Areva reference document 2007; Areva document de reference 2007

Energy Technology Data Exchange (ETDEWEB)

NONE

2008-07-01

This reference document contains information on the AREVA group's objectives, prospects and development strategies, particularly in Chapters 4 and 7. It contains also information on the markets, market shares and competitive position of the AREVA group. Content: 1 - Person responsible for the reference document and persons responsible for auditing the financial statements; 2 - Information pertaining to the transaction (not applicable); 3 - General information on the company and its share capital: Information on Areva, Information on share capital and voting rights, Investment certificate trading, Dividends, Organization chart of AREVA group companies, Equity interests, Shareholders' agreements; 4 - Information on company operations, new developments and future prospects: Overview and strategy of the AREVA group, The Nuclear Power and Transmission and Distribution markets, The energy businesses of the AREVA group, Front End division, Reactors and Services division, Back End division, Transmission and Distribution division, Major contracts 140 Principal sites of the AREVA group, AREVA's customers and suppliers, Sustainable Development and Continuous Improvement, Capital spending programs, Research and Development programs, Intellectual Property and Trademarks, Risk and insurance; 5 - Assets financial position financial performance: Analysis of and comments on the group's financial position and performance, Human Resources report, Environmental report, Consolidated financial statements 2007, Notes to the consolidated financial statements, Annual financial statements 2007, Notes to the corporate financial statements; 6 - Corporate governance: Composition and functioning of corporate bodies, Executive compensation, Profit-sharing plans, AREVA Values Charter, Annual Ordinary General Meeting of Shareholders of April 17, 2008; 7 - Recent developments and future prospects: Events subsequent to year-end closing for 2007, Outlook; Glossary; table of

Areva, reference document 2006; Areva, document de reference 2006

Energy Technology Data Exchange (ETDEWEB)

NONE

2006-07-01

This reference document contains information on the AREVA group's objectives, prospects and development strategies, particularly in Chapters 4 and 7. It contains information on the markets, market shares and competitive position of the AREVA group. Content: - 1 Person responsible for the reference document and persons responsible for auditing the financial statements; - 2 Information pertaining to the transaction (Not applicable); - 3 General information on the company and its share capital: Information on AREVA, on share capital and voting rights, Investment certificate trading, Dividends, Organization chart of AREVA group companies, Equity interests, Shareholders' agreements; - 4 Information on company operations, new developments and future prospects: Overview and strategy of the AREVA group, The Nuclear Power and Transmission and Distribution markets, The energy businesses of the AREVA group, Front End division, Reactors and Services division, Back End division, Transmission and Distribution division, Major contracts, The principal sites of the AREVA group, AREVA's customers and suppliers, Sustainable Development and Continuous Improvement, Capital spending programs, Research and development programs, intellectual property and trademarks, Risk and insurance; - 5 Assets - Financial position - Financial performance: Analysis of and comments on the group's financial position and performance, 2006 Human Resources Report, Environmental Report, Consolidated financial statements, Notes to the consolidated financial statements, AREVA SA financial statements, Notes to the corporate financial statements; 6 - Corporate Governance: Composition and functioning of corporate bodies, Executive compensation, Profit-sharing plans, AREVA Values Charter, Annual Combined General Meeting of Shareholders of May 3, 2007; 7 - Recent developments and future prospects: Events subsequent to year-end closing for 2006, Outlook; 8 - Glossary; 9 - Table of concordance.

AREVA - 2013 Reference document

International Nuclear Information System (INIS)

2014-01-01

This Reference Document contains information on the AREVA group's objectives, prospects and development strategies, as well as estimates of the markets, market shares and competitive position of the AREVA group. Content: 1 - Person responsible for the Reference Document; 2 - Statutory auditors; 3 - Selected financial information; 4 - Description of major risks confronting the company; 5 - Information about the issuer; 6 - Business overview; 7 - Organizational structure; 8 - Property, plant and equipment; 9 - Situation and activities of the company and its subsidiaries; 10 - Capital resources; 11 - Research and development programs, patents and licenses; 12 - Trend information; 13 - Profit forecasts or estimates; 14 - Management and supervisory bodies; 15 - Compensation and benefits; 16 - Functioning of the management and supervisory bodies; 17 - Human resources information; 18 - Principal shareholders; 19 - Transactions with related parties; 20 - Financial information concerning assets, financial positions and financial performance; 21 - Additional information; 22 - Major contracts; 23 - Third party information, statements by experts and declarations of interest; 24 - Documents on display; 25 - Information on holdings; Appendix 1: report of the supervisory board chairman on the preparation and organization of the board's activities and internal control procedures; Appendix 2: statutory auditors' reports; Appendix 3: environmental report; Appendix 4: non-financial reporting methodology and independent third-party report on social, environmental and societal data; Appendix 5: ordinary and extraordinary general shareholders' meeting; Appendix 6: values charter; Appendix 7: table of concordance of the management report; glossaries

AREVA 2009 reference document

International Nuclear Information System (INIS)

2009-01-01

This Reference Document contains information on the AREVA group's objectives, prospects and development strategies. It contains information on the markets, market shares and competitive position of the AREVA group. This information provides an adequate picture of the size of these markets and of the AREVA group's competitive position. Content: 1 - Person responsible for the Reference Document and Attestation by the person responsible for the Reference Document; 2 - Statutory and Deputy Auditors; 3 - Selected financial information; 4 - Risks: Risk management and coverage, Legal risk, Industrial and environmental risk, Operating risk, Risk related to major projects, Liquidity and market risk, Other risk; 5 - Information about the issuer: History and development, Investments; 6 - Business overview: Markets for nuclear power and renewable energies, AREVA customers and suppliers, Overview and strategy of the group, Business divisions, Discontinued operations: AREVA Transmission and Distribution; 7 - Organizational structure; 8 - Property, plant and equipment: Principal sites of the AREVA group, Environmental issues that may affect the issuer's; 9 - Analysis of and comments on the group's financial position and performance: Overview, Financial position, Cash flow, Statement of financial position, Events subsequent to year-end closing for 2009; 10 - Capital Resources; 11 - Research and development programs, patents and licenses; 12 -trend information: Current situation, Financial objectives; 13 - Profit forecasts or estimates; 14 - Administrative, management and supervisory bodies and senior management; 15 - Compensation and benefits; 16 - Functioning of corporate bodies; 17 - Employees; 18 - Principal shareholders; 19 - Transactions with related parties: French state, CEA, EDF group; 20 - Financial information concerning assets, financial positions and financial performance; 21 - Additional information: Share capital, Certificate of incorporation and by-laws; 22 - Major

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.

Reference document 2001. A (AREVA) for..; Document de reference 2001. A (AREVA) comme..

Energy Technology Data Exchange (ETDEWEB)

NONE

2002-07-01

This reference document 2001, on the group Areva, provides data and information on the Areva emerges, overview of operations, sustainable development policy, research and development programs, nuclear power activities (front-end, reactors and services back-end divisions), components (connectors division and STMicroelectronics, human resources, share data and financial information (financial report 2001, financial report first-half 2002). (A.L.B.)

Generic component reliability data for research reactors PSA. Final report of the CRP on data acquisition for research reactor PSA. Working material

International Nuclear Information System (INIS)

1993-01-01

The scope of this document is to provide the final reference generic component reliability database information for a variety of research reactor types. As noted in Section 2.1 and Table 3a, many years of component data are represented in the database so that it is expected that the report should provide representative data valid for a number of years. The database provides component failure rates on a time and/or a demand related basis according to the operational modes of the components. At the current time an update of the database is not planned. As a result of the implementation of data collection systems in the research reactors represented in these studies, updating of data from individual facilities could be made available from the contributing research reactor facilities themselves. As noted in Section 1.2, the report does not include detailed discussion of information regarding component classification and reliability parameter definitions. The report does provide some insights and discussion regarding the practicalities of the data collection process and some guidelines for database usage. 9 refs, tabs

Generic component reliability data for research reactors PSA. Final report of the CRP on data acquisition for research reactor PSA. Working material

Energy Technology Data Exchange (ETDEWEB)

NONE

1994-12-31

The scope of this document is to provide the final reference generic component reliability database information for a variety of research reactor types. As noted in Section 2.1 and Table 3a, many years of component data are represented in the database so that it is expected that the report should provide representative data valid for a number of years. The database provides component failure rates on a time and/or a demand related basis according to the operational modes of the components. At the current time an update of the database is not planned. As a result of the implementation of data collection systems in the research reactors represented in these studies, updating of data from individual facilities could be made available from the contributing research reactor facilities themselves. As noted in Section 1.2, the report does not include detailed discussion of information regarding component classification and reliability parameter definitions. The report does provide some insights and discussion regarding the practicalities of the data collection process and some guidelines for database usage. 9 refs, tabs.

Proposed Oral Reference Dose (RfD) for Barium and Compounds (Final Report, 2004)

Science.gov (United States)

This document is the final report from the 2004 external peer review of the Proposed Oral Reference Dose (RfD) for Barium and Compounds, prepared by the U.S. Environmental Protection Agency (EPA), National Center for Environmental Assessment (NCEA), for the Integrated Risk...

Technology, safety and costs of decommissioning a reference pressurized water reactor power station: Technical support for decommissioning matters related to preparation of the final decommissioning rule

International Nuclear Information System (INIS)

Konzek, G.J.; Smith, R.I.

1988-07-01

Preparation of the final Decommissioning Rule by the Nuclear Regulatory Commission (NRC) staff has been assisted by Pacific Northwest Laboratory (PNL) staff familiar with decommissioning matters. These efforts have included updating previous cost estimates developed during the series of studies on conceptually decommissioning reference licensed nuclear facilities for inclusion in the Final Generic Environmental Impact Statement (FGEIS) on decommissioning; documenting the cost updates; evaluating the cost and dose impacts of post-TMI-2 backfits on decommissioning; developing a revised scaling formula for estimating decommissioning costs for reactor plants different in size from the reference pressurized water reactor (PWR) described in the earlier study; defining a formula for adjusting current cost estimates to reflect future escalation in labor, materials, and waste disposal costs; and completing a study of recent PWR steam generator replacements to determine realistic estimates for time, costs and doses associated with steam generator removal during decommissioning. This report presents the results of recent PNL studies to provide supporting information in four areas concerning decommissioning of the reference PWR: updating the previous cost estimates to January 1986 dollars; assessing the cost and dose impacts of post-TMI-2 backfits; assessing the cost and dose impacts of recent steam generator replacements; and developing a scaling formula for plants different in size than the reference plant and an escalation formula for adjusting current cost estimates for future escalation

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

A Nonlinear Dynamic Inversion Predictor-Based Model Reference Adaptive Controller for a Generic Transport Model

Science.gov (United States)

Campbell, Stefan F.; Kaneshige, John T.

2010-01-01

Presented here is a Predictor-Based Model Reference Adaptive Control (PMRAC) architecture for a generic transport aircraft. At its core, this architecture features a three-axis, non-linear, dynamic-inversion controller. Command inputs for this baseline controller are provided by pilot roll-rate, pitch-rate, and sideslip commands. This paper will first thoroughly present the baseline controller followed by a description of the PMRAC adaptive augmentation to this control system. Results are presented via a full-scale, nonlinear simulation of NASA s Generic Transport Model (GTM).

Areva, reference document 2006

International Nuclear Information System (INIS)

2006-01-01

This reference document contains information on the AREVA group's objectives, prospects and development strategies, particularly in Chapters 4 and 7. It contains information on the markets, market shares and competitive position of the AREVA group. Content: - 1 Person responsible for the reference document and persons responsible for auditing the financial statements; - 2 Information pertaining to the transaction (Not applicable); - 3 General information on the company and its share capital: Information on AREVA, on share capital and voting rights, Investment certificate trading, Dividends, Organization chart of AREVA group companies, Equity interests, Shareholders' agreements; - 4 Information on company operations, new developments and future prospects: Overview and strategy of the AREVA group, The Nuclear Power and Transmission and Distribution markets, The energy businesses of the AREVA group, Front End division, Reactors and Services division, Back End division, Transmission and Distribution division, Major contracts, The principal sites of the AREVA group, AREVA's customers and suppliers, Sustainable Development and Continuous Improvement, Capital spending programs, Research and development programs, intellectual property and trademarks, Risk and insurance; - 5 Assets - Financial position - Financial performance: Analysis of and comments on the group's financial position and performance, 2006 Human Resources Report, Environmental Report, Consolidated financial statements, Notes to the consolidated financial statements, AREVA SA financial statements, Notes to the corporate financial statements; 6 - Corporate Governance: Composition and functioning of corporate bodies, Executive compensation, Profit-sharing plans, AREVA Values Charter, Annual Combined General Meeting of Shareholders of May 3, 2007; 7 - Recent developments and future prospects: Events subsequent to year-end closing for 2006, Outlook; 8 - Glossary; 9 - Table of concordance

Areva reference document 2007

International Nuclear Information System (INIS)

2008-01-01

This reference document contains information on the AREVA group's objectives, prospects and development strategies, particularly in Chapters 4 and 7. It contains also information on the markets, market shares and competitive position of the AREVA group. Content: 1 - Person responsible for the reference document and persons responsible for auditing the financial statements; 2 - Information pertaining to the transaction (not applicable); 3 - General information on the company and its share capital: Information on Areva, Information on share capital and voting rights, Investment certificate trading, Dividends, Organization chart of AREVA group companies, Equity interests, Shareholders' agreements; 4 - Information on company operations, new developments and future prospects: Overview and strategy of the AREVA group, The Nuclear Power and Transmission and Distribution markets, The energy businesses of the AREVA group, Front End division, Reactors and Services division, Back End division, Transmission and Distribution division, Major contracts 140 Principal sites of the AREVA group, AREVA's customers and suppliers, Sustainable Development and Continuous Improvement, Capital spending programs, Research and Development programs, Intellectual Property and Trademarks, Risk and insurance; 5 - Assets financial position financial performance: Analysis of and comments on the group's financial position and performance, Human Resources report, Environmental report, Consolidated financial statements 2007, Notes to the consolidated financial statements, Annual financial statements 2007, Notes to the corporate financial statements; 6 - Corporate governance: Composition and functioning of corporate bodies, Executive compensation, Profit-sharing plans, AREVA Values Charter, Annual Ordinary General Meeting of Shareholders of April 17, 2008; 7 - Recent developments and future prospects: Events subsequent to year-end closing for 2007, Outlook; Glossary; table of concordance

Synthesis document on the long life behavior of packages: reference operational document ''CSD-C'' 2004

International Nuclear Information System (INIS)

Helie, M.

2004-12-01

This document is realized in the framework of the law of 1991 on the radioactive wastes management. The 2004 synthesis document on long time behavior of standard packages of compacted wastes is constituted by two documents, the reference document and the operational document. This paper presents the operational model describing the packages alteration by the water and the associated radionuclide release. (A.L.B.)

The Role of Generic Competence and Professional Expertise in Legal Translation. The Case of English and Polish Probate Documents

Directory of Open Access Journals (Sweden)

Goźdź-Roszkowski Stanisław

2016-06-01

Full Text Available This paper seeks to demonstrate how the concept of generic competence (primarily intended for monolingual specialized communication could be extended to address important issues in translating legal texts. First, generic competence is discussed against the backdrop of the related concept of translation competence. Then, a case study is presented which examines a closely related set of documents employed by the professional community of lawyers (represented by an English solicitor and Polish advocate engaged in the specialist domain of probate law (legal process related to the estate of a deceased person. It is argued that both generic competence and professional expertise should be included in the range of competencies required for the translator of legal texts.

The investigation of crimes refering to forgery of documents and possession of forged documents

OpenAIRE

Kotovienė, Danutė

2011-01-01

THE INVESTIGATION OF CRIMES REFERING TO FORGERY OF DOCUMENTS AND POSSESSION OF FORGED DOCUMENTS Constantly improving informational technologies more and more get into our daily routine: nowadays it is widely spread internet payments, purchases, signing on-line agreements using electronic signatures. However, paper documents or other made of appropriate materials, which have material evidence, still have a very significant impact on our life. Its convey different aspects of states’ public work...

The impact on health outcomes and healthcare utilisation of switching to generic medicines consequent to reference pricing: the case of lamotrigine in New Zealand.

Science.gov (United States)

Lessing, Charon; Ashton, Toni; Davis, Peter

2014-10-01

Many countries have implemented generic reference pricing and substitution as methods of containing pharmaceutical expenditure. However, resistance to switching between medicines is apparent, especially in the case of anti-epileptic medicines. This study sought to exploit a nation-wide policy intervention on generic reference pricing in New Zealand to evaluate the health outcomes of patients switching from originator to generic lamotrigine, an anti-epileptic medicine. A retrospective study using the national health collections and prescription records was conducted comparing patients who switched from originator brand to generic lamotrigine with patients who remained on the originator brand. Primary outcome measures included switch behaviour, changes in utilisation of healthcare services at emergency departments, hospitalisations and use of specialist services, and mortality. Approximately one-quarter of all patients using the originator brand of lamotrigine switched to generic lamotrigine, half of whom made the switch within 60 days of the policy implementation. Multiple switches (three or more) between generic and brand products were evident for around 10% of switchers. Switch-back rates of 3% were apparent within 30 days post-switch. No difference in heath outcome measures was associated with switching from originator lamotrigine to a generic equivalent and hence no increased costs could be found for switchers. Switching from brand to generic lamotrigine is largely devoid of adverse health outcomes; however, creating an incentive to ensure a greater proportion of patients switch to generic lamotrigine is required to achieve maximal financial savings from a policy of generic reference pricing.

Reference document 2001. A (AREVA) for.

International Nuclear Information System (INIS)

2002-01-01

This reference document 2001, on the group Areva, provides data and information on the Areva emerges, overview of operations, sustainable development policy, research and development programs, nuclear power activities (front-end, reactors and services back-end divisions), components (connectors division and STMicroelectronics, human resources, share data and financial information (financial report 2001, financial report first-half 2002). (A.L.B.)

EDF group - Reference Document, Annual Financial Report 2014

International Nuclear Information System (INIS)

2015-01-01

The EDF Group is the world's leading electricity company and very well established in Europe. Its business covers all electricity-related activities, from generation to networks and commerce. It is an important player in energy trading through EDF trading. This document is EDF Group's Reference Document and Annual Financial Report for the year 2014. It contains information about Group profile, governance, business, investments, property, plant and equipment, management, financial position, human resources, shareholders, etc. The document includes the half-year financial report

Advanced Air Transportation Technologies Project, Final Document Collection

Science.gov (United States)

Mogford, Richard H.; Wold, Sheryl (Editor)

2008-01-01

This CD ROM contains a compilation of the final documents of the Advanced Air Transportation Technologies (AAIT) project, which was an eight-year (1996 to 2004), $400M project managed by the Airspace Systems Program office, which was part of the Aeronautics Research Mission Directorate at NASA Headquarters. AAIT focused on developing advanced automation tools and air traffic management concepts that would help improve the efficiency of the National Airspace System, while maintaining or enhancing safety. The documents contained in the CD are final reports on AAIT tasks that serve to document the project's accomplishments over its eight-year term. Documents include information on: Advanced Air Transportation Technologies, Autonomous Operations Planner, Collaborative Arrival Planner, Distributed Air/Ground Traffic Management Concept Elements 5, 6, & 11, Direct-To, Direct-To Technology Transfer, Expedite Departure Path, En Route Data Exchange, Final Approach Spacing Tool - (Active and Passive), Multi-Center Traffic Management Advisor, Multi Center Traffic Management Advisor Technology Transfer, Surface Movement Advisor, Surface Management System, Surface Management System Technology Transfer and Traffic Flow Management Research & Development.

EDF group - Reference Document 2007

International Nuclear Information System (INIS)

2008-01-01

The EDF Group is a leading player in the European energy industry, active in all areas of the electricity value chain, from generation to trading and network management. The leader in the French electricity market, the Group also has solid positions in the United Kingdom, Germany and Italy, with a portfolio of 38.5 million European customers and a generation fleet which is unique in the world. It intends to play a major role in the global revival of nuclear and is increasingly active in the gas chain. The Group has a sound business model, evenly balanced between regulated and deregulated activities. Given its R and D capability, its track record and expertise in nuclear, fossil-fired and hydro generation and in renewable energies, together with its energy eco-efficiency offers, EDF is well placed to deliver competitive solutions to reconcile sustainable economic growth and climate preservation. This document is EDF Group's Reference Document and Annual Financial Report for the year 2007. It contains information about Group profile, governance, business, investments, property, plant and equipment, management, financial position, human resources, shareholders, etc. The document includes the 2008 half-year financial report and consolidated financial statements, and the report drafted by the Statutory Auditors

Areva - 2016 Reference document

International Nuclear Information System (INIS)

2017-01-01

Areva supplies high added-value products and services to support the operation of the global nuclear fleet. The company is present throughout the entire nuclear cycle, from uranium mining to used fuel recycling, including nuclear reactor design and operating services. Areva is recognized by utilities around the world for its expertise, its skills in cutting-edge technologies and its dedication to the highest level of safety. Areva's 36,000 employees are helping build tomorrow's energy model: supplying ever safer, cleaner and more economical energy to the greatest number of people. This Reference Document contains information on Areva's objectives, prospects and development strategies. It contains estimates of the markets, market shares and competitive position of Areva

Part B Excess Cost Quick Reference Document

Science.gov (United States)

Ball, Wayne; Beridon, Virginia; Hamre, Kent; Morse, Amanda

2011-01-01

This Quick Reference Document has been prepared by the Regional Resource Center Program ARRA/Fiscal Priority Team to aid RRCP State Liaisons and other (Technical Assistance) TA providers in understanding the general context of state questions surrounding excess cost. As a "first-stop" for TA providers in investigating excess cost…

AREVA - 2012 Reference document

International Nuclear Information System (INIS)

2013-03-01

After a presentation of the person responsible for this Reference Document, of statutory auditors, and of a summary of financial information, this report address the different risk factors: risk management and coverage, legal risk, industrial and environmental risk, operational risk, risk related to major projects, liquidity and market risk, and other risks (related to political and economic conditions, to Group's structure, and to human resources). The next parts propose information about the issuer, a business overview (markets for nuclear power and renewable energies, customers and suppliers, group's strategy, operations), a brief presentation of the organizational structure, a presentation of properties, plants and equipment (principal sites, environmental issues which may affect these items), analysis and comments on the group's financial position and performance, a presentation of capital resources, a presentation of research and development activities (programs, patents and licenses), a brief description of financial objectives and profit forecasts or estimates, a presentation of administration, management and supervision bodies, a description of the operation of corporate bodies, an overview of personnel, of principal shareholders, and of transactions with related parties, a more detailed presentation of financial information concerning assets, financial positions and financial performance. Addition information regarding share capital is given, as well as an indication of major contracts, third party information, available documents, and information on holdings

EDF group - Reference Document 2004

International Nuclear Information System (INIS)

2005-01-01

The EDF Group is an integrated energy supplier operating in a wide range of electricity-related businesses: generation, transmission, distribution, sale and trading of energy. It is the main operator in the French electricity market and one of the leading electricity groups in Europe. With an installed capacity of 125,4 GW, it contributes to the supply of energy and services to more than 42 million customers throughout the world (with approximately 36 million customers in Europe, more than 28 million of whom are in France). The EDF Group has built a business model balanced between deregulated and regulated operations in France and an international presence. In 2004, the Group recorded consolidated sales of euros 46,928 million, net income (Group share) of euros 1,341 million, and it achieved earnings before interests, taxes, depreciation and amortization of euros 12,127 million. This document is EDF Group's Reference Document for the year 2004. It contains information about: the Group activities, capital, relations with Gaz de France utility, strategy, industrial environment, history, activity in France, international activity, transverse activities and functions, disputes, arbitration and risk factors, Property, Plants and Equipment, Operating and Financial Review, Administrative, Management, and Supervisory Bodies and Senior Management, Remuneration and Benefits, recent trends and perspectives

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.

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.

[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.

LDRD 149045 final report distinguishing documents.

Energy Technology Data Exchange (ETDEWEB)

Mitchell, Scott A.

2010-09-01

This LDRD 149045 final report describes work that Sandians Scott A. Mitchell, Randall Laviolette, Shawn Martin, Warren Davis, Cindy Philips and Danny Dunlavy performed in 2010. Prof. Afra Zomorodian provided insight. This was a small late-start LDRD. Several other ongoing efforts were leveraged, including the Networks Grand Challenge LDRD, and the Computational Topology CSRF project, and the some of the leveraged work is described here. We proposed a sentence mining technique that exploited both the distribution and the order of parts-of-speech (POS) in sentences in English language documents. The ultimate goal was to be able to discover 'call-to-action' framing documents hidden within a corpus of mostly expository documents, even if the documents were all on the same topic and used the same vocabulary. Using POS was novel. We also took a novel approach to analyzing POS. We used the hypothesis that English follows a dynamical system and the POS are trajectories from one state to another. We analyzed the sequences of POS using support vector machines and the cycles of POS using computational homology. We discovered that the POS were a very weak signal and did not support our hypothesis well. Our original goal appeared to be unobtainable with our original approach. We turned our attention to study an aspect of a more traditional approach to distinguishing documents. Latent Dirichlet Allocation (LDA) turns documents into bags-of-words then into mixture-model points. A distance function is used to cluster groups of points to discover relatedness between documents. We performed a geometric and algebraic analysis of the most popular distance functions and made some significant and surprising discoveries, described in a separate technical report.

Areva - 2014 Reference document

International Nuclear Information System (INIS)

2015-01-01

Areva supplies high added-value products and services to support the operation of the global nuclear fleet. The company is present throughout the entire nuclear cycle, from uranium mining to used fuel recycling, including nuclear reactor design and operating services. Areva is recognized by utilities around the world for its expertise, its skills in cutting-edge technologies and its dedication to the highest level of safety. Areva's 44,000 employees are helping build tomorrow's energy model: supplying ever safer, cleaner and more economical energy to the greatest number of people. This Reference Document contains information on Areva's objectives, prospects and development strategies. It contains estimates of the markets, market shares and competitive position of Areva. Contents: 1 - Person responsible; 2 - Statutory auditors; 3 - Selected financial information; 4 - Risk factors; 5 - Information about the issuer; 6 - Business overview; 7 - Organizational structure; 8 - Property, plant and equipment; 9 - Analysis of and comments on the group's financial position and performance; 10 - Capital resources; 11 - Research and development programs, patents and licenses; 12 - Trend information; 13 - Profit forecasts; 14 - Administrative, management and supervisory bodies and senior management; 15 - Compensation and benefits; 16 - Functioning of administrative, management and supervisory bodies and senior management; 17 - Employees; 18 - Principal shareholders; 19 - Transactions with related parties; 20 - Financial information concerning assets, financial positions and financial performance; 21 - Additional information; 22 - Major contracts; 23 - Third party information, statements by experts and declarations of interest; 24 - Documents on display; 25 - information on holdings; appendix: Report of the Chairman of the Board of Directors on governance, internal control procedures and risk management, Statutory Auditors' report, Corporate social

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

A transportation economics reference for practitioners : final report.

Science.gov (United States)

2013-03-01

Transportation projects and policies are rooted in economic considerations and consequences. This report : documents the development of a relatively comprehensive transportation economics reference for practitioners, : entitled The Economics of Trans...

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

EDF group - Reference Document 2005

International Nuclear Information System (INIS)

2006-01-01

The EDF Group is an integrated energy supplier operating in a wide range of electricity-related businesses: generation, transmission, distribution, sale and trading of energy. It is the main operator in the French electricity market and one of the leading electricity groups in Europe. With an installed capacity of 130.8 GW (123.9 GW in Europe), it contributes to the supply of energy and services to more than 40 million customers throughout the world (with approximately 36.7 million customers in Europe, more than 28 million of whom are in France). The EDF Group has built a business model balanced between deregulated and regulated operations in France and an international presence. In 2005, the Group recorded consolidated sales of euros 51,051 million, net income (Group share) of euros 3,242 million, and it achieved earnings before interests, taxes, depreciation and amortization of euros 13,010 million. This document is EDF Group's Reference Document for the year 2005. It contains information about: the Group activities, risk factors, Business Overview, Organizational Structure, Property, Plants and Equipment, Operating and Financial Review, Capital Resources, Research and Development, Patents and Licences, Trend Information, Financial Prospects, Administrative, Management, and Supervisory Bodies and Senior Management, Remuneration and Benefits, Board Practices, Employees/Human Resources, Major Shareholders, Related Party Transactions, Financial Information Concerning the Company's Assets and Liabilities, Financial Position and Profits and Losses, Material Contracts, Information on Holdings etc

Advisory Committee on human radiation experiments. Final report, Supplemental Volume 2. Sources and documentation

International Nuclear Information System (INIS)

1995-01-01

This volume and its appendixes supplement the Advisory Committee's final report by reporting how we went about looking for information concerning human radiation experiments and intentional releases, a description of what we found and where we found it, and a finding aid for the information that we collected. This volume begins with an overview of federal records, including general descriptions of the types of records that have been useful and how the federal government handles these records. This is followed by an agency-by-agency account of the discovery process and descriptions of the records reviewed, together with instructions on how to obtain further information from those agencies. There is also a description of other sources of information that have been important, including institutional records, print resources, and nonprint media and interviews. The third part contains brief accounts of ACHRE's two major contemporary survey projects (these are described in greater detail in the final report and another supplemental volume) and other research activities. The final section describes how the ACHRE information-nation collections were managed and the records that ACHRE created in the course of its work; this constitutes a general finding aid for the materials deposited with the National Archives. The appendices provide brief references to federal records reviewed, descriptions of the accessions that comprise the ACHRE Research Document Collection, and descriptions of the documents selected for individual treatment. Also included are an account of the documentation available for ACHRE meetings, brief abstracts of the almost 4,000 experiments individually described by ACHRE staff, a full bibliography of secondary sources used, and other information

Advisory Committee on human radiation experiments. Final report, Supplemental Volume 2. Sources and documentation

Energy Technology Data Exchange (ETDEWEB)

NONE

1995-01-01

This volume and its appendixes supplement the Advisory Committee`s final report by reporting how we went about looking for information concerning human radiation experiments and intentional releases, a description of what we found and where we found it, and a finding aid for the information that we collected. This volume begins with an overview of federal records, including general descriptions of the types of records that have been useful and how the federal government handles these records. This is followed by an agency-by-agency account of the discovery process and descriptions of the records reviewed, together with instructions on how to obtain further information from those agencies. There is also a description of other sources of information that have been important, including institutional records, print resources, and nonprint media and interviews. The third part contains brief accounts of ACHRE`s two major contemporary survey projects (these are described in greater detail in the final report and another supplemental volume) and other research activities. The final section describes how the ACHRE information-nation collections were managed and the records that ACHRE created in the course of its work; this constitutes a general finding aid for the materials deposited with the National Archives. The appendices provide brief references to federal records reviewed, descriptions of the accessions that comprise the ACHRE Research Document Collection, and descriptions of the documents selected for individual treatment. Also included are an account of the documentation available for ACHRE meetings, brief abstracts of the almost 4,000 experiments individually described by ACHRE staff, a full bibliography of secondary sources used, and other information.

Areva - 2011 Reference document; Areva - Document de reference 2011

Energy Technology Data Exchange (ETDEWEB)

NONE

2011-07-01

After having indicated the person responsible of this document and the legal account auditors, and provided some financial information, this document gives an overview of the different risk factors existing in the company: law risks, industrial and environmental risks, operational risks, risks related to large projects, market and liquidity risks. Then, after having recalled the history and evolution of the company and the evolution of its investments over the last five years, it proposes an overview of Areva's activities on the markets of nuclear energy and renewable energies, of its clients and suppliers, of its strategy, of the activities of its different departments. Other information are provided: company's flow chart, estate properties (plants, equipment), an analysis of its financial situation, its research and development policy, the present context, profit previsions or estimations, management organization and operation

Generic impact statement for commercial radioactive waste management

International Nuclear Information System (INIS)

Unruh, C.M.

1976-01-01

ERDA is preparing a generic environmental impact statement on the treatment and disposal of waste resulting from commercial reactors and post fission operations in the light water reactor (LWR) fuel cycle. Expert contributions will be provided by many of the ERDA national laboratories and contractors. The waste management aspects of the statement will be based on available technology as presented in the recently issued ''Alternatives for Managing Waste from Reactors and Post Fission Operations in the LWR Fuel Cycle,'' ERDA-76-43 Document. This 1500 page, five volume Technical Alternative Document (TAD) describes the status of technology (to September, 1975) for handling post fission radioactive waste generated by the production of electricity by nuclear power light water reactor-generator systems. The statement will be generic in nature discussing typical or hypothetical facilities in typical or hypothetical environments. It is not intended to replace environmental statements required in support of specific projects nor for Nuclear Regulatory Commission licensing procedures. A major purpose of the generic statement is to inform the public and to solicit comments on the ERDA program for: (1) the final disposition of commercial radioactive waste, (2) waste treatment, (3) waste interim storage, and (4) transportation of waste. The statement will discuss the ERDA contingency program to provide retrievable storage of such waste if they should be transferred to Federal custody prior to the availability of the geologic isolation facilities for terminal disposal. The generic statement will not address radioactive waste resulting from U.S. Defense Programs, the mining or milling of uranium, the management of waste from the breeder reactor program, waste from other nations, nor will it include an evaluation of the impact of waste resulting from power sources other than light water reactors

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.

Use of contaminated well water, example reference biospheres 1 and 2A

International Nuclear Information System (INIS)

Santucci, P.; Kontic, B.; Coughtrey, P.; McKenney, C.; Smith, G.

2005-01-01

The BIOMASS programme's Theme 1 evaluated a number of scenarios, which assisted in the development of practical guidance. A total of four Example Reference Biospheres were fully developed, with the assumptions, data, and models thoroughly documented. These Examples display both the practicality and the transparency available through the use of the Reference Biosphere Methodology. While the methodology is designed to promote transparency and traceability, proper documentation and justification is still the responsibility of the user. The Examples can also be used as generic analyses in some situations. Although it is anticipated that each of the Reference Biospheres explored within BIOMASS Theme 1 should be a useful practical example, the quantitative results of the model calculations are not intended to be understood as prescribed biosphere 'conversion factors'. In choosing to implement an Example, careful consideration would need to be given to their relevance (including associated data) to the particular assessment context at hand. In general, the more complex the model is, the more limited applicability it has for generic purposes. For example, ERB1A (direct use of well water for drinking) can be used straightforwardly, with minor or no adjustments, at a number of generic sites. Example 2A, however, for which climatic conditions and agricultural practices need to be specified, would need to be implemented for each specific situation

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

Science.gov (United States)

Quevauviller, P; Bennink, D; Bøwadt, S

2001-05-01

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

Project summary plan for HTGR recycle reference facility

International Nuclear Information System (INIS)

Baxter, B.J.

