue; Quanquin, Natalie; Deng, Yong-Qiang; Tian, Min; Aliyari, Roghiyh; Zuo, Xiangyang; Yuan, Ling; Afridi, Shabbir Khan; Li, Xiao-Feng; Jung, Jae U; Nielsen-Saines, Karin; Qin, Frank Xiao-Feng; Qin, Cheng-Feng; Xu, Zhiheng; Cheng, Genhong

    2017-10-01

    Zika virus (ZIKV) has become a global public health emergency due to its rapidly expanding range and its ability to cause severe congenital defects such as microcephaly. However, there are no FDA-approved therapies or vaccines against ZIKV infection. Through our screening of viral entry inhibitors, we found that chloroquine (CQ), a commonly used antimalarial and a FDA-approved drug that has also been repurposed against other pathogens, could significantly inhibit ZIKV infection in vitro, by blocking virus internalization. We also demonstrated that CQ attenuates ZIKV-associated morbidity and mortality in mice. Finally, we proved that CQ protects fetal mice from microcephaly caused by ZIKV infection. Our methodology of focusing on previously identified antivirals in screens for effectiveness against ZIKV proved to be a rapid and efficient means of discovering new ZIKV therapeutics. Selecting drugs that were previously FDA-approved, such as CQ, also improves the likelihood that they may more quickly reach stages of clinical testing and use by the public. Copyright © 2017. Published by Elsevier B.V.

  10. High-risk medical devices, children and the FDA: regulatory challenges facing pediatric mechanical circulatory support devices.

    Science.gov (United States)

    Almond, Christopher S D; Chen, Eric A; Berman, Michael R; Less, Joanne R; Baldwin, J Timothy; Linde-Feucht, Sarah R; Hoke, Tracey R; Pearson, Gail D; Jenkins, Kathy; Duncan, Brian W; Zuckerman, Bram D

    2007-01-01

    Pediatric mechanical circulatory support is a critical unmet need in the United States. Infant- and child-sized ventricular assist devices are currently being developed largely through federal contracts and grants through the National Heart, Lung, and Blood Institute (NHLBI). Human testing and marketing of high-risk devices for children raises epidemiologic and regulatory issues that will need to be addressed. Leaders from the US Food and Drug Administration (FDA), NHLBI, academic pediatric community, and industry convened in January 2006 for the first FDA Workshop on the Regulatory Process for Pediatric Mechanical Circulatory Support Devices. The purpose was to provide the pediatric community with an overview of the federal regulatory process for high-risk medical devices and to review the challenges specific to the development and regulation of pediatric mechanical circulatory support devices. Pediatric mechanical circulatory support present significant epidemiologic, logistic, and financial challenges to industry, federal regulators, and the pediatric community. Early interactions with the FDA, shared appreciation of challenges, and careful planning will be critical to avoid unnecessary delays in making potentially life-saving devices available for children. Collaborative efforts to address these challenges are warranted.

  11. Proposal of quality indicators for cardiac rehabilitation after acute coronary syndrome in Japan: a modified Delphi method and practice test.

    Science.gov (United States)

    Ohtera, Shosuke; Kanazawa, Natsuko; Ozasa, Neiko; Ueshima, Kenji; Nakayama, Takeo

    2017-01-27

    Cardiac rehabilitation is underused and its quality in practice is unclear. A quality indicator is a measurable element of clinical practice performance. This study aimed to propose a set of quality indicators for cardiac rehabilitation following an acute coronary event in the Japanese population and conduct a small-size practice test to confirm feasibility and applicability of the indicators in real-world clinical practice. This study used a modified Delphi technique (the RAND/UCLA appropriateness method), a consensus method which involves an evidence review, a face-to-face multidisciplinary panel meeting and repeated anonymous rating. Evidence to be reviewed included clinical practice guidelines available in English or Japanese and existing quality indicators. Performance of each indicator was assessed retrospectively using medical records at a university hospital in Japan. 10 professionals in cardiac rehabilitation for the consensus panel. In the literature review, 23 clinical practice guidelines and 16 existing indicators were identified to generate potential indicators. Through the consensus-building process, a total of 30 indicators were assessed and finally 13 indicators were accepted. The practice test (n=39) revealed that 74% of patients underwent cardiac rehabilitation. Median performance of process measures was 93% (IQR 46-100%). 'Communication with the doctor who referred the patient to cardiac rehabilitation' and 'continuous participation in cardiac rehabilitation' had low performance (32% and 38%, respectively). A modified Delphi technique identified a comprehensive set of quality indicators for cardiac rehabilitation. The single-site, small-size practice test confirmed that most of the proposed indicators were measurable in real-world clinical practice. However, some clinical processes which are not covered by national health insurance in Japan had low performance. Further studies will be needed to clarify and improve the quality of care in cardiac

  12. A Descriptive Longitudinal Study of Changes in Vape Shop Characteristics and Store Policies in Anticipation of the 2016 FDA Regulations of Tobacco Products, Including E-Cigarettes

    Directory of Open Access Journals (Sweden)

    Sheila Yu

    2018-02-01

    Full Text Available After proposing the “Deeming Rule” in 2014, the U.S. Food and Drug Administration (FDA began regulating the manufacturing, marketing, and sales of electronic cigarette (e-cigarette products as tobacco products in 2016. The current study conducted vape shop store observations and surveyed Los Angeles–area shop employees (assessing their beliefs, awareness, and perceptions of e-cigarettes and related FDA regulations at two time points one year apart to better understand what vape shop retailers would do given FDA’s soon-to-be-enacted Deeming Rule. The study also compared retailer beliefs/awareness/actions and store characteristics immediately after the Deeming Rule proposal versus a year after the Rule had been proposed, right before its enactment. Two data collection waves occurred before the Deeming Rule enactment, with Year 1 surveying 77 shops (2014 and Year 2 surveying 61 shops (2015–2016. Between the data collection points, 16 shops had closed. Among the shops that were open at both time points, the majority (95% in Year 1; 74% in Year 2 were aware of some FDA regulations or other policies applying to vape shops. However, overall awareness of FDA regulations and state/local policies governing e-cigarettes significantly decreased from Year 1 to Year 2. At both time points, all shops offered customers free puffs of nicotine-containing e-liquids (prohibited by the then upcoming Deeming Rule. Perceptions of e-cigarette safety also significantly decreased between the years. Exploring vape shop retailer perceptions and store policies (i.e., free puffs/samples displays, perceptions of e-cigarette safety, etc. over time will help the FDA assess the needs of the vape shop community and develop more effective retailer education campaigns and materials targeted to increase compliance with the newly enacted regulations.

  13. Environmental assessments and findings of no significant impact--FDA. Notice.

    Science.gov (United States)

    1998-05-18

    The Food and Drug Administration (FDA) is announcing that it has reviewed environmental assessments (EA's) and issued findings of no significant impact (FONSI's) relating to the 167 new drug applications (NDA's) and supplemental applications listed in this document. FDA is publishing this notice because Federal regulations require public notice of the availability of environmental documents.

  14. 21 CFR 516.34 - FDA recognition of exclusive marketing rights.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false FDA recognition of exclusive marketing rights. 516... SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES Designation of a Minor Use or Minor Species New Animal Drug § 516.34 FDA recognition of exclusive...

  15. The FDA's failure to address the lack of generalisability of antidepressant efficacy trials in product labelling.

    Science.gov (United States)

    Zimmerman, Mark

    2016-06-01

    According to the US Food and Drug Administration's (FDA's) regulations, the criteria used to select patients into registration studies should be addressed in a product's label. The FDA's labelling guidelines, which specifically indicate that the routine exclusion of patients of a certain level of severity should be noted in the label, has been uniformly ignored. © The Royal College of Psychiatrists 2016.

  16. Proposed heat transfer model for the gas-liquid heat transfer effects observed in the Stanford Research Institute scaled tests

    International Nuclear Information System (INIS)

    Corradini, M.; Sonin, A.A.; Todreas, N.

    1976-12-01

    In 1971-72, the Stanford Research Institute conducted a series of scaled experiments which simulated a sodium-vapor expansion in a hypothetical core disruptive accident (HCDA) for the Fast Flux Test Facility. A non-condensible explosive source was used to model the pressure-volume expansion characteristics of sodium vapor as predicted by computer code calculations. Rigid piston-cylinder experiments ( 1 / 10 and 1 / 30 scale) were undertaken to determine these expansion characteristics. The results showed that the pressure-volume characteristics depend significantly on the presence of water in the cylinder reducing the work output by about 50 percent when a sufficient water depth was present. The study presented proposes that the mechanism of heat transfer between the water and high temperature gas was due to area enhancement by Taylor instabilities at the gas-liquid interface. A simple heat transfer model is proposed which describes this energy transport process and agrees well with the experimental data from both scaled experiments. The consequences of this analysis suggest that an estimate of the heat transfer to the cold slug during a full-scale HCDA due to sodium vapor expansion and the accompanying reduction in mechanical work energy warrants further investigation. The implication of this analysis is that for either sodium or fuel vapor expansion in an HCDA, there is an inherent heat transfer mechanism which significantly reduces the work output of the expanding bubble

  17. FDA-Approved Natural Polymers for Fast Dissolving Tablets

    Directory of Open Access Journals (Sweden)

    Md Tausif Alam

    2014-01-01

    Full Text Available Oral route is the most preferred route for administration of different drugs because it is regarded as safest, most convenient, and economical route. Fast disintegrating tablets are very popular nowadays as they get dissolved or facilely disintegrated in mouth within few seconds of administration without the need of water. The disadvantages of conventional dosage form, especially dysphagia (arduousness in swallowing, in pediatric and geriatric patients have been overcome by fast dissolving tablets. Natural materials have advantages over synthetic ones since they are chemically inert, non-toxic, less expensive, biodegradable and widely available. Natural polymers like locust bean gum, banana powder, mango peel pectin, Mangifera indica gum, and Hibiscus rosa-sinenses mucilage ameliorate the properties of tablet and utilized as binder, diluent, and superdisintegrants increase the solubility of poorly water soluble drug, decrease the disintegration time, and provide nutritional supplement. Natural polymers are obtained from the natural origin and they are cost efficacious, nontoxic, biodegradable, eco-friendly, devoid of any side effect, renewable, and provide nutritional supplement. It is proved from the studies that natural polymers are more safe and efficacious than the synthetic polymers. The aim of the present article is to study the FDA-approved natural polymers utilized in fast dissolving tablets.

  18. Agreements and Discrepancies between FDA Reports and Journal Papers on Biologic Agents Approved for Rheumatoid Arthritis

    DEFF Research Database (Denmark)

    Amarilyo, Gil; Furst, Daniel E; Woo, Jennifer M P

    2016-01-01

    BACKGROUND: Sponsors that seek to commercialize new drugs apply to the Food and Drug Administration (FDA) which independently analyzes the raw data and reports the results on its website. OBJECTIVES: This study sought to determine if there are differences between the FDA assessments and journal...... reports on biologic agents developed for the treatment of rheumatoid arthritis. METHODS: Available data on FDA-approved drugs were extracted from the website, and a systematic literature search was conducted to identify matching studies in peer-reviewed medical journals. Outcome measures were the American...... College of Rheumatology response criteria ACR20 (efficacy) and withdrawal due to adverse events (safety). As effect size odds ratios were estimated for each active trial arm vs. control arm (i.e. for both sources: FDA and journal report), followed by calculation of the ratios of the FDA and journal report...

  19. Adherence of pharmaceutical advertisements in medical journals to FDA guidelines and content for safe prescribing.

    Science.gov (United States)

    Korenstein, Deborah; Keyhani, Salomeh; Mendelson, Ali; Ross, Joseph S

    2011-01-01

    Physician-directed pharmaceutical advertising is regulated in the United States by the Food and Drug Administration (FDA); adherence to current FDA guidelines is unknown. Our objective was to determine adherence rates of physician-directed print advertisements in biomedical journals to FDA guidelines and describe content important for safe prescribing. Cross-sectional analysis of November 2008 pharmaceutical advertisements within top U.S.-based biomedical journals publishing original research. We excluded advertisements for devices, over the counter medications, and disease awareness. We utilized FDA guideline items identifying unique forms of advertisement bias to categorize advertisements as adherent to FDA guidelines, possibly non-adherent to at least 1 item, or non-adherent to at least 1 item. We also evaluated advertisement content important for safe prescribing, including benefit quantification, risk information and verifiable references. All advertisements were evaluated by 2 or more investigators, with differences resolved by discussion. Twelve journals met inclusion criteria. Nine contained pharmaceutical advertisements, including 192 advertisements for 82 unique products; median 2 per product (range 1-14). Six "teaser" advertisements presented only drug names, leaving 83 full unique advertisements. Fifteen advertisements (18.1%) adhered to all FDA guidelines, 41 (49.4%) were non-adherent with at least one form of FDA-described bias, and 27 (32.5%) were possibly non-adherent due to incomplete information. Content important for safe prescribing was often incomplete; 57.8% of advertisements did not quantify serious risks, 48.2% lacked verifiable references and 28.9% failed to present adequate efficacy quantification. Study limitations included its focus on advertisements from a single month, the subjectivity of FDA guidelines themselves, and the necessary subjectivity of determinations of adherence. Few physician-directed print pharmaceutical advertisements

  20. Formation of defect-free 6FDA-DAM asymmetric hollow fiber membranes for gas separations

    KAUST Repository

    Xu, Liren

    2014-06-01

    This paper reports the formation of defect-free 6FDA-DAM asymmetric hollow fiber membranes. 6FDA-polyimides are of great interest for advanced gas separation membranes, and 6FDA-DAM polyimide is a representative polymer in this family with attractive dense film properties for several potential applications. The work reported here for the 6FDA-DAM polyimide provides insight for the challenging fabrication of defect-free asymmetric hollow fiber membranes for this class of 6FDA-polyimides, which behave rather different from lower free volume polymers. Specifically, the 6FDA based materials show relatively slow phase separation rate in water quench baths, which presents a challenge for fiber spinning. For convenience, we refer to the behavior as more "non-solvent resistant" in comparison to other lower free volume polymers, since the binodal phase boundary is displaced further from the conventional position near the pure polymer-solvent axis on a ternary phase diagram in conventional polymers like Matrimid® and Ultem®. The addition of lithium nitrate to promote phase separation has a useful impact on 6FDA-DAM asymmetric hollow fiber formation. 6FDA-DAM phase diagrams using ethanol and water as non-solvent are reported, and it was found that water is less desirable as a non-solvent dope additive for defect-free fiber spinning. Phase diagrams are also reported for 6FDA-DAM dope formulation with and without the addition of lithium nitrate, and defect-free asymmetric hollow fiber membranes are reported for both cases. The effect of polymer molecular weight on defect-free fiber spinning was also investigated. Gas transport properties and morphology of hollow fibers were characterized. With several thorough case studies, this work provides a systematic guideline for defect-free fiber formation from 6FDA-polymers. © 2014 Elsevier B.V.

  1. Adherence of pharmaceutical advertisements in medical journals to FDA guidelines and content for safe prescribing.

    Directory of Open Access Journals (Sweden)

    Deborah Korenstein

    Full Text Available Physician-directed pharmaceutical advertising is regulated in the United States by the Food and Drug Administration (FDA; adherence to current FDA guidelines is unknown. Our objective was to determine adherence rates of physician-directed print advertisements in biomedical journals to FDA guidelines and describe content important for safe prescribing.Cross-sectional analysis of November 2008 pharmaceutical advertisements within top U.S.-based biomedical journals publishing original research. We excluded advertisements for devices, over the counter medications, and disease awareness. We utilized FDA guideline items identifying unique forms of advertisement bias to categorize advertisements as adherent to FDA guidelines, possibly non-adherent to at least 1 item, or non-adherent to at least 1 item. We also evaluated advertisement content important for safe prescribing, including benefit quantification, risk information and verifiable references. All advertisements were evaluated by 2 or more investigators, with differences resolved by discussion. Twelve journals met inclusion criteria. Nine contained pharmaceutical advertisements, including 192 advertisements for 82 unique products; median 2 per product (range 1-14. Six "teaser" advertisements presented only drug names, leaving 83 full unique advertisements. Fifteen advertisements (18.1% adhered to all FDA guidelines, 41 (49.4% were non-adherent with at least one form of FDA-described bias, and 27 (32.5% were possibly non-adherent due to incomplete information. Content important for safe prescribing was often incomplete; 57.8% of advertisements did not quantify serious risks, 48.2% lacked verifiable references and 28.9% failed to present adequate efficacy quantification. Study limitations included its focus on advertisements from a single month, the subjectivity of FDA guidelines themselves, and the necessary subjectivity of determinations of adherence.Few physician-directed print pharmaceutical

  2. 76 FR 39105 - Beiersdorf, Inc.; Analysis of Proposed Consent Order To Aid Public Comment

    Science.gov (United States)

    2011-07-05

    ... proposed order. This matter involves the advertising, marketing, and sale of ``NIVEA My Silhouette... regulations issued by the FDA under the Nutrition Labeling and Education Act of 1990. Part V of the proposed...

  3. Proposed minimum requirements for the operational characteristics and testing of closed circuit life support system control electronics.

    Science.gov (United States)

    Kirk, J C

    1998-01-01

    The popularization and transformation of scuba diving into a broadly practiced sport has served to ignite the interest of technically oriented divers into ever more demanding areas. This, along with the gradual release of military data, equipment, and techniques of closed circuit underwater breathing apparatus, has resulted in a virtual explosion of semiclosed and closed circuit systems for divers. Although many of these systems have been carefully thought out by capable designers, the impulse to rush to market with equipment that has not been fully developed and carefully tested is irresistible to marketers. In addition, the presence of systems developed by well-intentioned and otherwise competent designers who are, nonetheless, inexperienced in the field of life support can result in the sale of failure-prone equipment to divers who lack the knowledge and skills to identify deficiencies before disaster occurs. For this reason, a set of industry standards establishing minimum requirements and testing is needed to guide the designers of this equipment, and to protect the user community from incomplete or inadequate design. Many different technologies go into the development of closed circuit scuba. One key area is the design of electronics to monitor and maintain the critical gas mixtures of the closed circuit loop. Much of the system reliability and inherent danger is resident in the design of the circuitry and the software (if any) that runs it. This article will present a set of proposed minimum requirements, with the goal of establishing a dialog for the creation of guidelines for the classification, rating, design, and testing of embedded electronics for life support systems used in closed circuit applications. These guidelines will serve as the foundation for the later creation of a set of industry specifications.

  4. Sensitivity analysis of a complex, proposed geologic waste disposal system using the Fourier Amplitude Sensitivity Test method

    International Nuclear Information System (INIS)

    Lu Yichi; Mohanty, Sitakanta

    2001-01-01

    The Fourier Amplitude Sensitivity Test (FAST) method has been used to perform a sensitivity analysis of a computer model developed for conducting total system performance assessment of the proposed high-level nuclear waste repository at Yucca Mountain, Nevada, USA. The computer model has a large number of random input parameters with assigned probability density functions, which may or may not be uniform, for representing data uncertainty. The FAST method, which was previously applied to models with parameters represented by the uniform probability distribution function only, has been modified to be applied to models with nonuniform probability distribution functions. Using an example problem with a small input parameter set, several aspects of the FAST method, such as the effects of integer frequency sets and random phase shifts in the functional transformations, and the number of discrete sampling points (equivalent to the number of model executions) on the ranking of the input parameters have been investigated. Because the number of input parameters of the computer model under investigation is too large to be handled by the FAST method, less important input parameters were first screened out using the Morris method. The FAST method was then used to rank the remaining parameters. The validity of the parameter ranking by the FAST method was verified using the conditional complementary cumulative distribution function (CCDF) of the output. The CCDF results revealed that the introduction of random phase shifts into the functional transformations, proposed by previous investigators to disrupt the repetitiveness of search curves, does not necessarily improve the sensitivity analysis results because it destroys the orthogonality of the trigonometric functions, which is required for Fourier analysis

  5. Investigating drug repositioning opportunities in FDA drug labels through topic modeling.

    Science.gov (United States)

    Bisgin, Halil; Liu, Zhichao; Kelly, Reagan; Fang, Hong; Xu, Xiaowei; Tong, Weida

    2012-01-01

    Drug repositioning offers an opportunity to revitalize the slowing drug discovery pipeline by finding new uses for currently existing drugs. Our hypothesis is that drugs sharing similar side effect profiles are likely to be effective for the same disease, and thus repositioning opportunities can be identified by finding drug pairs with similar side effects documented in U.S. Food and Drug Administration (FDA) approved drug labels. The safety information in the drug labels is usually obtained in the clinical trial and augmented with the observations in the post-market use of the drug. Therefore, our drug repositioning approach can take the advantage of more comprehensive safety information comparing with conventional de novo approach. A probabilistic topic model was constructed based on the terms in the Medical Dictionary for Regulatory Activities (MedDRA) that appeared in the Boxed Warning, Warnings and Precautions, and Adverse Reactions sections of the labels of 870 drugs. Fifty-two unique topics, each containing a set of terms, were identified by using topic modeling. The resulting probabilistic topic associations were used to measure the distance (similarity) between drugs. The success of the proposed model was evaluated by comparing a drug and its nearest neighbor (i.e., a drug pair) for common indications found in the Indications and Usage Section of the drug labels. Given a drug with more than three indications, the model yielded a 75% recall, meaning 75% of drug pairs shared one or more common indications. This is significantly higher than the 22% recall rate achieved by random selection. Additionally, the recall rate grows rapidly as the number of drug indications increases and reaches 84% for drugs with 11 indications. The analysis also demonstrated that 65 drugs with a Boxed Warning, which indicates significant risk of serious and possibly life-threatening adverse effects, might be replaced with safer alternatives that do not have a Boxed Warning. In

  6. FDA (Food and Drug Administration) Compliance Program Guidance Manual (FY 88). Section 4. Medical and radiological devices

    International Nuclear Information System (INIS)

    1988-01-01

    The FDA Compliance Program Guidance Manual provides a system for issuing and filing program plans and instructions directed to Food and Drug Administration Field operations for project implementation. Section IV provides those chapters of the Compliance Program Guidance Manual which pertain to the areas of medical and radiological devices. Some of the areas of coverage include laser and sunlamp standards inspections, compliance testing of various radiation-emitting products such as television receivers and microwave ovens, emergency response planning and policy, premarket approval and device manufacturers inspections, device problem reporting, sterilization of devices, and consumer education programs on medical and radiological devices

  7. 77 FR 22247 - Veterinary Feed Directive; Draft Text for Proposed Regulation

    Science.gov (United States)

    2012-04-13

    .... FDA-2010-N-0155] Veterinary Feed Directive; Draft Text for Proposed Regulation AGENCY: Food and Drug... the efficiency of FDA's Veterinary Feed Directive (VFD) program. The Agency is making this draft text..., rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Sharon Benz, Center for Veterinary...

  8. 78 FR 35279 - Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Products

    Science.gov (United States)

    2013-06-12

    ... proposed extension of an existing collection of information, and to allow 60 days for public comment in...)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in... Products'' FDA Form 3646 ``Mercury Vapor Lamp Products Radiation Safety Report'' FDA Form 3647 ``Guide for...

  9. Repositioning FDA Drugs as Potential Cruzain Inhibitors from Trypanosoma cruzi: Virtual Screening, In Vitro and In Vivo Studies

    Directory of Open Access Journals (Sweden)

    Isidro Palos

    2017-06-01

    Full Text Available Chagas disease (CD is a neglected disease caused by the parasite Trypanosoma cruzi, which affects underdeveloped countries. The current drugs of choice are nifurtimox and benznidazole, but both have severe adverse effects and less effectivity in chronic infections; therefore, the need to discover new drugs is essential. A computer-guided drug repositioning method was applied to identify potential FDA drugs (approved and withdrawn as cruzain (Cz inhibitors and trypanocidal effects were confirmed by in vitro and in vivo studies. 3180 FDA drugs were virtually screened using a structure-based approach. From a first molecular docking analysis, a set of 33 compounds with the best binding energies were selected. Subsequent consensus affinity binding, ligand amino acid contact clustering analysis, and ranked position were used to choose four known pharmacological compounds to be tested in vitro. Mouse blood samples infected with trypomastigotes from INC-5 and NINOA strains were used to test the trypanocidal effect of four selected compounds. Among these drugs, one fibrate antilipemic (etofyllin clofibrate and three β-lactam antibiotics (piperacillin, cefoperazone, and flucloxacillin showed better trypanocidal effects (LC50 range 15.8–26.1 μg/mL in comparison with benznidazole and nifurtimox (LC50 range 33.1–46.7 μg/mL. A short-term in vivo evaluation of these compounds showed a reduction of parasitemia in infected mice (range 90–60% at 6 h, but this was low compared to benznidazole (50%. This work suggests that four known FDA drugs could be used to design and obtain new trypanocidal agents.

  10. Parallel screening of FDA-approved antineoplastic drugs for identifying sensitizers of TRAIL-induced apoptosis in cancer cells

    International Nuclear Information System (INIS)

    Taylor, David J; Parsons, Christine E; Han, Haiyong; Jayaraman, Arul; Rege, Kaushal

    2011-01-01

    Tumor Necrosis Factor-α Related Apoptosis Inducing Ligand (TRAIL) and agonistic antibodies to death receptor 4 and 5 are promising candidates for cancer therapy due to their ability to induce apoptosis selectively in a variety of human cancer cells, while demonstrating little cytotoxicity in normal cells. Although TRAIL and agonistic antibodies to DR4 and DR5 are considered safe and promising candidates in cancer therapy, many malignant cells are resistant to DR-mediated, TRAIL-induced apoptosis. In the current work, we screened a small library of fifty-five FDA and foreign-approved anti-neoplastic drugs in order to identify candidates that sensitized resistant prostate and pancreatic cancer cells to TRAIL-induced apoptosis. FDA-approved drugs were screened for their ability to sensitize TRAIL resistant prostate cancer cells to TRAIL using an MTT assay for cell viability. Analysis of variance was used to identify drugs that exhibited synergy with TRAIL. Drugs demonstrating the highest synergy were selected as leads and tested in different prostate and pancreatic cancer cell lines, and one immortalized human pancreatic epithelial cell line. Sequential and simultaneous dosing modalities were investigated and the annexin V/propidium iodide assay, in concert with fluorescence microscopy, was employed to visualize cells undergoing apoptosis. Fourteen drugs were identified as having synergy with TRAIL, including those whose TRAIL sensitization activities were previously unknown in either prostate or pancreatic cancer cells or both. Five leads were tested in additional cancer cell lines of which, doxorubicin, mitoxantrone, and mithramycin demonstrated synergy in all lines. In particular, mitoxantrone and mithramycin demonstrated significant synergy with TRAIL and led to reduction of cancer cell viability at concentrations lower than 1 μM. At these low concentrations, mitoxantrone demonstrated selectivity toward malignant cells over normal pancreatic epithelial cells

  11. Parallel screening of FDA-approved antineoplastic drugs for identifying sensitizers of TRAIL-induced apoptosis in cancer cells

    Directory of Open Access Journals (Sweden)

    Taylor David J

    2011-11-01

    Full Text Available Abstract Background Tumor Necrosis Factor-α Related Apoptosis Inducing Ligand (TRAIL and agonistic antibodies to death receptor 4 and 5 are promising candidates for cancer therapy due to their ability to induce apoptosis selectively in a variety of human cancer cells, while demonstrating little cytotoxicity in normal cells. Although TRAIL and agonistic antibodies to DR4 and DR5 are considered safe and promising candidates in cancer therapy, many malignant cells are resistant to DR-mediated, TRAIL-induced apoptosis. In the current work, we screened a small library of fifty-five FDA and foreign-approved anti-neoplastic drugs in order to identify candidates that sensitized resistant prostate and pancreatic cancer cells to TRAIL-induced apoptosis. Methods FDA-approved drugs were screened for their ability to sensitize TRAIL resistant prostate cancer cells to TRAIL using an MTT assay for cell viability. Analysis of variance was used to identify drugs that exhibited synergy with TRAIL. Drugs demonstrating the highest synergy were selected as leads and tested in different prostate and pancreatic cancer cell lines, and one immortalized human pancreatic epithelial cell line. Sequential and simultaneous dosing modalities were investigated and the annexin V/propidium iodide assay, in concert with fluorescence microscopy, was employed to visualize cells undergoing apoptosis. Results Fourteen drugs were identified as having synergy with TRAIL, including those whose TRAIL sensitization activities were previously unknown in either prostate or pancreatic cancer cells or both. Five leads were tested in additional cancer cell lines of which, doxorubicin, mitoxantrone, and mithramycin demonstrated synergy in all lines. In particular, mitoxantrone and mithramycin demonstrated significant synergy with TRAIL and led to reduction of cancer cell viability at concentrations lower than 1 μM. At these low concentrations, mitoxantrone demonstrated selectivity toward

  12. Inhibition of Urease by Disulfiram, an FDA-Approved Thiol Reagent Used in Humans.

    Science.gov (United States)

    Díaz-Sánchez, Ángel Gabriel; Alvarez-Parrilla, Emilio; Martínez-Martínez, Alejandro; Aguirre-Reyes, Luis; Orozpe-Olvera, Jesica Aline; Ramos-Soto, Miguel Armando; Núñez-Gastélum, José Alberto; Alvarado-Tenorio, Bonifacio; de la Rosa, Laura Alejandra

    2016-11-26

    Urease is a nickel-dependent amidohydrolase that catalyses the decomposition of urea into carbamate and ammonia, a reaction that constitutes an important source of nitrogen for bacteria, fungi and plants. It is recognized as a potential antimicrobial target with an impact on medicine, agriculture, and the environment. The list of possible urease inhibitors is continuously increasing, with a special interest in those that interact with and block the flexible active site flap. We show that disulfiram inhibits urease in Citrullus vulgaris (CVU), following a non-competitive mechanism, and may be one of this kind of inhibitors. Disulfiram is a well-known thiol reagent that has been approved by the FDA for treatment of chronic alcoholism. We also found that other thiol reactive compounds (l-captopril and Bithionol) and quercetin inhibits CVU. These inhibitors protect the enzyme against its full inactivation by the thiol-specific reagent Aldrithiol (2,2'-dipyridyl disulphide, DPS), suggesting that the three drugs bind to the same subsite. Enzyme kinetics, competing inhibition experiments, auto-fluorescence binding experiments, and docking suggest that the disulfiram reactive site is Cys592, which has been proposed as a "hinge" located in the flexible active site flap. This study presents the basis for the use of disulfiram as one potential inhibitor to control urease activity.

  13. Bringing smart pills to market: FDA regulation of ingestible drug/device combination products.

    Science.gov (United States)

    Avery, Matthew; Liu, Dan

    2011-01-01

    Imagine a pill that, after you swallow it, can track its position in your body. Or imagine a pill that can transmit a message to a doctor to tell him that you have taken your bitter medicine. Pills like this already exist. These so-called smart pills are an emerging type of medical therapy. However, this nascent technology has yet to reach the market and developers of these novel therapies face significant regulatory challenges. This article predicts how the Food and Drug Administration will regulate smart pills and shows how the current regulatory regime is inadequate. The article then proposes modifying the current regulatory regime to encourage development of smart pills and other innovative combination products by: (1) regulating combination products based on their "novel mode of action" rather than their "primary mode of action," (2) creating a marketing approval pathway specifically for combination products, and (3) eliminating regulations that require sponsors to get marketing approval from multiple centers within FDA and providing regulatory guidance specifically for ingestible drug/device combination products.

  14. Quality assessment of digital annotated ECG data from clinical trials by the FDA ECG Warehouse.

    Science.gov (United States)

    Sarapa, Nenad

    2007-09-01

    The FDA mandates that digital electrocardiograms (ECGs) from 'thorough' QTc trials be submitted into the ECG Warehouse in Health Level 7 extended markup language format with annotated onset and offset points of waveforms. The FDA did not disclose the exact Warehouse metrics and minimal acceptable quality standards. The author describes the Warehouse scoring algorithms and metrics used by FDA, points out ways to improve FDA review and suggests Warehouse benefits for pharmaceutical sponsors. The Warehouse ranks individual ECGs according to their score for each quality metric and produces histogram distributions with Warehouse-specific thresholds that identify ECGs of questionable quality. Automatic Warehouse algorithms assess the quality of QT annotation and duration of manual QT measurement by the central ECG laboratory.

  15. Small Area Estimate Maps: Does the FDA Regulate Tobacco? - Small Area Estimates

    Science.gov (United States)

    This metric is defined as a person 18 years of age or older who must have reported that he/she believes that the United States Food and Drug Administration (FDA) regulates tobacco products in the U.S.

  16. MedWatch, the FDA Safety Information and Adverse Event Reporting Program

    Science.gov (United States)

    ... Reporting Program MedWatch: The FDA Safety Information and Adverse Event Reporting Program Share Tweet Linkedin Pin it ... approved information that can help patients avoid serious adverse events. Potential Signals of Serious Risks/New Safety ...

  17. FDA publishes conflict of interest rules for clinical trials. Food and Drug Administration.

    Science.gov (United States)

    James, J S

    1998-03-06

    The Food and Drug Administration (FDA) published new rules defining conflict of interests between drug companies and medical researchers and clinicians. Certain financial arrangements will need to be disclosed, although the FDA estimates that only one to ten percent of pharmaceutical companies will need to submit disclosures for one or more of their investigators. The purpose of the new rule is to prevent bias in safety and efficacy studies of drugs and medical devices. The full rule is published in the Federal Register.

  18. [Discussion about traditional Chinese medicine pharmacokinetics study based on first botanical drug approved by FDA].

    Science.gov (United States)

    Huang, Fanghua

    2010-04-01

    Pharmacokinetics study is one of main components of pharmaceuticals development. Food and Drug Administration (FDA) approved Veregen as the first botanical drug in 2006. This article introduced FDA's requirement on pharmacokinetics study of botanical drug and pharmacokinetics studies of Veregen, summarized current requirement and status quo of pharmacokinetics study on traditional Chinese medicine (TCM) and natural medicine in China, and discussed about pharmacokinetics study strategy for TCM and natural medicine.

  19. Emerging Resistance, New Antimicrobial Agents  …  but No Tests! The Challenge of Antimicrobial Susceptibility Testing in the Current US Regulatory Landscape.

    Science.gov (United States)

    Humphries, R M; Hindler, J A

    2016-07-01

    Accurate and timely performance of antimicrobial susceptibility testing (AST) by the clinical laboratory is paramount to combating antimicrobial resistance. The ability of laboratories in the United States to effectively perform ASTs is challenged by several factors. Some, such as new resistance mechanisms and the associated evolution of testing recommendations and breakpoints, are inevitable. Others are entirely man-made. These include unnecessarily strict US Food and Drug Administration (FDA) limitations on how commercial AST systems can be used for diagnostic testing, the absence of up-to-date performance data on these systems, and the lack of commercially available FDA-cleared tests for newer antimicrobial agents or for older agents with updated breakpoints. This viewpoint will highlight contemporary AST challenges faced by the clinical laboratory, and propose some solutions. © The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com.

  20. A proposed hardness assurance test methodology for bipolar linear circuits and devices in a space ionizing radiation environment

    International Nuclear Information System (INIS)

    Pease, R.L.; Brown, D.B.; Cohn, L.

    1997-01-01

    A hardness assurance test approach has been developed for bipolar linear circuits and devices in space. It consists of a screen for dose rate sensitivity and a characterization test method to develop the conditions for a lot acceptance test at high dose rate

  1. Analysis of lomustine drug content in FDA-approved and compounded lomustine capsules.

    Science.gov (United States)

    KuKanich, Butch; Warner, Matt; Hahn, Kevin

    2017-02-01

    OBJECTIVE To determine the lomustine content (potency) in compounded and FDA-approved lomustine capsules. DESIGN Evaluation study. SAMPLE 2 formulations of lomustine capsules (low dose [7 to 11 mg] and high dose [40 to 48 mg]; 5 capsules/dose/source) from 3 compounders and from 1 manufacturer of FDA-approved capsules. PROCEDURES Lomustine content was measured by use of a validated high-pressure liquid chromatography method. An a priori acceptable range of 90% to 110% of the stated lomustine content was selected on the basis of US Pharmacopeia guidelines. RESULTS The measured amount of lomustine in all compounded capsules was less than the stated content (range, 59% to 95%) and was frequently outside the acceptable range (failure rate, 2/5 to 5/5). Coefficients of variation for lomustine content ranged from 4.1% to 16.7% for compounded low-dose capsules and from 1.1% to 10.8% for compounded high-dose capsules. The measured amount of lomustine in all FDA-approved capsules was slightly above the stated content (range, 104% to 110%) and consistently within the acceptable range. Coefficients of variation for lomustine content were 0.5% for low-dose and 2.3% for high-dose FDA-approved capsules. CONCLUSIONS AND CLINICAL RELEVANCE Compounded lomustine frequently did not contain the stated content of active drug and had a wider range of lomustine content variability than did the FDA-approved product. The sample size was small, and larger studies are needed to confirm these findings; however, we recommend that compounded veterinary formulations of lomustine not be used when appropriate doses can be achieved with FDA-approved capsules or combinations of FDA-approved capsules.

