WorldWideScience

Sample records for generic drugs sparks

  1. Generic Drugs: Questions and Answers

    Science.gov (United States)

    ... Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Drugs Home Drugs Resources for You Information for Consumers (Drugs) Questions & Answers Generic Drugs: Questions & Answers Share Tweet Linkedin Pin it More ...

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

    Science.gov (United States)

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

    2018-01-01

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

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

    Science.gov (United States)

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

    2017-04-01

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

  4. 78 FR 22553 - Generic Drug Facilities, Sites, and Organizations

    Science.gov (United States)

    2013-04-16

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

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

    Science.gov (United States)

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

    2003-01-01

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

  6. South African patient's acceptance of generic drugs

    African Journals Online (AJOL)

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

  7. 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

  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 drug...

  9. [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.

  10. Mixed WTO ruling on generic drug development.

    Science.gov (United States)

    Elliott, R

    2000-01-01

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

  11. Generic drugs: myths, facts, and limitations

    Directory of Open Access Journals (Sweden)

    Antonio Marzo

    2012-10-01

    Full Text Available 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-release tablets, transdermal delivery systems, generic drugs. These applications take advantage of the Abridged New Drug Application (ANDA procedure, which exempts them from a series of expensive investigations and limits the requirement for clinical testing to bioequivalence trials. Since 1991, bioequivalence trials have been regulated by US Food and Drug Administration (FDA and European Medicines Agency (EMA guidelines that provide precise indications on the most specific procedures to be adopted. In spite of these guidelines, however, some aspects of the process have not been fully defined, the most important of which regards the management of endogenous substances. Additional problems are how to manage bioequivalence protocols with drugs that have long half-lives and those whose clearance is characterized by high intrinsic variability. The view that bioequivalence data would be more reliable if they were based on studies in target populations is a myth to be discredited. The present paper reviews issues relative to pharmacokinetics (PK, bioavailability (BA, and bioequivalence, also from an historical viewpoint, and includes a stimulating “questions and answers” section on some key aspects of the bioequivalence of generic drugs.

  12. 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.

  13. Generic Drugs: The Same Medicine for Less Money

    Science.gov (United States)

    ... about brand-name drugs. Resources Consumer Reports Best Buy Drugs can help you find lower-cost generic drugs. ... produced by Consumers Union and Consumer Reports Best Buy Drugs , a public information project supported by grants from ...

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

    Science.gov (United States)

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

    2017-08-04

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

  15. 76 FR 79198 - Generic Drug User Fee; Public Meeting; Correction

    Science.gov (United States)

    2011-12-21

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0381] Generic Drug User Fee; Public Meeting; Correction AGENCY: Food and Drug Administration, HHS. ACTION... meeting entitled ``Generic Drug User Fee.'' The document published with an inadvertent error in the Dates...

  16. 77 FR 60125 - Generic Drug Facilities, Sites and Organizations

    Science.gov (United States)

    2012-10-02

    ...] Generic Drug Facilities, Sites and Organizations AGENCY: Food and Drug Administration, HHS. ACTION: Notice..., and certain sites and organizations identified in a generic drug submission, that they must provide... and Innovation Act (FDASIA). This notice is intended to help organizations ascertain if they need to...

  17. GENERIC DRUG IN GLOBAL MARKET AND REGULATORY ENVIRONMENT

    OpenAIRE

    Pankaj Kumar*, Bharti Mangla2, Satbir Singh, Arapna Rana

    2017-01-01

    Different regulatory authorities regulate the drug development in various countries of the world. Various Regulatory authority for generic drug application Food and Drug Administration (FDA), European Medicines Agency (EMA), Pharmaceutical and Medical Devices Agency (PMDA), Health Product and Food Branch (HPFB) Central Drug Standard of Organization (CDSO). Generic manufacturers may file an abbreviated New Drug Application (ANDA) that incorporates the safety/effectiveness data submitted by ori...

