WorldWideScience

Sample records for generic site safety

  1. Generic Site Safety Report

    CERN Document Server

    International Atomic Energy Agency. Vienna. ITER Joint Central Team

    2001-01-01

    The ITER Engineering Design Activities (EDA) are being conducted jointly by Euratom, Japan, and the Russian Federation, as Parties to the ITER EDA Agreement signed on 21 July 1992 and subsequently extended until July 20th 2001. (The United States of America was an ITER Party until September 30th 1999). The activities are conducted under the auspices of the IAEA by the ITER Joint Central Team and by the Home Teams (HT). The JCT is composed of qualified persons made available by each of the Parties in approximately equal numbers. The JCT members are located at the ITER Joint Work Sites (JWS) in Naka (Japan), Garching (Germany), and formerly in San Diego (USA). The Home Teams are established and organized by each Party for performing the tasks of the work programme for the EDA, assigned to them in approximately equal shares. Home Teams in each of the Parties perform specific design tasks, and perform research and development in technology (physics R&D is contributed voluntarily). The Home Team Leaders (HTL) ...

  2. Generic safety documentation model

    Energy Technology Data Exchange (ETDEWEB)

    Mahn, J.A.

    1994-04-01

    This document is intended to be a resource for preparers of safety documentation for Sandia National Laboratories, New Mexico facilities. It provides standardized discussions of some topics that are generic to most, if not all, Sandia/NM facilities safety documents. The material provides a ``core`` upon which to develop facility-specific safety documentation. The use of the information in this document will reduce the cost of safety document preparation and improve consistency of information.

  3. 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.

  4. Enhancing Safety through Generic Competencies

    Directory of Open Access Journals (Sweden)

    S. Mockel

    2014-03-01

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

  5. Savannah River Site generic data base development

    Energy Technology Data Exchange (ETDEWEB)

    Blanton, C.H.; Eide, S.A.

    1993-06-30

    This report describes the results of a project to improve the generic component failure data base for the Savannah River Site (SRS). A representative list of components and failure modes for SRS risk models was generated by reviewing existing safety analyses and component failure data bases and from suggestions from SRS safety analysts. Then sources of data or failure rate estimates were identified and reviewed for applicability. A major source of information was the Nuclear Computerized Library for Assessing Reactor Reliability, or NUCLARR. This source includes an extensive collection of failure data and failure rate estimates for commercial nuclear power plants. A recent Idaho National Engineering Laboratory report on failure data from the Idaho Chemical Processing Plant was also reviewed. From these and other recent sources, failure data and failure rate estimates were collected for the components and failure modes of interest. This information was aggregated to obtain a recommended generic failure rate distribution (mean and error factor) for each component failure mode.

  6. Savannah River Site generic data base development

    Energy Technology Data Exchange (ETDEWEB)

    Blanchard , A.

    2000-01-04

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

  7. [Generic drugs: quality, efficacy, safety and interchangeability].

    Science.gov (United States)

    Tschabitscher, Doris; Platzer, Peter; Baumgärtel, Christoph; Müllner, Marcus

    2008-01-01

    Since the introduction of generic drugs to the pharmaceutical market a sometimes emotional debate exists whether they are well-investigated and of high quality. There is some uncertainty about whether evidence of bioequivalence is enough to guarantee efficacy and safety of generic drugs. Some physicians ask the question if competent authorities are able to ascertain that the pharmaceutical quality of generics is acceptable. Doctors and patients sometimes are ill at ease about the interchangeability of innovator and generic products. This article describes how the European Union legislation ensures that a generic drug is only approved if its risk-benefit relationship is favourable and that it is essentially similar to the innovator product. In this context pharmacokinetic parameters are accepted as surrogates for clinical results because bioequivalence means therapeutic equivalence as well. For most drugs, current bioequivalence testing generally enables clinicians to routinely substitute generic for innovator products. Published findings, however, suggest that particular drugs may not be ideally suited for generic substitution when a patient is already on that drug. These are the so called critical dose medicinal products (drugs with a narrow therapeutic range). When starting a new therapy with any generic drug, however, its similarity to the innovator drug in terms of efficacy, safety and quality is guaranteed.

  8. 77 FR 60125 - Generic Drug Facilities, Sites and Organizations

    Science.gov (United States)

    2012-10-02

    ... HUMAN SERVICES Food and Drug Administration Generic Drug Facilities, Sites and Organizations AGENCY... Administration (FDA) is notifying generic drug facilities, and certain sites and organizations identified in a generic drug submission, that they must provide identification information to FDA. This information...

  9. 78 FR 22553 - Generic Drug Facilities, Sites, and Organizations

    Science.gov (United States)

    2013-04-16

    ... HUMAN SERVICES Food and Drug Administration Generic Drug Facilities, Sites, and Organizations AGENCY... announcing that the generic drug facility self-identification reporting period for fiscal year (FY) 2014 will begin on May 1, 2013, and close on June 1, 2013. Generic drug facilities, certain sites,...

  10. A generic operational strategy to qualify translational safety biomarkers.

    Science.gov (United States)

    Matheis, Katja; Laurie, David; Andriamandroso, Christiane; Arber, Nadir; Badimon, Lina; Benain, Xavier; Bendjama, Kaïdre; Clavier, Isabelle; Colman, Peter; Firat, Hüseyin; Goepfert, Jens; Hall, Steve; Joos, Thomas; Kraus, Sarah; Kretschmer, Axel; Merz, Michael; Padro, Teresa; Planatscher, Hannes; Rossi, Annamaria; Schneiderhan-Marra, Nicole; Schuppe-Koistinen, Ina; Thomann, Peter; Vidal, Jean-Marc; Molac, Béatrice

    2011-07-01

    The importance of using translational safety biomarkers that can predict, detect and monitor drug-induced toxicity during human trials is becoming increasingly recognized. However, suitable processes to qualify biomarkers in clinical studies have not yet been established. There is a need to define clear scientific guidelines to link biomarkers to clinical processes and clinical endpoints. To help define the operational approach for the qualification of safety biomarkers the IMI SAFE-T consortium has established a generic qualification strategy for new translational safety biomarkers that will allow early identification, assessment and management of drug-induced injuries throughout R&D. Copyright © 2011 Elsevier Ltd. All rights reserved.

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

    Energy Technology Data Exchange (ETDEWEB)

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

    1986-07-01

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

  12. 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.

  13. National Ignition Facility Project Site Safety Program

    Energy Technology Data Exchange (ETDEWEB)

    Dun, C

    2003-09-30

    This Safety Program for the National Ignition Facility (NIF) presents safety protocols and requirements that management and workers shall follow to assure a safe and healthful work environment during activities performed on the NIF Project site. The NIF Project Site Safety Program (NPSSP) requires that activities at the NIF Project site be performed in accordance with the ''LLNL ES&H Manual'' and the augmented set of controls and processes described in this NIF Project Site Safety Program. Specifically, this document: (1) Defines the fundamental NIF site safety philosophy. (2) Defines the areas covered by this safety program (see Appendix B). (3) Identifies management roles and responsibilities. (4) Defines core safety management processes. (5) Identifies NIF site-specific safety requirements. This NPSSP sets forth the responsibilities, requirements, rules, policies, and regulations for workers involved in work activities performed on the NIF Project site. Workers are required to implement measures to create a universal awareness that promotes safe practice at the work site and will achieve NIF management objectives in preventing accidents and illnesses. ES&H requirements are consistent with the ''LLNL ES&H Manual''. This NPSSP and implementing procedures (e.g., Management Walkabout, special work procedures, etc.,) are a comprehensive safety program that applies to NIF workers on the NIF Project site. The NIF Project site includes the B581/B681 site and support areas shown in Appendix B.

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

    Energy Technology Data Exchange (ETDEWEB)

    None, None

    1996-12-31

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

  15. 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.

  16. Safety and efficacy of generic drugs with respect to brand formulation

    Directory of Open Access Journals (Sweden)

    Luca Gallelli

    2013-01-01

    Full Text Available 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.

  17. Qualified Presumption of Safety (QPS) is a generic risk assessment approach applied by the European Food Safety Authority (EFSA)

    DEFF Research Database (Denmark)

    Leuschner, R. G. K.; Robinson, T. P.; Hugas, M.;

    2010-01-01

    Qualified Presumption of Safety (QPS) is a generic risk assessment approach applied by the European Food Safety Authority (EFSA) to notified biological agents aiming at simplifying risk assessments across different scientific Panels and Units. The aim of this review is to outline the implementation...... and value of the QPS assessment for EFSA and to explain its principles such as the unambiguous identity of a taxonomic unit, the body of knowledge including potential safety concerns and how these considerations lead to a list of biological agents recommended for QPS which EFSA keeps updated through...

  18. Efficacy and safety of innovator versus generic drugs in patients with epilepsy: a systematic review.

    Science.gov (United States)

    Talati, Ripple; Scholle, Jennifer M; Phung, Olivia P; Baker, Erika L; Baker, William L; Ashaye, Ajibade; Kluger, Jeffrey; Coleman, Craig I; White, C Michael

    2012-04-01

    Generic antiepileptic drugs achieve blood concentrations similar to those of innovator drugs in healthy volunteers, but their comparative effectiveness has not been well evaluated. Thus, we assessed the efficacy, tolerability, and safety of innovator versus generic antiepileptic drugs. We searched the MEDLINE database, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and Web of Science for studies that evaluated innovator and generic antiepileptic drugs in patients with epilepsy and reported data on prespecified outcomes. We extracted data on study design, interventions, quality criteria, study population, baseline characteristics, and outcomes. Compared with initiation of innovator antiepileptic drugs, initiation of generic antiepileptic drugs did not significantly alter seizure occurrence (relative risk [RR] 0.87, 95% confidence interval [CI] 0.64-1.18; strength of evidence: low) or frequency (standardized mean difference 0.03, 95% CI -0.08-0.14; strength of evidence: low), withdrawals due to lack of efficacy (RR 1.02, 95% CI 0.41-2.54; strength of evidence: low) or adverse events (RR 0.79, 95% CI 0.28-2.20; strength of evidence: low), pharmacokinetic concentrations (maximum, minimum, or area under the curve [strength of evidence: low]), or a myriad of adverse events (strength of evidence: low or insufficient) in clinical trials. In qualitatively evaluated observational studies, switching between forms of antiepileptic drug (innovator to generic, generic to generic) may increase the risk of hospitalization (strength of evidence: low), hospital stay duration (strength of evidence: low), and a composite end point of medical service utilization (strength of evidence: insufficient) but may not increase outpatient service utilization (strength of evidence: low). Data are limited predominantly to carbamazepine, phenytoin, and valproic acid. Clinical trials are limited by small sample size, short-term nature, and lack of

  19. 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.

  20. Comparative analysis of safety related site characteristics

    Energy Technology Data Exchange (ETDEWEB)

    Andersson, Johan (ed.)

    2010-12-15

    This document presents a comparative analysis of site characteristics related to long-term safety for the two candidate sites for a final repository for spent nuclear fuel in Forsmark (municipality of Oesthammar) and in Laxemar (municipality of Oskarshamn) from the point of view of site selection. The analyses are based on the updated site descriptions of Forsmark /SKB 2008a/ and Laxemar /SKB 2009a/, together with associated updated repository layouts and designs /SKB 2008b and SKB 2009b/. The basis for the comparison is thus two equally and thoroughly assessed sites. However, the analyses presented here are focussed on differences between the sites rather than evaluating them in absolute terms. The document serves as a basis for the site selection, from the perspective of long-term safety, in SKB's application for a final repository. A full evaluation of safety is made for a repository at the selected site in the safety assessment SR-Site /SKB 2011/, referred to as SR-Site main report in the following

  1. 77 FR 51811 - Draft Guidance for Industry on Self-Identification of Generic Drug Facilities, Sites, and...

    Science.gov (United States)

    2012-08-27

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Self-Identification of... guidance for industry entitled ``Self- Identification of Generic Drug Facilities, Sites, and... generic drugs to the public and reduce costs to industry, requires that generic drug facilities,...

  2. COMPARATIVE EFFICACY AND SAFETY OF HYPOLIPIDEMIC THERAPY WITH GENERIC AND ORIGINAL MEDICINAL PRODUCTS OF SIMVASTATIN

    Directory of Open Access Journals (Sweden)

    E. I. Tarlovskaya

    2011-01-01

    Full Text Available Aim. To compare efficacy , safety and pharmacoeconomical characteristics of generic and original medicinal products of simvastatin in achievement of cholesterol and low density lipoprotein target levels. Material and methods. 38 patients with arterial hypertension accompanied by type 2 diabetes with dyslipidemia were included into the study. They had no clinically obvious ischemic heart disease and did not receive hypolipidemic pharmacotherapy for a month before the study start. The patients were randomized into group A or group B. Patients of group A (n=18 received original simvastatin, patients of group B (n=20 received generic simvastatin. Initial simvastatin dose was 20 mg daily. Lipid plasma profile, liver enzymes, creatine phosphokinase were evaluated every 4 weeks. Cost-effectiveness ratio was calculated. Results. 11 patients (61% in group A and only 5 patients (25% in group B (χ2=5.05; р<0.05 achieved cholesterol target level with simvastatin in dose of 20 mg daily in 3 months of the treatment. Creatine phosphokinase blood level did not increase significantly. Achievement of cholesterol target level cost 814 and 952 RUB per patient in groups A and B, respectively , in 1 month of simvastatin treatment. These costs were 643 and 417 RUB per patient in groups A and B, respectively , in 3 months of treatment. Conclusion. The original simvastatin in comparison with generic one has advantages in hypolipidemic effect. Safety profile is similar for both medications. Original simvastatin therapy has lower cost than this for generic simvastatin therapy in achievement of cholesterol target level in 1 month of treatment. In 3 months the cost of treatment per patient is 227 RUB higher for original medication in comparison with this for generic medication.

  3. Savannah River Site reactor safety assessment. Draft

    Energy Technology Data Exchange (ETDEWEB)

    Woody, N.D.; Brandyberry, M.D. [eds.] [Westinghouse Savannah River Co., Aiken, SC (United States); Baker, W.H.; Brandyberry, M.D.; Kearnaghan, D.P.; O`Kula, K.R.; Woody, N.D. [Westinghouse Savannah River Co., Aiken, SC (United States); Amos, C.N.; Weingardt, J.J. [Science Applications International Corp., San Diego, CA (United States)

    1991-02-28

    This report gives the results of a Savannah River Site (SRS) Production Reactor risk assessment. Measures of adverse consequences to health and safety resulting from representations of severe accidents in SRS reactors are presented. In addition, the report gives a summary of the methods employed to represent these accidents and to assess the resultant consequences. The report is issued to provide timely information to the US Department of Energy (DOE) on the risk of operation of SRS reactors, for insights into severe accident phenomena that contribute to this risk, and in support of improved bases for other Site programs in Heavy Water Reactor safety.

  4. EFFICIENCY AND SAFETY ASSESSMENT OF GENERIC ATORVASTATINE IN PATIENTS WITH HYPERLIPIDEMIA

    Directory of Open Access Journals (Sweden)

    J. E. Semyonova

    2015-12-01

    Full Text Available Aim. To assess in a short-term study efficiency and safety of hypolipidemic therapy with atorvastatine generic, Tulip, in comparison with simvastatine generic, Vasilip, in hyperlipidemic patients.Material and methods. Open, randomized, comparative, cross over study included 87 patients with hyperlipidemia, who didn’t receive hypolipidemic drugs within 6 weeks, or followed hypolipidemic diet for 4 weeks. Each patient received therapy with one of the studied drugs within 6 weeks. Then after 4-week wash-out period the second therapy with the other drug was held. Consequence of courses with each drug was set by randomization. Initial dose of both drugs was 10 mg daily. Dose was adjusted after 3 weeks. The dose was increased to 20 mg daily if cholesterol of low density lipoproteid (CLDL hadn’t reached target level (< 115 mg/dl. of Treatment safety was assessed on the basis of clinical data, hepatic enzymes activity and creatine phosphokinase levels.Results. It is shown, that to reach target figures of plasma lipid spectrum, Vasilip dose was increased significantly more often, than Tulip dose. Average Tulip dose after titration was 14,8 mg daily, Vasilip dose – 15,6 mg daily. Patients with initially higher level of triglycerides (TG > 170 mg/dl after 6 weeks with Tulip treatment showed TG reduction by 38% and with Vasilip treatment – by 20%. Both drugs showed good tolerance, no significant differences in number of side-effects were observed.Conclusion. 6-week treatment with atorvastatine generic Tulip shows significant hypolipidemic effect, which appears in significant reduction of CLDL, total cholesterol, TG compared to the initial levels. Degree of total cholesterol reduction is significantly higher with Tulip treatment compared to Vasilip treatment. Analyses shown that target levels of the assessed figures were reached in more patients, treated with Tulip. Side-effects in Tulip treatment were not severe.

  5. 77 FR 57094 - Draft Guidance for Industry on Self-Identification of Generic Drug Facilities, Sites, and...

    Science.gov (United States)

    2012-09-17

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Self-Identification of Generic Drug Facilities, Sites, and Organizations; Availability; Correction AGENCY: Food and Drug... announced a draft guidance for industry entitled ``Self-Identification of Generic Drug Facilities,...

  6. Status of safety issues at licensed power plants: TMI Action Plan requirements; unresolved safety issues; generic safety issues; other multiplant action issues. Supplement 3

    Energy Technology Data Exchange (ETDEWEB)

    1993-12-01

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

  7. Comparison of the long-term efficacy and safety of generic Tacrobell with original tacrolimus (Prograf) in kidney transplant recipients

    Science.gov (United States)

    Son, Seung Yeon; Jang, Hye Ryoun; Lee, Jung Eun; Yoo, Heejin; Kim, Kyunga; Park, Jae Berm; Kim, Sung Joo; Oh, Ha Young; Huh, Wooseong

    2017-01-01

    This study aimed to evaluate the long-term efficacy and safety of a generic tacrolimus (Tacrobell [TCB]) compared to the original tacrolimus (Prograf [PGF]) in kidney transplant recipients. In this retrospective observational study, we analyzed the data from 444 patients who took TCB as a first-line immunosuppressive drug and 245 patients who took PGF. The 5-year graft survival rate was 92% for patients in the PGF group and 97% for patients in the TCB group, respectively. Cox proportional hazards for a one-sided, noninferiority model showed noninferiority (upper confidence interval [CI] limit of the hazard ratio [HR]drug. Producers of generics should support further study of their products after approval to assure physicians of their efficacy and safety. PMID:28138224

  8. Radionuclide transport report for the safety assessment SR-Site

    Energy Technology Data Exchange (ETDEWEB)

    2010-12-15

    This document compiles radionuclide transport calculations of a KBS-3 repository for the safety assessment SR-Site. The SR-Site assessment supports the licence application for a final repository at Forsmark, Sweden

  9. Geosphere process report for the safety assessment SR-Site

    Energy Technology Data Exchange (ETDEWEB)

    Skagius, Kristina (ed.) (Kemakta Konsult AB, Stockholm (Sweden))

    2010-11-15

    This report documents geosphere processes identified as relevant to the long-term safety of a KBS-3 repository, and forms an important part of the reporting of the safety assessment SR-Site. The detailed assessment methodology, including the role of the process reports in the assessment, is described in the SR-Site Main report /SKB 2011/

  10. [GENERIC DRUGS: IS BIOEQUIVALENCE SUFFICIENT TO ENSURE QUALITY, EFFICACY AND SAFETY?].

    Science.gov (United States)

    Carrillo Norte, Juan Antonio; Postigo Mota, Salvador

    2015-05-01

    This article is focusing on the current debate that prescription of generic drugs is producing among patients and healthcare professionals. Following European Medicine Agency (EMA) recommendations, a number of generic medicines have recently been withdrawn from the market in Spain. The authorization for these generic drugs was primarily based on clinical studies conducted at GVK Biosciences in Hyderabad, India. The EMA inspection of GVK revealed data manipulation of electrocardiograms during the development of some studies of generic medicines. These manipulations had taken place over a period of at least five years. The article is also dealing with the consideration that bioavailability and bioequivalence studies receive as a cornerstone to approve generic drugs, and the discrepancies between the national regulatory agencies of medicines to implement guidelines of approval. Likewise, in the last few years, the rapid expansion of clinical trial activity regarding generic medicines and other drugs in emerging markets, is often leading to doubt on the integrity of the way trials were performed and on the reliability of data obtained from these studies.

  11. Safety Sound interpretive site designation environmental assessment

    Data.gov (United States)

    US Fish and Wildlife Service, Department of the Interior — The purpose of this environmental assessment is to analyze the impacts of designating a 70 acre parcel of the Alaska Maritime National Wildlife Refuge as the Safety...

  12. Regulatory analysis for the resolution of Generic Safety Issue 29: Bolting degradation or failure in nuclear power plants

    Energy Technology Data Exchange (ETDEWEB)

    Chang, T.Y.

    1991-09-01

    Generic Safety Issue (GSI)-29 deals with staff concerns about public risk due to degradation or failure of safety-related bolting in nuclear power plants. The issue was initiated in November 1982. Value-impact studies of a mandatory program on safety-related bolting for operating plants were inconclusive: therefore, additional regulatory requirements for operating plants could not be justified in accordance with provisions of 10 CFR 50.109. In addition, based on operating experience with bolting in both nuclear and conventional power plants, the actions already taken through bulletins, generic letters, and information notices, and the industry-proposed actions, the staff concluded that a sufficient technical basis exists for the resolution of GSI-29. The staff further concluded that leakage of bolted pressure joints is possible but catastrophic failure of a reactor coolant pressure boundary joint that will lead to significant accident sequences is highly unlikely. For future plants, it was concluded that a new Standard Review Plant section should be developed to codify existing bolting requirements and industry-developed initiatives. 9 refs., 1 tab.

  13. Behavior-based safety on construction sites: a case study.

    Science.gov (United States)

    Choudhry, Rafiq M

    2014-09-01

    This work presents the results of a case study and describes an important area within the field of construction safety management, namely behavior-based safety (BBS). This paper adopts and develops a management approach for safety improvements in construction site environments. A rigorous behavioral safety system and its intervention program was implemented and deployed on target construction sites. After taking a few weeks of safety behavior measurements, the project management team implemented the designed intervention and measurements were taken. Goal-setting sessions were arranged on-site with workers' participation to set realistic and attainable targets of performance. Safety performance measurements continued and the levels of performance and the targets were presented on feedback charts. Supervisors were asked to give workers recognition and praise when they acted safely or improved critical behaviors. Observers were requested to have discussions with workers, visit the site, distribute training materials to workers, and provide feedback to crews and display charts. They were required to talk to operatives in the presence of line managers. It was necessary to develop awareness and understanding of what was being measured. In the process, operatives learned how to act safely when conducting site tasks using the designed checklists. Current weekly scores were discussed in the weekly safety meetings and other operational site meetings with emphasis on how to achieve set targets. The reliability of the safety performance measures taken by the company's observers was monitored. A clear increase in safety performance level was achieved across all categories: personal protective equipment; housekeeping; access to heights; plant and equipment, and scaffolding. The research reveals that scores of safety performance at one project improved from 86% (at the end of 3rd week) to 92.9% during the 9th week. The results of intervention demonstrated large decreases in

  14. Wrong site frenulectomy in a child: a serious safety event.

    Science.gov (United States)

    Rampersad, Sally; Rossi, Michael G; Yarnell, Christie; Uejima, Tetsu

    2014-07-01

    Wrong site surgery is a serious safety event that can result in temporary or even permanent harm. Various safety checklists and procedures have been added to our standard work in the operating room, but errors still get through our safety nets and patients are harmed. In this case report, we describe a wrong site frenulectomy in a child and discuss the root cause analysis of this error and also SMART (specific, measurable, achievable, realistic, timed) preventative actions that could be put into place to prevent a recurrence.

  15. Data quality objectives for generic in-tank health and safety vapor issue resolution. Revision 1

    Energy Technology Data Exchange (ETDEWEB)

    Osborne, J.W.

    1995-04-28

    Data Quality Objectives (DQOs) for generic waste storage tank vapor and gas sampling were developed in facilitated meetings and a stakeholder review session, using the most recent US EPA DQO guidelines. These meetings elicited DQOs for two major vapor problem areas: flammability and toxicity. This is a summary of the outputs of the planning team for each of the 7 steps of the DQO process.

  16. Mitigative techniques and analysis of generic site conditions for ground-water contamination associated with severe accidents

    Energy Technology Data Exchange (ETDEWEB)

    Shafer, J.M.; Oberlander, P.L.; Skaggs, R.L.

    1984-04-01

    The purpose of this study is to evaluate the feasibility of using ground-water contaminant mitigation techniques to control radionuclide migration following a severe commercial nuclear power reactor accident. The two types of severe commercial reactor accidents investigated are: (1) containment basemat penetration of core melt debris which slowly cools and leaches radionuclides to the subsurface environment, and (2) containment basemat penetration of sump water without full penetration of the core mass. Six generic hydrogeologic site classifications are developed from an evaluation of reported data pertaining to the hydrogeologic properties of all existing and proposed commercial reactor sites. One-dimensional radionuclide transport analyses are conducted on each of the individual reactor sites to determine the generic characteristics of a radionuclide discharge to an accessible environment. Ground-water contaminant mitigation techniques that may be suitable, depending on specific site and accident conditions, for severe power plant accidents are identified and evaluated. Feasible mitigative techniques and associated constraints on feasibility are determined for each of the six hydrogeologic site classifications. The first of three case studies is conducted on a site located on the Texas Gulf Coastal Plain. Mitigative strategies are evaluated for their impact on contaminant transport and results show that the techniques evaluated significantly increased ground-water travel times. 31 references, 118 figures, 62 tables.

  17. Generic Selection Criteria for Safety and Patient Benefit [IV] - Physicochemical and pharmaceutical properties of brand-name and generic ketoprofen tapes.

    Science.gov (United States)

    Wada, Yuko; Kihara, Maki; Nozawa, Mitsuru; Shimokawa, Ken-Ichi; Ishii, Fumiyoshi

    2015-06-01

    The physicochemical and pharmaceutical properties (pH, peel force, water-vapor permeability, and stretchability) of brand-name and generic ketoprofen products were evaluated and compared. The pHs of Mohrus as a brand-name product and Teikoku as a generic product were low (about 4). Among the other generic products, Patell and Nichi-Iko had a pH of about 4.3 while Frestol, Raynanon, BMD, and Touchron showed a pH of 4.6-5.2, which was in the pH range of normal healthy skin (4.5-6.5). The adhesive force was high (≥ 1.38) for Mohrus as a brand-name product as well as for Teikoku and Patell as generic products, but it was low (≤ 0.57) for the other 5 generic products. The water-vapor permeabilities of Mohrus as a brand-name product and Teikoku and Patell as generic products were low, being less than 1/6 of those for the other 5 generic products. Among the 5 generic products, BMD showed the highest water-vapor permeability (1,330 g/m²), and the other products also showed a value ≥ 1,100 g/m². The elongatedness of Mohrus was the lowest (15.5 cm), and that of Raynanon was the highest (24.5 cm); the difference was 9 cm. In this study, the physiochemical and pharmaceutical properties of ketoprofen tapes were clarified, which will allow pharmacists to provide products according to the needs of each patient when a brand-name product is changed to a generic one.

  18. Siting of nuclear facilities. Selections from Nuclear Safety

    Energy Technology Data Exchange (ETDEWEB)

    Buchanan, J.R.

    1976-07-01

    The report presented siting policy and practice for nuclear power plants as developed in the U.S. and abroad. Twenty-two articles from Nuclear Safety on this general topic are reprinted since they provide a valuable reference source. The appendices also include reprints of some relevant regulatory rules and guides on siting. Advantages and disadvantages of novel siting concepts such as underground containment, offshore siting, and nuclear energy parks are addressed. Other topics include site criteria, risk criteria, and nuclear ship criteria.

  19. Site safety plan for Lawrence Livermore National Laboratory CERCLA investigations at site 300. Revision 2

    Energy Technology Data Exchange (ETDEWEB)

    Kilmer, J.

    1997-08-01

    Various Department of Energy Orders incorporate by reference, health and safety regulations promulgated by the Occupational Safety and Health Administration (OSHA). One of the OSHA regulations, 29 CFR 1910.120, Hazardous Waste Operations and Emergency Response, requires that site safety plans are written for activities such as those covered by work plans for Site 300 environmental investigations. Based upon available data, this Site Safety Plan (Plan) for environmental restoration has been prepared specifically for the Lawrence Livermore National Laboratory Site 300, located approximately 15 miles east of Livermore, California. As additional facts, monitoring data, or analytical data on hazards are provided, this Plan may need to be modified. It is the responsibility of the Environmental Restoration Program and Division (ERD) Site Safety Officer (SSO), with the assistance of Hazards Control, to evaluate data which may impact health and safety during these activities and to modify the Plan as appropriate. This Plan is not `cast-in-concrete.` The SSO shall have the authority, with the concurrence of Hazards Control, to institute any change to maintain health and safety protection for workers at Site 300.

  20. Savannah River Site K-Reactor Probabilistic Safety Assessment

    Energy Technology Data Exchange (ETDEWEB)

    Brandyberry, M.D.; Bailey, R.T.; Baker, W.H.; Kearnaghan, D.P.; O`Kula, K.R.; Wittman, R.S.; Woody, N.D. [Westinghouse Savannah River Co., Aiken, SC (United States); Amos, C.N.; Weingardt, J.J. [Science Applications International Corp. (United States)

    1992-12-01

    This report gives the results of a Savannah River Site (SRS) K-Reactor Probabilistic Safety Assessment (PSA). Measures of adverse consequences to health and safety resulting from representations of severe accidents in SRS reactors are presented. In addition, the report gives a summary of the methods employed to represent these accidents and to assess the resultant consequences. The report is issued to provide useful information to the U. S. Department of Energy (DOE) on the risk of operation of SRS reactors, for insights into severe accident phenomena that contribute to this risk, and in support of improved bases for other DOE programs in Heavy Water Reactor safety.

  1. A comparative study of the efficacy and safety of the original and generic orlistat in obese patients in the PROFIL register

    Directory of Open Access Journals (Sweden)

    A. V. Zakharova

    2016-01-01

    Full Text Available Aim. To study the efficacy and safety of generic orlistat in comparison with the original drug in obese patients.Material and methods. Patients with obesity degree 1-3 (n=60; 11.7% men and 88.3% women were included into the open comparative randomized controlled study in parallel groups. After randomization 40 patients received of generic orlistat and 20 – the original orlistat. The duration of follow-up was 12 weeks. Changes in body weight, body mass index, and waist circumference were assessed, as well as the proportion of patients with a weight loss of 5-10% or more from baseline.Results. Weight loss >5% was observed in 28 and 25% of patients in the groups of generic and original orlistat, respectively, and weight loss >10% - in 7.7% of patients only in the group of generic drug. No significant changes in blood pressure and heart rate were found. A significant reduction in total cholesterol and low density lipoprotein cholesterol was revealed. 11 (27.5% adverse events were observed in the group of generic orlistat and 5 (25% – in the group of original orlistat.Conclusion. Generic orlistat 120 mg in capsules showed clinical equivalence to the original drug. Safety and tolerability of treatment with both drugs were comparable.

  2. GENERIC DRUG USER FEE: AN OVERVIEW

    Directory of Open Access Journals (Sweden)

    Darshit S. Patel*, Abhishek R. Patel and Narendra A. Patel

    2012-09-01

    Full Text Available The globalization of generic drug manufacturing, supply and testing, and a growing workload that has far outpaced USFDA’s resources has created new challenges. USFDA & Industry propose generic drug user fee to address the need for globalization of the inspection process, and to speed the timely review of generic product applications. The Generic Drug User Fee (GDUF proposal is agreed by generic industry & USFDA and is focused on three key aims: safety, access, and transparency. Under the program, USFDA will receive nearly $1.5 billion over five years in supplemental funding through generic industry user fees in order to help the agency expedite access to generic drugs, enhance drug quality and safety and ensure inspection parity of both foreign and domestic manufacturing sites. GDUF also will help accelerate the market entry of additional manufacturers of drugs currently in short supply and improve quality, consistency, and availability within the supply chain, further helping to mitigate drug shortages. The GDUF new legislation is a milestone for the generic giants and a major win for American health care consumers.

  3. Empirical estimation of school siting parameter towards improving children's safety

    Science.gov (United States)

    Aziz, I. S.; Yusoff, Z. M.; Rasam, A. R. A.; Rahman, A. N. N. A.; Omar, D.

    2014-02-01

    Distance from school to home is a key determination in ensuring the safety of hildren. School siting parameters are made to make sure that a particular school is located in a safe environment. School siting parameters are made by Department of Town and Country Planning Malaysia (DTCP) and latest review was on June 2012. These school siting parameters are crucially important as they can affect the safety, school reputation, and not to mention the perception of the pupil and parents of the school. There have been many studies to review school siting parameters since these change in conjunction with this ever-changing world. In this study, the focus is the impact of school siting parameter on people with low income that live in the urban area, specifically in Johor Bahru, Malaysia. In achieving that, this study will use two methods which are on site and off site. The on site method is to give questionnaires to people and off site is to use Geographic Information System (GIS) and Statistical Product and Service Solutions (SPSS), to analyse the results obtained from the questionnaire. The output is a maps of suitable safe distance from school to house. The results of this study will be useful to people with low income as their children tend to walk to school rather than use transportation.

  4. Approach for tank safety characterization of Hanford site waste

    Energy Technology Data Exchange (ETDEWEB)

    Meacham, J.E.; Babad, H.; Cash, R.J.; Dukelow, G.T.; Eberlein, S.J.; Hamilton, D.W.; Johnson, G.D.; Osborne, J.W.; Payne, M.A.; Sherwood, D.J. [and others

    1995-03-01

    The overall approach and associated technical basis for characterizing Hanford Site waste to help identify and resolve Waste Tank Safety Program safety issues has been summarized. The safety issues include flammable gas, noxious vapors, organic solvents, condensed-phase exothermic reactions (ferrocyanide and organic complexants), criticality, high heat, and safety screening. For the safety issues involving chemical reactions (i.e., flammable gas, organic solvents, ferrocyanide, and organic complexants), the approach to safety characterization is based on the fact that rapid exothermic reactions cannot occur if either fuel, oxidizer, or temperature (initiators) is not sufficient or controlled. The approach to characterization has been influenced by the progress made since mid-1993: (1) completion of safety analyses on ferrocyanide, criticality, organic solvent in tank 241-C-103, and sludge dryout. (2) successful mitigation of tank 241-SY-101; (3) demonstration of waste aging in laboratory experiments and from waste sampling, and (4) increased understanding of the information that can be obtained from headspace sampling. Headspace vapor sampling is being used to confirm that flammable gas does not accumulate in the single-shell tanks, and to determine whether organic solvents are present. The headspaces of tanks that may contain significant quantities of flammable gas will be monitored continuously using standard hydrogen monitors. For the noxious vapors safety issue, characterization will consist of headspace vapor sampling of most of the Hanford Site waste tanks. Sampling specifically for criticality is not required to confirm interim safe storage; however, analyses for fissile material will be conducted as waste samples are obtained for other reasons. High-heat tanks will be identified through temperature monitoring coupled with thermal analyses.

  5. A safety and regulatory assessment of generic BWR and PWR permanently shutdown nuclear power plants

    Energy Technology Data Exchange (ETDEWEB)

    Travis, R.J.; Davis, R.E.; Grove, E.J.; Azarm, M.A. [Brookhaven National Lab., Upton, NY (United States)

    1997-08-01

    The long-term availability of less expensive power and the increasing plant modification and maintenance costs have caused some utilities to re-examine the economics of nuclear power. As a result, several utilities have opted to permanently shutdown their plants. Each licensee of these permanently shutdown (PSD) plants has submitted plant-specific exemption requests for those regulations that they believe are no longer applicable to their facility. This report presents a regulatory assessment for generic BWR and PWR plants that have permanently ceased operation in support of NRC rulemaking activities in this area. After the reactor vessel is defueled, the traditional accident sequences that dominate the operating plant risk are no longer applicable. The remaining source of public risk is associated with the accidents that involve the spent fuel. Previous studies have indicated that complete spent fuel pool drainage is an accident of potential concern. Certain combinations of spent fuel storage configurations and decay times, could cause freshly discharged fuel assemblies to self heat to a temperature where the self sustained oxidation of the zircaloy fuel cladding may cause cladding failure. This study has defined four spent fuel configurations which encompass all of the anticipated spent fuel characteristics and storage modes following permanent shutdown. A representative accident sequence was chosen for each configuration. Consequence analyses were performed using these sequences to estimate onsite and boundary doses, population doses and economic costs. A list of candidate regulations was identified from a screening of 10 CFR Parts 0 to 199. The continued applicability of each regulation was assessed within the context of each spent fuel storage configuration and the results of the consequence analyses.

  6. Product-Specific Regulatory Pathways to Approve Generic Drugs: The Need for Follow-up Studies to Ensure Safety and Effectiveness.

    Science.gov (United States)

    Kesselheim, Aaron S; Gagne, Joshua J

    2015-10-01

    Generic drugs possessing the same active ingredients, dosage form, strength, route of administration, and labeling can be approved by the US Food and Drug Administration (FDA) as interchangeable with a brand-name drug without needing to repeat the formal Phase I, II, and III clinical trials conducted by the original manufacturers. In recent years, the FDA has approved several generic drugs using product-specific testing to determine therapeutic equivalence in accordance with the unique features of the particular drug. These have been used in two primary situations: (1) cases for which certain bioequivalence studies were not relevant; and (2) cases of complex molecules that may require specially tailored pharmaceutical equivalence studies. Examples include venlafaxine extended release, acarbose, vancomycin capsules, sodium ferric gluconate, salmon calcitonin nasal spray, and enoxaparin. Product-specific approaches to demonstrating therapeutic equivalence are essential to avoid delays in low-cost generic drug availability but can have important clinical implications; yet, currently, there is no formal process in place to monitor the safety and effectiveness of generic drugs approved using modified regulatory pathways. Several strategies can be used to monitor the safety and effectiveness of generic drugs approved via product-specific determinations of therapeutic equivalence.

  7. Data report for the safety assessment SR-Site

    Energy Technology Data Exchange (ETDEWEB)

    2010-12-15

    This report compiles, documents, and qualifies input data identified as essential for the long-term safety assessment of a KBS-3 repository, and forms an important part of the reporting of the safety assessment project SR-Site. The input data concern the repository system, broadly defined as the deposited spent nuclear fuel, the engineered barriers surrounding it, the host rock, and the biosphere in the proximity of the repository. The input data also concern external influences acting on the system, in terms of climate related data. Data are provided for a selection of relevant conditions and are qualified through traceable standardised procedures

  8. Site Safety Plan for Lawrence Livermore National Laboratory CERCLA investigations

    Energy Technology Data Exchange (ETDEWEB)

    Bainer, R.; Duarte, J.

    1993-07-01

    The safety policy of LLNL is to take every reasonable precaution in the performance of work to protect the environment and the health and safety of employees and the public, and to prevent property damage. With respect to hazardous agents, this protection is provided by limiting human exposures, releases to the environment, and contamination of property to levels that are as low as reasonably achievable (ALARA). It is the intent of this Plan to supply the broad outline for completing environmental investigations within ALARA guidelines. It may not be possible to determine actual working conditions in advance of the work; therefore, planning must allow the opportunity to provide a range of protection based upon actual working conditions. Requirements will be the least restrictive possible for a given set of circumstances, such that work can be completed in an efficient and timely fashion. Due to the relatively large size of the LLNL Site and the different types of activities underway, site-specific Operational Safety Procedures (OSPs) will be prepared to supplement activities not covered by this Plan. These site-specific OSPs provide the detailed information for each specific activity and act as an addendum to this Plan, which provides the general plan for LLNL Main Site operation.

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

    Energy Technology Data Exchange (ETDEWEB)

    Martinez-Guridi, G.; Samanta, P.; Chu, L.; Yang, J. [Brookhaven National Lab., Upton, NY (United States)

    1998-03-01

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

  10. National Ignition Facility Project Site Safety Program Appendix A

    Energy Technology Data Exchange (ETDEWEB)

    Moses, E

    2001-09-30

    These rules apply to all National Ignition Facility (NIF) workers (workers), which include Lawrence Livermore National Laboratory (LLNL) employees, non-LLNL employees (including contract labor, supplemental labor, vendors, personnel matrixed/assigned from other national laboratories, participating guests, visitors and students) and contractors/subcontractors. The General Rules and NIF Code of Safe Practices shall be used by management to promote the prevention of incidents through indoctrination, safety and health training, and on-the-job application. As a condition for contract award, all employers shall conduct an orientation for all newly hired and rehired employees before those workers will be permitted to start work in this facility. This orientation shall include a discussion of the following information. The General Rules and NIF Code of Safe Practices must be posted at a conspicuous location at the job site office or be provided to each supervisory worker who shall have it readily available. Copies of the General Rules and NIF Code of Safe Practices can also be included in employee safety pamphlets. The Environmental, Safety, and Health (ES&H) rules at the NIF Project site are based upon compliance with the most stringent of Department of Energy (DOE), LLNL, Federal Occupational Safety and Health Administration (OSHA), California (Cal)/OSHA, and federal and state environmental requirements.

  11. Health and Safety Procedures Manual for hazardous waste sites

    Energy Technology Data Exchange (ETDEWEB)

    Thate, J.E.

    1992-09-01

    The Oak Ridge National Laboratory Chemical Assessments Team (ORNL/CAT) has developed this Health and Safety Procedures Manual for the guidance, instruction, and protection of ORNL/CAT personnel expected to be involved in hazardous waste site assessments and remedial actions. This manual addresses general and site-specific concerns for protecting personnel, the general public, and the environment from any possible hazardous exposures. The components of this manual include: medical surveillance, guidance for determination and monitoring of hazards, personnel and training requirements, protective clothing and equipment requirements, procedures for controlling work functions, procedures for handling emergency response situations, decontamination procedures for personnel and equipment, associated legal requirements, and safe drilling practices.

  12. Environment, Safety and Health Progress Assessment of the Hanford Site

    Energy Technology Data Exchange (ETDEWEB)

    1992-05-01

    This report documents the result of the US Department of Energy (DOE) Environment, Safety and Health (ES&H) Progress Assessment of the Hanford Site, in Richland, Washington. The assessment, which was conducted from May 11 through May 22, 1992, included a selective-review of the ES&H management systems and programs of the responsible DOE Headquarters Program Offices the DOE Richland Field Office, and the site contractors. The ES&H Progress Assessments are part of the Secretary of Energy`s continuing effort to institutionalize line management accountability and the self-assessment process throughout DOE and its contractor organizations. The purpose of the Hanford Site ES&H Progress Assessment is to provide the Secretary with an independent assessment of the adequacy and effectiveness of the DOE and contractor management structures, resources, and systems to address ES&H problems and requirements. They are not intended to be comprehensive compliance assessments of ES&H activities. The point of reference for assessing programs at the Hanford Site was, for the most part, the Tiger Team Assessment of the Hanford Site, which was conducted from May 21 through July 18, 1990. A summary of issues and progress in the areas of environment, safety and health, and management is included.

  13. Technical safety appraisal of the Nevada Test Site

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1990-12-01

    This report presents the results of one of a series of Technical Safety Appraisals (TSAs) being conducted of Department of Energy (DOE) operations (nuclear and non-nuclear) by the Assistant Secretary of Environment, Safety and Health (ES&H), Office of Safety Appraisals. These TSAs are one of the initiatives announced by the Secretary of Energy on September 18, 1985, to enhance the DOE`s environment, safety, and health program. This TSA report focuses on the safety and health operations of the Nevada Operations Office (NV) at the Nevada Test Site (NTS), which was conducted concurrently, with and supporting a Tiger Team Assessment. The total effort of all the Tiger Team assessment, including environmental and manager evaluations, is reported in the Tiger Team Report, issued January 1990. The assessment of the NTS began November 5, 1989 with the briefing of the Tiger Team in Las Vegas at the Nevada Operations Office. The TSA team evaluation was conducted November 6--17, and November 26--December 1, 1989 at the NTS.

  14. Methodology for calculating guideline concentrations for safety shot sites

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1997-06-01

    Residual plutonium (Pu), with trace quantities of depleted uranium (DU) or weapons grade uranium (WU), exists in surficial soils at the Nevada Test Site (NTS), Nellis Air Force Range (NAFR), and the Tonopah Test Range (TTR) as the result of the above-ground testing of nuclear weapons and special experiments involving the detonation of plutonium-bearing devices. The special experiments (referred to as safety shots) involving plutonium-bearing devices were conducted to study the behavior of Pu as it was being explosively compressed; ensure that the accidental detonation of the chemical explosive in a production weapon would not result in criticality; evaluate the ability of personnel to manage large-scale Pu dispersal accidents; and develop criteria for transportation and storage of nuclear weapons. These sites do not pose a health threat to either workers or the general public because they are under active institutional control. The DOE is committed to remediating the safety shot sites so that radiation exposure to the public, both now and in the future, will be maintained within the established limits and be as low as reasonably achievable. Remediation requires calculation of a guideline concentration for the Pu, U, and their decay products that are present in the surface soil. This document presents the methodology for calculating guideline concentrations of weapons grade plutonium, weapons grade uranium, and depleted uranium in surface soils at the safety shot sites. Emphasis is placed on obtaining site-specific data for use in calculating dose to potential residents from the residual soil contamination.

  15. FEP report for the safety assessment SR-Site

    Energy Technology Data Exchange (ETDEWEB)

    2010-12-15

    This report documents the analysis and processing of features, events and processes, FEPs, that has been carried out within the safety assessment SR-Site, and forms an important part of the reporting of the project. The main part of the work was conducted within the earlier safety assessment SR-Can, which was a preparatory stage for the SR-Site assessment. The overall objective of the FEP analysis and processing in both SR-Can and SR-Site included development of a database of features, events and processes, an SKB FEP database, in a format that facilitates both a systematic analysis of FEPs and documentation of that FEP analysis, as well as facilitating revisions and updates to be made in connection with new safety assessments. The primary objective in SR-Site was to establish an SR-Site FEP catalogue within the framework of the SKB FEP database. This FEP catalogue was required to contain all FEPs that needed to be handled in SR-Site and is an update of the corresponding SR-Can FEP catalogue that was established for the SR-Can assessment. The starting point for the handling of FEPs in SR-Site was the SR-Can version of the SKB FEP database and associated SR-Can reports. The SR-Can version of the SKB FEP database includes the SR-Can FEP catalogue, as well as the sources for the identification of FEPs in SR-Can, namely the SR 97 processes and variables, Project FEPs in the NEA International FEP database version 1.2 and matrix interactions in the Interaction matrices developed for a deep repository of the KBS-3 type. Since the completion of the FEP work within SR-Can, an updated electronic version, version 2.1, of the NEA FEP database has become available. Compared with version 1.2 of the NEA FEP database, version 2.1 contains FEPs from two more projects. As part of SR-Site, all new Project FEPs in version 2.1 of the NEA FEP database have been mapped according to the methodology adopted in SR-Can resulting in an SR-Site version of the SKB FEP database. The SKB FEP

  16. Hanford Site Wide Transportation Safety Document [SEC 1 Thru 3

    Energy Technology Data Exchange (ETDEWEB)

    MCCALL, D L

    2002-06-01

    This safety evaluation report (SER) documents the basis for the US Department of Energy (DOE), Richland Operations Office (RL) to approve the Hanford Sitewide Transportation Safety Document (TSD) for onsite Transportation and Packaging (T&P) at Hanford. Hanford contractors, on behalf of DOE-RL, prepared and submitted the Hanford Sitewide Transportation Safety Document, DOE/RL-2001-0036, Revision 0, (DOE/RL 2001), dated October 4, 2001, which is referred to throughout this report as the TSD. In the context of the TSD, Hanford onsite shipments are the activities of moving hazardous materials, substances, and wastes between DOE facilities and over roadways where public access is controlled or restricted and includes intra-area and inter-area movements. The TSD sets forth requirements and standards for onsite shipment of radioactive and hazardous materials and wastes within the confines of the Hanford Site on roadways where public access is restricted by signs, barricades, fences, or other means including road closures and moving convoys controlled by Hanford Site security forces.

  17. Improving the safety of remote site emergency airway management.

    Science.gov (United States)

    Wijesuriya, Julian; Brand, Jonathan

    2014-01-01

    Airway management, particularly in non-theatre settings, is an area of anaesthesia and critical care associated with significant risk of morbidity & mortality, as highlighted during the 4th National Audit Project of the Royal College of Anaesthetists (NAP4). A survey of junior anaesthetists at our hospital highlighted a lack of confidence and perceived lack of safety in emergency airway management, especially in non-theatre settings. We developed and implemented a multifaceted airway package designed to improve the safety of remote site airway management. A Rapid Sequence Induction (RSI) checklist was developed; this was combined with new advanced airway equipment and drugs bags. Additionally, new carbon dioxide detector filters were procured in order to comply with NAP4 monitoring recommendations. The RSI checklists were placed in key locations throughout the hospital and the drugs and advanced airway equipment bags were centralised in the Intensive Care Unit (ICU). It was agreed with the senior nursing staff that an appropriately trained ICU nurse would attend all emergency situations with new airway resources upon request. Departmental guidelines were updated to include details of the new resources and the on-call anaesthetist's responsibilities regarding checks and maintenance. Following our intervention trainees reported higher confidence levels regarding remote site emergency airway management. Nine trusts within the Northern Region were surveyed and we found large variations in the provision of remote site airway management resources. Complications in remote site airway management due lack of available appropriate drugs, equipment or trained staff are potentially life threatening and completely avoidable. Utilising the intervention package an anaesthetist would be able to safely plan and prepare for airway management in any setting. They would subsequently have the drugs, equipment, and trained assistance required to manage any difficulties or complications

  18. Technical report for the generic site add-on facility for plutonium polishing

    Energy Technology Data Exchange (ETDEWEB)

    Collins, E. D.

    1998-06-01

    The purpose of this report is to provide environmental data and reference process information associated with incorporating plutonium polishing steps (dissolution, impurity removal, and conversion to oxide powder) into the genetic-site Mixed-Oxide Fuel Fabrication Facility (MOXFF). The incorporation of the plutonium polishing steps will enable the removal of undesirable impurities, such as gallium and americium, known to be associated with the plutonium. Moreover, unanticipated impurities can be removed, including those that may be contained in (1) poorly characterized feed materials, (2) corrosion products added from processing equipment, and (3) miscellaneous materials contained in scrap recycle streams. These impurities will be removed to the extent necessary to meet plutonium product purity specifications for MOX fuels. Incorporation of the plutonium polishing steps will mean that the Pit Disassembly and Conversion Facility (PDCF) will need to produce a plutonium product that can b e dissolved at the MOXFF in nitric acid at a suitable rate (sufficient to meet overall production requirements) with the minimal usage of hydrofluoric acid, and its complexing agent, aluminum nitrate. This function will require that if the PDCF product is plutonium oxide powder, that powder must be produced, stored, and shipped without exceeding a temperature of 600 C.

  19. 78 FR 48468 - Delphi Corporation, Electronics and Safety Division, Including On-Site Leased Workers From...

    Science.gov (United States)

    2013-08-08

    ... Employment and Training Administration Delphi Corporation, Electronics and Safety Division, Including On-Site... to workers of Delphi Corporation, Electronics and Safety Division, including on-site leased workers... Delphi Corporation, Electronics and Safety Division. The Department has determined that these...

  20. Model summary report for the safety assessment SR-Site

    Energy Technology Data Exchange (ETDEWEB)

    Vahlund, Fredrik; Zetterstroem Evins, Lena (Swedish Nuclear Fuel and Waste Management Co., Stockholm (Sweden)); Lindgren, Maria (Kemakta Konsult AB, Stockholm (Sweden))

    2010-12-15

    This document is the model summary report for the safety assessment SR-Site. In the report, the quality assurance (QA) measures conducted for assessment codes are presented together with the chosen QA methodology. In the safety assessment project SR-Site, a large number of numerical models are used to analyse the system and to show compliance. In order to better understand how the different models interact and how information are transferred between the different models Assessment Model Flowcharts, AMFs, are used. From these, different modelling tasks can be identify and the computer codes used. As a large number of computer codes are used in the assessment the complexity of these differs to a large extent, some of the codes are commercial while others are developed especially for the assessment at hand. QA requirements must on the one hand take this diversity into account and on the other hand be well defined. In the methodology section of the report the following requirements are defined for all codes: - It must be demonstrated that the code is suitable for its purpose. - It must be demonstrated that the code has been properly used. - It must be demonstrated that the code development process has followed appropriate procedures and that the code produces accurate results. - It must be described how data are transferred between the different computational tasks. Although the requirements are identical for all codes in the assessment, the measures used to show that the requirements are fulfilled will be different for different types of codes (for instance due to the fact that for some software the source-code is not available for review). Subsequent to the methodology section, each assessment code is presented together with a discussion on how the requirements are met

  1. Economic grand rounds: experience with mandated use of generic medications for patients covered by the mental health safety net.