  2. Single Cigarette Sales: State Differences in FDA Advertising and Labeling Violations, 2014, United States.

    Science.gov (United States)

    Baker, Hannah M; Lee, Joseph G L; Ranney, Leah M; Goldstein, Adam O

    2016-02-01

    Single cigarettes, which are sold without warning labels and often evade taxes, can serve as a gateway for youth smoking. The Family Smoking Prevention and Tobacco Control Act of 2009 gives the US Food and Drug Administration (FDA) authority to regulate the manufacture, distribution, and marketing of tobacco products, including prohibiting the sale of single cigarettes. To enforce these regulations, the FDA conducted over 335,661 inspections between 2010 and September 30, 2014, and allocated over $115 million toward state inspections contracts. To examine differences in single cigarette violations across states and determine if likely correlates of single cigarette sales predict single cigarette violations at the state level. Cross-sectional study of publicly available FDA warning letters from January 1 to July 31, 2014. All 50 states and the District of Columbia. Tobacco retailer inspections conducted by FDA (n = 33 543). State cigarette tax, youth smoking prevalence, poverty, and tobacco production. State proportion of FDA warning letters issued for single cigarette violations. There are striking differences in the number of single cigarette violations found by state, with 38 states producing no warning letters for selling single cigarettes even as state policymakers developed legislation to address retailer sales of single cigarettes. The state proportion of warning letters issued for single cigarettes is not predicted by state cigarette tax, youth smoking, poverty, or tobacco production, P = .12. Substantial, unexplained variation exists in violations of single cigarette sales among states. These data suggest the possibility of differences in implementation of FDA inspections and the need for stronger quality monitoring processes across states implementing FDA inspections. © The Author 2015. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  3. Gas separation performance of 6FDA-based polyimides with different chemical structures

    KAUST Repository

    Qiu, Wulin

    2013-10-01

    This work reports the gas separation performance of several 6FDA-based polyimides with different chemical structures, to correlate chemical structure with gas transport properties with a special focus on CO2 and CH 4 transport and plasticization stability of the polyimides membranes relevant to natural gas purification. The consideration of the other gases (He, O2 and N2) provided additional insights regarding effects of backbone structure on detailed penetrant properties. The polyimides studied include 6FDA-DAM, 6FDA-mPDA, 6FDA-DABA, 6FDA-DAM:DABA (3:2), 6FDA-DAM:mPDA (3:2) and 6FDA-mPDA:DABA (3:2). Both pure and binary gas permeation were investigated. The packing density, which is tunable by adjusting monomer type and composition of the various samples, correlated with transport permeability and selectivity. The separation performance of the polyimides for various gas pairs were also plotted for comparison to the upper bound curves, and it was found that this family of materials shows attractive performance. The CO 2 plasticization responses for the un-cross-linked polyimides showed good plasticization resistance to CO2/CH4 mixed gas with 10% CO2; however, only the cross-linked polyimides showed good plasticization resistance under aggressive gas feed conditions (CO 2/CH4 mixed gas with 50% CO2 or pure CO 2). For future work, asymmetric hollow fibers and carbon molecular sieve membranes based on the most attractive members of the family will be considered. © 2013 Elsevier Ltd. All rights reserved.

  4. Regulatory ecotoxicity testing of nanomaterials – proposed modifications of OECD test guidelines based on laboratory experience with silver and titanium dioxide nanoparticles

    DEFF Research Database (Denmark)

    Hund-Rinke, Kerstin; Baun, Anders; Cupi, Denisa

    2016-01-01

    of the sediment-living worm Lumbriculus variegatus (TG 225), activity of soil microflora (TGs 216, 217), and reproduction of the invertebrates (Enchytraeus crypticus, Eisenia fetida, TGs 220, 222). Additionally, test descriptions for two further test systems (root elongation of plants in hydroponic culture; test...

  5. A Proposal for a Methodology to Develop a Cyber-Attack Penetration Test Scenario Including NPPs Safety

    Energy Technology Data Exchange (ETDEWEB)

    Lee, In Hyo [KAIST, Daejeon (Korea, Republic of); Son, Han Seong [Joongbu Univ., Geumsan (Korea, Republic of); Kim, Si Won [Korea Institute of Nuclear Nonproliferation and Control, Daejeon (Korea, Republic of); Kang, Hyun Gook [Rensselaer Polytechnic Institute, Troy (United States)

    2016-10-15

    Penetration test is a method to evaluate the cyber security of NPPs; so, this approach was performed in some studies. Because they focused on vulnerability finding or test bed construction, scenario based approach was not performed. However, to test the cyber security of NPPs, a proper test scenario should be needed. Ahn et al. developed cyber-attack scenarios but those scenarios couldn't be applied in penetration test because they developed the scenarios based on past incidents of NPPs induced by cyber-attack. That is, those scenarios only covered scenarios which were happened before; so, they couldn't cover other various scenarios and couldn't reflect them into a penetration test. In this study, a method to develop a cyber-attack penetration test scenario of NPPs especially focused on safety point of view is suggested. To evaluate the cyber security of NPPs, penetration test can be a possible way. In this study, a method to develop a penetration test scenario was explained. Especially, the goal of hacker was focused on nuclear fuel integrity deterioration. So, in the methodology, Level 1 PSA results were utilized to reflect plant safety into the security. From the PSA results, basic event was post processed and possible cyber-attacks were reviewed with vulnerabilities of digital control system.

  6. Proposed retrofit of HEPA filter plenums with injection and sampling manifolds for in-place filter testing

    Energy Technology Data Exchange (ETDEWEB)

    Fretthold, J.K. [EG& G Rocky Flats, Inc., Golden, CO (United States)

    1995-02-01

    The importance of testing HEPA filter exhaust plenums with consideration for As Low as Reasonably Achievable (ALARA) will require that new technology be applied to existing plenum designs. HEPA filter testing at Rocky Flats has evolved slowly due to a number of reasons. The first plenums were built in the 1950`s, preceding many standards. The plenums were large, which caused air dispersal problems. The systems were variable air flow. Access to the filters was difficult. The test methods became extremely conservative. Changes in methods were difficult to make. The acceptance of new test methods has been made in recent years with the change in plant mission and the emphasis on worker safety.

  7. A Proposal for a Methodology to Develop a Cyber-Attack Penetration Test Scenario Including NPPs Safety

    International Nuclear Information System (INIS)

    Lee, In Hyo; Son, Han Seong; Kim, Si Won; Kang, Hyun Gook

    2016-01-01

    Penetration test is a method to evaluate the cyber security of NPPs; so, this approach was performed in some studies. Because they focused on vulnerability finding or test bed construction, scenario based approach was not performed. However, to test the cyber security of NPPs, a proper test scenario should be needed. Ahn et al. developed cyber-attack scenarios but those scenarios couldn't be applied in penetration test because they developed the scenarios based on past incidents of NPPs induced by cyber-attack. That is, those scenarios only covered scenarios which were happened before; so, they couldn't cover other various scenarios and couldn't reflect them into a penetration test. In this study, a method to develop a cyber-attack penetration test scenario of NPPs especially focused on safety point of view is suggested. To evaluate the cyber security of NPPs, penetration test can be a possible way. In this study, a method to develop a penetration test scenario was explained. Especially, the goal of hacker was focused on nuclear fuel integrity deterioration. So, in the methodology, Level 1 PSA results were utilized to reflect plant safety into the security. From the PSA results, basic event was post processed and possible cyber-attacks were reviewed with vulnerabilities of digital control system

  8. Proposal for an Experimental Test of the Role of Confining Potentials in the Integral Quantum Hall Effect

    OpenAIRE

    Brueckner, Reinhold

    2000-01-01

    We propose an experiment using a three-gate quantum Hall device to probe the dependence of the integral quantum Hall effect (IQHE) on the shape of the lateral confining potential in edge regions. This shape can, in a certain configuration determine whether or not the IQHE occurs.

  9. Evidence behind FDA alerts for drugs with adverse cardiovascular effects: implications for clinical practice.

    Science.gov (United States)

    Rackham, Daniel M; C Herink, Megan; Stevens, Ian G; Cardoza, Natalie M; Singh, Harleen

    2014-01-01

    The U.S. Food and Drug Administration (FDA) periodically publishes Drug Safety Communications and Drug Alerts notifying health care practitioners and the general public of important information regarding drug therapies following FDA approval. These alerts can result in both positive and negative effects on patient care. Most clinical trials are not designed to detect long-term safety end points, and postmarketing surveillance along with patient reported events are often instrumental in signaling the potential harmful effect of a drug. Recently, many cardiovascular (CV) safety announcements have been released for FDA-approved drugs. Because a premature warning could discourage a much needed treatment or prompt a sudden discontinuation, it is essential to evaluate the evidence supporting these FDA alerts to provide effective patient care and to avoid unwarranted changes in therapy. Conversely, paying attention to these warnings in cases involving high-risk patients can prevent adverse effects and litigation. This article reviews the evidence behind recent FDA alerts for drugs with adverse CV effects and discusses the clinical practice implications. © 2013 Pharmacotherapy Publications, Inc.

  10. 76 FR 9024 - Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic...

    Science.gov (United States)

    2011-02-16

    ...] Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Records; Electronic Signatures AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug... relating to FDA's electronic records and electronic signatures. DATES: Submit either electronic or written...

  11. 77 FR 29352 - Agency Information Collection Activities; Proposed Collection; Comment Request; Irradiation in...

    Science.gov (United States)

    2012-05-17

    ...] Agency Information Collection Activities; Proposed Collection; Comment Request; Irradiation in the... information collection provisions of FDA's requirements for food irradiation processors. DATES: Submit either... of information technology. Irradiation in the Production, Processing, and Handling of Food--21 CFR...

  12. 76 FR 61366 - Food and Drug Administration Transparency Initiative: Draft Proposals for Public Comment to...

    Science.gov (United States)

    2011-10-04

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0247] Food and Drug Administration Transparency Initiative: Draft Proposals for Public Comment to Increase...: Food and Drug Administration, HHS. [[Page 61367

  13. 75 FR 12546 - Agency Information Collection Activities; Proposed Collection; Comment Request; Cosmetic Labeling...

    Science.gov (United States)

    2010-03-16

    ...] Agency Information Collection Activities; Proposed Collection; Comment Request; Cosmetic Labeling... FDA's cosmetic labeling regulations. DATES: Submit written or electronic comments on the collection of... of information technology. Cosmetic Labeling Regulations--21 CFR Part 701 (OMB Control Number 0910...

  14. ASTM F739 method for testing the permeation resistance of protective clothing materials: critical analysis with proposed changes in procedure and test-cell design.

    Science.gov (United States)

    Anna, D H; Zellers, E T; Sulewski, R

    1998-08-01

    ASTM (American Society for Testing and Materials) Method F739-96 specifies a test-cell design and procedures for measuring the permeation resistance of chemical protective clothing. Among the specifications are open-loop collection stream flow rates of 0.050 to 0.150 L/min for a gaseous medium. At elevated temperatures the test must be maintained within 1 degree C of the set point. This article presents a critical analysis of the effect of the collection stream flow rate on the measured permeation rate and on the temperature uniformity within the test cell. Permeation tests were conducted on four polymeric glove materials with 44 solvents at 25 degrees C. Flow rates > 0.5 L/min were necessary to obtain accurate steady-state permeation rate (SSPR) values in 25 percent of the tests. At the lower flow rates the true SSPR typically was underestimated by a factor of two or less, but errors of up to 33-fold were observed. No clear relationship could be established between the need for a higher collection stream flow rate and either the vapor pressure or the permeation rate of the solvent, but test results suggest that poor mixing within the collection chamber was a contributing factor. Temperature gradients between the challenge and collection chambers and between the bottom and the top of the collection chamber increased with the water-bath temperature and the collection stream flow rate. Use of a test cell modified to permit deeper submersion reduced the gradients to < or = 0.5 degrees C. It is recommended that all SSPR measurements include verification of the adequacy of the collection stream flow rate. For testing at nonambient temperatures, the modified test cell described here could be used to ensure temperature uniformity throughout the cell.

  15. Model-Scale Aerodynamic Performance Testing of Proposed Modifications to the NASA Langley Low Speed Aeroacoustic Wind Tunnel

    Science.gov (United States)

    Booth, Earl R., Jr.; Coston, Calvin W., Jr.

    2005-01-01

    Tests were performed on a 1/20th-scale model of the Low Speed Aeroacoustic Wind Tunnel to determine the performance effects of insertion of acoustic baffles in the tunnel inlet, replacement of the existing collector with a new collector design in the open jet test section, and addition of flow splitters to the acoustic baffle section downstream of the test section. As expected, the inlet baffles caused a reduction in facility performance. About half of the performance loss was recovered by addition the flow splitters to the downstream baffles. All collectors tested reduced facility performance. However, test chamber recirculation flow was reduced by the new collector designs and shielding of some of the microphones was reduced owing to the smaller size of the new collector. Overall performance loss in the facility is expected to be a 5 percent top flow speed reduction, but the facility will meet OSHA limits for external noise levels and recirculation in the test section will be reduced.

  16. Fabrication of 6FDA-durene membrane incorporated with zeolite T and aminosilane grafted zeolite T for CO2/CH4 separation

    Science.gov (United States)

    Jusoh, Norwahyu; Fong Yeong, Yin; Keong Lau, Kok; Shariff, Azmi Mohd

    2017-08-01

    In the present work, zeolite T and aminosilane grafted zeolite T are embedded into 6FDA-durene polyimide phase for the fabrication of mixed matrix membranes (MMMs). FESEM images demonstrated that the improvement of interfacial adhesion between zeolite and polymer phases in MMM loaded with aminosilane grafted zeolite T was not significant as compared to zeolite T/6FDA-durene MMM. From the gas permeation test, CO2/CH4 selectivity up to 26.4 was achieved using MMM containing aminosilane grafted zeolite T, while MMM loaded with ungrafted zeolite T showed CO2/CH4 selectivity of 19.1. In addition, MMM incorporated with aminosilane grafted zeolite T particles successfully lies on Robeson upper bound 2008, which makes it an attractive candidate for CO2/CH4 separation.

  17. FDA Regulation of Clinical Applications of CRISPR-CAS Gene-Editing Technology.

    Science.gov (United States)

    Grant, Evita V

    Scientists have repurposed an adaptive immune system of single cell organisms to create a new type of gene-editing tool: CRISPR (clustered regularly interspaced short palindromic repeats)-Cas technology. Scientists in China have reported its use in the genome modification of non-viable human embryos. This has ignited a spirited debate about the moral, ethical, scientific, and social implications of human germline genome engineering. There have also been calls for regulations; however, FDA has yet to formally announce its oversight of clinical applications of CRISPR-Cas systems. This paper reviews FDA regulation of previously controversial biotechnology breakthroughs, recombinant DNA and human cloning. It then shows that FDA is well positioned to regulate CRISPR-Cas clinical applications, due to its legislative mandates, its existing regulatory frameworks for gene therapies and assisted reproductive technologies, and other considerations.

  18. Small-molecule kinase inhibitors: an analysis of FDA-approved drugs

    DEFF Research Database (Denmark)

    Wu, Peng; Nielsen, Thomas Eiland; Clausen, Mads Hartvig

    2016-01-01

    Small-molecule kinase inhibitors (SMKIs), 28 of which are approved by the US Food and Drug Administration (FDA), have been actively pursued as promising targeted therapeutics. Here, we assess the key structural and physicochemical properties, target selectivity and mechanism of function, and ther......Small-molecule kinase inhibitors (SMKIs), 28 of which are approved by the US Food and Drug Administration (FDA), have been actively pursued as promising targeted therapeutics. Here, we assess the key structural and physicochemical properties, target selectivity and mechanism of function...

  19. We really need to talk: adapting FDA processes to rapid change.

    Science.gov (United States)

    Lykken, Sara

    2013-01-01

    The rapidly evolving realm of modern commerce strains traditional regulatory paradigms. This paper traces the historical evolution of FDA crisis-response regulation and provides examples of ways in which the definitions and procedures resulting from that past continue to be challenged by new products as market entrants, some in good faith and others not, take actions that create disconnects between actual product and marketing controls and those that consumers might expect. The paper then explores some of the techniques used by other federal agencies that have faced similar challenges in environments characterized by rapid innovation, and draws from this analysis suggestions for improvement of the FDA's warning letter system.

  20. FDA publishes checklist of Y2K high-risk devices.

    Science.gov (United States)

    1999-09-01

    Key points. The federal Food and Drug Administration (FDA) has developed a list of types of medical devices that have the potential for the most serious consequences for patients should they fail because of Y2K-related problems. This list of computer-controlled potentially high-risk devices can provide a guide to health care facilities regarding the types of devices that should receive priority in their assessment and remediation of medical devices. The list may change as the FDA receives comments on the types of devices included in the list.

  1. Integro-differential equation analysis and radioisotope imaging systems. Research proposal. [Testing of radioisotope imaging system in phantoms

    Energy Technology Data Exchange (ETDEWEB)

    Hart, H.

    1976-03-09

    Design modifications of a five-probe focusing collimator coincidence radioisotope scanning system are described. Clinical applications of the system were tested in phantoms using radioisotopes with short biological half-lives, including /sup 75/Se, /sup 192/Ir, /sup 43/K, /sup 130/I, and /sup 82/Br. Data processing methods are also described. (CH)

  2. Creep-fatigue evaluation method for weld joint of Mod.9Cr-1Mo steel Part II: Plate bending test and proposal of a simplified evaluation method

    Energy Technology Data Exchange (ETDEWEB)

    Ando, Masanori, E-mail: ando.masanori@jaea.go.jp; Takaya, Shigeru, E-mail: takaya.shigeru@jaea.go.jp

    2016-12-15

    Highlights: • Creep-fatigue evaluation method for weld joint of Mod.9Cr-1Mo steel is proposed. • A simplified evaluation method is also proposed for the codification. • Both proposed evaluation method was validated by the plate bending test. • For codification, the local stress and strain behavior was analyzed. - Abstract: In the present study, to develop an evaluation procedure and design rules for Mod.9Cr-1Mo steel weld joints, a method for evaluating the creep-fatigue life of Mod.9Cr-1Mo steel weld joints was proposed based on finite element analysis (FEA) and a series of cyclic plate bending tests of longitudinal and horizontal seamed plates. The strain concentration and redistribution behaviors were evaluated and the failure cycles were estimated using FEA by considering the test conditions and metallurgical discontinuities in the weld joints. Inelastic FEA models consisting of the base metal, heat-affected zone and weld metal were employed to estimate the elastic follow-up behavior caused by the metallurgical discontinuities. The elastic follow-up factors determined by comparing the elastic and inelastic FEA results were determined to be less than 1.5. Based on the estimated elastic follow-up factors obtained via inelastic FEA, a simplified technique using elastic FEA was proposed for evaluating the creep-fatigue life in Mod.9Cr-1Mo steel weld joints. The creep-fatigue life obtained using the plate bending test was compared to those estimated from the results of inelastic FEA and by a simplified evaluation method.

  3. Creep-fatigue evaluation method for weld joint of Mod.9Cr-1Mo steel Part II: Plate bending test and proposal of a simplified evaluation method

    International Nuclear Information System (INIS)

    Ando, Masanori; Takaya, Shigeru

    2016-01-01

    Highlights: • Creep-fatigue evaluation method for weld joint of Mod.9Cr-1Mo steel is proposed. • A simplified evaluation method is also proposed for the codification. • Both proposed evaluation method was validated by the plate bending test. • For codification, the local stress and strain behavior was analyzed. - Abstract: In the present study, to develop an evaluation procedure and design rules for Mod.9Cr-1Mo steel weld joints, a method for evaluating the creep-fatigue life of Mod.9Cr-1Mo steel weld joints was proposed based on finite element analysis (FEA) and a series of cyclic plate bending tests of longitudinal and horizontal seamed plates. The strain concentration and redistribution behaviors were evaluated and the failure cycles were estimated using FEA by considering the test conditions and metallurgical discontinuities in the weld joints. Inelastic FEA models consisting of the base metal, heat-affected zone and weld metal were employed to estimate the elastic follow-up behavior caused by the metallurgical discontinuities. The elastic follow-up factors determined by comparing the elastic and inelastic FEA results were determined to be less than 1.5. Based on the estimated elastic follow-up factors obtained via inelastic FEA, a simplified technique using elastic FEA was proposed for evaluating the creep-fatigue life in Mod.9Cr-1Mo steel weld joints. The creep-fatigue life obtained using the plate bending test was compared to those estimated from the results of inelastic FEA and by a simplified evaluation method.

  4. A proposal of ITER vacuum vessel fabrication specification and results of the full-scale partial mock-up test

    International Nuclear Information System (INIS)

    Nakahira, M.; Takeda, N.; Kakudate, S.; Onozuka, M.

    2008-01-01

    The structure and fabrication methods of the ITER vacuum vessel (VV) have been investigated and defined by the ITER International Team (IT). However, some of the current technical specifications are difficult to be achieved from the manufacturing point of view. To solve such an issue, this paper proposes an alternative specification of the VV to the IT's design. A series of the fabrication and assembly procedures for the mock-up are presented, together with candidates of welding configurations. Finally, the paper summarizes the results of mock-up fabrication, such as non-destructive examination of weld lines, obtained welding deformation and issues revealed from the fabrication experience. Based on the results, it is suggested that several issues such as clarification of conditions of repair welding, demonstration of welding distortion control and detectability/localization of internal defects should be solved before manufacturing the ITER VV

  5. A proposal of ITER vacuum vessel fabrication specification and results of the full-scale partial mock-up test

    Energy Technology Data Exchange (ETDEWEB)

    Nakahira, M. [Japan Atomic Energy Agency, Mukouyama 801-1, Naka-machi, Naka-gun, Ibaraki 311-0193 (Japan)], E-mail: nakahira.masataka@jaea.go.jp; Takeda, N.; Kakudate, S. [Japan Atomic Energy Agency, Mukouyama 801-1, Naka-machi, Naka-gun, Ibaraki 311-0193 (Japan); Onozuka, M. [Mitsubishi Nuclear Energy Systems, Inc., 1700K Street NW, Suite 440, Washington, DC 20006 (United States)

    2008-12-15

    The structure and fabrication methods of the ITER vacuum vessel (VV) have been investigated and defined by the ITER International Team (IT). However, some of the current technical specifications are difficult to be achieved from the manufacturing point of view. To solve such an issue, this paper proposes an alternative specification of the VV to the IT's design. A series of the fabrication and assembly procedures for the mock-up are presented, together with candidates of welding configurations. Finally, the paper summarizes the results of mock-up fabrication, such as non-destructive examination of weld lines, obtained welding deformation and issues revealed from the fabrication experience. Based on the results, it is suggested that several issues such as clarification of conditions of repair welding, demonstration of welding distortion control and detectability/localization of internal defects should be solved before manufacturing the ITER VV.

  6. Ground tests with prototype of CeBr{sub 3} active gamma ray spectrometer proposed for future venus surface missions

    Energy Technology Data Exchange (ETDEWEB)

    Litvak, M.L., E-mail: litvak@mx.iki.rssi.ru [Space Research Institute, RAS, Moscow 117997 (Russian Federation); Sanin, A.B.; Golovin, D.V. [Space Research Institute, RAS, Moscow 117997 (Russian Federation); Jun, I. [Jet Propulsion Laboratory, Pasadena, CA (United States); Mitrofanov, I.G. [Space Research Institute, RAS, Moscow 117997 (Russian Federation); Shvetsov, V.N.; Timoshenko, G.N. [Joint Institute for Nuclear Research, Dubna (Russian Federation); Vostrukhin, A.A. [Space Research Institute, RAS, Moscow 117997 (Russian Federation)

    2017-03-11

    The results of a series of ground tests with a prototype of an active gamma-ray spectrometer based on a new generation of scintillation crystal (CeBr{sub 3}) are presented together with a consideration to its applicability to future Venus landing missions. We evaluated the instrument's capability to distinguish the subsurface elemental composition of primary rock forming elements such as O, Na, Mg, Al, Si, K and Fe. Our study uses heritage from previous ground and field tests and applies to the analysis of gamma lines from activation reaction products generated by a pulsed neutron generator. We have estimated that the expected accuracies achieved in this approach could be as high as 1–10% for the particular chemical element being studied.

  7. Towards reporting standards for neuropsychological study results: A proposal to minimize communication errors with standardized qualitative descriptors for normalized test scores.

    Science.gov (United States)

    Schoenberg, Mike R; Rum, Ruba S

    2017-11-01

    Rapid, clear and efficient communication of neuropsychological results is essential to benefit patient care. Errors in communication are a lead cause of medical errors; nevertheless, there remains a lack of consistency in how neuropsychological scores are communicated. A major limitation in the communication of neuropsychological results is the inconsistent use of qualitative descriptors for standardized test scores and the use of vague terminology. PubMed search from 1 Jan 2007 to 1 Aug 2016 to identify guidelines or consensus statements for the description and reporting of qualitative terms to communicate neuropsychological test scores was conducted. The review found the use of confusing and overlapping terms to describe various ranges of percentile standardized test scores. In response, we propose a simplified set of qualitative descriptors for normalized test scores (Q-Simple) as a means to reduce errors in communicating test results. The Q-Simple qualitative terms are: 'very superior', 'superior', 'high average', 'average', 'low average', 'borderline' and 'abnormal/impaired'. A case example illustrates the proposed Q-Simple qualitative classification system to communicate neuropsychological results for neurosurgical planning. The Q-Simple qualitative descriptor system is aimed as a means to improve and standardize communication of standardized neuropsychological test scores. Research are needed to further evaluate neuropsychological communication errors. Conveying the clinical implications of neuropsychological results in a manner that minimizes risk for communication errors is a quintessential component of evidence-based practice. Copyright © 2017 Elsevier B.V. All rights reserved.

  8. Evaluation of an FDA approved library against laboratory models of human intestinal nematode infections.

    Science.gov (United States)

    Keiser, Jennifer; Panic, Gordana; Adelfio, Roberto; Cowan, Noemi; Vargas, Mireille; Scandale, Ivan

    2016-07-01

    Treatment options for infections with soil-transmitted helminths (STH) - Ascaris lumbricoides, Trichuris trichiura and the two hookworm species, Ancylostoma duodenale and Necator americanus - are limited despite their considerable global health burden. The aim of the present study was to test the activity of an openly available FDA library against laboratory models of human intestinal nematode infections. All 1,600 drugs were first screened against Ancylostoma ceylanicum third-stage larvae (L3). Active compounds were scrutinized and toxic compounds, drugs indicated solely for topical use, and already well-studied anthelmintics were excluded. The remaining hit compounds were tested in parallel against Trichuris muris first-stage larvae (L1), Heligmosomoides polygyrus third-stage larvae (L3), and adult stages of the three species in vitro. In vivo studies were performed in the H. polygyrus and T. muris mice models. Fifty-four of the 1,600 compounds tested revealed an activity of > 60 % against A. ceylanicum L3 (hit rate of 3.4 %), following incubation at 200 μM for 72 h. Twelve compounds progressed into further screens. Adult A. ceylanicum were the least affected (1/12 compounds active at 50 μM), while eight of the 12 test compounds revealed activity against T. muris L1 (100 μM) and adults (50 μM), and H. polygyrus L3 (200 μM). Trichlorfon was the only compound active against all stages of A. ceylanicum, H. polygyrus and T. muris. In addition, trichlorfon achieved high worm burden reductions of 80.1 and 98.9 %, following a single oral dose of 200 mg/kg in the T. muris and H. polygyrus mouse model, respectively. Drug screening on the larval stages of intestinal parasitic nematodes is feasible using small libraries and important given the empty drug discovery and development pipeline for STH infections. Differences and commonalities in drug activities across the different STH species and stages were confirmed. Hits identified might serve as a

  9. Putting New Laboratory Tests Into Practice

    Science.gov (United States)

    ... some patients may have to pay out-of-pocket for these tests. Non-FDA approved tests are ... view/article/4775/. Accessed October 2016. The Free Dictionary. Class III device. Available online at http://medical- ...

  10. The fish sexual development test: an OECD test guideline proposal with possible relevance for environmental risk assessment. Results from the validation programme

    DEFF Research Database (Denmark)

    Holbech, Henrik; Brande-Lavridsen, Nanna; Kinnberg, Karin Lund

    2010-01-01

    The Fish Sexual Development Test (FSDT) has gone through two validations as an OECD test guideline for the detection of endocrine active chemicals with different modes of action. The validation has been finalized on four species: Zebrafish (Danio rerio), Japanese medaka (Oryzias latipes), three s...... as a population relevant endpoint and the results of the two validation rounds will be discussed in relation to environmental risk assessment and species selection....... for histology. For all three methods, the fish parts were numbered and histology could therefore be linked to the vitellogenin concentration in individual fish. The two core endocrine relevant endpoints were vitellogenin concentrations and phenotypic sex ratio. Change in the sex ratio is presented...

  11. Language and Nutrition (Mis)Information: Food Labels, FDA Policies and Meaning

    Science.gov (United States)

    Taylor, Christy Marie

    2013-01-01

    In this dissertation, I address the ways in which food manufacturers can exploit the often vague and ambiguous nature of FDA policies concerning language and images used on food labels. Employing qualitative analysis methods (Strauss, 1987; Denzin and Lincoln, 2003; Mackey and Gass, 2005) that drew upon critical discourse analysis (Fairclough,…

  12. The rosiglitazone decision process at FDA and EMA : What should we learn?

    NARCIS (Netherlands)

    Pouwels, Koen B.; van Grootheest, Kees

    2012-01-01

    In September 2010 the EMA decided to suspend the market authorisation of rosiglitazone, while the FDA decided to restrict the use of rosiglitazone. These actions were taken approximately 10 years after the introduction of rosiglitazone, because rosiglitazone might be associated with an increased

  13. Ten years after the FDA black box warning for antidepressant drugs: a critical narrative review

    Directory of Open Access Journals (Sweden)

    Juan Carlos Martínez-Aguayo

    2016-06-01

    Full Text Available ABSTRACT Background The United States Food and Drug Administration (FDA has warned about the increased suicidality risk associated with the use of selective serotonin reuptake inhibitors (SSRI and venlafaxine in children and adolescents. Objectives To critically appraise the available evidence supporting the FDA Black box warning concerning to the use of antidepressants in child and adolescents. Methods A critical review of articles in Medline/PubMed and SciELO databases regarding the FDA Black box warning for antidepressants, and the impact of FDA warnings on antidepressant prescriptions and suicide rates. Results The warning was based on surveys that did not report either cases of suicide nor a significant difference supporting an increased suicidality rate. The concept was defined in an ambiguous way and there is currently more available evidence to support such definition. The use of SSRI and venlafaxine has been associated to lower suicidality rates, but the prescription fall due to the warning increased suicide rates. Discussion Suicidality is an inherent feature of depressive disorders so it would be desirable to consider how much of the phenomenon may be attributed to antidepressants per se. It would be appropriate to consider that suicide rates might increase also as a consequence of the warning.

  14. FDA Approves Immunotherapy for a Cancer that Affects Infants and Children | FNLCR

    Science.gov (United States)

    The U.S. Food and Drug Administration (FDA) has approved dinutuximab (ch14.18) as an immunotherapy for neuroblastoma, a rare type of childhood cancer that offers poor prognosis for about half of the children who are affected.  The National Cancer In

  15. FDA Approves Immunotherapy for a Cancer that Affects Infants and Children | FNLCR Staging

    Science.gov (United States)

    The U.S. Food and Drug Administration (FDA) has approved dinutuximab (ch14.18) as an immunotherapy for neuroblastoma, a rare type of childhood cancer that offers poor prognosis for about half of the children who are affected.  The National Cancer In

  16. A Good Year: FDA Approved Nine New Cancer Drugs in 2014

    Science.gov (United States)

    In 2014, the Food and Drug Administration (FDA) approved 41 drugs that had not been approved previously for any indication, the most in nearly 20 years. Of these 41 novel drugs, 9 were approved for the treatment of cancer or cancer-related conditions.

  17. Impact of FDA Actions, DTCA, and Public Information on the Market for Pain Medication.

    Science.gov (United States)

    Bradford, W David; Kleit, Andrew N

    2015-07-01

    Nonsteroidal anti-inflammatory drugs (NSAIDs) are one of the most important classes of prescription drugs used by primary care physicians to manage pain. The NSAID class of products has a somewhat controversial history, around which a complex regulatory and informational environment has developed. This history includes a boxed warning mandated by the Food and Drug Administration (FDA) for all NSAIDs in 2005. We investigate the impact that various information shocks have had on the use of prescription medications for pain in primary care in the USA. We accomplish this by extracting data on nearly 600,000 patients from a unique nationwide electronic medical record database and estimate the probability of any active prescription for the four types of pain medications as a function of FDA actions, advertising, media coverage, and patient characteristics. We find that even after accounting for multiple sources of information, the FDA label changes and boxed warnings had a significant effect on pain medication prescribing. The boxed warning did not have the same impact on the use of all NSAID inhibitors. We find that the boxed warning reduced the use of NSAID COX-2 inhibitor use, which was the focus of much of the press attention. In contrast, however, the warning actually increased the use of non-COX-2 NSAID inhibitors. Thus, the efficacy of the FDA's black box warning is clearly mixed. Copyright © 2014 John Wiley & Sons, Ltd.

  18. Nanotechnology Laboratory Continues Partnership with FDA and National Institute of Standards and Technology | Poster

    Science.gov (United States)

    The NCI-funded Nanotechnology Characterization Laboratory (NCL)—a leader in evaluating promising nanomedicines to fight cancer—recently renewed its collaboration with the U.S. Food and Drug Administration (FDA) and the National Institute of Standards and Technology (NIST) to continue its groundbreaking work on characterizing nanomedicines and moving them toward the clinic. In

  19. 21 CFR 111.610 - What records must be made available to FDA?

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false What records must be made available to FDA? 111.610 Section 111.610 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING...

  20. 21 CFR 1.378 - What criteria does FDA use to order a detention?

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false What criteria does FDA use to order a detention? 1.378 Section 1.378 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL GENERAL ENFORCEMENT REGULATIONS Administrative Detention of Food for Human or Animal Consumption...

  1. 21 CFR 1.405 - When does FDA have to issue a decision on an appeal?

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false When does FDA have to issue a decision on an appeal? 1.405 Section 1.405 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL GENERAL ENFORCEMENT REGULATIONS Administrative Detention of Food for Human or Animal...

  2. 21 CFR 1.406 - How will FDA handle classified information in an informal hearing?

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false How will FDA handle classified information in an informal hearing? 1.406 Section 1.406 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL GENERAL ENFORCEMENT REGULATIONS Administrative Detention of Food for Human or...

  3. 21 CFR Appendix A to Part 201 - Examples of Graphic Enhancements Used by FDA

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Examples of Graphic Enhancements Used by FDA A... (CONTINUED) DRUGS: GENERAL LABELING Pt. 201, App. A Appendix A to Part 201—Examples of Graphic Enhancements.... Examples of § 201.66 Standard Labeling and Modified Labeling Formats A. Section 201.66 Standard Labeling...

  4. 21 CFR 14.171 - Utilization of an advisory committee on the initiative of FDA.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Utilization of an advisory committee on the initiative of FDA. 14.171 Section 14.171 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... technical advisory committee for human prescription drugs. The Commissioner's determinations on the agenda...

  5. 21 CFR 14.15 - Committees working under a contract with FDA.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Committees working under a contract with FDA. 14.15 Section 14.15 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... committee: (1) The committee shall give public notice of its meetings and agenda, and provide interested...

  6. Competence to consent to voluntary psychiatric hospitalization: a test of a standard proposed by APA. American Psychiatric Association.

    Science.gov (United States)

    Appelbaum, B C; Appelbaum, P S; Grisso, T

    1998-09-01

    In the wake of the U.S. Supreme Court's 1990 decision in Zinermon v. Burch, renewed attention has been given to capacities patients must have to be considered competent to consent to voluntary hospitalization. An American Psychiatric Association (APA) task force suggested that strong policy interests support the establishment of a low threshold for competence in this situation. The study examined whether, as previous research suggested, patients would have difficulty meeting even this lenient standard. One hundred voluntarily hospitalized psychiatric patients were read two brief paragraphs, one explaining the purposes of psychiatric hospitalization and and the other explaining policies for discharge. The paragraphs' readability measured about eighth-grade level. After each paragraph, participants were read two sets of questions, one testing recall of the presented information and the other testing recognition of the information in a true-false format. The scores of patients grouped by selected demographic and clinical variables were compared. The vast majority of patients were able to comprehend the information that the APA task force suggested was relevant to their decision. However, a subgroup of patients who were initially admitted involuntarily had significantly poorer performance and may constitute a group who need special educational efforts focused on the consequences of voluntary admission.

  7. An experimental investigation of masking in the US FDA adverse event reporting system database.

    Science.gov (United States)

    Wang, Hsin-wei; Hochberg, Alan M; Pearson, Ronald K; Hauben, Manfred

    2010-12-01

    A phenomenon of 'masking' or 'cloaking' in pharmacovigilance data mining has been described, which can potentially cause signals of disproportionate reporting (SDRs) to be missed, particularly in pharmaceutical company databases. Masking has been predicted theoretically, observed anecdotally or studied to a limited extent in both pharmaceutical company and health authority databases, but no previous publication systematically assesses its occurrence in a large health authority database. To explore the nature, extent and possible consequences of masking in the US FDA Adverse Event Reporting System (AERS) database by applying various experimental unmasking protocols to a set of drugs and events representing realistic pharmacovigilance analysis conditions. This study employed AERS data from 2001 through 2005. For a set of 63 Medical Dictionary for Regulatory Activities (MedDRA®) Preferred Terms (PTs), disproportionality analysis was carried out with respect to all drugs included in the AERS database, using a previously described urn-model-based algorithm. We specifically sought masking in which drug removal induced an increase in the statistical representation of a drug-event combination (DEC) that resulted in the emergence of a new SDR. We performed a series of unmasking experiments selecting drugs for removal using rational statistical decision rules based on the requirement of a reporting ratio (RR) >1, top-ranked statistical unexpectedness (SU) and relatedness as reflected in the WHO Anatomical Therapeutic Chemical level 4 (ATC4) grouping. In order to assess the possible extent of residual masking we performed two supplemental purely empirical analyses on a limited subset of data. This entailed testing every drug and drug group to determine which was most influential in uncovering masked SDRs. We assessed the strength of external evidence for a causal association for a small number of masked SDRs involving a subset of 29 drugs for which level of evidence

  8. Customizable orthopaedic oncology implants: one institution's experience with meeting current IRB and FDA requirements.

