WorldWideScience

Sample records for generic plant states

  1. Generic nuclear power plant component failure data bank

    International Nuclear Information System (INIS)

    Araujo Goes, A.G. de; Gibelli, S.M.O.

    1988-11-01

    This report consist in the development of a generic nuclear power plant component failure data bank. This data bank was implemented in a PC-XT microcomputer, IBM compatible, using the Open Access II program. Generic failure data tables for Westinghouse nuclear power plants and for general PWR power plants are presented. They are the final product of a research which included a preselection and a selection of data collected from the available sources in the library of CNEN (National Nuclear Energy Commission) and from the CIN/CNEN (Neclear Information Center). Futhermore, a proposal of evaluating models of average failure rates of pumps and valves are also presented. Through the electronic data bank one can easily have a generic view of failure rate ranges as well as failure models foe a certain component. It is very importante to develop procedures to collect and store generic failure data that can be quickly accessed, in order to update the Probabilistic Safety Study of Angra-1 and to used in studies which may have component failures of nuclear power plant safety systems. In the future, data specialization can be achieved by means of statistical calculations involving specific data collected from the operational experience of Angra-1 nuclear power plant and the generic data bank. (author) [pt

  2. Using Service Oriented Architecture in a Generic Virtual Power Plant

    DEFF Research Database (Denmark)

    Andersen, Peter Bach; Poulsen, Bjarne; Træholt, Chresten

    2009-01-01

    The purpose of this paper is to find and describe a suitable software framework that can be used to help implement the concept of a Generic Virtual Power Plant in the future power system. The Generic Virtual Power Plant concept, along with the utilization of distributed energy resources, has many...... the Generic Virtual Power Plant, an array of different software design principles, patterns and architectures must be applied. Especially Service Oriented Architecture (SOA) can aid in implementing the Generic Virtual Power Plant.......The purpose of this paper is to find and describe a suitable software framework that can be used to help implement the concept of a Generic Virtual Power Plant in the future power system. The Generic Virtual Power Plant concept, along with the utilization of distributed energy resources, has many...... interesting properties that can influence the future shape of power markets. The concept holds many promises including cheaper power to the consumer, a more flexible and responsive power production and the support of a more environment-friendly development. In order to realize a software solution supporting...

  3. Draft report on compilation of generic safety issues for light water reactor nuclear power plants

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1997-07-01

    A generally accepted approach to characterizing the safety concerns in nuclear power plants is to express them as safety issues which need to be resolved. When such safety issues are applicable to a generation of plants of a particular design or to a family of plants of similar design, they are termed generic safety issues. Examples of generic safety issues are those related to reactor vessel embrittlement, control rod insertion reliability or strainer clogging. The safety issues compiled in this document are based on broad international experience. This compilation is one element in the framework of IAEA activities to assist Member States in reassessing the safety of operating nuclear power plants. Refs.

  4. Draft report on compilation of generic safety issues for light water reactor nuclear power plants

    International Nuclear Information System (INIS)

    1997-07-01

    A generally accepted approach to characterizing the safety concerns in nuclear power plants is to express them as safety issues which need to be resolved. When such safety issues are applicable to a generation of plants of a particular design or to a family of plants of similar design, they are termed generic safety issues. Examples of generic safety issues are those related to reactor vessel embrittlement, control rod insertion reliability or strainer clogging. The safety issues compiled in this document are based on broad international experience. This compilation is one element in the framework of IAEA activities to assist Member States in reassessing the safety of operating nuclear power plants. Refs

  5. Catalogue of generic plant states leading to core melt in PWRs: includes appendix 1: detailed description of sequences leading to core melt

    International Nuclear Information System (INIS)

    1996-11-01

    The Task Group on thermal-hydraulic system behaviour was given a mandate from PWG 2 on Coolant System-Behaviour with the approval of CSNI to deal with the topic of Accident Management. A writing group was set up to identify generic plant states leading to core melt for pressurized water reactors (PWR) and find 'possible approaches to accident management measures' (AM-Measures) for dealing with them. From a matrix of 15 initiating events and 12 system failures (i.e. from 180 possibilities), 32 event sequences have been identified as leading to core melt. Each sequence has been divided into characteristic plant state intervals according to safety function challenges. For each of the 141 defined characteristic plant state intervals, the members of the Writing Group made proposals for AM-Measures

  6. Generic safety issues for nuclear power plants with light water reactors and measures taken for their resolution

    International Nuclear Information System (INIS)

    1998-09-01

    The IAEA Conference on 'The Safety of Nuclear Power: Strategy for the Future' in 1991 was a milestone in nuclear safety. Two of the important items addressed by this conference were ensuring and enhancing safety of operating plants and treatment of nuclear power plants built to earlier safety standards. A number of publications related to these two items issued subsequent to this conference were: A Common Basis for Judging the Safety of Nuclear Power Plants Built to Earlier Standards, INSAG-9 (1995), the IAEA Safety Guide 50-SG-O12, periodic Safety Review of Operational Nuclear Power Plants (1994) and an IAEA publication on the Safety Evaluation of Operating Nuclear Power Plants Built to Earlier Standards - A Common Basis for Judgement (1997). Some of the findings of the 1991 Conference have not yet been fully addressed. An IAEA Symposium on reviewing the Safety of Existing Nuclear Power Plants in 1996 showed that there is an urgent need for operating organizations and national authorities to review operating nuclear power plants which do not meet the high safety levels of the vast majority of plants and to undertake improvements with assistance from the international community if required. Safety reviews of operating nuclear power plants take on added importance in the context of the Convention on Nuclear safety and its implementation. The purpose of this TECDOC compilation based on broad international experience, is to assist the Member States in the reassessment of operating plants by providing a list of generic safety issues identified in nuclear power plants together with measures taken to resolve these issues. These safety issues are generic in nature with regard to light water reactors and the measures for their resolution are for use as a reference for the safety reassessment of operating plants. The TECDOC covers issues thought to be significant to Member States based on consensus process. It provides an introduction to the use of generic safety issues for

  7. The Northeast Utilities generic plant computer system

    International Nuclear Information System (INIS)

    Spitzner, K.J.

    1980-01-01

    A variety of computer manufacturers' equipment monitors plant systems in Northeast Utilities' (NU) nuclear and fossil power plants. The hardware configuration and the application software in each of these systems are essentially one of a kind. Over the next few years these computer systems will be replaced by the NU Generic System, whose prototype is under development now for Millstone III, an 1150 Mwe Pressurized Water Reactor plant being constructed in Waterford, Connecticut. This paper discusses the Millstone III computer system design, concentrating on the special problems inherent in a distributed system configuration such as this. (auth)

  8. Method for assigning sites to projected generic nuclear power plants

    Energy Technology Data Exchange (ETDEWEB)

    Holter, G.M.; Purcell, W.L.; Shutz, M.E.; Young, J.R.

    1986-07-01

    Pacific Northwest Laboratory developed a method for forecasting potential locations and startup sequences of nuclear power plants that will be required in the future but have not yet been specifically identified by electric utilities. Use of the method results in numerical ratings for potential nuclear power plant sites located in each of the 10 federal energy regions. The rating for each potential site is obtained from numerical factors assigned to each of 5 primary siting characteristics: (1) cooling water availability, (2) site land area, (3) power transmission land area, (4) proximity to metropolitan areas, and (5) utility plans for the site. The sequence of plant startups in each federal energy region is obtained by use of the numerical ratings and the forecasts of generic nuclear power plant startups obtained from the EIA Middle Case electricity forecast. Sites are assigned to generic plants in chronological order according to startup date.

  9. Method for assigning sites to projected generic nuclear power plants

    International Nuclear Information System (INIS)

    Holter, G.M.; Purcell, W.L.; Shutz, M.E.; Young, J.R.

    1986-07-01

    Pacific Northwest Laboratory developed a method for forecasting potential locations and startup sequences of nuclear power plants that will be required in the future but have not yet been specifically identified by electric utilities. Use of the method results in numerical ratings for potential nuclear power plant sites located in each of the 10 federal energy regions. The rating for each potential site is obtained from numerical factors assigned to each of 5 primary siting characteristics: (1) cooling water availability, (2) site land area, (3) power transmission land area, (4) proximity to metropolitan areas, and (5) utility plans for the site. The sequence of plant startups in each federal energy region is obtained by use of the numerical ratings and the forecasts of generic nuclear power plant startups obtained from the EIA Middle Case electricity forecast. Sites are assigned to generic plants in chronological order according to startup date

  10. Generic environmental impact statement for license renewal of nuclear plants. Final report

    International Nuclear Information System (INIS)

    1996-05-01

    This GEIS examines the possible environmental impacts that could occur as a result of renewing the licenses of individual nuclear power plants under 10 CFR 54. To the extent possible, it establishes the bounds and significance of these potential impacts. The analysis encompasses all operating light-water reactors. For each type of environmental impact, the GEIS attempts to establish generic findings covering as many plants as possible. While plant and site-specific information is used in developing the generic findings, the NRC does not intend for the GEIS to be a compilation of individual plant environmental impacts statements. This document has three principal objectives: (1) to provide an understanding of the types and severity of environmental impacts that may occur as a result of license renewal, (2) to identify and assess those impacts that are expected to be generic to license renewal, and (3) to support rulemaking (10 CFR 51) to define the number and scope of issues that need to be addressed by the applicants in plant-by-plant license renewal proceedings

  11. Evaluation of the Latest Generic Data for PSA Applications of Domestic Nuclear Plants

    International Nuclear Information System (INIS)

    Hwang, Seok Won; Oh, Ji Yong; Lee, Byung Sik

    2009-01-01

    Generic data of domestic PSAs have mostly referred to 'Advanced Light Water Reactor (ALWR) Utility Requirements Document (URD) 'issued by EPRI. Generally, current data of domestic PSA have been customized with the generic and plant specific data through Bayesian analysis. The generic reference has established by collecting US nuclear plant practices from mid 1980s to early 1990s. Over the decade, US plants had showed low performances and capabilities in operation. On the other hand, the current domestic nuclear plants shows world class performance in operation and maintenance compared with the corresponding US nuclear plants in URD. Therefore, it is necessary to apply proper generic sources which can represent the current domestic plant performances and status. In 2007, the latest generic source (NUREG/CR-6928) is published by US NRC, which deals with new types of failure modes and analysis methods. A fundamental improvement in NUREG/CR-6928 compared with previous data source is the distinction between standby and alternating/running component basic events, which shows different failure mechanisms. Significant differences were also noted running failure events occurred within and beyond the first hour for emergency diesel generators, cooling units, and pumps. This was done because the historical perspective on running failure rates indicated approximately a factor of 15 differences between the two failure rates for several component types. ALWR URD uses lognormal distribution in the estimation of failure rates. On the contrary, NUREG/CR-6928 uses beta and gamma distributions for demand and running failures, respectively. This work has proposed an approach to the application of NUREG/CR-6928 to current PSA practice by comparing it with URD data. Moreover, this attempt results in eliciting substantial insights of the establishment of the domestic generic database

  12. Evaluation of a Generic Virtual Power Plant Framework Using Service Oriented Architecture

    DEFF Research Database (Denmark)

    Andersen, Peter Bach; Poulsen, Bjarne; Decker, Morten

    2008-01-01

    interesting properties that can influence the future shape of power markets. The concept holds many promises including cheaper power to the consumer, a more flexible and responsive power production and the support of a more environment- friendly development. In order to realize a software solution supporting...... the generic virtual power plant, an array of different software design principles, patterns and architectures must be applied. Especially Service Oriented Architecture (SOA) can aid in implementing the generic virtual power plant. An analysis of the Nordic power market has been carried out in order...... to identify potential issues and barriers, henceforth mentioned as challenges, connected with the introduction of the generic virtual power plant concept. In this paper, three use case scenarios will show how each of these challenges can be overcome by the proposed solution framework. The use case scenarios...

  13. MAAP4 CANDU analysis of a generic CANDU-6 plant: preliminary results

    Energy Technology Data Exchange (ETDEWEB)

    Petoukhov, S.M.; Mathew, P.M

    2001-10-01

    To support the generic probabilistic safety analysis (PSA) program at AECL, in particular to conduct Level 2 PSA analysis of a CANDU 6 plant undergoing a postulated severe accident, the capability to conduct severe accident consequence analysis for a CANDU plant is required. For this purpose, AECL selected MAAP4 CANDU from a number of other severe accident codes. The necessary models for a generic CANDU 6 station have been implemented in the code, and the code version 0.2 beta was tested using station data, which were assembled for a generic CANDU 6 station. This paper describes the preliminary results of the consequence analysis using MAAP4 CANDU for a generic CANDU 6 station, when it undergoes a station blackout and a large loss-of-coolant accident scenario. The analysis results show that the plant response is consistent with the physical phenomena modeled and the failure criteria used. The results also confirm that the CANDU design is robust with respect to severe accidents, which is reflected in the calculated long times that are available for administering accident management measures to arrest the accident progression before the calandria vessel or containment become at risk. (author)

  14. Comparing Generic Drug Markets in Europe and the United States: Prices, Volumes, and Spending.

    Science.gov (United States)

    Wouters, Olivier J; Kanavos, Panos G; McKEE, Martin

    2017-09-01

    Policy Points: Our study indicates that there are opportunities for cost savings in generic drug markets in Europe and the United States. Regulators should make it easier for generic drugs to reach the market. Regulators and payers should apply measures to stimulate price competition among generic drugmakers and to increase generic drug use. To meaningfully evaluate policy options, it is important to analyze historical context and understand why similar initiatives failed previously. Rising drug prices are putting pressure on health care budgets. Policymakers are assessing how they can save money through generic drugs. We compared generic drug prices and market shares in 13 European countries, using data from 2013, to assess the amount of variation that exists between countries. To place these results in context, we reviewed evidence from recent studies on the prices and use of generics in Europe and the United States. We also surveyed peer-reviewed studies, gray literature, and books published since 2000 to (1) outline existing generic drug policies in European countries and the United States; (2) identify ways to increase generic drug use and to promote price competition among generic drug companies; and (3) explore barriers to implementing reform of generic drug policies, using a historical example from the United States as a case study. The prices and market shares of generics vary widely across Europe. For example, prices charged by manufacturers in Switzerland are, on average, more than 2.5 times those in Germany and more than 6 times those in the United Kingdom, based on the results of a commonly used price index. The proportion of prescriptions filled with generics ranges from 17% in Switzerland to 83% in the United Kingdom. By comparison, the United States has historically had low generic drug prices and high rates of generic drug use (84% in 2013), but has in recent years experienced sharp price increases for some off-patent products. There are policy

  15. Generic Virtual Power Plants: Management of Distributed Energy Resources under Liberalized Electricity Market

    DEFF Research Database (Denmark)

    You, Shi; Træholt, Chresten; Poulsen, Bjarne

    2009-01-01

    The emergence of Virtual Power Plant (VPP) can be attributed to the major boost of distributed energy resources (DER), which satisfies the changing needs of modern society on energy industry. Based on this concept, DER units disregarding the differences in each individualtechnology are loosely...... aggregated with a unique interface to the external grid and energy market. This paper gives a broad overview of state-of-the-art VPP concepts and proposes a detailed generic VPP (GVPP) model running in liberalized electricity market environment. An attempt is made to provide an outline of the main functions...

  16. Generic environmental impact statement for license renewal of nuclear plants

    International Nuclear Information System (INIS)

    1996-05-01

    Volume 2 of the Generic Environmental Impact Statement for License Renewal of Nuclear Plants contains the appendices. These include: (A) General characterisitics and environmental settings of domestic nuclear plants, (B) Definition of impact initiators, (C) Socioeconomics and case studies, (D) Aquatic organisms and human health, (E) Radiation protection considerations, (F) Methodology for assessing impacts to aquatic ecology and water resources, (G) Postulated accidents, and (H) Environmental statutes and regulations affecting license renewal

  17. A generic task approach to a real time nuclear power plant fault diagnosis and advisory system

    International Nuclear Information System (INIS)

    Hajek, B.K.; Miller, D.W.; Bhatnagar, R.; Stasenko, J.E.; Punch, W.F. III; Yamada, N.

    1988-01-01

    A generic task toolkit developed at The Ohio State University Laboratory for Artificial Intelligence Research (LAIR) has been used in the development of an aid for operators of nuclear power plants. The toolkit consists of high level programming tools that enable knowledge to be used in accordance with its need. That is, if diagnosis is the need, a framework for performing diagnosis is provided. The operator aid provides for monitoring the conditions in the plant, detecting abnormal events, and providing the operator with guidance and advice through procedures on what path should be followed to mitigate the consequences. 8 refs., 5 figs

  18. Generic implications of ATWS events at the Salem Nuclear Power Plant: generic implications. Vol. 1

    International Nuclear Information System (INIS)

    1983-04-01

    This report is the first of two volumes. It documents the work of an interoffice, interdisciplinary NRC Task Force established to determine the generic implications of two anticipated transients without scram (ATWS) at the Salem Nuclear Power Plant, Unit 1 on February 22 and 25, 1983. A second report will document the NRC actions to be taken based on the work of the Task Force. The Task Force was established to address three questions: (1) Is there a need for prompt action for similar equipment in other facilities. (2) Are NRC and its licensees learning the sefety-management lessons, and, (3) How should the priority and content of the ATWS rule be adjusted. A number of short-term actions were taken through Bulletins and an Information Notice. Intermediate-term actions to address the generic issues will be addressed in the separate report and implemented through appropriate regulatory mechanisms

  19. Generic Hurricane Extreme Seas State

    DEFF Research Database (Denmark)

    Wehmeyer, Christof; Skourup, Jesper; Frigaard, Peter

    2012-01-01

    Extreme sea states, which the IEC 61400-3 (2008) standard requires for the ultimate limit state (ULS) analysis of offshore wind turbines are derived to establish the design basis for the conceptual layout of deep water floating offshore wind turbine foundations in hurricane affected areas....... Especially in the initial phase of floating foundation concept development, site specific metocean data are usually not available. As the areas of interest are furthermore not covered by any design standard, in terms of design sea states, generic and in engineering terms applicable environmental background...... data is required for a type specific conceptual design. ULS conditions for different return periods are developed, which can subsequently be applied in siteindependent analysis and conceptual design. Recordings provided by National Oceanic and Atmospheric Administration (NOAA), of hurricanes along...

  20. Nuclear power plant Generic Aging Lessons Learned (GALL). Appendix B

    International Nuclear Information System (INIS)

    Kasza, K.E.; Diercks, D.R.; Holland, J.W.; Choi, S.U.

    1996-12-01

    The purpose of this generic aging lessons learned (GALL) review is to provide a systematic review of plant aging information in order to assess materials and component aging issues related to continued operation and license renewal of operating reactors. Literature on mechanical, structural, and thermal-hydraulic components and systems reviewed consisted of 97 Nuclear Plant Aging Research (NPAR) reports, 23 NRC Generic Letters, 154 Information Notices, 29 Licensee Event Reports (LERs), 4 Bulletins, and 9 Nuclear Management and Resources Council Industry Reports (NUMARC IRs) and literature on electrical components and systems reviewed consisted of 66 NPAR reports, 8 NRC Generic Letters, 111 Information Notices, 53 LERs, 1 Bulletin, and 1 NUMARC IR. More than 550 documents were reviewed. The results of these reviews were systematized using a standardized GALL tabular format and standardized definitions of aging-related degradation mechanisms and effects. The tables are included in volumes 1 and 2 of this report. A computerized data base has also been developed for all review tables and can be used to expedite the search for desired information on structures, components, and relevant aging effects. A survey of the GALL tables reveals that all ongoing significant component aging issues are currently being addressed by the regulatory process. However, the aging of what are termed passive components has been highlighted for continued scrutiny. This report consists of Volume 2, which consists of the GALL literature review tables for the NUMARC Industry Reports reviewed for the report

  1. 78 FR 37325 - License Renewal of Nuclear Power Plants; Generic Environmental Impact Statement and Standard...

    Science.gov (United States)

    2013-06-20

    ... Nuclear Power Plants; Generic Environmental Impact Statement and Standard Review Plans for Environmental... for Nuclear Power Plants, Supplement 1: Operating License Renewal'' (ESRP). The ESRP serves as a guide... published a final rule, ``Revisions to Environmental Review for Renewal of Nuclear Power Plant Operating...

  2. Validation of generic cost estimates for construction-related activities at nuclear power plants: Final report

    International Nuclear Information System (INIS)

    Simion, G.; Sciacca, F.; Claiborne, E.; Watlington, B.; Riordan, B.; McLaughlin, M.

    1988-05-01

    This report represents a validation study of the cost methodologies and quantitative factors derived in Labor Productivity Adjustment Factors and Generic Methodology for Estimating the Labor Cost Associated with the Removal of Hardware, Materials, and Structures From Nuclear Power Plants. This cost methodology was developed to support NRC analysts in determining generic estimates of removal, installation, and total labor costs for construction-related activities at nuclear generating stations. In addition to the validation discussion, this report reviews the generic cost analysis methodology employed. It also discusses each of the individual cost factors used in estimating the costs of physical modifications at nuclear power plants. The generic estimating approach presented uses the /open quotes/greenfield/close quotes/ or new plant construction installation costs compiled in the Energy Economic Data Base (EEDB) as a baseline. These baseline costs are then adjusted to account for labor productivity, radiation fields, learning curve effects, and impacts on ancillary systems or components. For comparisons of estimated vs actual labor costs, approximately four dozen actual cost data points (as reported by 14 nuclear utilities) were obtained. Detailed background information was collected on each individual data point to give the best understanding possible so that the labor productivity factors, removal factors, etc., could judiciously be chosen. This study concludes that cost estimates that are typically within 40% of the actual values can be generated by prudently using the methodologies and cost factors investigated herein

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

    Energy Technology Data Exchange (ETDEWEB)

    Demuth, Scott Francis [Los Alamos National Lab. (LANL), Los Alamos, NM (United States); Sprinkle, James K. [Los Alamos National Lab. (LANL), Los Alamos, NM (United States)

    2015-05-26

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

  4. 76 FR 54507 - Proposed Generic Communication; Draft NRC Generic Letter 2011-XX: Seismic Risk Evaluations for...

    Science.gov (United States)

    2011-09-01

    ... NUCLEAR REGULATORY COMMISSION [NRC-2011-0204] Proposed Generic Communication; Draft NRC Generic... functions. SSCs in operating nuclear power plants are designed either in accordance with, or have been... nuclear reactors. The background information relevant to this GL includes the individual plant...

  5. LISSAT Analysis of a Generic Centrifuge Enrichment Plant

    International Nuclear Information System (INIS)

    Lambert, H; Elayat, H A; O'Connell, W J; Szytel, L; Dreicer, M

    2007-01-01

    The U.S. Department of Energy (DOE) is interested in developing tools and methods for use in designing and evaluating safeguards systems for current and future plants in the nuclear power fuel cycle. The DOE is engaging several DOE National Laboratories in efforts applied to safeguards for chemical conversion plants and gaseous centrifuge enrichment plants. As part of the development, Lawrence Livermore National Laboratory has developed an integrated safeguards system analysis tool (LISSAT). This tool provides modeling and analysis of facility and safeguards operations, generation of diversion paths, and evaluation of safeguards system effectiveness. The constituent elements of diversion scenarios, including material extraction and concealment measures, are structured using directed graphs (digraphs) and fault trees. Statistical analysis evaluates the effectiveness of measurement verification plans and randomly timed inspections. Time domain simulations analyze significant scenarios, especially those involving alternate time ordering of events or issues of timeliness. Such simulations can provide additional information to the fault tree analysis and can help identify the range of normal operations and, by extension, identify additional plant operational signatures of diversions. LISSAT analyses can be used to compare the diversion-detection probabilities for individual safeguards technologies and to inform overall strategy implementations for present and future plants. Additionally, LISSAT can be the basis for a rigorous cost-effectiveness analysis of safeguards and design options. This paper will describe the results of a LISSAT analysis of a generic centrifuge enrichment plant. The paper will describe the diversion scenarios analyzed and the effectiveness of various safeguards systems alternatives

  6. Generic Containment: Detailed comparison of containment simulations performed on plant scale

    International Nuclear Information System (INIS)

    Kelm, St.; Klauck, M.; Beck, S.; Allelein, H.-J.; Preusser, G.; Sangiorgi, M.; Klein-Hessling, W.; Bakalov, I.; Bleyer, A.; Bentaib, A.; Kljenak, I.; Stempniewicz, M.; Kostka, P.; Morandi, S.; Ada del Corno, B.; Bratfisch, C.; Risken, T.; Denk, L.; Parduba, Z.; Paci, S.

    2014-01-01

    Highlights: • Consequent implementation of the recommendations derived from the OECD/NEA ISP-47. • Phenomenological code-to-code comparison performed on plant scale. • Systematic identification and elimination of the user effect. • Identification of fundamental differences in the model basis. • Application to PAR system analysis. - Abstract: One outcome of the OECD/NEA ISP-47 activity was the recommendation to elaborate a ‘Generic Containment’ in order to allow comparing and rating the results obtained by different lumped-parameter models on plant scale. Within the European SARNET2 project ( (http://www.sar-net.eu)), such a Generic Containment nodalisation, based on a German PWR (1300 MW el ), was defined. This agreement on the nodalisation allows investigating the remaining differences among the results, especially the ‘user-effect’, related to the modelling choices, as well as fundamental differences in the underlying model basis in detail. The methodology applied in order to compare the different code predictions consisted of a series of three benchmark steps with increasing complexity as well as a systematic comparison of characteristic variables and observations. This paper summarises the benchmark series, the lessons learned during specifying the steps, comparing and discussing the results and finally gives an outlook on future steps

  7. Development of generic soil profiles and soil data development for SSI analyses

    Energy Technology Data Exchange (ETDEWEB)

    Parker, Josh, E-mail: jparker@nuscalepower.com [NuScale Power, 1000 NE Circle Boulevard, Suite 10310, Corvallis, OR 97330 (United States); Khan, Mohsin; Rajagopal, Raj [ARES Corporation, 1990N California Boulevard, Suite 500, Walnut Creek, CA 94596 (United States); Groome, John [NuScale Power, 1000 NE Circle Boulevard, Suite 10310, Corvallis, OR 97330 (United States)

    2014-04-01

    This paper presents the approach to developing generic soil profiles for the design of reactor building for small modular reactor (SMR) nuclear power plant developed by NuScale Power. The reactor building is a deeply embedded structure. In order to perform soil structure interaction (SSI) analyses, generic soil profiles are required to be defined for the standardized Nuclear Power Plant (NPP) designs for the United States Nuclear Regulatory Commission (NRC) in a design control document (DCD). The development of generic soil profiles is based on utilization of information on generic soil profiles from the new standardized nuclear power plant designs already submitted to the NRC for license certification. Eleven generic soil profiles have been recommended, and those profiles cover a wide range of parameters such as soil depth, shear wave velocity, unit weight, Poisson's ratio, water table, and depth to rock strata. The soil profiles are developed for a range of shear wave velocities between bounds of 1000 fps and 8000 fps as inferred from NRC Standard Review Plan (NUREG 0800) Sections 3.7.1 and 3.7.2. To account for the soil degradation due to seismic events, the strain compatible soil properties are based on the EPRI generic soil degradation curves. In addition, one dimensional soil dynamic response analyses were performed to study the soil layer input motions for performing the SSI analyses.

  8. Regulatory analysis for the resolution of Generic Issue 115, enhancement of the reliability of the Westinghouse Solid State Protection System

    International Nuclear Information System (INIS)

    Basdekas, D.L.

    1989-05-01

    Generic Issue 115 addresses a concern related to the reliability of the Westinghouse reactor protection system for plants using the Westinghouse Solid State Protection System (SSPS). Several options for improving the reliability of the Westinghouse reactor trip function for these plants and their effect on core damage frequency (CDF) and overall risk were evaluated. This regulatory analysis includes a quantitative assessment of the costs and benefits associated with the various options for enhancing the reliability of the Westinghouse SSPS and provides insights for consideration and industry initiatives. No new regulatory requirements are proposed. 25 refs., 11 tabs

  9. Variation in cash price of the generic medications most prescribed by dermatologists in pharmacies across the United States.

    Science.gov (United States)

    Alghanem, Noor; Abokwidir, Manal; Fleischer, Alan B; Feldman, Steven R; Alghanem, Ward

    2017-03-01

    The United States has the highest drug costs in the world. Consumers complain about large price differences at pharmacies on generic drugs. To evaluate variation in cash prices of generic medications most prescribed in dermatology across different drugstores and states in United States. The 11 generic drugs most prescribed by dermatologists according to National Ambulatory Medical Care Survey were assessed. By using Google, the most common used pharmacies in United States were listed, which are located at a random selection of six states. By calling the first available number of each pharmacy in the six states and asking about the generic cash price of the smallest stock size and the most prescribed type, the data were collected. Drug prices varied; the median cumulative price of the 11 medications was highest at Rite Aid ($1226) and lowest at Walmart ($795.34) with 35% difference. The prices at CVS differed by 20% across different states; however, the prices at Walmart, Rite Aid and Walgreens were consistent. New York has the highest and Iowa the lowest prices, especially at CVS, ($1160.79) versus ($931.32). There are varieties in the prices for the generic medications in different pharmacies and States.

  10. Contribution of Anticipated Transients Without Scram (ATWS) to core melt at United States nuclear power plants

    International Nuclear Information System (INIS)

    Giachetti, R.T.

    1989-09-01

    This report looks at WASH-1400 and several other Probabilistic Risk Assessments (PRAs) and Probabilistic Safety Studies (PSSs) to determine the contribution of Anticipated Transients Without Scram (ATWS) events to the total core melt probability at eight nuclear power plants in the United States. After considering each plant individually, the results are compared from plant to plant to see if any generic conclusions regarding ATWS, or core melt in general, can be made. 8 refs., 34 tabs

  11. Nuclear power plant Generic Aging Lessons Learned (GALL). Main report and appendix A

    Energy Technology Data Exchange (ETDEWEB)

    Kaza, K.E.; Diercks, D.R.; Holland, J.W.; Choi, S.U. [and others

    1996-12-01

    The purpose of this generic aging lessons learned (GALL) review is to provide a systematic review of plant aging information in order to assess materials and component aging issues related to continued operation and license renewal of operating reactors. Literature on mechanical, structural, and thermal-hydraulic components and systems reviewed consisted of 97 Nuclear Plant Aging Research (NPAR) reports, 23 NRC Generic Letters, 154 Information Notices, 29 Licensee Event Reports (LERs), 4 Bulletins, and 9 Nuclear Management and Resources Council Industry Reports (NUMARC IRs) and literature on electrical components and systems reviewed consisted of 66 NPAR reports, 8 NRC Generic Letters, 111 Information Notices, 53 LERs, 1 Bulletin, and 1 NUMARC IR. More than 550 documents were reviewed. The results of these reviews were systematized using a standardized GALL tabular format and standardized definitions of aging-related degradation mechanisms and effects. The tables are included in volume s 1 and 2 of this report. A computerized data base has also been developed for all review tables and can be used to expedite the search for desired information on structures, components, and relevant aging effects. A survey of the GALL tables reveals that all ongoing significant component aging issues are currently being addressed by the regulatory process. However, the aging of what are termed passive components has been highlighted for continued scrutiny. This document is Volume 1, consisting of the executive summary, summary and observations, and an appendix listing the GALL literature review tables.

  12. Nuclear power plant Generic Aging Lessons Learned (GALL). Main report and appendix A

    International Nuclear Information System (INIS)

    Kasza, K.E.; Diercks, D.R.; Holland, J.W.; Choi, S.U.

    1996-12-01

    The purpose of this generic aging lessons learned (GALL) review is to provide a systematic review of plant aging information in order to assess materials and component aging issues related to continued operation and license renewal of operating reactors. Literature on mechanical, structural, and thermal-hydraulic components and systems reviewed consisted of 97 Nuclear Plant Aging Research (NPAR) reports, 23 NRC Generic Letters, 154 Information Notices, 29 Licensee Event Reports (LERs), 4 Bulletins, and 9 Nuclear Management and Resources Council Industry Reports (NUMARC IRs) and literature on electrical components and systems reviewed consisted of 66 NPAR reports, 8 NRC Generic Letters, 111 Information Notices, 53 LERs, 1 Bulletin, and 1 NUMARC IR. More than 550 documents were reviewed. The results of these reviews were systematized using a standardized GALL tabular format and standardized definitions of aging-related degradation mechanisms and effects. The tables are included in volumes 1 and 2 of this report. A computerized data base has also been developed for all review tables and can be used to expedite the search for desired information on structures, components, and relevant aging effects. A survey of the GALL tables reveals that all ongoing significant component aging issues are currently being addressed by the regulatory process. However, the aging of what are termed passive components has been highlighted for continued scrutiny. This document is Volume 1, consisting of the executive summary, summary and observations, and an appendix listing the GALL literature review tables

  13. Seismic sensitivity study of a generic CANDU nuclear power plant: Soil-structure interaction

    International Nuclear Information System (INIS)

    Lee, L.S.S.; Duff, C.G.

    1983-01-01

    The seismic sensitivity and capability study for a generic CANDU Plant is part of an overall development program of design standardization. The purpose of this paper is to investigate the sensitivities of structural responses and floor response spectra (FRS) to variations of structural and soil parameters. In the seismic design standardization, a wide range of soil conditions is considered and the envelopes of the resulting site spectra (soil-structure interaction effect) are then used for the design of the generic plant. The nuclear island structures considered herein have different relative stiffness and one of them has two layout/structure schemes: one is relatively flexible and the other is moderately stiff. In the preliminary phase of the seismic sensitivity study presented hereby, the soil-structure interaction seismic analysis is based on the half-space modelling (soil-spring lumped-mass) method and the response spectrum method for the seismic responses. Distinct patterns and sensitivity of the site spectrum analysis for structure schemes of different relative stiffness and for different structural elevations are observed and discussed. (orig.)

  14. IAEA's experience in compiling a generic component reliability data base

    International Nuclear Information System (INIS)

    Tomic, B.; Lederman, L.

    1988-01-01

    Reliability data are an essential part of probabilistic safety assessment. The quality of data can determine the quality of the study as a whole. It is obvious that component failure data originated from the plant being analyzed would be most appropriate. However, in few cases complete reliance on plant experience is possible, mainly because of the rather limited operating experience. Nuclear plants, although of different design, often use fairly similar components, so some of the experience could be combined and transferred from one plant to another. In addition information about component failures is available also from experts with knowledge on component design, manufacturing and operation. That bring us to the importance of assessing generic data. (Generic is meant to be everything that is not plant specific regarding the plant being analyzed). The generic data available in the open literature, can be divided in three broad categories. The first one includes data base used in previous analysis. These can be plant specific or updated from generic with plant specific information (latter case deserve special attention). The second one is based on compilation of plants' operating experience usually based on some kind of event reporting system. The third category includes data sources based on expert opinions (single or aggregate) or combination of expert opinions and other nuclear and non-nuclear experience. This paper reflects insights gained in compiling data from generic data sources and highlights advantages and pitfalls of using generic component reliability data in PSAs

  15. Simulation study of near-real-time accounting in a generic reprocessing plant

    International Nuclear Information System (INIS)

    Coulter, C.A.; Whiteson, R.; Zardecki, A.

    1992-01-01

    Our simulation program FacSim has been used to estimate balance closure variances for a number of real proposed nuclear material processing facilities that rely primarily on item measurements. We are enhancing the program so that it can be applied to facilities such as reprocessing plants that handle bulk materials ad primarily perform bulk and flow measurements. The extended simulation program can apply any of several types of sequential statistical tests to near-real-time accounting information to evaluate the capability of the facility accounting system to detect material and operational anomalies in a timely fashion. The program allows facility designers and operators to evaluate measurement and anomaly detection strategies before system implementation and to demonstrate facility's capability for maintaining accurate inventory information during plant operation. These features are illustrated by application to a generic reprocessing plant

  16. Method for developing cost estimates for generic regulatory requirements

    International Nuclear Information System (INIS)

    1985-01-01

    The NRC has established a practice of performing regulatory analyses, reflecting costs as well as benefits, of proposed new or revised generic requirements. A method had been developed to assist the NRC in preparing the types of cost estimates required for this purpose and for assigning priorities in the resolution of generic safety issues. The cost of a generic requirement is defined as the net present value of total lifetime cost incurred by the public, industry, and government in implementing the requirement for all affected plants. The method described here is for commercial light-water-reactor power plants. Estimating the cost for a generic requirement involves several steps: (1) identifying the activities that must be carried out to fully implement the requirement, (2) defining the work packages associated with the major activities, (3) identifying the individual elements of cost for each work package, (4) estimating the magnitude of each cost element, (5) aggregating individual plant costs over the plant lifetime, and (6) aggregating all plant costs and generic costs to produce a total, national, present value of lifetime cost for the requirement. The method developed addresses all six steps. In this paper, we discuss on the first three

  17. U.S. NRC's generic issues program

    International Nuclear Information System (INIS)

    Kauffman, J.V.; Foster, J.W.

    2008-01-01

    The United States Nuclear Regulatory Commission (NRC) has a Generic Issues Program (GIP) to address Generic Issues (GI). A GI is defined as 'a regulatory matter involving the design, construction, operation, or decommissioning of several, or a class of, NRC licensees or certificate holders that is not sufficiently addressed by existing rules, guidance, or programs'. This rather legalistic definition has several practical corollaries: First, a GI must involve safety. Second, the issue must involve at least two plants, or it would be a plant-specific issue rather than a GI. Third, the potential safety question must not be covered by existing regulations and guidance (compliance). Thus, the effect of a GI is to potentially change the body of regulations and associated guidance (e.g., regulatory guides). The GIP was started in 1976, thus it is a relatively mature program. Approximately 850 issues have been processed by the program to date. More importantly, even after 30 years, new GIs continue to be proposed. The entire set of Generic Issues (GIs) is updated annually in NUREG-0933, 'A Prioritization of Generic Safety Issues'. GIs normally involve complex questions of safety and regulation. Efficient and effective means of addressing these issues are very important for regulatory effectiveness. If an issue proves to pose a genuine, significant safety question, then swift, effective, enforceable, and cost-effective action needs to be taken. Conversely, if an issue is of little safety significance, the issue should be dismissed in an expeditious manner, avoiding unnecessary expenditure of resources and regulatory burden or uncertainty. This paper provides a summary of the 5-stage program, from identification through the regulatory assessment stage. The paper also includes a discussion of the program's seven criteria, sources of proposed GIs, recent improvements, publicly available information, historical performance, and status of current GIs. (authors)

  18. Resolution of Generic Safety Issue 29: Bolting degradation or failure in nuclear power plants

    International Nuclear Information System (INIS)

    Johnson, R.E.

    1990-06-01

    This report describes the US Nuclear Regulatory Commission's (NRC's) Generic Safety Issue 29, ''Bolting Degradation or Failure in Nuclear Power Plants,'' including the bases for establishing the issue and its historical highlights. The report also describes the activities of the Atomic Industrial Forum (AIF) relevant to this issue, including its cooperation with the Materials Properties Council (MPC) to organize a task group to help resolve the issue. The Electric Power Research Institute, supported by the AIF/MPC task group, prepared and issued a two-volume document that provides, in part, the technical basis for resolving Generic Safety Issue 29. This report presents the NRC's review and evaluation of the two-volume document and NRC's conclusion that this document, in conjunction with other information from both industry and NRC, provides the bases for resolving this issue

  19. Generic safety issues for nuclear power plants with pressurized heavy water reactors and measures for their resolution

    International Nuclear Information System (INIS)

    2007-06-01

    be used in reassessing the safety of individual operating plants. In 1998, the IAEA completed IAEA-TECDOC-1044 entitled Generic Safety Issues for Nuclear Power Plants with Light Water Reactors and Measures Taken for their Resolution and established the associated LWRGSIDB database (Computer Manual Series No. 13). The present compilation, which is based on broad international experience, is an extension of this work to cover pressurized heavy water reactors (PHWRs). As in the case of LWRs, it is one element in the framework of IAEA activities to assist Member States in reassessing the safety of operating nuclear power plants. It addresses generic safety issues identified in nuclear power plants using PHWRs. In most cases, the measures taken or planned to resolve these issues are also identified. The work on this report was initiated by the Senior Regulators of Countries Operating CANDU-Type Nuclear Power Plants at one of their annual meetings. It was carried out within the framework of the IAEA's programme on National Regulatory Infrastructure for Nuclear Installation Safety and serves to enhance regulatory effectiveness through the exchange of safety related information

  20. Generic Escherichia coli contamination of spinach at the preharvest stage: effects of farm management and environmental factors.

    Science.gov (United States)

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

    2013-07-01

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

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

    Science.gov (United States)

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

    2013-01-01

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

  2. Development of a generic data base for failure rate

    International Nuclear Information System (INIS)

    Mosleh, A.; Apostolakis, G.

    1985-01-01

    The data analysis task in a probabilistic risk assessment (PRA) involves the assessment of data needs, the collection of information, and, finally, the analysis of the data to generate estimates for various parameters. This paper describes a framework for developing a data base for component failure rates and presents mathematical methods for the analysis of various types of information. The discussion is focused on the development of generic data bases used in PRAs. For plants without an operating history, the generic distributions are used directly to calculate component unavailability. In the case of plants that have operated for some time, the generic distributions can be used as priors in Bayesian analysis and, thus, specialized by plant-specific experience

  3. Diagnosing component faults in a generic nuclear power plant using counterfactual and temporal reasoning

    International Nuclear Information System (INIS)

    Oehrstroem, P.; Nielsen, F.R.; Pedersen, S.A.

    1992-01-01

    The subject of main interest is the logical and epistemological aspects of diagnostic reasoning. The aim was to understand the role of conditionals and causality in this respect. A model of causal and temporal reasoning was developed and evaluated in a controlled but complex setting. The generic nuclear power plant was used as a test ground. The coherence and scope of a logical theory of diagnostic reasoning was studied in order to discover whether the theory constitutes an adequate tool for making correct diagnoses of component faults in a generic nuclear power plant. A diagnosing system based on the CIMP system was run on a computer model of a nuclear power plant, various errors were then introduced. The aim of the diagnosis is mainly explanation and only partly repair. The causal field defines a conceptual framework within which the diagnostic purpose is given and within which various diagnostic possibilities and causal relationships are given, here with regard to error detection in a control room. The causal field is tacitly given and related to the operator's training and experience. The logical aspects of the problem of the diagnosis is described. The computer model is described and the symptom language is introduced. The process of reasoning about the possible diagnosis is presented. The utilization of ideas similiar to the heuristic classification is discussed. A data base command language for manipulating lists of symptoms is described and the design of a CIMP user interface for symptom language visualization is outlined. (AB)

  4. HTGR generic technology program plan (FY 80)

    International Nuclear Information System (INIS)

    1980-01-01

    Purpose of the program is to develop base technology and to perform design and development common to the HTGR Steam Cycle, Gas Turbine, and Process Heat Plants. The generic technology program breaks into the base technology, generic component, pebble-bed study, technology transfer, and fresh fuel programs

  5. FPFPspace2: A code for following airborne fission products in generic nuclear plant flow paths

    International Nuclear Information System (INIS)

    Owcarski, P.C.; Burk, K.W.; Ramsdell, J.V.; Yasuda, D.D.

    1991-03-01

    In order to assure that a nuclear power plant control room remains habitable during certain types of postulated accidents, Pacific Northwest Laboratory (PNL) has undertaken a special study for the US Nuclear Regulatory Commission. This purpose of this study is to develop software that can aid in the analyses of control room habitability during accidents in which airborne fission products could challenge internal air pathways to the control room. PNL has completed an initial version (FPFP) and final version (FPFP 2) of a software package that can estimate the unsteady-state invasion of quantities of fission products into the control room or any other destination within the nuclear plant via generic internal flow paths. This report consists of three parts: Section 2.0, Technical Bases, describes the flow path components and mechanisms of natural fission product deposition; Section 3.0, FPFP 2 Code Description, describes code organization and the functions of the subroutines; and Section 4.0, Code Operation, discusses details of input requirements, code output, and a sample case demonstration. The appendices consist of an FPFP 2 Fortran code listing, a listing of a code for building input files, forms for building input files, and the sample case input and output files. 7 refs., 3 figs

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

    Science.gov (United States)

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

    2012-01-01

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

  7. Benefits of Digital Equipment Generic Qualification Activities

    International Nuclear Information System (INIS)

    Thomas, James E.; Steiman, Samuel C.

    2002-01-01

    As a result of nuclear power plant instrumentation and control obsolescence issues, there have been numerous activities during recent years relating to the qualification of digital equipment. Some of these activities have been 'generic' in nature in that the qualification was not limited to plant specific applications, but was intended to cover a broad base of potential applications of the digital equipment. These generic qualifications have been funded by equipment manufacturers and by utility groups and organizations. The generic activities sponsored by the Electric Power Research Institute (EPRI) have been pilot projects for an overall generic qualification approach. The primary benefit resulting from the generic qualification work to date is that a number of digital platforms and digital devices are now available for use in various nuclear safety-related applications. Many of the tests and evaluations necessary to support plant specific applications have been completed. The amount of data and documentation that each utility must develop on a case by case basis has been significantly reduced. There are also a number of additional benefits resulting from these industry efforts. The challenges and difficulties in qualifying digital equipment for safety-related applications are now more clearly understood. EPRI has published a lessons learned document (EPRI Report 1001452, Generic Qualification of Commercial Grade Digital Devices: Lessons Learned from Initial Pilots, which covers several different qualification areas, including device selection, project planning, vendor surveys and design reviews, and electromagnetic compatibility (EMC) qualification. Application of the experience and lessons learned from the EPRI pilot activities should help reduce the effort and cost required for future qualification work. Most generic qualification activities for commercial equipment have been conducted using the approach of EPRI TR-106439, Guideline on Evaluation and Acceptance

  8. Regulatory application of seismic experience data for nuclear power plants in the United States

    Energy Technology Data Exchange (ETDEWEB)

    Chen, Pei-Ying [Nuclear Regulatory Commission, Washington, DC (United States)

    1997-03-01

    On the basis of its review and evaluation (Reference 3) of the SQUG GIP (Reference 2) and on the basis of the differences between current seismic qualification requirements and the criteria and procedures provided in the GIP, the NRC staff does not consider the USI A-46 methodology given in the GIP to be a `seismic qualification` procedure. Rather, the staff considers the GIP methodology to be a seismic adequacy verification procedure, which was developed on the basis of generic equipment earthquake experience data, supplemented by generic equipment test data. The implementation of the GIP approach for USI A-46 plants provides safety enhancement, in certain aspects, beyond the original licensing bases. Therefore, the GIP methodology is an acceptable evaluation method, for USI A-46 plants only, to verify the seismic adequacy of the safe-shutdown equipment installed in the NPPs in the United States. With the new development in the experience-based approach for seismic qualification of equipment currently underway in the U.S. nuclear industry, there is a potential for future regulatory application of an experience-based approach as a seismic qualification method for certain selected equipment installed in NPPs in the United States. However, industry`s use of the experience-based approach will be dependent on the submittal and staff approval of this approach. (J.P.N.)

  9. Bayesian methodology for generic seismic fragility evaluation of components in nuclear power plants

    International Nuclear Information System (INIS)

    Yamaguchi, Akira; Campbell, R.D.; Ravindra, M.K.

    1991-01-01

    Bayesian methodology for updating the seismic fragility of components in nuclear power plants is presented. The generic fragility data which have been evaluated based on the past SPSAs are combined with the seismic experience data. Although the seismic experience is limited to the acceleration range below the median capacity of the components, it has been found that the evidence is effective to update the fragility tail. In other words, the uncertainty of the fragility is reduced although the median capacity itself is not modified to a great extent. The annual frequency of failure is also reduced as a result of the updating of the fragility tail. The PDF of the seismic capacity is handled in discrete form, which enables the use of arbitrary type of prior distribution. Accordingly, the Log-N prior can be used which is consistent with the widely used fragility model. For evaluating posterior fragility parameters (A m and B U ), two methods have been proposed. Furthermore, it has been found that the importance of evidence used in the Bayesian methodology can be quantified by the entropy of the evidence. Only the events with high entropy need to be considered in the Bayesian updating of the fragility. The currently available seismic experience database for typical components can be utilized to develop the fragility tail which is contributive to the seismically-induced failure frequency. The combined use of generic fragility and seismic experience data, with the aid of Bayesian methodology, provides refined generic fragility curves which are useful for SPSA studies. (author)

  10. Generic penetration in the retail antidepressant market.

    Science.gov (United States)

    Ventimiglia, Jeffrey; Kalali, Amir H

    2010-06-01

    In this article, we explore the accelerated penetration of generic antidepressants in the United States market following the availability of generic citalopram and sertraline. Analysis suggests that overall, generic penetration into the antidepressant market has grown from approximately 41 percent in January 2004 to over 73 percent in January 2010. Similar trends are uncovered when branded and generic prescriptions are analyzed by specialty.

  11. IAEA's experience in compiling a generic component reliability data base

    International Nuclear Information System (INIS)

    Tomic, B.; Lederman, L.

    1991-01-01

    Reliability data are essential in probabilistic safety assessment, with component reliability parameters being particularly important. Component failure data which is plant specific would be most appropriate but this is rather limited. However, similar components are used in different designs. Generic data, that is all data that is not plant specific to the plant being analyzed but which relates to components more generally, is important. The International Atomic Energy Agency has compiled the Generic Component Reliability Data Base from data available in the open literature. It is part of the IAEA computer code package for fault/event tree analysis. The Data Base contains 1010 different records including most of the components used in probabilistic safety analyses of nuclear power plants. The data base input was quality controlled and data sources noted. The data compilation procedure and problems associated with using generic data are explained. (UK)

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

    Science.gov (United States)

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

    2018-01-01

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

  13. Generic safety insights for inspection of boiling water reactors

    International Nuclear Information System (INIS)

    Higgins, J.C.; Taylor, J.H.; Fresco, A.N.; Hillman, B.M.

    1987-01-01

    As the number of operating nuclear power plants (NPP) increases, safety inspection has increased in importance. However, precisely what is important, and what is not important? What should one focus inspection efforts on. Over the last two years Probabilistic Risk Assessment (PR) techniques have been developed to aid in the inspection process. Broad interest in generic PRA-based methods has arisen in the past year, since only about 25% of the US nuclear power plants have completed PRAs, and also, inspectors want PRA-based tools for these plants. This paper describes the BNL program to develop generic BWR PRA-based inspection insights or inspection guidance designed to be applied to plants without PRAs

  14. Knowledge-based operation guidance system for nuclear power plants based on generic task methodology

    International Nuclear Information System (INIS)

    Yamada, Naoyuki; Chandrasekaran, B.; Bhatnager, R.

    1989-01-01

    A knowledge-based system for operation guidance of nuclear power plants is proposed. The Dynamic Procedure Management System (DPMS) is designed and developed to assist human operators interactively by selecting and modifying predefined operation procedures in a dynamic situation. Unlike most operation guidance systems, DPMS has been built based on Generic Task Methodology, which makes the overall framework of the system perspicuous and also lets domain knowledge be represented in a natural way. This paper describes the organization of the system, the definition of each task, and the form and organization of knowledge, followed by an application example. (author)

  15. Lawsuits allege price fixing by generic drug makers

    Directory of Open Access Journals (Sweden)

    Robbins RA

    2016-12-01

    Full Text Available No abstract available. Article truncated at 150 words. Two years after high generic drug prices became a public controversy, Reuters is reporting that 20 states filed a lawsuit Thursday against Mylan, Teva Pharmaceuticals and four other generic drug makers (1. The suit alleges the companies conspired to fix prices or allocated markets to prop up prices. The civil lawsuit, led by antitrust investigators in Connecticut, comes one day after the U.S. Department of Justice filed criminal charges against two former executives of the generic drug maker, Heritage. The states attorneys general asked the court to order the companies to disgorge ill-gotten gains, which were not defined, pay attorneys' fees and stop collusion. Of the states in the Southwest only Nevada is participating in the lawsuit. The cases are part of a broader generic drug pricing probe that remains under way at the state and federal level, as well as in the U.S. Congress. In 2014, media reports of …

  16. Guide for generic application of Reliability Centered Maintenance (RCM) recommendations

    International Nuclear Information System (INIS)

    Schwan, C.A.; Toomey, G.E.; Morgan, T.A.; Darling, S.S.

    1991-02-01

    Previously completed reliability centered maintenance (RCM) studies form the basis for developing or refining a preventive maintenance program. This report describes a generic methodology that will help utilities optimize nuclear plant maintenance programs using RCM techniques. This guide addresses the following areas: history of the generic methodology development process, and use of the generic methodology for conducting system-to-system and component-to-component evaluations. 2 refs., 2 figs., 5 tabs

  17. Generic hyper-diversity in Stachybotriaceae

    Czech Academy of Sciences Publication Activity Database

    Lombard, L.; Houbraken, J.; Decock, C.; Samson, R.A.; Meijer, M.; Réblová, Martina; Groenewald, J.Z.; Crous, P. W.

    2016-01-01

    Roč. 36, SI Jun (2016), s. 156-246 ISSN 0031-5850 R&D Projects: GA ČR GAP506/12/0038 Institutional support: RVO:67985939 Keywords : biodegraders * generic concept * human and plant pathogens Subject RIV: EF - Botanics Impact factor: 7.511, year: 2016

  18. Development of generic floor response spectra for equipment qualification for seismic loads

    International Nuclear Information System (INIS)

    Curren, J.R.; Costantino, C.J.

    1984-01-01

    A generic floor response spectra has been developed for use in the qualification of electrical and mechanical equipment in operating nuclear power plants. Actual PWR and BWR - Mark I structural models were used as representative of a class of structures. For each model, the stiffness properties were varied, with the same mass, so as to extend the fundamental base structure natural frequency from 2 cps to 36 cps. This resulted in fundamental mode coupled natural frequencies as low as 0.86 cps and as high as 30 cps. The characteristics of 1000 floor response spectra were studied to determine the generic spectra. A procedure for its application to any operating plant has been established. The procedure uses as much or as little information that currently exists at the plant relating to the question of equipment qualification. A generic floor response spectra is proposed for the top level of a generic structure. Reduction factors are applied to the peak acceleration for equipment at lower levels

  19. Development of generic floor response spectra for equipment qualification for seismic loads

    International Nuclear Information System (INIS)

    Curreri, J.R.; Costantino, C.J.

    1984-10-01

    A generic floor response spectra has been developed for use in the qualification of electrical and mechanical equipment in operating nuclear power plants. Actual PWR and BWR - Mark I structural models were used as representative of a class of structures. For each model, the stiffness properties were varied, with the same mass, so as to extend the fundamental base structure natural frequency from 2 cps to 36 cps. This resulted in fundamental mode coupled natural frequencies as low as 0.86 cps and as high as 30 cps. The characteristics of 1000 floor response spectra were studied to determine the generic spectra. A procedure for its application to any operating plant has been established. The procedure uses as much or as little information that currently exists at the plant relating to the question of equipment qualification. A generic floor response spectra is proposed for the top level of a generic structure. Reduction factors are applied to the peak acceleration for equipment at lower levels

  20. Comparison of Generic-to-Brand Switchback Rates Between Generic and Authorized Generic Drugs.

    Science.gov (United States)

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

    2017-04-01

    Generic drugs contain identical active ingredients as their corresponding brand drugs and are pharmaceutically equivalent and bioequivalent, whereas authorized generic drugs (AGs) contain both identical active and inactive ingredients as their corresponding brand drugs but are marketed as generics. This study compares generic-to-brand switchback rates between generic and AGs. Retrospective cohort study. Claims and electronic health record data from a regional U.S. health care system. The full cohort consisted of 5542 unique patients who received select branded drugs during the 6 months prior to their generic drug market availability (between 1999 and 2014) and then were switched to an AG or generic drug within 30 months of generic drug entry. For these patients, 5929 unique patient-drug combinations (867 with AGs and 5062 with generic drugs) were evaluated. Ten drugs with AGs and generics marketed between 1999 and 2014 were evaluated. The date of the first generic prescription was considered the index date for each drug, and it marked the beginning of follow-up to evaluate the occurrence of generic-to-brand switchback patterns over the subsequent 30 months. Switchback rates were compared between patients receiving AGs versus those receiving generics using multivariable Cox proportional hazards models, controlling for individual drug effects, age, sex, Charlson Comorbidity Score, pre-index drug use characteristics, and pre-index health care utilization. Among the 5542 unique patients who switched from brand to generic or brand to AG, 264 (4.8%) switched back to the brand drug. Overall switchback rates were similar for AGs compared with generics (hazard ratio [HR] 0.86, 95% confidence interval [CI] 0.65-1.15). The likelihood of switchback was higher for alendronate (HR 1.64, 95% CI 1.20-2.23) and simvastatin (HR 1.81, 95% CI 1.30-2.54) and lower for amlodipine (HR 0.27, 95% CI 0.17-0.42) compared with the other drugs evaluated. Overall switchback rates were similar

  1. Co-ordinated research programme on benchmark study for the seismic analysis and testing of WWER-type nuclear power plants. V. 2. Generic material: Codes, standards, criteria. Working material

    International Nuclear Information System (INIS)

    1995-01-01

    The Co-ordinated research programme on the benchmark study for the seismic analysis and testing of WWER-type nuclear power plants was initiated subsequent to the request from representatives of Member States. The conclusions adopted at the Technical Committee Meeting on Seismic Issues related to existing nuclear power plants held in Tokyo in 1991 called for the harmonization of methods and criteria used in Member States in issues related to seismic safety. The Consulltants' Meeting which followed resulted in producing a working document for CRP. It was decided that a benchmark study is the most effective way to achieve the principal objective. Two types of WWER reactors (WWER-440/213 and WWER-1000) were selected as prototypes for the benchmark exercise to be tested on a full scale using explosions and/or vibration generators. The two prototypes are Kozloduy Units 5/6 for WWER-1000 and Paks for WWER-440/213 nuclear power plants. This volume of Working material contains reports related to generic material, namely codes, standards and criteria for benchmark analysis

  2. Co-ordinated research programme on benchmark study for the seismic analysis and testing of WWER-type nuclear power plants. V. 2. Generic material: Codes, standards, criteria. Working material

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1995-07-01

    The Co-ordinated research programme on the benchmark study for the seismic analysis and testing of WWER-type nuclear power plants was initiated subsequent to the request from representatives of Member States. The conclusions adopted at the Technical Committee Meeting on Seismic Issues related to existing nuclear power plants held in Tokyo in 1991 called for the harmonization of methods and criteria used in Member States in issues related to seismic safety. The Consulltants' Meeting which followed resulted in producing a working document for CRP. It was decided that a benchmark study is the most effective way to achieve the principal objective. Two types of WWER reactors (WWER-440/213 and WWER-1000) were selected as prototypes for the benchmark exercise to be tested on a full scale using explosions and/or vibration generators. The two prototypes are Kozloduy Units 5/6 for WWER-1000 and Paks for WWER-440/213 nuclear power plants. This volume of Working material contains reports related to generic material, namely codes, standards and criteria for benchmark analysis.