    Science.gov (United States)

    Amirsadri, Alireza; Chapman, Timothy; Breen, Michael; Drake, William; Arfken, Cynthia L

    2014-07-01

    Reducing pharmacy costs without increasing adverse outcomes would relieve some pressure on mental health budgets. This column describes the experience of a publicly funded provider network in a Michigan county that mandated generic use of psychotropic medications to address financial challenges. The percentage of brand-name medications and cost per prescription declined with the policy change, resulting in lower total pharmacy expenditures. No increase was noted in prescriptions per patient or psychiatric hospitalizations. Changes were sustained after the initial implementation period. Mandating generic use may be feasible as a tool for constraining pharmacy costs in mental health budgets.

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

    Science.gov (United States)

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

    2017-04-01

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

  3. 78 FR 66420 - Proposed Enhancements to the Motor Carrier Safety Measurement System (SMS) Public Web Site

    Science.gov (United States)

    2013-11-05

    ... System (SMS) Public Web Site AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT. ACTION... enhancements to the display of information on the Agency's Safety Measurement System (SMS) public Web site... and Fitness Electronic Records System (SAFER) Web site. Displaying current insurance and authority...

  4. Preliminary safety evaluation for the Laxemar subarea. Based on data and site descriptions after the initial site investigation stage

    Energy Technology Data Exchange (ETDEWEB)

    Andersson, Johan [JA Streamflow AB, Aelvsjoe (Sweden)

    2006-03-15

    The main objectives of this Preliminary Safety Evaluation (PSE) of the Laxemar subarea have been to determine, with limited efforts, whether the feasibility study's judgement of the suitability of the candidate area with respect to long-term safety holds up in the light of the actual site investigation data; to provide feedback to continued site investigations and site-specific repository design and to identify site-specific scenarios and geoscientific issues for further analyses. The PSE focuses on comparing the attained knowledge of the sites with the suitability criteria as set out by SKB in 2000. These criteria both concern properties of the site judged to be necessary for safety and engineering (requirements) and properties judged to be beneficial (preferences). The findings are then evaluated in order to provide feedback to continued investigations and design work. The PSE does not aim at comparing sites and does not assess compliance with safety and radiation protection criteria. The latter is eventually done in coming Safety Assessments. This preliminary safety evaluation shows that, according to existing data, the Laxemar subarea meets all safety requirements. The evaluation also shows that the Laxemar subarea meets most of the safety preferences, but for some aspects of the site description further reduction of the uncertainties would enhance the safety case. Despite the stated concerns, there is no reason, from a safety point of view, not to continue the Site Investigations at the Laxemar subarea. There are uncertainties to resolve and the safety would eventually need to be verified through a proper safety assessment. Only some of the uncertainties noted in the Site Descriptive Model have safety implications and need further resolution for this reason. Furthermore, uncertainties may need resolving for other reasons, such as giving an adequate assurance of site understanding or assisting in optimising design. Notably, there are questions about the

  5. Corrosion calculations report for the safety assessment SR-Site

    Energy Technology Data Exchange (ETDEWEB)

    2010-12-15

    This report is a compilation of the quantitative assessments of corrosion of the copper canisters in a KBS-3 repository. The calculations are part of the safety assessment SR-Site that is the long-term safety assessment to support the license application for building a final repository for spent nuclear fuel at Forsmark, Sweden. The safety assessment methodology gives the frame for the structured and documented approach to assess all conceivable corrosion processes. The quantitative assessments are done in different ways depending on the nature of the process and on the implications for the long-term safety. The starting point for the handling of the corrosion processes is the description of all known corrosion processes for copper with the current knowledge base and applied to the specific system and geology. Already at this stage some processes are excluded for further analysis, for example if the repository environment is not a sufficient prerequisite for the process to occur. The next step is to identify processes where the extent of corrosion could be bounded, e.g. by a mass balance approach. For processes where a mass balance is not limiting, the mass transport of corrodants (or corrosion products) is taken into account. A simple approach would be just to calculate the diffusive transport of corrodants through the bentonite, but generally the transport resistance for the interface between groundwater in a rock fracture intersecting the deposition hole and the bentonite buffer is more important. In SR-Site, the concept of equivalent flowrate, Q{sub eq}, is used. This assessment is done integrated with the evaluation of the geochemical and hydrogeological evolution of the repository. For most of the corrosion processes analysed, the corrosion depth is much smaller than the copper shell thickness, even for the assessment time of 106 years. Several processes give corrosion depths less than 100 mum, but no process give corrosion depths larger than a few

  6. Application of the Spanish methodological approach for biosphere assessment to a generic high-level waste disposal site.

    Science.gov (United States)

    Agüero, A; Pinedo, P; Simón, I; Cancio, D; Moraleda, M; Trueba, C; Pérez-Sánchez, D

    2008-09-15

    A methodological approach which includes conceptual developments, methodological aspects and software tools have been developed in the Spanish context, based on the BIOMASS "Reference Biospheres Methodology". The biosphere assessments have to be undertaken with the aim of demonstrating compliance with principles and regulations established to limit the possible radiological impact of radioactive waste disposals on human health and on the environment, and to ensure that future generations will not be exposed to higher radiation levels than those that would be acceptable today. The biosphere in the context of high-level waste disposal is defined as the collection of various radionuclide transfer pathways that may result in releases into the surface environment, transport within and between the biosphere receptors, exposure of humans and biota, and the doses/risks associated with such exposures. The assessments need to take into account the complexity of the biosphere, the nature of the radionuclides released and the long timescales considered. It is also necessary to make assumptions related to the habits and lifestyle of the exposed population, human activities in the long term and possible modifications of the biosphere. A summary on the Spanish methodological approach for biosphere assessment are presented here as well as its application in a Spanish generic case study. A reference scenario has been developed based on current conditions at a site located in Central-West Spain, to indicate the potential impact to the actual population. In addition, environmental change has been considered qualitatively through the use of interaction matrices and transition diagrams. Unit source terms of (36)Cl, (79)Se, (99)Tc, (129)I, (135)Cs, (226)Ra, (231)Pa, (238)U, (237)Np and (239)Pu have been taken. Two exposure groups of infants and adults have been chosen for dose calculations. Results are presented and their robustness is evaluated through the use of uncertainty and

  7. Towards rapid on-site phage-mediated detection of generic Escherichia coli in water using luminescent and visual readout.

    Science.gov (United States)

    Burnham, Sean; Hu, Jing; Anany, Hany; Brovko, Lubov; Deiss, Frederique; Derda, Ratmir; Griffiths, Mansel W

    2014-09-01

    Wild-type T4 bacteriophage and recombinant reporter lac Z T4 bacteriophage carrying the β-galactosidase gene were used for detection of generic Escherichia coli by monitoring the release of β-galactosidase upon phage-mediated cell lysis. The reaction was performed on a paper-based portable culture device to limit the diffusion of reagents and, hence, increase the sensitivity of the assay, and to avoid handling large sample volumes, making the assay suitable for on-site analysis. Chromogenic (chlorophenol red-β-D-galactopyranoside, CPRG) and bioluminescent (6-O-β-galactopyranosyl-luciferin, Beta-Glo(®)) β-galactosidase substrates were tested in the assay. Water samples were first filtered through 0.45-μm pore size filters to concentrate bacteria. The filters were then placed into the paper-based device containing nutrient medium and incubated at 37 °C for 4 h. Bacteriophage with the respective indicator substrate was added to the device, and signal (color, luminescence) development was recorded with a digital camera, luminometer, or luminescence imaging device. It was demonstrated that as low as 40 or visually within 8 h when wild-type T4 bacteriophage or recombinant lacZ T4 bacteriophage were used in the assay, respectively. Application of the bioluminescent β-galactosidase substrate allowed reliable detection of <10 cfu ml(-1) within 5.5 h. The specificity of the assay was demonstrated using a panel of microorganisms including Aeromonas hydrophila, Enterobacter cloacae, E. coli, and Salmonella Typhimurium.

  8. Bioequivalence of generic drugs.

    Science.gov (United States)

    Andrade, Chittaranjan

    2015-09-01

    Generic drugs are bioequivalent to the original brand; this is a prerequisite for marketing approval. It is theoretically possible that one generic drug may overestimate the pharmacokinetic (PK) parameters of the original and another generic may underestimate these PK parameters; in consequence, these 2 generics may not be bioequivalent between themselves. The result could be loss of efficacy or development of drug-related adverse effects if these generics are interchanged in stable patients. In a recent study involving 292 indirect comparisons of generic formulations of 9 different drugs, mathematical modeling showed that in most cases (87.0% for maximum concentration, 90.1% for area under the curve, and 80.5% for both) generic drugs are bioequivalent to each other. These reassuring findings notwithstanding, prudence dictates that, in stable patients, generic drugs should be interchanged only if there is a good reason for it. This is because bioequivalent brands of drugs may differ in their excipient content, and this can result in variations in safety profiles.

  9. The Impact of Transformational Leadership on Safety Climate and Individual Safety Behavior on Construction Sites.

    Science.gov (United States)

    Shen, Yuzhong; Ju, Chuanjing; Koh, Tas Yong; Rowlinson, Steve; Bridge, Adrian J

    2017-01-05

    Unsafe acts contribute dominantly to construction accidents, and increasing safety behavior is essential to reduce accidents. Previous research conceptualized safety behavior as an interaction between proximal individual differences (safety knowledge and safety motivation) and distal contextual factors (leadership and safety climate). However, relatively little empirical research has examined this conceptualization in the construction sector. Given the cultural background of the sample, this study makes a slight modification to the conceptualization and views transformational leadership as an antecedent of safety climate. Accordingly, this study establishes a multiple mediator model showing the mechanisms through which transformational leadership translates into safety behavior. The multiple mediator model is estimated by the structural equation modeling (SEM) technique, using individual questionnaire responses from a random sample of construction personnel based in Hong Kong. As hypothesized, transformational leadership has a significant impact on safety climate which is mediated by safety-specific leader-member exchange (LMX), and safety climate in turn impacts safety behavior through safety knowledge. The results suggest that future safety climate interventions should be more effective if supervisors exhibit transformational leadership, encourage construction personnel to voice safety concerns without fear of retaliation, and repeatedly remind them about safety on the job.

  10. The Impact of Transformational Leadership on Safety Climate and Individual Safety Behavior on Construction Sites

    Directory of Open Access Journals (Sweden)

    Yuzhong Shen

    2017-01-01

    Full Text Available Unsafe acts contribute dominantly to construction accidents, and increasing safety behavior is essential to reduce accidents. Previous research conceptualized safety behavior as an interaction between proximal individual differences (safety knowledge and safety motivation and distal contextual factors (leadership and safety climate. However, relatively little empirical research has examined this conceptualization in the construction sector. Given the cultural background of the sample, this study makes a slight modification to the conceptualization and views transformational leadership as an antecedent of safety climate. Accordingly, this study establishes a multiple mediator model showing the mechanisms through which transformational leadership translates into safety behavior. The multiple mediator model is estimated by the structural equation modeling (SEM technique, using individual questionnaire responses from a random sample of construction personnel based in Hong Kong. As hypothesized, transformational leadership has a significant impact on safety climate which is mediated by safety-specific leader–member exchange (LMX, and safety climate in turn impacts safety behavior through safety knowledge. The results suggest that future safety climate interventions should be more effective if supervisors exhibit transformational leadership, encourage construction personnel to voice safety concerns without fear of retaliation, and repeatedly remind them about safety on the job.

  11. The Impact of Transformational Leadership on Safety Climate and Individual Safety Behavior on Construction Sites

    Science.gov (United States)

    Shen, Yuzhong; Ju, Chuanjing; Koh, Tas Yong; Rowlinson, Steve; Bridge, Adrian J.

    2017-01-01

    Unsafe acts contribute dominantly to construction accidents, and increasing safety behavior is essential to reduce accidents. Previous research conceptualized safety behavior as an interaction between proximal individual differences (safety knowledge and safety motivation) and distal contextual factors (leadership and safety climate). However, relatively little empirical research has examined this conceptualization in the construction sector. Given the cultural background of the sample, this study makes a slight modification to the conceptualization and views transformational leadership as an antecedent of safety climate. Accordingly, this study establishes a multiple mediator model showing the mechanisms through which transformational leadership translates into safety behavior. The multiple mediator model is estimated by the structural equation modeling (SEM) technique, using individual questionnaire responses from a random sample of construction personnel based in Hong Kong. As hypothesized, transformational leadership has a significant impact on safety climate which is mediated by safety-specific leader–member exchange (LMX), and safety climate in turn impacts safety behavior through safety knowledge. The results suggest that future safety climate interventions should be more effective if supervisors exhibit transformational leadership, encourage construction personnel to voice safety concerns without fear of retaliation, and repeatedly remind them about safety on the job. PMID:28067775

  12. 78 FR 76391 - Proposed Enhancements to the Motor Carrier Safety Measurement System (SMS) Public Web Site

    Science.gov (United States)

    2013-12-17

    ... System (SMS) Public Web Site AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT. ACTION... Safety Measurement System (SMS) public Web site. On December 6, 2013, Advocates ] for Highway and Auto... Management System Number FMCSA-2013-0392 by any of the following methods: Federal eRulemaking Portal: http...

  13. Fuel and canister process report for the safety assessment SR-Site

    Energy Technology Data Exchange (ETDEWEB)

    Werme, Lars; Lilja, Christina (eds.)

    2010-12-15

    This report documents fuel and canister processes identified as relevant to the long-term safety of a KBS-3 repository. It forms an important part of the reporting of the safety assessment SR-Site. The detailed assessment methodology, including the role of the process reports in the assessment, is described in the SR-Site Main report /SKB 2011/

  14. Deep Borehole Disposal Safety Analysis.

    Energy Technology Data Exchange (ETDEWEB)

    Freeze, Geoffrey A. [Sandia National Laboratories (SNL-NM), Albuquerque, NM (United States); Stein, Emily [Sandia National Laboratories (SNL-NM), Albuquerque, NM (United States); Price, Laura L. [Sandia National Laboratories (SNL-NM), Albuquerque, NM (United States); MacKinnon, Robert J. [Sandia National Laboratories (SNL-NM), Albuquerque, NM (United States); Tillman, Jack Bruce [Sandia National Laboratories (SNL-NM), Albuquerque, NM (United States)

    2016-10-01

    This report presents a preliminary safety analysis for the deep borehole disposal (DBD) concept, using a safety case framework. A safety case is an integrated collection of qualitative and quantitative arguments, evidence, and analyses that substantiate the safety, and the level of confidence in the safety, of a geologic repository. This safety case framework for DBD follows the outline of the elements of a safety case, and identifies the types of information that will be required to satisfy these elements. At this very preliminary phase of development, the DBD safety case focuses on the generic feasibility of the DBD concept. It is based on potential system designs, waste forms, engineering, and geologic conditions; however, no specific site or regulatory framework exists. It will progress to a site-specific safety case as the DBD concept advances into a site-specific phase, progressing through consent-based site selection and site investigation and characterization.

  15. SAFETY

    CERN Document Server

    Niels Dupont

    2013-01-01

    CERN Safety rules and Radiation Protection at CMS The CERN Safety rules are defined by the Occupational Health & Safety and Environmental Protection Unit (HSE Unit), CERN’s institutional authority and central Safety organ attached to the Director General. In particular the Radiation Protection group (DGS-RP1) ensures that personnel on the CERN sites and the public are protected from potentially harmful effects of ionising radiation linked to CERN activities. The RP Group fulfils its mandate in collaboration with the CERN departments owning or operating sources of ionising radiation and having the responsibility for Radiation Safety of these sources. The specific responsibilities concerning "Radiation Safety" and "Radiation Protection" are delegated as follows: Radiation Safety is the responsibility of every CERN Department owning radiation sources or using radiation sources put at its disposition. These Departments are in charge of implementing the requi...

  16. Supporting Fernald Site Closure with Integrated Health and Safety Plans as Documented Safety Analyses

    Energy Technology Data Exchange (ETDEWEB)

    Kohler, S.; Brown, T.; Fisk, P.; Krach, F.; Klein, B.

    2004-03-01

    At the Fernald Closure Project (FCP) near Cincinnati, Ohio, environmental restoration activities are supported by Documented Safety Analyses (DSAs) that combine the required project-specific Health and Safety Plans, Safety Basis Requirements (SBRs), and Process Requirements (PRs) into single Integrated Health and Safety Plans (I-HASPs). These integrated DSAs employ Integrated Safety Management methodology in support of simplified restoration and remediation activities that, so far, have resulted in the decontamination and demolition (D&D) of over 200 structures, including eight major nuclear production plants. There is one of twelve nuclear facilities still remaining (Silos containing uranium ore residues) with its own safety basis documentation. This paper presents the status of the FCP's safety basis documentation program, illustrating that all of the former nuclear facilities and activities have now replaced. Basis of Interim Operations (BIOs) with I-HASPs as their safety basis during the closure process.

  17. Generic variation?

    DEFF Research Database (Denmark)

    Jensen, Torben Juel

    2009-01-01

    Abstract In modern Danish, a handful of pronouns may be used to refer to a generic referent. In recent decades, the second person singular pronoun du has gained ground, apparently in parallel to similar recent developments in other languages. Even though generic du may not be as old as the tradit...

  18. Safety and efficacy of once-daily single generic fixed-drug combination tablet of tenofovir, lamivudine and efavirenz among HIV-infected Thais

    Directory of Open Access Journals (Sweden)

    W Maek-a-Nantawat

    2012-11-01

    Full Text Available Background: Generic fixed dose combinations (FDCs of nucleoside reverse transcriptase inhibitors (NRTIs and non-nucleoside reverse transcriptase inhibitors (NNRTIs is commonly used in resource-limited settings to increase adherence to lifelong treatment. However, the cumulative evidence of the long-term complications, particularly mitochondrial toxicity of NRTIs, especially stavudine (or zidovudine, brings about widespread use of tenofovir (TDF. This study was aimed to assess the efficacy and safety of a FDC comprising 300 mg tenofovir (TDF, 300 mg LAM and 600 mg efavirenz (EFV. Methods: A Phase II open-label clinical trial was conducted at HIV-NAT, Thai AIDS Research Center, Thai Red Cross from April 2010 to December 2011. Patients were eligible to enroll if they were either: 1 on TDF, LAM and EFV as separate tablets, for at least 6 months with an undetectable viral load (= switch arm or 2 treatment-naïve. Safety profiles, including liver and renal functions, were assessed at baseline, weeks 4, 12, 24 and 48. In switch group, mid-dose TDF plasma concentrations were measured by HPLC at baseline and week 4 after a switch to single FDC tablet. Results: A total of 100 patients were enrolled (51 naïve. Median age was 34 years and 30% were female. The median baseline CD4 cell count (IQR was 512 (395–620 cells/L and 232 (164–284 cells/L for the switch arm and ARV-naïve group, respectively. The median (IQR log10 HIV-1 RNA for ARV-naïve group was 4.9 (4.2–5.3 copies/mL. By ITT analysis, the proportion of cases with HIV RNA<50 copies/mL was 93% and 92% at week 24 and 48, respectively. Only 1 confirmed virological failure at week 12 with NNRTI-resistant mutations (A98G, K103N, V118I, E138Q, Y181C. The reported 3 SAEs (severe headache, infective endocarditis, cervical dysplasia were found and one was possibly related to the study drug. There were 49 mild to moderate efavirenz-related central nervous system events, occurring in first few days

  19. Active Tectonic Research for Seismic Safety Evaluation of Long-Line Engineering Sites in China

    Institute of Scientific and Technical Information of China (English)

    Ran Yongkang; Chen Lichun

    2005-01-01

    Long-line engineering sites usually have to pass through active tectonics, so the research of active tectonics is of great importance to seismic safety evaluation of this sort of site. In the paper, basing on the summarization and analysis of the requirements for seismic safety evaluation of long-line engineering site and the status quo of active tectonics research, we propose the focal points of active tectonics research for seismic safety evaluation of long-line engineering sites, including the research contents, technical targets and routes, and the submission of the achievements, etc. Finally, we make a preliminary analysis and discussion about the problems existing in the present-day active tectonics research for seismic safety evaluation of long-line engineering sites.

  20. Preliminary safety evaluation for the Simpevarp subarea. Based on data and site descriptions after the initial site investigation stage

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2005-04-01

    The main objectives of this Preliminary safety evaluation (PSE) of the Simpevarp subarea are: to determine, whether the feasibility study's judgement of the suitability of the candidate area with respect to long-term safety holds up in the light of the site investigation data; to provide feedback to continued site investigations and site-specific repository design and to identify site specific scenarios and geoscientific issues for further analyses. The PSE focuses on comparing the attained knowledge of the sites with the suitability criteria as set out by SKB in the report SKB-TR--00-12. These criteria both concern properties of the site judged to be necessary for safety and engineering (requirements) and properties judged to be beneficial (preferences). The findings are then evaluated in order to provide feedback to continued investigations and design work. The PSE does not aim at comparing sites and does not assess compliance with safety and radiation protection criteria. The evaluation shows that even considering remaining uncertainties, the Simpevarp subarea meets all safety requirements and most of the safety preferences. Consequently, from a safety point of view, there is no reason not to continue the Site Investigations of the Simpevarp subarea. There are still uncertainties to resolve and the safety would eventually need to be verified through a full safety assessment. Still, this Preliminary Safety Evaluation demonstrates that it is likely that a safe repository for spent nuclear fuel of the KBS-3 type could be constructed at the site. The following feedback is provided to the site investigations and the associated site modelling: Reducing the uncertainty on the deformation zone geometry within the Simpevarp subarea would allow for a more specified layout, although the sensitivity analysis shows that the space needed is rather robust with respect to uncertainties in the zones. There is substantial uncertainty in the discrete fracture network (DFN

  1. A study for the domestic application plan of the Generic Safety Issue(GSI) for the Pressurized Heavy Water Reactor

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Un Chul; Jang, Jin Wook; Lee, Sang Kyung; Lee, Doo Yong; Park, Chang Hwan [Seoul National Univ., Seoul (Korea, Republic of)

    2002-03-15

    In this study, a base work to construct the database of the domestic and foreign GSls were done through performing the deviation of GSls for the PHWR by investigating the development trend of international joint studies and the GSls of 4 countries as the PHWR state and examined the IAEA acceptance of GSls classification for the GSls of Canada, Korea Republic of, Argentina and India. We evaluated the possibility of application of the safety Issue for PHWR by investigating causes, contents and follow-up measures of each items. To evaluate the domestic application validity of the safety issue, We made the investigation matrix for the safety issue of each countries and also are reflecting new results in investigation matrix by examining IAEA PHWR GSI development trend. We intended to derive the GSls which are most appropriate in our PHWR by examining every issues. the derived GSls are divided into the design parts and the operation parts. And they have to be solved as soon as possible.

  2. Climate and climate-related issues for the safety assessment SR-Site

    Energy Technology Data Exchange (ETDEWEB)

    2010-12-15

    The purpose of this report is to document current scientific knowledge on climate and climate-related conditions, relevant to the long-term safety of a KBS-3 repository, to a level required for an adequate treatment in the safety assessment SR-Site. The report also presents a number of dedicated studies on climate and selected climate-related processes of relevance for the assessment of long term repository safety. Based on this information, the report presents a number of possible future climate developments for Forsmark, the site selected for building a repository for spent nuclear fuel in Sweden (Figure 1-1). The presented climate developments are used as basis for the selection and analysis of SR-Site safety assessment scenarios in the SR-Site main report /SKB 2011/. The present report is based on research conducted and published by SKB as well as on research reported in the general scientific literature

  3. Construction Site Workers’ Awareness on Using Safety Equipment: Case Study

    Directory of Open Access Journals (Sweden)

    Ulang N. Md

    2014-01-01

    Full Text Available Construction sector is an important sector and contributed significantly to national development. However, this sector poses higher risk to accident. This is due to fact that construction site can be considered as a dangerous zone to workers and to the public. Due to the variety of cases occurs on site, the contractor will usually have to pay the cost related to accidents in the form of higher insurance premium. Despite various measures, accidents still occur at construction sites. Personal Protective Equipment (PPE is one of the important means to protect the wearer from hazards in the workplace. Since this equipment is the last frontier of the wearer from worksite hazards, it is important to select it based on the job scope and the intended protection. Therefore, this study was formulated to find out the level of knowledge and awareness of construction workers on PPE usage. It was also important to know what make the workers would want or do not want to use the PPE. It was found in this study that the level of awareness and knowledge among workers on the proper use of PPE is moderate. Construction sites accident can be further be reduced with proper implementation of PPE voluntarily by all workers.

  4. SAFETY HEALTH IMPACTS OF PARTICULATE MATTER FROM EXCAVATION WORK SITES

    Directory of Open Access Journals (Sweden)

    Giuseppe Pizzo

    2012-01-01

    Full Text Available Epidemiological studies have shown a linear relationship between airborne particulates and effects on human health. This study examines the risk that can be run by populations which are exposed to significant pollutant sources such as excavation in urban areas for renovation work. The health risk assessment methodology defined by the WHO air quality guidelines for Europe was applied to assess the possible health effects from exposure to PM10 for daily average concentrations greater than 50 µg m-3 and greater than 100 µg m-3 for three consecutive days and for increments of 10 µg m-3. The methodology adopted was based on daily average concentrations detected in a monitoring period of 8 months in different areas in and around the excavation work site with concentrations of PM10 below or above the legal limits. The exposure estimates calculated show that urban areas with excavation work sites are damaging to human health, due to the large number of people exposed and the already high concentrations of PM10 within cities. It was found that even when in parts of a work site legal limits of PM10 are not exceeded, adverse effects on health still occur. The application, in the present study, of the WHO methodology of exposure assessment indicates the risk ratio for effects on human health. Epidemiological data do not suggest exposition threshold values below which there are no adverse health effects. It is not possible to identify a PM10 concentration value, attributable to an additional source, such as an excavation work site, below which there is no damage. The purpose of this research is therefore to stimulate debate and decisions by public authorities, in order to deepen knowledge and to address issues related to airborne particulates.

  5. Strategies for effective management of health and safety in confined site construction

    Directory of Open Access Journals (Sweden)

    John Spillane

    2013-12-01

    Full Text Available Purpose: The overall aim of this research is to identify and catalogue the numerous managerial strategies for effective management of health and safety on a confined, urban, construction site. Design/Methodology/Approach: This is achieved by utilising individual interviews, focus groups discussion on selected case studies of confined construction sites, coupled with a questionnaire survey. Findings: The top five key strategies include (1 Employ safe system of work plans to mitigate personnel health and safety issues; (2 Inform personnel, before starting on-site, of the potential issues using site inductions; (3 Effective communication among site personnel; (4 Draft and implement an effective design site layout prior to starting on-site; and (5 Use of banksman (traffic co-ordinator to segregate personnel from vehicular traffic. Practical Implication: The construction sector is one of the leading industries in accident causation and with the continued development and regeneration of our urban centres, confined site construction is quickly becoming the norm - an environment which only fuels accident creation within the construction sector. Originality/Value: This research aids on-site management that requires direction and assistance in the identification and implementation of key strategies for the management of health and safety, particularly in confined construction site environments.

  6. Strategies for effective management of health and safety in confined site construction

    Directory of Open Access Journals (Sweden)

    John Spillane

    2013-12-01

    Full Text Available Purpose: The overall aim of this research is to identify and catalogue the numerous managerial strategies for effective management of health and safety on a confined, urban, construction site. Design/Methodology/Approach: This is achieved by utilising individual interviews, focus groups discussion on selected case studies of confined construction sites, coupled with a questionnaire survey. Findings: The top five key strategies include (1 Employ safe system of work plans to mitigate personnel health and safety issues; (2 Inform personnel, before starting on-site, of the potential issues using site inductions; (3 Effective communication among site personnel; (4 Draft and implement an effective design site layout prior to starting on-site; and (5 Use of banksman (traffic co-ordinator to segregate personnel from vehicular traffic. Practical Implication: The construction sector is one of the leading industries in accident causation and with the continued development and regeneration of our urban centres, confined site construction is quickly becoming the norm - an environment which only fuels accident creation within the construction sector. Originality/Value: This research aids on-site management that requires direction and assistance in the identification and implementation of key strategies for the management of health and safety, particularly in confined construction site environments.

  7. Preliminary safety evaluation for the Forsmark area. Based on data and site descriptions after the initial site investigation stage

    Energy Technology Data Exchange (ETDEWEB)

    Andersson, Johan [JA Streamflow AB, Aelvsjoe (Sweden)

    2005-08-01

    The main objectives of this Preliminary Safety Evaluation (PSE) of the Forsmark area have been to determine, with limited efforts, whether the feasibility study's judgement of the suitability of the candidate area with respect to long-term safety holds up in the light of the actual site investigation data; to provide feedback to continued site investigations and site-specific repository design and to identify site-specific scenarios and geoscientific issues for further analyses. The PSE focuses on comparing the attained knowledge of the sites with the suitability criteria as set out by SKB. The PSE does not aim at comparing sites and does not assess compliance with safety and radiation protection criteria. The evaluation shows that, even considering remaining uncertainties, the Forsmark area meets all stated safety requirements and preferences. Consequently, from a safety point of view, there is no reason not to continue the Site Investigations of the Forsmark area. There are still uncertainties to resolve and the safety would eventually need to be verified through a full safety assessment. Nevertheless, this Preliminary Safety Evaluation demonstrates that it is likely that a safe repository for spent nuclear fuel of the KBS-3 type could be constructed at the site. The following feedback is provided to the site investigations and the associated site modelling: Reducing the uncertainty on the deformation zone geometry inside the target area would be needed to more firmly define locations of the suitable deposition volumes. There is substantial uncertainty in the Discrete Fracture Network model. Further reduction of the uncertainties, if needed, would probably only be possible from the underground, detailed investigation phase. Efforts need also be spent on improving the DFN-modelling. There are assumptions made in current models that could be challenged and there seems to be room for better use of the borehole information. It is particularly important to

  8. Preliminary safety evaluation for the Forsmark area. Based on data and site descriptions after the initial site investigation stage

    Energy Technology Data Exchange (ETDEWEB)

    Andersson, Johan [JA Streamflow AB, Aelvsjoe (Sweden)

    2005-08-01

    The main objectives of this Preliminary Safety Evaluation (PSE) of the Forsmark area have been to determine, with limited efforts, whether the feasibility study's judgement of the suitability of the candidate area with respect to long-term safety holds up in the light of the actual site investigation data; to provide feedback to continued site investigations and site-specific repository design and to identify site-specific scenarios and geoscientific issues for further analyses. The PSE focuses on comparing the attained knowledge of the sites with the suitability criteria as set out by SKB. The PSE does not aim at comparing sites and does not assess compliance with safety and radiation protection criteria. The evaluation shows that, even considering remaining uncertainties, the Forsmark area meets all stated safety requirements and preferences. Consequently, from a safety point of view, there is no reason not to continue the Site Investigations of the Forsmark area. There are still uncertainties to resolve and the safety would eventually need to be verified through a full safety assessment. Nevertheless, this Preliminary Safety Evaluation demonstrates that it is likely that a safe repository for spent nuclear fuel of the KBS-3 type could be constructed at the site. The following feedback is provided to the site investigations and the associated site modelling: Reducing the uncertainty on the deformation zone geometry inside the target area would be needed to more firmly define locations of the suitable deposition volumes. There is substantial uncertainty in the Discrete Fracture Network model. Further reduction of the uncertainties, if needed, would probably only be possible from the underground, detailed investigation phase. Efforts need also be spent on improving the DFN-modelling. There are assumptions made in current models that could be challenged and there seems to be room for better use of the borehole information. It is particularly important to

  9. Safety leadership at construction sites: the importance of rule-oriented and participative leadership.

    Science.gov (United States)

    Grill, Martin; Pousette, Anders; Nielsen, Kent; Grytnes, Regine; Törner, Marianne

    2017-07-01

    Objectives The construction industry accounted for >20% of all fatal occupational accidents in Europe in 2014. Leadership is an essential antecedent to occupational safety. The aim of the present study was to assess the influence of transformational, active transactional, rule-oriented, participative, and laissez-faire leadership on safety climate, safety behavior, and accidents in the Swedish and Danish construction industry. Sweden and Denmark are similar countries but have a large difference in occupational accidents rates. Methods A questionnaire study was conducted among a random sample of construction workers in both countries: 811 construction workers from 85 sites responded, resulting in site and individual response rates of 73% and 64%, respectively. Results The results indicated that transformational, active transactional, rule-oriented and participative leadership predict positive safety outcomes, and laissez-faire leadership predict negative safety outcomes. For example, rule-oriented leadership predicts a superior safety climate (β=0.40, Pconstruction industry, which may partly explain the difference in occupational accident rates. Conclusions Applying less laissez-faire leadership and more transformational, active transactional, participative and rule-oriented leadership appears to be an effective way for construction site managers to improve occupational safety in the industry.

  10. The occupational safety on the construction sites of the farm production buildings in Finland

    Directory of Open Access Journals (Sweden)

    M. Hellstedt

    2013-09-01

    Full Text Available The size of farms has increased considerably during Finland's EU membership. The growth has meant big investments in the new production buildings. The buildings have been switched to big industrialhall- like constructions from small-scale ones which have contained own timber and own work contribution. The objective of the project financed by Farmers' Social Insurance Institution was to improve occupational safety on farm building construction and renovation sites by disseminating current safety practices and by developing ways of action which are better than the prevailing ones. The project consisted of a literature review, statistical analysis, as well as a farmer and designer interviews. In the statistical analysis the MATA occupational injuries insurance claims database on farmers’ claims during construction and renovation work for the years 2005 - 2008 was compared with the register of Federation of Accident Insurance Institutions on the construction workers' injuries. In comparing the reasons of the accidents a clear difference was found; poor scaffoldings and ladders are still the main culprits on farm accidents. Farmer interviews were used to assess occupational safety measures on the construction site, occurred injuries and their types, nearmiss situations and the underlying factors which have led to the injuries. Also construction safety deficiencies as well as the direct and indirect costs caused for instance because of the delay in completion of construction project were discussed. Designer interviews aimed to find out how occupational safety and health considerations are taken into account in farm building planning and counseling, and how this experience of the designers should be utilized in order to improve safety at the construction sites on farms. Farmers knew their obligations on occupational safety poorly. The situation was further worsened by the fact that on the site the supervisor tasks were only nominally executed. The

  11. Alcohol abuse, road traffic and safety on the site

    CERN Multimedia

    DSU Department

    2008-01-01

    In the light of the serious road accident that occurred on 3 February 2008, you are reminded that: the legal blood alcohol limit in force under the Host States’ traffic regulations (0.5 g per 1000 ml of blood) also applies on the CERN site; the consumption of alcohol is forbidden during working hours and is only tolerated in the restaurants at certain times, unless an exception is granted for special events; failure to observe these rules may result in disciplinary action by the Organization, independently of any sanctions that may be applicable pursuant to the road traffic regulations of the Host State concerned. Furthermore, the Reception and Access Control Service, the site guards and the Fire Brigade have been instructed to stop any driver in an obvious state of intoxication and to ask him to abandon his vehicle on the spot. In case of disagreement, they may also suggest that he submits to a voluntary blood alcohol level test at the CERN Medical Service or Fire Brigade...

  12. Reminder: Alcohol abuse, road traffic and safety on the site

    CERN Multimedia

    HSE Unit

    2011-01-01

    You are reminded that: - the legal blood alcohol limit in force under the Host States’ traffic regulations (0.5 g per 1000 ml of blood) also applies on the CERN site; - the consumption of alcohol is forbidden during working hours and is only tolerated in the restaurants at certain times, unless an exception is granted for special events (Operational Circular No. 8); - failure to observe these rules may result in disciplinary action by the Organization, independently of any sanctions that may be applicable pursuant to the road traffic regulations of the Host State concerned. Furthermore, the Reception and Access Control Service, the site guards and the Fire Brigade have been instructed to stop any driver in an obvious state of intoxication and to ask him/her to abandon the vehicle on the spot. In case of disagreement, they may also suggest that he/she submits to a voluntary blood alcohol level test at the CERN Medical Service or Fire Brigade. They will also stop and question any obviously intoxicate...

  13. Alcohol abuse, road traffic and safety on the site

    CERN Document Server

    DSU Department

    2008-01-01

    In the light of the serious road accident that occurred on 3 February 2008, you are reminded that: the legal blood alcohol limit in force under the Host States’ traffic regulations (0.5 g per 1000 ml of blood) also applies on the CERN site; the consumption of alcohol is forbidden during working hours and is only tolerated in the restaurants at certain times, unless an exception is granted for special events; failure to observe these rules may result in disciplinary action by the Organization, independently of any sanctions that may be applicable pursuant to the road traffic regulations of the Host State concerned. Furthermore, the Reception and Access Control Service, the site guards and the Fire Brigade have been instructed to stop any driver in an obvious state of intoxication and to ask him to abandon his vehicle on the spot. In case of disagreement, they may also suggest that he submits to a voluntary blood alcohol level test at the CERN Medical Service or Fire Brigade...

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

    Energy Technology Data Exchange (ETDEWEB)

    Boenigke, Guenther; Eismar, Shanna

    2016-03-15

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

  15. 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....

  16. 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....

  17. Oak Ridge National Laboratory site data for safety-analysis report

    Energy Technology Data Exchange (ETDEWEB)

    Fitzpatrick, F.C.

    1982-12-01

    The Oak Ridge National Laboratory site data contained herein were compiled in support of the United States Department of Energy (USDOE) Oak Ridge Operations Office Order OR 5481.1. That order sets forth assignment of responsibilities for safety analysis and review responsibilities and provides guidance relative to the content and format of safety analysis reports. The information presented in this document is intended for use by reference in individual safety analysis reports where applicable to support accident analyses or the establishment of design bases of significance to safety, and it is applicable only to Oak Ridge National Laboratory facilities in Bethel and Melton Valleys. This information includes broad descriptions of the site characteristics, radioactive waste handling and monitoring practices, and the organization and operating policies at Oak Ridge National Laboratory. The historical background of the Laboratory is discussed briefly and the overall physical situation of the facilities is described in the following paragraphs.

  18. Generics and the specific features of their regulation

    Directory of Open Access Journals (Sweden)

    E. A. Ushkalova

    2016-01-01

    Full Text Available The article discusses the factors that influence the efficacy and safety of generic drugs, including regular generics, biosimilars, and generic nonbiological complex drugs. It emphasizes the importance of adequate regulatory requirements to provide a comparable therapeutic efficacy and a comparable cost-effectiveness ratio for generics versus brand-name drugs.

  19. Criticality Safety Evaluation of Hanford Site High Level Waste Storage Tanks

    Energy Technology Data Exchange (ETDEWEB)

    ROGERS, C.A.

    2000-02-17

    This criticality safety evaluation covers operations for waste in underground storage tanks at the high-level waste tank farms on the Hanford site. This evaluation provides the bases for criticality safety limits and controls to govern receipt, transfer, and long-term storage of tank waste. Justification is provided that a nuclear criticality accident cannot occur for tank farms operations, based on current fissile material and operating conditions.

  20. Public safety risk management at socio-economic and / or historic-cultural significant dam sites

    Energy Technology Data Exchange (ETDEWEB)

    Earle, Gordon D.; Ryan, Katherine; Pyykonen, Nicole K.; Pitts, Lucas [Otonabee Region Conservation Authority, Peterborough, (Canada)

    2010-07-01

    The Lang Dam and adjoining gristmill, located near Peterborough are integral parts of the Lang Pioneer Village museum. Activities occurring within close proximity to the dam have led to safety issues. The owner (ORCA) has developed and implemented public safety management plans (PSMPs) for each of its water control structures, including the Lang Dam. ORCA gave special attention to the social, economic, aesthetic, historic and cultural dimensions associated the implementation of public safety management plans. These factors play a significant role in how well public safety measures (PSMs) are received by stakeholder groups and the general public. This paper reported the challenges of developing and implementing a PSMP for the Lang Dam, with the focus on property site-specific PSMS while preserving socio-economic and historic-cultural character and values. It was demonstrated that the dam owners, regulatory authorities, control agencies and preservationists need to come together to develop a holistic public safety management process.

  1. Workers’ Age and the Impact of Psychological Factors on the Perception of Safety at Construction Sites

    Directory of Open Access Journals (Sweden)

    Muhammad Dawood Idrees

    2017-05-01

    Full Text Available The safety of construction workers is always a major concern at construction sites as the construction industry is inherently dangerous with many factors influencing worker safety. Several studies concluded that psychological factors such as workload, organizational relationships, mental stress, job security, and job satisfaction have significant effects on workers’ safety. However, research on psychological factors that are characteristic of different age groups have been limited. The aim of this study was to examine the impact of psychological factors on the perception of worker safety for two different age groups. After an extensive literature review, different psychological factors were identified, and a hypothetical research model was developed based on psychological factors that could affect workers’ perception of safety. A survey instrument was developed, and data were collected from seven different construction sites in Pakistan. Structural equation modeling (SEM was employed to test the hypothetical model for both age groups. The results revealed that workload and job satisfaction are significantly dominant factors on workers’ perception of safety in older workers, whereas organizational relationships, mental stress, and job security are dominant factors for younger workers at construction sites.

  2. Lawrence Livermore National Laboratory Site Seismic Safety Program: Summary of Findings

    Energy Technology Data Exchange (ETDEWEB)

    Savy, J B; Foxall, W

    2002-04-01

    The Lawrence Livermore National Laboratory (LLNL) Site Seismic Safety Program was conceived in 1979 during the preparation of the site Draft Environmental Impact Statement. The impetus for the program came from the development of new methodologies and geologic data that affect assessments of geologic hazards at the LLNL site; it was designed to develop a new assessment of the seismic hazard to the LLNL site and LLNL employees. Secondarily, the program was also intended to provide the technical information needed to make ongoing decisions about design criteria for future construction at LLNL and about the adequacy of existing facilities. This assessment was intended to be of the highest technical quality and to make use of the most recent and accepted hazard assessment methodologies. The basic purposes and objectives of the current revision are similar to those of the previous studies. Although all the data and experience assembled in the previous studies were utilized to their fullest, the large quantity of new information and new methodologies led to the formation of a new team that includes LLNL staff and outside consultants from academia and private consulting firms. A peer-review panel composed of individuals from academia (A. Cornell, Stanford University), the Department of Energy (DOE; Jeff Kimball), and consulting (Kevin Coppersmith), provided review and guidance. This panel was involved from the beginning of the project in a ''participatory'' type of review. The Senior Seismic Hazard Analysis Committee (SSHAC, a committee sponsored by the U.S. Nuclear Regulatory Commission, DOE, and the Electric Power Research Institute) strongly recommends the use of participatory reviews, in which the reviewers follow the progress of a project from the beginning, rather than waiting until the end to provide comments (Budnitz et al., 1997). Following the requirements for probabilistic seismic hazard analysis (PSHA) stipulated in the DOE standard DOE

  3. Lawrence Livermore National Laboratory Site Seismic Safety Program: Summary of Findings

    Energy Technology Data Exchange (ETDEWEB)

    Savy, J B; Foxall, W

    2002-04-01

    The Lawrence Livermore National Laboratory (LLNL) Site Seismic Safety Program was conceived in 1979 during the preparation of the site Draft Environmental Impact Statement. The impetus for the program came from the development of new methodologies and geologic data that affect assessments of geologic hazards at the LLNL site; it was designed to develop a new assessment of the seismic hazard to the LLNL site and LLNL employees. Secondarily, the program was also intended to provide the technical information needed to make ongoing decisions about design criteria for future construction at LLNL and about the adequacy of existing facilities. This assessment was intended to be of the highest technical quality and to make use of the most recent and accepted hazard assessment methodologies. The basic purposes and objectives of the current revision are similar to those of the previous studies. Although all the data and experience assembled in the previous studies were utilized to their fullest, the large quantity of new information and new methodologies led to the formation of a new team that includes LLNL staff and outside consultants from academia and private consulting firms. A peer-review panel composed of individuals from academia (A. Cornell, Stanford University), the Department of Energy (DOE; Jeff Kimball), and consulting (Kevin Coppersmith), provided review and guidance. This panel was involved from the beginning of the project in a ''participatory'' type of review. The Senior Seismic Hazard Analysis Committee (SSHAC, a committee sponsored by the U.S. Nuclear Regulatory Commission, DOE, and the Electric Power Research Institute) strongly recommends the use of participatory reviews, in which the reviewers follow the progress of a project from the beginning, rather than waiting until the end to provide comments (Budnitz et al., 1997). Following the requirements for probabilistic seismic hazard analysis (PSHA) stipulated in the DOE standard DOE

  4. Acquisition system for the "EMSO Generic Instrument Module" (EGIM) and analysis of the data obtained during its first deployment at OBSEA site (Spain)

    Science.gov (United States)

    Garcia, Oscar; Mihai Toma, Daniel; Dañobeitia, Juanjo; del Rio, Joaquin; Bartolome, Rafael; Martínez, Enoc; Nogueras, Marc; Bghiel, Ikram; Lanteri, Nadine; Rolin, Jean Francois; Beranzoli, Laura; Favali, Paolo

    2017-04-01

    The EMSODEV project (EMSO implementation and operation: DEVelopment of instrument module) is an Horizon-2020 UE project whose overall objective is the operation of eleven seafloor observatories and four test sites. These infrastructures are distributed throughout European seas, from the Arctic across the Atlantic and the Mediterranean to the Black Sea, and are managed by the European consortium EMSO-ERIC (European Research Infrastructure Consortium) with the participation of 8 European countries and other associated partners. Recently, we have implemented a Generic Sensor Module (EGIM) within the EMSO-ERIC distributed marine research infrastructure. EGIM is able to operate on any EMSO observatory node, mooring line, seabed station, cabled or non-cabled and surface buoy. The main role of EGIM is to measure homogeneously a set of core variables using the same hardware, sensor references, qualification methods, calibration methods, data format and access, maintenance procedures in several European ocean locations. The EGIM module acquires a wide range of ocean parameters in a long-term consistent, accurate and comparable manner from disciplines such as biology, geology, chemistry, physics, engineering, and computer science, from polar to subtropical environments, through the water column down to the deep sea. Our work includes developing standard-compliant generic software for Sensor Web Enablement (SWE) on EGIM and to perform the first onshore and offshore test bench, to support the sensors data acquisition on a new interoperable EGIM system. EGIM in its turn is linked to an acquisition drives processes, a centralized Sensor Observation Service (SOS) server and a laboratory monitor system (LabMonitor) that records events and alarms during acquisition. The measurements recorded along EMSO NODES are essential to accurately respond to the social and scientific challenges such as climate change, changes in marine ecosystems, and marine hazards. This presentation shows

  5. Hanford Site Environmental Safety and Health Fiscal Year 2001 Budget-Risk management summary

    Energy Technology Data Exchange (ETDEWEB)

    REEP, I.E.

    1999-05-12

    The Hanford Site Environment, Safety and Health (ES&H) Budget-Risk Management Summary report is prepared to support the annual request to sites in the U.S. Department of Energy (DOE) Complex by DOE, Headquarters. The request requires sites to provide supplementary crosscutting information related to ES&H activities and the ES&H resources that support these activities. The report includes the following: (1) A summary status of fiscal year (FY) 1999 ES&H performance and ES&H execution commitments; (2)Status and plans of Hanford Site Office of Environmental Management (EM) cleanup activities; (3) Safety and health (S&H) risk management issues and compliance vulnerabilities of FY 2001 Target Case and Below Target Case funding of EM cleanup activities; (4) S&H resource planning and crosscutting information for FY 1999 to 2001; and (5) Description of indirect-funded S&H activities.

  6. Trephination of the equine rostral maxillary sinus: efficacy and safety of two trephine sites.

    Science.gov (United States)

    Barakzai, Safia Z; Kane-Smyth, Justine; Lowles, Joanna; Townsend, Neil

    2008-04-01

    To examine 2 rostral maxillary sinus (RMS) trephine sites for safety and efficacy using skulls of horses of varying age. Descriptive study. Cadaveric equine skulls (n=40). Two RMS trephination sites (rostral, caudal) were made in each skull. Radiographic projections using markers at each site were used to determine if sites were within the RMS and directly overlying a cheek tooth. Sinusotomy in 14 skulls was used to determine correlation between radiographic and anatomic location of trephine sites, and of the rostrolateral aspect of the maxillary septum. Age-related risk of trephine site being directly over a cheek tooth was determined using logistic regression. Trephine site was within the RMS in 98% of skulls using the rostral portal and 68% using the caudal portal. The rostral site was over a cheek tooth in 18% of skulls compared with 10% using the caudal site. There was a significant negative relationship between the trephine site overlying a tooth and horse age for rostral (P=.02) and caudal (P=.03) sites. The radiographic appearance of the maxillary septum correlated to the rostrolateral portion of the septum in 12 of 14 skulls that had sinusotomy. The rostral RMS trephine portal is more reliable than the caudal site for entering the RMS. Horses trephine site overlying a cheek tooth and we advise that RMS trephination in this age group be performed with radiographic guidance.

  7. Environmental Management Waste Management Facility (EMWMF) Site-Specific Health and Safety Plan, Oak Ridge, Tennessee

    Energy Technology Data Exchange (ETDEWEB)

    Flynn, N.C. Bechtel Jacobs

    2008-04-21

    The Bechtel Jacobs Company LLC (BJC) policy is to provide a safe and healthy workplace for all employees and subcontractors. The implementation of this policy requires that operations of the Environmental Management Waste Management Facility (EMWMF), located one-half mile west of the U.S. Department of Energy (DOE) Y-12 National Security Complex, be guided by an overall plan and consistent proactive approach to environment, safety and health (ES&H) issues. The BJC governing document for worker safety and health, BJC/OR-1745, 'Worker Safety and Health Program', describes the key elements of the BJC Safety and Industrial Hygiene (IH) programs, which includes the requirement for development and implementation of a site-specific Health and Safety Plan (HASP) where required by regulation (refer also to BJC-EH-1012, 'Development and Approval of Safety and Health Plans'). BJC/OR-1745, 'Worker Safety and Health Program', implements the requirements for worker protection contained in Title 10 Code of Federal Regulations (CFR) Part 851. The EMWMF site-specific HASP requirements identifies safe operating procedures, work controls, personal protective equipment, roles and responsibilities, potential site hazards and control measures, site access requirements, frequency and types of monitoring, site work areas, decontamination procedures, and outlines emergency response actions. This HASP will be available on site for use by all workers, management and supervisors, oversight personnel and visitors. All EMWMF assigned personnel will be briefed on the contents of this HASP and will be required to follow the procedures and protocols as specified. The policies and procedures referenced in this HASP apply to all EMWMF operations activities. In addition the HASP establishes ES&H criteria for the day-to-day activities to prevent or minimize any adverse effect on the environment and personnel safety and health and to meet standards that define acceptable

  8. Buffer, backfill and closure process report for the safety assessment SR-Site

    Energy Technology Data Exchange (ETDEWEB)

    Sellin, Patrik (ed.)

    2010-11-15

    This report gives an account of how processes in buffer, deposition tunnel backfill and the closure important for the long-term evolution of a KBS-3 repository for spent nuclear fuel, will be documented in the safety assessment SR-Site

  9. WAG 2 remedial investigation and site investigation site-specific work plan/health and safety checklist for the sediment transport modeling task

    Energy Technology Data Exchange (ETDEWEB)

    Holt, V.L.; Baron, L.A.

    1994-05-01

    This site-specific Work Plan/Health and Safety Checklist (WP/HSC) is a supplement to the general health and safety plan (HASP) for Waste Area Grouping (WAG) 2 remedial investigation and site investigation (WAG 2 RI&SI) activities [Health and Safety Plan for the Remedial Investigation and Site Investigation of Waste Area Grouping 2 at the Oak Ridge National Laboratory, Oak Ridge, Tennessee (ORNL/ER-169)] and provides specific details and requirements for the WAG 2 RI&SI Sediment Transport Modeling Task. This WP/HSC identifies specific site operations, site hazards, and any recommendations by Oak Ridge National Laboratory (ORNL) health and safety organizations [i.e., Industrial Hygiene (IH), Health Physics (HP), and/or Industrial Safety] that would contribute to the safe completion of the WAG 2 RI&SI. Together, the general HASP for the WAG 2 RI&SI (ORNL/ER-169) and the completed site-specific WP/HSC meet the health and safety planning requirements specified by 29 CFR 1910.120 and the ORNL Hazardous Waste Operations and Emergency Response (HAZWOPER) Program Manual. In addition to the health and safety information provided in the general HASP for the WAG 2 RI&SI, details concerning the site-specific task are elaborated in this site-specific WP/HSC, and both documents, as well as all pertinent procedures referenced therein, will be reviewed by all field personnel prior to beginning operations.

  10. Site-specific temporal and spatial validation of a generic plant pest forecast system with observations of Bactrocera dorsalis (oriental fruit fly).

    Science.gov (United States)

    This study introduces a simple generic model, the Generic Pest Forecast System (GPFS), for simulatingthe relative populations of non-indigenousarthropod pests in space and time. The model was designed to calculate the population index or relative population using hourly weather dataas influenced by...