1979-11-01

A summary plan is introduced for completing conceptual definition of an HTGR Recycle Reference Facility (HRRF). The plan describes a generic project management concept, often referred to as the requirements approach to systems engineering. The plan begins with reference flow sheets and provides for the progressive evolution of HRRF requirements and definition through feasibility, preconceptual, and conceptual phases. The plan lays end-to-end all the important activities and elements to be treated during each phase of design. Identified activities and elements are further supported by technical guideline documents, which describe methodology, needed terminology, and where relevant a worked example

Bioequivalence of generic alendronate sodium tablets (70 mg to Fosamax® tablets (70 mg in fasting, healthy volunteers: a randomized, open-label, three-way, reference-replicated crossover study

Directory of Open Access Journals (Sweden)

Zhang Y

2017-07-01

Full Text Available Yifan Zhang,1 Xiaoyan Chen,1 Yunbiao Tang,2 Youming Lu,1 Lixia Guo,1 Dafang Zhong1 1State Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai, 2Department of Pharmacy, The General Hospital of Shenyang Military Region, Shenyang, People’s Republic of China Purpose: The aim of this study was to evaluate the bioequivalence of a generic product 70 mg alendronate sodium tablets with the reference product Fosamax® 70 mg tablet. Materials and methods: A single-center, open-label, randomized, three-period, three-sequence, reference-replicated crossover study was performed in 36 healthy Chinese male volunteers under fasting conditions. In each study period, the volunteers received a single oral dose of the generic or reference product (70 mg. Blood samples were collected at pre-dose and up to 8 h after administration. The bioequivalence of the generic product to the reference product was assessed using the US Food and Drug Administration (FDA and European Medicines Agency (EMA reference-scaled average bioequivalence (RSABE methods. Results: The average maximum concentrations (Cmax of alendronic acid were 64.78±43.76, 56.62±31.95, and 60.15±37.12 ng/mL after the single dose of the generic product and the first and second doses of the reference product, respectively. The areas under the plasma concentration–time curves from time 0 to the last timepoint (AUC0–t were 150.36±82.90, 148.15±85.97, and 167.11±110.87 h·ng/mL, respectively. Reference scaling was used because the within-subject standard deviations of the reference product (sWR for Cmax and AUC0–t were all higher than the cutoff value of 0.294. The 95% upper confidence bounds were -0.16 and -0.17 for Cmax and AUC0–t, respectively, and the point estimates for the generic/reference product ratio were 1.08 and 1.00, which satisfied the RSABE acceptance criteria of the FDA. The 90% CIs for Cmax and AUC0–t were 90.35%–129

A comparative neutron activation analysis study of common generic manipulated and reference medicines commercialized in Brazil

International Nuclear Information System (INIS)

Leal, A.S.; Menezes, M.A.B.C.; Rodrigues, R.R.; Andonie, O.; Vermaercke, P.; Sneyers, L.

2008-01-01

In this work, a comparative study of neutron activation analysis (NAA) was performed by the nuclear institutes: CDTN/CNEN-Brazil, CCHEN-Chile and the SCK.CEN-Belgium aiming to investigate some generic, manipulated and reference medicines largely commercialized in Brazil. Some impurities such as: As, Ba, Br, Ce, Co, Cr, Eu, Fe, Hf, Sb, Sc, Sm, Ti and Zn were found, and the heterogeneity of the samples pointed out the lack of an efficient public system of quality control

The MetaLex Document Server : Legal Documents as Versioned Linked Data

NARCIS (Netherlands)

Hoekstra, R.; Aroyo, L.; Welty, C.; Alani, H.; Taylor, J.; Bernstein, A.; Kagal, L.; Noy, N.; Blomqvist, E.

2011-01-01

This paper introduces the MetaLex Document Server (MDS), an ongoing project to improve access to legal sources (regulations, court rulings) by means of a generic legal XML syntax (CEN MetaLex) and Linked Data. The MDS defines a generic conversion mechanism from legacy legal XML syntaxes to CEN

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.

78 FR 16279 - HUD Healthcare Facility Documents: Notice Announcing Final Approved Documents and Assignment of...

Science.gov (United States)

2013-03-14

... some unaffiliated operators may not agree with this policy choice and may choose not to participate in... reflect current policy and practices, and to improve accountability and strengthen risk management. A... references in this notice. III. Selected Policy Determinations Some of the changes suggested to the documents...

A proposal for generic competence assessment in a serious game

Directory of Open Access Journals (Sweden)

María José Bezanilla

2014-01-01

Full Text Available This paper focuses on the design of a serious game for the teaching and assessment of generic competences, placing particular emphasis on the competences assessment aspect. Taking into account important aspects of competence assessment such as context, feedback and transparency, among other aspects, and using the University of Deusto's Generic Competences Assessment Model based on the defining of levels, indicators and descriptors as a reference point, a serious game has been designed for the development and evaluation of two Generic Competences: Problem Solving and Entrepreneurship, aimed at final-year undergraduate and first-year postgraduate students. The design process shows that having a Competence Assessment Model based on levels, indicators and descriptors is of great help in defining the game's scenarios and learning and assessment activities. Serious games can also be excellent resources to help in the development and assessment of generic competences, but not as a unique tool, since the concept of competence in itself is highly complex (integrating knowledge, skills, attitudes and values and some elements might require other methods and techniques for its development. It also reveals the difficulties of evaluating competences in general and through serious games in particular.

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

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.

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

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

Impact of European pharmaceutical price regulation on generic price competition: a review.

Science.gov (United States)

Puig-Junoy, Jaume

2010-01-01

Although economic theory indicates that it should not be necessary to intervene in the generic drug market through price regulation, most EU countries intervene in this market, both by regulating the maximum sale price of generics (price cap) and by setting the maximum reimbursement rate, especially by means of reference pricing systems. We analyse current knowledge of the impact of direct price-cap regulation of generic drugs and the implementation of systems regulating the reimbursement rate, particularly through reference pricing and similar tools, on dynamic price competition between generic competitors in Europe. A literature search was carried out in the EconLit and PubMed databases, and on Google Scholar. The search included papers published in English or Spanish between January 2000 and July 2009. Inclusion criteria included that studies had to present empirical results of a quantitative nature for EU countries of the impact of price capping and/or regulation of the reimbursement rate (reference pricing or similar systems) on price dynamics, corresponding to pharmacy sales, in the generic drug market. The available evidence indicates that price-cap regulation leads to a levelling off of generic prices at a higher level than would occur in the absence of this regulation. Reference pricing systems cause an obvious and almost compulsory reduction in the consumer price of all pharmaceuticals subject to this system, to a varying degree in different countries and periods, the reduction being greater for originator-branded drugs than for generics. In several countries with a reference pricing system, it was observed that generics with a consumer price lower than the reference price do not undergo price reductions until the reference price is reduced, even when there are other lower-priced generics on the market (absence of price competition below the reference price). Beyond the price reduction forced by the price-cap and/or reference pricing regulation itself

Non-Federal participation in AC Intertie: Final environmental impact statement

International Nuclear Information System (INIS)

1994-01-01

This document contains the appendices for the Non-Federal Participation in AC Intertie Final Environmental Impact Statement. It contains all the supporting materials, documents and data for the EIS in nine appendices: A. Life-of-facilities capacity ownership proposal; B. Long-term Intertie access policy; C. Glossary; D. Biological assessment and supporting materials; E. Environmental impacts of generic resource types; F. Technical information on analysis methods and results; G. Affected environment supporting documentation; H. Public involvement activities; and I. Bibliography

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

Tank characterization reference guide

International Nuclear Information System (INIS)

De Lorenzo, D.S.; DiCenso, A.T.; Hiller, D.B.; Johnson, K.W.; Rutherford, J.H.; Smith, D.J.; Simpson, B.C.

1994-09-01

Characterization of the Hanford Site high-level waste storage tanks supports safety issue resolution; operations and maintenance requirements; and retrieval, pretreatment, vitrification, and disposal technology development. Technical, historical, and programmatic information about the waste tanks is often scattered among many sources, if it is documented at all. This Tank Characterization Reference Guide, therefore, serves as a common location for much of the generic tank information that is otherwise contained in many documents. The report is intended to be an introduction to the issues and history surrounding the generation, storage, and management of the liquid process wastes, and a presentation of the sampling, analysis, and modeling activities that support the current waste characterization. This report should provide a basis upon which those unfamiliar with the Hanford Site tank farms can start their research

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...

Security Policy for a Generic Space Exploration Communication Network Architecture

Science.gov (United States)

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

2016-01-01

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

Development of the NIREX generic transport safety assessment to assist in the provision of waste packaging advice

International Nuclear Information System (INIS)

Hutchinson, D.L.; Marrison, A.R.; Sievwright, R.W.T.

2002-01-01

The current Nirex Mission is to provide the United Kingdom with safe, environmentally sound and publicly acceptable options for the long-term management of radioactive materials. As part of this role, Nirex has developed a phased deep geological disposal concept which is defined by six 'generic documents' that describe systems, processes and safety assessments that are not specific to any one location or geology. These generic documents give access to detailed information about the ideas and approaches that underpin the phased disposal concept, and have been published with an invitation to enter into dialogue with Nirex regarding these issues. The generic documents identify the requirements for an integrated transport system that would be necessary for the management of the intermediate-level (ILW) and low-level (LLW) wastes within Nirex's remit - the so-called reference case volume. This has involved Nirex in the development of transport hardware and associated safety reports and modelling and assessment tools for transport system logistics and system safety. Although the phased disposal concept is only one option for the long-term management of waste, the integrated transport system and associated modelling tools, is likely to be of equal relevance to other options. The safety assessment of the generic transport operation for the movement of ILW and LLW waste from waste producers' sites to a future radioactive waste disposal facility is described in one of the generic documents - the generic transport safety assessment (GTSA). The GTSA demonstrates that the transport operation is compliant with Nirex safety principles, and that the nuclear and non-nuclear risks to the public and workers from routine transport and from accidents are acceptable. This paper describes the types of risk that are calculated, and discusses the data requirements and calculation methodology. The verification and validation methodology is outlined, together with a discussion of the results

[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.

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 ...

Uranium milling, project M-25. Volume I. summary and text. Final generic environmental impact statement

International Nuclear Information System (INIS)

1980-09-01

The Final Generic Environmental Impact Statement (GEIS) on Uranium Milling focuses primarily upon the matter of mill tailings disposal. It evaluates both the costs and benefits of alternative tailings disposal modes and draws conclusions about criteria which should be incorporated into regulations. Both institutional and technical controls are evaluated. Health impacts considered were both short and long term. Restatement and resolution of all public comments received on the draft (GEIS) are presented. There are three volumes: Volume I is the main text and Volumes II and III are supporting appendices

EDF group - Reference Document 2006

International Nuclear Information System (INIS)

2007-01-01

The EDF Group is an integrated energy supplier operating in a wide range of electricity-related businesses: generation, transmission, distribution, sale and trading of energy. It is the main operator in the French electricity market and holds strong positions in the other three principal European markets (Germany, the United Kingdom, Italy) making it one of the leading electricity groups in Europe, and a recognized actor in the gas market. With an installed capacity of 123.7 GW in Europe (128.2 GW worldwide) it holds, among the major European energy specialists, the largest production fleet and the one emitting the least CO 2 , owing to the share of nuclear technology and hydropower in its generation mix. The EDF group supplies electricity, gas and associated services to more than 37.8 million customers throughout the world and in Europe (more than 28 million of whom are in France). The EDF Group has built a business model balanced between France and the international markets, and between deregulated and regulated operations. In 2006, the Group recorded consolidated sales of euros 58,932 million, net income (Group share) of euros 5,605 million, and it achieved earnings before interest, taxes, depreciation and amortization of euros 13,930 million. From July 1, 2007, the EDF group will carry out its trading activities in a European energy market fully open to competition. This document is EDF Group's Reference Document for the year 2006. It contains information about: the Group activities, risk factors, Business overview, Organizational structure, Property, plants and equipment, Operating and financial review, Capital resources and cash flows, Research and Development, Patents and Licenses, Trend information, Financial forecasts or estimates, Administrative, management and supervisory bodies and senior management, Remuneration and benefits, Board practices, Employees/Human resources, Major shareholders, Related party transactions, Financial information

EDF group - Reference Document 2009

International Nuclear Information System (INIS)

2010-01-01

The EDF group is an integrated energy company with a presence in a wide range of electricity-related businesses: generation, transmission, distribution, supply and energy trading. It is France's leading electricity operator and has a strong position in the three other main European markets (Germany, the United Kingdom and Italy), making it one of Europe's leading electrical players as well as a recognized player in the gas industry. With worldwide installed power capacity totaling 136.3 GW as of December 31, 2009 (134.0 GW in Europe) and global energy generation of 618.5 TWh, it has the largest generating capacity of all the major European energy corporations with the lowest level of CO 2 emissions due to the significant proportion of nuclear and hydroelectric power in its generation mix. The EDF group supplies gas, electricity, and associated services to more than 37.9 million customer accounts worldwide (including approximately 27.7 million in France). The EDF group's businesses reflect its adoption of a model aimed at finding the best balance between French and international activities, competitive and regulated operations and based on an upstream-downstream integration. In 2009, the Group's consolidated revenues were euros 66.3 billion, the net income (Group share) was euros 3.9 billion, and earnings before interest, tax, depreciation and amortization was euros 17.5 billion. This document is EDF Group's Reference Document and Annual Financial Report for the year 2009. It contains information about: the Group activities, risk factors, Business, Organizational structure, Property plant and equipment, Operating and financial review, Capital resources and cash flows, Research and Development, Patents and Licenses, Information on trends, Financial outlook, Administrative, management, and supervisory bodies and senior management, Compensation and benefits, Functioning of the administration and management bodies, Employees/Human resources

German rules and regulations eith special reference to application documents

International Nuclear Information System (INIS)

Kraut, A.

1979-01-01

Regulations and standards play an essential role in achieving a safe and economic technology and in making the licensing procedure systematic, effective and clear. German rules and regulations applicable to the nuclear field are presented in this paper together with references to the rulemaking organizations. Detailed information is given on those rules and regulations, which prescribe the requirements concerning necessary documents for the nuclear licensing procedure. (author)

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.

EDF Group - 2010 Reference Document

International Nuclear Information System (INIS)

2011-04-01

Beside the accounts of EDF for 2008 and 2009, this voluminous document presents persons in charge, legal account auditors, and how risks are managed within the company. It gives an overview of EDF activities, of its organization, of its assets. It presents and discusses its financial situation and results, indicates the main contracts, and proposes other documents concerning the company. Many documents and reports are provided in appendix

Document status for 1 and 2 Kozloduy NPP decommissioning activities -Phase 'Final Shutdown'

International Nuclear Information System (INIS)

Vangev, A.; Boyadjiev, Z.

1997-01-01

Decommissioning process (D and D) is the final phase of each nuclear reactor life cycle. The first nuclear reactor generation has reached his expiration life date. Decommissioning working documentation had not been taken into account at the project and construction stage. The decommissioning activities, planning and legislation has to develop along their operation. Most of developed nuclear energetic countries have gathered good experience and have create their own decommissioning strategy. This report represents in brief an overview of different country's approaches and the Kozloduy NPP decommissioning activity intention in near future and reviews the D and D working document status for 1 and 2 Kozloduy NPP Units decommissioning. Kozloduy NPP D and D task to the moment is to plan the first stage of the decommissioning process - 'The Final Shutdown' and to prepare the working documents for the phase execution. The Final Shutdown of Kozloduy NPP - 1 is the termination of operation of the Units 1 and 2 and the electricity production cessation after their useful life exhaust. In accordance with the legal legislation in Bulgaria only the normal planned termination of operation on units 1 and 2 should be prescribed. The project results concern the initial condition of the equipment and systems, their preparation and sequence for defueling, decontamination and dismantling. A plan for activities' organization for D and D and Complex Characterization of the Site under consideration will contain the following documents: 1. Time-schedule for the sequence of activities during the stages of the Final Shutdown and Safe Enclosure preparation. Technical project for organization of work related to Final Shutdown; 2. Complex Characterization Programme for a condition investigation of the Units 1 and 2 equipment and systems. 3. Technical project for design modifications and dismantling of equipment and systems which violate the radiation and nuclear safety during the Final Shutdown

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…

[Consensus clinical practice guidelines of the Andalusian Epilepsy Society on prescribing generic antiepileptic drugs].

Science.gov (United States)

Cañadillas-Hidalgo, F M; Sánchez-Alvarez, J C; Serrano-Castro, P J; Mercadé-Cerdá, J M

Pharmaceutical spending in Spain accounts for 1.2-1.4% of the gross domestic product and is increasing by 5-12% per year. One of the measures adopted by the government to cut this spending is the possible substitution of original prescribed drugs by generics. In the case of antiepileptic drugs (AED), which are characterised by a scant therapeutic margin, these steps have sparked a scientific debate about their repercussion on the control of epileptic patients. We propose to draw up a set of implicit evidence-based consensus practice guidelines concerning issues related with this topic. A selective search for quality scientific information on the subject was conducted on PubMed-Medline, Tripdatabase and the Biblioteca Cochrane Plus. The selected references were analysed and discussed by the authors, and the recommendations deriving from them were collected. A total of 21 primary documents and 16 practice guidelines, protocols or experts' recommendations were identified. Our recommendations were explicitly included at the end of the text. The Andalusian Epilepsy Society makes the following recommendations: 1) not replacing an innovative AED by its generic in a controlled patient; 2) beginning treatment with a generic AED in monotherapy or in association is acceptable; 3) not exchanging generic AED from different pharmaceutical companies; 4) explaining to the patient the rules governing the authorization of generics and the importance of avoiding exchanges between different generic AED; and 5) if there is some worsening of the clinical condition or side effects appear following the introduction of a generic, the causes must be investigated and communicated to the bodies responsible for pharmacovigilance.

Document retrieval on repetitive string collections.

Science.gov (United States)

Gagie, Travis; Hartikainen, Aleksi; Karhu, Kalle; Kärkkäinen, Juha; Navarro, Gonzalo; Puglisi, Simon J; Sirén, Jouni

2017-01-01

Most of the fastest-growing string collections today are repetitive, that is, most of the constituent documents are similar to many others. As these collections keep growing, a key approach to handling them is to exploit their repetitiveness, which can reduce their space usage by orders of magnitude. We study the problem of indexing repetitive string collections in order to perform efficient document retrieval operations on them. Document retrieval problems are routinely solved by search engines on large natural language collections, but the techniques are less developed on generic string collections. The case of repetitive string collections is even less understood, and there are very few existing solutions. We develop two novel ideas, interleaved LCPs and precomputed document lists , that yield highly compressed indexes solving the problem of document listing (find all the documents where a string appears), top- k document retrieval (find the k documents where a string appears most often), and document counting (count the number of documents where a string appears). We also show that a classical data structure supporting the latter query becomes highly compressible on repetitive data. Finally, we show how the tools we developed can be combined to solve ranked conjunctive and disjunctive multi-term queries under the simple [Formula: see text] model of relevance. We thoroughly evaluate the resulting techniques in various real-life repetitiveness scenarios, and recommend the best choices for each case.

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

Assessment of prescribing information for generic drugs manufactured in the Middle East and marketed in Saudi Arabia

International Nuclear Information System (INIS)

Gebran, N.; Al-Haldari, K.

2006-01-01

Little research has assessed the quality of manufacturer provided prescribing information or documented difference in key aspects of drug information among different marketed generic products of the same drug particularly in Middle East and Arabian Gulf. We assessed the quality of written prescribing information for selected generic drugs marketed in Saudi Arabia and manufactured in various countries of Middle East. We assessed the correctness and completeness of information pertaining to indications, dosage cautions/contraindications, side effects and drug interactions in 37 packages inserts for generic products registered in Saudi Arabia and manufactured in the Middle East, including atenolol (6 inserts), fluoxetine (4 inserts), ciprofloxacin (11 inserts), melformin (7 inserts) and omeprazole (9 inserts). We also described deficiencies in quality and quantity of manufacturers provided information that could be misleading to patients and prescribes. We found substantial disagreement in information between generic packages inserts versus the British National Formulary and the package insert of the brand product marketed in Saudi Arabia. A cumulative average of 63.16% of drug information indicators were in agreement with these standard references. Section headings with the least conformity with study references were those related to dosage (57, 28%) and side effects (54+-30%). Our results indicate that national authorities should implement appropriate measures aimed at removing misleading and incorrect information in generic package inserts and incorporating crucial prescribing information that is missing. National authorities in the Middle East and Arabian Gulf should strengthen collaboration and information interchange among each other and with international agencies to maintain common quality standards for delivering information through package inserts. (author)

Interventions promoting the acceptance and uptake of generic medicines: a narrative review of the literature.

Science.gov (United States)

Babar, Z U D; Kan, S W; Scahill, S

2014-09-01

The objective of this paper was to undertake a narrative review of the literature regarding strategies and interventions promoting the acceptance and uptake of generic medicines. A literature search was performed between November 2011 and January 2012 to identify published full text original research articles documenting interventions to promote the use of generic medicines. Keywords used were: "generic medicine", "generic drug", "intervention", "promotion", "acceptance", "uptake", "generic/therapeutic substitution" and their related root words. The electronic databases comprised of Embase (1980 - present), Google, Google Scholar, Medline (1948 - present), PubMed, Science Direct, Scopus, Springer Link and The Cochrane Library. An interpretative narrative synthesis was undertaken and emergent themes analysed and reported. Eighteen studies were included in the final analysis. There were seven main themes which including; education, financial incentives, advertising to promote generic medicines, free generic medicine trials, administrative forms and medicines use review (MUR). These themes were further classified into subthemes. Education was subdivided into consumer and physician education. Financial incentives included the influence of financial incentives on both consumers and physicians. The subthemes in the financial incentives category included the changes in co-payment for consumers, reward payment for physicians and fund-holding schemes. Advertising included the sub-themes of print media and the use of anthropomorphic images, while free generic medicines trial was made up of free vouchers for generic medicines and generic medicines sampling system. The studies have mixed results; some interventions in some settings were useful, while others were not. Not all interventions consistently improved the uptake of generic medicines. There was limited literature available and further work is required to develop a range of interventions to support the uptake of generic

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)

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

Analysis Relationship Among Descriptor, References and Citation to Contruct the Inherent Structure of Document Collection

International Nuclear Information System (INIS)

Hasibuan, Zainal A.; Mustangimah

2001-01-01

There are many characteristics can be used to identify a document which cover characteristics of the documents, cited documents, and citing documents This research explored the inherent structure of a document collection as one of main components of information retrieval system. The characteristics examined are: descriptors, references (cited documents), and citations (citing documents). Three independent variables were studied: co-descriptor, bibliographic coupling, and co-citation. A test collection was constructed by searching on a single descriptor i nformation retrieval i n the CD-ROM version of Education Resource Information Clearinghouse (ERIC), covering the period 1981 through 1985. Descriptors were extracted from ERIC; cited and citing documents associated with the test collection were derived from Social Sciences Citation Index (SSCI), covering the period 1981 through 1990. Three hypothesis were tested in this study, that are: (1) the higher the frequency of co-descriptors between documents, the higher the frequencies of their bibliographic coupling and co-citation; (2) the higher the frequency of bibliographic coupling between documents, the higher the frequencies of their co-citation and co-descriptors; and (3) the higher the frequency of co-citation between documents, the higher the frequencies of their co-descriptors and bibliographic coupling. The results showed that all of three hypothesis are supported statistically and there is a significant linear relationship among the observed variables. It is mean that there is a significant relationship among descriptors, references, and citation, so that it can be used to construct the inherent structure of document collection in order to improve information retrieval system performance

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...

Influence of generic reference pricing on medicine cost in Slovenia: a retrospective study

Science.gov (United States)

Marđetko, Nika; Kos, Mitja

2018-01-01

Aim To assess the impact of the generic reference pricing (GRP) system on the prices and cost of medicines in Slovenia approximately 8 years after its introduction in 2003 and before the implementation of the therapeutic reference pricing system. Methods A retrospective study of all medicines (N = 789) included in the GRP system on January 31, 2012 was performed. Medicine prices and cost were analyzed between January 31, 2012 and December 31, 2013 after every update (N = 11) of the maximum reimbursable price (MRP) and were compared to the price and cost on January 31, 2012 (index date). Time trends of different types of medicine prices (maximum allowed price, MRP, and actual wholesale price) were graphically analyzed, and actual wholesale price adjustments to the MRP changes and the budget impact of the GRP were assessed. Results In the 2-year study period, the long-term performance of the GRP system was associated with an approximate 45% decrease in the average MRP or an approximate 20% cost reduction. For each MRP update period, the GRP reduced the cost based on the maximum allowed price for approximately 30%. The wholesale price adjustments were mostly made for medicines priced above the MRP and reduced patients’ out-of-pocket cost. Conclusions In the long term, the GRP system effectively reduced medicine prices and the cost of reimbursed products. PMID:29740992

Influence of generic reference pricing on medicine cost in Slovenia: a retrospective study.

Science.gov (United States)

Marđetko, Nika; Kos, Mitja

2018-04-30

To assess the impact of the generic reference pricing (GRP) system on the prices and cost of medicines in Slovenia approximately 8 years after its introduction in 2003 and before the implementation of the therapeutic reference pricing system. A retrospective study of all medicines (N=789) included in the GRP system on January 31, 2012 was performed. Medicine prices and cost were analyzed between January 31, 2012 and December 31, 2013 after every update (N=11) of the maximum reimbursable price (MRP) and were compared to the price and cost on January 31, 2012 (index date). Time trends of different types of medicine prices (maximum allowed price, MRP, and actual wholesale price) were graphically analyzed, and actual wholesale price adjustments to the MRP changes and the budget impact of the GRP were assessed. In the 2-year study period, the long-term performance of the GRP system was associated with an approximate 45% decrease in the average MRP or an approximate 20% cost reduction. For each MRP update period, the GRP reduced the cost based on the maximum allowed price for approximately 30%. The wholesale price adjustments were mostly made for medicines priced above the MRP and reduced patients' out-of-pocket cost. In the long term, the GRP system effectively reduced medicine prices and the cost of reimbursed products.

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.

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)

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

Reactor risk reference document: Main report: Draft for comment

International Nuclear Information System (INIS)

1987-02-01

The Reactor Risk Reference Document, NUREG-1150, provides the results of major risk analyses for five different US light-water reactors (Surry, Zion, Sequoyah, Peach Bottom, and Grand Gulf) using state-of-the-art methods. The broad base of probabilistic risk information contained in this document is intended to provide a data base and insights to be used in a number of regulatory applications. It is anticipated that these regulatory actions will include implementation of the NRC Severe Accident Policy Statement, implementation of NRC safety goal policy, consideration of the NRC Backfit Rule, evaluation and possible revision of regulations or regulatory requirements for emergency preparedness, plant siting, and equipment qualification, and establishment of risks-oriented priorities for allocating agency resources. This report has been published in draft form. For the plants analyzed, this document describes the major factors related to internally initiated events that contribute to severe core damage, frequencies and related uncertainty ranges of severe core damage events, the major factors and severe accident phenomena that could lead to containment failure, the conditional probabilities and uncertainty ranges of early containment failure, the consequences and risks of severe accidents, including the sensitivity of these risks to factors such as evacuation or sheltering measures, comparisons of the risks with NRC safety goals, and cost and risk-reduction analyses of plant-specific measures that could reduce risk from severe accidents

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

Codes and standards and other guidance cited in regulatory documents. Revision 1

International Nuclear Information System (INIS)

Ankrum, A.; Nickolaus, J.; Vinther, R.; Maguire-Moffitt, N.; Hammer, J.; Sherfey, L.; Warner, R.

1994-08-01

As part of the US Nuclear Regulatory Commission (NRC) Standard Review Plan Update and Development Program, Pacific Northwest Laboratory developed a listing of industry consensus codes and standards and other government and industry guidance referred to in regulatory documents. In addition to updating previous information, Revision 1 adds citations from the NRC Inspection Manual and the Improved Standard Technical Specifications. This listing identifies the version of the code or standard cited in the regulatory document, the regulatory document, and the current version of the code or standard. It also provides a summary characterization of the nature of the citation. This listing was developed from electronic searches of the Code of Federal Regulations and the NRC's Bulletins, Information Notices, Circulars, Generic Letters, Policy Statements, Regulatory Guides, and the Standard Review Plan (NUREG-0800)

Codes and standards and other guidance cited in regulatory documents. Revision 1

Energy Technology Data Exchange (ETDEWEB)

Ankrum, A.; Nickolaus, J.; Vinther, R.; Maguire-Moffitt, N.; Hammer, J.; Sherfey, L.; Warner, R. [Pacific Northwest Lab., Richland, WA (United States)

1994-08-01

As part of the US Nuclear Regulatory Commission (NRC) Standard Review Plan Update and Development Program, Pacific Northwest Laboratory developed a listing of industry consensus codes and standards and other government and industry guidance referred to in regulatory documents. In addition to updating previous information, Revision 1 adds citations from the NRC Inspection Manual and the Improved Standard Technical Specifications. This listing identifies the version of the code or standard cited in the regulatory document, the regulatory document, and the current version of the code or standard. It also provides a summary characterization of the nature of the citation. This listing was developed from electronic searches of the Code of Federal Regulations and the NRC`s Bulletins, Information Notices, Circulars, Generic Letters, Policy Statements, Regulatory Guides, and the Standard Review Plan (NUREG-0800).

Technology, safety and costs of decommissioning a refernce boiling water reactor power station: Technical support for decommissioning matters related to preparation of the final decommissioning rule

International Nuclear Information System (INIS)

Konzek, G.J.; Smith, R.I.

1988-07-01

Preparation of the final Decommissioning Rule by the Nuclear Regulatory Commission (NRC) staff has been assisted by Pacific Northwest Laboratory (PNL) staff familiar with decommissioning matters. These efforts have included updating previous cost estimates developed during the series of studies of conceptually decommissioning reference licensed nuclear facilities for inclusion in the Final Generic Environmental Impact Statement (FGEIS) on decommissioning; documenting the cost updates; evaluating the cost and dose impacts of post-TMI-2 backfits on decommissioning; developing a revised scaling formula for estimating decommissioning costs for reactor plants different in size from the reference boiling water reactor (BWR) described in the earlier study; and defining a formula for adjusting current cost estimates to reflect future escalation in labor, materials, and waste disposal costs. This report presents the results of recent PNL studies to provide supporting information in three areas concerning decommissioning of the reference BWR: updating the previous cost estimates to January 1986 dollars; assessing the cost and dose impacts of post-TMI-2 backfits; and developing a scaling formula for plants different in size than the reference plant and an escalation formula for adjusting current cost estimates for future escalation

Areva - 2011 Reference document

International Nuclear Information System (INIS)

2011-01-01

After having indicated the person responsible of this document and the legal account auditors, and provided some financial information, this document gives an overview of the different risk factors existing in the company: law risks, industrial and environmental risks, operational risks, risks related to large projects, market and liquidity risks. Then, after having recalled the history and evolution of the company and the evolution of its investments over the last five years, it proposes an overview of Areva's activities on the markets of nuclear energy and renewable energies, of its clients and suppliers, of its strategy, of the activities of its different departments. Other information are provided: company's flow chart, estate properties (plants, equipment), an analysis of its financial situation, its research and development policy, the present context, profit previsions or estimations, management organization and operation

Exploring the Knowledge and Perception of Generic Medicines among Final Year Undergraduate Medical, Pharmacy, and Nursing Students in Sierra Leone: A Comparative Cross-Sectional Approach

Directory of Open Access Journals (Sweden)

Peter Bai James

2018-01-01

Full Text Available Most low-income nations have national medicine policy that emphasized the use of generic medicines in the public health sector. However, the use of generics is often debatable as there are concerns over its efficacy, quality, and safety compared to their branded counterparts. This study was conducted to compare the knowledge and perception of generic medicines among final year undergraduate medical, pharmacy, and nursing students in Sierra Leone. We conducted a questionnaire-based cross-sectional study among these students at the College of Medicine and Allied Health Sciences University of Sierra Leone. Out of the 62 students, only two (2/62, 3.2% knew about the acceptable bioequivalence limit. At least half of respondents in all three groups agreed that all generics are therapeutically equivalent to their innovator brand. At least half of the medicine (21/42, 50% and nursing (6/9, 66.6% students, compared to pharmacy students (5/11, 45.5%, believed that higher safety standards are required for proprietary medicines than for generic medicines. Most of them agreed that they need more information on the safety, quality, and efficacy aspects of generics (59/62, 95.2%. All three groups of healthcare students, despite variations in their responses, demonstrated a deficiency in knowledge and misconception regarding generic medicines. Training on issues surrounding generic drugs in healthcare training institutions is highly needed among future healthcare providers in Sierra Leone.

Development of the biosphere code BIOMOD: final report

International Nuclear Information System (INIS)

Kane, P.

1983-05-01

Final report to DoE on the development of the biosphere code BIOMOD. The work carried out under the contract is itemised. Reference is made to the six documents issued along with the final report. These consist of two technical notes issued as interim consultative documents, a user's guide and a programmer's guide to BIOMOD, a database description, program test document and a technical note entitled ''BIOMOD - preliminary findings''. (author)

Codes and standards and other guidance cited in regulatory documents

International Nuclear Information System (INIS)

Nickolaus, J.R.; Bohlander, K.L.

1996-08-01

As part of the U.S. Nuclear Regulatory Commission (NRC) Standard Review Plan Update and Development Program (SRP-UDP), Pacific Northwest National Laboratory developed a listing of industry consensus codes and standards and other government and industry guidance referred to in regulatory documents. The SRP-UDP has been completed and the SRP-Maintenance Program (SRP-MP) is now maintaining this listing. Besides updating previous information, Revision 3 adds approximately 80 citations. This listing identifies the version of the code or standard cited in the regulatory document, the regulatory document, and the current version of the code or standard. It also provides a summary characterization of the nature of the citation. This listing was developed from electronic searches of the Code of Federal Regulations and the NRC's Bulletins, Information Notices, Circulars, Enforcement Manual, Generic Letters, Inspection Manual, Policy Statements, Regulatory Guides, Standard Technical Specifications and the Standard Review Plan (NUREG-0800)

Codes and standards and other guidance cited in regulatory documents

Energy Technology Data Exchange (ETDEWEB)

Nickolaus, J.R.; Bohlander, K.L.

1996-08-01

As part of the U.S. Nuclear Regulatory Commission (NRC) Standard Review Plan Update and Development Program (SRP-UDP), Pacific Northwest National Laboratory developed a listing of industry consensus codes and standards and other government and industry guidance referred to in regulatory documents. The SRP-UDP has been completed and the SRP-Maintenance Program (SRP-MP) is now maintaining this listing. Besides updating previous information, Revision 3 adds approximately 80 citations. This listing identifies the version of the code or standard cited in the regulatory document, the regulatory document, and the current version of the code or standard. It also provides a summary characterization of the nature of the citation. This listing was developed from electronic searches of the Code of Federal Regulations and the NRC`s Bulletins, Information Notices, Circulars, Enforcement Manual, Generic Letters, Inspection Manual, Policy Statements, Regulatory Guides, Standard Technical Specifications and the Standard Review Plan (NUREG-0800).