  18. The Impact of Information on Doctors’ Attitudes Toward Generic Drugs

    Directory of Open Access Journals (Sweden)

    Aggeliki V. Tsaprantzi MD

    2016-03-01

    Full Text Available The objective of this study is to assess the impact of information on doctors’ attitudes and perceptions toward generics. A cross-sectional survey based on a specially designed 21-item questionnaire was conducted. The survey involved doctors of different specialties working in a public hospital in Greece. The analysis includes descriptive and inferential statistics, reliability and validity tests, as well as structural equation modeling to evaluate the causal model. Statistical analysis was accomplished by using SPSS 20 and Amos 20. A total of 134 questionnaires out of 162 were received, providing a response rate of 82.71%. A number of significant associations were found between information and perceptions about generic medicines with demographic characteristics. It seems that the provision of quality information on generic drugs influences doctors’ attitudes and prescription practices toward generic drugs. This is not a static process but a rather dynamic issue involving information provision policies for strengthening the proper doctors’ attitudes toward generic drugs.

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

    Science.gov (United States)

    Xanthopoulou, Sofia-Sotiria; Katsaliaki, Korina

    2018-01-01

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

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

    Science.gov (United States)

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

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

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

    Science.gov (United States)

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

    2017-04-01

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

  2. [Users sceptical about generic drugs: an anthropological approach].

    Science.gov (United States)

    Sarradon-Eck, A; Blanc, M-A; Faure, M

    2007-06-01

    Since the enactment of the 2002 legislative measures favoring the prescription of generic drugs, various quantitative studies have shown that approval by prescribers and users has risen in France. Nevertheless, scepticism remains as well as distrust towards these drugs focusing on their effectiveness compared with brand-name drugs, on potential dangers, and on the interruption they cause in prescription and consumption habits. Using a comprehensive approach, this article analyzes the social and cultural logic behind the negative image of generic drugs. The materials issued from an ethnographic study on the prescription of drugs for high blood pressure. Sixty-eight interviews were undertaken between April 2002 and October 2004 with people (39 women and 29 men, between the age of 40 and 95, 52 over the age of 60) treated for over a year for high blood pressure in rural areas in the Southeast of France. Thirteen people provided unsolicited opinions about generic drugs. Analysis of the information collected shows that users have various representations of generic drugs, including the idea of counterfeited and foreign drugs. These representations interfere with the adjustment process and the development of consumer loyalty. They are part of a set of social representations about drugs which form and express the user's reality. In these representations, the drug is an ambivalent object, carrier of both biological effectiveness and toxicity; it is also the metonymical extension of the prescriber, bestowing upon the prescription a symbolic value. By placing the generic drug in its network of symbolic and social meaning, this study highlights the coherence of the scepticism towards generic drugs by consumers (and prescribers) with a system of common opinion in which drugs are everyday things, personalized and compatible with users, symbolic exchange carriers in the physician-patient relationship, and in which confidence in the drug is also that given to the health care

  3. [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.

  4. Generic drugs: Review and experiences from South India

    Directory of Open Access Journals (Sweden)

    Philip Mathew

    2015-01-01

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

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

    Science.gov (United States)

    Beecroft, Grahame

    2007-01-01

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

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

    Science.gov (United States)

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

    2013-01-01

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

  7. The generic drug user fee amendments: an economic perspective

    Science.gov (United States)

    Berndt, Ernst R; Murphy, Stephen J

    2018-01-01

    Abstract Since the vast majority of prescription drugs consumed by Americans are off patent (‘generic’), their regulation and supply is of wide interest. We describe events leading up to the US Congress's 2012 passage of the Generic Drug User Fee Amendments (GDUFA I) as part of the Food and Drug Administration Safety and Innovation Act (FDASIA). Under GDUFA I, generic manufacturers agreed to pay approximately $300 million in fees each year of the five-year program. In exchange, the US Food and Drug Administration (FDA) committed to performance goals. We describe GDUFA I’s FDA commitments, provisions, goals, and annual fee structure and compare it to that entailed in the authorization and implementation of GDUFA II on October 1, 2017. We explain how user fees required under GDUFA I erected barriers to entry and created scale and scope economies for incumbent manufacturers. Congress changed user fees under GDUFA II in part to lessen these incentives. In order to initiate and sustain user fees under GDUFA legislation, FDA requires the submission of self-reported data on generic manufacturers including domestic and foreign facilities. These data are public and our examination of them provides an unprecedented window into the recent organization of generic drug manufacturers supplying the US market. Our results suggest that generic drug manufacturing is increasingly concentrated and foreign. We discuss the implications of this observed market structure for GDUFA II’s implementation among other outcomes. PMID:29707218