    Science.gov (United States)

    Willis, Alexander R; Ippolito, Joseph A; Patterson, Francis R; Benevenia, Joseph; Beebe, Kathleen S

    2016-01-01

    Customizable orthopaedic implants are often needed for patients with primary malignant bone tumors due to unique anatomy or complex mechanical problems. Currently, obtaining customizable orthopaedic implants for orthopaedic oncology patients can be an arduous task involving submitting approval requests to the Institutional Review Board (IRB) and the Food and Drug Administration (FDA). There is great potential for the delay of a patient's surgery and unnecessary paperwork if the submission pathways are misunderstood or a streamlined protocol is not in place. The objective of this study was to review the existing FDA custom implant approval pathways and to determine whether this process was improved with an institutional protocol. An institutional protocol for obtaining IRB and FDA approval for customizable orthopaedic implants was established with the IRB at our institution in 2013. This protocol was approved by the IRB, such that new patients only require submission of a modification to the existing protocol with individualized patient information. During the two-year period of 2013-2014, eight patients were retrospectively identified as having required customizable implants for various orthopaedic oncology surgeries. The dates of request for IRB approval, request for FDA approval, and total time to surgery were recorded, along with the specific pathway utilized for FDA approval. The average patient age was 12 years old (7-21 years old). The average time to IRB approval of a modification to the pre-approved protocol was 14 days (7-21 days). Average time to FDA approval after submission of the IRB approval to the manufacturer was 12.5 days (7-19 days). FDA approval was obtained for all implants as compassionate use requests in accordance with Section 561 of the Federal Food Drug and Cosmetic Act's expanded access provisions. Establishment of an institutional protocol with pre-approval by the IRB can expedite the otherwise time-consuming and complicated

  9. TU-AB-204-00: CDRH/FDA Regulatory Processes and Device Science Activities

    International Nuclear Information System (INIS)

    2016-01-01

    The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) and the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC

  10. TU-AB-204-00: CDRH/FDA Regulatory Processes and Device Science Activities

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2016-06-15

    The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) and the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC

  11. Justification of disintegration testing beyond current FDA criteria using in vitro and in silico models

    OpenAIRE

    Uebbing L; Klumpp L; Webster GK; Löbenberg R

    2017-01-01

    Lukas Uebbing,1,2,* Lukas Klumpp,1,3,* Gregory K Webster,4 Raimar Löbenberg1 1Faculty of Pharmacy and Pharmaceutical Sciences, Katz Group-Rexall Centre for Pharmacy and Health Research, University of Alberta, Edmonton, Canada; 2Institute of Pharmacy and Biochemistry, Johannes Gutenberg University, Mainz, 3Institute of Pharmaceutical Technology, Goethe University Frankfurt, Frankfurt, Germany; 4Global Research and Development, AbbVie Inc., North Chicago, IL, USA *These authors contr...

  12. Medication overuse headache and chronic migraine in a specialized headache centre: field-testing proposed new appendix criteria

    DEFF Research Database (Denmark)

    Zeeberg, P; Olesen, Jes; Jensen, R

    2009-01-01

    The classification subcommittee of the International Headache Society (IHS) has recently suggested revised criteria for medication overuse headache (MOH) and chronic migraine (CM). We field tested these revised criteria by applying them to the headache population at the Danish Headache Centre...... suggest that the IHS has succeeded in choosing new criteria for CM which are neither too strict, nor too loose. For MOH, a shift to the appendix criteria will increase the number of MOH patients, but take into account the possibility of permanent changes in pain perception due to medication overuse...... and the possibility of a renewed effect of prophylactic drugs due to medication withdrawal. We therefore recommend the implementation of the appendix criteria for both MOH and CM into the main body of the International Classification of Headache Disorders....

  13. The 1993 baseline biological studies and proposed monitoring plan for the Device Assembly Facility at the Nevada Test Site

    Energy Technology Data Exchange (ETDEWEB)

    Woodward, B.D.; Hunter, R.B.; Greger, P.D.; Saethre, M.B.

    1995-02-01

    This report contains baseline data and recommendations for future monitoring of plants and animals near the new Device Assembly Facility (DAF) on the Nevada Test Site (NTS). The facility is a large structure designed for safely assembling nuclear weapons. Baseline data was collected in 1993, prior to the scheduled beginning of DAF operations in early 1995. Studies were not performed prior to construction and part of the task of monitoring operational effects will be to distinguish those effects from the extensive disturbance effects resulting from construction. Baseline information on species abundances and distributions was collected on ephemeral and perennial plants, mammals, reptiles, and birds in the desert ecosystems within three kilometers (km) of the DAF. Particular attention was paid to effects of selected disturbances, such as the paved road, sewage pond, and the flood-control dike, associated with the facility. Radiological monitoring of areas surrounding the DAF is not included in this report.

  14. One and done: Reasons principal investigators conduct only one FDA-regulated drug trial

    Directory of Open Access Journals (Sweden)

    Amy Corneli, PhD, MPH

    2017-06-01

    Full Text Available Concerns have been raised over the high turnover rate for clinical investigators. Using the U.S. Food and Drug Administration's (FDA Bioresearch Monitoring Information System database, we conducted an online survey to identify factors that affect principal investigators' (PIs decisions to conduct only a single FDA-regulated drug trial. Of the 201 PIs who responded, 54.2% were classified as “one-and-done.” Among these investigators, 28.9% decided for personal reasons to not conduct another trial, and 44.4% were interested in conducting another trial, but no opportunities were available. Three categories of broad barriers were identified as generally burdensome or challenging by the majority of investigators: 1 workload balance (balancing trial implementation with other work obligations and opportunities (63.8%; 2 time requirements (time to initiate and implement trial; investigator and staff time (63.4%; and 3 data and safety reporting (56.5%. Additionally, 46.0% of investigators reported being generally unsatisfied with finance-related issues. These same top three barriers also affected investigators' decisions to no longer conduct FDA-regulated trials. Our findings illuminate three key aspects of investigator turnover. First, they confirm that investigator turnover occurs, as more than half of respondents were truly “one-and-done.” Second, because a large proportion of respondents wanted to conduct more FDA-regulated trials but lacked opportunities to do so, mechanisms that match interested investigators with research sponsors are needed. Third, by focusing on the barriers we identified that affected investigators' decisions to no longer conduct FDA-regulated trials, future efforts to reduce investigator turnover can target issues that matter the most to investigators.

  15. Tests of load resilient matching procedures for the ITER ICRH system on a mock-up and layout proposals

    International Nuclear Information System (INIS)

    Dumortier, P.; Lamalle, P.; Messiaen, A.; Vervier, M.

    2006-01-01

    The ICRH antenna of ITER consists of an array of 24 radiating straps and must radiate 20 MW with resilience to load variations due to the ELMs. Because of its compactness the mutual coupling effects between the straps are far from negligible. Moreover they considerably increase the difficulty of matching and lead to coupling between the generators. Different external matching system layouts are under consideration. A reduced scale (1/5) mock-up loaded by a movable water tank is used for their experimental investigation. A first layout using full passive power distribution among the straps and a single matching circuit with one '' Conjugate-T '' (CT) or one hybrid has already been successfully tested. Its drawbacks are the difficulty of changing the toroidal phasing and the use of a single 20 MW feeding line section. In this paper we describe the mock-up tests of a second layout based on two 10 MW CT circuits, and allowing switching between heating or current drive phasings without any hardware modification. Two decouplers are used to minimize the effect of mutual coupling on matching. A robust four-parameter CT matching procedure has been developed based on adjusting the two first parameters - the positions of the line stretchers in the CT branches - of each CT in vacuum conditions (this is done once for all for each frequency). High load resilience, i.e. a VSWR remaining < 1.5 for an 8-fold increase of antenna resistance, can be obtained for the 4 toroidal phasing configurations considered: (0π/2π3π/2), (0-π/2-π-3π/2), (00ππ) and (0ππ0). The change of phasing only requires the adjustment of the phase difference between the two power sources and of the two last parameters (stub and line stretcher in the common line) of each of the two CT circuits. These properties have first been derived from the experimental scattering matrix of the antenna array and are verified by reflection measurements on the mock-up. Feedback control of the phasing and the last two

  16. 76 FR 62073 - Guidance for Industry on Implementation of the Fee Provisions of the FDA Food Safety...

    Science.gov (United States)

    2011-10-06

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0721] Guidance for Industry on Implementation of the Fee Provisions of the FDA Food Safety Modernization Act; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

  17. De besluitvorming over werkzaamheid en veiligheid van rosiglitazon bij de FDA en de EMA. Wat zijn de lessen?

    NARCIS (Netherlands)

    Pouwels, Koen; Van Grootheest, Kees

    2013-01-01

    The rosiglitazone decision process at FDA and EMA. What should we learn? In September 2010 the EMA decided to suspend the market authorisation of rosiglitazone while the FDA decided to restrict its use. These actions were taken because rosiglitazone had been associated with an increased risk of

  18. Pharmacokinetics of pediatric lopinavir/ritonavir tablets in children when administered twice daily according to FDA weight bands

    NARCIS (Netherlands)

    Bastiaans, D.E.T.; Forcat, S.; Lyall, H.; Cressey, T.R.; Hansudewechakul, R.; Kanjanavanit, S.; Noguera-Julian, A.; Konigs, C.; Inshaw, J.R.; Chalermpantmetagul, S.; Saidi, Y.; Compagnucci, A.; Harper, L.M.; Giaquinto, C.; Colbers, A.P.; Burger, D.M.

    2014-01-01

    BACKGROUND: Lopinavir/ritonavir (LPV/r) pediatric tablets (100/25 mg) are approved by the United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) as part of combination antiretroviral therapy. Dosing is based on body weight bands or body surface area under FDA approval

  19. Cost estimate of grouting the proposed test pits at Idaho National Engineering Laboratory using the ORNL-recommended grouts

    International Nuclear Information System (INIS)

    Spence, R.D.

    1987-08-01

    EG and G Idaho will construct three experimental pits to simulate the TRU waste trenches at Idaho National Engineering Laboratory (INEL). Two of these pits will be grouted and then one will be destructively examined as soon as the grout cures and the other will be monitored for 10 years. Oak Ridge National Laboratory (ORNL) is evaluating grouts and will recommend a grout to EG and G Idaho to reduce the permeability of the pit, fill the large voids, and encapsulate the waste. A previous ORNL report (ORNL/TM-9881) discusses the grouts evaluated and the grout recommended based on those evaluations. This report evaluates the economics of grouting the experimental pits. The cost of double grouting two of the EG and G Idaho design pits at the Idaho National Engineering Laboratory using lance injection was estimated to be $100,000. Jet grouting the same two pits was estimated to cost $85,000. Both should be tried as part of the test EG and G Idaho is conducting

  20. A coupled mechanical-hydrological investigation of crystalline rocks: Annual technical progress report, proposed test matrix, and preliminary results

    International Nuclear Information System (INIS)

    Bastian, R.J.; Voss, C.F.; Apted, M.J.; Shotwell, L.R.

    1988-02-01

    This report reviews the Fracture Flow Behavior in Rock Study being performed at the Pacific Northwest Laboratory. The study's objective is to determine the feasibility of predicting mechanical-hydrological behavior of natural rock fractures by accurately characterizing fracture surface topography and mineralization. A laboratory-scale facility is currently being used to ensure optimum control of variables. Devising a technique to study small-scale samples is the first step to understanding the complex coupled processes encountered in geomechanics and hydrology. The major accomplishments during fiscal year 1987 were initial development of the innovative testing method, identification of appropriate specimens, substantial renovation to the facility, completion of several sets of experiments, and procurement of hardware components for a laser-imaging device used to characterize fracture surfaces. A complete set of preliminary results and findings is presented in this report. These results, gathered from a basalt core with a natural fracture, have demonstrated that the methodology is valid, and definite trends in the data are readily apparent. 10 refs., 14 figs., 1 tab

  1. Disadvantages of using the area under the receiver operating characteristic curve to assess imaging tests: A discussion and proposal for an alternative approach

    International Nuclear Information System (INIS)

    Halligan, Steve; Altman, Douglas G.; Mallett, Susan

    2015-01-01

    The objectives are to describe the disadvantages of the area under the receiver operating characteristic curve (ROC AUC) to measure diagnostic test performance and to propose an alternative based on net benefit. We use a narrative review supplemented by data from a study of computer-assisted detection for CT colonography. We identified problems with ROC AUC. Confidence scoring by readers was highly non-normal, and score distribution was bimodal. Consequently, ROC curves were highly extrapolated with AUC mostly dependent on areas without patient data. AUC depended on the method used for curve fitting. ROC AUC does not account for prevalence or different misclassification costs arising from false-negative and false-positive diagnoses. Change in ROC AUC has little direct clinical meaning for clinicians. An alternative analysis based on net benefit is proposed, based on the change in sensitivity and specificity at clinically relevant thresholds. Net benefit incorporates estimates of prevalence and misclassification costs, and it is clinically interpretable since it reflects changes in correct and incorrect diagnoses when a new diagnostic test is introduced. ROC AUC is most useful in the early stages of test assessment whereas methods based on net benefit are more useful to assess radiological tests where the clinical context is known. Net benefit is more useful for assessing clinical impact. (orig.)

  2. Trends in utilization of smoking cessation agents before and after the passage of FDA boxed warning in the United States.

    Science.gov (United States)

    Shah, Drishti; Shah, Anuj; Tan, Xi; Sambamoorthi, Usha

    2017-08-01

    In 2009, the FDA required a black box warning (BBW) on bupropion and varenicline, the two commonly prescribed smoking cessation agents due to reports of adverse neuropsychiatric events. We investigated if there was a decline in use of bupropion and varenicline after the BBW by comparing the percent using these medications before and after BBW. We conducted a retrospective observational study using data from the Medical Expenditure Panel Survey from 2007 to 2014. The study sample consisted of adult smokers, who were advised by their physicians to quit smoking. We divided the time period into "pre-warning", "post-warning: immediate", and "post-warning: late." Unadjusted analysis using chi-square tests and adjusted analyses using logistic regressions were conducted to evaluate the change in bupropion and varenicline use before and after the BBW. Secondary analyses using piecewise regression were also conducted. On an average, 49.04% of smokers were advised by their physicians to quit smoking. We observed a statistically significant decline in varenicline use from 22.1% in year 2007 to 9.23% in 2014 (p valuesmoking by their physicians were less likely to use varenicline in the immediate post-BBW period as compared to pre-BBW period. While the use of varenicline continued to be significantly low in the late post-BBW period (AOR=0.45, 95% CI=0.31-0.64) as compared to the pre-BBW period, the trend in use as seen in piecewise regression remained stable (OR=0.90, 95% CI=0.75-1.06). We did not observe significant differences in bupropion use between the pre- and post-BBW periods. The passage of the FDA boxed warning was associated with a significant decline in the use of varenicline, but not in the use of bupropion. Copyright © 2017 Elsevier B.V. All rights reserved.

  3. Proposal for the testing of a tool for assessing the risk of dehydration in the elderly patient.

    Science.gov (United States)

    Bulgarelli, Ketty

    2015-09-09

    analyzed using a statistical method. The results showed no statistically significant differences in the identification of the risk of dehydration in the two groups. It is believed, however, that the data will guide checklists to consider the above-mentioned instrument valid and useful in nursing practice in order to assess the risk of dehydration in older people and early detection of its onset and thus enable prompt and effective management. It will take more extensive studies of case studies to test this hypothesis.

  4. Proposed limiting values for performance criteria in acceptance testing of diagnostic X-ray equipment in the Federal Republic of Germany

    International Nuclear Information System (INIS)

    Baeuml, A.

    1989-01-01

    In the Federal Republic of Germany a new X-ray ordinance came into force in 1988 containing a specific paragraph on quality assurance for all medical X-ray units stipulating acceptance tests, regular checks and supervision by medical bodies and the competent authorities. Acceptance testing is to be performed by engineers from equipment suppliers of manufacturers in new and existing installations. It is expected that the service engineers will adjust the equipment in such a way as to obtain optimal performance before measurements are made, the results of which are to be stated in a certificate describing quality status of the equipment. A working group has developed guidelines for these acceptance tests. Items to be measured are reported and proposed limiting values and their tolerances are discussed. (author)

  5. Proposed limiting values for performance criteria in acceptance testing of diagnostic X-ray equipment in the Federal Republic of Germany

    International Nuclear Information System (INIS)

    Baeuml, A.

    1989-01-01

    In the Federal Republic of Germany a new X-ray ordinance came into force in 1988 containing a specific paragraph on quality assurance for all medical X-ray units stipulating acceptance tests, regular checks and supervision by medical bodies and the competent authorities. Acceptance testing is to be performed by engineers from the equipment suppliers or manufacturers in new and also existing installations. It is expected that the service engineers will adjust the equipment in such a way as to obtain optimal performance before measurements are made, the results of which are to be stated in a certificate describing the quality status of the equipment. A working group has developed guidelines for these acceptance tests. The items to be measured are reported and the proposed limiting values and their tolerances are discussed. (author)

  6. Algorithms to analyze the quality test parameter values of seafood in the proposed ontology based seafood quality analyzer and miner (ONTO SQAM model

    Directory of Open Access Journals (Sweden)

    Vinu Sherimon

    2017-07-01

    Full Text Available Ensuring the quality of food, particularly seafood has increasingly become an important issue nowadays. Quality Management Systems empower any organization to identify, measure, control and improve the quality of the products manufactured that will eventually lead to improved business performance. With the advent of new technologies, now intelligent systems are being developed. To ensure the quality of seafood, an ontology based seafood quality analyzer and miner (ONTO SQAM model is proposed. The knowledge is represented using ontology. The domain concepts are defined using ontology. This paper presents the initial part of the proposed model – the analysis of quality test parameter values. Two algorithms are proposed to do the analysis – Comparison Algorithm and Data Store Updater algorithm. The algorithms ensure that the values of various quality tests are in the acceptable range. The real data sets taken from different seafood companies in Kerala, India, and validated by the Marine Product Export Development Authority of India (MPEDA are used for the experiments. The performance of the algorithms is evaluated using standard performance metrics such as precision, recall, and accuracy. The results obtained show that all the three measures achieved good results.

  7. Summary Report of Comprehensive Laboratory Testing to Establish the Effectiveness of Proposed Treatment Methods for Unremediated and Remediated Nitrate Salt Waste Streams

    Energy Technology Data Exchange (ETDEWEB)

    Anast, Kurt Roy [Los Alamos National Lab. (LANL), Los Alamos, NM (United States); Funk, David John [Los Alamos National Lab. (LANL), Los Alamos, NM (United States); Hargis, Kenneth Marshall [Los Alamos National Lab. (LANL), Los Alamos, NM (United States)

    2017-10-04

    The inadvertent creation of transuranic waste carrying hazardous waste codes D001 and D002 requires the treatment of the material to eliminate the hazardous characteristics and allow its eventual shipment and disposal at the Waste Isolation Pilot Plant (WIPP). This report documents the effectiveness of two treatment methods proposed to stabilize both the unremediated and remediated nitrate salt waste streams (UNS and RNS, respectively) at Los Alamos National Laboratory (LANL). The two technologies include the addition of zeolite (with and without the addition of water as a processing aid) and cementation. Surrogates were developed to evaluate both the solid and liquid fractions expected from parent waste containers, and both the solid and liquid fractions were tested. Both technologies are shown to be effective at eliminating the characteristic of ignitability (D001), and the addition of zeolite was determined to be effective at eliminating corrosivity (D002), with the preferred option1 of adding zeolite currently planned for implementation at LANL’s Waste Characterization, Reduction, and Repackaging Facility (WCRRF). The course of this work verified the need to evaluate and demonstrate the effectiveness of the proposed remedy for debris material, if required. The evaluation determined that WypAlls, cheesecloth, and Celotex absorbed with saturated nitrate salt solutions exhibit the ignitability characteristic (all other expected debris is not classified as ignitable). Finally, liquid surrogates containing saturated nitrate salts did not exhibit the characteristic of ignitability in their pure form (those neutralized with Kolorsafe and mixed with sWheat did exhibit D001). Sensitivity testing and an analysis were conducted to evaluate the waste form for reactivity. Tests included subjecting surrogate material to mechanical impact, friction, electrostatic discharge and thermal insults. The testing confirmed that the waste does not exhibit the characteristic of

  8. Proposal for Testing and Validation of Vacuum Ultra-Violet Atomic Laser-Induced Fluorescence as a Method to Analyze Carbon Grid Erosion in Ion Thrusters

    Science.gov (United States)

    Stevens, Richard

    2003-01-01

    Previous investigation under award NAG3-25 10 sought to determine the best method of LIF to determine the carbon density in a thruster plume. Initial reports from other groups were ambiguous as to the number of carbon clusters that might be present in the plume of a thruster. Carbon clusters would certainly affect the ability to LIF; if they were the dominant species, then perhaps the LIF method should target clusters. The results of quadrupole mass spectroscopy on sputtered carbon determined that minimal numbers of clusters were sputtered from graphite under impact from keV Krypton. There were some investigations in the keV range by other groups that hinted at clusters, but at the time the proposal was presented to NASA, there was no data from low-energy sputtering available. Thus, the proposal sought to develop a method to characterize the population only of atoms sputtered from a graphite target in a test cell. Most of the ground work had been established by the previous two years of investigation. The proposal covering 2003 sought to develop an anti-Stokes Raman shifting cell to generate VUW light and test this cell on two different laser systems, ArF and YAG- pumped dye. The second goal was to measure the lowest detectable amounts of carbon atoms by 156.1 nm and 165.7 nm LIF. If equipment was functioning properly, it was expected that these goals would be met easily during the timeframe of the proposal, and that is the reason only modest funding was requested. The PI was only funded at half- time by Glenn during the summer months. All other work time was paid for by Whitworth College. The college also funded a student, Charles Shawley, who worked on the project during the spring.

  9. The complications of controlling agency time discretion: FDA review deadlines and postmarket drug safety.

    Science.gov (United States)

    Carpenter, Daniel; Chattopadhyay, Jacqueline; Moffitt, Susan; Nall, Clayton

    2012-01-01

    Public agencies have discretion on the time domain, and politicians deploy numerous policy instruments to constrain it. Yet little is known about how administrative procedures that affect timing also affect the quality of agency decisions. We examine whether administrative deadlines shape decision timing and the observed quality of decisions. Using a unique and rich dataset of FDA drug approvals that allows us to examine decision timing and quality, we find that this administrative tool induces a piling of decisions before deadlines, and that these “just-before-deadline” approvals are linked with higher rates of postmarket safety problems (market withdrawals, severe safety warnings, safety alerts). Examination of data from FDA advisory committees suggests that the deadlines may impede quality by impairing late-stage deliberation and agency risk communication. Our results both support and challenge reigning theories about administrative procedures, suggesting they embody expected control-expertise trade-offs, but may also create unanticipated constituency losses.

  10. FDA direct-to-consumer advertising for prescription drugs: what are consumer preferences and response tendencies?

    Science.gov (United States)

    Khanfar, Nile; Loudon, David; Sircar-Ramsewak, Feroza

    2007-01-01

    The effect of direct-to-consumer (DTC) television advertising of prescription medications is a growing concern of the United States (U.S.) Congress, state legislatures, and the Food and Drug Administration (FDA). This research study was conducted in order to examine consumers' perceived preferences of DTC television advertisement in relation to "reminder" "help-seeking," and "product-claim" FDA-approved advertisement categories. An additional objective was to examine the influence of DTC television advertising of prescription drugs on consumers' tendency to seek more information about the medication and/or the medical condition. The research indicates that DTC television drug ads appear to be insufficient for consumers to make informed decisions. Their mixed perception and acceptance of the advertisements seem to influence them to seek more information from a variety of medical sources.

  11. A Comprehensive Review of US FDA-Approved Immune Checkpoint Inhibitors in Urothelial Carcinoma

    Directory of Open Access Journals (Sweden)

    Fu-Shun Hsu

    2017-01-01

    Full Text Available Few effective treatment options are available for patients with advanced or metastatic urothelial carcinoma (UC after unsuccessful first-line platinum-based chemotherapy. To date, immune checkpoint inhibitors are novel therapeutic agents for UC treatment. From May 2016 to May 2017, five anti-PD-1/PD-L1 monoclonal antibodies received accelerated or regular approval from the US Food and Drug Administration (FDA for the treatment of patients with locally advanced or metastatic UC. The present comprehensive review presents the background information of these five US FDA-approved anticancer agents to provide a basic but concise understanding of these agents for advanced studies. We summarize their immune checkpoint mechanisms, clinical efficacy, recommended usage protocols, adverse events, and the limitations of the PD-L1 biomarker assays.

  12. Testing consumer perception of nutrient content claims using conjoint analysis.

    Science.gov (United States)

    Drewnowski, Adam; Moskowitz, Howard; Reisner, Michele; Krieger, Bert

    2010-05-01

    The US Food and Drug Administration (FDA) proposes to establish standardized and mandatory criteria upon which front-of-pack (FOP) nutrition labelling must be based. The present study aimed to estimate the relative contribution of declared amounts of different nutrients to the perception of the overall 'healthfulness' of foods by the consumer. Protein, fibre, vitamin A, vitamin C, calcium and iron were nutrients to encourage. Total fat, saturated fat, cholesterol, total and added sugar, and sodium were the nutrients to limit. Two content claims per nutrient used the FDA-approved language. An online consumer panel (n 320) exposed to multiple messages (n 48) rated the healthfulness of each hypothetical food product. Utility functions were constructed using conjoint analysis, based on multiple logistic regression and maximum likelihood estimation. Consumer perception of healthfulness was most strongly driven by the declared presence of protein, fibre, calcium and vitamin C and by the declared total absence of saturated fat and sodium. For this adult panel, total and added sugar had lower utilities and contributed less to the perception of healthfulness. There were major differences between women and men. Conjoint analysis can lead to a better understanding of how consumers process information about the full nutrition profile of a product, and is a powerful tool for the testing of nutrient content claims. Such studies can help the FDA develop science-based criteria for nutrient profiling that underlies FOP and shelf labelling.

  13. The FDA Food Safety and Modernization Act and the Exemption for Small Firms

    OpenAIRE

    Pouliot, Sebastien

    2011-01-01

    The FDA Food Safety Modernization Act of 2010 is new legislation that mandates, among other things, new food safety standards. The act includes a clause that exempts small firms from new regulatory requirements. This paper investigates the effects of a small firm exemption from more stringent food safety standards. The model compares food safety, total output and the number of market participants for different food safety regulation with and without an exemption for small firms. The numerical...

  14. Level of Evidence Associated with FDA Safety Communications with Drug Labeling Changes: 2010-2014

    Directory of Open Access Journals (Sweden)

    Benjamin Hixon

    2017-02-01

    Full Text Available Purpose: Approximately 800,000 safety reports are submitted to the FDA annually, however, only significant issues generate drug safety communications (DSC. The purpose of this study was to determine the type of clinical evidence used to warrant a change in drug labeling for drugs with DSC between January 1, 2010 and December 31, 2014. Methods: Selected data was obtained from the FDA website. The primary endpoint of the study was the frequency of the types of clinical evidence used in FDA communications, as reported through the FDA DSC. Results were evaluated via descriptive statistics, and chi-squared for nominal data. Results: A total of 2521 drug safety labeling changes were identified and 99 (3.9% of safety communications met the inclusion criteria. The majority of the labeling changes were associated with single agents (83.8%. The three most frequently reported labeling changes were warnings (68.7%, precautions (58.6%, and patient package insert/medication guide (23.2%. Case reports resulted in the greatest number of documented literature types (n = 791, followed by randomized controlled trials (n = 76, and case control/cohort studies (n = 74. Significantly more evidence for DSCs were classified as Level of Evidence B (LOE B, 68.6%, compared to LOE A (17.1%, and LOE C (14.1% (p = 0.007. Conclusions: The majority of drug labeling change initiators was associated with LOE equivalent to B. Practitioners should evaluate data associated with labeling changes to determine how to interpret the information for their patients. Conflict of Interest We declare no conflicts of interest or financial interests that the authors or members of their immediate families have in any product or service discussed in the manuscript, including grants (pending or received, employment, gifts, stock holdings or options, honoraria, consultancies, expert testimony, patents and royalties.   Type: Original Research

  15. Regulating (for the benefit of) future persons: a different perspective on the FDA's jurisdiction to regulate human reproductive cloning.

    Science.gov (United States)

    Javitt, Gail H; Hudson, Kathy

    2003-01-01

    The Food and Drug Administration (FDA) has taken the position that human reproductive cloning falls within its regulatory jurisdiction. This position has been subject to criticism on both procedural and substantive grounds. Some have contended that the FDA has failed to follow administrative law principles in asserting its jurisdiction, while others claim the FDA is ill suited to the task of addressing the ethical and social implications of human cloning. This Article argues, that, notwithstanding these criticisms, the FDA could plausibly assert jurisdiction over human cloning as a form of human gene therapy, an area in which the FDA is already regarded as having primary regulatory authority. Such an assertion would require that the FDA's jurisdiction extend to products affecting future persons, i.e., those not yet born. This Article demonstrates, for the first time, that such jurisdiction was implicit in the enactment of the 1962 Kefauver-Harris Amendments to the Federal Food, Drug, and Cosmetic Act and that the FDA has historically relied on such authority in promulgating regulations for drugs and devices.

  16. FDA & digital mammography: why has FDA required full field digital mammography systems to be regulated as potentially dangerous devices for more than 10 years?

    Science.gov (United States)

    Nields, Morgan W

    2010-05-01

    Digital mammography is routinely used in the US to screen asymptomatic women for breast cancer and currently over 50% of US screening centers employ the technology. In spite of FDAs knowledge that digital mammography requires less radiation than film mammography and that its equivalence has been proven in a prospective randomized trial, the agency has failed to allow the technology market access via the 510(k) pre market clearance pathway. As a result of the restrictive Pre Market Approval process, only four suppliers have received FDA approval. The resulting lack of a competitive market has kept costs high, restricted technological innovation, and impeded product improvements as a result of PMA requirements. Meanwhile, at least twelve companies are on the market in the EU and the resulting competitive market has lowered costs and provided increased technological choice. A cultural change with new leadership occurred in the early 90's at FDA. The historical culture at the Center for Devices and Radiological Health of collaboration and education gave way to one characterized by a lack of reliance on outside scientific expertise, tolerance of decision making by unqualified reviewers, and an emphasis on enforcement and punishment. Digital mammography fell victim to this cultural change and as a result major innovations like breast CT and computer aided detection technologies are also withheld from the market. The medical device law, currently under review by the Institute of Medicine, should be amended by the Congress so that new technologies can be appropriately classified in accordance with the risk based assessment classification system detailed in Chapter V of the Federal Food, Drug, and Cosmetic Act. A panel of scientific experts chartered by the NIH or IOM should determine the classification appropriate for new technologies that have no historical regulatory framework. This would be binding on FDA. Unless the law is changed we will likely again experience

  17. FDA Food Code recommendations: how do popular US baking shows measure up?

    Directory of Open Access Journals (Sweden)

    Valerie Cadorett

    2018-05-01

    Full Text Available The purpose of this study was to determine if popular US baking shows follow the FDA Food Code recommendations and critical food safety principles. This cross-sectional study examined a convenience sample of 75 episodes from three popular baking shows. The three shows were about competitively baking cupcakes, competitively baking cakes, and baking in a popular local bakery. Twenty-five episodes from each show were viewed. Coding involved tallying how many times 17 FDA Food Code recommendations were or were not followed. On each show, bare hands frequently came in contact with ready-to-eat food. On a per-hour basis, this occurred 80, 155, and 176 times on shows 1-3, respectively. Hands were washed before cooking three times on the three shows and never for the recommended 20 seconds. On each show, many people touched food while wearing jewelry other than a plain wedding band, for an average of at least 7 people per hour on each show. Shows 1-3 had high rates of long-haired bakers not wearing hair restraints (11.14, 6.57, and 14.06 per hour, respectively. Shows 1 and 2 had high rates of running among the bakers (22.29 and 10.57 instances per hour, respectively. These popular baking shows do not demonstrate proper food safety techniques put forth by the FDA and do not contribute the reduction of foodborne illnesses through proper food handling.

  18. Heparin crisis 2008: a tipping point for increased FDA enforcement in the pharma sector?

    Science.gov (United States)

    Rosania, Larry

    2010-01-01

    Against a backdrop of steady deregulation, the pharmaceutical industry is increasingly outsourcing manufacturing, resulting in decentralized control of the global supply chain. Established products such as heparin have been held to outdated analytical standards. Ten million Americans receive heparin every year; Baxter International accounts for half of this market. In 2008, contamination of Baxter's heparin--sourced in China--resulted in about 350 adverse events and 150 deaths in the United States. In future, increasingly stringent FDA inspections and enforcement are expected for imported drugs and ingredients. More regional FDA offices will be set up overseas. FDA funding will likely be supplemented in future by user fees charged to importers. For newer products, companies will face pressure to adopt Quality by Design, with solid control of the global supply chain and a proactive focus on GMP. Older products will be held to modern standards. Long-term, imports of drugs and ingredients from developing markets will continue. This makes sense to companies from an economic standpoint, but protections will be essential to ensure that it is also justifiable from a public health perspective.

  19. FDA (Food and Drug Administration) compliance program guidance manual and updates (FY 86). Section 4. Medical and radiological devices. Irregular report

    International Nuclear Information System (INIS)

    1986-01-01

    The FDA Compliance Program Guidance Manual provides a system for issuing and filing program plans and instructions directed to Food and Drug Administration Field operations for project implementation. Section IV provides those chapters of the Compliance Program Guidance Manual which pertain to the areas of medical and radiological devices. Some of the areas of coverage include laser and sunlamp standards inspections, compliance testing of various radiation-emitting products such as television receivers and microwave ovens, emergency response planning and policy, premarket approval and device manufacturers inspections, device problem reporting, sterilization of devices, and consumer education programs on medical and radiological devices

  20. Safety assessment for the proposed pilot-scale treatability tests for the 200-UP-1 and 200-ZP-1 groundwater operable units. Revision 1

    International Nuclear Information System (INIS)

    1994-12-01

    This safety assessment provides an analysis of the proposed pilot-scale treatability test activities to be and conducted within the 200 Area groundwater operable units on the Hanford Site. The 200-UP-1 and 200-ZP-1 operable units are located in the 200 West Area of the Hanford Site. These tests will evaluate an ion exchange (IX) water purification treatment system and granular activated carbon (GAC). A detailed engineering analysis of (GAC) adsorption for remediation of groundwater contamination. A detailed engineering analysis of the IX treatment system. The principal source of information for this assessment, states that the performance objective of the treatment systems is to remove 90% of the uranium and technetium-99 ( 99 Tc) from the extracted groundwater at the 200-UP-1 site. The performance objective for 200-ZP-1 is to remove 90% of the carbon tetrachloride (CCl 4 ), chloroform, and trichloroethylene (TCE) from the extracted groundwater

  1. Proposals for the type tests criteria and calibration conditions of passive eye lens dosemeters to be used in interventional cardiology and radiology workplaces

    International Nuclear Information System (INIS)

    Bordy, J.M.; Daures, J.; Denozière, M.; Gualdrini, G.; Ginjaume, M.; Carinou, E.; Vanhavere, F.

    2011-01-01

    The paper is aimed at making a proposal for the type test and calibration of eye lens passive dosemeters especially used in the interventional cardiology/radiology (IC/IR). Starting from the only existing standard dealing with eye lens dosimetry using TLDs (), parameters such as, detection threshold, energy and angle dependence of response criteria have been reviewed and it has been tried to harmonise them as much as possible with the IEC 62387 requirements, taking into account the particular use at IC/IR workplaces. Conversion coefficients from air kerma to dose equivalent at 3 mm depth for RQR and ISO radiation qualities, employed for type test and calibration purposes, have been calculated in a new phantom introduced within the ORAMED (Optimization of RAdiation protection for MEDical staff) project. This phantom is more representative of the head so that the estimation of H lens by H p (3) is more accurate.

  2. Flight Tests of a 0.13-Scale Model of the Convair XFY-1 Vertically Rising Airplane in a Setup Simulating that Proposed for Captive-Flight Tests in a Hangar, TED No. NACA DE 368

    Science.gov (United States)

    Lovell, Powell M., Jr.

    1953-01-01

    An experimental investigation has been conducted to determine the dynamic stability and control characteristics of a 0.13-scale free-flight model of the Convair XFY-1 airplane in test setups representing the setup proposed for use in the first flight tests of the full-scale airplane in the Moffett Field airship hangar. The investigation was conducted in two parts: first, tests with the model flying freely in an enclosure simulating the hangar, and second, tests with the model partially restrained by an overhead line attached to the propeller spinner and ground lines attached to the wing and tail tips. The results of the tests indicated that the airplane can be flown without difficulty in the Moffett Field airship hangar if it does not approach too close to the hangar walls. If it does approach too close to the walls, the recirculation of the propeller slipstream might cause sudden trim changes which would make smooth flight difficult for the pilot to accomplish. It appeared that the tethering system proposed by Convair could provide generally satisfactory restraint of large-amplitude motions caused by control failure or pilot error without interfering with normal flying or causing any serious instability or violent jerking motions as the tethering lines restrained the model.

  3. Proposal for agar disk diffusion interpretive criteria for susceptibility testing of bovine mastitis pathogens using cefoperazone 30μg disks.

    Science.gov (United States)

    Feßler, Andrea T; Kaspar, Heike; Lindeman, Cynthia J; Peters, Thomas; Watts, Jeffrey L; Schwarz, Stefan

    2017-02-01

    Cefoperazone is a third generation cephalosporin which is commonly used for bovine mastitis therapy. Bacterial pathogens involved in bovine mastitis are frequently tested for their susceptibility to cefoperazone. So far, the cefoperazone susceptibility testing using 30μg disks has been hampered by the lack of quality control (QC) ranges as well as the lack of interpretive criteria. In 2014, QC ranges for 30 μg cefoperazone disks have been established for Staphylococcus aureus ATCC ® 25923 and Escherichia coli ATCC ® 25922. As a next step, interpretive criteria for the susceptibility testing of bovine mastitis pathogens should be developed. For this, 637 bovine mastitis pathogens (including 112 S. aureus, 121 coagulase-negative staphylococci (CoNS), 103 E. coli, 101 Streptococcus agalactiae, 100 Streptococcus dysgalactiae and 100 Streptococcus uberis) were investigated by agar disk diffusion according to the document Vet01-A4 of the Clinical and Laboratory Standards Institute (CLSI) using 30μg cefoperazone disks and the results were compared to the corresponding MIC values as determined by broth microdilution also according to the aforementioned CLSI document. Based on the results obtained and taking into account the achievable milk concentration of cefoperazone after regular dosing, the following interpretive criteria were proposed as a guidance for mastitis diagnostic laboratories: for staphylococci and E. coli ≥23mm (susceptible), 18-22mm (intermediate) and ≤17mm (resistant) and for streptococci ≥18mm (susceptible), and ≤17mm (non-susceptible). These proposed interpretive criteria shall contribute to a harmonization of cefoperazone susceptibility testing of bovine mastitis pathogens. Copyright © 2016 Elsevier B.V. All rights reserved.