Reference values for generic instruments used in routine outcome monitoring: the leiden routine outcome monitoring study

Directory of Open Access Journals (Sweden)

Schulte-van Maaren Yvonne WM

2012-11-01

Full Text Available Abstract Introduction The Brief Symptom Inventory (BSI, Mood & Anxiety Symptom Questionnaire −30 (MASQ-D30, Short Form Health Survey 36 (SF-36, and Dimensional Assessment of Personality Pathology-Short Form (DAPP-SF are generic instruments that can be used in Routine Outcome Monitoring (ROM of patients with common mental disorders. We aimed to generate reference values usually encountered in 'healthy' and ‘psychiatrically ill’ populations to facilitate correct interpretation of ROM results. Methods We included the following specific reference populations: 1294 subjects from the general population (ROM reference group recruited through general practitioners, and 5269 psychiatric outpatients diagnosed with mood, anxiety, or somatoform (MAS disorders (ROM patient group. The outermost 5% of observations were used to define limits for one-sided reference intervals (95th percentiles for BSI, MASQ-D30 and DAPP-SF, and 5th percentiles for SF-36 subscales. Internal consistency and Receiver Operating Characteristics (ROC analyses were performed. Results Mean age for the ROM reference group was 40.3 years (SD=12.6 and 37.7 years (SD=12.0 for the ROM patient group. The proportion of females was 62.8% and 64.6%, respectively. The mean for cut-off values of healthy individuals was 0.82 for the BSI subscales, 23 for the three MASQ-D30 subscales, 45 for the SF-36 subscales, and 3.1 for the DAPP-SF subscales. Discriminative power of the BSI, MASQ-D30 and SF-36 was good, but it was poor for the DAPP-SF. For all instruments, the internal consistency of the subscales ranged from adequate to excellent. Discussion and conclusion Reference values for the clinical interpretation were provided for the BSI, MASQ-D30, SF-36, and DAPP-SF. Clinical information aided by ROM data may represent the best means to appraise the clinical state of psychiatric outpatients.

Bituminous reference document: synthesis of knowledge on the long time behavior of bituminous packages; Dossier de reference bitume: synthese des connaissances sur le comportement a long terme des colis bitumes

Energy Technology Data Exchange (ETDEWEB)

Sercombe, J.; Adenot, F.; Vistoli, P.P.; Parraud, S.; Riglet-Martial, C.; Gwinner, B.; Felines, I.; Tiffreau, C.; Libert, M

2004-07-01

This document is a synthesis of the knowledge acquired at the CEA on the behavior of bituminous packages. In this framework, the CEA studied bituminous packages in generic conditions of a package lifetime. The main factors, the evolution mechanisms and influential parameters have been determined and quantitative s simulation have been developed. After a description of the main initial bituminous packages characterizations, the evolutions in saturated and un-saturated environment are exposed. (A.L.B.)

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

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

Development of a reference biospheres methodology for radioactive waste disposal. Final report

Energy Technology Data Exchange (ETDEWEB)

Dorp, F van [NAGRA (Switzerland); and others

1996-09-01

The BIOMOVS II Working Group on Reference Biospheres has focused on the definition and testing of a methodology for developing models to analyse radionuclide behaviour in the biosphere and associated radiological exposure pathways(a Reference Biospheres Methodology). The Working Group limited the scope to the assessment of the long-term implications of solid radioactive waste disposal. Nevertheless, it is considered that many of the basic principles would be equally applicable to other areas of biosphere assessment. The recommended methodology has been chosen to be relevant to different types of radioactive waste and disposal concepts. It includes the justification, arguments and documentation for all the steps in the recommended methodology. The previous experience of members of the Reference Biospheres Working Group was that the underlying premises of a biosphere assessment have often been taken for granted at the early stages of model development, and can therefore fail to be recognized later on when questions of model sufficiency arise, for example, because of changing regulatory requirements. The intention has been to define a generic approach for the formation of an 'audit trail' and hence provide demonstration that a biosphere model is fit for its intended purpose. The starting point for the methodology has three. The Assessment Context sets out what the assessment has to achieve, eg. in terms of assessment purpose and related regulatory criteria, as well as information about the repository system and types of release from the geosphere. The Basic System Description includes the fundamental premises about future climate conditions and human behaviour which, to a significant degree, are beyond prediction. The International FEP List is a generically relevant list of Features, Events and Processes potentially important for biosphere model development. The International FEP List includes FEPs to do with the assessment context. The context examined in detail by

Development of a reference biospheres methodology for radioactive waste disposal. Final report

Energy Technology Data Exchange (ETDEWEB)

Dorp, F. van [NAGRA (Switzerland)] [and others

1996-09-01

The BIOMOVS II Working Group on Reference Biospheres has focused on the definition and testing of a methodology for developing models to analyse radionuclide behaviour in the biosphere and associated radiological exposure pathways(a Reference Biospheres Methodology). The Working Group limited the scope to the assessment of the long-term implications of solid radioactive waste disposal. Nevertheless, it is considered that many of the basic principles would be equally applicable to other areas of biosphere assessment. The recommended methodology has been chosen to be relevant to different types of radioactive waste and disposal concepts. It includes the justification, arguments and documentation for all the steps in the recommended methodology. The previous experience of members of the Reference Biospheres Working Group was that the underlying premises of a biosphere assessment have often been taken for granted at the early stages of model development, and can therefore fail to be recognized later on when questions of model sufficiency arise, for example, because of changing regulatory requirements. The intention has been to define a generic approach for the formation of an 'audit trail' and hence provide demonstration that a biosphere model is fit for its intended purpose. The starting point for the methodology has three. The Assessment Context sets out what the assessment has to achieve, eg. in terms of assessment purpose and related regulatory criteria, as well as information about the repository system and types of release from the geosphere. The Basic System Description includes the fundamental premises about future climate conditions and human behaviour which, to a significant degree, are beyond prediction. The International FEP List is a generically relevant list of Features, Events and Processes potentially important for biosphere model development. The International FEP List includes FEPs to do with the assessment context. The context examined in

VBE reference framework

NARCIS (Netherlands)

Afsarmanesh, H.; Camarinha-Matos, L.M.; Ermilova, E.; Camarinha-Matos, L.M.; Afsarmanesh, H.; Ollus, M.

2008-01-01

Defining a comprehensive and generic "reference framework" for Virtual organizations Breeding Environments (VBEs), addressing all their features and characteristics, is challenging. While the definition and modeling of VBEs has become more formalized during the last five years, "reference models"

Semantic validation of standard-based electronic health record documents with W3C XML schema.

Science.gov (United States)

Rinner, C; Janzek-Hawlat, S; Sibinovic, S; Duftschmid, G

2010-01-01

The goal of this article is to examine whether W3C XML Schema provides a practicable solution for the semantic validation of standard-based electronic health record (EHR) documents. With semantic validation we mean that the EHR documents are checked for conformance with the underlying archetypes and reference model. We describe an approach that allows XML Schemas to be derived from archetypes based on a specific naming convention. The archetype constraints are augmented with additional components of the reference model within the XML Schema representation. A copy of the EHR document that is transformed according to the before-mentioned naming convention is used for the actual validation against the XML Schema. We tested our approach by semantically validating EHR documents conformant to three different ISO/EN 13606 archetypes respective to three sections of the CDA implementation guide "Continuity of Care Document (CCD)" and an implementation guide for diabetes therapy data. We further developed a tool to automate the different steps of our semantic validation approach. For two particular kinds of archetype prescriptions, individual transformations are required for the corresponding EHR documents. Otherwise, a fully generic validation is possible. In general, we consider W3C XML Schema as a practicable solution for the semantic validation of standard-based EHR documents.

Technical support document for the surface disposal of sewage sludge. Final report

International Nuclear Information System (INIS)

1992-11-01

The document provides the technical background and justification for the U.S. Environmental Protection Agency's (EPA) final regulation (40 CFR Part 503) covering the surface disposal of sewage sludge. The document summarizes current practices in land application and presents data supporting the risk assessment methodology used to derive human health and environmental risk-based limits for contaminants in sewage sludge placed on surface disposal sites. The management practices associated with surface disposal are outlined and the different pathways by which contaminants reach highly-exposed individuals (HEIs) through surface disposal are discussed

Technical support document for the surface disposal of sewage sludge. Final report

Energy Technology Data Exchange (ETDEWEB)

1992-11-01

The document provides the technical background and justification for the U.S. Environmental Protection Agency's (EPA) final regulation (40 CFR Part 503) covering the surface disposal of sewage sludge. The document summarizes current practices in land application and presents data supporting the risk assessment methodology used to derive human health and environmental risk-based limits for contaminants in sewage sludge placed on surface disposal sites. The management practices associated with surface disposal are outlined and the different pathways by which contaminants reach highly-exposed individuals (HEIs) through surface disposal are discussed.

Final design of the generic equatorial port plug structure for ITER diagnostic systems

International Nuclear Information System (INIS)

Udintsev, V.S.; Maquet, P.; Alexandrov, E.; Casal, N.; Cuenca, D.; Drevon, J.-M.; Feder, R.; Friconneau, J.P.; Giacomin, T.; Guirao, J.; Iglesias, S.; Josseaume, F.; Levesy, B.; Loesser, D.; Ordieres, J.; Quinn, E.; Pak, S.; Penot, C.; Pitcher, C.S.; Portalès, M.

2015-01-01

The Diagnostic Generic Equatorial Port Plug (GEPP) is designed to be common to all equatorial port-based diagnostic systems. It is designed to survive throughout the lifetime of ITER for 20 years, 30,000 discharges, and 3000 disruptions. The EPP structure dimensions (without Diagnostic First Walls and Diagnostic Shield Modules) are L2.9 × W1.9 × H2.4 m"3. The length of the fully integrated EPP is 3174 mm. The weight of the EPP structure is about 15 t, whereas the total weight of the integrated EPP may be up to 45 t. The EPP structure provides a flexible platform for a variety of diagnostics. The Diagnostic Shield Module assemblies, or drawers, allow a modular approach with respect to diagnostic integration and maintenance. In the nuclear phase of ITER operations, they will be remotely inserted into the EPP structure in the Hot Cell Facility. The port plug structure must also contribute to the nuclear shielding, or plugging, of the port and further contain circulated water to allow cooling during operation and heating during bake-out. The Final Design of the GEPP has been successfully passed in late 2013 and is now heading toward manufacturing. The final design of the GEPP includes interfaces, manufacturing, R&D, operation and maintenance, load cases and analysis of failure modes.

AREVA 2010 Reference document

International Nuclear Information System (INIS)

2010-01-01

After a presentation of the person responsible for this document, and of statutory auditors, this report proposes some selected financial information. Then, it addresses, presents and comments the different risk factors: risk management and coverage, legal risk, industrial and environmental risk, operational risk, risks related to major projects, liquidity and market risk, and other risk. Then, after a presentation of the issuer, it proposes a business overview (markets for nuclear and renewable energies, AREVA customers and suppliers, strategy, activities), a presentation of the organizational structure, a presentation of AREVA properties, plants and equipment (sites, environmental issues), an analysis and comment of the group's financial position and performance, a presentation of its capital resources, an overview of its research and development activities, programs, patents and licenses. It indicates profit forecast and estimates, presents the administrative, management and supervisory bodies, and compensation and benefits amounts, reports of the functioning of corporate bodies. It describes the human resource company policy, indicates the main shareholders and transactions with related parties. It proposes financial information concerning assets, financial positions and financial performance. This document contains its French and its English versions

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

GENERIC VERIFICATION PROTOCOL FOR AQUEOUS CLEANER RECYCLING TECHNOLOGIES

Science.gov (United States)

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

Mixed waste characterization reference document

International Nuclear Information System (INIS)

1997-09-01

Waste characterization and monitoring are major activities in the management of waste from generation through storage and treatment to disposal. Adequate waste characterization is necessary to ensure safe storage, selection of appropriate and effective treatment, and adherence to disposal standards. For some wastes characterization objectives can be difficult and costly to achieve. The purpose of this document is to evaluate costs of characterizing one such waste type, mixed (hazardous and radioactive) waste. For the purpose of this document, waste characterization includes treatment system monitoring, where monitoring is a supplement or substitute for waste characterization. This document establishes a cost baseline for mixed waste characterization and treatment system monitoring requirements from which to evaluate alternatives. The cost baseline established as part of this work includes costs for a thermal treatment technology (i.e., a rotary kiln incinerator), a nonthermal treatment process (i.e., waste sorting, macronencapsulation, and catalytic wet oxidation), and no treatment (i.e., disposal of waste at the Waste Isolation Pilot Plant (WIPP)). The analysis of improvement over the baseline includes assessment of promising areas for technology development in front-end waste characterization, process equipment, off gas controls, and monitoring. Based on this assessment, an ideal characterization and monitoring configuration is described that minimizes costs and optimizes resources required for waste characterization

Effects of reference pricing in pharmaceutical markets: a review.

Science.gov (United States)

Galizzi, Matteo Maria; Ghislandi, Simone; Miraldo, Marisa

2011-01-01

This work aims to provide a systematic and updated survey of original scientific studies on the effect of the introduction of reference pricing (RP) policies in Organisation for Economic Co-operation and Development (OECD) countries. We searched PubMed, EconLit and Web of Knowledge for articles on RP. We reviewed studies that met the inclusion criteria established in the search strategy. From a total of 468 references, we selected the 35 that met all of the inclusion criteria. Some common themes emerged in the literature. The first was that RP was generally associated with a decrease in the prices of the drugs subject to the policy. In particular, price drops seem to have been experienced in virtually every country that implemented a generic RP (GRP) policy. A GRP policy applies only to products with expired patents and generic competition, and clusters drugs according to chemical equivalence (same form and active compound). More significant price decreases were observed in the sub-markets in which drugs were already facing generic competition prior to RP. Price drops varied widely according to the amount of generic competition and industrial strategies: brand-named drugs originally priced above RP values decreased their prices to a greater extent. A second common theme was that both therapeutic RP (TRP) and GRP have been associated with significant and consistent savings in the first years of application. A third general result is that generic market shares significantly increased whenever the firms producing brand-named drugs did not adopt one of the following strategies: lowering prices to RP values; launching new dosages and/or formulations; or marketing substitute drugs still under patent protection. Finally, concerning TRP, although more evidence is needed, studies based on a large number of patient-level observations showed no association between the RP policy and health outcomes.

An In Vitro Aerosolization Efficiency Comparison of Generic and Branded Salbutamol Metered Dose Inhalers

Directory of Open Access Journals (Sweden)

Sara Rahimkhani, Saeed Ghanbarzadeh, Ali Nokhodchi, Hamed Hamishehkar

2017-03-01

Full Text Available Background: Due to the high rate of pulmonary diseases, respiratory drug delivery systems have been attracted excessive attention for the past decades. Because of limitations and growing drug bill, physicians are encouraged to prescribe generically whenever possible. The purpose of this study was to evaluate whether there was any significant difference in aerosolization performance between a reference brand Salbutamol (A Metered Dose Inhalers (MDIs and two generic products (B and C. Methods: The aerosolization performance of MDIs was evaluated by calculating aerosolization indexes including fine particle fraction (FPF, fine particle dose (FPD, geometric standard deviation (GSD and mass median aerodynamic diameters (MMAD by using the next generation impactor. Results: Although aerosolization indexes of MDI A were superior than the Iranian brands, but the differences were not statistically significant. Conclusion: These results verified that generic MDIs deliver similar quantities of Salbutamol to the reference brand and aerosolization performance parameters of generic Salbutamol MDIs did not differ significantly from the reference brand.

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)

Use of a generic protocol in documentation of prescription errors in Estonia, Norway and Sweden

Directory of Open Access Journals (Sweden)

Haavik S

2012-06-01

Full Text Available Pharmacists have an important role in detecting, preventing, and solving prescription problems, which if left unresolved, may pose a risk of harming the patient.Objective: The objectives of this study were to evaluate the feasibility of a generic study instrument for documentation of prescription problems requiring contact with prescriber before dispensing. The study was organized: 1 by countries: Estonia, Norway and Sweden; 2 by type of prescriptions: handwritten prescriptions, printouts of prescriptions in the electronic medical record and electronically transmitted prescriptions to pharmacies; and 3 by recording method - self-completion by pharmacists and independent observers.Methods: Observational study with independent observers at community pharmacies in Estonia (n=4 and Sweden (n=7 and self-completed protocols in Norway (n=9.Results: Pharmacists’ in Estonia contacted the prescriber for 1.47% of the prescriptions, about 3 times as often as in Norway (0.45% and Sweden (0.38%. Handwritten prescriptions dominated among the problem prescriptions in Estonia (73.2%, printouts of prescriptions in the electronic medical record (89.1% in Norway and electronically transmitted prescriptions to pharmacies (55.9% in Sweden.More administrative errors were identified on handwritten prescriptions and printouts of prescriptions in the electronic medical record in Estonia and in Norway compared with electronically transmitted prescriptions to pharmacies in Sweden (p<0.05 for prescription types and p<0.01 for countries. However, clinically important errors and delivery problems appeared equally often on the different types of prescriptions. In all three countries, only few cases of drug interactions and adverse drug reactions were identified.Conclusion: Despite the different patterns of prescription problems in three countries, the instrument was feasible and can be regarded appropriate to document and classify prescription problems necessitating contact

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.

D2.3 - ENCOURAGE platform reference architecture

DEFF Research Database (Denmark)

Ferreira, Luis Lino; Pinho, Luis Miguel; Albano, Michele

2012-01-01

documents produced in work package WP2, the framework for the detailed specification activities to be developed in the technical work packages of the project (WP3-WP6). In order to provide the required background for the ENCOURAGE platform reference, the document describes the most relevant standards...... and functionalities of the modules of the architecture logical blocks. Furthermore, the document defines the main interface standards to be used for interoperability. These functionalities and interfaces will then be specified in detail in work packages WP3-WP6. Finally, the document provides the mapping...

Practical reference - radiation standards in Canada

International Nuclear Information System (INIS)

1983-07-01

In developing a policy that will require licensees to calibrate their radiation dose measuring devices and trace such calibrations to approved reference standards, the AECB has consulted recognized experts. This document presents the experts' reports and recommendations which will be considered in finalizing the policy

Generic patch inference

DEFF Research Database (Denmark)

Andersen, Jesper; Lawall, Julia

2010-01-01

A key issue in maintaining Linux device drivers is the need to keep them up to date with respect to evolutions in Linux internal libraries. Currently, there is little tool support for performing and documenting such changes. In this paper we present a tool, spdiff, that identifies common changes...... developers can use it to extract an abstract representation of the set of changes that others have made. Our experiments on recent changes in Linux show that the inferred generic patches are more concise than the corresponding patches found in commits to the Linux source tree while being safe with respect...

Biomass Scenario Model Documentation: Data and References

Energy Technology Data Exchange (ETDEWEB)

Lin, Y.; Newes, E.; Bush, B.; Peterson, S.; Stright, D.

2013-05-01

The Biomass Scenario Model (BSM) is a system dynamics model that represents the entire biomass-to-biofuels supply chain, from feedstock to fuel use. The BSM is a complex model that has been used for extensive analyses; the model and its results can be better understood if input data used for initialization and calibration are well-characterized. It has been carefully validated and calibrated against the available data, with data gaps filled in using expert opinion and internally consistent assumed values. Most of the main data sources that feed into the model are recognized as baseline values by the industry. This report documents data sources and references in Version 2 of the BSM (BSM2), which only contains the ethanol pathway, although subsequent versions of the BSM contain multiple conversion pathways. The BSM2 contains over 12,000 total input values, with 506 distinct variables. Many of the variables are opportunities for the user to define scenarios, while others are simply used to initialize a stock, such as the initial number of biorefineries. However, around 35% of the distinct variables are defined by external sources, such as models or reports. The focus of this report is to provide insight into which sources are most influential in each area of the supply chain.

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.

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.

Generic Skills for Graduate Accountants: The Bigger Picture, a Social and Economic Imperative in the New Knowledge Economy

Science.gov (United States)

Bunney, Diane; Sharplin, Elaine; Howitt, Christine

2015-01-01

The case for integrating generic skills in university accounting programmes is well documented in the literature, but the implementation of strategies designed to teach generic skills in the context of accounting courses has posed ongoing challenges for academics and course administrators. The imperative for generic skills in accounting programmes…

Has the increase in the availability of generic drugs lowered the ...

African Journals Online (AJOL)

Comparison of price ratios between the originator drug, lowest priced generic and international reference price values revealed that the originator drug prices had a median price ratio of 20.99 (interquartile range 7.31e53.46) and the lowest priced generics had a median price ratio of 4.28 (interquartile range 2.10e8.47).

Areva - Updated Reference Document 2015 Including the 2016 half-year financial report

International Nuclear Information System (INIS)

2016-01-01

Areva supplies high added-value products and services to support the operation of the global nuclear fleet. The company is present throughout the entire nuclear cycle, from uranium mining to used fuel recycling, including nuclear reactor design and operating services. Areva is recognized by utilities around the world for its expertise, its skills in cutting-edge technologies and its dedication to the highest level of safety. Areva's 40,000 employees are helping build tomorrow's energy model: supplying ever safer, cleaner and more economical energy to the greatest number of people. This Reference Document contains information on Areva's objectives, prospects and development strategies. It contains estimates of the markets, market shares and competitive position of Areva. Contents: 1 - Persons responsible; 2 - Information on operations and recent events (Overview of the Group's operations, Simplified organization chart of the Group, Implementation of the Group's strategic roadmap and Restructuring Plan, Deployment of the performance plan, Other significant transactions since the filing of the Reference Document, Review of third quarter 2016 operations, Press releases); 3 - Financial information (2016 Half-year financial report, Statutory auditors' report on the half-year financial information for the period January 1 to June 30, 2016, Unaudited consolidated pro-forma financial information, Statutory auditors' report on the pro-forma financial information); 4 - Risk factors (Risks related to the Restructuring Plan, Legal risks, Industrial and environmental risks, Operational risks, Liquidity and market risks); 5 - Cash and capital resources (Financial outlook, 12-month liquidity); 6 - Governance; 7 - Workforce - jobs (Voluntary departure plan and change in the Group's workforce, Signature of a memorandum of understanding ensuring the stability of labor agreements, Reorganization and refinancing of the Group); 8 - Share

Technical support document for land application of sewage sludge. Volume 1. Final report

International Nuclear Information System (INIS)

Jones, A.; Beyer, L.; Rookwood, M.; Pacenka, J.; Bergin, J.

1992-11-01

The document provides the technical background and justification for the U.S. Environmental Protection Agency's (EPA) final regulation (40 CFR Part 503) covering the land application of sewage sludge. The document summarizes current practices in land application and presents data supporting the risk assessment methodology used to derive human health and environmental risk-based limits for contaminants in land applied sewage sludge. The management practices associated with land application are outlined and the different pathways by which contaminants reach highly-exposed individuals (HEIs) through land application are discussed

Review of the generic aging lessons learned (GALL) report for U.S. NPPs

International Nuclear Information System (INIS)

Gong Yi; Dou Yikang

2014-01-01

Generic aging lessons learned (GALL) report is a technical basis document issued by U.S. nuclear regulatory commission (NRC) for guiding the review of license renewal application (LRA) of its domestic nuclear power plants (NPPs). By form of tabulations, GALL report addresses the correlation among materials, environments, aging effects/mechanisms, and aging management programs (AMPs) from the level of specific structures and/or components. Based on literature investigation and analysis, the essential information of GALL report in the aspects of background, development history, content framework, and application was reviewed in this paper, which should be the first time in China and would have reference value for establishment of both the AMPs and the nuclear safety regulations of extending the lifetime of its NPPs. (authors)

Interim report on reference biospheres for radioactive waste disposal

International Nuclear Information System (INIS)

Dorp, F. van

1994-10-01

significant effect on biosphere modelling, for normal and accidental releases from nuclear installations, and also for waste disposal. For example, increased attention is being given to natural and semi-natural environments. Against this background, the primary objective of the BIOMOVS II Reference Biospheres Working Group is to establish a consensus on the development and application of a Reference Biosphere approach to the evaluation of long-term radiological consequences of solid radioactive waste disposal systems. The Working Group is expecting to provide: 1. A recommended methodology for biosphere analysis within the assessment of radioactive waste disposal, which is consistent for different types of radioactive waste and disposal concepts. This should include the justification, arguments and documentation for all the steps in the recommended methodology. A preliminary illustration of the approach is shown in the figure opposite. 2. An internationally developed and structured list of Features, Events and Processes (FEPs), which can be used to support the development of biosphere models for specific assessments. 3. Example(s) of how to apply the methodology. If these examples are developed in a suitably generic assessment context, they can be defined as generic 'Reference Biospheres' and their applicability and limitations should be identified. Such 'Reference Biospheres' could then be used e.g: a) for generic site independent evaluation of disposal plans; b) to provide sets of factors to convert geosphere release into doses or risks; c) as 'stylised biospheres' (which might be defined as a biosphere which contains only the most essential FEPs); d) as benchmarks for comparisons with other assessments, and e) as sources of detailed information on biosphere modelling for waste disposal assessments. In order to complete an assessment of a particular site, there will not only be a need to take account of site specific issues, such as the geosphere-biosphere interface and the

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.

Radiation analysis for a generic centralized interim storage facility

International Nuclear Information System (INIS)

Gillespie, S.G.; Lopez, P.; Eble, R.G.

1997-01-01

This paper documents the radiation analysis performed for the storage area of a generic Centralized Interim Storage Facility (CISF) for commercial spent nuclear fuel (SNF). The purpose of the analysis is to establish the CISF Protected Area and Restricted Area boundaries by modeling a representative SNF storage array, calculating the radiation dose at selected locations outside the storage area, and comparing the results with regulatory radiation dose limits. The particular challenge for this analysis is to adequately model a large (6000 cask) storage array with a reasonable amount of analysis time and effort. Previous analyses of SNF storage systems for Independent Spent Fuel Storage Installations at nuclear plant sites (for example in References 5.1 and 5.2) had only considered small arrays of storage casks. For such analyses, the dose contribution from each storage cask can be modeled individually. Since the large number of casks in the CISF storage array make such an approach unrealistic, a simplified model is required

THEREDA. Thermodynamic reference data base. Phase II. Release of thermodynamic data. Summary and final report; THEREDA. Thermodynamische Referenz-Datenbasis. Phase II. Freigabe thermodynamischer Daten. Zusammenfassung der Abschlussberichte

Energy Technology Data Exchange (ETDEWEB)

Altmaier, Marcus; Gaona, Xavier; Marquardt, Christian; Montoya, Vanessa [Karlsruher Institut fuer Technologie (KIT), Eggenstein-Leopoldshafen (Germany). Institut fuer Nukleare Entsorgung; Bok, Frank; Richter, Anke [Helmholtz-Zentrum Dresden-Rossendorf e.V., Dresden (Germany). Inst. of Resource Ecology; Moog, Helge C.; Scharge, Tina [Gesellschaft fuer Anlagen- und Reaktorsicherheit mbH (GRS), Koeln (Germany); Voigt, Wolfgang [Technische Univ. Bergakademie Freiberg (Germany); Wilhelm, Stefan [AF Consult AG, Baden-Daettwil (Switzerland)

2015-12-15

The final report on the thermodynamic reference data base THEREDA covers the following issues: project management, quality management (Helmholtz-Zentrum Dresden-Rossendorf HZDR and GRS), data base interfaces, documentation, uranium (HZDR), other nuclides (Karlsruhe Institute for technology, KIT), data for cement minerals and their reaction products (AF-Consult, GRS), phosphate (GRS), systems with CO2 and carbonate at variable temperatures and pressure (Bergakademie Freiberg, TUBAF).

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

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

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.

Gaz de France. 2006 reference document; Gaz de France. Document de reference 2006

Energy Technology Data Exchange (ETDEWEB)

NONE

2006-07-01

This document was issued by Gaz de France, the French gas utility, at the occasion of the opening of the capital of the company. It is intended to shareholders and presents the relevant informations relative to the annual consolidated financial statements of the group according to IFRS and French standards for the year 2005 (selected financial information, business overview, liquidity and capital resources, profit forecasts or estimates, compensation and benefits, issuer assets etc..). It includes also some complementary information about the activities of the group, its estate property, plants and equipments, its R and D and patenting activities, its management and administration, its 2005 and 2006 contracts etc.. (J.S.)

Development of a reference biospheres methodology for radioactive waste disposal. Final report

International Nuclear Information System (INIS)

Dorp, F. van

1996-09-01

The BIOMOVS II Working Group on Reference Biospheres has focused on the definition and testing of a methodology for developing models to analyse radionuclide behaviour in the biosphere and associated radiological exposure pathways (a Reference Biospheres Methodology). The Working Group limited the scope to the assessment of the long-term implications of solid radioactive waste disposal. Nevertheless, it is considered that many of the basic principles would be equally applicable to other areas of biosphere assessment. The recommended methodology has been chosen to be relevant to different types of radioactive waste and disposal concepts. It includes the justification, arguments and documentation for all the steps in the recommended methodology. The previous experience of members of the Reference Biospheres Working Group was that the underlying premises of a biosphere assessment have often been taken for granted at the early stages of model development, and can therefore fail to be recognized later on when questions of model sufficiency arise, for example, because of changing regulatory requirements. The intention has been to define a generic approach for the formation of an 'audit trail' and hence provide demonstration that a biosphere model is fit for its intended purpose. The starting point for the methodology has three. The Assessment Context sets out what the assessment has to achieve, eg. in terms of assessment purpose and related regulatory criteria, as well as information about the repository system and types of release from the geosphere. The Basic System Description includes the fundamental premises about future climate conditions and human behaviour which, to a significant degree, are beyond prediction. The International FEP List is a generically relevant list of Features, Events and Processes potentially important for biosphere model development. The International FEP List includes FEPs to do with the assessment context. The context examined in detail by

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

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

Generic component reliability data for research reactor PSA

International Nuclear Information System (INIS)

1997-02-01

The purpose of this document is to provide reference generic component-reliability information for a variety of research reactor types. As noted in Section 2 and Table IV, component data accumulated over many years is in the database. It is expected that the report should provide representative data which will remain valid for a number of years. The database provides component failure rates on a time and/or demand related basis according to the operational modes of the components. No update of the database is presently planned. As a result of the implementation of data collection systems in the research reactors represented in these studies, updating of data from individual facilities could be made available by the contributing research reactor facilities themselves. As noted in Section 1.1, the report does not include a detailed discussion of information regarding component classification and reliability parameter definitions. The report does provide some insights and discussions regarding the practicalities of the data collection process and some guidelines for database usage. 9 refs, 7 tabs

Has the increase in the availability of generic drugs lowered the price of cardiovascular drugs in South Africa?

Directory of Open Access Journals (Sweden)

Varsha Bangalee

2016-10-01

Objective: To examine the relationship between originator drug prices and the number of generic brands within the cardiovascular class of drugs and to compare South African prices with international reference prices. Method: Data on private sector drug prices was sourced from the South African Medicine Price Registry. The relationship between the median proportional price and the number of brands in the therapeutic class was analysed using correlation analysis. International reference prices were obtained from the Management Sciences for Health International Drug Price Indicator Guide (2012 edition. Results: A weak correlation between originator and generic drug prices and the number of available brands was observed, the exception being diuretic drugs. The median prices per strength of the originator generic were still higher than the most expensive generic version manufactured by any other company, the exception being telmisartan. Comparison of price ratios between the originator drug, lowest priced generic and international reference price values revealed that the originator drug prices had a median price ratio of 20.99 (interquartile range 7.31—53.46 and the lowest priced generics had a median price ratio of 4.28 (interquartile range 2.10—8.47. Conclusion: Increased generic competition is not a predictor of lower drug prices. The study also concludes that the current South African pharmaceutical policies have not yet achieved the lowest prices for drugs when compared internationally.

Virtualized Network Control. Final Report

Energy Technology Data Exchange (ETDEWEB)

Ghani, Nasir [Univ. of New Mexico, Albuquerque, NM (United States)

2013-02-01

This document is the final report for the Virtualized Network Control (VNC) project, which was funded by the United States Department of Energy (DOE) Office of Science. This project was also informally referred to as Advanced Resource Computation for Hybrid Service and TOpology NEtworks (ARCHSTONE). This report provides a summary of the project's activities, tasks, deliverable, and accomplishments. It also provides a summary of the documents, software, and presentations generated as part of this projects activities. Namely, the Appendix contains an archive of the deliverables, documents, and presentations generated a part of this project.