  11. US Department of Energy DOE Nevada Operations Office, Nevada Test Site: Underground safety and health standards

    Energy Technology Data Exchange (ETDEWEB)

    1993-05-01

    The Nevada Test Site Underground Safety and Health Standards Working Group was formed at the direction of John D. Stewart, Director, Nevada Test Site Office in April, 1990. The objective of the Working Group was to compile a safety and health standard from the California Tunnel Safety Orders and OSHA for the underground operations at the NTS, (excluding Yucca Mountain). These standards are called the NTS U/G Safety and Health Standards. The Working Group submits these standards as a RECOMMENDATION to the Director, NTSO. Although the Working Group considers these standards to be the most integrated and comprehensive standards that could be developed for NTS Underground Operations, the intent is not to supersede or replace any relevant DOE orders. Rather the intent is to collate the multiple safety and health references contained in DOE Order 5480.4 that have applicability to NTS Underground Operations into a single safety and heath standard to be used in the underground operations at the NTS. Each portion of the standard was included only after careful consideration by the Working Group and is judged to be both effective and appropriate. The specific methods and rationale used by the Working Group are outlined as follows: The letter from DOE/HQ, dated September 28, 1990 cited OSHA and the CTSO as the safety and health codes applicable to underground operations at the NTS. These mandated codes were each originally developed to be comprehensive, i.e., all underground operations of a particular type (e.g., tunnels in the case of the CTSO) were intended to be adequately regulated by the appropriate code. However, this is not true; the Working Group found extensive and confusing overlap in the codes in numerous areas. Other subjects and activities were addressed by the various codes in cursory fashion or not at all.

  12. Generic medications in ophthalmology.

    Science.gov (United States)

    Zore, Matt; Harris, Alon; Tobe, Leslie Abrams; Siesky, Brent; Januleviciene, Ingrida; Behzadi, Jennifer; Amireskandari, Annahita; Egan, Patrick; Garff, Kevin; Wirostko, Barbara

    2013-03-01

    The purpose of this review is to discuss the process of genericisation of medications in the US and Europe with a focus on ophthalmic drugs. Regulatory guidelines of the US Food and Drug Administration and the European Medicines Agency will be discussed, and the advantages and concerns of genericisation will be explored. We will look at various studies concerning the safety and efficacy of generic drugs compared to their branded counterparts. In particular, the challenges of assuring bioequivalence and therapeutic equivalence in topical ophthalmic drugs will be examined.

  13. US Department of Energy Environment, Safety and Health Progress Assessment of the Nevada Test Site

    Energy Technology Data Exchange (ETDEWEB)

    1992-08-01

    This report documents the result of the US Department of Energy (DOE) Environment, Safety, and Health (ES&H) Progress Assessment of the Nevada Test Site (NTS), Nye County, Nevada. The assessment, which was conducted from July 20 through August 4, 1992, included a selective review of the ES&H management systems and progress of the responsible DOE Headquarters Program Offices; the DOE Nevada Field Office (NV); and the site contractors. The ES&H Progress Assessments are part of the Secretary of Energy`s continuing effort to institutionalize line management accountability and the self-assessment process throughout DOE and its contractor organizations. This report presents a summary of issues and progress in the areas of environment, safety and health, and management.

  14. Department of the Navy Explosives Safety Site Approval Process Improvement Initiative

    Science.gov (United States)

    2010-07-01

    software deployment and sustainment within the DON for: • Automated Site Planning Tool ( ASPT )—ESSv6 • WebSAR • Explosives Safety Database The...Measures  Administrative Record for ESA  Configuration/Data Control of facility-related ES data for ASPT The NOSSA level roll-up of the...the DDESB by 30 December 2010. At this point, the following principles are guiding the development of the implementation plan:  Use DDESB ASPT

  15. On the Seismic Safety of Nuclear Power Plant Sites in South Korea

    Science.gov (United States)

    Choi, H.; Park, S.; Yang, J.; Shim, T.; Im, C. B.

    2016-12-01

    The Korean Peninsula is located at the far eastern part of Eurasian Plate, and within the intra-plate region several hundred km away from the nearest plate boundary. The earthquakes around the Korean Peninsula show the typical characteristics of intra-plate earthquakes. So to speak, those are low seismicity, relatively smaller magnitude than that of inter-plate earthquakes, and spatially irregular epicenters. There are 24 nuclear power plants (NPPs) in operation, 4 NPPs in completion of construction, and 4 NPPs in preparation of construction in South Korea. Even though the seismicity of the Korean Peninsula is known as relatively low, but because there are more than 30 NPPs within not so large territory, thorough the preparedness of NPPs' safety against earthquakes is required. The earthquake preparedness of NPPs in South Korea is composed of 4 stages: site election, design, construction and operation. Since regulatory codes and standards are strictly applied in each stage, the NPPs in South Korea are believed to be safe enough against the maximum potential earthquake ground motion. Through data analysis on geological and seismological characteristics of the region within a radius of 320 km from the site and the detailed geological survey of the area within a radius of 8 km from the site, the design earthquake ground motion of NPPs in South Korea is determined to be 0.2g (in case of newly constructed NPPs is 0.3g) considering the maximum potential earthquake ground motion and some safety margin. The ground motions and surface deformation caused by capable faults are also considered in the seismic design of NPPs. In addition, the Korea Institute of Nuclear Safety as a regulatory technical expert organization, has been operating independent real time earthquake monitoring network as a part of securing the seismic safety of NPP sites in South Korea since late 1990's. If earthquakes with more than magnitude 3.0 are occurred in the Korean Peninsula or the peak ground

  16. Development of the generic drug industry in the US after the Hatch-Waxman Act of 1984

    OpenAIRE

    Garth Boehm; Lixin Yao; Liang Han; Qiang Zheng

    2013-01-01

    The key events in the development of the US generic drug industry after the Hatch-Waxman Act of 1984 are systematically reviewed, including the process of approval for generic drugs, bioequivalence issues including “switchability”, bioequivalence for complicated dosage forms, patent extension, generic drug safety, generic substitution and low-cost generics. The backlog in generic review, generic drug user fees, and “quality by design” for generic drugs is also discussed. The evolution of the ...

  17. Determining Safety Inspection Thresholds for Employee Incentives Programs on Construction Sites.

    Science.gov (United States)

    Sparer, Emily; Dennerlein, Jack

    2013-01-01

    The goal of this project was to evaluate approaches of determining the numerical value of a safety inspection score that would activate a reward in an employee safety incentive program. Safety inspections are a reflection of the physical working conditions at a construction site and provide a safety score that can be used in incentive programs to reward workers. Yet it is unclear what level of safety should be used when implementing this kind of program. This study explored five ways of grouping safety inspection data collected during 19 months at Harvard University-owned construction projects. Each approach grouped the data by one of the following: owner, general contractor, project, trade, or subcontractor. The median value for each grouping provided the threshold score. These five approaches were then applied to data from a completed project in order to calculate the frequency and distribution of rewards in a monthly safety incentive program. The application of each approach was evaluated qualitatively for consistency, competitiveness, attainability, and fairness. The owner-specific approach resulted in a threshold score of 96.3% and met all of the qualitative evaluation goals. It had the most competitive reward distribution (only 1/3 of the project duration) yet it was also attainable. By treating all workers equally and maintaining the same value throughout the project duration, this approach was fair and consistent. The owner-based approach for threshold determination can be used by owners or general contractors when creating leading indicator incentives programs and by researchers in future studies on incentive program effectiveness.

  18. Design and implementation of an identification system in construction site safety for proactive accident prevention.

    Science.gov (United States)

    Yang, Huanjia; Chew, David A S; Wu, Weiwei; Zhou, Zhipeng; Li, Qiming

    2012-09-01

    Identifying accident precursors using real-time identity information has great potential to improve safety performance in construction industry, which is still suffering from day to day records of accident fatality and injury. Based on the requirements analysis for identifying precursor and the discussion of enabling technology solutions for acquiring and sharing real-time automatic identification information on construction site, this paper proposes an identification system design for proactive accident prevention to improve construction site safety. Firstly, a case study is conducted to analyze the automatic identification requirements for identifying accident precursors in construction site. Results show that it mainly consists of three aspects, namely access control, training and inspection information and operation authority. The system is then designed to fulfill these requirements based on ZigBee enabled wireless sensor network (WSN), radio frequency identification (RFID) technology and an integrated ZigBee RFID sensor network structure. At the same time, an information database is also designed and implemented, which includes 15 tables, 54 queries and several reports and forms. In the end, a demonstration system based on the proposed system design is developed as a proof of concept prototype. The contributions of this study include the requirement analysis and technical design of a real-time identity information tracking solution for proactive accident prevention on construction sites. The technical solution proposed in this paper has a significant importance in improving safety performance on construction sites. Moreover, this study can serve as a reference design for future system integrations where more functions, such as environment monitoring and location tracking, can be added.

  19. WAG 2 remedial investigation and site investigation site-specific work plan/health and safety checklist for the soil and sediment task. Environmental Restoration Program

    Energy Technology Data Exchange (ETDEWEB)

    Holt, V.L.; Burgoa, B.B.

    1993-12-01

    This document is a site-specific work plan/health and safety checklist (WP/HSC) for a task of the Waste Area Grouping 2 Remedial Investigation and Site Investigation (WAG 2 RI&SI). Title 29 CFR Part 1910.120 requires that a health and safety program plan that includes site- and task-specific information be completed to ensure conformance with health- and safety-related requirements. To meet this requirement, the health and safety program plan for each WAG 2 RI&SI field task must include (1) the general health and safety program plan for all WAG 2 RI&SI field activities and (2) a WP/HSC for that particular field task. These two components, along with all applicable referenced procedures, must be kept together at the work site and distributed to field personnel as required. The general health and safety program plan is the Health and Safety Plan for the Remedial Investigation and Site Investigation of Waste Area Grouping 2 at the Oak Ridge National Laboratory, Oak Ridge, Tennessee (ORNL/ER-169). The WP/HSCs are being issued as supplements to ORNL/ER-169.

  20. Biosphere models for safety assesment of radioactive waste disposal

    Energy Technology Data Exchange (ETDEWEB)

    Proehl, G.; Olyslaegers, G.; Zeevaert, T. [SCK/CEN, Mol (Belgium); Kanyar, B. [University of Veszprem (Hungary). Dept. of Radiochemistry; Pinedo, P.; Simon, I. [Centro de Investigaciones Energeticas Medioambientales y Tecnologicas (CIEMAT), Madrid (Spain); Bergstroem, U.; Hallberg, B. [Studsvik Ecosafe, Nykoeping (Sweden); Mobbs, S.; Chen, Q.; Kowe, R. [NRPB, Chilton, Didcot (United Kingdom)

    2004-07-01

    The aim of the BioMoSA project has been to contribute in the confidence building of biosphere models, for application in performance assessments of radioactive waste disposal. The detailed objectives of this project are: development and test of practical biosphere models for application in long-term safety studies of radioactive waste disposal to different European locations, identification of features, events and processes that need to be modelled on a site-specific rather than on a generic base, comparison of the results and quantification of the variability of site-specific models developed according to the reference biosphere methodology, development of a generic biosphere tool for application in long term safety studies, comparison of results from site-specific models to those from generic one, Identification of possibilities and limitations for the application of the generic biosphere model. (orig.)

  1. Supporting documents for LLL area 27 (410 area) safety analysis reports, Nevada Test Site

    Energy Technology Data Exchange (ETDEWEB)

    Odell, B. N. [comp.

    1977-02-01

    The following appendices are common to the LLL Safety Analysis Reports Nevada Test Site and are included here as supporting documents to those reports: Environmental Monitoring Report for the Nevada Test Site and Other Test Areas Used for Underground Nuclear Detonations, U. S. Environmental Protection Agency, Las Vegas, Rept. EMSL-LV-539-4 (1976); Selected Census Information Around the Nevada Test Site, U. S. Environmental Protection Agency, Las Vegas, Rept. NERC-LV-539-8 (1973); W. J. Hannon and H. L. McKague, An Examination of the Geology and Seismology Associated with Area 410 at the Nevada Test Site, Lawrence Livermore Laboratory, Livermore, Rept. UCRL-51830 (1975); K. R. Peterson, Diffusion Climatology for Hypothetical Accidents in Area 410 of the Nevada Test Site, Lawrence Livermore Laboratory, Livermore, Rept. UCRL-52074 (1976); J. R. McDonald, J. E. Minor, and K. C. Mehta, Development of a Design Basis Tornado and Structural Design Criteria for the Nevada Test Site, Nevada, Lawrence Livermore Laboratory, Livermore, Rept. UCRL-13668 (1975); A. E. Stevenson, Impact Tests of Wind-Borne Wooden Missiles, Sandia Laboratories, Tonopah, Rept. SAND 76-0407 (1976); and Hydrology of the 410 Area (Area 27) at the Nevada Test Site.

  2. Handling of future human actions in the safety assessment SR-Site

    Energy Technology Data Exchange (ETDEWEB)

    2010-12-15

    This report documents the future human actions, FHA, considered in the long-term safety analysis of a KBS-3 repository. The report is one of the supporting documents to the safety assessment SR-Site (see further the Main report /SKB 2011/). The purpose of this report is to provide an account of general considerations concerning FHA, the methodology applied in SR-Site to assess FHA, the aspects of FHA needed to be considered in the evaluation of their impact on a deep geological repository and to select and analyse representative scenarios for illustrative consequence analysis. The main focus of this report is a time period when institutional control has ceased to be effective, thereby permitting inadvertent intrusion. However, a brief discussion of the earlier period when the repository has been closed, sealed and continuously kept under institutional control is also provided. General The potential exposure to large quantities of radiotoxic material is an inescapable consequence of the deposition of spent nuclear fuel in a final repository, and consequently intrusion into the repository needs to be considered in repository design and safety assessment. In accordance with ICRP recommendations /ICRP 2000/, intrusion in the post-closure phase of institutional control and beyond is primarily prevented through the design of the repository. In addition to that there will presumably continue to be safeguards measures, preservation of information (record keeping) and possibly some sort of markers placed at the site. During the institutional control period, activities at the site have to be restricted or directed if they have the potential to interfere with or hinder surveillance of the site, but this does not necessarily rule out all forms of access to the area. Also the fact that the repository contains fissile materials is an important aspect. Control of safeguards measures will most likely be upheld by national as well as international agencies. Furthermore, the

  3. HTGR Generic Technology Program: safety, systems and component design and development. Quarterly progress report for the period ending March 31, 1978

    Energy Technology Data Exchange (ETDEWEB)

    1978-04-01

    The work documented includes HTGR safety and safety-related studies to better understand and more accurately define safety characteristics and safety margins of GCRs under postulated accident conditions. Also included are the design, analysis, and testing of th PCRV, liner, penetrations, thermal barrier, reactor internals, steam generator, CAHE, and rotating machinery. Design studies and analysis plus experimental procedures and results are discussed and, where appropriate, the data are presented in tables, graphs, and photographs.

  4. YUCCA MOUNTAIN SITE CHARACTERIZATIONS PROJECT TUNNEL BORING MACHINE (TBM) SYSTEM SAFETY ANALYSIS

    Energy Technology Data Exchange (ETDEWEB)

    N/A

    1997-02-19

    The purpose of this analysis is to systematically identify and evaluate hazards related to the tunnel boring machine (TBM) used in the Exploratory Studies Facility (ESF) at the Yucca Mountain Site Characterization Project. This process is an integral part of the systems engineering process; whereby safety is considered during planning, design, testing, and construction. Since the TBM is an ''as built'' system, the M&O is conducting the System Safety Analysis during the construction or assembly phase of the TBM. A largely qualitative approach was used since a radiological System Safety Analysis is not required. The risk assessment in this analysis characterizes the accident scenarios associated with the TBM in terms of relative risk and includes recommendations for mitigating all identified risks. The priority for recommending and implementing mitigation control features is: (1) Incorporate measures to reduce risks and hazards into the system/subsystem/component design, (2) add safety features and capabilities to existing designs, and (3) develop procedures and conduct training to increase worker awareness of potential hazards, on methods to reduce exposure to hazards, and on the actions required to avoid accidents or correct hazardous conditions. The scope of this analysis is limited to the TBM during normal operations, excluding hazards occurring during assembly and test of the TBM or maintenance of the TBM equipment.

  5. The Most Effective Safety Codes on Occupational Accidents Prevention in Construction Sites

    Directory of Open Access Journals (Sweden)

    Shirazeh Arghami

    2017-03-01

    Full Text Available Background: Rapid pace of the construction projects have led to safety negligence on the part of the contractors causing higher numbers of accidents in construction industry. Thus, over 2200 legal provisions have been established for the prevention of accidents on construction sites. Not only contractors are unable to implement all provisions, but also it is hard for regulatory bodies to implement all rules, but they are also hard to remember and attend to by regulatory forces. Therefore, identifying the set of codes with the highest effect on reducing accidents would be most beneficial. The aim of this study was to determine the most effective legal provisions in reducing accidents on construction sites in Zanjan city. Methods: In this study, 378 work-related accidents in construction sites in Zanjan city, already registered in the Labor Inspection Authority, were investigated .Then the codes that had not been respected in the construction industry accidents were identified. Effective codes were determined based on their frequency on Pareto chart. Results: Results indicated that out of 2200 legal matters, only 164 were broken in the accidents. Conclusion: Application of Pareto chart could raise safety professionals' awareness of the specific broken codes in accidents, thus draw higher attention to the codes.

  6. Real-Time Safety Risk Assessment Based on a Real-Time Location System for Hydropower Construction Sites

    Directory of Open Access Journals (Sweden)

    Hanchen Jiang

    2014-01-01

    Full Text Available The concern for workers’ safety in construction industry is reflected in many studies focusing on static safety risk identification and assessment. However, studies on real-time safety risk assessment aimed at reducing uncertainty and supporting quick response are rare. A method for real-time safety risk assessment (RTSRA to implement a dynamic evaluation of worker safety states on construction site has been proposed in this paper. The method provides construction managers who are in charge of safety with more abundant information to reduce the uncertainty of the site. A quantitative calculation formula, integrating the influence of static and dynamic hazards and that of safety supervisors, is established to link the safety risk of workers with the locations of on-site assets. By employing the hidden Markov model (HMM, the RTSRA provides a mechanism for processing location data provided by the real-time location system (RTLS and analyzing the probability distributions of different states in terms of false positives and negatives. Simulation analysis demonstrated the logic of the proposed method and how it works. Application case shows that the proposed RTSRA is both feasible and effective in managing construction project safety concerns.

  7. Real-time safety risk assessment based on a real-time location system for hydropower construction sites.

    Science.gov (United States)

    Jiang, Hanchen; Lin, Peng; Fan, Qixiang; Qiang, Maoshan

    2014-01-01

    The concern for workers' safety in construction industry is reflected in many studies focusing on static safety risk identification and assessment. However, studies on real-time safety risk assessment aimed at reducing uncertainty and supporting quick response are rare. A method for real-time safety risk assessment (RTSRA) to implement a dynamic evaluation of worker safety states on construction site has been proposed in this paper. The method provides construction managers who are in charge of safety with more abundant information to reduce the uncertainty of the site. A quantitative calculation formula, integrating the influence of static and dynamic hazards and that of safety supervisors, is established to link the safety risk of workers with the locations of on-site assets. By employing the hidden Markov model (HMM), the RTSRA provides a mechanism for processing location data provided by the real-time location system (RTLS) and analyzing the probability distributions of different states in terms of false positives and negatives. Simulation analysis demonstrated the logic of the proposed method and how it works. Application case shows that the proposed RTSRA is both feasible and effective in managing construction project safety concerns.

  8. Final Review of Safety Assessment Issues at Savannah River Site, August 2011

    Energy Technology Data Exchange (ETDEWEB)

    Napier, Bruce A.; Rishel, Jeremy P.; Bixler, Nathan E.

    2011-12-15

    At the request of Savannah River Nuclear Solutions (SRNS) management, a review team composed of experts in atmospheric transport modeling for environmental radiation dose assessment convened at the Savannah River Site (SRS) on August 29-30, 2011. Though the meeting was prompted initially by suspected issues related to the treatment of surface roughness inherent in the SRS meteorological dataset and its treatment in the MELCOR Accident Consequence Code System Version 2 (MACCS2), various topical areas were discussed that are relevant to performing safety assessments at SRS; this final report addresses these topical areas.

  9. Safety Evaluation Report Restart of K-Reactor Savannah River Site

    Energy Technology Data Exchange (ETDEWEB)

    1991-10-01

    In April 1991, the Department of Energy (DOE) issued DOE/DP-0084T, Safety Evaluation Report Restart of K-Reactor Savannah River Site.'' The Safety Evaluation Report (SER) documents the results of DOE reviews and evaluations of the programmatic aspects of a large number of issues necessary to be satisfactorily addressed before restart. The issues were evaluated for compliance with the restart criteria included in the SER. The results of those evaluations determined that the restart criteria had been satisfied for some of the issues. However, for most of the issues at least part of the applicable restart criteria had not been found to be satisfied at the time the evaluations were prepared. For those issues, open or confirmatory items were identified that required resolution. In August 1991, DOE issued DOE/DP-0090T, Safety Evaluation Report Restart of K-Reactor Savannah River Site Supplement 1.'' That document was the first Supplement to the April 1991 SER, and documented the resolution of 62 of the open items identified in the SER. This document is the second Supplement to the April 1991 SER. This second SER Supplement documents the resolution of additional open times identified in the SER, and includes a complete list of all remaining SER open items. The resolution of those remaining open items will be documented in future SER Supplements. Resolution of all open items for an issue indicates that its associated restart criteria have been satisfied, and that DOE concludes that the programmatic aspects of the issue have been satisfactorily addressed.

  10. Safety assessment document for the environmental test complex (Building 834) at Site 300

    Energy Technology Data Exchange (ETDEWEB)

    Odell, B.N.; Pfeifer, H.E.

    1981-03-03

    A safety assessment was performed to determine if accidents occurring at the 834 Complex at Site 300 could present undue hazards to the general public, personnel at Site 300, or have an adverse effect on the environment. The credible accidents that might have an effect on these facilities or have off-site consequences were considered. These were earthquake, extreme wind (including missiles), lightning, flood, criticality, high explosive (HE) detonation that disperses uranium and beryllium, spontaneous oxidation of plutonium, explosions due to finely divided particles, and a fire. Seismic and extreme wind (including missiles) analyses indicate that the buildings are basically sound. (However, there are a few recommendations to further enhance the structural integrity of these facilities). Additional lightning protection for these facilities is being installed. These buildings are located high above the dry creek bed so that a flood is improbable. A criticality or a high explosive detonation involving plutonium is very remote since the radioactive materials are encased and plutonium and HE are not permitted concurrently in the same area at Site 300. (The exceptions to this policy are that explosive actuating devices are sometimes located in assemblies containing fissile materials. However, a planned or accidental actuation will not effect the safe containment of the fissile material within the assembly). Even though the possibility of an HE explosion involving uranium and beryllium is remote, the off-site lung doses were calculated and found to be below the accepted standards. It was determined that a fire was unlikely due to the low fire loading and the absence of ignition sources. It was also determined that the consequences of any accidents were reduced by the remote location of these facilities, their design, and by administrative controls.

  11. Site Environmental Report for 2004. Volume 1, Environment, Health, and Safety Division

    Energy Technology Data Exchange (ETDEWEB)

    None

    2005-09-30

    Each year, Ernest Orlando Lawrence Berkeley National Laboratory prepares an integrated report on its environmental programs to satisfy the requirements of United States Department of Energy Order 231.1A, Environment, Safety, and Health Reporting.1 The Site Environmental Report for 2004 summarizes Berkeley Lab’s environmental management performance, presents environmental monitoring results, and describes significant programs for calendar year 2004. (Throughout this report, Ernest Orlando Lawrence Berkeley National Laboratory is referred to as “Berkeley Lab,” “the Laboratory,” “Lawrence Berkeley National Laboratory,” and “LBNL.”) The report is separated into two volumes. Volume I contains an overview of the Laboratory, the status of environmental programs, and summarized results from surveillance and monitoring activities. Volume II contains individual data results from these activities. This year, the Site Environmental Report was distributed by releasing it on the Web from the Berkeley Lab Environmental Services Group (ESG) home page, which is located at http://www.lbl.gov/ehs/esg/. Many of the documents cited in this report also are accessible from the ESG Web page. CD and printed copies of this Site Environmental Report are available upon request.

  12. Site Environmental Report for 2006. Volume I, Environment, Health, and Safety Division

    Energy Technology Data Exchange (ETDEWEB)

    None

    2007-09-30

    Each year, Ernest Orlando Lawrence Berkeley National Laboratory prepares an integrated report on its environmental programs to satisfy the requirements of United States Department of Energy Order 231.1A, Environment, Safety, and Health Reporting.1 The Site Environmental Report for 2006 summarizes Berkeley Lab’s environmental management performance, presents environmental monitoring results, and describes significant programs for calendar year 2006. (Throughout this report, Ernest Orlando Lawrence Berkeley National Laboratory is referred to as “Berkeley Lab,” “the Laboratory,” “Lawrence Berkeley National Laboratory,” and “LBNL.”) The report is separated into two volumes. Volume I is organized into an executive summary followed by six chapters that contain an overview of the Laboratory, a discussion of the Laboratory’s environmental management system, the status of environmental programs, and summarized results from surveillance and monitoring activities. Volume II contains individual data results from surveillance and monitoring activities.

  13. Finding generically stable measures

    CERN Document Server

    Simon, Pierre

    2010-01-01

    We discuss two constructions for obtaining generically stable Keisler measures in an NIP theory. First, we show how to symmetrize an arbitrary invariant measure to obtain a generically stable one from it. Next, we show that suitable sigma-additive probability measures give rise to generically stable measures. Also included is a proof that generically stable measures over o-minimal theories and the p-adics are smooth.

  14. Biosphere analyses for the safety assessment SR-Site - synthesis and summary of results

    Energy Technology Data Exchange (ETDEWEB)

    Saetre, Peter (comp.)

    2010-12-15

    ice free period between two glaciations. The radionuclide model used in SR-Site has been improved in several important ways since previous safety assessments conducted by SKB. For example, the aquatic and terrestrial ecosystems are handled in the same model, which gives a continuous transition from the sea stage to the lake and terrestrial stages. Transport and accumulation in till (lower regolith) is represented in the model. The uptake by plants is included in the mass-balance, and it is related to biomass growth. Moreover, parameter values including hydrological flows, sedimentation and resuspension rates, biomass growth rates, gas exchange rates, as well as element specific distribution coefficients and concentration rations, were as far as possible based on site data. One endpoint from the simulations with the radionuclide model was the landscape dose conversion factors (LDFs).

  15. 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 invo

  16. Environment, Safety and Health Progress Assessment of the Argonne Illinois Site

    Energy Technology Data Exchange (ETDEWEB)

    1993-11-01

    This report documents the results of the US Department of Energy (DOE) Environment, Safety and Health (ES&H) Progress Assessment of the Argonne Illinois Site (AIS), near Chicago, Illinois, conducted from October 25 through November 9, 1993. During the Progress Assessment, activities included a selective review of the ES&H management systems and programs with principal focus on the DOE Office of Energy Research (ER); CH, which includes the Argonne Area Office; the University of Chicago; and the contractor`s organization responsible for operation of Argonne National Laboratory (ANL). The ES&H Progress Assessments are part of DOE`s continuing effort to institutionalize line management accountability and the self-assessment process throughout DOE and its contractor organizations. The purpose of the AIS ES&H Progress Assessment was to provide the Secretary of Energy, senior DOE managers, and contractor management with concise independent information on the following: change in culture and attitude related to ES&H activities; progress and effectiveness of the ES&H corrective actions resulting from the previous Tiger Team Assessment; adequacy and effectiveness of the ES&H self-assessment process of the DOE line organizations, the site management, and the operating contractor; and effectiveness of DOE and contractor management structures, resources, and systems to effectively address ES&H problems and new ES&H initiatives.

  17. Safety

    CERN Multimedia

    2003-01-01

    Please note that the safety codes A9, A10 AND A11 (ex annexes of SAPOCO/42) entitled respectively "Safety responsibilities in the divisions" "The safety policy committee (SAPOCO) and safety officers' committees" and "Administrative procedure following a serious accident or incident" are available on the web at the following URLs: Code A9: http://edms.cern.ch/document/337016/LAST_RELEASED Code A10: http://edms.cern.ch/document/337019/LAST_RELEASED Code A11: http://edms.cern.ch/document/337026/LAST_RELEASED Paper copies can also be obtained from the TIS divisional secretariat, e-mail: tis.secretariat@cern.ch. TIS Secretariat

  18. RECOMMENDED TRITIUM OXIDE DEPOSITION VELOCITY FOR USE IN SAVANNAH RIVER SITE SAFETY ANALYSES

    Energy Technology Data Exchange (ETDEWEB)

    Lee, P.; Murphy, C.; Viner, B.; Hunter, C.; Jannik, T.

    2012-04-03

    The Defense Nuclear Facilities Safety Board (DNFSB) has recently questioned the appropriate value for tritium deposition velocity used in the MELCOR Accident Consequence Code System Ver. 2 (Chanin and Young 1998) code when estimating bounding dose (95th percentile) for safety analysis (DNFSB 2011). The purpose of this paper is to provide appropriate, defensible values of the tritium deposition velocity for use in Savannah River Site (SRS) safety analyses. To accomplish this, consideration must be given to the re-emission of tritium after deposition. Approximately 85% of the surface area of the SRS is forested. The majority of the forests are pine plantations, 68%. The remaining forest area is 6% mixed pine and hardwood and 26% swamp hardwood. Most of the path from potential release points to the site boundary is through forested land. A search of published studies indicate daylight, tritiated water (HTO) vapor deposition velocities in forest vegetation can range from 0.07 to 2.8 cm/s. Analysis of the results of studies done on an SRS pine plantation and climatological data from the SRS meteorological network indicate that the average deposition velocity during daylight periods is around 0.42 cm/s. The minimum deposition velocity was determined to be about 0.1 cm/s, which is the recommended bounding value. Deposition velocity and residence time (half-life) of HTO in vegetation are related by the leaf area and leaf water volume in the forest. For the characteristics of the pine plantation at SRS the residence time corresponding to the average, daylight deposition velocity is 0.4 hours. The residence time corresponding to the night-time deposition velocity of 0.1 cm/s is around 2 hours. A simple dispersion model which accounts for deposition and re-emission of HTO vapor was used to evaluate the impact on exposure to the maximally exposed offsite individual (MOI) at the SRS boundary (Viner 2012). Under conditions that produce the bounding, 95th percentile MOI exposure

  19. 原研和仿制氨氯地平治疗高血压有效性和安全性的Meta分析%Efficacy and Safety of Generic and Patented Amlodipine for Hypertension:A Meta-Analysis

    Institute of Scientific and Technical Information of China (English)

    余正; 王海兵; 段君军; 李洪超

    2016-01-01

    Objective:To systematically estimate the efficacy and safety of generic and patented amlodipine for hypertension.Methods:VIP,WANFANG and CNKI were searched for relevant literatures published before December 25,2014.Based on quality of literature eval-uation,we extract the literature data, using RevMan 5.3 software.Results:After retrieving and eliminating duplicate documents, we re-ceived 62 papers with 4 RCTs being reviewed eventually.Meta-analysis results show that the generic amlodipine and original amlodipine are efficient for the treatment of hypertension with RR=0.99(95%CI:0.65,1.52,P=0.97).According to the dosage and patients in-clusion criteria, we conduct subgroup analysis; Clinical studies reported a significant efficiency with the combined effect of RR=0.99 (95%CI:0.83,1.19,P=0.95).The incidence rate of adverse drug reactions is RR=1.01 (95% CI:0.51,1.99,P=0.98).The re-sults show that there is no statistically significant difference.Conclusion:The efficacy and safety of generic and patented amlodipine is e-qual.As a result, generic amlodipine is safe and effective in hypertension treatment.%目的:运用Meta分析的方法系统评价原研与仿制氨氯地平治疗高血压的有效性和安全性。方法:在维普数据库( VIP)、万方数据库( WANFANG)和中国期刊网全文数据库( CNKI)中检索2014年12月25日之前发表的相关文献。在进行文献质量评估基础上提取文献数据,采用RevMan 5.3软件进行Meta分析。结果:经过检索并剔除重复文献后共获得62篇文献,最终纳入综述文献4篇。 Meta分析结果显示,仿制氨氯地平与原研氨氯地平治疗高血压的有效率RR=0.99(95%CI:0.65,1.52,P=0.97);根据用药剂量、病例纳入标准进行亚组分析;临床研究报道了显效率,合并效应量RR=0.99(95%CI:0.83,1.19,P=0.95);不良反应发生率 RR =1.01(95%CI:0.51,1.99,P=0.98)。研究结果显示均无

  20. The Importance of Safety in Construction Sector: Costs of Occupational Accidents in Construction Sites

    Directory of Open Access Journals (Sweden)

    Fatih Yılmaz

    2015-04-01

    Full Text Available Occupational accidents cause important social and economic problems by loss of life and physical injuries. Construction sector involves high risk due to its production processes and labor intensive characteristic and because of occupational accidents the sector brings up against financial loss in large scale. In developing countries, construction sector is one of the most important sectors that have a great contribution to economic development with its employment capacity and added-value to the economy. On the other hand, due to the lack of preventive measures, occupational accidents occur, frequently in construction in Turkey. Major occupational accidents are defined as the cause of serious injuries and a long-term disability; minor occupational accidents are defined as the cause of insignificant injuries and short-term disability. Minor occupational accidents are not considered sufficiently, they are even not kept as a record. It is known that minor occupational accidents, which are not considered sufficiently and even not registered, cause great financial loss in workplaces. The aim of this paper is to investigate the cost of workforce loss caused by the accidents in construction sites by using the statistics of three construction sites in Turkey and to compare the financial losses of minor and major occupational accidents. In this study, three construction project are investigated in Turkey in 2009 and it is obtained that the cost of workday loss caused by major occupational accidents is 19431.75 $ and minor occupational accidents cause a loss of 6924.25 $. The cost of workday loss caused by minor occupational accidents are almost 35 % of major workday losses’. These costs presents the importance of preventive measures for workers’ health and safety in construction.

  1. Improving risk-adjusted measures of surgical site infection for the national healthcare safety network.

    Science.gov (United States)

    Mu, Yi; Edwards, Jonathan R; Horan, Teresa C; Berrios-Torres, Sandra I; Fridkin, Scott K

    2011-10-01

    The National Healthcare Safety Network (NHSN) has provided simple risk adjustment of surgical site infection (SSI) rates to participating hospitals to facilitate quality improvement activities; improved risk models were developed and evaluated. Data reported to the NHSN for all operative procedures performed from January 1, 2006, through December 31, 2008, were analyzed. Only SSIs related to the primary incision site were included. A common set of patient- and hospital-specific variables were evaluated as potential SSI risk factors by univariate analysis. Some ific variables were available for inclusion. Stepwise logistic regression was used to develop the specific risk models by procedure category. Bootstrap resampling was used to validate the models, and the c-index was used to compare the predictive power of new procedure-specific risk models with that of the models with the NHSN risk index as the only variable (NHSN risk index model). From January 1, 2006, through December 31, 2008, 847 hospitals in 43 states reported a total of 849,659 procedures and 16,147 primary incisional SSIs (risk, 1.90%) among 39 operative procedure categories. Overall, the median c-index of the new procedure-specific risk was greater (0.67 [range, 0.59-0.85]) than the median c-index of the NHSN risk index models (0.60 [range, 0.51-0.77]); for 33 of 39 procedures, the new procedure-specific models yielded a higher c-index than did the NHSN risk index models. A set of new risk models developed using existing data elements collected through the NHSN improves predictive performance, compared with the traditional NHSN risk index stratification.

  2. 76 FR 16446 - Delphi Corporation Electronics And Safety Division Including On-Site Leased Workers From Acro...

    Science.gov (United States)

    2011-03-23

    ... Employment and Training Administration Delphi Corporation Electronics And Safety Division Including On- Site... Alternative Trade Adjustment Assistance In accordance with Section 223 of the Trade Act of 1974 (19 U.S.C. 2273), and Section 246 of the Trade Act of 1974 (26 U.S.C. 2813), as amended, the Department of...

  3. Generic tacrolimus in solid organ transplantation.

    Science.gov (United States)

    Taube, D; Jones, G; O'Beirne, J; Wennberg, L; Connor, A; Rasmussen, A; Backman, L

    2014-05-01

    The availability of a wide range of immunosuppressive therapies has revolutionized the management of patients who have undergone solid organ transplantation (SOT). However, the cost of immunosuppressive drugs remains high. This situation has led to the development of generic equivalents, which are similar in quality, safety, and efficacy to their approved innovator drugs. There are data available for three generic brands, tacrolimus (Intas), tacrolimus (PharOS), and tacrolimus (Sandoz). Bioequivalence has been demonstrated for generic tacrolimus (Sandoz) within a narrow therapeutic range to its innovator tacrolimus drug (Prograf) in both healthy volunteers and kidney transplant patients. Clinical experience with this generic tacrolimus formulation has also been established in both de novo and conversion patients who have undergone kidney and liver transplantation, as well as in conversion of other SOT patients, including lung and heart recipients.

  4. A Multi-centric Bioequivalence Trial in Ph+ Chronic Myeloid Leukemia Patients to Assess Bioequivalence and Safety Evaluation of Generic Imatinib Mesylate 400 mg Tablets

    Science.gov (United States)

    Arora, Rachna; Sharma, Manju; Monif, Tausif; Iyer, Sunil

    2016-01-01

    Purpose This study was designed to characterize the pharmacokinetic profile and to assess bioequivalence of the sponsor’s test formulation (imatinib mesylate 400 mg tablets) with an innovator product (Gleevec 400 mg tablets, Novartis Pharmaceuticals) under fed conditions, in adult patients of Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) stabilized on imatinib mesylate 400 mg. In addition, the aim of this study was to monitor the safety profile of investigational medicinal products (IMPs). Materials and Methods A multicenter, randomized, open label, two-period, crossover, single dose bioequivalence study was designed for conduct under fed conditions in 42 adult Ph+ CML patients already stabilized on imatinib 400 mg tablets. Pharmacokinetic parameters Tmax, Cmax, and AUC0-24 were calculated using a non-compartmental model on validated WinNonlin software. Validated SAS software was used for statistical evaluation of data. The safety profile of investigational products was monitored during the course of study by applying a clinical process for recording observed untoward effects postadministration of investigational products. Results The 90% confidence intervals for the test/reference mean ratios of the ln-transformed PK variables Cmax (99.0%) and AUC0-24 (99.2%) were within an acceptable range of 80%-125%, as per bioequivalence assumptions. Both formulations were well tolerated after oral administration of IMPs. Conclusion The test product was found to be bioequivalent and safe, and thus can be used interchangeably in clinical practice. PMID:26875198

  5. Site specific health and safety plan, 233-S decontamination and decommissioning

    Energy Technology Data Exchange (ETDEWEB)

    J. E. Fasso

    1997-12-31

    The deactivated 233-S Plutonium Concentration Facility, located in the 200 Area at the Hanford Site, is the subject of this Health and Safety Plan.The 233-S Facility operated from January 1952 until July 1967 at which time the building entered the U.S. Department of Energy`s Surplus Facility Management Program as a retired facility. The facility has since undergone severe degradation due to exposure to extreme weather conditions. Additionally, the weather caused existing cracks in concrete structures of the building to lengthen, thereby increasing the potential for failed confinement of the radioactive material in the building. Differential settlement has also occurred causing portions of the facility to separate from the main building structure, increasing the potential for release of radioactive material to the environment. An expedited response is proposed to remove this threat and ensure protection of human health and the environment. On this premise it is intended that the 233-S Facility removal action be performed as a Comprehensive Environmental Response, Compensation, and Liability Act of 1980 Time-Critical Project being conducted under the Pilot Hanford Environmental Restoration (ER) Initiative

  6. Equivalent linear and nonlinear site response analysis for design and risk assessment of safety-related nuclear structures

    Energy Technology Data Exchange (ETDEWEB)

    Bolisetti, Chandrakanth, E-mail: cb76@buffalo.edu [University at Buffalo, The State University of New York, North Campus, 212 Ketter Hall, Amherst, NY 14260 (United States); Whittaker, Andrew S., E-mail: awhittak@buffalo.edu [University at Buffalo, The State University of New York, North Campus, 212 Ketter Hall, Amherst, NY 14260 (United States); Mason, H. Benjamin, E-mail: ben.mason@oregonstate.edu [Oregon State University, 101 Kearney Hall, Corvallis, OR 97331 (United States); Almufti, Ibrahim, E-mail: ibrahim.almufti@arup.com [Advanced Technology + Research, ARUP, 560 Mission Street, Suite 700, San Francisco, CA (United States); Willford, Michael, E-mail: michael.willford@arup.com [Advanced Technology + Research, ARUP, 560 Mission Street, Suite 700, San Francisco, CA (United States)

    2014-08-15

    Highlights: • Performed equivalent linear and nonlinear site response analyses using industry-standard numerical programs. • Considered a wide range of sites and input ground motions. • Noted the practical issues encountered while using these programs. • Examined differences between the responses calculated from different programs. • Results of biaxial and uniaxial analyses are compared. - Abstract: Site response analysis is a precursor to soil-structure interaction analysis, which is an essential component in the seismic analysis of safety-related nuclear structures. Output from site response analysis provides input to soil-structure interaction analysis. Current practice in calculating site response for safety-related nuclear applications mainly involves the equivalent linear method in the frequency-domain. Nonlinear time-domain methods are used by some for the assessment of buildings, bridges and petrochemical facilities. Several commercial programs have been developed for site response analysis but none of them have been formally validated for large strains and high frequencies, which are crucial for the performance assessment of safety-related nuclear structures. This study sheds light on the applicability of some industry-standard equivalent linear (SHAKE) and nonlinear (DEEPSOIL and LS-DYNA) programs across a broad range of frequencies, earthquake shaking intensities, and sites ranging from stiff sand to hard rock, all with a focus on application to safety-related nuclear structures. Results show that the equivalent linear method is unable to reproduce the high frequency acceleration response, resulting in almost constant spectral accelerations in the short period range. Analysis using LS-DYNA occasionally results in some unrealistic high frequency acceleration ‘noise’, which can be removed by smoothing the piece-wise linear backbone curve. Analysis using DEEPSOIL results in abrupt variations in the peak strains of consecutive soil layers

  7. From Site Data to Safety Assessment: Analysis of Present and Future Hydrological Conditions at a Coastal Site in Sweden

    Energy Technology Data Exchange (ETDEWEB)

    Berglund, Sten [HydroResearch AB, Taeby (Sweden)], E-mail: sten.berglund@hydroresearch.se; Bosson, Emma [Swedish Nuclear Fuel and Waste Management Co (SKB), Stockholm (Sweden); Sassner, Mona [DHI Sverige AB, Stockholm (Sweden)

    2013-05-15

    This paper presents an analysis of present and future hydrological conditions at the Forsmark site in Sweden, which has been proposed as the site for a geological repository for spent nuclear fuel. Forsmark is a coastal site that changes in response to shoreline displacement. In the considered time frame (until year 10 000 ad), the hydrological system will be affected by landscape succession associated with shoreline displacement and changes in vegetation, regolith stratigraphy, and climate. Based on extensive site investigations and modeling of present hydrological conditions, the effects of different processes on future site hydrology are quantified. As expected, shoreline displacement has a strong effect on local hydrology (e.g., groundwater flow) in areas that change from sea to land. The comparison between present and future land areas emphasizes the importance of climate variables relative to other factors for main hydrological features such as water balances.

  8. Workers’ Age and the Impact of Psychological Factors on the Perception of Safety at Construction Sites

    National Research Council Canada - National Science Library

    Muhammad Dawood Idrees; Maria Hafeez; Jung-Yong Kim

    2017-01-01

    .... Several studies concluded that psychological factors such as workload, organizational relationships, mental stress, job security, and job satisfaction have significant effects on workers’ safety...

  9. Generic Fortran Containers (GFC)

    Energy Technology Data Exchange (ETDEWEB)

    2016-09-01

    The Fortran language does not provide a standard library that implements generic containers, like linked lists, trees, dictionaries, etc. The GFC software provides an implementation of generic Fortran containers natively written in Fortran 2003/2008 language. The following containers are either already implemented or planned: Stack (done), Linked list (done), Tree (done), Dictionary (done), Queue (planned), Priority queue (planned).

  10. A studies on characteristics of groundwater system in discontinuous rockmass for evaluation of safety on disposal site of radioactive waste

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Yeong Hoon; Han, Jeong Sang; Kim, Kyu Sang; Shin, Hyeon Joon; Lee, Chee Hyeong [Yonsei Univ., Seoul (Korea, Republic of)

    1997-07-15

    This study contains the development of numerical model of groundwater system and its application for the evaluation of safety in disposal site of radioactive waste. Through the identification of hydraulic properties, characteristics of discontinuity and selection of discontinuity model around LPG underground storage facility, the application of continuum model and discrete fracture network model was evaluated for the analysis of groundwater flow and solute transport.

  11. Preliminary site description Laxemar stage 2.1. Feedback for completion of the site investigation including input from safety assessment and repository engineering

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2006-09-15

    The Laxemar subarea is the focus for the complete site investigations in the Simpevarp area. The south and southwestern parts of the subarea (the so-called 'focused area') have been designated for focused studies during the remainder of the site investigations. This area, some 5.3 square kilometres in size, is characterised on the surface by an arc shaped body of quartz monzodiorite gently dipping to the north, flanked in the north and south by Aevroe granite. The current report documents work conducted during stage 2.1 of the site-descriptive modelling of the Laxemar subarea. The primary objective of the work performed is to provide feedback to the site investigations at Laxemar to ensure that adequate and timely data and information are obtained during the remaining investigation stage. The work has been conducted in cooperation with the site investigation team at Laxemar and representatives from safety assessment and repository engineering. The principal aim of this joint effort has been to safeguard that adequate data are collected that resolve the remaining issues/uncertainties which are of importance for repository layout and long-term safety. The proposed additional works presented in this report should be regarded as recommended additions and/or modifications in relation to the CSI programme published early 2006. The overall conclusion of the discipline-wise review of critical issues is that the CSI programme overall satisfies the demands to resolve the remaining uncertainties. This is interpreted to be partly a result of the close interaction between the site modelling team, site investigation team and the repository engineering teams, which has been in operation since early 2005. In summary, the performed interpretations and modelling have overall confirmed the version 1.2 results. The exception being Hydrogeology where the new Laxemar 2.1 borehole data suggest more favourable conditions in the south and west parts of the focused area compared

  12. Improvement of worker safety through the investigation of the site response to rockbursts

    CSIR Research Space (South Africa)

    Hagan, TO

    1998-12-01

    Full Text Available The objective of this investigation is to improve worker safety through a better understanding of mine excavation response to rockbursts. The improved understanding should lead to improved mine layout and support design. The project is continuation...

  13. SAFETY

    CERN Multimedia

    M. Plagge, C. Schaefer and N. Dupont

    2013-01-01

    Fire Safety – Essential for a particle detector The CMS detector is a marvel of high technology, one of the most precise particle measurement devices we have built until now. Of course it has to be protected from external and internal incidents like the ones that can occur from fires. Due to the fire load, the permanent availability of oxygen and the presence of various ignition sources mostly based on electricity this has to be addressed. Starting from the beam pipe towards the magnet coil, the detector is protected by flooding it with pure gaseous nitrogen during operation. The outer shell of CMS, namely the yoke and the muon chambers are then covered by an emergency inertion system also based on nitrogen. To ensure maximum fire safety, all materials used comply with the CERN regulations IS 23 and IS 41 with only a few exceptions. Every piece of the 30-tonne polyethylene shielding is high-density material, borated, boxed within steel and coated with intumescent (a paint that creates a thick co...

  14. SAFETY

    CERN Multimedia

    C. Schaefer and N. Dupont

    2013-01-01

      “Safety is the highest priority”: this statement from CERN is endorsed by the CMS management. An interpretation of this statement may bring you to the conclusion that you should stop working in order to avoid risks. If the safety is the priority, work is not! This would be a misunderstanding and misinterpretation. One should understand that “working safely” or “operating safely” is the priority at CERN. CERN personnel are exposed to different hazards on many levels on a daily basis. However, risk analyses and assessments are done in order to limit the number and the gravity of accidents. For example, this process takes place each time you cross the road. The hazard is the moving vehicle, the stake is you and the risk might be the risk of collision between both. The same principle has to be applied during our daily work. In particular, keeping in mind the general principles of prevention defined in the late 1980s. These principles wer...

  15. Generic medicines: issues and relevance for global health.

    Science.gov (United States)

    Rana, Proteesh; Roy, Vandana

    2015-12-01

    Generic medicine is a pharmaceutical product which is bioequivalent to the innovator product in terms of dosage form, strength, route of administration, quality, safety, performance characteristics, and intended use. Generic medicines are a cornerstone for providing affordable medicines to patients. The major generic markets in the world include United States of America followed by European Union, Canada, Japan, and Australia. The major suppliers of generic medicines China and India are showing tremendous growth in the generic medicine sector. There are many legal and regulatory issues along with quality concerns associated with the use of the generic products. Lately, bilateral international agreements called free trade agreements, delaying tactics by originator companies like strategic patenting and litigations on generic manufacturers, have been a major setback for the generic medicine industry. These issues need to be addressed to optimize the use of generic medicines. The sustainability of generic medicine sector is crucial for improving access to essential medicines for the worldwide. © 2015 Société Française de Pharmacologie et de Thérapeutique.

  16. 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....

  17. Health and Safety Plan for Operations Performed for the Environmental Restoration Program: Task, Characterization of Potential Waste Sources at Auxiliary Reactor Area-1 Operable Unit 5--07 site ARA-02

    Energy Technology Data Exchange (ETDEWEB)

    Pickett, S.L.; Morton, S.L.

    1992-06-01

    This document constitutes the generic health and safety plan for the Environmental Restoration Program (ERP). It addresses the health and safety requirements of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA); Occupational Safety and Health Administration (OSHA) 29 CFR 1910.120 standard; and EG G Idaho, Inc. This plan is a guide to individuals who must complete a health and safety plan for a task performed for the ERP. It contains a task specific addendum that, when completed, specifically addresses task specific health and safety issues. This health and safety plan reduces the time it takes to write a task specific health and safety plan by providing discussions of requirements, guidance on where specific information is located, and specific topics in the Addendum that must be discussed at a task level. This format encourages a complete task specific health and safety plan and a standard for all health and safety plans written for ERP.

  18. Health and Safety Plan for Operations Performed for the Environmental Restoration Program: Task, Characterization of Potential Waste Sources at Auxiliary Reactor Area-1 Operable Unit 5--07 site ARA-02

    Energy Technology Data Exchange (ETDEWEB)

    Pickett, S.L.; Morton, S.L.

    1992-06-01

    This document constitutes the generic health and safety plan for the Environmental Restoration Program (ERP). It addresses the health and safety requirements of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA); Occupational Safety and Health Administration (OSHA) 29 CFR 1910.120 standard; and EG&G Idaho, Inc. This plan is a guide to individuals who must complete a health and safety plan for a task performed for the ERP. It contains a task specific addendum that, when completed, specifically addresses task specific health and safety issues. This health and safety plan reduces the time it takes to write a task specific health and safety plan by providing discussions of requirements, guidance on where specific information is located, and specific topics in the Addendum that must be discussed at a task level. This format encourages a complete task specific health and safety plan and a standard for all health and safety plans written for ERP.

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

    Science.gov (United States)

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

    2013-01-01

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

  20. Occupational safety during the remediation of a contaminated site: monitoring of PCDD/PCDF levels in blood of employees

    Energy Technology Data Exchange (ETDEWEB)

    Rottler, H. [Eurofins Oekometric, Bayreuth (Germany); Uffinger, H. [Tiefbau-Berufsgenossenschaft (TBG), Arbeitsmedizinischer Dienst, Frankfurt/Main (Germany)

    2004-09-15

    In connection with road construction activities a dioxin contaminated site was discovered during the 1990's in a German city, containing residues of early industrial activities. PCDD/PCDF levels up to 41 ng I-TEQ/g dry matter could be detected in the material with a 1,2,3,4,7,8-HxCDF dominated pattern. This pattern is very similar to samples related to the production and use of chlorine in the early 20{sup th} century. Furthermore, sandy material showing a deviating and 1,2,3,7,8-PeCDF dominated pattern with an at least a factor of 10 lower concentrations was found. A remediation program was initiated including removal of contaminated soil and installing a drainage layer below the final asphalt layer sealing the site. Occupational safety for employees involved in any on-site activities was of primary importance following regulations for work in contaminated areas and for preventive occupational medicine. Hygiene was strictly obeyed. On-site monitoring via chromatographic dust analysis was performed by surveying engineers. Employees working in contaminated areas wore Air-Filters A2P3 with motor support. The mandatory personal safety equipment included dust-proof protective suits for single use, chemical-proof gloves and boots. In this context, it was the task of the Employer's Liability Insurance Association (Tiefbau- Berufsgenossenschaft, TBG) to strictly control compliance of occupational safety measures. The occupational medical service of this association was commissioned monitoring the health situation of the employees involved. Among other parameters, the corresponding control program included monitoring of PCDD/PCDF blood levels to identify possible alterations.

  1. Thermal-Hydraulic-Mechanical (THM) Coupled Simulation of a Generic Site for Disposal of High Level Nuclear Waste in Claystone in Germany: Exemplary Proof of the Integrity of the Geological Barrier

    Science.gov (United States)

    Massmann, J.; Ziefle, G.; Jobmann, M.