  4. RCRA Part A and Part B Permit Application for Waste Management Activities at the Nevada Test Site: Proposed Mixed Waste Disposal Unit (MWSU)

    Energy Technology Data Exchange (ETDEWEB)

    NSTec Environmental Management

    2010-07-19

    The proposed Mixed Waste Storage Unit (MWSU) will be located within the Area 5 Radioactive Waste Management Complex (RWMC). Existing facilities at the RWMC will be used to store low-level mixed waste (LLMW). Storage is required to accommodate offsite-generated LLMW shipped to the Nevada Test Site (NTS) for disposal in the new Mixed Waste Disposal Unit (MWDU) currently in the design/build stage. LLMW generated at the NTS (onsite) is currently stored on the Transuranic (TRU) Pad (TP) in Area 5 under a Mutual Consent Agreement (MCA) with the Nevada Division of Environmental Protection, Bureau of Federal Facilities (NDEP/BFF). When the proposed MWSU is permitted, the U.S. Department of Energy (DOE) will ask that NDEP revoke the MCA and onsite-generated LLMW will fall under the MWSU permit terms and conditions. The unit will also store polychlorinated biphenyl (PCB) waste and friable and non-friable asbestos waste that meets the acceptance criteria in the Waste Analysis Plan (Exhibit 2) for disposal in the MWDU. In addition to Resource Conservation and Recovery Act (RCRA) requirements, the proposed MWSU will also be subject to Department of Energy (DOE) orders and other applicable state and federal regulations. Table 1 provides the metric conversion factors used in this application. Table 2 provides a list of existing permits. Table 3 lists operational RCRA units at the NTS and their respective regulatory status.

  5. RCRA Part A and Part B Permit Application for Waste Management Activities at the Nevada Test Site: Proposed Mixed Waste Disposal Unit (MWSU)

    International Nuclear Information System (INIS)

    2010-01-01

    The proposed Mixed Waste Storage Unit (MWSU) will be located within the Area 5 Radioactive Waste Management Complex (RWMC). Existing facilities at the RWMC will be used to store low-level mixed waste (LLMW). Storage is required to accommodate offsite-generated LLMW shipped to the Nevada Test Site (NTS) for disposal in the new Mixed Waste Disposal Unit (MWDU) currently in the design/build stage. LLMW generated at the NTS (onsite) is currently stored on the Transuranic (TRU) Pad (TP) in Area 5 under a Mutual Consent Agreement (MCA) with the Nevada Division of Environmental Protection, Bureau of Federal Facilities (NDEP/BFF). When the proposed MWSU is permitted, the U.S. Department of Energy (DOE) will ask that NDEP revoke the MCA and onsite-generated LLMW will fall under the MWSU permit terms and conditions. The unit will also store polychlorinated biphenyl (PCB) waste and friable and non-friable asbestos waste that meets the acceptance criteria in the Waste Analysis Plan (Exhibit 2) for disposal in the MWDU. In addition to Resource Conservation and Recovery Act (RCRA) requirements, the proposed MWSU will also be subject to Department of Energy (DOE) orders and other applicable state and federal regulations. Table 1 provides the metric conversion factors used in this application. Table 2 provides a list of existing permits. Table 3 lists operational RCRA units at the NTS and their respective regulatory status.

  6. Toward the establishment of standardized in vitro tests for lipid-based formulations, part 4: proposing a new lipid formulation performance classification system.

    Science.gov (United States)

    Williams, Hywel D; Sassene, Philip; Kleberg, Karen; Calderone, Marilyn; Igonin, Annabel; Jule, Eduardo; Vertommen, Jan; Blundell, Ross; Benameur, Hassan; Müllertz, Anette; Porter, Christopher J H; Pouton, Colin W

    2014-08-01

    The Lipid Formulation Classification System Consortium looks to develop standardized in vitro tests and to generate much-needed performance criteria for lipid-based formulations (LBFs). This article highlights the value of performing a second, more stressful digestion test to identify LBFs near a performance threshold and to facilitate lead formulation selection in instances where several LBF prototypes perform adequately under standard digestion conditions (but where further discrimination is necessary). Stressed digestion tests can be designed based on an understanding of the factors that affect LBF performance, including the degree of supersaturation generated on dispersion/digestion. Stresses evaluated included decreasing LBF concentration (↓LBF), increasing bile salt, and decreasing pH. Their capacity to stress LBFs was dependent on LBF composition and drug type: ↓LBF was a stressor to medium-chain glyceride-rich LBFs, but not more hydrophilic surfactant-rich LBFs, whereas decreasing pH stressed tolfenamic acid LBFs, but not fenofibrate LBFs. Lastly, a new Performance Classification System, that is, LBF composition independent, is proposed to promote standardized LBF comparisons, encourage robust LBF development, and facilitate dialogue with the regulatory authorities. This classification system is based on the concept that performance evaluations across three in vitro tests, designed to subject a LBF to progressively more challenging conditions, will enable effective LBF discrimination and performance grading. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

  7. Comparison of Unlicensed and Off-Label Use of Antipsychotics Prescribed to Child and Adolescent Psychiatric Outpatients for Treatment of Mental and Behavioral Disorders with Different Guidelines: The China Food and Drug Administration Versus the FDA.

    Science.gov (United States)

    Zhu, Xiuqing; Hu, Jinqing; Sun, Bin; Deng, Shuhua; Wen, Yuguan; Chen, Weijia; Qiu, Chang; Shang, Dewei; Zhang, Ming

    2018-04-01

    This study aims to compare the prevalence of unlicensed and off-label use of antipsychotics among child and adolescent psychiatric outpatients with guidelines proposed by the China Food and Drug Administration (CFDA) and the U.S. Food and Drug Administration (FDA), and to identify factors associated with inconsistencies between the two regulations. A retrospective analysis of 29,326 drug prescriptions for child and adolescent outpatients from the Affiliated Brain Hospital of Guangzhou Medical University was conducted. Antipsychotics were classified as "unlicensed" or "off-label use" according to the latest pediatric license information registered by the CFDA and the FDA or the package inserts of antipsychotics authorized by the CFDA or the FDA for the treatment of pediatric mental and behavioral disorders, respectively. Binary logistic regression analysis was performed to assess factors associated with inconsistencies between the two regulations. The total unlicensed use, according to the CFDA analysis, was higher than that found in the FDA analysis (74.14% vs. 22.04%, p according to the FDA analysis, was higher than that found in the CFDA analysis (46.53% vs. 15.77%, p gender, diagnosis of schizophrenia and schizotypal and delusional disorders, diagnosis of mood [affective] disorders, diagnosis of mental retardation, and diagnosis of psychological development disorders were associated with inconsistent off-label use. The difference in prevalence of total unlicensed and off-label use of antipsychotics between the two regulations was statistically significant. This inconsistency could be partly attributed to differences in pediatric license information and package inserts of antipsychotics. The results indicate a need for further clinical pediatric studies and better harmonization between agencies regarding antipsychotic used in pediatrics.

  8. Operational tests and irradiation programming proposal for the industrial production of 131 I in the TRIGA Mark III reactor of the Nuclear Centre (ININ)

    International Nuclear Information System (INIS)

    Alanis M, J.; Reyes J, J.L.; Ruiz C, M.A.

    2003-01-01

    In the National Institute of Nuclear Research it was recently finished the project for the production of I-131 at industrial level, the one which can divide basically in: (a) Preparation of the raw materials (TeO 2 ), (b) Sintering, (c) Neutron irradiation and (d) Separation of the I-131. With the end of starting the industrial production of this process, in this work it is presented the operational tests and an irradiation proposal of the TeO 2 to obtain quantities of I-131 that cover, if not totally, partially the national market. For this, they were carried out irradiation tests of 6 samples to different flows of neutrons. The result of these tests settles down that irradiating a mass of 240 g TeO 2 to a neutron flow of 6.53 x 10 12 n/cm 2 s in 4 cycles of 30 h per week approximately 2.54 Ci/week of I-131 distilled are obtained, which represents 35% of the demand of the Plant of Radioisotopes production of the ININ. (Author)

  9. Schedules of Controlled Substances: Placement of FDA-Approved Products of Oral Solutions Containing Dronabinol [(-)-delta-9-trans-

    Science.gov (United States)

    2017-11-22

    This final rule adopts without changes an interim final rule with request for comments published in the Federal Register on March 23, 2017. On July 1, 2016, the U.S. Food and Drug Administration (FDA) approved a new drug application for Syndros, a drug product consisting of dronabinol [(-)-delta-9-trans-tetrahydrocannabinol (delta-9-THC)] oral solution. The Drug Enforcement Administration (DEA) maintains FDA-approved products of oral solutions containing dronabinol in schedule II of the Controlled Substances Act.

  10. Medical devices: reports of corrections and removals; delay of effective data--FDA. Direct final rule; delay of effective date.

    Science.gov (United States)

    1998-11-18

    The Food and Drug Administration (FDA) published in the Federal Register of August 7, 1998 (63 FR 42229), a direct final rule. The direct final rule notified the public of FDA's intention to amend the regulations that govern reports of corrections and removals of medical devices to eliminate the requirement for distributors to make such reports. This document delays the effective date of the direct final rule.

  11. Medicare covers the majority of FDA-approved devices and Part B drugs, but restrictions and discrepancies remain.

    Science.gov (United States)

    Chambers, James D; May, Katherine E; Neumann, Peter J

    2013-06-01

    The Food and Drug Administration (FDA) and Medicare use different standards to determine, first, whether a new drug or medical device can be marketed to the public and, second, if the federal health insurance program will pay for use of the drug or device. This discrepancy creates hurdles and uncertainty for drug and device manufacturers. We analyzed discrepancies between FDA approval and Medicare national coverage determinations for sixty-nine devices and Part B drugs approved during 1999-2011. We found that Medicare covered FDA-approved drugs or devices 80 percent of the time. However, Medicare often added conditions beyond FDA approval, particularly for devices and most often restricting coverage to patients with the most severe disease. In some instances, Medicare was less restrictive than the FDA. Our findings highlight the importance for drug and device makers of anticipating Medicare's needs when conducting clinical studies to support their products. Our findings also provide important insights for the FDA's and Medicare's pilot parallel review program.

  12. FDA drug safety communications: a narrative review and clinical considerations for older adults.

    Science.gov (United States)

    Marcum, Zachary A; Vande Griend, Joseph P; Linnebur, Sunny A

    2012-08-01

    The US Food and Drug Administration (FDA) has new regulatory authorities intended to enhance drug safety monitoring in the postmarketing period. This has resulted in an increase in communication from the FDA in recent years about the safety profile of certain drugs. It is important to stay abreast of the current literature on drug risks to effectively communicate these risks to patients, other health care providers, and the general public. To summarize 4 new FDA drug safety communications by describing the evidence supporting the risks and the clinical implications for older adults. The FDA Web site was reviewed for new drug safety communications from May 2011 to April 2012 that would be relevant to older adults. Approved labeling for each drug or class was obtained from the manufacturer, and PubMed was searched for primary literature that supported the drug safety concern. FDA drug safety communications for 4 drugs were chosen because of the potential clinical importance in older adults. A warning for citalopram was made because of potential problems with QT prolongation in patients taking less than 40 mg per day. The evidence suggests minor changes in QT interval. Given the flat dose-response curve in treating depression with citalopram, the new 20-mg/d maximum dose in older adults is sensible. Another warning was made for proton pump inhibitors (PPIs) and an increased risk of Clostridium difficile infection. A dose-response relationship was found for this drug risk. With C. difficile infections on the rise in older adults, along with other safety risks of PPI therapy, PPIs should only be used in older adults indicated for therapy for the shortest duration possible. In addition, a warning about dabigatran was made. There is strong evidence from a large clinical trial, as well as case reports, of increased bleeding risk in older adults taking dabigatran, especially in older adults with decreased renal function. This medication should be used with caution in older

  13. Summary Report of Laboratory Testing to Establish the Effectiveness of Proposed Treatment Methods for Unremediated and Remediated Nitrate Salt Waste Streams

    Energy Technology Data Exchange (ETDEWEB)

    Anast, Kurt Roy [Los Alamos National Lab. (LANL), Los Alamos, NM (United States); Funk, David John [Los Alamos National Lab. (LANL), Los Alamos, NM (United States)

    2016-05-12

    The inadvertent creation of transuranic waste carrying hazardous waste codes D001 and D002 requires the treatment of the material to eliminate the hazardous characteristics and allow its eventual shipment and disposal at the Waste Isolation Pilot Plant (WIPP). This report documents the effectiveness of two treatment methods proposed to stabilize both the unremediated and remediated nitrate salt waste streams (UNS and RNS, respectively). The two technologies include the addition of zeolite (with and without the addition of water as a processing aid) and cementation. Surrogates were developed to evaluate both the solid and liquid fractions expected from parent waste containers, and both the solid and liquid fractions were tested. Both technologies are shown to be effective at eliminating the characteristic of ignitability (D001), and the addition of zeolite was determined to be effective at eliminating corrosivity (D002), with the preferred option1 of zeolite addition currently planned for implementation at the Waste Characterization, Reduction, and Repackaging Facility. During the course of this work, we established the need to evaluate and demonstrate the effectiveness of the proposed remedy for debris material, if required. The evaluation determined that Wypalls absorbed with saturated nitrate salt solutions exhibit the ignitability characteristic (all other expected debris is not classified as ignitable). Follow-on studies will be developed to demonstrate the effectiveness of stabilization for ignitable Wypall debris. Finally, liquid surrogates containing saturated nitrate salts did not exhibit the characteristic of ignitability in their pure form (those neutralized with Kolorsafe and mixed with sWheat did exhibit D001). As a result, additional nitrate salt solutions (those exhibiting the oxidizer characteristic) will be tested to demonstrate the effectiveness of the remedy.

  14. Association of Attorney Advertising and FDA Action with Prescription Claims: A Time Series Segmented Regression Analysis.

    Science.gov (United States)

    Tippett, Elizabeth C; Chen, Brian K

    2015-12-01

    Attorneys sponsor television advertisements that include repeated warnings about adverse drug events to solicit consumers for lawsuits against drug manufacturers. The relationship between such advertising, safety actions by the US Food and Drug Administration (FDA), and healthcare use is unknown. To investigate the relationship between attorney advertising, FDA actions, and prescription drug claims. The study examined total users per month and prescription rates for seven drugs with substantial attorney advertising volume and FDA or other safety interventions during 2009. Segmented regression analysis was used to detect pre-intervention trends, post-intervention level changes, and changes in post-intervention trends relative to the pre-intervention trends in the use of these seven drugs, using advertising volume, media hits, and the number of Medicare enrollees as covariates. Data for these variables were obtained from the Center for Medicare and Medicaid Services, Kantar Media, and LexisNexis. Several types of safety actions were associated with reductions in drug users and/or prescription rates, particularly for fentanyl, varenicline, and paroxetine. In most cases, attorney advertising volume rose in conjunction with major safety actions. Attorney advertising volume was positively correlated with prescription rates in five of seven drugs, likely because advertising volume began rising before safety actions, when prescription rates were still increasing. On the other hand, attorney advertising had mixed associations with the number of users per month. Regulatory and safety actions likely reduced the number of users and/or prescription rates for some drugs. Attorneys may have strategically chosen to begin advertising adverse drug events prior to major safety actions, but we found little evidence that attorney advertising reduced drug use. Further research is needed to better understand how consumers and physicians respond to attorney advertising.

  15. FDA Approves Immunotherapy for a Cancer that Affects Infants and Children | Poster

    Science.gov (United States)

    By Frank Blanchard, Staff Writer The U.S. Food and Drug Administration (FDA) recently approved dinutuximab (ch14.18) as an immunotherapy for neuroblastoma, a rare type of childhood cancer that offers poor prognosis for about half of the children who are affected. The National Cancer Institute’s (NCI) Biopharmaceutical Development Program (BDP) at the Frederick National Laboratory for Cancer Research produced ch14.18 for the NCI-sponsored clinical trials that proved the drug’s effectiveness against the disease.

  16. Changes in FDA enforcement activities following changes in federal administration: the case of regulatory letters released to pharmaceutical companies.

    Science.gov (United States)

    Nguyen, Diane; Seoane-Vazquez, Enrique; Rodriguez-Monguio, Rosa; Montagne, Michael

    2013-01-22

    The United States (US) Food and Drug Administration (FDA) is responsible for the protection of the public health by assuring the safety, effectiveness and security of human drugs and biological products through the enforcement of the Federal Food, Drug and Cosmetic Act (FDCA) and related regulations. These enforcement activities include regulatory letters (i.e. warning letters and notice of violation) to pharmaceutical companies. A regulatory letter represents the FDA's first official notification to a pharmaceutical company that the FDA has discovered a product or activity in violation of the FDCA.This study analyzed trends in the pharmaceutical-related regulatory letters released by the FDA during the period 1997-2011 and assessed differences in the average number and type of regulatory letters released during the last four federal administrations. Data derived from the FDA webpage. Information about the FDA office releasing the letter, date, company, and drug-related violation was collected. Regulatory letters were classified by federal administration. Descriptive statistics were performed for the analysis. Between 1997 and 2011 the FDA released 2,467 regulatory letters related to pharmaceuticals. FDA headquarters offices released 50.6% and district offices 49.4% of the regulatory letters. The Office of Prescription Drug Promotion released the largest number of regulatory letters (850; 34.5% of the total), followed by the Office of Scientific Investigations (131; 5.3%), and the Office of Compliance (105; 4.3%). During the 2nd Clinton Administration (1997-2000) the average number of regulatory letters per year was 242.8 ± 45.6, during the Bush Administration (2001-2008) it was 120.4 ± 33.7, and during the first three years of the Obama administration (2009-2011) it was 177.7.0 ± 17.0. The average number of regulatory letters released by the Office of Prescription Drug Promotion also varied by administration: Clinton (122.3 ± 36.4), Bush (29.5

  17. A proposal for a test method for assessment of hazard property HP 12 ("Release of an acute toxic gas") in hazardous waste classification - Experience from 49 waste.

    Science.gov (United States)

    Hennebert, Pierre; Samaali, Ismahen; Molina, Pauline

    2016-12-01

    A stepwise method for assessment of the HP 12 is proposed and tested with 49 waste samples. The hazard property HP 12 is defined as "Release of an acute toxic gas": waste which releases acute toxic gases (Acute Tox. 1, 2 or 3) in contact with water or an acid. When a waste contains a substance assigned to one of the following supplemental hazards EUH029, EUH031 and EUH032, it shall be classified as hazardous by HP 12 according to test methods or guidelines (EC, 2014a, 2014b). When the substances with the cited hazard statement codes react with water or an acid, they can release HCl, Cl 2 , HF, HCN, PH 3 , H 2 S, SO 2 (and two other gases very unlikely to be emitted, hydrazoic acid HN 3 and selenium oxide SeO 2 - a solid with low vapor pressure). Hence, a method is proposed:For a set of 49 waste, water addition did not produce gas. Nearly all the solid waste produced a gas in contact with hydrochloric acid in 5 min in an automated calcimeter with a volume >0.1L of gas per kg of waste. Since a plateau of pressure is reached only for half of the samples in 5 min, 6 h trial with calorimetric bombs or glass flasks were done and confirmed the results. Identification of the gases by portable probes showed that most of the tested samples emit mainly CO 2 . Toxic gases are emitted by four waste: metallic dust from the aluminum industry (CO), two air pollution control residue of industrial waste incinerator (H 2 S) and a halogenated solvent (organic volatile(s) compound(s)). HF has not been measured in these trials started before the present definition of HP 12. According to the definition of HP 12, only the H 2 S emission of substances with hazard statement EUH031 is accounted for. In view of the calcium content of the two air pollution control residue, the presence of calcium sulphide (EUH031) can be assumed. These two waste are therefore classified potentially hazardous for HP 12, from a total of 49 waste. They are also classified as hazardous for other properties (HP 7

  18. Gas separation performance of carbon molecular sieve membranes based on 6FDA-mPDA/DABA (3:2) polyimide.

    Science.gov (United States)

    Qiu, Wulin; Zhang, Kuang; Li, Fuyue Stephanie; Zhang, Ke; Koros, William J

    2014-04-01

    6FDA-mPDA/DABA (3:2) polyimide was synthesized and characterized for uncross-linked, thermally crosslinked, and carbon molecular sieve (CMS) membranes. The membranes were characterized with thermogravimetric analysis, FTIR spectroscopy, wide-angle X-ray diffraction, and gas permeation tests. Variations in the d spacing, the formation of pore structures, and changes in the pore sizes of the CMS membranes were discussed in relation to pyrolysis protocols. The uncross-linked polymer membranes showed high CO2 /CH4 selectivity, whereas thermally crosslinked membranes exhibited significantly improved CO2 permeability and excellent CO2 plasticization resistance. The CMS membranes showed even higher CO2 permeability and CO2 /CH4 selectivity. An increase in the pyrolysis temperature resulted in CMS membranes with lower gas permeability but higher selectivity. The 550 °C pyrolyzed CMS membranes showed CO2 permeability as high as 14 750 Barrer with CO2 /CH4 selectivity of approximately 52. Even 800 °C pyrolyzed CMS membranes still showed high CO2 permeability of 2610 Barrer with high CO2 /CH4 selectivity of approximately 118. Both polymer membranes and the CMS membranes are very attractive in aggressive natural gas purification applications. © 2014 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  19. Proposed Rule and Related Materials for Control of Emissions of Air Pollution From Nonroad Diesel Engines Control of Air Pollution From Aircraft and Aircraft Engines; Proposed Emission Standards and Test Procedures

    Science.gov (United States)

    EPA is proposing to adopt emission standards and related provisions for aircraft gas turbine engines with rated thrusts greater than 26.7 kilonewtons. These engines are used primarily on commercial passenger and freight aircraft.

  20. High performance ZIF-8/6FDA-DAM mixed matrix membrane for propylene/propane separations

    KAUST Repository

    Zhang, Chen

    2012-02-01

    We report significantly enhanced propylene/propane (C 3H 6/C 3H 8) selectivity in mixed matrix membranes fabricated using 6FDA-DAM polyimide and a zeolitic imidazolate framework (ZIF-8). Equilibrium isotherms and sorption kinetics of C 3H 6 and C 3H 8 at 35°C were studied on a 200nm commercially available ZIF-8 sample produced by BASF. Mixed matrix dense films were formed with 6FDA-DAM and 200nm BASF ZIF-8 particles. SEM imaging showed generally good adhesion between the ZIF-8 and 6FDA-DAM without the need for surface-treating ZIF-8. Pure gas permeation showed significantly enhanced mixed matrix ZIF-8/6FDA-DAM membrane C 3H 6/C 3H 8 separation performance over the pure 6FDA-DAM membrane performance. A C 3H 6 permeability of 56.2Barrer and C 3H 6/C 3H 8 ideal selectivity of 31.0 was found in ZIF-8/6FDA-DAM mixed matrix membrane with 48.0wt% ZIF-8 loading, which are 258% and 150% higher than the pure 6FDA-DAM membrane, respectively for permeability and selectivity. Permeation properties of C 3H 6 and C 3H 8 in ZIF-8 were back-calculated by the Maxwell model for composite permeability using pure gas permeation data, leading to a C 3H 6 permeability of 277Barrer and C 3H 6/C 3H 8 selectivity of 122. Mixed gas permeation also verified that selectivity enhancements were achievable in mixed gas environment by ZIF-8. © 2011 Elsevier B.V.

  1. Comparison of the FDA and ASCO/CAP Criteria for HER2 Immunohistochemistry in Upper Urinary Tract Urothelial Carcinoma

    Directory of Open Access Journals (Sweden)

    Gilhyang Kim

    2016-11-01

    Full Text Available Background Human epidermal growth factor receptor 2 (HER2 is one of the known oncogenes in urothelial carcinoma. However, the association between HER2 and the prognosis of upper urinary tract urothelial carcinoma (UUTUC has not yet been fully clarified. The aim of this study was to evaluate HER2 expression using the United States Food and Drug Administration (FDA criteria and American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP criteria and compare their prognostic significance in UUTUC. Methods HER2 expression was evaluated in 144 cases of UUTUC by immunohistochemistry (IHC using tissue microarrays. We separately analyzed HER2 expression using the FDA and ASCO/CAP criteria. The IHC results were categorized into low (0, 1+ and high (2+, 3+ groups. Results Using the FDA criteria, 94 cases were negative, 38 cases were 1+, nine cases were 2+, and three cases were 3+. Using the ASCO/CAP criteria, 94 cases were negative, 34 cases were 1+, 13 cases were 2+, and three cases were 3+. Four cases showing 2+ according to the ASCO/CAP criteria were reclassified as 1+ by the FDA criteria. High HER2 expression by both the FDA criteria and ASCO/CAP criteria was significantly associated with International Society of Urological Pathology high grade (p = .001 and p < .001. The high HER2 expression group classified with the FDA criteria showed significantly shorter cancer-specific survival (p = .004, but the HER2 high and low expression groups classified with the ASCO/CAP criteria did not show significant differences (p = .161 in cancer-specific survival. Conclusions HER2 high expression groups were significantly associated with shorter cancer-specific survival, and our study revealed that the FDA criteria are more suitable for determining HER2 expression in UUTUC.

  2. High performance ZIF-8/6FDA-DAM mixed matrix membrane for propylene/propane separations

    KAUST Repository

    Zhang, Chen; Dai, Ying; Johnson, Justin R.; Karvan, Oguz; Koros, William J.

    2012-01-01

    We report significantly enhanced propylene/propane (C 3H 6/C 3H 8) selectivity in mixed matrix membranes fabricated using 6FDA-DAM polyimide and a zeolitic imidazolate framework (ZIF-8). Equilibrium isotherms and sorption kinetics of C 3H 6 and C 3H 8 at 35°C were studied on a 200nm commercially available ZIF-8 sample produced by BASF. Mixed matrix dense films were formed with 6FDA-DAM and 200nm BASF ZIF-8 particles. SEM imaging showed generally good adhesion between the ZIF-8 and 6FDA-DAM without the need for surface-treating ZIF-8. Pure gas permeation showed significantly enhanced mixed matrix ZIF-8/6FDA-DAM membrane C 3H 6/C 3H 8 separation performance over the pure 6FDA-DAM membrane performance. A C 3H 6 permeability of 56.2Barrer and C 3H 6/C 3H 8 ideal selectivity of 31.0 was found in ZIF-8/6FDA-DAM mixed matrix membrane with 48.0wt% ZIF-8 loading, which are 258% and 150% higher than the pure 6FDA-DAM membrane, respectively for permeability and selectivity. Permeation properties of C 3H 6 and C 3H 8 in ZIF-8 were back-calculated by the Maxwell model for composite permeability using pure gas permeation data, leading to a C 3H 6 permeability of 277Barrer and C 3H 6/C 3H 8 selectivity of 122. Mixed gas permeation also verified that selectivity enhancements were achievable in mixed gas environment by ZIF-8. © 2011 Elsevier B.V.

  3. Drugs Cleared Through The FDA's Expedited Review Offer Greater Gains Than Drugs Approved By Conventional Process.

    Science.gov (United States)

    Chambers, James D; Thorat, Teja; Wilkinson, Colby L; Neumann, Peter J

    2017-08-01

    We investigated whether drugs approved by the Food and Drug Administration (FDA) through expedited review have offered larger health gains, compared to drugs approved through conventional review processes. We identified published estimates of additional health gains (measured in quality-adjusted life-years, or QALYs) associated with drugs approved in the period 1999-2012 through expedited (seventy-six drugs) versus conventional (fifty-nine) review processes. We found that drugs in at least one expedited review program offered greater gains than drugs reviewed through conventional processes (0.182 versus 0.003 QALYs). We also found that, compared to drugs not included in the same program, greater gains were provided by drugs in the priority review (0.175 versus 0.007 QALYs), accelerated approval (0.370 versus 0.031 QALYs), and fast track (0.254 versus 0.014 QALYs) programs. Our analysis suggests that the FDA has prioritized drugs that offer the largest health gains. Project HOPE—The People-to-People Health Foundation, Inc.

  4. Smokers' reactions to FDA regulation of tobacco products: Findings from the 2009 ITC United States survey

    Directory of Open Access Journals (Sweden)

    Fix Brian V

    2011-12-01

    Full Text Available Abstract Background On June 22, 2009, the US FDA was granted the authority to regulate tobacco products through the Family Smoking Prevention and Tobacco Control Act (FSPTCA. The intent is to improve public health through regulations on tobacco product marketing and tobacco products themselves. This manuscript reports baseline data on smokers' attitudes and beliefs on specific issues relevant to the FSPTCA. Method Between November 2009 and January 2010, a telephone survey among a nationally representative sample of n = 678 smokers in the US was performed as part of the International Tobacco Control (ITC United States Survey. Participants answered a battery of questions on their attitudes and beliefs about aspects of the FSPTCA. Results Most smokers were unaware of the new FDA tobacco regulations. Smokers indicated support for banning cigarette promotion and nearly a quarter supported requiring tobacco companies to sell cigarettes in plain packaging. Seventy two percent of smokers supported reducing nicotine levels to make cigarettes less addictive if nicotine was made easily available in non-cigarette form. Conclusion Most smokers were limited in their understanding of efforts to regulate tobacco products in general. Smokers were supportive of efforts to better inform the public about health risks, restrict advertising, and make tobacco products less addictive.

  5. FDA, CE mark or something else?—Thinking fast and slow

    Directory of Open Access Journals (Sweden)

    Sundeep Mishra

    2017-01-01

    Full Text Available There is a robust debate going on among the Medical Device stake-holders whether FDA is better or CE mark or something else. Currently process of obtaining an FDA approval is bogged down by ever-increasing unpredictability, inconsistency, prolonged time, and huge expense but CE mark has its own problems. Historically, the Japanese review process has tended to be the slowest among the big three but recently with the introduction of accelerated review process there has been a significant progress. While the goal of an innovator/manufacturer is to develop, manufacture and market a medical device that addresses an unmet clinical need, the requisite regulatory approval process can be very confusing. Not only there is a whole lot of jargon tossed around by regulatory affair professionals: “substantial equivalence,” “PMDA,” “CE mark,” “Notified body,” “510K” and “PMA” but the actual approval process can also be very tardy, inconsistent and expensive.

  6. FDA, CE mark or something else?-Thinking fast and slow.

    Science.gov (United States)

    Mishra, Sundeep

    There is a robust debate going on among the Medical Device stake-holders whether FDA is better or CE mark or something else. Currently process of obtaining an FDA approval is bogged down by ever-increasing unpredictability, inconsistency, prolonged time, and huge expense but CE mark has its own problems. Historically, the Japanese review process has tended to be the slowest among the big three but recently with the introduction of accelerated review process there has been a significant progress. While the goal of an innovator/manufacturer is to develop, manufacture and market a medical device that addresses an unmet clinical need, the requisite regulatory approval process can be very confusing. Not only there is a whole lot of jargon tossed around by regulatory affair professionals: "substantial equivalence," "PMDA," "CE mark," "Notified body," "510K" and "PMA" but the actual approval process can also be very tardy, inconsistent and expensive. Copyright © 2016 Cardiological Society of India. Published by Elsevier B.V. All rights reserved.

  7. New insights from direct monitoring of turbidity currents; and a proposal for co-ordinating international efforts at a series of global "turbidity current test sites"

    Science.gov (United States)

    Talling, Peter

    2015-04-01

    Turbidity currents, and other types of submarine sediment density flow, arguably redistribute more sediment across the surface of the Earth than any other flow process. It is now over 60 years since the seminal publication of Kuenen and Migliorini (1950) in which they made the link between sequences of graded bedding and turbidity currents. The deposits of submarine sediment density flows have been described in numerous locations worldwide, and this might lead to the view that these flows are well understood. However, it is sobering to note quite how few direct measurements we have from these submarine flows in action. Sediment concentration is the critical parameter controlling such flows, yet it has never been measured directly for flows that reach and build submarine fans. How then do we know what type of flow to model in flume tanks, or which assumptions to use to formulate numerical simulations or analytical models? It is proposed here that international efforts are needed for an initiative to monitor active turbidity currents at a series of 'test sites' where flows occur frequently. The flows evolve significantly, such that source to sink data are needed. We also need to directly monitor flows in different settings with variable triggering factors and flow path morphologies because their character can vary significantly. Such work should integrate numerical and physical modelling with the collection of field observations in order to understand the significance of field observations. Such an international initiative also needs to include coring of deposits to link flow processes to deposit character, because in most global locations flow behaviour must be inferred from deposits alone. Collection of seismic datasets is also crucial for understanding the larger-scale evolution and resulting architecture of these systems, and to link with studies of subsurface reservoirs. Test site datasets should thus include a wide range of data types, not just from direct flow

  8. 78 FR 78796 - Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products...

    Science.gov (United States)

    2013-12-27

    ... FDA's review of the change. The proposed rule published without a reference or a link to the... comments received, go to http://www.regulations.gov and insert the docket number(s), found in brackets in... rulemaking. The proposed rule published without reference or a link to the accompanying Regulatory Impact...

  9. Changes in FDA enforcement activities following changes in federal administration: the case of regulatory letters released to pharmaceutical companies

    Directory of Open Access Journals (Sweden)

    Nguyen Diane

    2013-01-01

    Full Text Available Abstract Background The United States (US Food and Drug Administration (FDA is responsible for the protection of the public health by assuring the safety, effectiveness and security of human drugs and biological products through the enforcement of the Federal Food, Drug and Cosmetic Act (FDCA and related regulations. These enforcement activities include regulatory letters (i.e. warning letters and notice of violation to pharmaceutical companies. A regulatory letter represents the FDA’s first official notification to a pharmaceutical company that the FDA has discovered a product or activity in violation of the FDCA. This study analyzed trends in the pharmaceutical-related regulatory letters released by the FDA during the period 1997–2011 and assessed differences in the average number and type of regulatory letters released during the last four federal administrations. Methods Data derived from the FDA webpage. Information about the FDA office releasing the letter, date, company, and drug-related violation was collected. Regulatory letters were classified by federal administration. Descriptive statistics were performed for the analysis. Results Between 1997 and 2011 the FDA released 2,467 regulatory letters related to pharmaceuticals. FDA headquarters offices released 50.6% and district offices 49.4% of the regulatory letters. The Office of Prescription Drug Promotion released the largest number of regulatory letters (850; 34.5% of the total, followed by the Office of Scientific Investigations (131; 5.3%, and the Office of Compliance (105; 4.3%. During the 2nd Clinton Administration (1997–2000 the average number of regulatory letters per year was 242.8 ± 45.6, during the Bush Administration (2001–2008 it was 120.4 ± 33.7, and during the first three years of the Obama administration (2009–2011 it was 177.7.0 ± 17.0. The average number of regulatory letters released by the Office of Prescription Drug Promotion also varied by

  10. Usefulness of [18F]-DA and [18F]-DOPA for PET imaging in a mouse model of pheochromocytoma

    International Nuclear Information System (INIS)

    Martiniova, Lucia; Cleary, Susannah; Lai, Edwin W.; Kiesewetter, Dale O.; Seidel, Jurgen; Dawson, Linda F.; Phillips, Jacqueline K.; Thomasson, David; Chen Xiaoyuan; Eisenhofer, Graeme; Powers, James F.; Kvetnansky, Richard

    2012-01-01

    Purpose: To evaluate the usefulness of [ 18 F]-6-fluorodopamine ([ 18 F]-DA) and [ 18 F]-L-6-fluoro-3,4-dihydroxyphenylalanine ([ 18 F]-DOPA) positron emission tomography (PET) in the detection of subcutaneous (s.c.) and metastatic pheochromocytoma in mice; to assess the expression of the norepinephrine transporter (NET) and vesicular monoamine transporters 1 and 2 (VMAT1 and VMAT2), all important for [ 18 F]-DA and [ 18 F]-DOPA uptake. Furthermore, to compare tumor detection by micro-computed tomography (microCT) to magnetic resonance imaging (MRI) in individual mouse. Methods: SUV max values were calculated from [ 18 F]-DA and [ 18 F]-DOPA PET, tumor-to-liver ratios (TLR) were obtained and expression of NET, VMAT1 and VMAT2 was evaluated. Results: [ 18 F]-DA detected less metastatic lesions compared to [ 18 F]-DOPA. TLR values for liver metastases were 2.26–2.71 for [ 18 F]-DOPA and 1.83–2.83 for [ 18 F]-DA. A limited uptake of [ 18 F]-DA was found in s.c. tumors (TLR=0.22-0.27) compared to [ 18 F]-DOPA (TLR=1.56-2.24). Overall, NET and VMAT2 were expressed in all organ and s.c. tumors. However, s.c. tumors lacked expression of VMAT1. We confirmed [ 18 F]-DA's high affinity for the NET for its uptake and VMAT1 and VMAT2 for its storage and retention in pheochromocytoma cell vesicles. In contrast, [ 18 F]-DOPA was found to utilize only VMAT2. Conclusion: MRI was superior in the detection of all organ tumors compared to microCT and PET. [ 18 F]-DOPA had overall better sensitivity than [ 18 F]-DA for the detection of metastases. Subcutaneous tumors were localized only with [ 18 F]-DOPA, a finding that may reflect differences in expression of VMAT1 and VMAT2, perhaps similar to some patients with pheochromocytoma where [ 18 F]-DOPA provides better visualization of lesions than [ 18 F]-DA.

  11. Test

    DEFF Research Database (Denmark)

    Bendixen, Carsten

    2014-01-01

    Bidrag med en kortfattet, introducerende, perspektiverende og begrebsafklarende fremstilling af begrebet test i det pædagogiske univers.......Bidrag med en kortfattet, introducerende, perspektiverende og begrebsafklarende fremstilling af begrebet test i det pædagogiske univers....