EDF group - Reference Document, Annual Financial Report 2015

International Nuclear Information System (INIS)

2016-01-01

The EDF group is an integrated utility, active in all electricity businesses: nuclear, renewable and thermal generation, transmission, distribution, supply, efficiency and energy services and trading. It is the leading player in the French electricity market and holds strong positions in Europe (United Kingdom (UK), Italy, central and eastern European countries), which makes it one of the world's leading electric utility and a renowned gas player. With a global installed net generation capacity of 134.2 GWe as at 31 December 2015 producing 619.3 TWh, the Group has one of the largest generation fleet in the world. Among the ten largest global power suppliers, it produces the smallest amount of CO 2 per kilowatt-hour generated 2 thanks to the share of nuclear, hydro and other renewable energies in its generation mix. The EDF group supplies electricity, gas and related services to 37.6 million customer accounts 3 worldwide (of which 27.8 million in France). Electricity generation is a non-regulated activity, which is open to competition in the same way as the sale of electricity and gas and upstream/downstream optimisation. The Group is thus implementing an integrated model for the joint operational management of its portfolio of assets upstream (generation and procurement of energy and fuels) and downstream (wholesale and retail) to guarantee supply of energy to its customers through the best possible management of operational and market risks and with a view to maximising gross margin. In addition, the Group is also active in regulated sectors such as electricity transmission and distribution. This document is EDF Group's Reference Document and Annual Financial Report for the year 2015. It contains information about: the History and development of the Company, the organisation of the Group, the risk factors and control framework, the environmental and societal information - Human Resources, the corporate governance, The Group's performance in 2015 and

EDF group - Reference Document, Annual Financial Report 2012

International Nuclear Information System (INIS)

2013-01-01

The EDF Group is an integrated energy utility active in all areas of the electricity market: nuclear, renewable and fossil fuel energy generation, transmission, distribution and marketing, energy efficiency and management services, as well as energy trading. It is the leading player in the French electricity market, and holds strong positions in Europe (UK, Italy, Central and Eastern Europe) that make it one of the world's leading electricity utilities and a renowned player in the gas industry. With a net installed capacity of 139.5 GWe worldwide at 31 December 2012 (128.5 GWe in Europe), and global production of 642.6 TWh, the Group ranks among the world's leading energy utilities, with the biggest fleet emitting the least amount of CO 2 per kilowatt-hour generated 3 thanks to the proportion of nuclear, hydropower and other renewable energies in its generation mix. The EDF Group supplies electricity, gas and related services to more than 39.3 million customer accounts 4 worldwide (nearly 28.6 million in France). The Group's activities reflect the choice of a model balanced between France and international markets, spanning competitive and regulated operations and based on upstream-downstream integration. In 2012, the Group recorded consolidated revenue of euros 72.7 billion, operating profit before depreciation and amortisation of euros 16.1 billion and net income excluding non-recurring items of euros 4.2 billion. This document is EDF Group's Reference Document and Annual Financial Report for the year 2012. It contains information about: the Group activities, risk factors, Organisational charts, Property, plant and equipment, Operating and financial data, Cash flows and capital, Research and development, patents and licenses, Information on trends, Financial outlook, Administrative, management and supervisory bodies and Executive Management, Compensation and benefits, Functioning of administrative and management bodies, Employees - Human

EDF group - Reference Document, Annual Financial Report 2013

International Nuclear Information System (INIS)

2014-01-01

The EDF Group is an integrated energy utility active in all areas of the electricity market: nuclear, renewable and fossil fuel energy generation, transmission, distribution and marketing, energy efficiency and management services, as well as energy trading. It is the leading player in the French electricity market, and holds strong positions in Europe (UK, Italy, Central and Eastern Europe) that make it one of the world's leading electricity utilities and a renowned player in the gas industry. With a net installed capacity of 140.4 GWe worldwide at 31 December 2013 and global production of 653.9 TWh, the Group ranks among the world's leading energy utilities, with the biggest fleet emitting the least amount of CO 2 per kilowatt-hour generated 2 thanks to the proportion of nuclear, hydropower and other renewable energies in its generation mix. The EDF Group supplies electricity, gas and related services to more than 39.1 million customer accounts 3 worldwide (nearly 28.5 million in France). The Group's activities reflect the choice of a model balanced between France and international markets, spanning competitive and regulated operations and based on upstream-downstream integration. In 2013, the Group recorded consolidated revenue of euros 75.6 billion, operating profit before depreciation and amortisation of euros 16.8 billion and net income excluding non-recurring items of euros 4.1 billion. This document is EDF Group's Reference Document and Annual Financial Report for the year 2013. It contains information about: the Group activities, Organisational charts, Property, plant and equipment, Operating and financial data, Cash flows and capital, Research and development, patents and licenses, Information on trends, Financial outlook, Administrative, management and supervisory bodies and Executive Management, Compensation and benefits, Functioning of administrative and management bodies, Employees - Human Resources, Major Shareholders, Related

Exploring knowledge perceptions and attitudes about generic medicines among finalyear health science students

Directory of Open Access Journals (Sweden)

Varsha Bangalee

2016-05-01

Full Text Available Background. The use of generic medicines to reduce healthcare costs has become a mandated policy in South Africa. An increase in the use of generics can be achieved through improved knowledge, attitudes and perceptions of generic medicine among healthcare professionals. Objective. To explore knowledge, attitudes and perceptions among final-year health science students on generic medication. Methods. A cross-sectional survey was carried out among the final-year audiology, dental therapy, pharmacy, physiotherapy, occupational therapy, optometry, speech-language and sport science students enrolled at the University of KwaZulu-Natal. A questionnaire was used as the study tool, developed using information adapted from literature reviews. Data analysis was completed using Statistical Package for the Social Sciences (SPSS version 21, and computed using descriptive statistics. Results. Total number of participants was 211, as follows: audiology (n=14, dental therapy (n=15, pharmacy (n=81, physiotherapy (n=41, occupational therapy (n=6, optometry (n=25, speech-language (n=6 and sport science (n=23. A total of 90.0% of students had heard of generic medicines, with 20.9% of them agreeing that generic medicines are less effective than brand-name medicines. Concerning safety, 30.4% believed that brand-name medicines are required to meet higher safety standards than generic medicines. Regarding the need for information on issues pertaining to safety and efficacy of medicines, 53.3% of participants felt that this need was not being met. Conclusion. All groups 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.

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)

Best Available Techniques (BAT) Reference Document for the Production of Wood-based Panels: Industrial Emissions Directive 2010/75/EU (Integrated Pollution Prevention and Control)

OpenAIRE

STUBDRUP KAREN KRISTINE RAUNKJAER; KARLIS PANAGIOTIS; ROUDIER Serge; DELGADO SANCHO Luis

2016-01-01

The BAT reference document (BREF) entitled ‘Production of Wood-based Panels' forms part of a series presenting the results of an exchange of information between EU Member States, the industries concerned, non-governmental organisations promoting environmental protection, and the Commission, to draw up, review and, where necessary, update BAT reference documents as required by Article 13(1) of the Directive 2010/75/EU on industrial emissions. This document is published by the European Commissi...

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)

Ethical aspects of final disposal. Final report

International Nuclear Information System (INIS)

Baltes, B.; Leder, W.; Achenbach, G.B.; Spaemann, R.; Gerhardt, V.

2003-01-01

In fulfilment of this task the Federal Environmental Ministry has commissioned GRS to summarise the current national and international status of ethical aspects of the final disposal of radioactive wastes as part of the project titled ''Final disposal of radioactive wastes as seen from the viewpoint of ethical objectives''. The questions arising from the opinions, positions and publications presented in the report by GRS were to serve as a basis for an expert discussion or an interdisciplinary discussion forum for all concerned with the ethical aspects of an answerable approach to the final disposal of radioactive wastes. In April 2001 GRS held a one-day seminar at which leading ethicists and philosophers offered statements on the questions referred to above and joined in a discussion with experts on issues of final disposal. This report documents the questions that arose ahead of the workshop, the specialist lectures held there and a summary of the discussion results [de

A generic access to shot-based data for European Tokamaks

Energy Technology Data Exchange (ETDEWEB)

Signoret, J.; Imbeaux, F. [Association EURATOM-CEA, CEA / DSM / Institut de Recherche sur la Fusion par confinement Magnetique, CEA-Cadarache, 13 - ST-Paul-Lez-Durance (France)

2009-07-01

The EFDA Integrated Tokamak Modeling Task Force has defined a data structure offering a generic representation of the properties of physics problems and tokamak subsystem characteristics. It gathers the hardware description, modeling results and data measured during experiments, structured in terms of Consistent Physical Objects (CPOs). A generic tool has been developed to retrieve shot-based data from the various European tokamak databases: Exp2ITM. A tokamak specific XML 'mapping file' is used to map the local data formats to the ITM (Integrated Tokamak Modeling) data format. Exp2ITM is then dynamically generated from the ITM data structure and uses generic procedures to import the shot-based data. Successful tests show we have managed to import into the ITM DB experimental data from Jet and Tore-Supra. This document is a poster. (authors)

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

Generic adaptation framework for unifying adaptive web-based systems

NARCIS (Netherlands)

Knutov, E.

2012-01-01

The Generic Adaptation Framework (GAF) research project first and foremost creates a common formal framework for describing current and future adaptive hypermedia (AHS) and adaptive webbased systems in general. It provides a commonly agreed upon taxonomy and a reference model that encompasses the

Final design of the generic upper port plug structure for ITER diagnostic systems

Energy Technology Data Exchange (ETDEWEB)

Pak, Sunil, E-mail: paksunil@nfri.re.kr [National Fusion Research Institute, Daejeon (Korea, Republic of); Feder, Russell [Princeton Plasma Physics Laboratory, Princeton, NJ (United States); Giacomin, Thibaud; Guirao, Julio; Iglesias, Silvia; Josseaume, Fabien [ITER Organization, Route de Vinon sur Verdon, 13115 St Paul-lez-Durance (France); Kalish, Michael; Loesser, Douglas [Princeton Plasma Physics Laboratory, Princeton, NJ (United States); Maquet, Philippe [ITER Organization, Route de Vinon sur Verdon, 13115 St Paul-lez-Durance (France); Ordieres, Javier; Panizo, Marcos [NATEC, Ingenieros, Gijón (Spain); Pitcher, Spencer; Portalès, Mickael [ITER Organization, Route de Vinon sur Verdon, 13115 St Paul-lez-Durance (France); Proust, Maxime [CEA, Cadarache, St. Paul-lez-Durance (France); Ronden, Dennis [FOM Institute DIFFER, Nieuwegein (Netherlands); Serikov, Arkady [Karlsruhe Institute of Technology, Eggenstein-Leopoldshafen (Germany); Suarez, Alejandro [ITER Organization, Route de Vinon sur Verdon, 13115 St Paul-lez-Durance (France); Tanchuk, Victor [NIIEFA, St.-Petersburg (Russian Federation); Udintsev, Victor; Vacas, Christian [ITER Organization, Route de Vinon sur Verdon, 13115 St Paul-lez-Durance (France); and others

2016-01-15

The generic upper port plug (GUPP) structure in ITER is a 6 m long metal box which deploys diagnostic components into the vacuum vessel. This structure is commonly used for all the diagnostic upper ports. The final design of the GUPP structure, which has successfully passed the final design review in 2013, is described here. The diagnostic port plug is cantilevered to the vacuum vessel with a heavy payload at the front, so called the diagnostic first wall (DFW) and the diagnostic shield module (DSM). Most of electromagnetic (EM) load (∼80%) occurs in DFW/DSM. Therefore, the mounting design to transfer the EM load from DFW/DSM to the GUPP structure is challenging, which should also comply with thermal expansion and tolerance for assembly and manufacturing. Another key design parameter to be considered is the gap between the port plug and the vacuum vessel port. The gap should be large enough to accommodate the remote handling of the heavy port plug (max. 25 t), the structural deflection due to external loads and machine assembly tolerance. At the same time, the gap should be minimized to stop the neutron streaming according to the ALARA (as low as reasonably achievable) principle. With these design constraints, the GUPP structure should also provide space for diagnostic integration as much as possible. This requirement has led to the single wall structure having the gun-drilled water channels inside the structure. Furthermore, intensive efforts have been made on the manufacturing study including material selection, manufacturing codes and French regulation related to nuclear equipment and safety. All these main design and manufacturing aspects are discussed in this paper, including requirements, interfaces, loads and structural assessment and maintenance.

[Availability of generic drugs in the public sector and prices in the private sector in different regions of Brazil].

Science.gov (United States)

Miranda, Elaine Silva; Pinto, Cláudia Du Bocage Santos; dos Reis, André Luis de Almeida; Emmerick, Isabel Cristina Martins; Campos, Mônica Rodrigues; Luiza, Vera Lucia; Osorio-de-Castro, Claudia Garcia Serpa

2009-10-01

A study to identify availability and prices of medicines, according to type of provider, was conducted in the five regions of Brazil. A list of medicines to treat prevalent diseases was investigated, using the medicines price methodology developed by the World Health Organization and Health Action International, adapted for Brazil. In the public sector, bioequivalent (vis-à-vis reference brand) generics are less available than multisource products. For most medicines (71.4%), the availability of bioequivalent generics was less than 10%. In the private sector, the average number of different bioequivalent generic versions in the outlets was far smaller than the number of versions on the market. There was a positive correlation between the number of generics on the market, or those found at outlets, and the price variation in bioequivalent generic products, in relation to the maximum consumer price. It is estimated that price competition is occurring among bioequivalent generic drugs and between them and multisource products for the same substance, but not with reference brands.

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

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

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.

Safety and efficacy of generic drugs with respect to brand formulation

OpenAIRE

Gallelli, Luca; Palleria, Caterina; De Vuono, Antonio; Mumoli, Laura; Vasapollo, Piero; Piro, Brunella; Russo, Emilio

2013-01-01

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 gener...

Advisory Committee on human radiation experiments. Supplemental Volume 2a, Sources and documentation appendices. Final report

International Nuclear Information System (INIS)

1995-01-01

This large document provides a catalog of the location of large numbers of reports pertaining to the charge of the Presidential Advisory Committee on Human Radiation Research and is arranged as a series of appendices. Titles of the appendices are Appendix A- Records at the Washington National Records Center Reviewed in Whole or Part by DoD Personnel or Advisory Committee Staff; Appendix B- Brief Descriptions of Records Accessions in the Advisory Committee on Human Radiation Experiments (ACHRE) Research Document Collection; Appendix C- Bibliography of Secondary Sources Used by ACHRE; Appendix D- Brief Descriptions of Human Radiation Experiments Identified by ACHRE, and Indexes; Appendix E- Documents Cited in the ACHRE Final Report and other Separately Described Materials from the ACHRE Document Collection; Appendix F- Schedule of Advisory Committee Meetings and Meeting Documentation; and Appendix G- Technology Note

Advisory Committee on human radiation experiments. Supplemental Volume 2a, Sources and documentation appendices. Final report

Energy Technology Data Exchange (ETDEWEB)

NONE

1995-01-01

This large document provides a catalog of the location of large numbers of reports pertaining to the charge of the Presidential Advisory Committee on Human Radiation Research and is arranged as a series of appendices. Titles of the appendices are Appendix A- Records at the Washington National Records Center Reviewed in Whole or Part by DoD Personnel or Advisory Committee Staff; Appendix B- Brief Descriptions of Records Accessions in the Advisory Committee on Human Radiation Experiments (ACHRE) Research Document Collection; Appendix C- Bibliography of Secondary Sources Used by ACHRE; Appendix D- Brief Descriptions of Human Radiation Experiments Identified by ACHRE, and Indexes; Appendix E- Documents Cited in the ACHRE Final Report and other Separately Described Materials from the ACHRE Document Collection; Appendix F- Schedule of Advisory Committee Meetings and Meeting Documentation; and Appendix G- Technology Note.

Contribution to draft generic environmental impact statement on commercial waste management: radioactive waste isolation in geologic formations

International Nuclear Information System (INIS)

1978-04-01

This document concentrates on deep geologic isolation of wastes in bedded salt, granite, shale, and basalt with emphasis on wastes from three fuel cycles: reprocessing wastes from uranium and plutonium recycling, reprocessing wastes from uranium-only recycling, and spent unreprocessed fuel with no recycling. The analyses presented in this document are based on preconceptual repository designs. As the repository designs progress through future phases, refinements will occur which might modify some of these results. The 12 sections in the report are: introduction; selection and description of generic repository sites; LWR wastes to be isolated in geologic formations; description of waste isolation facilities; effluents from the waste isolation facility; assessment of environment impacts for various geographical locations of a waste isolation facility; environmental monitoring; decommissioning; mine decommissioning site restoration; deep geologic alternative actions; potential mechanisms of containment failure; and considerations relevant to provisional versus final storage

Preservation of Records, Knowledge and Memory Across Generations. Reference Bibliography within the NEA RK and M Project

International Nuclear Information System (INIS)

2016-01-01

This bibliography aims at providing an overview over the work performed in the field of the preservation of records, knowledge and memory in relation with radioactive waste management, especially disposal. For each entry, an abstract outlining the relevance of the document to the topic of RKM is provided. The following criteria are currently used to select the references: - The document (or at least part of it) addresses the preservation of RKM in connection with the management of radioactive waste - The document is publicly available or can be made available upon request - One synthesis document (such as a report) is preferable to a list of papers with a similar content. - Original documents (scientific reports and papers) are preferred to reviews or press coverage. The bibliography should help the participants in the project to identify the topics of concern in the field of RKM and, eventually, the issues that have not yet been addressed. The current bibliography is not meant to be an all-encompassing list that includes any generic reference that might be useful in the study of those topics. Therefore it does not include: - general studies outside RWM, e.g. on memory loss, communication, or the history of institutions - studies belonging to the field of RWM but that are only indirectly related to RKM preservation

Practical considerations in the development and application of reference levels

International Nuclear Information System (INIS)

Selby, J. M.; Kennedy, W. E. Jr.; Swinth, K. L.; Gilbert, R. O.; Soldat, J. K.

1988-05-01

Radiological exposures to the public during an accident that releases radioactive materials to the environment occur initially through the air pathway, secondly through a water pathway, and finally, through the food chain. From these exposure pathways, reference levels of radionuclides must be applied to limit public radiation doses. Such reference levels are difficult to develop and apply, particularly if the contaminants are transuranic elements such as plutonium. The reference level must be related to a resultant theoretical dose to the public through generic calculations. However, to permit rapid decisions after an accident, the reference levels need to be related to conditions or media in the environment that can be directly measured. They must also be tied to specific countermeasures such as sheltering, evacuation, or interdiction of drinking water or food supplies. This paper discusses the practical considerations in the development and application of reference levels for transuranic in the environment and the present capability to rapidly detect and quantify their concentrations following accidental contamination events. 16 refs., 3 tabs

EDF group - Reference Document, Annual Financial Report 2016

International Nuclear Information System (INIS)

2017-01-01

The EDF group is an integrated energy company, active in all electricity businesses: nuclear, renewable and thermal generation, transmission (activity handled by RTE, share-holding consolidated resorting to the equity method), distribution (handled by Enedis), sales and marketing, efficiency and energy services and energy trading. It is the leading player in the French electricity market and holds strong positions in Europe (mainly in the United Kingdom (UK), Italy and Belgium), which makes it one of the world's leading electric energy companies and a renowned gas player. With a global installed net generation capacity of 132.3 GWe 2 as at 31 December 2016, generating 583.9 TWh, the Group has one of the largest generation fleets in the world. Among the ten largest global power suppliers, it produces the smallest amount of CO 2 per kilowatt-hour generated 3 thanks to the share of nuclear, hydro and other renewable energies in its generation mix. The EDF group supplies electricity, gas and related services to 37.1 million customer accounts 4 worldwide (of which 26.2 million in France). Electricity generation is a non-regulated activity, which is open to competition in the same way as the sale of electricity and gas and upstream/downstream optimisation. The Group is thus implementing an integrated model for the joint operational management of its portfolio of assets upstream (generation and procurement of energy and fuels) and downstream (wholesale and retail) to guarantee supply of energy to its customers through the best possible management of operational and market risks and with a view to maximising gross margin. In addition, the Group is also present in regulated sectors such as electricity transmission and distribution, in particular via RTE and Enedis, respectively, which are fully independent subsidiaries as for the purposes of the Energy Code. This document is EDF Group's Reference Document and Annual Financial Report for the year 2016. It contains

EDF group - Reference Document, Annual Financial Report 2011

International Nuclear Information System (INIS)

2012-01-01

The EDF group is an integrated energy company with a presence in a wide range of electricity-related businesses: nuclear, renewable and fossil-fuel fired energy production, transmission, distribution, marketing as well as energy management and efficiency services, along with energy trading. It is France's leading electricity operator and has a strong position in Europe (United Kingdom, Italy, countries in Central and Eastern Europe), making it one of the world's leading electrical providers as well as a recognized player in the gas industry. With a worldwide net installed capacity of 134.6 GWe as of 31 December 2011 (124.2 GWe in Europe) and global energy generation of 628.2 TWh, the Group has one of the largest generating capacities of all the major worldwide energy corporations with the lowest level of CO 2 emissions per KWh generated due to the proportion of nuclear, hydroelectric power and other renewable energies in its generation mix. The EDF group supplies electricity, gas and associated services to more than 37.7 million customer accounts worldwide (including nearly 27.9 million in France). The Group's businesses reflect its adoption of a model aimed at finding the best balance between French and international activities, competitive and regulated operations and based on an upstream-downstream integration. In 2011, the Group's consolidated sales revenues was 65.3 billion Euros, earnings before interest, tax, depreciation and amortization came to 14.8 billion Euros, and net income excluding non-recurring items stood at 3.5 billion Euros. This document is EDF Group's Reference Document and Annual Financial Report for the year 2012. It contains information about: the Group activities, risk factors, Investments, Business, Strategy, Organisational charts, Property, plant and equipment, Operating and financial review, Cash flows and capital, Research and development, patents and licenses, Information on trends, Financial outlook

International experiences of promoting generics use and its implications to China.

Science.gov (United States)

Sun, Jing

2013-05-01

To summarize international experiences in promoting use of generics and to extract essence for China's reference. This is a commentary of two systematic reviews about policies to promote use of generics and its implications to China. Price, reimbursement, and generic substitution policies in European countries, and approaches in low and middle income countries in promoting market competition, appropriate intellectual property right protection strategy, and necessary demand side incentives, are all meaningful for China to contain soaring pharmaceutical expenditures, and to maintain the achievements and outcomes of the national health system reform. Effective promotion of generics use must be practice based on the real situation. Tailor-made and comprehensive measures are needed to address both demand and supply sides barriers before achieving tangible cost containment effect without unexpected side effects. © 2013 Wiley Publishing Asia Pty Ltd and Chinese Cochrane Center, West China Hospital of Sichuan University.

Generic multiset programming with discrimination-based joins and symbolic Cartesian products

DEFF Research Database (Denmark)

Henglein, Fritz; Larsen, Ken Friis

2010-01-01

This paper presents GMP, a library for generic, SQL-style programming with multisets. It generalizes the querying core of SQL in a number of ways: Multisets may contain elements of arbitrary first-order data types, including references (pointers), recur- sive data types and nested multisets......: symbolic (term) repre- sentations of multisets, specifically for Cartesian products, for facilitating dynamic symbolic computation, which intersperses algebraic simplification steps with conventional data pro- cessing; and discrimination-based joins, a generic technique for computing equijoins based...

Generic Patch Inference

DEFF Research Database (Denmark)

Andersen, Jesper; Lawall, Julia Laetitia

2008-01-01

A key issue in maintaining Linux device drivers is the need to update drivers in response to evolutions in Linux internal libraries. Currently, there is little tool support for performing and documenting such changes. In this paper we present a tool, spfind, that identifies common changes made...... developers can use it to extract an abstract representation of the set of changes that others have made. Our experiments on recent changes in Linux show that the inferred generic patches are more concise than the corresponding patches found in commits to the Linux source tree while being safe with respect...

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.

Competition and the Reference Pricing Scheme for pharmaceuticals.

Science.gov (United States)

Ghislandi, Simone

2011-12-01

By introducing n (>1) firms with infinite cross-price elasticity (i.e. generic drugs), we explore the effects of competition on the optimal pricing strategies under a Reference Pricing Scheme (RPS). A two-stage model repeated infinite number of times is presented. When stage 1 is competitive, the equilibrium in pure strategies exists and is efficient only if the reference price (R) does not depend on the price of the branded product. When generics collude, the way R is designed is crucial for both the stability of the cartel among generics and the collusive prices in equilibrium. An optimally designed RPS must set R as a function only of the infinitely elastic side of the market and should provide the right incentives for competition. Copyright © 2011 Elsevier B.V. All rights reserved.

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)

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.

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)

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

Generic communications index: User's manual

International Nuclear Information System (INIS)

Dean, R.S.; Steinbrecher, D.H.; Hennick, A.

1987-12-01

This report is a manual for providing information required to use a special computer program developed by the NRC for indexing generic communications. The program is written in a user-friendly menu driven form using dBASE III programming language. It facilitates use of the required dBASE III search and sort capabilities to access records in a database called Generic Communications Index. This index is made up of one record each for all bulletins, circulars, and information notices, including revisions and supplements, from 1971, when such documentation started, through 1986 (or to the latest update). The program is designed for use by anyone modestly acquainted with the general use of IBM-compatible personal computers. The manual contains both a brief overview and a detailed description of the program, as well as detailed instructions for getting started using the program on a personal computer with either a two-floppy disk or a hard disk system. Included at the end are a brief description of how to handle problems which might occur, and notes on the makeup of the program and database files for help in adding records of communications for future years

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.

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.

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

Independent Electricity Market Operator integration management participant technical reference manual

International Nuclear Information System (INIS)

1999-01-01

The document provides potential participants with the essential technical information to permit them to participate in the IMO-administered markets, and is not intended to be a complete technical reference manual for all issues within the realm of electricity production, distribution, or consumption. Written for the participants, it provides only that information which is relevant to the participant for interfacing with the IMO and participating in the market. Written as a generic guide, all the information contained within it may not be relevant to all the participants. The document's intent is to provide participants with a description of the various facilities and interfaces required by market participants to take part in the IMO-administered markets. The document supplements the market rules and provides installation, set-up, and configuration information for the various tools and facilities that will be required for market participation as a supplier, carrier/delivery (transmitter/distributor), generator, or consumer in the market. Aspects considered include: participant workstation specifications, dispatch workstation specification, message exchange, remote terminal unit specification, AGC operational RTU specification, real time network connection specification, telephone connection specification, revenue administration specification, funds administration specification, data catalogues, market information, power grid connection requirements, and appendices

Towards a Web-Based Handbook of Generic, Process-Oriented Learning Designs

Science.gov (United States)

Marjanovic, Olivera

2005-01-01

Process-oriented learning designs are innovative learning activities that include a set of inter-related learning tasks and are generic (could be used across disciplines). An example includes a problem-solving process widely used in problem-based learning today. Most of the existing process-oriented learning designs are not documented, let alone…

Initial Northwest Power Act Power Sales Contracts : Final Environmental Impact Statement. Volume 2, Appendices A--L.

Energy Technology Data Exchange (ETDEWEB)

United States. Bonneville Power Administration.

1992-01-01

This report consists of appendices A-L of the final environmental impact statement for the Bonneville Power Administration. The appendices provide information on the following: Ninth circuit Court opinion in Forelaws on Board v. Johnson; guide to Northwest Power act contracts; guide to hydro operations; glossary; affected environment supporting documentation; environmental impacts of generic resource types; information on models used; technical information on analysis; public involvement activities; bibliography; Pacific Northwest Electric Power Planning and Conservation Act; and biological assessment. (CBS)

PVWatts Version 1 Technical Reference

Energy Technology Data Exchange (ETDEWEB)

Dobos, A. P.

2013-10-01

The NREL PVWatts(TM) calculator is a web application developed by the National Renewable Energy Laboratory (NREL) that estimates the electricity production of a grid-connected photovoltaic system based on a few simple inputs. PVWatts combines a number of sub-models to predict overall system performance, and makes several hidden assumptions about performance parameters. This technical reference details the individual sub-models, documents assumptions and hidden parameters, and explains the sequence of calculations that yield the final system performance estimation.

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.

Detector Control System for an LHC experiment - User Requirements Document

CERN Document Server

CERN. Geneva

1997-01-01

The purpose of this document is to provide the user requirements for a detector control system kernel for the LHC experiments following the ESA standard PSS-05 [1]. The first issue will be used to provide the basis for an evaluation of possible development philosophies for a kernel DCS. As such it will cover all the major functionality but only to a level of detail sufficient for such an evaluation to be performed. Many of the requirements are therefore intentionally high level and generic, and are meant to outline the functionality that would be required of the kernel DCS, but not yet to the level of the detail required for implementation. The document is also written in a generic fashion in order not to rule out any implementation technology.

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.

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

[The patents game. Generic and biosimilar drugs].

Science.gov (United States)

Villamañán, E; González, D; Armada, E; Ruano, M; Álvarez-Sala, R; Herrero, A

2016-01-01

The protection provided by patents on medicines has a limited duration. The expiry of patents expiration allows copies of the drugs to be released, competing with original. At first, they were identical to the original, known as generic drugs, but in recent years, due to the marketing of biological therapies and the expiry of many of their patents, biosimilar drugs have also emerged. These are not exact copies of the original, but, like generic drugs, biosimilar drugs have to demonstrate equivalence to the reference drugs in quality, safety and efficacy. Nevertheless, despite their importance and contribution to sustainability of health system, doctors are sometimes unaware of differences between them, and their impact in terms of clinical and economic effects. An attempt is made to review and clarify certain aspects often unknown by physicians, despite their involvement in their use. Copyright © 2015 SECA. Published by Elsevier Espana. All rights reserved.

Compression of Probabilistic XML Documents

Science.gov (United States)

Veldman, Irma; de Keijzer, Ander; van Keulen, Maurice

Database techniques to store, query and manipulate data that contains uncertainty receives increasing research interest. Such UDBMSs can be classified according to their underlying data model: relational, XML, or RDF. We focus on uncertain XML DBMS with as representative example the Probabilistic XML model (PXML) of [10,9]. The size of a PXML document is obviously a factor in performance. There are PXML-specific techniques to reduce the size, such as a push down mechanism, that produces equivalent but more compact PXML documents. It can only be applied, however, where possibilities are dependent. For normal XML documents there also exist several techniques for compressing a document. Since Probabilistic XML is (a special form of) normal XML, it might benefit from these methods even more. In this paper, we show that existing compression mechanisms can be combined with PXML-specific compression techniques. We also show that best compression rates are obtained with a combination of PXML-specific technique with a rather simple generic DAG-compression technique.

The physical properties of generic latanoprost ophthalmic solutions are not identical

DEFF Research Database (Denmark)

Kolko, Miriam; Koch Jensen, Peter

2017-01-01

was determined by linear regression of timed gravity flow from a vertical syringe through a 21-G cannula. The hardness of the bottles was evaluated by gradually increasing tension on a hook placed around each bottle until a drop was expelled reading the tension on an attached spring scale. RESULTS: Drop sizes...... products. Finally, the viscosity revealed a significant variability between brands. Remarkable differences were found in bottle shapes, bottle hardness and costs of the latanoprost generics. CONCLUSION: Generic latanoprost eye drops should not be considered identical to the original brand version...

EDF group - Reference Document 2008. Leading the energy change

International Nuclear Information System (INIS)

2009-01-01

The EDF group is an integrated energy company with a presence in a wide range of electricity-related businesses: generation, transmission, distribution, supply and energy trading. It is France's leading electricity operator and has a strong position in the three other main European markets (Germany, the United Kingdom and Italy), making it one of Europe's leading electrical players as well as a recognized player in the gas industry. With worldwide installed power capacity totaling 127.1 GW (124.8 GW in Europe) and global energy generation of 609.9 TWh, it has the largest generating capacity of all the major European energy corporations with the lowest level of CO 2 emissions due to the significant proportion of nuclear and hydroelectric power in its generation mix. The EDF group supplies gas, electricity, and associated services to more than 38 million customer accounts worldwide (including approximately 28 million in France). The EDF group's businesses reflect its adoption of a model aimed at finding the best balance between French and international activities, and between competitive and regulated operations. In 2008, the Group's consolidated revenues were euros 64.3 billion, the net income (Group share) was euros 3.4 billion, and earnings before interest, tax, depreciation and amortization was euros 14.2 billion. Since July 1, 2007, the EDF group conducts its business in a European market that is completely open to competition. Since January 1, 2008, ERDF, a wholly owned subsidiary of EDF, has assumed responsibility for all distribution in France, while RTE-EDF Transport is responsible for all transmission activities. This document is EDF Group's Reference Document for the year 2008. It contains information about: the Group activities, risk factors, Business overview, Organizational structure, Property plant and equipment, Operating and financial review, Capital resources and cash flows, Research and development, patents and licenses

Use of Solr and Xapian in the Invenio document repository software

CERN Document Server

Glauner, Patrick; Le Meur, Jean-Yves; Simko, Tibor

2013-01-01

Invenio is a free comprehensive web-based document repository and digital library software suite originally developed at CERN. It can serve a variety of use cases from an institutional repository or digital library to a web journal. In order to fully use full-text documents for efficient search and ranking, Solr was integrated into Invenio through a generic bridge. Solr indexes extracted full-texts and most relevant metadata. Consequently, Invenio takes advantage of Solr’s efficient search and word similarity ranking capabilities. In this paper, we first give an overview of Invenio, its capabilities and features. We then present our open source Solr integration as well as scalability challenges that arose for an Invenio- based multi-million record repository: the CERN Document Server. We also compare our Solr adapter to an alternative Xapian adapter using the same generic bridge. Both integrations are distributed with the Invenio package and ready to be used by the institutions using or adopting Invenio.

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

ITER final design report, cost review and safety analysis (FDR) and relevant documents

International Nuclear Information System (INIS)

1999-01-01

This volume contains the fourth major milestone report and documents associated with its acceptance, review and approval. This ITER Final Design Report, Cost Review and Safety Analysis was presented to the ITER Council at its 13th meeting in February 1998 and was approved at its extraordinary meeting on 25 June 1998. The contents include an outline of the ITER objectives, the ITER parameters and design overview as well as operating scenarios and plasma performance. Furthermore, design features, safety and environmental characteristics and schedule and cost estimates are given

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

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

Risk Factors of Clinical and Immunological Failure in South Indian Cohort on Generic Antiretroviral Therapy.

Science.gov (United States)

Sadashiv, Mucheli Shravan; Rupali, Priscilla; Manesh, Abi; Kannangai, Rajesh; Abraham, Ooriapadickal Cherian; Pulimood, Susanne A; Karthik, Rajiv; Rajkumar, S; Thomas, Kurien

2017-12-01

Since the time of NACO Antiretroviral (ART) roll-out, generic ART has been the mainstay of therapy. There are many studies documenting the efficacy of generic ART but with the passage of time, failure of therapy is on the rise. As institution of second line ART has significant financial implications both for a program and for an individual it is imperative that we determine factors which contribute towards treatment failure in a cohort of patients on generic antiretroviral therapy. This was a nested matched case-control study assessing the predictors for treatment failure in our cohort who had been on Anti-retroviral therapy for at least a year. We identified 42 patients (Cases) with documented treatment failure out of our cohort of 823 patients and 42 sex, age and duration of therapy-matched controls. Using a structured proforma, we collected information from the out-patient and in-patient charts of the Infectious Diseases clinic Cohort in CMC, Vellore. A set of predetermined variables were studied as potential risk factors for treatment failure on ART. Univariate analysis showed significant association with 1) Self-reported nonadherenceART and thus help development of targeted interventions.

Synthesis document on the storage and packages concepts: phenomenological and operational reference corrosion HAVL

International Nuclear Information System (INIS)

Helie, M.; Bataillon, Ch.; Desgranges, C.; Perrin, S.

2004-12-01

In the today concept, the long life high activity nuclear wastes (HAVL) would be storage in metallic containers. In the framework of the COCON program, simulations and knowledge of the corrosion problems bond to the wastes containers management are realized, in order to predict the long time behavior of packages storage and disposal. This reference document takes stock on the knowledge and the scientific simulation of corrosion phenomena which are decisive for the long life behavior of the external metallic wall of high activity nuclear wastes packages for the storage and the disposal and aims to provide bases of an operational modelization of these phenomena. (A.L.B.)