  3. Generic penetration in the retail atypical antipsychotic market.

    Science.gov (United States)

    Lenderts, Susan; Kalali, Amir H; Buckley, Peter

    2010-03-01

    In this article, we explore the penetration of generic atypical antipsychotics in the United States market before and after the availability of generic risperidone in July 2008. Analysis suggests that, overall, generic penetration into the atypical antipsychotic market has grown from approximately three percent in January 2008 to more than 25 percent in December 2009. Similar trends are uncovered when branded and generic prescriptions are analyzed by specialty.

  4. Practicing the Generic (City)

    DEFF Research Database (Denmark)

    Hansen, Lone Koefoed

    2010-01-01

    Flanagan proposes that most locative media artworks neglect the particularities of spaces, their historical and political layers. Koolhaas, on the other hand, states that all urban areas are alike, that we are facing a global Generic City. The paper analyses digital media artist Esther Polak......’s NomadicMILK project in light of the generic and particular properties of space as laid out by Flanagan and Koolhaas in order to discuss the possible reconfiguring practices of locative media....

  5. The Politics and Policies of Regulating Generics in Latin America: A Survey of Seventeen States.

    Science.gov (United States)

    Sweet, Cassandra M

    2017-06-01

    When patents expire, are equivalent generic alternatives available to citizens? This article contributes to current discussion on access to medicine in the aftermath of the World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The focus is on off-patent or "generic" medicines: their product definitions, quality standards and prescription procedures. Drawing from a survey conducted of seventeen countries across the Latin American region, this article examines the differences in definition of off-patent products and the paradox of their relatively lower consumption across multiple developing states. The findings point to pathways for improving standards, consumer information, and access in off-patent pharmaceutical markets. Copyright © 2017 by Duke University Press.

  6. Advances on generic exemption levels and generic clearance levels in the argentinean regulatory field

    International Nuclear Information System (INIS)

    Muñiz, C.C.; Bossio, M.C.

    2011-01-01

    With the aim of optimizing the regulatory effort in Argentina, the Nuclear Regulatory Authority (ARN) evaluated two worldwide concepts used in the radioactive waste management field: “Generic Exemption Levels” and “Generic Clearance Levels”. The objective of this paper is to present the progress made in the past two years in relation to these topics and to present the results of the specific requests received from users of radioactive material. Since the approval of both Generic Levels, the ARN received two exemption requests. The first one, regarding the practice of dismantling lighting rods with 241 Am. The other case regards the international trade, distribution, usage and final disposal of lighting products with radioactive material ( 85 Kr and 232 Th). Concerning clearance, there has not been any request yet. However, in the future the ARN expects to receive this kind of requests from nuclear power plants and other facilities related to the nuclear fuel cycle. (authors) [es

  7. RBMK nuclear power plants: Generic safety issues. A publication of the extrabudgetary programme on the safety of WWER and RBMK nuclear power plants

    International Nuclear Information System (INIS)

    1996-05-01

    This report has been prepared on the basis of above mentioned report and it is intended to provide information on RBMK NPPs generic safety issues. As all other insights, recommendations and conclusions resulting from the IAEA Programme, this report is intended to assist national decision makers, who have sole responsibility for the regulation and safe operation of their nuclear power plants. It also serves to focus national and international projects on priority of the RBMK safety improvements. 23 refs, 10 figs, 3 tabs

  8. Light Water Reactor Generic Safety Issues Database (LWRGSIDB). User's manual

    International Nuclear Information System (INIS)

    1999-01-01

    resolved in other plants and which can be used in reassessing the safety of individual operating plants. The IAEA-TECDOC-1044, Generic Safety Issues for Nuclear Power Plants with Light Water Reactors and Measures Taken for Their Resolution (September 1998), is a compilation of such safety issues which is based on broad international experience. This compilation is one element within the framework of IAEA activities to assist Member States in reassessing the safety of operating nuclear power plants. It is a compilation not only of the generic safety issues identified in nuclear power plants but also, in almost all cases, the measures taken to resolve these issues. The safety issues, which are generic in nature with regard to light water reactors (LWRs), and the measures taken for their resolution, are intended for use as a reference in the reassessment of the safety of operating plants.The information contained in the main body of the TECDOC has been used to establish a database. This database has search, query and report functions. This information is thus available in an electronic form which can be selectively queried and with which reports can be produced according to the requirements of the user. The database also enables the IAEA to update the data periodically on the basis of information made available by Member States

  9. Generic safety questions. evaluation of investigations, studies and expertises of other states for the knowledge base GeSi; Generische Sicherheitsfragen. Auswertung von Untersuchungen, Studien und Gutachten anderer Staaten fuer die Wissensbasis GeSi

    Energy Technology Data Exchange (ETDEWEB)

    Boenigke, Guenther; Eismar, Shanna

    2016-03-15

    For the non-profit-making expert organization Gesellschaft fuer Anlagen- und Reaktorsicherheit (GRS) gGmbH, maintaining know-how and broadening its knowledge in the field of nuclear safety is of fundamental relevance. One important approach to achieving this goal is to collect and assess national and international findings and events in the field of nuclear safety e.g. in connection with generic issues - i.e. issues that are not specific to a particular plant. The GeSi/GeSi International database and its subsystems serves for reflecting the current state of the art in science and technology in the field of generic issues and also as a tool in the area of knowledge management. Within the framework of Project 3611 I 01500 sponsored by the BMUB, information on these issues was compiled systematically. The aim of the project was to examine the safety issues that are cur-rently discussed at national and international level with regard to their relevance for the conditions prevailing in Germany and to follow up in detail those issues that are of relevance for national safety practice. Similar knowledge databases also exist in other major nuclear-power-plant-operating countries such as the US, Canada, and France. At present (September 2014), there are 303 issues in the overall database, of which 23 are assessed to be of ''high'' significance for German plants. Of these, 16 issues belong to the sub-database for generic safety issues (GSI) and seven belong to the sub-database for generic research issues (GFO). The database GSI currently contains 138 issues that need to be further addressed and 101 issues that are considered as solved. 43 issues from the database GFO require further investigation, while 21 issues are considered as solved.

  10. Effect of generic issues program on improving safety

    International Nuclear Information System (INIS)

    Fard, M. R.; Kauffman, J. V.

    2010-01-01

    The U.S. Nuclear Regulatory Commission (NRC) identifies (by its assessment of plant operation) certain issues involving public health and safety, the common defense and security, or the environment that could affect multiple entities under NRC jurisdiction. The Generic Issues Program (GIP) addresses the resolution of these Generic Issues (GIs). The resolution of these issues may involve new or revised rules, new or revised guidance, or revised interpretation of rules or guidance that affect nuclear power plant licensees, nuclear material certificate holders, or holders of other regulatory approvals. U.S. NRC provides information related to the past and ongoing GIP activities to the general public by the use of three main resources, namely NUREG-0933, 'Resolution of Generic Safety Issues, ' Generic Issues Management Control System (GIMCS), and GIP public web page. GIP information resources provide information such as historical information on resolved GIs, current status of the open GIs, policy documents, program procedures, GIP annual and quarterly reports and the process to contact GIP and propose a GI This paper provides an overview of the GIP and several examples of safety improvements resulting from the resolution of GIs. In addition, the paper provides a brief discussion of a few recent GIs to illustrate how the program functions to improve safety. (authors)

  11. Generic phytosanitary irradiation treatments

    Energy Technology Data Exchange (ETDEWEB)

    Hallman, Guy J [United States Department of Agriculture, Agricultural Research Service, Weslaco, TX (United States)

    2013-01-15

    The history of the development of generic phytosanitary irradiation (PI) treatments is discussed beginning with its initial proposal in 1986. Generic PI treatments in use today are 150 Gy for all hosts of Tephritidae, 250 Gy for all arthropods on mango and papaya shipped from Australia to New Zealand, 300 Gy for all arthropods on mango shipped from Australia to Malaysia, 350 Gy for all arthropods on lychee shipped from Australia to New Zealand and 400 Gy for all hosts of insects other than pupae and adult Lepidoptera shipped to the United States. Efforts to develop additional generic PI treatments and reduce the dose for the 400 Gy treatment are ongoing with a broad based 5-year, 12-nation cooperative research project coordinated by the joint Food and Agricultural Organization/International Atomic Energy Agency Program on Nuclear Techniques in Food and Agriculture. Key groups identified for further development of generic PI treatments are Lepidoptera (eggs and larvae), mealybugs and scale insects. A dose of 250 Gy may suffice for these three groups plus others, such as thrips, weevils and whiteflies. (author)

  12. Generic phytosanitary irradiation treatments

    Science.gov (United States)

    Hallman, Guy J.

    2012-07-01

    The history of the development of generic phytosanitary irradiation (PI) treatments is discussed beginning with its initial proposal in 1986. Generic PI treatments in use today are 150 Gy for all hosts of Tephritidae, 250 Gy for all arthropods on mango and papaya shipped from Australia to New Zealand, 300 Gy for all arthropods on mango shipped from Australia to Malaysia, 350 Gy for all arthropods on lychee shipped from Australia to New Zealand and 400 Gy for all hosts of insects other than pupae and adult Lepidoptera shipped to the United States. Efforts to develop additional generic PI treatments and reduce the dose for the 400 Gy treatment are ongoing with a broad based 5-year, 12-nation cooperative research project coordinated by the joint Food and Agricultural Organization/International Atomic Energy Agency Program on Nuclear Techniques in Food and Agriculture. Key groups identified for further development of generic PI treatments are Lepidoptera (eggs and larvae), mealybugs and scale insects. A dose of 250 Gy may suffice for these three groups plus others, such as thrips, weevils and whiteflies.

  13. Generic component failure data base

    International Nuclear Information System (INIS)

    Eide, S.A.; Calley, M.B.

    1992-01-01

    This report discusses comprehensive component generic failure data base which has been developed for light water reactor probabilistic risk assessments. The Nuclear Computerized Library for Assessing Reactor Reliability (NUCLARR) was used to generate component failure rates. Using this approach, most of the failure rates are based on actual plant data rather then existing estimates

  14. Plant state display device

    International Nuclear Information System (INIS)

    Kadota, Kazuo; Ito, Toshiichiro.

    1994-01-01

    The device of the present invention conducts information processing suitable for a man to solve a problem in a plant such as a nuclear power plant incorporating a great amount of information, where safety is required and provides information to an operator. Namely, theories and rules with respect to the flow and balanced state of materials and energy upon plant start-up, and a vapor cycle of operation fluids are symbolized and displayed on the display screen of the device. Then, the display of the plant information suitable to the information processing for a man to dissolve problems is provided. Accordingly, a mechanism for analyzing a purpose of the plant is made more definite, thereby enabling to prevent an erroneous judgement of an operator and occurrence of plant troubles. In addition, a simular effect can also be expected when the theories and rules with respect to the flow and the balanced state of materials and energy and thermohydrodynamic behavior of the operation fluids in a state of after-heat removing operation during shutdown of the plant are symbolized and displayed. (I.S.)

  15. Generic evaluation of feedwater transients and small break loss-of-coolant accidents in combustion engineering designed operating plants

    International Nuclear Information System (INIS)

    1980-01-01

    The purpose of this report is to summarize the results of a generic evaluation of feedwater transients, small break loss-of-coolant accidents (LOCAs), and other TMI-2-related events in the Combustion Engineering (CE)-designed operating plants and to establish or confirm the bases for their continued operation. The results of this evaluation are presented in this report in the form of a set of findings and recommendations in each of the principal review areas

  16. Generic phytosanitary irradiation treatments

    International Nuclear Information System (INIS)

    Hallman, Guy J.

    2012-01-01

    The history of the development of generic phytosanitary irradiation (PI) treatments is discussed beginning with its initial proposal in 1986. Generic PI treatments in use today are 150 Gy for all hosts of Tephritidae, 250 Gy for all arthropods on mango and papaya shipped from Australia to New Zealand, 300 Gy for all arthropods on mango shipped from Australia to Malaysia, 350 Gy for all arthropods on lychee shipped from Australia to New Zealand and 400 Gy for all hosts of insects other than pupae and adult Lepidoptera shipped to the United States. Efforts to develop additional generic PI treatments and reduce the dose for the 400 Gy treatment are ongoing with a broad based 5-year, 12-nation cooperative research project coordinated by the joint Food and Agricultural Organization/International Atomic Energy Agency Program on Nuclear Techniques in Food and Agriculture. Key groups identified for further development of generic PI treatments are Lepidoptera (eggs and larvae), mealybugs and scale insects. A dose of 250 Gy may suffice for these three groups plus others, such as thrips, weevils and whiteflies. - Highlights: ► The history of phytosanitary irradiation (PI) treatments is given. ► Generic PI treatments in use today are discussed. ► Suggestions for future research are presented. ► A dose of 250 Gy for most insects may suffice.

  17. A survey exploring knowledge and perceptions of general practitioners towards the use of generic medicines in the northern state of Malaysia.

    Science.gov (United States)

    Chua, Gin Nie; Hassali, Mohamed Azmi; Shafie, Asrul Akmal; Awaisu, Ahmed

    2010-05-01

    The objective of this study was to evaluate the general practitioners' (GPs') knowledge and perceptions towards generic medicines in a northern state of Malaysia. A postal cross-sectional survey involving registered GPs in Penang, Malaysia was undertaken. A 23-item questionnaire was developed, validated and administered on the GPs. Eighty-seven GPs responded to the survey (response rate 26.8%). The majority of the respondents (85.1%) claimed that they actively prescribed generic medicines in their practice. On the other hand, only 4.6% of the respondents correctly identified the Malaysia's National Pharmaceutical Control Bureau's bioequivalence standard for generic products. There were misconceptions among the respondents about the concepts of "bioequivalence", "efficacy", "safety", and "manufacturing standards" of generic medicines. GPs in this survey believed that a standard guideline on brand substitution process, collaboration with pharmacists, patient education and information on safety and efficacy of generic medicines were necessary to ensure quality use of generics. Furthermore, advertisements and product bonuses offered by pharmaceutical companies, patient's socio-economic factors as well as credibility of manufacturers were factors reported to influence their choice of medicine. Although it appeared that GPs have largely accepted the use of generic medicines, they still have concerns regarding the reliability and quality of such products. GPs need to be educated and reassured about generic products approval system in Malaysia concerning bioequivalence, quality, and safety. The current findings have important implications in establishing generic medicines policy in Malaysia. Copyright (c) 2009 Elsevier Ireland Ltd. All rights reserved.

  18. Is bioavailability altered in generic versus brand anticonvulsants?

    Science.gov (United States)

    Jankovic, Slobodan M; Ignjatovic Ristic, Dragana

    2015-03-01

    Therapeutic window of anticonvulsants is not a wide one, with phenytoin being one extreme, which can be classified as a narrow therapeutic index drug, since its ratio between the least toxic and the least effective concentration is less than twofold. In order to obtain marketing authorization, a generic anticonvulsant should demonstrate relative bioequivalence with its brand-name counterpart. However, although bioequivalent, generic anticonvulsants still do not have the same bioavailability as brand-name drugs, which may lead to larger fluctuations of steady-state plasma concentrations, and sometimes to loss of seizure control if a patient is switched from brand-name to generic or from generic to generic anticonvulsant. Generic anticonvulsants are effective, safe and affordable drugs for treatment of epilepsy, and patients could be successfully treated with them from the very beginning. It is switching from brand-name to generic anticonvulsant or from one generic anticonvulsant to another that should be avoided in clinical practice, since subtle differences in bioavailability may disturb optimal degree of seizure control to which the patient was previously successfully titrated.

  19. Once more the generic name Passerina Vieillot

    NARCIS (Netherlands)

    Oort, van E.D.

    1910-01-01

    The note on the generic name of the Snow-bunting by Dr. E. Hartert in this part of our periodical gives me cause to revert to the subject of my note on the generic name Passerina Vieillot and to state here, that I stand to what I have said about the rejection of this name in Zoology (Notes Leyden

  20. Modified enforcement policy relating to 10 CFR 50.49, ''Environmental qualification of electrical equipment important to safety for nuclear power plants'' (Generic Letter 88-07)

    International Nuclear Information System (INIS)

    Miraglia, F.J.

    1992-01-01

    Generic Letters, Bulletins, and Information Notices have been issued to provide guidance regarding the application and enforcement of 10 CFR 50.49, ''Environmental Qualification of Electric Equipment Important to Safety for Nuclear Power Plants.'' Generic Letter 85-15, issued August 6, 1985, and Generic Letter 86-15, issued September 22, 1986, provided information related to the deadlines for compliance with 10 CFR 50.49 and possible civil penalties applicable to licensees who were not in compliance with the rule as of the November 30, 1985 deadline. Upon review, the Commission found that the EQ Enforcement Policy promulgated in Generic Letter 86-15, could result in imposition of civil penalties that did not properly reflect the safety significance of EQ violations with respect to civil penalties imposed in the past. In the interest of continuing a tough but fair enforcement policy, the Commission determined that the EQ Enforcement Policy should be revised. The purpose of this letter is to provide a modification to the NRC's enforcement policy, as approved by the Commission, for environmental qualification (EQ) violations. This letter replaces the guidance provided in Generic Letters 85-15 and 86-15

  1. Status of safety issues at licensed power plants: TMI Action Plan requirements, unresolved safety issues, generic safety issues, other multiplant action issues

    International Nuclear Information System (INIS)

    1992-12-01

    This report is to provide a comprehensive description of the implementation and verification status of Three Mile Island (TMI) Action Plan requirements, safety issues designated as Unresolved Safety Issues (USIs), Generic Safety Issues(GSIs), and other Multiplant Actions (MPAs) that have been resolved and involve implementation of an action or actions by licensees. This report makes the information available to other interested parties, including the public. An additional purpose of this NUREG report is to serve as a follow-on to NUREG-0933, ''A Prioritization of Generic Safety Issues,'' which tracks safety issues up until requirements are approved for imposition at licensed plants or until the NRC issues a request for action by licensees

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

    Energy Technology Data Exchange (ETDEWEB)

    Granovsky, Alexander A., E-mail: alex.granovsky@gmail.com [Firefly project, Moscow, 117593 Moscow (Russian Federation)

    2015-12-21

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

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

    International Nuclear Information System (INIS)

    Granovsky, Alexander A.

    2015-01-01

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

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

    Science.gov (United States)

    Granovsky, Alexander A

    2015-12-21

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

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

    DEFF Research Database (Denmark)

    Zeni, Lorenzo; Gevorgian, Vahan; Wallen, Robb

    2016-01-01

    This article presents an example of application of a modern test facility conceived for experiments regarding the integration of renewable energy in the power system. The capabilities of the test facility are used to validate dynamic simulation models of wind power plants and their controllers....... The models are based on standard and generic blocks. The successful validation of events related to the control of active power (control phenomena in...

  6. Generic evaluation of small break loss-of-coolant accident behavior in Babcock and Wilcox designed 177-FA operating plants

    International Nuclear Information System (INIS)

    1980-01-01

    Slow system depressurization resulting from small break loss-of-coolant accidents (LOCAs) in the reactor coolant system have not, until recently, received detailed analytical study comparable to that devoted to large breaks. Following the TMI-2 accident, the staff had a series of meetings with Babcock and Wilcox (B and W) and the B and W licensees. The staff requested that B and W and the licensees: (1) systematically evaluate plant response for small break loss-of-coolant accidents; (2) address each of the concerns documented in the Michelson report; (3) validate the computer codes used against the TMI-2 accident; (4) extend the break spectrum analysis to very small breaks, giving special consideration to failure of pressurizer valves to close; (5) analyze degraded conditions where AFW is not available; (6) prepare design changes aimed at reducing the probability of loss-of-coolant accidents produced by the failure of a PORV to close; and (7) develop revised emergency procedures for small breaks. This report describes the review of the generic analyses performed by B and W based on the requests stated above

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

    Science.gov (United States)

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

    2015-12-15

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

  8. Technical resolution of Generic Safety Issue A-29

    International Nuclear Information System (INIS)

    1989-09-01

    This report summarizes key technical findings related to Generic Safety Issue A-29, ''Nuclear Power Plant Design for Reduction of Vulnerability to Industrial Sabotage.'' The findings in this report deal with (1) a historical review of reported sabotage-related events at nuclear facilities, (2) NRC physical security requirements, (3) industry measures to prevent/mitigate sabotage, (4) design and procedural approaches that could be used to deter sabotage, (5) current NRC and industry initiatives aimed at personnel screening and selection, and (6) design considerations applicable to Advanced Light Water Reactors (ALWRs). The results reveal that insider sabotage at operating nuclear plants has not been a significant problem in the United States to date and that there are no singular design modifications or procedures that by themselves would completely eliminate or mitigate the threat of insider sabotage. Rather, it will take a combination of systematic and focused improvements in the three areas of reliable personnel, effective design features, and plant procedures developed to provide a strategy to deal with prevention of insider sabotage and to be able to mitigate adverse actions. 24 refs., 2 figs., 5 tabs

  9. Influencers of generic drug utilization: A systematic review.

    Science.gov (United States)

    Howard, Jennifer N; Harris, Ilene; Frank, Gavriella; Kiptanui, Zippora; Qian, Jingjing; Hansen, Richard

    2017-08-04

    With an increase in prescription drug spending and rising drug costs there is a need to encourage the use of generic prescription drugs. However, maximizing generic drug use is not possible without the public's positive perception and meeting their informational needs about generic drugs. Thus, improving the public's confidence in, and knowledge of generic drugs on the market is critical. The objective of this systematic review is to examine and evaluate the studies focusing on the nature and extent of key factors influencing generic drug use in the United States in order to help guide policy, education and practice interventions. Using multiple search engines and key word screening criteria, empirical studies published in English between January 1, 2005 and December 31, 2015 were identified. A qualitative synthesis of the evidence identified domains of key factors that influenced generic drug use across studies. Over 3000 citations met the key word screening criteria; 67 of these met inclusion criteria for the systematic review. Seven domains of factors that influence generic drug utilization were identified: 1) patient-related factors, 2) formulary management or cost containment, 3) healthcare policies, 4) promotional activities, 5) educational initiatives, 6) technology, and 7) physician-related factors. Patients, physicians, pharmacists, formulary managers, and policymakers play an important role in generic drug use. Understanding the factors influencing generic drug use can help guide future policy, education, and practice interventions to increase generic drug use. Copyright © 2017 Elsevier Inc. All rights reserved.

  10. Generic Screening Models for Assessing Exposures to the Public and ICRP Reference Animals and Plants

    Energy Technology Data Exchange (ETDEWEB)

    Yankovich, Tamara L.; Proehl, Gerhard; Telleria, Diego [International Atomic Energy Agency, P.O. Box 100, 1400 Vienna (Austria); Berkovskyy, Volodymyr [Ukrainian Radiation Protection Institute (RPI), 53, Melnikova Street, 04050, Kiev (Ukraine)

    2014-07-01

    With the update of the IAEA Fundamental Safety Principles (SF-1) stating the objective to protect people and the environment from harmful effects of ionizing radiation, it has been necessary to update International Basic Safety Standards (BSS) on Radiation Protection and Safety of Radiation Sources and the underlying safety guides and technical documents to provide guidance on how this could be achieved in practice. The current paper provides an update on the status and plans to revise the IAEA Safety Report 'Generic Models for Use in Assessing the Impact of Discharges of Radioactive Substances to the Environment' (SRS 19) that was published in 2001. The models of SRS 19 (2001), which was focused on assessment of exposures to the public, is being expanded into three volumes that provide methodologies for screening assessments for the public, as well as for flora and fauna. The revised SRS 19 guide will ultimately facilitate the application of screening models for different levels of assessment using updated parameter values from database that have been developed as part of the IAEA's EMRAS (Environmental Modelling for Radiation Safety) and EMRAS II international model validation programmes. The scope of the revised SRS 19 covers prospective screening assessment of doses to the representative person and Reference Animals and Plants (RAPs), and will provide simple and robust assessment methods for radiological assessment related to planning and design, applying a graded approach. Tabulated screening coefficients and environmental dilution factors will be included for 825 radionuclides. The screening coefficients are developed assuming equilibrium conditions; they can be used to assess radiological impacts arising from routine discharges of radionuclides to terrestrial and aquatic receptors for planned exposure situations. Volumes 1 and 2 of the revised SRS 19 are at an advanced stage of completion and are focused on 'Screening Assessment of Public

  11. Savannah River Site generic data base development

    International Nuclear Information System (INIS)

    Blanchard, A.

    2000-01-01

    This report describes the results of a project to improve the generic component failure database for the Savannah River Site (SRS). Additionally, guidelines were developed further for more advanced applications of database values. A representative list of components and failure modes for SRS risk models was generated by reviewing existing safety analyses and component failure data bases and from suggestions from SRS safety analysts. Then sources of data or failure rate estimates were identified and reviewed for applicability. A major source of information was the Nuclear Computerized Library for Assessing Reactor Reliability, or NUCLARR. This source includes an extensive collection of failure data and failure rate estimates for commercial nuclear power plants. A recent Idaho National Engineering Laboratory report on failure data from the Idaho Chemical Processing Plant was also reviewed. From these and other recent sources, failure data and failure rate estimates were collected for the components and failure modes of interest. For each component failure mode, this information was aggregated to obtain a recommended generic failure rate distribution (mean and error factor based on a lognormal distribution). Results are presented in a table in this report. A major difference between generic database and previous efforts is that this effort estimates failure rates based on actual data (failure events) rather than on existing failure rate estimates. This effort was successful in that over 75% of the results are now based on actual data. Also included is a section on guidelines for more advanced applications of failure rate data. This report describes the results of a project to improve the generic component failure database for the Savannah River site (SRS). Additionally, guidelines were developed further for more advanced applications of database values

  12. Evaluation and proposed improvements to effectiveness of US Nuclear Regulatory Commission generic communications

    International Nuclear Information System (INIS)

    Thurber, J.A.; Melber, B.D.; Geisendorfer, C.L.; Vallario, R.W.

    1988-01-01

    This report describes an evaluation of NRC generic communications with industry concerning safety related issues of commercial nuclear power plandts. The analysis builds on the findings presented in the 1986 Office of Analysis and Evaluation of Operational Data (AEOD) Special Study Report, ''An Overview of Nuclear Power Plant Operating Experience Feedback Programs'' (AEOD/S602). The primary objective of the report is to present practical recommendations for improving NRC's documents and generic communications system. The report is based upon a systematic review and evaluation of NRC and industry operating experience documents. It also includes an analysis of interviews with licensee personnel at five utilities and their nuclear power plants. NRC regional and headquarters managers and staff were also interviewed for the study. NRC and licensee personnel interviewed are generally satisfied with the current NRC-industry communications system; however, several problems and potential solutions to those problems are identified in this study. The report makes seven major recommendations for improvement in the effectiveness of NRC-industry generic communications about nuclear power plant operating experience

  13. Summary of inspection findings of licensee inservice testing programs at United States commercial nuclear power plants

    Energy Technology Data Exchange (ETDEWEB)

    Dunlop, A.; Colaccino, J.

    1996-12-01

    Periodic inspections of pump and valve inservice testing (IST) programs in United States commercial nuclear power plants are performed by Nuclear Regulatory Commission (NRC) Regional Inspectors to verify licensee regulatory compliance and licensee commitments. IST inspections are conducted using NRC Inspection Procedure 73756, {open_quotes}Inservice Testing of Pumps and Valves{close_quotes} (IP 73756), which was updated on July 27, 1995. A large number of IST inspections have also been conducted using Temporary Instruction 2515/114, {open_quotes}Inspection Requirements for Generic Letter 89-04, Acceptable Inservice Testing Programs{close_quotes} (TI-2515/114), which was issued January 15, 1992. A majority of U.S. commercial nuclear power plants have had an IST inspection to either IP 73756 or TI 2515/114. This paper is intended to summarize the significant and recurring findings from a number of these inspections since January of 1990.

  14. Brand and generic medications: Are they interchangeable

    International Nuclear Information System (INIS)

    Al-Jazairi, Abdulrazak S.; Blhareth, S.; Eqtefan, Iyad S.; Al-Suwayeh, Saleh A.

    2008-01-01

    Generic substitution has become a common practice since the late 1970s in the United States. At that time, many of these generics caused bioavailability problems, which fueled suspicions about their efficacy and safety and the Food and Drug Administration (FDA) standards for bioequivalence. In Saudi Arabia, the increasing number of local products raised several concerns with regard to switching from brands to generics. Our objective was to review and examine the basis of the controversy surrounding brand and generic interchangeability and to explore a practical approach in pursuing a switch. Articles indexed initially under terms such as generic medications, generic substitution, bioequivalence and bioinequivalence were identified. These terms were used to search the indexing service, MEDLINE (1966-2006). References from the extracted articles and additional data sources, including the Code of Federal Regulations and Regulatory Guidelines from the FDA Center for Drug Evaluation and research were also reviewed. Foe most drugs, bioequivalence testing generally should enable clinicians to routinely substitute generic for innovator products. However, for narrow therapeutic, critical dose drugs, or for highly variable drugs, safe switching between products can not be assured. These drugs need special precautions and blood level monitoring upon switching. FDA firmly believes that approved generic and brand drugs can be dispensed with the full expectation that the consumer will receive the same clinical benefit. Performing the switch process is an advisable practice to reduce health care costs in countries with strong post-marketing surveillance program, but caution is to be exercised when narrow therapeutic index drugs or highly variable drugs are prescribed. (author)

  15. Generic maintenance immunosuppression in solid organ transplant recipients.

    Science.gov (United States)

    Ensor, Christopher R; Trofe-Clark, Jennifer; Gabardi, Steven; McDevitt-Potter, Lisa M; Shullo, Michael A

    2011-11-01

    Survival after solid organ transplantation has increased in the era of tacrolimus and mycophenolate. This increased survival could be due in part to the broad clinical use of these potent and specific agents for maintenance immunosuppression. These drugs have enhanced specificity and potency for T and B lymphocytes compared with their predecessors, cyclosporine and azathioprine. Between 2008 and 2010, the United States Food and Drug Administration approved several generic formulations of both tacrolimus and mycophenolate mofetil. Deciding whether generic products can be safely substituted for the innovator product is a clinical dilemma similar to that which occurred when generic formulations of cyclosporine became available. We describe the concerns regarding generic immunosuppression use, summarize expert opinion and consensus statements in transplantation, analyze the potential impact of generic substitution, and provide estimates of populations affected based on generic drug market penetration. Formulary considerations such as cost, availability, and potential drug ordering and drug selection errors are described, and transplant coordinator and patient perspectives are reviewed. Finally, general recommendations about the use of generic maintenance immunosuppression in solid organ transplant recipients are provided. Although more research is needed to confirm clinical and therapeutic equivalence and pharmacoeconomic benefit, generic immunosuppressants can be safely substituted for innovator products as long as patients consistently receive the same product, patients and clinicians are aware of when substitutions occur, and enhanced therapeutic drug monitoring is provided during the transition.

  16. Generic phylogeny, historical biogeography and character evolution of the cosmopolitan aquatic plant family Hydrocharitaceae

    Directory of Open Access Journals (Sweden)

    Chen Ling-Yun

    2012-03-01

    Full Text Available Abstract Background Hydrocharitaceae is a fully aquatic monocot family, consists of 18 genera with approximately 120 species. The family includes both fresh and marine aquatics and exhibits great diversity in form and habit including annual and perennial life histories; submersed, partially submersed and floating leaf habits and linear to orbicular leaf shapes. The family has a cosmopolitan distribution and is well represented in the Tertiary fossil record in Europe. At present, the historical biogeography of the family is not well understood and the generic relationships remain controversial. In this study we investigated the phylogeny and biogeography of Hydrocharitaceae by integrating fossils and DNA sequences from eight genes. We also conducted ancestral state reconstruction for three morphological characters. Results Phylogenetic analyses produced a phylogeny with most branches strongly supported by bootstrap values greater than 95 and Bayesian posterior probability values of 1.0. Stratiotes is the first diverging lineage with the remaining genera in two clades, one clade consists of Lagarosiphon, Ottelia, Blyxa, Apalanthe, Elodea and Egeria; and the other consists of Hydrocharis-Limnobium, Thalassia, Enhalus, Halophila, Najas, Hydrilla, Vallisneria, Nechamandra and Maidenia. Biogeographic analyses (DIVA, Mesquite and divergence time estimates (BEAST resolved the most recent common ancestor of Hydrocharitaceae as being in Asia during the Late Cretaceous and Palaeocene (54.7-72.6 Ma. Dispersals (including long-distance dispersal and migrations through Tethys seaway and land bridges probably played major roles in the intercontinental distribution of this family. Ancestral state reconstruction suggested that in Hydrocharitaceae evolution of dioecy is bidirectional, viz., from dioecy to hermaphroditism, and from hermaphroditism to dioecy, and that the aerial-submerged leaf habit and short-linear leaf shape are the ancestral states. Conclusions

  17. Generic phylogeny, historical biogeography and character evolution of the cosmopolitan aquatic plant family Hydrocharitaceae.

    Science.gov (United States)

    Chen, Ling-Yun; Chen, Jin-Ming; Gituru, Robert Wahiti; Wang, Qing-Feng

    2012-03-10

    Hydrocharitaceae is a fully aquatic monocot family, consists of 18 genera with approximately 120 species. The family includes both fresh and marine aquatics and exhibits great diversity in form and habit including annual and perennial life histories; submersed, partially submersed and floating leaf habits and linear to orbicular leaf shapes. The family has a cosmopolitan distribution and is well represented in the Tertiary fossil record in Europe. At present, the historical biogeography of the family is not well understood and the generic relationships remain controversial. In this study we investigated the phylogeny and biogeography of Hydrocharitaceae by integrating fossils and DNA sequences from eight genes. We also conducted ancestral state reconstruction for three morphological characters. Phylogenetic analyses produced a phylogeny with most branches strongly supported by bootstrap values greater than 95 and Bayesian posterior probability values of 1.0. Stratiotes is the first diverging lineage with the remaining genera in two clades, one clade consists of Lagarosiphon, Ottelia, Blyxa, Apalanthe, Elodea and Egeria; and the other consists of Hydrocharis-Limnobium, Thalassia, Enhalus, Halophila, Najas, Hydrilla, Vallisneria, Nechamandra and Maidenia. Biogeographic analyses (DIVA, Mesquite) and divergence time estimates (BEAST) resolved the most recent common ancestor of Hydrocharitaceae as being in Asia during the Late Cretaceous and Palaeocene (54.7-72.6 Ma). Dispersals (including long-distance dispersal and migrations through Tethys seaway and land bridges) probably played major roles in the intercontinental distribution of this family. Ancestral state reconstruction suggested that in Hydrocharitaceae evolution of dioecy is bidirectional, viz., from dioecy to hermaphroditism, and from hermaphroditism to dioecy, and that the aerial-submerged leaf habit and short-linear leaf shape are the ancestral states. Our study has shed light on the previously controversial

  18. Handbook for quick cost estimates. A method for developing quick approximate estimates of costs for generic actions for nuclear power plants

    Energy Technology Data Exchange (ETDEWEB)

    Ball, J.R.

    1986-04-01

    This document is a supplement to a ''Handbook for Cost Estimating'' (NUREG/CR-3971) and provides specific guidance for developing ''quick'' approximate estimates of the cost of implementing generic regulatory requirements for nuclear power plants. A method is presented for relating the known construction costs for new nuclear power plants (as contained in the Energy Economic Data Base) to the cost of performing similar work, on a back-fit basis, at existing plants. Cost factors are presented to account for variations in such important cost areas as construction labor productivity, engineering and quality assurance, replacement energy, reworking of existing features, and regional variations in the cost of materials and labor. Other cost categories addressed in this handbook include those for changes in plant operating personnel and plant documents, licensee costs, NRC costs, and costs for other government agencies. Data sheets, worksheets, and appropriate cost algorithms are included to guide the user through preparation of rough estimates. A sample estimate is prepared using the method and the estimating tools provided.

  19. Handbook for quick cost estimates. A method for developing quick approximate estimates of costs for generic actions for nuclear power plants

    International Nuclear Information System (INIS)

    Ball, J.R.

    1986-04-01

    This document is a supplement to a ''Handbook for Cost Estimating'' (NUREG/CR-3971) and provides specific guidance for developing ''quick'' approximate estimates of the cost of implementing generic regulatory requirements for nuclear power plants. A method is presented for relating the known construction costs for new nuclear power plants (as contained in the Energy Economic Data Base) to the cost of performing similar work, on a back-fit basis, at existing plants. Cost factors are presented to account for variations in such important cost areas as construction labor productivity, engineering and quality assurance, replacement energy, reworking of existing features, and regional variations in the cost of materials and labor. Other cost categories addressed in this handbook include those for changes in plant operating personnel and plant documents, licensee costs, NRC costs, and costs for other government agencies. Data sheets, worksheets, and appropriate cost algorithms are included to guide the user through preparation of rough estimates. A sample estimate is prepared using the method and the estimating tools provided

  20. HTGR generic technology program. Semiannual report ending March 31, 1980

    International Nuclear Information System (INIS)

    1980-05-01

    This document reports the technical accomplishments on the HTGR Generic Technology Program at General Atomic during the first half of FY-80. It covers a period when the design direction of the National HTGR Program is in the process of an overall review. The HTGR Generic Technology Program activities have continued so as to provide the basic technology required for all HTGR applications. The activities include the need to develop an MEU fuel and the need to qualify materials and components for the higher temperatures of the gas turbine and process heat plants

  1. Binary mixtures of condensates in generic confining potentials

    Energy Technology Data Exchange (ETDEWEB)

    Facchi, P [Dipartimento di Matematica and MECENAS, Universita di Bari, I-70125 Bari (Italy); Florio, G; Pascazio, S; Pepe, F V, E-mail: Francesco.Pepe@ba.infn.it [INFN, Sezione di Bari, I-70126 Bari (Italy)

    2011-12-16

    We study a binary mixture of Bose-Einstein condensates, confined in a generic potential, in the Thomas-Fermi approximation. We search for the zero-temperature ground state of the system, both in the case of fixed numbers of particles and fixed chemical potentials. For generic potentials, we analyze the transition from mixed to separated ground-state configurations as the inter-species interaction increases. We derive a simple formula that enables one to determine the location of the domain walls. Finally, we find criteria for the energetic stability of separated configurations, depending on the number and the position of the domain walls separating the two species. (paper)

  2. Binary mixtures of condensates in generic confining potentials

    Science.gov (United States)

    Facchi, P.; Florio, G.; Pascazio, S.; Pepe, F. V.

    2011-12-01

    We study a binary mixture of Bose-Einstein condensates, confined in a generic potential, in the Thomas-Fermi approximation. We search for the zero-temperature ground state of the system, both in the case of fixed numbers of particles and fixed chemical potentials. For generic potentials, we analyze the transition from mixed to separated ground-state configurations as the inter-species interaction increases. We derive a simple formula that enables one to determine the location of the domain walls. Finally, we find criteria for the energetic stability of separated configurations, depending on the number and the position of the domain walls separating the two species.

  3. Binary mixtures of condensates in generic confining potentials

    International Nuclear Information System (INIS)

    Facchi, P; Florio, G; Pascazio, S; Pepe, F V

    2011-01-01

    We study a binary mixture of Bose–Einstein condensates, confined in a generic potential, in the Thomas–Fermi approximation. We search for the zero-temperature ground state of the system, both in the case of fixed numbers of particles and fixed chemical potentials. For generic potentials, we analyze the transition from mixed to separated ground-state configurations as the inter-species interaction increases. We derive a simple formula that enables one to determine the location of the domain walls. Finally, we find criteria for the energetic stability of separated configurations, depending on the number and the position of the domain walls separating the two species. (paper)

  4. Model of a Generic Natural Uranium Conversion Plant ? Suggested Measures to Strengthen International Safeguards

    Energy Technology Data Exchange (ETDEWEB)

    Raffo-Caiado, Ana Claudia [ORNL; Begovich, John M [ORNL; Ferrada, Juan J [ORNL

    2009-11-01

    This is the final report that closed a joint collaboration effort between DOE and the National Nuclear Energy Commission of Brazil (CNEN). In 2005, DOE and CNEN started a collaborative effort to evaluate measures that can strengthen the effectiveness of international safeguards at a natural uranium conversion plant (NUCP). The work was performed by DOE s Oak Ridge National Laboratory and CNEN. A generic model of a NUCP was developed and typical processing steps were defined. Advanced instrumentation and techniques for verification purposes were identified and investigated. The scope of the work was triggered by the International Atomic Energy Agency s 2003 revised policy concerning the starting point of safeguards at uranium conversion facilities. Prior to this policy only the final products of the uranium conversion plant were considered to be of composition and purity suitable for use in the nuclear fuel cycle and therefore, subject to the IAEA safeguards control. DOE and CNEN have explored options for implementing the IAEA policy, although Brazil understands that the new policy established by the IAEA is beyond the framework of the Quadripartite Agreement of which it is one of the parties, together with Argentina, the Brazilian-Argentine Agency for Accounting and Control of Nuclear Materials (ABACC) and the IAEA. Two technical papers on this subject were published at the 2005 and 2008 INMM Annual Meetings.

  5. Generic licensing issues applicable to Wolsong 3 and 4 licensing review

    International Nuclear Information System (INIS)

    Boyd, Frederick C.

    1994-01-01

    The Wolsong 3 and 4 nuclear power plants are of CANDU type which were designed according to the rules and regulations of the Atomic Energy Control Board (AECB) of Canada. In 1992 AECB staff issued a first formal report (to the AECB Board) on 'generic safety issues affecting power reactors'. This was followed by a second report in 1993. These reports dealt with safety issues associated with Canadian CANDU nuclear power plants that applied to all or several plants and were considered insufficiently resolved. In most cases the concern was lack of certainty in the related safety analyses. The AECB staff report of 1993 identified eight 'generic action items' and six 'long-term research issues', three of which AECB staff have indicated may be moved into the 'action' category. This report, prepared for the Korea Institute of Nuclear Safety (KINS), reviews the background of the AECB 'generic action items' and the three 'long-term research issues' noted above. It also reviews an additional topic - steam line failure outside of containment - which was included in the request from KINS. In all, twelve issues are covered. These background reviews are followed by a discussion of the relevance of each issue to the licensing review (for Construction Permit) of Wolsong 3 and 4 and recommended actions to be taken by KINS

  6. The generic article

    NARCIS (Netherlands)

    Farkas, D.F.; Swart, Henriëtte de

    2005-01-01

    We take a fresh look at the connection between genericity and (in)definiteness by reconsidering a long-standing puzzle concerning the relation between definiteness and genericity. We contrast English on the one hand and Romance languages and Hungarian on the other, focusing on generic sentences

  7. An overview of the United States Department of Energy Plant Lifetime Improvement Program

    International Nuclear Information System (INIS)

    Rosinski, S.T.; Clauss, J.M.; Harrison, D.L.

    2004-01-01

    Since 1985, the U.S. Department of Energy (DOE) has been working with the nuclear industry and the U.S. Nuclear Regulatory Commission (NRC) to establish and demonstrate the option to extend the life of nuclear power plants through the renewal of operating licenses. This paper focuses primarily on DOE'S Plant Lifetime Improvement (PLIM) Program efforts to develop the technical criteria and bases for effective aging management and lifetime improvement for continued operation of nuclear power plants. This paper describes current projects to resolve generic technical issues, including degradation of long-lived components, reactor pressure vessel (RPV) embrittlement management approaches, and analytical methodologies to characterize RPV integrity. (author)

  8. Seismic and dynamic qualification of safety-related electrical and mechanical equipment in operating nuclear power plants: development of a method to generate generic floor-response spectra

    International Nuclear Information System (INIS)

    Curreri, J.; Costantino, C.; Subudhi, M.; Reich, M.

    1983-09-01

    Generic floor response spectra were developed for use in the qualification of electrical and mechanical equipment in operating nuclear power plants. The characteristics of 1000 floor response spectra were studied to determine the generic spectra. The procedure developed uses as much or as little information that currently exists at the plant relating to the question of equipment qualification. The general approach was to study the effects on the dynamic characteristics of each of the elements in the chain of events that goes between the loads and the responses. This includes the loads, the soils and the structures. A free-field earthquake response spectra was used to generate horizontal earthquake time histories. The excitation was applied through the soil and into the various structures to produce responses in equipment. An entire range of soil conditions was used with each structure. Actual PWR and BWR - Mark I structural models were used. For each model, the stiffness properties were varied, with the same mass, so as to extend the fundamental base structure natural frequency from 2 cps to 36 cps. The natural frequencies of the structures were varied to obtain maximum response conditions. The actual properties were first used to locate the natural frequencies. The stiffness properties were than varied, with the same mass, to extend the range of the fundamental base structure natural frequency. The intention was to have the coupled structural material frequencies in the vicinity of the peak amplitude frequency content of the excitation spectrum. Particular attention was therefore given to the frequency band between 2 Hz and 4 Hz. A horizontal generic floor response spectra is proposed for the top level of a generic structure. Reduction factors are applied to the peak acceleration for equipment at lower levels

  9. 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...

  10. Generic evaluation of feedwater transients and small break loss-of-coolant accidents in GE-designed operating plants and near-term operating license applications

    International Nuclear Information System (INIS)

    1980-01-01

    The results are presented of a generic evaluation of feedwater transients, small-break loss-of-coolant accidents (LOCAs), and other TMI-2-related events for General Electric Company (GE)-designed operating plants and near-term operating license applications to confirm or establish the bases for the continued safe operation of the operating plants. The results of this evaluation are presented in this report in the form of a set of findings and recommendations in each of the principal review areas. Additional review of the accident is continuing and further information is being obtained and evaluated. Any new information will be reviewed and modifications will be made as appropriate

  11. Perspectives on plant vulnerabilities ampersand other plant and containment improvements

    International Nuclear Information System (INIS)

    LaChance, J.; Kolaczkowski, A.; Kahn, J.

    1996-01-01

    The primary goal of the Individual Plant Examination (IPE) Program was for licensees to identify plant-unique vulnerabilities and actions to address these vulnerabilities. A review of these vulnerabilities and plant improvements that were identified in the IPEs was performed as part of the IPE Insights Program sponsored by the U.S. Nuclear Regulatory Commission (NRC). The purpose of this effort was to characterize the identified vulnerabilities and the impact of suggested plant improvements. No specific definition for open-quotes vulnerabilityclose quotes was provided in NRC Generic Letter 88-20 or in the subsequent NRC IPE submittal guidance documented in NUREG-1335. Thus licensees were left to use their own definitions. Only 20% of the plants explicitly stated that they had vulnerabilities. However, most licensees identified other plant improvements to address issues not explicitly classified as vulnerabilities, but pertaining to areas in which overall plant safety could potentially be increased. The various definitions of open-quotes vulnerabilityclose quotes used by the licensees, explicitly identified vulnerabilities, proposed plant improvements to address these vulnerabilities, and other plant improvements are summarized and discussed

  12. Sharing, samples, and generics: an antitrust framework.

    Science.gov (United States)

    Carrier, Michael A

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

  13. Encouraging the use of generic medicines: implications for transition economies.

    Science.gov (United States)

    King, Derek R; Kanavos, Panos

    2002-08-01

    Generic drugs have a key role to play in the efficient allocation of financial resources for pharmaceutical medicines. Policies implemented in the countries with a high rate of generic drug use, such as Canada, Denmark, Germany, the Netherlands, the United Kingdom, and the United States, are reviewed, with consideration of the market structures that facilitate strong competition. Savings in these countries are realized through increases in the volume of generic drugs used and the frequently significant differences in the price between generic medicines and branded originator medicines. Their policy tools include the mix of supply-side measures and demand-side measures that are relevant for generic promotion and higher generic use. On the supply-side, key policy measures include generic drug marketing regulation that facilitates market entry soon after patent expiration, reference pricing, the pricing of branded originator products, and the degree of price competition in pharmaceutical markets. On the demand-side, measures typically encompass influencing prescribing and dispensing patterns as well as introducing a co-payment structure for consumers/patients that takes into consideration the difference in cost between branded and generic medicines. Quality of generic medicines is a pre-condition for all other measures discussed to take effect. The paper concludes by offering a list of policy options for decision-makers in Central and Eastern European economies in transition.

  14. [Generic drugs: good or bad? Physician's knowledge of generic drugs and prescribing habits].

    Science.gov (United States)

    García, A J; Martos, F; Leiva, F; Sánchez de la Cuesta, F

    2003-01-01

    In this article we analyze the responses of 1220 Spanish physicians who participated in a survery about generic drugs. A previously validated questionnaire was sent to physicians through the Spanish Medical Councils of the different provinces. Four items were analyzed: what doctors know about generic drugs (knowledge); physicians' prescribing habits concerning these drugs (attitude and professional competence); how prescription of generic drugs effects pharmaceutical costs amd, finally, what doctors believe a generic drug should be. The influence of physician-related variables (age, type of contract, specialty, workload, etc.) on prescribing of generic drugs was also analyzed. In view of the results, we believe that to rationalize expenditure through and appropriate policy on generic drugs Spanish health authorities should offer more and better training and information (clear and independent) about what generic drugs are.

  15. Evaluation of Patient Assistance Program Eligibility and Availability for Top 200 Brand Name and Generic Drugs in the United States

    Directory of Open Access Journals (Sweden)

    Chin-Fun Chu

    2012-01-01

    Full Text Available One strategy to encourage uninsured and underinsured patients' compliance with medication regimen is to refer them to pharmaceutical industry-sponsored patient assistance programs (PAPs. In order to receive the requested medications, patients should be qualified based on the program eligibility requirements. The purpose of this study was to examine PAP eligibility criteria for the most commonly dispensed prescriptions in the United States. We identified 136 unique chemical entities in the Top 200 drug list and 111 (82% of these pharmaceutical products were offered by PAPs. Among the available medications, 69 (62% were brand name; 29 (26% were generic, and 13 (12% had both brand name/generic forms. In terms of the availability of types of drugs (brand name vs. generic provided by PAPs, differences in PAP eligibility requirements were found for citizenship (p < 0.001, permanent residency (p < 0.001, and prescription drug coverage (p< 0.001, but not for income limits (p= 0.051. Overall, PAPs could help low-income patients to obtain necessary medications; however, U.S. citizenship/permanent residency and restriction on prescription coverage are more likely to be required for brand name drugs rather than for generics. PAPs also provide some options for the underinsured and those with private insurance or Medicare Part D plan that offers inadequate prescription coverage.   Type: Original Research

  16. Evaluation of Patient Assistance Program Eligibility and Availability for Top 200 Brand Name and Generic Drugs in the United States

    Directory of Open Access Journals (Sweden)

    Chin-Fun Chu

    2012-01-01

    Full Text Available One strategy to encourage uninsured and underinsured patients’ compliance with medication regimen is to refer them to pharmaceutical industry–sponsored patient assistance programs (PAPs. In order to receive the requested medications, patients should be qualified based on the program eligibility requirements. The purpose of this study was to examine PAP eligibility criteria for the most commonly dispensed prescriptions in the United States. We identified 136 unique chemical entities in the Top 200 drug list and 111 (82% of these pharmaceutical products were offered by PAPs. Among the available medications, 69 (62% were brand name; 29 (26% were generic, and 13 (12% had both brand name/generic forms. In terms of the availability of types of drugs (brand name vs. generic provided by PAPs, differences in PAP eligibility requirements were found for citizenship (p < 0.001, permanent residency (p < 0.001, and prescription drug coverage (p< 0.001, but not for income limits (p= 0.051. Overall, PAPs could help low-income patients to obtain necessary medications; however, U.S. citizenship/permanent residency and restriction on prescription coverage are more likely to be required for brand name drugs rather than for generics. PAPs also provide some options for the underinsured and those with private insurance or Medicare Part D plan that offers inadequate prescription coverage.

  17. Regulatory analysis for the resolution of Generic Safety Issue 106: Piping and the use of highly combustible gases in vital areas

    International Nuclear Information System (INIS)

    Graves, C.C.

    1993-06-01

    Highly combustible gases such as hydrogen, propane, and acetylene are used at all nuclear power plants. Hydrogen is of particular importance because it is stored in large quantities and is distributed and used continuously in buildings containing safety-related equipment. Large hydrogen releases at the hydrogen storage facilities or in these buildings could lead to fires or explosions that might result in loss of safety-related equipment. This report gives the regulatory analysis for the resolution of Generic Safety Issue 106, open-quotes Piping and the Use of Highly Combustible Gases in Vital Areas.close quotes Scoping analyses showed that the risk associated with the storage and distribution of hydrogen for cooling electric generators at boiling-water reactors (BWRs), the off-gas system at BWRs, the waste gas system at pressurized-water reactors (PWRs), and station battery rooms and portable bottles of combustible gas used for maintenance at PWRs and BWRs is small. On the basis of generic evaluations, the NRC staff has concluded that several possible methods to reduce risk could provide cost-effective safety benefits at some plants. However, in view of the observed large differences in plant-specific characteristics affecting the risk associated with the use of hydrogen, and the marginal generic safety benefit that can be achieved in a cost-effective manner, it is recommended that this generic issue be resolved simply by making these results available in a generic letter. This information may help licensees in their plant evaluations recommended by Generic Letter 88-20, Supplement 4, open-quotes Individual Plant Examination of External Events for Severe Accident Vulnerabilities,close quotes June 28, 1991

  18. A PLC generic requirements and specification for safety-related applications in nuclear power plants

    International Nuclear Information System (INIS)

    Han, Jea Bok; Lee, C. K.; Lee, D. Y.

    2001-12-01

    This report presents the requirements and specification to be applied to the generic qualification of programmable Logic Controller(PLC), which is being developed as part of the KNICS project, 'Development of the Digital Reactor Safety Systems' of which purpose is the application to safety-related instrumentation and control systems in nuclear power plants. This report defines the essential and critical characteristics that shall be included as part of a PLC design for safety-related application. The characteristics include performance, reliability, accuracy, the overall response time from an input to the PLC exceeding it trip condition to the resulting outputs, and the specification of processors and memories in digital controller. It also specifies the quality assurance process for software development, dealing with executive software, firmware, application software tools for developing the application software, and human machine interface(HMI). In addition, this report reviews the published standards and guidelines that are required for the PLC development and the quality assurance processes such as environment requirements, seismic withstand requirements, EMI/RFI withstand requirements, and isolation test

  19. A generic Approach for Reliability Predictions considering non-uniformly Deterioration Behaviour

    International Nuclear Information System (INIS)

    Krause, Jakob; Kabitzsch, Klaus

    2012-01-01

    Predictive maintenance offers the possibility to prognosticate the remaining time until a maintenance action of a machine has to be scheduled. Unfortunately, current predictive maintenance solutions are only suitable for very specific use cases like reliability predictions based on vibration monitoring. Furthermore, they do not consider the fact that machines may deteriorate non-uniformly, depending on external influences (e.g., the work piece material in a milling machine or the changing fruit acid concentration in a bottling plant). In this paper two concepts for a generic predictive maintenance solution which also considers non-uniformly aging behaviour are introduced. The first concept is based on system models representing the health state of a technical system. As these models are usually statically (viz. without a timely dimension) their coefficients are determined periodically and the resulting time series is used as aging indicator. The second concept focuses on external influences (contexts) which change the behaviour of the previous mentioned aging indicators in order to increase the accuracy of reliability predictions. Therefore, context-depended time series models are determined and used to predict machine reliability. Both concepts were evaluated on data of an air ventilation system. Thereby, it could be shown that they are suitable to determine aging indicators in a generic way and to incorporate external influences in the reliability prediction. Through this, the quality of reliability predictions can be significantly increased. In reality this leads to a more accurate scheduling of maintenance actions. Furthermore, the generic character of the solutions makes the concepts suitable for a wide range of aging processes.

  20. Brand vs generic adverse event reporting patterns: An authorized generic-controlled evaluation of cardiovascular medications.

    Science.gov (United States)

    Alatawi, Y; Rahman, Md M; Cheng, N; Qian, J; Peissig, P L; Berg, R L; Page, C D; Hansen, R A

    2018-06-01

    Some public scepticism exists about generics in terms of whether brand and generic drugs produce identical outcomes. This study explores whether adverse event (AE) reporting patterns are similar between brand and generic drugs, using authorized generics (AGs) as a control for possible generic drug perception biases. Events reported to the FDA Adverse Event Reporting System from the years 2004-2015 were analysed. Drugs were classified as brand, AG or generic based on drug and manufacturer names. Reports were included if amlodipine, losartan, metoprolol extended release (ER) or simvastatin were listed as primary or secondary suspect drugs. Disproportionality analyses using the reporting odds ratio (ROR) assessed the relative rate of reporting labelled AEs compared to reporting these AEs with all other drugs. The Breslow-Day test compared RORs across brand, AG and generic. Interrupted time series analysis evaluated the impact of generic entry on reporting trends. Generics accounted for significant percentages of total U.S. reports, but AGs accounted for smaller percentages of reports, including for amlodipine (14.26%), losartan (1.48%), metoprolol ER (0.35%) and simvastatin (0.70%). Whereas the RORs were significantly different for multiple brand vs generic comparisons, the AG vs generic comparisons yielded fewer statistically significant findings. Namely, only the ROR for AG differed from generic for amlodipine with peripheral oedema (P brand and generic compared with AG and generic. Use of AGs as a control for perception biases against generics is useful, but this approach can be limited by small AG report numbers. Requiring the manufacturer name to be printed on the prescription bottle or packaging could improve the accuracy of assignment for products being reported. © 2017 John Wiley & Sons Ltd.

  1. Bioequivalence and in vitro antimicrobial activity between generic and brand-name levofloxacin.

    Science.gov (United States)

    Sun, Hsin-Yun; Liao, Hsiao-Wei; Sheng, Meng-Huei; Tai, Hui-Min; Kuo, Ching-Hua; Sheng, Wang-Huei

    2016-07-01

    Generic agents play a crucial role in reducing the cost of medical care in many countries. However, the therapeutic equivalence remains a great concern. Our study aims to assess the in vitro antimicrobial activity and bioequivalence between generic and brand-name levofloxacin. Enantiomeric purity test, dissolution test, and in vitro antimicrobial susceptibility against seven clinically important pathogens by the agar dilution method were employed to assess the similarity between four generic products and brand-name levofloxacin (Daiichi Sankyo). All the generic and brand-name levofloxacin passed enantiomeric purity test. The results of dissolution tests were not similar among the generic products and the brand-name levofloxacin. Compared with the generic products, the brand-name levofloxacin had the smallest mean variations (-25% to 13%) with reference standard (United States Pharmacopeia levofloxacin Reference Standards). Variations were observed particularly in dissolution profiles and in vitro activity between generic products and brand-name levofloxacin. Copyright © 2016 Elsevier Inc. All rights reserved.