  12. America, you are digging your grave with your spoon--should the FDA tell you that on food labels?

    Science.gov (United States)

    Card, Melissa M

    2013-01-01

    R.J. Reynolds Tobacco Co. v. Food & Drug Admin. discussed whether the FDA's promulgation of graphic images violated tobacco companies' First Amendment rights. While the tobacco companies contested the graphic images, the tobacco companies did not contest the promulgation of nine textual statements about the adverse effects of cigarettes. This uncontested mandate opens a door for the FDA to further expand its regulatory scheme. If the FDA can mandate textual statements about the adverse effects of cigarettes, can the FDA mandate textual statements about the adverse effects of sugar to combat the obesity crisis? This Article presents three textual statements about the adverse effects of sugar, to define the line between acceptable and unacceptable forms of compelled commercial speech under Central Hudson. Establishing this line ensures that the commercial speech doctrine does not deny the FDA from its authority to provide consumers with accurate information. While three textual statements are presented, this Article advocates that one of the textual statements is likely to serve as the best solution to the obesity crisis. The chosen textual statement serves as an effective solution because it presents meaningful information to the consumers enabling consumers to make healthful decisions about their food and encourages manufacturers to modify their products.

  13. Proposal to negotiate a collaboration agreement for the design, testing and prototyping of superconducting elements for the High Luminosity LHC (HL-LHC) project and for the production of spare quadrupole magnets for LHC

    CERN Document Server

    2016-01-01

    Proposal to negotiate a collaboration agreement for the design, testing and prototyping of superconducting elements for the High Luminosity LHC (HL-LHC) project and for the production of spare quadrupole magnets for LHC

  14. Proposal of a neutron transmutation doping facility for n-type spherical silicon solar cell at high-temperature engineering test reactor.

    Science.gov (United States)

    Ho, Hai Quan; Honda, Yuki; Motoyama, Mizuki; Hamamoto, Shimpei; Ishii, Toshiaki; Ishitsuka, Etsuo

    2018-05-01

    The p-type spherical silicon solar cell is a candidate for future solar energy with low fabrication cost, however, its conversion efficiency is only about 10%. The conversion efficiency of a silicon solar cell can be increased by using n-type silicon semiconductor as a substrate. This study proposed a new method of neutron transmutation doping silicon (NTD-Si) for producing the n-type spherical solar cell, in which the Si-particles are irradiated directly instead of the cylinder Si-ingot as in the conventional NTD-Si. By using a 'screw', an identical resistivity could be achieved for the Si-particles without a complicated procedure as in the NTD with Si-ingot. Also, the reactivity and neutron flux swing could be kept to a minimum because of the continuous irradiation of the Si-particles. A high temperature engineering test reactor (HTTR), which is located in Japan, was used as a reference reactor in this study. Neutronic calculations showed that the HTTR has a capability to produce about 40t/EFPY of 10Ωcm resistivity Si-particles for fabrication of the n-type spherical solar cell. Copyright © 2018 Elsevier Ltd. All rights reserved.

  15. New FDA-Approved Disease-Modifying Therapies for Multiple Sclerosis.

    Science.gov (United States)

    English, Clayton; Aloi, Joseph J

    2015-04-01

    Interferon injectables and glatiramer acetate have served as the primary disease-modifying treatments for multiple sclerosis (MS) since their introduction in the 1990s and are first-line treatments for relapsing-remitting forms of MS (RRMS). Many new drug therapies were launched since early 2010, expanding the drug treatment options considerably in a disease state that once had a limited treatment portfolio. The purpose of this review is to critically evaluate the safety profile and efficacy data of disease-modifying agents for MS approved by the US Food and Drug Administration (FDA) from 2010 to the present and provide cost and available pharmacoeconomic data about each new treatment. Peer-reviewed clinical trials, pharmacoeconomic studies, and relevant pharmacokinetic/pharmacologic studies were identified from MEDLINE (January 2000-December 2014) by using the search terms multiple sclerosis, fingolimod, teriflunomide, alemtuzumab, dimethyl fumarate, pegylated interferon, peginterferon beta-1a, glatiramer 3 times weekly, and pharmacoeconomics. Citations from available articles were also reviewed for additional references. The databases publically available at www.clinicaltrials.gov and www.fda.gov were searched for unpublished studies or studies currently in progress. A total of 5 new agents and 1 new dosage formulation were approved by the FDA for the treatment of RRMS since 2010. Peginterferon beta-1a and high-dose glatiramer acetate represent 2 new effective injectable options for MS that reduce burden of administration seen with traditional interferon and low-dose glatiramer acetate. Fingolimod, teriflunomide, and dimethyl fumarate represent new oral agents available for MS, and their efficacy in reducing annualized relapse rates is 48% to 55%, 22% to 36.3%, and 44% to 53%, respectively, compared with placebo. Alemtuzumab is a biologic given over a 2-year span that reduced annualized relapse rates by 55% in treatment-naive patients and by 49% in patients

  16. Mining FDA drug labels using an unsupervised learning technique--topic modeling.

    Science.gov (United States)

    Bisgin, Halil; Liu, Zhichao; Fang, Hong; Xu, Xiaowei; Tong, Weida

    2011-10-18

    The Food and Drug Administration (FDA) approved drug labels contain a broad array of information, ranging from adverse drug reactions (ADRs) to drug efficacy, risk-benefit consideration, and more. However, the labeling language used to describe these information is free text often containing ambiguous semantic descriptions, which poses a great challenge in retrieving useful information from the labeling text in a consistent and accurate fashion for comparative analysis across drugs. Consequently, this task has largely relied on the manual reading of the full text by experts, which is time consuming and labor intensive. In this study, a novel text mining method with unsupervised learning in nature, called topic modeling, was applied to the drug labeling with a goal of discovering "topics" that group drugs with similar safety concerns and/or therapeutic uses together. A total of 794 FDA-approved drug labels were used in this study. First, the three labeling sections (i.e., Boxed Warning, Warnings and Precautions, Adverse Reactions) of each drug label were processed by the Medical Dictionary for Regulatory Activities (MedDRA) to convert the free text of each label to the standard ADR terms. Next, the topic modeling approach with latent Dirichlet allocation (LDA) was applied to generate 100 topics, each associated with a set of drugs grouped together based on the probability analysis. Lastly, the efficacy of the topic modeling was evaluated based on known information about the therapeutic uses and safety data of drugs. The results demonstrate that drugs grouped by topics are associated with the same safety concerns and/or therapeutic uses with statistical significance (P<0.05). The identified topics have distinct context that can be directly linked to specific adverse events (e.g., liver injury or kidney injury) or therapeutic application (e.g., antiinfectives for systemic use). We were also able to identify potential adverse events that might arise from specific

  17. Mining FDA drug labels using an unsupervised learning technique - topic modeling

    Science.gov (United States)

    2011-01-01

    Background The Food and Drug Administration (FDA) approved drug labels contain a broad array of information, ranging from adverse drug reactions (ADRs) to drug efficacy, risk-benefit consideration, and more. However, the labeling language used to describe these information is free text often containing ambiguous semantic descriptions, which poses a great challenge in retrieving useful information from the labeling text in a consistent and accurate fashion for comparative analysis across drugs. Consequently, this task has largely relied on the manual reading of the full text by experts, which is time consuming and labor intensive. Method In this study, a novel text mining method with unsupervised learning in nature, called topic modeling, was applied to the drug labeling with a goal of discovering “topics” that group drugs with similar safety concerns and/or therapeutic uses together. A total of 794 FDA-approved drug labels were used in this study. First, the three labeling sections (i.e., Boxed Warning, Warnings and Precautions, Adverse Reactions) of each drug label were processed by the Medical Dictionary for Regulatory Activities (MedDRA) to convert the free text of each label to the standard ADR terms. Next, the topic modeling approach with latent Dirichlet allocation (LDA) was applied to generate 100 topics, each associated with a set of drugs grouped together based on the probability analysis. Lastly, the efficacy of the topic modeling was evaluated based on known information about the therapeutic uses and safety data of drugs. Results The results demonstrate that drugs grouped by topics are associated with the same safety concerns and/or therapeutic uses with statistical significance (P<0.05). The identified topics have distinct context that can be directly linked to specific adverse events (e.g., liver injury or kidney injury) or therapeutic application (e.g., antiinfectives for systemic use). We were also able to identify potential adverse events that

  18. Could FDA approval of pre-exposure prophylaxis make a difference? A qualitative study of PrEP acceptability and FDA perceptions among men who have sex with men

    OpenAIRE

    Underhill, Kristen; Morrow, Kathleen M.; Operario, Don; Mayer, Kenneth H.

    2014-01-01

    The FDA has approved tenofovir-emtricitabine for use as HIV pre-exposure prophylaxis, but it is unknown how approval may affect PrEP acceptability among US men who have sex with men. We conducted 8 focus groups among 38 Rhode Island MSM, including 3 groups among 16 male sex workers and 5 groups among 22 men in the general MSM community. Participants reported wide-ranging beliefs regarding consequences and meanings of FDA approval. Some participants would not use PrEP without approval, while o...

  19. Year 2000 (Y2K) computer compliance guide; guidance for FDA personnel. Food and Drug Administration. Notice.

    Science.gov (United States)

    1999-05-14

    The Food and Drug Administration (FDA) is announcing the availability of a new compliance policy guide (CPG) entitled "Year 2000 (Y2K) Computer Compliance" (section 160-800). This guidance document represents the agency's current thinking on the manufacturing and distribution of domestic and imported products regulated by FDA using computer systems that may not perform properly before, or during, the transition to the year 2000 (Y2K). The text of the CPG is included in this notice. This compliance guidance document is an update to the Compliance Policy Guides Manual (August 1996 edition). It is a new CPG, and it will be included in the next printing of the Compliance Policy Guides Manual. This CPG is intended for FDA personnel, and it is available electronically to the public.

  20. Supplemental Environmental Baseline Survey for Proposed Land Use Permit Modification for Expansion of the Dynamic Explosive Test Site (DETS) 9940 Main Complex Parking Lot

    Energy Technology Data Exchange (ETDEWEB)

    Peek, Dennis W. [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States)

    2016-10-01

    The “subject property” is comprised of a parcel of land within the Kirtland Military Reservation, Bernalillo County, New Mexico, as shown on the map in Appendix B of this document. The land requirement for the parking lot addition to the 9940 Main Complex is approximately 2.7 acres. The scope of this Supplemental Environmental Baseline Survey (SEBS) is for the parking lot addition land transfer only. For details on the original 9940 Main Complex see Environmental Baseline Survey, Land Use Permit Request for the 9940 Complex PERM/0-KI-00-0001, August 21, 2003, and for details on the 9940 Complex Expansion see Environmental Baseline Survey, Proposed Land Use Permit Expansion for 9940 DETS Complex, June 24, 2009. The 2.7-acre parcel of land for the new parking lot, which is the subject of this EBS (also referred to as the “subject property”), is adjacent to the southwest boundary of the original 12.3- acre 9940 Main Complex. No testing is known to have taken place on the subject property site. The only activity known to have taken place was the burial of overhead utility lines in 2014. Adjacent to the subject property, the 9940 Main Complex was originally a 12.3-acre site used by the Department of Energy (DOE) under a land use permit from the United States Air Force (USAF). Historical use of the site, dating from 1964, included arming, fusing, and firing of explosives and testing of explosives systems components. In the late 1970s and early 1980s experiments at the 9940 Main Complex shifted toward reactor safety issues. From 1983 to 1988, fuel coolant interaction (FCI) experiments were conducted, as were experiments with conventional high explosives (HE). Today, the land is used for training of the Nuclear Emergency Response community and for research on energetic materials. In 2009, the original complex was expanded to include four additional 20-acre areas: 9940 Training South, 9940 Training East, T-Range 6, and Training West Landing Zone. The proposed use of

  1. An analysis of FDA-approved drugs: natural products and their derivatives.

    Science.gov (United States)

    Patridge, Eric; Gareiss, Peter; Kinch, Michael S; Hoyer, Denton

    2016-02-01

    Natural products contribute greatly to the history and landscape of new molecular entities (NMEs). An assessment of all FDA-approved NMEs reveals that natural products and their derivatives represent over one-third of all NMEs. Nearly one-half of these are derived from mammals, one-quarter from microbes and one-quarter from plants. Since the 1930s, the total fraction of natural products has diminished, whereas semisynthetic and synthetic natural product derivatives have increased. Over time, this fraction has also become enriched with microbial natural products, which represent a significant portion of approved antibiotics, including more than two-thirds of all antibacterial NMEs. In recent years, the declining focus on natural products has impacted the pipeline of NMEs from specific classes, and this trend is likely to continue without specific investment in the pursuit of natural products. Copyright © 2015 Elsevier Ltd. All rights reserved.

  2. Chiron Vision files FDA application to market intraocular implant for CMV retinitis. Food and Drug Administration.

    Science.gov (United States)

    1995-07-01

    Chiron Corporation and Hoffman-LaRoche announced a filing of a New Drug Application with the Food and Drug Administration (FDA) to market Vitrasert, its intraocular implant which delivers ganciclovir directly to the eye for treatment of CMV retinitis. Clinical trials show that Vitrasert offers a clinical improvement versus intravenous ganciclovir in further delaying progression of CMV retinitis in the treated eye. One study reported that the median time to progression of CMV retinitis was 186 days for eyes receiving Vitrasert compared to 72 days for eyes receiving intravenous ganciclovir therapy. Chiron's intraocular implant contains ganciclovir embedded in a polymer-based system that slowly releases the drug into the eye for up to eight months. Two additional trials are underway. For further information contact the Professional Services Group at Chiron Corporation at (800) 244-7668, select 2.

  3. An analysis of the FDA Food Safety Modernization Act: protection for consumers and boon for business.

    Science.gov (United States)

    Strauss, Debra M

    2011-01-01

    This article analyzes components of the FDA Food Safety Modernization Act, which was prompted by incidents of food contamination, exploring the history of its passage and explaining its significance, as well as its limitations. As the first time in 70 years that food law has been changed substantially, this new law represents only an initial but significant step in the direction of improving food safety. With bipartisan support from both Congress and the President, this legislation embodies a mandate that food safety is at this moment becoming a priority. As a result, the time is ripe for a reassessment of other areas of food laws--particularly genetically modified foods and the use of milk and meat from cloned animals and their progeny--which are allowed under current U.S. law with no labeling, preapprovals, or post-market monitoring. These areas warrant special regulation consistent with the new proactive policy towards securing the safety of the food supply.

  4. Impact of the FDA warning of potential ceftriaxone and calcium interactions on drug use policy in clinical practice.

    Science.gov (United States)

    Esterly, John S; Steadman, Emily; Scheetz, Marc H

    2011-06-01

    In September 2007, the FDA issued an alert recommending that ceftriaxone and calcium-containing solutions should not be administered to any patient within 48 h of each other. Due to the widespread use of ceftriaxone, significant concern was expressed by the greater healthcare community about the warning, which the FDA eventually retracted in April of 2009. We sought to quantify the impact of the warning on healthcare institutions. A survey was administered to the membership of the Society of Infectious Diseases Pharmacists to quantify perceived changes in ceftriaxone use among healthcare institutions across the United States. A survey of Infectious Diseases experts was conducted. Participants were queried for hospital policies/drug use statistics during two times: immediately after the FDA warning and approximately 13 months post warning (preceding the FDA retraction). Related changes in formulary, drug-use policy, and the number of employee hours that were devoted to addressing the FDA warning were assessed. Ninety-four surveys representing 94 hospital systems were included in the analysis. Approximately half (n = 49, 52%) of respondent institutions enacted at least one drug-use policy change based on the warning; one institution removed ceftriaxone from a clinical protocol. Institutions' final interpretations of the warning differed slightly from initial understanding of the warning, and there was an overall minor decrease in the perceived use of ceftriaxone. The majority of those surveyed (n = 70, 74%) estimated that their respective institutions devoted between 1 and 49 employee hours to address the warning. Hospitals with ID pharmacists had minimal changes to ceftriaxone use after the 2007 FDA warning. Specialized pharmacists may be uniquely situated to help hospitals interpret global recommendations locally.

  5. Maternal characteristics associated with pregnancy exposure to FDA category C, D, and X drugs in a Canadian population.

    Science.gov (United States)

    Yang, Tubao; Walker, Mark C; Krewski, Daniel; Yang, Qiuying; Nimrod, Carl; Garner, Peter; Fraser, William; Olatunbosun, Olufemi; Wen, Shi Wu

    2008-03-01

    To estimate the frequency of exposure to prescription Food and Drug Administration (FDA) category C, D, and X drugs in pregnant women, and to analyze the maternal characteristics associated with such an exposure. A 50% random sample of women who gave a birth in Saskatchewan between January 1, 1997 and December 31, 2000 was chosen for the study. The rate of exposure to FDA category C, D, or X drugs recorded in the pharmacist database was estimated. Associations of exposure to FDA category C, D, and X drugs with maternal characteristics were evaluated using multiple logistical regression, with adjusted odds ratios (ORs) and its 95% confidence intervals (CIs) as the association measures. A total of 18 575 women were included in this study. Among them, 3604 (19.4%) had exposure to one or more FDA category C, D, and X drugs during pregnancy. Category C drugs were the most frequently used drugs (15.8%), followed by D drugs (5.2%), and X drugs (3.9%). Women with chronic health conditions had fourfold at increased risk of exposure than women without. Regardless of health status, women who were or =3, and who were on social assistance plan were at increased risk of pregnancy exposure to these drugs. About 19.4% pregnant women are exposed to FDA C, D or X drugs during pregnancy. Women with chronic diseases, younger age, increased parity, and under social assistance are at increased risk of exposure to FDA C, D, or X drugs. Copyright 2008 John Wiley & Sons, Ltd.

  6. QUADrATiC: scalable gene expression connectivity mapping for repurposing FDA-approved therapeutics.

    Science.gov (United States)

    O'Reilly, Paul G; Wen, Qing; Bankhead, Peter; Dunne, Philip D; McArt, Darragh G; McPherson, Suzanne; Hamilton, Peter W; Mills, Ken I; Zhang, Shu-Dong

    2016-05-04

    Gene expression connectivity mapping has proven to be a powerful and flexible tool for research. Its application has been shown in a broad range of research topics, most commonly as a means of identifying potential small molecule compounds, which may be further investigated as candidates for repurposing to treat diseases. The public release of voluminous data from the Library of Integrated Cellular Signatures (LINCS) programme further enhanced the utilities and potentials of gene expression connectivity mapping in biomedicine. We describe QUADrATiC ( http://go.qub.ac.uk/QUADrATiC ), a user-friendly tool for the exploration of gene expression connectivity on the subset of the LINCS data set corresponding to FDA-approved small molecule compounds. It enables the identification of compounds for repurposing therapeutic potentials. The software is designed to cope with the increased volume of data over existing tools, by taking advantage of multicore computing architectures to provide a scalable solution, which may be installed and operated on a range of computers, from laptops to servers. This scalability is provided by the use of the modern concurrent programming paradigm provided by the Akka framework. The QUADrATiC Graphical User Interface (GUI) has been developed using advanced Javascript frameworks, providing novel visualization capabilities for further analysis of connections. There is also a web services interface, allowing integration with other programs or scripts. QUADrATiC has been shown to provide an improvement over existing connectivity map software, in terms of scope (based on the LINCS data set), applicability (using FDA-approved compounds), usability and speed. It offers potential to biological researchers to analyze transcriptional data and generate potential therapeutics for focussed study in the lab. QUADrATiC represents a step change in the process of investigating gene expression connectivity and provides more biologically-relevant results than

  7. The FDA guidance for industry on PROs: the point of view of a pharmaceutical company.

    Science.gov (United States)

    Arpinelli, Fabio; Bamfi, Francesco

    2006-10-31

    The importance of the patients point of view on their health status is widely recognised. Patient-reported outcomes is a broad term encompassing a large variety of different health data reported by patients, as symptoms, functional status, Quality of Life and Health-Related Quality of Life. Measurements of Health-Related Quality of Life have been developed during many years of researches, and a lot of validated questionnaires exist. However, few attempts have been made to standardise the evaluation of instruments characteristics, no recommendations are made about interpretation on Health-Related Quality of Life results, especially regarding the clinical significance of a change leading a therapeutic approach. Moreover, the true value of Health-Related Quality of Life evaluations in clinical trials has not yet been completely defined. An important step towards a more structured and frequent use of Patient-Reported Outcomes in drug development is represented by the FDA Guidance, issued on February 2006. In our paper we aim to report some considerations on this Guidance. Our comments focus especially on the characteristics of instruments to use, the Minimal Important Difference, and the methods to calculate it. Furthermore, we present the advantages and opportunities of using the Patient-Reported Outcomes in drug development, as seen by a pharmaceutical company. The Patient-Reported Outcomes can provide additional data to make a drug more competitive than others of the same pharmacological class, and a well demonstrated positive impact on the patient' health status and daily life might allow a higher price and/or the inclusion in a reimbursement list. Applying extensively the FDA Guidance in the next trials could lead to a wider culture of subjective measurement, and to a greater consideration for the patient's opinions on his/her care. Moreover, prescribing doctors and payers could benefit from subjective information to better define the value of drugs.

  8. Comparison of FDA safety and efficacy data for KAMRA and Raindrop corneal inlays

    Directory of Open Access Journals (Sweden)

    Majid Moshirfar

    2017-09-01

    Full Text Available AIM: To provide a side-by-side analysis of the summary of safety and effectiveness data (SSED submitted to the FDA for the KAMRA and Raindrop corneal inlays for the correction of presbyopia. METHODS: SSED reports submitted to the FDA for KAMRA and Raindrop were compared with respect to loss of corrected distance visual acuity (CDVA, adverse event rates, induction of astigmatism, retention of contrast sensitivity, stability of manifest refractive spherical equivalent (MRSE, and achieved monocular uncorrected near visual acuity (UNVA at 24mo. RESULTS: Totally 442/508 of KAMRA patients and 344/373 Raindrop patients remained enrolled in the clinical trials at 24mo. The proportion of KAMRA and Raindrop patients who lost ≥2 lines of CDVA at 24mo was 3.4% and 1%, respectively. The adverse event rate was comparable between the devices. No significant inductions of astigmatism were noted. Both technologies induced a transient myopic shift in MRSE followed by a hyperopic shift and subsequent stabilization. Totally 87% of KAMRA and 98% of Raindrop patients attained a monocular UNVA of J5 (20/40 or better at 24mo, 28% of KAMRA and 67% of Raindrop patients attained a monocular UNVA of J1 (20/20 or better at 24mo. CONCLUSION: Both devices can be considered safe and effective, however, the results of corneal inlay implantation are mixed, and long-term patient satisfaction will likely depend on subjective expectations about the capabilities of the inlays. Variability in surgical technique and postoperative care within and between the two clinical trials diminishes the comparative power of this article.

  9. 中文檢索評估系統可行性研究 | Proposing a Prototype for Chinese Corpus Test Collection

    Directory of Open Access Journals (Sweden)

    吳美美 Mei-Mei Wu

    1999-04-01

    desperately needed for the IR research and development community.

    The purpose of this study is to propose a prototype of CTREC. Main tasks and tracks, test collections, topics, measurement procedures and evaluation criteria are proposed. Some solutions for implementing CTREC are also suggested.

  10. COMPASS-II Proposal

    CERN Document Server

    Gautheron, F; Koivuniemi, J; Meyer, W; Reicherz, G; Bisplinghoff, J; Eversheim, D; Hinterberger, F; Jahn, R; Joosten, R; Negrini, T; Barth, J; Klein, F; Goertz, S; Panknin, R; Pretz, J; Windmolders, R; Srnka, A; Dasgupta, S; Dhara, L; Sarkara, S; Sinha, L; Alexakhin, V Yu; Alexeev, G D; Anosov, V A; Antonov, A; Efremov, A; Gavrichtchouk, O P; Guskov, A; Ivanshin, Yu; Ivanov, O; Kisselev, Yu; Kouznetsov, O; Kroumchtein, Z; Meshcheryakov, G V; Nagaytsev, A; Olshevski, A; Peshekhonov, D V; Pontecorvo, G; Rossiyskaya, N; Sapozhnikov, M G; Savin, I A; Shevchenko, O Yu; Sissakian, A N; Smirnov, G I; Teryaev, O V; Tkatchev, L G; Vlassov, N V; Zemlyanichkina, E; Adolph, Ch; Braun, Ch; Eyrich, W; Lehmann, A; Richter, A; Fischer, H; Heinsius, F-H; Herrmann, F; Guthörl, T; Lauser, L; Königsmann, K; Nerling, F; Schill, Ch; Wollny, H; Schmidt, K; Schopferer, S; Mallot, G K; Nowak, W-D; Schönning, K; Schott, M; Sulc, M; Bordalo, P; Franco, C; Nunes, A S; Quintans, C; Ramos, S; Silva, L; Stolarski, M; Bernhard, J; Chaberny, D; du Fresne von Hohenesche, N; von Harrach, D; Jasinski, P; Kabuß, E M; Kang, D-H; Ostrick, M; Pochodzalla, J; Alexandrov, Yu; Zavertyaev, M; Böhmer, F; Dørheim, S; Friedrich, J M; Gerassimov, S; Grabmüller, S; Grube, B; Haas, F; Höppner, Ch; Ketzer, B; Konorov, I; Krämer, M; Mann, A; Nagel, T; Neubert, S; Paul, S; Schmitt, L; Uhl, S; Bettinelli, M; Dünnweber, W; Faessler, M A; Geyer, R; Rajotte, J-F; Schlüter, T; Uman, I; Zvyagin, A; Finger, M; Finger jr, M; Slunecka, M; Jary, V; Virius, M; Donskov, S V; Filin, A; Khaustov, G V; Khokhlov, Yu; Kolosov, V; Konstantinov, V; Lednev, A A; Mikhailov, Yu V; Nikolaenko, V I; Polyakov, V A; Ryabchikov, D; Samoylenko, V D; Bedfer, Y; Burtin, E; Ferrero, A; d’Hose, N; Kunne, F; Magnon, A; Makke, N; Marchand, C; Morreale, A; Neyret, D; Platchkov, S; Vandenbroucke, M; Lichtenstadt, J; Moinester, M A; Birsa, R; Bradamante, F; Bressan, A; Dalla Torre, S; Duic, V; Elia, C; Giorgi, M; Gobbo, B; Levorato, S; Martin, A; Pesaro, G; Rocco, E; Sbrizzai, G; Schiavon, P; Sozzi, F; Tessaro, S; Tessarotto, F; Alexeev, M G; Amoroso, A; Balestra, F; Bertini, R; Chiosso, M; Denisov, O; Garfagnini, R; Gnesi, I; Grasso, A; Kotzinian, A; Maggiora, A; Melis, S; Panzieri, D; Parsamyan, B; Piragino, G; Sosio, S; Takekawa, S; Badelek, B; Brona, G; Gazda, R; Klimaszewski, K; Kurek, K; Rondio, E; Sandacz, A; Sznajder, P; Wislicki, W; Marzec, J; Dziewiecki, M; Sulej, R; Zaremba, K; Ziembicki, M; Doshita, N; Iwata, T; Ishimoto, S; Horikawa, N; Kondo, K; Matsuda, T; Miyachi, Y

    2010-01-01

    The proposed new measurements comprise a Generalised Parton Distributions programme, an unpolarised PDF and FF programme, a transverse momentum dependent PDF programme and a programme for tests of chiral perturbation theory.

  11. Stress-Testing the EU Proposal on Matrimonial Property Regimes : Co-operation between EU private international law instruments on family matters and succession

    NARCIS (Netherlands)

    Gray, Jaki; Quinza Redondo, Pablo

    2013-01-01

    This article seeks to critically analyse the European Commission's Proposal for a Council Regulation on jurisdiction, applicable law and recognition and enforcement of decisions in matters of matrimonial property regimes (COM (2011) 126). It focuses upon the coordination of the Proposal's provisions

  12. Could FDA approval of pre-exposure prophylaxis make a difference? A qualitative study of PrEP acceptability and FDA perceptions among men who have sex with men.

    Science.gov (United States)

    Underhill, Kristen; Morrow, Kathleen M; Operario, Don; Mayer, Kenneth H

    2014-02-01

    The FDA has approved tenofovir-emtricitabine for use as HIV pre-exposure prophylaxis, but it is unknown how approval may affect PrEP acceptability among US men who have sex with men. We conducted 8 focus groups among 38 Rhode Island MSM, including 3 groups among 16 male sex workers and 5 groups among 22 men in the general MSM community. Participants reported wide-ranging beliefs regarding consequences and meanings of FDA approval. Some participants would not use PrEP without approval, while others perceived approval as irrelevant or less significant than other sources of information. Our results suggest that FDA approval sends a signal that directly shapes PrEP acceptability among some MSM, while indirect influences of approval may affect uptake by others. Efforts to educate MSM about PrEP can increase acceptability by incorporating information about FDA approval, and outreach strategies should consider how this information may factor into personal decisions about PrEP use.

  13. Gas Separation Performance of Carbon Molecular Sieve Membranes Based on 6FDA-mPDA/DABA (3:2) Polyimide

    KAUST Repository

    Qiu, Wulin

    2014-02-23

    6FDA-mPDA/DABA (3:2) polyimide was synthesized and characterized for uncross-linked, thermally crosslinked, and carbon molecular sieve (CMS) membranes. The membranes were characterized with thermogravimetric analysis, FTIR spectroscopy, wide-angle X-ray diffraction, and gas permeation tests. Variations in the d spacing, the formation of pore structures, and changes in the pore sizes of the CMS membranes were discussed in relation to pyrolysis protocols. The uncross-linked polymer membranes showed high CO 2/CH4 selectivity, whereas thermally crosslinked membranes exhibited significantly improved CO2 permeability and excellent CO2 plasticization resistance. The CMS membranes showed even higher CO2 permeability and CO2/CH4 selectivity. An increase in the pyrolysis temperature resulted in CMS membranes with lower gas permeability but higher selectivity. The 550 °C pyrolyzed CMS membranes showed CO2 permeability as high as 14 750 Barrer with CO 2/CH4 selectivity of approximately 52. Even 800 °C pyrolyzed CMS membranes still showed high CO2 permeability of 2610 Barrer with high CO2/CH4 selectivity of approximately 118. Both polymer membranes and the CMS membranes are very attractive in aggressive natural gas purification applications. Permeating through: Polyimide-based uncross-linked, thermally crosslinked, and carbon molecular sieve (CMS) membranes are prepared. Variations in the d spacing, the formation of pore structures, and changes in the pore sizes of the CMS membranes are discussed in relation to pyrolysis protocols. Both the polymer and CMS membranes are very attractive in aggressive natural gas purification applications. © 2014 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  14. Effectiveness of FDA's new over-the-counter acetaminophen warning label in improving consumer risk perception of liver damage.

    Science.gov (United States)

    Goyal, R K; Rajan, S S; Essien, E J; Sansgiry, S S

    2012-12-01

    The Food and Drug Administration (FDA) issued new organ-specific warning label requirements for over-the-counter (OTC) analgesic products in order to make consumers aware of the risk of liver damage when using acetaminophen. However, awareness of a health risk alone cannot ensure consumers' engagement in safe and preventive behaviour. In this study, we attempted to: (i) measure consumer risk perception of liver damage due to the OTC acetaminophen products and (ii) analyse the effectiveness of the new organ-specific warning label in improving consumer risk perception of liver damage and intention to perform protective behaviours while using OTC acetaminophen products. This within-subject experimental study used a convenience sample of English-speaking adults visiting OTC segments of selected pharmacy stores in Houston. Participants were randomly exposed to the old and new warning labels and their respective risk perception (measured on a visual analogue scale, 0%, no risk, to 100%, extreme risk) and behavioural intention (measured on a 7-point Likert scale) were recorded using a validated, self-administered questionnaire. Descriptive statistics and non-parametric Wilcoxon signed-rank tests were performed using sas statistical software (v 9.2) at a priori significance level of 0.05. Majority of participants (74.4%) were not aware of the new warnings; however, majority (67.8%) had prior knowledge of the risk. The mean risk perception score for the new warning label was found to be significantly higher (72.2% vs. 65.9%, P risk perception of potential liver damage and may encourage protective behaviour. However, future studies are essential to assess the impact of the new label on actual changes in consumer behaviour and subsequent reduction in acetaminophen-related morbidity and mortality. © 2012 Blackwell Publishing Ltd.

  15. Thesis Proposal

    DEFF Research Database (Denmark)

    Sloth, Erik

    2010-01-01

    Strukturen i Thesis proposal er følgende: Først præsenteres mine konkrete empiriske forskningsprojekter som skal munde ud i afhandlingens artikler. Jeg præsenterer herefter de teoretiske overvejelser omkring oplevelsesbegrebet og forbrugerkulturteori som danner baggrund for at jeg er nået frem til...

  16. Awareness and trust of the FDA and CDC: Results from a national sample of US adults and adolescents.

    Directory of Open Access Journals (Sweden)

    Sarah D Kowitt

    Full Text Available Trust in government agencies plays a key role in advancing these organizations' agendas, influencing behaviors, and effectively implementing policies. However, few studies have examined the extent to which individuals are aware of and trust the leading United States agencies devoted to protecting the public's health. Using two national samples of adolescents (N = 1,125 and adults (N = 5,014, we examined demographic factors, with a focus on vulnerable groups, as correlates of awareness of and trust in the Centers for Disease Control and Prevention (CDC, Food and Drug Administration (FDA, and the federal government. From nine different weighted and adjusted logistic regression models, we found high levels of awareness of the existence of the FDA and CDC (ranging from 55.7% for adolescents' awareness of the CDC to 94.3% for adults' awareness of the FDA and moderate levels of trust (ranging from a low of 41.8% for adults' trust in the federal government and a high of 78.8% for adolescents' trust of the FDA. In the adolescent and adult samples, awareness was higher among non-Hispanic Blacks and respondents with low numeracy. With respect to trust, few consistent demographic differences emerged. Our findings provide novel insights regarding awareness and trust in the federal government and specific United States public health agencies. Our findings suggest groups to whom these agencies may want to selectively communicate to enhance trust and thus facilitate their communication and regulatory agendas.

  17. Modeling and simulation for medical product development and evaluation : highlights from the FDA-C-Path-ISOP 2013 workshop

    NARCIS (Netherlands)

    Romero, Klaus; Sinha, Vikram; Allerheiligen, Sandra; Danhof, Meindert; Pinheiro, Jose; Kruhlak, Naomi; Wang, Yaning; Wang, Sue-Jane; Sauer, John-Michael; Marier, J. F.; Corrigan, Brian; Rogers, James; Heerspink, H. J. Lambers; Gumbo, Tawanda; Vis, Peter; Watkins, Paul; Morrison, Tina; Gillespie, William; Gordon, Mark Forrest; Stephenson, Diane; Hanna, Debra; Pfister, Marc; Lalonde, Richard; Colatsky, Thomas

    2014-01-01

    Medical-product development has become increasingly challenging and resource-intensive. In 2004, the Food and Drug Administration (FDA) described critical challenges facing medical-product development by establishing the critical path initiative [1]. Priorities identified included the need for

  18. 76 FR 41506 - Draft Guidance for Industry and FDA Staff on In Vitro Companion Diagnostic Devices; Availability

    Science.gov (United States)

    2011-07-14

    ...., Bldg. 51, rm. 2201, Silver Spring, MD 20993- 0002, or Office of Communication, Outreach and Development... help make critical treatment decisions. FDA oversight of companion diagnostics will protect patients... current thinking on companion diagnostic devices. It does not create or confer any rights for or on any...

  19. 21 CFR 1.383 - What expedited procedures apply when FDA initiates a seizure action against a detained perishable...

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false What expedited procedures apply when FDA initiates a seizure action against a detained perishable food? 1.383 Section 1.383 Food and Drugs FOOD AND... Administrative Detention of Food for Human or Animal Consumption General Provisions § 1.383 What expedited...

  20. The FDA's decision-making process: isn't it time to temper the principle of protective paternalism?

    Science.gov (United States)

    Brandt, Lawrence J

    2008-05-01

    The authors conducted a well-designed, multinational, large study of women younger than 65 yr of age with irritable bowel syndrome (IBS) with a mixed pattern of diarrhea and constipation (IBS-M) or constipation (IBS-C) and showed that a statistically greater percentage of patients in each group responded to tegaserod compared with patients treated with placebo. Practicality looms large, however, in that the Food and Drug Administration (FDA) disallowed the continued marketing of tegaserod because of cardiovascular safety concerns, and it now is only available under a restricted access program. The wisdom of this decision aside, it is disturbing that the FDA revealed a zero-tolerance for any significant risk of disease when a drug (e.g., tegaserod) was used for a nonlife-threatening condition; the FDA chose to neglect any potential benefit of significant improvement in quality of life, while at the same time allowing the continued availability of sildenifil for erectile dysfunction and other medications (e.g., rosiglitazone and nonsteroidal anti-inflammatory drugs [NSAIDs]), each with a far greater risk of cardiovascular complications. Whether tegaserod will be re-released and, if so, under what conditions, is yet to be determined, as is the question of whether the FDA will decide to allow a more transparent decision-making process with input from all interested parties affected by their decision.

  1. Association between change of health care providers and pregnancy exposure to FDA category C, D and X drugs.

    Science.gov (United States)

    Yang, Jianzhou; Xie, Rihua; Krewski, Daniel; Wang, Yongjin; Walker, Mark; Cao, Wenjun; Wen, Shi Wu

    2014-01-01

    Changing health care providers frequently breaks the continuity of care, which is associated with many health care problems. The purpose of this study was to examine the association between a change of health care providers and pregnancy exposure to FDA category C, D and X drugs. A 50% random sample of women who gave a birth in Saskatchewan between January 1, 1997 and December 31, 2000 were chosen for this study. The association between the number of changes in health care providers and with pregnancy exposure to category C, D, and X drugs for those women with and without chronic diseases were evaluated using multiple logistical regression, with adjusted odds ratios (ORs) and its 95% confidence intervals (CIs) as the association measures. A total of 18 568 women were included in this study. Rates of FDA C, D, and X drug uses were 14.35%, 17.07%, 21.72%, and 31.14%, in women with no change of provider, 1-2 changes, 3-5 changes, and more than 5 changes of health care providers. An association between the number of changes of health care providers and pregnancy exposure to FDA C, D, and X drugs existed in women without chronic diseases but not in women with chronic disease. Change of health care providers is associated with pregnancy exposure to FDA category C, D and X drugs in women without chronic diseases.