    2016-12-01

    Claystone is investigated as a potential host rock for the disposal of high level nuclear waste (HLW). In Germany, DBE TECHNOLOGY GmbH, the BGR and the "Gesellschaft für Anlagen- und Reaktorsicherheit (GRS)" are developing an integrated methodology for safety assessment within the R&D project "ANSICHT". One part herein is the demonstration of integrity of the geological barrier to ensure safe containment of radionuclides over 1 million years. The mechanical excavation of an underground repository, the ex­po­si­tion of claystone to at­mos­pheric air, the insertion of backfill, buffer, sealing and supporting material as well as the deposition of heat producing waste constitute a sig­nif­i­cant disturbance of the underground system. A complex interacting scheme of thermal, hydraulic and mechanical (THM) processes can be expected. In this work, the finite element software OpenGeoSys, main­ly de­vel­oped at the "Helmholtz Centre for Environmental Research GmbH (UFZ)", is used to simulate and evaluate several THM coupled effects in the repository surroundings up to the surface over a time span of 1 million years. The numerical setup is based on two generic geological models inspired by the representative geology of potentially suitable regions in North- and South Germany. The results give an insight into the evolution of temperature, pore pressure, stresses as well as deformation and enables statements concerning the extent of the significantly influenced area. One important effect among others is the temperature driven change in the densities of the solid and liquid phase and its influence on the stress field. In a further step, integrity criteria have been quantified, based on specifications of the German federal ministry of the environment. The exemplary numerical evaluation of these criteria demonstrates, how numerical simulations can be used to prove the integrity of the geological barrier and detect potential vulnerabilities. Fig.: Calculated zone of

  2. Biosphere analyses for the safety assessment SR-Site - synthesis and summary of results

    Energy Technology Data Exchange (ETDEWEB)

    Saetre, Peter (comp.)

    2010-12-15

    This report summarises nearly 20 biosphere reports and gives a synthesis of the work performed within the SR-Site Biosphere project, i.e. the biosphere part of SR-Site. SR-Site Biosphere provides the main project with dose conversion factors (LDFs), given a unit release rate, for calculation of human doses under different release scenarios, and assesses if a potential release from the repository would have detrimental effects on the environment. The intention of this report is to give sufficient details for an overview of methods, results and major conclusions, with references to the biosphere reports where methods, data and results are presented and discussed in detail. The philosophy of the biosphere assessment was to make estimations of the radiological risk for humans and the environment as realistic as possible, based on the knowledge of present-day conditions at Forsmark and the past and expected future development of the site. This was achieved by using the best available knowledge, understanding and data from extensive site investigations from two sites. When sufficient information was not available, uncertainties were handled cautiously. A systematic identification and evaluation of features and processes that affect transport and accumulation of radionuclides at the site was conducted, and the results were summarised in an interaction matrix. Data and understanding from the site investigation was an integral part of this work, the interaction matrix underpinned the development of the radionuclide model used in the biosphere assessment. Understanding of the marine, lake and river and terrestrial ecosystems at the site was summarized in a conceptual model, and relevant features and process have been characterized to capture site specific parameter values. Detailed investigations of the structure and history of the regolith at the site and simulations of regolith dynamics were used to describe the present day state at Forsmark and the expected development of

  3. Recommended Tritium Oxide Deposition Velocity For Use In Savannah River Site Safety Analyses

    Energy Technology Data Exchange (ETDEWEB)

    Lee, P. L.; Murphy, C. E.; Viner, B. J.; Hunter, C. H.

    2012-07-31

    This report documents the results of examining the deposition velocity of water to forests, the residence time of HTO in forests, and the relation between deposition velocity and residence time with specific consideration given to the topography and experimental work performed at SRS. A simple mechanistic model is used to obtain plausible deposition velocity and residence time values where experimental data are not available and recommendations are made for practical application in a safety analysis model.

  4. Generic Airspace Survey

    Science.gov (United States)

    Mogford, Richard H.; Bridges, Wayne; Gujarl, Vimmy; Lee, Paul U.; Preston, William

    2013-01-01

    This paper reports on an extension of generic airspace research to explore the amount of memorization and specialized skills required to manage sectors with specific characteristics or factors. Fifty-five retired controllers were given an electronic survey where they rated the amount of memorization or specialized skills needed for sixteen generic airspace factors. The results suggested similarities in the pattern of ratings between different areas of the US (East, Central, and West). The average of the ratings for each area also showed some differences between regions, with ratings being generally higher in the East area. All sixteen factors were rated as moderately to highly important and may be useful for future research on generic airspace, air traffic controller workload, etc.

  5. 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.

  6. Restart of K-Reactor, Savannah River Site: Safety evaluation report

    Energy Technology Data Exchange (ETDEWEB)

    1991-04-01

    This Safety Evaluation Report (SER) focuses on those issues required to support the restart of the K-Reactor at the Savannah River Plant. This SER provides the safety criteria for restart and documents the results of the staff reviews of the DOE and operating contractor activities to meet these criteria. To develop the restart criteria for the issues discussed in this SER, the Savannah River Restart Office and Savannah River Special Projects Office staffs relied, when possible, on commercial industry codes and standards and on NRC requirements and guidelines for the commercial nuclear industry. However, because of the age and uniqueness of the Savannah River reactors, criteria for the commercial plants were not always applicable. In these cases, alternate criteria were developed. The restart criteria applicable to each of the issues are identified in the safety evaluations for each issue. The restart criteria identified in this report are intended to apply only to restart of the Savannah River reactors. Following the development of the acceptance criteria, the DOE staff and their support contractors evaluated the results of the DOE and operating contractor (WSRC) activities to meet these criteria. The results of those evaluations are documented in this report. Deviations or failures to meet the requirements are either justified in the report or carried as open or confirmatory items to be completed and evaluated in supplements to this report before restart. 62 refs., 1 fig.

  7. Patients' attitude about generics –Bulgarian perspective

    Directory of Open Access Journals (Sweden)

    Hristina Lebanova

    2012-01-01

    Full Text Available OBJECTIVE: The aim of the present study is to investigate (1 what is the patients' attitude towards and (2 preferences to use generic medicines in Bulgaria and (3 which are the main factors influencing their opinion.METHODS: Using pseudo-randomization we select a sample of 225 participants, men and women from general population, patients in community pharmacies. For our survey we used a standardized self-questionnaire of ten points. The influence of sex, age, education, medical history, knowledge of generic drugs and experience with generic substitution and medicines was examined through Chi-square tests.RESULTS: The results show that 74% of the participants seemed not to be informed on generic drugs and 26% received valuable and relevant information from their general practitioner or pharmacist. 94% believed that generic medicines are inferior to brand medicines on quality, safety and efficacy.CONCLUSIONS: The main reason for almost all the participants (94% to prefer original medicines, over generics is the insufficient information, they have. The core factors forming patients' opinion and expectations for generic drugs are medical professionals' recommendation and previous experience. The main advantages of the generics according to the participants in the study are the lower price and better accessibility. The results raise the issue of the awareness and level knowledge about generic medicines and the rational drug use in the general population.

  8. UMTRA Project environmental, health, and safety plan

    Energy Technology Data Exchange (ETDEWEB)

    1989-02-01

    The basic health and safety requirements established in this plan are designed to provide guidelines to be applied at all Uranium Mill Tailings Remedial Action (UMTRA) Project sites. Specific restrictions are given where necessary. However, an attempt has been made to provide guidelines which are generic in nature, and will allow for evaluation of site-specific conditions. Health and safety personnel are expected to exercise professional judgment when interpreting these guidelines to ensure the health and safety of project personnel and the general population. This UMTRA Project Environmental, Health, and Safety (EH S) Plan specifies the basic Federal health and safety standards and special DOE requirements applicable to this program. In addition, responsibilities in carrying out this plan are delineated. Some guidance on program requirements and radiation control and monitoring is also included. An Environmental, Health, and Safety Plan shall be developed as part of the remedial action plan for each mill site and associated disposal site. Special conditions at the site which may present potential health hazards will be described, and special areas that should should be addressed by the Remedial Action Contractor (RAC) will be indicated. Site-specific EH S concerns will be addressed by special contract conditions in RAC subcontracts. 2 tabs.

  9. Plasma concentrations of generic lopinavir/ritonavir in HIV type-1-infected individuals.

    NARCIS (Netherlands)

    Lugt, J. van der; Lange, J.; Avihingsanon, A.; Ananworanich, J.; Sealoo, S.; Burger, D.M.; Gorowara, M.; Phanuphak, P.; Ruxrungtham, K.

    2009-01-01

    BACKGROUND: Generic drugs can contribute to access to treatment for HIV-infected patients. However quality and safety remains an issue of concern. Therefore, we evaluated minimal plasma concentrations and short-term safety of a generic lopinavir/ritonavir 200/50 mg tablet formulation. METHODS: In a

  10. 网站安全防范技巧%Web Site Safety Prevention Tips

    Institute of Scientific and Technical Information of China (English)

    王兆林

    2012-01-01

      Whether corporate website or personal Web site,Website security is a very important aspect,Because site security problems may cause your Web site credibility, flow, profit, and even political influence.Web sites were brought by black hung horses,Website content has been tampered,The proliferation of viruses, user information leakage problems can bring to the site of catastrophe,Web site security testing and security maintenance is a very important work.Experience in security work through a Web site here, divided into several parts to talk about website security construction and management practices.In practical work, ensure that the site's normal application.%  无论是企业网站还是个人网站,网站安全都是一个很重要的方面,因为网站安全问题可能对网站造成信誉、流量、盈利,甚至政治影响。网站被黑带来的挂马,网站内容篡改,病毒的扩散点,用户信息泄漏等等的问题都可能会给网站带来灭顶之灾,故做好网站的安全检测和安全维护都是非常重要的工作。这里通过网站安全工作中的经验积累,分几个部分谈谈网站安全建设与管理方面的做法。在实际工作中,保证了网站的正常应用。

  11. 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.

  12. Generic Kalman Filter Software

    Science.gov (United States)

    Lisano, Michael E., II; Crues, Edwin Z.

    2005-01-01

    The Generic Kalman Filter (GKF) software provides a standard basis for the development of application-specific Kalman-filter programs. Historically, Kalman filters have been implemented by customized programs that must be written, coded, and debugged anew for each unique application, then tested and tuned with simulated or actual measurement data. Total development times for typical Kalman-filter application programs have ranged from months to weeks. The GKF software can simplify the development process and reduce the development time by eliminating the need to re-create the fundamental implementation of the Kalman filter for each new application. The GKF software is written in the ANSI C programming language. It contains a generic Kalman-filter-development directory that, in turn, contains a code for a generic Kalman filter function; more specifically, it contains a generically designed and generically coded implementation of linear, linearized, and extended Kalman filtering algorithms, including algorithms for state- and covariance-update and -propagation functions. The mathematical theory that underlies the algorithms is well known and has been reported extensively in the open technical literature. Also contained in the directory are a header file that defines generic Kalman-filter data structures and prototype functions and template versions of application-specific subfunction and calling navigation/estimation routine code and headers. Once the user has provided a calling routine and the required application-specific subfunctions, the application-specific Kalman-filter software can be compiled and executed immediately. During execution, the generic Kalman-filter function is called from a higher-level navigation or estimation routine that preprocesses measurement data and post-processes output data. The generic Kalman-filter function uses the aforementioned data structures and five implementation- specific subfunctions, which have been developed by the user on

  13. Seismic safety margins research program. Phase I. Final report: plant/site selection and data collection (Project I)

    Energy Technology Data Exchange (ETDEWEB)

    Chuang, T. Y.

    1981-05-01

    Project I of Phase I of the Seismic Safety Margins Research Program (SSMRP) comprised two parts: the selection of a representative nuclear power plant/site for study in Phase I and the collection of data needed by the other SSMRP projects. Unit 1 of the Zion Nuclear Power Plant in Zion, Illinois, was selected for the SSMRP Phase I studies. The Zion plant and its site were found to be reasonably representative of operating and future plants with regard to its nuclear steam supply system; the type of containment structure (prestressed concrete); its electrical capacity (1100 MWe); its location (the Midwest); the peak seismic accelaration used for design (0.17g); and the properties of the underlying soil (the low-strain shear-wave velocity is 1650 ft/s in a 50- to 100-ft-thick layer of soil overlying sedimentary bedrock).

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

    Energy Technology Data Exchange (ETDEWEB)

    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.

  15. Bayesian ranking of sites for engineering safety improvements: decision parameter, treatability concept, statistical criterion, and spatial dependence.

    Science.gov (United States)

    Miaou, Shaw-Pin; Song, Joon Jin

    2005-07-01

    In recent years, there has been a renewed interest in applying statistical ranking criteria to identify sites on a road network, which potentially present high traffic crash risks or are over-represented in certain type of crashes, for further engineering evaluation and safety improvement. This requires that good estimates of ranks of crash risks be obtained at individual intersections or road segments, or some analysis zones. The nature of this site ranking problem in roadway safety is related to two well-established statistical problems known as the small area (or domain) estimation problem and the disease mapping problem. The former arises in the context of providing estimates using sample survey data for a small geographical area or a small socio-demographic group in a large area, while the latter stems from estimating rare disease incidences for typically small geographical areas. The statistical problem is such that direct estimates of certain parameters associated with a site (or a group of sites) with adequate precision cannot be produced, due to a small available sample size, the rareness of the event of interest, and/or a small exposed population or sub-population in question. Model based approaches have offered several advantages to these estimation problems, including increased precision by "borrowing strengths" across the various sites based on available auxiliary variables, including their relative locations in space. Within the model based approach, generalized linear mixed models (GLMM) have played key roles in addressing these problems for many years. The objective of the study, on which this paper is based, was to explore some of the issues raised in recent roadway safety studies regarding ranking methodologies in light of the recent statistical development in space-time GLMM. First, general ranking approaches are reviewed, which include naïve or raw crash-risk ranking, scan based ranking, and model based ranking. Through simulations, the

  16. Exploring Generic Haskell

    NARCIS (Netherlands)

    Löh, A.

    2004-01-01

    This thesis is an exploration -- an exploration of a language extension of the functional programming language Haskell. The extension is called Generic Haskell, albeit the name has been used to refer to different objects over the last several years: Many papers have described different proposals, fe

  17. Generic Market Models

    NARCIS (Netherlands)

    R. Pietersz (Raoul); M. van Regenmortel

    2005-01-01

    textabstractCurrently, there are two market models for valuation and risk management of interest rate derivatives, the LIBOR and swap market models. In this paper, we introduce arbitrage-free constant maturity swap (CMS) market models and generic market models featuring forward rates that span perio

  18. Monitoring human factor risk characteristics at nuclear legacy sites in northwest Russia in support of radiation safety regulation.

    Science.gov (United States)

    Scheblanov, V Y; Sneve, M K; Bobrov, A F

    2012-12-01

    This paper describes research aimed at improving regulatory supervision of radiation safety during work associated with the management of spent nuclear fuel and radioactive waste at legacy sites in northwest Russia through timely identification of employees presenting unfavourable human factor risk characteristics. The legacy sites of interest include sites of temporary storage now operated by SevRAO on behalf of Rosatom. The sites were previously operational bases for servicing nuclear powered submarines and are now subject to major remediation activities. These activities include hazardous operations for recovery of spent nuclear fuel and radioactive waste from sub-optimal storage conditions. The paper describes the results of analysis of methods, procedures, techniques and informational issues leading to the development of an expert-diagnostic information system for monitoring of workers involved in carrying out the most hazardous operations. The system serves as a tool for human factor and professional reliability risk monitoring and has been tested in practical working environments and implemented as part of regulatory supervision. The work has been carried out by the Burnasyan Federal Medical Biophysical Center, within the framework of the regulatory cooperation programme between the Federal Medical-Biological Agency of Russia and the Norwegian Radiation Protection Authority.

  19. Hanford Site Environment Safety and Health (ES and H) FY 1999 and FY 2000 Execution Commitment Summary

    Energy Technology Data Exchange (ETDEWEB)

    REEP, I.E.

    1999-12-01

    All sites in the U.S. Department of Energy (DOE) Complex prepare this report annually for the DOE Office of Environment, Safety and Health (EH). The purpose of this report is to provide a summary of the previous and current year's Environment, Safety and Health (ES&H) execution commitments and the S&H resources that support these activities. The fiscal year (FY) 1999 and 2000 information (Sieracki 1999) and data contained in the ''Hanford Site Environment, Safety and Health Fiscal Year 2001 Budget-Risk Management Summary'' (RL 1999) were the basis for preparing this report. Fiscal year 2000 finding of Office of Environmental Management (EM) and Office of Nuclear Energy, Science and Technology (NE) activities is based on the President's budget of $1,065.1 million and $28.0 million, plus $2.7 million carryover finding, respectively, as of October 31, 1999. Any funding changes as a result of the Congressional appropriation process will be reflected in the Fiscal Year 2002 ES&H Budget-Risk Management Summary to be issued in May 2000. This report provides the end-of-year status of FY 1999 ES&H execution commitments, including actual S&H expenditures, and describes planned FY 2000 ES&H execution commitments and the S&H resources needed to support those activities. This requirement is included in the ES&H ''Guidance for FY200l Budget Formulations and Execution'' (DOE 1999).

  20. Hanford Site organic waste tanks: History, waste properties, and scientific issues. Hanford Tank Safety Project

    Energy Technology Data Exchange (ETDEWEB)

    Strachan, D.M.; Schulz, W.W.; Reynolds, D.A.

    1993-01-01

    Eight Hanford single-shell waste tanks are included on a safety watch list because they are thought to contain significant concentrations of various organic chemical. Potential dangers associated with the waste in these tanks include exothermic reaction, combustion, and release of hazardous vapors. In all eight tanks the measured waste temperatures are in the range 16 to 46{degree}C, far below the 250 to 380{degree}C temperatures necessary for onset of rapid exothermic reactions and initiation of deflagration. Investigation of the possibility of vapor release from Tank C-103 has been elevated to a top safety priority. There is a need to obtain an adequate number of truly representative vapor samples and for highly sensitive and capable methods and instruments to analyze these samples. Remaining scientific issues include: an understanding of the behavior and reaction of organic compounds in existing underground tank environments knowledge of the types and amounts of organic compounds in the tanks knowledge of selected physical and chemical properties of organic compounds source, composition, quality, and properties of the presently unidentified volatile organic compound(s) apparently evolving from Tank C-103.

  1. Discussion on safety management of construction site%刍议建筑施工现场安全管理

    Institute of Scientific and Technical Information of China (English)

    王跃军

    2012-01-01

    The building construction is a complex system engineering with more than one type of work and multi-disciplinary , with features of strong liquidity, long cycle, and subject to environmental impact, the management objective of construction site is to effectively complete the construction project contracting goals, and enable enterprises to achieve certain economic benefits. Security management is the basis of the construction site management, and construction site safety management is a systematic project. The involved system includes person, machine, material , method, ring and measurement, and the studied problems are also the relavent system engineering issues. The fundamental task of security management is the implementation of the " safety first, prevention first, comprehensive management security policies, in order to reduce security risks, prevent accidents and protect people's lives and property safety. In this article the status of the construction site safety management was described the main reasons for construction safety accidents were analyzed, and the countermeasures to strengthen the site security management were proposed.%建筑工程施工是一项多工种、多专业的复杂的系统工程,具有流动性强、周期长、受环境影响大的特点,施工现场管理的目的是有效地完成施工项目的合同目标,使企业取得一定的经济效益.安全管理是施工现场管理的基础,施工现场安全管理是一个系统工程,它所涉及的系统是一个人、机、料、法、环、测的系统,所研究的问题,也是人、机、料、法、环、测系统工程学的问题.安全管理的根本任务在于贯彻“安全第一,预防为主、综合治理”的安全方针,降低安全风险,防止事故发生,保障人民生命和财产安全.本文介绍了建筑施工现场安全管理的现状,分析了造成建筑施工安全事故的主要原因,并就如何贯彻“安全第一、预防为主、综合治理”的

  2. Preliminary safety criteria for organic watch list tanks at the Hanford site

    Energy Technology Data Exchange (ETDEWEB)

    Webb, A.B.; Stewart, J.L.; Turner, O.A. [Westinghouse Hanford Co., Richland, WA (United States); Plys, M.G.; Malinovic, B. [Fauske and Associates, Inc., Burr Ridge, IL (United States); Grigsby, J.M. [G & P Consulting, Inc. (United States); Camaioni, D.M.; Heasler, P.G.; Samuels, W.O.; Toth, J.J. [Pacific Northwest Lab., Portland, OR (United States)

    1995-11-01

    Condensed-phase, rapid reactions of organic salts with nitrates/nitrites in Hanford High Level Radioactive Waste single-shell tanks could lead to structural failure of the tanks resulting in significant releases of radionuclides and toxic materials. This report establishes appropriate preliminary safety criteria to ensure that tank wastes will be maintained safe. These criteria show that if actual dry wastes contain less than 1.2 MJ/kg of reactants reaction energy or less 4.5 wt % of total organic carbon, then the waste will be safe and will not propagate if ignited. Waste moisture helps to retard reactions; when waste moisture exceeds 20 wt %, rapid reactions are prevented, regardless of organic carbon concentrations. Aging and degradation of waste materials has been considered to predict the types and amounts to organic compounds present in the waste. Using measurements of 3 waste phases (liquid, salt cake, and sludge) obtained from tank waste samples analyzed in the laboratory, analysis of variance (ANOVA) models were used to estimate waste states for unmeasured tanks. The preliminary safety criteria are based upon calorimetry and propagation testing of likely organic compounds which represent actual tank wastes. These included sodium salts of citrate, formate, acetate and hydroxyethylethylenediaminetricetate (HEDTA). Hot cell tests of actual tank wastes are planned for the future to confirm propagation tests performed in the laboratory. The effects of draining liquids from the tanks which would remove liquids and moisture were considered because reactive waste which is too dry may propagate. Evaporation effects which could remove moisture from the tanks were also calculated. The various ways that the waste could be heated or ignited by equipment failures or tank operations activities were considered and appropriate monitoring and controls were recommended.

  3. Improvement of worker safety through the investigation of the site response to rockbursts.

    CSIR Research Space (South Africa)

    Durrheim, RJ

    1997-12-01

    Full Text Available Recommendations B-60 5 ERPM, 24/7/95, ML\\site B-63 5.4 Seismic history B-65 5.5 Rockburst mechanism B-65 5.6 conclusions B-67 5.7...-152 11.7 Rockburst mechanism 8-153 11.8 Conclusions 8-153 11.9 Recommendations 8-154 12 Vaal Reefs # 5,10/2/97, ML=4,O 8-155 12.1 Introduction . 8-155 12.2 Mining environment 8-1S 6 12.3 Observations at the rockburst site 8-159 12.4 Assessment...

  4. Improvement of worker safety through the investigation of the site response to rockbursts.

    CSIR Research Space (South Africa)

    Hagan, TO

    1998-12-01

    Full Text Available result in inappropriate layouts. Tunnels positioned in fault loss zones sustained serious damage in some cases. Inappropriate and poorly designed support in tunnels, gullies and stopes and in some cases sub-standard application of the support... was to thoroughly instrument the resultant "rockburst" site in order to gain further insight into the damage mechanisms involved. The results were startlingly similar to what would be expected in a rockburst. Ground penetrating radar scans and petroscope probes...

  5. Development of the generic drug industry in the US after the Hatch-Waxman Act of 1984

    Directory of Open Access Journals (Sweden)

    Garth Boehm

    2013-09-01

    Full Text Available The key events in the development of the US generic drug industry after the Hatch-Waxman Act of 1984 are systematically reviewed, including the process of approval for generic drugs, bioequivalence issues including “switchability”, bioequivalence for complicated dosage forms, patent extension, generic drug safety, generic substitution and low-cost generics. The backlog in generic review, generic drug user fees, and “quality by design” for generic drugs is also discussed. The evolution of the US generic drug industry after the Hatch-Waxman Act in 1984 has afforded several lessons of great benefit to other countries wishing to establish or re-establish a domestic generic drug industry.

  6. Generic and biosimilar medicines: quid?

    Directory of Open Access Journals (Sweden)

    Steven Simoens

    2012-12-01

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

  7. Safety-related site characteristics - a relative comparison of the Forsmark reference areas; Saekerhetsrelaterade platsegenskaper - en relativ jaemfoerelse av Forsmark med referensomraaden

    Energy Technology Data Exchange (ETDEWEB)

    Winberg, Anders (Conterra AB, Uppsala (Sweden))

    2010-12-15

    SKB has over the years from 2002 to 2008 conducted site investigations in Forsmark and Laxemar, with associated site modeling, design and safety analysis. In mid-2009 Forsmark was selected on the basis of analysis made as site for a future repository for spent nuclear fuel. Based on defined safety-related geoscientific location factors data from Forsmark are compared in relative terms with data from a number of locations in Sweden, previously studied by SKB. The factors compared include: the rock's composition and structures, future climate evolution, rock mechanical conditions, earthquakes, groundwater flow, groundwater composition, delay of solutes, and the ability to characterize and describe the location. Past comparisons of these properties for the selected sites show that none of these sites collectively show any significant benefit over Forsmark site for a repository. This does not preclude that there may be places on the basis of an overall assessment of geoscientific location factors could be equivalent to Forsmark

  8. 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.

  9. Safety criteria for organic watch list tanks at the Hanford Site

    Energy Technology Data Exchange (ETDEWEB)

    Meacham, J.E., Westinghouse Hanford

    1996-08-01

    This document reviews the hazards associated with the storage of organic complexant salts in Hanford Site high-level waste single- shell tanks. The results of this analysis were used to categorize tank wastes as safe, unconditionally safe, or unsafe. Sufficient data were available to categorize 67 tanks; 63 tanks were categorized as safe, and four tanks were categorized as conditionally safe. No tanks were categorized as unsafe. The remaining 82 SSTs lack sufficient data to be categorized.Historic tank data and an analysis of variance model were used to prioritize the remaining tanks for characterization.

  10. Generic wormhole throats

    CERN Document Server

    Visser, M; Visser, Matt; Hochberg, David

    1997-01-01

    Wormholes and black holes have traditionally been treated a quite separate objects with relatively little overlap. The possibility of a connection arises in that wormholes, if they exist, might have profound influence on black holes, their event horizons, and their internal structure. After discussing some connections, we embark on an overview of what can generally be said about traversable wormhole throats. We discuss the violations of the energy conditions that typically occur at and near the throat of any traversable wormhole and emphasize the generic nature of this result. We discuss the original Morris-Thorne wormhole and its generalization to a spherically symmetric time-dependent wormhole, and also discuss spherically symmetric Brans-Dicke wormholes. We also discuss the relationship with the topological censorship theorem. Finally we turn to a rather general class of wormholes that permit explicit analysis: generic static traversable wormholes (without any symmetry). We define the wormhole throat in te...

  11. Generic Network Location Service

    Directory of Open Access Journals (Sweden)

    Laban Mwansa

    2010-11-01

    Full Text Available This work presents the Generic Network Location Service based on the Chord implementation utilizing data structures called distributed hash tables (DHT or structured overlay networks, which are used to build scalable self-managing distributed systems. The provided algorithms guarantee resilience in the presence of dynamism: they guarantee consistent lookup results in the presence of nodes failing and leaving. Generic Network Location Service provides a Location Service system based on DHT technology, which is storing device location records in nodes within a Chord DHT. Location records are consisting of network device identification keys as attributes, which are used to create replicas of additional location records through established Chord hashing mechanisms. Storing device location records, in places address-able (using the DHT lookup by individual location record keys provides a simple way of implementing transla¬tion functions similar to well¬ known network services (e.g. ARP, DNS, ENUM. The generic network location ser¬vice presented in the paper is not supposed to be a substitu¬tion of the existing translation techniques (e.g. ARP, DNS, ENUM, but it is considered as an overlay service that uses data available in existing systems and provides some translations currently unavailable.

  12. Chemical conditions in present and future ecosystems in Forsmark - implications for selected radionuclides in the safety assessment SR-Site

    Energy Technology Data Exchange (ETDEWEB)

    Troejbom, Mats (Mats Troejbom Konsult AB (Sweden)); Grolander, Sara (Facilia AB (Sweden))

    2010-12-15

    This report is a background report for the biosphere analysis of the SR-Site Safety Assessment. This work aims to describe the future development of the chemical conditions at Forsmark, based on the present chemical conditions at landscape level taking landscape development and climate cases into consideration. The results presented contribute to the overall understanding of the present and future chemistry in the Forsmark area, and specifically, to the understanding of the behaviour of some selected radionuclides in the surface system. The future development of the chemistry at the site is qualitatively discussed with focus on the interglacial within the next 10,000 years. The effects on the chemical environment of future climate cases as Global Warming and cold permafrost climates are also briefly discussed. The work is presented in two independent parts describing background radionuclide activities in the Forsmark area and the distribution and behaviour of a large number of stable elements in the landscape. In a concluding section, implications of the future chemical environment of a selection of radionuclides important in the Safety Assessment are discussed based on the knowledge of stable elements. The broad range of elements studied show that there are general and expected patterns for the distribution and behaviour in the landscape of different groups of elements. Mass balances reveal major sources and sinks, pool estimations show where elements are accumulated in the landscape and estimations of time-scales give indications of the potential future development. This general knowledge is transferred to radionuclides not measured in order to estimate their behaviour and distribution in the landscape. It could be concluded that the future development of the chemical environment in the Forsmark area might affect element specific parameters used in de radionuclide model in different directions depending on element. The alternative climate cases, Global Warming

  13. Preliminary Review of Safety Assessment Issues at Savannah River Site, August 2011

    Energy Technology Data Exchange (ETDEWEB)

    Napier, Bruce A.; Rishel, Jeremy P.; Bixler, Nathan E.

    2011-09-19

    At the request of Savannah River Nuclear Solutions (SRNS) management, a review team composed of experts in atmospheric transport modeling for environmental radiation dose assessment convened at the Savannah River Site (SRS) on August 29-30, 2011. Several issues were presented at the meeting for discussion. This is a short summary that is organized in accordance with the primary issues discussed, which is not necessarily a chronological record. Issues include: SRS Meteorological Data and its Use in MACCS2; Deposition Velocities for Particles; Deposition Velocities for Tritium; MACCS2 Dispersion Coefficients; Use of Low Surface Roughness in Open Areas; Adequacy of Meteorological Tower and Instrumentation; Displacement Height; and Validity of MACCS2 Calculations at Close-in Distances. A longer report will be issued at a later date that expands upon these topics and recommendations.

  14. Preliminary Review of Safety Assessment Issues at Savannah River Site, August 2011

    Energy Technology Data Exchange (ETDEWEB)

    Napier, Bruce A.; Rishel, Jeremy P.; Bixler, Nathan E.

    2011-09-19

    At the request of Savannah River Nuclear Solutions (SRNS) management, a review team composed of experts in atmospheric transport modeling for environmental radiation dose assessment convened at the Savannah River Site (SRS) on August 29-30, 2011. Several issues were presented at the meeting for discussion. This is a short summary that is organized in accordance with the primary issues discussed, which is not necessarily a chronological record. Issues include: SRS Meteorological Data and its Use in MACCS2; Deposition Velocities for Particles; Deposition Velocities for Tritium; MACCS2 Dispersion Coefficients; Use of Low Surface Roughness in Open Areas; Adequacy of Meteorological Tower and Instrumentation; Displacement Height; and Validity of MACCS2 Calculations at Close-in Distances. A longer report will be issued at a later date that expands upon these topics and recommendations.

  15. [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.

  16. Landscape dose conversion factors used in the safety assessment SR-Site

    Energy Technology Data Exchange (ETDEWEB)

    Avila, Rodolfo; Ekstroem, Per-Anders; Aastrand, Per-Gustav (Facilia AB (Sweden))

    2010-12-15

    In this report two types of Dose Conversion Factors have been derived: i) a Landscape Dose Conversion Factor (LDF) that is applicable to continuous long-term releases to the biosphere at a constant rate, and ii) a Landscape Dose Conversion Factor for pulse releases (LDF pulse) that is applicable to a radionuclide release that reaches the biosphere in a pulse within years to hundreds of years. In SR-Site these Dose Factors are multiplied with modelled release rates or pulse releases from the geosphere to obtain dose estimates used in assessment of compliance with the regulatory risk criterion. The LDFs were calculated for three different periods of the reference glacial cycle; a period of submerged conditions following the deglaciation, the temperate period, and a prolonged period of periglacial conditions. Additionally, LDFs were calculated for the global warming climate case. The LDF pulse was calculated only for temperate climate conditions. The LDF and LDF pulse can be considered as Best Estimate values, which can be used in calculations of Best Estimate values of doses to a representative individual of the most exposed group from potential releases from a future repository. A systematic analysis of the effects of system, model and parameter uncertainties on the LDFs has been carried out. This analysis has shown that the use of the derived LDF would lead to cautious or realistic dose estimates. The models and methods that were used for derivation of the LDFs and LDF pulse are also described in this report

  17. Safety and Efficacy of the Prostar XL Vascular Closing Device for Percutaneous Closure of Large Arterial Access Sites

    Directory of Open Access Journals (Sweden)

    Christoph Thomas

    2013-01-01

    Full Text Available Purpose. The purpose of this study is to retrospectively evaluate the efficacy and safety of the Prostar XL device for percutaneous large access site closure in an unselected patient and operator collective. Materials and Methods. All patients ( who had received percutaneous vascular closing with the Prostar XL device in our institution with follow-up data of at least 6 months were retrospectively included. Primary (freedom from surgical conversion and continued (freedom from groin surgery in further course technical success and major (deviations from expected outcome requiring surgery and minor (other deviations from expected outcome complications were assessed. Success and complications rates were correlated with delivery system size (Mann-Whitney Rank Sum Tests and operator experience (paired samples t-test. Results. Rates of primary and continued technical success as well as major and minor complications were 93.6%, 89.7%, 10.3%, and 10.3% (groin based and 90.0%, 84.0%, 16.0%, and 16.0% (patient based, respectively. No correlation of success and complications rate was found with delivery system sizes and operator experience. Conclusions. Application of the Prostar XL device for percutaneous closure of large arterial access sites is safe with a relatively high rate of technical success and low rate of major complications. Sizes of the delivery systems and the experience of the operator did not influence the results.

  18. NASA Aerospace Flight Battery Program: Generic Safety, Handling and Qualification Guidelines for Lithium-Ion (Li-Ion) Batteries; Availability of Source Materials for Lithium-Ion (Li-Ion) Batteries; Maintaining Technical Communications Related to Aerospace Batteries (NASA Aerospace Battery Workshop). Volume 1, Part 1

    Science.gov (United States)

    Manzo, Michelle A.; Brewer, Jeffrey C.; Bugga, Ratnakumar V.; Darcy, Eric C.; Jeevarajan, Judith A.; McKissock, Barbara I.; Schmitz, Paul C.

    2010-01-01

    This NASA Aerospace Flight Battery Systems Working Group was chartered within the NASA Engineering and Safety Center (NESC). The Battery Working Group was tasked to complete tasks and to propose proactive work to address battery related, agency-wide issues on an annual basis. In its first year of operation, this proactive program addressed various aspects of the validation and verification of aerospace battery systems for NASA missions. Studies were performed, issues were discussed and in many cases, test programs were executed to generate recommendations and guidelines to reduce risk associated with various aspects of implementing battery technology in the aerospace industry. This document contains Part 1 - Volume I: Generic Safety, Handling and Qualification Guidelines for Lithium-Ion (Li-Ion) Batteries, Availability of Source Materials for Lithium-Ion (Li-Ion) Batteries, and Maintaining Technical Communications Related to Aerospace Batteries (NASA Aerospace Battery Workshop).

  19. Final disposal of spent fuel in the Finnish bedrock. Scope and requirements for site-specific safety analysis; Kaeytetyn polttoaineen loppusijoitus Suomen kallioperaeaen. Paikkakohtaisen turvallisuusanalyysin edellytykset ja mahdollisuudet

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1996-12-01

    The report is a summary of the research conducted in the period 1993 to 1996 into safety of spent fuel final disposal. The principal goal of the research in this period, as set in 1993, was to develop a strategy for site-specific safety analysis. At the same time efforts were to be continued to gather data and validate the technical approach for the analysis. The work aimed at having the data needed for the analysis available at the end of year 1998. A safety assessment update, TILA-96, prepared by VTT Energy, is published as a separate report. The assessment is based on the TVO-92 safety analysis, but takes into account the knowledge acquired after 1992 on safety aspects of the disposal system and the data gathered from the site investigations made by TVO and from the beginning of 1996, by Posiva. Since the site investigations are still ongoing and much of the data gathered still pending interpretation, only limited amount of new site-specific information has been available for the present assessment. (172 refs.).

  20. Health and safety impacts of nuclear, geothermal, and fossil-fuel electric generation in California. Volume 9. Methodologies for review of the health and safety aspects of proposed nuclear, geothermal, and fossil-fuel sites and facilities

    Energy Technology Data Exchange (ETDEWEB)

    Nero, A.V.; Quinby-Hunt, M.S.

    1977-01-01

    This report sets forth methodologies for review of the health and safety aspects of proposed nuclear, geothermal, and fossil-fuel sites and facilities for electric power generation. The review is divided into a Notice of Intention process and an Application for Certification process, in accordance with the structure to be used by the California Energy Resources Conservation and Development Commission, the first emphasizing site-specific considerations, the second examining the detailed facility design as well. The Notice of Intention review is divided into three possible stages: an examination of emissions and site characteristics, a basic impact analysis, and an assessment of public impacts. The Application for Certification review is divided into five possible stages: a review of the Notice of Intention treatment, review of the emission control equipment, review of the safety design, review of the general facility design, and an overall assessment of site and facility acceptability.

  1. 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...

  2. Safety approach for a facility coupling a nuclear reactor to a chemical plant, generic principles and application to a hydrogen production process; Approche de surete d'une installation associant un reacteur nucleaire a une usine chimique, principes generiques et application a un procede de production d'hydrogene

    Energy Technology Data Exchange (ETDEWEB)

    Bertrand, F.; Barbier, D.; Bassi, A. [CEA Cadarache, Direction de l' Energie Nucleaire, 13 - Saint-Paul-lez-Durance (France). Dept. d' Etudes des Reacteurs

    2006-07-01

    The aim of this paper is to propose an overall safety approach devoted to the coupling on a same site of a nuclear reactor to a plant of hydrogen production. Such facilities depend on their own safety principles and practices and are submitted to their own regulation. Therefore, the approach presented here takes into account the aforementioned constraints and takes into consideration the various risks on the site in the design process of the coupling system. This approach relying on the defence in depth concept declined in five levels led to a generalization of the notion of physical barriers and safety functions applied in the French nuclear safety approach. Three main safety functions can be considered for the whole coupled facility : the control of the nuclear and chemical reactivity, the power extraction and the confinement of hazardous materials. Moreover, according to the concept of defence in depth, different plant conditions (normal, incidents and accidents) have been analyzed for the whole facility. Furthermore, the safety approach proposed for the chemical plant is aimed to select reference scenarios taking into account their probability and their consequences on the basis of the methodology presented in the ARAMIS European project. Finally, the purpose of the safety analysis of the chemical plant is the assessment of adequate safety distances to protect people outside of the site as well as the coupling system and, above everything, the nuclear reactor containment. In other respects, a progressive response aiming to avoid the reactor scram is proposed to manage with incidents. (authors)

  3. FHR Generic Design Criteria

    Energy Technology Data Exchange (ETDEWEB)

    Flanagan, G.F.; Holcomb, D.E.; Cetiner, S.M.

    2012-06-15

    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.

  4. 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.

  5. Technology, safety and costs of decommissioning a reference boiling water reactor power station. Appendices. Volume 2

    Energy Technology Data Exchange (ETDEWEB)

    Oak, H.D.; Holter, G.M.; Kennedy, W.E. Jr.; Konzek, G.J.

    1980-06-01

    Appendices are presented concerning the evaluations of decommissioning financing alternatives; reference site description; reference BWR facility description; radiation dose rate and concrete surface contamination data; radionuclide inventories; public radiation dose models and calculated maximum annual doses; decommissioning methods; generic decommissioning information; immediate dismantlement details; passive safe storage, continuing care, and deferred dismantlement details; entombment details; demolition and site restoration details; cost estimating bases; public radiological safety assessment details; and details of alternate study bases.

  6. Generic drugs for hypertension: are they really equivalent?

    Science.gov (United States)

    Cooper-DeHoff, Rhonda M; Elliott, William J

    2013-08-01

    Many antihypertensive drugs are now available in generic formulations at fractions of the cost of their branded counterparts. In the United States, marketing approval for generic medications is usually granted by the Food and Drug Administration on the basis of two simple studies involving dissolution rates and bioavailability in 24 - 36 healthy people, without data regarding antihypertensive efficacy, safety, or long-term outcomes. This process leaves many true disciples of "Evidence-Based Medicine" in a quandary: prescribe only brand-name medications that have been demonstrated in clinical trials to both lower blood pressure and prevent cardiovascular events, or instead recommend lower-priced generic agents that are usually supported by no such data. This review summarizes the current evidence that generic antihypertensive drugs are likely to be safe and effective, may increase the probability of medication availability and adherence for many patients, but, by law, must have a different physical appearance than the original product.

  7. Safety analysis--200 Area Savannah River Site: Separations Area operations Building 211-H Outside Facilities. Supplement 11, Revision 1

    Energy Technology Data Exchange (ETDEWEB)

    1993-01-01

    The H-Area Outside Facilities are located in the 200-H Separations Area and are comprised of a number of processes, utilities, and services that support the separations function. Included are enriched uranium loadout, bulk chemical storage, water handling, acid recovery, general purpose evaporation, and segregated solvent facilities. In addition, services for water, electricity, and steam are provided. This Safety Analysis Report (SAR) documents an analysis of the H-Area Outside Facilities and is one of a series of documents for the Separations Area as specified in the SR Implementation Plan for DOE order 5481.1A. The primary purpose of the analysis was to demonstrate that the facility can be operated without undue risk to onsite or offsite populations, to the environment, and to operating personnel. In this report, risks are defined as the expected frequencies of accidents, multiplied by the resulting radiological consequences in person-rem. Following the summary description of facility and operations is the site evaluation including the unique features of the H-Area Outside Facilities. The facility and process design are described in Chapter 3.0 and a description of operations and their impact is given in Chapter 4.0. The accident analysis in Chapter 5.0 is followed by a list of safety related structures and systems (Chapter 6.0) and a description of the Quality Assurance program (Chapter 7.0). The accident analysis in this report focuses on estimating the risk from accidents as a result of operation of the facilities. The operations were evaluated on the basis of three considerations: potential radiological hazards, potential chemical toxicity hazards, and potential conditions uniquely different from normal industrial practice.

  8. Regulation of Generic Drugs in Japan: the Current Situation and Future Prospects.

    Science.gov (United States)

    Kuribayashi, Ryosuke; Matsuhama, Maki; Mikami, Kenichi

    2015-09-01

    Generic drugs are interchangeable with original proprietary drugs, as they have the same active pharmaceutical ingredients, dosage forms, strength, quality, indications, effects, directions, and dosage. The cost of generic drugs is lower than original drugs, because the developmental cost is lower. The expansion of medical expenses is an important issue in many countries, including Japan, the USA, and Europe, and promotion of generic drugs has been demanded to solve this issue in Japan. Generic drug approval review in Japan is conducted by the Pharmaceuticals and Medical Devices Agency (PMDA), which reviews the equivalence of the original drugs from the viewpoint of quality, efficacy, and safety, based on documentation submitted by the generic drug applicants. However, the details of the generic drug review in Japan have not been reported. In this report, we introduce the application types, the number of applications and approvals, and the review timeline of generic drugs in Japan. In addition, we discuss recent consultations and future prospects.

  9. 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

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

    Directory of Open Access Journals (Sweden)

    Mohamed Azmi Hassali

    2014-11-01

    Full Text Available 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.

  11. Generic Substitution of Lamotrigine Among Medicaid Patients with Diverse Indications

    Science.gov (United States)

    Hartung, Daniel M.; Middleton, Luke; Svoboda, Leanne; McGregor, Jessina C.

    2013-01-01

    Background Controversy exists about the safety of substituting generic anti-epileptic drugs (AEDs). Lamotrigine, the prototypical newer AED, is often used for psychiatric and neurological conditions other than epilepsy. The safety of generic substitution of lamotrigine in diverse populations of AED users is unclear. Objective The objective of this study was to evaluate potential associations between generic substitution of lamotrigine and adverse consequences in a population of diverse users of this drug. Study Design This study was a retrospective cohort-crossover design using state Medicaid claims data from July 2006 through June 2009. Methods Subjects were included in the cohort if they converted from brand to generic lamotrigine and had 2 years of lamotrigine use prior to conversion. The frequency of emergency department (ED) visits, hospitalizations and condition-specific ED visits or hospitalizations were recorded in the 60 days immediately following the conversion to generic lamotrigine, then compared with the incidence of the same events during a randomly selected time period indexed to one of the patient’s past refills of branded lamotrigine. Multivariate conditional logistic regression was used to quantify the association between generic conversion and health services utilization while controlling for changes in lamotrigine dose and concurrent drug use. Results Of the 616 unique subjects included in this analysis, epilepsy was the most common diagnosis (41%), followed by bipolar disorder (32%), pain (30%) and migraine (18%). Conversion to generic lamotrigine was not associated with a statistically significant increase in the odds of an ED visit (adjusted odds ratio [AOR] = 1.35; 95% confidence interval [CI] 0.92, 1.97), hospitalization (AOR = 1.21; 95% CI 0.60, 2.50) or condition-specific encounter (AOR 1.75; 95 CI 0.87, 3.51). Conclusions A statistically significant increase in ED visits, hospitalizations or condition-specific encounters was not

  12. 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.

  13. Pathways and factors for food safety and food security at PFOS contaminated sites within a problem based learning approach.

    Science.gov (United States)

    Brambilla, Gianfranco; D'Hollander, Wendy; Oliaei, Fardin; Stahl, Thorsten; Weber, Roland

    2015-06-01

    Perfluorooctanesulfonic acid (PFOS) and related substances have been listed in Annex B of the Stockholm Convention. The implementation requires inventories of use, stockpiles, and environmental contamination including contaminated sites and measures for (risk) reduction and phase out. In most countries monitoring capacity is not available and therefore other approaches for assessment of contaminated sites are needed. Available informations about PFOS contamination in hot spot areas and its bio-accumulation in the food webs have been merged to build up a worst-case scenario We model PFOS transfer from 1 to 100ngL(-1) range in water to extensive and free-range food producing animals, also via the spread of contaminated sludges on agriculture soils. The modeling indicates that forages represented 78% of the exposure in ruminants, while soil accounted for >80% in outdoor poultry/eggs and pigs. From the carry-over rates derived from literature, in pork liver, egg, and feral fish computed concentration falls at 101, 28 and 2.7ngg(-1), respectively, under the 1ngL(-1) PFOS scenario. Assuming a major consumption of food produced from a contaminated area, advisories on egg and fish, supported by good agriculture/farming practices could abate 75% of the human food intake. Such advisories would allow people to become resilient in a PFOS contaminated area through an empowerment of the food choices, bringing the alimentary exposure toward the current Tolerable Daily Intake (TDI) of 150ngkg(-1)bodyweightd(-1) proposed by the European Food Safety Authority (EFSA).

  14. Generic drug names and social welfare.

    Science.gov (United States)

    Lobo, Félix; Feldman, Roger

    2013-06-01

    This article studies how well International Nonproprietary Names (INNs), the "generic" names for pharmaceuticals, address the problems of imperfect information. Left in private hands, the identification of medicines leads to confusion and errors. Developed in the 1950s by the World Health Organization, INNs are a common, global, scientific nomenclature designed to overcome this failure. Taking stock after sixty years, we argue that the contribution of INNs to social welfare is paramount. They enhance public health by reducing errors and improving patient safety. They also contribute to economic efficiency by creating transparency as the foundation of competitive generic drug markets, reducing transaction costs, and favoring trade. The law in most countries requires manufacturers to designate pharmaceuticals with INNs in labeling and advertising. Generic substitution is also permitted or mandatory in many countries. But not all the benefits of INNs are fully realized because prescribers may not use them. We advocate strong incentives or even legally binding provisions to extend the use of INNs by prescribing physicians and dispensing pharmacists, but we do not recommend replacing brand names entirely with INNs. Instead, we propose dual use of brand names and INNs in prescribing, as in drug labeling.

  15. Technology, Safety and Costs of Decommissioning a Reference Low-Level Waste Burial Ground. Main Report

    Energy Technology Data Exchange (ETDEWEB)

    Murphy, E. S.; Holter, G. M.

    1980-06-01

    Safety and cost information are developed for the conceptual decommissioning of commercial low-level waste (LLW) burial grounds. Two generic burial grounds, one located on an arid western site and the other located on a humid eastern site, are used as reference facilities for the study. The two burial grounds are assumed to have the same site capacity for waste, the same radioactive waste inventory, and similar trench characteristics and operating procedures. The climate, geology. and hydrology of the two sites are chosen to be typical of real western and eastern sites. Volume 1 (Main Report) contains background information and study results in summary form.

  16. Technology, Safety and Costs of Decommissioning a Reference Low-Level Waste Burial Ground. Appendices

    Energy Technology Data Exchange (ETDEWEB)

    None

    1980-06-01

    Safety and cost information are developed for the conceptual decommissioning of commercial low-level waste (LLW) burial grounds. Two generic burial grounds, one located on an arid western site and the other located on a humid eastern site, are used as reference facilities for the study. The two burial grounds are assumed to have the same site capacity for waste, the same radioactive waste inventory, and similar trench characteristics and operating procedures. The climate, geology. and hydrology of the two sites are chosen to be typical of real western and eastern sites. Volume 2 (Appendices) contains the detailed analyses and data needed to support the results given in Volume 1.

  17. Generic Quantum Fourier Transforms

    CERN Document Server

    Moore, Cristopher; Russell, A; Moore, Cristopher; Rockmore, Daniel; Russell, Alexander

    2003-01-01

    The quantum Fourier transform (QFT) is the principal algorithmic tool underlying most efficient quantum algorithms. We present a generic framework for the construction of efficient quantum circuits for the QFT by ``quantizing'' the separation of variables technique that has been so successful in the study of classical Fourier transform computations. Specifically, this framework applies the existence of computable Bratteli diagrams, adapted factorizations, and Gel'fand-Tsetlin bases to offer efficient quantum circuits for the QFT over a wide variety a finite Abelian and non-Abelian groups, including all group families for which efficient QFTs are currently known and many new group families. Moreover, the method gives rise to the first subexponential-size quantum circuits for the QFT over the linear groups GL_k(q), SL_k(q), and the finite groups of Lie type, for any fixed prime power q.

  18. Dimensional regularization is generic

    CERN Document Server

    Fujikawa, Kazuo

    2016-01-01

    The absence of the quadratic divergence in the Higgs sector of the Standard Model in the dimensional regularization is usually regarded to be an exceptional property of a specific regularization. To understand what is going on in the dimensional regularization, we illustrate how to reproduce the results of the dimensional regularization for the $\\lambda\\phi^{4}$ theory in the more conventional regularization such as the higher derivative regularization; the basic postulate involved is that the quadratically divergent induced mass, which is independent of the scale change of the physical mass, is kinematical and unphysical. This is consistent with the derivation of the Callan-Symanzik equation, which is a comparison of two theories with slightly different masses, for the $\\lambda\\phi^{4}$ theory without encountering the quadratic divergence. We thus suggest that the dimensional regularization is generic in a bottom-up approach starting with a successful low-energy theory. We also define a modified version of t...

  19. Multiple sclerosis. Generic glatiramer acetate--a step toward cheaper MS drugs?

    Science.gov (United States)

    Sørensen, Per Soelberg

    2016-01-01

    A randomized, double-blind, phase III trial of generic glatiramer acetate has shown equivalent efficacy and safety compared with the approved formulation, Copaxone. The impact of approval of generic glatiramer acetate, however, will mainly depend on the pricing of the drug.

  20. Generic torus canards

    Science.gov (United States)

    Vo, Theodore

    2017-10-01

    Torus canards are special solutions of fast/slow systems that alternate between attracting and repelling manifolds of limit cycles of the fast subsystem. A relatively new dynamic phenomenon, torus canards have been found in neural applications to mediate the transition from tonic spiking to bursting via amplitude-modulated spiking. In R3, torus canards are degenerate: they require one-parameter families of 2-fast/1-slow systems in order to be observed and even then, they only occur on exponentially thin parameter intervals. The addition of a second slow variable unfolds the torus canard phenomenon, making it generic and robust. That is, torus canards in fast/slow systems with (at least) two slow variables occur on open parameter sets. So far, generic torus canards have only been studied numerically, and their behaviour has been inferred based on averaging and canard theory. This approach, however, has not been rigorously justified since the averaging method breaks down near a fold of periodics, which is exactly where torus canards originate. In this work, we combine techniques from Floquet theory, averaging theory, and geometric singular perturbation theory to show that the average of a torus canard is a folded singularity canard. In so doing, we devise an analytic scheme for the identification and topological classification of torus canards in fast/slow systems with two fast variables and k slow variables, for any positive integer k. We demonstrate the predictive power of our results in a model for intracellular calcium dynamics, where we explain the mechanisms underlying a novel class of elliptic bursting rhythms, called amplitude-modulated bursting, by constructing the torus canard analogues of mixed-mode oscillations. We also make explicit the connection between our results here with prior studies of torus canards and torus canard explosion in R3, and discuss how our methods can be extended to fast/slow systems of arbitrary (finite) dimension.