  2. Control of heavy loads at nuclear power plants: Resolution of Generic Technical Activity A-36. Technical report

    International Nuclear Information System (INIS)

    George, H.J.

    1980-07-01

    This report summarizes work performed by the NRC staff in the resolution of Generic Technical Activity A-36, Control of Heavy Loads Near Spent Fuel. Generic Technical Activity A-36 is one of the generic technical subjects designated as unresolved safety issues pursuant to Section 210 of the Energy Reorganization Act of 1974. The report describes the technical studies and evaluations performed by the NRC staff, the staff's guidelines based on these studies, and the staff's plans for implementaton of its technical guidelines

  3. EURANOS. Generic handbook for assisting in the management of contaminated inhabited areas in Europe following a radiological emergency

    DEFF Research Database (Denmark)

    Nisbet, A.F.; Andersson, Kasper Grann; Brown, J.

    industry and others who may be affected. The handbook is a living document that requires updating from time to time to remain state-of-the-art and customisation of the generic handbook is an essential part of its use within individual countries. The handbook includes management options for application...... and plants; trees and shrubs. The handbook is divided into several independent sections comprising: supporting scientific and technical information; an analysis of the factors influencing recovery; compendia of comprehensive, state-of-the-art datasheets for more than 50 management options; guidance....... The handbook for inhabited areas complements the two other handbooks for food production systems and drinking water supplies....

  4. Structural Design of HRA Database using generic task for Quantitative Analysis of Human Performance

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Seung Hwan; Kim, Yo Chan; Choi, Sun Yeong; Park, Jin Kyun; Jung Won Dea [KAERI, Daejeon (Korea, Republic of)

    2016-05-15

    This paper describes a design of generic task based HRA database for quantitative analysis of human performance in order to estimate the number of task conductions. The estimation method to get the total task conduction number using direct counting is not easy to realize and maintain its data collection framework. To resolve this problem, this paper suggests an indirect method and a database structure using generic task that enables to estimate the total number of conduction based on instructions of operating procedures of nuclear power plants. In order to reduce human errors, therefore, all information on the human errors taken by operators in the power plant should be systematically collected and examined in its management. Korea Atomic Energy Research Institute (KAERI) is carrying out a research to develop a data collection framework to establish a Human Reliability Analysis (HRA) database that could be employed as technical bases to generate human error probabilities (HEPs) and performance shaping factors (PSFs)]. As a result of the study, the essential table schema was designed to the generic task database which stores generic tasks, procedure lists and task tree structures, and other supporting tables. The number of task conduction based on the operating procedures for HEP estimation was enabled through the generic task database and framework. To verify the framework applicability, case study for the simulated experiments was performed and analyzed using graphic user interfaces developed in this study.

  5. Structural Design of HRA Database using generic task for Quantitative Analysis of Human Performance

    International Nuclear Information System (INIS)

    Kim, Seung Hwan; Kim, Yo Chan; Choi, Sun Yeong; Park, Jin Kyun; Jung Won Dea

    2016-01-01

    This paper describes a design of generic task based HRA database for quantitative analysis of human performance in order to estimate the number of task conductions. The estimation method to get the total task conduction number using direct counting is not easy to realize and maintain its data collection framework. To resolve this problem, this paper suggests an indirect method and a database structure using generic task that enables to estimate the total number of conduction based on instructions of operating procedures of nuclear power plants. In order to reduce human errors, therefore, all information on the human errors taken by operators in the power plant should be systematically collected and examined in its management. Korea Atomic Energy Research Institute (KAERI) is carrying out a research to develop a data collection framework to establish a Human Reliability Analysis (HRA) database that could be employed as technical bases to generate human error probabilities (HEPs) and performance shaping factors (PSFs)]. As a result of the study, the essential table schema was designed to the generic task database which stores generic tasks, procedure lists and task tree structures, and other supporting tables. The number of task conduction based on the operating procedures for HEP estimation was enabled through the generic task database and framework. To verify the framework applicability, case study for the simulated experiments was performed and analyzed using graphic user interfaces developed in this study.

  6. Generic drugs: Review and experiences from South India

    Directory of Open Access Journals (Sweden)

    Philip Mathew

    2015-01-01

    Full Text Available The cost of pharmaceuticals, as a percentage of total healthcare spending, has been rising worldwide. This has resulted in strained national budgets and a high proportion of people without access to essential medications. Though India has become a global hub of generic drug manufacturing, the expected benefits of cheaper drugs are not translating into savings for ordinary people. This is in part due to the rise of branded generics, which are marketed at a price point close to the innovator brands. Unbranded generic medicines are not finding their way into prescriptions due to issues of confidence and perception, though they are proven to be much cheaper and comparable in efficacy to branded medicines. The drug inventory of unbranded generic manufacturers fares reasonably when reviewed using the World Health Organization-Health Action International (WHO-HAI tool for analysing drug availability. Also, unbranded generic medicines are much cheaper when compared to the most selling brands and they can bring down the treatment costs in primary care and family practice. We share our experience in running a community pharmacy for an urban health center in the Pathanamthitta district of Kerala State, which is run solely on generic medicines. The drug availability at the community pharmacy was 73.3% when analyzed using WHO-HAI tool and the savings for the final consumers were up to 93.1%, when compared with most-selling brand of the same formulation.

  7. Generic antibiotics in Japan.

    Science.gov (United States)

    Fujimura, Shigeru; Watanabe, Akira

    2012-08-01

    Generic drugs have been used extensively in many developed countries, although their use in Japan has been limited. Generic drugs reduce drug expenses and thereby national medical expenditure. Because generic drugs provide advantages for both public administration and consumers, it is expected that they will be more widely used in the future. However, the diffusion rate of generic drugs in Japan is quite low compared with that of other developed countries. An investigation on generic drugs conducted by the Ministry of Health, Labour and Welfare in Japan revealed that 17.2 % of doctors and 37.2 % of patients had not used generic drugs. The major reasons for this low use rate included distrust of off-patent products and lower drug price margin compared with the brand name drug. The generic drugs available in the market include external drugs such as wet packs, antihypertensive agents, analgesics, anticancer drugs, and antibiotics. Among them, antibiotics are frequently used in cases of acute infectious diseases. When the treatment of these infections is delayed, the infection might be aggravated rapidly. The pharmacokinetics-pharmacodynamics (PK-PD) theory has been adopted in recent chemotherapy, and in many cases, the most appropriate dosage and administration of antibiotics are determined for individual patients considering renal function; high-dosage antibiotics are used preferably for a short duration. Therefore, a highly detailed antimicrobial agent is necessary. However, some of the generic antibiotics have less antibacterial potency or solubility than the brand name products. We showed that the potency of the generic products of vancomycin and teicoplanin is lower than that of the branded drugs by 14.6 % and 17.3 %, respectively. Furthermore, we confirmed that a generic meropenem drug for injection required about 82 s to solubilize in saline, whereas the brand product required only about 21 s. It was thought that the cause may be the difference in size of bulk

  8. Application of the ICRP approach for radiological protection of the marine environment in generic impact assessments

    Energy Technology Data Exchange (ETDEWEB)

    Kliaus, Viktoryia [Republican Scientific-Practical Centre of Hygiene, Laboratory of Radiation Safety, Akademicheskaya str. 8, 220012, Minsk (Belarus); Telleria, Diego M. [IAEA-Assessment and Management of Environmental Releases Unit, Wagramer Strasse 5 - PO Box 100, A-1400, Vienna (Austria); Cabianca, Tiberio [Centre for Radiation, Chemical and Environmental Hazards, PHE, Chilton, Didcot, Oxfordshire OX11 0RQ (United Kingdom)

    2014-07-01

    This paper presents a way to use the ICRP approach for protection of the environment in generic assessments of the radiological impact of radioactive releases to the marine environment. Generic assessments of radiological impact to the environment are needed in certain circumstances, for example, when input data are limited or when the likely radiological consequences are expected to be not significant. Under these circumstances the effort in performing the assessment must be commensurate with the potential radiological consequences. The generic assessment described in this paper is a simple tool which provides reasonable and cautious results and is applicable to multiple exposure scenarios associated with the assessment of the radiological impact of releases to the marine the environment. This generic assessment can be also used to provide preliminary results which, when compared to radiological criteria, may determine the need of further specific assessments. The ICRP based its approach to protect the environment in the definition of a set of reference animals and plants and the use of related radiological criteria, in the form of derived consideration reference levels. The paper discusses selection and exposure conditions of the reference animals and plants, methods to estimate their doses and the use of the radiological criteria, for the purpose of a generic assessment. The IAEA is elaborating applications of these generic impact assessments presented in the paper to be included in international guidance under development. (authors)

  9. Integration of renewable energy plants based on generic data models in the energy management of a virtual power plant; Integration von erneuerbaren Energieanlagen auf Basis generischer Datenmodelle in das Energiemanagement eines virtuellen Kraftwerks

    Energy Technology Data Exchange (ETDEWEB)

    Wickert, Manuel; Slaby, Wolfgang; Hochloff, Patrick [Fraunhofer Institut fuer Windenergie und Energiesystemtechnik (IWES), Kassel (Germany); Winter, Martin [Siemens AG, Muenchen (Germany). Corporate Technology

    2012-07-01

    The integration of different types of energy resources manufactured by different vendors is one of the main challenges for virtual power plants. One of the important problems is a highly heterogeneous standardization environment for decentralized renewable energy resources. On the one hand proprietary solutions are implemented for some types of energy resources. In a future smart grid it is getting more and more important to handle decentralized energy generation. The project RegModHarz researched the dynamic integration of energy resources in virtual power plants based on generic data models. This paper introduces a concept for the integration of heterogeneous energy resources into the energy management of a virtual power plant using a uniform data model. On the assumption of a market-oriented virtual power plant the main attributes of this data model are generally identified and afterwards explained by examples. The capability of this data model is shown in a comprehensive field test with different renewable energy resources. (orig.)

  10. Scripting XML with Generic Haskell

    NARCIS (Netherlands)

    Atanassow, F.; Clarke, D.; Jeuring, J.T.

    2003-01-01

    A generic program is written once and works on values of many data types. Generic Haskell is a recent extension of the functional programming language Haskell that supports generic programming. This paper discusses how Generic Haskell can be used to implement XML tools whose behaviour depends on

  11. Scripting XML with Generic Haskell

    NARCIS (Netherlands)

    Atanassow, F.; Clarke, D.; Jeuring, J.T.

    2007-01-01

    A generic program is written once and works on values of many data types. Generic Haskell is a recent extension of the functional programming language Haskell that supports generic programming. This paper discusses how Generic Haskell can be used to implement XML tools whose behaviour depends on

  12. Merger mania: mergers and acquisitions in the generic drug sector from 1995 to 2016.

    Science.gov (United States)

    Gagnon, Marc-André; Volesky, Karena D

    2017-08-22

    Drug shortages and increasing generic drug prices are associated with low levels of competition. Mergers and acquisitions impact the level of competition. Record merger and acquisition activity was reported for the pharmaceutical sector in 2014/15, yet information on mergers and acquisitions in the generic drug sector are absent from the literature. This information is necessary to understand if and how such mergers and acquisitions can be a factor in drug shortages and increasing prices. Data on completed merger and acquisition deals that had a generic drug company being taken over (i.e. 'target') were extracted from Bloomberg Finance L.P. The number and announced value of deals are presented globally, for the United States, and globally excluding the United States annually from 1995 to 2016 in United States dollars. Generic drug companies comprised 9.3% of the value of all deals with pharmaceutical targets occurring from 1995 to 2016. Globally, in 1995 there were no deals, in 2014 there were 22 deals worth $1.86 billion, in 2015 there were 34 deals totalling $33.56 billion, and in 2016 there were 42 deals worth in excess of $44 billion. This substantial increase was partially attributed to Teva's 2016 acquisition of Allergan's generic drug business. The surge in mergers and acquisitions for 2015/16 was driven by deals in the United States, where they represented 89.7% of the dollar value of deals in those years. The recent blitz in mergers and acquisitions signals that the generic drug industry is undergoing a transformation, especially in the United States. This restructuring can negatively affect the level of competition that might impact prices and shortages for some products, emphasizing the importance of updating regulations and procurement policies.

  13. Prioritization of generic safety issues

    International Nuclear Information System (INIS)

    Emrit, R.; Minners, W.; VanderMolen, H.

    1983-12-01

    This report presents the priority rankings for generic safety issues related to nuclear power plants. The purpose of these rankings is to assist in the timely and efficient allocation of NRC resources for the resolution of those safety issues that have a significant potential for reducing risk. The report focuses on the prioritization of generic safety issues. Issues primarily concerned with the licensing process or environmental protection and not directly related to safety have been excluded from prioritization. The prioritized issues include: TMI Action Plan items under development; previously proposed issues covered by Task Action Plans, except issues designated at Unresolved Safety Issues (USIs) which had already been assigned high priority; and newly-proposed issues. Future supplements to this report will include the prioritization of additional issues. The safety priority rankings are HIGH, MEDIUM, LOW, and DROP and have been assigned on the basis of risk significance estimates, the ratio of risk to costs and other impacts estimated to result if resolutions of the safety issues were implemented, and the consideration of uncertainties and other quantitative or qualitative factors. To the extent practical, estimates are quantitative

  14. The global biopharma industry and the rise of Indian drug multinationals: implications for Australian generics policy.

    Science.gov (United States)

    Löfgren, Hans

    2007-06-01

    This article provides a synopsis of the new dynamics of the global biopharma industry. The emergence of global generics companies with capabilities approximating those of 'big pharma' has accelerated the blurring of boundaries between the innovator and generics sectors. Biotechnology-based products form a large and growing segment of prescription drug markets and regulatory pathways for biogenerics are imminent. Indian biopharma multinationals with large-scale efficient manufacturing plants and growing R&D capabilities are now major suppliers of Active Pharmaceutical Ingredients (APIs) and generic drugs across both developed and developing countries. In response to generic competition, innovator companies employ a range of life cycle management techniques, including the launch of 'authorised generics'. The generics segment in Australia will see high growth rates in coming years but the prospect for local manufacturing is bleak. The availability of cheap generics in international markets has put pressure on Pharmaceutical Benefits Scheme (PBS) pricing arrangements, and a new policy direction was announced in November 2006. Lower generics prices will have a negative impact on some incumbent suppliers but industrial renewal policies for the medicines industry in Australia are better focused on higher value R&D activities and niche manufacturing of sophisticated products.

  15. Value impact analysis of Generic Issue 143, Availability of Heating, Ventilation, Air Conditioning (HVAC) and Chilled Water Systems

    Energy Technology Data Exchange (ETDEWEB)

    Daling, P.M.; Marler, J.E.; Vo, T.V.; Phan, H.; Friley, J.R. [Pacific Northwest Lab., Richland, WA (United States)

    1993-11-01

    This study evaluates the values (benefits) and impacts (costs) associated with potential resolutions to Generic Issue 143, ``Availability of HVAC and Chilled Water Systems.`` The study identifies vulnerabilities related to failures of HVAC, chilled water, and room cooling systems; develops estimates of room heatup rates and safety-related equipment vulnerabilities following losses of HVAC/room cooler systems; develops estimates of the core damage frequencies and public risks associated with failures of these systems; develops three proposed resolution strategies to this generic issue; and performs a value/impact analysis of the proposed resolutions. Existing probabilistic risk assessments for four representative plants, including one plant from each vendor, form the basis for the core damage frequency and public risk calculations. Both internal and external events were considered. It was concluded that all three proposed resolution strategies exceed the $1,000/person-rem cost-effectiveness ratio. Additional evaluations were performed to develop ``generic`` insights on potential design-related and configuration-related vulnerabilities and potential high-frequency ({approximately}1E-04/RY) accident sequences that involve failures of HVAC/room cooling functions. It was concluded that, although high-frequency accident sequences may exist at some plants, these high-frequency sequences are plant-specific in nature or have been resolved through hardware and/or operational changes. The plant-specific Individual Plant Examinations are an effective vehicle for identification and resolution of these plant-specific anomalies and hardware configurations.

  16. Value impact analysis of Generic Issue 143, Availability of Heating, Ventilation, Air Conditioning (HVAC) and Chilled Water Systems

    International Nuclear Information System (INIS)

    Daling, P.M.; Marler, J.E.; Vo, T.V.; Phan, H.; Friley, J.R.

    1993-11-01

    This study evaluates the values (benefits) and impacts (costs) associated with potential resolutions to Generic Issue 143, ''Availability of HVAC and Chilled Water Systems.'' The study identifies vulnerabilities related to failures of HVAC, chilled water, and room cooling systems; develops estimates of room heatup rates and safety-related equipment vulnerabilities following losses of HVAC/room cooler systems; develops estimates of the core damage frequencies and public risks associated with failures of these systems; develops three proposed resolution strategies to this generic issue; and performs a value/impact analysis of the proposed resolutions. Existing probabilistic risk assessments for four representative plants, including one plant from each vendor, form the basis for the core damage frequency and public risk calculations. Both internal and external events were considered. It was concluded that all three proposed resolution strategies exceed the $1,000/person-rem cost-effectiveness ratio. Additional evaluations were performed to develop ''generic'' insights on potential design-related and configuration-related vulnerabilities and potential high-frequency (∼1E-04/RY) accident sequences that involve failures of HVAC/room cooling functions. It was concluded that, although high-frequency accident sequences may exist at some plants, these high-frequency sequences are plant-specific in nature or have been resolved through hardware and/or operational changes. The plant-specific Individual Plant Examinations are an effective vehicle for identification and resolution of these plant-specific anomalies and hardware configurations

  17. Implications of the accident at Chernobyl for safety regulation of commercial nuclear power plants in the United States: Volume 1, Main report: Final report

    International Nuclear Information System (INIS)

    1989-04-01

    This report was prepared by the Nuclear Regulatory Commission (NRC) staff to assess the implications of the accident at the Chernobyl nuclear power plant as they relate to reactor safety regulation for commercial nuclear power plants in the United States. The facts used in this assessment have been drawn from the US fact-finding report (NUREG-1250) and its sources. The general conclusions of the document are that there are generic lessons to be learned but that no changes in regulations are needed due to the substantial differences in the design, safety features and operation of US plants as compared to those in the USSR. Given these general conclusions, further consideration of certain specific areas is recommended by the report. These include: administrative controls over reactor regulation, reactivity accidents, accidents at low or zero power, multi-unit protection, fires, containment, emergency planning, severe accident phenomena, and graphite-moderated reactors

  18. Generic evolution of mixing in heterogeneous media

    Science.gov (United States)

    De Dreuzy, J.; Carrera, J.; Dentz, M.; Le Borgne, T.

    2011-12-01

    Mixing in heterogeneous media results from the competition bewteen flow fluctuations and local scale diffusion. Flow fluctuations quickly create concentration contrasts and thus heterogeneity of the concentration field, which is slowly homogenized by local scale diffusion. Mixing first deviates from Gaussian mixing, which represents the potential mixing induced by spreading before approaching it. This deviation fundamentally expresses the evolution of the interaction between spreading and local scale diffusion. We characterize it by the ratio γ of the non-Gaussian to the Gaussian mixing states. We define the Gaussian mixing state as the integrated squared concentration of the Gaussian plume that has the same longitudinal dispersion as the real plume. The non-Gaussian mixing state is the difference between the overall mixing state defined as the integrated squared concentration and the Gaussian mixing state. The main advantage of this definition is to use the full knowledge previously acquired on dispersion for characterizing mixing even when the solute concentration field is highly non Gaussian. Using high precision numerical simulations, we show that γ quickly increases, peaks and slowly decreases. γ can be derived from two scales characterizing spreading and local mixing, at least for large flux-weighted solute injection conditions into classically log-normal Gaussian correlated permeability fields. The spreading scale is directly related to the longitudinal dispersion. The local mixing scale is the largest scale over which solute concentrations can be considered locally uniform. More generally, beyond the characteristics of its maximum, γ turns out to have a highly generic scaling form. Its fast increase and slow decrease depend neither on the heterogeneity level, nor on the ratio of diffusion to advection, nor on the injection conditions. They might even not depend on the particularities of the flow fields as the same generic features also prevail for

  19. Lessons learned from the CEOG generic accident management guidelines confirmation (validation) exercise

    International Nuclear Information System (INIS)

    Khalil, Y.F.; Schneider, R.E.; Greene, M.A.

    1996-01-01

    In July 1995, the CE Owner's Group completed and issued Revision 0 of the Generic Accident Management Guidelines (AMG's) to the owners group task participants. This guidance provides a structured mechanism for the plant staff at CE utilities to respond to accidents that beyond the plant design basis and, possibly, the Emergency Operating Procedures. Prior to final issue of the generic AMGs, the CEOG conducted an AMG Confirmation Exercise to establish the ability of the AMGs to fulfill this important role. The specific objectives of the AMG Confirmation Exercise were to (1) clarify the interactions and transitions between the AMG/Technical Support Center (TSC) and the EOPS/Operations Personnel (2) validate the adequacy of the AMG data collection and plant condition diagnostic evaluation process and (3) assess the feasibility of the mechanical material and recommendations contained in the AMG's. The purpose of paper is to provide a detailed description of the AMG Confirmation Exercise as well as important lessons learned during the planning and implementation of the exercise. In addition, a discussion will be presented pertaining to the relationship between the AMG's (incumbent to the Technical Support Center) and the plants Emergency Operating Procedures (incumbent to the Control Room Operations Staff)

  20. HTGR Generic Technology Program. Semiannual report for the period ending September 30, 1980

    International Nuclear Information System (INIS)

    1980-11-01

    This document reports the technical accomplishments on the HTGR Generic Technology Program at General Atomic during the second half of FY-80. It covers a period when the design direction of the National HTGR Program is in the process of an overall review. The HTGR Generic Technology Program activities have continued so as to provide the basic technology required for all HTGR applications. The activities include the need to develop an LEU fuel and the need to qualify materials and components for the higher temperatures of the gas turbines and process heat plants

  1. Examining Generic Competitive Strategy Types in U.S. and European Markets

    OpenAIRE

    Susan P Douglas; Dong Kee Rhee

    1989-01-01

    Identification of generic competitive strategy types has recently attracted considerable attention. Most of this research has, however, focused on competitive strategy of U.S. businesses in their domestic market. The present study extends these findings to markets outside the United States, and more specifically Europe, based on a sample of industrial businesses drawn from the PIMS database. Similar dimensions underlying competitive strategy, and similar generic types are found among business...

  2. 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

  3. Optimizing Generic Functions

    NARCIS (Netherlands)

    Alimarine, A.; Smetsers, J.E.W.

    2004-01-01

    Generic functions are defined by induction on the structural representation of types. As a consequence, by defining just a single generic operation, one acquires this operation over any particular type. An instance on a specific type is generated by interpretation of the type's structure. A direct

  4. Availability Performance Analysis of Thermal Power Plants

    Science.gov (United States)

    Bhangu, Navneet Singh; Singh, Rupinder; Pahuja, G. L.

    2018-03-01

    This case study presents the availability evaluation method of thermal power plants for conducting performance analysis in Indian environment. A generic availability model has been proposed for a maintained system (thermal plants) using reliability block diagrams and fault tree analysis. The availability indices have been evaluated under realistic working environment using inclusion exclusion principle. Four year failure database has been used to compute availability for different combinatory of plant capacity, that is, full working state, reduced capacity or failure state. Availability is found to be very less even at full rated capacity (440 MW) which is not acceptable especially in prevailing energy scenario. One of the probable reason for this may be the difference in the age/health of existing thermal power plants which requires special attention of each unit from case to case basis. The maintenance techniques being used are conventional (50 years old) and improper in context of the modern equipment, which further aggravate the problem of low availability. This study highlights procedure for finding critical plants/units/subsystems and helps in deciding preventive maintenance program.

  5. Generic Example Proving Criteria for All

    Science.gov (United States)

    Yopp, David; Ely, Rob; Johnson­-Leung, Jennifer

    2015-01-01

    We review literature that discusses generic example proving and highlight ambiguities that pervade our research community's discourse about generic example arguments. We distinguish between pedagogical advice for choosing good examples that can serve as generic examples when teaching and advice for developing generic example arguments. We provide…

  6. Generic and biosimilar medicines: quid?

    Directory of Open Access Journals (Sweden)

    Steven Simoens

    2012-12-01

    Full Text Available Once intellectual property protection, data and marketing exclusivity of reference medicines have expired, generic medicines and biosimilar medicines can enter the off-patent market. This market entry is conditional on the approval of marketing authorization, pricing and reimbursement. Given that there tends to be confusion surrounding generic and biosimilar medicines, this Editorial introduces basic concepts related to generic and biosimilar medicines and presents the different studies and articles included in this supplement dedicated to generic and biosimilar medicines.

  7. A prioritization of generic safety issues

    International Nuclear Information System (INIS)

    Emrit, R.; Riggs, R.; Milstead, W.; Pittman, J.

    1991-07-01

    This report presents the priority rankings for generic safety issues and related to nuclear power plants. The purpose of these rankings is to assist in the timely and efficient allocation of NRC resources for the resolution of those safety issues that have a significant potential for reducing risk. The report focuses on the prioritization of generic safety issues. Issues primarily concerned with the licensing process or environmental protection and not directly related to safety have been excluded from prioritization. The prioritized issues include: TMI Action Plan items under development; previously proposed issues covered by Task Action Plans, except issues designated as Un-resolved Safety Issues (USIs) which had already been assigned high priority; and newly-proposed issues. Future supplements to this report will include the prioritization of additional issues. The safety priority rankings are High, Medium, Low, and Drop and have been assigned on the basis of risk significance estimates, the ratio of risk to costs and other impacts estimated to result if resolutions of the safety issues were implemented, and the consideration of uncertainties and other quantitative or qualitative factors. To the extent practical, estimates are quantitative. 1310 refs

  8. Advertising and generic market entry.

    Science.gov (United States)

    Königbauer, Ingrid

    2007-03-01

    The effect of purely persuasive advertising on generic market entry and social welfare is analysed. An incumbent has the possibility to invest in advertising which affects the prescribing physician's perceived relative qualities of the brand-name and the generic version of the drug. Advertising creates product differentiation and can induce generic market entry which is deterred without differentiation due to strong Bertrand competition. However, over-investment in advertising can deter generic market entry under certain conditions and reduces welfare as compared to accommodated market entry.

  9. Data analysis treatment in the Juragua Nuclear Power Plant preoperational PSA

    International Nuclear Information System (INIS)

    Valhuerdi Debesa, C.

    1996-01-01

    Data Analysis is an important task within Probabilistic safety Assessment,. which usually determines the level of detail of the analysis, being the way to feed the PSA with the operational experience of the Nuclear Power Plant analysed. In this paper the role of the Data Analysis Task as part of the PSA process and the different kinds of data to be estimated are explained. A description is presented of the organization of the data Analysis in the Juragua NPP Preoperational PSA, the information sources and the criteria handled for the estimation of the different kinds of Data. The Generic Data Base adopted for equipment failures and the state of the generic data issue for VVER reactors and its prospects are also dealt with. The paper concludes with suggestions for the further development of Juragua NPP generic Data Base

  10. Cost assessment of a generic magnetic fusion reactor

    International Nuclear Information System (INIS)

    Sheffield, J.; Dory, R.A.; Cohn, S.M.; Delene, J.G.; Parsly, L.F.; Ashby, D.E.T.F.; Reiersen, W.T.

    1986-03-01

    A generic reactor model is used to examine the economic viability of generating electricity by magnetic fusion. The simple model uses components that are representative of those used in previous reactor studies of deuterium-tritium-burning tokamaks, stellarators, bumpy tori, reversed-field pinches (RFPs), and tandem mirrors. Conservative costing assumptions are made. The generic reactor is not a tokamak; rather, it is intended to emphasize what is common to all magnetic fusion rectors. The reactor uses a superconducting toroidal coil set to produce the dominant magnetic field. To this extent, it is not as good an approximation to systems such as the RFP in which the main field is produced by a plasma current. The main output of the study is the cost of electricity as a function of the weight and size of the fusion core - blanket, shield, structure, and coils. The model shows that a 1200-MW(e) power plant with a fusion core weight of about 10,000 tonnes should be competitive in the future with fission and fossil plants. Studies of the sensitivity of the model to variations in the assumptions show that this result is not sensitively dependent on any given assumption. Of particular importance is the result that a fusion reactor of this scale may be realized with only moderate advances in physics and technology capabilities

  11. Generic Bell inequalities for multipartite mulit-dimensional systems

    International Nuclear Information System (INIS)

    Son, W.; Lee, J.; Kim, M.S.

    2005-01-01

    Full text: We present generic Bell inequalities for multipartite multi-dimensional systems. They utilize the set of measurements, which are coincident with the generalized version of Greenberger, Horne and Zeilinger (GHZ) paradox. The inequalities that must be satisfied by any local realistic theories are violated by quantum mechanics for even-dimensional multipartite systems. It is also shown that the maximal violation of the inequality is obtained by the generalized GHZ state, which is true multi-body nonseparable state. As a special case for the multipartite two-dimensional systems, it can be shown that the inequality agrees with Bell-Mermin version of inequality. Large sets of variants are shown to naturally emerge from the generic Bell inequalities. We will discuss the particular variants of Bell inequalities that are violated for all the systems including odd-dimensional multipartite systems. Interestingly the variants can be reduced into the Clauser-Horne-Shimony-Holt (CHSH) inequality as well as Ardehali inequality. (author)

  12. Generic risk insights for General Electric boiling water reactors

    International Nuclear Information System (INIS)

    Travis, R.; Taylor, J.; Chung, J.

    1991-05-01

    A methodology has been developed to extract generic risk-based information from probabilistic risk assessments (PRAs) of General Electric boiling water rectors and applying the insights gained to plants that have not been subjected to a PRA. The available risk assessments (six plants) were examined to identify the most probable, i.e., dominant accident sequences at each plants. The goal was to include all sequences which represented at least 80% of core damage frequency. If the same plant specific dominant accident sequence appeared within this boundary in at least two plant PRAs, the sequence was considered to be a representative sequence. Eight sequences met this definition. From these sequences, the most important component failures and human error that contributed to each sequence have been prioritized. Guidance is provided to prioritize the representative sequences and modify selected basic events that have been shown to be sensitive to the plant specific design or operating variations of the contributing PRAs. This risk-based guidance can be used for utility and NRC activities including operator training, maintenance, design review, and inspections. 13 refs., 6 tabs

  13. Mark II containment lead plant program load evaluation and acceptance criteria

    International Nuclear Information System (INIS)

    1978-10-01

    The report, prepared by the Office of Nuclear Reactor Regulation, addresses the portion of the Mark II owner's program that provides a generic methodology for establishing design basis LOCA and safety relief valve loads for the lead Mark II facilities (Zimmer, Shoreham, and LaSalle), i.e., the lead plant program. The report includes an evaluation of the Mark II owner's load methodology, a description of load methodologies that we find acceptable for use in the individual plant unique assessments, and the basis for the stated conclusions

  14. Plant operation state monitoring system

    International Nuclear Information System (INIS)

    Sakai, Masanori; Babuchi, Katsumi; Arato, Toshiaki

    1994-01-01

    The system of the present invention accurately monitors a plant operation state of a plant, such as a nuclear power plant and a thermal power plant by using high temperature water, based on water quality informations. That is, water quality informations for the objective portion by using an electrochemical water quality sensor disposed in the objective portion to be monitored in the plant are continuously extracted for a predetermined period of time. Water quality is evaluated based on the extracted information. Obtained results for water quality evaluation and predetermined reference values of the plant operation handling are compared. Necessary part among the results of the measurement is displayed or recorded. The predetermined period of time described above is a period that the water quality information reaches at least a predetermined value or a period that the predetermined value is estimated by the water quality information, and it is defined as a period capable of measuring the information for three months continuously. The measurement is preferably conducted continuously in a period up to each periodical inspection on about every one year. (I.S.)

  15. Controllability of non-linear systems: generic singularities and their stability

    International Nuclear Information System (INIS)

    Davydov, Alexey A; Zakalyukin, Vladimir M

    2012-01-01

    This paper presents an overview of the state of the art in applications of singularity theory to the analysis of generic singularities of controllability of non-linear systems on manifolds. Bibliography: 40 titles.

  16. Encouraging generic use can yield significant savings.

    Science.gov (United States)

    Zimmerman, Christina

    2012-11-01

    Key findings. (1) Zero copayment for generic drugs is the greatest influencer of generic statin utilization. (2) Both higher copayments for generic drugs and lower copayments for competing brands are associated with a decreased probability of using generic statins. (3) Prior authorization and step therapy requirements for brand-name statins are associated with an increased use of generic drugs. (4) Greater use of generic statins should reduce costs for patients, plans, and Medicare.

  17. State regulation and power plant productivity: background and recommendations

    International Nuclear Information System (INIS)

    1980-09-01

    This report was prepared by representatives of several state regulatory agencies. It is a guide to some of the activities currently under way in state agencies to promote increased availability of electrical generating power plants. Standard measures of plant performance are defined and the nature of data bases that report such measures is discussed. It includes reviews of current state, federal, and industry programs to enhance power plant productivity and provides detailed outlines of programs in effect in California, Illinois, Michigan, New York, North Carolina, Ohio, and Texas. A number of actions are presented that could be adopted by state regulatory agencies, depending on local conditions. They include: develop a commission position or policy statement to encourage productivity improvements by utilities; coordinate state efforts with ongoing industry and government programs to improve the acquisition of power plant performance data and the maintenance of quality information systems; acquire the capability to perform independent analyses of power plant productivity; direct the establishment of productivity improvement programs, including explicit performance objectives for both existing and planned power plants, and a performance program; establish a program of incentives to motivate productivity improvement activities; and participate in ongoing efforts at all levels and initiate new actions to promote productivity improvements

  18. Diode-pumped solid-state-laser drivers and the competitiveness of inertial fusion energy

    International Nuclear Information System (INIS)

    Orth, C.D.

    1993-12-01

    Based on five technical advances at LLNL and a new systems-analysis code that we have written, we present conceptual designs for diode-pumped solid-state laser (DPSSL) drivers for Inertial Fusion Energy (IFE) power plants. Such designs are based on detailed physics calculations for the drive, and on generic scaling relationships for the reactor and balance of plant (BOP). We describe the performance and economics of such power plants, show how sensitive these results are to changes in the major parameters, and indicate how technological improvements can make DPSSL-driven IFE plants more competitive

  19. 76 FR 57767 - Proposed Generic Communication; Draft NRC Generic Letter 2011-XX: Seismic Risk Evaluations for...

    Science.gov (United States)

    2011-09-16

    ... NUCLEAR REGULATORY COMMISSION [NRC-2011-0204] Proposed Generic Communication; Draft NRC Generic Letter 2011-XX: Seismic Risk Evaluations for Operating Reactors AGENCY: Nuclear Regulatory Commission... FR 54507), that requested public comment on Draft NRC Generic Letter 2011- XX: Seismic Risk...

  20. Generic aging management programs for license renewal of BWR reactor coolant systems components

    International Nuclear Information System (INIS)

    Shah, V.N.; Liu, Y.Y.

    2002-01-01

    The paper reviews the existing generic aging management programs (AMPs) for the reactor coolant system (RCS) components in boiling water reactors (BWRs), including the reactor pressure vessel and internals, the reactor recirculation system, and the connected piping. These programs have been evaluated in the U.S. Nuclear Regulatory Commission (NRC) report, Generic Aging Lessons Learned (GALL), NUREG-1801, for their use in the license renewal process to manage several aging effects, including loss of material, crack initiation and growth, loss of fracture toughness, loss of preload, wall thinning, and cumulative fatigue damage. The program evaluation includes a review of ten attributes (scope of program, preventive actions, parameters monitored/inspected, detection of aging effects, monitoring and trending, acceptance criteria, corrective actions, confirmative process, administrative control, and operating experience) for their effectiveness in managing a specific aging effect in a given component(s). The generic programs are based on the ASME Section XI inservice inspection requirements; industry guidelines for inspection and evaluation of aging effects in BWR reactor vessel, internals, and recirculation piping; monitoring and control of BWR water chemistry; and operating experience as reported in the USNRC generic communications and industry reports. The review concludes that all generic AMPs are acceptable for managing aging effects in BWR RCS components during an extended period of operation and do not need further evaluation. However, the plant-specific programs for managing aging in certain RCS components during an extended period of operation do require further evaluation. For some plant-specific AMPs, the GALL report recommends an aging management activity to verify their effectiveness. An example of such an activity is a one-time inspection of Class 1 small-bore piping to ensure that service-induced weld cracking is not occurring in the piping. Several of

  1. Generic Aging Management Programs for License Renewal of BWR Reactor Coolant System Components

    International Nuclear Information System (INIS)

    Shah, V.N.; Liu, Y.Y.

    2002-01-01

    The paper reviews the existing generic aging management programs (AMPs) for the reactor coolant system (RCS) components in boiling water reactors (BWRs), including the reactor pressure vessel and internals, the reactor recirculation system, and the connected piping. These programs have been evaluated in the U.S. Nuclear Regulatory Commission (NRC) report, Generic Aging Lessons Learned (GALL), NUREG-1801, for their use in the license renewal process to manage several aging effects, including loss of material, crack initiation and growth, loss of fracture toughness, loss of preload, wall thinning, and cumulative fatigue damage. The program evaluation includes a review of ten attributes (scope of program, preventive actions, parameters monitored/inspected, detection of aging effects, monitoring and trending, acceptance criteria, corrective actions, confirmative process, administrative control, and operating experience) for their effectiveness in managing a specific aging effect in a given component(s). The generic programs are based on the ASME Section XI inservice inspection requirements; industry guidelines for inspection and evaluation of aging effects in BWR reactor vessel, internals, and recirculation piping; monitoring and control of BWR water chemistry; and operating experience as reported in the USNRC generic communications and industry reports. The review concludes that all generic AMPs are acceptable for managing aging effects in BWR RCS components during an extended period of operation and do not need further evaluation. However, the plant-specific programs for managing aging in certain RCS components during an extended period of operation do require further evaluation. For some plant-specific AMPs, the GALL report recommends an aging management activity to verify their effectiveness. An example of such an activity is a one-time inspection of Class 1 small-bore piping to ensure that service-induced weld cracking is not occurring in the piping. Several of

  2. Locality in Generic Instance Search from One Example

    NARCIS (Netherlands)

    Tao, R.; Gavves, E.; Snoek, C.G.M.; Smeulders, A.W.M.

    2014-01-01

    This paper aims for generic instance search from a single example. Where the state-of-the-art relies on global image representation for the search, we proceed by including locality at all steps of the method. As the first novelty, we consider many boxes per database image as candidate targets to

  3. Towards a generic user support system (GUS)

    International Nuclear Information System (INIS)

    Garland, W.J.; Wilson, R.J.

    1993-01-01

    One relevant issue confronting the operator of a nuclear power plant is information and task overload. The goal, then, of the various developers is to improve the current situations by creating an environment where the operator can perform at optimum capacity. This is to be accomplished by providing tools and techniques which reduce operator involvement in low level tasks (freeing up time for higher level cognitive tasks) and assist in information and knowledge manipulation so that high level tasks can be performed more efficiently. This paper reviews the operational environment of nuclear plants from the viewpoint of engineering design and from the viewpoint of the operators and technical support staff. Principles are advanced for a generic operator companion. These design principles are being applied to a test case: the Point Lepreau NGS secondary side central sampling system. 6 refs., 6 figs

  4. Role of seismic PRA in seismic safety decisions of nuclear power plants

    International Nuclear Information System (INIS)

    Ravindra, M.K.; Kennedy, R.P.; Sues, R.H.

    1985-01-01

    This paper highlights the important roles that seismic probabilistic risk assessments (PRAs) can play in the seismic safety decisions of nuclear power plants. If a seismic PRA has been performed for a plant, its results can be utilized to evaluate the seismic capability beyond the safe shutdown event (SSE). Seismic fragilities of key structures and equipment, fragilities of dominant plant damage states and the frequencies of occurrence of these plant damage states are reviewed to establish the seismic safety of the plant beyond the SSE level. Guidelines for seismic margin reviews and upgrading may be developed by first identifying the generic classes of structures and equipment that have been shown to be dominant risk contributors in the completed seismic PRAs, studying the underlying causes for their contribution and examining why certain other items (e.g., piping) have not proved to be high-risk-contributors

  5. Generic information can retrieve known biological associations: implications for biomedical knowledge discovery.

    Directory of Open Access Journals (Sweden)

    Herman H H B M van Haagen

    Full Text Available MOTIVATION: Weighted semantic networks built from text-mined literature can be used to retrieve known protein-protein or gene-disease associations, and have been shown to anticipate associations years before they are explicitly stated in the literature. Our text-mining system recognizes over 640,000 biomedical concepts: some are specific (i.e., names of genes or proteins others generic (e.g., 'Homo sapiens'. Generic concepts may play important roles in automated information retrieval, extraction, and inference but may also result in concept overload and confound retrieval and reasoning with low-relevance or even spurious links. Here, we attempted to optimize the retrieval performance for protein-protein interactions (PPI by filtering generic concepts (node filtering or links to generic concepts (edge filtering from a weighted semantic network. First, we defined metrics based on network properties that quantify the specificity of concepts. Then using these metrics, we systematically filtered generic information from the network while monitoring retrieval performance of known protein-protein interactions. We also systematically filtered specific information from the network (inverse filtering, and assessed the retrieval performance of networks composed of generic information alone. RESULTS: Filtering generic or specific information induced a two-phase response in retrieval performance: initially the effects of filtering were minimal but beyond a critical threshold network performance suddenly drops. Contrary to expectations, networks composed exclusively of generic information demonstrated retrieval performance comparable to unfiltered networks that also contain specific concepts. Furthermore, an analysis using individual generic concepts demonstrated that they can effectively support the retrieval of known protein-protein interactions. For instance the concept "binding" is indicative for PPI retrieval and the concept "mutation abnormality" is

  6. Generics Pricing: The Greek Paradox.

    Science.gov (United States)

    Karafyllis, Ioannis; Variti, Lamprini

    2017-01-01

    This paper explains and develops a methodological framework to help evaluate the performance of generic pharmaceutical policies and the correct evaluation of generics sales. Until today erroneous recording of generics does not help proper pricing and their penetration in the Greek market. This classifies Greece on the outliners in every study or comparison that is referred on papers or studies.

  7. NRC program for the resolution of generic issues related to nuclear power plants. (Includes plans for the resolution of ''unresolved safety issues'' pursuant to Section 210 of the Energy Reorganization Act of 1974, as amended)

    International Nuclear Information System (INIS)

    1977-12-01

    This report provides a description of the Nuclear Regulatory Commission's Program for the Resolution of Generic Issues Related to Nuclear Power Plants. The NRC program is of considerably broader scope than the ''Unresolved Safety Issues Plan'' required by Section 210. The NRC program does include plans for the resolution of ''Unresolved Safety Issues''; however, in addition, it includes generic tasks for the resolution of environmental issues, for the development of improvements in the reactor licensing process and for consideration of less conservative design criteria or operating limitations in areas where over conservatisms may be unnecessarily restrictive or costly

  8. Status of safety issues at licensed power plants: TMI action plan requirements, unresolved safety issues, generic safety issues

    International Nuclear Information System (INIS)

    1991-12-01

    As part of ongoing US Nuclear Regulatory Commission (NRC) efforts to ensure the quality and accountability of safety issue information, a program was established whereby an annual NUREG report would be published on the status of licensee implementation and NRC verification of safety issues in major NRC requirements areas. This information was compiled and reported in three NUREG volumes. Volume 1, published in March 1991, addressed the status of of Three Mile Island (TMI) Action Plan Requirements. Volume 2, published in May 1991, addressed the status of unresolved safety issues (USIs). Volume 3, published in June 1991, addressed the implementation and verification status of generic safety issues (GSIs). This annual NUREG report combines these volumes into a single report and provides updated information as of September 30, 1991. The data contained in these NUREG reports are a product of the NRC's Safety Issues Management System (SIMS) database, which is maintained by the Project Management Staff in the Office of Nuclear Reactor Regulation and by NRC regional personnel. This report is to provide a comprehensive description of the implementation and verification status of TMI Action Plan Requirements, safety issues designated as USIs, and GSIs that have been resolved and involve implementation of an action or actions by licensees. This report makes the information available to other interested parties, including the public. An additional purpose of this NUREG report is to serve as a follow-on to NUREG-0933, ''A Prioritization of Generic Safety Issues,'' which tracks safety issues up until requirements are approved for imposition at licensed plants or until the NRC issues a request for action by licensees

  9. NET 40 Generics Beginner's Guide

    CERN Document Server

    Mukherjee, Sudipta

    2012-01-01

    This is a concise, practical guide that will help you learn Generics in .NET, with lots of real world and fun-to-build examples and clear explanations. It is packed with screenshots to aid your understanding of the process. This book is aimed at beginners in Generics. It assumes some working knowledge of C# , but it isn't mandatory. The following would get the most use out of the book: Newbie C# developers struggling with Generics. Experienced C++ and Java Programmers who are migrating to C# and looking for an alternative to other generic frameworks like STL and JCF would find this book handy.

  10. HTGR Generic Technology Program. Semiannual report for the period ending September 30, 1979

    International Nuclear Information System (INIS)

    1979-11-01

    The technical accomplishments on the HTGR Generic Technology Program at General Atomic during the second half of FY-79 are reported. The report covers a period when the major design direction of the National HTGR Program is in the process of changing from the HTGR-SC emphasis to an HTGR-GT emphasis in the near term. The HTGR Generic Technology Program activities have been redirected to ensure that the tasks covered are supportive of this changing emphasis in HTGR applications. The activities include the need to develop an MEU fuel, and the need to qualify materials and components for the higher temperatures of the gas turbine plant

  11. HTGR Generic Technology Program. Semiannual report for the period ending March 31, 1979

    Energy Technology Data Exchange (ETDEWEB)

    1979-06-01

    This document reports the technical accomplishments on the HTGR Generic Technology Program at General Atomic during the first half of FY-79. It covers a period when the major design direction of the National HTGR Program is in the process of changing from the HTGR-SC emphasis to an HTGR-GT emphasis in the near term. The HTGR Generic Technology Program activities have been redirected to ensure that the tasks covered are supportive of this changing emphasis in HTGR applications. The activities include the need to develop a medium enriched uranium (MEU) fuel, and the need to qualify materials and components for the higher temperatures of the gas turbine plant.

  12. HTGR Generic Technology Program. Semiannual report for the period ending March 31, 1979

    International Nuclear Information System (INIS)

    1979-06-01

    This document reports the technical accomplishments on the HTGR Generic Technology Program at General Atomic during the first half of FY-79. It covers a period when the major design direction of the National HTGR Program is in the process of changing from the HTGR-SC emphasis to an HTGR-GT emphasis in the near term. The HTGR Generic Technology Program activities have been redirected to ensure that the tasks covered are supportive of this changing emphasis in HTGR applications. The activities include the need to develop a medium enriched uranium (MEU) fuel, and the need to qualify materials and components for the higher temperatures of the gas turbine plant

  13. The Generic Containment SB-LOCA accident simulation: Comparison of the parameter uncertainties and user-effect

    International Nuclear Information System (INIS)

    Povilaitis, Mantas; Kelm, Stephan; Urbonavičius, Egidijus

    2017-01-01

    Highlights: • Uncertainty and sensitivity analysis for the Generic Containment severe accident. • Comparison of the analysis results with the uncertainties based in the user effect. • Demonstration of the similar importance of both the reducing the user effect and input uncertainties. - Abstract: Uncertainties in safety assessment of the nuclear power plants using computer codes come from several sources: choice of computer code, user effect (a strong impact of user choices on the simulation’s outcome) and uncertainty of various physical parameters. The “Generic Containment” activity was performed in the frames of the EU-FP7 project SARNET2 to investigate the influence of user effect and computer code choice on the results on the nuclear power plant scale. During this activity, a Generic Containment nodalisation was developed and used for exercise by the participants applying various computer codes. Even though the model of the Generic Containment and the transient scenario were precisely and uniquely defined, considerably different results were obtained not only among different codes but also among participants using the same code, showing significant influence of the user effect. This paper present analysis, which is an extension of the “Generic Containment” benchmark and investigates the effect of input parameter’s uncertainties in comparison to the user effect. Calculations were performed using the computer code ASTEC, the uncertainty and sensitivity of the results were estimated using GRS method and tool SUSA. The results of the present analysis show, that while there are differences between the uncertainty bands of the parameters, in general the deviation bands caused by parameters’ uncertainty and the user effect are comparable and of the same order. The properties of concrete and the surface areas may have more influence on containment pressure than the user effect and choice of computer code as identified in the SARNET2 Generic

  14. Generic Sensor Failure Modeling for Cooperative Systems

    Science.gov (United States)

    Jäger, Georg; Zug, Sebastian

    2018-01-01

    The advent of cooperative systems entails a dynamic composition of their components. As this contrasts current, statically composed systems, new approaches for maintaining their safety are required. In that endeavor, we propose an integration step that evaluates the failure model of shared information in relation to an application’s fault tolerance and thereby promises maintainability of such system’s safety. However, it also poses new requirements on failure models, which are not fulfilled by state-of-the-art approaches. Consequently, this work presents a mathematically defined generic failure model as well as a processing chain for automatically extracting such failure models from empirical data. By examining data of an Sharp GP2D12 distance sensor, we show that the generic failure model not only fulfills the predefined requirements, but also models failure characteristics appropriately when compared to traditional techniques. PMID:29558435

  15. An Internet of Things Generic Reference Architecture

    DEFF Research Database (Denmark)

    Bhalerao, Dipashree M.; Riaz, Tahir; Madsen, Ole Brun

    2013-01-01

    Internet of things Network is a future application of Internet. This network has three major basic blocks as business process or Application, core network or internetwork and peripheral network as Things or objects. The assembly has the basic intention of connecting all physical and virtual things......, and keeping track of all these things for monitoring and controlling some information. IoT architecture is studied from software architecture, overall system architecture and network architecture point of view. Paper puts forward the requirements of software architecture along with, its component...... and deployment diagram, process and interface diagram at abstract level. Paper proposes the abstract generic IoT reference and concrete abstract generic IoT reference architectures. Network architecture is also put up as a state of the art. Paper shortly gives overviews of protocols used for IoT. Some...

  16. Handbook for cost estimating. A method for developing estimates of costs for generic actions for nuclear power plants

    International Nuclear Information System (INIS)

    Ball, J.R.; Cohen, S.; Ziegler, E.Z.

    1984-10-01

    This document provides overall guidance to assist the NRC in preparing the types of cost estimates required by the Regulatory Analysis Guidelines and to assist in the assignment of priorities in resolving generic safety issues. The Handbook presents an overall cost model that allows the cost analyst to develop a chronological series of activities needed to implement a specific regulatory requirement throughout all applicable commercial LWR power plants and to identify the significant cost elements for each activity. References to available cost data are provided along with rules of thumb and cost factors to assist in evaluating each cost element. A suitable code-of-accounts data base is presented to assist in organizing and aggregating costs. Rudimentary cost analysis methods are described to allow the analyst to produce a constant-dollar, lifetime cost for the requirement. A step-by-step example cost estimate is included to demonstrate the overall use of the Handbook

  17. Efficient Generic Functional Programming

    NARCIS (Netherlands)

    Alimarine, A.; Smetsers, J.E.W.

    2005-01-01

    Generic functions are defined by induction on the structural representation of types. As a consequence, by defining just a single generic operation, one acquires this operation over any particular data type. An instance on a specific type is generated by interpretation of the type's structure. A

  18. A report by the Health and Safety Executive to the Secretary of State for Energy on a review of the generic safety issues of pressurised water reactors

    International Nuclear Information System (INIS)

    1979-01-01

    The Nuclear Installations Inspectorate (NII) has completed a detailed technical study of certain generic safety aspects of the Pressurized Water Reactor (PWR). Although a particular design has been used as a reference, the conclusions reached are not intended to relate to any specific plant. The NII consider that there is no fundamental reason for regarding safety as an obstacle to the selection of a PWR for commercial electricity generation in Britain. Although there are some safety aspects about which present information and investigations are insufficient to allow final conclusions to be reached, and some areas where more work would lead to greater confidence, the NII are satisfied that these issues are not such as to prejudice an immediate decision in principle about the suitability of the PWR for commercial use in Britain. Further progress would appropriately form part of the more detailed review of any specific design of reactor put forward for licensing. Headings of the report include: organization of the review; the PWR; reactor safety issues; basis of judgement; the generic topics (potential plant faults and their analysis, loss of coolant, integrity of primary coolant circuit, fuel elements, reactor protection system, containment, radiological risk in normal operation, radioactive wastes); alternative PWR concepts; risk evaluation; light water reactor safety R and D; conclusions. (author)

  19. Generic implications of ATWS events at the Salem Nuclear Power Plant. Licensee and staff actions

    International Nuclear Information System (INIS)

    1983-08-01

    This report, Volume 2 of two volumes of NUREG-1000, describes the intermediate term actions to be taken by licensees and applicants of the US Nuclear Regulatory Commission (NRC), on the one hand, and by NRC staff, on the other, to address the generic issues raised by two anticipated transients without scram (ATWS) at the Salem Nuclear Generating Station, Unit 1, on February 22 and 25, 1983. These actions came about as a result of the findings of NUREG-1000, Volume 1, and of reviews by the NRC Committee to Review Generic Requirements, the NRC Program Offices, and the Commission. The actions to be taken by licensees and applicants have been detailed in a letter pursuant to 10 CFR 50.54(f)

  20. Generic robot architecture

    Science.gov (United States)

    Bruemmer, David J [Idaho Falls, ID; Few, Douglas A [Idaho Falls, ID

    2010-09-21

    The present invention provides methods, computer readable media, and apparatuses for a generic robot architecture providing a framework that is easily portable to a variety of robot platforms and is configured to provide hardware abstractions, abstractions for generic robot attributes, environment abstractions, and robot behaviors. The generic robot architecture includes a hardware abstraction level and a robot abstraction level. The hardware abstraction level is configured for developing hardware abstractions that define, monitor, and control hardware modules available on a robot platform. The robot abstraction level is configured for defining robot attributes and provides a software framework for building robot behaviors from the robot attributes. Each of the robot attributes includes hardware information from at least one hardware abstraction. In addition, each robot attribute is configured to substantially isolate the robot behaviors from the at least one hardware abstraction.

  1. Task Action Plans for generic activities: Category A

    International Nuclear Information System (INIS)

    1978-10-01

    The document contains listings of generic technical activities as identified and placed in priority categories by the Office of Nuclear Reactor Regulation (NRR). In addition, it contains definitions of Priority Categories A, B, C, and D and copies of forty approved Task Action Plans for Category A activites. Problem Descriptions for the Category B, C and D tasks are contained in NUREG--0471. This material was developed within the context of NRR's Program for the Resolution of Generic Issues Related to Nuclear Power Plants. As part of this program, the assignment of identified issues to priority categories and the approval of Task Action Plans were made by NRR's Technical Activities Steering Committee, chaired by the Deputy Director, NRR. The original document was published in November 1977. In December 1977 it was updated to add the Task Action Plan for Task No. A-17, Systems Interactions in Nuclear Power Plants. This update adds Task Action Plans for Tasks A-13, A-18, A-21, A-22, A-32, A-37, A-38 and A-40. Task A-41 has been included in Task A-40. In addition, as part of this update, the following changes were made to each Task Action Plan (with the exception of the Task Action Plan for Task A-9): (1) a title page was added that includes information such as Lead NRR Organization, Lead Supervisor, Task Manager, Applicability, and Projected Completion Date; (2) detailed schedule information was deleted; and (3) a new Section 3 entitled Basis for Continued Plant Operation and Licensing Pending Completion of Task was added. These changes represent general reformatting and the addition or deletion of certain general types of information. Some substantive revisions were made to several of the plans, however, a general revision of all of the plans was not undertaken at this time

  2. Generic conditional clearance for very low level active charcoal generated in nuclear power plant operation

    International Nuclear Information System (INIS)

    Gomez Perales, J. J.; Burgos Gallego, J.; Alvarez Mir, F.; Luis de Diego, J.; Adrada Garcia, J.

    1998-01-01

    This report proposes a generic conditional exemption to the very low level active charcoal generated in the operation of a NPP. The project has been developed in two parts: a common one (applied to the stream to be exempted) and a specific one (specific to the NPP that fulfills already the common part requirements). The common project specifies the methodology and the disposal options. It provides derived exemption levels and maximum amount of activity the exemption of which be feasible, demonstrating the viability of their conventional management. The specific project of each NPP will develop the amount of waste to be managed and other details that supplement the previous project, adjusting to the methodology and disposal options in the common project. The proposed management suggestion consists in burning the waste in a coal-burning plant and disposing of the scum in a controlled landfill. The resultant radiological dose is considered negligible according to the document Safety Series N 89 of the IAEA. The calculation of the radiological dose associated to several stages has been carried out using the IMPACTS-BRC code, contained in NUREG/CR-3585 and NUREG/5517. The methodology used in the radiological dose evaluation is as recommended in the Safety Guide n. 7.8 of the Spanish Nuclear Safety Council. (Author)

  3. 42 CFR 447.506 - Authorized generic drugs.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 4 2010-10-01 2010-10-01 false Authorized generic drugs. 447.506 Section 447.506... (CONTINUED) MEDICAL ASSISTANCE PROGRAMS PAYMENTS FOR SERVICES Payment for Drugs § 447.506 Authorized generic drugs. (a) Authorized generic drug defined. For the purposes of this subpart, an authorized generic drug...

  4. Generic Local Hamiltonians are Gapless

    Science.gov (United States)

    Movassagh, Ramis

    2017-12-01

    We prove that generic quantum local Hamiltonians are gapless. In fact, we prove that there is a continuous density of states above the ground state. The Hamiltonian can be on a lattice in any spatial dimension or on a graph with a bounded maximum vertex degree. The type of interactions allowed for include translational invariance in a disorder (i.e., probabilistic) sense with some assumptions on the local distributions. Examples include many-body localization and random spin models. We calculate the scaling of the gap with the system's size when the local terms are distributed according to a Gaussian β orthogonal random matrix ensemble. As a corollary, there exist finite size partitions with respect to which the ground state is arbitrarily close to a product state. When the local eigenvalue distribution is discrete, in addition to the lack of an energy gap in the limit, we prove that the ground state has finite size degeneracies. The proofs are simple and constructive. This work excludes the important class of truly translationally invariant Hamiltonians where the local terms are all equal.