A Study on Generic Representation of Skeletal Remains Replication of Prehistoric Burial

Directory of Open Access Journals (Sweden)

C.-W. Shao

2015-08-01

Full Text Available Generic representation of skeletal remains from burials consists of three dimensions which include physical anthropologists, replication technicians, and promotional educators. For the reason that archaeological excavation is irreversible and disruptive, detail documentation and replication technologies are surely needed for many purposes. Unearthed bones during the process of 3D digital scanning need to go through reverse procedure, 3D scanning, digital model superimposition, rapid prototyping, mould making, and the integrated errors generated from the presentation of colours and textures are important issues for the presentation of replicate skeleton remains among professional decisions conducted by physical anthropologists, subjective determination of makers, and the expectations of viewers. This study presents several cases and examines current issues on display and replication technologies for human skeletal remains of prehistoric burials. This study documented detail colour changes of human skeleton over time for the reference of reproduction. The tolerance errors of quantification and required technical qualification is acquired according to the precision of 3D scanning, the specification requirement of rapid prototyping machine, and the mould making process should following the professional requirement for physical anthropological study. Additionally, the colorimeter is adopted to record and analyse the “colour change” of the human skeletal remains from wet to dry condition. Then, the “colure change” is used to evaluate the “real” surface texture and colour presentation of human skeletal remains, and to limit the artistic presentation among the human skeletal remains reproduction. The“Lingdao man No.1”, is a well preserved burial of early Neolithic period (8300 B.P. excavated from Liangdao-Daowei site, Matsu, Taiwan , as the replicating object for this study. In this study, we examined the reproduction procedures step by

Customization of a generic 3D model of the distal femur using diagnostic radiographs.

Science.gov (United States)

Schmutz, B; Reynolds, K J; Slavotinek, J P

2008-01-01

A method for the customization of a generic 3D model of the distal femur is presented. The customization method involves two steps: acquisition of calibrated orthogonal planar radiographs; and linear scaling of the generic model based on the width of a subject's femoral condyles as measured on the planar radiographs. Planar radiographs of seven intact lower cadaver limbs were obtained. The customized generic models were validated by comparing their surface geometry with that of CT-reconstructed reference models. The overall mean error was 1.2 mm. The results demonstrate that uniform scaling as a first step in the customization process produced a base model of accuracy comparable to other models reported in the literature.

GenMed 010: a one day workshop on generic medicines

Directory of Open Access Journals (Sweden)

Shankar PR

2011-03-01

Full Text Available This report outlines the content of a one-day workshop onGeneric Medicines that was held at KIST Medical College,Lalitpur, Nepal on 13th December 2010, which was attendedby 32 delegates from different institutions in Nepal, includingpharmacists, pharmacologists and medical doctors. Rightmedicine, right patient, right dose, right frequency andduration, right information and right monitoring areconditions to be fulfilled for the rational use of medicine(RUM. The World Health Organization (WHO defines genericmedicine as ‘a pharmaceutical product, usually intended to beinterchangeable with the innovator product, marketed afterthe expiry of patent or other exclusivity rights’. Economicfactors, supportive legislation and regulation, public andprofessional acceptance and quality assurance are keyenabling factors promoting use of generics. Increased patentprotection for medicines and removing process patents is akey feature of new trade agreements and newer medicines fordiseases like HIV/AIDS, tuberculosis and infectious diseasesare likely to be more expensive. The Medicine andTherapeutics Committee (MTC can play a key role inpromoting generic medicine use in institutions.Nepal being among the Least Developed Countries (LDCsneed not provide patent protection for medicines until 31stDecember 2015. Only a few ‘true’ generics are available inNepal and there is huge cost variation in the price of differentbranded generics. Clinicians have concerns about the qualityof medicines in general, substitution of poor quality brands bypharmacists and about therapeutic substitution. Genericshave to meet the same regulatory requirements and bebioequivalent to reference preparations assuring their quality.

Repository documentation rethought. A comprehensive approach from untreated waste to waste packages for final disposal

Energy Technology Data Exchange (ETDEWEB)

Anthofer, Anton Philipp; Schubert, Johannes [VPC GmbH, Dresden (Germany)

2017-11-15

The German Act on Reorganization of Responsibility for Nuclear Disposal (Entsorgungsuebergangsgesetz (EntsorgUebG)) adopted in June 2017 provides the energy utilities with the new option of transferring responsibility for their waste packages to the Federal Government. This is conditional on the waste packages being approved for delivery to the Konrad final repository. A comprehensive approach starts with the dismantling of nuclear facilities and extends from waste disposal and packaging planning to final repository documentation. Waste package quality control measures are planned and implemented as early as in the process qualification stage so that the production of waste packages that are suitable for final deposition can be ensured. Optimization of cask and loading configuration can save container and repository volume. Workflow planning also saves time, expenditure and exposure time for personnel at the facilities. VPC has evaluated this experience and developed it into a comprehensive approach.

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

Science.gov (United States)

Gimenez, Julio

2012-01-01

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

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.

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

Model documentation renewable fuels module of the National Energy Modeling System

Energy Technology Data Exchange (ETDEWEB)

NONE

1997-04-01

This report documents the objectives, analytical approach, and design of the National Energy Modeling System (NEMS) Renewable Fuels Module (RFM) as it relates to the production of the 1997 Annual Energy Outlook forecasts. The report catalogues and describes modeling assumptions, computational methodologies, data inputs. and parameter estimation techniques. A number of offline analyses used in lieu of RFM modeling components are also described. This documentation report serves three purposes. First, it is a reference document for model analysts, model users, and the public interested in the construction and application of the RFM. Second, it meets the legal requirement of the Energy Information Administration (EIA) to provide adequate documentation in support of its models. Finally, such documentation facilitates continuity in EIA model development by providing information sufficient to perform model enhancements and data updates as part of EIA`s ongoing mission to provide analytical and forecasting information systems.

Model documentation renewable fuels module of the National Energy Modeling System

International Nuclear Information System (INIS)

1997-04-01

This report documents the objectives, analytical approach, and design of the National Energy Modeling System (NEMS) Renewable Fuels Module (RFM) as it relates to the production of the 1997 Annual Energy Outlook forecasts. The report catalogues and describes modeling assumptions, computational methodologies, data inputs. and parameter estimation techniques. A number of offline analyses used in lieu of RFM modeling components are also described. This documentation report serves three purposes. First, it is a reference document for model analysts, model users, and the public interested in the construction and application of the RFM. Second, it meets the legal requirement of the Energy Information Administration (EIA) to provide adequate documentation in support of its models. Finally, such documentation facilitates continuity in EIA model development by providing information sufficient to perform model enhancements and data updates as part of EIA's ongoing mission to provide analytical and forecasting information systems

A survey on new nuclear legislative documents

International Nuclear Information System (INIS)

Chiripus, Vlad

2005-01-01

The paper is an overview of 21 legislative documents concerning the nuclear field in Romania published in the 'Official Gazette' of Romania (Monitorul Oficial al Romaniei) between February 2, 2005 and September 12, 2005. A list of these documents is as follows: 1. Standards concerning the requirements of the quality management systems for product manufacturing and services for nuclear facilities; 2. The Agreement of July 19, 2004 between Romanian Nuclear Agency, AN, the Romanian National Commission for Nuclear Activities Control, CNCAN, and US Department of Energy, DOE, referring to cooperation in the combat against nuclear weapon and technologies proliferation; 3. Governmental Ordinance on continuation of the Cernavoda NPP Unit 2 construction in the frame of the 5x700 MW Cernavoda NPP Project. Within the Ordinance provisions are given concerning the exportation of heavy water produced by Heavy Water Plant of Romanian Authority for Nuclear Activities; 4. Environmental License for Nuclear Fuel Plant at Pitesti; 5. Ministry of Economy and Trade Order concerning the reports of data on environmental protection by industrial agents implied in nuclear power production and nuclear fuel fabrication; 6. Governmental Decision (Gov. D.) on criteria for ensuring individual protection of Romanian citizens working in units presenting nuclear, radiologic, chemical or biological risk; 7. Law referring to the Agreement with EURATOM on information exchange in radiological emergency (EUCURIE) and tasks of National Center for Coordination of Interventions in case nuclear accident or radiological emergency; 8. Ministerial Order referring to Generic procedures concerning the data acquisition, validation and actions in case of radiological emergency; 9. Methodological norms on planning, preparation and interventions in case of nuclear accident or radiologic emergency; 10; A CNCAN Order referring to Norms for classification of radioactive wastes in Romania; 11. General provisions

Risk Assessment References: Documented Literature Search

Science.gov (United States)

2012-10-01

concepts specified in ISO /IEC 27001 and is designed to assist the satisfactory implementation of information security based on a risk management approach...Knowledge of the concepts, models, processes and terminologies described in ISO /IEC 27001 and ISO /IEC 27002 is important for a complete...Standardization ( ISO ). • Section 2.2: national standards for Canada and Australia/New Zealand. Note: Though most of the references in this section are

Potential impact of policy regulation and generic competition on sales of cholesterol lowering medication, antidepressants and acid blocking agents in Belgium.

Science.gov (United States)

Fraeyman, J; Van Hal, G; De Loof, H; Remmen, R; De Meyer, G R Y; Beutels, P

2012-01-01

Pharmaceutical expenditures are increasing as a proportion of health expenditures in most rich countries. Antidepressants, acid blocking agents and cholesterol lowering medication are major contributors to medicine sales around the globe. We aimed to document the possible impact of policy regulations and generic market penetration on the evolution of sales volume and average cost per unit (Defined Daily Doses and packages) of antidepressants, acid blocking agents and cholesterol lowering medication. We extracted data from the IMS health database regarding the public price and sales volume of the antidepressants (selective serotonin reuptake inhibitors (SSRI's), monoamine oxidase inhibitors (MAOl's) and tricyclic and remaining antidepressants (TCA's)), acid blocking agents (proton pump inhibitors (PPl's) and H2 receptor antagonists) and cholesterol lowering medication (statins and fibrates) in Belgium between 1995 and 2009. We describe these sales data in relation to various national policy measures which were systematically searched in official records. Our analysis suggests that particular policy regulations have had immediate impact on sales figures and expenditures on pharmaceuticals in Belgium: changes in reimbursement conditions, a public tender and entry of generic competitors in a reference pricing system. However, possible sustainable effects seem to be counteracted by other mechanisms such as marketing strategies, prescribing behaviour, brand loyalty and the entry of pseudogenerics. It is likely that demand-side measures have a more sustainable impact on expenditure. Compared with other European countries, generic penetration in Belgium remains low. Alternative policy regulations aimed at enlarging the generic market and influencing pharmaceutical expenditures deserve consideration. This should include policies aiming to influence physicians' prescribing and a shared responsibility of pharmacists, physicians and patients towards expenditures.

Gaz de France. 2006 reference document

International Nuclear Information System (INIS)

2006-01-01

This document was issued by Gaz de France, the French gas utility, at the occasion of the opening of the capital of the company. It is intended to shareholders and presents the relevant informations relative to the annual consolidated financial statements of the group according to IFRS and French standards for the year 2005 (selected financial information, business overview, liquidity and capital resources, profit forecasts or estimates, compensation and benefits, issuer assets etc..). It includes also some complementary information about the activities of the group, its estate property, plants and equipments, its R and D and patenting activities, its management and administration, its 2005 and 2006 contracts etc.. (J.S.)

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

Documentation, User Support, and Verification of Wind Turbine and Plant Models

Energy Technology Data Exchange (ETDEWEB)

Robert Zavadil; Vadim Zheglov; Yuriy Kazachkov; Bo Gong; Juan Sanchez; Jun Li

2012-09-18

As part of the Utility Wind Energy Integration Group (UWIG) and EnerNex's Wind Turbine Modeling Project, EnerNex has received ARRA (federal stimulus) funding through the Department of Energy (DOE) to further the progress of wind turbine and wind plant models. Despite the large existing and planned wind generation deployment, industry-standard models for wind generation have not been formally adopted. Models commonly provided for interconnection studies are not adequate for use in general transmission planning studies, where public, non-proprietary, documented and validated models are needed. NERC MOD (North American Electric Reliability Corporation) reliability standards require that power flow and dynamics models be provided, in accordance with regional requirements and procedures. The goal of this project is to accelerate the appropriate use of generic wind turbine models for transmission network analysis by: (1) Defining proposed enhancements to the generic wind turbine model structures that would allow representation of more advanced; (2) Comparative testing of the generic models against more detailed (and sometimes proprietary) versions developed by turbine vendors; (3) Developing recommended parameters for the generic models to best mimic the performance of specific commercial wind turbines; (4) Documenting results of the comparative simulations in an application guide for users; (5) Conducting technology transfer activities in regional workshops for dissemination of knowledge and information gained, and to engage electric power and wind industry personnel in the project while underway; (6) Designing of a "living" homepage to establish an online resource for transmission planners.

Extended Subject Access to Hypertext Online Documentation. Part III: The Document-Boundaries Problem.

Science.gov (United States)

Girill, T. R.

1991-01-01

This article continues the description of DFT (Document, Find, Theseus), an online documentation system that provides computer-managed on-demand printing of software manuals as well as the interactive retrieval of reference passages. Document boundaries in the hypertext database are discussed, search vocabulary complexities are described, and text…

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

Responsiveness to physicians' requests for information concerning drug interactions: a comparison of brand and generic companies.

Science.gov (United States)

Thomas, M; Lexchin, J

1990-01-01

Research-based pharmaceutical companies maintain that there are important differences between themselves and their generic competitors. Prominent among them is an alleged greater ability to provide accurate and rapid responses to requests from physicians for information about drug products. This study evaluates pharmaceutical company behavior with regard to these issues. Two drug-drug interactions were identified, along with all of the companies in Canada marketing any of the four drugs involved. Each company received a letter describing symptoms suggestive of an interaction in a patient taking its particular product and the relevant second drug. The companies were asked if they were aware of any evidence of an interaction involving the two drugs. They were also asked to provide references regarding the interaction. Responses were received from all companies contacted except one. There were no significant differences (in the hypothesized direction) between the generic and brand companies with regard to either the accuracy or promptness of the response, or the usefulness of the references cited. On the contrary, generic firms were markedly quicker to respond than were brand manufacturers. The latter were slightly more likely to acknowledge evidence of an adverse drug interaction, and to provide useful references to relevant published research.

75 FR 39252 - Release of Final Documents Related to the Review of the National Ambient Air Quality Standards...

Science.gov (United States)

2010-07-08

... Quality Standards: Scope and Methods Plan for Health Risk and Exposure Assessment and Particulate Matter... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OAR-2007-0492; FRL-9171-8] Release of Final Documents...: Environmental Protection Agency (EPA). ACTION: Notice of Availability. SUMMARY: The Office of Air Quality...

Applications for electronic documents

International Nuclear Information System (INIS)

Beitel, G.A.

1995-01-01

This paper discusses the application of electronic media to documents, specifically Safety Analysis Reports (SARs), prepared for Environmental Restoration and Waste Management (ER ampersand WM) programs being conducted for the Department of Energy (DOE) at the Idaho National Engineering Laboratory (INEL). Efforts are underway to upgrade our document system using electronic format. To satisfy external requirements (DOE, State, and Federal), ER ampersand WM programs generate a complement of internal requirements documents including a SAR and Technical Safety Requirements along with procedures and training materials. Of interest, is the volume of information and the difficulty in handling it. A recently prepared ER ampersand WM SAR consists of 1,000 pages of text and graphics; supporting references add 10,000 pages. Other programmatic requirements documents consist of an estimated 5,000 pages plus references

MIT LMFBR blanket research project. Final summary report

International Nuclear Information System (INIS)

Driscoll, M.J.

1983-08-01

This is a final summary report on an experimental and analytical program for the investigation of LMFBR blanket characteristics carried out at MIT in the period 1969 to 1983. During this span of time, work was carried out on a wide range of subtasks, ranging from neutronic and photonic measurements in mockups of blankets using the Blanket Test Facility at the MIT Research Reactor, to analytic/numerical investigations of blanket design and economics. The main function of this report is to serve as a resource document which will permit ready reference to the more detailed topical reports and theses issued over the years on the various aspects of project activities. In addition, one aspect of work completed during the final year of the project, on doubly-heterogeneous blanket configurations, is documented for the record

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

Science.gov (United States)

Magazzini, Laura; Pammolli, Fabio; Riccaboni, Massimo

2004-06-01

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

General document environmental impact report (m.e.r.) oil and gas exploitation industry. Update and supplement of the general document; Generiek document m.e.r. offshore olie- en gaswinningsindustrie. Update en aanvulling van het generiek document environmental impact report (m.e.r.) offshore, 1999

Energy Technology Data Exchange (ETDEWEB)

NONE

2008-04-15

The generic environmental impact assessment (EIA or MER in Dutch) in 1999 is intended to serve as a template for specific environmental impact assessments for oil and gas exploitation projects at sea. Since 1999, a number of innovations and changes were implemented. Particularly in offshore technologies and regulations new insights and ideas came up in recent years. Therefore the existing generic document has to be updated with new information, relevant in the preparation of specific environmental impact assessments in the offshore oil and gas exploitation industry in the Dutch part of the Continental Shelf [Dutch] De generieke milieu effect rapportage (MER) uit 1999 is bedoeld om te dienen als een sjabloon voor specifieke Milieueffectrapportages bij olie- en gaswinningprojecten op zee. Sinds 1999 is een aantal vernieuwingen en veranderingen doorgevoerd. Met name in offshore technologieen en wet- en regelgeving zijn de afgelopen jaren nieuwe inzichten en ideeen ontstaan. Hierdoor is de wens ontstaan om het bestaande generieke document aan te vullen met nieuwe informatie die relevant is voor het opstellen van specifieke Milieueffectrapportages in de offshore olie- en gaswinningsindustrie op het Nederlands deel van het Continentaal Plat.

[Policies encouraging price competition in the generic drug market: Lessons from the European experience].

Science.gov (United States)

Puig-Junoy, Jaume

2010-01-01

To describe alternative policies aimed at encouraging price competition in generic drug markets in countries with strict price regulation, and to present some case studies drawn from the European experience. Systematic literature review of articles and technical reports published after 1999. The shortcomings in consumer price competition observed in some European generic markets, including Spain, may be reduced through three types of public reimbursement or financing reforms: policies aimed at improving the design of current maximum reimbursement level policies; policies aimed at monitoring competitive prices in order to reimburse real acquisition cost to pharmacies; and, more radical and market-oriented policies such as competitive tendering of public drug purchases. The experience of recent reforms adopted in Germany, Belgium, Holland, Norway, and Sweden offers a useful guide for highly price-regulated European countries, such as Spain, currently characterized by limited consumer price competition and the high discounts offered to pharmacy purchases. Direct price regulation and/or the generic reference pricing systems used to reduce generic drug prices in many European countries can be successfully reformed by adopting measures more closely aimed at encouraging consumer price competition in generic drug markets. Copyright 2009 SESPAS. Published by Elsevier Espana. All rights reserved.

PENGEMBANGAN TUGAS AKHIR MELALUI PROJECT BASED LEARNING MODEL UNTUK MENINGKATKAN GENERIC GREEN SKILLS SISWA

Directory of Open Access Journals (Sweden)

Ana Ana

2015-02-01

Full Text Available ABSTRACT The development of students’ final project through Project-based Learning (PBLapproach was conducted in the workshop of family resource management (FRM in 7th semester.PBL approach is expected to give contribution to students’ motivation and experience to finish their final assignments of FRM workshop. The objectives of the research are to: (1 develop PBL model for the students’final project; (2 produce learning instruments of PBL such as lesson plans, manual of FRM workshop, and scientific report of FRM workshop. The method of the study was using research and development of Plomp model and quasi experiment for testing the effectiveness of the model. The research subjects were the students from the class of 2009 and 2010 who joined FRM workshop course. The study produced model, lesson plans, and manual of FRM workshop as the outputs. The result showed that project based learning model was effective to improve the students’ generic green skills for project management, collaborative skills, and communicative competence. Keywords: final project, generic green skill, family resource management, Project-Based Learning

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…

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.

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

Safety in the final disposal of radioactive waste. Final report

International Nuclear Information System (INIS)

Broden, K.; Carugati, S.; Brodersen, K.

1997-12-01

During 1994-1997 a project on the disposal of radioactive waste was carried out as part of the NKS program. The objective of the project was to give authorities and waste producers in the Nordic countries background material for determinations about the management and disposal of radioactive waste. The project NKS/AFA-1 was divided into three sub-projects: AFA-1.1, AFA-1.2 and AFA-1.3. AFA-1.1 dealt with waste characterisation, AFA-1.2 dealt with performance assessment for repositories and AFA-1.3 dealt with Environmental Impact Assessment (EIA). The studies mainly focused on the management of long-lived low- and intermediate-level radioactive waste from research, hospitals and industry. The AFA-1.1 study included an overview on waste categories in the Nordic countries and methods to determine or estimate the waste content. The results from the AFA-1.2 study include a short overview of different waste management systems existing and planned in the Nordic countries. However, the main emphasis of the study was a general discussion of methodologies developed and employed for performance assessments of waste repositories. Some of the phenomena and interactions relevant for generic types of repository were discussed as well. Among the different approaches for the development of scenarios for safety and performance assessments one particular method, the Rock Engineering System (RES), was chosen to be tested by demonstration. The possible interactions and their safety significance were discussed, employing a simplified and generic Nordic repository system as the reference system. New regulations for the inventory of a repository may demand new assessments of old radioactive waste packages. The existing documentation of a waste package is then the primary information source although additional measurements may be necessary. (EG)

Safety in the final disposal of radioactive waste. Final report

Energy Technology Data Exchange (ETDEWEB)

Broden, K.; Carugati, S.; Brodersen, K. [and others

1997-12-01

During 1994-1997 a project on the disposal of radioactive waste was carried out as part of the NKS program. The objective of the project was to give authorities and waste producers in the Nordic countries background material for determinations about the management and disposal of radioactive waste. The project NKS/AFA-1 was divided into three sub-projects: AFA-1.1, AFA-1.2 and AFA-1.3. AFA-1.1 dealt with waste characterisation, AFA-1.2 dealt with performance assessment for repositories and AFA-1.3 dealt with Environmental Impact Assessment (EIA). The studies mainly focused on the management of long-lived low- and intermediate-level radioactive waste from research, hospitals and industry. The AFA-1.1 study included an overview on waste categories in the Nordic countries and methods to determine or estimate the waste content. The results from the AFA-1.2 study include a short overview of different waste management systems existing and planned in the Nordic countries. However, the main emphasis of the study was a general discussion of methodologies developed and employed for performance assessments of waste repositories. Some of the phenomena and interactions relevant for generic types of repository were discussed as well. Among the different approaches for the development of scenarios for safety and performance assessments one particular method, the Rock Engineering System (RES), was chosen to be tested by demonstration. The possible interactions and their safety significance were discussed, employing a simplified and generic Nordic repository system as the reference system. New regulations for the inventory of a repository may demand new assessments of old radioactive waste packages. The existing documentation of a waste package is then the primary information source although additional measurements may be necessary. (EG) 33 refs.

Generic top-down discrimination for sorting and partitioning in linear time

DEFF Research Database (Denmark)

Henglein, Fritz

2012-01-01

orders for rst-order recursive types, the discriminators execute in worst-case linear time. The generic discriminators can be coded compactly using list comprehensions, with order expressions specied using Generalized Algebraic Data Types (GADTs). We give some examples of the uses of discriminators....... The basic multiset discriminator for references, originally due to Paige et al., is shown to be both ecient and fully abstract: it nds all duplicates of all references occurring in a list in linear time without leaking information about their representation. In particular, it behaves deterministically...

Synthesis document on the long time behavior of packages: operational document ''bituminous'' 2204

International Nuclear Information System (INIS)

Tiffreau, C.

2004-09-01

This document is realized in the framework of the law of 1991 on the radioactive wastes management. The 2004 synthesis document on long time behavior of bituminous sludges packages is constituted by two documents, the reference document and the operational document. This paper presents the operational model describing the water alteration of the packages and the associated radioelements release, as the gas term source and the swelling associated to the self-irradiation and the bituminous radiolysis. (A.L.B.)

Results of reference pricing and reimbursement discount rate schemes of Turkey

Directory of Open Access Journals (Sweden)

Guvenc Kockaya

2013-06-01

Full Text Available OBJECTIVES: General Directorate of Pharmaceuticals and Pharmacy (IEGM is responsible for setting all prices for human medicinal products. The reference pricing system is used for setting these prices. Reference countries are reviewed annually and may be subject to certain alterations. There were 5 reference countries in 2009: Spain, Italy, Germany, France and Greece. The aim of this study is to show the distribution of reference countries which were used for reference pricing.METHODS: The price list of pharmaceuticals which was published by IEGM on 15.04.2011 was used for analysis. Distribution of reference countries and prices were evaluated.RESULTS: Prices of 6,251 generic and 3,703 original products were set according to the price list. 5,283 of generics and 3,306 of originals were in the positive list for reimbursement. Reference pricing was used for 2,352 generics and 2,281 originals. Prices of the remaining were set outside of reference pricing. 32 different countries were used for reference pricing. Italy was the most popular country for reference pricing. Even if it was not a reference country, Germany was used in some of the pharmaceuticals. The average reimbursement discount rate and price were 24.43% and 249 TL, respectively. There were no colerations between price and reimbursement discount rate, or reference country and reimbursement rate.CONCLUSION: It has been shown that Italy has the highest impact on the pricing of all pharmaceuticals in Turkey. Even if it was not a reference country, Germany showed to affect pharmaceuticals more than other countries which were also not used for reference pricing. Even if reimbursement discount rates are stated by the Social Security Institution (SGK, there are different discount rates for pharmaceuticals. The analysis stated that there were correlation between price, country and discount rates. This analysis is first for the literature. Further analysis is necessary in the light of price

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.

Developing A Generic Optical Avionic Network

DEFF Research Database (Denmark)

Zhang, Jiang; An, Yi; Berger, Michael Stübert

2011-01-01

We propose a generic optical network design for future avionic systems in order to reduce the weight and power consumption of current networks on board. A three-layered network structure over a ring optical network topology is suggested, as it can provide full reconfiguration flexibility...... and support a wide range of avionic applications. Segregation can be made on different hierarchies according to system criticality and security requirements. The structure of each layer is discussed in detail. Two network configurations are presented, focusing on how to support different network services...... by such a network. Finally, three redundancy scenarios are discussed and compared....

Modeling of Generic Slung Load System

DEFF Research Database (Denmark)

Bisgaard, Morten; Bendtsen, Jan Dimon; la Cour-Harbo, Anders

2009-01-01

This paper presents the result of the modelling and verification of a generic slung load system using a small-scale helicopter. The model is intended for use in simulation, pilot training, estimation, and control. The model is derived using a redundant coordinate formulation based on Gauss...... slackening and tightening as well as aerodynamic coupling between the helicopter and the load. Furthermore, it is shown how the model can be easily used for multi-lift systems either with multiple helicopters or multiple loads. A numerical stabilisation algorithm is introduced and finally the use...... of the model is illustrated through simulations and flight verifications.  ...

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.

Nonlinear wave-packet dynamics for a generic one-dimensional time-independent system and its application to the hydrogen atom in a weak magnetic field

International Nuclear Information System (INIS)

Dupret, K.; Delande, D.

1996-01-01

We study the time propagation of an initially localized wave packet for a generic one-dimensional time-independent system, using the open-quote open-quote nonlinear wave-packet dynamics close-quote close-quote [S. Tomsovic and E. J. Heller, Phys. Rev. Lett. 67, 664 (1991)], a semiclassical approximation using a local linearization of the wave packet in the vicinity of classical reference trajectories. Several reference trajectories are needed to describe the behavior of the full wave packet. The introduction of action-angle variables allows us to obtain a simple analytic expression for the autocorrelation function, and to show that a universal behavior (quantum collapses, quantum revivals, etc.) is obtained via interferences between the reference trajectories. A connection with the standard WKB approach is established. Finally, we apply the nonlinear wave-packet dynamics to the case of the hydrogen atom in a weak magnetic field, and show that the semiclassical expressions obtained by nonlinear wave-packet dynamics are extremely accurate. copyright 1996 The American Physical Society

77 FR 3152 - New Mexico: Final Authorization of State-Initiated Changes and Incorporation-by-Reference of...

Science.gov (United States)

2012-01-23

... relations, Penalties, Reporting and recordkeeping requirements, Water pollution control, Water supply... Mexico: Final Authorization of State-Initiated Changes and Incorporation-by-Reference of State Hazardous.... SUMMARY: During a review of New Mexico's regulations, the EPA identified a variety of State-initiated...

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...

Generic vs. Modality-Specific Competencies for K-12 Online and Blended Teaching

Science.gov (United States)

Pulham, Emily B.; Graham, Charles R.; Short, Cecil R.

2018-01-01

Although research has explored teacher competencies in K-12 blended and online learning, it has not specified which competencies are appropriate to an online or digital medium, which refer to blending in-person with online experiences, or which are generic--applicable in any teaching modality. This article explores selected K-12 online and blended…

A Novel Generic Ball Recognition Algorithm Based on Omnidirectional Vision for Soccer Robots

Directory of Open Access Journals (Sweden)

Hui Zhang

2013-11-01

Full Text Available It is significant for the final goal of RoboCup to realize the recognition of generic balls for soccer robots. In this paper, a novel generic ball recognition algorithm based on omnidirectional vision is proposed by combining the modified Haar-like features and AdaBoost learning algorithm. The algorithm is divided into offline training and online recognition. During the phase of offline training, numerous sub-images are acquired from various panoramic images, including generic balls, and then the modified Haar-like features are extracted from them and used as the input of the AdaBoost learning algorithm to obtain a classifier. During the phase of online recognition, and according to the imaging characteristics of our omnidirectional vision system, rectangular windows are defined to search for the generic ball along the rotary and radial directions in the panoramic image, and the learned classifier is used to judge whether a ball is included in the window. After the ball has been recognized globally, ball tracking is realized by integrating a ball velocity estimation algorithm to reduce the computational cost. The experimental results show that good performance can be achieved using our algorithm, and that the generic ball can be recognized and tracked effectively.

Topological Hausdorff dimension and level sets of generic continuous functions on fractals

International Nuclear Information System (INIS)

Balka, Richárd; Buczolich, Zoltán; Elekes, Márton

2012-01-01

Highlights: ► We examine a new fractal dimension, the so called topological Hausdorff dimension. ► The generic continuous function has a level set of maximal Hausdorff dimension. ► This maximal dimension is the topological Hausdorff dimension minus one. ► Homogeneity implies that “most” level sets are of this dimension. ► We calculate the various dimensions of the graph of the generic function. - Abstract: In an earlier paper we introduced a new concept of dimension for metric spaces, the so called topological Hausdorff dimension. For a compact metric space K let dim H K and dim tH K denote its Hausdorff and topological Hausdorff dimension, respectively. We proved that this new dimension describes the Hausdorff dimension of the level sets of the generic continuous function on K, namely sup{ dim H f -1 (y):y∈R} =dim tH K-1 for the generic f ∈ C(K), provided that K is not totally disconnected, otherwise every non-empty level set is a singleton. We also proved that if K is not totally disconnected and sufficiently homogeneous then dim H f −1 (y) = dim tH K − 1 for the generic f ∈ C(K) and the generic y ∈ f(K). The most important goal of this paper is to make these theorems more precise. As for the first result, we prove that the supremum is actually attained on the left hand side of the first equation above, and also show that there may only be a unique level set of maximal Hausdorff dimension. As for the second result, we characterize those compact metric spaces for which for the generic f ∈ C(K) and the generic y ∈ f(K) we have dim H f −1 (y) = dim tH K − 1. We also generalize a result of B. Kirchheim by showing that if K is self-similar then for the generic f ∈ C(K) for every y∈intf(K) we have dim H f −1 (y) = dim tH K − 1. Finally, we prove that the graph of the generic f ∈ C(K) has the same Hausdorff and topological Hausdorff dimension as K.

FHR Generic Design Criteria

Energy Technology Data Exchange (ETDEWEB)

Flanagan, George F [ORNL; Holcomb, David Eugene [ORNL; Cetiner, Sacit M [ORNL

2012-06-01

The purpose of this document is to provide an initial, focused reference to the safety characteristics of and a licensing approach for Fluoride-Salt-Cooled High-Temperature Reactors (FHRs). The document does not contain details of particular reactor designs nor does it attempt to identify or classify either design basis or beyond design basis accidents. Further, this document is an initial attempt by a small set of subject matter experts to document the safety and licensing characteristics of FHRs for a larger audience. The document is intended to help in setting the safety and licensing research, development, and demonstration path forward. Input from a wider audience, further technical developments, and additional study will be required to develop a consensus position on the safety and licensing characteristics of FHRs. This document begins with a brief overview of the attributes of FHRs and then a general description of their anticipated safety performance. Following this, an overview of the US nuclear power plant approval process is provided that includes both test and power reactors, as well as the role of safety standards in the approval process. The document next describes a General Design Criteria (GDC) - based approach to licensing an FHR and provides an initial draft set of FHR GDCs. The document concludes with a description of a path forward toward developing an FHR safety standard that can support both a test and power reactor licensing process.

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.

Tank Monitoring and Document control System (TMACS) As Built Software Design Document

International Nuclear Information System (INIS)

GLASSCOCK, J.A.

2000-01-01

This document describes the software design for the Tank Monitor and Control System (TMACS). This document captures the existing as-built design of TMACS as of November 1999. It will be used as a reference document to the system maintainers who will be maintaining and modifying the TMACS functions as necessary. The heart of the TMACS system is the ''point-processing'' functionality where a sample value is received from the field sensors and the value is analyzed, logged, or alarmed as required. This Software Design Document focuses on the point-processing functions

Final characterization and safety screen report of double shell tank 241-AP-105 for evaporator campaign 97-1

International Nuclear Information System (INIS)

Miller, G.L.

1997-01-01

Evaporator candidate feed from tank 241-AP-105 (hereafter referred to as AP-105) was characterized for physical, inorganic, organic and radiochemical parameters by the 222-S Laboratory as directed by the Tank Sample and Analysis Plan (TSAP), References 1 through 4, and Engineering Change Notice, number 635332, Reference 5. This data package satisfies the requirement for a format IV, final report as described in Reference 1. This data package is also a follow-up to the 45-Day safety screen results for tank AP-105, Reference 8, which was issued on November 5, 1996, and is attached as Section II to this report. Preliminary data in the form of summary analytical tables were provided to the project in advance of this final report to enable early estimation of evaporator operational parameters, using the Predict modeling program. Analyses were performed at the 222-S Laboratory as defined and specified in the TSAP and the Laboratory's Quality Assurance P1an, References 6 and 7. Any deviations from the instructions documented in the TSAP are discussed in this narrative and are supported with additional documentation

Strategic mistakes (AVOIDABLE) The topicality of Michel Porter’s generic strategies

OpenAIRE

Viltard, Leandro Adolfo

2017-01-01

This article explores the topicality of Porter’s generic strategies, assessing about their applicability on two specific automotive industry projects: The Smart and the New Beetle.   After performing a documentation analysis on these two projects, it was concluded that both of them may be considered avoidable strategic mistakes as they show the risks of higher differentiation that is not being paid by the customer, no matter how if it is about recognized brands or icon products. Hazards a...