  1. 9 CFR 317.5 - Generically approved labeling.

    Science.gov (United States)

    2010-01-01

    ... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Generically approved labeling. 317.5 Section 317.5 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE... section), or guarantees, or which is not a domestic product labeled in a foreign language; (2) Labeling...

  2. Post-mining safety implementations and environmental aspects of abandoned mine sites in Limousin. 2006 status (and perspectives 2007); Mises en securite en apres-mine et aspects environnementaux des anciens sites miniers en Limousin. Bilan 2006 (et perspectives 2007)

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2007-07-01

    This document summarizes the actions carried out in 2006 at some French abandoned mine sites: 1 - safety implementations and risks abatement in the framework of post-mining actions: coal mines of Ahun (23) and Argentat (19), antimony mines of Biard (87); 2 - remedial actions at the tin/tungsten mine of Puy-les-Vignes (87) and at the gold mine of Chatelet (23); 3 - 2007 post-mining perspectives; 4 - environmental aspects of abandoned mine sites: gold mines of Chatelet (23), Cheni and Bourneix (87), uranium mines of Haute-Vienne (expertise, control of effluents, financial warranties about tailings storage sites maintenance). (J.S.)

  3. Typed combinators for generic traversal

    NARCIS (Netherlands)

    Lämmel, R.; Vonk, J.

    2001-01-01

    Lacking support for generic traversal, functional programming languages suffer from a scalability problem when applied to large-scale program transformation problems. As a solution, we introduce emph{functional strategies: typeful generic functions that not only can be applied to terms of any type,

  4. 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 generalizations (‘Dogs a

  5. Long-term safety for the final repository for spent nuclear fuel at Forsmark. Main report of the SR-Site project

    Energy Technology Data Exchange (ETDEWEB)

    2011-03-15

    The central conclusion of the safety assessment SR-Site is that a KBS-3 repository that fulfils long-term safety requirements can be built at the Forsmark site. This conclusion is reached because the favourable properties of the Forsmark site ensure the required long-term durability of the barriers of the KBS-3 repository. In particular, the copper canisters with their cast iron inserts have been demonstrated to provide a sufficient resistance to the mechanical and chemical loads to which they may be subjected in the repository environment. The conclusion is underpinned by: - The reliance of the KBS-3 repository on i) a geological environment that exhibits long-term stability with respect to properties of importance for long-term safety, i.e. mechanical stability, low groundwater flow rates at repository depth and the absence of high concentrations of detrimental components in the groundwater, and ii) the choice of naturally occurring materials (copper and bentonite clay) for the engineered barriers that are sufficiently durable in the repository environment to provide the barrier longevity required for safety. - The understanding, through decades of research at SKB and in international collaboration, of the phenomena that affect long-term safety, resulting in a mature knowledge base for the safety assessment. - The understanding of the characteristics of the site through several years of surface-based investigations of the conditions at depth and of scientific interpretation of the data emerging from the investigations, resulting in a mature model of the site, adequate for use in the safety assessment. - The detailed specifications of the engineered parts of the repository and the demonstration of how components fulfilling the specifications are to be produced in a quality assured manner, thereby providing a quality assured initial state for the safety assessment. The detailed analyses demonstrate that canister failures in a one million year perspective are rare

  6. Long-term safety for the final repository for spent nuclear fuel at Forsmark. Main report of the SR-Site project

    Energy Technology Data Exchange (ETDEWEB)

    2011-03-15

    The central conclusion of the safety assessment SR-Site is that a KBS-3 repository that fulfils long-term safety requirements can be built at the Forsmark site. This conclusion is reached because the favourable properties of the Forsmark site ensure the required long-term durability of the barriers of the KBS-3 repository. In particular, the copper canisters with their cast iron inserts have been demonstrated to provide a sufficient resistance to the mechanical and chemical loads to which they may be subjected in the repository environment. The conclusion is underpinned by: - The reliance of the KBS-3 repository on i) a geological environment that exhibits long-term stability with respect to properties of importance for long-term safety, i.e. mechanical stability, low groundwater flow rates at repository depth and the absence of high concentrations of detrimental components in the groundwater, and ii) the choice of naturally occurring materials (copper and bentonite clay) for the engineered barriers that are sufficiently durable in the repository environment to provide the barrier longevity required for safety. - The understanding, through decades of research at SKB and in international collaboration, of the phenomena that affect long-term safety, resulting in a mature knowledge base for the safety assessment. - The understanding of the characteristics of the site through several years of surface-based investigations of the conditions at depth and of scientific interpretation of the data emerging from the investigations, resulting in a mature model of the site, adequate for use in the safety assessment. - The detailed specifications of the engineered parts of the repository and the demonstration of how components fulfilling the specifications are to be produced in a quality assured manner, thereby providing a quality assured initial state for the safety assessment. The detailed analyses demonstrate that canister failures in a one million year perspective are rare

  7. Comprehensive work plan and health and safety plan for the 7500 Area Contamination Site sampling at Oak Ridge National Laboratory, Oak Ridge, Tennessee

    Energy Technology Data Exchange (ETDEWEB)

    Burman, S.N.; Landguth, D.C.; Uziel, M.S.; Hatmaker, T.L.; Tiner, P.F.

    1992-05-01

    As part of the Environmental Restoration Program sponsored by the US Department of Energy's Office of Environmental Restoration and Waste Management, this plan has been developed for the environmental sampling efforts at the 7500 Area Contamination Site, Oak Ridge National Laboratory (ORNL), Oak Ridge, Tennessee. This plan was developed by the Measurement Applications and Development Group (MAD) of the Health and Safety Research Division of ORNL and will be implemented by ORNL/MAD. Major components of the plan include (1) a quality assurance project plan that describes the scope and objectives of ORNL/MAD activities at the 7500 Area Contamination Site, assigns responsibilities, and provides emergency information for contingencies that may arise during field operations; (2) sampling and analysis sections; (3) a site-specific health and safety section that describes general site hazards, hazards associated with specific tasks, personnel protection requirements, and mandatory safety procedures; (4) procedures and requirements for equipment decontamination and responsibilities for generated wastes, waste management, and contamination control; and (5) a discussion of form completion and reporting required to document activities at the 7500 Area Contamination Site.

  8. Comprehensive work plan and health and safety plan for the 7500 Area Contamination Site sampling at Oak Ridge National Laboratory, Oak Ridge, Tennessee. Environmental Restoration Program

    Energy Technology Data Exchange (ETDEWEB)

    Burman, S.N.; Landguth, D.C.; Uziel, M.S.; Hatmaker, T.L.; Tiner, P.F.

    1992-05-01

    As part of the Environmental Restoration Program sponsored by the US Department of Energy`s Office of Environmental Restoration and Waste Management, this plan has been developed for the environmental sampling efforts at the 7500 Area Contamination Site, Oak Ridge National Laboratory (ORNL), Oak Ridge, Tennessee. This plan was developed by the Measurement Applications and Development Group (MAD) of the Health and Safety Research Division of ORNL and will be implemented by ORNL/MAD. Major components of the plan include (1) a quality assurance project plan that describes the scope and objectives of ORNL/MAD activities at the 7500 Area Contamination Site, assigns responsibilities, and provides emergency information for contingencies that may arise during field operations; (2) sampling and analysis sections; (3) a site-specific health and safety section that describes general site hazards, hazards associated with specific tasks, personnel protection requirements, and mandatory safety procedures; (4) procedures and requirements for equipment decontamination and responsibilities for generated wastes, waste management, and contamination control; and (5) a discussion of form completion and reporting required to document activities at the 7500 Area Contamination Site.

  9. HAZWOPER work plan and site safety and health plan for the Alpha characterization project at the solid waste storage area 4 bathtubbing trench at Oak Ridge National Laboratory

    Energy Technology Data Exchange (ETDEWEB)

    1994-07-01

    This work plan/site safety and health plan is for the alpha sampling project at the Solid Waste Storage Area 4 bathtubbing trench. The work will be conducted by the Oak Ridge National Laboratory (ORNL) Environmental Sciences Division and associated ORNL environmental, safety, and health support groups. This activity will fall under the scope of 29 CFR 1910.120, Hazardous Waste Operations and Emergency Response (HAZWOPER). The purpose of this document is to establish health and safety guidelines to be followed by all personnel involved in conducting work for this project. Work will be conducted in accordance with requirements as stipulated in the ORNL HAZWOPER Program Manual and applicable ORNL; Martin Marietta Energy Systems, Inc.; and U.S. Department of Energy policies and procedures. The levels of protection and the procedures specified in this plan are based on the best information available from historical data and preliminary evaluations of the area. Therefore, these recommendations represent the minimum health and safety requirements to be observed by all personnel engaged in this project. Unforeseeable site conditions or changes in scope of work may warrant a reassessment of the stated protection levels and controls. All adjustments to the plan must have prior approval by the safety and health disciplines signing the original plan.

  10. Generic physical protection logic trees

    Energy Technology Data Exchange (ETDEWEB)

    Paulus, W.K.

    1981-10-01

    Generic physical protection logic trees, designed for application to nuclear facilities and materials, are presented together with a method of qualitative evaluation of the trees for design and analysis of physical protection systems. One or more defense zones are defined where adversaries interact with the physical protection system. Logic trees that are needed to describe the possible scenarios within a defense zone are selected. Elements of a postulated or existing physical protection system are tagged to the primary events of the logic tree. The likelihood of adversary success in overcoming these elements is evaluated on a binary, yes/no basis. The effect of these evaluations is propagated through the logic of each tree to determine whether the adversary is likely to accomplish the end event of the tree. The physical protection system must be highly likely to overcome the adversary before he accomplishes his objective. The evaluation must be conducted for all significant states of the site. Deficiencies uncovered become inputs to redesign and further analysis, closing the loop on the design/analysis cycle.

  11. Feasibility and safety of outpatient brachytherapy in 37 patients with brain tumors using the GliaSite Radiation Therapy System.

    Science.gov (United States)

    Chino, Kazumi; Silvain, Daniel; Grace, Ana; Stubbs, James; Stea, Baldassarre

    2008-07-01

    Temporary, low dose rate brachytherapy to the margins of resected brain tumors, using a balloon catheter system (GliaSite Radiation Therapy System) and liquid I-125 radiation source (Iotrex), began in 2002 at the University of Arizona Medical Center. Initially, all patients were treated on an inpatient basis. For patient convenience, we converted to outpatient therapy. In this article we review the exposure data and safety history for the 37 patients treated as outpatients. Proper patient selection and instruction is crucial to having a successful outpatient brachytherapy program. A set of evaluation criteria and patient instructions were developed in compliance with the U.S. Nuclear Regulatory Commission's document NUREG-1556 Volume 9 (Appendix U) and Arizona State Nuclear regulatory guidelines, which specify acceptable exposure rates for outpatient release in this setting. Of the 37 patients monitored, 26 patients were treated for recurrent glioblastoma multiforme (GBM), six for primary GBM, and five for metastatic brain tumors. All 37 patients and their primary caregivers gave signed agreement to follow a specific set of instructions and were released for the duration of brachytherapy (3-7 days). The typical prescription dose was 60 Gy delivered at 0.5 cm from the balloon surface. Afterloaded activities in these patients ranged from 90.9 to 750.0 mCi and measured exposure rates at 1 m from the head were less than 14 mR/h. The mean exposure to the caretaker measured by personal radiation Landauer Luxel + whole body dosimeters for 25 caretakers was found to be 9.6 mR, which was significantly less than the mean calculated exposure of 136.8 mR. For properly selected patients, outpatient brachytherapy is simple and can be performed within established regulatory guidelines.

  12. 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.

  13. A Generic Dynamic Emulator

    CERN Document Server

    Albert, Carlo

    2011-01-01

    In applied sciences, we often deal with deterministic simulation models that are too slow for simulation-intensive tasks such as calibration or real-time control. In this paper, an emulator for a generic dynamic model, given by a system of ordinary non-linear differential equations, is developed. The non-linear differential equations are linearized and Gaussian white noise is added to account for the non-linearities. The resulting linear stochastic system is conditioned on a set of solutions of the non-linear equations that have been calculated prior to the emulation. A path-integral approach is used to derive the Gaussian distribution of the emulated solution. The solution reveals that most of the computational burden can be shifted to the conditioning phase of the emulator and the complexity of the actual emulation step only scales like $\\mathcal O(Nnm^2)$, where $N$ is the number of time-points at which the solution is to be emulated, $n$ the number of solutions the emulator is conditioned on and $m$ the n...

  14. Electronuclear reactors - EDF - Orientations of generic studies to be performed for the safety re-examination of 1300 MWe reactors associated to their third decennial inspection; Reacteurs electronucleaires - EDF - Orientations des etudes generiques a mener pour le reexamen de surete des reacteurs de 1300 MWe associe a leur troisieme visite decennale

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2011-07-01

    This report expresses the ASN's opinion on the framework and objectives of the EDF program concerning the generic studies of the safety re-examination of the 1300 MWe reactors associated with their third decennial inspection. This comprises lessons from the Fukushima accident, the improvement of the 'internal explosion' referential by using a probabilistic study, the application of the seismic margin assessment approach as soon as possible, checking the absence of any 'cliff effect' for cooling functions, a deepened re-examination of hurricane frequencies in France. Other request by the ASN concern the verification of the pertinence of release authorizations, taking the TSN law into account, taking the AP1300 project into account, the expansion of the complementary domain, the project of reactor lifetime extension. Some technical requests are discussed in appendix

  15. Generic substitution - comparing the clinical efficacy of a generic ...

    African Journals Online (AJOL)

    1998-03-03

    Mar 3, 1998 ... Departments of Psychiatry and Biostatistics, University of the. Orange Free State ... industry has expanded rapidly during the last 2 decades! The need to contain the ... Substitution of a generic drug product for an innovator.

  16. Documentation of Hanford Site independent review of the Hanford Waste Vitrification Plant Preliminary Safety Analysis Report. Revision 3

    Energy Technology Data Exchange (ETDEWEB)

    Herborn, D.I.

    1993-11-01

    Westinghouse Hanford Company (WHC) is the Integrating Contractor for the Hanford Waste Vitrification Plant (HWVP) Project, and as such is responsible for preparation of the HWVP Preliminary Safety Analysis Report (PSAR). The HWVP PSAR was prepared pursuant to the requirements for safety analyses contained in US Department of Energy (DOE) Orders 4700.1, Project Management System (DOE 1987); 5480.5, Safety of Nuclear Facilities (DOE 1986a); 5481.lB, Safety Analysis and Review System (DOE 1986b) which was superseded by DOE order 5480-23, Nuclear Safety Analysis Reports, for nuclear facilities effective April 30, 1992 (DOE 1992); and 6430.lA, General Design Criteria (DOE 1989). The WHC procedures that, in large part, implement these DOE requirements are contained in WHC-CM-4-46, Nonreactor Facility Safety Analysis Manual. This manual describes the overall WHC safety analysis process in terms of requirements for safety analyses, responsibilities of the various contributing organizations, and required reviews and approvals.

  17. Status of Progress Made Toward Safety Analysis and Technical Site Evaluations for DOE Managed HLW and SNF.

    Energy Technology Data Exchange (ETDEWEB)

    Sevougian, S. David [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Stein, Emily [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Gross, Michael B [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Hammond, Glenn Edward [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Frederick, Jennifer M [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Mariner, Paul [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States)

    2016-11-01

    The Spent Fuel and Waste Science and Technology (SFWST) Campaign of the U.S. Department of Energy (DOE) Office of Nuclear Energy (NE) is conducting research and development (R&D) on generic deep geologic disposal systems (i.e., repositories). This report describes specific activities in FY 2016 associated with the development of a Defense Waste Repository (DWR)a for the permanent disposal of a portion of the HLW and SNF derived from national defense and research and development (R&D) activities of the DOE.

  18. Perceptions and patterns of use of generic drugs among Italian family pediatricians: first round results of a web survey.

    Science.gov (United States)

    Fabiano, Valentina; Mameli, Chiara; Cattaneo, Dario; Delle Fave, Antonella; Preziosa, Alessandra; Mele, Giuseppe; Clementi, Emilio; Zuccotti, Gian Vincenzo

    2012-03-01

    Prescription of generic medicines represents an efficacious healthcare cost containment strategy. In some European countries and in the US, generic medicines are largely prescribed. In Italy, generic drugs prescription rate is lower. General Practitioners and Family Pediatricians may be less confident in prescribing generic equivalents instead of "branded" medicines. There are currently no data about Italian Family Pediatricians' perceptions and patterns of use of generic drugs. This is a first nationwide web survey conducted with the aim to evaluate generic medicines knowledge and prescribing habits of Italian Family Pediatricians. 303 Family Pediatricians completed the online questionnaire. 37.2% and 32.6% of them declared to have a sufficient or fairly good knowledge of generic medicines, respectively, and the majority of them believed that efficacy of generic medicines was sufficient (33.6%) or good (45.2%). Nevertheless, Italian Family Pediatricians are still prone to prescribe trade medicines more frequently, since only 13.5% of them declared that more than a half of their patients were treated with generic medicines. Major issues related with generic medicines prescriptions by Italian Family Pediatricians seem to be represented by diffuse scepticism about reliability of bioequivalence tests and safety of switchability from branded to generic equivalents. More information about generic drugs and more research in the field of pediatric pharmacology are needed for increasing generic medicines prescription rate among Italian Family Pediatricians.

  19. Generic interpreters and microprocessor verification

    Science.gov (United States)

    Windley, Phillip J.

    1990-01-01

    The following topics are covered in viewgraph form: (1) generic interpreters; (2) Viper microprocessors; (3) microprocessor verification; (4) determining correctness; (5) hierarchical decomposition; (6) interpreter theory; (7) AVM-1; (8) phase-level specification; and future work.

  20. Generic ISIS Transport Module Project

    Data.gov (United States)

    National Aeronautics and Space Administration — The purpose of the Generic ISIS Transport Module is to provide a means to bring living specimens to and from orbit. In addition to living specimens, the module can...

  1. Nuclear safety in EU candidate countries

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2000-10-01

    Nuclear safety in the candidate countries to the European Union is a major issue that needs to be addressed in the framework of the enlargement process. Therefore WENRA members considered it was their duty to offer their technical assistance to their Governments and the European Union Institutions. They decided to express their collective opinion on nuclear safety in those candidate countries having at least one nuclear power plant: Bulgaria, the Czech Republic, Hungary, Lithuania, Romania, Slovakia and Slovenia. The report is structured as follows: A foreword including background information, structure of the report and the methodology used, General conclusions of WENRA members reflecting their collective opinion, For each candidate country, an executive summary, a chapter on the status of the regulatory regime and regulatory body, and a chapter on the nuclear power plant safety status. Two annexes are added to address the generic safety characteristics and safety issues for RBMK and VVER plants. The report does not cover radiation protection and decommissioning issues, while safety aspects of spent fuel and radioactive waste management are only covered as regards on-site provisions. In order to produce this report, WENRA used different means: For the chapters on the regulatory regimes and regulatory bodies, experts from WENRA did the work. For the chapters on nuclear power plant safety status, experts from WENRA and from French and German technical support organisations did the work. Taking into account the contents of these chapters, WENRA has formulated its general conclusions in this report.

  2. Design and proof of function of a closure system for an HLW-repository in rock salt. Results of the preliminary safety analysis for the Gorleben site (VSG)

    Energy Technology Data Exchange (ETDEWEB)

    Mueller-Hoeppe, Nina; Breustedt, Michael; Engelhardt, Hans-Joachim; Wolf, Johanna [DBE Technology GmbH, Peine (Germany); Buhmann, Dieter; Czaikowski, Oliver; Herbert, Horst-Juergen; Wieczorek, Klaus; Xie, Mingliang [Gesellschaft fuer Anlagen- und Reaktorsicherheit mbH, Braunschweig (Germany)

    2015-07-01

    Within the preliminary safety analysis for the Gorleben site (VSG), a closure system was designed in order to complement the containment providing rock zone (CRZ) by sealing and backfilling measures. The design procedure as well as the technical proof of function was mainly performed according to standard procedures in civil engineering. In the context of VSG, rough individual technical proofs of several measures were carried out. Meanwhile, this gap has been closed by subsequent investigations. Altogether the results of all the individual technical proofs of function indicate that safe containment of radioactive waste is a realistic possibility at the Gorleben site.

  3. The Generic Data Capture Facility

    Science.gov (United States)

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

    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.

  4. Knowledge Development Generic Framework Concept

    Science.gov (United States)

    2008-12-18

    Branch This is the final MNE 5 document on Knowledge Development. Contact ZTransfBw Abt II CDE@bundeswehr.org for inquiries regarding...subsequent updates beyond MNE 5 efforts. VERSION 1.30 18. December 2008 Knowledge Development Generic Framework Concept Draft Report...2. REPORT TYPE Final 3. DATES COVERED - 4. TITLE AND SUBTITLE Knowledge Development Generic Framework Concept 5a. CONTRACT NUMBER 5b

  5. A safety assessment for proposed pump mixing operations to mitigate episodic gas releases in tank 241-SY-101: Hanford Site,Richland, Washington

    Energy Technology Data Exchange (ETDEWEB)

    Lentsch, J.W.

    1996-07-01

    This safety assessment addresses each of the elements required for the proposed action to remove a slurry distributor and to install, operate, and remove a mixing pump in Tank 241-SY-101,which is located within the Hanford Site, Richland, Washington.The proposed action is required as part of an ongoing evaluation of various mitigation concepts developed to eliminate episodic gas releases that result in hydrogen concentrations in the tank dome space that exceed the lower flammability limit.

  6. Safety assessment for proposed pump mixing operations to mitigate episodic gas releases in tank 241-101-SY: Hanford Site, Richland, Washington

    Energy Technology Data Exchange (ETDEWEB)

    Lentsch, J.W., Westinghouse Hanford

    1996-05-16

    This safety assessment addresses each of the elements required for the proposed action to remove a slurry distributor and to install, operate, and remove a mixing pump in Tank 241-SY-101, which is located within the Hanford Site, Richland, Washington. The proposed action is required as part of an ongoing evaluation of various mitigation concepts developed to eliminate episodic gas releases that result in hydrogen concentrations in the tank dome space that exceed the lower flammability limit.

  7. Early Site Permit Demonstration Program: Plant parameters envelope report. Volume 1

    Energy Technology Data Exchange (ETDEWEB)

    1993-03-01

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

  8. Network Meta-analysis of Randomized Trials on the Safety of Vascular Closure Devices for Femoral Arterial Puncture Site Haemostasis

    OpenAIRE

    Jun Jiang; Junjie Zou; Hao Ma; Yuanyong Jiao; Hongyu Yang; Xiwei Zhang; Yi Miao

    2015-01-01

    The safety of vascular closure devices (VCDs) is still debated. The emergence of more related randomized controlled trials (RCTs) and newer VCDs makes it necessary to further evaluate the safety of VCDs. Relevant RCTs were identified by searching PubMed, EMBASE, Google Scholar and the Cochrane Central Register of Controlled Trials electronic databases updated in December 2014. Traditional and network meta-analyses were conducted to evaluate the rate of combined adverse vascular events (CAVEs)...

  9. ASSESSMENT OF QUALITY OF GENERICS IN CARDIOLOGY: REALITY AND POSSIBILITIES

    Directory of Open Access Journals (Sweden)

    V. V. Yakusevich

    2005-01-01

    Full Text Available Wide presence of original drugs’ copies, the so-called “generics”, on the pharmaceutical market is analyzed. The positive side of this expansion is connected with the lower price of generics, which makes it possible to decrease the costs of treatment. From the other side with the advent of big number of copies of the original drugs it becomes more difficult to assess the quality of each particular generic. Russian legislation in the field of registration allows selling in the country almost all drugs, which have at least minimal similarity to the original. The problem of pre-registration studies of bioequivalency of original and analogue drugs, therapeutical equivalency is widely observed. Concrete proposals of how to prevent the overflow of the Russian market with the generics with the unproved efficacy and safety are considered.

  10. Health and safety plan for the Remedial Investigation and Site Investigation of Waste Area Grouping 2 at the Oak Ridge National Laboratory, Oak Ridge, Tennessee. Environmental Restoration Program

    Energy Technology Data Exchange (ETDEWEB)

    Cofer, G.H.; Holt, V.L.; Roupe, G.W.

    1993-11-01

    This health and safety plan (HASP) was developed by the members of the Measurement Applications and Development Group of the Health Science Research Division at the Oak Ridge National Laboratory (ORNL). This plan was prepared to ensure that health and safety related items for the Waste Area Grouping (WAG) 2 Remedial Investigation (RI)/Feasibility Study and Site Investigation projects conform with the requirements of 29 CFR 1910.120 (April 18, 1992). The RI Plan calls for the characterization, monitoring, risk assessment, and identification of remedial needs and alternatives that have been structured and staged with short-term and long-term objectives. In early FY 1992, the WAG 2 RI was integrated with the ORNL Environmental Restoration (ER) Site Investigations program in order to achieve the complimentary objectives of the projects more effectively by providing an integrated basis of support. The combined effort was named the WAG 2 Remedial Investigation and Site Investigations Program (WAG 2 RI&SI). The Site Investigation activities are a series of monitoring efforts and directed investigations that support other ER activities by providing information about (1) watershed hydrogeology; (2) contaminants, pathways, and fluxes for groundwater at ORNL; (3) shallow subsurface areas that can act as secondary sources of contaminants; and (4) biological populations and contaminants in biota, in addition to other support and coordination activities.

  11. Presentation of safety after closure of the repository for spent nuclear fuel. Main report of the project SR-Site. Part II; Redovisning av saekerhet efter foerslutning av slutfoervaret foer anvaent kaernbraensle. Huvudrapport fraan projekt SR-Site. Del II

    Energy Technology Data Exchange (ETDEWEB)

    2011-07-01

    The purpose of the safety assessment SR-Site is to investigate whether a safe repository for spent nuclear fuel by KBS-3 type can be constructed at Forsmark in Oesthammar in Sweden. The location of the Forsmark has been selected based on results of several surveys from surface conditions at depth in Forsmark and in Laxemar in Oskarshamn. The choice of location is not justified in SR-Site Report, but in other attachments to SKB's permit applications. SR-Site Report is an important part of SKB's permit applications to construct and operate a repository for spent nuclear fuel at Forsmark in Oesthammar. The purpose of the report in the applications is to show that a repository at Forsmark is safe after closure

  12. Presentation of safety after closure of the repository for spent nuclear fuel. Main report of the project SR-Site. Part III; Redovisning av saekerhet efter foerslutning av slutfoervaret foer anvaent kaernbraensle. Huvudrapport fraan projekt SR-Site. Del III

    Energy Technology Data Exchange (ETDEWEB)

    2011-07-01

    The purpose of the safety assessment SR-Site is to investigate whether a safe repository for spent nuclear fuel by KBS-3 type can be constructed at Forsmark in Oesthammar in Sweden. The location of the Forsmark has been selected based on results of several surveys from surface conditions at depth in Forsmark and in Laxemar in Oskarshamn. The choice of location is not justified in SR-Site Report, but in other attachments to SKB's permit applications. SR-Site Report is an important part of SKB's permit applications to construct and operate a repository for spent nuclear fuel at Forsmark in Oesthammar. The purpose of the report in the applications is to show that a repository at Forsmark is safe after closure

  13. Presentation of safety after closure of the repository for spent nuclear fuel. Main report of the project SR-Site. Part I; Redovisning av saekerhet efter foerslutning av slutfoervaret foer anvaent kaernbraensle. Huvudrapport fraan projekt SR-Site. Del I

    Energy Technology Data Exchange (ETDEWEB)

    2011-07-01

    The purpose of the safety assessment SR-Site is to investigate whether a safe repository for spent nuclear fuel by KBS-3 type can be constructed at Forsmark in Oesthammar in Sweden. The location of the Forsmark has been selected based on results of several surveys from surface conditions at depth in Forsmark and in Laxemar in Oskarshamn. The choice of location is not justified in SR-Site Report, but in other attachments to SKB's permit applications. SR-Site Report is an important part of SKB's permit applications to construct and operate a repository for spent nuclear fuel at Forsmark in Oesthammar. The purpose of the report in the applications is to show that a repository at Forsmark is safe after closure

  14. WAG 2 remedial investigation and site investigation site-specific work plan/health and safety checklist for the ecological assessment task, Kingfisher Study

    Energy Technology Data Exchange (ETDEWEB)

    Holt, V.L.; Baron, L.A.

    1994-05-01

    This report provides specific details and requirements for the WAG 2 remedial investigation and site investigation Ecological Assessment Task, Kingfisher Study, including information that will contribute to safe completion of the project. The report includes historical background; a site map; project organization; task descriptions and hazard evaluations; controls; and monitoring, personal protective equipment, decontamination, and medical surveillance program requirements. The report also includes descriptions of site personnel and their certifications as well as suspected WAG 2 contaminants and their characteristics. The primary objective of the WAG 2 Kingfisher Study is to assess the feasibility of using kingfishers as biological monitors of contaminants on the Oak Ridge Reservation (ORR). Kingfisher sample collection will be used to determine the levels of contaminants and degree of bioaccumulation within a common piscivorous bird feeding on contaminated fish from streams on the ORR.

  15. Generic small modular reactor plant design.

    Energy Technology Data Exchange (ETDEWEB)

    Lewis, Tom Goslee,; Cipiti, Benjamin B.; Jordan, Sabina Erteza; Baum, Gregory A.

    2012-12-01

    This report gives an overview of expected design characteristics, concepts, and procedures for small modular reactors. The purpose of this report is to provide those who are interested in reducing the cost and improving the safety of advanced nuclear power plants with a generic design that possesses enough detail in a non-sensitive manner to give merit to their conclusions. The report is focused on light water reactor technology, but does add details on what could be different in a more advanced design (see Appendix). Numerous reactor and facility concepts were used for inspiration (documented in the bibliography). The final design described here is conceptual and does not reflect any proposed concept or sub-systems, thus any details given here are only relevant within this report. This report does not include any design or engineering calculations.

  16. Safety for Users

    CERN Document Server

    HR Department

    2008-01-01

    CERN welcomes more than 8000 Users every year. The PH Department as host to these scientific associates requires the highest safety standards. The PH Safety Office has published a Safety Flyer for Users. Important safety topics and procedures are presented. Although the Flyer is intended primarily to provide safety information for Users, the PH Safety Office invites all those on the CERN sites to keep a copy of the flyer as it gives guidance in matters of safety and explains what to do in the event of an emergency. Link: http://ph-dep.web.cern.ch/ph-dep/Safety/SafetyOffice.html PH-Safety Office PH Department

  17. Safety for Users

    CERN Document Server

    HR Department

    2008-01-01

    CERN welcomes more than 8000 Users every year. The PH Department as host to these scientific associates requires the highest safety standards. The PH Safety Office has published a safety flyer for Users. Important safety topics and procedures are presented. Although the flyer is intended primarily to provide safety information for Users, the PH Safety Office invites all those on the CERN sites to keep a copy of the flyer as it gives guidance in matters of safety and explains what to do in the event of an emergency. The flyer is available at: http://ph-dep.web.cern.ch/ph-dep/Safety/SafetyOffice.html PH-Safety Office PH Department

  18. Pharmaceutical quality of nine generic orlistat products compared with Xenical(r).

    Science.gov (United States)

    Taylor, Peter W; Arnet, Isabelle; Fischer, Anton; Simpson, Iain N

    2010-08-01

    To compare the pharmaceutical quality of Xenical (chemically produced orlistat) with nine generic products, each produced by fermentation processes. Xenical 120 mg capsules (Roche, Basel, Switzerland) were used as reference material. Generic products were from India, Malaysia, Argentina, Philippines, Uruguay, and Taiwan. Colour, melting temperature, crystalline form, particle size, capsule fill mass, active pharmaceutical ingredient content, amount of impurities, and dissolution were compared. Standard physical and chemical laboratory tests were those developed by Roche for Xenical. All nine generic products failed the Xenical specifications in four or more tests, and two generic products failed in seven tests. A failure common to all generic products was the amount of impurities present, mostly due to different by-products, including side-chain homologues not present in Xenical. Some impurities were unidentified. Two generic products tested failed the dissolution test, one product formed a capsule-shaped agglomerate on storage and resulted in poor (generic products were powder formulations. All tested generic orlistat products were pharmaceutically inferior to Xenical. The high levels of impurities in generic orlistat products are a major safety and tolerability concern. Copyright © 2010 S. Karger AG, Basel.

  19. Department of Energy's High Flux Beam Reactor (HFBR), September 15--19, 1980: An independent on-site safety review

    Energy Technology Data Exchange (ETDEWEB)

    1981-02-01

    The intent of this on-site safety review was to make a broad management assessment of HFBR operations, rather than conduct a detailed in-depth audit. The result of the review should only be considered as having identified trends or indications. The Team's observations and recommendations for the most part are based upon licensed reactor facility practices used to meet industry standards. These standards form the basis for many of the comments in this report. The Team believes that a uniform minimum standard of performance should be achieved in the operation of DOE reactors. In order to assure that this is accomplished, clear standards are necessary. Consistent with the past AEC and ERDA policy, the team has used the standards of the commercial nuclear power industry. It is recognized that this approach is conservative in that the HFBR reactor has a significantly greater degree of inherent safety (low pressure, temperature, power, etc.) than a licensed reactor.

  20. An application of the Pareto Method in Surveys to Diagnose the Managers and Workers Perception of Occupational Safety and Health on Selected Polish Construction Sites.

    Science.gov (United States)

    Obolewicz, Jerzy; Dąbrowski, Andrzej

    2017-09-06

    The construction industry is an important sector of the economy in Poland. According to the National Labour Inspectorate (PIP) data of 2014, the number of victims of fatal accidents in the construction sector amounted to 80 as compared with 187 injured in all other sectors of economy in Poland. This paper presents the results of surveys on the impact of construction worker behaviour on the occupational safety and health outcomes. The surveys took into account the point of view of both construction site management (tactical level) and construction workers (operational level). For the analysis of results, the method of numerical taxonomy and Pareto charts was employed, which allowed the authors to identify the areas of occupational safety and health at both an operational and tactical level, in which improvement actions needed to be proposed for workers employed in micro, small, medium and large construction enterprises.

  1. Participatory Training to Improve Safety and Health in Small Construction Sites in Some Countries in Asia: Development and Application of the WISCON Training Program.

    Science.gov (United States)

    Kawakami, Tsuyoshi

    2016-08-01

    A participatory training program, Work Improvement in Small Construction Sites, was developed to provide practical support measures to the small construction sector. Managers and workers from selected small sites were interviewed about their occupational safety and health risks. The Work Improvement in Small Construction Sites training program comprised a 45-item action checklist, photos, and illustrations showing local examples and group work methods. Pilot training workshops were carried out with workers and employers in Cambodia, Laos, Mongolia, Thailand, and Vietnam. Participants subsequently planned, and using locally available low-cost materials, implemented their own improvements such as hand-made hand trucks to carry heavy materials, removal of projecting nails from timber materials, and fences to protect roof workers from falling. Local Work Improvement in Small Construction Sites trainers consisting of government officials, workers, employers, and nongovernment organization representatives were then trained to implement the Work Improvement in Small Construction Sites training widely. Keys to success were easy-to-apply training tools aiming at immediate, low-cost improvements, and collaboration with various local people's networks.

  2. Studies relating to human intrusion into a repository. Report pertaining to work package 11. Preliminary safety case of the Gorleben site (VSG)

    Energy Technology Data Exchange (ETDEWEB)

    Beuth, Thomas; Buhmann, Dieter; Fischer-Appelt, Klaus; Moenig, Joerg; Ruebel, Andre; Wolf, Jens [Gesellschaft fuer Anlagen- und Reaktorsicherheit mbH (GRS), Koeln (Germany); Bollingerfehr, Wilhelm; Filbert, Wolfgang [DBE Technology GmbH, Peine (Germany); Charlier, Frank [international nuclear safety engineering gmbh (nse), Aachen (Germany); Baltes, Bruno

    2014-10-15

    The question of the long-term safety of a repository system is inseparably linked with the intensive technical examination of the possible future evolution of the site and the repository system e. g. as a result of climatic, geologic, waste-related and repository-related processes. Here, the possible evolutions to be considered are those that have the potential to have a negative impact on the intended, furthest-possible, immediate, and lasting isolation of the radioactive waste in a defined area around the underground workings of the repository mine in salt rock, which is referred to as the containment-providing rock zone (CPRZ).

  3. Rectification of two generic names

    NARCIS (Netherlands)

    Büttikofer, J.

    1896-01-01

    I am sorry to say that amongst the new generic names, occurring in my recent paper on the genus Pycnonotus and some allied Genera (N. L. M. XVII), Centrolophus and Gymnocrotaphus are already preoccupied among the Fishes, the first being used by Lacépède, the second by Günther. I propose, therefore,

  4. GENERIC model for multiphase systems

    NARCIS (Netherlands)

    Sagis, L.M.C.

    2010-01-01

    GENERIC is a nonequilibrium thermodynamic formalism in which the dynamic behavior of a system is described by a single compact equation involving two types of brackets: a Poisson bracket and a dissipative bracket. This formalism has proved to be a very powerful instrument to model the dynamic behavi

  5. Generic Hurricane Extreme Seas State

    DEFF Research Database (Denmark)

    Wehmeyer, Christof; Skourup, Jesper; Frigaard, Peter

    2012-01-01

    the US east coast and the Gulf of Mexico (1851 - 2009) and Japanese east coast (1951 -2009) form the basis for Weibull extreme value analyses to determine return period respective maximum wind speeds. Unidirectional generic sea state spectra are obtained by application of the empirical models...

  6. 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.

  7. [Generic drugs: we must cut pharmaceutical spending but undertaking drug quality].

    Science.gov (United States)

    Carrillo Norte, Juan Antonio; Postigo Mota, Salvador

    2012-02-01

    The World Health Organization and all drug regulatory agencies (DRA) support the commercialization of generic medicines because they control costs and are irreplaceable therapeutic options in countries lacking the innovator product. Generic drugs are widely considered to be cost-efficient substitutes for brand-name medications. They make up about 20% of the total number of prescriptions in Spain, a figure that is still far from the use of generic drugs in USA and other European countries. Despite economical interest in this issue, in this article we review the interest of generic drugs from a pharmacological and clinical perspective that must undertake drug quality to ensure drug efficacy and safety of the patients. A generic drug (generic drugs, short: generics) is defined as "a drug product that is comparable to brand/reference listed drug product in dosage form, strength, route of administration, quality and performance characteristics, and intended use". Both the reference drug and the generic drug have to demonstrate previously they are therapeutically equivalent. With the exception of parenteral drugs, two products have demonstrated to be therapeutically equivalent if after administration in the same molar dose, their effects with respect to both efficacy and safety are essentially the same, as determined from bioequivalence studies in terms of comparison of appropriate pharmacokinetic parameters and bioavailability. Parenteral formulations, however, are not required to demonstrate therapeutic equivalence because it may be considered self-evident. Such assumptions have never been challenged, but there are reasons to do so for parenteral antimicrobials. It is interesting to highlight that although brand-name drugs and generic drugs are both approved by DRA and may be interchangeable with respect to their clinical effects, they can differ substantially in their appearance. Consumers of brand-name medications receive identical-appearing batches of pills with

  8. Plutonium working group report on environmental, safety and health vulnerabilities associated with the department`s plutonium storage. Volume II, Appendix B, Part 9: Oak Ridge site site team report

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1994-09-01

    This report provides the input to and results of the Department of Energy (DOE) - Oak Ridge Operations (ORO) DOE Plutonium Environment, Safety and Health (ES & H) Vulnerability Assessment (VA) self-assessment performed by the Site Assessment Team (SAT) for the Oak Ridge National Laboratory (ORNL or X-10) and the Oak Ridge Y-12 Plant (Y-12) sites that are managed by Martin Marietta Energy Systems, Inc. (MMES). As initiated (March 15, 1994) by the Secretary of Energy, the objective of the VA is to identify and rank-order DOE-ES&H vulnerabilities associated for the purpose of decision making on the interim safe management and ultimate disposition of fissile materials. This assessment is directed at plutonium and other co-located transuranics in various forms.

  9. Efficacy and safety of generic escitalopram versus Lexapro in the treatment of major depression: a multicenter double-blinded randomized controlled trial%国产草酸依地普仑片与来士普治疗抑郁症有效性和安全性:随机双盲、对照、多中心临床研究

    Institute of Scientific and Technical Information of China (English)

    余一旻; 李华芳; 王飚; 栗克清; 许秀峰; 师建国; 高成阁; 谭庆荣

    2013-01-01

    imported antidepressant medications.Aim:Compare the efficacy and safety of the generic form of the selective serotonin re-uptake inhibitory (SSRI) antidepressant escitalopram to the proprietary form of escitalopram (Lexapro)in the treatment of major depression.Methods:A multicenter double-blinded randomized controlled trial enrolled 260 patients with depression and randomly assigned them to receive eight weeks of treatment with either generic escitalopram (n=130) or Lexapro (n=130).Efficacy was assessed by the Hamilton rating scale for depression (HAMD-17).Safety was assessed by evaluating adverse events reported by patients,regularly recording vital signs,and conducting laboratory tests and electrocardiograms.Results:There were 35 (27%) dropouts during the 8 weeks of treatment in the generic escitalopram group and 32 (25%) in the Lexapro group.In the intention-to-treat analysis (i.e.,including all patients) the mean (s.d.) drop in the HAMD total score at the end of the 8th week of treatment was 13.9 (8.2) in the generic escitalopram group and 14.3 (8.1) in the Lexapro group (t=0.44,p=0.664).The proportions of patients responsive to treatment (i.e.,>50% drop in total HAMD score) were 69% and 67% in the generic escitalopram group and Lexapro group,respectively (x2=0.16,df=1,p=0.690; and the proportions that achieved remission (i.e.,final HAMD <7) were 51% and 49% (x2=0.06,df=1,p=0.804).The most frequently reported adverse events were dry mouth (12.3%),nausea (9.2 %) and dizziness (6.2%) in the generic escitalopram group and nausea (10.8%),fainting (7.7%) and drowsiness (6.9%) in the Lexapro group.During the first 35 days of treatment,one suicide and two suicide attempts occurred in the generic escitalopram group and one suicide occurred in the Lexapro group (Fisher exact test,p=0.314).Conclusion:Generic escitalopram is as effective and safe as Lexapro in the initial treatment of patients with moderate to severe episodes of major depression who

  10. Generic products of antiepileptic drugs: a perspective on bioequivalence and interchangeability.

    Science.gov (United States)

    Bialer, Meir; Midha, Kamal K

    2010-06-01

    Most antiepileptic drugs (AEDs) are currently available as generic products, yet neurologists and patients are reluctant to switch to generics. Generic AEDs are regarded as bioequivalent to brand AEDs after meeting the average bioequivalence criteria; consequently, they are considered to be interchangeable with their respective brands without loss of efficacy and safety. According to the U.S. Food and Drug Administration (FDA) the present bioequivalence requirements are already so rigorous and constrained that there is little possibility that generics that meet regulatory bioequivalence criteria could lead to therapeutic problems. So is there a scientific rationale for the concerns about switching patients with epilepsy to bioequivalent generics? Herein we discuss the assessment of bioequivalence and propose a scaled-average bioequivalence approach where scaling of bioequivalence is carried out based on brand lot-to-lot variance as an alternative to the conventional bioequivalence test as a means to determine whether switching patients to generic formulations, or vice versa, is a safe and effective therapeutic option. Meeting the proposed scaled-average bioequivalence requirements will ensure that when an individual patient is switched, he or she has fluctuations in plasma levels similar to those from lot-to-lot of the brand reference levels and thus should make these generic products safely switchable without change in efficacy and safety outcomes.

  11. Mylan to Offer Generic EpiPen

    Science.gov (United States)

    ... news/fullstory_160669.html Mylan to Offer Generic EpiPen Manufacturer responds to mounting criticism about price hikes ... cheaper generic version of the emergency allergy treatment EpiPen will be made available within the next few ...

  12. The Equilibrium-agreement Theory About Hostage Safety in Kidnapping-sites%绑架现场人质安全均衡契约论

    Institute of Scientific and Technical Information of China (English)

    吴西彬

    2015-01-01

    The essential conditions of Equilibrium in Kidnapping -sites include:the tri-parties ( kidnapper , rescuer and hostage ) in the kidnapping -site at the same time;the tri-parties with same intention for guarding the safety of hostage;the tri-parties having same negative behavior to maintain confrontation relationship .The three essential characteristics of Equilibrium -agreement are:to ensure hostage safety and to maintain confrontation rela-tionship in the content;to have the "silence -contract"in the form; to be uncertain in the term .Field control , space of negotiation , safety of hostage and social education are the functions of Equilibrium -agreement.And kid-napper shot-dead by chance , lack of patience and sympathy are all wrong and irrational factors in the Equilibrium-agreement Theory .%绑架现场均衡构成要件:绑架者、解救者、人质三方须同时参与;三方都有“人质安全”的故意;三方在客观上均为维持对峙现状的消极不作为。均衡契约有三个特点:内容是“人质安全、维持现状”;形式主要为自然形成的“默契”;期限不特定。均衡契约具备现场控制、提供谈判空间、人质安全以及社会教育功能等既定效果。寻机击毙绑架者,耐心不足,缺乏同情心,均是错误和非理性的。

  13. Review of decision methodologies for evaluating regulatory actions affecting public health and safety. [Nuclear industry site selection

    Energy Technology Data Exchange (ETDEWEB)

    Hendrickson, P.L.; McDonald, C.L.; Schilling, A.H.

    1976-12-01

    This report examines several aspects of the problems and choices facing the governmental decision maker who must take regulatory actions with multiple decision objectives and attributes. Particular attention is given to the problems facing the U.S. Nuclear Regulatory Commission (NRC) and to the decision attribute of chief concern to NRC, the protection of human health and safety, with emphasis on nuclear power plants. The study was undertaken to provide background information for NRC to use in refining its process of value/impact assessment of proposed regulatory actions. The principal conclusion is that approaches to rationally consider the value and impact of proposed regulatory actions are available. These approaches can potentially improve the decision-making process and enable the agency to better explain and defend its decisions. They also permit consistent examination of the impacts, effects of uncertainty and sensitivity to various assumptions of the alternatives being considered. Finally, these approaches can help to assure that affected parties are heard and that technical information is used appropriately and to the extent possible. The principal aspects of the regulatory decision problem covered in the report are: the legal setting for regulatory decisions which affect human health and safety, elements of the decision-making process, conceptual approaches to decision making, current approaches to decision making in several Federal agencies, and the determination of acceptable risk levels.

  14. Network Meta-analysis of Randomized Trials on the Safety of Vascular Closure Devices for Femoral Arterial Puncture Site Haemostasis.

    Science.gov (United States)

    Jiang, Jun; Zou, Junjie; Ma, Hao; Jiao, Yuanyong; Yang, Hongyu; Zhang, Xiwei; Miao, Yi

    2015-09-08

    The safety of vascular closure devices (VCDs) is still debated. The emergence of more related randomized controlled trials (RCTs) and newer VCDs makes it necessary to further evaluate the safety of VCDs. Relevant RCTs were identified by searching PubMed, EMBASE, Google Scholar and the Cochrane Central Register of Controlled Trials electronic databases updated in December 2014. Traditional and network meta-analyses were conducted to evaluate the rate of combined adverse vascular events (CAVEs) and haematomas by calculating the risk ratios and 95% confidence intervals. Forty RCTs including 16868 patients were included. Traditional meta-analysis demonstrated that there was no significant difference in the rate of CAVEs between all the VCDs and manual compression (MC). Subgroup analysis showed that FemoSeal and VCDs reported after the year 2005 reduced CAVEs. Moreover, the use of VCDs reduced the risk of haematomas compared with MC. Network meta-analysis showed that AngioSeal, which might be the best VCD among all the included VCDs, was associated with reduced rates of both CAVE and haematomas compared with MC. In conclusion, the use of VCDs is associated with a decreased risk of haematomas, and FemoSeal and AngioSeal appears to be better than MC for reducing the rate of CAVEs.

  15. Generic substitution of antiepileptic drugs: a systematic review of prospective and retrospective studies.

    Science.gov (United States)

    Yamada, Mikiko; Welty, Timothy E

    2011-11-01

    To systematically review the literature on generic antiepileptic drugs (AEDs), evaluate the efficacy and safety of generic AED substitution, and perform pharmacokinetic (PK) analysis using the American Academy of Neurology (AAN) scheme to classify evidence. PubMed and Cumulative Index to Nursing and Allied Health Literature searches from January 1, 1980, to October 15, 2010, were performed using the search terms anticonvulsant, antiepileptic drug, carbamazepine, divalproex, ethosuximide, gabapentin, lamotrigine, levetiracetam, oxcarbazepine, pheno-barbital, phenytoin, primidone, topiramate, valproate, valproic acid, and zonisamide; bioavailability, bioequivalence, bioequivalency, bioequivalent, and substitution; and generic. Retrospective and prospective controlled studies of generic substitution of AEDs were included in the review. Non-English-language articles and uncontrolled clinical studies were excluded. Published articles were categorized using the AAN criteria for systematic reviews. We identified 156 articles. Of these, 20 met our inclusion criteria; 7 were retrospective studies, 6 were prospective studies in patients with epilepsy, and 7 were prospective studies in healthy subjects. All articles were rated Class I to Class III, using AAN criteria. The retrospective studies were categorized as Class III and showed a significant relationship between generic substitution and increased use of health care resources because of seizures or AED toxicity. Prospective studies were categorized as Class I, II, and III. Prospective studies in patients showed no differences between brand and generic drugs in PK parameters of bioequivalence. Three prospective studies in healthy subjects reported significant differences in maximum drug concentrations. Comparison of brand and generic drugs revealed no significant difference in seizure frequency; however, some prospective studies showed significant differences in PK parameters, primarily those not used for bioequivalence

  16. Compositional Design of a Generic Design Agent

    NARCIS (Netherlands)

    Brazier, F.M.T.; Jonker, C.M.; Treur, J.; Wijngaards, N.J.E.

    2001-01-01

    This paper presents a generic architecture for a design agent, to be used in an Internet environment. The design agent is based on an existing generic agent model, and includes a refinement of a generic model for design, in which strategic reasoning

  17. Comparing approaches to generic programming in Haskell

    NARCIS (Netherlands)

    Hinze, R.; Jeuring, J.T.; Löh, A.

    2007-01-01

    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 sugge

  18. Efficient Generation of Generic Entanglement

    CERN Document Server

    Oliveira, R; Plenio, M B

    2006-01-01

    We find that generic entanglement is physical, in the sense that it can be generated in polynomial time from two-qubit gates picked at random. We prove as the main result that such a process generates the average entanglement of the uniform (Haar) measure in at most $O(N^3)$ steps for $N$ qubits. This is despite an exponentially growing number of such gates being necessary for generating that measure fully on the state space. Numerics furthermore show a variation cut-off allowing one to associate a specific time with the achievement of the uniform measure entanglement distribution. Various extensions of this work are discussed. The results are relevant to entanglement theory and to protocols that assume generic entanglement can be achieved efficiently.

  19. Structural safety evaluation of Karun III Dam and calibration of its finite element model using instrumentation and site observation

    Directory of Open Access Journals (Sweden)

    H. Mirzabozorg

    2014-06-01

    Full Text Available In the present paper, a comprehensive finite element model of Karun III double curvature arch dam is calibrated based on the micro geodesies measurements and instrumentation. Thermal properties of concrete are obtained by transient thermal analysis and the results are compared with those obtained from thermometers. Thermal analysis features include air temperature, water layers temperatures, and the solar radiation on the exposed faces. Structural calibration features include thermal distribution within the dam body, dam self-weight, hydrostatic pressure, and silt load applied on the model of dam–reservoir–foundation system. Finite element model calibration provides updated information related to the current dam status and can be used for further safety evaluations.

  20. A fuzzy MCDA framework for safety assessment in the remediation of a uranium mill tailings site in Ukraine

    OpenAIRE

    Jiménez Martín, Antonio; Martín Blanco, Miguel Carlos; Mateos Caballero, Alfonso; Pérez-Sánchez, Danyl; Dvorzhak, Alla

    2013-01-01

    The Pridneprovsky Chemical Plant was one of the largest uranium processing enterprises in the former USSR, producing a huge amount of uranium residues. The Zapadnoe tailings site contains most of these residues. We propose a theoretical framework based on multicriteria decision analysis and fuzzy logic to analyze different remediation alternatives for the Zapadnoe tailings, which simultaneously accounts for potentially conflicting economic, social and environmental objectives. We build an obj...

  1. Generic drugs in dermatology: part II.

    Science.gov (United States)

    Payette, Michael; Grant-Kels, Jane M

    2012-03-01

    In part I, we discussed new drug development, reviewed the history of the generic drug industry, described how generic drugs are approved by the US Food and Drug Administration, and defined the concepts of bioequivalence and therapeutic equivalence. Herein, we explore various factors impacting generic drug use across the different parties involved: the prescriber, the pharmacist, the patient, and the payer. We also include original cost analysis of dermatologic brand name and generic drugs and show the potential cost savings that can be achieved through generic substitution. We conclude with a review of the data addressing potential differences in the effectiveness of brand name versus generic drugs in dermatology. The cost of brand name and generic medications is highly variable by pharmacy, state, and payer. We used one source (www.drugstore.com) as an example and for consistency across all medications discussed herein. Prices included here may not reflect actual retail prices across the United States.