  2. 76 FR 13643 - FDA Food Safety Modernization Act: Title III-A New Paradigm for Importers; Public Meeting

    Science.gov (United States)

    2011-03-14

    ... Act: Title III--A New Paradigm for Importers; Public Meeting AGENCY: Food and Drug Administration, HHS... announcing a public meeting entitled ``FDA Food Safety Modernization Act: Title III--A New Paradigm for... provided. Request special accommodations due By March 22, 2011.... Patricia M. Kuntze, 301- to disability...

  3. The Role of Glutamate Dehydrogenase (GDH Testing Assay in the Diagnosis of Clostridium difficile Infections: A High Sensitive Screening Test and an Essential Step in the Proposed Laboratory Diagnosis Workflow for Developing Countries like China.

    Directory of Open Access Journals (Sweden)

    Jing-Wei Cheng

    Full Text Available The incidence and severity of Clostridium difficile infection (CDI in North America and Europe has increased significantly since the 2000s. However, CDI is not widely recognized in China and other developing countries due to limited laboratory diagnostic capacity and low awareness. Most published studies on laboratory workflows for CDI diagnosis are from developed countries, and thus may not be suitable for most developing countries. Therefore, an alternative strategy for developing countries is needed. In this study, we evaluated the performance of the Glutamate Dehydrogenase (GDH test and its associated workflow on 416 fecal specimens from suspected CDI cases. The assay exhibited excellent sensitivity (100.0% and specificity (92.8%, compared to culture based method, and thus could be a good screening marker for C. difficile but not for indication of toxin production. The VIDAS CDAB assay, which can detect toxin A/B directly from fecal specimens, showed good specificity (99.7% and positive predictive value (97.2%, but low sensitivity (45.0% and negative predictive value (88.3%, compared with PCR-based toxin gene detection. Therefore, we propose a practical and efficient GDH test based workflow strategy for the laboratory diagnosis of CDI in developing countries like China. By applying this new workflow, the CDI laboratory diagnosis rate was notably improved in our center, yet the increasing cost was kept at a minimum level. Furthermore, to gain some insights into the genetic population structure of C. difficile isolates from our hospital, we performed MLST and PCR toxin gene typing.

  4. The 2014 FDA assessment of commercial fish: practical considerations for improved dietary guidance.

    Science.gov (United States)

    McGuire, Jennifer; Kaplan, Jason; Lapolla, John; Kleiner, Rima

    2016-07-13

    The U.S. Food and Drug Administration (FDA) recently released its report: A Quantitative Assessment of the Net Effects on Fetal Neurodevelopment from Eating Commercial Fish (As Measured by IQ and also by Early Age Verbal Development in Children). By evaluating the benefits and potential concerns of eating fish during pregnancy and breastfeeding, the analysis suggests that pregnant women consuming two seafood meals (8-12 oz) per week could provide their child with an additional 3.3 IQ points by age 9. Recent insights from behavioral economics research indicate that other factors, such as concerns about price and methylmercury (MeHg) exposure, appear to reduce fish consumption in many individuals.To assess the net effects of eating commercial fish during pregnancy, we compared the consumption of select fish species necessary to achieve IQ benefits with the amount necessary to have adverse developmental effects due to MeHg exposure. For the species or market types evaluated, the number of servings necessary to reach MeHg exposure to observe an adverse effect was at least twice that the amount estimated to achieve peak developmental benefit. We then reported average costs of fresh and canned or pouched fish, and calculated the cost per week for pregnant women to achieve maximum IQ benefits for their gestating child. Canned light tuna was the least expensive option at $1.83 per week to achieve maximum IQ benefit.Due to their relatively low cost, canned and pouched fish products eaten with enough regularity are likely to provide peak cognitive benefits. Because of its popularity, canned and pouched tuna could provide some of the largest cognitive benefits from fish consumption in the U.S. Future FDA consumer advice and related educational initiatives could benefit from a broader perspective that highlights the importance of affordable and accessible fish choices. These observations underscore the importance of clear public health messaging that address both health

  5. Clients of sex workers in Switzerland: it makes sense to counsel and propose rapid test for HIV on the street, a preliminary report.

    Science.gov (United States)

    Diserens, Esther-Amélie; Bodenmann, Patrick; N'Garambe, Chantal; Ansermet-Pagot, Anne; Vannotti, Marco; Masserey, Eric; Cavassini, Matthias

    2010-03-19

    Clients of street sex workers may be at higher risk for HIV infection than the general population. Furthermore, there is a lack of knowledge regarding HIV testing of clients of sex workers in developed countries. This pilot study assessed the feasibility and acceptance of rapid HIV testing by the clients of street-based sex workers in Lausanne, Switzerland. For 5 evenings, clients in cars were stopped by trained field staff for face-to-face interviews focusing on sex-related HIV risk behaviors and HIV testing history. The clients were then offered a free anonymous rapid HIV test in a bus parked nearby. Rapid HIV testing and counselling were performed by experienced nurse practitioners. Clients with reactive tests were offered confirmatory testing, medical evaluation, and care in our HIV clinic. We intercepted 144 men, 112 (77.8%) agreed to be interviewed. Among them, 50 (46.6%) had never been tested for HIV. A total of 31 (27.7%) rapid HIV tests were performed, 16 (51.6%) in clients who had not previously been tested. None were reactive. Initially, 19 (16.9%) additional clients agreed to HIV testing but later declined due to the 40-minute queue for testing. This pilot study showed that rapid HIV testing in the red light district of Lausanne was feasible, and that the clients of sex workers accepted testing at an unexpectedly high rate. This setting seems particularly appropriate for targeted HIV screening, since more than 40% of the clients had not previously been tested for HIV even though they engaged in sex-related HIV risk behaviour.

  6. Direct-to-Consumer Broadcast Advertisements for Pharmaceuticals: Off-Label Promotion and Adherence to FDA Guidelines.

    Science.gov (United States)

    Klara, Kristina; Kim, Jeanie; Ross, Joseph S

    2018-05-01

    Direct-to-consumer (DTC) advertisements for prescription drugs in the United States are regulated by the Food and Drug Administration (FDA). Off-label promotion, or the advertisement of a drug for an indication not approved by the FDA, is prohibited. Our objective was to examine the presence of off-label promotion in broadcast DTC ads and to assess their adherence to FDA guidelines mandating fair balance in presentation of risks and benefits and prohibiting misleading advertisement claims. All English-language broadcast DTC ads for prescription drugs that aired in the United States from January 2015 to July 2016 were obtained from AdPharm, an online collection of healthcare advertisements. Ad length was measured and adherence to FDA guidelines was assessed for several categories: key regulatory items, indicators of false or misleading ads, and indicators of fair balance in presentation of risks and benefits. Our sample included 97 unique DTC ads, representing 60 unique drugs and 67 unique drug-indication combinations. No ads described drug risks quantitatively, whereas drug efficacy was presented quantitatively in 25 (26%) ads. Thirteen (13%) ads, all for diabetes medications, suggested off-label uses for weight loss and blood pressure reduction. The most commonly advertised drugs were indicated for the treatment of inflammatory conditions (n = 12; 18%), diabetes or diabetic neuropathy (n = 11; 16%), bowel or bladder dysfunction (n = 6; 9%), and infections or allergic reaction (n = 6; 9%). More than three-quarters (n = 51; 76%) advertised drugs to treat chronic conditions. Few broadcast DTC ads were fully compliant with FDA guidelines. The overall quality of information provided in ads was low, and suggestions of off-label promotion were common for diabetes medications. The impact of current DTC ads and off-label marketing on patient and prescriber decisions merits further scrutiny.

  7. Proposal of law relative to the follow-up of the sanitary and environmental consequences of nuclear tests. Wastes, pollution and nuisances; Proposition de loi relative au suivi des consequences sanitaires et environnementales des essais nucleaires. Dechets, pollution et nuisances

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2002-07-01

    This proposal of law aims at answering the expectations of all people, civil and military, who participated to the nuclear tests carried out by France between February 13, 1960 and January 27, 1996, or who lived in the vicinity of the Sahara and French Polynesia experimentation sites. It proposes the application of the link presumption principle to any illness affecting these people, the creation of an indemnization fund for the victims of these tests and the creation of a national commission for the follow-up of the enforcement of this law. (J.S.)

  8. A History of the Sonocare CST-100: The First FDA-approved HIFU Device

    Science.gov (United States)

    Muratore, Robert

    2006-05-01

    The Sonocare CST-100 Therapeutic Ultrasound System, designed for the treatment of glaucoma, was developed in the 1980s and became the first high intensity focused ultrasound (HIFU) device to receive Food and Drug Administration approval. The system arose from studies done by F.L. Lizzi, Eng.Sc.D., of Riverside Research Institute and D.J. Coleman, M.D., of Cornell Medical Center/New York Hospital on the safety of ultrasound diagnosis of the eye. As safety limits were probed, therapeutic regimes were discovered. Optimization of operational parameters, clinical experience, and engineering design came together through a spin-off company, Sonocare, Inc., formed to produce and market the ophthalmic device. Various precedents were set during the approval process, including the acceptance by the FDA of radiation momentum imparted to an absorber as a measure of acoustic power. Many devices were sold, but the laser industry, grandfathered into the therapeutic field, eventually out-marketed Sonocare. The CST-100 remains as a model of elegant industrial design, and existing units are used daily in HIFU laboratory experiments.

  9. Towards a Computational Analysis of Status and Leadership Styles on FDA Panels

    Science.gov (United States)

    Broniatowski, David A.; Magee, Christopher L.

    Decisions by committees of technical experts are increasingly impacting society. These decision-makers are typically embedded within a web of social relations. Taken as a whole, these relations define an implicit social structure which can influence the decision outcome. Aspects of this structure are founded on interpersonal affinity between parties to the negotiation, on assigned roles, and on the recognition of status characteristics, such as relevant domain expertise. This paper build upon a methodology aimed at extracting an explicit representation of such social structures using meeting transcripts as a data source. Whereas earlier results demonstrated that the method presented here can identify groups of decision-makers with a contextual affinity (i.e., membership in a given medical specialty or voting clique), we now can extract meaningful status hierarchies, and can identify differing facilitation styles among committee chairs. Use of this method is demonstrated on the transcripts of U.S. Food and Drug Administration (FDA) advisory panel meeting transcripts; nevertheless, the approach presented here is extensible to other domains and requires only a meeting transcript as input.

  10. Medication Exposures and Subsequent Development of Ewing Sarcoma: A Review of FDA Adverse Event Reports

    Directory of Open Access Journals (Sweden)

    Judith U. Cope

    2015-01-01

    Full Text Available Background. Ewing sarcoma family of tumors (ESFT are rare but deadly cancers of unknown etiology. Few risk factors have been identified. This study was undertaken to ascertain any possible association between exposure to therapeutic drugs and ESFT. Methods. This is a retrospective, descriptive study. A query of the FDA Adverse Event Reporting System (FAERS was conducted for all reports of ESFT, January 1, 1998, through December 31, 2013. Report narratives were individually reviewed for patient characteristics, underlying conditions and drug exposures. Results. Over 16 years, 134 ESFT reports were identified, including 25 cases of ESFT following therapeutic drugs and biologics including immunosuppressive agents and hormones. Many cases were confounded by concomitant medications and other therapies. Conclusions. This study provides a closer look at medication use and underlying disorders in patients who later developed ESFT. While this study was not designed to demonstrate any clear causative association between ESFT and prior use of a single product or drug class, many drugs were used to treat immune-related disease and growth or hormonal disturbances. Further studies may be warranted to better understand possible immune or neuroendocrine abnormalities or exposure to specific classes of drugs that may predispose to the later development of ESFT.

  11. Repurposing the FDA-approved pinworm drug pyrvinium as a novel chemotherapeutic agent for intestinal polyposis.

    Directory of Open Access Journals (Sweden)

    Bin Li

    Full Text Available Mutations in the WNT-pathway regulator ADENOMATOUS POLYPOSIS COLI (APC promote aberrant activation of the WNT pathway that is responsible for APC-associated diseases such as Familial Adenomatous Polyposis (FAP and 85% of spontaneous colorectal cancers (CRC. FAP is characterized by multiple intestinal adenomas, which inexorably result in CRC. Surprisingly, given their common occurrence, there are few effective chemotherapeutic drugs for FAP. Here we show that the FDA-approved, anti-helminthic drug Pyrvinium attenuates the growth of WNT-dependent CRC cells and does so via activation of CK1α. Furthermore, we show that Pyrvinium can function as an in vivo inhibitor of WNT-signaling and polyposis in a mouse model of FAP: APCmin mice. Oral administration of Pyrvinium, a CK1α agonist, attenuated the levels of WNT-driven biomarkers and inhibited adenoma formation in APCmin mice. Considering its well-documented safe use for treating enterobiasis in humans, our findings suggest that Pyrvinium could be repurposed for the clinical treatment of APC-associated polyposes.

  12. Tamoxifen: an FDA approved drug with neuroprotective effects for spinal cord injury recovery

    Directory of Open Access Journals (Sweden)

    Jennifer M Colón

    2016-01-01

    Full Text Available Spinal cord injury (SCI is a condition without a cure, affecting sensory and/or motor functions. The physical trauma to the spinal cord initiates a cascade of molecular and cellular events that generates a non-permissive environment for cell survival and axonal regeneration. Among these complex set of events are damage of the blood-brain barrier, edema formation, inflammation, oxidative stress, demyelination, reactive gliosis and apoptosis. The multiple events activated after SCI require a multi-active drug that could target most of these events and produce a permissive environment for cell survival, regeneration, vascular reorganization and synaptic formation. Tamoxifen, a selective estrogen receptor modulator, is an FDA approved drug with several neuroprotective properties that should be considered for the treatment of this devastating condition. Various investigators using different animal models and injury parameters have demonstrated the beneficial effects of this drug to improve functional locomotor recovery after SCI. Results suggest that the mechanism of action of Tamoxifen administration is to modulate anti-oxidant, anti-inflammatory and anti-gliotic responses. A gap of knowledge exists regarding the sex differences in response to Tamoxifen and the therapeutic window available to administer this treatment. In addition, the effects of Tamoxifen in axonal outgrowth or synapse formation needs to be investigated. This review will address some of the mechanisms activated by Tamoxifen after SCI and the results recently published by investigators in the field.

  13. The informational turn in food politics: The US FDA's nutrition label as information infrastructure.

    Science.gov (United States)

    Frohlich, Xaq

    2017-04-01

    This article traces the history of the US FDA regulation of nutrition labeling, identifying an 'informational turn' in the evolving politics of food, diet and health in America. Before nutrition labeling was introduced, regulators actively sought to segregate food markets from drug markets by largely prohibiting health information on food labels, believing such information would 'confuse' the ordinary food consumer. Nutrition labeling's emergence, first in the 1970s as consumer empowerment and then later in the 1990s as a solution to information overload, reflected the belief that it was better to manage markets indirectly through consumer information than directly through command-and-control regulatory architecture. By studying product labels as 'information infrastructure', rather than a 'knowledge fix', the article shows how labels are situated at the center of a legally constructed terrain of inter-textual references, both educational and promotional, that reflects a mix of market pragmatism and evolving legal thought about mass versus niche markets. A change to the label reaches out across a wide informational environment representing food and has direct material consequences for how food is produced, distributed, and consumed. One legacy of this informational turn has been an increasing focus by policymakers, industry, and arguably consumers on the politics of information in place of the politics of the food itself.

  14. Hepatitis B infection reported with cancer chemotherapy: analyzing the US FDA Adverse Event Reporting System.

    Science.gov (United States)

    Sanagawa, Akimasa; Hotta, Yuji; Kataoka, Tomoya; Maeda, Yasuhiro; Kondo, Masahiro; Kawade, Yoshihiro; Ogawa, Yoshihiro; Nishikawa, Ryohei; Tohkin, Masahiro; Kimura, Kazunori

    2018-04-16

    We conducted data mining using the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database on spontaneously reported adverse events to evaluate the association between anticancer drug therapy and hepatitis B infection. Reports of hepatitis B infection were retrieved from the FAERS database. The reporting odds ratio (ROR) was used to estimate the association between hepatitis B infection and various anticancer agents and drug combinations. We detected statistically significant risk signals of hepatitis B for 33 of 64 anticancer agents by ROR (26 cytotoxicity drugs and seven molecular-targeted drugs). We focused on molecular-targeted drugs and assessed the risk of hepatitis B from specific anticancer drug combinations. The frequency of hepatitis B infection was significantly high for drugs such as rituximab, bortezomib, imatinib, and everolimus. The addition of cyclophosphamide, doxorubicin, and fludarabine to drug combinations additively enhanced the frequency of hepatitis B infection. There were no reports on hepatitis B infection associated with trastuzumab or azacitidine monotherapy. However, trastuzumab-containing regimens (e.g., combinations with docetaxel or paclitaxel) were correlated with the incidence of hepatitis B infection, similar to azacitidine monotherapy. Our findings suggest that the concomitant use of anticancer drugs, such as trastuzumab, taxane, and azacitidine, may contribute to the risk of hepatitis B infection. The unique signals detected from the public database might provide clues to eliminate the threat of HBV in oncology. © 2018 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.

  15. The analysis of the market success of FDA approvals by probing top 100 bestselling drugs

    Science.gov (United States)

    Polanski, Jaroslaw; Bogocz, Jacek; Tkocz, Aleksandra

    2016-05-01

    Target-oriented drug discovery is the main research paradigm of contemporary drug discovery. In target-oriented approaches, we attempt to maximize in vitro drug potency by finding the optimal fit to the target. This can result in a higher molecular complexity, in particular, the higher molecular weight (MW) of the drugs. However, a comparison of the successful developments of pharmaceuticals with the general trends that can be observed in medicinal chemistry resulted in the conclusion that the so-called molecular obesity is an important reason for the attrition rate of drugs. When analyzing the list of top 100 drug bestsellers versus all of the FDA approvals, we discovered that on average lower-complexity (MW, ADMET score) drugs are winners of the top 100 list in terms of numbers but that, especially, up to some optimal MW value, a higher molecular complexity can pay off with higher incomes. This indicates that slim drugs are doing better but that fat drugs are bigger fishes to catch.

  16. Security and privacy qualities of medical devices: an analysis of FDA postmarket surveillance.

    Science.gov (United States)

    Kramer, Daniel B; Baker, Matthew; Ransford, Benjamin; Molina-Markham, Andres; Stewart, Quinn; Fu, Kevin; Reynolds, Matthew R

    2012-01-01

    Medical devices increasingly depend on computing functions such as wireless communication and Internet connectivity for software-based control of therapies and network-based transmission of patients' stored medical information. These computing capabilities introduce security and privacy risks, yet little is known about the prevalence of such risks within the clinical setting. We used three comprehensive, publicly available databases maintained by the Food and Drug Administration (FDA) to evaluate recalls and adverse events related to security and privacy risks of medical devices. Review of weekly enforcement reports identified 1,845 recalls; 605 (32.8%) of these included computers, 35 (1.9%) stored patient data, and 31 (1.7%) were capable of wireless communication. Searches of databases specific to recalls and adverse events identified only one event with a specific connection to security or privacy. Software-related recalls were relatively common, and most (81.8%) mentioned the possibility of upgrades, though only half of these provided specific instructions for the update mechanism. Our review of recalls and adverse events from federal government databases reveals sharp inconsistencies with databases at individual providers with respect to security and privacy risks. Recalls related to software may increase security risks because of unprotected update and correction mechanisms. To detect signals of security and privacy problems that adversely affect public health, federal postmarket surveillance strategies should rethink how to effectively and efficiently collect data on security and privacy problems in devices that increasingly depend on computing systems susceptible to malware.

  17. Cloned animal products in the human food chain: FDA should protect American consumers.

    Science.gov (United States)

    Butler, Jennifer E F

    2009-01-01

    Animal cloning is "complex process that lets one exactly copy the genetic, or inherited, traits of an animal." In 1997, Dolly the sheep was the first animal cloned and since then "scientists have used animal cloning to breed dairy cows, beef cattle, poultry, hogs and other species of livestock." Cloned animals are highly attractive to livestock breeders because "cloning essentially produces an identical copy of an animal with superior traits." The main purpose of cloning livestock is "more focused on efficiency and economic benefits of the producer rather than the overall effect of cloning on an animal's physical and mental welfare." The focus of this article is threefold. First, the science behind animal cloning is explained and some potential uses and risks of this technology are explored. Second, FDA's historical evolution, current regulatory authority, and limitations of that authority, is described. Lastly, a new regulatory vision recognizes the realities of 21st century global markets and the dynamic evolution of scientific discovery and technology.

  18. Acute renal failure with sodium-glucose-cotransporter-2 inhibitors: Analysis of the FDA adverse event report system database.

    Science.gov (United States)

    Perlman, A; Heyman, S N; Matok, I; Stokar, J; Muszkat, M; Szalat, A

    2017-12-01

    Sodium-glucose-cotransporter-2 (SGLT2) inhibitors have recently been approved for the treatment of type II diabetes mellitus (T2DM). It has been proposed that these agents could induce acute renal failure (ARF) under certain conditions. This study aimed to evaluate the association between SGLT2-inhibitors and ARF in the FDA adverse event report system (FAERS) database. We analyzed adverse event cases submitted to FAERS between January 2013 and September 2016. ARF cases were identified using a structured medical query. Medications were identified using both brand and generic names. During the period evaluated, 18,915 reports (out of a total of 3,832,015 registered in FAERS) involved the use of SGLT2-inhibitors. SGLT2-inhibitors were reportedly associated with ARF in 1224 of these cases (6.4%), and were defined as the "primary" or "secondary" cause of the adverse event in 96.8% of these cases. The proportion of reports with ARF among reports with SGLT2 inhibitor was almost three-fold higher compared to reports without these drugs (ROR 2.88, 95% CI 2.71-3.05, p SGLT2-inhibitors was significantly greater than the proportion of ARF among cases with T2DM without SGLT2-inhibitors (ROR 1.68, 95% CI 1.57-1.8, p SGLT2-inhibitors, canagliflozin was associated with a higher proportion of reports of renal failure (7.3%), compared to empagliflozin and dapagliflozin (4.7% and 4.8% respectively, p SGLT2-inhibitors are associated with an increase in the proportion of reports of ARF compared to other medications. SGLT2-inhibitor agents may differ from one another in their respective risk for ARF. Copyright © 2017 The Italian Society of Diabetology, the Italian Society for the Study of Atherosclerosis, the Italian Society of Human Nutrition, and the Department of Clinical Medicine and Surgery, Federico II University. Published by Elsevier B.V. All rights reserved.

  19. A proposed scalable parallel open architecture data acquisition system for low to high rate experiments, test beams and all SSC detectors

    International Nuclear Information System (INIS)

    Barsotti, E.; Booth, A.; Bowden, M.; Swoboda, C.; Lockyer, N.; Vanberg, R.

    1990-01-01

    A new era of high-energy physics research is beginning requiring accelerators with much higher luminosities and interaction rates in order to discover new elementary particles. As a consequence, both orders of magnitude higher data rates from the detector and online processing power, well beyond the capabilities of current high energy physics data acquisition systems, are required. This paper describes a proposed new data acquisition system architecture which draws heavily from the communications industry, is totally parallel (i.e., without any bottlenecks), is capable of data rates of hundreds of Gigabytes per second from the detector and into an array of online processors (i.e., processor farm), and uses an open systems architecture to guarantee compatibility with future commercially available online processor farms. The main features of the proposed Scalable Parallel Open Architecture data acquisition system are standard interface ICs to detector subsystems wherever possible, fiber optic digital data transmission from the near-detector electronics, a self-routing parallel event builder, and the use of industry-supported and high-level language programmable processors in the proposed BCD system for both triggers and online filters. A brief status report of an ongoing project at Fermilab to build a prototype of the proposed data acquisition system architecture is given in the paper. The major component of the system, a self-routing parallel event builder, is described in detail

  20. 78 FR 57391 - Agency Information Collection Activities; Proposed Collection; Comment Request; Food Canning...

    Science.gov (United States)

    2013-09-18

    ... data entry fields for the ``food product group'' (such as liquid, ready-to-eat ``breakfast foods''). We... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-1119] Agency Information Collection Activities; Proposed Collection; Comment Request; Food Canning...

  1. 75 FR 47599 - Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Food and...

    Science.gov (United States)

    2010-08-06

    ... frequency of response was determined by the maximum number of questionnaires that will be sent to any... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0380] Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Food and Drug...

  2. 77 FR 18826 - Agency Information Collection Activities; Proposed Collection; Comment Request; Financial...

    Science.gov (United States)

    2012-03-28

    ... financial information to the sponsors of marketing applications. Under Sec. 54.4(a) (21 CFR 54.4(a... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0280] Agency Information Collection Activities; Proposed Collection; Comment Request; Financial Disclosure by...

  3. 77 FR 8880 - Agency Information Collection Activities; Proposed Collection; Comment Request; General Licensing...

    Science.gov (United States)

    2012-02-15

    ... Competition and Innovation Act of 2009 (BPCI Act) which amends the Public Health Service Act (PHS Act) and... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-1029... product and an application for a supplement for a proposed interchangeable product. DATES: Submit either...

  4. 76 FR 1168 - Agency Information Collection Activities; Proposed Collection; Comment Request; Health and Diet...

    Science.gov (United States)

    2011-01-07

    ... Supplement will include: (1) Awareness and sources of information, (2) attitudes toward diet and physical... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0001] Agency Information Collection Activities; Proposed Collection; Comment Request; Health and Diet Survey...

  5. 77 FR 8260 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device...

    Science.gov (United States)

    2012-02-14

    ... will be used to evaluate risks associated with medical devices which will enable FDA to take...] Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Reporting... comment in response to the notice. This notice solicits comments on medical device reporting (MDR...

  6. 77 FR 8879 - Agency Information Collection Activities; Proposed Collection; Comment Request: Guidance for...

    Science.gov (United States)

    2012-02-15

    ... report will alert FDA to trends or clusters of events that might be a safety issue otherwise unreported...] Agency Information Collection Activities; Proposed Collection; Comment Request: Guidance for Industry and... of information technology. Guidance for Industry and Food and Drug Administration Staff; Class II...

  7. 75 FR 8963 - Agency Information Collection Activities; Proposed Collection; Comment Request; Reporting and...

    Science.gov (United States)

    2010-02-26

    ..., including each proposed extension of an existing collection of information, and to allow 60 days for public...)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in... Vapor Lamp Products Radiation Safety Report'' FDA Form 3647 ``Guide for Preparing Annual Reports on...

  8. 77 FR 69630 - Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drug...

    Science.gov (United States)

    2012-11-20

    ... must be assembled and submitted. The application must include safety and effectiveness data, proposed labeling, product manufacturing information, and where necessary, complete information on food safety... Applications and Supporting Regulations, and Form FDA 356V AGENCY: Food and Drug Administration, HHS. ACTION...

  9. Experimental evaluation of wall Mach number distributions of the octagonal test section proposed for NASA Lewis Research Center's altitude wind tunnel

    Science.gov (United States)

    Harrington, Douglas E.; Burley, Richard R.; Corban, Robert R.

    1986-01-01

    Wall Mach number distributions were determined over a range of test-section free-stream Mach numbers from 0.2 to 0.92. The test section was slotted and had a nominal porosity of 11 percent. Reentry flaps located at the test-section exit were varied from 0 (fully closed) to 9 (fully open) degrees. Flow was bled through the test-section slots by means of a plenum evacuation system (PES) and varied from 0 to 3 percent of tunnel flow. Variations in reentry flap angle or PES flow rate had little or no effect on the Mach number distributions in the first 70 percent of the test section. However, in the aft region of the test section, flap angle and PES flow rate had a major impact on the Mach number distributions. Optimum PES flow rates were nominally 2 to 2.5 percent wtih the flaps fully closed and less than 1 percent when the flaps were fully open. The standard deviation of the test-section wall Mach numbers at the optimum PES flow rates was 0.003 or less.

  10. First derivative emission spectrofluorimetric method for the determination of LCZ696, a newly approved FDA supramolecular complex of valsartan and sacubitril in tablets.

    Science.gov (United States)

    Ragab, Marwa A A; Galal, Shereen M; Korany, Mohamed A; Ahmed, Aya R

    2017-12-01

    LCZ696 (sacubitril/valsartan, Entresto™) is a therapy lately approved by United States Food and Drug Administration (US FDA) as a heart failure therapy. It is claimed to decrease the mortality rate and hospitalization for patients with chronic heart failure. This study is considered as the first report to investigate the fluorimetric behavior of sacubitril in addition to pursuing all the different conditions that may affect its fluorescence. Various conditions were studied, for example studying the effects of organized media, solvents and pH, which may affect the fluorescence behavior of sacubitril. For the simultaneous determination of the newly approved supramolecular complex of valsartan (VAL) and sacubitril (SAC) in their tablets, a sensitive and simple first derivative spectrofluorimetric method was developed. The method involved the measurement of native fluorescence at 416 nm and 314 nm (λ ex 249 nm) for VAL and SAC, respectively. The first (D1) derivative technique was applied to the emission data to resolve a partial overlap that appeared in their emission spectra. The proposed method was successfully applied for the assay of the two drugs in their supramolecular complex LCZ696 with no interference from common pharmaceutical additives. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines were followed in order to validate the proposed method. Copyright © 2017 John Wiley & Sons, Ltd.

  11. Model-based development and testing of advertising messages: A comparative study of two campaign proposals based on the MECCAS model and a conventional approach

    DEFF Research Database (Denmark)

    Bech-Larsen, Tino

    2001-01-01

    Traditionally, the development of advertising messages has been based on "creative independence", sometimes catalysed by inductively generated empirical data. Due to the recent intensified focus on advertising effectiveness, this state of affairs is beginning to change. The purpose of the study....... The comparison involved the efficiency of the managerial communication taking place in the message development process as well as target group communication effects. The managerial communication was studied by interviews with the involved advertising agency (Midtmarketing, Ikast, Denmark) and client staff...... described in this article is to compare the development and effects of two campaign proposals, with the sommon aim of increasing the consumption of apples among young Danes (18 to 35 years of age). One of the proposals is the result of an inductive-creative process, while the other is base on the MECCAS...

  12. Settlement behavior of the container for high-level nuclear waste disposal. Centrifuge model tests and proposal for simple evaluation method for settlement behavior

    International Nuclear Information System (INIS)

    Nakamura, Kunihiko; Tanaka, Yukihisa

    2004-01-01

    In Japan, bentonite will be used as buffer materials in high-level nuclear waste disposal. In the softened buffer material with the infiltration of various properties of under ground water, if the container deeply sinks, the decrease of the thickness of the buffer materials may lose the required abilities. Therefore, it is very important to consider settlement of container. In this study, influences of distilled water and artificial seawater on the settlement of the container were investigated and a simple evaluation method for settlement of the container was proposed. The following findings were obtained from this study. (1) Under the distilled water, amount of settlement decreases exponentially as dry density becomes larger. (2) While the amount of settlement of container under the 10% artificial seawater was almost equal to the one in the distilled water, the container was floating under the 100% artificial seawater. (3) The simple evaluation method for settlement of container was proposed based on the diffuse double layer theory, and the effectiveness of the proposed method was demonstrated by the results of several experiments. (author)

  13. Comments from the Behavioral Teratology Committee of the Japanese Teratology Society on OECD guideline for the testing of chemicals, proposal for a new guideline 426, developmental neurotoxicity study, draft document (September 2003).

    Science.gov (United States)

    Fukui, Yoshihiro; Ema, Makoto; Fujiwara, Michio; Higuchi, Hashihiro; Inouye, Minoru; Iwase, Takayuki; Kihara, Takahide; Nishimura, Tatsuya; Oi, Akihide; Ooshima, Yojiro; Otani, Hiroki; Shinomiya, Mitsuhiro; Sugioka, Kozo; Yamano, Tsunekazu; Yamashita, Keisuke H; Tanimura, Takashi

    2004-09-01

    In September 2003, a new revision of the draft guideline (Organization for Economic Co-operation and Development [OECD] Guideline for the Testing of Chemicals, Proposal for a New Guideline 426, Developmental Neurotoxicity Study) was distributed. The draft guideline consists of 51 paragraphs and an appendix. The National Coordinators were requested to arrange national expert reviews of the guideline proposal in their member countries. The member of the Behavioral Teratology (BT) Committee of the Japanese Teratology Society (JTS) reviewed, discussed and commented on the draft Test Guideline proposal. The BT Committee of the JTS also commented that the International Collaborative Study to validate this protocol should be definitely performed. These comments were sent to the OECD Secretariat. The BT Committee of the JTS expects that the comments are useful for further discussion.

  14. Security and Privacy Qualities of Medical Devices: An Analysis of FDA Postmarket Surveillance

    Science.gov (United States)

    Kramer, Daniel B.; Baker, Matthew; Ransford, Benjamin; Molina-Markham, Andres; Stewart, Quinn; Fu, Kevin; Reynolds, Matthew R.

    2012-01-01

    Background Medical devices increasingly depend on computing functions such as wireless communication and Internet connectivity for software-based control of therapies and network-based transmission of patients’ stored medical information. These computing capabilities introduce security and privacy risks, yet little is known about the prevalence of such risks within the clinical setting. Methods We used three comprehensive, publicly available databases maintained by the Food and Drug Administration (FDA) to evaluate recalls and adverse events related to security and privacy risks of medical devices. Results Review of weekly enforcement reports identified 1,845 recalls; 605 (32.8%) of these included computers, 35 (1.9%) stored patient data, and 31 (1.7%) were capable of wireless communication. Searches of databases specific to recalls and adverse events identified only one event with a specific connection to security or privacy. Software-related recalls were relatively common, and most (81.8%) mentioned the possibility of upgrades, though only half of these provided specific instructions for the update mechanism. Conclusions Our review of recalls and adverse events from federal government databases reveals sharp inconsistencies with databases at individual providers with respect to security and privacy risks. Recalls related to software may increase security risks because of unprotected update and correction mechanisms. To detect signals of security and privacy problems that adversely affect public health, federal postmarket surveillance strategies should rethink how to effectively and efficiently collect data on security and privacy problems in devices that increasingly depend on computing systems susceptible to malware. PMID:22829874

  15. Monitoring Antimicrobial Resistance in the Food Supply Chain and Its Implications for FDA Policy Initiatives.

    Science.gov (United States)

    Zawack, Kelson; Li, Min; Booth, James G; Love, Will; Lanzas, Cristina; Gröhn, Yrjö T

    2016-09-01

    In response to concerning increases in antimicrobial resistance (AMR), the Food and Drug Administration (FDA) has decided to increase veterinary oversight requirements for antimicrobials and restrict their use in growth promotion. Given the high stakes of this policy for the food supply, economy, and human and veterinary health, it is important to rigorously assess the effects of this policy. We have undertaken a detailed analysis of data provided by the National Antimicrobial Resistance Monitoring System (NARMS). We examined the trends in both AMR proportion and MIC between 2004 and 2012 at slaughter and retail stages. We investigated the makeup of variation in these data and estimated the sample and effect size requirements necessary to distinguish an effect of the policy change. Finally, we applied our approach to take a detailed look at the 2005 withdrawal of approval for the fluoroquinolone enrofloxacin in poultry water. Slaughter and retail showed similar trends. Both AMR proportion and MIC were valuable in assessing AMR, capturing different information. Most variation was within years, not between years, and accounting for geographic location explained little additional variation. At current rates of data collection, a 1-fold change in MIC should be detectable in 5 years and a 6% decrease in percent resistance could be detected in 6 years following establishment of a new resistance rate. Analysis of the enrofloxacin policy change showed the complexities of the AMR policy with no statistically significant change in resistance of both Campylobacter jejuni and Campylobacter coli to ciprofloxacin, another second-generation fluoroquinolone. Copyright © 2016, American Society for Microbiology. All Rights Reserved.

  16. A Systematic Screen of FDA-Approved Drugs for Inhibitors of Biological Threat Agents

    Science.gov (United States)

    Madrid, Peter B.; Chopra, Sidharth; Manger, Ian D.; Gilfillan, Lynne; Keepers, Tiffany R.; Shurtleff, Amy C.; Green, Carol E.; Iyer, Lalitha V.; Dilks, Holli Hutcheson; Davey, Robert A.; Kolokoltsov, Andrey A.; Carrion, Ricardo; Patterson, Jean L.; Bavari, Sina; Panchal, Rekha G.; Warren, Travis K.; Wells, Jay B.; Moos, Walter H.; Burke, RaeLyn L.; Tanga, Mary J.