Preliminary Analysis of Assessment Instrument Design to Reveal Science Generic Skill and Chemistry Literacy

Science.gov (United States)

Sumarni, Woro; Sudarmin; Supartono, Wiyanto

2016-01-01

The purpose of this research is to design assessment instrument to evaluate science generic skill (SGS) achievement and chemistry literacy in ethnoscience-integrated chemistry learning. The steps of tool designing refers to Plomp models including 1) Investigation Phase (Prelimenary Investigation); 2) Designing Phase (Design); 3)…

The System 80+ Standard Plant design control document. Volume 23

International Nuclear Information System (INIS)

1997-01-01

This Design Control Document (DCD) is a repository of information comprising the System 80+trademark Standard Plant Design. The DCD also provides that design-related information to be incorporated by reference in the design certification rule for the System 80+ Standard Plant Design. Applicants for a combined license pursuant to 10 CFR 52 must ensure that the final Design Certification Rule and the associated Statements of Consideration are used when making all licensing decisions relevant to the System 80+ Standard Plant Design. The Design Control Document contains the DCD introduction, The Certified Design Material (CDM) [i.e., ''Tier 1''] and the Approved Design Material (ADM) [i.e., ''Tier 2''] for the System 80+ Standard Plant Design. The CDM includes the following sections: (1) Introductory material; (2) Certified Design Material for System 80+ systems and structures; (3) Certified Design Material for non-system-based aspects of the System 80+ Certified design; (4) Interface requirements; and (5) Site parameters. The ADM, to the extent applicable for the System 80+ Standard Plant Design, includes: (1) the information required for the final safety analysis report under 20 CFR 50.34; (2) other relevant information required by 10 CFR 52.47; and (3) emergency operations guidelines. This volume contains part 16 References and Appendix 19 A Design Alternatives for section 19 (Probabilistic Risk Assessment) of the ADM Design and Analysis. Also covered is section 20 Unresolved Safety Issues of the ADM Design and Analysis. Finally sections 1--6 of the ADM Emergency Operations Guidelines are contained in this volume. Information covered in these sections include: standard post-trip actions; diagnostic actions; reactor trip recovery guideline; LOCA recovery; SG tube rupture recovery

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

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.

Airborne radionuclide waste-management reference document

International Nuclear Information System (INIS)

Brown, R.A.; Christian, J.D.; Thomas, T.R.

1983-07-01

This report provides the detailed data required to develop a strategy for airborne radioactive waste management by the Department of Energy (DOE). The airborne radioactive materials of primary concern are tritium (H-3), carbon-14 (C-14), krypton-85 (Kr-85), iodine-129 (I-129), and radioactive particulate matter. The introductory section of the report describes the nature and broad objectives of airborne waste management. The relationship of airborne waste management to other waste management programs is described. The scope of the strategy is defined by considering all potential sources of airborne radionuclides and technologies available for their management. Responsibilities of the regulatory agencies are discussed. Section 2 of this document deals primarily with projected inventories, potential releases, and dose commitments of the principal airborne wastes from the light water reactor (LWR) fuel cycle. In Section 3, dose commitments, technologies, costs, regulations, and waste management criteria are analyzed. Section 4 defines goals and objectives for airborne waste management

Releasing the full potential of AIKAN - a dry anaerobic digestion biogas technology. Final report

Energy Technology Data Exchange (ETDEWEB)

Joernsgaerd, B.; Broegger Kristensen, M.; Wittrup Hansen, M. [Solum Gruppen, Hedehusene (Denmark); Uellendahl, H. [Aalborg Univ. (AAU), Aalborg (Denmark)

2013-07-15

This final project report contains a summary of the findings and documentation which have been carried out as a part of the EUDP-supported project ''Documentation and En-ergy Yield Optimisation of AIKAN{sup }- a dry anaerobic digestion biogas technology''. The aim was to improve documentation of the AIKAN{sup }technology, improve performance of the AIKAN{sup }technology and thus remove important barriers for market entry on principal export markets caused by the lack of performance documentation. The final report also contains a description of the subsequent process and technology improvements which have been carried out in order to improve and optimize the production process at the full scale AIKAN{sup }biogas plant, Biovaekst, in Audebo, Denmark. The relevant analyses carried out as part of the different work packages are attached as appendixes to the report. It is the intention that the final report and the attached appendices should function as a work of reference for the employees involved in the day to day running and optimization of the AIKAN{sup }technology. (Author)

Generic environmental impact statement in support of rulemaking on radiological criteria for license termination of NRC-licensed nuclear facilities. Final report, main report

International Nuclear Information System (INIS)

1997-07-01

The action being considered in this Final Generic Environmental Impact Statement (GEIS) is an amendment to the Nuclear Regulatory Commission's (NRC) regulations in 10 CFR Part 20 to include radiological criteria for decommissioning of lands and structures at nuclear facilities. Under the National Environmental Policy Act (NEPA), all Federal agencies must consider the effect of their actions on the environment. To fulfill NRC's responsibilities under NEPA, the Commission is preparing this GEIS which analyzes alternative courses of action and the costs and impacts associated with those alternatives. In preparing the final GEIS, the following approach was taken: (1) a listing was developed of regulatory alternatives for establishing radiological criteria for decommissioning; (2) for each alternative, a detailed analysis and comparison of incremental impacts, both radiological and nonradiological, to workers, members of the public, and the environment, and costs, were performed; and (3) based on the analysis of impacts and costs, conclusions on radiological criteria for decommissioning were provided. Contained in the GEIS are results and conclusions related to achieving, as an objective of decommissioning ALARA, reduction to preexisting background, the radiological criterion for unrestricted use, decommissioning ALARA analysis for soils and structures containing contamination, restricted use and alternative analysis for special site specific situations, and groundwater cleanup. In its analyses, the final GEIS includes consideration of comments made on the draft GEIS during the public comment period

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...

Financial incentives for generic drugs: case study on a reimbursement program

Directory of Open Access Journals (Sweden)

Marcos Inocencio

2010-06-01

Full Text Available Objective: To discuss the use of financial incentives in choice of medication and to assess the economic results concerning the use of financial incentives to promote the use of genetic medication in lieu of reference drugs in a company with a reimbursement program. Methods: A case study was carried out in a large supermarket. The data was obtained in the company responsible for managing medication. The study reached 83,625 users between August 2005 and July 2007. The data was submitted to regressions in order to analyze trends and hypothesis tests to assess differences in medication consumption. The results were compared with general data regarding medication consumption of five other organizations and also with data about the national consumption of generic medication in Brazil. Results: The use of financial incentives to replace brand medications for generics, in the company studied, increased the consumption of generic drugs without reducing the company expenses with the reimbursement programs. Conclusions: This study show the occurrence of unplanned results (increase in the consumption of medications and the positive consequences of the reimbursement program concerning access to medication.

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.

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

Tank Monitoring and Document control System (TMACS) As Built Software Design Document

Energy Technology Data Exchange (ETDEWEB)

GLASSCOCK, J.A.

2000-01-27

This document describes the software design for the Tank Monitor and Control System (TMACS). This document captures the existing as-built design of TMACS as of November 1999. It will be used as a reference document to the system maintainers who will be maintaining and modifying the TMACS functions as necessary. The heart of the TMACS system is the ''point-processing'' functionality where a sample value is received from the field sensors and the value is analyzed, logged, or alarmed as required. This Software Design Document focuses on the point-processing functions.

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.

Tiered co-payments, pricing, and demand in reference price markets for pharmaceuticals.

Science.gov (United States)

Herr, Annika; Suppliet, Moritz

2017-12-01

Health insurance companies curb price-insensitive behavior and the moral hazard of insureds by means of cost-sharing, such as tiered co-payments or reference pricing in drug markets. This paper evaluates the effect of price limits - below which drugs are exempt from co-payments - on prices and on demand. First, using a difference-in-differences estimation strategy, we find that the new policy decreases prices by 5 percent for generics and increases prices by 4 percent for brand-name drugs in the German reference price market. Second, estimating a nested-logit demand model, we show that consumers appreciate co-payment exempt drugs and calculate lower price elasticities for brand-name drugs than for generics. This explains the different price responses of brand-name and generic drugs and shows that price-related co-payment tiers are an effective tool to steer demand to low-priced drugs. Copyright © 2017 Elsevier B.V. All rights reserved.

Application of a generic biosphere model for dose assessments to five European sites

International Nuclear Information System (INIS)

Chen, Q; Kowe, R; Mobbs, S F; Proehl, G; Olyslaegers, G; Zeevaert, T; Kanyar, B; Pinedo, P; Simon, I; Bergstroem, U; Hallberg, B; Jones, J A; Oatway, W B; Watson, S J

2006-01-01

The BIOMOSA (BIOsphere MOdels for Safety Assessment of radioactive waste disposal) project was part of the EC fifth framework research programme. The main goal of this project was to improve the scientific basis for the application of biosphere models in the framework of long-term safety studies of radioactive waste disposal facilities and to enhance the confidence in using biosphere models for performance assessments. The study focused on the development and application of a generic biosphere tool BIOGEM (BIOsphere GEneric Model) using the IAEA BIOMASS reference biosphere methodology, and the comparison between BIOGEM and five site-specific biosphere models. The site-specific models and the generic model were applied to five typical locations in Europe, resulting in estimates of the annual effective individual doses to the critical groups and the ranking of the importance of the exposure pathways for each of the sites. Uncertainty in the results was also estimated by means of stochastic calculations based on variation of the site-specific parameter values. This paper describes the generic model and the deterministic and stochastic results obtained when it was applied to the five sites. Details of the site-specific models and the corresponding results are described in two companion papers. This paper also presents a comparison of the results between the generic model and site-specific models. In general, there was an acceptable agreement of the BIOGEM for both the deterministic and stochastic results with the results from the site-specific models

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

Science.gov (United States)

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

2013-04-23

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

Definition of an XML markup language for clinical laboratory procedures and comparison with generic XML markup.

Science.gov (United States)

Saadawi, Gilan M; Harrison, James H

2006-10-01

Clinical laboratory procedure manuals are typically maintained as word processor files and are inefficient to store and search, require substantial effort for review and updating, and integrate poorly with other laboratory information. Electronic document management systems could improve procedure management and utility. As a first step toward building such systems, we have developed a prototype electronic format for laboratory procedures using Extensible Markup Language (XML). Representative laboratory procedures were analyzed to identify document structure and data elements. This information was used to create a markup vocabulary, CLP-ML, expressed as an XML Document Type Definition (DTD). To determine whether this markup provided advantages over generic markup, we compared procedures structured with CLP-ML or with the vocabulary of the Health Level Seven, Inc. (HL7) Clinical Document Architecture (CDA) narrative block. CLP-ML includes 124 XML tags and supports a variety of procedure types across different laboratory sections. When compared with a general-purpose markup vocabulary (CDA narrative block), CLP-ML documents were easier to edit and read, less complex structurally, and simpler to traverse for searching and retrieval. In combination with appropriate software, CLP-ML is designed to support electronic authoring, reviewing, distributing, and searching of clinical laboratory procedures from a central repository, decreasing procedure maintenance effort and increasing the utility of procedure information. A standard electronic procedure format could also allow laboratories and vendors to share procedures and procedure layouts, minimizing duplicative word processor editing. Our results suggest that laboratory-specific markup such as CLP-ML will provide greater benefit for such systems than generic markup.

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

Reference document on the long life behavior of nuclear glasses

International Nuclear Information System (INIS)

Godon, N.

2004-01-01

This document exposes the scientific analysis of the operational modelizations concerning the behavior of glasses (C wastes) for the long time storage and for the retrieval or ultimate underground disposal. The scientific approach adopted to establish the behavior of glasses uses a methodology, a strategy and defined approaches, described in this document. The containment glasses specifications, the glass behavior dry or in non saturated open environment, the glass behavior in aqueous environment, predictions models of glasses alteration and elements of validation are also presented. (A.L.B.)

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)

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.

A survey exploring the knowledge and perceptions of senior medical students in Nepal toward generic medicines

Directory of Open Access Journals (Sweden)

Sudesh Gyawali

2016-08-01

Full Text Available Background: The accurate knowledge of generic medicine issues among future prescribers will enhance the prescribing of cost-effective medicines. This study aimed to explore the knowledge and perception of senior medical students about the generic medicines. Methodology: A cross-sectional study was conducted among 237 senior medical students (final year students and interns using a validated self-administered questionnaire. The collected data were analyzed using Statistical Package for the Social Sciences version 20 for windows and comparison of difference was done using linear by linear association. A p value of less than 0.05 was taken as statistically significant. Results: The average age (standard deviation of the respondents was 23.54 (1.39 years. Almost 5% of respondents correctly answered the question regarding the regulatory limits for bioequivalence. Almost two-thirds of respondents correctly agreed that generic medicine is bioequivalent to a brand-name medicine, and 79.3% and 72.5% of respondents correctly agreed that the medicine should be present in the same dosage form and same dose, respectively, as the brand-name medicines. However, almost half of the respondents had impression that brand-name medicines are required to meet higher safety standard than generic medicines. Almost 90% of respondents felt that advertisement by the drug companies would influence the use of brand-name medicine and they need more information about generic medicine. Conclusion: This study highlights the negative perception and knowledge deficit among the respondents. The students’ responses to almost all the statements were almost similar to the respondents’ academic year (final year students and interns, gender and nationality.

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.

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

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.

Generic Advertising Optimum Budget for Iran’s Milk Industry

Directory of Open Access Journals (Sweden)

H. Shahbazi

2016-05-01

Full Text Available Introduction One of the main targets of planners, decision makers and governments is increasing society health with promotion and production of suitable and healthy food. One of the basic commodities that have important role in satisfaction of required human food is milk. So, some part of government and producer healthy budget allocate to milk consumption promotion by using generic advertising. If effectiveness of advertising budget on profitability is more, producer will have more willing to spend for advertising. Determination of optimal generic advertising budget is one of important problem in managerial decision making in producing firm as well as increase in consumption and profit and decrease in wasting and non-optimality of budget. Materials and Methods: In this study, optimal generic advertising budget intensity index (advertising budget share of production cost was estimated under two different scenarios by using equilibrium replacement model. In equilibrium replacement model, producer surplus are maximized in respect to generic advertising in retail level. According to market where two levels of farm and processing before retail exist and there is trade in farm and retail level, we present different models. Fixed and variable proportion hypothesis is another one. Finally, eight relations are presented for determination of milk generic advertising optimum budget. So, we use data from several resources such as previous studies, national (Iran Static center and international institute (Fao formal data and own estimation. Because there are several estimations in previous studies, we identify some scenarios (in two general scenarios for calculation of milk generic advertising optimum budget. Results and Discussion: Estimation of milk generic advertising optimum budget in scenario 1 shows that in case of one market level, fixed supplies and no trade, optimum budget is 0.4672539 percent. In case of one market level and no trade, optimum

Generic Safety Requirements for Developing Safe Insulin Pump Software

Science.gov (United States)

Zhang, Yi; Jetley, Raoul; Jones, Paul L; Ray, Arnab

2011-01-01

Background The authors previously introduced a highly abstract generic insulin infusion pump (GIIP) model that identified common features and hazards shared by most insulin pumps on the market. The aim of this article is to extend our previous work on the GIIP model by articulating safety requirements that address the identified GIIP hazards. These safety requirements can be validated by manufacturers, and may ultimately serve as a safety reference for insulin pump software. Together, these two publications can serve as a basis for discussing insulin pump safety in the diabetes community. Methods In our previous work, we established a generic insulin pump architecture that abstracts functions common to many insulin pumps currently on the market and near-future pump designs. We then carried out a preliminary hazard analysis based on this architecture that included consultations with many domain experts. Further consultation with domain experts resulted in the safety requirements used in the modeling work presented in this article. Results Generic safety requirements for the GIIP model are presented, as appropriate, in parameterized format to accommodate clinical practices or specific insulin pump criteria important to safe device performance. Conclusions We believe that there is considerable value in having the diabetes, academic, and manufacturing communities consider and discuss these generic safety requirements. We hope that the communities will extend and revise them, make them more representative and comprehensive, experiment with them, and use them as a means for assessing the safety of insulin pump software designs. One potential use of these requirements is to integrate them into model-based engineering (MBE) software development methods. We believe, based on our experiences, that implementing safety requirements using MBE methods holds promise in reducing design/implementation flaws in insulin pump development and evolutionary processes, therefore improving

Let Documents Talk to Each Other: A Computer Model for Connection of Short Documents.

Science.gov (United States)

Chen, Z.

1993-01-01

Discusses the integration of scientific texts through the connection of documents and describes a computer model that can connect short documents. Information retrieval and artificial intelligence are discussed; a prototype system of the model is explained; and the model is compared to other computer models. (17 references) (LRW)

Technology, safety, and costs of decommissioning reference light-water reactors following postulated accidents. Appendices

Energy Technology Data Exchange (ETDEWEB)

Murphy, E S; Holter, G M

1982-11-01

Appendices contain information concerning the reference site description; reference PWR facility description; details of reference accident scenarios and resultant contamination levels; generic cleanup and decommissioning information; details of activities and manpower requirements for accident cleanup at a reference PWR; activities and manpower requirements for decommissioning at a reference PWR; costs of decommissioning at a reference PWR; cost estimating bases; safety assessment details; and details of post-accident cleanup and decommissioning at a reference BWR.

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

Proposed amendment to the final decision document for the hydrazine blending and storage facility, interim response action

Energy Technology Data Exchange (ETDEWEB)

1991-02-25

From April through August 1989, a bench-/pilot-scale testing program was conducted to evaluate whether qualified manufactures of ultraviolet (UV)/chemical oxidation equipment could reduce the concentrations of hydrazine fuel compounds (hydrazine, monomethyl hydrazine (MMH), and unsymmetrical dimethyl hydrazine (UDMH)) and n-nitrosodimethylamine (NDMA) in the wastewater to action levels identified in the Final Decision Document. A secondary objective of this testing program was to generate design and operational information for use during the full-scale startup program.

GALE: a generic open source extensible adaptation engine

Science.gov (United States)

De Bra, Paul; Knutov, Evgeny; Smits, David; Stash, Natalia; Ramos, Vinicius F. C.

2013-06-01

This paper motivates and describes GALE, the Generic Adaptation Language and Engine that came out of the GRAPPLE EU FP7 project. The main focus of the paper is the extensible nature of GALE. The purpose of this description is to illustrate how a single core adaptation engine can be used for different types of adaptation, applied to different types of information items and documents. We illustrate the adaptive functionality on some examples of hypermedia documents. In April 2012, David Smits defended the world's first adaptive PhD thesis on this topic. The thesis, available for download and direct adaptive access at http://gale.win.tue.nl/thesis, shows that a single source of information can serve different audiences and at the same time also allows more freedom of navigation than is possible in any paper or static hypermedia document. The same can be done for course texts, hyperfiction, encyclopedia, museum, or other cultural heritage websites, etc. We explain how to add functionality to GALE if desired, to adapt the system's behavior to whatever the application requires. This stresses our main objective: to provide a technological base for adaptive (hypermedia) system researchers on which they can build extensions for the specific research they have in mind.

Generic Procedures for Medical Response During a Nuclear or Radiological Emergency

International Nuclear Information System (INIS)

2009-01-01

The aim of this manual is to provide the medical community with practical guidance for medical emergency preparedness and response, describing the tasks and actions of different members of the national, regional or local medical infrastructure in accordance with international standards. This document provides generic response procedures for medical personnel responding to different types of radiation emergencies and at the different stages of the emergency response (at the scene of the emergency, pre-hospital, hospital), and during the early post-emergency stage (about 1-2 months afterwards).

[Healthy sleep: evidence and guidelines for action. Official document of the Spanish Sleep Society].

Science.gov (United States)

Merino-Andreu, M; Alvarez-Ruiz de Larrinaga, A; Madrid-Perez, J A; Martinez-Martinez, M A; Puertas-Cuesta, F J; Asencio-Guerra, A J; Romero Santo-Tomas, O; Jurado-Luque, M J; Segarra-Isern, F J; Canet-Sanz, T; Gimenez-Rodriguez, P; Teran-Santos, J; Alonso-Alvarez, M L; Garcia-Borreguero Diaz-Varela, D; Barriuso-Esteban, B

2016-10-03

One of the main objectives of the Spanish Sleep Society is to promote healthy sleep in both the general population and in health professionals. This document aims to conduct a review of the current scientific literature on sleep habits that can serve as the basis on which to establish a set of general recommendations, regarding healthy sleep, for use by the general population in Spain as well as to identify the main challenges faced by research into sleep habits. The document has been developed by a multidisciplinary team made up of members of the Spanish Sleep Society who are experts in paediatric sleep medicine, clinical neurophysiology, pulmonology, neurology, chronobiology, physiology and psychology. The existing scientific literature dealing with sleep habits in the general population was reviewed, and the following aspects were addressed: the current state of sleep habits in the Spanish population; a generic review of the optimum number of hours of sleep; the impact of the environmental setting (noise, temperature, illumination, etc.), hours of sleep, diet and sport, together with several specific sections for children and teenagers, shift-workers and drivers of different vehicles. The conclusions from all the aspects addressed in this document have resulted in a set of final general recommendations that will serve as a guide for the general population and health professionals. Likewise, the principal environmental challenges and future lines of research are also discussed.

INFCE plenary conference documents

International Nuclear Information System (INIS)

This document consists of the reports to the First INFCE Plenary Conference (November 1978) by the Working Groups a Plenary Conference of its actions and decisions, the Communique of the Final INFCE Plenary Conference (February 1980), and a list of all documents in the IAEA depository for INFCE

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

Building generic anatomical models using virtual model cutting and iterative registration

Directory of Open Access Journals (Sweden)

Hallgrímsson Benedikt

2010-02-01

Full Text Available Abstract Background Using 3D generic models to statistically analyze trends in biological structure changes is an important tool in morphometrics research. Therefore, 3D generic models built for a range of populations are in high demand. However, due to the complexity of biological structures and the limited views of them that medical images can offer, it is still an exceptionally difficult task to quickly and accurately create 3D generic models (a model is a 3D graphical representation of a biological structure based on medical image stacks (a stack is an ordered collection of 2D images. We show that the creation of a generic model that captures spatial information exploitable in statistical analyses is facilitated by coupling our generalized segmentation method to existing automatic image registration algorithms. Methods The method of creating generic 3D models consists of the following processing steps: (i scanning subjects to obtain image stacks; (ii creating individual 3D models from the stacks; (iii interactively extracting sub-volume by cutting each model to generate the sub-model of interest; (iv creating image stacks that contain only the information pertaining to the sub-models; (v iteratively registering the corresponding new 2D image stacks; (vi averaging the newly created sub-models based on intensity to produce the generic model from all the individual sub-models. Results After several registration procedures are applied to the image stacks, we can create averaged image stacks with sharp boundaries. The averaged 3D model created from those image stacks is very close to the average representation of the population. The image registration time varies depending on the image size and the desired accuracy of the registration. Both volumetric data and surface model for the generic 3D model are created at the final step. Conclusions Our method is very flexible and easy to use such that anyone can use image stacks to create models and

Document Organization Using Kohonen's Algorithm.

Science.gov (United States)

Guerrero Bote, Vicente P.; Moya Anegon, Felix de; Herrero Solana, Victor

2002-01-01

Discussion of the classification of documents from bibliographic databases focuses on a method of vectorizing reference documents from LISA (Library and Information Science Abstracts) which permits their topological organization using Kohonen's algorithm. Analyzes possibilities of this type of neural network with respect to the development of…

Enhancing regulatory effectiveness by improving the process for identifying and resolving generic issues

International Nuclear Information System (INIS)

Vander Molen, Harold J.

2001-01-01

The Generic Issues Program first began formally in response to a Commission directive in October of 1976. In 1983, it became one of the first programs to make successful use of probabilistic risk information to aid in regulatory decision-making. In the 16 years since the program became quantitative, 836 issues have been processed. Of these, 106 reactor safety issues were prioritized as requiring further evaluation to determine the final resolution. Approximately a dozen generic issues remain unresolved. Although there is far less reactor licensing activity than in the 1970s, new issues continue to be identified from research and operational experience. These issues often involve complex and controversial questions of safety and regulation, and an efficient and effective means of addressing these issues is essential for regulatory effectiveness. Issues that involve a significant safety question require swift, effective, enforceable, and cost-effective regulatory actions. Issues that are of little safety significance must be quickly shown to be so and dismissed in an expeditious manner so as to avoid unnecessary expenditure of limited resources and to reduce regulatory uncertainty. Additionally, in the time since the generic issue program began, probabilistic risk assessment techniques have advanced significantly while agency resources have continued to diminish. Accordingly, the paper discusses the steps that have been taken to enhance the effectiveness and efficiency of the generic issue resolution process. Additionally, four resolved issues are discussed, along with key elements of a proposed new procedure for resolving potential generic issues

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

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.

Xyce parallel electronic simulator : reference guide.

Energy Technology Data Exchange (ETDEWEB)

Mei, Ting; Rankin, Eric Lamont; Thornquist, Heidi K.; Santarelli, Keith R.; Fixel, Deborah A.; Coffey, Todd Stirling; Russo, Thomas V.; Schiek, Richard Louis; Warrender, Christina E.; Keiter, Eric Richard; Pawlowski, Roger Patrick

2011-05-01

This document is a reference guide to the Xyce Parallel Electronic Simulator, and is a companion document to the Xyce Users Guide. The focus of this document is (to the extent possible) exhaustively list device parameters, solver options, parser options, and other usage details of Xyce. This document is not intended to be a tutorial. Users who are new to circuit simulation are better served by the Xyce Users Guide. The Xyce Parallel Electronic Simulator has been written to support, in a rigorous manner, the simulation needs of the Sandia National Laboratories electrical designers. It is targeted specifically to run on large-scale parallel computing platforms but also runs well on a variety of architectures including single processor workstations. It also aims to support a variety of devices and models specific to Sandia needs. This document is intended to complement the Xyce Users Guide. It contains comprehensive, detailed information about a number of topics pertinent to the usage of Xyce. Included in this document is a netlist reference for the input-file commands and elements supported within Xyce; a command line reference, which describes the available command line arguments for Xyce; and quick-references for users of other circuit codes, such as Orcad's PSpice and Sandia's ChileSPICE.

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 ...

Drinking-water-criteria document for phthalic acid esters (PAES). Final report

International Nuclear Information System (INIS)

1991-08-01

The document provides the health effects basis to be considered in establishing the MCLG. To achieve the objective, data on pharmacokinetics human exposure, acute and chronic toxicity to animals and humans, epidemiology and mechanisms of toxicity are evaluated for phthalic acid esters. Specific emphasis is placed on literature data providing dose-response information. Thus, while the literature search and evaluation performed in support of the document has been comprehensive, only the reports considered most pertinent in the derivation of the MCLG are cited in the document. The comprehensive literature data base in support of the document includes information published up to 1986; however, more recent data may have been added during the review process

Nuclide release calculation in the near-field of a reference HLW repository

International Nuclear Information System (INIS)

Lee, Youn Myoung; Hwang, Yong Soo; Kang, Chul Hyung

2004-01-01

The HLW-relevant R and D program for disposal of high-level radioactive waste has been carried out at Korea Atomic Energy Research Institute (KAERI) since early 1997 in order to develop a conceptual Korea Reference Repository System for direct disposal of nuclear spent fuel by the end of 2007. A preliminary reference geologic repository concept considering such established criteria and requirements as waste and generic site characteristics in Korea was roughly envisaged in 2003 focusing on the near-field components of the repository system. According to above basic repository concept, which is similar to that of Swedish KBS-3 repository, the spent fuel is first encapsulated in corrosion resistant canisters, even though the material has not yet been determined, and then emplaced into the deposition holes surrounded by high density bentonite clay in tunnels constructed at a depth of about 500 m in a stable plutonic rock body. Not only to demonstrate how much a reference repository is safe in the generic point of view with several possible scenarios and cases associated with a preliminary repository concept by conducting calculations for nuclide release and transport in the near-field components of the repository, even though enough information has not been available that much yet, but also to show a methodology by which a generic safety assessment could be performed for further development of Korea reference repository concept, nuclide release calculation study strongly seems to be necessary

Scheme Program Documentation Tools

DEFF Research Database (Denmark)

Nørmark, Kurt

2004-01-01

are separate and intended for different documentation purposes they are related to each other in several ways. Both tools are based on XML languages for tool setup and for documentation authoring. In addition, both tools rely on the LAML framework which---in a systematic way---makes an XML language available...... as named functions in Scheme. Finally, the Scheme Elucidator is able to integrate SchemeDoc resources as part of an internal documentation resource....

Development and optimisation of generic decommissioning strategies for civil Magnox reactors

International Nuclear Information System (INIS)

Carpenter, G.; Hebditch, D.; Meek, N.; Patel, A.; Reeve, P.

2004-01-01

BNFL Environmental Services has formulated updated proposals for the use of decision analysis in the development of decommissioning strategy. The proposals are based on the Department of Transport, Local Government and the Regions manual for practitioners on multi-criteria analysis, specifically multi-criteria decision analysis, as suited to complex problems with a mixture of monetary and non-monetary objectives. They take account of up-to-date academic methodology, the newly issued BNFL decision analysis framework for environmental decisions and a wide variety of other engineering, optioneering and optimisation processes. The paper also summarises legislative and company policy areas of importance to decommissioning strategy development. Higher-level generic reactor and site remediation strategies already exist. At the lower level, various generic decommissioning reference processes and project options need development. For the past year, Environmental Services has held responsibility to respond to the Nuclear Installations Inspectorates' quinquennial review, develop and maintain up-to-date strategies, institute the review of a selected number of key strategies, and respond to changing circumstances including stakeholder views. Environmental Services is performing a range of generic studies for selection of strategies and end-points as used for a variety of waste management and site care and maintenance preparations. (author)

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.

DSRS guidelines. Reference document for the IAEA Design Safety Review Services

International Nuclear Information System (INIS)

1999-01-01

The publication covers the general topic of design safety review of a nuclear power plant. It is intended to make Member States aware of the possibility of a service through which they can have a better appreciation of the overall design of a facility or of a plant already in operation. It includes a generic and procedural part followed by a technical part corresponding to different systems of a nuclear power plant. It is intended to be used mainly in preparation and execution of a design review service by the IAEA and to provide information to potential recipients of the service regarding the effort involved and the topics that can be covered. it is expected to be useful if Member States decide to conduct such reviews themselves either through regulatory authorities or as part of self assessment activities by plant management

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

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

Pharmaceutical policies: effects of reference pricing, other pricing, and purchasing policies.

Science.gov (United States)

Acosta, Angela; Ciapponi, Agustín; Aaserud, Morten; Vietto, Valeria; Austvoll-Dahlgren, Astrid; Kösters, Jan Peter; Vacca, Claudia; Machado, Manuel; Diaz Ayala, Diana Hazbeydy; Oxman, Andrew D

2014-10-16

Pharmaceuticals are important interventions that could improve people's health. Pharmaceutical pricing and purchasing policies are used as cost-containment measures to determine or affect the prices that are paid for drugs. Internal reference pricing establishes a benchmark or reference price within a country which is the maximum level of reimbursement for a group of drugs. Other policies include price controls, maximum prices, index pricing, price negotiations and volume-based pricing. To determine the effects of pharmaceutical pricing and purchasing policies on health outcomes, healthcare utilisation, drug expenditures and drug use. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), part of The Cochrane Library (including the Effective Practice and Organisation of Care Group Register) (searched 22/10/2012); MEDLINE In-Process & Other Non-Indexed Citations and MEDLINE, Ovid (searched 22/10/2012); EconLit, ProQuest (searched 22/10/2012); PAIS International, ProQuest (searched 22/10/2012); World Wide Political Science Abstracts, ProQuest (searched 22/10/2012); INRUD Bibliography (searched 22/10/2012); Embase, Ovid (searched 14/12/2010); NHSEED, part of The Cochrane Library (searched 08/12/2010); LILACS, VHL (searched 14/12/2010); International Political Science Abstracts (IPSA), Ebsco (searched (17/12/2010); OpenSIGLE (searched 21/12/10); WHOLIS, WHO (searched 17/12/2010); World Bank (Documents and Reports) (searched 21/12/2010); Jolis (searched 09/10/2011); Global Jolis (searched 09/10/2011) ; OECD (searched 30/08/2005); OECD iLibrary (searched 30/08/2005); World Bank eLibrary (searched 21/12/2010); WHO - The Essential Drugs and Medicines web site (browsed 21/12/2010). Policies in this review were defined as laws; rules; financial and administrative orders made by governments, non-government organisations or private insurers. To be included a study had to include an objective measure of at least one of the following outcomes: drug use

Canister storage building design basis accident analysis documentation

International Nuclear Information System (INIS)

KOPELIC, S.D.

1999-01-01

This document provides the detailed accident analysis to support HNF-3553, Spent Nuclear Fuel Project Final Safety Analysis Report, Annex A, ''Canister Storage Building Final Safety Analysis Report.'' All assumptions, parameters, and models used to provide the analysis of the design basis accidents are documented to support the conclusions in the Canister Storage Building Final Safety Analysis Report

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...

Registration document 2005

International Nuclear Information System (INIS)

2005-01-01

This reference document of Gaz de France provides information and data on the Group activities in 2005: financial informations, business, activities, equipments factories and real estate, trade, capital, organization charts, employment, contracts and research programs. (A.L.B.)

Bibliographic Citations With Special Reference Indian Bibliographic Standard

Directory of Open Access Journals (Sweden)

Reshmi Sarkar

2015-08-01

Full Text Available Bibliographic citation is playing an important role today to ensure the completeness of all research activities. They occupy an integral part as a reference in all types of resources need. The author while writing a paper takes the references from a number of documents and finally quotes them with its bibliographic details to recognize the work of earlier authors in the same field of study. With the virtually exponential growth in the research literatures throughout the 20th century it has become clear that the larger the literature the more difficult are the problems caused by poorly crafted bibliographic references. Scholarly societies like publishers of research journals have either produced their own or have endorsed common bibliographic style manuals or standards. In this study we have studied several style manuals and standards for bibliographic referencing and several editorial guidelines for this purpose to compare them. Indian bibliographic standard gets special attention.

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...

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

Integrated plant safety assessment. Systematic evaluation program, Big Rock Point Plant (Docket No. 50-155). Final report

International Nuclear Information System (INIS)

1984-05-01

The Systematic Evaluation Program was initiated in February 1977 by the U.S. Nuclear Regulatory Commission to review the designs of older operating nuclear reactor plants to reconfirm and document their safety. The review provides (1) an assessment of how these plants compare with current licensing safety requirements relating to selected issues, (2) a basis for deciding how these differences should be resolved in an integrated plant review, and (3) a documented evaluation of plant safety when the supplement to the Final Integrated Plant Safety Assessment Report has been issued. 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

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...

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...