  2. 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......Methods for procedural modelling tend to be designed either for organic objects, which are described well by skeletal structures, or for man-made objects, which are described well by surface primitives. Procedural methods, which allow for modelling of both kinds of objects, are few and usually...

  3. Safety and quality management and administration Fiscal Year 1995 site support program plan WBS 6.7.2.6

    Energy Technology Data Exchange (ETDEWEB)

    Hagan, J.W.

    1994-09-01

    The mission of the Emergency, Safety, and Quality Services (ESQ) management and Program Integration is to provide leadership for the ESQ Department, coordinate business management activities of the ESQ department, and the programs it supports, as well as to plan organize, direct, and control other activities that require department-wide coordination. Primary activities include providing strategic and business planning and reporting support to ESQ management; developing and documenting ESQ management systems and procedures; coordinating ESQ`s self-assessment and Award Fee self evaluation efforts; coordinating the ESQ departments`s communication, total quality, cost savings, and productivity efforts; and tracking ESQ commitments and staffing data. This program element also provides program direction and performance assessment for the ESH&Q division of ICF KH. The ESH&Q Division educates ICF KH management and employees to protect personnel and the environment; identifies, interprets and inspects to requirements; provides administrative and field support; performs final acceptance of construction; assesses effectiveness of ICF KH programs and processes, and performs baseline ESH&Q assessments.

  4. Generic Reliability-Based Inspection Planning for Fatigue Sensitive Details

    DEFF Research Database (Denmark)

    Sørensen, John Dalsgaard; Straub, Daniel; Faber, Michael Havbro

    2005-01-01

    of fatigue sensitive details in fixed offshore steel jacket platforms and FPSO ship structures. Inspection and maintenance activities are planned such that code based requirements to the safety of personnel and environment for the considered structure are fulfilled and at the same time such that the overall......The generic approach for planning of in-service NDT inspections is extended to cover the case where the fatigue load is modified during the design lifetime of the structure. Generic reliability-based inspection planning has been developed as a practical approach to perform inspection planning...... expected costs for design, inspections, repairs and failures are minimized. The method is based on the assumption of “no-finds” of cracks during inspections. Each fatigue sensitive detail is categorized according to their type of details (SN curves), FDF values, RSR values, inspection, repair and failure...

  5. Scientific considerations for generic synthetic salmon calcitonin nasal spray products.

    Science.gov (United States)

    Lee, Sau L; Yu, Lawrence X; Cai, Bing; Johnsons, Gibbes R; Rosenberg, Amy S; Cherney, Barry W; Guo, Wei; Raw, Andre S

    2011-03-01

    Under the Abbreviated New Drug Application pathway, a proposed generic salmon calcitonin nasal spray is required to demonstrate pharmaceutical equivalence and bioequivalence to the brand-name counterpart or the reference listed drug. This review discusses two important aspects of pharmaceutical equivalence for this synthetic peptide nasal spray product. The first aspect is drug substance sameness, in which a proposed generic salmon calcitonin product is required to demonstrate that it contains the same active ingredient as that in the brand-name counterpart. The second aspect is comparability in product- and process-related factors that may influence immunogenicity (i.e., peptide-related impurities, aggregates, formulation, and leachates from the container/closure system). The comparability of these factors helps to ensure the product safety, particularly with respect to immunogenicity. This review also highlights the key features of in vitro and/or in vivo studies for establishing bioequivalence for a solution nasal spray containing a systemically acting salmon calcitonin.

  6. Identification of structures, systems, and components important to safety at the potential repository at Yucca Mountain; Yucca Mountain Site Characterization Project

    Energy Technology Data Exchange (ETDEWEB)

    Hartman, D.J.; Miller, D.D. [Bechtel National, Inc., San Francisco, CA (United States); Klamerus, L.J. [Sandia National Labs., Albuquerque, NM (United States)

    1991-10-01

    This study recommends which structures, systems, and components of the potential repository at Yucca Mountain are important to safety. The assessment was completed in April 1990 and uses the reference repository configuration in the Site Characterization Plan Conceptual Design Report and follows the methodology required at that time by DOE Procedure AP6.10-Q. Failures of repository items during the preclosure period are evaluated to determine the potential offsite radiation doses and associated probabilities. Items are important to safety if, in the event they fail to perform their intended function, an accident could result which causes a dose commitment greater than 0.5 rem to the whole body or any organ of an individual in an unrestricted area. This study recommends that these repository items include the structures that house spent fuel and high-level waste, the associated filtered ventilation exhaust systems, certain waste- handling equipment, the waste containers, the waste treatment building structure, the underground waste transporters, and other items listed in this report. This work was completed April 1990. 27 refs., 7 figs., 9 tabs.

  7. Characterization of discontinuities in an argillaceous medium (Tournemire site): key questions related to safety assessment of radioactive waste disposal

    Energy Technology Data Exchange (ETDEWEB)

    Cabrera Nunez, J. [CEA Fontenay-aux-Roses, 92 (France). Inst. de Protection et de Surete Nucleaire

    2001-07-01

    The safety assessment of deep radioactive waste disposal in argillaceous medium concerns the evaluation of the possibilities and transfer processes through this geological barrier. Generally, this material is characterized by a very low permeability. However, faults and fractures may affect this medium and consequently it is important to analyse the transfer possibilities along these discontinuities. The first phase of this evaluation is the detection or survey of the fractures, and the second one is the evaluation of their hydraulic properties. A discontinuity is not a synonymous of fluid transfer, which in turn may be inhomogeneous along the same fracture. The well-compacted Tournemire argillaceous medium (argilites and marls) is affected by some faults and fractures of natural (tectonic) and artificial (excavation) origin. The natural fractures are of different scales: major regional faults that limit blocks, secondary fault and fractured zones that affect the blocks, and local fractures and micro-fractures. These discontinuities are studied from the surface analyses, transversal boreholes and drifts. Geophysical methods are tested to detect these discontinuities to different scales. The present-day fluids are shown in some fractured sectors that allow us to analyse the possibilities of fluid transfer along these discontinuities. The fracture analyses show that permeability or transmissivity properties may change along the discontinuities. A decametric fluid transfer is shown along some fractures; however, their integration in a larger scale is not yet analysed. It is necessary to understand how the transfer in the near field may be connected to the possible far field transfer, or these transfers are not possible through the argillaceous medium. (author)

  8. Assessment of technologies for hazardous waste site remediation: Non-treatment technologies and pilot scale facility implementation -- excavation -- storage technology -- safety analysis and review statement. Final report

    Energy Technology Data Exchange (ETDEWEB)

    Johnson, H.R.; Overbey, W.K. Jr.; Koperna, G.J. Jr.

    1994-02-01

    The purpose of this study is to assess the state-of-the-art of excavation technology as related to environmental remediation applications. A further purpose is to determine which of the excavation technologies reviewed could be used by the US Corp of Engineers in remediating contaminated soil to be excavated in the near future for construction of a new Lock and Dam at Winfield, WV. The study is designed to identify excavation methodologies and equipment which can be used at any environmental remediation site but more specifically at the Winfield site on the Kanawha River in Putnam County, West Virginia. A technical approach was determined whereby a functional analysis was prepared to determine the functions to be conducted during the excavation phase of the remediation operations. A number of excavation technologies were identified from the literature. A set of screening criteria was developed that would examine the utility and ranking of the technologies with respect to the operations that needed to be conducted at the Winfield site. These criteria were performance, reliability, implementability, environmental safety, public health, and legal and regulatory compliance. The Loose Bulk excavation technology was ranked as the best technology applicable to the Winfield site. The literature was also examined to determine the success of various methods of controlling fugitive dust. Depending upon any changes in the results of chemical analyses, or prior remediation of the VOCs from the vadose zone, consideration should be given to testing a new ``Pneumatic Excavator`` which removes the VOCs liberated during the excavation process as they outgas from the soil. This equipment however would not be needed on locations with low levels of VOC emissions.

  9. Generic Crystalline Disposal Reference Case

    Energy Technology Data Exchange (ETDEWEB)

    Painter, Scott Leroy [Los Alamos National Lab. (LANL), Los Alamos, NM (United States); Chu, Shaoping [Los Alamos National Lab. (LANL), Los Alamos, NM (United States); Harp, Dylan Robert [Los Alamos National Lab. (LANL), Los Alamos, NM (United States); Perry, Frank Vinton [Los Alamos National Lab. (LANL), Los Alamos, NM (United States); Wang, Yifeng [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States)

    2015-02-20

    A generic reference case for disposal of spent nuclear fuel and high-level radioactive waste in crystalline rock is outlined. The generic cases are intended to support development of disposal system modeling capability by establishing relevant baseline conditions and parameters. Establishment of a generic reference case requires that the emplacement concept, waste inventory, waste form, waste package, backfill/buffer properties, EBS failure scenarios, host rock properties, and biosphere be specified. The focus in this report is on those elements that are unique to crystalline disposal, especially the geosphere representation. Three emplacement concepts are suggested for further analyses: a waste packages containing 4 PWR assemblies emplaced in boreholes in the floors of tunnels (KBS-3 concept), a 12-assembly waste package emplaced in tunnels, and a 32-assembly dual purpose canister emplaced in tunnels. In addition, three failure scenarios were suggested for future use: a nominal scenario involving corrosion of the waste package in the tunnel emplacement concepts, a manufacturing defect scenario applicable to the KBS-3 concept, and a disruptive glaciation scenario applicable to both emplacement concepts. The computational approaches required to analyze EBS failure and transport processes in a crystalline rock repository are similar to those of argillite/shale, with the most significant difference being that the EBS in a crystalline rock repository will likely experience highly heterogeneous flow rates, which should be represented in the model. The computational approaches required to analyze radionuclide transport in the natural system are very different because of the highly channelized nature of fracture flow. Computational workflows tailored to crystalline rock based on discrete transport pathways extracted from discrete fracture network models are recommended.

  10. Generic behaviours in impact fragmentation

    Energy Technology Data Exchange (ETDEWEB)

    Sator, N.; Mechkov, S.; Sausset, F. [Paris-6 Univ. Pierre et Marie Curie, Lab. de Physique Theorique de la Matiere Condensee, UMR CNRS 7600, 75 - Paris (France); Mechkov, S. [Ecole Normale Superieure, Lab. de Physique Statistique, 75 - Paris (France)

    2008-02-15

    From atomic nuclei to supernovae, including plates and rocks, every cohesive system can be broken into fragments, provided that the deposited energy is sufficiently large compared to its cohesive energy. We present a simple numerical model for investigating the general properties of fragmentation. By use of molecular dynamics simulations, we study the impact fragmentation of a solid disk of interacting particles with a wall. Regardless of the particular form of the interaction potential, the fragment size distribution exhibits a power law behaviour with an exponent that increases logarithmically with the energy deposited in the system, in agreement with experiments. We expect this behaviour to be generic in fragmentation phenomena. (authors)

  11. Generic maximum likely scale selection

    DEFF Research Database (Denmark)

    Pedersen, Kim Steenstrup; Loog, Marco; Markussen, Bo

    2007-01-01

    The fundamental problem of local scale selection is addressed by means of a novel principle, which is based on maximum likelihood estimation. The principle is generally applicable to a broad variety of image models and descriptors, and provides a generic scale estimation methodology. The focus...... on second order moments of multiple measurements outputs at a fixed location. These measurements, which reflect local image structure, consist in the cases considered here of Gaussian derivatives taken at several scales and/or having different derivative orders....

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

    Science.gov (United States)

    Drozdowska, Aleksandra; Hermanowski, Tomasz

    2016-02-01

    important to address all concerns pharmacists may have over generics, for example by implementing comprehensive awareness-raising campaigns. Also, pharmacotherapy monitoring systems (i.e. provided in a framework of pharmaceutical care) could be considered to identify any safety or quality concerns that may arise.

  13. Generic Opinion Mining System for Decision Support

    Directory of Open Access Journals (Sweden)

    Dr.P.G.Naik

    2016-04-01

    Full Text Available Social networking sites prove to be indispensible tools for decision making owing to the large repository of user views accumulated over a period of time. Such a real data can be exploited for various purposes such as making buying decisions, analysing the user views about new product launched by a company, product promotion campaign , impact of policy decisions made by a political party on society etc. In the current work the authors have proposed a generic model for feature based polarity determination by sentiment analysis of tweets. This model has been implemented by the seamless integration of R tool, XML, JAVA, Link Parser A practical multistep system, in place, efficiently extracts data from tweet text, pre-process the raw data to remove noise, and tags their polarity. Data used in the current study is derived from online product feature based reviews collected from tweeter tweets. Link parser version 4.1 b is employed for parsing a natural sentence which is broken into multiple tokens corresponding to noun and adjective before being stored in a persistent storage medium. The objectivity score is determined using SentiWordNet 3.0 lexical resource which is parsed using a tool implemented in Java. The linguistic hedges are taken care of using Zadeh’s proposition which modifies the final objectivity score. The objectivity score so computed, provides the necessary guidelines in influencing decisions. The authors have tested the model for product purchase decisions of two different sets of products, smart phone and laptop based on predefined set of features. The model is generic and can be applied to any set of products evaluated on a predefined set of features.

  14. Patient knowledge, perceptions, and acceptance of generic medicines: a comprehensive review of the current literature

    Directory of Open Access Journals (Sweden)

    Alrasheedy AA

    2014-04-01

    Full Text Available Alian A Alrasheedy,1 Mohamed Azmi Hassali,1 Kay Stewart,2 David CM Kong,2 Hisham Aljadhey,3 Mohamed Izham Mohamed Ibrahim,4 Saleh Karamah Al-Tamimi1 1Discipline of Social and Administrative Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia, Penang, Malaysia; 2Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Melbourne, VIC, Australia; 3Medication Safety Research Chair, Clinical Pharmacy Department, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia; 4College of Pharmacy, Qatar University, Doha, Qatar Background: Generic medicines have the same quality, safety, and efficacy as their counterpart original brand medicines. Generic medicines provide the same therapeutic outcomes but at a much cheaper cost, so are promoted in many countries to contain pharmaceutical expenditure and sustain the health care system. Thus, the perspective of patients and medicine consumers as end users of these medicines is an important factor to enhance the use and utilization of generic medicines. The objective of this paper is to review patients’ and consumers’ knowledge, perceptions, acceptance, and views of generic medicines in the current literature. Methods: An extensive literature search was performed in several databases, namely Scopus, PubMed, ISI Web of Knowledge, Proquest, and the Wiley online library, to identify relevant studies published in the English literature for the period 1990–2013. Results: A total of 53 studies were included in the review, comprising 24 studies from Europe, ten from North America, six from Asia, five from Australia and New Zealand, five from the Middle East, one from Africa, one from Latin America, and one from the Caribbean region. A large body of literature has reported misconceptions and negative perceptions about generic medicines on the part of patients and medicine consumers. Moreover, although it is reported in almost all countries, the percentage of consumers who had

  15. A safety assessment of rotary mode core sampling in flammable gas single shell tanks: Hanford Site, Richland, Washington

    Energy Technology Data Exchange (ETDEWEB)

    Raymond, R.E.

    1996-04-15

    This safety assessment (SA) addresses each of the required elements associated with the installation, operation, and removal of a rotary-mode core sampling (RMCS) device in flammable-gas single-shell tanks (SSTs). The RMCS operations are needed in order to retrieve waste samples from SSTs with hard layers of waste for which push-mode sampling is not adequate for sampling. In this SA, potential hazards associated with the proposed action were identified and evaluated systematically. Several potential accident cases that could result in radiological or toxicological gas releases were identified and analyzed and their consequences assessed. Administrative controls, procedures and design changes required to eliminate or reduce the potential of hazards were identified. The accidents were analyzed under nine categories, four of which were burn scenarios. In SSTS, burn accidents result in unacceptable consequences because of a potential dome collapse. The accidents in which an aboveground burn propagates into the dome space were shown to be in the ``beyond extremely unlikely`` frequency category. Given the unknown nature of the gas-release behavior in the SSTS, a number of design changes and administrative controls were implemented to achieve these low frequencies. Likewise, drill string fires and dome space fires were shown to be very low frequency accidents by taking credit for the design changes, controls, and available experimental and analytical data. However, a number of Bureau of Mines (BOM) tests must be completed before some of the burn accidents can be dismissed with high confidence. Under the category of waste fires, the possibility of igniting the entrapped gases and the waste itself were analyzed. Experiments are being conducted at the BOM to demonstrate that the drill bit is not capable of igniting the trapped gas in the waste. Laboratory testing and thermal analysis demonstrated that, under normal operating conditions, the drill bit will not create high

  16. Comparing the biological impact of glatiramer acetate with the biological impact of a generic.

    Directory of Open Access Journals (Sweden)

    Fadi Towfic

    Full Text Available For decades, policies regarding generic medicines have sought to provide patients with economical access to safe and effective drugs, while encouraging the development of new therapies. This balance is becoming more challenging for physicians and regulators as biologics and non-biological complex drugs (NBCDs such as glatiramer acetate demonstrate remarkable efficacy, because generics for these medicines are more difficult to assess. We sought to develop computational methods that use transcriptional profiles to compare branded medicines to generics, robustly characterizing differences in biological impact. We combined multiple computational methods to determine whether differentially expressed genes result from random variation, or point to consistent differences in biological impact of the generic compared to the branded medicine. We applied these methods to analyze gene expression data from mouse splenocytes exposed to either branded glatiramer acetate or a generic. The computational methods identified extensive evidence that branded glatiramer acetate has a more consistent biological impact across batches than the generic, and has a distinct impact on regulatory T cells and myeloid lineage cells. In summary, we developed a computational pipeline that integrates multiple methods to compare two medicines in an innovative way. This pipeline, and the specific findings distinguishing branded glatiramer acetate from a generic, can help physicians and regulators take appropriate steps to ensure safety and efficacy.

  17. Hybrid reactor safety study. Annual report, October 1, 1978-September 30, 1979

    Energy Technology Data Exchange (ETDEWEB)

    1979-12-01

    A preliminary generic safety evaluation of the fusion-fission hybrid reactor concept has been performed and a hybrid reactor safety program plan for guiding future safety work has been proposed. The emphasis of the work was limited to accident analysis where the main concern is for the health and safety of the public. Major radioactive sources in the hybrid were identified and their inventories compared to those of fission reactors. The means for accidental release of radioactivity to the public were identified, as were the barriers which preclude such accidental releases. Consequence analyses of hypothetical bounding accidents potentially defining the upper bound envelope of risk/consequence to the population and environment surrounding the hybrid site were performed.

  18. Skin rash during treatment with generic itraconazole

    Directory of Open Access Journals (Sweden)

    Antonio De Vuono

    2014-01-01

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

  19. A Hazard Analysis for a Generic Insulin Infusion Pump

    Science.gov (United States)

    Zhang, Yi; Jones, Paul L.; Jetley, Raoul

    2010-01-01

    Background Researchers at the Food and Drug Administration (FDA)/Center for Device and Radiological Health/Office of Science and Engineering Laboratories have been exploring the concept of model-based engineering as a means for improving the quality of medical device software. Insulin pumps were chosen as a research subject because their design provides the desired degree of research complexity and these types of devices present an ongoing regulatory challenge. Methods Insulin pump hazards and their contributing factors are considered in the context of a highly abstract generic insulin infusion pump (GIIP) model. Hazards were identified by consulting with manufacturers, pump users, and clinicians; by reviewing national and international standards and adverse event reports collected by the FDA; and from workshops sponsored by Diabetes Technology Society. This information has been consolidated in tabular form to facilitate further community analysis and discussion. Results A generic insulin infusion pump model architecture has been established. A fairly comprehensive hazard analysis document, corresponding to the GIIP model, is presented in this article. Conclusions We believe that this work represents the genesis of an insulin pump safety reference standard upon which future insulin pump designs can be based to help ensure a basic level of safety. More interaction with the diabetes community is needed to assure the quality of this safety modeling process. PMID:20307387

  20. Toward a generic UGV autopilot

    Science.gov (United States)

    Moore, Kevin L.; Whitehorn, Mark; Weinstein, Alejandro J.; Xia, Junjun

    2009-05-01

    Much of the success of small unmanned air vehicles (UAVs) has arguably been due to the widespread availability of low-cost, portable autopilots. While the development of unmanned ground vehicles (UGVs) has led to significant achievements, as typified by recent grand challenge events, to date the UGV equivalent of the UAV autopilot is not available. In this paper we describe our recent research aimed at the development of a generic UGV autopilot. Assuming we are given a drive-by-wire vehicle that accepts as inputs steering, brake, and throttle commands, we present a system that adds sonar ranging sensors, GPS/IMU/odometry, stereo camera, and scanning laser sensors, together with a variety of interfacing and communication hardware. The system also includes a finite state machine-based software architecture as well as a graphical user interface for the operator control unit (OCU). Algorithms are presented that enable an end-to-end scenario whereby an operator can view stereo images as seen by the vehicle and can input GPS waypoints either from a map or in the vehicle's scene-view image, at which point the system uses the environmental sensors as inputs to a Kalman filter for pose estimation and then computes control actions to move through the waypoint list, while avoiding obstacles. The long-term goal of the research is a system that is generically applicable to any drive-by-wire unmanned ground vehicle.

  1. PROBLEM OF GENERIC REPLACEMENT: ADVANTAGES AND DISADVANTAGES

    Directory of Open Access Journals (Sweden)

    S. N. Tolpygina

    2009-01-01

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

  2. Generic domain models in software engineering

    Science.gov (United States)

    Maiden, Neil

    1992-01-01

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

  3. GENERIC COMMODITY PROMOTION AND PRODUCT DIFFERENTIATION

    OpenAIRE

    1999-01-01

    This paper considers whether generic promotion lowers the differentiation among competing brands as claimed in the 1997 Supreme Court case (Wileman et al. v. Glickman). Commodity promotion is modeled as a multi-stage game where products are vertically differentiated. Analytical results show that if the benefits of generic advertising from increased demand are outweighed by the costs from lower product differentiation then high-quality producers will not benefit from generic promotion but prod...

  4. 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

  5. PROBLEM OF GENERIC REPLACEMENT: ADVANTAGES AND DISADVANTAGES

    Directory of Open Access Journals (Sweden)

    S. N. Tolpygina

    2016-01-01

    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. 

  6. Generic substitution of lamotrigine among medicaid patients with diverse indications: a cohort-crossover study.

    Science.gov (United States)

    Hartung, Daniel M; Middleton, Luke; Svoboda, Leanne; McGregor, Jessina C

    2012-08-01

    Controversy exists about the safety of substituting generic antiepileptic drugs (AEDs). Lamotrigine, the prototypical newer AED, is often used for psychiatric and neurological conditions other than epilepsy. The safety of generic substitution of lamotrigine in diverse populations of AED users is unclear. The objective of this study was to evaluate potential associations between generic substitution of lamotrigine and adverse consequences in a population of diverse users of this drug. This study was a retrospective cohort-crossover design using state Medicaid claims data from July 2006 through June 2009. Subjects were included in the cohort if they converted from brand to generic lamotrigine and had 2 years of lamotrigine use prior to conversion. The frequency of emergency department (ED) visits, hospitalizations and condition-specific ED visits or hospitalizations were recorded in the 60 days immediately following the conversion to generic lamotrigine, then compared with the incidence of the same events during a randomly selected time period indexed to one of the patient's past refills of branded lamotrigine. Multivariate conditional logistic regression was used to quantify the association between generic conversion and health services utilization while controlling for changes in lamotrigine dose and concurrent drug use. Of the 616 unique subjects included in this analysis, epilepsy was the most common diagnosis (41%), followed by bipolar disorder (32%), pain (30%) and migraine (18%). Conversion to generic lamotrigine was not associated with a statistically significant increase in the odds of an ED visit (adjusted odds ratio [AOR] = 1.35; 95% confidence interval [CI] 0.92, 1.97), hospitalization (AOR = 1.21; 95% CI 0.60, 2.50) or condition-specific encounter (AOR 1.75; 95 CI 0.87, 3.51). A statistically significant increase in ED visits, hospitalizations or condition-specific encounters was not observed following the switch from brand to generic lamotrigine

  7. Reference pricing with endogenous generic entry.

    OpenAIRE

    Kurt R. Brekke; Canta, Chiara; Straume, Odd Rune

    2015-01-01

    In this paper we study the effect of reference pricing on pharmaceutical prices and ex-penditures when generic entry is endogenously determined. We develop a Salop-type model where a brand-name producer competes with generic producers in terms of prices. In the market there are two types of consumers: (i) brand biased consumers who choose between brand-name and generic drugs, and (ii) brand neutral consumers who choose between the different generic drugs. We find that, for a given number of ...

  8. Generic modules for trivial extension algebras

    Institute of Scientific and Technical Information of China (English)

    杜先能

    1995-01-01

    Let A be a finite-dimensional algebra over an algebraically closed field. An indecomposable (right) ,4-module M is called generic provided M is infinite k-dimensional but finite length as (left) EndA(M)-module. Let R = A DA be the trivial extension algebra of A- Generic R-modules are constructed from generic A-modules using some functors between Mod A and Mod R. it is also proved that if A is a tame hereditary algebra, then R has only two generic modules.

  9. "Generic Entry and the Pricing of Pharmaceuticals"

    OpenAIRE

    Frank, Richard G.; David S. Salkever

    1995-01-01

    During the 1980s the share of prescriptions sold by retail pharmacies that was accounted for by generic products roughly doubled. The price response to generic entry of brand-name products has been a source of controversy. In this paper we estimate models of price responses to generic entry in the market for brand-name and generic drugs. We study a sample of 32 drugs that lost patent protection during the early to mid-1980s. Our results provide strong evidence that brand-name prices increase ...

  10. Rational use of generic psychotropic drugs.

    Science.gov (United States)

    Carbon, Maren; Correll, Christoph U

    2013-05-01

    For economic reasons, the generic substitution of branded medications is common and welcome. These replacements are based on the concept of bioequivalence, which is considered equal to therapeutic equivalence. Regulatory standards for bioequivalence require the 90 % confidence intervals of group averages of pharmacokinetic measures of a generic and the original drug to overlap within ±20 %. However, therapeutic equivalence has been challenged for several psychotropic agents by retrospective studies and case reports. To evaluate the degree of bioequivalence and therapeutic equivalence of branded and generic psychotropic drugs, we performed an electronic search (from database inception until 24 May 2012 and without language restrictions) in PubMed/MEDLINE, Cochrane Library, and Web of Science. Search terms were "(generic) AND (psychotropic OR psychoactive OR antipsychotic OR antiepileptic OR antidepressant OR stimulant OR benzodiazepine)" or the respective individual substances. We included clinical studies, regardless of design, comparing branded with generic psychotropic drug formulations, identifying 35 such studies. We also included case reports/series reporting on outcomes after a switch between brand and generic psychotropics, identifying 145 clinical cases. Bioequivalence studies in healthy controls or animals, in-vitro studies, and health economics studies without medical information were excluded. An overview of the few randomized controlled studies supports that US FDA regulations assure clinically adequate drug delivery in the majority of patients switched from brand to generic. However, with a growing number of competing generic products for one substance, and growing economic pressure to substitute with the currently cheapest generic, frequent generic-generic switches, often unbeknownst to prescribing clinicians, raise concerns, particularly for antiepileptics/mood stabilizers. Generic-generic switches may vary by more than ±20 % from each other in

  11. 76 FR 54507 - Proposed Generic Communication; Draft NRC Generic Letter 2011-XX: Seismic Risk Evaluations for...

    Science.gov (United States)

    2011-09-01

    ... COMMISSION Proposed Generic Communication; Draft NRC Generic Letter 2011-XX: Seismic Risk Evaluations for... the effects of natural phenomena, including earthquakes, without losing the capability to perform... Electric Power Research Institute models to estimate earthquake ground motion and updated models...

  12. Analysis of French generic medicines retail market: why the use of generic medicines is limited.

    Science.gov (United States)

    Dylst, Pieter; Vulto, Arnold; Simoens, Steven

    2014-12-01

    The market share of generic medicines in France is low compared to other European countries. This perspective paper provides an overview of the generic medicines retail market in France and how the current policy environment may affect the long-term sustainability. Looking at the French generic medicines retail market and the surrounding regulatory framework, all conditions seem to be in place to create a healthy generic medicines market: the country has well-respected regulatory authorities, generic medicines enter the market in a timely manner and prices of generic medicines are competitive compared with other European countries. Despite the success of the demand-side policies targeted at pharmacists and patients, those targeted at physicians were less successful due to a lack of enforcement and a lack of trust in generic medicines by French physicians. Recommendations to increase the use of generic medicines in France round off this perspective paper.

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

    Science.gov (United States)

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

    2010-05-01

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

  14. Site Safety and Health Plan (Phase 3) for the treatability study for in situ vitrification at Seepage Pit 1 in Waste Area Grouping 7, Oak Ridge National Laboratory, Oak Ridge, TN

    Energy Technology Data Exchange (ETDEWEB)

    Spalding, B.P.; Naney, M.T.

    1995-06-01

    This plan is to be implemented for Phase III ISV operations and post operations sampling. Two previous project phases involving site characterization have been completed and required their own site specific health and safety plans. Project activities will take place at Seepage Pit 1 in Waste Area Grouping 7 at ORNL, Oak Ridge, Tennessee. Purpose of this document is to establish standard health and safety procedures for ORNL project personnel and contractor employees in performance of this work. Site activities shall be performed in accordance with Energy Systems safety and health policies and procedures, DOE orders, Occupational Safety and Health Administration Standards 29 CFR Part 1910 and 1926; applicable United States Environmental Protection Agency requirements; and consensus standards. Where the word ``shall`` is used, the provisions of this plan are mandatory. Specific requirements of regulations and orders have been incorporated into this plan in accordance with applicability. Included from 29 CFR are 1910.120 Hazardous Waste Operations and Emergency Response; 1910.146, Permit Required - Confined Space; 1910.1200, Hazard Communication; DOE Orders requirements of 5480.4, Environmental Protection, Safety and Health Protection Standards; 5480.11, Radiation Protection; and N5480.6, Radiological Control Manual. In addition, guidance and policy will be followed as described in the Environmental Restoration Program Health and Safety Plan. The levels of personal protection and the procedures specified in this plan are based on the best information available from reference documents and site characterization data. Therefore, these recommendations represent the minimum health and safety requirements to be observed by all personnel engaged in this project.

  15. Pharmaceutical policy regarding generic drugs in Belgium.

    Science.gov (United States)

    Simoens, Steven; De Bruyn, Kristien; Bogaert, Marc; Laekeman, Gert

    2005-01-01

    Pressure to control pharmaceutical expenditure and price competition among pharmaceutical companies are fuelling the development of generic drug markets in EU countries. However, in Belgium, the market for generic drugs is underdeveloped compared with other countries. To promote the use of generic drugs, the government introduced a reference pricing (RP) scheme in 2001. The aim of this paper is to discuss Belgian pharmaceutical policy regarding generic drugs and to analyse how the Belgian drug market has evolved following initiation of the RP scheme. The market share held by generic drugs increased following implementation of the RP scheme. Focusing on volume, average market share (by semester) for generic drugs amounted to 2.05% of the total pharmaceutical market from January 1998 to June 2001, compared with 6.11% from July 2001 to December 2003. As new generic drugs are introduced, their market share tends to increase in the first couple of months, after which it levels off. Faced with increasing generic competition, some manufacturers have launched new variants of their original drug, thereby effectively extending the period of patent protection. Strategies consisting of price reductions in return for the abolition of prescribing conditions and the launch of new dosages or formulations appear to have been successful in maintaining the market share of original drugs. Nevertheless, the introduction of the RP scheme was associated with savings amounting to 1.8% of pharmaceutical expenditure by the third-party payer in 2001 and 2.1% in 2002. The findings of this paper indicate that the RP scheme has stimulated the Belgian generic drug market. However, existing policy has largely failed to take into account the role that physicians and pharmacists can play in stimulating generic drug use. Therefore, further development of the Belgian generic drug market seems to hinge on the creation of appropriate incentives for physicians to prescribe, and for pharmacists to

  16. 78 FR 78366 - Draft Generic Drug User Fee Act Information Technology Plan; Availability for Comment

    Science.gov (United States)

    2013-12-26

    ... shortages, drug supply chain, safety, security, and drug innovation. As generic drugs account for more than... approvals, drug supply chain, and other topics related to human pharmaceuticals. The draft GDUFA IT plan... the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,...

  17. Generic Form of Bayesian Monte Carlo For Models With Partial Monotonicity

    NARCIS (Netherlands)

    Rajabalinejad, M.

    2012-01-01

    This paper presents a generic method for the safety assessments of models with partial monotonicity. For this purpose, a Bayesian interpolation method is developed and implemented in the Monte Carlo process. integrated approach is the generalization of the recently developed techniques used in safet

  18. Generic form of Bayesian Monte Carlo for models with partial monotonicity

    NARCIS (Netherlands)

    Rajabalinejad, M.; Spitas, C.

    2012-01-01

    This paper presents a generic method for the safety assessments of models with partial monotonicity. For this purpose, a Bayesian interpolation method is developed and implemented in the Monte Carlo process. integrated approach is the generalization of the recently developed techniques used in safet

  19. HOW AUTHENTIC SHOULD A LEARNING CONTEXT BE? USING REAL AND SIMULATED PROFILES IN A CLASSROOM INTERVENTION TO IMPROVE SAFETY ON SOCIAL NETWORK SITES

    Directory of Open Access Journals (Sweden)

    Ellen Vanderhoven

    2015-06-01

    Full Text Available With the rise of social network sites (SNSs, there is an increasing need for safety education within the current cyber society. To this end, a variety of educational materials have been developed to prepare children to be vigilant when interacting on such sites. However, little is known about the critical design aspects necessary to make these materials effective. In this study, we build on the results of two previous studies, in which we found that general instructional principles drawn from constructivism, such as collaborative learning, are not always appropriate to teach children how to behave safely online. This study therefore focuses on the importance of authentic learning and active learning as critical design features. A quasi-experimental study was conducted in secondary schools in order to compare the impact of two classroom interventions about the risks on SNSs. As part of the intervention, students were presented scaffolds towards different risks related to an SNS-profile through a series of questions. In the control condition, these questions concerned a simulated SNS-profile on paper containing signs of many risks. In the experimental condition, students had to answer the same questions about their own SNS-profile on a computer. It was hypothesized that the simulated profile would not be experienced as realistic, and that students would have difficulties identifying with it. On the other hand, teenagers were expected to be able to recognize more risks on the simulated ‘worst-case scenario’ profile than on their own profile, which would facilitate the scaffolding process in the control condition. The results of the study mostly confirmed these hypotheses. Furthermore, the question arose as to whether the intervention based on the student’s own realistic profile was educationally more valuable than the intervention based on the simulated profile, but no such added value was found. On the contrary, the scaffolding questions

  20. Once more the generic name Passerina Vieillot

    NARCIS (Netherlands)

    Oort, van E.D.

    1910-01-01

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

  1. Designing Generic and Efficient Negotiation Strategies

    NARCIS (Netherlands)

    Tykhonov, D.

    2010-01-01

    The central aim of this thesis is the design of generic and efficient automated strategies for two-party negotiations in which negotiating parties do not reveal their preferences explicitly. A strategy for negotiation is the decision mechanism for determining the actions of a negotiator. Generic ref

  2. Typed generic traversals in $S_gamma^'$

    NARCIS (Netherlands)

    Lämmel, R.

    2001-01-01

    A typed model of strategic rewriting is developed. An innovation is that generic traversals are covered. To this end, we define a rewriting calculus $S'_{gamma$. The calculus offers a few strategy combinators for generic traversals. There is, for example, a combinator to apply a strategy to all imme

  3. Generic drugs in dermatology: part I.

    Science.gov (United States)

    Payette, Michael; Grant-Kels, Jane M

    2012-03-01

    The cost of health care in the United States is increasing. In order to help control these rising costs, all parties involved in the delivery of health care, including dermatologists, need to be part of the solution of ethically reducing the cost of delivery of care. One potential means of meeting this goal is to increase the use of generic medications in daily practice. Generic medications can offer equally efficacious therapy at significantly lower prices, which can translate into large scale savings for the individual patient, the payer, and the overall health care system. Herein we provide an overview of new drug development, review the history of the generic drug industry, describe how generic drugs are approved by the US Food and Drug Administration, and define the concepts of bioequivalence and therapeutic equivalence. In part II, we explore various factors impacting generic drug use, provide cost analyses of dermatologic brand name and generic drugs, and review data addressing potential differences in the effectiveness of brand name versus generic drugs in dermatology. The cost of brand name and generic medications is highly variable by pharmacy, state, and payer. We used one source (www.drugstore.com) as an example and for consistency across all medications discussed herein. Prices included here may not reflect actual retail prices across the United States.

  4. Defining Generic Skills. At a Glance.

    Science.gov (United States)

    National Centre for Vocational Education Research, Leabrook (Australia).

    Generic skills--skills that apply across a variety of jobs and life contexts--are taking on increased importance in Australia and internationally. There is a high demand for generic skills in the workplace because employers seek to ensure business success by recruiting and retaining employees who have a variety of skills and personal attributes as…

  5. Chemical Safety Vulnerability Working Group report. Volume 1

    Energy Technology Data Exchange (ETDEWEB)

    1994-09-01

    The Chemical Safety Vulnerability (CSV) Working Group was established to identify adverse conditions involving hazardous chemicals at DOE facilities that might result in fires or explosions, release of hazardous chemicals to the environment, or exposure of workers or the public to chemicals. A CSV Review was conducted in 148 facilities at 29 sites. Eight generic vulnerabilities were documented related to: abandoned chemicals and chemical residuals; past chemical spills and ground releases; characterization of legacy chemicals and wastes; disposition of legacy chemicals; storage facilities and conditions; condition of facilities and support systems; unanalyzed and unaddressed hazards; and inventory control and tracking. Weaknesses in five programmatic areas were also identified related to: management commitment and planning; chemical safety management programs; aging facilities that continue to operate; nonoperating facilities awaiting deactivation; and resource allocations. Volume 1 contains the Executive summary; Introduction; Summary of vulnerabilities; Management systems weaknesses; Commendable practices; Summary of management response plan; Conclusions; and a Glossary of chemical terms.

  6. The problem of choosing between the original and of generic drugs in patients with overweight and obesity

    Directory of Open Access Journals (Sweden)

    M L Maksimov

    2013-10-01

    Full Text Available This review article discusses the similarities and differences in the research, production and use in clinical practice, original and generic drugs. Reproduced drugs (generics present on the Russian pharmaceutical market that have the bioequivalence data are not always equal in therapeutic equivalence of the original drug. The article presents evidence base of efficacy and safety of the original drug Xenical in the complex treatment of patients with overweight and obesity.

  7. Perception of the value of generic drugs in São Paulo, Brazil

    Directory of Open Access Journals (Sweden)

    Elene Paltrinieri Nardi

    2016-01-01

    Full Text Available Abstract The objective of this study was to assess the perceptions of opinion-leaders, patients and their accompanying family members or carers about generic drugs. Three groups of participants were surveyed: (i 50 customers while they were visiting commercial pharmacies located in São Paulo city, Brazil, (ii 25 patients and 25 companions while they were waiting at the university outpatient clinic, and (iii 50 healthcare opinion-leaders from government, hospitals, health plans, academia, and pharmaceutical companies. The questions explored socio-demographic characteristics and perceptions regarding value attributes of generic drugs compared to brand name drugs. Respondents had an average age of 52 years and 53% were women. Respondents believed generic drugs to be cheaper than brand name drugs (97%, and 31% thought generic drugs to be less effective than brand name drugs. Also, generic drugs were perceived by 54% of respondents to be as safe as brand name drugs and 74% would prefer brand name drugs if there was no price difference. In conclusion, multiple factors may contribute to the decision to buy generic drugs; among these, perceived effectiveness, safety and price appear to be the most important factors.

  8. Perception of the value of generic drugs in São Paulo, Brazil.

    Science.gov (United States)

    Nardi, Elene Paltrinieri; Ferraz, Marcos Bosi

    2016-02-01

    The objective of this study was to assess the perceptions of opinion-leaders, patients and their accompanying family members or carers about generic drugs. Three groups of participants were surveyed: (i) 50 customers while they were visiting commercial pharmacies located in São Paulo city, Brazil, (ii) 25 patients and 25 companions while they were waiting at the university outpatient clinic, and (iii) 50 healthcare opinion-leaders from government, hospitals, health plans, academia, and pharmaceutical companies. The questions explored socio-demographic characteristics and perceptions regarding value attributes of generic drugs compared to brand name drugs. Respondents had an average age of 52 years and 53% were women. Respondents believed generic drugs to be cheaper than brand name drugs (97%), and 31% thought generic drugs to be less effective than brand name drugs. Also, generic drugs were perceived by 54% of respondents to be as safe as brand name drugs and 74% would prefer brand name drugs if there was no price difference. In conclusion, multiple factors may contribute to the decision to buy generic drugs; among these, perceived effectiveness, safety and price appear to be the most important factors.

  9. Risks and benefits of generic antiepileptic drugs.

    Science.gov (United States)

    Gómez-Alonso, Juan; Kanner, Andrés M; Herranz, José Luis; Molins, Albert; Gil-Nagel, Antonio

    2008-11-01

    In most therapeutic areas, prescribing generic drugs seems to lower costs without sacrificing efficacy. The use of generic drugs for treating epilepsy may, however, be more controversial. A systematic review of the literature on generic antiepileptic drugs has been carried out based primarily on a bibliographical search in the Medline database. Published studies are usually of a descriptive nature and are sometimes based on generic drugs that were approved in times when regulatory agency requirements were not as strict as they are now. Experts claim that a change in pharmaceutical formulations could cause seizure recurrence in cases that had been successfully controlled in the past, with severe effects on patients. Meanwhile, several health organizations have provided inconsistent recommendations on the use of generic antiepileptic drugs. In order to obtain scientific evidence on the potential risks and benefits of interchanging branded and generic antiepileptic drugs, high methodological comparative studies are necessary. These studies could bring consensus about the role of generic drugs for treating epilepsy.

  10. Generic Magnetic Fusion Reactor Revisited

    Science.gov (United States)

    Sheffield, John; Milora, Stanley

    2015-11-01

    The original Generic Magnetic Fusion Reactor paper was published in 1986. This update describes what has changed in 30 years. Notably, the construction of ITER is providing important benchmark numbers for technologies and costs. In addition, we use a more conservative neutron wall flux and fluence. But these cost-increasing factors are offset by greater optimism on the thermal-electric conversion efficiency and potential availability. The main examples show the cost of electricity (COE) as a function of aspect ratio and neutron flux to the first wall. The dependence of the COE on availability, thermo-electric efficiency, electrical power output, and the present day's low interest rates is also discussed. Interestingly, at fixed aspect ratio there is a shallow minimum in the COE at neutron flux around 2.5 MW/m2. The possibility of operating with only a small COE penalty at even lower wall loadings (to 1.0 MW/m2 at larger plant size) and the use of niobium-titanium coils are also investigated. J. Sheffield was supported by ORNL subcontract 4000088999 with the University of Tennessee.

  11. Generic Argillite/Shale Disposal Reference Case

    Energy Technology Data Exchange (ETDEWEB)

    Zheng, Liange; Colon, Carlos Jové; Bianchi, Marco; Birkholzer, Jens

    2014-08-08

    Radioactive waste disposal in a deep subsurface repository hosted in clay/shale/argillite is a subject of widespread interest given the desirable isolation properties, geochemically reduced conditions, and widespread geologic occurrence of this rock type (Hansen 2010; Bianchi et al. 2013). Bianchi et al. (2013) provides a description of diffusion in a clay-hosted repository based on single-phase flow and full saturation using parametric data from documented studies in Europe (e.g., ANDRA 2005). The predominance of diffusive transport and sorption phenomena in this clay media are key attributes to impede radionuclide mobility making clay rock formations target sites for disposal of high-level radioactive waste. The reports by Hansen et al. (2010) and those from numerous studies in clay-hosted underground research laboratories (URLs) in Belgium, France and Switzerland outline the extensive scientific knowledge obtained to assess long-term clay/shale/argillite repository isolation performance of nuclear waste. In the past several years under the UFDC, various kinds of models have been developed for argillite repository to demonstrate the model capability, understand the spatial and temporal alteration of the repository, and evaluate different scenarios. These models include the coupled Thermal-Hydrological-Mechanical (THM) and Thermal-Hydrological-Mechanical-Chemical (THMC) models (e.g. Liu et al. 2013; Rutqvist et al. 2014a, Zheng et al. 2014a) that focus on THMC processes in the Engineered Barrier System (EBS) bentonite and argillite host hock, the large scale hydrogeologic model (Bianchi et al. 2014) that investigates the hydraulic connection between an emplacement drift and surrounding hydrogeological units, and Disposal Systems Evaluation Framework (DSEF) models (Greenberg et al. 2013) that evaluate thermal evolution in the host rock approximated as a thermal conduction process to facilitate the analysis of design options. However, the assumptions and the

  12. Nuclear waste old warehousing sites. ASN Report to the High Committee for nuclear safety information and transparency. session of the 23 september 2008; Les anciens sites d'entreposage de dechets radioactifs. Rapport de l'ASN au Haut comite pour la transparence et l'information sur la securite nucleaire. Seance du 23 septembre 2008

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2008-07-01

    This report aims at giving a complete assessment of nuclear waste old storage sites in France, i.e. sites where nuclear wastes have been stored, which do not comply with current safety requirements any more, and where either waste recovery operations, or operations of improvement and reinforcement of warehousing installations must be programmed. For each of these sites, the report recalls the storage function, describes the currently undertaken actions, and indicates the underground water status below the warehousing installation according to the available information. It also indicates the ASN's position about the site status.

  13. Chemical Safety Vulnerability Working Group report. Volume 3

    Energy Technology Data Exchange (ETDEWEB)

    1994-09-01

    The Chemical Safety Vulnerability (CSV) Working Group was established to identify adverse conditions involving hazardous chemicals at DOE facilities that might result in fires or explosions, release of hazardous chemicals to the environment, or exposure of workers or the public to chemicals. A CSV Review was conducted in 148 facilities at 29 sites. Eight generic vulnerabilities were documented related to: abandoned chemicals and chemical residuals; past chemical spills and ground releases; characterization of legacy chemicals and wastes; disposition of legacy chemicals; storage facilities and conditions; condition of facilities and support systems; unanalyzed and unaddressed hazards; and inventory control and tracking. Weaknesses in five programmatic areas were also identified related to: management commitment and planning; chemical safety management programs; aging facilities that continue to operate; nonoperating facilities awaiting deactivation; and resource allocations. Volume 3 consists of eleven appendices containing the following: Field verification reports for Idaho National Engineering Lab., Rocky Flats Plant, Brookhaven National Lab., Los Alamos National Lab., and Sandia National Laboratories (NM); Mini-visits to small DOE sites; Working Group meeting, June 7--8, 1994; Commendable practices; Related chemical safety initiatives at DOE; Regulatory framework and industry initiatives related to chemical safety; and Chemical inventory data from field self-evaluation reports.

  14. Generic substitution, financial interests, and imperfect agency.

    Science.gov (United States)

    Rischatsch, Maurus; Trottmann, Maria; Zweifel, Peter

    2013-06-01

    Policy makers around the world seek to encourage generic substitution. In this paper, the importance of prescribing physicians' imperfect agency is tested using the fact that some Swiss jurisdictions allow physicians to dispense drugs on their own account (physician dispensing, PD) while others disallow it. We estimate a model of physician drug choice with the help of drug claim data, finding a significant positive association between PD and the use of generics. While this points to imperfect agency, generics are prescribed more often to patients with high copayments or low incomes.

  15. Key safety parameters in the optimization of fuel management

    Energy Technology Data Exchange (ETDEWEB)

    Kollmar, W.; Boehm, R.; Dernedde, I.; Haase, H.; Kiehlmann, H.D.; Neufert, A.

    1988-08-01

    Nuclear design related key safety parameters and admissible parameter ranges are defined for reload cycles which are so similar in safety terms as to allow these to be covered by generic reload safety analyses in advance. The conceptual frame of such safety analyses together with the resulting economic benefits are illustrated by four concrete applications demonstrating reduction of excessive safety margins, increase in discharge burnup, streamlining of steam break analysis, and increase in operational flexibility of first cores.

  16. Are generic drugs really inferior medicines?

    Science.gov (United States)

    Moore, N; Berdaï, D; Bégaud, B

    2010-09-01

    In this issue Gagne et al. report an elegant case-crossover study of seizures in patients on antiepileptic drugs. They found that a dispensation episode approximately triples the risk of having a seizure within 21 days, but the risk is not statistically different whether the dispensation was of the same brand-name or generic drug as previously used or a switch from brand-name to a generic or from a generic to a brand name. The cause of the seizure might be a delay in taking medication or late redispensation, among others, but apparently the nature of the product dispensed is not relevant in this study; this may alleviate some of the concerns about generic drugs and epilepsy.

  17. Generic substitution: issues for problematic drugs.

    Science.gov (United States)

    Henderson, J D; Esham, R H

    2001-01-01

    The methodology and criteria for bioequivalence testing have been firmly established by the Food and Drug Administration (FDA). For certain drugs with a narrow therapeutic index (e.g., digoxin, levothyroxine, warfarin), generic substitution may not be advisable or even allowable, depending on the substitution laws of individual states. Digoxin and levothyroxine tablets are examples of drugs for which no New Drug Applications (NDAs) currently exist. However, commercially available generic products for both of these drugs have not been determined by the FDA to be therapeutically equivalent to the innovator products. Generic versions of warfarin have been approved by the FDA as being therapeutically equivalent to the innovator products, as have generic versions of the rescue inhaler albuterol. Yet, misinformation and myths persist regarding the adequacy and proven reliability of the FDA's determination of bioequivalence for these products.

  18. Impacts of Generic Competition and Benefit Management...

    Data.gov (United States)

    U.S. Department of Health & Human Services — According to findings reported in Impacts of Generic Competition and Benefit Management Practices on Spending for Prescription Drugs - Evidence from Medicares Part D...

  19. Impacts of Generic Competition and Benefit Management...

    Data.gov (United States)

    U.S. Department of Health & Human Services — According to findings reported in Impacts of Generic Competition and Benefit Management Practices on Spending for Prescription Drugs - Evidence from Medicares Part D...

  20. Generic User Process Interface for Event Generators

    CERN Document Server

    Boos, E; Giele, W T; Hinchliffe, Ian; Huston, J; Ilyin, V A; Kanzaki, J; Kato, K; Kurihara, Y; Lönnblad, L; Mangano, Michelangelo L; Mrenna, S; Paige, Frank E; Richter-Was, Elzbieta; Seymour, Michael H; Sjöstrand, Torbjörn; Webber, Bryan R; Zeppenfeld, Dieter

    2001-01-01

    Generic Fortran common blocks are presented for use by High Energy Physics event generators for the transfer of event configurations from parton level generators to showering and hadronization event generators.

  1. Generic methodology for calibrating profiling nacelle lidars

    DEFF Research Database (Denmark)

    Borraccino, Antoine; Courtney, Michael; Wagner, Rozenn

    is calibrated rather than a reconstructed parameter. This contribution presents a generic methodology to calibrate profiling nacelle-mounted lidars. The application of profiling lidars to wind turbine power performance and corresponding need for calibration procedures is introduced in relation to metrological...... standards. Further, two different calibration procedure concepts are described along with their strengths and weaknesses. The main steps of the generic methodology are then explained and illustrated by calibration results from two types of profiling lidars. Finally, measurement uncertainty assessment...

  2. On the genericity of spacetime singularities

    Indian Academy of Sciences (India)

    Pankaj S Joshi

    2007-07-01

    We consider here the genericity aspects of spacetime singularities that occur in cosmology and in gravitational collapse. The singularity theorems (that predict the occurrence of singularities in general relativity) allow the singularities of gravitational collapse to be either visible to external observers or covered by an event horizon of gravity. It is shown that the visible singularities that develop as final states of spherical collapse are generic. Some consequences of this fact are discussed.

  3. Generic Dynamic Scaling in Kinetic Roughening

    OpenAIRE

    Ramasco, José J.; López, Juan M.; Rodríguez, Miguel A.

    2000-01-01

    We study the dynamic scaling hypothesis in invariant surface growth. We show that the existence of power-law scaling of the correlation functions (scale invariance) does not determine a unique dynamic scaling form of the correlation functions, which leads to the different anomalous forms of scaling recently observed in growth models. We derive all the existing forms of anomalous dynamic scaling from a new generic scaling ansatz. The different scaling forms are subclasses of this generic scali...

  4. On Phases of Generic Toric Singularities

    CERN Document Server

    Sarkar, Tapobrata

    2007-01-01

    We systematically study the phases of generic toric singularities, using methods initiated in hep-th/0612046. These correspond to Gauged Linear Sigma Models with arbitrary charges. We show that complete information about generic $U(1)^r$ GLSMs can be obtained by studying the GLSM Lagrangian, appropriately modified in the different phases of the theory. This can be used to study the different phases of $L^{a,b,c}$ spaces and their non-supersymmetric counterparts.