    2013-01-01

    Background The rapid development of effective medical countermeasures against potential biological threat agents is vital. Repurposing existing drugs that may have unanticipated activities as potential countermeasures is one way to meet this important goal, since currently approved drugs already have well-established safety and pharmacokinetic profiles in patients, as well as manufacturing and distribution networks. Therefore, approved drugs could rapidly be made available for a new indication in an emergency. Methodology/Principal Findings A large systematic effort to determine whether existing drugs can be used against high containment bacterial and viral pathogens is described. We assembled and screened 1012 FDA-approved drugs for off-label broad-spectrum efficacy against Bacillus anthracis; Francisella tularensis; Coxiella burnetii; and Ebola, Marburg, and Lassa fever viruses using in vitro cell culture assays. We found a variety of hits against two or more of these biological threat pathogens, which were validated in secondary assays. As expected, antibiotic compounds were highly active against bacterial agents, but we did not identify any non-antibiotic compounds with broad-spectrum antibacterial activity. Lomefloxacin and erythromycin were found to be the most potent compounds in vivo protecting mice against Bacillus anthracis challenge. While multiple virus-specific inhibitors were identified, the most noteworthy antiviral compound identified was chloroquine, which disrupted entry and replication of two or more viruses in vitro and protected mice against Ebola virus challenge in vivo. Conclusions/Significance The feasibility of repurposing existing drugs to face novel threats is demonstrated and this represents the first effort to apply this approach to high containment bacteria and viruses. PMID:23577127

  17. A systematic screen of FDA-approved drugs for inhibitors of biological threat agents.

    Directory of Open Access Journals (Sweden)

    Peter B Madrid

    Full Text Available BACKGROUND: The rapid development of effective medical countermeasures against potential biological threat agents is vital. Repurposing existing drugs that may have unanticipated activities as potential countermeasures is one way to meet this important goal, since currently approved drugs already have well-established safety and pharmacokinetic profiles in patients, as well as manufacturing and distribution networks. Therefore, approved drugs could rapidly be made available for a new indication in an emergency. METHODOLOGY/PRINCIPAL FINDINGS: A large systematic effort to determine whether existing drugs can be used against high containment bacterial and viral pathogens is described. We assembled and screened 1012 FDA-approved drugs for off-label broad-spectrum efficacy against Bacillus anthracis; Francisella tularensis; Coxiella burnetii; and Ebola, Marburg, and Lassa fever viruses using in vitro cell culture assays. We found a variety of hits against two or more of these biological threat pathogens, which were validated in secondary assays. As expected, antibiotic compounds were highly active against bacterial agents, but we did not identify any non-antibiotic compounds with broad-spectrum antibacterial activity. Lomefloxacin and erythromycin were found to be the most potent compounds in vivo protecting mice against Bacillus anthracis challenge. While multiple virus-specific inhibitors were identified, the most noteworthy antiviral compound identified was chloroquine, which disrupted entry and replication of two or more viruses in vitro and protected mice against Ebola virus challenge in vivo. CONCLUSIONS/SIGNIFICANCE: The feasibility of repurposing existing drugs to face novel threats is demonstrated and this represents the first effort to apply this approach to high containment bacteria and viruses.

  18. Identification of Additional Anti-Persister Activity against Borrelia burgdorferi from an FDA Drug Library

    Directory of Open Access Journals (Sweden)

    Jie Feng

    2015-09-01

    Full Text Available Lyme disease is a leading vector-borne disease in the United States. Although the majority of Lyme patients can be cured with standard 2–4 week antibiotic treatment, 10%–20% of patients continue to suffer from prolonged post-treatment Lyme disease syndrome (PTLDS. While the cause for this is unclear, persisting organisms not killed by current Lyme antibiotics may be involved. In our previous study, we screened an FDA drug library and reported 27 top hits that showed high activity against Borrelia persisters. In this study, we present the results of an additional 113 active hits that have higher activity against the stationary phase B. burgdorferi than the currently used Lyme antibiotics. Many antimicrobial agents (antibiotics, antivirals, antifungals, anthelmintics or antiparasitics used for treating other infections were found to have better activity than the current Lyme antibiotics. These include antibacterials such as rifamycins (3-formal-rifamycin, rifaximin, rifamycin SV, thiostrepton, quinolone drugs (sarafloxacin, clinafloxacin, tosufloxacin, and cell wall inhibitors carbenicillin, tazobactam, aztreonam; antifungal agents such as fluconazole, mepartricin, bifonazole, climbazole, oxiconazole, nystatin; antiviral agents zanamivir, nevirapine, tilorone; antimalarial agents artemisinin, methylene blue, and quidaldine blue; antihelmintic and antiparasitic agents toltrazuril, tartar emetic, potassium antimonyl tartrate trihydrate, oxantel, closantel, hycanthone, pyrimethamine, and tetramisole. Interestingly, drugs used for treating other non-infectious conditions including verteporfin, oltipraz, pyroglutamic acid, pidolic acid, and dextrorphan tartrate, that act on the glutathione/γ-glutamyl pathway involved in protection against free radical damage, and also the antidepressant drug indatraline, were found to have high activity against stationary phase B. burgdorferi. Among the active hits, agents that affect cell membranes, energy

  19. Identification of Additional Anti-Persister Activity against Borrelia burgdorferi from an FDA Drug Library.

    Science.gov (United States)

    Feng, Jie; Weitner, Megan; Shi, Wanliang; Zhang, Shuo; Sullivan, David; Zhang, Ying

    2015-09-16

    Lyme disease is a leading vector-borne disease in the United States. Although the majority of Lyme patients can be cured with standard 2-4 week antibiotic treatment, 10%-20% of patients continue to suffer from prolonged post-treatment Lyme disease syndrome (PTLDS). While the cause for this is unclear, persisting organisms not killed by current Lyme antibiotics may be involved. In our previous study, we screened an FDA drug library and reported 27 top hits that showed high activity against Borrelia persisters. In this study, we present the results of an additional 113 active hits that have higher activity against the stationary phase B. burgdorferi than the currently used Lyme antibiotics. Many antimicrobial agents (antibiotics, antivirals, antifungals, anthelmintics or antiparasitics) used for treating other infections were found to have better activity than the current Lyme antibiotics. These include antibacterials such as rifamycins (3-formal-rifamycin, rifaximin, rifamycin SV), thiostrepton, quinolone drugs (sarafloxacin, clinafloxacin, tosufloxacin), and cell wall inhibitors carbenicillin, tazobactam, aztreonam; antifungal agents such as fluconazole, mepartricin, bifonazole, climbazole, oxiconazole, nystatin; antiviral agents zanamivir, nevirapine, tilorone; antimalarial agents artemisinin, methylene blue, and quidaldine blue; antihelmintic and antiparasitic agents toltrazuril, tartar emetic, potassium antimonyl tartrate trihydrate, oxantel, closantel, hycanthone, pyrimethamine, and tetramisole. Interestingly, drugs used for treating other non-infectious conditions including verteporfin, oltipraz, pyroglutamic acid, pidolic acid, and dextrorphan tartrate, that act on the glutathione/γ-glutamyl pathway involved in protection against free radical damage, and also the antidepressant drug indatraline, were found to have high activity against stationary phase B. burgdorferi. Among the active hits, agents that affect cell membranes, energy production, and reactive

  20. FDA-EPA Public Health Guidance on Fish Consumption: A Case Study on Informal Interagency Cooperation in "Shared Regulatory Space".

    Science.gov (United States)

    Holden, Mark

    2015-01-01

    This article is a case study on how administrative agencies interact with each other in cases of shared regulatory jurisdiction. The theoretical literature on the topic of overlapping jurisdiction both (1) makes predictions about how agencies are expected to behave when they share jurisdiction, and (2) in recent iterations argues that overlapping jurisdiction can confer unique policymaking benefits. Through the lens of that theoretical literature, this article examines the relations between the Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA) regarding the public health risks posed by mercury in fish. It concludes that the FDA-EPA case study (1) corroborates the extant theoretical accounts of how agencies behave in cases of overlapping jurisdiction, (2) supports the conclusion of the recent scholarship that overlapping jurisdiction can confer unique policy benefits, and (3) reveals a few wrinkles not given adequate treatment in the extant literature.

  1. The liberal state and the rogue agency: FDA's regulation of drugs for mood disorders, 1950s-1970s.

    Science.gov (United States)

    Shorter, Edward

    2008-01-01

    The theory of the liberal state does not generally contemplate the possibility that regulatory agencies will turn into "rogues," regulating against the interests of their clients and, indeed, the public interest. In the years between circa 1955 and 1975 this seems to have happened to one of the prime regulatory agencies of the US federal government: the Food and Drug Administration (FDA). Intent upon transforming itself from a traditional "cop" agency to a regulatory giant, the FDA campaigned systematically to bring down some safe and effective drugs. This article concentrates on hearings in the area of psychopharmacology regarding several antianxiety drugs, namely meprobamate (Miltown), chlordiazepoxide (Librium) and diazepam (Valium). In addition, from 1967 to 1973 this regulatory vengefulness occurred on a broad scale in the Drug Efficacy Study Implementation (DESI), an administrative exercise that removed from the market almost half of the psychopharmacopoeia. The article explores possible bureaucratic motives for these actions.

  2. The teratology testing of food additives.

    Science.gov (United States)

    Barrow, Paul C; Spézia, François

    2013-01-01

    The developmental and reproductive toxicity testing (including teratogenicity) of new foods and food additives is performed worldwide according to the guidelines given in the FDA Redbook. These studies are not required for substances that are generally recognized as safe, according to the FDA inventory. The anticipated cumulated human exposure level above which developmental or reproduction studies are required depends on the structure-alert category. For food additives of concern, both developmental (prenatal) and reproduction (multigeneration) studies are required. The developmental studies are performed in two species, usually the rat and the rabbit. The reproduction study is generally performed in the rat. The two rat studies are preferably combined into a single experimental design, if possible. The test methods described in the FDA Redbook are similar to those specified by the OECD for the reproductive toxicity testing of chemicals.

  3. Consumer's risk in the EMA and FDA regulatory approaches for bioequivalence in highly variable drugs.

    Science.gov (United States)

    Muñoz, Joel; Alcaide, Daniel; Ocaña, Jordi

    2016-05-30

    The 2010 US Food and Drug Administration and European Medicines Agency regulatory approaches to establish bioequivalence in highly variable drugs are both based on linearly scaling the bioequivalence limits, both take a 'scaled average bioequivalence' approach. The present paper corroborates previous work suggesting that none of them adequately controls type I error or consumer's risk, so they result in invalid test procedures in the neighbourhood of a within-subject coefficient of variation osf 30% for the reference (R) formulation. The problem is particularly serious in the US Food and Drug Administration regulation, but it is also appreciable in the European Medicines Agency one. For the partially replicated TRR/RTR/RRT and the replicated TRTR/RTRT crossover designs, we quantify these type I error problems by means of a simulation study, discuss their possible causes and propose straightforward improvements on both regulatory procedures that improve their type I error control while maintaining an adequate power. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

  4. Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters.

    Science.gov (United States)

    Kim, Hyosun

    2015-08-25

    For the purpose of understanding the Food and Drug Administration's (FDA's) concerns regarding online promotion of prescription drugs advertised directly to consumers, this study examines notices of violations (NOVs) and warning letters issued by the FDA to pharmaceutical manufacturers. The FDA's warning letters and NOVs, which were issued to pharmaceutical companies over a 10-year period (2005 to 2014) regarding online promotional activities, were content-analyzed. Six violation categories were identified: risk information, efficacy information, indication information, product labeling, material information issues, and approval issues. The results reveal that approximately 95% of the alleged violations were found on branded drug websites, in online paid advertisements, and in online videos. Of the total 179 violations, the majority of the alleged violations were concerned with the lack of risk information and/or misrepresentation of efficacy information, suggesting that achieving a fair balance of benefit versus risk information is a major problem with regard to the direct-to-consumer advertising (DTCA) of prescription drugs. In addition, the character space limitations of online platforms, eg, sponsored links on search engines, pose challenges for pharmaceutical marketers with regard to adequately communicating important drug information, such as indication information, risk information, and product labeling. Presenting drug information in a fair and balanced manner remains a major problem. Industry guidance should consider addressing visibility and accessibility of information in the web environment to help pharmaceutical marketers meet the requirements for direct-to-consumer promotion and to protect consumers from misleading drug information. Promotion via social media warrants further attention, as pharmaceutical manufacturers have already begun actively establishing a social media presence, and the FDA has thus begun to keep tabs on social media promotions of

  5. Dissolution comparisons using a Multivariate Statistical Distance (MSD) test and a comparison of various approaches for calculating the measurements of dissolution profile comparison.

    Science.gov (United States)

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

    2017-07-01

    The f 2 test is generally used for comparing dissolution profiles. In cases of high variability, the f 2 test is not applicable, and the Multivariate Statistical Distance (MSD) test is frequently proposed as an alternative by the FDA and EMA. The guidelines provide only general recommendations. MSD tests can be performed either on raw data with or without time as a variable or on parameters of models. In addition, data can be limited-as in the case of the f 2 test-to dissolutions of up to 85% or to all available data. In the context of the present paper, the recommended calculation included all raw dissolution data up to the first point greater than 85% as a variable-without the various times as parameters. The proposed MSD overcomes several drawbacks found in other methods.

  6. Fundamental limits of measurement in telecommunications: Experimental and modeling studies in a test optical network on proposal for the reform of telecommunication quantitations

    International Nuclear Information System (INIS)

    Egan, James; McMillan, Normal; Denieffe, David

    2011-01-01

    Proposals for a review of the limits of measurement for telecommunications are made. The measures are based on adapting work from the area of chemical metrology for the field of telecommunications. Currie has introduced recommendations for defining the limits of measurement in chemical metrology and has identified three key fundamental limits of measurement. These are the critical level, the detection limit and the determination limit. Measurements on an optical system are used to illustrate the utility of these measures and discussion is given into the advantages of using these fundamental quantitations over existing methods.

  7. Design Studies for Flux and Polarization Measurements of Photons and Positrons for SLAC Proposal E166: An experiment to test polarized positron production in the FFTB (LCC-0107)

    Energy Technology Data Exchange (ETDEWEB)

    Woods, M

    2003-10-02

    We present results from design studies carried out to investigate measurements of the flux, spectrum and polarization of undulator photons for SLAC Proposal E166. A transmission Compton polarimeter is considered for measuring the photon circular polarization. We also present results for measuring the flux and spectrum of positrons produced by the undulator photons in an 0.5X{sub 0} Titanium target. And we present some considerations for use of a transmission Compton polarimeter to measure the circular polarization of bremsstrahlung photons emitted by the polarized positrons in a thin radiator.

  8. Fundamental limits of measurement in telecommunications: Experimental and modeling studies in a test optical network on proposal for the reform of telecommunication quantitations

    Energy Technology Data Exchange (ETDEWEB)

    Egan, James; McMillan, Normal; Denieffe, David, E-mail: eganj@itcarlow.ie [IT Carlow (Ireland)

    2011-08-17

    Proposals for a review of the limits of measurement for telecommunications are made. The measures are based on adapting work from the area of chemical metrology for the field of telecommunications. Currie has introduced recommendations for defining the limits of measurement in chemical metrology and has identified three key fundamental limits of measurement. These are the critical level, the detection limit and the determination limit. Measurements on an optical system are used to illustrate the utility of these measures and discussion is given into the advantages of using these fundamental quantitations over existing methods.

  9. The "natural" aversion: the FDA's reluctance to define a leading food-industry marketing claim, and the pressing need for a workable rule.

    Science.gov (United States)

    Farris, April L

    2010-01-01

    As of 2009, the "natural foods" industry has become a 22.3 billion dollar giant and "all-natural" is the second-leading marketing claim for all new food products. Even in such a flourishing market, the Food and Drug Administration (FDA) has never defined the term "natural" through rulemaking. FDA and the U.S. Department of Agriculture (USDA) have instead created separate, non-identical policy statements governing the use of the term "natural," and FDA has abandoned efforts to define "natural" through rulemaking in the face of more pressing priorities. In absence of any governing federal standard, consumer advocacy groups and warring food industries have attempted to define "natural" to fit their preferences through high-stakes litigation of state law claims, leaving courts free to apply diverging standards without the expertise of FDA. Recent case law from federal district courts and the Supreme Court leaves little hope that FDA's current policy statement will preempt state law causes of action. To prevent a potential patchwork of definitions varying by state, and to create a legitimate standard resting on informed scientific expertise rather than consumer whims, FDA should engage in rulemaking to define the term "natural." This paper concludes by sketching potential formulations for such a rule based on FDA's previous successful rule-making ventures and standards used by natural foods retailers.

  10. Proposal of how to update the standard information requirements in REACH, PPPR and BPR – a testing strategy for identification of endocrine disruptors

    DEFF Research Database (Denmark)

    Holbech, Henrik; Bjerregaard, Poul; Hass, Ulla

    to these, new test methods that include endocrine sensitive endpoints have been included with regard to human health and the environment. Similar data requirements and new test methods that include endocrine sensitive endpoints are included in the guidance on Regulation (EU) No 528/2012 on how to fulfil...... review on EDs and the revised strategy for the future work on endocrine disruptors, focusing on adequate detection of substances with endocrine disrupting properties under various legislative frameworks, including REACH (EC No 1907/2006), the Plant Protection Products Regulation (PPPR) (EC No 1107....../2009) and the Biocidal Products Regulation (BPR) (EC No 528/2012). There are currently no specific information requirements or testing strategies with regard to endocrine disruption in REACH and other relevant legislations. However, in relation to biocides and recently also to plant protection products, indications...

  11. Proposal of law relative to the follow up of the sanitary and environmental consequences of nuclear tests; Proposition de loi relative au suivi des consequences sanitaires et environnementales des essais nucleaires

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2008-01-15

    This proposal of law aims at coming up to the expectations of the people (military or civilian) who participated to the nuclear tests performed by France in Sahara (Reggane and In Eker) and in French Polynesia between February 13, 1960 and January 27, 1996, and of those who lived in the vicinity of these test-sites. Many of these people suffer from health and sanitary problems which may have a direct connection with their participation to the nuclear activities in these areas. This proposal of law foresees the creation of a fund for the indemnification of the victims of these tests and the creation of a commission for the follow up of epidemiological and environmental questions. (J.S.)

  12. FDA Approval: Ibrutinib for Patients with Previously Treated Mantle Cell Lymphoma and Previously Treated Chronic Lymphocytic Leukemia.

    Science.gov (United States)

    de Claro, R Angelo; McGinn, Karen M; Verdun, Nicole; Lee, Shwu-Luan; Chiu, Haw-Jyh; Saber, Haleh; Brower, Margaret E; Chang, C J George; Pfuma, Elimika; Habtemariam, Bahru; Bullock, Julie; Wang, Yun; Nie, Lei; Chen, Xiao-Hong; Lu, Donghao Robert; Al-Hakim, Ali; Kane, Robert C; Kaminskas, Edvardas; Justice, Robert; Farrell, Ann T; Pazdur, Richard

    2015-08-15

    On November 13, 2013, the FDA granted accelerated approval to ibrutinib (IMBRUVICA capsules; Pharmacyclics, Inc.) for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. On February 12, 2014, the FDA granted accelerated approval for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy. Ibrutinib is a first-in-class Bruton's tyrosine kinase (BTK) inhibitor that received all four expedited programs of the FDA: Fast-Track designation, Breakthrough Therapy designation, Priority Review, and Accelerated Approval. Both approvals were based on overall response rate (ORR) and duration of response (DOR) in single-arm clinical trials in patients with prior treatment. In MCL (N = 111), the complete and partial response rates were 17.1% and 48.6%, respectively, for an ORR of 65.8% [95% confidence interval (CI), 56.2%-74.5%]. The median DOR was 17.5 months (95% CI, 15.8-not reached). In CLL (N = 48), the ORR was 58.3% (95% CI, 43.2%-72.4%), and the DOR ranged from 5.6 to 24.2 months. The most common adverse reactions (≥ 30% in either trial) were thrombocytopenia, diarrhea, neutropenia, bruising, upper respiratory tract infection, anemia, fatigue, musculoskeletal pain, peripheral edema, and nausea. ©2015 American Association for Cancer Research.

  13. Does the FDA have regulatory authority over adult autologous stem cell therapies? 21 CFR 1271 and the emperor's new clothes

    Directory of Open Access Journals (Sweden)

    Freeman Michael

    2012-03-01

    Full Text Available Abstract FDA has recently asserted that many autologous cell therapies once considered the practice of medicine are in fact drugs. These changes began with the creation of new sections of 21 CFR 1271 and a subsequent one word change where the FDA, without public commentary, altered a single word in its regulatory language regarding cell and tissue based therapies that asserted the authority to classify autologous tissue as drugs. The bright line between medical care and drug production can be delineated in many ways, but a simple metric that defines the dichotomy is the consent status of the patient. In healthcare, a patient can either be consented individually for a medical procedure or exposed to an unconsented risk where regulatory assurances are already in place. These new FDA policies apply rules meant to keep drugs safe in a drug factory (unconsented mass production risks to individually consented surgical procedures. We argue that there is little societal benefit to these changes and that they are already stifling medical innovation.

  14. A clinical plan for MDMA (Ecstasy) in the treatment of posttraumatic stress disorder (PTSD): partnering with the FDA.

    Science.gov (United States)

    Doblin, Rick

    2002-01-01

    The FDA and the Spanish Ministry of Health have concluded that the risk/benefit ratio is favorable under certain circumstances for clinical studies investigating MDMA-assisted psychotherapy. Both agencies have approved pilot studies in chronic posttraumatic stress disorder (PTSD) patients who have failed to obtain relief from at least one course of conventional treatment. These studies, the only ones in the world into the therapeutic use of MDMA, are being funded by a nonprofit research and educational organization, the Multidisciplinary Association for Psychedelic Studies (MAPS, www.maps.org). A rationale is offered explaining why MAPS chose to focus its limited resources on MDMA, and also on PTSD patients. A Clinical Plan is elaborated for the conduct of the "adequate and well-controlled" trials necessary to evaluate the safety and efficacy of MDMA-assisted psychotherapy for PTSD, with the studies estimated to cost about 5 million dollars and to take about five years. The Clinical Plan has been developed, in part, through analysis of the studies conducted by Pfizer in its successful effort to have Zoloft approved by the FDA for use with PTSD patients, and through review of transcripts of the FDA's Psychopharmacologic Drugs Advisory Committee meeting that recommended approval of Zoloft for PTSD.

  15. Proposal for new experimental tests of the Bose-Einstein condensation mechanism for low-energy nuclear reaction and transmutation processes in deuterium loaded micro- and nano-scale cavities

    International Nuclear Information System (INIS)

    Yeong, E. Kim; Koltick, David S.; Reifenberger, Ronald G.; Zubarev, Alexander L.

    2006-01-01

    Most of experimental results of low-energy nuclear reaction (LENR) reported so far cannot be reproduced on demand. There have been persistent. experimental results indicating that the LENR und transmutation processes in condensed matter (LENRTPCM) are surface phenomena rather than bulk phenomena. Recently, proposed Bose-Einstein condensation (BEC) mechanism may provide a suitable theoretical description of the surface phenomena. New experiments are proposed and described for testing the BEC mechanism for LENR and transmutation processes in micro- and nano-scale traps. (1) We propose the use of micro-or nano-porous conducting materials as a cathode in electrolysis experiments with heavy water with or without Li in order to stabilize the active surface spots and to enhance the effect for the purpose of improving the reproducibility of excess heat generation and nuclear emission. (2) We propose new experimental tests of the BEC mechanism by measuring the pressure and temperature dependence of LENR events using deuterium gas and those deuterated metals with or without Li. If the LENRTPCM are surface phenomena, the proposed use of micro-/nano-scale porous materials is expected to enhance and scale up the LENRTPCM effects by many orders of magnitude, and thus may lead to better reproducibility and theoretical understanding of the phenomena. (authors)

  16. Proposal for new experimental tests of the Bose-Einstein condensation mechanism for low-energy nuclear reaction and transmutation processes in deuterium loaded micro- and nano-scale cavities

    Energy Technology Data Exchange (ETDEWEB)

    Yeong, E. Kim; Koltick, David S.; Reifenberger, Ronald G.; Zubarev, Alexander L. [Department of Phsysics, Purdue University, West Lafayette, IN 47907 (United States)

    2006-07-01

    Most of experimental results of low-energy nuclear reaction (LENR) reported so far cannot be reproduced on demand. There have been persistent. experimental results indicating that the LENR und transmutation processes in condensed matter (LENRTPCM) are surface phenomena rather than bulk phenomena. Recently, proposed Bose-Einstein condensation (BEC) mechanism may provide a suitable theoretical description of the surface phenomena. New experiments are proposed and described for testing the BEC mechanism for LENR and transmutation processes in micro- and nano-scale traps. (1) We propose the use of micro-or nano-porous conducting materials as a cathode in electrolysis experiments with heavy water with or without Li in order to stabilize the active surface spots and to enhance the effect for the purpose of improving the reproducibility of excess heat generation and nuclear emission. (2) We propose new experimental tests of the BEC mechanism by measuring the pressure and temperature dependence of LENR events using deuterium gas and those deuterated metals with or without Li. If the LENRTPCM are surface phenomena, the proposed use of micro-/nano-scale porous materials is expected to enhance and scale up the LENRTPCM effects by many orders of magnitude, and thus may lead to better reproducibility and theoretical understanding of the phenomena. (authors)

  17. Proposal for New Experimental Tests of the Bose-Einstein Condensation Mechanism for Low-Energy Nuclear Reaction and Transmutation Processes in Deuterium Loaded - and Nano-Scale Cavities

    Science.gov (United States)

    Kim, Yeong E.; Koltick, David S.; Reifenberger, Ronald G.; Zubarev, Alexander L.

    2006-02-01

    Most of experimental results of low-energy nuclear reaction (LENR) reported so far cannot be reproduced on demand. There have been persistent experimental results indicating that the LENR and transmutation processes in condensed matters (LENRTPCM) are surface phenomena rather than bulk phenomena. Recently proposed Bose-Einstein condensation (BEC) mechanism may provide a suitable theoretical description of the surface phenomena. New experiments are proposed and described for testing the BEC mechanism for LENR and transmutation processes in micro- and nano-scale traps. (1) We propose the use of micro- or nano-porous conducting materials as a cathode in electrolysis experiments with heavy water with or without Li in order to stabilize the active surface spots and to enhance the effect for the purpose of improving the reproducibility of excess heat generation and nuclear emission. (2) We propose new experimental tests of the BEC mechanism by measuring the pressure and temperature dependence of LENR events using deuterium gas and these deuterated metals with or without Li. If the LENRTPCM are surface phenomena, the proposed use of micro-/nano-scale porous materials is expected to enhance and scale up the LENRTPCM effects by many order of magnitude, and thus may lead to better reproductivity and theoretical understanding of the phenomena.

  18. An Experimental Copyright Moratorium: Study of a Proposed Solution to the Copyright Photocopying Problem. Final Report to the American Society for Testing and Materials (ASTM).

    Science.gov (United States)

    Heilprin, Laurence B.

    The Committee to Investigate Copyright Problems (CICP), a non-profit organization dedicated to resolving the conflict known as the "copyright photocopying problem" was joined by the American Society for Testing and Materials (ASTM), a large national publisher of technical and scientific standards, in a plan to simulate a long-proposed…

  19. Incorporation of gypsum waste in ceramic block production: Proposal for a minimal battery of tests to evaluate technical and environmental viability of this recycling process.

    Science.gov (United States)

    Godinho-Castro, Alcione P; Testolin, Renan C; Janke, Leandro; Corrêa, Albertina X R; Radetski, Claudemir M

    2012-01-01

    Civil engineering-related construction and demolition debris is an important source of waste disposed of in municipal solid waste landfills. After clay materials, gypsum waste is the second largest contributor to the residential construction waste stream. As demand for sustainable building practices grows, interest in recovering gypsum waste from construction and demolition debris is increasing, but there is a lack of standardized tests to evaluate the technical and environmental viability of this solid waste recycling process. By recycling gypsum waste, natural deposits of gypsum might be conserved and high amounts of the waste by-product could be reused in the civil construction industry. In this context, this paper investigates a physical property (i.e., resistance to axial compression), the chemical composition and the ecotoxicological potential of ceramic blocks constructed with different proportions of clay, cement and gypsum waste, and assesses the feasibility of using a minimal battery of tests to evaluate the viability of this recycling process. Consideration of the results for the resistance to axial compression tests together with production costs revealed that the best formulation was 35% of plastic clay, 35% of non-plastic clay, 10% of Portland cement and 20% of gypsum waste, which showed a mean resistance of 4.64MPa. Energy dispersive X-ray spectrometry showed calcium and sulfur to be the main elements, while quartz, gypsum, ettringite and nacrite were the main crystalline compounds found in this formulation. Ecotoxicity tests showed that leachate from this formulation is weakly toxic toward daphnids and bacteria (EC(20%)=69.0 and 75.0, respectively), while for algae and fish the leachate samples were not toxic at the EC(50%) level. Overall, these results show that the addition of 20% of gypsum waste to the ceramic blocks could provide a viable substitute for clay in the ceramics industry and the tests applied in this study proved to be a useful tool

  20. A proposal for a precision test of the standard model by neutrino-electron scattering (Large /hacek C/erenkov Detector Project)

    International Nuclear Information System (INIS)

    Allen, R.C.; Lu, X-Q.; Gollwitzer, K.

    1988-04-01

    A precision measurement of neutrino-electron elastic scattering from a beam stop neutrino source at LAMPF is proposed. The total error in sin 2 θ/sub W/ is estimated to be +-0.89/percent/. The experiment also will be sensitive to neutrino oscillations and supernova-neutrino bursts, and should set improved limits on the neutrino-charge radius and magnetic-dipole moment. The detector consists of a 2.5-million-gallon tank of water with approximately 14,000 photomultiplier tubes lining the surfaces of the tank. Neutrino-electron scattering events will be observed from the /hacek C/erenkov radiation emitted by the electrons in the water. 19 refs

  1. A proposal for a precision test of the standard model by neutrino-electron scattering (Large /hacek C/erenkov Detector Project)

    Energy Technology Data Exchange (ETDEWEB)

    Allen, R.C.; Lu, X-Q.; Gollwitzer, K.; Igo, G.J.; Gulmez, E.; Whitten, C.; VanDalen, G.; Layter, J.; Fung, Sun Yui; Shen, B.C.

    1988-04-01

    A precision measurement of neutrino-electron elastic scattering from a beam stop neutrino source at LAMPF is proposed. The total error in sin/sup 2/theta/sub W/ is estimated to be +-0.89/percent/. The experiment also will be sensitive to neutrino oscillations and supernova-neutrino bursts, and should set improved limits on the neutrino-charge radius and magnetic-dipole moment. The detector consists of a 2.5-million-gallon tank of water with approximately 14,000 photomultiplier tubes lining the surfaces of the tank. Neutrino-electron scattering events will be observed from the /hacek C/erenkov radiation emitted by the electrons in the water. 19 refs.

  2. Model-based development and testing of advertising messages: A comparative study of two campaign proposals based on the MECCAS model and a conventional approach

    DEFF Research Database (Denmark)

    Bech-Larsen, Tino

    theoretically valid and comprehensible guidelines for message development potentially enhances the effects of advertising messages and improves the possibility of measuring such effects. Moreover, such guidelines also have potential implications for the managerial communication processes (client......1. Traditionally the development of advertising messages has been based on "creative independence", sometimes catalysed by inductively generated empirical data. Due to the recent intensified focus on advertising effectiveness, this state of affair is now beginning to change. 2. Implementing......-agency and intra-agency) involved in the development of advertising messages. 3. The purpose of the study described in this paper is to compare the development and effects of two campaign proposals, with the common aim of increasing the consumption of apples among young Danes (18 to 35 years of age). One...

  3. The FDA Unapproved Drugs Initiative: An Observational Study of the Consequences for Drug Prices and Shortages in the United States.

    Science.gov (United States)

    Gupta, Ravi; Dhruva, Sanket S; Fox, Erin R; Ross, Joseph S

    2017-10-01

    Hundreds of drug products are currently marketed in the United States without approval from the FDA. The 2006 Unapproved Drugs Initiative (UDI) requires manufacturers to remove these drug products from the market or obtain FDA approval by demonstrating evidence of safety and efficacy. Once the FDA acts against an unapproved drug, fewer manufacturers remain in the market, potentially enabling drug price increases and greater susceptibility to drug shortages. There is a need for systematic study of the UDI's effect on prices and shortages of all targeted drugs. To examine the clinical evidence for approval and association with prices and shortages of previously unapproved prescription drugs after being addressed by the UDI. Previously unapproved prescription drugs that faced UDI regulatory action or with at least 1 product that received FDA approval through manufacturers' voluntary compliance with the UDI between 2006 and 2015 were identified. The clinical evidence was categorized as either newly conducted clinical trials or use of previously published literature and/or bioequivalence studies to demonstrate safety and efficacy. We determined the change in average wholesale price, presence of shortage, and duration of shortage for each drug during the 2 years before and after UDI regulatory action or approval through voluntary compliance. Between 2006 and 2015, 34 previously unapproved prescription drugs were addressed by the UDI. Nearly 90% of those with a drug product that received FDA approval were supported by literature reviews or bioequivalence studies, not new clinical trial evidence. Among the 26 drugs with available pricing data, average wholesale price during the 2 years before and after voluntary approval or UDI action increased by a median of 37% (interquartile range [IQR] = 23%-204%; P Innovation; from the Blue Cross Blue Shield Association to better understand medical technology evidence generation; from the Centers for Medicare & Medicaid Services to

  4. Synthesis and characterization of a microporous 6FDA-polyimide made from a novel carbocyclic pseudo Tröger's base diamine: Effect of bicyclic bridge on gas transport properties

    KAUST Repository

    Abdulhamid, Mahmoud A.; Ma, Xiaohua; Miao, Xiaohe; Pinnau, Ingo

    2017-01-01

    ,11-methanodibenzo[a,e][8]annulene (iCTBDA), were designed for the synthesis of microporous 6FDA-based polyimides (6FDA-CTBDA and 6FDA-iCTBDA). Both polyimides were soluble, exhibited excellent thermal stability of ∼490 °C, and had high surface areas of 587 m2 g−1 (6

  5. Twentieth Anniversary of Leptin discovery and the Approval of Myalept by FDA

    Directory of Open Access Journals (Sweden)

    Ata Mahmoodpoor

    2015-04-01

    Full Text Available Leptin is a 16 kDa hormone that is mainly expressed in adipose tissues (1. The major target of leptin is hypothalamus and it suppresses food intake and energy consumption, consequently diminishing adipose deposits and body weight (2, 3. The OB gene was isolated by Friedman in 1994 (4.  Based on the suggestion of Roger Guillemin, Friedman named this new hormone "leptin" from the Greek lepto meaning thin (5, 6. Since leptin discovery, numerous studies have been conducted on its physiological effects and its function in pathological conditions. Most of studies on leptin concentrated on its metabolic actions (7, receptors (8 and further broad functions such as immunity modulation (9 and memory processing (10. Considering such a vast range of functions, it is clear that patients with lack of leptin physiologically need pharmacological interventions. At this moment, we are in the twentieth year of leptin discovery. Finally, FDA approved a drug named Myalept (metreleptin for injection on February 2014 to treat rare metabolic disease caused by leptin deficiency. Congenital generalized lipodystrophy is a disorder with partial lack of fat tissues (11. The trial for the safety and effectiveness of Myalept demonstrated decrease in HbA1c, fasting blood glucose, and triglycerides (11. Nevertheless, there are some limitations to the usage of Myalept in HIV-related lipodystrophy and some metabolic disorders (11. Moreover, it may increase the risk of lymphoma by producing anti-metreleptin antibodies neutralizing endogenous leptin. Considering these concerns, Myalept is available only through a limited profile under a Risk Evaluation and Mitigation Strategy (REMS. Myalept is contraindicated in patients with general obesity not related to congenital leptin deficiency (12. Even though, Myalept has very limited indications for use in general population, it is considered a milestone towards the discovery of novel treatments for Leptin deficiencies and disorders

  6. Proposal of the concept of selection of accidents that release large amounts of radioactive substances in the high temperature engineering test reactor

    International Nuclear Information System (INIS)

    Ono, Masato; Honda, Yuki; Takada, Shoji; Sawa, Kazuhiro

    2015-01-01

    In Position, construction and equipment of testing and research reactor to be subjected to the use standards for rules Article 53 (prevention of expansion of the accident to release a large amount of radioactive material) generation the frequency is a lower accident than design basis accident, when what is likely to release a large amount of radioactive material or radiation from the facility has occurred, and take the necessary measures in order to prevent the spread of the accident. There is provided a lower accident than frequency design basis accidents, for those that may release a large amount of radioactive material or radiation. (author)

  7. A PROPOSED NOVEL ARCHITECTURE OF EC CONTROL SYSTEM USING IEEE 802.11n NETWORK AT ITER-INDIA GYROTRON TEST FACILITY

    Directory of Open Access Journals (Sweden)

    Deepak Mandge

    2017-06-01

    Full Text Available IEEE 802.11 Wi-Fi networks are increasingly becoming popular for its use in industrial applications. With the availability of recent amendments to IEEE 802.11 series of standards, particularly IEEE 802.11n, the adoption of Wi-Fi networks for process automation is gaining more focus and importance. The installation of Wireless networks naturally provides reduction in cable and its maintenance related costs, provides increased flexibility and mobility to enhance performance of industrial control system. The IEEE 802.11n supports parameterization that can be set for particular industrial applications and hence it has addressed to the aspects of timeliness and criticality to some extent. This paper proposes the use of IEEE 802.11n network to interconnect field instruments with Siemens PLC controller in harsh EMI/EMC environment. An application example is shown where the alternate control system architecture is developed in which non-critical and non-safety signals are communicated over Wi-Fi. While, for critical and safety signals, traditional hardwired signals methods can be implemented.

  8. Surveys for desert tortoise on the proposed site of a high-level nuclear waste repository at the Nevada Test Site

    International Nuclear Information System (INIS)

    Collins, E.; Sauls, M.L.; O'Farrell, T.P.

    1983-01-01

    The National Waste Terminal Storage Program is a national search for suitable sites to isolate commercial spent nuclear fuel or high-level radioactive waste. The Nevada Nuclear Waste Storage Investigation (NNWSI) managed by the U.S. Department of Energy (DOE), Nevada Operations Office, was initiated to study the suitability of a portion of Yucca Mountain on the DOE's Nevada Test Site (NTS) as a location for such a repository. EG and G was contracted to provide information concerning the ecosystems encountered on the site. A comprehensive literature survey was conducted to evaluate the status and completeness of the existing biological information for the previously undisturbed area. Site specific studies were begun in 1981 when preliminary field surveys confirmed the presence of the desert tortoise (Gopherus agassizi) within the project area FY82 studies were designed to determine the overall distribution and abundance of the tortoise within the area likely to be impacted by NNWSI activities. The Yucca Mountain area of the Nevada Test Site is situated close to the northern range limit of the desert tortoise. Prior to the 1982 surveys, the desert tortoise was reported from only nine locations on NTS. A known population had been under study in Rock Valley about 25 miles southeast of the project area. However, the distribution and population densities of tortoise in the southwest portion of NTS were virtually unknown. Results of our surveys indicate that desert tortoise can be expected, albeit in small numbers, in a wide range of Mojavean and Transitional habitats

  9. Proposal for a Full-Scale Prototype Single-Phase Liquid Argon Time Projection Chamber and Detector Beam Test at CERN

    CERN Document Server

    Kutter, T

    2015-01-01

    The Deep Underground Neutrino Experiment (DUNE) will use a large liquid argon (LAr) detector to measure the CP violating phase, determine the neutrino mass hier- archy and perform precision tests of the three-flavor paradigm in long-baseline neutrino oscillations. The detector will consist of four modules each with a fiducial mass of 10 kt of LAr and due to its unprecedented size will allow sensitive searches for proton decay and the detection and measurement of electron neutrinos from core collapse supernovae [1]. The first 10 kt module will use single-phase LAr detection technique and be itself modular in design. The successful manufacturing, installation and operation of several full-scale detector components in a suitable configuration represents a critical engineering milestone prior to the construction and operation of the first full 10 kt DUNE detector module at the SURF underground site. A charged particle beam test of a prototype detector will provide critical calibration measurements as well as inva...