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

Interim report on reference biospheres for radioactive waste disposal

Energy Technology Data Exchange (ETDEWEB)

Dorp, F. van [NAGRA (Switzerland)] [and others

1994-10-01

significant effect on biosphere modelling, for normal and accidental releases from nuclear installations, and also for waste disposal. For example, increased attention is being given to natural and semi-natural environments. Against this background, the primary objective of the BIOMOVS II Reference Biospheres Working Group is to establish a consensus on the development and application of a Reference Biosphere approach to the evaluation of long-term radiological consequences of solid radioactive waste disposal systems. The Working Group is expecting to provide: 1. A recommended methodology for biosphere analysis within the assessment of radioactive waste disposal, which is consistent for different types of radioactive waste and disposal concepts. This should include the justification, arguments and documentation for all the steps in the recommended methodology. A preliminary illustration of the approach is shown in the figure opposite. 2. An internationally developed and structured list of Features, Events and Processes (FEPs), which can be used to support the development of biosphere models for specific assessments. 3. Example(s) of how to apply the methodology. If these examples are developed in a suitably generic assessment context, they can be defined as generic 'Reference Biospheres' and their applicability and limitations should be identified. Such 'Reference Biospheres' could then be used e.g: (a) for generic site independent evaluation of disposal plans; (b) to provide sets of factors to convert geosphere release into doses or risks; (c) as 'stylised biospheres' (which might be defined as a biosphere which contains only the most essential FEPs); (d) as benchmarks for comparisons with other assessments, and (e) as sources of detailed information on biosphere modelling for waste disposal assessments. In order to complete an assessment of a particular site, there will not only be a need to take account of site specific issues, such as the

Interim report on reference biospheres for radioactive waste disposal

Energy Technology Data Exchange (ETDEWEB)

Dorp, F van [NAGRA (Switzerland); and others

1994-10-01

significant effect on biosphere modelling, for normal and accidental releases from nuclear installations, and also for waste disposal. For example, increased attention is being given to natural and semi-natural environments. Against this background, the primary objective of the BIOMOVS II Reference Biospheres Working Group is to establish a consensus on the development and application of a Reference Biosphere approach to the evaluation of long-term radiological consequences of solid radioactive waste disposal systems. The Working Group is expecting to provide: 1. A recommended methodology for biosphere analysis within the assessment of radioactive waste disposal, which is consistent for different types of radioactive waste and disposal concepts. This should include the justification, arguments and documentation for all the steps in the recommended methodology. A preliminary illustration of the approach is shown in the figure opposite. 2. An internationally developed and structured list of Features, Events and Processes (FEPs), which can be used to support the development of biosphere models for specific assessments. 3. Example(s) of how to apply the methodology. If these examples are developed in a suitably generic assessment context, they can be defined as generic 'Reference Biospheres' and their applicability and limitations should be identified. Such 'Reference Biospheres' could then be used e.g: (a) for generic site independent evaluation of disposal plans; (b) to provide sets of factors to convert geosphere release into doses or risks; (c) as 'stylised biospheres' (which might be defined as a biosphere which contains only the most essential FEPs); (d) as benchmarks for comparisons with other assessments, and (e) as sources of detailed information on biosphere modelling for waste disposal assessments. In order to complete an assessment of a particular site, there will not only be a need to take account of site specific issues, such as the geosphere-biosphere interface and

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.

Canister storage building design basis accident analysis documentation

Energy Technology Data Exchange (ETDEWEB)

KOPELIC, S.D.

1999-02-25

This document provides the detailed accident analysis to support HNF-3553, Spent Nuclear Fuel Project Final Safety Analysis Report, Annex A, ''Canister Storage Building Final Safety Analysis Report.'' All assumptions, parameters, and models used to provide the analysis of the design basis accidents are documented to support the conclusions in the Canister Storage Building Final Safety Analysis Report.

Generic Adaptively Secure Searchable Phrase Encryption

Directory of Open Access Journals (Sweden)

Kissel Zachary A.

2017-01-01

Full Text Available In recent years searchable symmetric encryption has seen a rapid increase in query expressiveness including keyword, phrase, Boolean, and fuzzy queries. With this expressiveness came increasingly complex constructions. Having these facts in mind, we present an efficient and generic searchable symmetric encryption construction for phrase queries. Our construction is straightforward to implement, and is proven secure under adaptively chosen query attacks (CQA2 in the random oracle model with an honest-but-curious adversary. To our knowledge, this is the first encrypted phrase search system that achieves CQA2 security. Moreover, we demonstrate that our document collection preprocessing algorithm allows us to extend a dynamic SSE construction so that it supports phrase queries. We also provide a compiler theorem which transforms any CQA2-secure SSE construction for keyword queries into a CQA2-secure SSE construction that supports phrase queries.

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.

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.

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.

Reference design description for a geologic repository. Revision 02

International Nuclear Information System (INIS)

1999-01-01

This Reference Design Description explains the current design for a potential geologic repository that may be located at Yucca Mountain in Nevada. It describes the proposed design for a surface facility, subsurface repository, and waste packaging; it also presents the current design of the key engineering systems for the final four phases: operations, monitoring, closure, and postclosure. In addition, this Reference Design Description reviews the expected long-term performance of the potential repository. In accordance with current law, this design does not include an interim storage option. This document has six major sections. Section 1 describes the physical layout of the proposed repository. The second section describes the 4-phase evolution of the development of the proposed repository. Section 3 describes the reception of waste from offsite locations. The fourth section details the various systems that will package the waste and move it below ground as well as safety monitoring and closure. Section 5 describes the systems (both physical and analytical) that ensure continued safety after closure. The final section offers design options that may be adopted to increase the margin of safety

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.

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.

THEREDA. Thermodynamic reference database. Summary of final report

Energy Technology Data Exchange (ETDEWEB)

Altmaier, Marcus; Bube, Christiane; Marquardt, Christian [Karlsruher Institut fuer Technologie (KIT), Eggenstein-Leopoldshafen (Germany). Institut fuer Nukleare Entsorgung; Brendler, Vinzenz; Richter, Anke [Helmholtz-Zentrum Dresden-Rossendorf (Germany). Inst. fuer Radiochemie; Moog, Helge C.; Scharge, Tina [Gesellschaft fuer Anlagen- und Reaktorsicherheit mbH (GRS), Koeln (Germany); Voigt, Wolfgang [TU Bergakademie Freiburg (Germany). Inst. fuer Anorganische Chemie; Wilhelm, Stefan [AF-Colenco AG, Baden (Switzerland)

2011-03-15

A long term safety assessment of a repository for radioactive waste requires evidence, that all relevant processes are known and understood, which might have a significant positive or negative impact on its safety. In 2002, a working group of five institutions was established to create a common thermodynamic database for nuclear waste disposal in deep geological formations. The common database was named THEREDA: Thermodynamic Reference Database. The following institutions are members of the working group: Helmholtz-Zentrum Dresden-Rossendorf, Institute of Radiochemistry - Karlsruhe Institute of Technology, Institute for Nuclear Waste Disposal - Technische Universitaet Bergakademie Freiberg, Institute of Inorganic Chemistry - AF-Colenco AG, Baden, Switzerland, Department of Groundwater Protection and Waste Disposal - Gesellschaft fur Anlagen- und Reaktorsicherheit, Braunschweig. For the future it is intended that its usage becomes mandatory for geochemical model calculations for nuclear waste disposal in Germany. Furthermore, it was agreed that the new database should be established in accordance with the following guidelines: Long-term usability: The disposal of radioactive waste is a task encompassing decades. The database is projected to operate on a long-term basis. This has influenced the choice of software (which is open source), the documentation and the data structure. THEREDA is adapted to the present-day necessities and computational codes but also leaves many degrees of freedom for varying demands in the future. Easy access: The database is accessible via the World Wide Web for free. Applicability: To promote the usage of the database in a wide community, THEREDA is providing ready-to-use parameter files for the most common codes. These are at present: PHREEQC, EQ3/6, Geochemist's Workbench, and CHEMAPP. Internal consistency: It is distinguished between dependent and independent data. To ensure the required internal consistency of THEREDA, the

THEREDA. Thermodynamic reference database. Summary of final report

International Nuclear Information System (INIS)

Altmaier, Marcus; Bube, Christiane; Marquardt, Christian; Voigt, Wolfgang

2011-03-01

A long term safety assessment of a repository for radioactive waste requires evidence, that all relevant processes are known and understood, which might have a significant positive or negative impact on its safety. In 2002, a working group of five institutions was established to create a common thermodynamic database for nuclear waste disposal in deep geological formations. The common database was named THEREDA: Thermodynamic Reference Database. The following institutions are members of the working group: Helmholtz-Zentrum Dresden-Rossendorf, Institute of Radiochemistry - Karlsruhe Institute of Technology, Institute for Nuclear Waste Disposal - Technische Universitaet Bergakademie Freiberg, Institute of Inorganic Chemistry - AF-Colenco AG, Baden, Switzerland, Department of Groundwater Protection and Waste Disposal - Gesellschaft fur Anlagen- und Reaktorsicherheit, Braunschweig. For the future it is intended that its usage becomes mandatory for geochemical model calculations for nuclear waste disposal in Germany. Furthermore, it was agreed that the new database should be established in accordance with the following guidelines: Long-term usability: The disposal of radioactive waste is a task encompassing decades. The database is projected to operate on a long-term basis. This has influenced the choice of software (which is open source), the documentation and the data structure. THEREDA is adapted to the present-day necessities and computational codes but also leaves many degrees of freedom for varying demands in the future. Easy access: The database is accessible via the World Wide Web for free. Applicability: To promote the usage of the database in a wide community, THEREDA is providing ready-to-use parameter files for the most common codes. These are at present: PHREEQC, EQ3/6, Geochemist's Workbench, and CHEMAPP. Internal consistency: It is distinguished between dependent and independent data. To ensure the required internal consistency of THEREDA, the

Generic linking of finite element models for non-linear static and global dynamic analyses for aircraft structures

NARCIS (Netherlands)

de Wit, A.J.; Akcay-Perdahcioglu, Didem; van den Brink, W.M.; de Boer, Andries; Rolfes, R.; Jansen, E.L.

2011-01-01

Depending on the type of analysis, Finite Element(FE) models of different fidelity are necessary. Creating these models manually is a labor intensive task. This paper discusses a generic approach for generating FE models of different fidelity from a single reference FE model. These different

Generic environmental impact statement in support of rulemaking on radiological criteria for license termination of NRC-licensed nuclear facilities. Final report, appendices A and B

International Nuclear Information System (INIS)

1997-07-01

The action being considered in this Final Generic Environmental Impact Statement (GEIS) is an amendment to the Nuclear Regulatory Commission''s (NRC) regulations in 10 CFR Part 20 to include radiological criteria for decommissioning of lands and structures at nuclear facilities. Under the National Environmental Policy Act (NEPA), all Federal agencies must consider the effect of their actions on the environment. To fulfill NRC''s responsibilities under NEPA, the Commission is preparing this GEIS which analyzes alternative courses of action and the costs and impacts associated with those alternatives. In preparing the final GEIS, the following approach was taken: (1) a listing was developed of regulatory alternatives for establishing radiological criteria for decommissioning; (2) for each alternative, a detailed analysis and comparison of incremental impacts, both radiological and nonradiological, to workers, members of the public, and the environment, and costs were performed; and (3) based on the analysis of impacts and costs, conclusions on radiological criteria for decommissioning were provided. Contained in the GEIS are results and conclusions related to achieving, as an objective of decommissioning ALARA, reduction to preexisting background, the radiological criterion for unrestricted use, decommissioning ALARA analysis for soils and structures containing contamination, restricted use and alternative analysis for special site-specific situations and groundwater cleanup. In its analyses, the final GEIS includes consideration of comments made on the draft GEIS during the public comment period

Alternative control technology document for bakery oven emissions. Final report

Energy Technology Data Exchange (ETDEWEB)

Sanford, C.W.

1992-12-01

The document was produced in response to a request by the baking industry for Federal guidance to assist in providing a more uniform information base for State decision-making with regard to control of bakery oven emissions. The information in the document pertains to bakeries that produce yeast-leavened bread, rolls, buns, and similar products but not crackers, sweet goods, or baked foodstuffs that are not yeast leavened. Information on the baking processes, equipment, operating parameters, potential emissions from baking, and potential emission control options are presented. Catalytic and regenerative oxidation are identified as the most appropriate existing control technologies applicable to VOC emissions from bakery ovens. Cost analyses for catalytic and regenerative oxidation are included. A predictive formula for use in estimating oven emissions has been derived from source tests done in junction with the development of the document. Its use and applicability are described.

TagDust2: a generic method to extract reads from sequencing data.

Science.gov (United States)

Lassmann, Timo

2015-01-28

Arguably the most basic step in the analysis of next generation sequencing data (NGS) involves the extraction of mappable reads from the raw reads produced by sequencing instruments. The presence of barcodes, adaptors and artifacts subject to sequencing errors makes this step non-trivial. Here I present TagDust2, a generic approach utilizing a library of hidden Markov models (HMM) to accurately extract reads from a wide array of possible read architectures. TagDust2 extracts more reads of higher quality compared to other approaches. Processing of multiplexed single, paired end and libraries containing unique molecular identifiers is fully supported. Two additional post processing steps are included to exclude known contaminants and filter out low complexity sequences. Finally, TagDust2 can automatically detect the library type of sequenced data from a predefined selection. Taken together TagDust2 is a feature rich, flexible and adaptive solution to go from raw to mappable NGS reads in a single step. The ability to recognize and record the contents of raw reads will help to automate and demystify the initial, and often poorly documented, steps in NGS data analysis pipelines. TagDust2 is freely available at: http://tagdust.sourceforge.net .

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...

Aceptación de los fármacos genéricos en equipos de atención primaria: efecto de una intervención educativa y de los precios de referencia Acceptance of generic prescribing in general practice: effect of patient education and reference prices

Directory of Open Access Journals (Sweden)

J.A. Vallès

2002-12-01

referencia incrementó de forma relativa el uso de genéricos.Aims: To assess patient acceptance of the substitution of brand-name drugs for generic equivalents in the context of repeat prescriptions for chronic diseases. Methods: A prospective multicenter study of drug use was performed. Of the 31 centers included in the study, 8 were randomized to the intervention group and 23 to the control group. For 1 year, patients in the intervention group who visited the center to collect repeat prescriptions received verbal and written information on the advantages and disadvantages of generic and brand name drugs. Data on the number of patients taking brand-name drugs for which generic equivalents were available, as well as the reasons and variables related to refusal of generic drugs (age, gender, education, primary care centre, general practitioner, type of drug and total number of repeat prescriptions were collected. The percentage of generic drugs among the total number of drugs prescribed was calculated at 2-monthly intervals. Results: A total of 98.9% of the 4620 patients in the intervention group agreed to change to a generic formulation. The percentage of patients accepting generic drugs was significantly associated with the primary care centre, the class of drug, doctors' influence, and patient satisfaction with the drug. Generic prescriptions represented 5.9% in the intervention practices compared with 2.8% in controls. After the intervention, and before the application of reference prices, the percentages were 6.7% and 3.9%, respectively. Immediately after application of the reference prices, the percentages were 8.6% and 6.3%, respectively. Conclusions: Direct patient education is an effective strategy in increasing the prescription of generic equivalents. General practitioners' motivation and knowledge of generic drugs influenced their use. The application of reference prices increased the use of generic equivalents.

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....

Document control system as an integral part of RA documentation database application

International Nuclear Information System (INIS)

Steljic, M.M; Ljubenov, V.Lj. . E-mail address of corresponding author: milijanas@vin.bg.ac.yu; Steljic, M.M.)

2005-01-01

The decision about the final shutdown of the RA research reactor in Vinca Institute has been brought in 2002, and therefore the preparations for its decommissioning have begun. All activities are supervised by the International Atomic Energy Agency (IAEA), which also provides technical and experts' support. This paper describes the document control system is an integral part of the existing RA documentation database. (author)

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

Technology, safety, and costs of decommissioning a reference pressurized water reactor power station. Appendices

International Nuclear Information System (INIS)

Smith, R.I.; Konzek, G.J.; Kennedy, W.E. Jr.

1978-05-01

Detailed appendices are presented under the following headings: reference PWR facility description, reference PWR site description, estimates of residual radioactivity, alternative methods for financing decommissioning, radiation dose methodology, generic decommissioning activities, intermediate dismantlement activities, safe storage and deferred dismantlement activities, compilation of unit cost factors, and safety assessment details

17 CFR 230.411 - Incorporation by reference.

Science.gov (United States)

2010-04-01

... following provisions: (1) Non-financial information may be incorporated by reference to any document; (2) Financial information may be incorporated by reference to any document, provided any financial statement so incorporated meets the requirements of the forms on which the statement is filed. Financial statements or other...

[Analysis of the decision to buy medicine in light of the existence of generic products: a study in the city of Belo Horizonte, Brazil].

Science.gov (United States)

Sousa, Caissa Veloso E; Mesquita, Jose Marcos Carvalho de; Lara, José Edson

2013-11-01

The scope of this study is to identify the factors that influence the consumer's decision when buying medicine. Prior to the Generics Act (Lei dos Genéricos), consumers had at their disposal two product purchase options in the private market, namely buying a reference drug and a similar one. Generic drugs are part of a public policy which was intended to broaden access to medication by the general population at more accessible costs, while maintaining the same quality as the reference drug, as ensured by bioequivalence tests from the national health surveillance agency ANVISA. Nevertheless, a question arises as to whether the potential consumer knows the difference between generic, similar and reference drugs, especially when taking into account the decision at the moment of purchase. In order to fulfill the proposed objective, a survey was conducted with 403 residents in Belo Horizonte, Brazil. The data gathered was tabulated and analyzed using factor analysis and crosstab. The results made it possible to infer that there is a strong predisposition among consumers to accept the suggestions of the pharmacists and/or salesman, and a significant portion of the population is confused at the moment of purchase.

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.

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.

Microgrid cyber security reference architecture.

Energy Technology Data Exchange (ETDEWEB)

Veitch, Cynthia K.; Henry, Jordan M.; Richardson, Bryan T.; Hart, Derek H.

2013-07-01

This document describes a microgrid cyber security reference architecture. First, we present a high-level concept of operations for a microgrid, including operational modes, necessary power actors, and the communication protocols typically employed. We then describe our motivation for designing a secure microgrid; in particular, we provide general network and industrial control system (ICS)-speci c vulnerabilities, a threat model, information assurance compliance concerns, and design criteria for a microgrid control system network. Our design approach addresses these concerns by segmenting the microgrid control system network into enclaves, grouping enclaves into functional domains, and describing actor communication using data exchange attributes. We describe cyber actors that can help mitigate potential vulnerabilities, in addition to performance bene ts and vulnerability mitigation that may be realized using this reference architecture. To illustrate our design approach, we present a notional a microgrid control system network implementation, including types of communica- tion occurring on that network, example data exchange attributes for actors in the network, an example of how the network can be segmented to create enclaves and functional domains, and how cyber actors can be used to enforce network segmentation and provide the neces- sary level of security. Finally, we describe areas of focus for the further development of the reference architecture.

Conceptual and safety-related questions in the final storage of radioactive waste - a comparison of various types of host rock

International Nuclear Information System (INIS)

Kleemann, U.

2005-01-01

The German Federal Office for Radiation Protection (BfS) in early November published the synthesis report (BfS 2005) about the conceptual and safety-related specific questions associated with the final storage of radioactive waste. In addition to a condensed version of twelve individual projects, the report contains a description of the results of the peer review and the workshops carried out, in particular an evaluation comparing different types of host rock in Germany. The whole project constitutes a comprehensive documentation of the current state of the art. Findings are expressed at a general level referring neither to the suitability of any specific repository site nor to that of salts as a repository formation, but covering all potential repository formations in deep geologic strata in Germany. The limits to and possibilities of, generic comparisons of various types of host rock are shown. It si seen that, in principle, none of the host rock varieties in Germany would be preferable to others. Numerous problems can be solved only for specific sites, thus requiring site comparisons. While some questions indicate a need for regulatory treatment, the need for basic research is considered to be low. The contribution presents the main findings made in each of the specific projects and the evaluations by the Office. (orig.)

ETM documentation update – including modelling conventions and manual for software tools

DEFF Research Database (Denmark)

Grohnheit, Poul Erik

This is the final report for the DTU contribution to Socio Economic Research on Fusion (SERF), EFDA Technology Work programme 2013. The structure and contents of this report was presented at the EFDA-TIMES workshop in Garching 12-13 December 2013. This report gives further background and references......, it summarises the work done during 2013, and it also contains presentations for promotion of fusion as a future element in the electricity generation mix and presentations for the modelling community concerning model development and model documentation – in particular for TIAM collaboration workshops....

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.

Semiotics, Information Science, Documents and Computers.

Science.gov (United States)

Warner, Julian

1990-01-01

Discusses the relationship and value of semiotics to the established domains of information science. Highlights include documentation; computer operations; the language of computing; automata theory; linguistics; speech and writing; and the written language as a unifying principle for the document and the computer. (93 references) (LRW)

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.

Canister Storage Building (CSB) Design Basis Accident Analysis Documentation

International Nuclear Information System (INIS)

CROWE, R.D.; PIEPHO, M.G.

2000-01-01

This document provided the detailed accident analysis to support HNF-3553, Spent Nuclear Fuel Project Final Safety Analysis Report, Annex A, ''Canister Storage Building Final Safety Analysis Report''. All assumptions, parameters, and models used to provide the analysis of the design basis accidents are documented to support the conclusions in the Canister Storage Building Final Safety Analysis Report

Canister Storage Building (CSB) Design Basis Accident Analysis Documentation

International Nuclear Information System (INIS)

CROWE, R.D.

1999-01-01

This document provides the detailed accident analysis to support ''HNF-3553, Spent Nuclear Fuel Project Final Safety, Analysis Report, Annex A,'' ''Canister Storage Building Final Safety Analysis Report.'' All assumptions, parameters, and models used to provide the analysis of the design basis accidents are documented to support the conclusions in the Canister Storage Building Final Safety Analysis Report

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...

Waste management system requirements document

International Nuclear Information System (INIS)

1991-02-01

This volume defines the top level requirements for the Mined Geologic Disposal System (MGDS). It is designed to be used in conjunction with Volume 1 of the WMSR, General System Requirements. It provides a functional description expanding the requirements allocated to the MGDS in Volume 1 and elaborates on each requirement by providing associated performance criteria as appropriate. Volumes 1 and 4 of the WMSR provide a minimum set of requirements that must be satisfied by the final MGDS design. This document sets forth specific requirements that must be fulfilled. It is not the intent or purpose of this top level document to describe how each requirement is to be satisfied in the final MGDS design. Each subsequent level of the technical document hierarchy must provide further guidance and definition as to how each of these requirements is to be implemented in the design. It is expected that each subsequent level of requirements will be significantly more detailed. Section 2 of this volume provides a functional description of the MGDS. Each function is addressed in terms of requirements, and performance criteria. Section 3 provides a list of controlling documents. Each document cited in a requirement of Chapter 2 is included in this list and is incorporated into this document as a requirement on the final system. The WMSR addresses only federal requirements (i.e., laws, regulations and DOE orders). State and local requirements are not addressed. However, it will be specifically noted at the potentially affected WMSR requirements that there could be additional or more stringent regulations imposed by a state or local requirements or administering agency over the cited federal requirements

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

A generic standard for assessing and managing activities with significant risk to health and safety

International Nuclear Information System (INIS)

Wilde, T.S.; Sandquist, G.M.

2005-01-01

Some operations and activities in industry, business, and government can present an unacceptable risk to health and safety if not performed according to established safety practices and documented procedures. The nuclear industry has extensive experience and commitment to assessing and controlling such risks. This paper provides a generic standard based upon DOE Standard DOE-STD-3007- 93, Nov 1993, Change Notice No. 1, Sep 1998. This generic standard can be used to assess practices and procedures employed by any industrial and government entity to ensure that an acceptable level of safety and control prevail for such operations. When any activity and operation is determined to involve significant risk to health and safety to workers or the public, the organization should adopt and establish an appropriate standard and methodology to ensure that adequate health and safety prevail. This paper uses DOE experience and standards to address activities with recognized potential for impact upon health and safety. Existing and future assessments of health and safety issues can be compared and evaluated against this generic standard for insuring that proper planning, analysis, review, and approval have been made. (authors)

The EDF Group - Reference Document, annual financial report 2011

International Nuclear Information System (INIS)

2012-04-01

This report gathers information and comments about the French electric utility EDF, persons in charge of this document, account legal auditors, risk factors, activities in France and abroad, the company's organization and flowchart, its estate properties, its financial situation and results, its accounts and capitals, its research and development activities, patents and licenses, trends, financial perspectives, its administration, management and control bodies and their operation, its salaries, shareholders

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...

Initial Northwest Power Act Power Sales Contracts : Final Environmental Impact Statement. Volume 3, Appendix M, Contract Copies.

Energy Technology Data Exchange (ETDEWEB)

United States. Bonneville Power Administration.

1992-01-01

This report, is part of the final environmental impact statement of the Bonneville Power Administration, consists of an appendix of contract copies related to the following: Detailed Index to Generic Utility Power Sales Contracts, Text of Generic Utility Contract, Detailed Index to Generic DSI Power Sales Contracts, Text of Generic DSI Contract, Text of Residential Purchase and Sale Agreement (Residential Exchange), and Detailed Index to General Contract Provisions -- GCP Form PSC-2 (Incorporated into all three types of contracts as an Exhibit).

On bridging relational and document-centric data stores

NARCIS (Netherlands)

Roijackers, J.; Fletcher, G.H.L.; Gottlob, G.; Grasso, G.; Olteanu, D.; Schallhart, C.

2013-01-01

Big Data scenarios often involve massive collections of nested data objects, typically referred to as "documents." The challenges of document management at web scale have stimulated a recent trend towards the development of document-centric "NoSQL" data stores. Many query tasks naturally involve

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.

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. 

Feasibility of using gadolinium as a burnable poison in PWR cores. Final report

International Nuclear Information System (INIS)

Rothleder, B.M.

1981-02-01

As an alternative to the use of lumped burnable absorbers in PWR cores, distributed burnable absorbers are being considered for generic application. These burnable absorbers take the form of Gd 2 O 3 mixed with UO 2 in selected fuel rods (as is currently done in BWR cores). The work discussed herein concerns a three-dimensional feasibility study of the use of such distributed burnable absorbers in PWR cores. This study of distributed burnable absorbers was performed for the first cycle of a typical current design PWR using the following steps: analysis of a generic reference core design; determination of gadolinium assembly designs; determination of a generic gadolinium core design; evaluation of feasibility by examining selected parameters; and redesign of the generic gadolinium core, using axial zoning

ENRAF gauge reference level calculations

Energy Technology Data Exchange (ETDEWEB)

Huber, J.H., Fluor Daniel Hanford

1997-02-06

This document describes the method for calculating reference levels for Enraf Series 854 Level Detectors as installed in the tank farms. The reference level calculation for each installed level gauge is contained herein.

Nuclear power plants documentation system

International Nuclear Information System (INIS)

Schwartz, E.L.

1991-01-01

Since the amount of documents (type and quantity) necessary for the entire design of a NPP is very large, this implies that an overall and detailed identification, filling and retrieval system shall be implemented. This is even more applicable to the FINAL QUALITY DOCUMENTATION of the plant, as stipulated by IAEA Safety Codes and related guides. For such a purpose it was developed a DOCUMENTATION MANUAL, which describes in detail the before mentioned documentation system. Here we present the expected goals and results which we have to reach for Angra 2 and 3 Project. (author)

Assessment of LANL asbestos waste management documentation

International Nuclear Information System (INIS)

Davis, K.D.; Hoevemeyer, S.S.; Stirrup, T.S.; Jennrich, E.A.; Lund, D.M.

1991-04-01

The intent of this effort is to evaluate the Los Alamos National Laboratory (LANL) Waste Acceptance Criteria (WAC) for asbestos to determine if it meets applicable DOE, EPA, and OSHA requirements. There are numerous regulations that provide specific guidelines on the management of asbestos waste. An annotated outline for a generic asbestos WAC was developed using the type of information specified by 5820.2A. The outline itself is included in Appendix A. The major elements that should be addressed by the WAC were determined to be as follows: Waste Forms; Waste Content/Concentration; Waste Packaging; and Waste Documentation/Certification

Report on AECB consultative document C-70: The use of fault trees in licensing submissions

International Nuclear Information System (INIS)

1984-01-01

The Atomic Energy Control Board (AECB) has issued Consultative Document C-70, 'The Use of Fault Trees in Licensing Submissions', for public comment. The Advisory Committee on Nuclear Safety (ACNS) has examined this document and ACNS members have met with AECB staff and representatives of the nuclear industry to discuss it. The ACNS presents its comments and recommendations in this report. The consultative document defines a fault tree as a hierarchically-structured graphical representation of system failures and their potential causes. The document then states certain basic characteristics or attributes which fault trees should possess, and certain conditions affecting the use of fault trees. It defines fault tree fundamentals, sets criteria for the application of fault trees to systems and defines ground rules for a fault tree format. Finally, in two appendices, it includes specific rules for fault tree symbols and fault tree description files for computer use. The appendices are referred to in the text as 'acceptable' standards or methods

Documents on Disarmament.

Science.gov (United States)

Arms Control and Disarmament Agency, Washington, DC.

This publication, latest in a series of volumes issued annually since 1960, contains primary source documents on arms control and disarmament developments during 1969. The main chronological arrangement is supplemented by both chronological and topical lists of contents. Other reference aids include a subject/author index, and lists of…

76 FR 24507 - HUD Multifamily Rental Project Closing Documents: Notice Announcing Final Approved Documents and...

Science.gov (United States)

2011-05-02

... transactions, although these are familiar roles in commercial lending transactions. Accordingly, HUD has... advantage of this language is that it identifies the specific, longstanding, and familiar types of... the documents, HUD is limiting its role and giving lenders more ability to address any problems that...

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.

UFOs, NGOs, or IGOs: Using International Documents for General Reference.

Science.gov (United States)

Shreve, Catherine

1997-01-01

Discusses accessing and using documents from international (intergovernmental) organizations. Profiles the United Nations, the European Union and other Intergovernmental Organizations (IGOs). Discusses the librarian as "Web detective," notes questions to focus on, and presents examples to demonstrate navigation of IGO sites. Lists basic…

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...

Pilot-scale production of grout with simulated double-shell slurry feed. Final report

Energy Technology Data Exchange (ETDEWEB)

Whyatt, G.A.

1994-08-01

This report describes the pilot-scale production of grout with simulated double-shell slurry feed (DSSF) waste performed in November 1988, and the subsequent thermal behavior of the grout as it cured in a large, insulated vessel. The report was issued in draft form in April 1989 and comments were subsequently received; however, the report was not finalized until 1994. In finalizing this report, references or information gained after the report was drafted in April 1989 have not been incorporated to preserve the report`s historical perspective. This report makes use of criteria from Ridelle (1987) to establish formulation criteria. This document has since been superseded by a document prepared by Reibling and Fadeef (1991). However, the reference to Riddelle (1987) and any analysis based on its content have been maintained within this report. In addition, grout is no longer being considered as the waste form for disposal of Hanford`s low-level waste. However, grout disposal is being maintained as an option in case there is an emergency need to provide additional tank space. Current plans are to vitrify low-level wastes into a glass matrix.

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.’

The use of generic drugs in prevention of chronic disease is far more cost-effective than thought, and may save money.

Science.gov (United States)

Shrank, William H; Choudhry, Niteesh K; Liberman, Joshua N; Brennan, Troyen A

2011-07-01

In this article we highlight the important role that medication therapy can play in preventing disease and controlling costs. Focusing on coronary artery disease, we demonstrate that prevention, with the appropriate use of generic medications, appears far more cost-effective than previously documented, and it may even save on costs. For example, an earlier study estimated that reducing blood pressure to widely established clinical guidelines in nondiabetic patients cost an estimated $52,983 per quality-adjusted life-year if a brand-name drug was used. However, we estimate that the cost is just $7,753 per quality-adjusted life-year at generic medication prices. As the nation attempts to find strategies to improve population health without adding to the unsustainably high cost of care, policy makers should focus on ensuring that patients have access to essential generic medications.

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...

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.

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...

Scaling Limits and Generic Bounds for Exploration Processes

Science.gov (United States)

Bermolen, Paola; Jonckheere, Matthieu; Sanders, Jaron

2017-12-01

We consider exploration algorithms of the random sequential adsorption type both for homogeneous random graphs and random geometric graphs based on spatial Poisson processes. At each step, a vertex of the graph becomes active and its neighboring nodes become blocked. Given an initial number of vertices N growing to infinity, we study statistical properties of the proportion of explored (active or blocked) nodes in time using scaling limits. We obtain exact limits for homogeneous graphs and prove an explicit central limit theorem for the final proportion of active nodes, known as the jamming constant, through a diffusion approximation for the exploration process which can be described as a unidimensional process. We then focus on bounding the trajectories of such exploration processes on random geometric graphs, i.e., random sequential adsorption. As opposed to exploration processes on homogeneous random graphs, these do not allow for such a dimensional reduction. Instead we derive a fundamental relationship between the number of explored nodes and the discovered volume in the spatial process, and we obtain generic bounds for the fluid limit and jamming constant: bounds that are independent of the dimension of space and the detailed shape of the volume associated to the discovered node. Lastly, using coupling techinques, we give trajectorial interpretations of the generic bounds.

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

Canister Storage Building (CSB) Design Basis Accident Analysis Documentation

Energy Technology Data Exchange (ETDEWEB)

CROWE, R.D.

1999-09-09

This document provides the detailed accident analysis to support ''HNF-3553, Spent Nuclear Fuel Project Final Safety, Analysis Report, Annex A,'' ''Canister Storage Building Final Safety Analysis Report.'' All assumptions, parameters, and models used to provide the analysis of the design basis accidents are documented to support the conclusions in the Canister Storage Building Final Safety Analysis Report.

Impact of Spacing of Practice on Learning Brand Name and Generic Drugs.

Science.gov (United States)

Terenyi, James; Anksorus, Heidi; Persky, Adam M

2018-02-01

Objective. To test the impact of schedules of retrieval practice on learning brand and generic name drug information in a self-paced course. Methods. Students completed weekly quizzes on brand and generic name conversions for 100 commonly prescribed drugs. Each student completed part of the drug list on a schedule of equal, expanding, or contracting spacing, one practice (massed) or study only in a partial block design. Results. On measures of long-term retention, the contracting spacing schedule led to superior retention (67%) compared to the massed practice (50%) and study-only condition (46%); contracting practice also was significantly higher than expanding practice (58%,) or equal practice (59%). Overall performance decreased by almost 50% (final exam 95%, long-term retention 55%) over a 6-week period. Conclusion. A contracting spacing schedule was the most effective schedule of practice, and all spacing schedules were superior to massed practice or study-only conditions.