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

    Science.gov (United States)

    Ross, Malcolm S F

    2010-04-01

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

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

    Science.gov (United States)

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

    2013-10-01

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

  10. Generic legislation of new psychoactive drugs

    NARCIS (Netherlands)

    van Amsterdam, Jan; Nutt, David; van den Brink, Wim

    2013-01-01

    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

  11. Hospitals plan to start their own generic drug company

    Directory of Open Access Journals (Sweden)

    Robbins RA

    2018-01-01

    Full Text Available The New York Times reports that groups representing more than 450 hospitals plan to form their own generic drug company (1. Intermountain Healthcare is leading the collaboration with several other large hospital groups, Ascension, SSM Health and Trinity Health, in consultation with the U.S. Department of Veterans Affairs, to form a not-for-profit drug company. The new firm is looking to create generic versions of about 20 existing drugs that the group says cost too much now or are in short supply. The article did not name the drugs targeted but expects the first of its pharmaceutical products to become available in 2019. Members of the consortium will contribute funds to finance the new drug company.

  12. 77 FR 45629 - Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2013

    Science.gov (United States)

    2012-08-01

    ..., beginning with the letters ``AG'', from the upper right-hand corner of your completed Animal Generic Drug...] Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2013 AGENCY: Food and Drug... payment procedures for fiscal year (FY) 2013 generic new animal drug user fees. The Federal Food, Drug...

  13. Lawsuits allege price fixing by generic drug makers

    Directory of Open Access Journals (Sweden)

    Robbins RA

    2016-12-01

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

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

    Science.gov (United States)

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

    2018-01-01

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

  15. Deeply discounted medications: Implications of generic prescription drug wars.

    Science.gov (United States)

    Czechowski, Jessica L; Tjia, Jennifer; Triller, Darren M

    2010-01-01

    To describe the history of generic prescription pricing programs at major pharmacy chains and their potential implications on prescribing, quality of care, and patient safety. Publicly available generic prescription discount program drug lists as of May 1, 2009. Fierce competition among major pharmacy chains such as Walgreens, CVS, and Walmart has led to a generic prescription pricing war with unclear public health implications. Introduced in 2006, currently 7 of the 10 largest pharmacy chains advertise a version of a deeply discounted medication (DDM) program, accounting for more than 25,000 locations nationally. By early 2008, almost 70 million Americans had used these programs. Although DDM programs lower drug costs for many patients, DDM formularies include potentially ineffective or harmful medications, have the potential to influence physician prescribing behavior, and may impair pharmacists' ability to review complete drug-dispensing records. DDMs are widespread but have the potential for unintended consequences on patients, providers, and the health care system. A systematic review of DDMs needs to evaluate the clinical, economic, and system-level implications of such programs.

  16. Generic versus brand-name drugs used in cardiovascular diseases.

    Science.gov (United States)

    Manzoli, Lamberto; Flacco, Maria Elena; Boccia, Stefania; D'Andrea, Elvira; Panic, Nikola; Marzuillo, Carolina; Siliquini, Roberta; Ricciardi, Walter; Villari, Paolo; Ioannidis, John P A

    2016-04-01

    This meta-analysis aimed to compare the efficacy and adverse events, either serious or mild/moderate, of all generic versus brand-name cardiovascular medicines. We searched randomized trials in MEDLINE, Scopus, EMBASE, Cochrane Controlled Clinical Trial Register, and ClinicalTrials.gov (last update December 1, 2014). Attempts were made to contact the investigators of all potentially eligible trials. Two investigators independently extracted and analyzed soft (including systolic blood pressure, LDL cholesterol, and others) and hard efficacy outcomes (including major cardiovascular adverse events and death), minor/moderate and serious adverse events. We included 74 randomized trials; 53 reported ≥1 efficacy outcome (overall sample 3051), 32 measured mild/moderate adverse events (n = 2407), and 51 evaluated serious adverse events (n = 2892). We included trials assessing ACE inhibitors (n = 12), anticoagulants (n = 5), antiplatelet agents (n = 17), beta-blockers (n = 11), calcium channel blockers (n = 7); diuretics (n = 13); statins (n = 6); and others (n = 3). For both soft and hard efficacy outcomes, 100 % of the trials showed non-significant differences between generic and brand-name drugs. The aggregate effect size was 0.01 (95 % CI -0.05; 0.08) for soft outcomes; -0.06 (-0.71; 0.59) for hard outcomes. All but two trials showed non-significant differences in mild/moderate adverse events, and aggregate effect size was 0.07 (-0.06; 0.20). Comparable results were observed for each drug class and in each stratified meta-analysis. Overall, 8 serious possibly drug-related adverse events were reported: 5/2074 subjects on generics; 3/2076 subjects on brand-name drugs (OR 1.69; 95 % CI 0.40-7.20). This meta-analysis strengthens the evidence for clinical equivalence between brand-name and generic cardiovascular drugs. Physicians could be reassured about prescribing generic cardiovascular drugs, and health care organization about endorsing their wider