  5. Determinants of generic drug substitution in Switzerland

    Directory of Open Access Journals (Sweden)

    Lufkin Thomas M

    2011-01-01

    Full Text Available Abstract Background Since generic drugs have the same therapeutic effect as the original formulation but at generally lower costs, their use should be more heavily promoted. However, a considerable number of barriers to their wider use have been observed in many countries. The present study examines the influence of patients, physicians and certain characteristics of the generics' market on generic substitution in Switzerland. Methods We used reimbursement claims' data submitted to a large health insurer by insured individuals living in one of Switzerland's three linguistic regions during 2003. All dispensed drugs studied here were substitutable. The outcome (use of a generic or not was modelled by logistic regression, adjusted for patients' characteristics (gender, age, treatment complexity, substitution groups and with several variables describing reimbursement incentives (deductible, co-payments and the generics' market (prices, packaging, co-branded original, number of available generics, etc.. Results The overall generics' substitution rate for 173,212 dispensed prescriptions was 31%, though this varied considerably across cantons. Poor health status (older patients, complex treatments was associated with lower generic use. Higher rates were associated with higher out-of-pocket costs, greater price differences between the original and the generic, and with the number of generics on the market, while reformulation and repackaging were associated with lower rates. The substitution rate was 13% lower among hospital physicians. The adoption of the prescribing practices of the canton with the highest substitution rate would increase substitution in other cantons to as much as 26%. Conclusions Patient health status explained a part of the reluctance to substitute an original formulation by a generic. Economic incentives were efficient, but with a moderate global effect. The huge interregional differences indicated that prescribing behaviours and

  6. Firm- and drug-specific patterns of generic drug payments by US medicaid programs: 1991-2008.

    Science.gov (United States)

    Kelton, Christina M L; Chang, Lenisa V; Guo, Jeff J; Yu, Yan; Berry, Edmund A; Bian, Boyang; Heaton, Pamela C

    2014-04-01

    The entry of generic drugs into markets previously monopolized by patented, branded drugs often represents large potential savings for healthcare payers in the USA. Our objectives were to describe and explain the trends in drug reimbursement by public Medicaid programmes post-generic entry for as many drug markets and for as long a time period as possible. The data were the Medicaid State Drug Utilization Data maintained by the Centers for Medicare and Medicaid Services. Quarterly utilization and expenditure data from 1991 to 2008 were extracted for 83 drugs, produced by 229 firms, that experienced initial generic entry between 1992 and 2004. A relative 'price' for a specific drug, firm and quarter was constructed as Medicaid reimbursement per unit (e.g. tablet, capsule or vial) divided by average reimbursement per unit for the branded drug the year before entry. Fixed-effects models controlling for time-, firm- and drug-specific differences were estimated to explain reimbursement. Twelve quarters after generic entry, 18 % of drugs had average per-unit reimbursement less than 50 % of the original branded-drug reimbursement. For each additional firm manufacturing the drug, reimbursement per unit, relative to the pre-generic-entry branded-drug reimbursement, was estimated to fall by 17 (p < 0.01) and 3 (p < 0.01) percentage points for generic and branded-drug companies, respectively. Each additional quarter post-generic entry brought a 2 (p < 0.01) percentage point drop in relative reimbursement. State Medicaid programmes generally have been able to obtain relief from high drug prices following patent expirations for many branded-drug medications by adjusting reimbursement following the expanded competition in the pharmaceutical market.

  7. Generic clearance values

    International Nuclear Information System (INIS)

    Bossio, M.C.; Muniz, C.C.

    2009-01-01

    This paper analyzes the Generic Clearance Values established for natural and artificial radionuclides with the objective of evaluating their degree of conservatism in views of adopting them into the regulatory body. Generic clearance values for natural radionuclides have been chosen by experts judgments as the optimum boundary between, on one hand, the ubiquitous unmodified soil concentrations and, on the other hand, activity concentrations in ores, mineral sands, industrial residues and wastes. For artificial radionuclides the clearance levels have been derived from the scenarios postulated in the document 'Safety Reports Series Nr 44' of the IAEA considering quantitative exemption criteria. A set of 8 scenarios were postulated covering external, ingestion and inhalation exposure pathways. For each radionuclide, the generic clearance level was derived as the more restrictive value obtained from the scenarios, that is the lowest ratio between the applicable individual dose and the dose per unit activity concentration (Bq/g). The individual dose was calculated by a formula depending on each scenario and pathway, with different parameters, such as exposure time, dosimetric factors, dilution factor, density of the material, geometric factors, etc. It was concluded that the basis and parameters used for the derivation of the generic clearance levels are quite conservative and therefore its the adoption in Argentina has been recommended. It is expected that their implementation will contribute to optimize the regulatory management system. (author)

  8. Generic Clearance Values

    International Nuclear Information System (INIS)

    Bossio, M.C.; Muniz, C.C.

    2010-01-01

    This paper analyzes the Generic Clearance Values established for natural and artificial radionuclides with the objective of evaluating their degree of conservatism in views of adopting them into the regulatory body. Generic clearance values for natural radionuclides have been chosen by experts judgments as the optimum boundary between, on the one hand, the ubiquitous unmodified soil concentrations and, on the other hand, activity concentrations in ores, mineral sands, industrial residues and wastes. For artificial radionuclides the clearance levels have been derived from the scenarios postulated in the document Safety Reports Series 44 of the IAEA considering quantitative exemption criteria. A set of 8 scenarios were postulated covering external, ingestion and inhalation exposure pathways. For each radionuclide, the generic clearance level was derived as the more restrictive value obtained from the scenarios, that is the lowest ratio between the applicable individual dose and the dose per unit activity concentration (Bq/g). The individual dose was calculated by a formula depending on each scenario and pathway, with different parameters, such as exposure time, dosimetric factors, dilution factor, density of the material, geometric factors, etc. It was concluded that the basis and parameters used for the derivation of the generic clearance levels are quite conservative and therefore its the adoption in Argentina has been recommended. It is expected that their implementation will contribute to optimize the regulatory management system. (authors) [es

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

    Science.gov (United States)

    Phillips, Karen; Reddy, Prabashni; Gabardi, Steven

    2017-02-01

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

  10. Inventory of power plants in the United States: December 1979

    International Nuclear Information System (INIS)

    Gilliam, L.R.

    1980-01-01

    This 1979 inventory of power plants provides a comprehensive list of existing, standby, out-of-service, retired and projected electric generating plants in the U.S. Arranged under the broad sections of existing, jointly owned and projected units, tabulated data on individual plants in each state are presented. These data include unit name, location, type, MW rating, primary fuel, alternative fuel, status, year built, and whether or not it is jointly owned. Jointly owned plants are separately identified as to the percent of ownership belonging to named owners. Projected plants have data on plant characteristics, current status and scheduled completion date. Summaries of the total number of each type of power plant in each state are also provided

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

    Directory of Open Access Journals (Sweden)

    Edeline Gagnon

    2016-10-01

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

  12. Generic Advantages

    Indian Academy of Sciences (India)

    First page Back Continue Last page Overview Graphics. Generic Advantages. Scalability an incremental coverage. Standardization. Business Plan Flexibility. Lifecycle Flexibility. Reliability. Service Interoperability. Changed Industry dynamics.

  13. A generic model for estimating biomass accumulation and greenhouse gas emissions from perennial crops

    Science.gov (United States)

    Ledo, Alicia; Heathcote, Richard; Hastings, Astley; Smith, Pete; Hillier, Jonathan

    2017-04-01

    Agriculture is essential to maintain humankind but is, at the same time, a substantial emitter of greenhouse gas (GHG) emissions. With a rising global population, the need for agriculture to provide secure food and energy supply is one of the main human challenges. At the same time, it is the only sector which has significant potential for negative emissions through the sequestration of carbon and offsetting via supply of feedstock for energy production. Perennial crops accumulate carbon during their lifetime and enhance organic soil carbon increase via root senescence and decomposition. However, inconsistency in accounting for this stored biomass undermines efforts to assess the benefits of such cropping systems when applied at scale. A consequence of this exclusion is that efforts to manage this important carbon stock are neglected. Detailed information on carbon balance is crucial to identify the main processes responsible for greenhouse gas emissions in order to develop strategic mitigation programs. Perennial crops systems represent 30% in area of total global crop systems, a considerable amount to be ignored. Furthermore, they have a major standing both in the bioenergy and global food industries. In this study, we first present a generic model to calculate the carbon balance and GHGs emissions from perennial crops, covering both food and bioenergy crops. The model is composed of two simple process-based sub-models, to cover perennial grasses and other perennial woody plants. The first is a generic individual based sub-model (IBM) covering crops in which the yield is the fruit and the plant biomass is an unharvested residue. Trees, shrubs and climbers fall into this category. The second model is a generic area based sub-model (ABM) covering perennial grasses, in which the harvested part includes some of the plant parts in which the carbon storage is accounted. Most second generation perennial bioenergy crops fall into this category. Both generic sub

  14. Development of fragility descriptions of equipment for seismic risk assessment of nuclear power plants

    International Nuclear Information System (INIS)

    Hardy, G.S.; Campbell, R.D.

    1983-01-01

    Probabilistic risk assessment (PRA) of a nuclear power plant for postulated hazard requires the development of fragility relationships for the plants' safety related equipment. The objective of this paper is to present some general results and conclusions concerning the development of these seismic fragility levels. Participation in fragility-related research and experience gained from the completion of several PRA studies of a variety of nuclear power plants have provided much insight as to the most vulnerable equipment and the most efficient use of resources for development of fragilities. Plants studied had seismic design bases ranging from very simple equivalent static analysis for some of the earlier plants to state-of-the-art complex multimode dyanamic analyses for plants currently under construction. Increased sophistication and rigor in seismic qualification of equipment has resulted for the most part in increased seismic resistance. The majority of equipment has been found, however, to possess more than adequate resistance to seismic loading regardless of the degree of sophistication utilized in design as long as seismic loading was included in the design process. This paper presents conclusions of the authors as to which items of equipment typically require an individual ''plant-specific'' fragility analysis and which can be treated in a generic fashion. In addition, general conclusions on the relative seismic capacity levels and most frequent failure modes are summarized for generic equipment groups

  15. Periodic Safety Review of Nuclear Power Plants: Experience of Member States

    International Nuclear Information System (INIS)

    2010-04-01

    Routine reviews of nuclear power plant operation (including modifications to hardware and procedures, operating experience, plant management and personnel competence) and special reviews following major events of safety significance are the primary means of safety verification. In addition, many Member States of the IAEA have initiated systematic safety reassessments, termed periodic safety reviews, of nuclear power plants, to assess the cumulative effects of plant ageing and plant modifications, operating experience, technical developments and siting aspects. The reviews include an assessment of plant design and operation against current safety standards and practices, and they have the objective of ensuring a high level of safety throughout the plant's operating lifetime. They are complementary to the routine and special safety reviews and do not replace them. Periodic safety reviews of nuclear power plants are considered an effective way to obtain an overall view of actual plant safety, and to determine reasonable and practical modifications that should be made in order to maintain a high level of safety. They can be used as a means of identifying time limiting features of the plant in order to determine nuclear power plant operation beyond the designed lifetime. The periodic safety review process can be used to support the decision making process for long term operation or licence renewal. Since 1994, the use of periodic safety reviews by Member States has substantially broadened and confirmed its benefits. Periodic safety review results have, for example, been used by some Member States to help provide a basis for continued operation beyond the current licence term, to communicate more effectively with stakeholders regarding nuclear power plant safety, and to help identify changes to plant operation that enhance safety. This IAEA-TECDOC is intended to assist Member States in the implementation of a periodic safety review. This publication complements the

  16. Brand name and generic proton pump inhibitor prescriptions in the United States: insights from the national ambulatory medical care survey (2006-2010).

    Science.gov (United States)

    Gawron, Andrew J; Feinglass, Joseph; Pandolfino, John E; Tan, Bruce K; Bove, Michiel J; Shintani-Smith, Stephanie

    2015-01-01

    Introduction. Proton pump inhibitors (PPI) are one of the most commonly prescribed medication classes with similar efficacy between brand name and generic PPI formulations. Aims. We determined demographic, clinical, and practice characteristics associated with brand name PPI prescriptions at ambulatory care visits in the United States. Methods. Observational cross sectional analysis using the National Ambulatory Medical Care Survey (NAMCS) of all adult (≥18 yrs of age) ambulatory care visits from 2006 to 2010. PPI prescriptions were identified by using the drug entry code as brand name only or generic available formulations. Descriptive statistics were reported in terms of unweighted patient visits and proportions of encounters with brand name PPI prescriptions. Global chi-square tests were used to compare visits with brand name PPI prescriptions versus generic PPI prescriptions for each measure. Poisson regression was used to determine the incidence rate ratio (IRR) for generic versus brand PPI prescribing. Results. A PPI was prescribed at 269.7 million adult ambulatory visits, based on 9,677 unweighted visits, of which 53% were brand name only prescriptions. In 2006, 76.0% of all PPI prescriptions had a brand name only formulation compared to 31.6% of PPI prescriptions in 2010. Visits by patients aged 25-44 years had the greatest proportion of brand name PPI formulations (57.9%). Academic medical centers and physician-owned practices had the greatest proportion of visits with brand name PPI prescriptions (58.9% and 55.6% of visits with a PPI prescription, resp.). There were no significant differences in terms of median income, patient insurance type, or metropolitan status when comparing the proportion of visits with brand name versus generic PPI prescriptions. Poisson regression results showed that practice ownership type was most strongly associated with the likelihood of receiving a brand name PPI over the entire study period. Compared to HMO visits

  17. Steady-state optimization of ore-dressing plants

    International Nuclear Information System (INIS)

    Niemi, A.J.

    1989-01-01

    The ore-dressing plant consists of the steps of grinding and flotation. Its optimization is based on steady state simulation of the mass balances with a plant model. The model data are obtained by tracer tests and analysis. An evaluation of performance of the plant has to observe the recovery of the valuable mineral, the throughput of the system and the grade of the concentrate which are outputs of the flotation plant. Simulation with the flotation plant model yields that combination of values of controllable inputs to flotation which corresponds to an optimal operation of the conditioning an flotation system, for a specified feed and its fractional composition. Simulations for other feeds and compositions advise how they should be chosen, for a better overall performance. (author)

  18. Rethinking generic skills

    Directory of Open Access Journals (Sweden)

    Roy Canning

    2013-10-01

    Full Text Available The paper provides a critical analysis of the notion of generic or transversal skillscontained with European Union policy discourses. The author presents a conceptualframework that challenges the idea that generic skills are universal, transferable andautonomous. An alternative analysis is put forward that argues the case forcontextualising skills and knowledge within particular understandings and cultures thatare more collective than individualistic in nature. The arguments are framed withinwider cross-disciplinary debates in linguistics, geosemiotics and social-cultural theoryand build upon an earlier paper exploring core skills in the UK (Canning, 2007.

  19. Quality of generic medicines in South Africa

    DEFF Research Database (Denmark)

    Patel, Aarti; Gauld, Robin; Norris, Pauline

    2012-01-01

    Generic Medicines are an important policy option allowing for access to affordable, essential medicines. Quality of generic medicines must be guaranteed through the activities of national medicines regulatory authorities. Existing negative perceptions surrounding the quality of generic medicines ...

  20. GASICA: Generic Automated Stress Induction and Control ApplicationDesign of an application for controlling the stress state

    Directory of Open Access Journals (Sweden)

    Benny Van Der Vijgh

    2014-12-01

    Full Text Available 1.In a multitude of research and therapy paradigms it is relevant to know, and desirably to control, the stress state of a patient or participant. Examples include research paradigms in which the stress state is the dependent or independent variable, or therapy paradigms where this state indicates the boundaries of the therapy. To our knowledge, no application currently exists that focuses specifically on the automated control of the stress state while at the same time being generic enough to be used in various therapy and research purposes. Therefore, we introduce GASICA, an application aimed at the automated control of the stress state in a multitude of therapy and research paradigms. The application consists of three components: a digital stressor game, a set of measurement devices and a feedback model. These three components form a closed loop (called a biocybernetic loop by Pope, Bogart, & Bartolome, 1995 and Fairclough, 2009 that continuously presents an acute psychological stressor, measures several physiological responses to this stressor, and adjusts the stressor intensity based on these measurements by means of the feedback model, hereby aiming to control the stress state. In this manner GASICA presents multidimensional and ecological valid stressors, whilst continuously in control of the form and intensity of the presented stressors, aiming at the automated control of the stress state. Furthermore, the application is designed as a modular open-source application to easily implement different therapy and research tasks using a high-level programming interface and configuration file, and allows for the addition of (existing measurement equipment, making it usable for various paradigms.

  1. GASICA: generic automated stress induction and control application design of an application for controlling the stress state.

    Science.gov (United States)

    van der Vijgh, Benny; Beun, Robbert J; van Rood, Maarten; Werkhoven, Peter

    2014-01-01

    In a multitude of research and therapy paradigms it is relevant to know, and desirably to control, the stress state of a patient or participant. Examples include research paradigms in which the stress state is the dependent or independent variable, or therapy paradigms where this state indicates the boundaries of the therapy. To our knowledge, no application currently exists that focuses specifically on the automated control of the stress state while at the same time being generic enough to be used in various therapy and research purposes. Therefore, we introduce GASICA, an application aimed at the automated control of the stress state in a multitude of therapy and research paradigms. The application consists of three components: a digital stressor game, a set of measurement devices, and a feedback model. These three components form a closed loop (called a biocybernetic loop by Pope et al. (1995) and Fairclough (2009) that continuously presents an acute psychological stressor, measures several physiological responses to this stressor, and adjusts the stressor intensity based on these measurements by means of the feedback model, hereby aiming to control the stress state. In this manner GASICA presents multidimensional and ecological valid stressors, whilst continuously in control of the form and intensity of the presented stressors, aiming at the automated control of the stress state. Furthermore, the application is designed as a modular open-source application to easily implement different therapy and research tasks using a high-level programming interface and configuration file, and allows for the addition of (existing) measurement equipment, making it usable for various paradigms.

  2. An overview of the United States Department of Energy plant lifetime improvement program

    International Nuclear Information System (INIS)

    Rosinski, S.T.; Clauss, J.M.; Harrison, D.L.

    1993-01-01

    Today, 109 nuclear power plants provide over 20 percent of the electrical energy generated in the US. The operating license of the first of these plants will expire in the year 2000; one third of the operating licenses will expire by 2010 and the remaining plant licenses are scheduled to expire by 2033. The National Energy Strategy assumes that 70 percent of these plants will continue to operate beyond their current license expiration to assist in ensuring an adequate, diverse, and environmentally acceptable energy supply for economic growth. In order to preserve this energy resource in the US three major tasks must be successfully completed: (1) establishment of the regulations, technical standards, and procedures for the preparation and review of a license renewal application; (2) development, verification, and validation of the various technical criteria and bases for needed monitoring, refurbishment, or replacement of plant equipment; and (3) demonstration of the regulatory process. Since 1985, the US Department of Energy (DOE) has been working with the nuclear industry and the US Nuclear Regulatory Commission (NRC) to establish and demonstrate the option to extend the life of nuclear power plants through the renewal of operating licenses. This paper focuses primarily on DOE's Plant Lifetime Improvement (PLIM) Program efforts to develop the technical criteria and bases for effective aging management and lifetime improvement for continued operation of nuclear power plants. This paper describes current projects to resolve generic technical issues, including degradation of long-lived components, reactor pressure vessel (RPV) embrittlement management approaches, and analytical methodologies to characterize RPV integrity

  3. Exploring knowledge, perceptions and attitudes about generic ...

    African Journals Online (AJOL)

    Exploring knowledge, perceptions and attitudes about generic medicines among final-year health science students. ... had knowledge deficits about the safety, quality and efficacy of generic medicines. The dissemination of information about generic medicines may strengthen future knowledge, attitudes and perceptions.

  4. Generic methods for design of small-bore pipe supports

    International Nuclear Information System (INIS)

    Clark, G.L.; LaSalle, F.R.

    1981-01-01

    Large numbers of supports for small-bore, low-temperature pipe are utilized in nuclear power plants. These supports often must meet ASME code and project seismic design requirements. Detailed analysis for each support is time consuming and costly. This paper describes some economical generic methods developed to design and qualify supports for two-inch and smaller pipe operating at temperatures less than 300 0 F (185 0 C), on the Fast Flux Test Facility. Use of standard designs, standard support spacing tables, anchor bolt and baseplate considerations, and field qualification methods are discussed

  5. Generic medicines: solutions for a sustainable drug market?

    Science.gov (United States)

    Dylst, Pieter; Vulto, Arnold; Godman, Brian; Simoens, Steven

    2013-10-01

    Generic medicines offer equally high-quality treatment as originator medicines do at much lower prices. As such, they represent a considerable opportunity for authorities to obtain substantial savings. At the moment, the pharmaceutical landscape is changing and many pharmaceutical companies have altered their development and commercial strategies, combining both originator and generic divisions. In spite of this, the generic medicines industry is currently facing a number of challenges: delayed market access; the limited price differential with originator medicines; the continuous downwards pressure on prices; and the negative perception regarding generic medicines held by some key stakeholder groups. This could jeopardize the long-term sustainability of the generic manufacturing industry. Therefore, governments must focus on demand-side policies, alongside policies to accelerate market access, as the generic medicines industry will only be able to deliver competitive and sustainable prices if they are ensured a high volume. In the future, the generic medicines industry will increasingly look to biosimilars and generic versions of orphan drugs to expand their business.

  6. Generic medicines: Perceptions of Physicians in Basrah, Iraq

    Directory of Open Access Journals (Sweden)

    Adheed Khalid Sharrad

    2009-08-01

    Full Text Available BackgroundThe use of cheaper generic medicines is a strategy promotedin many countries to reduce rising health care costs. The aimof this study was to explore factors affecting generic medicineprescribing by physicians in Basrah, Iraq.MethodologyA purposive sample of ten physicians practicing in Basrahwas interviewed using a semi-structured interview guide.ResultsAnalysis of the interviews identified seven major themes:medicine prescribing practice, knowledge of therapeuticequivalency of generic medicine, patients’ acceptance ofgeneric medicine, counterfeit medicine, drug informationsource and effect of drug advertising on medicines choice,brand substitution practice by community pharmacists, and,finally strategies to improve generic medicine usefulness.Participants identified helpful strategies to increase genericprescribing including; physician and patient education ongeneric medicine; persuading physicians about the safety andefficacy of generic medicines; and finally educating seniormedical students on generic prescribing.ConclusionThe data suggest that participants were enthusiasticabout prescribing generic medicines. However physiciansinsist that pharmacists should not be allowed tosubstitute generic drugs without prior approval ofdoctors.

  7. Cost-Effectiveness of Single- Versus Generic Multiple-Tablet Regimens for Treatment of HIV-1 Infection in the United States.

    Directory of Open Access Journals (Sweden)

    Donna E Sweet

    Full Text Available The possibility of incorporating generics into combination antiretroviral therapy and breaking apart once-daily single-tablet regimens (STRs, may result in less efficacious medications and/or more complex regimens with the expectation of marked monetary savings. A modeling approach that assesses the merits of such policies in terms of lifelong costs and health outcomes using adherence and effectiveness data from real-world U.S. settings.A comprehensive computer-based microsimulation model was developed to assess the lifetime health (life expectancy and quality adjusted life-years--QALYs and economic outcomes in HIV-1 infected patients initiating STRs compared with multiple-table regimens including generic medications where possible (gMTRs. The STRs considered included tenofovir disoproxil fumarate/emtricitabine and efavirenz or rilpivirine or elvitegravir/cobicistat. gMTRs substitutions included each counterpart to STRs, including generic lamivudine for emtricitabine and generic versus branded efavirenz.Life expectancy is estimated to be 1.301 years higher (discounted 0.619 QALY gain in HIV-1 patients initiating a single-tablet regimen in comparison to a generic-based multiple-table regimen. STRs were associated with an average increment of $26,547.43 per patient in medication and $1,824.09 in other medical costs due to longer survival which were partially offset by higher inpatients costs ($12,035.61 with gMTRs treatment. Overall, STRs presented incremental lifetime costs of $16,335.91 compared with gMTRs, resulting in an incremental cost-effectiveness ratio of $26,383.82 per QALY gained.STRs continue to represent good value for money under contemporary cost-effectiveness thresholds despite substantial price reductions of generic medications in the U. S.

  8. Comparing approaches to generic programming in Haskell

    NARCIS (Netherlands)

    Hinze, R.; Jeuring, J.T.; Löh, A.

    2006-01-01

    The last decade has seen a number of approaches to generic programming: PolyP, Functorial ML, `Scrap Your Boilerplate', Generic Haskell, `Generics for the Masses', etc. The approaches vary in sophistication and target audience: some propose full-blown pro- gramming languages, some suggest

  9. Generic Switching and Non-Persistence among Medicine Users

    DEFF Research Database (Denmark)

    Østergaard Rathe, Jette; Andersen, Morten; Jarbøl, Dorte Ejg

    2015-01-01

    BACKGROUND: Generic substitution means that one medicinal product is replaced by another product containing the same active substance. It is strictly regulated with respect to its bioequivalence, and all products must have undergone appropriate studies. Although generic substitution is widely...... implemented, it still remains to be answered how generic switch influences persistence to long-term treatment, and if it is modified by patients' concerns about medicine and views on generic medicine. This study focuses on users of antidepressants and antiepileptics, and their experience of generic switching....... METHODS: The study was an observational cohort study. By use of a prescription database, we identified patients who had redeemed prescriptions on generically substitutable drugs, and a questionnaire was mailed to them. We analyzed predictors of discontinuation in relation to generic switch and patients...

  10. Generic Safety Issue (GSI) 171 -- Engineered Safety Feature (ESF) failure from a loop subsequent to LOCA: Assessment of plant vulnerability and CDF contributions

    International Nuclear Information System (INIS)

    Martinez-Guridi, G.; Samanta, P.; Chu, L.; Yang, J.

    1998-01-01

    Generic Safety Issue 171 (GSI-171), Engineered Safety Feature (ESF) from a Loss Of Offsite Power (LOOP) subsequent to a Loss Of Coolant Accident (LOCA), deals with an accident sequence in which a LOCA is followed by a LOOP. This issue was later broadened to include a LOOP followed by a LOCA. Plants are designed to handle a simultaneous LOCA and LOOP. In this paper, the authors address the unique issues that are involved i LOCA with delayed LOOP (LOCA/LOOP) and LOOP with delayed LOCA (LOOP/LOCA) accident sequences. LOCA/LOOP accidents are analyzed further by developing event-tree/fault-tree models to quantify their contributions to core-damage frequency (CDF) in a pressurized water reactor and a boiling water reactor (PWR and a BWR). Engineering evaluation and judgments are used during quantification to estimate the unique conditions that arise in a LOCA/LOOP accident. The results show that the CDF contribution of such an accident can be a dominant contributor to plant risk, although BWRs are less vulnerable than PWRs

  11. Article choice in plural generics

    NARCIS (Netherlands)

    Farkas, D.F.; Swart, Henriëtte de

    2007-01-01

    We discuss two groups of languages where article use contrasts in generic plural sentences but is otherwise essentially similar. The languages in the first group (English and Dutch) use bare plurals in the expression of kind reference (‘Dinosaurs are extinct’) and in generic

  12. 40 CFR 721.9973 - Zirconium dichlorides (generic).

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Zirconium dichlorides (generic). 721... Substances § 721.9973 Zirconium dichlorides (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as zirconium dichlorides (PMNs P...

  13. Comparing approaches to generic programming in Haskell

    NARCIS (Netherlands)

    Hinze, R.; Jeuring, J.T.; Löh, A.

    2006-01-01

    The last decade has seen a number of approaches to data- type-generic programming: PolyP, Functorial ML, `Scrap Your Boiler- plate', Generic Haskell, `Generics for the Masses', etc. The approaches vary in sophistication and target audience: some propose full-blown pro- gramming languages, some

  14. 40 CFR 721.9959 - Polyurethane polymer (generic).

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Polyurethane polymer (generic). 721... Substances § 721.9959 Polyurethane polymer (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as a polyurethane polymer (PMN P-01...

  15. Proceedings Workshop on Generic Programming (WGP2000)

    NARCIS (Netherlands)

    Jeuring, J.T.

    2000-01-01

    This report contains the papers selected for presentation at the 2nd Workshop on Generic Programming (WGP2000), which was held on July 6, 2000 in Ponte de Lima, Portugal. Generic programming is about making programs more adaptable by making them more general. Generic programs often embody

  16. The development of an automatic classification system of nuclear power plant states

    International Nuclear Information System (INIS)

    Mitomo, Nobuo; Matsuoka, Takeshi

    2000-01-01

    For the future autonomous plant, automatic control and diagnostics are being incorporated and operators are mainly engaged in the high levels of diagnosis and decision-making in emergencies. Therefore these matters will be performed through the Man-Machine Interface(MMI). Ship Research Institute has been carrying out the research on the MMI system for autonomous power plants. The automatic classification system of plant states is one of the functions of this MMI and the system utilizes COBWEB, which is known as a way of clustering data to acquire concepts. In this paper, many plant states produced by a plant simulator we examined in order to confirm the effectiveness of this system. The system has well classified plant states produced by a plant simulator. (author)

  17. State of the art of large combustion plants and reference plants in Austria

    International Nuclear Information System (INIS)

    Boehmer, S.; Schindler, I.; Szednyj, I.; Winter, B.

    2003-01-01

    The aim of this study is to describe the state of the art of large combustion plants with respect to the European directive on integrated pollution prevention and control (IPPC-Directive 96/61/EG). For this purpose 10 sites where one or more thermal power or district heating plants with a rated thermal input of > 50 MW are operated were selected and described in detail. Only coal and oil fired power plants were chosen because of the larger environmental impacts compared to gas fired combustion units. Large industrial combustion plants, where in addition to regular fuels also special fuels and wastes are combusted (e.g. power plants from refineries and from the pulp and paper industry), and waste incineration plants are not treated in this study. The depiction of power plants comprises the whole chain of operation, starting from the description of the type and composition of fuels, the pretreatment and introduction into the boiler, the firing technology, measures for emission reduction (both into air and water) and treatment of solid waste and residues from combustion. Furthermore possibilities to increase energy efficiency and economic aspects are examined in this study. Also legal aspects are shortly described at the beginning of the respective chapters. An actual topic is co-combustion of biomass and waste in thermal power plants. Results of trial operation in Austrian power plants are summarized and conclusions were drawn with respect to environmental impacts of co-incineration, such as emissions into air and water, quality of solid wastes and residues from co-incineration. Important aspects such as shifting of pollutants and dilution effects are discussed. The study concludes with the chapter 'State of the art for power plants', which gives a survey of the relevant measures with particular attention to above mentioned crucial points. (author)

  18. Skin rash during treatment with generic itraconazole.

    Science.gov (United States)

    De Vuono, Antonio; Palleria, Caterina; Scicchitano, Francesca; Squillace, Aida; De Sarro, Giovambattista; Gallelli, Luca

    2014-04-01

    Generic drugs have the same active substance, the same pharmaceutical form, the same therapeutic indications and a similar bioequivalence with the reference medicinal product (branded). Although a similar efficacy is postulated, some cases of clinical inefficacy during treatment with generic formulations have been reported. In this case, we describe a woman with onychomycosis that developed a skin rash during treatment with a generic formulation of itraconazole. Drug administration and its re-challenge confirmed the association between itraconazole and skin rash. Both Naranjo probability scale and World Health Organization causality assessment scale documented a probable association between generic-itraconazole and skin rash. The switch from generic formulation to brand one induced an improvement of symptoms. Since we are unable to evaluate the role of each excipient in the development of skin rash, we cannot rule out their involvement. However, more data are necessary to better define the similarities or differences between branded and generic formulations.

  19. Generic risk insights for Westinghouse and Combustion Engineering pressurized water reactors

    International Nuclear Information System (INIS)

    Travis, R.; Taylor, J.; Fresco, A.; Chung, J.

    1990-11-01

    A methodology has been developed to extract generic risk-based information from probabilistic risk assessments (PRAs) of Westinghouse and Combustion Engineering (CE) pressurized water reactors (PWRs) and apply the insights gained to Westinghouse and Ce plants have not been subjected to a PRA. The available PRAs (five Westinghouse plants and one CE plant) were examined to identify the most probable, i.e., dominant accident sequences at each plant. The goal was to include all sequences which represented at least 80% of core damage frequency. If the same plant specific dominant accident sequence appeared within this boundary in at least two plant PRAs, the sequence was considered to be a representative sequence. Eleven sequences met this definition. From these sequences, the most important component failures and human errors that contributed to each sequence have been prioritized. Guidance is provided to prioritize the representative sequences and modify selected basic events that have been shown to be sensitive to the plant specific design or operating variations of the contributing PRAs. This risk-based guidance can be used for utility and NRC activities including operator training maintenance, design review, and inspections

  20. A multicenter experience with generic tacrolimus conversion.

    Science.gov (United States)

    McDevitt-Potter, Lisa M; Sadaka, Basma; Tichy, Eric M; Rogers, Christin C; Gabardi, Steven

    2011-09-27

    The first generic tacrolimus product gained Food and Drug Administration approval in August 2009. This prospective, observational trial sought to determine the need for dose titrations and measure drug cost savings on conversion to generic tacrolimus. Transplant recipients on stable tacrolimus doses were converted from brand to generic tacrolimus on a mg:mg basis. Data were collected at the time of generic conversion (study arm) and at a time point exactly 6 months before conversion (control arm) for all subjects. Seventy conversions from four centers are reported. Subjects were a mean of 70 months after kidney (n=37), liver (n=28), or multiorgan (n=5) transplant. In the study arm, mean tacrolimus doses were 4.4 and 4.5 mg/d and mean tacrolimus trough concentrations were 5.8 and 5.9 ng/mL before and after conversion, respectively. In the control arm, mean tacrolimus doses were 4.6 and 4.6 mg/d and mean tacrolimus trough concentrations were 6.1 and 5.9 ng/mL before and after the control time point, respectively. Dose titrations occurred in five patients (7%) in the control arm and 15 patients (21%) in the study arm (P=0.028). Mean monthly drug costs were $645 for brand, $593 for generic, and $595 for generic after dose titrations. Mean monthly patient copays were $38 for brand and $15 for generic. These cumulative data show that dose requirements and trough levels are similar between brand and generic tacrolimus and that generic substitution allows for savings. However, postconversion monitoring is prudent as patients may require dose titration.

  1. Brand loyalty, patients and limited generic medicines uptake.

    Science.gov (United States)

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

    2014-06-01

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

  2. Generic domain models in software engineering

    Science.gov (United States)

    Maiden, Neil

    1992-01-01

    This paper outlines three research directions related to domain-specific software development: (1) reuse of generic models for domain-specific software development; (2) empirical evidence to determine these generic models, namely elicitation of mental knowledge schema possessed by expert software developers; and (3) exploitation of generic domain models to assist modelling of specific applications. It focuses on knowledge acquisition for domain-specific software development, with emphasis on tool support for the most important phases of software development.

  3. High Generic Drug Prices and Market Competition: A Retrospective Cohort Study.

    Science.gov (United States)

    Dave, Chintan V; Kesselheim, Aaron S; Fox, Erin R; Qiu, Peihua; Hartzema, Abraham

    2017-08-01

    Prices for some generic drugs have increased in recent years, adversely affecting patients who rely on them. To determine the association between market competition levels and the change in generic drug prices in the United States. Retrospective cohort study. Prescription claims from commercial health plans between 2008 and 2013. The 5.5 years of data were divided into 11 study periods of 6 months each. The Herfindahl-Hirschman Index (HHI)-calculated by summing the squares of individual manufacturers' market shares, with higher values indicating a less competitive market-and average drug prices were estimated for the generic drugs in each period. The HHI value estimated in the baseline period (first half of 2008) was modeled as a fixed covariate. Models estimated price changes over time by level of competition, adjusting for drug shortages, market size, and dosage forms. From 1.08 billion prescription claims, a cohort of 1120 generic drugs was identified. After adjustment, drugs with quadropoly (HHI value of 2500, indicating relatively high levels of competition), duopoly (HHI value of 5000), near-monopoly (HHI value of 8000), and monopoly (HHI value of 10 000) levels of baseline competition were associated with price changes of -31.7% (95% CI, -34.4% to -28.9%), -11.8% (CI, -18.6% to -4.4%), 20.1% (CI, 5.5% to 36.6%), and 47.4% (CI, 25.4% to 73.2%), respectively, over the study period. Study findings may not be generalizable to drugs that became generic after 2008. Market competition levels were associated with a change in generic drug prices. Such measurements may be helpful in identifying older prescription drugs at higher risk for price change in the future. None.

  4. Differences in rates of switchbacks after switching from branded to authorized generic and branded to generic drug products: cohort study

    Science.gov (United States)

    Sarpatwari, Ameet; Dejene, Sara; Khan, Nazleen F; Lii, Joyce; Rogers, James R; Dutcher, Sarah K; Raofi, Saeid; Bohn, Justin; Connolly, John; Fischer, Michael A; Kesselheim, Aaron S; Gagne, Joshua J

    2018-01-01

    Abstract Objectives To compare rates of switchbacks to branded drug products for patients switched from branded to authorized generic drug products, which have the same active ingredients, appearance, and excipients as the branded product, with patients switched from branded to generic drug products, which have the same active ingredients as the branded product but may differ in appearance and excipients. Design Observational cohort study. Setting Private (a large commercial health plan) and public (Medicaid) insurance programs in the US. Participants Beneficiaries of a large US commercial health insurer between 2004 and 2013 (primary cohort) and Medicaid beneficiaries between 2000 and 2010 (replication cohort). Main outcome measures Patients taking branded products for one of the study drugs (alendronate tablets, amlodipine tablets, amlodipine-benazepril capsules, calcitonin salmon nasal spray, escitalopram tablets, glipizide extended release tablets, quinapril tablets, and sertraline tablets) were identified when they switched to an authorized generic or a generic drug product after the date of market entry of generic drug products. These patients were followed for switchbacks to the branded drug product in the year after their switch to an authorized generic or a generic drug product. Cox proportional hazard models were used to estimate hazard ratios and 95% confidence intervals after adjusting for demographics, including age, sex, and calendar year. Inverse variance meta-analysis was used to pool adjusted hazard ratios across all drug products. Results A total of 94 909 patients switched from branded to authorized generic drug products and 116 017 patients switched from branded to generic drug products and contributed to the switchback analysis. Unadjusted incidence rates of switchback varied across drug products, ranging from a low of 3.8 per 100 person years (for alendronate tablets) to a high of 17.8 per 100 person years (for amlodipine

  5. Regional approaches to power plant siting in the United States of America

    International Nuclear Information System (INIS)

    DiNunno, J.J.

    1975-01-01

    The selection and evaluation of sites for power plants in the United States of America have become increasingly difficult in recent years as pressures from various societal segments have resulted in governmental restraints on selection and burning of fossil fuels, methods of heat dissipation, acquisition of transmission rights of way, and on environmental impact of industrialization in general. New legislation at both Federal and state levels has been enacted that influences power plant siting. In addition to environmental requirements that must be satisfied, implementing procedures require documented justification for sites chosen and public disclosure of the basis for selection. Some states have consolidated their regulatory activities in the power plant siting area to provide for a more unified approach to these problems. Although nuclear plants have by far the most rigorous requirements for documentation of site selection and plant design, the application of the same general philosophies to fossil plants has been made in several states and can be anticipated elsewhere. Individual site-related investigations have not so much changed in basics as they have been enlarged in scope. Whereas in the past the search for siting alternatives was frequently confined to a utility's service area, the additional siting constraints represented in environmental laws, the economies of size of nuclear power plants, and the sharing of plant capacities among utilities have contributed to a widening of the search area. Several states have assumed the responsibility for site search and investigation and their efforts extend state-wide. This paper discusses applications of regional approaches to power plant siting in the United States of America using case studies made by NUS Corporation, an engineering/environmental consulting firm. The universality of these approaches is indicated, leaving to national policies and goals the importance of values assigned to the basic siting factors

  6. Improving plant state information for better operational safety

    International Nuclear Information System (INIS)

    Girard, C.; Olivier, E.; Grimaldi, X.

    1994-01-01

    Nuclear Power Plant (NPP) safety is strongly dependent on components' reliability and particularly on plant state information reliability. This information, used by the plant operators in order to produce appropriate actions, have to be of a high degree of confidence, especially in accidental conditions where safety is threatened. In this perspective, FRAMATOME, EDF and CEA have started a joint research program to prospect different solutions aiming at a better reliability for critical information needed to safety operate the plant. This paper gives the main results of this program and describes the developments that have been made in order to assess reliability of different information systems used in a Nuclear Power Plant. (Author)

  7. Incentive regulation of nuclear power plants by state public utility commissions

    International Nuclear Information System (INIS)

    Petersen, J.C.

    1987-12-01

    This report on incentive regulation of nuclear power plants by state public utility commissions (PUCs). Economic performance incentives established by state PUCs are applicable to the construction or operation of about 45 nuclear power reactors owned by 30 utilities in 17 states. The NRC staff monitors development of the incentives and periodically provides an updated report on all nuclear plant incentives to its regional offices. The staff maintains contact with the PUCs and the utilities responsible for implementing the incentives in order to obtain the updated information and to consider potential safety effects of the incentives. This report presents the NRC staff's concerns on potential safety effects of economic performance incentives. It also includes a plant-by-plant survey that describes the mechanics of each incentive and discusses the financial effects of the incentive on the utility-owner(s) of the plant

  8. GENERIC, COMPONENT FAILURE DATA BASE FOR LIGHT WATER AND LIQUID SODIUM REACTOR PRAs

    Energy Technology Data Exchange (ETDEWEB)

    S. A. Eide; S. V. Chmielewski; T. D. Swantz

    1990-02-01

    A comprehensive generic component failure data base has been developed for light water and liquid sodium reactor probabilistic risk assessments (PRAs) . The Nuclear Computerized Library for Assessing Reactor Reliability (NUCLARR) and the Centralized Reliability Data Organization (CREDO) data bases were used to generate component failure rates . Using this approach, most of the failure rates are based on actual plant data rather than existing estimates .

  9. Generic Competencies in the Education of Engineers: The Case of Engineering Program in a Public University in Mexico

    Science.gov (United States)

    Serna, Alejandra García; Vega, José Luis Arcos; García, Juan José Sevilla; Ruiz, María Amparo Oliveros

    2018-01-01

    We present an analysis regarding generic skills on engineering program offered in a public state university in Mexico (UABC). The university implemented a new educational model changing rigid programs to flexible programs based on competencies. The goal is to determine generic skills related to the four pillars of learning: learning to do,…

  10. Contact Geometry of Hyperbolic Equations of Generic Type

    Directory of Open Access Journals (Sweden)

    Dennis The

    2008-08-01

    Full Text Available We study the contact geometry of scalar second order hyperbolic equations in the plane of generic type. Following a derivation of parametrized contact-invariants to distinguish Monge-Ampère (class 6-6, Goursat (class 6-7 and generic (class 7-7 hyperbolic equations, we use Cartan's equivalence method to study the generic case. An intriguing feature of this class of equations is that every generic hyperbolic equation admits at most a nine-dimensional contact symmetry algebra. The nine-dimensional bound is sharp: normal forms for the contact-equivalence classes of these maximally symmetric generic hyperbolic equations are derived and explicit symmetry algebras are presented. Moreover, these maximally symmetric equations are Darboux integrable. An enumeration of several submaximally symmetric (eight and seven-dimensional generic hyperbolic structures is also given.

  11. Retailing policies for generic medicines.

    Science.gov (United States)

    Narciso, Susana

    2005-06-01

    As there is general disagreement about the way generic medicines should be commercialized, two retailing policies are analyzed, taking into account their effects on the welfare of patients, government, pharmacies and physicians. In the first policy scenario, pharmacies are allowed to substitute generic medicines for branded ones, while in the second, substitution is forbidden. In both cases a pharmacies association is allowed to have a share in the production of generic medicines. The model predicts that under some conditions patients may prefer substitution by pharmacies but when doctors' decisions are binding, they are never "excessively bad". However, the policy choice belongs to the government, which prefers to allow for substitution more often than patients would like.

  12. Regulatory analysis for the resolution of Generic Safety Issue 105: Interfacing system loss-of-coolant accident in light-water reactors

    International Nuclear Information System (INIS)

    1993-07-01

    An interfacing systems loss of coolant accident (ISLOCA) involves failure or improper operation of pressure isolation valves (PIVs) that compose the boundary between the reactor coolant system and low-pressure rated systems. Some ISLOCAs can bypass containment and result in direct release of fission products to the environment. A cost/benefit evaluation, using three PWR analyses, calculated the benefit of two potential modifications to the plants. Alternative 1 is improved plant operations to optimize the operator's performance and reduce human error probabilities. Alternative 2 adds pressure sensing devices, cabling, and instrumentation between two PIVs to provide operators with continuous monitoring of the first PIV. These two alternatives were evaluated for the base case plants (Case 1) and for each plant, assuming the plants had a particular auxiliary building design in which severe flooding would be a problem if an ISLOCA occurred. The auxiliary building design (Case 2) was selected from a survey that revealed a number of designs with features that provided less than optimal resistance to ECCS equipment loss caused by a ISLOCA-induced environment. The results were judged not to provide sufficient basis for generic requirements. It was concluded that the most viable course of action to resolve Generic Issue 105 is licensee participation in individual plant examinations (IPEs)

  13. Improvement of Diagnostic Flow Chart in Severe Accident Management Guidance for Nuclear Power Plants in Korea

    Energy Technology Data Exchange (ETDEWEB)

    Jang, So Won; Lee, Su Won [FNC Technology Co., Yongin (Korea, Republic of); Oh, Hae Cheol [KHNP CRI, Daejeon (Korea, Republic of)

    2016-10-15

    Development of generic SAMG in the United States was undertaken by WOG, Combustion Engineering Owner’s Group (CEOG), and Babcock and Wilcox Owner’s Group (BWOG) in the 1990s. They made efforts to develop generic SAMG specific to the individual plant designs to satisfy the regulatory concerns for severe accident managements. Recently, the SAMG of the Pressurized Water Reactor Owner's Group (PWROG) which is applicable to Babcock and Wilcox (B and W), Combustion Engineering (CE), and Westinghouse Pressurizer Water Reactor (PWR) Nuclear Steam Supply System (NSSS) designs was developed in February 2016 by incorporating the best features from the previous PWR generic SAMG. However, the structure of the PWROG SAMG is also based on the WOG SAMG. The purpose of this study is to provide improvements of the Korean SAMG by comparing between the Korean SAMG and the PWROG SAMG to reflect the state of the art and trends. The improved DFC for the Korean SAMG is proposed by comparing between the Korean SAMG and the PWROG SAMG. If the improved DFC is adopted, the level to identify the severity of the plant condition is diversified, the order of priority of the strategies is changed, the entry condition into the RCS injection strategy is changed, LTMG-01and SAEG-01 come under the DFC as parts of the step, and the step whether CCI is occurred or not is added in DFC. In order to increase the effectiveness of the Korean SAMG and to reflect the state of the art and trends, it is appropriate to apply the suggestions contained in this paper to the Korean SAMG.

  14. Mark I containment long-term program safety evaluation report, resolution of generic technical activity A-7. Report for February 1977-December 1979

    International Nuclear Information System (INIS)

    1980-07-01

    During testing for an advanced Boiling Water Reactor (BWR) containment system design (Mark III), suppression pool hydrodynamic loads were identified which had not been considered in the original design of the Mark I containment system. To address this issue, a Mark I Owners Group was formed and the assessment was divided into a short-term and long-term program. The results of the NRC staff's review of the Mark I Containment Short Term Program are described in NUREG-0408. This report describes the results of the NRC staff's review of the generic Mark I Containment Long Term Program (LTP). The LTP was conducted to provide a generic basis to define suppression pool hydrodynamic loads and the related structural acceptance criteria, such that a comprehensive reassessment of each Mark I containment system would be performed. A series of experimental and analytical programs were conducted by the Mark I Owners Group to provide the necessary bases for the generic load definition and structural assessment techniques. The generic methods proposed by the Mark I Owners Group, as modified by the NRC staff's requirements, will be used to perform plant-unique analyses, which will identify the plant modifications, if any, that will be needed to restore the originally intended margin of safety in the Mark I containment designs

  15. Incentive regulation of nuclear power plants by state Public Utility Commissions

    International Nuclear Information System (INIS)

    Martin, R.L.; Olson, J.; Hendrickson, P.

    1989-12-01

    Economic performance incentives established by state Public Utility Commissions (PUCs) currently are applicable to the construction or operation of approximately 73 nuclear power reactors owned by 27 utilities with investment greater than 10% in 18 states. The NRC staff monitors development of the incentives and periodically provides an updated report on all nuclear plant incentives to its headquarters and regional offices. The staff maintains contact with the PUCs and the utilities responsible for implementing the incentives in order to obtain the updated information and to consider potential safety effects of the incentives. This report on incentive regulation of nuclear power plants by state PUCs presents the NRC staff's concerns on potential safety effects of economic performance incentives. It also includes a plant-by-plant survey that describes the mechanics of each incentive and discusses the financial effects of the incentive on the utility-owner(s) of the plant

  16. 40 CFR 721.2083 - Polysubstituted carbomonocyclic hydroxylamine (generic).

    Science.gov (United States)

    2010-07-01

    ... hydroxylamine (generic). 721.2083 Section 721.2083 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... Specific Chemical Substances § 721.2083 Polysubstituted carbomonocyclic hydroxylamine (generic). (a... generically as a polysubstituted carbomonocyclic hydroxylamine (PMN P-97-878) is subject to reporting under...

  17. A method to generate generic floor response spectra for operating nuclear power plants

    International Nuclear Information System (INIS)

    Curreri, J.; Costantino, C.; Subudhi, M.; Reich, M.

    1985-01-01

    A free-field earthquake response spectra was used to generate horizontal earthquake time histories. The excitation was applied through the soil and into the various structures to produce responses in equipment. An entire range of soil conditions was used with each structure, from soft soil to solid rock. Actual PWR and BWR - Mark I structural models were used as representative of a class of structures. For each model, the stiffness properties were varied, with the same mass, so as to extend the fundamental base structure natural frequency from 2 cps to 36 cps. This resulted in fundamental mode coupled natural frequencies as low as 0.86 cps and as high as 30 cps. From all of these models of soils and structures, floor response spectra were generated at each floor level. The natural frequencies of the structures were varied to obtain maximum response conditions. The actual properties were first used to locate the natural frequencies. The stiffness properties were than varied, with the same mass, to extend the range of the fundamental base structure natural frequency. The intention was to have the coupled structural material frequencies in the vicinity of the peak amplitude frequency content of the excitation spectrum. Particular attention was therefore given to the frequency band between 2 Hz and 4 Hz. A horizontal generic floor response spectra is proposed for the top level of a generic structure. Reduction factors are applied to the peak acceleration for equipment at lower levels. (orig./HP)

  18. Associations between generic substitution and patients' attitudes, beliefs and experience

    DEFF Research Database (Denmark)

    Østergaard Rathe, Jette; Larsen, Pia Veldt; Andersen, Morten

    2013-01-01

    Abstract Background Generic substitution has been implemented in many countries, but knowledge about patients’ attitudes, beliefs and experiences is still sparse. Aim To assess associations between generic switching and patients’ attitudes, beliefs and experiences with previous generic switching...... on generic medicine and confidence in the healthcare system. Only prescriptions issued by the general practitioners were included. For each patient we focused on one purchase of a generically substitutable drug (index drug). Patients were identified by means of a dispensing database. Results Earlier generic...... switches within the index ATC code were statistically significantly associated with experience of a generic switch (adjusted OR 5.93 95% CI 4.70; 7.49). Having had more than 5 earlier switches within other ATC codes and having negative views on generic medicines reduced the odds of experiencing a generic...

  19. The knowledge-based framework for a nuclear power plant operator advisor

    International Nuclear Information System (INIS)

    Miller, D.W.

    1989-01-01

    An important facet in the design, development, and evaluation of aids for complex systems is the identification of the tasks performed by the operator. Operator aids utilizing artificial intelligence, or more specifically knowledge-based systems, require identification of these tasks in the context of a knowledge-based framework. In this context, the operator responses to the plant behavior are to monitor and comprehend the state of the plant, identify normal and abnormal plant conditions, diagnose abnormal plant conditions, predict plant response to specific control actions, and select the best available control action, implement a feasible control action, monitor system response to the control action, and correct for any inappropriate responses. These tasks have been identified to formulate a knowledge-based framework for an operator advisor under development at Ohio State University that utilizes the generic task methodology proposed by Chandrasekaran. The paper lays the foundation to identify the responses as a knowledge-based set of tasks in accordance with the expected human operator responses during an event. Initial evaluation of the expert system indicates the potential for an operator aid that will improve the operator's ability to respond to both anticipated and unanticipated events

  20. Generics, Supergenerics and Patent Strategies--SMi's 13th Annual Meeting.

    Science.gov (United States)

    Edwards, Catherine

    2010-07-01

    SMi's 13th Annual Meeting on Generics, Supergenerics and Patent Strategies, held in London, included topics covering new trends in the generics field, the difficulties faced by companies in entering the generics market and recent developments in IP. This conference report highlights selected presentations on generics in India, protecting pharmaceutical products in China, changes in generics law and litigation in the US and Europe, challenges for market selection and entry for generics companies, the influence of changes in the healthcare market on the generics industry, supergenerics, and biosimilars.

  1. PROBLEM OF GENERIC REPLACEMENT: ADVANTAGES AND DISADVANTAGES

    Directory of Open Access Journals (Sweden)

    S. N. Tolpygina

    2009-01-01

    Full Text Available The main differences between original and generic drugs as well as registration criteria for generics are described. Possible reasons of discrepancy in bioequivalence and therapeutic equivalence of original and generic drugs are reviewed. The examples of such a discrepancy as a result of comparative clinical trails (enalapril maleate are discussed. Approaches to planning of comparative trails on drug therapeutic equivalence are presented. 

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

    Science.gov (United States)

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

    2017-05-01

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

  3. A generic coordinate system and a set of generic variables for MFE database

    International Nuclear Information System (INIS)

    Miner, W.H. Jr.; Ross, D.W.; Solano, E.R.; Valanju, P.M.; Wiley, J.C.

    1993-01-01

    Over the last several years, profile data from nine different tokamaks have been stored in the magnetic fusion energy database (MFEDB). These data sets have come from a variety of sources and most are given in different coordinate systems. In order to attempt any intermachine analysis, it is convenient to transform these data sets into one generic coordinate system and to choose a uniform set of variable names. The authors describe the data sets from each tokamak indicating the source of the data and the coordinate system in which it is given. Next, they discuss the generic coordinate that has been adopted and show how it is implemented for each tokamak. Finally, the generic naming convention that has been adopted is discussed. It follows closely that which was used by Christiansen et al. for the ITER Global Energy Confinement H-Mode Database. For further clarification, they discuss the characteristics of the magnetic geometry given a Fourier representation of the magnetic equilibria

  4. Generic Software Architecture for Launchers

    Science.gov (United States)

    Carre, Emilien; Gast, Philippe; Hiron, Emmanuel; Leblanc, Alain; Lesens, David; Mescam, Emmanuelle; Moro, Pierre

    2015-09-01

    The definition and reuse of generic software architecture for launchers is not so usual for several reasons: the number of European launcher families is very small (Ariane 5 and Vega for these last decades); the real time constraints (reactivity and determinism needs) are very hard; low levels of versatility are required (implying often an ad hoc development of the launcher mission). In comparison, satellites are often built on a generic platform made up of reusable hardware building blocks (processors, star-trackers, gyroscopes, etc.) and reusable software building blocks (middleware, TM/TC, On Board Control Procedure, etc.). If some of these reasons are still valid (e.g. the limited number of development), the increase of the available CPU power makes today an approach based on a generic time triggered middleware (ensuring the full determinism of the system) and a centralised mission and vehicle management (offering more flexibility in the design and facilitating the long term maintenance) achievable. This paper presents an example of generic software architecture which could be envisaged for future launchers, based on the previously described principles and supported by model driven engineering and automatic code generation.

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

    Science.gov (United States)

    Walker, A D; Adachi, J D

    2011-09-01

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

  6. Plant walkdown

    International Nuclear Information System (INIS)

    Kostov, M.

    2000-01-01

    This report covers the following: preparatory steps for performing plant walk-down; the objective of the first plant walk-down; plant walk-down procedures; earthquake screening evaluation; walk-down documentation; second plant walk-down. The following objectives concerning the plant walk-down(s) were achieved. The plant system configuration is verified in order to proceed with event tree and fault tree analyses. Systems interactions, other types of dependencies or plant unique features are identified. he safety related components that are judged to generically possess high capacities (i.e., larger than the earthquake review level) have been verified to contain no weaknesses. Further analyses needed to establish the capacities of remaining safety-related components are identified and necessary field data are obtained. Information on components is obtained to assist in HCLPF (fragility) evaluation and peer review of the seismic margin study

  7. 40 CFR 721.324 - Alkoxylated acrylate polymer (generic).

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Alkoxylated acrylate polymer (generic... Substances § 721.324 Alkoxylated acrylate polymer (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkoxylated acrylate polymer...

  8. Skin rash during treatment with generic itraconazole

    OpenAIRE

    De Vuono, Antonio; Palleria, Caterina; Scicchitano, Francesca; Squillace, Aida; De Sarro, Giovambattista; Gallelli, Luca

    2014-01-01

    Generic drugs have the same active substance, the same pharmaceutical form, the same therapeutic indications and a similar bioequivalence with the reference medicinal product (branded). Although a similar efficacy is postulated, some cases of clinical inefficacy during treatment with generic formulations have been reported. In this case, we describe a woman with onychomycosis that developed a skin rash during treatment with a generic formulation of itraconazole. Drug administration and its re...

  9. Generic medicine and prescribing: A quick assessment

    Directory of Open Access Journals (Sweden)

    Mainul Haque

    2017-01-01

    Full Text Available Generic drugs are copies of brand-name drugs that have exactly the same dosage, intended use, effects, side effects, route of administration, risks, safety, and strength as the original drug. In other words, their pharmacological effects are exactly the same as those of their brand-name counterparts. The Food and Drug Administration (FDA describes that generic drugs are essential possibilities that allow better access to healthcare for all Americans. They are replicas of brand-name drugs and are the identical as those of brand-name drugs in dosage form, safety, strength, route of administration, quality, performance features, and anticipated to use. Healthcare authorities and users can be guaranteed that FDA-approved generic drug products have met the same stiff principles as the innovator drug. The company that made Bayer aspirin fought in court enthusiastically to keep generic versions off the shelves, in the 1920s. The company lost in court, and consumers suddenly had an array of choices in generic aspirin. The Supreme Court of India uttering ‘the Supreme Court's ruling will prevent companies from further seeking unwarranted patents on HIV and other essential medicines.’ Generic medicine cannot be sold at a price higher than the branded medicine, so it is regularly a low-priced option. Thereafter, both the end user and the government who pay for part of the price of the medicine under the Pharmaceutical Benefits Scheme in Australia are benefitted. The treatment of diseases using essential drugs, prescribed by their generic names, has been emphasised by the WHO and many national health policies. Although there are some improvements in generic medicine prescribing, it has been advised by the WHO that ‘countries should intensify efforts to measure and regularly monitor medicine prices and availability, and adopt policy measures to address the issues identified.’