  5. Development of a Dynamically Scaled Generic Transport Model Testbed for Flight Research Experiments

    Science.gov (United States)

    Jordan, Thomas; Langford, William; Belcastro, Christine; Foster, John; Shah, Gautam; Howland, Gregory; Kidd, Reggie

    2004-01-01

    This paper details the design and development of the Airborne Subscale Transport Aircraft Research (AirSTAR) test-bed at NASA Langley Research Center (LaRC). The aircraft is a 5.5% dynamically scaled, remotely piloted, twin-turbine, swept wing, Generic Transport Model (GTM) which will be used to provide an experimental flight test capability for research experiments pertaining to dynamics modeling and control beyond the normal flight envelope. The unique design challenges arising from the dimensional, weight, dynamic (inertial), and actuator scaling requirements necessitated by the research community are described along with the specific telemetry and control issues associated with a remotely piloted subscale research aircraft. Development of the necessary operational infrastructure, including operational and safety procedures, test site identification, and research pilots is also discussed. The GTM is a unique vehicle that provides significant research capacity due to its scaling, data gathering, and control characteristics. By combining data from this testbed with full-scale flight and accident data, wind tunnel data, and simulation results, NASA will advance and validate control upset prevention and recovery technologies for transport aircraft, thereby reducing vehicle loss-of-control accidents resulting from adverse and upset conditions.

  6. Population around the French nuclear power plant sites: a key-parameter for crisis management and safety economics; La population autour des sites nucleaires francais: un parametre determinant pour la gestion de crise et l'analyse economique des accidents nucleaires

    Energy Technology Data Exchange (ETDEWEB)

    PASCAL, A. [IRSN, Laboratoire d' economie de la surete, DSDP/SPIIC/LAERN, BP 17, 92262 Fontenay-aux-Roses (France)

    2012-01-15

    This paper undertakes an analysis of population around the French nuclear power plant sites, tackles the problem of evacuation planning and provides a glimpse into ongoing research at the Laboratory of Nuclear Safety Economics of the IRSN, about the cost assessment of a nuclear accident and long-term land contamination. (author)

  7. Construction safety

    CERN Document Server

    Li, Rita Yi Man

    2013-01-01

    A close-to-ideal blend of suburb and city, speedy construction of towers of Babylon, the sparkling proportion of glass and steel buildings’ facade at night showcase the wisdom of humans. They also witness the footsteps, sweats and tears of architects and engineers. Unfortunately, these signatures of human civilizations are swathed in towering figures of construction accidents. Fretting about these on sites, different countries adopt different measures on sites. This book firstly sketches the construction accidents on sites, followed by a review on safety measures in some of the developing countries such as Bermuda, Egypt, Kuwait and China; as well as developed countries, for example, the United States, France and Singapore. It also highlights the enormous compensation costs with the courts’ experiences in the United Kingdom and Hong Kong.

  8. 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...

  9. The diffusion of generics after patent expiry in Germany.

    Science.gov (United States)

    Fischer, Katharina Elisabeth; Stargardt, Tom

    2016-11-01

    To identify the influences on the diffusion of generics after patent expiry, we analyzed 65 generic entries using prescription data of a large German sickness fund between 2007 and 2012 in a sales model. According to theory, several elements are responsible for technology diffusion: (1) time reflecting the rate of adaption within the social system, (2) communication channels, and (3) the degree of incremental innovation, e.g., the modifications of existing active ingredient's strength. We investigated diffusion in two ways: (1) generic market share (percentage of generic prescriptions of all prescriptions of a substance) and, (2) generic sales quantity (number of units sold) over time. We specified mixed regression models. Generic diffusion takes considerable time. An average generic market share of about 75 % was achieved not until 48 months. There was a positive effect of time since generic entry on generic market share (p innovation influenced generic market share (mostly p < 0.001), but not generic sales quantity. Market structure, e.g., the number of generic manufacturers (p < 0.001) and prices influenced both generic market share and sales. Imperfections in generic uptake through informational cascades seem to be largely present. Third-party payers could enhance means to promote generic diffusion to amplify savings through generic entry.

  10. CDC Vital Signs: Child Passenger Safety

    Science.gov (United States)

    ... Academy of Pediatrics. Graphic design: adapted from National Highway Traffic Safety Administration. Top of Page What Can Be ... 0:60 seconds] On Other Web Sites National Highway Traffic Safety Administration: Parents Central National Highway Traffic Safety ...

  11. FDA Critical Path Initiatives: Opportunities for Generic Drug Development

    OpenAIRE

    Lionberger, Robert A.

    2008-01-01

    FDA’s critical path initiative documents have focused on the challenges involved in the development of new drugs. Some of the focus areas identified apply equally to the production of generic drugs. However, there are scientific challenges unique to the development of generic drugs as well. In May 2007, FDA released a document “Critical Path Opportunities for Generic Drugs” that identified some of the specific challenges in the development of generic drugs. The key steps in generic product de...

  12. Effects of generic versus non-generic feedback on motor learning in children.

    Directory of Open Access Journals (Sweden)

    Suzete Chiviacowsky

    Full Text Available Non-generic feedback refers to a specific event and implies that performance is malleable, while generic feedback implies that task performance reflects an inherent ability. The present study examined the influences of generic versus non-generic feedback on motor performance and learning in 10-year-old children. In the first experiment, using soccer ball kicking at a target as a task, providing participants with generic feedback resulted in worse performance than providing non-generic feedback, after both groups received negative feedback. The second experiment measured more permanent effects. Results of a retention test, performed one day after practicing a throwing task, showed that participants who received non-generic feedback during practice outperformed the generic feedback group, after receiving a negative feedback statement. The findings demonstrate the importance of the wording of feedback. Even though different positive feedback statements may not have an immediate influence on performance, they can affect performance, and presumably individuals' motivation, when performance is (purportedly poor. Feedback implying that performance is malleable, rather than due to an inherent ability, seems to have the potential to inoculate learners against setbacks--a situation frequently encountered in the context of motor performance and learning.

  13. Ferrocyanide Safety Program: Safety criteria for ferrocyanide watch list tanks

    Energy Technology Data Exchange (ETDEWEB)

    Postma, A.K.; Meacham, J.E.; Barney, G.S. [and others

    1994-01-01

    This report provides a technical basis for closing the ferrocyanide Unreviewed Safety Question (USQ) at the Hanford Site. Three work efforts were performed in developing this technical basis. The efforts described herein are: 1. The formulation of criteria for ranking the relative safety of waste in each ferrocyanide tank. 2. The current classification of tanks into safety categories by comparing available information on tank contents with the safety criteria; 3. The identification of additional information required to resolve the ferrocyanide safety issue.

  14. Vaccine Safety

    Science.gov (United States)

    ... Vaccine Safety Shingles (Herpes Zoster) Vaccine Safety Smallpox Vaccine Safety Common Concerns Adjuvants Autism CDC Statement: 2004 Pediatrics Paper on MMR and Autism Fainting (Syncope) Febrile ...

  15. [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.

  16. 76 FR 45814 - Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2012

    Science.gov (United States)

    2011-08-01

    ... INFORMATION CONTACT: Visit FDA's Web site at http://www.fda.gov/ForIndustry/UserFees/AnimalGenericDrugUserFee.... Background Section 741 of the FD&C Act (21 U.S.C. 379j-21) establishes three different kinds of user fees: (1.... Contact your bank or financial institution regarding the amount of the fees that need to be paid...

  17. MRI Safety during Pregnancy

    Science.gov (United States)

    ... News Physician Resources Professions Site Index A-Z MRI Safety During Pregnancy Magnetic resonance imaging (MRI) Illness ... during the exam? Contrast material MRI during pregnancy Magnetic resonance imaging (MRI) If you are pregnant and your doctor ...

  18. Design of Petrochemical Enterprise Work Site Safety Management System%石油化工企业生产现场安全管理系统的设计

    Institute of Scientific and Technical Information of China (English)

    王中雪; 许建军

    2012-01-01

    石油化工企业安全管理的重点在生产现场,落实各项规章制度和操作规程,按时到位巡检,及时发现隐患是生产现场安全的基本前提,也是石油化工企业安全管理的一道重要防线.通过分析大型石化企业作业现场安全管理现状,提出一种石化行业生产作业现场安全管理系统设计方案.该系统基于无线局域网络、手持电脑、二维条码和RFID等技术,实现生产作业现场的巡检智能化管理、电子作业许可证签发和厂区人员进出管控等多个功能.%The key point of security management for petrochemical enterprise is production field. The basic premise of safety is carrying out regulations and procedures, and inspecting and finding hidden danger on time in place. The safety management of petrochemical enterprise is an important thing. Through the analysis of safety management situation of petrochemical industry production operation site, the paper puts forward a design scheme of petrochemical operation site safety management system. Based on the wireless network, handheld computers, two dimensional barcode and RFID technology, this system realizes the site inspection of intelligent management, electronic permit to work issue and the control, personnel entering and leaving, and other functions.

  19. Hurricane Safety

    Science.gov (United States)

    ... English Hurricane Safety Checklist - Arabic Hurricane Safety Checklist - Chinese Hurricane Safety Checklist - French Hurricane Safety Checklist - Haitian ... Cross serves in the US, its territories and military installations around the world. Please try again. Your ...

  20. Generic and low dose antiretroviral therapy in adults and children: implication for scaling up treatment in resource limited settings

    Directory of Open Access Journals (Sweden)

    Ramautarsing Reshmie

    2010-06-01

    Full Text Available Abstract Although access to antiretroviral therapy (ART for the treatment of HIV has increased during the last decade, many patients are still in need of treatment. With limited funds to provide ART to millions of patients worldwide, there is a need for alternative ways to scale up ART in resource limited settings. This review provides an overview of pharmacokinetic, safety and efficacy studies of generic and reduced dose ART. The production of generic ART has greatly influenced the decline in drug prices and the increased in ART access. Generic ART has good pharmacokinetic profile, safety and efficacy. Toxicity is however the main cause for ART discontinuation. Several dose reduction studies have shown adequate pharmacokinetic parameters and short term efficacy with reduced dose ART. Ethnicity may affect drug metabolism; several pharmacokinetic studies have confirmed higher plasma ART concentration in Asians. Randomized efficacy trial of reduced versus standard ART is warranted.

  1. An Internet of Things Generic Reference Architecture

    DEFF Research Database (Denmark)

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

    2013-01-01

    , and keeping track of all these things for monitoring and controlling some information. IoT architecture is studied from software architecture, overall system architecture and network architecture point of view. Paper puts forward the requirements of software architecture along with, its component...... and deployment diagram, process and interface diagram at abstract level. Paper proposes the abstract generic IoT reference and concrete abstract generic IoT reference architectures. Network architecture is also put up as a state of the art. Paper shortly gives overviews of protocols used for IoT. Some...

  2. Generic Rigidity Matroids with Dilworth Truncations

    CERN Document Server

    Tanigawa, Shin-ichi

    2010-01-01

    We prove that the linear matroid that defines generic rigidity of $d$-dimensional body-rod-bar frameworks (i.e., structures consisting of disjoint bodies and rods mutually linked by bars) can be obtained from the union of ${d+1 \\choose 2}$ graphic matroids by applying variants of Dilworth truncation $n_r$ times, where $n_r$ denotes the number of rods. This leads to an alternative proof of Tay's combinatorial characterizations of generic rigidity of rod-bar frameworks and that of identified body-hinge frameworks.

  3. The SENSEI Generic In Situ Interface

    Energy Technology Data Exchange (ETDEWEB)

    Ayachit, Utkarsh [Kitware, Inc., Clifton Park, NY (United States); Whitlock, Brad [Intelligent Light, Rutherford, NJ (United States); Wolf, Matthew [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Loring, Burlen [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States); Geveci, Berk [Kitware, Inc., Clifton Park, NY (United States); Lonie, David [Kitware, Inc., Clifton Park, NY (United States); Bethel, E. Wes [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States)

    2017-04-11

    The SENSEI generic in situ interface is an API that promotes code portability and reusability. From the simulation view, a developer can instrument their code with the SENSEI API and then make make use of any number of in situ infrastructures. From the method view, a developer can write an in situ method using the SENSEI API, then expect it to run in any number of in situ infrastructures, or be invoked directly from a simulation code, with little or no modification. This paper presents the design principles underlying the SENSEI generic interface, along with some simplified coding examples.

  4. European solvent industry group generic exposure scenario risk and exposure tool

    OpenAIRE

    Zaleski, Rosemary T.; Qian, Hua; Zelenka, Michael P; George-Ares, Anita; Money, Chris

    2013-01-01

    The European Solvents Industry Group (ESIG) Generic Exposure Scenario (GES) Risk and Exposure Tool (EGRET) was developed to facilitate the safety evaluation of consumer uses of solvents, as required by the European Union Registration, Evaluation and Authorization of Chemicals (REACH) Regulation. This exposure-based risk assessment tool provides estimates of both exposure and risk characterization ratios for consumer uses. It builds upon the consumer portion of the European Center for Ecotoxic...

  5. 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...

  6. Site health and safety plan/work plan for further characterization of waste drums at Oak Ridge National Laboratory, Oak Ridge, Tennessee

    Energy Technology Data Exchange (ETDEWEB)

    Abston, J.P.; Burman, S.N.; Jones, D.L.

    1995-10-01

    The health and safety plan/work plan describes a strategy for characterizing the contents of 172 liquid waste and 33 solid waste drums. It also addresses the control measures that will be taken to (1) prevent or minimize any adverse impact on the environment or personnel safety and health and (2) meet standards that define acceptable management of hazardous and radioactive materials and wastes. When writing this document, the authors considered past experiences, recommendations, and best management practices to minimize possible hazards to human health or the environment from events such as fires, explosions, falls, mechanical hazards, or unplanned releases of hazardous or radioactive materials to air, soil, or surface water.

  7. 14 CFR 415.115 - Flight safety.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Flight safety. 415.115 Section 415.115... From a Non-Federal Launch Site § 415.115 Flight safety. (a) Flight safety analysis. An applicant's safety review document must describe each analysis method employed to meet the flight safety...

  8. Knowledge and perceptions of physicians from private medical centres towards generic medicines: a nationwide survey from Malaysia.

    Science.gov (United States)

    Kumar, Rohit; Hassali, Mohamed Azmi; Saleem, Fahad; Alrasheedy, Alian A; Kaur, Navneet; Wong, Zhi Yen; Kader, Muhamad Ali Sk Abdul

    2015-01-01

    Generic medicine prescribing has become a common practice in public hospitals. However, the trend in private medical centres seems to be different. The objective of this study was to investigate knowledge, perceptions and behavior of physicians from private medical centres in Malaysia regarding generic medicines. This study was a cross-sectional nationwide survey targeting physicians from private medical centres in Malaysia. The survey was conducted using questionnaire having (i) background and demographic data of the physicians, volume of prescription in a day, stock of generic medicines in their hospital pharmacy etc. (ii) their knowledge about bioequivalence (iii) prescribing behavior (iv) physicians' knowledge of quality, safety and efficacy of generic medicines, and their cost (v) perceptions of physicians towards issues pertaining to generic medicines utilization. A total of 263 questionnaires out of 735 were received, giving a response rate of 35.8%. Of the respondents, 214 (81.4%) were male and 49 (18.6%) were females. The majority of the participants were in the age range of 41-50 years and comprised 49.0% of the respondents. Only 2.3% of physicians were aware of the regulatory limits of bioequivalence standards in Malaysia. Of the respondents, 23.2% agreed that they 'always' write their prescriptions using originator product name whereas 50.2% do it 'usually'. A number of significant associations were found between their knowledge, perceptions about generic medicines and their demographic characteristics. The majority of the physicians from private medical centres in Malaysia had negative perceptions about safety, quality and the efficacy of generic medicines. These negative perceptions could be the cause of the limited use of generic medicines in the private medical centres. Therefore, in order to facilitate their use, it is recommended that the physicians need to be reassured and educated about the drug regulatory authority approval system of generic

  9. Should Physicians be Encouraged to use Generic Names and to Prescribe Generic Drugs?

    Science.gov (United States)

    Riaz, Haris; Krasuski, Richard A

    2016-06-01

    While using the brand names seems like a trivial issue at the outset, using these names is inherently problematic. Cardiovascular drugs remain the most commonly prescribed drugs by the physicians. The junior doctors are likely to introject practices of their seniors and consequently to reciprocate from the experiences learnt from their preceptors. Using the generic names may be one way to facilitate prescription of the generic drugs who have a better cost profile and similar efficacy than the more expensive branded drugs. In this editorial, we have outlined several arguments to suggest the importance of using the generic names in academic discussions and clinical documentation.

  10. 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.

  11. Chemical Safety Vulnerability Working Group report. Volume 2

    Energy Technology Data Exchange (ETDEWEB)

    1994-09-01

    The Chemical Safety Vulnerability (CSV) Working Group was established to identify adverse conditions involving hazardous chemicals at DOE facilities that might result in fires or explosions, release of hazardous chemicals to the environment, or exposure of workers or the public to chemicals. A CSV Review was conducted in 148 facilities at 29 sites. Eight generic vulnerabilities were documented related to: abandoned chemicals and chemical residuals; past chemical spills and ground releases; characterization of legacy chemicals and wastes; disposition of legacy chemicals; storage facilities and conditions; condition of facilities and support systems; unanalyzed and unaddressed hazards; and inventory control and tracking. Weaknesses in five programmatic areas were also identified related to: management commitment and planning; chemical safety management programs; aging facilities that continue to operate; nonoperating facilities awaiting deactivation; and resource allocations. Volume 2 consists of seven appendices containing the following: Tasking memorandums; Project plan for the CSV Review; Field verification guide for the CSV Review; Field verification report, Lawrence Livermore National Lab.; Field verification report, Oak Ridge Reservation; Field verification report, Savannah River Site; and the Field verification report, Hanford Site.

  12. Understanding and perceptions of final-year Doctor of Pharmacy students about generic medicines in Karachi, Pakistan: a quantitative insight

    Directory of Open Access Journals (Sweden)

    Jamshed SQ

    2015-05-01

    Full Text Available Shazia Qasim Jamshed,1 Mohamad Izham Mohamad Ibrahim,2 Mohamad Azmi Hassali,3 Adheed Khalid Sharrad,4 Asrul Akmal Shafie,3 Zaheer-Ud-Din Babar5 1Pharmacy Practice, Kulliyyah of Pharmacy, International Islamic University Malaysia, Kuantan Campus, Pahang, Malaysia; 2College of Pharmacy, Qatar University, Doha, Qatar; 3Discipline of Social and Administrative Pharmacy, School of Pharmaceutical Sciences, Penang, Malaysia; 4College of Pharmacy, University of Basra, Basra, Iraq; 5School of Pharmacy, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand General objective: To evaluate the understanding and perceptions of generic medicines among final-year Doctor of Pharmacy students in Karachi, Pakistan. Methods: A 23-item survey instrument that included a question on the bioequivalence limits and Likert-type scale questions regarding the understanding and perceptions of generic medicines among the students was executed. Cronbach’s alpha was found to be 0.62. Results: Responses were obtained from 236 final-year Doctor of Pharmacy students (n=85 from a publicly funded institute; n=151 from a privately funded institute. When comparing a brand-name medicine to a generic medicine, pharmacy students scored poorly on bioequivalence limits. More than 80% of the students incorrectly answered that all the products that are rated as generic equivalents are therapeutically equivalent to each other (P<0.04. Half of the students agreed that a generic medicine is bioequivalent to the brand-name medicine (P<0.001. With regard to quality, effectiveness, and safety, more than 75% of the students disagreed that generic medicines are of inferior quality and are less effective than brand-name medicines (P<0.001. More than 50% of the students disagreed that generic medicines produce more side effects than brand-name medicines (P<0.001. Conclusion: The current study identified a positive perception toward generic medicines but also gaps in

  13. Generic tacrolimus in solid organ transplantation

    DEFF Research Database (Denmark)

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

    2014-01-01

    The availability of a wide range of immunosuppressive therapies has revolutionized the management of patients who have undergone solid organ transplantation (SOT). However, the cost of immunosuppressive drugs remains high. This situation has led to the development of generic equivalents, which...

  14. Green's Conjecture for the generic canonical curve

    OpenAIRE

    Teixidor-I-Bigas, Montserrat

    1998-01-01

    Green's Conjecture states the following : syzygies of the canonical model of a curve are simple up to the p^th stage if and only if the Clifford index of C is greater than p. We prove that the generic curve of genus g satisfies Green's conjecture.

  15. First-class rules and generic traversal

    NARCIS (Netherlands)

    Dolstra, E.; Visser, Eelco

    2002-01-01

    In this paper we present a functional language supporting first-class rules and generic traversal. This is achieved by generalizing the pattern matching constructs of standard functional languages. The case construct that ties rules together and prevents their reuse, is replaced by separate, firstcl

  16. On generic representation of implicit induction procedures

    NARCIS (Netherlands)

    Naidich, D.

    1996-01-01

    We develop a generic representation of implicit induction proof procedures within the cover set induction framework. Our work further develops the approach of cover set induction on propositional orderings. We show that in order to represent a substantially wide range of implicit induction procedure

  17. Crystallization Kinetics within a Generic Modelling Framework

    DEFF Research Database (Denmark)

    Meisler, Kresten Troelstrup; von Solms, Nicolas; Gernaey, Krist

    2013-01-01

    An existing generic modelling framework has been expanded with tools for kinetic model analysis. The analysis of kinetics is carried out within the framework where kinetic constitutive models are collected, analysed and utilized for the simulation of crystallization operations. A modelling...... procedure is proposed to gain the information of crystallization operation kinetic model analysis and utilize this for faster evaluation of crystallization operations....

  18. Baldrige Theory into Practice: A Generic Model

    Science.gov (United States)

    Arif, Mohammed

    2007-01-01

    Purpose: The education system globally has moved from a push-based or producer-centric system to a pull-based or customer centric system. Malcolm Baldrige Quality Award (MBQA) model happens to be one of the latest additions to the pull based models. The purpose of this paper is to develop a generic framework for MBQA that can be used by…

  19. Matatti’s generic names for fungi

    NARCIS (Netherlands)

    Donk, M.A.

    1975-01-01

    The generic names for fungi used by Maratti in his ‘Flora romana’ must be accepted as validly published. Notes are given on the validly re-published names. Of these Agaricum and Coralloides may cause some difficulties. Conservation of Fomes (Fr.) Fr. against Agaricum [Mich.] Maratti is proposed. To

  20. On the Center of Generic Hecke Algebra

    Institute of Scientific and Technical Information of China (English)

    2006-01-01

    The concept of norm and cellular algebra are introduced and then the cellular basis is used to replace the Kazhdan-Lusztig basis. So a new base for the center of generic Hecke algebra associated with finite Coxeter group is found. The new base is described by using the notion of cell datum of Graham and Lehrer and the notion of norm.

  1. Baldrige Theory into Practice: A Generic Model

    Science.gov (United States)

    Arif, Mohammed

    2007-01-01

    Purpose: The education system globally has moved from a push-based or producer-centric system to a pull-based or customer centric system. Malcolm Baldrige Quality Award (MBQA) model happens to be one of the latest additions to the pull based models. The purpose of this paper is to develop a generic framework for MBQA that can be used by…

  2. Quality of generic medicines in South Africa

    DEFF Research Database (Denmark)

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

    2012-01-01

    must be addressed to ensure that people use them with confidence. Campaigns to increase the uptake of generic medicines by consumers and providers of healthcare need to be informed by local norms and practices. This study sought to compare South African consumers' and healthcare providers' perceptions...

  3. Modelling of Generic Slung Load System

    DEFF Research Database (Denmark)

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

    2006-01-01

    This paper presents the result of 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 Principle ...

  4. Intermediates and Generic Convergence to Equilibria

    DEFF Research Database (Denmark)

    Freitas, Michael Marcondes de; Wiuf, Carsten; Feliu, Elisenda

    2016-01-01

    Known graphical conditions for the generic or global convergence to equilibria of the dynamical system arising from a reaction network are shown to be invariant under the so-called successive removal of intermediates, a systematic procedure to simplify the network, making the graphical conditions...

  5. 'In situ simulation' versus 'off site simulation' in obstetric emergencies and their effect on knowledge, safety attitudes, team performance, stress, and motivation

    DEFF Research Database (Denmark)

    Sørensen, Jette Led; Van der Vleuten, Cees; Lindschou, Jane

    2013-01-01

    Unexpected obstetric emergencies threaten the safety of pregnant women. As emergencies are rare, they are difficult to learn. Therefore, simulation-based medical education (SBME) seems relevant. In non-systematic reviews on SBME, medical simulation has been suggested to be associated with improve...

  6. National Dam Safety Program. Little Choconut Watershed Site 2A Dam (Inventory Number NY 720), Susquehanna River Basin, Broome County, New York. Phase I Inspection Report,

    Science.gov (United States)

    1981-06-30

    in the Choco - nut and Susquehanna valleys. Till, associated with theI glacial advance, mantles the rest of the site. b. Subsurface Investigations 1...basis of the visual examination, the Little Choco - nut Watershed Site 2A Dam is considered to be in good condition. There were no signs of impending

  7. Safety Evaluation Report for the Tennessee Valley Authority's Plan to Decommission its Low-Level Radioactive Waste Burial Site at Muscle Shoals, Alabama

    Energy Technology Data Exchange (ETDEWEB)

    Gant, K.S.; Kettelle, R.H.

    1998-11-01

    From 1966 to 1981, the Tennessee Valley Authority (TVA) operated a burial site, licensed under the former 10 CFR 20.304, for low-level radioactive waste on its Muscle Shoals, Alabama, reservation. TVA submitted a decommissioning plan for the burial site and requested approval for unrestricted use of the site. The Nuclear Regulatory Commission requested Oak Ridge National Laboratory (ORNL) to evaluate this plan to determine if the site meets the radiological requirements for unrestricted use as specified in 10 CFR 20.1402; that is, an average member of the critical group would not receive more than 25 mrem/y from residual radioactivity at the TVA Low-Level Radioactive Waste Burial Site and the radioactivity has been reduced to levels as low as reasonably achievable (ALARA).

  8. Nuclear Criticality Safety Data Book

    Energy Technology Data Exchange (ETDEWEB)

    Hollenbach, D. F. [Y-12 National Security Complex, Oak Ridge, TN (United States)

    2016-11-14

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

  9. Current safety issues of CANDU licensing

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Y. [University of Ottawa, Ottawa (Canada); Natalizio, A. [ENSAC Associates, Ontario (Canada)

    1994-01-15

    As requested by Korea Institute of Nuclear Safety(KINS), the status of five generic licensing issues has been examined and their potential impact on a new plant that would be constructed in Canada has been evaluated. The results and conclusions of this evaluation are summarized as follows: steam explosion in calandria, hydrogen explosion in containment, use of PSA in reactor licensing, human factors, safety critical software.

  10. Safety Basis Report

    Energy Technology Data Exchange (ETDEWEB)

    R.J. Garrett

    2002-01-14

    As part of the internal Integrated Safety Management Assessment verification process, it was determined that there was a lack of documentation that summarizes the safety basis of the current Yucca Mountain Project (YMP) site characterization activities. It was noted that a safety basis would make it possible to establish a technically justifiable graded approach to the implementation of the requirements identified in the Standards/Requirements Identification Document. The Standards/Requirements Identification Documents commit a facility to compliance with specific requirements and, together with the hazard baseline documentation, provide a technical basis for ensuring that the public and workers are protected. This Safety Basis Report has been developed to establish and document the safety basis of the current site characterization activities, establish and document the hazard baseline, and provide the technical basis for identifying structures, systems, and components (SSCs) that perform functions necessary to protect the public, the worker, and the environment from hazards unique to the YMP site characterization activities. This technical basis for identifying SSCs serves as a grading process for the implementation of programs such as Conduct of Operations (DOE Order 5480.19) and the Suspect/Counterfeit Items Program. In addition, this report provides a consolidated summary of the hazards analyses processes developed to support the design, construction, and operation of the YMP site characterization facilities and, therefore, provides a tool for evaluating the safety impacts of changes to the design and operation of the YMP site characterization activities.

  11. Psychiatrists' decision making between branded and generic drugs.

    Science.gov (United States)

    Hamann, Johannes; Mendel, Rosmarie; Kissling, Werner; Leucht, Stefan

    2013-07-01

    To study psychiatrists' decision making between generic and branded antipsychotics or antidepressants a hypothetical decision scenario involving decisions between branded and generic drugs was presented to a sample of German psychiatrists. Factors influencing this decision were identified using a regression analysis. n=410 Psychiatrists participated in the survey. Psychiatrists were more likely to choose branded drugs when imagining choosing the drug for themselves (vs. recommending a drug to a patient). In addition, psychiatrists were more likely to choose generic antidepressants than generic antipsychotics. Additional predictors for choosing a generic drug were a higher share of outpatients, less negative attitudes toward generics and higher uncertainty tolerance. In conclusion, psychiatrists' decision making in choosing between branded or generic antidepressants or antipsychotics is to a large extent influenced by vague attitudes towards properties of generics and branded drugs as well as by "non-evidence based" factors such as uncertainty tolerance.

  12. Effect of curriculum changes to enhance generic skills proficiency of ...

    African Journals Online (AJOL)

    Effect of curriculum changes to enhance generic skills proficiency of 1st-year ... Feedback from these different evaluation methods identified specific needs in the ... positive effect on students' selfreported acquisition of generic learning skills.

  13. 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...

  14. A local reaction at or near injection site: case definition and guidelines for collection, analysis, and presentation of immunization safety data.

    Science.gov (United States)

    Gidudu, Jane; Kohl, Katrin S; Halperin, Scott; Hammer, Sandra Jo; Heath, Paul T; Hennig, Renald; Hoet, Bernard; Rothstein, Edward; Schuind, Anne; Varricchio, Frederick; Walop, Wikke

    2008-12-09

    The need for developing a case definition and guidelines for a local reaction at or near the injection site, methods for the development of the case definition and guidelines as an adverse event following immunization as well as the rationale for selected decisions about the case definition for a local reaction at or near the injection site are explained in the Preamble section. The case definition is structured in 2 levels of diagnostic certainty: level 1 includes any description of morphological or physiological change at or near the injection site that is described or identified by a healthcare provider. Level 2 is any description of morphological or physiological change at or near injection site that is described by any other person. In Guidelines section, the working group recommends to enable meaningful and standardized data collection, analysis, and presentation of information about a local reaction at or near the injection site. However, implementation of all guidelines might not be possible in all settings. The availability of information may vary depending upon resources, geographic region, and whether the source of information is a prospectively designed clinical trial, a post-marketing surveillance or epidemiologic study, or an individual report of a local reaction at injection site.

  15. Safety objectives for 2014

    CERN Multimedia

    HSE Unit

    2014-01-01

    This is the third year in which the CERN Management has presented annual safety objectives for the Organization, the “HSE Objectives”.   The HSE objectives for 2014, which were announced by the Director-General at his traditional New Year’s address to the staff and were presented at the first Enlarged Directorate meeting of the year, have been drawn up and agreed in close collaboration between the DSOs, the HSE Unit and the DG himself. From safety in the workplace to radiation and environmental protection, the document emphasises that “Safety is a priority for CERN” and that safety policy is a key element in how the Organization is run. And, like all policies, it generates objectives that “serve as a general framework for action”. The HSE objectives are broken down into the following fields: occupational health and safety on sites and in the workplace, radiation protection, radiation safety, environmental protection, emerge...

  16. 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...

  17. 40 CFR 721.3080 - Substituted phosphate ester (generic).

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Substituted phosphate ester (generic... Substances § 721.3080 Substituted phosphate ester (generic). (a) Chemical substances and significant new uses subject to reporting. (1) The chemical substance identified generically as a substituted phosphate...

  18. 40 CFR 721.3110 - Polycarboxylic acid ester (generic).

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Polycarboxylic acid ester (generic... Substances § 721.3110 Polycarboxylic acid ester (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as a polycarboxylic acid...

  19. 40 CFR 721.8660 - Propionic acid methyl ester (generic).

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Propionic acid methyl ester (generic... Substances § 721.8660 Propionic acid methyl ester (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as a propionic acid methyl...

  20. 40 CFR 721.2155 - Alkoxyamino-alkyl-coumarin (generic).

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Alkoxyamino-alkyl-coumarin (generic... Substances § 721.2155 Alkoxyamino-alkyl-coumarin (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as...

  1. 40 CFR 721.535 - Halogenated alkane (generic).

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Halogenated alkane (generic). 721.535... Substances § 721.535 Halogenated alkane (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as halogenated alkane (PMN P-01-433) is...

  2. 40 CFR 721.10163 - Chloro fluoro alkane (generic).

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Chloro fluoro alkane (generic). 721... Substances § 721.10163 Chloro fluoro alkane (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as chloro fluoro alkane (PMN...

  3. 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...

  4. 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...

  5. 40 CFR 721.5908 - Modified phenolic resin (generic).

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Modified phenolic resin (generic). 721... Substances § 721.5908 Modified phenolic resin (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as modified phenolic resin (PMN...

  6. 40 CFR 721.2673 - Aromatic epoxide resin (generic).

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Aromatic epoxide resin (generic). 721... Substances § 721.2673 Aromatic epoxide resin (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as aromatic epoxide resin (PMN...

  7. 40 CFR 721.5905 - Modified phenolic resin (generic).

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Modified phenolic resin (generic). 721... Substances § 721.5905 Modified phenolic resin (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as a modified phenolic resin...

  8. Generic Drugs: The Same Medicine for Less Money

    Science.gov (United States)

    Generic Drugs: The Same Medicine for Less Money What is a generic drug? A generic is a copy of a brand-name drug. A brand- name drug has a patent. When ... benefit to your health, and you will save money. 7KH IHGHUDO )RRG DQG 'UXJ $GPLQLVWUDWLRQ )'$ UHJXODWHV ERWK ...

  9. 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.

  10. 40 CFR 721.10113 - Thioether epoxy (generic).

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Thioether epoxy (generic). 721.10113... Substances § 721.10113 Thioether epoxy (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as thioether epoxy (PMN P-04-547) is subject to...

  11. 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...

  12. 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...

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

    Science.gov (United States)

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

    2016-01-01

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

  14. Radiation analysis for a generic centralized interim storage facility

    Energy Technology Data Exchange (ETDEWEB)

    Gillespie, S.G.; Lopez, P. [TRW Environmental Safety Systems, Inc., Vienna, VA (United States); Eble, R.G. [Duke Engineering and Services, Inc., Charlotte, NC (United States)

    1997-12-31

    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.

  15. Technical expertise on the safety of the proposed geological repository sites. Planning for geological deep repositories, step 1; Sicherheitstechnisches Gutachten zum Vorschlag geologischer Standortgebiete. Sachplan geologische Tiefenlager, Etappe 1

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2010-01-15

    On October 17, 2010, on request of those Swiss government institutions responsible for the disposal of radioactive wastes, the National Co-operative for the Disposal of Radioactive Waste (NAGRA) presented its project concerning geological sites for the foreseen disposal of radioactive wastes to the Federal Authorities. According to the present disposal concept, two types of repository are foreseen: one for highly radioactive wastes (HAA) and the other for low radioactive and intermediate-level radioactive wastes (SMA). If a site fulfils the necessary conditions for both HAA as well as for SMA, a combined site for both types of waste may be chosen. As a qualified control authority in Switzerland, the Federal Nuclear Safety Inspectorate (ENSI) has to examine the quality of the NAGRA proposals from the point of view of the nuclear safety of the sites. The project for deep underground waste disposal first defines the process and the criteria according to which sites for the geological storage of all types of radioactive wastes in Switzerland have to be chosen. The choice is based on the actual knowledge of Swiss geology. After dividing the wastes into SMA and HAA, some large-scale areas are to be identified according to their suitability from the geological and tectonic points of view. NAGRA's division of waste into SMA and HAA is based on calculations of the long-term safety for a broad range of different rock types and geological situations and takes the different properties of all waste types into account. As a conclusion, a small portion of SMA has to be stored with {alpha}-toxic wastes in the HAA repository. The estimation of the total volume of wastes to be stored is based on 60 years of operation of the actual nuclear power plants, augmented with the wastes from possible replacement plants with a total power of 5 GW{sub e} during a further 60 years. The safety concept of the repository is based on passive systems using technical and natural barriers. The

  16. Towards Generic Interaction Styles for Product Design

    DEFF Research Database (Denmark)

    Buur, Jacob; Stienstra, Marcelle

    2008-01-01

    A growing uneasiness among users with the experience of current product user interfaces mounts pressure on interaction designers to innovate user interface conventions. In previous research we have shown that a study of the history of product interaction triggers a broader discussion of interaction...... qualities among designers in a team, and that the naming of interaction styles helps establish an aesthetics of interaction design. However, that research focused on one particular product field, namely industrial controllers, and it was yet to be proven, if interaction styles do have generic traits across...... a wider range of interactive products. In this paper we report on five years of continued research into interaction styles for telephones, kitchen equipment, HiFi products and medical devices, and we show how it is indeed possible and beneficial to formulate a set of generic interaction styles....

  17. The Doppler peaks from a generic defect

    CERN Document Server

    Magueijo, J

    1996-01-01

    We investigate which of the exotic Doppler peak features found for textures and cosmic strings are generic novelties pertaining to defects. We find that the ``out of phase'' texture signature is an accident. Generic defects, when they generate a secondary peak structure similar to inflation, apply to it an additive shift. It is not necessary for this shift to be ``out of phase''. We also show which factors are responsible for the absence of secondary oscillations found for cosmic strings. Within this general analysis we finally consider the conditions under which topological defects and inflation can be confused. It is argued that only \\Omega=1 inflation and a defect with a horizon size coherence length have a chance to be confused. Any other inflationary or defect model always differ distinctly. (To appear in the proceedings of the XXXIth Moriond meeting, ``Microwave Background Anisotropies'')

  18. Towards Generic Models of Player Experience

    DEFF Research Database (Denmark)

    Shaker, Noor; Shaker, Mohammad; Abou-Zleikha, Mohamed

    2015-01-01

    -dependent and their applicability is usually limited to the system and the data used for model construction. Establishing models of user experience that are highly scalable while maintaing the performance constitutes an important research direction. In this paper, we propose generic models of user experience in the computer games...... further examine whether generic features of player be- haviour can be defined and used to boost the modelling per- formance. The accuracies obtained in both experiments in- dicate a promise for the proposed approach and suggest that game-independent player experience models can be built.......Context personalisation is a flourishing area of research with many applications. Context personalisation systems usually employ a user model to predict the appeal of the context to a particular user given a history of interactions. Most of the models used are context...

  19. Generic Data Pipelining Using ORAC-DR

    Science.gov (United States)

    Allan, Alasdair; Jenness, Tim; Economou, Frossie; Currie, Malcolm J.; Bly, Martin J.

    A generic data reduction pipeline is, perhaps, the holy grail for data reduction software. We present work which sets us firmly on the path towards this goal. ORAC-DR is an online data reduction pipeline written by the Joint Astronomy Center (JAC) and the UK Astronomy Technology Center (ATC) and distributed as part of the Starlink Software collection (SSC). It is intended to run with a minimum of observer interaction, and is able to handle data from many different instruments, including SCUBA, CGS4, UFTI, IRCAM and Michelle, with support for IRIS2 and UIST under development. Recent work by Starlink in collaboration with the JAC has resulted in an increase in the pipeline's flexibility, opening up the possibility that it could be used for truly generic data reduction for data from any imaging, and eventually spectroscopic, detector.

  20. Towards Generic Models of Player Experience

    DEFF Research Database (Denmark)

    Shaker, Noor; Shaker, Mohammad; Abou-Zleikha, Mohamed

    2015-01-01

    further examine whether generic features of player be- haviour can be defined and used to boost the modelling per- formance. The accuracies obtained in both experiments in- dicate a promise for the proposed approach and suggest that game-independent player experience models can be built.......-dependent and their applicability is usually limited to the system and the data used for model construction. Establishing models of user experience that are highly scalable while maintaing the performance constitutes an important research direction. In this paper, we propose generic models of user experience in the computer games...... domain. We employ two datasets collected from players in- teractions with two games from different genres where accu- rate models of players experience were previously built. We take the approach one step further by investigating the mod- elling mechanism ability to generalise over the two datasets. We...

  1. Unsteady Pressures on a Generic Capsule Shape

    Science.gov (United States)

    Burnside, Nathan; Ross, James C.

    2015-01-01

    While developing the aerodynamic database for the Orion spacecraft, the low-speed flight regime (transonic and below) proved to be the most difficult to predict and measure accurately. The flow over the capsule heat shield in descent flight was particularly troublesome for both computational and experimental efforts due to its unsteady nature and uncertainty about the boundary layer state. The data described here were acquired as part of a study to improve the understanding of the overall flow around a generic capsule. The unsteady pressure measurements acquired on a generic capsule shape are presented along with a discussion about the effects of various flight conditions and heat-shield surface roughness on the resulting pressure fluctuations.

  2. 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 supp......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...

  3. Generic Structure Potential of Christian Apologetics

    Directory of Open Access Journals (Sweden)

    Onwu Inya

    2012-01-01

    Full Text Available Religious texts have been examined by scholars from different theoretical standpoints. However, a close survey of the literature reveals that little attention has been paid to Christian apologetics from a linguistic perspective. Also, an examination of studies along the lines of Generic Structure Potential (henceforth GSP shows that the genre status of Christian apologetics has not been indicated. This gap provides the motivation for this paper, which investigates the GSP of Christian apologetics. Twenty texts written by various key contemporary apologetic writers were purposively selected for the study. The following generic structure potential catalogue was generated:The paper reveals that the elements of the GSP concertedly work to advance, argue for or defend the Christian belief system. The paper also suggests that the model could be applied to other forms of apologetic instances.

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

    Science.gov (United States)

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

    2017-03-01

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

  5. Safety culture

    Energy Technology Data Exchange (ETDEWEB)

    Keen, L.J. [Canadian Nuclear Safety Commission, Ottawa, Ontario (Canada)

    2003-07-01

    Safety culture has become a topic of increasing interest for industry and regulators as issues are raised on safety problems around the world. The keys to safety culture are organizational effectiveness, effective communications, organizational learning, and a culture that encourages the identification and resolution of safety issues. The necessity of a strong safety culture places an onus on all of us to continually question whether the safety measures already in place are sufficient, and are being applied. (author)

  6. Superrosy dependent groups having finitely satisfiable generics

    CERN Document Server

    Ealy, Clifton; Pillay, Anand

    2007-01-01

    We study a model theoretic context (finite thorn rank, NIP, with finitely satisfiable generics) which is a common generalization of groups of finite Morley rank and definably compact groups in o-minimal structures. We show that assuming thorn rank 1, the group is abelian-by-finite, and assuming thorn rank 2 the group is solvable by finite. Also a field is algebraically closed.

  7. Generic drugs: myths, facts, and limitations

    OpenAIRE

    Antonio Marzo; Elisabetta Porro; Anna Barassi

    2012-01-01

    Bioequivalence (BE) has always been an important pharmaceutical area, particularly (but not solely) in Mediterranean region, where the use of generic drugs is a relatively recent development. The lack of new therapeutic molecules has concentrated primary research in the hands of a few large pharmaceutical companies. For smaller companies, this has created opportunities for the development of new formulations of existing drugs (orodispersible tablets that dissolve in the mouth, extended-releas...

  8. Molten salts processes and generic simulation

    Energy Technology Data Exchange (ETDEWEB)

    Ogawa, Toru; Minato, Kazuo [Japan Atomic Energy Research Inst., Tokai, Ibaraki (Japan). Tokai Research Establishment

    2001-12-01

    Development of dry separation process (pyrochemical process) using molten salts for the application of spent-nuclear fuel reprocessing requires a rather complete fundamental database as well as process simulation technique with wide applicability. The present report concerns recent progress and problems in this field taking behaviors of co-electrodeposition of UO{sub 2} and PuO{sub 2} in molten salts as an example, and using analytical simulation of local equilibrium combined with generic diffusion. (S. Ohno)

  9. The generic model of General Relativity

    Energy Technology Data Exchange (ETDEWEB)

    Tsamparlis, Michael, E-mail: mtsampa@phys.uoa.g [Department of Physics, Section Astrophysics Astronomy Mechanics, University of Athens, University of Athens, Zografos 15783, Athens (Greece)

    2009-10-01

    We develop a generic spacetime model in General Relativity from which all existing model results are produced under specific assumptions, depending on the case. We classify each type of possible assumption, especially the role of observers and that of symmetries, and discuss their role in the development of a model. We apply the results in a step by step approach to the case of a Bianchi I spacetime and a string fluid.

  10. Does Reduction of Number of Intradetrusor Injection Sites of aboBoNTA (Dysport® Impact Efficacy and Safety in a Rat Model of Neurogenic Detrusor Overactivity?

    Directory of Open Access Journals (Sweden)

    Amélie Huynh Le Maux

    2015-12-01

    Full Text Available Intradetrusor injections of Botulinum toxin A—currently onabotulinumtoxinA—is registered as a second-line treatment to treat neurogenic detrusor overactivity (NDO. The common clinical practice is 30 × 1 mL injections in the detrusor; however, protocols remain variable and standardization is warranted. The effect of reducing the number of injection sites of Dysport® abobotulinumtoxinA (aboBoNTA was assessed in the spinal cord-injured rat (SCI. Nineteen days post-spinalization, female rats received intradetrusor injections of saline or aboBoNTA 22.5 U distributed among four or eight sites. Two days after injection, continuous cystometry was performed in conscious rats. Efficacy of aboBoNTA 22.5 U was assessed versus aggregated saline groups on clinically-relevant parameters: maximal pressure, bladder capacity, compliance, voiding efficiency, as well as amplitude, frequency, and volume threshold for nonvoiding contractions (NVC. AboBoNTA 22.5 U significantly decreased maximal pressure, without affecting voiding efficiency. Injected in four sites, aboBoNTA significantly increased bladder capacity and compliance while only the latter when in eight sites. AboBoNTA significantly reduced NVC frequency and amplitude. This preclinical investigation showed similar inhibiting effects of aboBoNTA despite the number of sites reduction. Further studies are warranted to optimize dosing schemes to improve the risk-benefit ratio of BoNTA-based treatment modalities for NDO and further idiopathic overactive bladder.

  11. Does Reduction of Number of Intradetrusor Injection Sites of aboBoNTA (Dysport®) Impact Efficacy and Safety in a Rat Model of Neurogenic Detrusor Overactivity?

    Science.gov (United States)

    Huynh Le Maux, Amélie; Pignol, Bernadette; Behr-Roussel, Delphine; Blachon, Jean-Luc; Chabrier, Pierre-Etienne; Compagnie, Sandrine; Picaut, Philippe; Bernabé, Jacques; Giuliano, François; Denys, Pierre

    2015-01-01

    Intradetrusor injections of Botulinum toxin A—currently onabotulinumtoxinA—is registered as a second-line treatment to treat neurogenic detrusor overactivity (NDO). The common clinical practice is 30 × 1 mL injections in the detrusor; however, protocols remain variable and standardization is warranted. The effect of reducing the number of injection sites of Dysport® abobotulinumtoxinA (aboBoNTA) was assessed in the spinal cord-injured rat (SCI). Nineteen days post-spinalization, female rats received intradetrusor injections of saline or aboBoNTA 22.5 U distributed among four or eight sites. Two days after injection, continuous cystometry was performed in conscious rats. Efficacy of aboBoNTA 22.5 U was assessed versus aggregated saline groups on clinically-relevant parameters: maximal pressure, bladder capacity, compliance, voiding efficiency, as well as amplitude, frequency, and volume threshold for nonvoiding contractions (NVC). AboBoNTA 22.5 U significantly decreased maximal pressure, without affecting voiding efficiency. Injected in four sites, aboBoNTA significantly increased bladder capacity and compliance while only the latter when in eight sites. AboBoNTA significantly reduced NVC frequency and amplitude. This preclinical investigation showed similar inhibiting effects of aboBoNTA despite the number of sites reduction. Further studies are warranted to optimize dosing schemes to improve the risk-benefit ratio of BoNTA-based treatment modalities for NDO and further idiopathic overactive bladder. PMID:26694464

  12. Generic superweak chaos induced by Hall effect.

    Science.gov (United States)

    Ben-Harush, Moti; Dana, Itzhack

    2016-05-01

    We introduce and study the "kicked Hall system" (KHS), i.e., charged particles periodically kicked in the presence of uniform magnetic (B) and electric (E) fields that are perpendicular to each other and to the kicking direction. We show that for resonant values of B and E and in the weak-chaos regime of sufficiently small nonintegrability parameter κ (the kicking strength), there exists a generic family of periodic kicking potentials for which the Hall effect from B and E significantly suppresses the weak chaos, replacing it by "superweak" chaos (SWC). This means that the system behaves as if the kicking strength were κ^{2} rather than κ. For E=0, SWC is known to be a classical fingerprint of quantum antiresonance, but it occurs under much less generic conditions, in particular only for very special kicking potentials. Manifestations of SWC are a decrease in the instability of periodic orbits and a narrowing of the chaotic layers, relative to the ordinary weak-chaos case. Also, for global SWC, taking place on an infinite "stochastic web" in phase space, the chaotic diffusion on the web is much slower than the weak-chaos one. Thus, the Hall effect can be relatively stabilizing for small κ. In some special cases, the effect is shown to cause ballistic motion for almost all parameter values. The generic global SWC on stochastic webs in the KHS appears to be the two-dimensional closest analog to the Arnol'd web in higher dimensional systems.

  13. 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.

  14. Bioequivalence study designs for generic solid oral anticancer drug products: scientific and regulatory considerations.

    Science.gov (United States)

    Kaur, Paramjeet; Chaurasia, Chandra S; Davit, Barbara M; Conner, Dale P

    2013-12-01

    The demonstration of bioequivalence (BE) between the test and reference products is an integral part of generic drug approval process. A sound BE study design is pivotal to the successful demonstration of BE of generic drugs to their corresponding reference listed drug product. Generally, BE of systemically acting oral dosage forms is demonstrated in a crossover, single-dose in vivo study in healthy subjects. The determination of BE of solid oral anticancer drug products is associated with its own unique challenges due to the serious safety risks involved. Unlike typical BE study in healthy subjects, the safety issues often necessitate conducting BE studies in cancer patients. Such BE studies of an anticancer drug should be conducted without disturbing the patients' therapeutic dosing regimen. Attributes such as drug permeability and solubility, pharmacokinetics, dosing regimen, and approved therapeutic indication(s) are considered in the BE study design of solid anticancer drug products. To streamline the drug approval process, the Division of Bioequivalence posts the Bioequivalence Recommendations for Specific Products guidances on the FDA public website. The objective of this article is to illustrate the scientific and regulatory considerations in the design of BE studies for generic solid oral anticancer drug products through examples.

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

    Science.gov (United States)

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

    2005-01-01

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

  16. A multi-site comparison of in vivo safety pharmacology studies conducted to support ICH S7A & B regulatory submissions.

    Science.gov (United States)

    Ewart, Lorna; Milne, Aileen; Adkins, Debbie; Benjamin, Amanda; Bialecki, Russell; Chen, Yafei; Ericsson, Ann-Christin; Gardner, Stacey; Grant, Claire; Lengel, David; Lindgren, Silvana; Lowing, Sarah; Marks, Louise; Moors, Jackie; Oldman, Karen; Pietras, Mark; Prior, Helen; Punton, James; Redfern, Will S; Salmond, Ross; Skinner, Matt; Some, Margareta; Stanton, Andrea; Swedberg, Michael; Finch, John; Valentin, Jean-Pierre

    2013-01-01

    Parts A and B of the ICH S7 guidelines on safety pharmacology describe the in vivo studies that must be conducted prior to first time in man administration of any new pharmaceutical. ICH S7A requires a consideration of the sensitivity and reproducibility of the test systems used. This could encompass maintaining a dataset of historical pre-dose values, power analyses, as well as a demonstration of acceptable model sensitivity and robust pharmacological validation. During the process of outsourcing safety pharmacology studies to Charles River Laboratories, AstraZeneca set out to ensure that models were performed identically in each facility and saw this as an opportunity to review the inter-laboratory variability of these essential models. The five in vivo studies outsourced were the conscious dog telemetry model for cardiovascular assessment, the rat whole body plethysmography model for respiratory assessment, the rat modified Irwin screen for central nervous system assessment, the rat charcoal meal study for gastrointestinal assessment and the rat metabolic cage study for assessment of renal function. Each study was validated with known reference compounds and data were compared across facilities. Statistical power was also calculated for each model. The results obtained indicated that each of the studies could be performed with comparable statistical power and could achieve a similar outcome, independent of facility. The consistency of results obtained from these models across multiple facilities was high thus providing confidence that the models can be run in different facilities and maintain compliance with ICH S7A and B. Copyright © 2013 Elsevier Inc. All rights reserved.