  10. Proposal for the award of a contract for the supply, testing, installation and commissioning of the proximity cryogenic system for the ATLAS toroid magnet system

    CERN Document Server

    European Organization for Nuclear Research

    2002-01-01

    This document concerns the award of a contract for the supply, testing, installation and commissioning of the proximity cryogenic system for the ATLAS toroid magnet system. Following a market survey carried out among 61 firms in ten Member States and 14 firms in three non-Member States, a call for tenders (IT-2624/EP/ATLAS) was sent on 19 April 2002 to four firms and three consortia in six Member States and two firms in one non-Member State. By the closing date, CERN had received three tenders. The Finance Committee is invited to agree to the negotiation of a contract with AIR LIQUIDE ITALIA (IT), the lowest bidder, for the supply, testing, installation and commissioning of the proximity cryogenic system for the ATLAS toroid magnet system for a total amount not exceeding 2 840 000 euros (4 191 300 Swiss francs), not subject to revision. The rate of exchange which has been used is that stipulated in the tender. This procurement will be financed by the ATLAS Common Fund and CERN's contribution will not exceed 8...

  11. Proposal for the award of a contract for the design, supply, installation, commissioning and testing at CERN of eight helium dryer units for the LHC

    CERN Document Server

    2001-01-01

    This document concerns the award of a contract for the design, supply, installation, commissioning and testing at CERN of eight helium dryer units for the LHC. Following a market survey carried out among 42 firms in ten Member States, a call for tenders (IT-2722/LHC/LHC) was sent on 10 August 2000 to seven firms and three consortia, consisting of two firms each, in seven Member States. By the closing date, CERN had received five tenders from three firms and two consortia in five Member States. The Finance Committee is invited to agree to the negotiation of a contract with the firm COSMI (IT), the lowest bidder fulfilling the technical requirements, for the design, supply, installation, commissioning and testing at CERN of eight helium dryer units for a total amount of 3 514 779 euros, (5 307 329 Swiss francs), not subject to revision, with options for additional equipment for heating the adsorber bed and additional heat exchanger/condenser equipment, for an additional amount of 80 081 euros (120 923 Swiss fra...

  12. Proposal to negotiate, without competitive tendering, a contract for the manufacture, testing and delivery of 320 cryogenic helium mass flowmeters for the LHC

    CERN Document Server

    2001-01-01

    This document concerns the manufacture, testing and delivery of 320 cryogenic helium mass flowmeters for the LHC. Following a market survey (MS-2602/LHC/LHC) carried out amoung 37 firms in twelve Member States and six firms in two non-Member States, a price enquiry for qualifying prototypes was sent on 20 November 1998 to nine selected firms and the received prototypes were evaluated. As a result of this process a request for quotation was sent to one firm The Finance Committee is invited to agree to the negotiation of a contract with the firm EMERSON PROCESS MANAGEMENT/FISHER-ROSEMOUNT (CH), without competitive tendering, for the manufacture, testing and delivery of 320 cryogenic helium mass flowmeters for an amount of 1 804 840 Swiss francs, not subject to revision, with options for up to 10 additional cryogenic helium mass flowmeters and an extension of the guarantee period to five years for all units for an amount of 219 090 Swiss francs, not subject to revision, bringing the total amount to 2 023 930 Swi...

  13. [HIVAb, HCVAb and HBsAg seroprevalence among inmates of the prison of Bologna and the effect of counselling on the compliance of proposed tests].

    Science.gov (United States)

    Sabbatani, Sergio; Giuliani, Ruggero; Fulgaro, Ciro; Paolillo, Pasquale; Baldi, Elena; Chiodo, Francesco

    2004-01-01

    The aims of the study were to evaluate the HIVAb, HCVAb and HBsAg seroprevalence among Italian and foreign inmates of the prison of Bologna, to evaluate if the extensive counselling of "new" inmates has significantly enhanced adherence to laboratory tests. The serological status was determined by a blood withdraw following the informed consent. Before asking their consent, patients were informed by cultural mediators who had been instructed about the aims of the study/exam during introductory meetings. The initial step managed by mediators was followed by further individual counselling interventions, carried out by hospital infective disease unit, prison and prison drug abuse service physicians. The laboratory tests were performed in an external structure. Prison of Bologna. The study was conducted on 433 subjects among a whole population of 900 inmates in the local prison: 390 subjects were males (90.1%) and 43 were females (9.9%). The median age of the whole population was 34.86 years (+/- 9.9). The studied population counted 147 (33.9%) intravenous drug users (IDU) and 286 not addicts (66.1%). As regards nationality, 212 subjects were Italian (48.9%) and 221 (51.1%) foreigners. Among the total 433 inmates considered, 78 (18%) were known as previous IDU with conviction history or condemned to long term sentences, while 59 (13.6%) were inmates recently convicted active IDU assisted by the internal drug abusers service. The third group was composed by 296 inmates imprisoned during the summer (103 Italians and 193 foreigners) self declared not IDU. A. 12.5% of inmates were HIV positive, 8.1% HBV positive and 31.1% HCV positive. 25 subjects were found positive both to HIV and HCV; 1 both to HIV and HBV and 5 to HIV, HBV and HCV. HIV positivity is more common among Italian vs. foreigners inmates, among IDU vs. not IDU. HCV positivity is more common among Italian vs. foreigners inmates, and among IDU vs. not IDU. The distribution of HBV seropositivity among the

  14. A proposal for a test method for assessment of hazard property HP 12 (“Release of an acute toxic gas”) in hazardous waste classification - Experience from 49 waste

    OpenAIRE

    Hennebert , Pierre; Samaali , Ismahen; Molina , Pauline

    2016-01-01

    International audience; A stepwise method for assessment of the HP 12 is proposed and tested with 49 waste samples. The hazard property HP 12 is defined as “Release of an acute toxic gas”: waste which releases acute toxic gases (Acute Tox. 1, 2 or 3) in contact with water or an acid. When a waste contains a substance assigned to one of the following supplemental hazards EUH029, EUH031 and EUH032, it shall be classified as hazardous by HP 12 according to test methods or guidelines (EC, 2014a, ...

  15. The "high solubility" definition of the current FDA Guidance on Biopharmaceutical Classification System may be too strict for acidic drugs.

    Science.gov (United States)

    Yazdanian, Mehran; Briggs, Katherine; Jankovsky, Corinne; Hawi, Amale

    2004-02-01

    The purpose of this study was to assess if the definition of high solubility as proposed in the FDA Guidance on Biopharmaceutical Classification System (BCS) is too strict for highly permeable acidic drugs. The solubility and permeability values of 20 (18 acidic and 2 non-acidic) nonsteroidal anti-inflammatory drugs (NSAID) were determined. The NSAIDs were grouped into three different sets having acetic acid, propionic acid, or other acidic moieties such as fenamate, oxicam, and salicylate. Two nonacidic NSAIDs (celecoxib and rofecoxib) were also included for comparison purposes. Equilibrium solubility values were determined at pH 1.2, 5.0, 7.4, and in biorelevant media simulating fed intestinal fluid at pH 5.0. For a select number of acids, we also measured solubility values in media simulating gastric and fasted intestinal fluids. Permeability classification was established relative to that of reference drugs in the Caco-2 cell permeability model. Permeability coefficients for all drugs were measured at concentrations corresponding to the lowest and highest marketed dose strengths dissolved in 250 ml volume, and their potential interaction with cellular efflux pumps was investigated. All NSAIDs with different acidic functional groups were classified as highly permeable based on their Caco-2 cell permeability. Only ketorolac appeared to have a potential for interaction with cellular efflux pumps. Solubility classification was based on comparison of equilibrium solubility at pH 1.2, 5.0. and 7.4 relative to marketed dose strengths in 250 ml. The pKa values for the acidic NSAIDs studied were between 3.5 and 5.1. and, as expected, their solubility increased dramatically at pH 7.4 compared to pH 1.2. Only three NSAIDs, ketorolac, ketoprofen. and acetyl salicylic acid, meet the current criteria for high solubility over the entire pH range. However, with the exception of ibuprofen, oxaprozin, and mefenamic acid, the remaining compounds can be classified as Class I drugs

  16. OSQAR-CHASE Proposal

    CERN Document Server

    (Pugnat, P; (Sulc, M

    2015-01-01

    For 2015, the OSQAR collaboration will focus on a new proposal for the search of chameleon, a hypothetical scalar particle postulated as a dark energy candidate with an environment-dependant mass. The required experimental set-up has been successfully tested and validated in 2014 at the SM-18 experimental hall. This proposal will focus on the sensitivity that can be reached during the OSQAR chameleon run in 2015 as well as to possible upgrade phases of the experiment for the coming years.

  17. Information Regarding the OraQuick In-Home HIV Test

    Science.gov (United States)

    ... detect HIV infection. Therefore, FDA cannot give the public any assurance that the results obtained using an unapproved test system are accurate. back to top More Information How can I obtain additional information about the ...

  18. [A study for testing the antifungal susceptibility of yeast by the Japanese Society for Medical Mycology (JSMM) method. The proposal of the modified JSMM method 2009].

    Science.gov (United States)

    Nishiyama, Yayoi; Abe, Michiko; Ikeda, Reiko; Uno, Jun; Oguri, Toyoko; Shibuya, Kazutoshi; Maesaki, Shigefumi; Mohri, Shinobu; Yamada, Tsuyoshi; Ishibashi, Hiroko; Hasumi, Yayoi; Abe, Shigeru

    2010-01-01

    The Japanese Society for Medical Mycology (JSMM) method used for testing the antifungal susceptibility of yeast, the MIC end point for azole antifungal agents, is currently set at IC(80). It was recently shown, however that there is an inconsistency in the MIC value between the JSMM method and the CLSI M27-A2 (CLSI) method, in which the end- point was to read as IC(50). To resolve this discrepancy and reassess the JSMM method, the MIC for three azoles, fluconazole, itraconazole and voriconazole were compared to 5 strains of each of the following Candida species: C. albicans, C. glabrata, C. tropicalis, C. parapsilosis and C. krusei, for a total of 25 comparisons, using the JSMM method, a modified JSMM method, and the CLSI method. The results showed that when the MIC end- point criterion of the JSMM method was changed from IC(80) to IC(50) (the modified JSMM method) , the MIC value was consistent and compatible with the CLSI method. Finally, it should be emphasized that the JSMM method, using a spectrophotometer for MIC measurement, was superior in both stability and reproducibility, as compared to the CLSI method in which growth was assessed by visual observation.

  19. 76 FR 34083 - Agency Information Collection Activities; Proposed Collection; Comment Request; Data To Support...

    Science.gov (United States)

    2011-06-10

    ... communication campaigns. Such knowledge will provide the needed target audience understanding to design... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0401... Communications Usability Testing, as Used by the Food and Drug Administration AGENCY: Food and Drug...

  20. An analysis of the warning letters issued by the FDA to pharmaceutical manufacturers regarding misleading health outcomes claims

    Directory of Open Access Journals (Sweden)

    Chatterjee S

    2012-12-01

    Full Text Available Objective: To evaluate the number and type of warning letters issued by the US Food and Drug Administration (FDA to pharmaceutical manufacturers for promotional violations.Methods: Two reviewers downloaded, printed and independently evaluated warning letters issued by the FDA to pharmaceutical manufacturers from years 2003-2008. Misleading claims were broadly classified as clinical, Quality-of-Life (QoL, and economic claims. Clinical claims included claims regarding unsubstantiated efficacy, safety and tolerability, superiority, broadening of indication and/or omission of risk information. QoL claims included unsubstantiated quality of life and/or health-related quality of life claims. Economic claims included any form of claim made on behalf of the pharmaceutical companies related to cost superiority of or cost savings from the drug compared to other drugs in the market.Results: In the 6-year study period, 65 warning letters were issued by FDA, which contained 144 clinical, three QoL, and one economic claim. On an average, 11 warning letters were issued per year. Omission of risk information was the most frequently violated claim (30.6% followed by unsubstantiated efficacy claims (18.6%. Warning letters were primarily directed to manufacturers of cardiovascular (14.6%, anti-microbial (14.6%, and CNS (12.5% drugs. Majority of the claims referenced in warning letters contained promotional materials directed to physicians (57%. Conclusion: The study found that misleading clinical outcome claims formed the majority of the promotional violations, and majority of the claims were directed to physicians. Since inadequate promotion of medications may lead to irrational prescribing, the study emphasizes the importance of disseminating reliable, credible, and scientific information to patients, and more importantly, physicians to protect public health.

  1. 4th Global CRO Council for Bioanalysis: coadministered drugs stability, EMA/US FDA guidelines, 483s and carryover.

    Science.gov (United States)

    Lowes, Steve; Jersey, Jim; Shoup, Ronald; Garofolo, Fabio; Needham, Shane; Couerbe, Philippe; Lansing, Tim; Bhatti, Masood; Sheldon, Curtis; Hayes, Roger; Islam, Rafiq; Lin, Zhongping; Garofolo, Wei; Moussallie, Marc; Teixeira, Leonardo de Souza; Rocha, Thais; Jardieu, Paula; Truog, James; Lin, Jenny; Lundberg, Richard; Breau, Alan; Dilger, Carmen; Bouhajib, Mohammed; Levesque, Ann; Gagnon-Carignan, Sofi; Jenkins, Rand; Nicholson, Robert; Lin, Ming Hung; Karnik, Shane; DeMaio, William; Smith, Kirk; Cojocaru, Laura; Allen, Mike; Fatmi, Saadya; Sayyarpour, Farhad; Malone, Michele; Fang, Xinping

    2012-04-01

    The Global CRO Council for Bioanalysis (GCC) was formed in September 2010. Since then, the representatives of the member companies come together periodically to openly discuss bioanalysis and the regulatory challenges unique to the outsourcing industry. The 4th GCC Closed Forum brought together experts from bioanalytical CROs to share and discuss recent issues in regulated bioanalysis, such as the impact of coadministered drugs on stability, some differences between European Medicines Agency and US FDA bioanalytical guidance documents and lessons learned following recent Untitled Letters. Recent 483s and agency findings, as well as issues on method carryover, were also part of the topics discussed.

  2. Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation: Report of an FDA Public Workshop.

    Science.gov (United States)

    Zhang, X; Duan, J; Kesisoglou, F; Novakovic, J; Amidon, G L; Jamei, M; Lukacova, V; Eissing, T; Tsakalozou, E; Zhao, L; Lionberger, R

    2017-08-01

    On May 19, 2016, the US Food and Drug Administration (FDA) hosted a public workshop, entitled "Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation." The topic of mechanistic oral absorption modeling, which is one of the major applications of physiologically based pharmacokinetic (PBPK) modeling and simulation, focuses on predicting oral absorption by mechanistically integrating gastrointestinal transit, dissolution, and permeation processes, incorporating systems, active pharmaceutical ingredient (API), and the drug product information, into a systemic mathematical whole-body framework. © 2017 The Authors CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.

  3. FDA-CDC Antimicrobial Resistance Isolate Bank: a Publicly Available Resource To Support Research, Development, and Regulatory Requirements.

    Science.gov (United States)

    Lutgring, Joseph D; Machado, María-José; Benahmed, Faiza H; Conville, Patricia; Shawar, Ribhi M; Patel, Jean; Brown, Allison C

    2018-02-01

    The FDA-CDC Antimicrobial Resistance Isolate Bank was created in July 2015 as a publicly available resource to combat antimicrobial resistance. It is a curated repository of bacterial isolates with an assortment of clinically important resistance mechanisms that have been phenotypically and genotypically characterized. In the first 2 years of operation, the bank offered 14 panels comprising 496 unique isolates and had filled 486 orders from 394 institutions throughout the United States. New panels are being added. Copyright © 2018 American Society for Microbiology.

  4. [Guidance of FDA risk evaluation and mitigation strategy and enlightenment to drug risk management of post-marketing Chinese medicine].

    Science.gov (United States)

    Li, Yuanyuan; Xie, Yanming

    2011-10-01

    The FDA risk evaluation and mitigation strategy (REMS) aims to drugs or biological products known or potential serious risk management. Analysis with the example of the content of the Onsolis REMS named FOCOS. Our country can be reference for the analysis of relevant experience and establish a scientific evaluation mechanism, strengthen the drug risk consciousness, promote the rational drug use, organic combined with the before-marketing and post-marketing evaluation of traditional Chinese medicine, and promote the evaluation of risk management of the drug development and improvement.

  5. Evaluating the Impact of U.S. Food and Drug Administration-Proposed Nutrition Facts Label Changes on Young Adults' Visual Attention and Purchase Intentions

    Science.gov (United States)

    Graham, Dan J.; Roberto, Christina A.

    2016-01-01

    Background: The U.S. Food and Drug Administration (FDA) has proposed modifying the Nutrition Facts Label (NFL) on food packages to increase consumer attention to this resource and to promote healthier dietary choices. Aims: The present study sought to determine whether the proposed NFL changes will affect consumer attention to the NFL or purchase…

  6. Agreements and Discrepancies between FDA Reports and Journal Papers on Biologic Agents Approved for Rheumatoid Arthritis: A Meta-Research Project.

    Directory of Open Access Journals (Sweden)

    Gil Amarilyo

    Full Text Available Sponsors that seek to commercialize new drugs apply to the Food and Drug Administration (FDA which independently analyzes the raw data and reports the results on its website.This study sought to determine if there are differences between the FDA assessments and journal reports on biologic agents developed for the treatment of rheumatoid arthritis.Available data on FDA-approved drugs were extracted from the website, and a systematic literature search was conducted to identify matching studies in peer-reviewed medical journals. Outcome measures were the American College of Rheumatology response criteria ACR20 (efficacy and withdrawal due to adverse events (safety. As effect size odds ratios were estimated for each active trial arm vs. control arm (i.e. for both sources: FDA and journal report, followed by calculation of the ratios of the FDA and journal report odds ratios. A ratio of odds ratios not equal to 1 was categorized as a discrepancy.FDA reports were available for 8 of 9 FDA-approved biologic agents for rheumatoid arthritis; all identified trials (34 except one were published in peer-reviewed journals. Overall, discrepancies were noted for 20 of the 33 evaluated trials. Differences in the apparent benefit reporting were found in 39% (24/61 pairwise comparisons and in 11 cases these were statistically significant; the FDA report showed greater benefit than the journal publication in 15 comparisons and lesser benefit in 9. Differences in the reported harms were found in 51% (28/55 pairwise comparisons and were statistically significant in 5. The "signal" in FDA reports showed a less harmful effect than the journal publication in 17 comparisons whereas a more harmful effect in 11. The differences were attributed to differences in analytic approach, patient inclusion, rounding effect, and counting discrepancies. However, no differences were categorized as critical.There was no empirical evidence to suggest biased estimates between the two

  7. Accurate identification of ALK positive lung carcinoma patients: novel FDA-cleared automated fluorescence in situ hybridization scanning system and ultrasensitive immunohistochemistry.

    Directory of Open Access Journals (Sweden)

    Esther Conde

    Full Text Available BACKGROUND: Based on the excellent results of the clinical trials with ALK-inhibitors, the importance of accurately identifying ALK positive lung cancer has never been greater. However, there are increasing number of recent publications addressing discordances between FISH and IHC. The controversy is further fuelled by the different regulatory approvals. This situation prompted us to investigate two ALK IHC antibodies (using a novel ultrasensitive detection-amplification kit and an automated ALK FISH scanning system (FDA-cleared in a series of non-small cell lung cancer tumor samples. METHODS: Forty-seven ALK FISH-positive and 56 ALK FISH-negative NSCLC samples were studied. All specimens were screened for ALK expression by two IHC antibodies (clone 5A4 from Novocastra and clone D5F3 from Ventana and for ALK rearrangement by FISH (Vysis ALK FISH break-apart kit, which was automatically captured and scored by using Bioview's automated scanning system. RESULTS: All positive cases with the IHC antibodies were FISH-positive. There was only one IHC-negative case with both antibodies which showed a FISH-positive result. The overall sensitivity and specificity of the IHC in comparison with FISH were 98% and 100%, respectively. CONCLUSIONS: The specificity of these ultrasensitive IHC assays may obviate the need for FISH confirmation in positive IHC cases. However, the likelihood of false negative IHC results strengthens the case for FISH testing, at least in some situations.

  8. FDA Approval: Palbociclib for the Treatment of Postmenopausal Patients with Estrogen Receptor-Positive, HER2-Negative Metastatic Breast Cancer.

    Science.gov (United States)

    Beaver, Julia A; Amiri-Kordestani, Laleh; Charlab, Rosane; Chen, Wei; Palmby, Todd; Tilley, Amy; Zirkelbach, Jeanne Fourie; Yu, Jingyu; Liu, Qi; Zhao, Liang; Crich, Joyce; Chen, Xiao Hong; Hughes, Minerva; Bloomquist, Erik; Tang, Shenghui; Sridhara, Rajeshwari; Kluetz, Paul G; Kim, Geoffrey; Ibrahim, Amna; Pazdur, Richard; Cortazar, Patricia

    2015-11-01

    On February 3, 2015, the FDA granted accelerated approval to palbociclib (IBRANCE, Pfizer Inc.), an inhibitor of cyclin-dependent kinases 4 and 6 (CDK4 and CDK6), for use in combination with letrozole for the treatment of postmenopausal women with estrogen receptor (ER)-positive, HER2-negative advanced breast cancer as initial endocrine-based therapy for their metastatic disease. The approval is based on a randomized, multicenter, open-label phase I/II trial (PALOMA-1) in 165 patients randomized to palbociclib (125 mg orally daily for 21 consecutive days, followed by 7 days off treatment) plus letrozole (2.5 mg orally daily) or letrozole alone. The phase II portion of the trial was divided into two cohorts: cohort 1 enrolled 66 biomarker-unselected patients and cohort 2 enrolled 99 biomarker-positive patients. The major efficacy outcome measure was investigator-assessed progression-free survival (PFS). A large magnitude of improvement in PFS was observed in patients receiving palbociclib plus letrozole compared with patients receiving letrozole alone (HR, 0.488; 95% confidence interval, 0.319-0.748). Multiple sensitivity analyses were supportive of clinical benefit. The most common adverse reaction in patients receiving palbociclib plus letrozole was neutropenia. This article summarizes the FDA thought process and data supporting accelerated approval based on PALOMA-1 that may be contingent upon verification and description of clinical benefit in the ongoing and fully accrued confirmatory trial PALOMA-2. ©2015 American Association for Cancer Research.

  9. Drug disposition and drug-drug interaction data in 2013 FDA new drug applications: a systematic review.

    Science.gov (United States)

    Yu, Jingjing; Ritchie, Tasha K; Mulgaonkar, Aditi; Ragueneau-Majlessi, Isabelle

    2014-12-01

    The aim of the present work was to perform a systematic review of drug metabolism, transport, pharmacokinetics, and DDI data available in the NDAs approved by the FDA in 2013, using the University of Washington Drug Interaction Database, and to highlight significant findings. Among 27 NMEs approved, 22 (81%) were well characterized with regard to drug metabolism, transport, or organ impairment, in accordance with the FDA drug interaction guidance (2012) and were fully analyzed in this review. In vitro, a majority of the NMEs were found to be substrates or inhibitors/inducers of at least one drug metabolizing enzyme or transporter. However, in vivo, only half (n = 11) showed clinically relevant drug interactions, with most related to the NMEs as victim drugs and CYP3A being the most affected enzyme. As perpetrators, the overall effects for NMEs were much less pronounced, compared with when they served as victims. In addition, the pharmacokinetic evaluation in patients with hepatic or renal impairment provided useful information for further understanding of the drugs' disposition. Copyright © 2014 by The American Society for Pharmacology and Experimental Therapeutics.

  10. Hypersensitivity reactions to anticancer agents: Data mining of the public version of the FDA adverse event reporting system, AERS

    Directory of Open Access Journals (Sweden)

    Sakaeda Toshiyuki

    2011-10-01

    Full Text Available Abstract Background Previously, adverse event reports (AERs submitted to the US Food and Drug Administration (FDA database were reviewed to confirm platinum agent-associated hypersensitivity reactions. The present study was performed to confirm whether the database could suggest the hypersensitivity reactions caused by anticancer agents, paclitaxel, docetaxel, procarbazine, asparaginase, teniposide, and etoposide. Methods After a revision of arbitrary drug names and the deletion of duplicated submissions, AERs involving candidate agents were analyzed. The National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 was applied to evaluate the susceptibility to hypersensitivity reactions, and standardized official pharmacovigilance tools were used for quantitative detection of signals, i.e., drug-associated adverse events, including the proportional reporting ratio, the reporting odds ratio, the information component given by a Bayesian confidence propagation neural network, and the empirical Bayes geometric mean. Results Based on 1,644,220 AERs from 2004 to 2009, the signals were detected for paclitaxel-associated mild, severe, and lethal hypersensitivity reactions, and docetaxel-associated lethal reactions. However, the total number of adverse events occurring with procarbazine, asparaginase, teniposide, or etoposide was not large enough to detect signals. Conclusions The FDA's adverse event reporting system, AERS, and the data mining methods used herein are useful for confirming drug-associated adverse events, but the number of co-occurrences is an important factor in signal detection.

  11. U.S. FDA Approval Summary: Nivolumab for Treatment of Unresectable or Metastatic Melanoma Following Progression on Ipilimumab.

    Science.gov (United States)

    Hazarika, Maitreyee; Chuk, Meredith K; Theoret, Marc R; Mushti, Sirisha; He, Kun; Weis, Shawna L; Putman, Alexander H; Helms, Whitney S; Cao, Xianhua; Li, Hongshan; Zhao, Hong; Zhao, Liang; Welch, Joel; Graham, Laurie; Libeg, Meredith; Sridhara, Rajeshwari; Keegan, Patricia; Pazdur, Richard

    2017-07-15

    On December 22, 2014, the FDA granted accelerated approval to nivolumab (OPDIVO; Bristol-Myers Squibb) for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Approval was based on a clinically meaningful, durable objective response rate (ORR) in a non-comparative analysis of 120 patients who received 3 mg/kg of nivolumab intravenously every 2 weeks with at least 6-month follow-up in an ongoing, randomized, open-label, active-controlled clinical trial. The ORR as assessed by a blinded independent review committee per RECIST v1.1 was 31.7% (95% confidence interval, 23.5-40.8). Ongoing responses were observed in 87% of responding patients, ranging from 2.6+ to 10+ months. In 13 patients, the response duration was 6 months or longer. The risks of nivolumab, including clinically significant immune-mediated adverse reactions (imARs), were assessed in 268 patients who received at least one dose of nivolumab. The FDA review considered whether the ORR and durations of responses were reasonably likely to predict clinical benefit, the adequacy of the safety database, and systematic approaches to the identification, description, and patient management for imARs in product labeling. Clin Cancer Res; 23(14); 3484-8. ©2017 AACR . ©2017 American Association for Cancer Research.

  12. Software-Related Recalls of Health Information Technology and Other Medical Devices: Implications for FDA Regulation of Digital Health.

    Science.gov (United States)

    Ronquillo, Jay G; Zuckerman, Diana M

    2017-09-01

    Policy Points: Medical software has become an increasingly critical component of health care, yet the regulation of these devices is inconsistent and controversial. No studies of medical devices and software assess the impact on patient safety of the FDA's current regulatory safeguards and new legislative changes to those standards. Our analysis quantifies the impact of software problems in regulated medical devices and indicates that current regulations are necessary but not sufficient for ensuring patient safety by identifying and eliminating dangerous defects in software currently on the market. New legislative changes will further deregulate health IT, reducing safeguards that facilitate the reporting and timely recall of flawed medical software that could harm patients. Medical software has become an increasingly critical component of health care, yet the regulatory landscape for digital health is inconsistent and controversial. To understand which policies might best protect patients, we examined the impact of the US Food and Drug Administration's (FDA's) regulatory safeguards on software-related technologies in recent years and the implications for newly passed legislative changes in regulatory policy. Using FDA databases, we identified all medical devices that were recalled from 2011 through 2015 primarily because of software defects. We counted all software-related recalls for each FDA risk category and evaluated each high-risk and moderate-risk recall of electronic medical records to determine the manufacturer, device classification, submission type, number of units, and product details. A total of 627 software devices (1.4 million units) were subject to recalls, with 12 of these devices (190,596 units) subject to the highest-risk recalls. Eleven of the devices recalled as high risk had entered the market through the FDA review process that does not require evidence of safety or effectiveness, and one device was completely exempt from regulatory review

  13. Submission to Ofcom: Invitation to comment for public interest test on the proposed acquisition of Sky plc by Twenty-First Century Fox, Inc.:Consultation response from the Centre for Competition Policy

    OpenAIRE

    Broughton Micova, Sarah; Reader, David

    2017-01-01

    The authors welcome the opportunity to respond to Ofcom’s invitation to comment on the application of the public interest test to the proposed Sky/21st Century Fox transaction. There already exists an abundance of evidence relating to Sky’s news production and distribution, as well as the prominence of its news content and that of the other news companies run by its senior management, which raise media plurality concerns in relation to this deal.1 We trust that Ofcom will be diligent and crea...

  14. Proposed experiment to test fundamentally binary theories

    Science.gov (United States)

    Kleinmann, Matthias; Vértesi, Tamás; Cabello, Adán

    2017-09-01

    Fundamentally binary theories are nonsignaling theories in which measurements of many outcomes are constructed by selecting from binary measurements. They constitute a sensible alternative to quantum theory and have never been directly falsified by any experiment. Here we show that fundamentally binary theories are experimentally testable with current technology. For that, we identify a feasible Bell-type experiment on pairs of entangled qutrits. In addition, we prove that, for any n , quantum n -ary correlations are not fundamentally (n -1 ) -ary. For that, we introduce a family of inequalities that hold for fundamentally (n -1 ) -ary theories but are violated by quantum n -ary correlations.

  15. Solar neutrinos: proposal for a new test

    International Nuclear Information System (INIS)

    Freedman, M.S.; Stevens, C.M.; Horivitz, E.P.; Fuchs, L.H.; Lerner, J.L.; Goodman, L.S.; Childs, W.J.; Hessler, J.

    1976-01-01

    The predicted flux on the earth of solar neutrinos has eluded detection, confounding current ideas of solar energy production by nuclear fusion. The dominant low-energy component of that flux can be detected by mass-spectrometric assay of the induced tiny concentration of 1.6 x 10 7 year lead-205 in old thallium minerals. Comments are solicited from those in all relevant disciplines

  16. Proposed test of macroscopic quantum contextuality

    International Nuclear Information System (INIS)

    Cabello, Adan

    2010-01-01

    We show that, for any system with a number of levels which can be identified with n qubits, there is an inequality for the correlations between three compatible dichotomic measurements which must be satisfied by any noncontextual theory, but is violated by any quantum state. Remarkably, the violation grows exponentially with n, and the tolerated error per correlation also increases with n, showing that state-independent quantum contextuality is experimentally observable in complex systems.

  17. Synthesis and characterization of a microporous 6FDA-polyimide made from a novel carbocyclic pseudo Tröger's base diamine: Effect of bicyclic bridge on gas transport properties

    KAUST Repository

    Abdulhamid, Mahmoud A.

    2017-10-12

    A newly designed carbocyclic pseudo Tröger\\'s base diamine (CTB) monomer, 2,8-dimethyl-3,9-diamino-5,6,11,12-tetrahydro-5,11-methanodibenzo[a,e][8]annulene (CTBDA) and its isomeric analogue 2,8-dimethyl-(1,7)(4,10)(3,9)-diamino-5,6,11,12-tetrahydro-5,11-methanodibenzo[a,e][8]annulene (iCTBDA), were designed for the synthesis of microporous 6FDA-based polyimides (6FDA-CTBDA and 6FDA-iCTBDA). Both polyimides were soluble, exhibited excellent thermal stability of ∼490 °C, and had high surface areas of 587 m2 g−1 (6FDA-CTBDA) and 562 m2 g−1 (6FDA-iCTBDA). A 6FDA-based polyimide derived from 4,10-dimethyl-3,9-diamino-6H,12H-5,11-methanodibenzo[b,f][1,5]-diazocine (6FDA-TBDA) was made for comparison to investigate the effects of the basic tertiary nitrogen functionality in the Tröger\\'s base diamine on the polymer properties relative to the carbocyclic 6FDA-CTBDA analogue. 6FDA-TBDA displayed lower gas permeabilities but moderately higher gas-pair permselectivities than 6FDA-CTBDA. The enhanced permselectivity of 6FDA-TBDA resulted exclusively from higher diffusion-based selectivity. Direct gas sorption measurements demonstrated that the basicity in the Tröger\\'s base bridge moiety enhanced the sorption capacity of CO2 only slightly and had no effect on the CO2/CH4 solubility selectivity in 6FDA-TBDA vs. 6FDA-CTBDA.

  18. Prosobranch snails as test organisms for the assessment of endocrine active chemicals--an overview and a guideline proposal for a reproduction test with the freshwater mudsnail Potamopyrgus antipodarum.

    Science.gov (United States)

    Duft, Martina; Schmitt, Claudia; Bachmann, Jean; Brandelik, Cornelius; Schulte-Oehlmann, Ulrike; Oehlmann, Jörg

    2007-02-01

    Recently, prosobranch snails have been recommended as promising candidates for test organisms for the assessment of endocrine active chemicals. Three prosobranch snail species, the freshwater mudsnail Potamopyrgus antipodarum, the freshwater ramshorn snail Marisa cornuarietis, and the marine netted whelk Nassarius reticulatus are portrayed and their respective biotests are presented together with results of laboratory experiments and biological effect monitoring surveys in the field. All characterized species are highly sensitive toward xeno-androgens [triphenyltin (TPT), tributyltin (TBT), methyltestosterone (MT) and fenarimol (FEN)], and xeno-estrogens [bisphenol A (BPA), octylphenol (OP), ethinylestradiol], and show effects at environmentally relevant, rather low concentrations in laboratory experiments. For exposure to the xeno-androgen TPT, EC(10) values range between 15.9 and 29.0 ng as Sn/L (sediment 0.03 mug as Sn/kg), for TBT, EC(10) values are found between 3.42 and 37.8 ng as Sn/L (sediment 2.98 microg as Sn/kg) and effect concentrations for FEN are calculated as 18.6 ng/L (EC(10)) and 0.19 microg/kg (EC(50) sediment; EC(10) not calculable). Exposure to xeno-estrogens yielded EC(10 )values of 13.9 ng/L (0.19 microg/kg) for BPA, a NOEC of <1 microg/L (EC(10) of 0.004 microg/kg) for OP and a NOEC of 1 ng/l (EC(10) sediment of 2.2 microg/kg) for ethinylestradiol. Responses to androgens comprised the development of imposex and the reduction of fertility or embryo production, effects of estrogens included the stimulation of egg production and embryo production, and the increased weight of glands. Also, biological effect monitoring studies with P. antipodarum and N. reticulatus in several rivers or estuarine areas revealed the capacity of the biotests to detect an androgenic or estrogenic potential of sediment samples. A comparison of the three test species with regard to sensitivity and practical aspects in routine application favors the freshwater mudsnail P

  19. FDA-iRISK--a comparative risk assessment system for evaluating and ranking food-hazard pairs: case studies on microbial hazards.

    Science.gov (United States)

    Chen, Yuhuan; Dennis, Sherri B; Hartnett, Emma; Paoli, Greg; Pouillot, Régis; Ruthman, Todd; Wilson, Margaret

    2013-03-01

    Stakeholders in the system of food safety, in particular federal agencies, need evidence-based, transparent, and rigorous approaches to estimate and compare the risk of foodborne illness from microbial and chemical hazards and the public health impact of interventions. FDA-iRISK (referred to here as iRISK), a Web-based quantitative risk assessment system, was developed to meet this need. The modeling tool enables users to assess, compare, and rank the risks posed by multiple food-hazard pairs at all stages of the food supply system, from primary production, through manufacturing and processing, to retail distribution and, ultimately, to the consumer. Using standard data entry templates, built-in mathematical functions, and Monte Carlo simulation techniques, iRISK integrates data and assumptions from seven components: the food, the hazard, the population of consumers, process models describing the introduction and fate of the hazard up to the point of consumption, consumption patterns, dose-response curves, and health effects. Beyond risk ranking, iRISK enables users to estimate and compare the impact of interventions and control measures on public health risk. iRISK provides estimates of the impact of proposed interventions in various ways, including changes in the mean risk of illness and burden of disease metrics, such as losses in disability-adjusted life years. Case studies for Listeria monocytogenes and Salmonella were developed to demonstrate the application of iRISK for the estimation of risks and the impact of interventions for microbial hazards. iRISK was made available to the public at http://irisk.foodrisk.org in October 2012.

  20. Testing Testing Testing.

    Science.gov (United States)

    Deville, Craig; O'Neill, Thomas; Wright, Benjamin D.; Woodcock, Richard W.; Munoz-Sandoval, Ana; Gershon, Richard C.; Bergstrom, Betty

    1998-01-01

    Articles in this special section consider (1) flow in test taking (Craig Deville); (2) testwiseness (Thomas O'Neill); (3) test length (Benjamin Wright); (4) cross-language test equating (Richard W. Woodcock and Ana Munoz-Sandoval); (5) computer-assisted testing and testwiseness (Richard Gershon and Betty Bergstrom); and (6) Web-enhanced testing…