  10. Method to generate generic floor response spectra for operating nuclear power plant

    International Nuclear Information System (INIS)

    Curreri, J.; Costantino, C.; Subudhi, M.; Reich, M.

    1985-01-01

    The general approach in the development of the response spectra was to study the effects on the dynamic characteristics of each of the elements in the chain of events that goes between the loads and the responses. This includes the loads, the soils and the structures. A free-field earthquake response spectra was used to generate horizontal earthquake time histories. The excitation was applied through the soil and into the various structures to produce responses in equipment. An entire range of soil conditions was used with each structure, from soft soil to solid rock. Actual PWR and BWR - Mark I structural models were used as representative of a class of structures. For each model, the stiffness properties were varied, with the same mass, so as to extend the fundamental base structure natural frequency from 2 cps to 36 cps. This resulted in fundamental mode coupled natural frequencies as low as 0.86 cps and as high as 30 cps. From all of these models of soils and structures, floor response spectra were generated at each floor level. The natural frequencies of the structures were varied to obtain maximum response conditions. The actual properties were first used to locate the natural frequencies. The stiffness properties were then varied, with the same mass, to extend the range of the fundamental base structure natural frequency. The intention was to have the coupled structural material frequencies in the vicinity of the peak amplitude frequency content of the excitation spectrum. Particular attention was therefore given to the frequency band between 2 Hz and 4 Hz. A horizontal generic floor response spectra is proposed for the top level of a generic structure. Reduction factors are applied to the peak acceleration for equipment at lower levels

  11. 40 CFR 721.5350 - Substituted nitrile (generic name).

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Substituted nitrile (generic name... Substances § 721.5350 Substituted nitrile (generic name). (a) Chemical substances and significant new uses subject to reporting. (1) The chemical substance identified generically as a substituted nitrile (PMN P-83...

  12. Generic Penetration of the SSRI Market.

    Science.gov (United States)

    Cascade, Elisa F; Kalali, Amir H

    2008-04-01

    In this article, we investigate the penetration of generic selective serotonin reuptake inhibitors (SSRIs) in the US market and the implications for patient out-of-pocket expense. The data suggest that generic penetration into the SSRI market has grown from approximately nine percent in 2000, the year that the patent for Prozac((R)) expired, to 72 percent in 2007. For December, 2007, the difference in patient out-of-pocket expense for branded vs. generic agents was, on average, $55.42 for patients paying by cash (i.e., they had no prescription drug insurance) and $22.39 for patients with insurance coverage.

  13. 40 CFR 721.555 - Alkyl amino nitriles (generic).

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Alkyl amino nitriles (generic). 721... Substances § 721.555 Alkyl amino nitriles (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as alkyl amino nitriles (PMNs P-96...

  14. A Generic Approach to Parameter Control

    NARCIS (Netherlands)

    Karafotias, G.; Smit, S.K.; Eiben, A.E.

    2012-01-01

    On-line control of EA parameters is an approach to parameter setting that offers the advantage of values changing during the run. In this paper, we investigate parameter control from a generic and parameter-independent perspective. We propose a generic control mechanism that is targeted to

  15. Developing competitive and sustainable Polish generic medicines market.

    Science.gov (United States)

    Simoens, Steven

    2009-10-01

    To descriptively analyze the policy environment surrounding the Polish generic medicines retail market. The policy analysis was based on an international literature review. Also, a simulation exercise was carried out to compute potential savings from substituting generic for originator medicines in Poland using IMS Health pharmaceutical intelligence data. Poland has a mature, high-volume, low-value generic medicines market, primarily driven by the establishment of the reference price at the price of the cheapest medicine in combination with pricing regulation and the low level of medicine prices. The practice of discounting in the distribution chain implies that the National Health Fund and patients do not capture the potential savings from a generic medicines market where companies compete on price. This high-volume market has benefited in the past from the limited availability of originator medicines and a short data exclusivity period, even though there are no incentives for physicians to prescribe generic medicines and a financial disincentive for pharmacists to dispense generic medicines. Increased generic substitution would be expected to reduce public expenditure on originator medicines by 21%. To develop a competitive and sustainable market, Poland needs to consider moving away from competition by discount to competition by price. This could be achieved by replacing maximum distribution margins by fixed margins. Also, Poland may wish to raise reference prices as a temporary measure to boost market entry for medicine classes with few generic medicines.

  16. The Generic Data Capture Facility

    Science.gov (United States)

    Connell, Edward B.; Barnes, William P.; Stallings, William H.

    1987-01-01

    The Generic Data Capture Facility, which can provide data capture support for a variety of different types of spacecraft while enabling operations costs to be carefully controlled, is discussed. The data capture functions, data protection, isolation of users from data acquisition problems, data reconstruction, and quality and accounting are addressed. The TDM and packet data formats utilized by the system are described, and the development of generic facilities is considered.

  17. Does educational intervention improve doctors’ knowledge and perceptions of generic medicines and their generic prescribing rate? A study from Malaysia

    Science.gov (United States)

    Wong, Zhi Yen; Alrasheedy, Alian A.; Saleem, Fahad; Mohamad Yahaya, Abdul Haniff; Aljadhey, Hisham

    2014-01-01

    Objectives: To investigate the impact of an educational intervention on doctors’ knowledge and perceptions towards generic medicines and their generic (international non-proprietary name) prescribing practice. Methods: This is a single-cohort pre-/post-intervention pilot study. The study was conducted in a tertiary care hospital in Perak, Malaysia. All doctors from the internal medicine department were invited to participate in the educational intervention. The intervention consisted of an interactive lecture, an educational booklet and a drug list. Doctors’ knowledge and perceptions were assessed by using a validated questionnaire, while the international non-proprietary name prescribing practice was assessed by screening the prescription before and after the intervention. Results: The intervention was effective in improving doctors’ knowledge towards bioequivalence, similarity of generic medicines and safety standards required for generic medicine registration (p = 0.034, p = 0.034 and p = 0.022, respectively). In terms of perceptions towards generic medicines, no significant changes were noted (p > 0.05). Similarly, no impact on international non-proprietary name prescribing practice was observed after the intervention (p > 0.05). Conclusion: Doctors had inadequate knowledge and misconceptions about generic medicines before the intervention. Moreover, international non-proprietary name prescribing was not a common practice. However, the educational intervention was only effective in improving doctors’ knowledge of generic medicines. PMID:26770747

  18. A without-prejudice list of generic names of fungi for protection under the International Code of Nomenclature for algae, fungi, and plants

    NARCIS (Netherlands)

    Kirk, P.M.; Stalpers, J.A.; Braun, U.; Crous, P.W.; Hansen, K.; Hawksworth, D.L.; Hyde, K.D.; Lücking, R.; Lumbsch, T.H.; Rossman, A.Y.; Seifert, K.A.; Stadler, M.

    2013-01-01

    As a first step towards the production of a List of Protected Generic Names for Fungi, a without-prejudice list is presented here as a basis for future discussion and the production of a List for formal adoption. We include 6995 generic names out of the 17072 validly published names proposed for

  19. Probabilistic analysis of safety of a production plant of hydrogen using nuclear energy

    International Nuclear Information System (INIS)

    Flores F, A.; Nelson E, P.F.; Francois L, J.L.

    2005-01-01

    The present work makes use of the Probabilistic Safety analysis to evaluate and to quantify the safety in a plant producer of hydrogen coupled to a nuclear reactor of high temperature, the one which is building in Japan. It is had the description of systems and devices of the HTTR, the pipe diagrams and instrumentation of the plant, as well as the rates of generic faults for the components of the plant. The first step was to carry out a HAZOP study (Hazard and Operability Study) with the purpose of obtaining the initiator events; once obtained these, it was developed a tree of events by each initiator event and for each system it was developed a fault tree; the data used for the quantification of the failure probability of the systems were obtained starting from several generic sources of information. In each tree of events different final states were obtained and it stops each one, their occurrence frequency. The construction and evaluation of the tree of events and of failures one carries out with the SAPHIRE program. The results show the safety of the shutdown system of the HTTR and they allow to suggest modifications to the auxiliary system of refrigeration and to the heat exchanger helium/water pressurized. (Author)

  20. AGE RELATED DEGRADATION OF STEAM GENERATOR INTERNALS BASED ON INDUSTRY RESPONSES TO GENERIC LETTER 97-06

    International Nuclear Information System (INIS)

    SUBUDHI, M.; SULLIVAN, JR. E.J.

    2002-01-01

    THIS PAPER PRESENTS THE RESULTS OF AN AGING ASSESSMENT OF THE NUCLEAR POWER INDUSTRY RESPONSES TO NRC GENERIC LETTER 97-06 ON THE DEGRADATION OF STEAM GENERATOR INTERNALS EXPERIENCED AT ELECTRICITE DE FRANCE (EDF) PLANTS IN FRANCE AND AT A UNITED STATES PRESSURIZED WATER REACTOR (PWR). WESTINGHOUSE (W), COMBUSTION ENGINEERING (CE), AND BABCOCK AND WILCOX (BW) STEAM GENERATOR MODELS, CURRENTLY IN SERVICE AT U.S. NUCLEAR POWER PLANTS, POTENTIALLY COULD EXPERIENCE DEGRADATION SIMILAR TO THATFOUND AT EDF PLANTS AND THE U.S. PLANT. THE STEAM GENERATORS IN MANY OF THE U.S. PWRS HAVE BEEN REPLACED WITH STEAM GENERATORS WITH STEAM GENERATORS WITH IMPROVED DESIGNS AND MATERIALS. THESE REPLACEMENT STEAM GENERATORS HAVE BEEN MANUFACTURED IN THE U.S. AND ABROAD. DURING THIS ASSESSMENT, EACH OF THE THREE OWNERS GROUPS (W,CE, AND BW) IDENTIFIED FOR ITS STEAM GENERATOR, MODELS ALL THE POTENTIAL INTERNAL COMPONENTS THAT ARE VULNERABLE TO DEGRADATION WHILE IN SERVICE. EACH OWNERS GROUPDEVELOPED INSPEC TION AND MONITORING GUIDANCE AND RECOMMENDATIONS FOR ITS PARTICULAR STEAM GENERATOR MODELS. THE NUCLEAR ENERGY INSTITUTE INCORPORATED IN NEI 97-06 STEAM GENERATOR PROGRAM GUIDELINES, A REQUIREMENT TO MONITOR SECONDARY SIDE STEAM GENERATOR COMPONENTS IF THEIR FAILURE COULD PREVENT THE STEAM GENERATOR FROM FULFILLING ITS INTENDED SAFETY-RELATED FUNCTION. LICENSEES INDICATED THAT THEY IMPLEMENTED OR PLANNED TO IMPLEMENT, AS APPROPRIATE FOR THEIR STEAM GENERATORS, THEIR OWNERS GROUPRECOMMENDATIONS TO ADDRESS THE LONG-TERM EFFECTS OF THE POTENTIAL DEGRADATION MECHANISMS ASSOCIATED WITH THE STEAM GENERATOR INTERNALS

  1. In-plant reliability data base for nuclear power plant components: data collection and methodology report

    International Nuclear Information System (INIS)

    Drago, J.P.; Borkowski, R.J.; Pike, D.H.; Goldberg, F.F.

    1982-07-01

    The development of a component reliability data for use in nuclear power plant probabilistic risk assessments and reliabiilty studies is presented in this report. The sources of the data are the in-plant maintenance work request records from a sample of nuclear power plants. This data base is called the In-Plant Reliability Data (IPRD) system. Features of the IPRD system are compared with other data sources such as the Licensee Event Report system, the Nuclear Plant Reliability Data system, and IEEE Standard 500. Generic descriptions of nuclear power plant systems formulated for IPRD are given

  2. A developmental analysis of generic nouns in Southern Peruvian Quechua.

    Science.gov (United States)

    Mannheim, Bruce; Gelman, Susan A; Escalante, Carmen; Huayhua, Margarita; Puma, Rosalía

    2010-01-01

    Generic noun phrases (e.g., "Cats like to drink milk") are a primary means by which adults express generalizations to children, yet they pose a challenging induction puzzle for learners. Although prior research has established that English speakers understand and produce generic noun phrases by preschool age, little is known regarding the cross-cultural generality of generic acquisition. Southern Peruvian Quechua provides a valuable comparison because, unlike English, it is a highly inflected language in which generics are marked by the absence rather than the presence of any linguistic markers. Moreover, Quechua is spoken in a cultural context that differs markedly from the highly educated, middle-class contexts within which earlier research on generics was conducted. We presented participants from 5 age groups (3-6, 7-9, 10-12, 14-35, and 36-90 years of age) with two tasks that examined the ability to distinguish generic from non-generic utterances. In Study 1, even the youngest children understood generics as applying broadly to a category (like "all") and distinct from indefinite reference ("some"). However, there was a developmental lag before children understood that generics, unlike "all", can include exceptions. Study 2 revealed that generic interpretations are more frequent for utterances that (a) lack specifying markers and (b) are animate. Altogether, generic interpretations are found among the youngest participants, and may be a default mode of quantification. These data demonstrate the cross-cultural importance of generic information in linguistic expression.

  3. Associations between generic substitution and patient-related factors

    DEFF Research Database (Denmark)

    Østergaard Rathe, Jette

    Associations between generic substitution and patient-related factors Jette Østergaard Rathe1, Pia V. Larsen1, Morten Andersen2, Janus L. Thomsen3, Maja S. Paulsen1, Jens Søndergaard1 1. Research Unit of General Practice, Institute of Public Health, University of Southern Denmark 2. Centre...... for Pharmacoepidemiology, Karolinska Institutet, Department of Medicine Solna, Stockholm, Sweden 3. Danish Quality Unit of General Practice, Odense, Denmark Background Generic substitution means that chemically equivalent but less expensive drugs are dispensed in place of a brand name product. Although generic medicines...... by definition are bioequivalent to their brand name counterparts there are concerns about whether generic substitution is always accompanied by clinical equivalence in terms of effectiveness and that it may cause concerns and thereby causing some skepticism towards generic substitution. There is, however...

  4. State and local planning procedures dealing with social and economic impacts from nuclear power plants

    International Nuclear Information System (INIS)

    Curry, M.; Goodrieght, J.; Green, M.; Merwin, D.; Smith, R.

    1977-01-01

    The roles of state and local agencies in planning for and managing social and economic impacts of nuclear power plants are studied. In order to be effective in these roles state and local agencies must work with each other as well as the NRC. A comparative case study approach is used which analyzes six sites in three West Coast states. The case studies included plants in operation, plants under construction, and plants still in the planning stages. In contrast to some states, all three of these states have moderately centralized procedures for siting power plants, and all have strong environmental laws

  5. Nondestructive assay technology and in-plant dynamic materials control: ''DYMAC''

    International Nuclear Information System (INIS)

    Keppin, G.R.; Maraman, W.J.

    1975-01-01

    An advanced system of in-plant materials control known as DYMAC, Dynamic Materials Control, is being developed. This major safeguards R and D effort merges state-of-the-art nondestructive assay instrumentation and computer technology, with the clear objective of demonstrating a workable, cost-effective system of stringent, real time control of nuclear materials in a modern plutonium processing facility. Emphasis is placed on developing practical solutions to generic problems of materials measurement and control, so that resulting safeguards techniques and instrumentation will have widespread applicability throughout the nuclear community. (auth)

  6. Overview of United States Department of Energy activities to support life extension of nuclear power plants

    International Nuclear Information System (INIS)

    Harrison, D.L.

    1993-01-01

    Today, 109 nuclear power plants provide over 20 percent of the electrical energy generated in the US The operating license of the first of these plants will expire in the year 2000; one-third of the operating licenses will expire by 2010 and the remaining plant licenses are scheduled to expire by 2033. The National Energy Strategy assumes that 70 percent of these plants will continue to operate beyond their current license expiration to assist in ensuring an adequate, diverse, and environmentally acceptable energy supply for economic growth. In order to preserve this energy resource in the US three major tasks must be successfully completed: establishment of regulations, technical standards, and procedures for the preparation and review of a license renewal application; development, verification, and validation of technical criteria and bases for monitoring, refurbishing, and/or replacing plant equipment; and demonstration of the regulatory process. Since 1985, the US Department of Energy (DOE) has been working with the nuclear industry and the US Nuclear Regulatory Commission (NRC) to establish and demonstrate the option to extend the life of nuclear power plants through the renewal of operating licenses. This paper focuses primarily on DOE's Plant Lifetime Improvement (PLIM) Program efforts to develop the technical criteria and bases for effective aging management and lifetime improvement for continued operation of nuclear power plants. This paper describes current projects to resolve generic technical issues in the principal areas of reactor pressure vessel (RPV) integrity, fatigue, and environmental qualification (EQ)

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

    Science.gov (United States)

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

    2015-04-01

    Generic medicines offer an opportunity for governments to contain pharmaceutical expenditures, since generics are generally 10%-80% lower in price than brand medicines. Belgium has a small generic market that takes up 15% of the total pharmaceutical market in packages sold. To determine the knowledge of consumers about the different available packages of a common over-the-counter medicine (acetaminophen) with regard to price advantage, quality, and effectiveness in a country with a small generic market. We conducted an online survey in the general Flemish population using a questionnaire with 25 statements. The questionnaire also contained 2 informative interventions. First, we showed the price per package and per tablet that the patient would pay in the pharmacy. Second, we provided the respondent with general information about generic medication (equivalence, effectiveness, price, and recognition). Before and after the interventions, we probed for preferences and knowledge about the different packages. Multivariate logistic models were used to examine the independent effects of consumer characteristics on responses to the survey statements. We obtained a sample of 1,636 respondents. The general attitude towards generic medication was positive-only 5% would rather not use a generic. Nevertheless, only 17% of the respondents were able to recognize a generic medicine. Older consumers (aged 60 years and above) were more often confused about the different packages (OR = 2.59, 95% CI = 1.76-3.80, P ≤ 0.001). Consumers without a higher education degree tended to be more doubtful about the difference in effectiveness and quality between the different brands (OR = 0.59, 95% CI = 0.44-0.79, P ≤ 0.001). Consumer recognition of the name of the active substance of acetaminophen was poor. When different brands were displayed, possible price advantage seemed to be an important motive to switch to a cheaper brand. Consumers generally found medicines

  8. Floating plant dominance as a stable state

    NARCIS (Netherlands)

    Scheffer, M.; Szabo, S.; Gragnani, A.; Nes, van E.H.; Rinaldi, S.; Kautsky, N.; Norberg, J.; Roijackers, R.M.M.; Franken, R.J.M.

    2003-01-01

    The authors demonstrate that floating-plant dominance can be a self-stabilizing ecosystem state, which may explain its notorious persistence in many situations. Their results, based on experiments, field data, and models (in Dutch ditches and Lake Kariba, Zimbabwe), represent evidence for

  9. Family Genericity

    DEFF Research Database (Denmark)

    Ernst, Erik

    2006-01-01

    Type abstraction in object-oriented languages embody two techniques, each with its own strenghts and weaknesses. The first technique is extension, yielding abstraction mechanisms with good support for gradual specification. The prime example is inheritance. The second technique is functional abst...... the result as family genericity. The presented language design has been implemented....

  10. Hanford Generic Interim Safety Basis

    International Nuclear Information System (INIS)

    Lavender, J.C.

    1994-01-01

    The purpose of this document is to identify WHC programs and requirements that are an integral part of the authorization basis for nuclear facilities that are generic to all WHC-managed facilities. The purpose of these programs is to implement the DOE Orders, as WHC becomes contractually obligated to implement them. The Hanford Generic ISB focuses on the institutional controls and safety requirements identified in DOE Order 5480.23, Nuclear Safety Analysis Reports

  11. Hanford Generic Interim Safety Basis

    Energy Technology Data Exchange (ETDEWEB)

    Lavender, J.C.

    1994-09-09

    The purpose of this document is to identify WHC programs and requirements that are an integral part of the authorization basis for nuclear facilities that are generic to all WHC-managed facilities. The purpose of these programs is to implement the DOE Orders, as WHC becomes contractually obligated to implement them. The Hanford Generic ISB focuses on the institutional controls and safety requirements identified in DOE Order 5480.23, Nuclear Safety Analysis Reports.

  12. Use of plant-specific PRA in an EOP scope audit

    International Nuclear Information System (INIS)

    O'Brien, J.J.

    1991-01-01

    Traditionally, decisions on which accident scenarios to proceduralize as emergency operating procedures (EOPs) have been based on existing design basis analyses, engineering judgment, and probabilistic risk assessments (PRAs) on generic plants. This approach has important strengths and limits. The major limitation of generic PRAs is their inability to account for plant-specific features. Use of plant-specific PRA to determine the impact of proceduralizing, or not proceduralizing, responses to scenarios considers plant-specific features. This helps to eliminate unnecessary EOPs, thus allowing resources to be concentrated on scenarios that are more important for a particular plant. In preparation for a US Nuclear Regulatory Commission audit, a plant-specific PRA was used to assess and quantify the plant's previous decision not to implement six reference emergency response guidelines (ERGs) as procedures. The original justification for nonimplementation of the ERGs was based on engineering judgment. The PRA provided a quantitative justification for implementation/nonimplementation of each guidelines. This analysis accounted for plant-specific design features not common to all reference plants

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

    Directory of Open Access Journals (Sweden)

    Philip J Domeyer

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

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

    Science.gov (United States)

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

    2012-01-01

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

  15. Towards Using a Generic Robot as Training Partner

    DEFF Research Database (Denmark)

    Sørensen, Anders Stengaard; Savarimuthu, Thiusius Rajeeth; Nielsen, Jacob

    2014-01-01

    In this paper, we demonstrate how a generic industrial robot can be used as a training partner, for upper limb training. The motion path and human/robot interaction of a non-generic upper-arm training robot is transferred to a generic industrial robot arm, and we demonstrate that the robot arm can...... implement the same type of interaction, but can expand the training regime to include both upper arm and shoulder training. We compare the generic robot to two affordable but custom-built training robots, and outline interesting directions for future work based on these training robots....

  16. Innovation strategies for generic drug companies: moving into supergenerics.

    Science.gov (United States)

    Ross, Malcolm S F

    2010-04-01

    Pharmaceutical companies that market generic products generally are not regarded as innovators, but rather as companies that produce copies of originator products to be launched at patent expiration. However, many generics companies have developed excellent scientific innovative skills in an effort to circumvent the defense patents of originator companies. More patents per product, in terms of both drug substances (process patents and polymorph patents) and formulations, are issued to generics companies than to companies that are traditionally considered to be 'innovators'. This quantity of issued patents highlights the technical knowledge and skill sets that are available in generics companies. In order to adopt a completely innovative model (ie, the development of NCEs), a generics company would require a completely new set of skills in several fields, including a sufficient knowledge base, project and risk management experience, and capability for clinical data evaluation. However, with relatively little investment, generics companies should be able to progress into the so-called 'supergeneric' drug space - an area of innovation that reflects the existing competencies of both innovative and generics companies.

  17. Application of leak-before-break to primary loop piping to eliminate pipe whip restraints in a Spanish nuclear power plant

    International Nuclear Information System (INIS)

    Rodriguez, M.; Esteban, A.

    1990-01-01

    The Spanish plant described in this study is a 982 MWe PWR with a three-loop primary circuit of piping made from centrifugally-cast stainless steel SA351 CF8A. The licensee requested from Consejo de Seguridad Nuclear (CSN) an exemption from the general design criterion, GDC-4, so as to avoid the need to postulate a guillotine rupture of the primary loop piping. The request was based on the generic work performed for a US PWR plant group in order to have such an exemption. As the piping material in the Spanish plant is different from that in the plants included in the generic work, CSN performed a review of the applicability of the generic results to the Spanish plant. Also, aspects such as fatigue evaluation, net section collapse, crack growth and leak detection, specifically analyzed for the Spanish plant, were reviewed. CSN found that fracture toughness test results from generic work are applicable to the Spanish plant; sufficient margin exists against unstable crack extension, and adequate leak detection capability exists with the leakage detection systems available in the plant. Exemption from GDC-4 was approved and CSN authorized the licensee to remove protection devices against dynamic loads from guillotine breaks in the primary coolant loops. (author)

  18. Bethe states of the trigonometric SU(3) spin chain with generic open boundaries

    Science.gov (United States)

    Sun, Pei; Xin, Zhirong; Qiao, Yi; Wen, Fakai; Hao, Kun; Cao, Junpeng; Li, Guang-Liang; Yang, Tao; Yang, Wen-Li; Shi, Kangjie

    2018-06-01

    By combining the algebraic Bethe ansatz and the off-diagonal Bethe ansatz, we investigate the trigonometric SU (3) model with generic open boundaries. The eigenvalues of the transfer matrix are given in terms of an inhomogeneous T - Q relation, and the corresponding eigenstates are expressed in terms of nested Bethe-type eigenstates which have well-defined homogeneous limit. This exact solution provides a basis for further analyzing the thermodynamic properties and correlation functions of the anisotropic models associated with higher rank algebras.

  19. “No generics, Doctor!” The perspective of general practitioners in two French regions

    Directory of Open Access Journals (Sweden)

    Béatrice Riner

    2017-11-01

    Full Text Available Abstract Background Generic medicines are essential to controlling health expenditures. Their market share is still small in France. The discourse and practices of prescribers may play a major role in their use. The purpose of this study was to explore the knowledge, attitudes and practices of general practitioners (GPs toward generic medicines in two French regions with the lowest penetration rate of these products. Methods An observational study was carried out from October 2015 to February 2016 in Guadeloupe and Martinique. The first qualitative phase involved a diversified sample of 14 GPs who underwent semi-structured interviews. The second phase involved a random sample of 316 GPs (response rate = 74% who were administered a structured questionnaire developed from the results of the first phase. Results Seventy-eight percent of the participants defined a generic drug as a drug containing an active substance identical to a brand-name drug, but only 11% considered generic drugs to be equivalent to brand-name drugs, and the same proportion believed that the generic drugs were of doubtful quality. The primary recognized advantage of generic medicines was their lower cost (82%. The main drawbacks cited were the variability of their presentation (44%, the confusion that they caused for some patients (47%, frequent allegations of adverse side effects (37% and a lack of efficacy (24%, and frequent refusal by patients (26%. Seventy-four percent of the participants stated that they adapted their prescribing practices to the situation, and of this group, 47% prescribed the originator product simply on demand. Conclusion Most surveyed GPs were not hostile towards generic medicines. They were caught between the requirements of health insurance regimes and the opposition of numerous users and suggested that the patient information provided by health authorities should be improved and that drug composition and packaging should be made uniform.

  20. Effectiveness of US state policies in reducing CO2 emissions from power plants

    Science.gov (United States)

    Grant, Don; Bergstrand, Kelly; Running, Katrina

    2014-11-01

    President Obama's landmark initiative to reduce the CO2 emissions of existing power plants, the nation's largest source of greenhouse gas (GHG) pollutants, depends heavily on states and their ability to devise policies that meet the goals set by the Environmental Protection Agency (EPA). Under the EPA's proposed Clean Power Plan, states will be responsible for cutting power plants' carbon pollution 30% from 2005 levels by 2030. States have already adopted several policies to reduce the electricity sector's climate impact. Some of these policies focus on reducing power plants' CO2 emissions, and others address this outcome in a more roundabout fashion by encouraging energy efficiency and renewable energy. However, it remains unclear which, if any, of these direct and indirect strategies actually mitigate plants' emissions because scholars have yet to test their effects using plant-level emission data. Here we use a newly released data source to determine whether states' policies significantly shape individual power plants' CO2 emissions. Findings reveal that certain types of direct strategy (emission caps and GHG targets) and indirect ones (public benefit funds and electric decoupling) lower plants' emissions and thus are viable building blocks of a federal climate regime.

  1. 78 FR 22553 - Generic Drug Facilities, Sites, and Organizations

    Science.gov (United States)

    2013-04-16

    ...] Generic Drug Facilities, Sites, and Organizations AGENCY: Food and Drug Administration, HHS. ACTION.... Generic drug facilities, certain sites, and organizations identified in a generic drug submission are... active pharmaceutical ingredients and certain other sites and organizations that support the manufacture...

  2. Plant breeding and rural development in the United States.

    Science.gov (United States)

    KE Woeste; SB Blanche; KA Moldenhauer; CD Nelson

    2010-01-01

    Plant breeders contributed enormously to the agricultural and economic development of the United States. By improving the profitability of farming, plant breeders improved the economic condition of farmers and contributed to the growth and structure of rural communities. In the years since World War II, agriculture and the quality of rural life have been driven by...

  3. Non-native plant invasions of United States National parks

    Science.gov (United States)

    Allen, J.A.; Brown, C.S.; Stohlgren, T.J.

    2009-01-01

    The United States National Park Service was created to protect and make accessible to the public the nation's most precious natural resources and cultural features for present and future generations. However, this heritage is threatened by the invasion of non-native plants, animals, and pathogens. To evaluate the scope of invasions, the USNPS has inventoried non-native plant species in the 216 parks that have significant natural resources, documenting the identity of non-native species. We investigated relationships among non-native plant species richness, the number of threatened and endangered plant species, native species richness, latitude, elevation, park area and park corridors and vectors. Parks with many threatened and endangered plants and high native plant species richness also had high non-native plant species richness. Non-native plant species richness was correlated with number of visitors and kilometers of backcountry trails and rivers. In addition, this work reveals patterns that can be further explored empirically to understand the underlying mechanisms. ?? Springer Science+Business Media B.V. 2008.

  4. Harmonic Resonances in Wind Power Plants

    DEFF Research Database (Denmark)

    Fernandez, Francisco Daniel Freijedo; Chaudhary, Sanjay; Teodorescu, Remus

    2015-01-01

    This work reviews the state-of-the-art in the field of harmonic resonance problems in Wind Power Plants (WPPs). Firstly, a generic WPP is modeled according to the equivalent circuits of its passive and active components. Main focus is put on modeling active components, i.e. the ones based on power...... converters. Subsequently, pros and cons of frequency and time domain analysis methods are outlined. The next sections are devoted to mitigation methods implemented in the power electronics converters. From the wind turbine perspective, different techniques to enhance the robustness of the controller...... are analyzed. Subsequently, the suitability for active damping of harmonics using STATCOM devices is assessed, with focus both on control techniques and power converter technologies....

  5. Integration of generic issues

    International Nuclear Information System (INIS)

    Thatcher, D.

    1989-01-01

    The NRC has recognized the need to integrate generic issues (GIs). The GI process includes a number of phases, all of which should recognize the potential for overlap and conflict among related issues. In addition to the issues themselves, other related NRC and industry programs and activities need to be factored into the GI process. Integration has taken place, or is taking place, for a number of GIs. Each case of integration involves a specific set of circumstances and, as a result, the way in which integration proceeds can vary. This paper discusses the integration of issues in the generic issue process and provides a number of examples

  6. In vitro disintegration studies of weekly generic alendronate sodium tablets (70 mg) available in the US.

    Science.gov (United States)

    Dansereau, Richard J; Crail, Debbie J; Perkins, Alan C

    2009-02-01

    Bisphosphonates as a class have the potential to cause upper gastrointestinal irritation. Although the generic alendronate sodium tablets are bioequivalent to the branded product, a potential concern is that the pharmaceutical attributes of the various generic formulations my affect the potential for local irritation and tolerability. The in vitro disintegration times were determined using the method described in the US Pharmacopeia 30 (USP 30). The disintegration of three generic alendronate sodium tablets 70 mg available in the United States was compared to that of the branded product. The mean disintegration times of the generic alendronate sodium tablets ranged from 9 to 10 s for the Barr lots to 108 s for the Watson lot. The disintegration time of the branded product (Fosamax) was 53 s. The three Barr lots and one Teva lot had rapid disintegration times which were similar to the disintegration standards (disintegrating tablets. Since there is no established disintegration time for alendronate sodium tablets there can be no assurance that the generic tablets are equivalent to the branded product in terms of esophageal exposure. However, the in vitro disintegration times have not been correlated with in vivo disintegration performance. Copies of generic alendronate sodium tablets are approved based on the results of single-dose bioavailability studies in healthy subjects and this is not considered adequate to establish similar disintegration characteristics.

  7. Description of reference (model) plant

    International Nuclear Information System (INIS)

    Schneider, R.A.

    1984-01-01

    For the workshop on Safeguards System design for a fuel fabrication plant, a generic example of a LEU bulk-handling facility that is based on the Exxon LWR fuel fabrication plants is used. The model plant information is given in the following separate sections: (1) process assumptions; (2) six-month material balance model; (3) measurements; (4) error parameters, measurements, and sigma MUF calculations; (5) material control areas; (6) accounting, records, and reports; (7) tamper-safing; and (8) measurement control program

  8. South African patient's acceptance of generic drugs

    African Journals Online (AJOL)

    mechanism in this regard for final consumers, insurance providers, and ... facilities are viewed as inferior, treated with sus- picion and ... to choose a generic drug if the decision was supported by their doctor ... The effect of brand to generic and ...

  9. Impact of generic substitution decision support on electronic prescribing behavior.

    Science.gov (United States)

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

    2010-01-01

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

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

    Science.gov (United States)

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

    2012-01-01

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

  11. Generic Graph Grammar: A Simple Grammar for Generic Procedural Modelling

    DEFF Research Database (Denmark)

    Christiansen, Asger Nyman; Bærentzen, Jakob Andreas

    2012-01-01

    in a directed cyclic graph. Furthermore, the basic productions are chosen such that Generic Graph Grammar seamlessly combines the capabilities of L-systems to imitate biological growth (to model trees, animals, etc.) and those of split grammars to design structured objects (chairs, houses, etc.). This results...

  12. The importance of being first: evidence from Canadian generic pharmaceuticals.

    Science.gov (United States)

    Hollis, Aidan

    2002-12-01

    This paper uses pooled cross-section data on Canadian ethical drug sales to examine the effect of entry timing on sales of generic drugs. The data is for all drugs for which the first generic competitor entered during the years 1994-1997. It is found that the first generic entrant has a lasting competitive advantage: being first into the market appears to lead to an increase of around 30% in market share (among generics) over a period of at least 4 years. This finding has considerable implications for the current policy of allowing brandname drug companies to issue pseudo-generic equivalents as a preemptive strike against true generic competitors. Copyright 2002 John Wiley & Sons, Ltd.

  13. Plant management in concurrent engineering

    International Nuclear Information System (INIS)

    Haubensack, D.; Malvache, P.; Valleix, P.

    1997-01-01

    The ImagIn project consist in a method and a set of computer tools apt to bring perceptible and assessable improvements in the operational safety of a nuclear plant. Its aim is to design an information system that would maintain a highly detailed computerised representation of a nuclear plant, in its initial state and throughout its in-service life. It is not a tool to drive or help driving the nuclear plant, but a tool that manages concurrent operations that modify the plant configuration in a very general way (maintenance for example). The configuration of the plant, as well as rules and constraints about it, are described in a object-oriented, knowledge database, which is built using a generic ImagIn meta-model based on the semantical network theory. An inference engine works on this database and is connected to reality through interfaces to operators and captors on the installation; it verifies constantly in real-time the consistency of the database according to its inner rules, and reports eventual problems to concerned operators. A special effort is made on interfaces to provide natural and intuitive tools (using virtual reality, natural language, voice recognition and synthesis). A laboratory application on a fictive but realistic installation already exist and is used to simulate various test and scenari. A real application is being constructed on SILOE, an experimental reactor of the CEA. (authors)

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

    Science.gov (United States)

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

    2017-10-01

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

  15. Evaluation of Component Failure Data of the Operating Nuclear Power Plants in Korea Based on NUREG/CR-6928

    International Nuclear Information System (INIS)

    Jeon, Hojun; Na, Janghwan; Shin, Taeyoung

    2014-01-01

    This paper focuses on ensuring the quality of component failure data. When performing data analysis in PSA, we have customized the component failure data based on Bayesian analysis using plant specific experiences and the generic data of Advanced Light Water Reactor Utility Requirements Document (ALWR URD). However, ALWR URD was established by collecting US nuclear power plant (NPP) practices from mid 1980s to early 1990s. We analyzed the component failure data using the raw data of component failures in Pressurized Water Reactor (PWR) plants by 2012. This paper presents the results from analyzing the component failure data based on the new generic data and the latest specific failure data. We also compare the new component failure data to the existing data of PSA models, and evaluate the risk impacts by applying the new data to the PSA models of reference NPPs in this paper. To apply the new generic data source to PSA models, we reviewed and compared NUREG/CR-6928 and the existing generic data source, ALWR URD. In addition, we analyzed the component failure data generated from 16 PWR plants by the end of 2012, and performed the Bayesian update with these raw data based on the new generic data source of NUREG/CR-6928. Also, we reviewed the PSA models of the reference NPP, and identified some important components to CDF. The failure data of the major components decreased in general by applying the new generic data and the latest plant specific data. As a result, the CDF of the reference NPP decreased over 30% compared to the value of the existing CDF

  16. Methodological Considerations for Comparison of Brand Versus Generic Versus Authorized Generic Adverse Event Reports in the US Food and Drug Administration Adverse Event Reporting System (FAERS).

    Science.gov (United States)

    Rahman, Md Motiur; Alatawi, Yasser; Cheng, Ning; Qian, Jingjing; Peissig, Peggy L; Berg, Richard L; Page, David C; Hansen, Richard A

    2017-12-01

    The US Food and Drug Administration Adverse Event Reporting System (FAERS), a post-marketing safety database, can be used to differentiate brand versus generic safety signals. To explore the methods for identifying and analyzing brand versus generic adverse event (AE) reports. Public release FAERS data from January 2004 to March 2015 were analyzed using alendronate and carbamazepine as examples. Reports were classified as brand, generic, and authorized generic (AG). Disproportionality analyses compared reporting odds ratios (RORs) of selected known labeled serious adverse events stratifying by brand, generic, and AG. The homogeneity of these RORs was compared using the Breslow-Day test. The AG versus generic was the primary focus since the AG is identical to brand but marketed as a generic, therefore minimizing generic perception bias. Sensitivity analyses explored how methodological approach influenced results. Based on 17,521 US event reports involving alendronate and 3733 US event reports involving carbamazepine (immediate and extended release), no consistently significant differences were observed across RORs for the AGs versus generics. Similar results were obtained when comparing reporting patterns over all time and just after generic entry. The most restrictive approach for classifying AE reports yielded smaller report counts but similar results. Differentiation of FAERS reports as brand versus generic requires careful attention to risk of product misclassification, but the relative stability of findings across varying assumptions supports the utility of these approaches for potential signal detection.

  17. Policies and perceptions on generic drugs: The case of Greece.

    Science.gov (United States)

    Xanthopoulou, Sofia-Sotiria; Katsaliaki, Korina

    2018-01-01

    The increase in the consumption of generic drugs to reduce pharmaceutical expenditure is a challenge for many countries, especially during the economic crisis. The purpose of the present study is to review the Greek market of generic drugs and the decisions that shape it, to determine the factors that affect Greek patients' and doctors' attitudes about generic substitution and present a set of measures for all stakeholders based on the findings of the secondary and primary analysis. The study includes (a) an analysis of international and national reports and legislation on drugs policies and (b) a questionnaire survey of 242 hospital patients and 85 doctors regarding their perceptions on generics. A small increase in the volume of generics is recorded, yet not followed by sales value, over the recent years that the measures for promoting generics prescription took effect. Distrust from both patients and doctors was observed toward generics' effectiveness and toward the appropriateness of the regulatory authorities' quality controls. The study presents a structured set of viable measures, applicable to many countries, for promoting generic drug consumption that can lead to economic efficiency without degrading the health care quality.

  18. Societal value of generic medicines beyond cost-saving through reduced prices.

    Science.gov (United States)

    Dylst, Pieter; Vulto, Arnold; Simoens, Steven

    2015-01-01

    This paper aims to provide an overview of the added societal value of generic medicines beyond their cost-saving potential through reduced prices. In addition, an observational case study will document the impact of generic entry on access to pharmacotherapy in The Netherlands and an illustrative exercise was carried out to highlight the budget impact of generic entry. A narrative literature review was carried out to explore the impact of generic medicines on access to pharmacotherapy, innovation and medication adherence. Data from the Medicines and Medical Devices Information Project database in The Netherlands were used for the case study in which the impact of generic medicine entrance on the budget and the number of users was calculated as an illustrative exercise. Generic medicines have an additional societal value beyond their cost-saving potential through reduced prices. Generic medicines increase access to pharmacotherapy, provide a stimulus for innovation by both originator companies and generic companies and, under the right circumstances, have a positive impact on medication adherence. Generic medicines offer more to society than just their cost-saving potential through reduced prices. As such, governments must not focus only on the prices of generic medicines as this will threaten their long-term sustainability. Governments must therefore act appropriately and implement a coherent set of policies to increase the use of generic medicines.

  19. Status of safety issues at licensed power plants: TMI Action Plan requirements; unresolved safety issues; generic safety issues; other multiplant action issues

    International Nuclear Information System (INIS)

    1993-12-01

    As part of ongoing US Nuclear Regulatory Commission (NRC) efforts to ensure the quality and accountability of safety issue information, the NRC established a program for publishing an annual report on the status of licensee implementation and NRC verification of safety issues in major NRC requirements areas. This information was initially compiled and reported in three NUREG-series volumes. Volume 1, published in March 1991, addressed the status of Three Mile Island (TMI) Action Plan Requirements. Volume 2, published in May 1991, addressed the status of unresolved safety issues (USIs). Volume 3, published in June 1991, addressed the implementation and verification status of generic safety issues (GSIs). The first annual supplement, which combined these volumes into a single report and presented updated information as of September 30, 1991, was published in December 1991. The second annual supplement, which provided updated information as of September 30, 1992, was published in December 1992. Supplement 2 also provided the status of licensee implementation and NRC verification of other multiplant action (MPA) issues not related to TMI Action Plan requirements, USIs, or GSIs. This third annual NUREG report, Supplement 3, presents updated information as of September 30, 1993. This report gives a comprehensive description of the implementation and verification status of TMI Action Plan requirements, safety issues designated as USIs, GSIs, and other MPAs that have been resolved and involve implementation of an action or actions by licensees. This report makes the information available to other interested parties, including the public. Additionally, this report serves as a follow-on to NUREG-0933, ''A Prioritization of Generic Safety Issues,'' which tracks safety issues until requirements are approved for imposition at licensed plants or until the NRC issues a request for action by licensees

  20. Generic switching of warfarin and risk of excessive anticoagulation

    DEFF Research Database (Denmark)

    Hellfritzsch, Maja; Rathe, Jette; Stage, Tore Bjerregaard

    2016-01-01

    PURPOSE: Generic switching of warfarin was recently repealed in Denmark, as adverse drug reaction (ADR) reports suggested risk of excessive anticoagulation following switches from branded to generic warfarin. We investigated this putative association in a formalized pharmacoepidemiological analysis....... METHODS: We conducted a nationwide cohort study based on Danish healthcare registries, including data from the introduction of generic warfarin until the repeal (January 2011-April 2015). We followed Danish warfarin users over time and compared the rate of incident hospitalizations due to excessive...... anticoagulation (i.e. increased INR or any bleeding requiring hospitalization) in periods following a recent switch to generic warfarin to the rate in periods without a recent switch. RESULTS: We included 105,751 warfarin users, filling a total of 1,539,640 prescriptions for warfarin (2.5% for generic warfarin...

  1. Generic communications index. Listings of communications 1971-1989

    Energy Technology Data Exchange (ETDEWEB)

    Hagemeyer, D; Towle, H

    1991-05-01

    As part of its program to feed back information on operating experience to industry, the U.S. Nuclear Regulatory Commission (NRC) issues generic communications called bulletins (about 5/yr), circulars (now discontinued), generic letters (about 20/yr), and information notices (about 100/yr). The report presents an updated Generic Communications Index (GCI; previously published in NUREG/CR-4690, Vol. 1, December 1987) of all such communications from 1971, when such documentation started, to 1989. The GCI consists of records, one for each communication, containing fields for identification number, title, NRC technical contact, general system or topic, specific component or topic, cause or defect, potential effect, remarks, and vendors involved. To facilitate information retrieval, the report also contains topical listings of generic communications numbers. (author)

  2. Request for information related to the resolution of generic issue 130, ''Essential service water system failures at multi-unit sites,'' pursuant to 10 CFR 50.54(f) - Generic Letter 91-13

    International Nuclear Information System (INIS)

    Partlow, J.G.

    1993-01-01

    The essential service water system (ESWS) is important in maintaining plant safety during power operation, shutdown, and accident conditions. As part of the Nuclear Regulatory Commission's (NRC) evaluation of loss of essential service water (LOSW), extensive analyses of this issue were performed at the Brookhaven National Laboratory (BNL). In addition, the NRC staff performed a regulatory analysis to evaluate the safety benefits and implementation costs associated with various equipment and the administrative-type improvements that were considered. These analyses assume that the flushing and flow testing provisions of Generic Letter (GL) 89-13, ''Service Water System Problems Affecting Safety-Related Equipment,'' will be applied to the crosstie lines as part of addressees' implementation of the resolution of GI-51, ''Improving the Reliability of Open-Cycle Service Water Systems'' (GL 89-13 and Supplement 1). On the basis of results of these evaluations of this generic safety issue, the NRC staff has concluded that the following administrative-type improvements would significantly enhance the availability of the ESWS in affected plants, and their implementation is warranted in view of the safety benefit to be derived and the cost of implementation: technical specification (TS) changes contained in Enclosure 1 to enhance the availability of the ESWS as applied to the design configuration of affected plants; and improvement of emergency procedures for a LOSW using existing design features, specifically: (a) operating and maintaining high-pressure injection (HPI) pump integrity in the event of loss of reactor coolant pump (RCP) seals as a result of ESWS failure, and (b) testing and manipulating the ESWS crosstie between the units during a LOSW accident

  3. License renewal in the United States

    International Nuclear Information System (INIS)

    Brons, Jack

    2002-01-01

    Full text: Nuclear plants in the United States are licensed for 40 years, a length specified in the Atomic Energy Act of 1954, which laid out much of the regulatory basis for the commercial nuclear industry. The Act, however, made provision for license renewal. The original 40-year license period was chosen arbitrarily by the U.S. Congress because it was the typical period over which utilities recovered their investment in electricity generating plants. Nuclear plants, however, are subject to a rigorous program of Nuclear Regulatory Commission oversight, maintenance and equipment replacement. In effect, they must be in the same operating condition on the last day of their licenses as they were on the first. As the industry matured, it became apparent that there was no physical limitation on the continued operation of nuclear plants past 40 years. The industry turned its attention toward license renewal. When the issue was first raised, the NRC considered stringent process equivalent to seeking a new operating license for each plant. The complexity, length and cost of the process made it unlikely that many nuclear plants would seek license renewal. The nuclear industry worked successfully with NRC on the application of generic principles to license renewal, however, and in 1995, the NRC issued an efficient, tightly-focused rule that made license renewal a safe, viable option. To extend the operating license for a reactor, a company must demonstrate to the NRC that aging effects will be adequately managed during the renewal terms, thus ensuring equipment functionality. The rule allows licensees to apply for extensions of up to 20 years. The first license renewal application was filed in 1998 by the owner of the two-unit Calvert Cliffs plant. Shortly thereafter, an application was filed for the three-unit Oconee Nuclear Station. The NRC renewed the licenses for all five units in 2000, and since then, five more licenses have been renewed. The NRC has received 37

  4. Generic Accounting and Reporting Software for Research Reactors

    International Nuclear Information System (INIS)

    Jaernry, C.

    2010-01-01

    This poster will give a general description of a generic accounting and reporting software for research reactors. The program has been designed to be a powerful working tool for the operator. The software is designed to be extremely easy to handle and at the same time give the operator the maximal power of searches, calculations and reports that a modern advanced system can produce. The systems are designed to take make the relevant accountancy for the site and perform the reporting to IAEA in Code 10. Generic software for accounting and reporting for research and other smaller facilities is something that has been asked for by many parties. Software like this could be distributed to facilities in need of a powerful accountancy and reporting system for a much lower cost than the systems that is now custom made for these facilities. This will greatly increase the quality of accountancy at these facilities and the quality of the reporting to IAEA and other state offices etc. The software is based on our advanced custom made software series 'STAR' that has been in use in many places for more than a decade with successful use. (author)

  5. The short-term impact of Ontario's generic pricing reforms.

    Directory of Open Access Journals (Sweden)

    Michael R Law

    Full Text Available Canadians pay amongst the highest generic drug prices in the world. In July 2010, the province of Ontario enacted a policy that halved reimbursement for generic drugs from the public drug plan, and substantially lowered prices for private purchases. We quantified the impact of this policy on overall generic drug expenditures in the province, and projected the impact in other provinces had they mimicked this pricing change.We used quarterly prescription generic drug dispensing data from the IMS-Brogan CompuScript Audit. We used the price per unit in both the pre- and post-policy period and two economics price indexes to estimate the expenditure reduction in Ontario. Further, we used the post-policy Ontario prices to estimate the potential reduction in other provinces.We estimate that total expenditure on generic drugs in Ontario during the second half of 2010 was between $181 and $194 million below what would be expected if prices had remained at pre-policy level. Over half of the reduction in spending was due to savings on just 10 generic ingredients. If other provinces had matched Ontario's prices, their expenditures over during the latter half of 2010 would have been $445 million lower.We found that if Ontario's pricing scheme were adopted nationally, overall spending on generic drugs in Canada would drop at least $1.28 billion annually--a 5% decrease in total prescription drug expenditure. Other provinces should seriously consider both changes to their generic drug prices and the use of more competitive bulk purchasing policies.

  6. A LabVIEW® based generic CT scanner control software platform.

    Science.gov (United States)

    Dierick, M; Van Loo, D; Masschaele, B; Boone, M; Van Hoorebeke, L

    2010-01-01

    UGCT, the Centre for X-ray tomography at Ghent University (Belgium) does research on X-ray tomography and its applications. This includes the development and construction of state-of-the-art CT scanners for scientific research. Because these scanners are built for very different purposes they differ considerably in their physical implementations. However, they all share common principle functionality. In this context a generic software platform was developed using LabVIEW® in order to provide the same interface and functionality on all scanners. This article describes the concept and features of this software, and its potential for tomography in a research setting. The core concept is to rigorously separate the abstract operation of a CT scanner from its actual physical configuration. This separation is achieved by implementing a sender-listener architecture. The advantages are that the resulting software platform is generic, scalable, highly efficient, easy to develop and to extend, and that it can be deployed on future scanners with minimal effort.

  7. Early Site Permit Demonstration Program: Plant parameters envelope report

    International Nuclear Information System (INIS)

    1993-03-01

    The Early Site Permit (ESP) Demonstration Program is the nuclear industry's initiative for piloting the early resolution of siting-related issues before the detailed design proceedings of the combined operating license review. The ESP Demonstration Program consists of three phases. The plant parameters envelopes task is part of Phase 1, which addresses the generic review of applicable federal regulations and develops criteria for safety and environmental assessment of potential sites. The plant parameters envelopes identify parameters that characterize the interface between an ALWR design and a potential site, and quantify the interface through values selected from the Utility Requirements Documents, vendor design information, or engineering assessments. When augmented with site-specific information, the plant parameters envelopes provide sufficient information to allow ESPs to be granted based on individual ALWR design information or enveloping design information for the evolutionary, passive, or generic ALWR plants. This document is expected to become a living document when used by future applicants

  8. State-space approach for evaluating the soil-plant-atmosphere system

    International Nuclear Information System (INIS)

    Timm, L.C.; Reichardt, K.; Cassaro, F.A.M.; Tominaga, T.T.; Bacchi, O.O.S.; Oliveira, J.C.M.; Dourado-Neto, D.

    2004-01-01

    Using as examples one sugarcane and one forage oat experiment, both carried out in the State of Sao Paulo, Brazil, this chapter presents recent state-space approaches used to evaluate the relation between soil and plant properties. A contrast is made between classical statistics methodologies that do not take into account the sampling position coordinates, and the more recently used methodologies which include the position coordinates, and allow a better interpretation of the field-sampled data. Classical concepts are first introduced, followed by spatially referenced methodologies like the autocorrelation function, the cross correlation function, and the state-space approach. Two variations of the state-space approach are given: one emphasizes the evolution of the state system while the other based on the bayesian formulation emphasizes the evolution of the estimated observations. It is concluded that these state-space analyses using dynamic regression models improve data analyses and are therefore recommended for analyzing time and space data series related to the performance of a given soil-plant-atmosphere system. (author)

  9. A generic double-curvature piezoelectric shell energy harvester: Linear/nonlinear theory and applications

    Science.gov (United States)

    Zhang, X. F.; Hu, S. D.; Tzou, H. S.

    2014-12-01

    Converting vibration energy to useful electric energy has attracted much attention in recent years. Based on the electromechanical coupling of piezoelectricity, distributed piezoelectric zero-curvature type (e.g., beams and plates) energy harvesters have been proposed and evaluated. The objective of this study is to develop a generic linear and nonlinear piezoelectric shell energy harvesting theory based on a double-curvature shell. The generic piezoelectric shell energy harvester consists of an elastic double-curvature shell and piezoelectric patches laminated on its surface(s). With a current model in the closed-circuit condition, output voltages and energies across a resistive load are evaluated when the shell is subjected to harmonic excitations. Steady-state voltage and power outputs across the resistive load are calculated at resonance for each shell mode. The piezoelectric shell energy harvesting mechanism can be simplified to shell (e.g., cylindrical, conical, spherical, paraboloidal, etc.) and non-shell (beam, plate, ring, arch, etc.) distributed harvesters using two Lamé parameters and two curvature radii of the selected harvester geometry. To demonstrate the utility and simplification procedures, the generic linear/nonlinear shell energy harvester mechanism is simplified to three specific structures, i.e., a cantilever beam case, a circular ring case and a conical shell case. Results show the versatility of the generic linear/nonlinear shell energy harvesting mechanism and the validity of the simplification procedures.

  10. 17 CFR 230.135a - Generic advertising.

    Science.gov (United States)

    2010-04-01

    ... 17 Commodity and Securities Exchanges 2 2010-04-01 2010-04-01 false Generic advertising. 230.135a Section 230.135a Commodity and Securities Exchanges SECURITIES AND EXCHANGE COMMISSION GENERAL RULES AND REGULATIONS, SECURITIES ACT OF 1933 General § 230.135a Generic advertising. (a) For the purposes only of...

  11. 78 FR 59911 - Generic Information Collection for Land Management Planning

    Science.gov (United States)

    2013-09-30

    ... DEPARTMENT OF AGRICULTURE Forest Service Generic Information Collection for Land Management... organizations on the proposed information collection, Generic Information Collection for Land Management... related to forest management. The intent of this generic information collection request (ICR) is to...

  12. High-resolution solution-state NMR of unfractionated plant cell walls

    Science.gov (United States)

    John Ralph; Fachuang Lu; Hoon Kim; Dino Ress; Daniel J. Yelle; Kenneth E. Hammel; Sally A. Ralph; Bernadette Nanayakkara; Armin Wagner; Takuya Akiyama; Paul F. Schatz; Shawn D. Mansfield; Noritsugu Terashima; Wout Boerjan; Bjorn Sundberg; Mattias Hedenstrom

    2009-01-01

    Detailed structural studies on the plant cell wall have traditionally been difficult. NMR is one of the preeminent structural tools, but obtaining high-resolution solution-state spectra has typically required fractionation and isolation of components of interest. With recent methods for dissolution of, admittedly, finely divided plant cell wall material, the wall can...

  13. Generic substitution: micro evidence from register data in Norway.

    Science.gov (United States)

    Dalen, Dag Morten; Furu, Kari; Locatelli, Marilena; Strøm, Steinar

    2011-02-01

    The importance of prices, doctor and patient characteristics, and market institutions for the likelihood of choosing generic drugs instead of the more expensive original brand-name version are examined. Using an extensive dataset extracted from The Norwegian Prescription Database containing all prescriptions dispensed to individuals in February 2004 and 2006 on 23 different drugs (chemical substances) in Norway, we find strong evidence for the importance of both doctor and patient characteristics for the choice probabilities. The price difference between brand and generic versions and insurance coverage both affect generic substitution. Moreover, controlling for the retail chain affiliation of the dispensing pharmacy, we find that pharmacies play an important role in promoting generic substitution. In markets with more recent entry of generic drugs, brand-name loyalty proves to be much stronger, giving less explanatory power to our demand model.

  14. A cross-sectional survey of pharmacists to understand their personal preference of brand and generic over-the-counter medications used to treat common health conditions.

    Science.gov (United States)

    Patel, Mira; Slack, Marion; Cooley, Janet; Bhattacharjee, Sandipan

    2016-01-01

    Consumers are hesitant in choosing generic medications as they are under the assumption that they are not as safe nor effective as brand medications. However, pharmacists do have the education and training to know that this is not the case. The aim of this study was to determine pharmacists' preference of generic versus brand over-the-counter (OTC) medication for their personal use as self-treatment for various health symptoms. A prospective, cross sectional study was conducted on 553 licensed pharmacists who were presumed to have expertise in the use of generic and brand name OTC medications. In a single Southwestern state in the United States, from December 2014 to January 2015, a web-based questionnaire was sent to pharmacists to explore their preference of brand and generic medications based on various health symptoms. Thirty-one brand-generic medication pairs were used to identify which medication type pharmacists preferred when asked about nine health symptoms. Frequency counts of pharmacists' preference of a brand medication or a generic OTC medication overall and for each of the nine health symptoms were determined. Chi-squared analyses and one-way ANOVA were conducted to determine if there were any differences between the preferences of brand and generic OTC medications across each symptom. The study overall showed that pharmacists preferred generic OTC medications to brand OTC medications (62 to 5 %, respectively). Based on an 11-point rating scale, pharmacists were likely to take OTC generic medications (as their choice of self-treatment) when presented with health symptoms (mean = 7.32 ± 2.88). In addition, pharmacists chose generic OTC medications over brand medications regardless of health symptoms (p brand name OTC medications for self-treating a variety of health symptoms. These study findings support the theory that expertise affects preference for generic versus brand name OTC medications. This information can be used to provide

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

    Directory of Open Access Journals (Sweden)

    Patel Aarti

    2012-09-01

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

  16. Generic drug policy in Australia: a community pharmacy perspective

    Science.gov (United States)

    Beecroft, Grahame

    2007-01-01

    This article provides a commentary, from a community pharmacy perspective, on the policy environment for the pharmacy sector in Australia, with a particular focus on present challenges arising from proposals to achieve substantial PBS cost savings from an anticipated surge of new generic drugs. Some $2 billion of medicines currently on the PBS will come off patent in the next 4 years. This growth comes from a low base where generics currently account for only 15% of the total PBS budget. Remuneration for PBS dispensing is fixed through five year agreements with the government, so trading terms on generics are important for the cross-subsidy of other dispensing activities and professional services. These trading terms (discounts provided by generics suppliers) have become part of the overall cost and revenue structure of pharmacies. Despite these arrangements, generic substitution rates in Australia are lower than in most comparable countries, which the government views as an opportunity to promote generic use. The future of generic drug supply via the PBS is important to allow consumers access to medications at the lowest possible price and to provide space for PBS listing of new and expensive drugs. But considerations of PBS reform need to take account of the role and viability of community pharmacy sector as provider of pharmaceuticals in a timely and efficient manner to Australian residents. PMID:17543112

  17. Seismic margins review of nuclear power plants: Fragility aspects

    International Nuclear Information System (INIS)

    Ravindra, M.K.; Hardy, G.S.; Hashimoto, P.S.