Generic waste management concepts for six LWR fuel cycles

International Nuclear Information System (INIS)

DePue, J.D.

1979-04-01

This report supplements the treatment of waste management issues provided in the Generic Environmental Statement on the use of recycle plutonium in mixed oxide fuel in light water cooled reactors (GESMO, NUREG-0002). Three recycle and three no-recycle options are described in this document. Management of the radioactive wastes that would result from implementation of either type of fuel cycle alternative is discussed. For five of the six options, wastes would be placed in deep geologic salt repositories for which thermal criteria are considered. Radiation doses to the workers at the repositories and to the general population are discussed. The report also covers the waste management schedule, the land and salt commitments, and the economic costs for the management of wastes generated

Tritium research laboratory cleanup and transition project final report

International Nuclear Information System (INIS)

Johnson, A.J.

1997-02-01

This Tritium Research Laboratory Cleanup and Transition Project Final Report provides a high-level summary of this project's multidimensional accomplishments. Throughout this report references are provided for in-depth information concerning the various topical areas. Project related records also offer solutions to many of the technical and or administrative challenges that such a cleanup effort requires. These documents and the experience obtained during this effort are valuable resources to the DOE, which has more than 1200 other process contaminated facilities awaiting cleanup and reapplication or demolition

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.

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

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

Science.gov (United States)

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

2018-03-01

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

Estimation of Engine Intake Air Mass Flow using a generic Speed-Density method

Directory of Open Access Journals (Sweden)

Vojtíšek Michal

2014-10-01

Full Text Available Measurement of real driving emissions (RDE from internal combustion engines under real-world operation using portable, onboard monitoring systems (PEMS is becoming an increasingly important tool aiding the assessment of the effects of new fuels and technologies on environment and human health. The knowledge of exhaust flow is one of the prerequisites for successful RDE measurement with PEMS. One of the simplest approaches for estimating the exhaust flow from virtually any engine is its computation from the intake air flow, which is calculated from measured engine rpm and intake manifold charge pressure and temperature using a generic speed-density algorithm, applicable to most contemporary four-cycle engines. In this work, a generic speed-density algorithm was compared against several reference methods on representative European production engines - a gasoline port-injected automobile engine, two turbocharged diesel automobile engines, and a heavy-duty turbocharged diesel engine. The overall results suggest that the uncertainty of the generic speed-density method is on the order of 10% throughout most of the engine operating range, but increasing to tens of percent where high-volume exhaust gas recirculation is used. For non-EGR engines, such uncertainty is acceptable for many simpler and screening measurements, and may be, where desired, reduced by engine-specific calibration.

Development of a technical concept for a generic final repository for heat-generating wastes and spent fuel elements in crystalline rock formations in Germany. Final report; Entwicklung eines technischen Konzeptes fuer ein generisches Endlager fuer waermeentwickelnde Abfaelle und ausgediente Brennelemente im Kristallingestein in Deutschland. Abschlussbericht

Energy Technology Data Exchange (ETDEWEB)

Bertrams, Niklas; Herold, Philipp; Herold, Maxi; Krone, Juergen; Lommerzheim, Andree; Prignitz, Sabine; Kuate, Eric Simo

2017-09-15

The research project concerning the development of a generic concept for final repositories in crystalline rock formations has identified three different concepts for long-term safe enclosure efficacy: (i) the KBS-3 concept as pursued in Sweden and Finland based on corrosion resistant copper containers and bentonite buffers in vertical bore holes; (ii) The concept of ''multiple enclosure efficient rock zones'', based on several spatially separated rock zones that allow the demonstration of efficient enclosure; (iii) the concept of a ''superposed enclosure efficient rock zone'', where a sedimentary coverage of the crystalline host rock (for instance clay or salt) shows enclosure efficacy. For each of these concepts a separate final repository concept was developed covering the construction of shafts, ramps and transport routes, the preparation of boreholes, and the backfilling and closure technology, the planning of mine buildings, ventilation, time and cost estimation.

Cultural diversity: blind spot in medical curriculum documents, a document analysis.

Science.gov (United States)

Paternotte, Emma; Fokkema, Joanne P I; van Loon, Karsten A; van Dulmen, Sandra; Scheele, Fedde

2014-08-22

Cultural diversity among patients presents specific challenges to physicians. Therefore, cultural diversity training is needed in medical education. In cases where strategic curriculum documents form the basis of medical training it is expected that the topic of cultural diversity is included in these documents, especially if these have been recently updated. The aim of this study was to assess the current formal status of cultural diversity training in the Netherlands, which is a multi-ethnic country with recently updated medical curriculum documents. In February and March 2013, a document analysis was performed of strategic curriculum documents for undergraduate and postgraduate medical education in the Netherlands. All text phrases that referred to cultural diversity were extracted from these documents. Subsequently, these phrases were sorted into objectives, training methods or evaluation tools to assess how they contributed to adequate curriculum design. Of a total of 52 documents, 33 documents contained phrases with information about cultural diversity training. Cultural diversity aspects were more prominently described in the curriculum documents for undergraduate education than in those for postgraduate education. The most specific information about cultural diversity was found in the blueprint for undergraduate medical education. In the postgraduate curriculum documents, attention to cultural diversity differed among specialties and was mainly superficial. Cultural diversity is an underrepresented topic in the Dutch documents that form the basis for actual medical training, although the documents have been updated recently. Attention to the topic is thus unwarranted. This situation does not fit the demand of a multi-ethnic society for doctors with cultural diversity competences. Multi-ethnic countries should be critical on the content of the bases for their medical educational curricula.

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...

Reference Mission Version 3.0 Addendum to the Human Exploration of Mars: The Reference Mission of the NASA Mars Exploration Study Team. Addendum; 3.0

Science.gov (United States)

Drake, Bret G. (Editor)

1998-01-01

This Addendum to the Mars Reference Mission was developed as a companion document to the NASA Special Publication 6107, "Human Exploration of Mars: The Reference Mission of the NASA Mars Exploration Study Team." It summarizes changes and updates to the Mars Reference Missions that were developed by the Exploration Office since the final draft of SP 6107 was printed in early 1999. The Reference Mission is a tool used by the exploration community to compare and evaluate approaches to mission and system concepts that could be used for human missions to Mars. It is intended to identify and clarify system drivers, significant sources of cost, performance, risk, and schedule variation. Several alternative scenarios, employing different technical approaches to solving mission and technology challenges, are discussed in this Addendum. Comparing alternative approaches provides the basis for continual improvement to technology investment plan and a general understanding of future human missions to Mars. The Addendum represents a snapshot of work in progress in support of planning for future human exploration missions through May 1998.

Title List of documents made publicly available

International Nuclear Information System (INIS)

1982-05-01

This document contains descriptions of the information received and generated by the US NRC. This information includes: (1) docketed material associated with civilian nuclear power plants and other uses of radioactive materials and (2) nondocketed material received and generated by NRC pertinent to its role as a regulatory agency. As used here, docketed does not refer to court dockets; it refers to the system by which NRC maintains its regulatory records. This series of documents is indexed by a Personal Author Index, a Corporate Source Index, and a Report Number Index

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.

Generic dynamic wind turbine models for power system stability analysis: A comprehensive review

DEFF Research Database (Denmark)

Honrubia-Escribano, A.; Gómez-Lázaro, E.; Fortmann, J.

2018-01-01

In recent years, international working groups, mainly from the International Electrotechnical Commission (IEC) and the Western Electricity Coordinating Council (WECC), have made a major effort to develop generic —also known as simplified or standard— dynamic wind turbine models to be used for power...... system stability analysis. These models are required by power system operators to conduct the planning and operation activities of their networks since the use of detailed manufacturer models is not practical. This paper presents a comprehensive review of the work done in this field, based on the results...... obtained by IEC and WECC working groups in the course of their research, which have motivated the publication of the IEC 61400-27 in February 2015. The final published versions of the generic models developed according to the existing four wind turbine technology types are detailed, highlighting...

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

47 CFR 1.14 - Citation of Commission documents.

Science.gov (United States)

2010-10-01

... 47 Telecommunication 1 2010-10-01 2010-10-01 false Citation of Commission documents. 1.14 Section... Rules of Practice and Procedure General § 1.14 Citation of Commission documents. The appropriate reference to the FCC Record shall be included as part of the citation to any document that has been printed...

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....

Strategic mistakes (AVOIDABLE The topicality of Michel Porter’s generic strategies

Directory of Open Access Journals (Sweden)

Leandro Adolfo Viltard

2017-06-01

Full Text Available This article explores the topicality of Porter’s generic strategies, assessing about their applicability on two specific automotive industry projects: The Smart and the New Beetle.   After performing a documentation analysis on these two projects, it was concluded that both of them may be considered avoidable strategic mistakes as they show the risks of higher differentiation that is not being paid by the customer, no matter how if it is about recognized brands or icon products. Hazards and risks, like big losses and negative margins, are applicable to every firm.   This is a qualitative investigation with a not experimental and transversal research design.

Lawrence Livermore National Laboratory Working Reference Material Production Pla

Energy Technology Data Exchange (ETDEWEB)

Wong, Amy; Thronas, Denise; Marshall, Robert

1998-11-04

This Lawrence Livermore National Laboratory (LLNL) Working Reference Material Production Plan was written for LLNL by the Los Alamos National Laboratory to address key elements of producing seven Pu-diatomaceous earth NDA Working Reference Materials (WRMS). These WRMS contain low burnup Pu ranging in mass from 0.1 grams to 68 grams. The composite Pu mass of the seven WRMS was designed to approximate the maximum TRU allowable loading of 200 grams Pu. This document serves two purposes: first, it defines all the operations required to meet the LLNL Statement of Work quality objectives, and second, it provides a record of the production and certification of the WRMS. Guidance provided in ASTM Standard Guide C1128-89 was used to ensure that this Plan addressed all the required elements for producing and certifying Working Reference Materials. The Production Plan was written to provide a general description of the processes, steps, files, quality control, and certification measures that were taken to produce the WRMS. The Plan identifies the files where detailed procedures, data, quality control, and certification documentation and forms are retained. The Production Plan is organized into three parts: a) an initial section describing the preparation and characterization of the Pu02 and diatomaceous earth materials, b) middle sections describing the loading, encapsulation, and measurement on the encapsulated WRMS, and c) final sections describing the calculations of the Pu, Am, and alpha activity for the WRMS and the uncertainties associated with these quantities.

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.

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....

From a Content Delivery Portal to a Knowledge Management System for Standardized Cancer Documentation.

Science.gov (United States)

Schlue, Danijela; Mate, Sebastian; Haier, Jörg; Kadioglu, Dennis; Prokosch, Hans-Ulrich; Breil, Bernhard

2017-01-01

Heterogeneous tumor documentation and its challenges of interpretation of medical terms lead to problems in analyses of data from clinical and epidemiological cancer registries. The objective of this project was to design, implement and improve a national content delivery portal for oncological terms. Data elements of existing handbooks and documentation sources were analyzed, combined and summarized by medical experts of different comprehensive cancer centers. Informatics experts created a generic data model based on an existing metadata repository. In order to establish a national knowledge management system for standardized cancer documentation, a prototypical tumor wiki was designed and implemented. Requirements engineering techniques were applied to optimize this platform. It is targeted to user groups such as documentation officers, physicians and patients. The linkage to other information sources like PubMed and MeSH was realized.

Synthesis document on the long life behavior of packages: phenomenological reference document ''concrete packages'' 2004

International Nuclear Information System (INIS)

Richet, C.; Le Bescop, P.; Galle, Ch.; Peycelon, H.; Bejaoui, S.; Pointeau, I.; L'Hostis, V.; Bary, B.

2004-12-01

In the framework of the law of 1991 on the radioactive wastes management, the CEA realized studies on the long time behavior of packages based on concrete for storage and disposal. This document takes stock on the 2003 and 2004 studies. It presents the cement materials specificities, their durability, the transport and the retention in the hydraulic binders, the couplings between degradation and hydraulic properties evolution of solutes and mechanic. The studies are applied to the the evaluation of ''CLT '' concrete packages. (A.L.B.)

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.

Mark III LOCA-related hydrodynamic load definition. Generic technical activity B-10. Final report

International Nuclear Information System (INIS)

Fields, M.B.; Kudrick, J.A.

1984-08-01

This report, prepared by the staff of the Office of Nuclear Reactor Regulation and its consultants at the Brookhaven National Laboratory, provides a discussion of LOCA-related suppression pool hydrodynamic loads in boiling water reactor (BWR) facilities with the Mark III pressure-suppression containment design. Its issuance completes NRC Generic Technical Activity B-10, Behavior of BWR Mark III Containment. On the basis of certain large-scale tests conducted between 1973 and 1979, the General Electric Company developed LOCA-related hydrodynamic load definitions for use in the design of the standard Mark III containment. The staff and its consultants have reviewed these load definitions and their bases and conclude that, with a few specified changes, the proposed load definitions provide conservative loading conditions. The staff approved acceptance criteria for LOCA-related hydrodynamic loads are provided in an appendix

7 CFR 1737.92 - Loan documents.

Science.gov (United States)

2010-01-01

... 7 Agriculture 11 2010-01-01 2010-01-01 false Loan documents. 1737.92 Section 1737.92 Agriculture... PRE-LOAN POLICIES AND PROCEDURES COMMON TO INSURED AND GUARANTEED TELECOMMUNICATIONS LOANS Final Loan Approval Procedures § 1737.92 Loan documents. Following approval of the loan, RUS shall forward the...

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...

Use of generic medicines by the Brazilian population: an evaluation of PNAUM 2014

Directory of Open Access Journals (Sweden)

Andréa Dâmaso Bertoldi

Full Text Available ABSTRACT OBJECTIVE To analyze the existence of differences in the use of generic medicines in Brazil according to demographic and socioeconomic variables and acquisition sources of the medicines. METHODS Population-based cross-sectional study, conducted with data from the Pesquisa Nacional de Acesso, Utilização e Promoção do Uso Racional de Medicamentos (PNAUM – National Survey on Access, Use and Promotion of Rational Use of Medicines. Data collection took place between September, 2013 and February, 2014 in homes of Brazilian cities (urban area. The use of medicines has been investigated in relation to the treatment of chronic diseases and, in the case of acute events, regarding use over the previous 15 days. Generics were identified by visualization of packaging presented by the users of the medicines. The independent variables used were sex, age, education level, economic class, and region of the Country. The statistical significance of differences between the groups was evaluated by Pearson’s Chi-squared test, considering a 5% significance level. RESULTS The prevalence of generic medicines use was 45.5% (95%CI 43.7–47.3. There was no difference considering education level. The prevalence was higher in females (47.0%; 95%CI 44.9–49.0 than in males (43.1%; 95%CI 40.5–45.8, and were higher with increasing age. Generic medicines were more used in the economic class C (47.0%; 95%CI 44.9–49.1 and in the South (50.6%; 95%CI 46.6–54.6 and Southeast (49.9%; 95%CI 46.8–53.0 regions. Generics accounted for 37.3% of the medicines provided by the Brazilian Unified Health System. CONCLUSIONS Currently, there is a choice of purchase or free provision by the Brazilian Unified Health System, characterized by quality assurance and reduced price regarding branded medicines considered as reference. In the private market, a considerable part of the population is choosing generic medicines thanks to the availability of this option for virtually

A New Technique For Information Processing of CLIC Technical Documentation

CERN Document Server

Tzermpinos, Konstantinos

2013-01-01

The scientific work presented in this paper could be described as a novel, systemic approach to the process of organization of CLIC documentation. The latter refers to the processing of various sets of archived data found on various CERN archiving services in a more friendly and organized way. From physics aspect, this is equal to having an initial system characterized by high entropy, which after some transformation of energy and matter will produce a final system of reduced entropy. However, this reduction in entropy can be considered valid for open systems only, which are sub-systems of grander isolated systems, to which the total entropy will always increase. Thus, using as basis elements from information theory, systems theory and thermodynamics, the unorganized form of data pending to be organized to a higher form, is modeled as an initial open sub-system with increased entropy, which, after the processing of information, will produce a final system with decreased entropy. This systemic approach to the ...

Document development, management and transmission

International Nuclear Information System (INIS)

Meister, K.

1998-01-01

Environmental monitoring can only be carried out by means of cartographic outputs allowing the representation of information in a compressed way and with a local reference. On account of this requirement and the continuously growing importance of international data exchange the development of a universal tool for the combination of data to so-called documents has been started for the management and for the exchange of these documents with other systems. (R.P.)

Spent Nuclear Fuel (SNF) Cold Vacuum Drying (CVD) Facility Operations Manual; FINAL

International Nuclear Information System (INIS)

IRWIN, J.J.

1999-01-01

This document provides the Operations Manual for the Cold Vacuum Drying Facility (CVDF). The Manual was developed in conjunction with HNF-553, Spent Nuclear Fuel Project Final Safety Analysis Report Annex B-Cold Vacuum Drying Facility. The HNF-SD-SNF-DRD-002, 1999, Cold Vacuum Drying Facility Design Requirements, Rev. 4, and the CVDF Final Design Report. The Operations Manual contains general descriptions of all the process, safety and facility systems in the CVDF, a general CVD operations sequence and references to the CVDF System Design Descriptions (SDDs). This manual has been developed for the SNFP Operations Organization and shall be updated, expanded, and revised in accordance with future design, construction and startup phases of the CVDF until the CVDF final ORR is approved

Final Report

Energy Technology Data Exchange (ETDEWEB)

Gurney, Kevin R. [Arizona Univ., Mesa, AZ (United States)

2015-01-12

This document constitutes the final report under DOE grant DE-FG-08ER64649. The organization of this document is as follows: first, I will review the original scope of the proposed research. Second, I will present the current draft of a paper nearing submission to Nature Climate Change on the initial results of this funded effort. Finally, I will present the last phase of the research under this grant which has supported a Ph.D. student. To that end, I will present the graduate student’s proposed research, a portion of which is completed and reflected in the paper nearing submission. This final work phase will be completed in the next 12 months. This final workphase will likely result in 1-2 additional publications and we consider the results (as exemplified by the current paper) high quality. The continuing results will acknowledge the funding provided by DOE grant DE-FG-08ER64649.

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

Final remarks

International Nuclear Information System (INIS)

1998-01-01

This document presents the fulfilling of the Brazilian obligations under the Convention on Nuclear Safety. The Chapter 7 of the document refers to the achievement and maintenance of a high level in the Brazilian nuclear installations, the establishment and maintenance of effective defenses against potential radiological hazards, the ability to prevent accidents with radiological consequences and preparedness for mitigating the consequences of such accidents should they occur

Cold Vacuum Drying Facility Design Basis Accident Analysis Documentation

International Nuclear Information System (INIS)

PIEPHO, M.G.

1999-01-01

This document provides the detailed accident analysis to support HNF-3553, Annex B, Spent Nuclear Fuel Project Final Safety Analysis Report, ''Cold Vacuum Drying Facility Final Safety Analysis Report (FSAR).'' All assumptions, parameters and models used to provide the analysis of the design basis accidents are documented to support the conclusions in the FSAR

Superconducting Super Collider: Final environmental impact statement: Volume 2, Comment/response document: Summary and index

International Nuclear Information System (INIS)

1988-12-01

This volume is divided into five parts as follows: Summary and Index; Letters submitted by commenters in response to the Draft Environmental Impact Statement (DEIS) from date of issue through October 17, 1988; Transcripts of testimony at the public hearings conducted by the DOE in the vicinity of each site alternative; Letters postmarked after October 17, 1988; and Comment responses to both the letters and the testimony. This summary and index is published as a guide to the reader in reviewing this document. The summary is of the approximately 7000 comments received by the DOE from a total of about 5700 commenters. It was prepared as a general reference and guide to the readers of this volume. The Index follows the summary. The first index is an alphabetical listing of commenters (of both letters and transcripts) and indicates the number each commenter was assigned. The commenter numbers guide the reader to DOE comment responses in Volume 2B which are in numerical order

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.

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...

Region-scale groundwater flow modelling of generic high level waste disposal sites

International Nuclear Information System (INIS)

Metcalfe, D.

1996-02-01

Regional-scale groundwater flow modelling analyses are performed on generic high level waste (HLW) disposal sites to assess the extent to which a large crystalline rock mass such as a pluton or batholith can be expected to contain and isolate HLW in terms of hydraulic considerations, for a variety of geologic and hydrogeologic conditions. The two-dimensional cross-sectional conceptual models of generic HLW disposal sites are evaluated using SWIFT III, which is a finite-difference flow and transport code. All steps leading to the final results and conclusions are incorporated in this report. The available data and information on geological and hydrogeologic conditions in plutons and batholiths are summarized. The generic conceptual models developed from this information are defined in terms of the finite difference grid, the geologic and hydrogeologic properties and the hydrologic boundary conditions used. The modelled results are described with contour maps showing the modelled head fields, groundwater flow paths and travel times and groundwater flux rates within the modelled systems. The results of the modelling analyses are used to develop general conclusions on the scales and patterns of groundwater flow in granitic plutons and batholiths. The conclusions focus on geologic and hydrogeologic characteristics that can result in favourable conditions, in terms of hydraulic considerations, for a HLW repository. (author) 43 refs., 9 tabs., 40 figs

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.

Comments from the Developmental Neurotoxicology Committee of the Japanese Teratology Society on the OECD Guideline for the Testing of Chemicals, Proposal for a New Guideline 426, Developmental Neurotoxicity Study, Draft Document (October 2006 version), and on the Draft Document of the Retrospective Performance Assessment of the Draft Test Guideline 426 on Developmental Neurotoxicity.

Science.gov (United States)

Ema, Makoto; Fukui, Yoshihiro; Aoyama, Hiroaki; Fujiwara, Michio; Fuji, Junichiro; Inouye, Minoru; Iwase, Takayuki; Kihara, Takahide; Oi, Akihide; Otani, Hiroki; Shinomiya, Mitsuhiro; Sugioka, Kozo; Yamano, Tsunekazu; Yamashita, Keisuke H; Tanimura, Takashi

2007-06-01

In October 2006, a new revision of the draft guideline (OECD Guideline for the Testing of Chemicals, Proposal for a New Guideline 426. Developmental Neurotoxicity Study) and Draft Document of the Retrospective Performance Assessment (RPA) of the Draft Test Guideline 426 on Developmental Neurotoxicity were distributed following incorporation of the results of the Expert Consultation Meeting in Tokyo on May 24-26, 2005. The draft guideline consists of 50 paragraphs and an appendix with 102 references; and the draft RPA consists of 37 paragraphs with 109 references. National coordinators were requested to arrange for national expert reviews of these draft documents in their member countries. Members of the Developmental Neurotoxicology (DNT) Committee of the Japanese Teratology Society (JTS) reviewed, discussed, and commented on the draft Test Guideline Proposal. The DNT Committee of the JTS also commented on the draft document of the RPA. These comments were sent to the OECD Secretariat. The DNT Committee of the JTS expects the comments to be useful for the finalization of these draft documents.

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.

Technical approach document

International Nuclear Information System (INIS)

1988-04-01

This document describes the general technical approaches and design criteria adopted by the US Department of Energy (DOE) in order to implement Remedial Action Plans (RAPs) and final designs that comply with EPS standards. This document is a revision to the original document. Major revisions were made to the sections in riprap selection and sizing, and ground-water; only minor revisions were made to the remainder of the document. The US Nuclear Regulatory Commission (NRC) has prepared a Standard Review Plan (NRC-SRP) which describes factors to be considered by the NRC in approving the RAP. Sections 3.0, 4.0, 5.0, and 7.0 of this document are arranged under the same headings as those used in the NRC-SRP. This approach is adopted in order to facilitate joint use of the documents. Section 2.0 (not included in the NRC-SRP) discusses design considerations; Section 3.0 describes surface-water hydrology and erosion control; Section 4.0 describes geotechnical aspects of pile design; Section 5.0 discusses the Alternate Site Selection Process; Section 6.0 deals with radiological issues (in particular, the design of the radon barrier); Section 7.0 discusses protection of groundwater resources; and Section 8.0 discusses site design criteria for the RAC

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.

KNOWLEDGE AND VALORIZATION OF HISTORICAL SITES THROUGH 3D DOCUMENTATION AND MODELING

Directory of Open Access Journals (Sweden)

E. Farella

2016-06-01

Full Text Available The paper presents the first results of an interdisciplinary project related to the 3D documentation, dissemination, valorization and digital access of archeological sites. Beside the mere 3D documentation aim, the project has two goals: (i to easily explore and share via web references and results of the interdisciplinary work, including the interpretative process and the final reconstruction of the remains; (ii to promote and valorize archaeological areas using reality-based 3D data and Virtual Reality devices. This method has been verified on the ruins of the archeological site of Pausilypon, a maritime villa of Roman period (Naples, Italy. Using Unity3D, the virtual tour of the heritage site was integrated and enriched with the surveyed 3D data, text documents, CAAD reconstruction hypotheses, drawings, photos, etc. In this way, starting from the actual appearance of the ruins (panoramic images, passing through the 3D digital surveying models and several other historical information, the user is able to access virtual contents and reconstructed scenarios, all in a single virtual, interactive and immersive environment. These contents and scenarios allow to derive documentation and geometrical information, understand the site, perform analyses, see interpretative processes, communicate historical information and valorize the heritage location.

Indoor air: Reference bibliography

International Nuclear Information System (INIS)

Campbell, D.; Staves, D.; McDonald, S.

1989-07-01

The U. S. Environmental Protection Agency initially established the indoor air Reference Bibliography in 1987 as an appendix to the Indoor Air Quality Implementation Plan. The document was submitted to Congress as required under Title IV--Radon Gas and Indoor Air Quality Research of the Superfund Amendments and Reauthorization Act of 1986. The Reference Bibliography is an extensive bibliography of reference materials on indoor air pollution. The Bibliography contains over 4500 citations and continues to increase as new articles appear

7 CFR 1753.49 - Closeout documents.

Science.gov (United States)

2010-01-01

... Construction Change Orders 1 1 224 Waiver and Release of Lien (from each supplier) 1 1 231 Certificate of... by inspection company or supplier) 1 None Final Key Map (when applicable) 1 1 None Final Central... the engineer that the project and all required documentation are satisfactory and complete...

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

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.

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.

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

Student Problems with Documentation.

Science.gov (United States)

Freimer, Gloria R.; Perry, Margaret M.

1986-01-01

Interviews with faculty, a survey of 20 students, and examination of style manuals revealed that students are confused by inconsistencies in and multiplicity of styles when confronted with writing and documenting a research paper. Librarians are urged to teach various citation formats and work for adoption of standardization. (17 references) (EJS)

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...

Title list of documents made publicly available

International Nuclear Information System (INIS)

1994-06-01

The Title List of Documents Made Publicly Available is a monthly publication. It contains descriptions of the information received and generated by the US Nuclear Regulatory Commission (NRC). This information includes (1) docketed material associated with civilian nuclear power plants and other uses of radioactive materials and (2) nondocketed material received and generated by NRC pertinent to its role as a regulatory agency. As used here, docketed does not refer to Court dockets; it refers to the system by which NRC maintains its regulatory records. This series of documents is indexed by a Personal Author Index, a Corporate Source Index, and a Report Number Index

Title list of documents made publicly available

International Nuclear Information System (INIS)

1982-03-01

The Title List of Documents Made Publicly Available is a monthly publication. It contains descriptions of the information received and generated by the US Nuclear Regulatory Commission (NRC). This information includes (1) docketed material associated with civilian nuclear power plants and other uses of radioactive materials and (2) nondocketed material received and generated by NRC pertinent to its role as a regulatory agency. As used here, docketed does not refer to Court dockets; it refers to the system by which NRC maintains its regulatory records. This series of documents is indexed by a Personal Author Index, a Corporate Source Index, and a Report Number Index

There is an agreement between constipation referred and that documented by objective criteria?

Directory of Open Access Journals (Sweden)

Isaac José Felippe Corrêa Neto

2016-07-01

Full Text Available Introduction: Chronic constipation is the most common digestive complaint at the doctor's office, with high prevalence in the population. However, many patients – and even those physicians not so familiar with pelvic floor disorders–define and consider constipation based on intestinal functionality and stool consistency. But symptoms of incomplete defecation, digital maneuvers, abdominal discomfort, and straining should not be overlooked. Objectives: To investigate the correlation between constipation referred and documented through objective criteria in patients admitted on a daytime-nursing ward basis at the Hospital Santa Marcelina, São Paulo. Methodology: This is a prospective study of a random sample of patients admitted on a daytime-ward hospitalization basis at Santa Marcelina Hospital to perform minor surgical procedures not related to functional disorders of the gastrointestinal tract in the period from September 2014 to June 2015; the only exclusion criterion was “not agreed to participate in the interview conducted by students of medicine at Santa Marcelina Medical School”. Results: 102 patients were randomly analyzed in the period considered (51% female with a mean overall age of 48.6 (19–82 years. Constipation has been reported spontaneously by 17.6% of participants and denied by 82.4%. With the implementation of the Cleveland Clinic's criteria for the diagnosis of constipation, the compliance with the referred symptomatology was 88.9%; the same value was found with the use of the Rome III criteria (Kappa = 0.665. In addition, a higher incidence of constipation was observed in female patients (p = 0.002. Conclusion: A higher incidence of constipation was observed in female participants, with no statistical difference with respect to age. Furthermore, a substantial agreement was found between constipation referred and constipation documented through objective criteria. Resumo: Introdução: A constipação intestinal

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.

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...

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...

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.

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

The IAEA Biomass programme: reference biospheres for long-term safety assessment of high level waste disposal facilities

International Nuclear Information System (INIS)

Metcalf, Phil; Crossland, Ian; Torres, Carlos; Crossland, Ian J.

2002-01-01

Phil Metcalf and Ian Crossland presented the IAEA Biomass project. Phil Metcalf explained that the Biomass project, begun in 1996, by an international forum organised by the IAEA was a very good exercise for exchanging information through technical meetings and documentation such as Biomass newsletters or CD Rom. Ian Crossland continued by giving a presentation of the Biomass theme 1 that concerns the radioactive waste disposal topic. Its objective was mainly to develop the reference biosphere methodology and to demonstrate its usefulness through some exercises related to the development of a practical set of example biospheres such as: 1. drinking water well, 2. agricultural irrigation, with a well source and 3. Set of natural groundwater discharges to natural, semi-natural systems. Input data would always change to accommodate a given repository simulation and location. Thus this project must be seen as a good exercise for the application of a methodology and should be considered as a good source of reference biospheres that might be viewed as a benchmark for comparison with site-specific safety assessments for a selected number of radionuclides. The main conclusion from the Biomass theme 1 project was that there appears to be an international consensus on preparing generic reference biospheres for postclosure safety assessment but waste management organisations should also consider the specific requirements of regulators and other stakeholders

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)

DOE evaluation document for DOT 7A Type A packaging

International Nuclear Information System (INIS)

Edling, D.A.; Hopkins, D.R.; Williams, R.L.

1987-03-01

This document is a support document for the ''DOE Evaluation Document for DOT 7A Type A Packaging,'' MLM-3245, March 1987. Provided herein are details concerning the performance requirements specified in 178.350 Specification 7A, General Packaging, Type A. MLM-3245 references appropriate sections in this document. This document does not by itself meet the documentation requirements specified in 49 CFR 173.415 and has compliance value only when used in conjunction with MLM-3245

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.

Cold Vacuum Drying (CVD) Facility Design Basis Accident Analysis Documentation

Energy Technology Data Exchange (ETDEWEB)

PIEPHO, M.G.

1999-10-20

This document provides the detailed accident analysis to support HNF-3553, Annex B, Spent Nuclear Fuel Project Final Safety Analysis Report, ''Cold Vacuum Drying Facility Final Safety Analysis Report (FSAR).'' All assumptions, parameters and models used to provide the analysis of the design basis accidents are documented to support the conclusions in the FSAR.

Status of generic actions items and safety analysis system of PHWR

Energy Technology Data Exchange (ETDEWEB)

Park, Joo Hwan; Min, Byung Joo

2001-05-01

This report described the review results of a GAIs(Generic Action Item) currently issued on safety analysis of PHWR(Pressurized Heavy Water Reactor) and the research activities and positions to solve the GAIs in each country which possess PHWRs. eviewing the Final Safety Analysis Report for Wolsong-2/3/4 Units, the safety analysis methodology, classification for accident scenarios, safety analysis codes, their interface, etc.. were described. From the present review report, it is intended to establish the CANDU safety analysis system by providing the better understandings and development plans for the safety analysis of PHWR. esults.

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.

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

Reference pricing system and competition: case study from Portugal.

Science.gov (United States)

Portela, Conceiçăo

2009-10-01

To characterize the patterns of competition for a sample of drugs in the Portuguese pharmaceutical market before (January 2002-March 2003) and after (April 2003-June 2003) the introduction of the reference pricing system (RPS). We performed a descriptive, retrospective, longitudinal analysis, with monthly observations from January 2002 until June 2003 of 15 homogeneous groups. The groups represented the upper limit of public pharmaceutical expenditure in the RPS segment in 2003 (n=270). Measures of competition were: 1) number of presentations; 2) prescriptions' concentration in the generic and originator (brand) segments, using Herfindahl-Hirschman Index (HHI); and 3) dominant positions of market leader in the homogeneous group. A correlation analysis between the number of presentations, the HHI, and the dominant position of the market leader was performed using Pearson coefficient of correlation. The structure of the market changed with the introduction of RPS. We found an increasing number of generic presentations (from 4+/-3 to 7+/-4; mean+/-standard deviation) and a decrease in the HHI for the generics market segment (from 0.7+/-0.2 to 0.6+/-0.3). There was a negative correlation between those variables that increased after the introduction of RPS (from -0.6 to -0.8). The HHI for brands and the dominant positions remained unchanged. After the implementation of RPS, the increased competition was mainly driven by economic and social agents in the generics market segment but not in the brands market segment.

ImgLib2--generic image processing in Java.

Science.gov (United States)

Pietzsch, Tobias; Preibisch, Stephan; Tomancák, Pavel; Saalfeld, Stephan

2012-11-15

ImgLib2 is an open-source Java library for n-dimensional data representation and manipulation with focus on image processing. It aims at minimizing code duplication by cleanly separating pixel-algebra, data access and data representation in memory. Algorithms can be implemented for classes of pixel types and generic access patterns by which they become independent of the specific dimensionality, pixel type and data representation. ImgLib2 illustrates that an elegant high-level programming interface can be achieved without sacrificing performance. It provides efficient implementations of common data types, storage layouts and algorithms. It is the data model underlying ImageJ2, the KNIME Image Processing toolbox and an increasing number of Fiji-Plugins. ImgLib2 is licensed under BSD. Documentation and source code are available at http://imglib2.net and in a public repository at https://github.com/imagej/imglib. Supplementary data are available at Bioinformatics Online. saalfeld@mpi-cbg.de