  17. Patient safety culture lives in departments and wards: Multilevel partitioning of variance in patient safety culture

    OpenAIRE

    Hofoss Dag; Deilkås Ellen

    2010-01-01

    Abstract Background Aim of study was to document 1) that patient safety culture scores vary considerably by hospital department and ward, and 2) that much of the variation is across the lowest level organizational units: the wards. Setting of study: 500-bed Norwegian university hospital, September-December 2006. Methods Data collected from 1400 staff by (the Norwegian version of) the generic version of the Safety Attitudes Questionnaire (SAQ Short Form 2006). Multilevel analysis by MLwiN vers...

  18. 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.

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

    Science.gov (United States)

    Gyawali, Sudesh; Hassali, Mohamed Azmi; Saha, Archana

    2016-01-01

    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. PMID:27551423

  20. Groundwater flow modeling of periods with periglacial and glacial climate conditions for the safety assessment of the proposed high-level nuclear waste repository site at Forsmark, Sweden

    Science.gov (United States)

    Vidstrand, Patrik; Follin, Sven; Selroos, Jan-Olof; Näslund, Jens-Ove

    2014-09-01

    The impact of periglacial and glacial climate conditions on groundwater flow in fractured crystalline rock is studied by means of groundwater flow modeling of the Forsmark site, which was recently proposed as a repository site for the disposal of spent high-level nuclear fuel in Sweden. The employed model uses a thermal-hydraulically coupled approach for permafrost modeling and discusses changes in groundwater flow implied by the climate conditions found over northern Europe at different times during the last glacial cycle (Weichselian glaciation). It is concluded that discharge of particles released at repository depth occurs very close to the ice-sheet margin in the absence of permafrost. If permafrost is included, the greater part discharges into taliks in the periglacial area. During a glacial cycle, hydraulic gradients at repository depth reach their maximum values when the ice-sheet margin passes over the site; at this time, also, the interface between fresh and saline waters is distorted the most. The combined effect of advances and retreats during several glaciations has not been studied in the present work; however, the results indicate that hydrochemical conditions at depth in the groundwater flow model are almost restored after a single event of ice-sheet advance and retreat.

  1. 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

  2. What Is the Future of Generics in Transplantation?

    Science.gov (United States)

    van Gelder, Teun

    2015-11-01

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

  3. Generic hierarchical engine for mask data preparation

    Science.gov (United States)

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

    2002-07-01

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

  4. Generic device controller for accelerator control systems

    Energy Technology Data Exchange (ETDEWEB)

    Mariotti, R.; Buxton, W.; Frankel, R.; Hoff, L.

    1987-01-01

    A new distributed intelligence control system has become operational at the AGS for transport, injection, and acceleration of heavy ions. A brief description of the functionality of the physical devices making up the system is given. An attempt has been made to integrate the devices for accelerator specific interfacing into a standard microprocessor system, namely, the Universal Device Controller (UDC). The main goals for such a generic device controller are to provide: local computing power; flexibility to configure; and real time event handling. The UDC assemblies and software are described. (LEW)

  5. A Generic Design Model for Evolutionary Algorithms

    Institute of Scientific and Technical Information of China (English)

    He Feng; Kang Li-shan; Chen Yu-ping

    2003-01-01

    A generic design model for evolutionary algo rithms is proposed in this paper. The model, which was described by UML in details, focuses on the key concepts and mechanisms in evolutionary algorithms. The model not only achieves separation of concerns and encapsulation of implementations by classification and abstraction of those concepts,it also has a flexible architecture due to the application of design patterns. As a result, the model is reusable, extendible,easy to understand, easy to use, and easy to test. A large number of experiments applying the model to solve many different problems adequately illustrate the generality and effectivity of the model.

  6. [Generic and biosimilar drug substitution: a panacea?].

    Science.gov (United States)

    Daly, M J; Guignard, B; Nendaz, M

    2015-10-14

    Drugs are the third largest source of expenditure under Switzerland's compulsory basic health insurance. Generics, the price of which should be at least 30 per cent less than the cost of the original drugs, can potentially allow substantial savings. Their approval requires bioequivalence studies and their use is safe, although some factors may influence patients' and physicians' acceptance. The increased substitution of biosimilar drugs for more expensive biotech drugs should allow further cost savings. In an attempt to extend the monopoly granted by the original drug patent, some pharmaceutical companies implement "evergreening" strategies including small modifications of the original substance for which the clinical benefit is not always demonstrated.

  7. Static aeroelastic analysis for generic configuration wing

    Science.gov (United States)

    Lee, IN; Miura, Hirokazu; Chargin, Mladen K.

    1991-01-01

    A static aeroelastic analysis capability that calculates flexible air loads for generic configuration wings was developed. It was made possible by integrating a finite element structural analysis code (MSC/NASTRAN) and a panel code of aerodynamic analysis based on linear potential flow theory. The framework already built in MSC/NASTRAN was used, and the aerodynamic influence coefficient matrix was computed externally and inserted in the NASTRAN by means of a DMAP program. It was shown that deformation and flexible air loads of an oblique wing configuration including asymmetric wings can be calculated reliably by this code both in subsonic and supersonic speeds.

  8. Holographic entanglement entropy on generic time slices

    Science.gov (United States)

    Kusuki, Yuya; Takayanagi, Tadashi; Umemoto, Koji

    2017-06-01

    We study the holographic entanglement entropy and mutual information for Lorentz boosted subsystems. In holographic CFTs at zero and finite temperature, we find that the mutual information gets divergent in a universal way when the end points of two subsystems are light-like separated. In Lifshitz and hyperscaling violating geometries dual to non-relativistic theories, we show that the holographic entanglement entropy is not well-defined for Lorentz boosted subsystems in general. This strongly suggests that in non-relativistic theories, we cannot make a real space factorization of the Hilbert space on a generic time slice except the constant time slice, as opposed to relativistic field theories.

  9. Generalized Hausdorff measure for generic compact sets

    CERN Document Server

    Balka, Richárd

    2012-01-01

    Let $X$ be a Polish space. We prove that the generic compact set $K\\subseteq X$ (in the sense of Baire category) is either finite or there is a continuous gauge function $h$ such that $0<\\mathcal{H}^{h}(K)<\\infty$, where $\\mathcal{H}^h$ denotes the $h$-Hausdorff measure. This answers a question of C. Cabrelli, U. B. Darji, and U. M. Molter. Moreover, for every weak contraction $f\\colon K\\to X$ we have $\\mathcal{H}^{h} (K\\cap f(K))=0$. This is a measure theoretic analogue of a result of M. Elekes.

  10. Commercial Generic Bioprocessing Apparatus Science Insert - 03

    Science.gov (United States)

    Moreno, Nancy; Stodieck, Louis; Cushing, Paula; Stowe, Mark; Hamilton, Mary Ann; Werner, Ken

    2008-01-01

    Commercial Generic Bioprocessing Apparatus Science Insert - 03 (CSI-03) is the third set of investigations in the CSI program series. The CSI program provides the K-12 community opportunities to utilize the unique microgravity environment of the International Space Station as part of the regular classroom to encourage learning and interest in science, technology, engineering and math. CSI-03 will examine the complete life cycle of the painted lady butterfly and the ability of an orb weaving spider to spin a web, eat and remain healthy in space.

  11. Developing A Generic Optical Avionic Network

    DEFF Research Database (Denmark)

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

    2011-01-01

    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......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...... by such a network. Finally, three redundancy scenarios are discussed and compared....

  12. Generic 'du' in time and context

    DEFF Research Database (Denmark)

    Jensen, Torben Juel

    2017-01-01

    speakers, and that variation also prevails within a micro-diachronic perspective (between conversations recorded within a few months, and even within the same conversation). The results emphasise that great caution should be exercised when taking the difference between two pieces of attested language use......This article considers the way individual speakers respond to a macro-level process of language change: an increased use of the second-person pronoun du for generic reference. Real time panel studies show that life span change is much more common than is often assumed, particularly among adult...

  13. Generic Wing-Body Aerodynamics Data Base

    Science.gov (United States)

    Holst, Terry L.; Olsen, Thomas H.; Kwak, Dochan (Technical Monitor)

    2001-01-01

    The wing-body aerodynamics data base consists of a series of CFD (Computational Fluid Dynamics) simulations about a generic wing body configuration consisting of a ogive-circular-cylinder fuselage and a simple symmetric wing mid-mounted on the fuselage. Solutions have been obtained for Nonlinear Potential (P), Euler (E) and Navier-Stokes (N) solvers over a range of subsonic and transonic Mach numbers and angles of attack. In addition, each solution has been computed on a series of grids, coarse, medium and fine to permit an assessment of grid refinement errors.

  14. Generic Interfaces for Managing Web Data

    Directory of Open Access Journals (Sweden)

    Oleg Burlaca

    2005-05-01

    Full Text Available This paper discusses a generic user interface for managing web data that is incorporated in a content management system. The interface is created at run-time from a set of XML documents stored in database. We accentuate the importance of content analysis phase that leads to a well formed data model. Another important aspect is the use of context in the interface and the hierarchical model to represent multiple relationships between hierarchy items. The proposed event model acts like a glue between data management and application logic.

  15. A Generic Middleware Model for Smart Home

    Directory of Open Access Journals (Sweden)

    Madhusudanan J.

    2014-07-01

    Full Text Available A Smart Home is an emerging technology, where the electronic devices are controlled automatically based on the occupants activities. The pervasive computing plays a vital role in the smart home environment, which provides the computer-based service to human beings anywhere and anytime. However, when discussing smart home of the future, related studies have focused on providing middleware. The middleware acts as a interface between human beings and the smart devices. In this paper, we have proposed a generic middleware model for smart home that enables interaction between human being and devices and also between various devices based on the context identified in the environment.

  16. Modelling of Generic Slung Load System

    DEFF Research Database (Denmark)

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

    2006-01-01

    of Least Constraint using the Udwadia-Kalaba equation and can be used to model all body to body slung load suspension types. The model gives an intuitive and easy-to-use way of modelling and simulating di erent slung load suspension types and it includes detection and response of wire slacking......This paper presents the result of 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 Principle...

  17. 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...

  18. Conversion to generic cyclosporine A in stable chronic patients after heart transplantation

    Directory of Open Access Journals (Sweden)

    Kraeuter M

    2013-11-01

    in chronic and stable HTx patients demonstrated no statistically significant differences in the CSA DNL after a conversion to generic CSA (Equoral. The generic CSA was generally well-tolerated. We concluded that a conversion from Neoral to Equoral is safe and clinically feasible in this distinct patient population. However, multiple switches between different generic immunosuppressants must especially be avoided in the interest of patient safety, and close follow-up examinations must be warranted. Keywords: heart transplantation, immunosuppression, generic cyclosporine A

  19. A Methodological Framework for Software Safety in Safety Critical Computer Systems

    Directory of Open Access Journals (Sweden)

    P. V. Srinivas Acharyulu

    2012-01-01

    Full Text Available Software safety must deal with the principles of safety management, safety engineering and software engineering for developing safety-critical computer systems, with the target of making the system safe, risk-free and fail-safe in addition to provide a clarified differentaition for assessing and evaluating the risk, with the principles of software risk management. Problem statement: Prevailing software quality models, standards were not subsisting in adequately addressing the software safety issues for real-time safety-critical embedded systems. At present no standard framework does exist addressing the safety management and safety engineering priniciples for the development of software safety in safety-critical computer systems. Approach: In this study we propose a methodological framework involving safety management practices, safety engineering practices and software development life cycle phases for the development of software safety. In this framework we make use of the safety management practices such as planning, defining priniciples, fixing responsibilities, creteria and targets, risk assessment, design for safety, formulating safety requirements and integrating skills and techniques to address safety issues early with a vision for assurance and so on. In this framework we have also analysed integration of applicability of generic industrial heirarchy and software development heirarchy, with derived cyclical review involving safety professionals generating a nodal point for software safety. Results: This framework is applied to safety-critical software based laboratory prototype Railroad Crossing Control System (RCCS with a limited complexity. The results have shown that all critical operations were safe and risk free. Conclusion: The development of software based on the proposed framework for RCCS have shown a clarified and improved safety-critical operations of the overall system peformance.

  20. Can Chronic Pain Patients Be Adequately Treated Using Generic Pain Medications to the Exclusion of Brand-Name Ones?

    Science.gov (United States)

    Candido, Kenneth D; Chiweshe, Joseph; Anantamongkol, Utchariya; Knezevic, Nebojsa Nick

    2016-01-01

    According to the Food and Drug Administration (FDA) reports, approximately 8 in 10 prescriptions filled in the United States are for generic medications, with an expectation that this number will increase over the next few years. The impetus for this emphasis on generics is the cost disparity between them and brand-name products. The use of FDA-approved generic drugs saved 158 billion dollars in 2010 alone. In the current health care climate, there is continually increasing pressure for prescribers to write for generic alternative medications, occasionally at the expense of best clinical practices. This creates a conflict wherein both physicians and patients may find brand-name medications clinically superior but nevertheless choose generic ones. The issue of generic versus brand medications is a key component of the discussion of health payers, physicians and their patients. This review evaluates some of the important medications in the armamentarium of pain physicians that are frequently used in the management of chronic pain, and that are currently at the forefront of this issue, including Opana (oxymorphone; Endo Pharmaceuticals, Inc., Malvern, PA), Gralise (gabapentin; Depomed, Newark, CA), and Horizant (gabapentin enacarbil; XenoPort, Santa Clara, CA) that are each available in generic forms as well. We also discuss the use of Lyrica (pregabalin; Pfizer, New York, NY), which is currently unavailable as generic medication, and Cymbalta (duloxetine; Eli Lilly, Indianapolis, IN), which has been recently FDA approved to be available in a generic form. It is clear that the use of generic medications results in large financial savings for the cost of prescriptions on a national scale. However, cost-analysis is only part of the equation when treating chronic pain patients and undervalues the relationships of enhanced compliance due to single-daily dosing and stable and reliable pharmacokinetics associated with extended-duration preparations using either retentive

  1. THERAPEUTIC EQUIVALENCE OF ORIGINAL CLOPIDOGREL (PLAVIX AND ITS GENERIC (EGITROMB. RESULTS OF COMPARATIVE RANDOMIZED CROSS-OVER BLIND STUDY

    Directory of Open Access Journals (Sweden)

    V. V. Yakusevich

    2011-01-01

    Full Text Available Aim. To study therapeutic equivalence (efficacy, safety and tolerability of original clopidogrel (Plavix and its generic (Egitromb in patients of high cardiovascular risk. Material and methods. Thirty one patients with coronary heart disease and indications for clopidogrel therapy were involved into the randomized cross-over blind study. Half of the patients received original clopidogrel (75 mg daily during the first 2 weeks and then they received generic clopidogrel in the same dose during next 2 weeks. Another half of the patients received the drugs in reverse order. Antiplatelet activity of Plavix and Egitromb was estimated by effects on ADP-induced platelet aggregation initially and after 2 weeks of treatment with each drug. Study blinding was provided by the following approach: doctors of cardiology clinic performed clinical monitoring and drug distribution; coded blood samples for platelet aggregation assessment were studied in independent laboratory of thrombosis; statistical data analysis was performed by biostatistics expert in other research center. Results. 2-week therapy with each drug led to a significant decrease of ADP-induced platelet aggregation which remained low after switching from original drug to generic and vice versa. Aggregation dynamics did not depend on the first administered drug. There were no significant differences between aggregation changes as a result of treatment with original or generic drug. No one adverse event was observed in association with both drugs therapy. Conclusion. Generic drug Egitromb (Egis, Hungary and original clopidogrel Plavix (Sanofi-Aventis, France have equivalent antiplatelet effect.

  2. [(3) H]-L685,458 binding sites are abundant in multiple peripheral organs in rats: implications for safety assessment of putative γ-secretase targeting drugs.

    Science.gov (United States)

    Yang, Zhi-Ying; Li, Jian-Ming; Xiao, Ling; Mou, Lin; Cai, Yan; Huang, He; Luo, Xue-Gang; Yan, Xiao-Xin

    2014-12-01

    γ-Secretase is a multimeric enzyme complex that carries out proteolytic processing to a variety of cellular proteins. It is currently explored as a therapeutic target for Alzheimer's disease (AD) and cancer. Mechanism-based toxicity needs to be thoroughly evaluated for γ-secretase inhibitory and/or modulatory drugs. This study comparatively assessed putative γ-secretase catalytic sites in rat peripheral tissues relative to brain and explored an effort of its pharmacological inhibition on hair regeneration. Using [(3) H]-labelled L685,458, a potent γ-secretase inhibitor, as probe, we found more abundant presence of γ-secretase binding sites in the liver, gastrointestinal tract, hair follicle, pituitary gland, ovary and testis, as compared to the brain. Local application of L658,458 delayed vibrissal regrowth following whisker removal. These results suggest that γ-secretase may execute important biological functions in many peripheral systems, as in the brain. The development of γ-secretase inhibitors/modulators for AD and cancer therapy should include close monitoring of toxicological panels for hepatic, gastrointestinal, endocrinal and reproductive functions.

  3. Radionuclide transport behavior in a generic geological radioactive waste repository.

    Science.gov (United States)

    Bianchi, Marco; Liu, Hui-Hai; Birkholzer, Jens T

    2015-01-01

    We performed numerical simulations of groundwater flow and radionuclide transport to study the influence of several factors, including the ambient hydraulic gradient, groundwater pressure anomalies, and the properties of the excavation damaged zone (EDZ), on the prevailing transport mechanism (i.e., advection or molecular diffusion) in a generic nuclear waste repository within a clay-rich geological formation. By comparing simulation results, we show that the EDZ plays a major role as a preferential flowpath for radionuclide transport. When the EDZ is not taken into account, transport is dominated by molecular diffusion in almost the totality of the simulated domain, and transport velocity is about 40% slower. Modeling results also show that a reduction in hydraulic gradient leads to a greater predominance of diffusive transport, slowing down radionuclide transport by about 30% with respect to a scenario assuming a unit gradient. In addition, inward flow caused by negative pressure anomalies in the clay-rich formation further reduces transport velocity, enhancing the ability of the geological barrier to contain the radioactive waste. On the other hand, local high gradients associated with positive pressure anomalies can speed up radionuclide transport with respect to steady-state flow systems having the same regional hydraulic gradients. Transport behavior was also found to be sensitive to both geometrical and hydrogeological parameters of the EDZ. Results from this work can provide useful knowledge toward correctly assessing the post-closure safety of a geological disposal system. © 2014, National Ground Water Association.

  4. Generic Dynamic Environment Perception Using Smart Mobile Devices.

    Science.gov (United States)

    Danescu, Radu; Itu, Razvan; Petrovai, Andra

    2016-10-17

    The driving environment is complex and dynamic, and the attention of the driver is continuously challenged, therefore computer based assistance achieved by processing image and sensor data may increase traffic safety. While active sensors and stereovision have the advantage of obtaining 3D data directly, monocular vision is easy to set up, and can benefit from the increasing computational power of smart mobile devices, and from the fact that almost all of them come with an embedded camera. Several driving assistance application are available for mobile devices, but they are mostly targeted for simple scenarios and a limited range of obstacle shapes and poses. This paper presents a technique for generic, shape independent real-time obstacle detection for mobile devices, based on a dynamic, free form 3D representation of the environment: the particle based occupancy grid. Images acquired in real time from the smart mobile device's camera are processed by removing the perspective effect and segmenting the resulted bird-eye view image to identify candidate obstacle areas, which are then used to update the occupancy grid. The occupancy grid tracked cells are grouped into obstacles depicted as cuboids having position, size, orientation and speed. The easy to set up system is able to reliably detect most obstacles in urban traffic, and its measurement accuracy is comparable to a stereovision system.

  5. 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...... substitutable drug. Data were linked with a prescription database. Results We found no associations between generic substitution and, respectively, gender, age, drug group and polypharmacy. Earlier switches of the index drug are statistically significant associated with acceptance of generic substitution...... generics in the antiepileptic and antidepressant groups (antiepileptics OR 0.37 and antidepressants OR 0.53). Conclusion We did not find any patient-related factors associated with generic substitution; however, patients who have once experienced a generic substitution with a specific drug are more likely...

  6. [Strategies for pharmaceutical research and development. II. Generic drugs].

    Science.gov (United States)

    Kuchar, M

    1996-07-01

    When the patent protection is terminated, the original registered-mark preparation becomes a generic drug, which results in a decrease in its price as compared with the original pharmaceutical. The effects of changes in price relation are discussed from the viewpoint of the generic firms and the manufacturers of original preparations. The differences in the insurance system and legislative regulations of the registration of generic preparations can markedly the size influence of the share of generic drugs in the total consumption of drugs. The future development of generic drugs from a general viewpoint is discussed in relation to the contemporary extensive expiration of patent protection of drugs. The hitherto results are summed up and the topics for the present strategy of the development of generic drugs in the Research Institute for Pharmacy and Biochemistry, or in the Czech Republic, respectively are discussed.

  7. Individual differences in children's and parents' generic language.

    Science.gov (United States)

    Gelman, Susan A; Ware, Elizabeth A; Kleinberg, Felicia; Manczak, Erika M; Stilwell, Sarah M

    2014-01-01

    Generics ("Dogs bark") convey important information about categories and facilitate children's learning. Two studies with parents and their 2- or 4-year-old children (N = 104 dyads) examined whether individual differences in generic language use are as follows: (a) stable over time, contexts, and domains, and (b) linked to conceptual factors. For both children and parents, individual differences in rate of generic production were stable across time, contexts, and domains, and parents' generic usage significantly correlated with that of their own children. Furthermore, parents' essentialist beliefs correlated with their own and their children's rates of generic frequency. These results indicate that generic language use exhibits substantial stability and may reflect individual differences in speakers' conceptual attitudes toward categories. © 2013 The Authors. Child Development © 2013 Society for Research in Child Development, Inc.

  8. The generic danger and the idiosyncratic support

    Science.gov (United States)

    Temme, Arnaud; Nijp, Jelmer; van der Meij, Marijn; Samia, Jalal; Masselink, Rens

    2016-04-01

    This contribution argues two main points. First, that generic landscapes used in some modelling studies sometimes have properties or cause simulation results that are unrealistic. Such initially flat or straight-sloped landscapes, sometimes with minor random perturbations, e.g. form the backdrop for ecological simulations of vegetation growth and competition that predict catastrophic shifts. Exploratory results for semi-arid systems suggest that the results based on these generic landscapes are end-members from a distribution of results, rather than an unbiased, typical outcome. Apparently, the desire to avoid idiosyncrasy has unintended consequences. Second, we argue and illustrate that in fact new insights often come from close inspection of idiosyncratic case studies. Our examples from landslide systems, connectivity and soil formation show how a central role for the case study - either in empirical work or to provide model targets - has advanced our understanding. Both points contribute to the conclusion that it is dangerous to forget about annoying, small-scale, idiosyncratic and, indeed, perhaps bad-ass case studies in Earth Sciences.

  9. MULTITASKS-GENERIC PLATFORM VIA WSN

    Directory of Open Access Journals (Sweden)

    Mahmoud Mezghani

    2011-08-01

    Full Text Available In recent years, the use of wireless sensor network invade various areas (domotic/home automationfields, medical, industrial …, which sets up several applications such as control of energy consumptionin the habitat, home entertainment system, security system of the intelligent home, health care, … Eachapplication employed its own platform what restore the system very complex. For thus and in this paper,we proposed only one platform for all applications, that’s qualified to generate endless tasks. It coversmany commands developed with a generic remote control interface created by C# language. This genericinterface is very adaptable & adjusts oneself to TinyOS operating system requirements and able to beaccessed via Internet using 6LoWPAN protocol. Validate the proper operation of this generic platformmulti-tasking is approved on several levels:at the implementation of a proposed solution to control energy consumption in the smart home which thesuggested solution is based on the techniques of scheduling under constraints of resources; at theautomation of habitat and in the overall context of the intelligent home and the other to improve thequality of life and make it more comfortable ;across of the practical assistance and to set monitoring ofthe patient and to keep track of his statement by the doctor and that, whether at home or in the route tothe hospital or in the hospital.

  10. A Generic Hybrid Encryption System (HES

    Directory of Open Access Journals (Sweden)

    Ijaz Ali Shoukat

    2013-03-01

    Full Text Available This study proposes a Generic Hybrid Encryption System (HES under mutual committee of symmetric and asymmetric cryptosystems. Asymmetric (public key Cryptosystems associates several performance issues like computational incompetence, memory wastages, energy consumptions and employment limitations on bulky data sets but they are quite secure and reliable in key exchange over insecure remote communication channels. Symmetric (private key cryptosystems are 100 times out performed, having no such issues but they cannot fulfill non-repudiation, false modifications in secret key, fake modifications in cipher text and origin authentication of both parties while exchanging information. These contradictory issues can be omitted by utilizing hybrid encryption mechanisms (symmetric+asymmetric to get optimal benefits of both schemes. Several hybrid mechanisms are available with different logics but our logic differs in infrastructural design, simplicity, computational efficiency and security as compared to prior hybrid encryption schemes. Some prior schemes are either diversified in performance aspects, customer satisfaction, memory utilization or energy consumptions and some are vulnerable against forgery and password guessing (session key recovery attacks. We have done some functional and design related changes in existing Public Key Infrastructure (PKI to achieve simplicity, optimal privacy and more customer satisfaction by providing Hybrid Encryption System (HES that is able to fulfill all set of standardized security constraints. No such PKI based generic hybrid encryption scheme persists as we have provided in order to manage all these kinds of discussed issues.

  11. Analytical Analysis of Generic Reusabilty: Weyukers Properties

    Directory of Open Access Journals (Sweden)

    Parul Gandhi

    2012-03-01

    Full Text Available Reusability is the key concept in todays software development environment. The concept of reusability can be achieved by Generic programming approach. C++ templates help us to develop generic code which results in reusable software modules and also identify effectiveness of this reuse strategy. Many researchers have already developed various reusability metrics [9] [7]. In this paper we emphasis on evaluating reusability metrics on weyukers set of properties. Weyukers list of properties has always been a point of reference and suggested as a guiding tool in identification of a good complexity measure by several researchers. We have chosen some recently reported reusability metrics Method Template Inheritance Factor (MTIF and Attribute Template Inheritance factor (ATIF and evaluated them against Weyukers set of principles. We divide our work in a two-step framework. In the first step the metrics are analytically evaluated against a formal list of Weyukers properties and in the second step we calculate LOC metric value by using three different programs designed using template and inheritance features of object-oriented programming and observe that by using template with inheritance property we can reduce number of lines of a project to a great extent.

  12. A Fast Generic Sequence Matching Algorithm

    CERN Document Server

    Musser, David R

    2008-01-01

    A string matching -- and more generally, sequence matching -- algorithm is presented that has a linear worst-case computing time bound, a low worst-case bound on the number of comparisons (2n), and sublinear average-case behavior that is better than that of the fastest versions of the Boyer-Moore algorithm. The algorithm retains its efficiency advantages in a wide variety of sequence matching problems of practical interest, including traditional string matching; large-alphabet problems (as in Unicode strings); and small-alphabet, long-pattern problems (as in DNA searches). Since it is expressed as a generic algorithm for searching in sequences over an arbitrary type T, it is well suited for use in generic software libraries such as the C++ Standard Template Library. The algorithm was obtained by adding to the Knuth-Morris-Pratt algorithm one of the pattern-shifting techniques from the Boyer-Moore algorithm, with provision for use of hashing in this technique. In situations in which a hash function or random a...

  13. USE OF AN EQUILIBRIUM MODEL TO FORECAST DISSOLUTION EFFECTIVENESS, SAFETY IMPACTS, AND DOWNSTREAM PROCESSABILITY FROM OXALIC ACID AIDED SLUDGE REMOVAL IN SAVANNAH RIVER SITE HIGH LEVEL WASTE TANKS 1-15

    Energy Technology Data Exchange (ETDEWEB)

    KETUSKY, EDWARD

    2005-10-31

    This thesis details a graduate research effort written to fulfill the Magister of Technologiae in Chemical Engineering requirements at the University of South Africa. The research evaluates the ability of equilibrium based software to forecast dissolution, evaluate safety impacts, and determine downstream processability changes associated with using oxalic acid solutions to dissolve sludge heels in Savannah River Site High Level Waste (HLW) Tanks 1-15. First, a dissolution model is constructed and validated. Coupled with a model, a material balance determines the fate of hypothetical worst-case sludge in the treatment and neutralization tanks during each chemical adjustment. Although sludge is dissolved, after neutralization more is created within HLW. An energy balance determines overpressurization and overheating to be unlikely. Corrosion induced hydrogen may overwhelm the purge ventilation. Limiting the heel volume treated/acid added and processing the solids through vitrification is preferred and should not significantly increase the number of glass canisters.

  14. The impact of web-based and face-to-face simulation on patient deterioration and patient safety: protocol for a multi-site multi-method design.

    Science.gov (United States)

    Cooper, Simon J; Kinsman, Leigh; Chung, Catherine; Cant, Robyn; Boyle, Jayne; Bull, Loretta; Cameron, Amanda; Connell, Cliff; Kim, Jeong-Ah; McInnes, Denise; McKay, Angela; Nankervis, Katrina; Penz, Erika; Rotter, Thomas

    2016-09-07

    There are international concerns in relation to the management of patient deterioration which has led to a body of evidence known as the 'failure to rescue' literature. Nursing staff are known to miss cues of deterioration and often fail to call for assistance. Medical Emergency Teams (Rapid Response Teams) do improve the management of acutely deteriorating patients, but first responders need the requisite skills to impact on patient safety. In this study we aim to address these issues in a mixed methods interventional trial with the objective of measuring and comparing the cost and clinical impact of face-to-face and web-based simulation programs on the management of patient deterioration and related patient outcomes. The education programs, known as 'FIRST(2)ACT', have been found to have an impact on education and will be tested in four hospitals in the State of Victoria, Australia. Nursing staff will be trained in primary (the first 8 min) responses to emergencies in two medical wards using a face-to-face approach and in two medical wards using a web-based version FIRST(2)ACTWeb. The impact of these interventions will be determined through quantitative and qualitative approaches, cost analyses and patient notes review (time series analyses) to measure quality of care and patient outcomes. In this 18 month study it is hypothesised that both simulation programs will improve the detection and management of deteriorating patients but that the web-based program will have lower total costs. The study will also add to our overall understanding of the utility of simulation approaches in the preparation of nurses working in hospital wards. (ACTRN12616000468426, retrospectively registered 8.4.2016).

  15. The future of generic HIV drugs in Rhode Island.

    Science.gov (United States)

    Lee, Jennifer Y; Reece, Rebecca; Montague, Brian; Rana, Aadia; Alexander-Scott, Nicole; Flanigan, Timothy

    2013-09-06

    The number of HIV-infected persons in the United States continues to increase and most patients with HIV will be on antiretroviral therapy (ART) for many decades. The introduction of generic antiretroviral medications has the potential for significant cost savings which may then be accompanied by improved access. State AIDS Drug Assistance Programs will be made more effective by the switch to generic ARTs. Cost savings and barriers to the introduction of generic ART are discussed.

  16. Bioequivalence studies: need for the reability of generic drugs

    OpenAIRE

    Laosa, Olga; Centro de Farmacología Clínica, Departamento de Farmacología y Terapéutica, Facultad de Medicina, Universidad Autónoma de Madrid. Madrid, España. Médico especialista en Farmacología Clínica.; Guerra, Pedro; Centro de Farmacología Clínica, Departamento de Farmacología y Terapéutica, Facultad de Medicina, Universidad Autónoma de Madrid. Madrid, España. Médico especialista en Farmacología Clínica.; López-Durán, Jose Luis; Centro de Farmacología Clínica, Departamento de Farmacología y Terapéutica, Facultad de Medicina, Universidad Autónoma de Madrid. Madrid, España. Médico especialista en Farmacología Clínica.; Mosquera, Beatriz; Centro de Farmacología Clínica, Departamento de Farmacología y Terapéutica, Facultad de Medicina, Universidad Autónoma de Madrid. Madrid, España. Licenciada en Ciencias Químicas.; Frías, Jesús; Centro de Farmacología Clínica, Departamento de Farmacología y Terapéutica, Facultad de Medicina, Universidad Autónoma de Madrid. Madrid, España. Servicio de Farmacología Clínica, Hospital Universitario la Paz. Madrid, España. Médico especialista en Farmacología Clínica.

    2009-01-01

    A generic medicine is a pharmaceutical product containing an active ingredient already known and previously developed and invented by others. The cost of these generic or multisource products should be less than their counterparts original. The clinical effects and the risk-benefit balance of a medicine do not depend exclusively on the activity of a pharmacologically active substance. Demonstration of bioequivalence of generic medicine is of great importance. In Europe and the United States g...

  17. Bioequivalence studies: need for the reability of generic drugs

    OpenAIRE

    Laosa, Olga; Centro de Farmacología Clínica, Departamento de Farmacología y Terapéutica, Facultad de Medicina, Universidad Autónoma de Madrid. Madrid, España. Médico especialista en Farmacología Clínica.; Guerra, Pedro; Centro de Farmacología Clínica, Departamento de Farmacología y Terapéutica, Facultad de Medicina, Universidad Autónoma de Madrid. Madrid, España. Médico especialista en Farmacología Clínica.; López-Durán, Jose Luis; Centro de Farmacología Clínica, Departamento de Farmacología y Terapéutica, Facultad de Medicina, Universidad Autónoma de Madrid. Madrid, España. Médico especialista en Farmacología Clínica.; Mosquera, Beatriz; Centro de Farmacología Clínica, Departamento de Farmacología y Terapéutica, Facultad de Medicina, Universidad Autónoma de Madrid. Madrid, España. Licenciada en Ciencias Químicas.; Frías, Jesús; Centro de Farmacología Clínica, Departamento de Farmacología y Terapéutica, Facultad de Medicina, Universidad Autónoma de Madrid. Madrid, España. Servicio de Farmacología Clínica, Hospital Universitario la Paz. Madrid, España. Médico especialista en Farmacología Clínica.

    2009-01-01

    A generic medicine is a pharmaceutical product containing an active ingredient already known and previously developed and invented by others. The cost of these generic or multisource products should be less than their counterparts original. The clinical effects and the risk-benefit balance of a medicine do not depend exclusively on the activity of a pharmacologically active substance. Demonstration of bioequivalence of generic medicine is of great importance. In Europe and the United States g...

  18. Geochemical analysis of the sealing system. Technical Report to work package 9.1.2. Preliminary safety case of the Gorleben site (VSG)

    Energy Technology Data Exchange (ETDEWEB)

    Xie, Mingliang; Herbert, Horst-Juergen

    2012-02-15

    The geochemical reaction simulation of ground water and brines with sealing materials for a proposed repository at the Gorleben site is a task under the framework of the VSG project. The calculations presented in this report are aimed to provide a preliminary evaluation of the geochemical stability of three potential engineering barrier materials foreseen in the shaft sealing system in case of groundwater and brine intrusion. The long-term stability of these materials is a key issue for the sealing function of the shaft seals. This is governed by many factors such as geotechnical, hydraulic and geochemical processes. In order to better understand the potential effect of geochemical processes on the long-term properties of these sealing materials, geochemical simulations of the potential interactions between groundwater and brine and shaft sealing materials were performed.

  19. Scientific opinion addressing the safety assessment of plants developed using Zinc Finger Nuclease 3 and other Site-Directed Nucleases with similar function

    Directory of Open Access Journals (Sweden)

    EFSA Panel on Genetically Modified Organisms (GMO

    2012-10-01

    Full Text Available

    The European Commission requested that the EFSA Panel on Genetically Modified Organisms deliver a scientific opinion related to risk assessment of plants developed using the zinc finger nuclease 3 technique (ZFN-3 which allows the integration of gene(s in a predefined insertion site in the genome of the recipient species. Since other nucleases with a similar function to ZFN are considered in this opinion the term site-directed nuclease 3 (SDN-3 is used to describe the technique rather than ZFN-3 specifically. The EFSA GMO Panel considers that its guidance documents are applicable for the evaluation of food and feed products derived from plants developed using the SDN-3 technique and for performing an environmental risk assessment. However, on a case-by-case basis lesser amounts of event specific data may be needed for the risk assessment of plants developed using the SDN-3 technique. The EFSA GMO Panel compared the hazards associated with plants produced by the SDN-3 technique with those obtained by conventional plant breeding techniques and by currently used transgenesis. With respect to the genes introduced, the SDN-3 technique does not differ from transgenesis or from the other genetic modification techniques currently used, and can be used to introduce transgenes, intragenes or cisgenes. The main difference between the SDN-3 technique and transgenesis is that the insertion of DNA is targeted to a predefined region of the genome. Therefore, the SDN-3 technique can minimise hazards associated with the disruption of genes and/or regulatory elements in the recipient genome. Whilst the SDN-3 technique can induce off-target changes in the genome of the recipient plant these would be fewer than those occurring with most mutagenesis techniques. Furthermore, where such changes occur they would be of the same types as those produced by conventional breeding techniques.

  20. A randomized study of the relative pharmacokinetics, pharmacodynamics, and safety of alirocumab, a fully human monoclonal antibody to PCSK9, after single subcutaneous administration at three different injection sites in healthy subjects.

    Science.gov (United States)

    Lunven, Catherine; Paehler, Tobias; Poitiers, Franck; Brunet, Aurélie; Rey, Jacques; Hanotin, Corinne; Sasiela, William J

    2014-12-01

    We investigated the relative pharmacokinetics, pharmacodynamics, and safety of the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor alirocumab following injection at three different sites. Sixty healthy subjects (39 male, 21 female; age 20-45 years) were randomized to receive a single subcutaneous injection of alirocumab 75 mg via 1-mL prefilled pen into the abdomen, upper arm, or thigh (NCT01785329). Subjects were followed for 85 days ± 2 days following study drug administration. Pharmacokinetic (PK) parameters for the systemic exposure of alirocumab were calculated, and levels of free PCSK9 were assessed. Percentage changes from baseline in LDL-C were compared between injection site groups using linear mixed-effects models. Alirocumab concentration-time profiles were similar, and free PCSK9 levels were reduced to approximately zero between Day 3 and Day 4 postinjection in all groups. LDL-C levels reached nadir on Day 15 postinjection in all groups with mean percentage reductions of 48.4% (abdomen), 39.5% (upper arm), and 45.6% (thigh) at this time point. A similar effect on LDL-C levels was seen across the entire time course of the study at all three injection sites. Treatment-emergent adverse events were experienced by 8/20 (abdomen), 11/20 (upper arm), and 13/20 (thigh) subjects. There were 2 mild/transient injection site reactions. There were no serious adverse events. A single subcutaneous administration of alirocumab 75 mg via prefilled pen was well tolerated with similar pharmacokinetics and pharmacodynamics when injected into the abdomen, upper arm, or thigh. These results suggest that alirocumab can be interchangeably injected in the abdomen, upper arm, or thigh. © 2014 Sanofi and Regeneron Pharmaceuticals Inc. Cardiovascular Therapeutics published by John Wiley & Sons Ltd.

  1. Associations between generic substitution and patient-related factors

    DEFF Research Database (Denmark)

    Østergaard Rathe, Jette

    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...... was made on beliefs about medicine, views on generic medicine and confidence in the health care system. The study comprised 2476 patients (736 users of antidepressants, 795 users of antiepileptics and 945 users of other substitutable drugs). For each patient we focused on one purchase of a generically...

  2. Generic medicine pricing in Europe: current issues and future perspective.

    Science.gov (United States)

    Simoens, Steven

    2008-01-01

    This editorial discusses a number of trends affecting the pricing of generic medicines in Europe. With respect to pricing, recent evidence has emerged that European generic medicine manufacturers face competition from Indian manufacturers; that the price level of generic medicines varies substantially between European countries; and that generic medicine manufacturers engage in competition by discount rather than price competition in France, The Netherlands and the UK. These trends suggest that there may be scope for further reducing the prices of generic medicines in several countries. In relation to reference pricing, most European countries have incorporated market incentives within reference pricing systems with a view to promoting price competition. The European experience indicates that the generic medicines industry delivers competitive prices under a reference pricing system if demand-side policies are in place that stimulate physicians, pharmacists and patients to use generic medicines. Finally, caution needs to be exercised when focusing on the drivers of generic medicine pricing as these drivers not only vary between countries, but may also vary within a country. Manufacturers of originator and generic medicines do not take a single pricing approach following patent expiry, but vary their pricing strategy from molecule to molecule.

  3. 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.

  4. 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....

  5. Pharmacy and generic substitution of antiepileptic drugs: missing in action?

    Science.gov (United States)

    Welty, Timothy E

    2007-06-01

    Generic substitution of antiepileptic drugs is an issue that is gathering a lot of attention in the neurology community but is not receiving much attention within pharmacy. Several proposals have been drafted that restrict a pharmacist's decision-making in generic substitution. These proposals highlight concerns about the pharmacy community related to generic substitution. Careful consideration needs to be given to these issues by pharmacists and pharmacy professional organizations. Unless pharmacy as a profession takes strong positions in support of a pharmacist's ability to make decisions about pharmacotherapy and addresses many of the pharmacy-related problems of generic substitution, policies that negatively impact pharmacy will be established.

  6. A generic method for evaluating crowding in the emergency department

    DEFF Research Database (Denmark)

    Eiset, Andreas Halgreen; Erlandsen, Mogens; Møllekær, Anders Brøns;

    2016-01-01

    Background Crowding in the emergency department (ED) has been studied intensively using complicated non-generic methods that may prove difficult to implement in a clinical setting. This study sought to develop a generic method to describe and analyse crowding from measurements readily available......, a ‘carry over’ effect was shown between shifts and days. Conclusions The presented method offers an easy and generic way to get detailed insight into the dynamics of crowding in an ED. Keywords Crowding, Emergency department, ED, Generic, Method, Model, Queue, Patient flow...

  7. Generic trajectory representation and trajectory following for wheeled robots

    DEFF Research Database (Denmark)

    Kjærgaard, Morten; Andersen, Nils Axel; Ravn, Ole

    2014-01-01

    This article presents the work towards a purely generic navigation solution for wheeled mobile robots motivated by the following goals: Generic: Works for different types of robots. Configurable: Parameters maps to geometric properties of the robot. Predictable: Well defined where the robot...... will drive. Safe: Avoid fatal collisions. Based on a survey of existing methods and algorithms the article presents a generic way to represent constraints for different types of robots, a generic way to represent trajectories using Bëzier curves, a method to convert the trajectory so it can be driven...

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

    Science.gov (United States)

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

    2011-01-01

    The push-pull framework was developed in hopes that an infrastructure would be created that could literally connect to any given remote site, and (given a set of restrictions) download files from that remote site based on those restrictions. The Cataloging and Archiving Service (CAS) has recently been re-architected and re-factored in its canonical services, including file management, workflow management, and resource management. Additionally, a generic CAS Crawling Framework was built based on motivation from Apache s open-source search engine project called Nutch. Nutch is an Apache effort to provide search engine services (akin to Google), including crawling, parsing, content analysis, and indexing. It has produced several stable software releases, and is currently used in production services at companies such as Yahoo, and at NASA's Planetary Data System. The CAS Crawling Framework supports many of the Nutch Crawler's generic services, including metadata extraction, crawling, and ingestion. However, one service that was not ported over from Nutch is a generic protocol layer service that allows the Nutch crawler to obtain content using protocol plug-ins that download content using implementations of remote protocols, such as HTTP, FTP, WinNT file system, HTTPS, etc. Such a generic protocol layer would greatly aid in the CAS Crawling Framework, as the layer would allow the framework to generically obtain content (i.e., data products) from remote sites using protocols such as FTP and others. Augmented with this capability, the Orbiting Carbon Observatory (OCO) and NPP (NPOESS Preparatory Project) Sounder PEATE (Product Evaluation and Analysis Tools Elements) would be provided with an infrastructure to support generic FTP-based pull access to remote data products, obviating the need for any specialized software outside of the context of their existing process control systems. This extensible configurable framework was created in Java, and allows the use of

  9. Road safety in practice

    CERN Multimedia

    2003-01-01

    On the 23 and 25 September come and test your driving skills and your reflexes on the two days of road safety in practice! To conclude the poster and article campaign on this topic which started last year, CERN now comes to the practical part with demonstrations, like a spectacular overturning test, information stands, where you can meet safety personnel from France, Switzerland and CERN, and discussions & debates. Come to ... ... the Meyrin site on 23 September: - From 8:30 hrs, stands and demonstrations on the parking site Cèdres, behind the Restaurant no. 1. - From 9:30 hrs, discussions and debates in the main auditorium. ... the Prévessin site on 25 September: - From 8:30 hrs, stands and demonstrations on the parking site of the building 866. - From 14:00 hrs, discussions and debates in the AB auditorium, building 864.

  10. Hand Safety

    Science.gov (United States)

    ... Gardening Safety Turkey Carving Removing a Ring Español Artritis de la base del pulgar Dedo en gatillo ... Gardening Safety Turkey Carving Removing a Ring Español Artritis de la base del pulgar Dedo en gatillo ...

  11. Water Safety

    Science.gov (United States)

    ... Old Feeding Your 1- to 2-Year-Old Water Safety KidsHealth > For Parents > Water Safety Print A ... best measure of protection. previous continue Making Kids Water Wise It's important to teach your kids proper ...

  12. SAFETY FIRST

    Institute of Scientific and Technical Information of China (English)

    2007-01-01

    Ensuring safety while peacefully utilizing nuclear energy is a top priority for China A fter a recent earthquake in Japan caused radioactive leaks at a nuclear power plant in Tokyo, the safety of nuclear energy has again aroused public attention.

  13. Safety Plan

    Data.gov (United States)

    US Fish and Wildlife Service, Department of the Interior — The Swan Lake National Wildlife Refuge Safety Plan discusses policies for the safety of the station employees, volunteers, and public. This plan seeks to identify...

  14. 基于6 SIGMA理论的建筑施工现场安全管理方法%Safety Management on Construction Site Based on Six SIGMA Theory

    Institute of Scientific and Technical Information of China (English)

    刘辉; 周芸竹; 周恩

    2013-01-01

    In order to improve the level of safety management on construction site, the six SIGMA management theory was adopted. The kind of high falling accident on construction site was taken as the topic for study. A DMAIC model was built for the kind of accident. The fusion of six SIGMA method and construction safety management was studied from five aspects including selecting topic and defining for project, measure, analysis, improvement and control. Then the key factors were identified by using the fishbone diagram and FMEA. The results show that operation time and season (X1 ) , construction safety laws and regulations system (X2), the relevant technical requirements of scaffold (X3) and weather conditions such as strong winds, thick fog, rain and snow (X4) are four key factors causing high falling accident. Based on the analysis results, specific improvement schemes were proposed for the 4 key factors.%为提高建筑施工企业的现场作业安全管理水平,针对建筑施工现场事故高发的特点,将6 SIGMA管理理论应用于安全管理研究.以建筑施工高处坠落事故为研究对象.建立高处坠落事故DMAIC模型.从项目选题与定义、测量、分析、改进和控制5个环节,研究6 SIGMA管理方法和建筑施工安全管理的融合.利用鱼刺图和故障类型影响分析,找出其关键影响因素.研究结果表明,作业时间与季节(X1),建筑安全法规体系(X2),脚手架相关技术要求(X3)及强风、浓雾、雨雪等天气情况(X4)是导致建筑施工高处坠落事故的4个关键影响因素.在此基础上,提出改进方案.

  15. A deformable generic 3D model of haptoral anchor of Monogenean.

    Directory of Open Access Journals (Sweden)

    Bee Guan Teo

    Full Text Available In this paper, a digital 3D model which allows for visualisation in three dimensions and interactive manipulation is explored as a tool to help us understand the structural morphology and elucidate the functions of morphological structures of fragile microorganisms which defy live studies. We developed a deformable generic 3D model of haptoral anchor of dactylogyridean monogeneans that can subsequently be deformed into different desired anchor shapes by using direct manipulation deformation technique. We used point primitives to construct the rectangular building blocks to develop our deformable 3D model. Point primitives are manually marked on a 2D illustration of an anchor on a Cartesian graph paper and a set of Cartesian coordinates for each point primitive is manually extracted from the graph paper. A Python script is then written in Blender to construct 3D rectangular building blocks based on the Cartesian coordinates. The rectangular building blocks are stacked on top or by the side of each other following their respective Cartesian coordinates of point primitive. More point primitives are added at the sites in the 3D model where more structural variations are likely to occur, in order to generate complex anchor structures. We used Catmull-Clark subdivision surface modifier to smoothen the surface and edge of the generic 3D model to obtain a smoother and more natural 3D shape and antialiasing option to reduce the jagged edges of the 3D model. This deformable generic 3D model can be deformed into different desired 3D anchor shapes through direct manipulation deformation technique by aligning the vertices (pilot points of the newly developed deformable generic 3D model onto the 2D illustrations of the desired shapes and moving the vertices until the desire 3D shapes are formed. In this generic 3D model all the vertices present are deployed for displacement during deformation.

  16. Early Site Permit Demonstration Program: Siting Guide, Site selection and evaluation criteria for an early site permit application. Revision 1

    Energy Technology Data Exchange (ETDEWEB)

    1993-03-24

    In August 1991, the Joint Contractors came to agreement with Sandia National Laboratories (SNL) and the Department of Energy (DOE) on a workscope for the cost-shared Early Site Permit Demonstration Program. One task within the scope was the development of a guide for site selection criteria and procedures. A generic Siting Guide his been prepared that is a roadmap and tool for applicants to use developing detailed siting plans for their specific region of the country. The guide presents three fundamental principles that, if used, ensure a high degree of success for an ESP applicant. First, the site selection process should take into consideration environmentally diverse site locations within a given region of interest. Second, the process should contain appropriate opportunities for input from the public. Third, the process should be applied so that it is clearly reasonable to an impartial observer, based on appropriately selected criteria, including criteria which demonstrate that the site can host an advanced light water reactor (ALWR). The Siting Guide provides for a systematic, comprehensive site selection process in which three basic types of criteria (exclusionary, avoidance, and suitability) are presented via a four-step procedure. It provides a check list of the criteria for each one of these steps. Criteria are applied qualitatively, as well as presented numerically, within the guide. The applicant should use the generic guide as an exhaustive checklist, customizing the guide to his individual situation.

  17. Modeling generic aspects of ideal fibril formation

    CERN Document Server

    Michel, Denis

    2016-01-01

    Many different proteins self-aggregate into insoluble fibrils growing apically by reversible addition of elementary building blocks. But beyond this common principle, the modalities of fibril formation are very disparate, with various intermediate forms which can be reshuffled by minor modifications of physico-chemical conditions or amino-acid sequences. To bypass this complexity, the multifaceted phenomenon of fibril formation is reduced here to its most elementary principles defined for a linear prototype of fibril. Selected generic features, including nucleation, elongation and conformational recruitment, are modeled using minimalist hypotheses and tools, by separating equilibrium from kinetic aspects and in vitro from in vivo conditions. These reductionist approaches allow to bring out known and new rudiments, including the kinetic and equilibrium effects of nucleation, the dual influence of elongation on nucleation, the kinetic limitations on nucleation and fibril numbers and the accumulation of complexe...

  18. Making sense of a generic label

    DEFF Research Database (Denmark)

    Lassen, Inger

    2016-01-01

    Making sense of a generic label through linguistic context analysis: A study of genre (re)cognition among novices’ Considerable work has been done on written and spoken genres characterized by a high degree of ritualization with “predictable elements occurring in a predictable order” (Fairclough...... (Bhatia 2008) assist the analytical process? Inspired by Sommers and Saltz (2004), Bhatia (2008) and Tardy (2009), these research questions will be addressed on the basis of 55 exam papers written in January 2014 by 3rd year undergraduate students. The exam tested students’ competences in genre......) that the students had studied during the course leading up to the exam. Given the lack of situated cognition (Bawarshi and Reiff, 2010: 79) of one of these genres, the students were requested to produce arguments and justification for assigning the genres presented to them to two different genre colonies...

  19. Static aeroelastic analysis for generic configuration aircraft

    Science.gov (United States)

    Lee, IN; Miura, Hirokazu; Chargin, Mladen K.

    1987-01-01

    A static aeroelastic analysis capability that can calculate flexible air loads for generic configuration aircraft was developed. It was made possible by integrating a finite element structural analysis code (MSC/NASTRAN) and a panel code of aerodynamic analysis based on linear potential flow theory. The framework already built in MSC/NASTRAN was used and the aerodynamic influence coefficient matrix is computed externally and inserted in the NASTRAN by means of a DMAP program. It was shown that deformation and flexible airloads of an oblique wing aircraft can be calculated reliably by this code both in subsonic and supersonic speeds. Preliminary results indicating importance of flexibility in calculating air loads for this type of aircraft are presented.

  20. A Generic Solution Approach to Nurse Rostering

    DEFF Research Database (Denmark)

    Hansen, Anders Dohn; Mason, Andrew; Ryan, David

    , which is solved in a branch-and-price framework. Columns of the set partitioning problem are generated dynamically and branch-and-bound is used to enforce integrality. The column generating subproblem is modeled in three stages that utilize the inherent structure of roster-lines. Some important features...... of the implementation are described. The implementation builds on the generic model and hence the program can be setup for any problem that fits the model. The adaption to a new problem is simple, as it requires only the input of a new problem definition. The solution method is internally adjusted according to the new...... definition. In this report, we present two different practical problems along with corresponding solutions. The approach captures all features of each problem and is efficient enough to provide optimal solutions. The solution time is still too large for the method to be immediately applicable in practice...