    1987-01-01

    The fragility analysis is utilised in the seismic margin review in initial screening of certain components in the plant based on their generically high seismic capacities. A detailed walkdown of the plant is conducted to confirm that the initial screening is valid i.e., the generically high seismic capacity components do not possess any potential weaknesses (e.g., inadequate bracing, inadequate anchorage and potential systems interaction). For the components that are screened in, their seismic capacities are evaluated using either a probabilistic analysis of a deterministic evaluation. Based on a system analysis, the Boolean expressions for critical accident sequences are derived. These Boolean expressions are quantified using the component fragilities and nonseismic unavailabilities of components. The final product is the High Confidence Low Probability of Failure (HCLPF) capacity of the plant and the identification of potential seismic vulnerabilities in the plant. The objective of the paper is to describe the application of fragility analysis procedures in the seismic margin review of Maine Yankee and to document the insights obtained in this trial plant review. (orig./HP)

  18. Generation and measurement of nonclassical states by quantum Fock filter

    International Nuclear Information System (INIS)

    D'Ariano, G.M.; Maccone, L.; Paris, M.G.A.; Sacchi, M.F.

    1999-01-01

    We study a novel optical setup which selects a specific Fock component from a generic input state. The device allows to synthesize number states and superpositions of few number states, and to measure the photon distribution and the density matrix of a generic signal. (Authors)

  19. Steady-state Manoeuvring of a Generic ASD Tug in Escort Pull and Bow-rope Aided Push Operation

    Directory of Open Access Journals (Sweden)

    Jaroslaw Artyszuk

    2014-09-01

    Full Text Available This paper is devoted to expand the very promising research undertaken in the author's previous work, basically done on simplified modelling the escort push operation. Now, the other two modes of a tug's employment, as stated in the title, are covered. The special focus is again set on the indirect towing in that the towline force is much higher than the thruster force. The ratio of these two forces, referred to as the relative towing force (or amplification ratio is evaluated together with the hull drift angle and the thruster(-s angle for a given escort speed. This mutual relationship is known as the tug performance diagram. Although rather generic (container-type formulas are derived, they are supplied for exemplification purposes with simple, analytically given hull hydrodynamic forces. The aim is also here to provide a basis for further sensitivity analysis of the model and possible improvement/optimisation to the tug design. The obtained charts also could serve as rough and clear guidance for towmasters while escorting.

  20. Time scaling internal state predictive control of a solar plant

    Energy Technology Data Exchange (ETDEWEB)

    Silva, R.N. [DEE-FCT/UNL, Caparica (Portugal); Rato, L.M. [INESC-ID/University, Evora (Portugal); Lemos, J.M. [INESC-ID/IST, Lisboa (Portugal)

    2003-12-01

    The control of a distributed collector solar field is addressed in this work, exploiting the plant's transport characteristic. The plant is modeled by a hyperbolic type partial differential equation (PDE) where the transport speed is the manipulated flow, i.e. the controller output. The model has an external distributed source, which is the solar radiation captured along the collector, approximated to depend only of time. From the solution of the PDE, a linear discrete state space model is obtained by using time-scaling and the redefinition of the control input. This method allows overcoming the dependency of the time constants with the operating point. A model-based predictive adaptive controller is derived with the internal temperature distribution estimated with a state observer. Experimental results at the solar power plant are presented, illustrating the advantages of the approach under consideration. (author)

  1. In-depth evaluations of operating experiences in nuclear power plants. Annual report 2015/2016 (June 2015 - May 2016); Vertiefte Untersuchungen von Betriebserfahrungen aus Kernreaktoren. Jahresbericht 2015/2016 (Juni 2015 - Mai 2016)

    Energy Technology Data Exchange (ETDEWEB)

    Mildenberger, Oliver

    2017-05-15

    A central task of GRS is the continuous evaluation of events in nuclear power plants in Germany and abroad on behalf of BMUB. GRS evaluates all reportable events from German plants as well as safety-relevant events in foreign nuclear power plants. It aims for the extraction of scientific insights and information to extend the knowledge base of GRS. Learning from operating experience is an important element for preserving and improving the safety level of nuclear power plants. Insights obtained from these in-depth evaluations form the scientific bas is for expert statements, information notices or generic reports on behalf of BMUB. This report presents major results of generic in-depth investigations on safety-relevant aspects detected during the screening of operating experience from all available sources in the reporting period. Moreover, the results of additional further works to determine and advance the state of the art in science and technology related to the evaluation of operating experience are summarized: Pilot study on evaluation of U.S. NRC Licensee Event Reports (LER); Update of knowledge base on transients; Extension of CCF checklist with CCF phenomena in valves and big machine components (pumps, emergency diesels, ventilations, heat exchangers and chillers); Generic analysis of events with errors during periodic inspections; Experiences with errors during construction and operation of nuclear concrete buildings; Assessment of results from precursor analyses.

  2. Do higher-priced generic medicines enjoy a competitive advantage under reference pricing?

    Science.gov (United States)

    Puig-Junoy, Jaume

    2012-11-01

    In many countries with generic reference pricing, generic producers and distributors compete by means of undisclosed discounts offered to pharmacies in order to reduce acquisition costs and to induce them to dispense their generic to patients in preference over others. The objective of this article is to test the hypothesis that under prevailing reference pricing systems for generic medicines, those medicines sold at a higher consumer price may enjoy a competitive advantage. Real transaction prices for 179 generic medicines acquired by pharmacies in Spain have been used to calculate the discount rate on acquisition versus reimbursed costs to pharmacies. Two empirical hypotheses are tested: the discount rate at which pharmacies acquire generic medicines is higher for those pharmaceutical presentations for which there are more generic competitors; and, the discount rate at which pharmacies acquire generic medicines is higher for those pharmaceutical forms for which the consumer price has declined less in relation to the consumer price of the brand drug before generic entry (higher-priced generic medicines). An average discount rate of 39.3% on acquisition versus reimbursed costs to pharmacies has been observed. The magnitude of the discount positively depends on the number of competitors in the market. The higher the ratio of the consumer price of the generic to that of the brand drug prior to generic entry (i.e. the smaller the price reduction of the generic in relation to the brand drug), the larger the discount rate. Under reference pricing there is intense price competition among generic firms in the form of unusually high discounts to pharmacies on official ex-factory prices reimbursed to pharmacies. However, this effect is highly distorting because it favours those medicines with a higher relative price in relation to the brand price before generic entry.

  3. State of the science and challenges of breeding landscape plants with ecological function

    Science.gov (United States)

    Wilde, H Dayton; Gandhi, Kamal J K; Colson, Gregory

    2015-01-01

    Exotic plants dominate esthetically-managed landscapes, which cover 30–40 million hectares in the United States alone. Recent ecological studies have found that landscaping with exotic plant species can reduce biodiversity on multiple trophic levels. To support biodiversity in urbanized areas, the increased use of native landscaping plants has been advocated by conservation groups and US federal and state agencies. A major challenge to scaling up the use of native species in landscaping is providing ornamental plants that are both ecologically functional and economically viable. Depending on ecological and economic constraints, accelerated breeding approaches could be applied to ornamental trait development in native plants. This review examines the impact of landscaping choices on biodiversity, the current status of breeding and selection of native ornamental plants, and the interdisciplinary research needed to scale up landscaping plants that can support native biodiversity. PMID:26504560

  4. Comparative effectiveness of generic versus brand-name antiepileptic medications.

    Science.gov (United States)

    Gagne, Joshua J; Kesselheim, Aaron S; Choudhry, Niteesh K; Polinski, Jennifer M; Hutchins, David; Matlin, Olga S; Brennan, Troyen A; Avorn, Jerry; Shrank, William H

    2015-11-01

    The objective of this study was to compare treatment persistence and rates of seizure-related events in patients who initiate antiepileptic drug (AED) therapy with a generic versus a brand-name product. We used linked electronic medical and pharmacy claims data to identify Medicare beneficiaries who initiated one of five AEDs (clonazepam, gabapentin, oxcarbazepine, phenytoin, zonisamide). We matched initiators of generic versus brand-name versions of these drugs using a propensity score that accounted for demographic, clinical, and health service utilization variables. We used a Cox proportional hazards model to compare rates of seizure-related emergency room (ER) visit or hospitalization (primary outcome) and ER visit for bone fracture or head injury (secondary outcome) between the matched generic and brand-name initiators. We also compared treatment persistence, measured as time to first 14-day treatment gap, between generic and brand-name initiators. We identified 19,760 AED initiators who met study eligibility criteria; 18,306 (93%) initiated a generic AED. In the matched cohort, we observed 47 seizure-related hospitalizations and ER visits among brand-name initiators and 31 events among generic initiators, corresponding to a hazard ratio of 0.53 (95% confidence interval, 0.30 to 0.96). Similar results were observed for the secondary clinical endpoint and across sensitivity analyses. Mean time to first treatment gap was 124.2 days (standard deviation [sd], 125.8) for brand-name initiators and 137.9 (sd, 148.6) for generic initiators. Patients who initiated generic AEDs had fewer adverse seizure-related clinical outcomes and longer continuous treatment periods before experiencing a gap than those who initiated brand-name versions. Copyright © 2015 Elsevier Inc. All rights reserved.

  5. Full State Feedback Control for Virtual Power Plants

    Energy Technology Data Exchange (ETDEWEB)

    Johnson, Jay Tillay [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States)

    2017-09-01

    This report presents an object-oriented implementation of full state feedback control for virtual power plants (VPP). The components of the VPP full state feedback control are (1) objectoriented high-fidelity modeling for all devices in the VPP; (2) Distribution System Distributed Quasi-Dynamic State Estimation (DS-DQSE) that enables full observability of the VPP by augmenting actual measurements with virtual, derived and pseudo measurements and performing the Quasi-Dynamic State Estimation (QSE) in a distributed manner, and (3) automated formulation of the Optimal Power Flow (OPF) in real time using the output of the DS-DQSE, and solving the distributed OPF to provide the optimal control commands to the DERs of the VPP.

  6. Applications of ASTEC integral code on a generic CANDU 6

    Energy Technology Data Exchange (ETDEWEB)

    Radu, Gabriela, E-mail: gabriela.radu@nuclear.ro [Institute for Nuclear Research, Campului 1, 115400 Mioveni, Arges (Romania); Prisecaru, Ilie [Power Engineering Department, University “Politehnica” of Bucharest, 313 Splaiul Independentei, Bucharest (Romania)

    2015-05-15

    Highlights: • Short overview of the models included in the ASTEC MCCI module. • MEDICIS/CPA coupled calculations for a generic CANDU6 reactor. • Two cases taking into account different pool/concrete interface models. - Abstract: In case of a hypothetical severe accident in a nuclear power plant, the corium consisting of the molten reactor core and internal structures may flow onto the concrete floor of containment building. This would cause an interaction between the molten corium and the concrete (MCCI), in which the heat transfer from the hot melt to the concrete would cause the decomposition and the ablation of the concrete. The potential hazard of this interaction is the loss of integrity of the containment building and the release of fission products into the environment due to the possibility of a concrete foundation melt-through or containment over-pressurization by the gases produced from the decomposition of the concrete or by the inflammation of combustible gases. In the safety assessment of nuclear power plants, it is necessary to know the consequences of such a phenomenon. The paper presents an example of application of the ASTECv2 code to a generic CANDU6 reactor. This concerns the thermal-hydraulic behaviour of the containment during molten core–concrete interaction in the reactor vault. The calculations were carried out with the help of the MEDICIS MCCI module and the CPA containment module of ASTEC code coupled through a specific prediction–correction method, which consists in describing the heat exchanges with the vault walls and partially absorbent gases. Moreover, the heat conduction inside the vault walls is described. Two cases are presented in this paper taking into account two different heat transfer models at the pool/concrete interface and siliceous concrete. The corium pool configuration corresponds to a homogeneous configuration with a detailed description of the upper crust.

  7. What do people really think of generic medicines? A systematic review and critical appraisal of literature on stakeholder perceptions of generic drugs.

    LENUS (Irish Health Repository)

    Dunne, Suzanne S

    2015-07-01

    Considerable emphasis is presently being placed on usage of generic medicines by governments focussed on the potential economic benefits associated with their use. Concurrently, there is increasing discussion in the lay media of perceived doubts regarding the quality and equivalence of generic medicines. The objective of this paper is to report the outcomes of a systematic search for peer-reviewed, published studies that focus on physician, pharmacist and patient\\/consumer perspectives of generic medicines.

  8. How Abbott’s Fenofibrate Franchise Avoided Generic Competition

    Science.gov (United States)

    Downing, Nicholas S.; Ross, Joseph S.; Jackevicius, Cynthia A.; Krumholz, Harlan M.

    2013-01-01

    The ongoing debate concerning the efficacy of fenofibrate has overshadowed an important aspect of the drug’s history: Abbott, the maker of branded fenofibrate, has produced several bioequivalent reformulations, which dominate the market even though generic fenofibrate has been available for almost a decade. This continued use of branded formulations, which cost twice as much as generic versions of fenofibrate, imposes an annual cost of approximately $700 million on our healthcare system. Abbott maintained its dominance of the fenofibrate market, in part, through a complex switching strategy involving the sequential launch of branded reformulations that had not been shown to be superior to the first generation product and patent litigation that delayed the approval of generic formulations. The small differences in dose of the newer branded formulations prevented substitution with generics of older generation products. As soon as direct generic competition seemed likely at the new dose level where substitution would be allowed, Abbott would launch another reformulation and the cycle would repeat. Our objective, using the fenofibrate example, is to describe how current policy can allow pharmaceutical companies to maintain market share using reformulations of branded medications without demonstrating the superiority of next generation products. PMID:22493409

  9. Final generic environmental impact statement on decommissioning of nuclear facilities

    International Nuclear Information System (INIS)

    1988-08-01

    This final generic environmental impact statement was prepared as part of the requirement for considering changes in regulations on decommissioning of commercial nuclear facilities. Consideration is given to the decommissioning of pressurized water reactors, boiling water reactors, research and test reactors, fuel reprocessing plants (FRPs) (currently, use of FRPs in the commercial sector is not being considered), small mixed oxide fuel fabrication plants, uranium hexafluoride conversion plants, uranium fuel fabrication plants, independent spent fuel storage installations, and non-fuel-cycle facilities for handling byproduct, source and special nuclear materials. Decommissioning has many positive environmental impacts such as the return of possibly valuable land to the public domain and the elimination of potential problems associated with increased numbers of radioactively contaminated facilities with a minimal use of resources. Major adverse impacts are shown to be routine occupational radiation doses and the commitment of nominally small amounts of land to radioactive waste disposal. Other impacts, including public radiation doses, are minor. Mitigation of potential health, safety, and environmental impacts requires more specific and detailed regulatory guidance than is currently available. Recommendations are made as to regulatory decommissioning particulars including such aspects as decommissioning alternatives, appropriate preliminary planning requirements at the time of commissioning, final planning requirements prior to termination of facility operations, assurance of funding for decommissioning, environmental review requirements. 26 refs., 7 figs., 68 tabs

  10. Quantum process estimation via generic two-body correlations

    International Nuclear Information System (INIS)

    Mohseni, M.; Rezakhani, A. T.; Barreiro, J. T.; Kwiat, P. G.; Aspuru-Guzik, A.

    2010-01-01

    Performance of quantum process estimation is naturally limited by fundamental, random, and systematic imperfections of preparations and measurements. These imperfections may lead to considerable errors in the process reconstruction because standard data-analysis techniques usually presume ideal devices. Here, by utilizing generic auxiliary quantum or classical correlations, we provide a framework for the estimation of quantum dynamics via a single measurement apparatus. By construction, this approach can be applied to quantum tomography schemes with calibrated faulty-state generators and analyzers. Specifically, we present a generalization of the work begun by M. Mohseni and D. A. Lidar [Phys. Rev. Lett. 97, 170501 (2006)] with an imperfect Bell-state analyzer. We demonstrate that for several physically relevant noisy preparations and measurements, classical correlations and a small data-processing overhead suffice to accomplish the full system identification. Furthermore, we provide the optimal input states whereby the error amplification due to inversion of the measurement data is minimal.

  11. Plant analyzer development for high-speed interactive simulation of BWR plant transients

    International Nuclear Information System (INIS)

    Wulff, W.; Cheng, H.S.; Mallen, A.N.

    1986-01-01

    Advanced modeling techniques have been combined with modern, special-purpose peripheral minicomputer technology to develop a plant analyzer which provides realistic and accurate predictions of plant transients and severe off-normal events in nuclear power plants through on-line simulations at speeds of approximately 10 times faster than actual process speeds. The new simulation technology serves not only for carrying out routinely and efficiently safety analyses, optimizations of emergency procedures and design changes, parametric studies for obtaining safety margins and for generic training but also for assisting plant operations. Five modeling principles are presented which serve to achieve high-speed simulation of neutron kinetics, thermal conduction, nonhomogeneous and nonequilibrium two-phase flow coolant dynamics, steam line acoustical effects, and the dynamics of the balance of plant and containment systems, control systems and plant protection systems. 21 refs

  12. Nuclear power plant decommissioning: state-of-the-art review

    International Nuclear Information System (INIS)

    Williams, D.H.

    1984-01-01

    A brief orientation to the state-of-the-art of nuclear power plant decommissioning discusses the related areas of experience, tools and techniques, and planning. There have been 68 nuclear reactor decommissionings to date, including 9 power plants, some of which were mothballed. The picture suggests that the term art may be misapplied since decommissioning is now more of a mature commercial industrial than a research and development endeavor. It also suggests that the nuclear industry has shown foresight by preparing for it before a crisis situation developed. Some of this has already influenced operators of coal power plants, especially where hazardous materials may be involved. 33 references, 1 table

  13. Generic Reed Solomon Encorder

    Directory of Open Access Journals (Sweden)

    Petrus Mursanto

    2006-11-01

    Full Text Available Reed Solomon (RS codes is a mechanism to detect and correct burst of errors in data transmission and storage systems. It provides a solid introduction to foundation mathematical concept of Galois Field algebra and its application. With the development of digital hardware technology, the RS concepts were brought into reality, i.e. the implementation of RS codec chips. This paper presents the development steps of a generic RS encoder using VHDL. The encoder is able to handle generic width of data, variable length of information, number of error as well as variable form of primitive polynomial and generator polynomial used in the system. The design has been implemented for FPGA chip Xilinx XC3S200-5FT256 and has a better performance than commercially available equivalent encoder.

  14. [Generic drugs and the consumption trends of antihypertensives in Morocco].

    Science.gov (United States)

    Berrada El Azizi, Ghizlane; Ahid, Samir; Ghanname, Imane; Ghannam, Imane; Belaiche, Abdelmajid; Hassar, Mohammed; Cherrah, Yahia

    2013-01-01

    To evaluate the evolution of consumption of antihypertensive drugs generic among 1991-2010, to assess the impacts after the institution of Mandatory Health Insurance and the marketing of generic drugs. We used sales data from the Moroccan subsidiary of IMS Health Intercontinental Marketing Service. Consumption of generic antihypertensive drugs increased from 0.08 to 10.65 DDD/1 000 inhabitants/day between 1991 and 2010. In 2010, generic of the calcium channel blockers (CCBs) represented 4.08 DDD/1 000 inhabitants/day (82.09%), followed by angiotensin converting enzyme inhibitors (ACEI) by 2.40 DDD/1 000 inhabitants/day (48.29%). The generics market of CCBs is the most dominant and represented in 2010, 79.21% in volume and 62.58% in value. In developing countries like Morocco, the generic drug is a key element for access to treatment especially for the poor population. © 2013 Société Française de Pharmacologie et de Thérapeutique.

  15. Steady-State Plant Model to Predict Hydroden Levels in Power Plant Components

    Energy Technology Data Exchange (ETDEWEB)

    Glatzmaier, Greg C.; Cable, Robert; Newmarker, Marc

    2017-06-27

    The National Renewable Energy Laboratory (NREL) and Acciona Energy North America developed a full-plant steady-state computational model that estimates levels of hydrogen in parabolic trough power plant components. The model estimated dissolved hydrogen concentrations in the circulating heat transfer fluid (HTF), and corresponding partial pressures within each component. Additionally for collector field receivers, the model estimated hydrogen pressure in the receiver annuli. The model was developed to estimate long-term equilibrium hydrogen levels in power plant components, and to predict the benefit of hydrogen mitigation strategies for commercial power plants. Specifically, the model predicted reductions in hydrogen levels within the circulating HTF that result from purging hydrogen from the power plant expansion tanks at a specified target rate. Our model predicted hydrogen partial pressures from 8.3 mbar to 9.6 mbar in the power plant components when no mitigation treatment was employed at the expansion tanks. Hydrogen pressures in the receiver annuli were 8.3 to 8.4 mbar. When hydrogen partial pressure was reduced to 0.001 mbar in the expansion tanks, hydrogen pressures in the receiver annuli fell to a range of 0.001 mbar to 0.02 mbar. When hydrogen partial pressure was reduced to 0.3 mbar in the expansion tanks, hydrogen pressures in the receiver annuli fell to a range of 0.25 mbar to 0.28 mbar. Our results show that controlling hydrogen partial pressure in the expansion tanks allows us to reduce and maintain hydrogen pressures in the receiver annuli to any practical level.

  16. [Analysis of generic drug supply in France].

    Science.gov (United States)

    Taboulet, F; Haramburu, F; Latry, Ph

    2003-09-01

    The list of generic medicines (LGM), published since 1997 by the Agence Française de Sécurité Sanitaire des Produits de Santé (AFFSSaPS), the French Medicine Agency, concerns a special part of the medicines reimbursed by the National Health Insurance (Social Security). The objectives of the present study were: i) to describe the components of this list, based on pharmaceutical, economical and therapeutic characteristics, ii) to study differences between generic and reference products (formulations, excipients, prices, etc.), iii) to analyze information on excipients provided to health care professionals. The 21st version of the LGM (April 2001) was used. Therapeutic value was retrieved from the 2001 AFSSaPS report on the therapeutic value of 4490 reimbursed medicines. Information on excipients in the LGM and the Vidal dictionary (reference prescription book in France) was compared. The products included in the LGM represent 20% of all reimbursed medicines. The mean price differences between generics and their reference products vary between 30 and 50% for more than two thirds of the generic groups. The therapeutic value of the products of the LGM was judged important in 71% of cases (vs 63% for the 4409 assessed medicines) and insufficient in 13% of cases (vs 19%). Information on excipients is often missing and sometimes erroneous. Although the LGM is regularly revised and thus the generic market in perpetual change, the 2001 cross description of this pharmaceutical market provides much informations and raises some concern.

  17. Evaluation of generic and branded herbicides : technical report.

    Science.gov (United States)

    2015-03-01

    As with other generic brand products in the marketplace, generic herbicides often have a lower initial product cost than : their brand-name counterparts. While the purchase price of herbicides is important to TxDOT, it is essential to look at : more ...

  18. Robustness in Regulatory Interaction Networks. A Generic Approach with Applications at Different Levels: Physiologic, Metabolic and Genetic

    Science.gov (United States)

    Demongeot, Jacques; Ben Amor, Hedi; Elena, Adrien; Gillois, Pierre; Noual, Mathilde; Sené, Sylvain

    2009-01-01

    Regulatory interaction networks are often studied on their dynamical side (existence of attractors, study of their stability). We focus here also on their robustness, that is their ability to offer the same spatiotemporal patterns and to resist to external perturbations such as losses of nodes or edges in the networks interactions architecture, changes in their environmental boundary conditions as well as changes in the update schedule (or updating mode) of the states of their elements (e.g., if these elements are genes, their synchronous coexpression mode versus their sequential expression). We define the generic notions of boundary, core, and critical vertex or edge of the underlying interaction graph of the regulatory network, whose disappearance causes dramatic changes in the number and nature of attractors (e.g., passage from a bistable behaviour to a unique periodic regime) or in the range of their basins of stability. The dynamic transition of states will be presented in the framework of threshold Boolean automata rules. A panorama of applications at different levels will be given: brain and plant morphogenesis, bulbar cardio-respiratory regulation, glycolytic/oxidative metabolic coupling, and eventually cell cycle and feather morphogenesis genetic control. PMID:20057955

  19. Robustness in Regulatory Interaction Networks. A Generic Approach with Applications at Different Levels: Physiologic, Metabolic and Genetic

    Directory of Open Access Journals (Sweden)

    Sylvain Sené

    2009-10-01

    Full Text Available Regulatory interaction networks are often studied on their dynamical side (existence of attractors, study of their stability. We focus here also on their robustness, that is their ability to offer the same spatiotemporal patterns and to resist to external perturbations such as losses of nodes or edges in the networks interactions architecture, changes in their environmental boundary conditions as well as changes in the update schedule (or updating mode of the states of their elements (e.g., if these elements are genes, their synchronous coexpression mode versus their sequential expression. We define the generic notions of boundary, core, and critical vertex or edge of the underlying interaction graph of the regulatory network, whose disappearance causes dramatic changes in the number and nature of attractors (e.g., passage from a bistable behaviour to a unique periodic regime or in the range of their basins of stability. The dynamic transition of states will be presented in the framework of threshold Boolean automata rules. A panorama of applications at different levels will be given: brain and plant morphogenesis, bulbar cardio-respiratory regulation, glycolytic/oxidative metabolic coupling, and eventually cell cycle and feather morphogenesis genetic control.

  20. Examining patterns in medication documentation of trade and generic names in an academic family practice training centre.

    Science.gov (United States)

    Summers, Alexander; Ruderman, Carly; Leung, Fok-Han; Slater, Morgan

    2017-09-22

    Studies in the United States have shown that physicians commonly use brand names when documenting medications in an outpatient setting. However, the prevalence of prescribing and documenting brand name medication has not been assessed in a clinical teaching environment. The purpose of this study was to describe the use of generic versus brand names for a select number of pharmaceutical products in clinical documentation in a large, urban academic family practice centre. A retrospective chart review of the electronic medical records of the St. Michael's Hospital Academic Family Health Team (SMHAFHT). Data for twenty commonly prescribed medications were collected from the Cumulative Patient Profile as of August 1, 2014. Each medication name was classified as generic or trade. Associations between documentation patterns and physician characteristics were assessed. Among 9763 patients prescribed any of the twenty medications of interest, 45% of patient charts contained trade nomenclature exclusively. 32% of charts contained only generic nomenclature, and 23% contained a mix of generic and trade nomenclature. There was large variation in use of generic nomenclature amongst physicians, ranging from 19% to 93%. Trade names in clinical documentation, which likely reflect prescribing habits, continue to be used abundantly in the academic setting. This may become part of the informal curriculum, potentially facilitating undue bias in trainees. Further study is needed to determine characteristics which influence use of generic or trade nomenclature and the impact of this trend on trainees' clinical knowledge and decision-making.

  1. Generic demonstration plant study (A/E package)

    International Nuclear Information System (INIS)

    Molzen, D.F.

    1979-01-01

    Molzen--Corbin and Associates, Albuquerque, New Mexico, under contract to Sandia Laboratories, has prepared preliminary drawings, descriptive material and a scale model of the demonstration plant. This information will be made available to A/E firms to assist them in the preparation of proposals for complete construction plans and specifications. The four categories for which preliminary work has been prepared consist of structural work, mechanical work, electrical work, and cost estimates. In addition, preliminary specifications, including a written description of the facility consisting of mechanical electrical systems and operations, a description of the safety features, the basic design criteria, three-dimensional sketches, and a scale model of the design have been prepared. The preliminary drawings indicate the required minimum wall thicknesses, overall dimensions and the necessary layout of the removable concrete blocks and slabs required for radiation protection and control

  2. Extension algorithm for generic low-voltage networks

    Science.gov (United States)

    Marwitz, S.; Olk, C.

    2018-02-01

    Distributed energy resources (DERs) are increasingly penetrating the energy system which is driven by climate and sustainability goals. These technologies are mostly connected to low- voltage electrical networks and change the demand and supply situation in these networks. This can cause critical network states. Network topologies vary significantly and depend on several conditions including geography, historical development, network design or number of network connections. In the past, only some of these aspects were taken into account when estimating the network investment needs for Germany on the low-voltage level. Typically, fixed network topologies are examined or a Monte Carlo approach is used to quantify the investment needs at this voltage level. Recent research has revealed that DERs differ substantially between rural, suburban and urban regions. The low-voltage network topologies have different design concepts in these regions, so that different network topologies have to be considered when assessing the need for network extensions and investments due to DERs. An extension algorithm is needed to calculate network extensions and investment needs for the different typologies of generic low-voltage networks. We therefore present a new algorithm, which is capable of calculating the extension for generic low-voltage networks of any given topology based on voltage range deviations and thermal overloads. The algorithm requires information about line and cable lengths, their topology and the network state only. We test the algorithm on a radial, a loop, and a heavily meshed network. Here we show that the algorithm functions for electrical networks with these topologies. We found that the algorithm is able to extend different networks efficiently by placing cables between network nodes. The main value of the algorithm is that it does not require any information about routes for additional cables or positions for additional substations when it comes to estimating

  3. Automated analysis in generic groups

    Science.gov (United States)

    Fagerholm, Edvard

    This thesis studies automated methods for analyzing hardness assumptions in generic group models, following ideas of symbolic cryptography. We define a broad class of generic and symbolic group models for different settings---symmetric or asymmetric (leveled) k-linear groups --- and prove ''computational soundness'' theorems for the symbolic models. Based on this result, we formulate a master theorem that relates the hardness of an assumption to solving problems in polynomial algebra. We systematically analyze these problems identifying different classes of assumptions and obtain decidability and undecidability results. Then, we develop automated procedures for verifying the conditions of our master theorems, and thus the validity of hardness assumptions in generic group models. The concrete outcome is an automated tool, the Generic Group Analyzer, which takes as input the statement of an assumption, and outputs either a proof of its generic hardness or shows an algebraic attack against the assumption. Structure-preserving signatures are signature schemes defined over bilinear groups in which messages, public keys and signatures are group elements, and the verification algorithm consists of evaluating ''pairing-product equations''. Recent work on structure-preserving signatures studies optimality of these schemes in terms of the number of group elements needed in the verification key and the signature, and the number of pairing-product equations in the verification algorithm. While the size of keys and signatures is crucial for many applications, another aspect of performance is the time it takes to verify a signature. The most expensive operation during verification is the computation of pairings. However, the concrete number of pairings is not captured by the number of pairing-product equations considered in earlier work. We consider the question of what is the minimal number of pairing computations needed to verify structure-preserving signatures. We build an

  4. Generation and utilization of knowledge concerning state change propagation using plant design information

    International Nuclear Information System (INIS)

    Nishizawa, Yasuo; Nagaoka, Yukio; Sato, Takao; Matsuki, Tsutomu.

    1992-01-01

    A method of knowledge generation and utilization using design information is described. This method is used to generate rules concerned with propagation of state change in a plant due to equipment manipulation or anomaly. The rules describe macroscopic behavior of plant subsystems consisting of many devices, and are used for high speed information processing in expert systems for plant diagnosis, maintenance, etc. Knowledge generation is comprised of two steps. In the first step, the changes of state values are propagated according to connectivity between devices and the input-output relationships of the devices. In the second step, the input change, output change of plant subsystems, and other information are edited according to the results of state change propagation, and rules for state change propagation are generated. By using these rules, the simulation of state change propagation can be accelerated about 10 times compared with the case of device level propagation. The method of knowledge generation has been applied to the inference system in a maintenance work scheduling system and a new-type expert system was realized. It grows by generating rules for problem solving and by expanding its knowledge base by itself. (author)

  5. Impact of alternative interventions on changes in generic dispensing rates.

    Science.gov (United States)

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

    2006-10-01

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

  6. A survey of plants used for family planning in Bayelsa State, southern Nigeria

    Directory of Open Access Journals (Sweden)

    Gideon Alade

    2018-03-01

    Full Text Available Plants with both male and female antifertility potential were surveyed in Bayelsa state of Nigeria. A total of 35 medicinal plant species representing 33 genera and 26 families were employed by the traditional birth attendants and elders for contraception, labour induction and abortion among the people of Bayelsa State, Nigeria. Among these, only three plant species were mentioned for male contraception purpose. A few animal inclusion was also documented. [J Complement Med Res 2018; 7(1.000: 25-44

  7. A prioritization of generic safety issues. Supplement 21, Revision insertion instructions

    Energy Technology Data Exchange (ETDEWEB)

    None, None

    1996-12-31

    The report presents the safety priority ranking for generic safety issues related to nuclear power plants. The purpose of these rankings is to assist in the timely and efficient allocation of NRC resources for the resolution of those safety issues that have a significant potential for reducing risk. The safety priority rankings are HIGH, MEDIUM, LOW, and DROP, and have been assigned on the basis of risk significance estimates, the ratio of risk to costs and other impacts estimated to result if resolution of the safety issues were implemented, and the consideration of uncertainties and other quantitative or qualitative factors. To the extent practical, estimates are quantitative.

  8. A prioritization of generic safety issues. Supplement 21, Revision insertion instructions

    International Nuclear Information System (INIS)

    1996-01-01

    The report presents the safety priority ranking for generic safety issues related to nuclear power plants. The purpose of these rankings is to assist in the timely and efficient allocation of NRC resources for the resolution of those safety issues that have a significant potential for reducing risk. The safety priority rankings are HIGH, MEDIUM, LOW, and DROP, and have been assigned on the basis of risk significance estimates, the ratio of risk to costs and other impacts estimated to result if resolution of the safety issues were implemented, and the consideration of uncertainties and other quantitative or qualitative factors. To the extent practical, estimates are quantitative.

  9. Cost-effectiveness of Tyrosine Kinase Inhibitor Treatment Strategies for Chronic Myeloid Leukemia in Chronic Phase After Generic Entry of Imatinib in the United States.

    Science.gov (United States)

    Padula, William V; Larson, Richard A; Dusetzina, Stacie B; Apperley, Jane F; Hehlmann, Rudiger; Baccarani, Michele; Eigendorff, Ekkehard; Guilhot, Joelle; Guilhot, Francois; Hehlmann, Rudiger; Mahon, Francois-Xavier; Martinelli, Giovanni; Mayer, Jiri; Müller, Martin C; Niederwieser, Dietger; Saussele, Susanne; Schiffer, Charles A; Silver, Richard T; Simonsson, Bengt; Conti, Rena M

    2016-07-01

    We analyzed the cost-effectiveness of treating incident chronic myeloid leukemia in chronic phase (CML-CP) with generic imatinib when it becomes available in United States in 2016. In the year following generic entry, imatinib's price is expected to drop 70% to 90%. We hypothesized that initiating treatment with generic imatinib in these patients and then switching to the other tyrosine-kinase inhibitors (TKIs), dasatinib or nilotinib, because of intolerance or lack of effectiveness ("imatinib-first") would be cost-effective compared with the current standard of care: "physicians' choice" of initiating treatment with any one of the three TKIs. We constructed Markov models to compare the five-year cost-effectiveness of imatinib-first vs physician's choice from a US commercial payer perspective, assuming 3% annual discounting ($US 2013). The models' clinical endpoint was five-year overall survival taken from a systematic review of clinical trial results. Per-person spending on incident CML-CP treatment overall care components was estimated using Truven's MarketScan claims data. The main outcome of the models was cost per quality-adjusted life-year (QALY). We interpreted outcomes based on a willingness-to-pay threshold of $100 000/QALY. A panel of European LeukemiaNet experts oversaw the study's conduct. Both strategies met the threshold. Imatinib-first ($277 401, 3.87 QALYs) offered patients a 0.10 decrement in QALYs at a savings of $88 343 over five years to payers compared with physician's choice ($365 744, 3.97 QALYs). The imatinib-first incremental cost-effectiveness ratio was approximately $883 730/QALY. The results were robust to multiple sensitivity analyses. When imatinib loses patent protection and its price declines, its use will be the cost-effective initial treatment strategy for CML-CP. © The Author 2016. Published by Oxford University Press.

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

    Science.gov (United States)

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

    2017-04-01

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

  11. Methodology and application of surrogate plant PRA analysis to the Rancho Seco Power Plant: Final report

    International Nuclear Information System (INIS)

    Gore, B.F.; Huenefeld, J.C.

    1987-07-01

    This report presents the development and the first application of generic probabilistic risk assessment (PRA) information for identifying systems and components important to public risk at nuclear power plants lacking plant-specific PRAs. A methodology is presented for using the results of PRAs for similar (surrogate) plants, along with plant-specific information about the plant of interest and the surrogate plants, to infer important failure modes for systems of the plant of interest. This methodology, and the rationale on which it is based, is presented in the context of its application to the Rancho Seco plant. The Rancho Seco plant has been analyzed using PRA information from two surrogate plants. This analysis has been used to guide development of considerable plant-specific information about Rancho Seco systems and components important to minimizing public risk, which is also presented herein

  12. Wind Plant Models in IEC 61400-27-2 and WECC - latest developments in international standards on wind turbine and wind plant modeling

    DEFF Research Database (Denmark)

    Fortmann, Jens; Miller, Nicholas; Kazachkov, Yuri

    2015-01-01

    This paper describes the latest developments in the standardization of wind plant and wind plant controller models. As a first step IEC TC88 WG 27 and WECC jointly developed generic wind turbine models which have been published by WECC in 2014 and IEC in 2015 as IEC 61400-27-1, which also include...

  13. State-of-the-art of large scale biogas plants

    International Nuclear Information System (INIS)

    Prisum, J.M.; Noergaard, P.

    1992-01-01

    A survey of the technological state of large scale biogas plants in Europe treating manure is given. 83 plants are in operation at present. Of these, 16 are centralised digestion plants. Transport costs at centralised digestion plants amounts to between 25 and 40 percent of the total operational costs. Various transport equipment is used. Most large scale digesters are CSTRs, but serial, contact, 2-step, and plug-flow digesters are also found. Construction materials are mostly steel and concrete. Mesophilic digestion is most common (56%), thermophilic digestion is used in 17% of the plants, combined mesophilic and thermophilic digestion is used in 28% of the centralised plants. Mixing of digester content is performed with gas injection, propellers, and gas-liquid displacement. Heating is carried out using external or internal heat exchangers. Heat recovery is only used in Denmark. Gas purification equipment is commonplace, but not often needed. Several plants use separation of the digested manure, often as part of a post-treatment/-purification process or for the production of 'compost'. Screens, sieve belt separaters, centrifuges and filter presses are employed. The use of biogas varies considerably. In some cases, combined heat and power stations are supplying the grid and district heating systems. Other plants use only either the electricity or heat. (au)

  14. Prototype of generic server for wind power plants using IEC 61400-25 standard

    DEFF Research Database (Denmark)

    Olsen, Andreas K.; Ösdil, B.; Poulsen, Bjarne

    2006-01-01

    from interfaces for control and monitoring to a standardized and secure way of handling communication. An analysis focusing on isolating the necessary requirements has been carried out based on the IEC61400-25 in order to create a generic prototype which can be used by WPP vendors. The main...... communications interface of the prototype utilizes web services and the prototype developed is comprised of several independent modules to allow for the possibility of choosing a fully customizable setup by the end user. Configuration of the system needs to be done in a simple way, ensuring a flexible...... and reusable system, where different choices for the system can be added or left out depending on user specifications. From the requirements a prototype with the purpose of examining the key aspects of these definitions has been elaborated....

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

    Science.gov (United States)

    Drozdowska, Aleksandra; Hermanowski, Tomasz

    2016-01-01

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

  16. Useful Principles in Plant Excellence Promotion

    International Nuclear Information System (INIS)

    Kavsek, D.; Bozin, B.

    2002-01-01

    This presentation offers a discussion of some principles identified from a review of significant industry events that affected the safety or reliability of a large number of nuclear power plants worldwide. Over the years of operation, a number of events have occurred in nuclear power plants that have involved problems in human performance. A review of these and other significant events has identified recurring weaknesses in plant safety culture and policy and procedure weaknesses. Focusing attention on strengthening relevant processes can help plants avoid similar significant events. Events continue to occur because the lessons learned from industry and plant operating experience are ineffectively used. In some cases, industry events have been communicated to the personnel of the plant in question, but without a thorough explanation of the lessons learned and applicability to the plant. The corrective actions identified have sometimes been limited in scope and have not fully addressed generic issues. The review and implementation of corrective actions for in-house events have sometimes been inadequate to prevent recurrences. An effective operating experience program can significantly reduce the potential for recurring events. The value of learning and applying the knowledge gained from operating experience should be an integral part of plant culture and promoted as an expectation. When operating experience is reviewed, generic issues and causal factors should be explored, rather than focusing on the unique problems that led to a specific event. Lessons learned and applicability to the plant must be clearly identified, corrective action taken, and changes thoroughly communicated to the plant personnel. Their understanding of the changes and the reasons for them should then be confirmed. The following principles will be discussed in this presentation: recognizing conditions during evolutions, promoting teamwork, recognizing fundamental knowledge weaknesses

  17. Value-impact assessment for resolution of generic safety issue 143 - availability of HVAC and chilled water systems

    Energy Technology Data Exchange (ETDEWEB)

    Daling, P.M.; Marler, J.E.; Vo, T.V. [Pacific Northwest Laboratory, Richland, WA (United States)] [and others

    1995-02-01

    The Pacific Northwest Laboratory (PNL), under contract to the U.S. Nuclear Regulatory Commission (NRC), has conducted an assessment of the values (benefits) and impacts (costs) associated with potential resolutions to Generic Issue 143, {open_quotes}Availability of Heating, Ventilation, and Air Conditioning (HVAC) and Chilled Water Systems.{close_quotes} This assessment was conducted to identify vulnerabilities related to failure of HVAC, chilled water and room cooling systems and develop estimates of the core damage frequencies and public risks associated with failures of these systems. This information was used to develop proposed resolution strategies to this generic issue and perform a value/impact assessment to determine their cost-effectiveness. Probabilistic risk assessments (PRAs) for four representative plants from the basis for the core damage frequency and public risk calculations. Internally-initiated core damage sequences as well as external events were considered. Three proposed resolution strategies were developed for this safety issue and it was determined that all three were not cost-effective. Additional evaluations were performed to develop {open_quotes}generic{close_quotes} insights on potential design-related vulnerabilities and potential high-frequency accident sequences that involve failures of HVAC/room cooling functions.

  18. Knowledge and abilities catalog for nuclear power plant operators: Boiling water reactors, Revision 1

    International Nuclear Information System (INIS)

    1995-08-01

    The Knowledge and Abilities Catalog for Nuclear Power Plant Operators: Boiling-Water Reactors (BWRs) (NUREG-1123, Revision 1) provides the basis for the development of content-valid licensing examinations for reactor operators (ROs) and senior reactor operators (SROs). The examinations developed using the BWR Catalog along with the Operator Licensing Examiner Standards (NUREG-1021) and the Examiner's Handbook for Developing Operator Licensing Written Examinations (NUREG/BR-0122), will cover the topics listed under Title 10, Code of Federal Regulations, Part 55 (10 CFR 55). The BWR Catalog contains approximately 7,000 knowledge and ability (K/A) statements for ROs and SROs at BWRs. The catalog is organized into six major sections: Organization of the Catalog, Generic Knowledge and Ability Statements, Plant Systems grouped by Safety Functions, Emergency and Abnormal Plant Evolutions, Components, and Theory. Revision 1 to the BWR Catalog represents a modification in form and content of the original catalog. The K/As were linked to their applicable 10 CFR 55 item numbers. SRO level K/As were identified by 10 CFR 55.43 item numbers. The plant-wide generic and system generic K/As were combined in one section with approximately one hundred new K/As. Component Cooling Water and Instrument Air Systems were added to the Systems Section. Finally, High Containment Hydrogen Concentration and Plant Fire On Site evolutions added to the Emergency and Abnormal Plant Evolutions section

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

    Science.gov (United States)

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

    2010-01-01

    Generic dispensing ratio (GDR) is an important measure of efficiency in pharmacy benefit management. A few studies have examined the effects of academic detailing or generic drug samples on GDR. On July 1, 2007, a physician-hospital organization (PHO) with a pay-for-performance incentive for generic utilization initiated a pilot generic medication voucher program that augmented its existing pharmacist-led academic detailing efforts. No published studies have examined the role of generic medication vouchers in promoting generic drug utilization. To determine if supplementing an existing academic detailing initiative in a PHO with a generic medication voucher program would be more effective in increasing the GDR compared with academic detailing alone. The intervention took place over the 9-month period from July 1, 2007, through March 31, 2008. Vouchers provided patients with the first fill of a 30-day supply of a generic drug at no cost to the patient for 8 specific generic medications obtained through a national community pharmacy chain. The study was conducted in a PHO composed of 7 hospitals and approximately 2,900 physicians (900 primary care providers [PCPs] and 2,000 specialists). Of the approximately 300 PCP practices, 21 practices with at least 2 physicians each were selected on the basis of high prescription volume (more than 500 pharmacy claims for the practice over a 12-month pre-baseline period) and low GDR (practice GDR less than 55% in the 12-month pre-baseline period). These 21 practices were then randomized to a control group of academic detailing alone or the intervention group that received academic detailing plus generic medication vouchers. One of 10 intervention groups declined to participate, and 2 of 11 control groups dropped out of the PHO. GDR was calculated monthly for all pharmacy claims including the 8 voucher medications. GDR was defined as the ratio of the total number of paid generic pharmacy claims divided by the total number of paid

  20. Generic tacrolimus in solid organ transplantation

    DEFF Research Database (Denmark)

    Taube, D; Jones, G; O'Beirne, J

    2014-01-01

    The availability of a wide range of immunosuppressive therapies has revolutionized the management of patients who have undergone solid organ transplantation (SOT). However, the cost of immunosuppressive drugs remains high. This situation has led to the development of generic equivalents, which...... innovator tacrolimus drug (Prograf) in both healthy volunteers and kidney transplant patients. Clinical experience with this generic tacrolimus formulation has also been established in both de novo and conversion patients who have undergone kidney and liver transplantation, as well as in conversion of other...

  1. Generic immunosuppression in transplantation: current evidence and controversial issues.

    Science.gov (United States)

    El Hajj, Sandra; Kim, Miae; Phillips, Karen; Gabardi, Steven

    2015-05-01

    The overall success of organ transplantation in the 21st century has been predicated, in part, on the use of newer, more potent, and selective immunosuppressive agents. However, the high cost of lifelong immunosuppression represents a financial burden for many patients. In the past 15 years, regulatory agencies in Europe and America have approved several generic immunosuppressants. One concern is whether the conversion between innovator and generic immunosuppressants will prove to be problematic. This manuscript aims to compare and contrast the bioequivalence requirements among regulatory authorities in the USA, Europe, and Canada, evaluate published studies of generic immunosuppressants in transplant recipients, summarize consensus statements made by transplant organizations and discuss how to engage patients in discussion regarding the choice between innovator and generic immunosuppressants.

  2. Plant operational states analysis in low power and shutdown PSA

    International Nuclear Information System (INIS)

    He Jiandong; Qiu Yongping; Zhang Qinfang; An Hongzhen; Li Maolin

    2013-01-01

    The purpose of Plant Operational States (POS) analysis is to disperse the continuous and dynamic process of low power and shutdown operation, which is the basis of developing event tree models for accident sequence analysis. According to the design of a 300 MW Nuclear Power Plant Project, operating experience and procedures of the reference plant, a detailed POS analysis is carried out based on relative criteria. Then, several kinds of POS are obtained, and the duration of each POS is calculated according to the operation records of the reference plant. The POS analysis is an important element in low power and shutdown PSA. The methodology and contents provide reference for POS analysis. (authors)

  3. Measuring the impact of cataract surgery on generic and vision-specific quality of life.

    Science.gov (United States)

    Groessl, Erik J; Liu, Lin; Sklar, Marisa; Tally, Steven R; Kaplan, Robert M; Ganiats, Theodore G

    2013-08-01

    Cataracts are the leading cause of blindness worldwide and cause visual impairment for millions of adults in the United States. We compared the sensitivity of a vision-specific health-related quality of life (HRQOL) measure to that of multiple generic measures of HRQOL before and at 2 time points after cataract surgery. Participants completed 1 vision-specific and 5 generic quality of life measures before cataract surgery, and again 1 and 6 months after surgery. Random effects modeling was used to measure changes over the three assessment points. The NEI-VFQ25 total score and all 11 subscales showed significant improvements during the first interval (baseline and 1 month). During the second interval (1-6 months post-surgery), significant improvements were observed on the total score and 5 of 11 NEI-VFQ25 subscales. There were significant increases in HRQOL during the first interval on some preference-based generic HRQOL measures, though changes during the second interval were mostly non-significant. None of the SF-36v2™ or SF6D scales changed significantly between any of the assessment periods. The NEI-VFQ25 was sensitive to changes in vision-specific domains of QOL. Some preference-based generic HRQOL measures were also sensitive to change and showed convergence with the NEI-VFQ25, but the effects were small. The SF-36v2™ and SF-6D did not change in a similar manner, possibly reflecting a lack of vision-related content. Studies seeking to document both the vision-specific and generic HRQOL improvements of cataract surgery should consider these results when selecting measures.

  4. Towards a minimal generic set of domains of functioning and health.

    Science.gov (United States)

    Cieza, Alarcos; Oberhauser, Cornelia; Bickenbach, Jerome; Chatterji, Somnath; Stucki, Gerold

    2014-03-03

    The World Health Organization (WHO) has argued that functioning, and, more concretely, functioning domains constitute the operationalization that best captures our intuitive notion of health. Functioning is, therefore, a major public-health goal. A great deal of data about functioning is already available. Nonetheless, it is not possible to compare and optimally utilize this information. One potential approach to address this challenge is to propose a generic and minimal set of functioning domains that captures the experience of individuals and populations with respect to functioning and health. The objective of this investigation was to identify a minimal generic set of ICF domains suitable for describing functioning in adults at both the individual and population levels. We performed a psychometric study using data from: 1) the German National Health Interview and Examination Survey 1998, 2) the United States National Health and Nutrition Examination Survey 2007/2008, and 3) the ICF Core Set studies. Random Forests and Group Lasso regression were applied using one self-reported general-health question as a dependent variable. The domains selected were compared to those of the World Health Survey (WHS) developed by the WHO. Seven domains of the International Classification of Functioning, Disability and Health (ICF) are proposed as a minimal generic set of functioning and health: energy and drive functions, emotional functions, sensation of pain, carrying out daily routine, walking, moving around, and remunerative employment. The WHS domains of self-care, cognition, interpersonal activities, and vision were not included in our selection. The minimal generic set proposed in this study is the starting point to address one of the most important challenges in health measurement--the comparability of data across studies and countries. It also represents the first step in developing a common metric of health to link information from the general population to information

  5. Regulatory analysis for the resolution of Generic Issue 99: Loss of RHR [residual heat removal] capability in PWRs

    International Nuclear Information System (INIS)

    Spano, A.H.

    1989-02-01

    Generic Issue 99 is concerned with the loss of residual heat removal (RHR) capability in pressurized water reactors during cold-plant outage operations. The issue focuses on two risk-significant common-cause failure modes of the RHR system: (1) air binding of the RHR pumps during reduced-inventory operations and (2) spurious closure of the RHR suction valves due to misapplication of the autoclosure interlocks. Resolution of this issue involves consideration of the adequacy of plant capabilities for (1) preventing losses of RHR, (2) responding promptly and effectively to such challenges in order to prevent core damage, and (3) ensuring timely containment protection against the release of radioactivity to the environment in the unlikely event of core damage due to loss of shutdown cooling. This entails examination of (1) relevant operational and accident response procedures, (2) the instrumentation available to the operator for accident diagnosis and mitigation, and (3) the administrative controls available for ensuring control room cognizance of ongoing maintenance activities that could potentially affect the stability of the reactor coolant system. This regulatory analysis provides quantitative assessments of the costs and benefits associated with several alternatives considered for the resolution of Generic Issue 99. 24 refs

  6. Mixed WTO ruling on generic drug development.

    Science.gov (United States)

    Elliott, R

    2000-01-01

    On 17 March 2000, the World Trade Organization upheld the provision in Canada's patent laws that allows generic drug manufacturers to develop (but not sell) their cheaper versions of patented medicines before the 20-year patients expire. The decision prevents pharmaceutical companies from enjoying market monopolies beyond their patent terms, avoiding what would otherwise be even lengthier delays in the sale of cheaper, generic drugs in Canada. This decision is of significance not only to Canada, but also to other WTO member countries and to all individuals who use pharmaceutical products. However, the decision is not all positive: the WTO also ruled that Canada is violating international agreements by letting generic manufacturers stockpile their versions of patented drugs before patents expire. This article explains the issues, the arguments, and the decision.

  7. 40 CFR 721.10036 - Acetaldehyde based polymer (generic).

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Acetaldehyde based polymer (generic... Specific Chemical Substances § 721.10036 Acetaldehyde based polymer (generic). (a) Chemical substance and... based polymer (PMN P-02-406) is subject to reporting under this section for the significant new uses...

  8. Enhancing Safety through Generic Competencies

    Directory of Open Access Journals (Sweden)

    S. Mockel

    2014-03-01

    Full Text Available This article provides insights into proactive safety management and mitigation. An analysis of accident reports reveals categories of supervening causes of accidents which can be directly linked to the concept of generic competencies (information management, communication and coordination, problem solving, and effect control. These findings strongly suggest adding the human element as another safety-constituting pillar to the concept of ship safety next to technology and regulation. We argue that the human element has unique abilities in dealing with critical and highly dynamic situations which can contribute to the system's recovery from non-routine or critical situations. By educating seafarers in generic competencies we claim to enable the people onboard to successfully deal with critical situations.

  9. Generic magnetic fusion reactor cost assessment

    International Nuclear Information System (INIS)

    Sheffield, J.

    1985-01-01

    The Fusion Energy Division of the Oak Ridge National Laboratory discusses ''generic'' magnetic fusion reactors. The author comments on DT burning magnetic fusion reactor models being possibly operational in the 21st century. Representative parameters from D-T reactor studies are given, as well as a shematic diagram of a generic fusion reactor. Values are given for winding pack current density for existing and future superconducting coils. Topics included are the variation of the cost of electricity (COE), the dependence of the COE on the net electric power of the reactor, and COE formula definitions

  10. Assessment of generic accident management strategies considered for near term implementation

    International Nuclear Information System (INIS)

    Lehner, J.R.; Luckas, W.J.; Vandenkieboom, J.J.

    1989-01-01

    The US Nuclear Regulatory Commission (NRC) and the industry are both participating in the identification of measures that can prevent the progression of a severe accident or mitigate its consequences. Information important for evaluating these accident management strategies for specific plants is expected to result from the ongoing Individual Plant Evaluation (IPE) program. However, NRC staff have identified a number of generic strategies which may not have to await the results of the IPE program and therefore can be considered for earlier implementation. The NRC requested two of its contractors, Brookhaven National Laboratory (BNL) and Battelle Pacific Northwest Laboratories (PNL) to evaluate these strategies. The twenty one candidate strategies fall under three broad global strategies: (1) conserving and replenishing limited resources, (2) use of systems/components in innovative applications, and (3) defeating interlocks and component protective trips in emergencies. Some strategies apply to BWRs or PWRs only, other apply to both types of plants. This paper describes the evaluation of the strategies performed by Brookhaven National Laboratory. Brookhaven National Laboratory assessed the proposed strategies by first detailing the objective of the strategy and listing the actions involved in the implementation. A description of the plant systems associated with the strategy was given. Next, the applicability of existing rules or plant procedures to a particular strategy was investigated. This was accomplished by a fairly detailed, but by no means exhaustive review of the emergency operating procedures of several plants, as well as utility and NRC reports related to accident management

  11. The Market Dynamics of Generic Medicines in the Private Sector of 19 Low and Middle Income Countries between 2001 and 2011: A Descriptive Time Series Analysis

    Science.gov (United States)

    Kaplan, Warren A.; Wirtz, Veronika J.; Stephens, Peter

    2013-01-01

    This observational study investigates the private sector, retail pharmaceutical market of 19 low and middle income countries (LMICs) in Latin America, Asia and the Middle East/South Africa analyzing the relationships between volume market share of generic and originator medicines over a time series from 2001 to 2011. Over 5000 individual pharmaceutical substances were divided into generic (unbranded generic, branded generic medicines) and originator categories for each country, including the United States as a comparator. In 9 selected LMICs, the market share of those originator substances with the largest decrease over time was compared to the market share of their counterpart generic versions. Generic medicines (branded generic plus unbranded generic) represent between 70 and 80% of market share in the private sector of these LMICs which exceeds that of most European countries. Branded generic medicine market share is higher than that of unbranded generics in all three regions and this is in contrast to the U.S. Although switching from an originator to its generic counterpart can save money, this narrative in reality is complex at the level of individual medicines. In some countries, the market behavior of some originator medicines that showed the most temporal decrease, showed switching to their generic counterpart. In other countries such as in the Middle East/South Africa and Asia, the loss of these originators was not accompanied by any change at all in market share of the equivalent generic version. For those countries with a significant increase in generic medicines market share and/or with evidence of comprehensive “switching” to generic versions, notably in Latin America, it would be worthwhile to establish cause-effect relationships between pharmaceutical policies and uptake of generic medicines. The absence of change in the generic medicines market share in other countries suggests that, at a minimum, generic medicines have not been strongly

  12. The market dynamics of generic medicines in the private sector of 19 low and middle income countries between 2001 and 2011: a descriptive time series analysis.

    Science.gov (United States)

    Kaplan, Warren A; Wirtz, Veronika J; Stephens, Peter

    2013-01-01

    This observational study investigates the private sector, retail pharmaceutical market of 19 low and middle income countries (LMICs) in Latin America, Asia and the Middle East/South Africa analyzing the relationships between volume market share of generic and originator medicines over a time series from 2001 to 2011. Over 5000 individual pharmaceutical substances were divided into generic (unbranded generic, branded generic medicines) and originator categories for each country, including the United States as a comparator. In 9 selected LMICs, the market share of those originator substances with the largest decrease over time was compared to the market share of their counterpart generic versions. Generic medicines (branded generic plus unbranded generic) represent between 70 and 80% of market share in the private sector of these LMICs which exceeds that of most European countries. Branded generic medicine market share is higher than that of unbranded generics in all three regions and this is in contrast to the U.S. Although switching from an originator to its generic counterpart can save money, this narrative in reality is complex at the level of individual medicines. In some countries, the market behavior of some originator medicines that showed the most temporal decrease, showed switching to their generic counterpart. In other countries such as in the Middle East/South Africa and Asia, the loss of these originators was not accompanied by any change at all in market share of the equivalent generic version. For those countries with a significant increase in generic medicines market share and/or with evidence of comprehensive "switching" to generic versions, notably in Latin America, it would be worthwhile to establish cause-effect relationships between pharmaceutical policies and uptake of generic medicines. The absence of change in the generic medicines market share in other countries suggests that, at a minimum, generic medicines have not been strongly promoted.

  13. The market dynamics of generic medicines in the private sector of 19 low and middle income countries between 2001 and 2011: a descriptive time series analysis.

    Directory of Open Access Journals (Sweden)

    Warren A Kaplan

    Full Text Available This observational study investigates the private sector, retail pharmaceutical market of 19 low and middle income countries (LMICs in Latin America, Asia and the Middle East/South Africa analyzing the relationships between volume market share of generic and originator medicines over a time series from 2001 to 2011. Over 5000 individual pharmaceutical substances were divided into generic (unbranded generic, branded generic medicines and originator categories for each country, including the United States as a comparator. In 9 selected LMICs, the market share of those originator substances with the largest decrease over time was compared to the market share of their counterpart generic versions. Generic medicines (branded generic plus unbranded generic represent between 70 and 80% of market share in the private sector of these LMICs which exceeds that of most European countries. Branded generic medicine market share is higher than that of unbranded generics in all three regions and this is in contrast to the U.S. Although switching from an originator to its generic counterpart can save money, this narrative in reality is complex at the level of individual medicines. In some countries, the market behavior of some originator medicines that showed the most temporal decrease, showed switching to their generic counterpart. In other countries such as in the Middle East/South Africa and Asia, the loss of these originators was not accompanied by any change at all in market share of the equivalent generic version. For those countries with a significant increase in generic medicines market share and/or with evidence of comprehensive "switching" to generic versions, notably in Latin America, it would be worthwhile to establish cause-effect relationships between pharmaceutical policies and uptake of generic medicines. The absence of change in the generic medicines market share in other countries suggests that, at a minimum, generic medicines have not been

  14. Draft environmental assessment: Ocean Thermal Energy Conversion (OTEC) Pilot Plants

    Energy Technology Data Exchange (ETDEWEB)

    Sullivan, S.M.; Sands, M.D.; Donat, J.R.; Jepsen, P.; Smookler, M.; Villa, J.F.

    1981-02-01

    This Environmental Assessment (EA) has been prepared, in accordance with the National Environmental Policy Act of 1969, for the deployment and operation of a commercial 40-Megawatt (MW) Ocean Thermal Energy Conversion (OTEC) Pilot Plant (hereafter called the Pilot Plant). A description of the proposed action is presented, and a generic environment typical of the candidate Pilot Plant siting regions is described. An assessment of the potential environmental impacts associated with the proposed action is given, and the risk of credible accidents and mitigating measures to reduce these risks are considered. The Federal and State plans and policies the proposed action will encompass are described. Alternatives to the proposed action are presented. Appendix A presents the navigation and environmental information contained in the US Coast Pilot for each of the candidate sites; Appendix B provides a brief description of the methods and calculations used in the EA. It is concluded that environmental disturbances associated with Pilot Plant activities could potentially cause significant environmental impacts; however, the magnitude of these potential impacts cannot presently be assessed, due to insufficient engineering and environmental information. A site- and design-specific OTEC Pilot Plant Environmental Impact Statement (EIS) is required to resolve the potentially significant environmental effects associated with Pilot Plant deployment and operation. (WHK)

  15. Early Site Permit Demonstration Program: Plant parameters envelope report. Volume 1

    Energy Technology Data Exchange (ETDEWEB)

    1993-03-01

    The Early Site Permit (ESP) Demonstration Program is the nuclear industry`s initiative for piloting the early resolution of siting-related issues before the detailed design proceedings of the combined operating license review. The ESP Demonstration Program consists of three phases. The plant parameters envelopes task is part of Phase 1, which addresses the generic review of applicable federal regulations and develops criteria for safety and environmental assessment of potential sites. The plant parameters envelopes identify parameters that characterize the interface between an ALWR design and a potential site, and quantify the interface through values selected from the Utility Requirements Documents, vendor design information, or engineering assessments. When augmented with site-specific information, the plant parameters envelopes provide sufficient information to allow ESPs to be granted based on individual ALWR design information or enveloping design information for the evolutionary, passive, or generic ALWR plants. This document is expected to become a living document when used by future applicants.

  16. Generic radiation safety design for SSRL synchrotron radiation beamlines

    Energy Technology Data Exchange (ETDEWEB)

    Liu, James C. [Radiation Protection Department, Stanford Linear Accelerator Center (SLAC), MS 48, P.O. Box 20450, Stanford, CA 94309 (United States)]. E-mail: james@slac.stanford.edu; Fasso, Alberto [Radiation Protection Department, Stanford Linear Accelerator Center (SLAC), MS 48, P.O. Box 20450, Stanford, CA 94309 (United States); Khater, Hesham [Radiation Protection Department, Stanford Linear Accelerator Center (SLAC), MS 48, P.O. Box 20450, Stanford, CA 94309 (United States); Prinz, Alyssa [Radiation Protection Department, Stanford Linear Accelerator Center (SLAC), MS 48, P.O. Box 20450, Stanford, CA 94309 (United States); Rokni, Sayed [Radiation Protection Department, Stanford Linear Accelerator Center (SLAC), MS 48, P.O. Box 20450, Stanford, CA 94309 (United States)

    2006-12-15

    To allow for a conservative, simple, uniform, consistent, efficient radiation safety design for all SSRL beamlines, a generic approach has been developed, considering both synchrotron radiation (SR) and gas bremsstrahlung (GB) hazards. To develop the methodology and rules needed for generic beamline design, analytic models, the STAC8 code, and the FLUKA Monte Carlo code were used to pre-calculate sets of curves and tables that can be looked up for each beamline safety design. Conservative beam parameters and standard targets and geometries were used in the calculations. This paper presents the SPEAR3 beamline parameters that were considered in the design, the safety design considerations, and the main pre-calculated results that are needed for generic shielding design. In the end, the rules and practices for generic SSRL beamline design are summarized.

  17. The generic strategy trap.

    Science.gov (United States)

    Miller, D

    1992-01-01

    Management experts claim that for a company to thrive, it must concentrate on a single generic strategy--on one thing it does better than its rivals. But specialization also has its disadvantages. The author suggests that a broader, mixed approach may be preferable.

  18. Acceptability and confidence in antiretroviral generics of physicians and HIV-infected patients in France.

    Science.gov (United States)

    Allavena, Clotilde; Jacomet, Christine; Pereira, Bruno; Morand-Joubert, Laurence; Bagheri, Haleh; Cotte, Laurent; Garaffo, Rodolphe; Gerbaud, Laurent; Dellamonica, Pierre

    2014-01-01

    Switching brand name medications to generics is recommended in France in the interest of cost effectiveness but patients and physicians are sometimes not convinced that switching is appropriate. Some antiretroviral (ARV) generics (ZDV, 3TC, NVP) have been marketed in France since 2013. A multicentric cross-sectional survey was performed in September 2013 to evaluate the perception of generics overall and ARV generics in physicians and HIV-infected patients and factors associated to their acceptability. Adult HIV outpatients were asked to complete a self-questionnaire on their perception of generics. Physicians completed a questionnaire on the acceptability of generics and ARV generics. Socio-demographic data, medical history and HIV history were collected. 116 physicians in 33 clinics (68% in University Hospital) included 556 patients (France-native 77%, active employment 59%, covered by social Insurance 100%, homosexual/bisexual contamination 47%, median HIV duration 13 years, hepatitis coinfection 16%, on ARV therapy 95%). Overall, patients accepted and had confidence in generics in 76% and 55% of the cases, respectively. Switching ARVs for generics was accepted by 44% of the patients but only by 17% if the pill burden was going to increase. 75% of the physicians would prescribe generics, but this decreased to only 26% if the combo had to be broken. The main reasons for non-prescription of generics were previous brand name ARV-induced side effects (35%), refusal of generics overall (37%), lack of understanding of generics (26%), risk of non-observance of treatment (44%), anxiety (47%) and depressive symptoms (25%). In multivariate analysis, factors associated with the acceptability of ARV generics in patients were the use of generics overall (p<0.001) and in physicians, the absence of concern regarding the drug efficacy (p<0.001) and being aware that the patient would accept generics overall (p=0.03) and ARV generics (p=0.04). No factors related to

  19. Generic 12-Bus Test System for Wind Power Integration Studies

    DEFF Research Database (Denmark)

    Adamczyk, Andrzej Grzegorz; Altin, Müfit; Göksu, Ömer

    2012-01-01

    , inertial response, frequency control, damping of electromechanical oscillations, balanced and unbalanced fault management, etc. Hence, the power system components: conventional power plants with controls, transmission lines, transformers and loads should be represented accurately to achieve realistic power......High wind power penetration levels into power systems requires an appropriate power system model when assessing impact on the overall system stability. The model should capture the wide range of dynamics related to the wind integration studies, such as voltage control, synchronizing power control...... system characteristics. Additionally, the power system model should be simple and computationally manageable in order to simulate multiple scenarios with different control parameters in a reasonable time. In this paper, a generic power system model is presented in order to comprehend the wind integration...

  20. On names of genera of prokaryotes that are later homonyms of generic names with standing in the zoological or the botanical nomenclature. Proposal of Neomegalonema gen. nov. and Neomegalonema perideroedes comb. nov. as replacements for the prokaryotic generic name Meganema and the species name Meganema perideroedes.

    Science.gov (United States)

    Oren, Aharon

    2017-10-01

    I here present a survey of generic names with standing in the prokaryotic nomenclature that have homonyms with standing under the International Code of Zoological Nomenclature and/or the International Code of Nomenclature for algae, fungi, and plants. I especially discuss such names added after Principle 2 of the Bacteriological Code/Prokaryotic Code was changed in 1999 to make the prokaryote nomenclature not independent of botanical and zoological nomenclature. Cases include the genera Micromonas, Quadrococcus, Yania, Sinococcus, and Meganema. The generic name Meganema was not previously recognized as a homonym of two genera with standing in the zoological nomenclature. Therefore, I here propose renaming Meganema and Meganema perideroedes as Neomegalonema gen. nov. and Neomegalonema perideroedes comb. nov., respectively.

  1. Introduction of developing a list of MSO generic scenarios for PHWR

    Energy Technology Data Exchange (ETDEWEB)

    Park, Jae Wan; Park, Jun Hyun; Bae, Hui Soo [STANDARD Testing and Engineering Ing. Ltd, Daejeon (Korea, Republic of)

    2016-10-15

    Multiple Spurious Operation(MSO) scenarios should contain scenarios threatening Post-fire safe shutdown function by MSO of Safe Shutdown Equipments(SSEs) as well as Non-SSEs. The list of MSO generic scenarios(NEI 00-01, Appendix G) was developed by industrial survey. Although not all scenarios of the list of MSO generic scenarios(NEI 00-01, Appendix G) are considered applicable to every reactor type, this list provides an input about MSO identification and treatment process. If NEI 00-01 is applied to other reactor type, analyst should review applicability of the list of generic scenarios(NEI 00-01, Appendix G) and consider potential MSO scenarios undescribed in the list of MSO generic scenarios(NEI 00-01, Appendix G). Especially, in PHWR case, there is no list of MSO generic scenarios in Canada or internationally. There are substantial physical variations between NPPs. So some generic scenarios(NEI 00-01, Appendix G) would need validation. Nevertheless, industrial stakeholder have not did any MSO work until now. In this paper, results of first stage research that develop the list of MSO generic scenarios for pressurized heavy water reactor(PHWR) is introduced. According to the review results, specific review of the list of MSO generic scenarios(NEI 00-01, Appendix G) is required such as how it applies to PHWR. And criteria was established for review of availability of the list of generic scenarios(NEI 00-01, Appendix G). However there are still many tasks such as potential scenario review, risk model review and expert panel review.

  2. Experiences Gained from Independent Assessment in Licensing of Advanced I and C Systems in Nuclear Power Plants

    International Nuclear Information System (INIS)

    Lindner, Arndt B.; Wach, Dieter H.

    2003-01-01

    Operational benefits and enlarged functionality of modern technology, but also the physical and the technological aging of conventional instrumentation and control (I and C) systems, are motivations for modernization of I and C systems in nuclear power plants (NPPs). In case of safety-relevant I and C systems, the licensing authorities require the demonstration of sufficient safety of the systems.In several countries ongoing research and development projects are directed to provide a scientific basis and engineering solutions for cost-effective assessment of software-based I and C systems important to safety in NPPs. International initiatives have been started to develop a harmonized safety assessment methodology. The Institute for Safety Technology (ISTec) has been engaged in national and international programs as well as in establishing a two-phase qualification approach, which comprises a generic plant-independent qualification of hardware and software components and a plant-specific system qualification phase.In both generic qualification and plant-specific system qualification, ISTec has been involved as an independent third-party assessor for the relevant state authority. This paper reports experiences from the ISTec involvement in the assessment projects, e.g., in the assessment of the I and C important to safety in the new German High-Flux Research Reactor (FRM-2) in Munich and in the assessments of I and C modernization in NPPs of foreign countries (Bohunice, Slovak Republic; Paks, Hungary; and others). Conclusions are drawn from the experiences with respect to the practicability of the two-phase qualification concept and from the major findings in the plant-specific I and C assessments

  3. Ageing management in German nuclear power plants

    International Nuclear Information System (INIS)

    Becker, D.E.; Reiner, M.

    1998-01-01

    In Germany, the term 'ageing management' comprises several aspects. A demand for a special ageing monitoring programme is not explicitly contained in the regulations. However, from the Atomic Energy Act and its regulations results the operator's obligation to perform extensive measures to maintain the quality of the plant and the operating personnel working in the plant. From this point of view, comprehensive ageing management in German nuclear power plants has taken place right from the start under the generic term of quality assurance. (author)

  4. Frequency and Informativeness of Gestural Cues Accompanying Generic and Particular Reference

    Science.gov (United States)

    Meyer, Meredith; Gelman, Susan A.; Stilwell, Sarah M.

    2015-01-01

    Generic noun phrases, or generics, refer to abstract categories ("Dogs" bark) rather than particular individuals ("Those dogs" bark). Study 1 investigated how parents use gestures in association with generic versus particular reference during naturalistic interactions with their 2- and 3-year-old children. Parents provided…

  5. An audit of generic prescribing in a general surgical department.

    LENUS (Irish Health Repository)

    Gleeson, M

    2013-01-17

    BACKGROUND: The Health Service Executive introduced a generic prescription policy to reduce costs. Despite this, generic prescription rates remain low. AIM: To audit in-patient prescription practice in a single surgical department and identify potential savings which could be realised by adherence to the generic prescribing policy. METHODS: Surgical in-patient charts were obtained at the point of discharge and their drug prescription information was recorded. RESULTS: 51 % of prescriptions involved a trade-name prescription where an appropriate generic equivalent existed. The cost implications for hospital and community patients were found to be greatly affected by substitution policies that exist at hospital pharmacy level. CONCLUSION: There is a need to promote greater adherence to generic prescribing amongst hospital doctors in line with international best practice. It can have a positive impact in terms of safe prescribing and can have cost implications at both hospital and community level.

  6. Plant species invasions along the latitudinal gradient in the United States

    Science.gov (United States)

    Thomas J. Stohlgren; David Barnett; Curtis Flather; John Kartesz; Bruce Peterjohn

    2005-01-01

    It has been long established that the richness of vascular plant species and many animal taxa decreases with increasing latitude, a pattern that very generally follows declines in actual and potential evapotranspiration, solar radiation, temperature, and thus, total productivity. Using county-level data on vascular plants from the United States (3000 counties in the...

  7. Status of safety issues at licensed power plants: TMI Action Plan requirements, unresolved safety issues, generic safety issues, other multiplant action issues. Supplement 4

    International Nuclear Information System (INIS)

    1994-12-01

    As part of ongoing US Nuclear Regulatory Commission (NRC) efforts to ensure the quality and accountability of safety issue information, the NRC established a program for publishing an annual report on the status of licensee implementation and NRC verification of safety issues in major NRC requirements areas. This information was initially compiled and reported in three NUREG-series volumes. Volume 1, published in March 1991, addressed the status of Three Mile Island (TMI) Action Plan Requirements. Volume 2, published in May 1991, addressed the status of unresolved safety issues (USIs). Volume 3, published in June 1991, addressed the implementation and verification status of generic safety issues (GSIs). The first annual supplement, which combined these volumes into a single report and presented updated information as of September 30, 1991, was published in December 1991. The second annual supplement, which provided updated information as of September 30, 1992, was published in December 1992. Supplement 2 also provided the status of licensee implementation and NRC verification of other multiplant action (MPA) issues not related to TMI Action Plan requirements, USIs, or GSIs. Supplement 3 gives status as of September 30, 1993. This annual report, Supplement 4, presents updated information as of September 30, 1994. This report gives a comprehensive description of the implementation and verification status of TMI Action Plan requirements, safety issues designated as USIs, GSIs, and other MPAs that have been resolved and involve implementation of an action or actions by licensees. This report makes the information available to other interested parties, including the public. Additionally, this report serves as a follow-on to NUREG-0933, ''A Prioritization of Generic Safety Issues,'' which tracks safety issues until requirements are approved for imposition at licensed plants or until the NRC issues a request for action by licensees

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

    Science.gov (United States)

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

    2011-02-01

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

  9. A generic coding approach for the examination of meal patterns.

    Science.gov (United States)

    Woolhead, Clara; Gibney, Michael J; Walsh, Marianne C; Brennan, Lorraine; Gibney, Eileen R

    2015-08-01

    Meal pattern analysis can be complex because of the large variability in meal consumption. The use of aggregated, generic meal data may address some of these issues. The objective was to develop a meal coding system and use it to explore meal patterns. Dietary data were used from the National Adult Nutrition Survey (2008-2010), which collected 4-d food diary information from 1500 healthy adults. Self-recorded meal types were listed for each food item. Common food group combinations were identified to generate a number of generic meals for each meal type: breakfast, light meals, main meals, snacks, and beverages. Mean nutritional compositions of the generic meals were determined and substituted into the data set to produce a generic meal data set. Statistical comparisons were performed against the original National Adult Nutrition Survey data. Principal component analysis was carried out by using these generic meals to identify meal patterns. A total of 21,948 individual meals were reduced to 63 generic meals. Good agreement was seen for nutritional comparisons (original compared with generic data sets mean ± SD), such as fat (75.7 ± 29.4 and 71.7 ± 12.9 g, respectively, P = 0.243) and protein (83.3 ± 26.9 and 80.1 ± 13.4 g, respectively, P = 0.525). Similarly, Bland-Altman plots demonstrated good agreement (<5% outside limits of agreement) for many nutrients, including protein, saturated fat, and polyunsaturated fat. Twelve meal types were identified from the principal component analysis ranging in meal-type inclusion/exclusion, varying in energy-dense meals, and differing in the constituents of the meals. A novel meal coding system was developed; dietary intake data were recoded by using generic meal consumption data. Analysis revealed that the generic meal coding system may be appropriate when examining nutrient intakes in the population. Furthermore, such a coding system was shown to be suitable for use in determining meal-based dietary patterns. © 2015

  10. Pointing As a Socio-Pragmatic Cue to Particular vs.Generic Reference

    Science.gov (United States)

    Meyer, Meredith; Baldwin, Dare A.

    2013-01-01

    Generic noun phrases, or generics, refer to abstract kind categories ("Dogs" bark) rather than particular individuals ("Those dogs" bark). How do children distinguish these distinct kinds of reference? We examined the role of one socio-pragmatic cue, namely pointing, in producing and comprehending generic versus particular…

  11. A prioritization of generic safety issues. Supplement 19, Revision insertion instructions

    International Nuclear Information System (INIS)

    1995-11-01

    The report presents the safety priority ranking for generic safety issues related to nuclear power plants. The purpose of these rankings is to assist in the timely and efficient allocation of NRC resources for the resolution of those safety issues that have a significant potential for reducing risk. The safety priority rankings are HIGH, MEDIUM, LOW, and DROP, and have been assigned on the basis of risk significance estimates, the ratio of risk to costs and other impacts estimated to result if resolution of the safety issues were implemented, and the consideration of uncertainties and other quantitative or qualitative factors. To the extent practical, estimates are quantitative. This document provides revisions and amendments to the report

  12. A prioritization of generic safety issues. Supplement 19, Revision insertion instructions

    Energy Technology Data Exchange (ETDEWEB)

    None

    1995-11-01

    The report presents the safety priority ranking for generic safety issues related to nuclear power plants. The purpose of these rankings is to assist in the timely and efficient allocation of NRC resources for the resolution of those safety issues that have a significant potential for reducing risk. The safety priority rankings are HIGH, MEDIUM, LOW, and DROP, and have been assigned on the basis of risk significance estimates, the ratio of risk to costs and other impacts estimated to result if resolution of the safety issues were implemented, and the consideration of uncertainties and other quantitative or qualitative factors. To the extent practical, estimates are quantitative. This document provides revisions and amendments to the report.

  13. [Users sceptical about generic drugs: an anthropological approach].

    Science.gov (United States)

    Sarradon-Eck, A; Blanc, M-A; Faure, M

    2007-06-01

    Since the enactment of the 2002 legislative measures favoring the prescription of generic drugs, various quantitative studies have shown that approval by prescribers and users has risen in France. Nevertheless, scepticism remains as well as distrust towards these drugs focusing on their effectiveness compared with brand-name drugs, on potential dangers, and on the interruption they cause in prescription and consumption habits. Using a comprehensive approach, this article analyzes the social and cultural logic behind the negative image of generic drugs. The materials issued from an ethnographic study on the prescription of drugs for high blood pressure. Sixty-eight interviews were undertaken between April 2002 and October 2004 with people (39 women and 29 men, between the age of 40 and 95, 52 over the age of 60) treated for over a year for high blood pressure in rural areas in the Southeast of France. Thirteen people provided unsolicited opinions about generic drugs. Analysis of the information collected shows that users have various representations of generic drugs, including the idea of counterfeited and foreign drugs. These representations interfere with the adjustment process and the development of consumer loyalty. They are part of a set of social representations about drugs which form and express the user's reality. In these representations, the drug is an ambivalent object, carrier of both biological effectiveness and toxicity; it is also the metonymical extension of the prescriber, bestowing upon the prescription a symbolic value. By placing the generic drug in its network of symbolic and social meaning, this study highlights the coherence of the scepticism towards generic drugs by consumers (and prescribers) with a system of common opinion in which drugs are everyday things, personalized and compatible with users, symbolic exchange carriers in the physician-patient relationship, and in which confidence in the drug is also that given to the health care

  14. An evaluation of consumers' knowledge, perceptions and attitudes regarding generic medicines in Auckland.

    Science.gov (United States)

    Babar, Zaheer-Ud-Din; Stewart, Joanna; Reddy, Shiwangni; Alzaher, Woroud; Vareed, Prateeka; Yacoub, Nineweh; Dhroptee, Bandhana; Rew, Anne

    2010-08-01

    The aim of this project was to evaluate the perceptions, knowledge and attitudes regarding generic medicines. A cross-sectional study, with self administered questionnaires, was conducted to survey consumers visiting pharmacies in four regions of Auckland (North Shore, Waitakere, Central Auckland and South Auckland). Through stratified random sampling, approximately 10% of pharmacies from each region were selected, which turn out to be 30 pharmacies. Every alternate customer coming to the pharmacy, who was eligible to participate in the study, was asked by the researchers to complete the questionnaire. A total of 441 questionnaires were included in the analysis. Different response rates were obtained in different regions of Auckland. Of all respondents, 51.6% had previous knowledge of generic medicines. Pharmacists were the main source of information regarding generic medicines followed by doctors and media. A higher level of education had a direct relationship with having correct knowledge of generics (P = .002). Attitude of participants toward the use of generic medicines was determined by their knowledge of generics, whether it was recommended by a pharmacist and their type of illness. Participants were more prepared to change to a generic for a minor illness (79%) than for a major illness (58.7%). Those who had better knowledge were more likely than those with poor knowledge to say they would to use a generic in major illness (P = .001) as well as minor illness (P < .0001). Previous positive experiences with generics also determined consumers' willingness to use generics. Many consumers have misconceptions regarding generic medicines. Having knowledge about generics and the advice by doctors and pharmacists are key indicators to improve the quality use of generic medicines.

  15. Stability of generic thin shells in conformally flat spacetimes

    Energy Technology Data Exchange (ETDEWEB)

    Amirabi, Z. [Eastern Mediterranean Univ., Gazimagusa (Turkey). Dept. of Physics

    2017-07-15

    Some important spacetimes are conformally flat; examples are the Robertson-Walker cosmological metric, the Einstein-de Sitter spacetime, and the Levi-Civita-Bertotti-Robinson and Mannheim metrics. In this paper we construct generic thin shells in conformally flat spacetime supported by a perfect fluid with a linear equation of state, i.e., p = ωσ. It is shown that, for the physical domain of ω, i.e., 0 < ω ≤ 1, such thin shells are not dynamically stable. The stability of the timelike thin shells with the Mannheim spacetime as the outer region is also investigated. (orig.)

  16. Information Theoretic Characterization of Physical Theories with Projective State Space

    Science.gov (United States)

    Zaopo, Marco

    2015-08-01

    Probabilistic theories are a natural framework to investigate the foundations of quantum theory and possible alternative or deeper theories. In a generic probabilistic theory, states of a physical system are represented as vectors of outcomes probabilities and state spaces are convex cones. In this picture the physics of a given theory is related to the geometric shape of the cone of states. In quantum theory, for instance, the shape of the cone of states corresponds to a projective space over complex numbers. In this paper we investigate geometric constraints on the state space of a generic theory imposed by the following information theoretic requirements: every non completely mixed state of a system is perfectly distinguishable from some other state in a single shot measurement; information capacity of physical systems is conserved under making mixtures of states. These assumptions guarantee that a generic physical system satisfies a natural principle asserting that the more a state of the system is mixed the less information can be stored in the system using that state as logical value. We show that all theories satisfying the above assumptions are such that the shape of their cones of states is that of a projective space over a generic field of numbers. Remarkably, these theories constitute generalizations of quantum theory where superposition principle holds with coefficients pertaining to a generic field of numbers in place of complex numbers. If the field of numbers is trivial and contains only one element we obtain classical theory. This result tells that superposition principle is quite common among probabilistic theories while its absence gives evidence of either classical theory or an implausible theory.

  17. Patients' concern about their medicine after a generic switch

    DEFF Research Database (Denmark)

    Østergaard Rathe, Jette; Søndergaard, Jens; Jarbøl, Dorte E

    2014-01-01

    PURPOSE: This study aims to investigate the possible association between patients' concerns about their medicine and generic switch. METHODS: Cross-sectional survey was carried out comprising responses from 2217 randomly selected persons aged 20 years or older and living in the Region of Southern...... Denmark, who had redeemed generically substitutable drugs in September 2008. For each patient, we focused on the purchase of one generically substitutable drug (index drug). We applied the specific concerns subscale from the Beliefs about Medicine Questionnaire (BMQ) to analyse lack of confidence....... RESULTS: No statistically significant associations were found between concerns about the index medicine and the generic switch (-0.02 95% CI: -0.10; 0.05). Viewing medicines as harmful in general was associated with increased concerns (BMQ general harm: 0.39 95% CI: 0.30; 0.47 and BMQ general overuse: 0...

  18. Generic Drugs: Questions and Answers

    Science.gov (United States)

    ... Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Drugs Home Drugs Resources for You Information for Consumers (Drugs) Questions & Answers Generic Drugs: Questions & Answers Share Tweet Linkedin Pin it More ...

  19. PSA based plant modifications and back-fits

    International Nuclear Information System (INIS)

    1997-01-01

    The mandate of Principal Working Group No. 5 - Risk Assessment states that 'The group should deal with the technology and methods for identifying contributors to risk and assessing their importance, and appropriate exchanges of information on current research'. Since being formulated in 1982, along with this mandate, the group has also endeavored to develop a common understanding of the different approaches taken in risk assessment. The focus of this report is to provide knowledge to experts on the role Probabilistic Safety Assessment (PSA) has had in safety decision making. PSA is a powerful tool for improving Nuclear Power Plant safety by identifying weaknesses in design or operation and setting priorities for plant modifications and back-fits. While the use is well recognised, it is also true that any safety decision is generally based on several elements, both probabilistic and deterministic. This document provides a general overview of insights gained from the representative set of examples collected from Member countries (Finland, France, Germany, Japan, Korea, Netherlands, Spain, Sweden, Switzerland, United Kingdom, United States). The report starts with basic types of plant modifications which were carried out (e.g. hardware or software, important or minor, etc.) and the characteristics of the PSAs used in the examples (e.g. level and scope, specific or generic, on-going or terminated, etc.). The insights gained from this small collection are then reviewed. The appendix gives a full text version of the Member country contributions

  20. A Domain-Specific Language for Generic Interlocking Models and Their Properties

    DEFF Research Database (Denmark)

    Vu, Linh Hong; Haxthausen, Anne Elisabeth; Peleska, Jan

    2017-01-01

    of this work is to provide a domain-specific language for generic models and an instantiator tool taking not only configuration data but also a generic model as input instead of using a hard-coded generator for instantiating only one fixed generic model and its properties with configuration data....

  1. Increased Topical Generic Prices by Manufacturers: An Isolated Trend or Worrisome Future?

    Science.gov (United States)

    Bhatt, Mehul D; Bhatt, Birju D; Dorrian, James T; McLellan, Beth N

    2018-03-12

    There is limited data regarding generic medication prices. Recent studies have shown price changes at the retail level, but much is not known about the pharmaceutical supply chain or price changes at the manufacturer level. We sought to examine the extent of price changes for topical generic medications. A comprehensive review of average wholesale prices (AWP) and manufacturers of topical generics and available corresponding branded medications was conducted for 2005 and 2016. A total of 51 topical chemical entities were examined. Between 2005 and 2016, the AWP of topical generics increased by 273% and the AWP of topical branded increased by 379%. The topical generic with the most price change increased by 2529%. Eight of the top twenty topical generics with the highest increase in AWP also had an increase in the number of manufacturers. These findings are not generalizable to medications used in other areas of medicine CONCLUSIONS: Topical generic prices are rapidly increasing at the manufacturer level. Copyright © 2018. Published by Elsevier Inc.

  2. Advances in RGB and RGBD Generic Object Trackers

    KAUST Repository

    Bibi, Adel

    2016-04-01

    Visual object tracking is a classical and very popular problem in computer vision with a plethora of applications such as vehicle navigation, human computer interface, human motion analysis, surveillance, auto-control systems and many more. Given the initial state of a target in the first frame, the goal of tracking is to predict states of the target over time where the states describe a bounding box covering the target. Despite numerous object tracking methods that have been proposed in recent years [1-4], most of these trackers suffer a degradation in performance mainly because of several challenges that include illumination changes, motion blur, complex motion, out of plane rotation, and partial or full occlusion, while occlusion is usually the most contributing factor in degrading the majority of trackers, if not all of them. This thesis is devoted to the advancement of generic object trackers tackling different challenges through different proposed methods. The work presented propose four new state-of-the-art trackers. One of which is 3D based tracker in a particle filter framework where both synchronization and registration of RGB and depth streams are adjusted automatically, and three works in correlation filters that achieve state-of-the-art performance in terms of accuracy while maintaining reasonable speeds.

  3. Model-based explanation of plant knowledge

    Energy Technology Data Exchange (ETDEWEB)

    Huuskonen, P.J. [VTT Electronics, Oulu (Finland). Embedded Software

    1997-12-31

    This thesis deals with computer explanation of knowledge related to design and operation of industrial plants. The needs for explanation are motivated through case studies and literature reviews. A general framework for analysing plant explanations is presented. Prototypes demonstrate key mechanisms for implementing parts of the framework. Power plants, steel mills, paper factories, and high energy physics control systems are studied to set requirements for explanation. The main problems are seen to be either lack or abundance of information. Design knowledge in particular is found missing at plants. Support systems and automation should be enhanced with ways to explain plant knowledge to the plant staff. A framework is formulated for analysing explanations of plant knowledge. It consists of three parts: 1. a typology of explanation, organised by the class of knowledge (factual, functional, or strategic) and by the target of explanation (processes, automation, or support systems), 2. an identification of explanation tasks generic for the plant domain, and 3. an identification of essential model types for explanation (structural, behavioural, functional, and teleological). The tasks use the models to create the explanations of the given classes. Key mechanisms are discussed to implement the generic explanation tasks. Knowledge representations based on objects and their relations form a vocabulary to model and present plant knowledge. A particular class of models, means-end models, are used to explain plant knowledge. Explanations are generated through searches in the models. Hypertext is adopted to communicate explanations over dialogue based on context. The results are demonstrated in prototypes. The VICE prototype explains the reasoning of an expert system for diagnosis of rotating machines at power plants. The Justifier prototype explains design knowledge obtained from an object-oriented plant design tool. Enhanced access mechanisms into on-line documentation are

  4. Model-based explanation of plant knowledge

    Energy Technology Data Exchange (ETDEWEB)

    Huuskonen, P J [VTT Electronics, Oulu (Finland). Embedded Software

    1998-12-31

    This thesis deals with computer explanation of knowledge related to design and operation of industrial plants. The needs for explanation are motivated through case studies and literature reviews. A general framework for analysing plant explanations is presented. Prototypes demonstrate key mechanisms for implementing parts of the framework. Power plants, steel mills, paper factories, and high energy physics control systems are studied to set requirements for explanation. The main problems are seen to be either lack or abundance of information. Design knowledge in particular is found missing at plants. Support systems and automation should be enhanced with ways to explain plant knowledge to the plant staff. A framework is formulated for analysing explanations of plant knowledge. It consists of three parts: 1. a typology of explanation, organised by the class of knowledge (factual, functional, or strategic) and by the target of explanation (processes, automation, or support systems), 2. an identification of explanation tasks generic for the plant domain, and 3. an identification of essential model types for explanation (structural, behavioural, functional, and teleological). The tasks use the models to create the explanations of the given classes. Key mechanisms are discussed to implement the generic explanation tasks. Knowledge representations based on objects and their relations form a vocabulary to model and present plant knowledge. A particular class of models, means-end models, are used to explain plant knowledge. Explanations are generated through searches in the models. Hypertext is adopted to communicate explanations over dialogue based on context. The results are demonstrated in prototypes. The VICE prototype explains the reasoning of an expert system for diagnosis of rotating machines at power plants. The Justifier prototype explains design knowledge obtained from an object-oriented plant design tool. Enhanced access mechanisms into on-line documentation are

  5. Generic policy in Bulgaria: a policy of failure or success?

    Directory of Open Access Journals (Sweden)

    Assena Stoimenova

    2016-09-01

    Full Text Available Generic medicines play a key role in managing the financial resources for pharmaceuticals in every country. This study analysed the generic policy legislative framework in Bulgaria with the aim to identify whether the policy implementation can be considered successful in the light of an international review of such policies introduced in other countries, or on the contrary, it has failed to deliver the main benefits. Legislative analysis, desktop study and macroeconomic overview of the Bulgarian pharmaceutical market were included. The study showed that only 3 out of 11 important policy elements are implemented in the country. Bulgaria has one of the highest shares of generics, an average of 81.39% (volume, for the studied period (2006–2014. However, further research is needed to evaluate the success of the existing generic policy in Bulgaria, as the market share of generic drugs is not the only measure of the policy efficiency.

  6. The Impact of Information on Doctors’ Attitudes Toward Generic Drugs

    Directory of Open Access Journals (Sweden)

    Aggeliki V. Tsaprantzi MD

    2016-03-01

    Full Text Available The objective of this study is to assess the impact of information on doctors’ attitudes and perceptions toward generics. A cross-sectional survey based on a specially designed 21-item questionnaire was conducted. The survey involved doctors of different specialties working in a public hospital in Greece. The analysis includes descriptive and inferential statistics, reliability and validity tests, as well as structural equation modeling to evaluate the causal model. Statistical analysis was accomplished by using SPSS 20 and Amos 20. A total of 134 questionnaires out of 162 were received, providing a response rate of 82.71%. A number of significant associations were found between information and perceptions about generic medicines with demographic characteristics. It seems that the provision of quality information on generic drugs influences doctors’ attitudes and prescription practices toward generic drugs. This is not a static process but a rather dynamic issue involving information provision policies for strengthening the proper doctors’ attitudes toward generic drugs.

  7. Generic features of the dynamics of complex open quantum systems: statistical approach based on averages over the unitary group.

    Science.gov (United States)

    Gessner, Manuel; Breuer, Heinz-Peter

    2013-04-01

    We obtain exact analytic expressions for a class of functions expressed as integrals over the Haar measure of the unitary group in d dimensions. Based on these general mathematical results, we investigate generic dynamical properties of complex open quantum systems, employing arguments from ensemble theory. We further generalize these results to arbitrary eigenvalue distributions, allowing a detailed comparison of typical regular and chaotic systems with the help of concepts from random matrix theory. To illustrate the physical relevance and the general applicability of our results we present a series of examples related to the fields of open quantum systems and nonequilibrium quantum thermodynamics. These include the effect of initial correlations, the average quantum dynamical maps, the generic dynamics of system-environment pure state entanglement and, finally, the equilibration of generic open and closed quantum systems.

  8. When Does an Argument Use a Generic Example?

    Science.gov (United States)

    Yopp, David A.; Ely, Rob

    2016-01-01

    We offer criteria that an observer can use to determine whether an argument that uses an example to argue for a general claim appeals to that example generically. We review existing literature on generic example and note the strengths of each contribution, as well as inconsistencies among uses of the term. We offer several examples from the…

  9. The generics in transplantation and the rules on their use.

    Science.gov (United States)

    Masri, Marwan

    2003-06-01

    By definition a product identified by its official chemical name rather than an advertised brand name is called a generic. If a drug exert its pharmacological effects at the same site, have the same potency, same dosage form and same bioavailability as a brand name, reference listed drug (RLD), is considered as a generic. However inactive ingredients can differ between brand name and generic. It is through the regulations of the FDA that the generics gained many ground in the drug market, they currently account to more than 42% of the total prescription in the USA. These regulations include the abbreviated new drug application (ANDA) for the registration process and drug substitution at the pharmacy level without patient or physician consent. This coupled with a keen interest of third party payers and the health authorities to reduce the high transplant health budget (over 2 Billion US $) made it a necessity to introduce the generics into the field of transplantation. Using the above mentioned definition we can theoretically say that all anti-lymphocytes, produced in the same animal species, are generic of each. Moreover, monoclonal antibodies that are directed against the same target and have the same bioavailability are also consider generics to each other. Of all the immunosuppressive drugs that have been introduced into the field of transplantation none has been as dominant as Cyclosporine. Cyclosporine became and still is the backbone for any immunosuppressive protocol. In the year 1992, Consupren, the first, non-FDA approved, generic to Sandimmun was introduced. Although Consupren was not bioequivalent to Neoral, however, long-term results in kidney transplantation have been similar for both drugs. The introduction of Consupren resulted in a near 40% reduction in the total cost of immunosuppressive therapy. Interestingly the cost of the brand name drug Neoral was also reduced by 20%. The cost reduction allowed the introduction of the new immunosuppressive

  10. The SENSEI Generic In Situ Interface

    Energy Technology Data Exchange (ETDEWEB)

    Ayachit, Utkarsh [Kitware, Inc., Clifton Park, NY (United States); Whitlock, Brad [Intelligent Light, Rutherford, NJ (United States); Wolf, Matthew [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Loring, Burlen [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States); Geveci, Berk [Kitware, Inc., Clifton Park, NY (United States); Lonie, David [Kitware, Inc., Clifton Park, NY (United States); Bethel, E. Wes [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States)

    2017-04-11

    The SENSEI generic in situ interface is an API that promotes code portability and reusability. From the simulation view, a developer can instrument their code with the SENSEI API and then make make use of any number of in situ infrastructures. From the method view, a developer can write an in situ method using the SENSEI API, then expect it to run in any number of in situ infrastructures, or be invoked directly from a simulation code, with little or no modification. This paper presents the design principles underlying the SENSEI generic interface, along with some simplified coding examples.

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

    Science.gov (United States)

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

    2018-02-01

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

  12. 40 CFR 721.10146 - Partially fluorinated condensation polymer (generic).

    Science.gov (United States)

    2010-07-01

    ... polymer (generic). 721.10146 Section 721.10146 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... Specific Chemical Substances § 721.10146 Partially fluorinated condensation polymer (generic). (a) Chemical... as partially fluorinated condensation polymer (PMN P-07-87) is subject to reporting under this...

  13. Evaluation of safety implications of control systems in LWR nuclear power plants

    International Nuclear Information System (INIS)

    Szukiewicz, A.J.

    1989-06-01

    An in-depth evaluation was performed on non-safety-related control systems (see Section 1) that are typically used during normal plant operation on four nuclear steam supply system plants: a General Electric Company boiling-water reactor, a Westinghouse 3-loop pressurized-water reactor (PWR), a Babcock ampersand Wilcox Co. (B ampersand W) once-through steam generator PWR, and a Combustion Engineering PWR design. A study was also conducted to determine the generic applicability of the results to the class of plants represented by the specific plants analyzed. Generic conclusions were then developed. Steam generator and reactor vessel overfill events and reactor vessel overcooling events were identified as major classes of events having the potential to be more severe than previously analyzed. Specific substasks of this issue were to study these events to determine the need for preventive and/or mitigating design measures. This report describes the technical studies performed by the laboratories, the NRC staff assessment of the results, the generic applicability of the evaluations, and the technical findings resulting from these studies. This final report contains the staff's responses to, and resolution of, the public comments that were solicited and received before September 16,1988, in response to the draft reports issued for public comment on May 27, 1988. 39 refs, 1 fig., 7 tabs

  14. A summary of the conclusions of generic issue 113: Dynamic qualification and testing of large bore hydraulic snubbers

    International Nuclear Information System (INIS)

    Ware, A.G.; Nitzel, M.E.

    1993-01-01

    The Nuclear Regulatory Commission (NRC) developed Generic Issue 113, Dynamic Qualification and Testing of Large Bore Hydraulic Snubbers (LBHSs), with the objective of evaluating the reliability of LBHSs in operating commercial nuclear power plants. For the purposes of this research, LBHSs were defined as those hydraulic snubbers with rated load capacities ≥50 kips. Relatively high LBHS failure rates were common during the early 1980s; however, industry actions taken during the last several years in response to increased inspection and testing requirements have resulted in lower LBHS failure rates. To address the issue of LBHS adequacy, the NRC developed Generic Issue 113 (GI-113). This paper provides a summary of the important findings of the GI-113 research program and a discussion of the recommendations that were made in NUREG/CR-5416. Fifteen potential improvements in LBHS reliability were identified, covering the areas of design, environmental (including dynamic) qualification, functional testing, visual inspection, and personnel training. Probabilistic risk assessment studies were used to perform a cost/benefit analysis for each. There were five potential improvements in functional testing and visual inspections with low cost/benefit ratios for both existing and future nuclear plants, and an additional six potential improvements that were determined to be cost beneficial only for future plants. Further investigations of the single failure of snubbers that could damage critical components or systems were recommended in NUREG/CR-5416

  15. Kismeth: Analyzer of plant methylation states through bisulfite sequencing

    Directory of Open Access Journals (Sweden)

    Martienssen Robert A

    2008-09-01

    Full Text Available Abstract Background There is great interest in probing the temporal and spatial patterns of cytosine methylation states in genomes of a variety of organisms. It is hoped that this will shed light on the biological roles of DNA methylation in the epigenetic control of gene expression. Bisulfite sequencing refers to the treatment of isolated DNA with sodium bisulfite to convert unmethylated cytosine to uracil, with PCR converting the uracil to thymidine followed by sequencing of the resultant DNA to detect DNA methylation. For the study of DNA methylation, plants provide an excellent model system, since they can tolerate major changes in their DNA methylation patterns and have long been studied for the effects of DNA methylation on transposons and epimutations. However, in contrast to the situation in animals, there aren't many tools that analyze bisulfite data in plants, which can exhibit methylation of cytosines in a variety of sequence contexts (CG, CHG, and CHH. Results Kismeth http://katahdin.mssm.edu/kismeth is a web-based tool for bisulfite sequencing analysis. Kismeth was designed to be used with plants, since it considers potential cytosine methylation in any sequence context (CG, CHG, and CHH. It provides a tool for the design of bisulfite primers as well as several tools for the analysis of the bisulfite sequencing results. Kismeth is not limited to data from plants, as it can be used with data from any species. Conclusion Kismeth simplifies bisulfite sequencing analysis. It is the only publicly available tool for the design of bisulfite primers for plants, and one of the few tools for the analysis of methylation patterns in plants. It facilitates analysis at both global and local scales, demonstrated in the examples cited in the text, allowing dissection of the genetic pathways involved in DNA methylation. Kismeth can also be used to study methylation states in different tissues and disease cells compared to a reference sequence.

  16. A without-prejudice list of generic names of fungi for protection under the International Code of Nomenclature for algae, fungi, and plants.

    Science.gov (United States)

    Kirk, Paul M; Stalpers, Joost A; Braun, Uwe; Crous, Pedro W; Hansen, Karen; Hawksworth, David L; Hyde, Kevin D; Lücking, Robert; Lumbsch, Thorsten H; Rossman, Amy Y; Seifert, Keith A; Stadler, Mark

    2013-12-01

    As a first step towards the production of a List of Protected Generic Names for Fungi, a without-prejudice list is presented here as a basis for future discussion and the production of a List for formal adoption. We include 6995 generic names out of the 17072 validly published names proposed for fungi and invite comments from all interested mycologists by 31 March 2014. The selection of names for inclusion takes note of recent major publications on different groups of fungi, and further the decisions reached so far by international working groups concerned with particular families or genera. Changes will be sought in the Code to provide for this and lists at other ranks to be protected against any competing unlisted names, and to permit the inclusion of names of lichen-forming fungi. A revised draft will be made available for further discussion at the 10(th) International Mycological Congress in Bangkok in August 2014. A schedule is suggested for the steps needed to produce a list for adoption by the International Botanical Congress in August 2017. This initiative provides mycologists with an opportunity to place nomenclature at the generic level on a more secure and stable base.

  17. Modelling the power conversion unit of a generic nuclear fusion plant, with a dual coolant blanket and a supercritical CO2 power cycle, by means of RELAP5-3D

    Energy Technology Data Exchange (ETDEWEB)

    Batet, L.

    2015-07-01

    In the framework of the Spanish fusion program TECNO-FUS, a dual coolant blanket design was proposed for DEMO. A generic power conversion system (supercritical recompression CO2 cycle) based on this proposal has been simulated using RELAP5-3D, a multipurpose system thermal-hydraulic code developed by the Idaho National Laboratory (USA). The code allows the dynamic simulation of thermal-hydraulic systems, including the control features. A model has been set up by assembling the available RELAP5-3D components: pipe, branch, pump, compressor, turbine, etc. Thermal fluxes between fluids in heat exchangers are simulated by means of heat structures, which are used as well to simulate the heating from plasma. A number of control features have been designed for the simulated plant, and their parameters have been adjusted. The code is then able to simulate robustly the dynamics of the system with a few boundary conditions. This paper exemplifies the usefulness of the code and model to understand the behavior of the plant and to perform sensitivity analyses of the control parameters or other design features. (Author)

  18. 40 CFR 721.10151 - Modified styrene, divinylbenzene polymer (generic).

    Science.gov (United States)

    2010-07-01

    ... polymer (generic). 721.10151 Section 721.10151 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... Specific Chemical Substances § 721.10151 Modified styrene, divinylbenzene polymer (generic). (a) Chemical... as modified styrene, divinylbenzene polymer (PMN P-07-642) is subject to reporting under this section...

  19. Generic task problem descriptions: Category B, C, and D tasks

    International Nuclear Information System (INIS)

    1978-06-01

    This document contains information relating to Category B, C, and D generic technical activities. The specific information provided for each task includes the reactor type to which the generic issue applies, the NRC division with lead responsibility and a description of the problem to be addressed by the task. Also provided in this document is a listing of Category A generic technical activities and definitions of Priority Categories A, B, C, and D

  20. Demonstration of risk-based approaches to nuclear plant regulation

    International Nuclear Information System (INIS)

    Rahn, F.J.; Sursock, J.P.; Darling, S.S.; Oddo, J.M.

    1993-01-01

    This paper describes generic technical support EPRI is providing to the nuclear power industry relative to its recent initiatives in the area of risk-based regulations (RBR). A risk-based regulatory approach uses probabilistic risk assessment (PRA), or similar techniques, to allocate safety resources commensurate with the risk posed by nuclear plant operations. This approach will reduce O ampersand M costs, and also improve nuclear plant safety. In order to enhance industry, Nuclear Regulatory Commission (NRC) and public confidence in RBR, three things need to be shown: (1) manpower/resource savings are significant for both NRC and industry; (2) the process is doable in a reasonable amount of time; and (3) the process, if uniformly applied, results in demonstrably cheaper power and safer plants. In 1992, EPRI performed a qualitative study of the key RBR issues contributing to high O ampersand M costs. The results are given on Table 1. This study is being followed up by an in-depth quantitative cost/benefit study to focus technical work on producing guidelines/procedures for licensing submittals to NRC. The guidelines/procedures necessarily will be developed from successful demonstration projects such as the Fitzpatrick pilot plant study proposed by the New York Power Authority and other generic applications. This paper presents three examples: two motor operated valve projects performed by QUADREX Energy Services Corporation working with utilities in responding to NRC Generic Letter 89-10, and a third project working with Yankee Atomic Electric Company on service water systems at a plant in its service system. These demonstration projects aim to show the following: (1) the relative ease of putting together a technical case based on RBR concepts; (2) clarity in differentiating the various risk trade-offs, and in communicating overall reductions in risk with NRC; and (3) improved prioritization of NRC directives

  1. Pre-big bang bubbles from the gravitational instability of generic string vacua

    CERN Document Server

    Buonanno, A; Veneziano, Gabriele

    1999-01-01

    We formulate the basic postulate of pre-big bang cosmology as one of ``asymptotic past triviality'', by which we mean that the initial state is a generic perturbative solution of the tree-level low-energy effective action. Such a past-trivial ``string vacuum'' is made of an arbitrary ensemble of incoming gravitational and dilatonic waves, and is generically prone to gravitational instability, leading to the possible formation of many black holes hiding singular space-like hypersurfaces. Each such singular space-like hypersurface of gravitational collapse becomes, in the string-frame metric, the usual big-bang t=0 hypersurface, i.e. the place of birth of a baby Friedmann universe after a period of dilaton-driven inflation. Specializing to the spherically-symmetric case, we review and reinterpret previous work on the subject, and propose a simple, scale-invariant criterion for collapse/inflation in terms of asymptotic data at past null infinity. Those data should determine whether, when, and where collapse/infl...

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

    Science.gov (United States)

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

    2017-06-26

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

  3. Analysis of Knowledge Level and Perception on Singkawang City Community towards Generic Medicines

    Directory of Open Access Journals (Sweden)

    Forid Morison

    2015-03-01

    Full Text Available Survey data show that the use of generic medicines in Indonesia is relatively very small, which only amounted 7%. This is due to lack of knowledge and poor perceptions towards generic medicines. Knowledge level and perceptions towards generic medicines are inflenced by community characteristics and information resource regarding generic medicines. The aim of this study was to determine the association between community characteristic and information resources with knowledge level and perception towards generic medicines. This study was an analytical survey with cross-sectional descriptive approach on 142 selected respondents who were fulfi inclusion and exclusion criteria. This study was conducted in June 2014 at several randomly selected locations on Singkawang City. The study show that 76 respondents (53.5% had inadequate knowledge and 123 respondents (86.6% had a good perception towards generic medicines. There is signifiant relationship between ethnicity (p=0.000 and information resources (p=0.009 with knowledge level regarding generic medicines at signifiance level of p<0.05. Although good perceptions were noted among the respondents, widespread dissemination of information regarding generic medicines should be continued to increase generic medicines used.

  4. 77 FR 60125 - Generic Drug Facilities, Sites and Organizations

    Science.gov (United States)

    2012-10-02

    ...] Generic Drug Facilities, Sites and Organizations AGENCY: Food and Drug Administration, HHS. ACTION: Notice..., and certain sites and organizations identified in a generic drug submission, that they must provide... and Innovation Act (FDASIA). This notice is intended to help organizations ascertain if they need to...

  5. Experimental study on the plant state estimation for the condition-based maintenance

    International Nuclear Information System (INIS)

    Harada, J. I.; Takahashi, M.; Kitamura, M.; Wakabayashi, T.

    2006-01-01

    A framework of maintenance support system based on the plant state estimation using diverse methods has been proposed and the validity of the plant state estimation methods has been experimentally evaluated. The focus has been set on the construction of the BN for the objective system with the scale and complexity as same as real world systems. Another focus has been set on the other functions for maintenance support system such as signal processing tool and similarity matching. The validity of the proposed inference method has been confirmed through numerical experiments. (authors)

  6. Comparison of Generic Drug Reviews for Marketing Authorization between Japan and Canada.

    Science.gov (United States)

    Kuribayashi, Ryosuke; Appleton, Scott

    2017-09-01

    Generic drugs are assuming an increasingly important role in sustaining modern healthcare systems, as the cost of healthcare, including drug usage, is gradually expanding around the world. To date, published articles comparing generic drug reviews between different countries are scarce. The objective of this study was to examine generic drug reviews in Japan and Canada. We surveyed generic drug reviews from Japan and Canada and compared the following points: general matter (application types, type of partial change or Supplement to an Abbreviated New Drug Submission, application and approval numbers, review period, application format, review report, responsibility for review), bioequivalence studies for solid oral dosage forms, and bioequivalence guidelines, guidance, or basic principles regarding various dosage forms. This survey described the many similarities and differences in generic drug reviews between the two countries and points that should be improved to promote better generic drug reviews. In particular, regulations for the definition of the same or different active pharmaceutical ingredients (APIs) are similar for both authorities. The results clarified the future challenges of generic drug reviews, and the differences highlighted by this survey will be important considerations for the future. This is the first article to present and discuss the details of generic drug reviews between Japan and Canada.

  7. Evaluation of Generic Issue 57: Effects of fire protection system actuation on safety-related equipment

    International Nuclear Information System (INIS)

    Lambright, J.; Bohn, M.; Lynch, J.; Ross, S.; Brosseau, D.

    1992-12-01

    Nuclear power plants have experienced actuations of fire protection systems (FPSs) under conditions for which these systems were not intended to actuate and also have experienced advertent actuations with the presence of a fire. These actuations have often damaged safety-related equipment. A review of the impact of past occurrences of both types of such events and their impact on plant safety systems, an analysis of the risk impacts of such events on nuclear power plant safety, and a cost-benefit analysis of potential corrective measures have been performed. Thirteen different scenarios leading to actuation of fire protection systems due to a variety of causes were identified. These scenarios ranged from inadvertent actuation caused by human error to hardware failure, and include seismic root causes and seismic/fire interactions. A quantification of these thirteen root causes, where applicable, was performed on generically applicable scenarios. This document, Volume 4, contains appendices E and F of this report

  8. Introduction to Exxon nuclear fuel fabrication plant

    International Nuclear Information System (INIS)

    Schneider, R.A.

    1985-01-01

    The Exxon Nuclear low-enriched uranium fuel fabrication plant in Richland, Washington produces fuel assemblies for both pressurized water and boiling water reactors. The Richland plant was the first US bulk-handling facility selected by the IAEA for inspection under the US-IAEA Safeguards Agreement. The plant was under IAEA inspection from March 1981 through October 1983. This text provides a written description of the plant layout, operation and process. The text also includes a one ton-a-day model (or reference) plant which was adapted from the Exxon Nuclear plant. The Model Plant provides a generic example of a low-enriched uranium (LEU) bulk-handling facility. The Model Plant is used to illustrate in a more quantitative way some of the key safeguards requirements for a bulk-handling facility

  9. Avoidance of generic competition by Abbott Laboratories' fenofibrate franchise.

    Science.gov (United States)

    Downing, Nicholas S; Ross, Joseph S; Jackevicius, Cynthia A; Krumholz, Harlan M

    2012-05-14

    The ongoing debate concerning the efficacy of fenofibrate has overshadowed an important aspect of the drug's history: Abbott Laboratories, the maker of branded fenofibrate, has produced several bioequivalent reformulations that dominate the market, although generic fenofibrate has been available for almost a decade. This continued use of branded formulations, which cost twice as much as generic versions of fenofibrate, imposes an annual cost of approximately $700 million on the US health care system. Abbott Laboratories maintained its dominance of the fenofibrate market in part through a complex switching strategy involving the sequential launch of branded reformulations that had not been shown to be superior to the first-generation product and patent litigation that delayed the approval of generic formulations. The small differences in dose of the newer branded formulations prevented their substitution with generics of older-generation products. As soon as direct generic competition seemed likely at the new dose level, where substitution would be allowed, Abbott would launch another reformulation, and the cycle would repeat. Based on the fenofibrate example, our objective is to describe how current policy can allow pharmaceutical companies to maintain market share using reformulations of branded medications, without demonstrating the superiority of next-generation products.

  10. Canada ordered to implement WTO ruling against "stockpiling" of generic drugs.

    Science.gov (United States)

    Elliott, R

    2000-01-01

    In the last issue, we reported on a mixed World Trade Organization (WTO) ruling regarding Canada's patent laws, based on a complaint by the member states of the European Communities (joined by the United States). In March 2000, a WTO Panel accepted the provision in Canada's Patent Act that creates an "early working exception" to patent rights--in other words, that allows a third party to use a patented invention during the term of patent protection, as long as the use is for obtaining regulatory approval of an equivalent product to be sold once the patent expires. This was an important victory from the perspective of allowing earlier access to generic versions of patented drugs.

  11. Generic legislation of new psychoactive drugs.

    Science.gov (United States)

    van Amsterdam, Jan; Nutt, David; van den Brink, Wim

    2013-03-01

    New psychoactive drugs (NPDs, new psychoactive substances) enter the market all the time. However, it takes several months to ban these NPDs and immediate action is generally not possible. Several European countries and drug enforcement officers insist on a faster procedure to ban NPDs. Introduction of generic legislation, in which clusters of psychotropic drugs are banned in advance, has been mentioned as a possible solution. Here we discuss the pros and cons of such an approach. First, generic legislation could unintentionally increase the expenditures of enforcement, black market practices, administrative burden and health risks for users. Second, it may have a negative impact on research and the development of new treatments. Third, due to the complexity of generic legislation, problems in the enforcement are anticipated due to lack of knowledge about the chemical nomenclature. Finally, various legal options are already available to ban the use, sale and trade of NPDs. We therefore conclude that the currently used scientific benefit-risk evaluation should be continued to limit the adverse health effects of NPDs. Only in emergency cases, where fatal incidents (may) occur, should this approach be overruled.

  12. A Generic Danish Distribution Grid Model for Smart Grid Technology Testing

    DEFF Research Database (Denmark)

    Cha, Seung-Tae; Wu, Qiuwei; Østergaard, Jacob

    2012-01-01

    This paper describes the development of a generic Danish distribution grid model for smart grid technology testing based on the Bornholm power system. The frequency dependent network equivalent (FDNE) method has been used in order to accurately preserve the desired properties and characteristics...... as a generic Smart Grid benchmark model for testing purposes....... by comparing the transient response of the original Bornholm power system model and the developed generic model under significant fault conditions. The results clearly show that the equivalent generic distribution grid model retains the dynamic characteristics of the original system, and can be used...

  13. Design of XML-based plant data model

    International Nuclear Information System (INIS)

    Nair, Preetha M.; Padmini, S.; Gaur, Swati; Diwakar, M.P.

    2013-01-01

    XML has emerged as an open standard for exchanging structured data on various platforms to handle rich, nested, complex data structures. XML with its flexible tree-like data structure allows a more natural representation as compared to traditional databases. In this paper we present data model for plant data acquisition systems captured using XML technologies. Plant data acquisition systems in a typical Nuclear Power Plant consists of embedded nodes at the first tier and operator consoles at the second tier for operator operation, interaction and display of Plant parameters. This paper discusses a generic data model that was designed to capture process, network architecture, communication/interface protocol and diagnostics aspects required for a Nuclear Power Plant. (author)

  14. Restructuring upstream bioprocessing: technological and economical aspects for production of a generic microbial feedstock from wheat.

    Science.gov (United States)

    Koutinas, A A; Wang, R; Webb, C

    2004-03-05

    Restructuring and optimization of the conventional fermentation industry for fuel and chemical production is necessary to replace petrochemical production routes. Guided by this concept, a novel biorefinery process has been developed as an alternative to conventional upstream processing routes, leading to the production of a generic fermentation feedstock from wheat. The robustness of Aspergillus awamori as enzyme producer is exploited in a continuous fungal fermentation on whole wheat flour. Vital gluten is extracted as an added-value byproduct by the conventional Martin process from a fraction of the overall wheat used. Enzymatic hydrolysis of gluten-free flour by the enzyme complex produced by A. awamori during fermentation produces a liquid stream rich in glucose (320 g/L). Autolysis of fungal cells produces a micronutrient-rich solution similar to yeast extract (1.6 g/L nitrogen, 0.5 g/L phosphorus). The case-specific combination of these two liquid streams can provide a nutrient-complete fermentation medium for a spectrum of microbial bioconversions for the production of such chemicals as organic acids, amino acids, bioethanol, glycerol, solvents, and microbial biodegradable plastics. Preliminary economic analysis has shown that the operating cost required to produce the feedstock is dependent on the plant capacity, cereal market price, presence and market value of added-value byproducts, labor costs, and mode of processing (batch or continuous). Integration of this process in an existing fermentation plant could lead to the production of a generic feedstock at an operating cost lower than the market price of glucose syrup (90% to 99% glucose) in the EU, provided that the plant capacity exceeds 410 m(3)/day. Further process improvements are also suggested. Copyright 2004 Wiley Periodicals, Inc.

  15. Endogenous versus exogenous generic reference pricing for pharmaceuticals.

    Science.gov (United States)

    Antoñanzas, F; Juárez-Castelló, C A; Rodríguez-Ibeas, R

    2017-12-01

    In this paper we carry out a vertical differentiation duopoly model applied to pharmaceutical markets to analyze how endogenous and exogenous generic reference pricing influence competition between generic and branded drugs producers. Unlike the literature, we characterize for the exogenous case the equilibrium prices for all feasible relevant reference prices. Competition is enhanced after the introduction of a reference pricing system. We also compare both reference pricing systems on welfare grounds, assuming two different objective functions for health authorities: (i) standard social welfare and (ii) gross consumer surplus net of total pharmaceutical expenditures. We show that regardless of the objective function, health authorities will never choose endogenous reference pricing. When health authorities are paternalistic, the exogenous reference price that maximizes standard social welfare is such that the price of the generic drug is the reference price while the price of the branded drug is higher than the reference price. When health authorities are not paternalistic, the optimal exogenous reference price is such that the price of the branded drug is the reference price while the price of the generic drug is lower than the reference price.

  16. Development of a generic virus behavioural detector: a preview ...

    African Journals Online (AJOL)

    The Generic Virus Behavioral Detector (GVBD) is a system (program) that monitors various system activities; reading and writing block of disks and memory and the use of Interrupts. A technique for its realisation is presented. Key Words: Computer virus, interrupts, handlers, GVBD (Generic Virus Behavioral Detector).

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

    Directory of Open Access Journals (Sweden)

    Marília Cruz Guttier

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

  18. 40 CFR 721.10017 - Amine terminated bisphenol A diglycidyl ether polymer (generic).

    Science.gov (United States)

    2010-07-01

    ... diglycidyl ether polymer (generic). 721.10017 Section 721.10017 Protection of Environment ENVIRONMENTAL... ether polymer (generic). (a) Chemical substances and significant new uses subject to reporting. (1) The chemical substances identified generically as amine terminated bisphenol A diglycidyl ether polymer (PMNs P...

  19. GENERIC DRUG IN GLOBAL MARKET AND REGULATORY ENVIRONMENT

    OpenAIRE

    Pankaj Kumar*, Bharti Mangla2, Satbir Singh, Arapna Rana

    2017-01-01

    Different regulatory authorities regulate the drug development in various countries of the world. Various Regulatory authority for generic drug application Food and Drug Administration (FDA), European Medicines Agency (EMA), Pharmaceutical and Medical Devices Agency (PMDA), Health Product and Food Branch (HPFB) Central Drug Standard of Organization (CDSO). Generic manufacturers may file an abbreviated New Drug Application (ANDA) that incorporates the safety/effectiveness data submitted by ori...

  20. Contributions towards a monograph of Phoma (Coelomycetes) — III. 2. Misapplications of the type species name and the generic synonyms of section Plenodomus (Excluded species)

    NARCIS (Netherlands)

    Boerema, G.H.; Loerakker, W.M.; Hamers, Maria E.C.

    1996-01-01

    Various old records of Phoma lingam (teleomorph Leptosphaeria maculans) on non-cruciferous plants proved to be based on misidentifications. In the past the fungus has also often been confused with other fungi occurring on crucifers. Forty-five species formerly classified under the generic synonyms

  1. Potential cost savings from generic medicines – protecting the ...

    African Journals Online (AJOL)

    the difference between brand and generic medicines listed for that algorithm, and also as the median of differences between generic medicines for the same condition. Results: Three of the algorithms .... Protecting the PMBs, as a key element of the new community-rated medical schemes environment, is therefore vital.

  2. Does the market share of generic medicines influence the price level?: a European analysis.

    Science.gov (United States)

    Dylst, Pieter; Simoens, Steven

    2011-10-01

    After the expiry of patents for originator medicines, generic medicines can enter the market, and price competition may occur. This process generates savings to the healthcare payer and to patients, but knowledge about the factors affecting price competition in the pharmaceutical market following patent expiry is still limited. This study aimed to investigate the relationship between the market share of generic medicines and the change of the medicine price level in European off-patent markets. Data on medicine volumes and values for 35 active substances were purchased from IMS Health. Ex-manufacturer prices were used, and the analysis was limited to medicines in immediate-release, oral, solid dosage forms. Countries included were Austria, Belgium, Denmark, Germany, France, Italy, the Netherlands, Spain, Sweden and the UK, which constitute a mix of countries with low and high generic medicines market shares. Data were available from June 2002 until March 2007. Market volume has risen in both high and low generic market share countries (+29.27% and +27.40%, respectively), but the cause of the rise is different for the two markets. In low generic market share countries, the rise was caused by the increased use of generic medicines, while in high market share countries, the rise was driven by the increased use of generic medicines and a shift of use from originator to generic medicines. Market value was substantially decreased in high generic market share countries (-26.6%), while the decrease in low generic market share countries was limited (-0.06%). In high generic market share countries, medicine prices dropped by -43.18% versus -21.56% in low market share countries. The extent to which price competition from generic medicines leads to price reductions appears to vary according to the market share of generic medicines. High generic market share countries have seen a larger decrease in medicine prices than low market share countries.

  3. Pharmaceutical quality of docetaxel generics versus originator drug product: a comparative analysis.

    Science.gov (United States)

    Vial, Jérôme; Cohen, Mélanie; Sassiat, Patrick; Thiébaut, Didier

    2008-07-01

    The aim of this study was to evaluate the quality of 31 commercially available generic formulations of docetaxel purchased in 14 countries by comparing their docetaxel content, impurity levels and pH versus those of the proprietary product Taxotere (Tx). Generic formulations were purchased in 14 countries in Asia, Africa, the Middle East and Latin America. Levels of docetaxel and impurities (chromatographic peaks above 0.05%) were obtained for each sample using reverse-phase liquid chromatography with ultraviolet detection. The pH of aqueous solutions of generic docetaxel formulations and Tx was also measured. A global evaluation of quality was conducted on each product using a multicriteria desirability analysis based on standards defined by the International Conference on Harmonisation guidelines and the US Pharmacopeia paclitaxel injection monograph. Most generic formulations contained a lower than expected amount of docetaxel and/or a high level of impurities: 21 generic docetaxel formulations had an average mass of docetaxel that was generic docetaxel formulations had a total impurity content of >3.0%, almost twice the level of impurities in Tx 20 mg. In total, 33 impurities not present in Tx were detected in the generic samples. Desirability analysis demonstrated that none of the generic docetaxel formulations had composition characteristics similar to those of Tx. This study demonstrated that from an analytical point of view, 90% of the generic docetaxel formulations evaluated contained insufficient active drug, high levels of impurities or both. This has the potential to affect both efficacy and safety of the drug.

  4. Cisplatin-induced hyponatremia in malignancy: comparison between brand-name and generic formulation.

    Science.gov (United States)

    Ochi, Nobuaki; Yamane, Hiromichi; Hotta, Katsuyuki; Fujii, Hiromi; Isozaki, Hideko; Honda, Yoshihiro; Yamagishi, Tomoko; Kubo, Toshio; Tanimoto, Mitsune; Kiura, Katsuyuki; Takigawa, Nagio

    2014-01-01

    Widespread use of generic drugs is considered to be indispensable if reductions in total health care costs are to be achieved, but the market share of such drugs remains low. In general, generic drugs have the same active ingredients as brand-name drugs, but this is not always the case. Thus, toxicity profiles may vary when brand-name and generic drugs are compared. We retrospectively investigated the incidence of hyponatremia in patients receiving brand-name cisplatin (CDDP) and a generic counterpart thereof. We reviewed the medical records of patients treated with brand-name CDDP (n=53) and a generic formulation (n=26), and compared the incidences of hyponatremia and renal toxicity. Toxicities were graded using the Common Terminology Criteria for Adverse Events, version 4.0. Differences between groups were evaluated using the Student's t-test, and the odds ratio for hyponatremia was estimated via logistic regression analysis. Serum creatinine levels after chemotherapy increased significantly in both the brand-name and generic CDDP groups; no significant difference was evident between the two groups. Hyponatremia of grade 3 or above developed in 30.7% of the generic CDDP group compared to 15.1% of the brand-name CDDP group (P=0.011). Multivariate analysis showed that the use of generic CDDP increased the incidence of hyponatremia (odds ratio =5.661, 95% confidence interval =1.403-22.839; P=0.015). Oncologists should be aware that use of a generic CDDP might be associated with more hyponatremia than would use of brand-name CDDP.

  5. Development of the generic drug industry in the US after the Hatch-Waxman Act of 1984

    Directory of Open Access Journals (Sweden)

    Garth Boehm

    2013-09-01

    Full Text Available The key events in the development of the US generic drug industry after the Hatch-Waxman Act of 1984 are systematically reviewed, including the process of approval for generic drugs, bioequivalence issues including “switchability”, bioequivalence for complicated dosage forms, patent extension, generic drug safety, generic substitution and low-cost generics. The backlog in generic review, generic drug user fees, and “quality by design” for generic drugs is also discussed. The evolution of the US generic drug industry after the Hatch-Waxman Act in 1984 has afforded several lessons of great benefit to other countries wishing to establish or re-establish a domestic generic drug industry.

  6. Construction labor productivity during nuclear power plant construction

    International Nuclear Information System (INIS)

    Murray, W.B.

    1980-01-01

    There is no single satisfactory way to measure productivity in the construction industry. The industry is too varied, too specialized and too dependent upon vast numbers of interrelations between trades, contractors, designers and owners. Hence, no universally reliable indices for measuring construction productivity has been developed. There are problems that are generic to all large union-built nuclear power plants. The actions of any one owner cannot rectify the shortcomings of the construction industry. The generic problems are being identified, and many national organizations are attempting to make the construction industry more productive by recommending various changes

  7. Factors influencing anti-asthmatic generic drug consumption in Morocco: 1999-2010.

    Science.gov (United States)

    Ghanname, Imane; Ahid, Samir; Berrada, Ghizlane; Belaiche, Abdelmjid; Hassar, Mohammed; Cherrah, Yahia

    2014-01-01

    The increasing availability of generic drugs (GD) resulted in a remarkable reduction in treatment costs that allowed a better access to health care.The aim of this study is to evaluate the share of anti-asthmatic generic drugs during the period 1999-2010 in Morocco and to look at the factors influencing generic development. In this study, we used Moroccan sales data from IMS Health (Intercontinental Marketing Services). The consumption of the drugs was expressed in DDD/1000 inhabitants/day according to the WHO ATC/DDD methodology. Between 1999 and 2010, anti-asthmatic consumption increased from 3.91 to 14.43 DDD/1000 inhabitants/day. The market of anti-asthmatic generic drugs progressed from 1.83 (47%) to 2.18 (23%) DDD/1000 inhabitants/day from 1999 to 2010. In 2010, inhaled glucocorticosteroids ranked first (0.83 DDD/1000 inhabitants/day), followed by inhaled short acting beta agonists (0.73 DDD/1000 inhabitants/day). The number of brands went from 27 in 1999 to 34 in 2010, with a generic share increasing from 55.55% to 70.59%. The number of anti-asthmatic pharmaceutical preparations increased from 57 to 64 during the same period, of which 31 and 42 were generic preparations. In 2010, the total cost of anti-asthmatic dugs was about 22 million euro, the generics representing 14 million euro. Despite the introduction of a compulsory insurance scheme called "AMO", that allows a refund for 69.5% of anti-asthmatic specialties marketed in Morocco, anti-asthmatic generic drug consumption remains limited. The Moroccan market is still largely dominated by the originator drugs with still valid patents.

  8. Optimal Anti-cancer Drug Profiles for Effective Penetration of the Anti-cancer Drug Market by Generic Drugs in Japan.

    Science.gov (United States)

    Shibata, Shoyo; Matsushita, Maiko; Saito, Yoshimasa; Suzuki, Takeshi

    2017-01-01

    The increased use of generic drugs is a good indicator of the need to reduce the increasing costs of prescription drugs. Since there are more expensive drugs compared with other therapeutic areas, "oncology" is an important one for generic drugs. The primary objective of this article was to quantify the extent to which generic drugs in Japan occupy each level of the Anatomical Therapeutic Chemical (ATC) classification system. The dataset used in this study was created from publicly available information obtained from the IMS Japan Pharmaceutical Market database. Data on the total amount of sales and number of prescriptions for anti-cancer drugs between 2010 and 2016 in Japan were selected. The data were categorized according to the third level of the ATC classification system. All categories of the ATC classification system had increased market shares in Japan between 2010 and 2016. The barriers to market entry were relatively low in L01F (platinum anti-neoplastics), L01C (plant-based neoplastics), L02B (cytostatic hormone antagonists), and L01D (anti-neoplastic antibiotics) but were high in L02A (cytostatic hormones), L01H (protein kinase inhibitors), and L01B (anti-metabolites). Generic cancer drugs could bring savings to Japanese health care systems. Therefore, their development should be directed toward niche markets, such as L02A, L01H, and L01B, and not competitive markets.

  9. Generic ICT Skills Profiles: Future Skills for Tomorrow's World.

    Science.gov (United States)

    International Co-operation Europe Ltd. (ICEL), Brussels, Belgium.

    This document describes generic skills profiles relevant to key jobs in information and communications technology (ICT). The profiles cover the main job areas for which the ICT industry is experiencing skills shortages. These types of information are provided for 18 generic job profiles: job description (vision, role, lifestyle); examples of job…

  10. Plant wealth of a sacred grove: Mallur Gutta, Telangana state, India

    Directory of Open Access Journals (Sweden)

    Suthari S

    2016-10-01

    Full Text Available Sateesh Suthari,1 Ramesh Kandagalta,2 Ajmeera Ragan,2 Vatsavaya S Raju,2 1Department of Plant Sciences, School of Life Sciences, University of Hyderabad, Hyderabad, 2Plant Systematics Laboratory, Department of Botany, Kakatiya University, Warangal, India Abstract: The Mallur Gutta (Hill of Warangal district in Telangana state, India, reputed as a habitat for medicinal plants, was inventoried from 2009 to 2015 for its plant wealth through the traditional knowledge of the local people. The Hindu temples of Lord Sri Laxminarasimha Swamy and Lord Hanuman, and the ethnic worship of mahua trees indicated it was a sacred grove which was selected as a Medicinal Plants Conservation Area. The exploration of Mallur Gutta resulted in the enumeration and documentation of plant wealth representing 470 species of 318 genera pertaining to 95 families of vascular plants. The importance of the grove as the residence for many rare or medicinal species in the state of Telangana is documented. The plant diversity is analyzed in terms of growth and life forms which indicate the prevailing microclimate, ecological opportunities and the species richness. The ecological services rendered by the Mallur Gutta forest ecosystem are documented to study how the great majority of the species are used by the ethnic and nonethnic people, and also the pilgrims who visit the shrine for its serenity. The study also identified two major threats to the conservation of hill ecosystem and the archeological site: 1 biotic pressure (the ever-increasing pilgrims, grazing by cattle, goat and sheep, the development activities taken up for the pilgrims, nondegradable litter thrown, collection of medicinal plants and widening of the pathway to the Chintamani perennial stream – the trampling and alien plant invasions of the marsh sustaining the stream; and 2 the potential for fire spreading from burning the litter. The study suggests the need to initiate remedial measures toward ecosystem

  11. ELMO Bumpy Torus Reactor and power plant: conceptual design study

    International Nuclear Information System (INIS)

    Bathke, C.G.; Dudziak, D.J.; Krakowski, R.A.

    1981-08-01

    A complete power plant design of a 1200-MWe ELMO Bumpy Torus Reactor (EBTR) is presented. An emphasis is placed on those features that are unique to the EBT confinement concept, with subsystems and balance-of-plant items that are more generic to magnetic fusion being adapted from past, more extensive tokamak reactor designs. Similar to the latter tokamak studies, this conceptual EBTR design also emphasizes the use of conventional or near state-of-the-art engineering technology and materials. An emphasis is also placed on system accessibility, reliability, and maintainability, as these crucial and desirable characteristics relate to the unique high-aspect-ratio configuration of EBTs. Equal and strong emphasis is given to physics, engineering/technology, and costing/economics components of this design effort. Parametric optimizations and sensitivity studies, using cost-of-electricity as an object function, are reported. Based on these results, the direction for future improvement on an already attractive reactor design is identified

  12. 75 FR 80547 - Carolina Power & Light Company, Shearon Harris Nuclear Power Plant, Unit No. 1; Exemption

    Science.gov (United States)

    2010-12-22

    ..., Shearon Harris Nuclear Power Plant, Unit No. 1; Exemption 1.0 Background Carolina Power & Light Company... operation of the Shearon Harris Nuclear Power Plant (HNP), Unit 1. The license provides, among other things... request to generically extend the rule's compliance date for all operating nuclear power plants, but noted...

  13. Out of the shadows : multiple nutrient limitations drive relationships among biomass, light and plant diversity

    NARCIS (Netherlands)

    Harpole, W. Stanley; Sullivan, Lauren L.; Lind, Eric M.; Firn, Jennifer; Adler, Peter B.; Borer, Elizabeth T.; Chase, Jonathan; Fay Jennifer Firn, Philip A.; Hautier, Yann; Hillebrand, Helmut; MacDougall, Andrew S.; Seabloom, Eric W.; Bakker, Jonathan D.; Cadotte, Marc W; Chaneton, Enrique J; Chu, Chengjin; Hagenah, Nicole; Kirkman, Kevin; La Pierre, Kimberly J.; Moore, Joslin L.; Morgan, John W.; Prober, Suzanne M.; Risch, Anita C.; Schuetz, Martin; Stevens, Carly J.

    2017-01-01

    The paradigmatic hypothesis for the effect of fertilisation on plant diversity represents a one-dimensional trade-off for plants competing for below-ground nutrients (generically) and above-ground light: fertilisation reduces competition for nutrients while increasing biomass and thereby shifts

  14. Generic Schemes for Single-Molecule Kinetics. 3: Self-Consistent Pathway Solutions for Nonrenewal Processes.

    Science.gov (United States)

    Piephoff, D Evan; Cao, Jianshu

    2018-04-23

    We recently developed a pathway analysis framework (paper 1) for describing single-molecule kinetics for renewal (i.e., memoryless) processes based on the decomposition of a kinetic scheme into generic structures. In our approach, waiting time distribution functions corresponding to such structures are expressed in terms of self-consistent pathway solutions and concatenated to form measurable probability distribution functions (PDFs), affording a simple way to decompose and recombine a network. Here, we extend this framework to nonrenewal processes, which involve correlations between events, and employ it to formulate waiting time PDFs, including the first-passage time PDF, for a general kinetic network model. Our technique does not require the assumption of Poissonian kinetics, permitting a more general kinetic description than the usual rate approach, with minimal topological restrictiveness. To demonstrate the usefulness of this technique, we provide explicit calculations for our general model, which we adapt to two generic schemes for single-enzyme turnover with conformational interconversion. For each generic scheme, wherein the intermediate state(s) need not undergo Poissonian decay, the functional dependence of the mean first-passage time on the concentration of an external substrate is analyzed. When conformational detailed balance is satisfied, the enzyme turnover rate (related to the mean first-passage time) reduces to the celebrated Michaelis-Menten functional form, consistent with our previous work involving a similar scheme with all rate processes, thereby establishing further generality to this intriguing result. Our framework affords a general and intuitive approach for evaluating measurable waiting time PDFs and their moments, making it a potentially useful kinetic tool for a wide variety of single-molecule processes.

  15. Inventory of power plants in the United States. [By state within standard Federal Regions, using county codes

    Energy Technology Data Exchange (ETDEWEB)

    None

    1977-12-01

    The purpose of this inventory of power plants is to provide a ready reference for planners whose focus is on the state, standard Federal region, and/or national level. Thus the inventory is compiled alphabetically by state within standard Federal regions. The units are listed alphabetically within electric utility systems which in turn are listed alphabetically within states. The locations are identified to county level according to the Federal Information Processing Standards Publication Counties and County Equivalents of the States of the United States. Data compiled include existing and projected electrical generation units, jointly owned units, and projected construction units.

  16. Use of plant specific PSA to evaluate incidents at nuclear power plants

    International Nuclear Information System (INIS)

    1991-06-01

    One of the possible applications of the plant specific probabilistic safety assessment (PSA) is its use in the analysis of operational events at the plant. The methodological development in that area was initiated recently in the framework of the IAEA's Incident Reporting System where determination of the safety significance of the event is essential for optimizing feedback of operating experience. This report provides details of the methodology and procedures to be used in event analysis. The report also contains three case studies which have been performed and summarizes lessons learned from those case studies. The results (event probabilities) obtained using plant specific PSA and the results of the analysis of the same events in the framework of the Accident Sequence Precursor (ASP) programmes (generic models) were compared and commented on. 6 refs, figs and tabs

  17. Applicability of federal and state environmental requirements to selected DOE field installations and recommendations for development of generic compliance guidance. Final report

    International Nuclear Information System (INIS)

    1982-01-01

    This final report identifies and describes federal and state environmental requirements applicable to selected Department of Energy (DOE) nuclear field installations, establishes priorities for the requirements, determines the need for development of additional compliance guidance, and recommends development of compliance guidance for specific priority requirements. Compliance guidance developed as part of the study is summarized. The applicability of environmental requirements to 12 DOE field installations was reviewed. Five installations were examined under Task 4. They are: Nevada Test Site; Lawrence Berkeley Laboratory; Paducah Gaseous Diffusion Plant; Oak Ridge Y-12 Plant; and Los Alamos Scientific Laboratory. Seven other installations were reviewed under Task 2 and included: Idaho National Engineering Laboratory; Hanford; Savannah River Plant; Oak Ridge Gaseous Diffusion Plant; Pantex Plant; Rocky Flats Plant; and Lawrence Livermore Laboratory. This report combines results of the two tasks. The objective of the study was to identify the set of environmental requirements which are applicable to DOE field installations, track changes in the requirements, and prepare compliance guidance for important requirements and important regulatory developments as necessary. A cumulative calendar update for July 1982 represents the current status of applicable requirements. Environmental profiles of each facility, along with ambient monitoring results, are presented. Applicable federal requirements are identified. The specific applicability of federal and state requirements is detailed for each installation. Compliance guidance available from various agencies is described. Each requirement described is ranked by priority, and recommendations are made for development of additional guidance

  18. Integrated plant-safety assessment, Systematic Evaluation Program: Big Rock Point Plant (Docket No. 50-155)

    International Nuclear Information System (INIS)

    1983-09-01

    The Systematic Evaluation Program was initiated in February 1977 by the US Nuclear Regulatory Commission to review the designs of older operating nuclear reactor plants to reconfirm and document their safety. This report documents the review of the Big Rock Point Plant, which is one of ten plants reviewed under Phase II of this program. This report indicates how 137 topics selected for review under Phase I of the program were addressed. It also addresses a majority of the pending licensing actions for Big Rock Point, which include TMI Action Plan requirements and implementation criteria for resolved generic issues. Equipment and procedural changes have been identified as a result of the review

  19. Consumers' views on generic medicines: a review of the literature.

    Science.gov (United States)

    Hassali, Mohamed A A; Shafie, Asrul A; Jamshed, Shazia; Ibrahim, Mohamed I M; Awaisu, Ahmed

    2009-04-01

    To review the literature on consumers' knowledge, attitudes and opinions of the use of generic medicines. A narrative review of studies conducted from 1970 to 2008 on consumers perceptions and views towards generic medicines was performed. An extensive literature search was undertaken using indexing services available at the authors' institution library. The following keywords were used for the search: brand, generic, multisource, medications, medicines, drugs, pharmaceuticals and consumers, customers, and patients. Electronic databases searched were Medline, Inside Web, ISI Web of Knowledge, Science Direct, Springer Link, JSTOR, Proquest, Ebsco Host and Google Scholar. These electronic databases were searched for full text papers published in English from 1970 to October 2008. Twenty studies were identified. Eleven were from the USA, four were from Europe, two were from Canada and one each was from Australia, Brazil and Malaysia. In general, consumers showed mixed reactions towards the use of generic medicines. This was evident from the divergence of views observed by country development level, consumers' socioeconomic characteristics, drug product characteristics, pharmaceutical reimbursement system, policy environment, contact with health care professionals, past experience with medications, and knowledge of the seriousness of a medical condition. Patient confidence and knowledge pertaining to generic medicines use have increased over the past four decades, especially in developed countries. Mass educational efforts, financial incentives, and greater communication among patients and health care professionals were seen as major drivers to the uptake of generic medicines among consumers.

  20. [Two cases of pulmonary aspergilosis, which deteriorated with generic itraconazole].

    Science.gov (United States)

    Saito, Wakana; Shishikura, Yutaka; Nishimaki, Katsushi; Kikuchi, Tadashi; Sasamori, Kan; Kikuchi, Yoshihiro; Miki, Hiroshi

    2014-07-01

    We experienced two cases of pulmonary aspergillosis, which deteriorated during treatment with generic itraconazole (ITCZ) because of low plasma concentration. One case was chronic pulmonary aspergillosis and the other was allergic bronchopulmonary aspergillosis (ABPA). Treatment of both cases was started with a brand-name-ITCZ, and changed to a generic ITCZ. Deterioration of pulmonary aspergillosis occurred after 8 months and 9 months from change to generic ITCZ respectively. In the first case, the ITCZ-plasma concentration was 46.9 ng/mL and of OH-ITCZ 96.5 ng/mL with generic ITCZ at the dose of 300 mg/day, but increased to 1,559.7 ng/mL and to 2,485.0 ng/mL with the brand-name-ITCZ 300 mg/day, respectively. In the second case, the ITCZ-plasma concentration was 27.2 ng/mL and of OH-ITCZ 20.1 ng/mL with 150 mg/day for generic ITCZ, but reached 857.3 ng/mL and to 1,144.2 ng/ml with the brand-name-ITCZ 300 mg/day, respectively. After treatment failure, the first case was changed to voriconazole, then brand-name-ITCZ 300 mg/day, and the second case to the brand-name-ITCZ 300 mg/day, with successful clinical course. Plasma concentrations of ITCZ can differ significantly depending on the patient or type of ITCZ. The ITCZ-plasma concentration should be controlled after changing from a brand-name-ITCZ to a generic ITCZ.

  1. Generic physical protection logic trees

    International Nuclear Information System (INIS)

    Paulus, W.K.

    1981-10-01

    Generic physical protection logic trees, designed for application to nuclear facilities and materials, are presented together with a method of qualitative evaluation of the trees for design and analysis of physical protection systems. One or more defense zones are defined where adversaries interact with the physical protection system. Logic trees that are needed to describe the possible scenarios within a defense zone are selected. Elements of a postulated or existing physical protection system are tagged to the primary events of the logic tree. The likelihood of adversary success in overcoming these elements is evaluated on a binary, yes/no basis. The effect of these evaluations is propagated through the logic of each tree to determine whether the adversary is likely to accomplish the end event of the tree. The physical protection system must be highly likely to overcome the adversary before he accomplishes his objective. The evaluation must be conducted for all significant states of the site. Deficiencies uncovered become inputs to redesign and further analysis, closing the loop on the design/analysis cycle

  2. Generic physical protection logic trees

    Energy Technology Data Exchange (ETDEWEB)

    Paulus, W.K.

    1981-10-01

    Generic physical protection logic trees, designed for application to nuclear facilities and materials, are presented together with a method of qualitative evaluation of the trees for design and analysis of physical protection systems. One or more defense zones are defined where adversaries interact with the physical protection system. Logic trees that are needed to describe the possible scenarios within a defense zone are selected. Elements of a postulated or existing physical protection system are tagged to the primary events of the logic tree. The likelihood of adversary success in overcoming these elements is evaluated on a binary, yes/no basis. The effect of these evaluations is propagated through the logic of each tree to determine whether the adversary is likely to accomplish the end event of the tree. The physical protection system must be highly likely to overcome the adversary before he accomplishes his objective. The evaluation must be conducted for all significant states of the site. Deficiencies uncovered become inputs to redesign and further analysis, closing the loop on the design/analysis cycle.

  3. Preliminary statement on general policy for rulemaking to improve nuclear power plant licensing

    International Nuclear Information System (INIS)

    1978-11-01

    In June 1977 an NRC study group seeking to identify ways to improve the effectiveness of NRC nuclear power plant licensing procedures, recommended (among other measures) that rulemaking should be considered for the generic resolution of certain major issues that are presently litigated in individual licensing proceedings (NUREG--0292). In response to a Commission directive, the staff prepared an interim statement of general policy and plans for rulemaking, which the Commission approved for publication n the Federal Register at Affirmation Session 78-7 held on October 26, 1978. This interim policy statement fully supports Executive Order 12044 of March 23, 1978, requesting improvement of existing and future government regulations so as to be as simple and clear as possible and avoid imposing unnecessary burdens on the economy, on individuals, on public and private organizations, or on State and local governments. This NUREG publication includes the full text of the Federal Register notice published concurrently. Also provided are Enclosures A and B which contain more complete information than is presented in the FR notice regarding the selection and discussion of issues proposed by the staff for generic rulemaking. However, the discussion of issues avoids being overly specific about the likely outcome of rulemaking in order to stimulate creative public and industry comments as desirable inputs to shaping the ultimate form of generic rules

  4. Analysis of the Italian generic medicines retail market: recommendations to enhance long-term sustainability.

    Science.gov (United States)

    Dylst, Pieter; Vulto, Arnold; Simoens, Steven

    2015-02-01

    Italy is among the European countries with the lowest uptake of generic medicines. This paper provides a perspective on the Italian generic medicines retail market. Fast market entrance of generic medicines in Italy is hindered by several factors: the existence of Complementary Protection Certificates in the past, the large market for copies and multiple cases of patent linkage. Prices of generic medicines in Italy are low compared to other European countries. To contain pharmaceutical expenditure, pharmaceutical companies are currently forced to pay back in case of overspending, which disproportionally penalizes small and fast growing companies, to which most generic companies belong to. Current demand-side policies do not successfully stimulate the use of generic medicines. The current market environment surrounding the Italian generic medicines retail market (i.e., low prices, low volumes) threatens its long-term sustainability. Recommendations to enhance the long-term sustainability of the Italian generic medicines retail market round off this perspective paper.

  5. Do All Ducks Lay Eggs? The Generic Overgeneralization Effect

    Science.gov (United States)

    Leslie, Sarah-Jane; Khemlani, Sangeet; Glucksberg, Sam

    2011-01-01

    Generics are statements such as "tigers are striped" and "ducks lay eggs". They express general, though not universal or exceptionless, claims about kinds (Carlson & Pelletier, 1995). For example, the generic "ducks lay eggs" seems true even though many ducks (e.g. the males) do not lay eggs. The universally quantified version of the statement…

  6. Development of Multi-physics (Multiphase CFD + MCNP) simulation for generic solution vessel power calculation

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Seung Jun [Los Alamos National Lab. (LANL), Los Alamos, NM (United States); Buechler, Cynthia Eileen [Los Alamos National Lab. (LANL), Los Alamos, NM (United States)

    2017-07-17

    The current study aims to predict the steady state power of a generic solution vessel and to develop a corresponding heat transfer coefficient correlation for a Moly99 production facility by conducting a fully coupled multi-physics simulation. A prediction of steady state power for the current application is inherently interconnected between thermal hydraulic characteristics (i.e. Multiphase computational fluid dynamics solved by ANSYS-Fluent 17.2) and the corresponding neutronic behavior (i.e. particle transport solved by MCNP6.2) in the solution vessel. Thus, the development of a coupling methodology is vital to understand the system behavior at a variety of system design and postulated operating scenarios. In this study, we report on the k-effective (keff) calculation for the baseline solution vessel configuration with a selected solution concentration using MCNP K-code modeling. The associated correlation of thermal properties (e.g. density, viscosity, thermal conductivity, specific heat) at the selected solution concentration are developed based on existing experimental measurements in the open literature. The numerical coupling methodology between multiphase CFD and MCNP is successfully demonstrated, and the detailed coupling procedure is documented. In addition, improved coupling methods capturing realistic physics in the solution vessel thermal-neutronic dynamics are proposed and tested further (i.e. dynamic height adjustment, mull-cell approach). As a key outcome of the current study, a multi-physics coupling methodology between MCFD and MCNP is demonstrated and tested for four different operating conditions. Those different operating conditions are determined based on the neutron source strength at a fixed geometry condition. The steady state powers for the generic solution vessel at various operating conditions are reported, and a generalized correlation of the heat transfer coefficient for the current application is discussed. The assessment of multi

  7. Generic Assessment Criteria for human health risk assessment of potentially contaminated land in China.

    Science.gov (United States)

    Cheng, Yuanyuan; Nathanail, Paul C

    2009-12-20

    Generic Assessment Criteria (GAC) are derived using widely applicable assumptions about the characteristics and behaviour of contaminant sources, pathways and receptors. GAC provide nationally consistent guidance, thereby saving money and time. Currently, there are no human health based Generic Assessment Criteria (GAC) for contaminated sites in China. Protection of human health is therefore difficult to ensure and demonstrate; and the lack of GAC makes it difficult to tell if there is potential significant risk to human health unless site-specific criteria are derived. This paper derived Chinese GAC (GAC) for five inorganic and eight organic substances for three regions in China for three land uses: urban residential without plant uptake, Chinese cultivated land, and commercial/industrial using the SNIFFER model. The SNIFFER model has been further implemented with a dermal absorption algorithm and the model default input values have been changed to reflect the Chinese exposure scenarios. It is envisaged that the modified SNIFFER model could be used to derive GAC for more contaminants, more Regions, and more land uses. Further research to enhance the reliability and acceptability of the GAC is needed in regional/national surveys in diet and working patterns.

  8. 'Genericism' in Danish welfare professions

    DEFF Research Database (Denmark)

    Larsen, Verner

    and skills in the basic disciplines of the professions also termed as disciplinary and procedural knowledge '. Thus the main research question for this paper is: What consequences do recent reform actions in Danish welfare education concerning generic competence have on developing professional knowledge...

  9. Regional siting survey for thermal power plants in the state of Ohio

    International Nuclear Information System (INIS)

    Elkins, M.L.; DiNunno, J.J.

    1975-01-01

    The selection and evaluation of sites for power plants have become increasingly difficult in recent years as pressures from various societal segments have resulted in government restraints on selection and burning of fossil fuels, on methods of heat dissipation, on acquisition of transmission line rights-of-way, and on environmental impact in general. The key elements in successful application of power plant siting technology are the development of the proper balance among the basic siting considerations and the understanding that level of detail in a study varies in an inverse relationship with the siting area under examination. As the first step in the process of selection and eventual licensing of new thermal power plant sites for a utility in the State of Ohio, the entire state was screened to determine promising candidate regions large enough to offer several possible candidate sites for thermal power plants. Because of the size of the area under consideration and the advantages of developing sites with an ultimate capacity for more than one power plant, sites with an installed capacity of 1100 to 4400 MW(e) were considered for this study. As a result of the preliminary screening conducted in four distinct steps, three candidate regions showed the best overall promise for either nuclear or fossil-fueled power plant development. Tentative identification was made of candidate sites within these candidate regions, and follow-on studies conducted in an increasing level of detail are presently in progress to determine the candidate site(s) most promising for power plant siting. (U.S.)

  10. The impact of price-cap regulations on market entry by generic pharmaceutical firms.

    Science.gov (United States)

    Zhang, Wei; Sun, Huiying; Guh, Daphne; Anis, Aslam H

    2017-04-01

    In 1998, the province of Ontario, Canada implemented price-cap '70/90' regulations: the first generic must be priced at ≤70% of the associated brand-name price and subsequent generics must be priced at ≤90% of the first generics' price. The price-cap was further lowered to 50% in 2006 and 25% in 2010 for all generic drugs regardless of the first or subsequent generic entrants. This study assessed the impact of such price-cap regulations on market entry by generic firms using the formulary database from 9 provinces (January 2004-March 2013). A logistic regression was estimated to compare the probability of entry during the three policy periods in Ontario ('70/90', '25', versus '50'). Since different price-caps were subsequently introduced in other provinces, Alberta, British Columbia, New Brunswick and Saskatchewan, difference-in-differences was used to compare market entry. In Ontario, compared with the period '50', generic firms were 76% and 63% less likely to enter markets in the periods '25' and '70/90', respectively. The difference-in-differences showed that the entry probability decreased the most in Ontario during the '25' period from the '50' period. Lowering the price-cap level to 25% leads to a significantly lower probability of market entry by generic firms.

  11. Policy objective of generic medicines from the investment perspective: The case of clopidogrel.

    Science.gov (United States)

    Elek, Péter; Harsányi, András; Zelei, Tamás; Csetneki, Kata; Kaló, Zoltán

    2017-05-01

    The objective of generic drug policies in most countries is defined from a disinvestment perspective: reduction in expenditures without compromising health outcomes. However, in countries with restricted access of patients to original patented drugs, the objective of generic drug policies can also be defined from an investment perspective: health gain by improved patient access without need for additional health budget. This study examines the investment aspect of generic medicines by analyzing clopidogrel utilization in European countries between 2004 and 2014 using multilevel panel data models. We find that clopidogrel consumption was strongly affected by affordability constraints before the generic entry around 2009, but this effect decayed by 2014. After controlling for other variables, utilization had a substantially larger trend increase in lower-income European countries than in the higher-income ones. Generic entry increased clopidogrel consumption only in lower- and average-income countries but not in the highest-income ones. An earlier generic entry was associated with a larger effect. The case of clopidogrel indicates that the entrance of generics may increase patient access to effective medicines, most notably in lower-income countries, thereby reducing inequalities between European patients. Policymakers should also consider this investment aspect of generic medicines when designing pharmaceutical policies. Copyright © 2017 Elsevier B.V. All rights reserved.

  12. Potential Clinical and Economic Impact of Switching Branded Medications to Generics

    Science.gov (United States)

    Straka, Robert J.; Keohane, Denis J.; Liu, Larry Z.

    2017-01-01

    Switching branded to generic medications has become a common cost-containment measure. Although this is an important objective for health care systems worldwide, the impact of this practice on patient outcomes needs to be carefully considered. We reviewed the literature summarizing the potential clinical and economic consequences of switching from branded to generic medications on patient outcomes. A literature search of peer-reviewed articles published 2003–2013 using key words of “generic switching” or “substitution” was conducted using PubMed, OvidSP, and ScienceDirect. Of 30 articles identified and reviewed, most were related to the diseases of the central nervous system, especially epilepsy. Based on our review, potential impacts of switching fell into 3 broad categories: patient attitudes and adherence, clinical and safety outcomes, and cost and resource utilization. Although in many cases generics may represent an appropriate alternative to branded products, this may not always be the case. Specifically, several studies suggested that switching may negatively impact medication adherence, whereas other studies found that generic switching was associated with poorer clinical outcomes and more adverse events. In some instances, switching accomplished cost savings but did so at increased total cost of care because of increased physician visits or hospitalizations. Although in many cases generics may represent an appropriate alternative, mandatory generic switching may lead to unintended consequences, especially in certain therapeutic areas. Although further study is warranted, based on our review, it may be medically justifiable for physicians and patients to retain the right to request the branded product in certain cases. PMID:26099048

  13. Systematic identification of crystallization kinetics within a generic modelling framework

    DEFF Research Database (Denmark)

    Abdul Samad, Noor Asma Fazli Bin; Meisler, Kresten Troelstrup; Gernaey, Krist

    2012-01-01

    A systematic development of constitutive models within a generic modelling framework has been developed for use in design, analysis and simulation of crystallization operations. The framework contains a tool for model identification connected with a generic crystallizer modelling tool-box, a tool...

  14. 40 CFR 721.10063 - Halo substituted hydroxy nitrophenyl amide (generic).

    Science.gov (United States)

    2010-07-01

    ... amide (generic). 721.10063 Section 721.10063 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... Specific Chemical Substances § 721.10063 Halo substituted hydroxy nitrophenyl amide (generic). (a) Chemical... as halo substituted hydroxy nitrophenyl amide (PMN P-04-792) is subject to reporting under this...

  15. Generic event trees and the treatment of dependencies and non-proceduralized actions in a low power and shutdown Probabilistic Risk Assessment

    International Nuclear Information System (INIS)

    Forester, J.; Yakle, J.; Whitehead, D.; Darby, J.

    1993-01-01

    Sandia National Laboratories was tasked by the US Nuclear Regulatory Commission to perform a Probabilistic Risk Assessment (PRA) of a boiling water reactor (BWR) during low power and shutdown (LP ampersand S) conditions. The plant chosen for the study was Grand Gulf Nuclear Station (GGNS), a BWR 6. In performing the analysis, it was found that in comparison with full-power PRAs, the low decay heat levels present during LP ampersand S conditions result in a relatively large number of ways by which cooling can be provided to the core. In addition, because of the less stringent requirements imposed on system configurations possible is large and the availability of plant systems is more difficult to specify. These aspects of the LP ampersand S environment led to the development and use of ''generic'' event trees in performing the analysis. The use of ''generic'' event trees, in turn, had a significant impact on the nature of the human reliability analysis (HRA) that was performed. This paper describes the development of the event trees for the LP ampersand S PRA and important aspects of the resulting HRA

  16. The generic drug user fee amendments: an economic perspective

    Science.gov (United States)

    Berndt, Ernst R; Murphy, Stephen J

    2018-01-01

    Abstract Since the vast majority of prescription drugs consumed by Americans are off patent (‘generic’), their regulation and supply is of wide interest. We describe events leading up to the US Congress's 2012 passage of the Generic Drug User Fee Amendments (GDUFA I) as part of the Food and Drug Administration Safety and Innovation Act (FDASIA). Under GDUFA I, generic manufacturers agreed to pay approximately $300 million in fees each year of the five-year program. In exchange, the US Food and Drug Administration (FDA) committed to performance goals. We describe GDUFA I’s FDA commitments, provisions, goals, and annual fee structure and compare it to that entailed in the authorization and implementation of GDUFA II on October 1, 2017. We explain how user fees required under GDUFA I erected barriers to entry and created scale and scope economies for incumbent manufacturers. Congress changed user fees under GDUFA II in part to lessen these incentives. In order to initiate and sustain user fees under GDUFA legislation, FDA requires the submission of self-reported data on generic manufacturers including domestic and foreign facilities. These data are public and our examination of them provides an unprecedented window into the recent organization of generic drug manufacturers supplying the US market. Our results suggest that generic drug manufacturing is increasingly concentrated and foreign. We discuss the implications of this observed market structure for GDUFA II’s implementation among other outcomes. PMID:29707218

  17. A randomized, double-blind, cross-over, phase IV trial of oros-methylphenidate (CONCERTA(®)) and generic novo-methylphenidate ER-C (NOVO-generic).

    Science.gov (United States)

    Fallu, Angelo; Dabouz, Farida; Furtado, Melissa; Anand, Leena; Katzman, Martin A

    2016-08-01

    Attention-deficit/hyperactivity disorder (ADHD) is a common neurobehavioral disorder with onset during childhood. Multiple aspects of a child's development are hindered, in both home and school settings, with negative impacts on social, emotional, and cognitive functioning. If left untreated, ADHD is commonly associated with poor academic achievement and low occupational status, as well as increased risk of substance abuse and delinquency. The objective of this study was to evaluate adult ADHD subject reported outcomes when switched from a stable dose of CONCERTA(®) to the same dose of generic Novo-methylphenidate ER-C(®). Randomized, double-blind, cross-over, phase IV trial consisted of two phases in which participants with a primary diagnosis of ADHD were randomized in a 1:1 ratio to 3 weeks of treatment with CONCERTA or generic Novo-Methylphenidate ER-C. Following 3 weeks of treatment, participants were crossed-over to receive the other treatment for an additional 3 weeks. Primary efficacy was assessed through the use of the Treatment Satisfaction Questionnaire for Medication, Version II (TSQM-II). Participants with ADHD treated with CONCERTA were more satisfied in terms of efficacy and side effects compared to those receiving an equivalent dose of generic Novo-Methylphenidate ER-C. All participants chose to continue with CONCERTA treatment at the conclusion of the study. Although CONCERTA and generic Novo-Methylphenidate ER-C have been deemed bioequivalent, however the present findings demonstrate clinically and statistically significant differences between generic and branded CONCERTA. Further investigation of these differences is warranted.

  18. Risk analysis of highly combustible gas storage, supply, and distribution systems in PWR plants

    International Nuclear Information System (INIS)

    Simion, G.P.; VanHorn, R.L.; Smith, C.L.; Bickel, J.H.; Sattison, M.B.; Bulmahn, K.D.

    1993-06-01

    This report presents the evaluation of the potential safety concerns for pressurized water reactors (PWRs) identified in Generic Safety Issue 106, Piping and the Use of Highly Combustible Gases in Vital Areas. A Westinghouse four-loop PWR plant was analyzed for the risk due to the use of combustible gases (predominantly hydrogen) within the plant. The analysis evaluated an actual hydrogen distribution configuration and conducted several sensitivity studies to determine the potential variability among PWRs. The sensitivity studies were based on hydrogen and safety-related equipment configurations observed at other PWRs within the United States. Several options for improving the hydrogen distribution system design were identified and evaluated for their effect on risk and core damage frequency. A cost/benefit analysis was performed to determine whether alternatives considered were justifiable based on the safety improvement and economics of each possible improvement

  19. Inventory of power plants in the United States, 1993

    International Nuclear Information System (INIS)

    1994-12-01

    The Inventory of Power Plants in the United States is prepared annually by the Survey Management Division, Office of Coal, Nuclear, Electric and Alternate Fuels, Energy Information Administration (EIA), U.S. Department of Energy (DOE). The purpose of this publication is to provide year-end statistics about electric generating units operated by electric utilities in the United States (the 50 States and the District of Columbia). The publication also provides a 10-year outlook of future generating unit additions. Data summarized in this report are useful to a wide audience including Congress, Federal and State agencies, the electric utility industry, and the general public. Data presented in this report were assembled and published by the EIA to fulfill its data collection and dissemination responsibilities as specified in the Federal Energy Administration Act of 1974 (Public Law 93-275) as amended

  20. Inventory of power plants in the United States, 1993

    Energy Technology Data Exchange (ETDEWEB)

    1994-12-01

    The Inventory of Power Plants in the United States is prepared annually by the Survey Management Division, Office of Coal, Nuclear, Electric and Alternate Fuels, Energy Information Administration (EIA), U.S. Department of Energy (DOE). The purpose of this publication is to provide year-end statistics about electric generating units operated by electric utilities in the United States (the 50 States and the District of Columbia). The publication also provides a 10-year outlook of future generating unit additions. Data summarized in this report are useful to a wide audience including Congress, Federal and State agencies, the electric utility industry, and the general public. Data presented in this report were assembled and published by the EIA to fulfill its data collection and dissemination responsibilities as specified in the Federal Energy Administration Act of 1974 (Public Law 93-275) as amended.

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

    Science.gov (United States)

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

    2016-02-01

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

  2. 76 FR 24920 - Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance...

    Science.gov (United States)

    2011-05-03

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

  3. 76 FR 35069 - Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance...

    Science.gov (United States)

    2011-06-15

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

  4. 78 FR 74175 - Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance...

    Science.gov (United States)

    2013-12-10

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

  5. 77 FR 52708 - Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance...

    Science.gov (United States)

    2012-08-30

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

  6. Energy prices and substitution in United States manufacturing plants

    Science.gov (United States)

    Grim, Cheryl

    Persistent regional disparities in electricity prices, growth in wholesale power markets, and recent deregulation attempts have intensified interest in the performance of the U.S. electric power industry, while skyrocketing fuel prices have brought renewed interest in the effect of changes in prices of all energy types on the U.S. economy. This dissertation examines energy prices and substitution between energy types in U.S. manufacturing. I use a newly constructed database that includes information on purchased electricity and electricity expenditures for more than 48,000 plants per year and additional data on the utilities that supply electricity to study the distribution of electricity prices paid by U.S. manufacturing plants from 1963 to 2000. I find a large compression in the dispersion of electricity prices from 1963 to 1978 due primarily to a decrease in quantity discounts for large electricity purchasers. I also find that spatial dispersion in retail electricity prices among states, counties and utility service territories is large, rises over time for smaller purchasers, and does not diminish as wholesale power markets expand in the 1990s. In addition, I examine energy type consumption patterns, prices, and substitution in U.S. manufacturing plants. I develop a plant-level dataset for 1998 with data on consumption and expenditures on energy and non-energy production inputs, output, and other plant characteristics. I find energy type consumption patterns vary widely across manufacturing plants. Further, I find a large amount of dispersion across plants in the prices paid for electricity, oil, natural gas, and coal. These high levels of dispersion are accounted for by the plant's location, industry, and purchase quantity. Finally, I present estimates of own- and cross-price elasticities of demand for both the energy and non-energy production inputs.

  7. The characteristics of the prestressed concrete reactor vessel of the HHT demonstration plant

    International Nuclear Information System (INIS)

    Schoening, J.; Schwiers, H.G.

    1979-01-01

    The paper concentrates on the design studies of the HTGR prestressed concrete reactor vessel (PCRV) for the HHT Demonstration Plant. The multi-cavity reactor pressure vessel accommodates all components carrying primary gas, including heat exchangers and gas turbine. For reasons of economics and availability of the reactor plant, generic requirements are made for the PCRV. A short description of the power plant is also presented

  8. Safety and efficacy of generic drugs with respect to brand formulation.

    Science.gov (United States)

    Gallelli, Luca; Palleria, Caterina; De Vuono, Antonio; Mumoli, Laura; Vasapollo, Piero; Piro, Brunella; Russo, Emilio

    2013-12-01

    Generic drugs are equivalent to the brand formulation if they have the same active substance, the same pharmaceutical form and the same therapeutic indications and a similar bioequivalence respect to the reference medicinal product. The use of generic drugs is indicated from many countries in order to reduce medication price. However some points, such as bioequivalence and the role of excipients, may be clarified regarding the clinical efficacy and safety during the switch from brand to generic formulations. In conclusion, the use of generic drugs could be related with an increased days of disease (time to relapse) or might lead to a therapeutic failure; on the other hand, a higher drug concentration might expose patients to an increased risk of dose-dependent side-effects.

  9. State-of-the-art explosion protection for dedusting of coal grinding plants; Explosionsschutz fuer die Entstaubung von Kohlemahlanlagen

    Energy Technology Data Exchange (ETDEWEB)

    Neuhaus, Tim [Intensiv-Filter GmbH und Co. KG, Velbert-Langenberg (Germany). Development; Schrooten, Theo [Intensiv-Filter GmbH und Co. KG, Velbert-Langenberg (Germany). Technology Dept.; Baldauf, Joerg [Thorwesten Vent GmbH, Beckum (Germany). Sales

    2010-07-01

    With dedusting of coal grinding plants, the state of the technology is determined by the explosion protection measures, the filtration performance and the design of the plant. To ensure safe operation of a plant, only certified and tested concepts and components should be used for its design and manufacture. With plants protected against explosion, such issues will always affect the plant's resistance, its explosion relief venting and its explosion decoupling systems. Economic factors, where the aim is minimising the filter level and lean design, should not be forgotten with dedusting and it is important that plants are aligned to the latest state of technological development. With their years of experience and continuing development in the area of dedusting for coal grinding plants, Intensiv-Filter and Thorwesten Vent have succeeded in implementing the state of the art. (orig.)

  10. InP-based generic foundry platform for photonic integrated circuits

    NARCIS (Netherlands)

    Augustin, L.M.; Lemos Alvares Dos Santos, R.M.; den Haan, E.; Kleijn, S.E.F.; Thijs, P.J.A.; Latkowski, S.; Zhao, D.; Yao, W.; Bolk, J.; Ambrosius, H.P.M.M.; Mingaleev, S.; Richter, A.; Bakker, A.; Korthorst, T.

    2017-01-01

    The standardization of photonic integration processes for InP has led to versatile and easily accessible generic integration platforms. The generic integration platforms enable the realization of a broad range of applications and lead to a dramatic cost reduction in the development costs of photonic

  11. Generic phase transitions and profit singularities in Arnol'd's model

    International Nuclear Information System (INIS)

    Davydov, Aleksei A; Matos, Helena Mena

    2007-01-01

    For a smooth one-parameter family of pairs of control systems and profit densities on a circle, the generic transitions between optimal rotations and stationary strategies are studied in the problem of maximization of the time-averaged profit on the infinite horizon. It is shown that there are only two types of such transitions, the corresponding singularities of the average profit as a function of the family parameter are found, and it is proved that these singularities are stable under small perturbations of a generic family. The classification of singularities of the maximum average profit is completed for generic families. Bibliography: 16 titles.

  12. Business engineering. Generic Software Architecture in an Object Oriented View

    Directory of Open Access Journals (Sweden)

    Mihaela MURESAN

    2006-01-01

    Full Text Available The generic software architecture offers a solution for the the information system's development and implementation. A generic software/non-software model could be developed by integrating the enterprise blueprint concept (Zachman and the object oriented paradigm (Coad's archetype concept. The standardization of the generic software architecture for various specific software components could be a direction of crucial importance, offering the guarantee of the quality of the model and increasing the efficiency of the design, development and implementation of the software. This approach is also useful for the implementation of the ERP systems designed to fit the user’s particular requirements.

  13. 77 FR 17493 - Agency Information Collection Activities: Proposed Collection; Comment Request; DOI Generic...

    Science.gov (United States)

    2012-03-26

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

  14. 75 FR 80542 - Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance...

    Science.gov (United States)

    2010-12-22

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

  15. 76 FR 12140 - Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance...

    Science.gov (United States)

    2011-03-04

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

  16. 76 FR 19826 - Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance...

    Science.gov (United States)

    2011-04-08

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

  17. 76 FR 17861 - Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance...

    Science.gov (United States)

    2011-03-31

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

  18. 76 FR 25693 - Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance...

    Science.gov (United States)

    2011-05-05

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

  19. Robust method for determining steady state initial values for MSS plant models

    International Nuclear Information System (INIS)

    Ringham, M.R.; Carlson, J.R.

    1987-01-01

    Results of an EPRI sponsored project (RP 2504-3 amend i) demonstrated that the methodology embodied in the existing System Performance and Analysis Code (SPANC) can be employed to provide initial values for MSS plant models. An EASY5 version of the TMI plant two loop approximation with primary coolant flow recirculation through a failed pump was selected for demonstration purposes. The project entailed replacing the 1967 ASME steam properties in SPANC with the simplified MSS functions. The MSS component models were then recast into equivalent steady state models compatible with the SPANC executive system. A special input routine was written to modify the MSS data to the SPANC data format. The accuracy of the obtained initial values was approximately four significant figures, sufficient to converge on the EASY5 steady state algorithms. Convergence is relatively insensitive to the initial guess in SPANC and are obtained at a computer cost of approximately two minutes on the UNIVAC 1100/60. Since plant configuration is established by data input in SPANC, it can easily be altered to provide initial values for an MMS simulation of all TMI type plants

  20. 76 FR 79198 - Generic Drug User Fee; Public Meeting; Correction

    Science.gov (United States)

    2011-12-21

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0381] Generic Drug User Fee; Public Meeting; Correction AGENCY: Food and Drug Administration, HHS. ACTION... meeting entitled ``Generic Drug User Fee.'' The document published with an inadvertent error in the Dates...