  17. Comparison of Outcomes Following a Switch From a Brand to an Authorized Versus Independent Generic Drug.

    Science.gov (United States)

    Hansen, R A; Qian, J; Berg, R L; Linneman, J G; Seoane-Vazquez, E; Dutcher, S; Raofi, S; Page, C D; Peissig, P L

    2018-02-01

    Authorized generics are identical in formulation to brand drugs, manufactured by the brand company but marketed as a generic. Generics, marketed by generic manufacturers, are required to demonstrate pharmaceutical and bioequivalence to the brand drug, but repetition of clinical trials is not required. This retrospective cohort study compared outcomes for generics and authorized generics, which serves as a generic vs. brand proxy that minimizes bias against generics. For the seven drugs studied between 1999 and 2014, 5,234 unique patients were on brand drugs prior to generic entry and 4,900 (93.6%) switched to a generic. During the 12 months following the brand-to-generic switch, patients using generics vs. authorized generics were similar in terms of outpatient visits, urgent care visits, hospitalizations, and medication discontinuation. The likelihood of emergency department (ED) visits was slightly higher for authorized generics compared with generics. These data suggest that generics were clinically no worse than their proxy brand comparators. © 2017 American Society for Clinical Pharmacology and Therapeutics.

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

    Science.gov (United States)

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

    2017-09-01

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

  19. Toward a generic approach for : Stress testing of drug substances and drug products

    NARCIS (Netherlands)

    Klick, Silke; Muijselaar, Pim G.; Waterval, Joop; Eichinger, Thomas; Korn, Christian; Gerding, Thijs K.; Debets, Alexander J.; Sänger-Van De Griend, Cari; Van Den Beld, Cas; Somsen, Govert W.; De Jong, Gerhardus J.

    The Impurity Profiling Group has developed a generic approach for conducting stress testing on drug substances and drug products. The proposed strategy is evaluated and verified with historical data and new experiments. Results demonstrate that the proposed approach is reasonable and generates

  20. 76 FR 44014 - Generic Drug User Fee; Public Meeting; Request for Comments

    Science.gov (United States)

    2011-07-22

    ... generic drug user fees. New legislation would be required for FDA to establish and collect user fees for... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0381] Generic Drug User Fee; Public Meeting; Request for Comments AGENCY: Food and Drug Administration, HHS...

  1. 76 FR 24035 - Generic Drug User Fee; Public Meeting; Request for Comments

    Science.gov (United States)

    2011-04-29

    ... legislation would be required for FDA to establish and collect user fees for generic drugs, and FDA is... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0381] Generic Drug User Fee; Public Meeting; Request for Comments AGENCY: Food and Drug Administration, HHS...

  2. Factors influencing the preference for purchasing generic drugs in a Southern Brazilian city

    Directory of Open Access Journals (Sweden)

    Marília Cruz Guttier

    Full Text Available ABSTRACT OBJECTIVE The objective of this study is to identify factors associated with the preference for purchasing generic drugs in a medium-sized municipality in Southern Brazil. METHODS We have analyzed data from a population-based cross-sectional study conducted in 2012 with a sample of 2,856 adults (≥ 20 years old. The preference for purchasing generic drugs was the main outcome. The explanatory variables were the demographic and socioeconomic variables. Statistical analyses included Poisson regressions. RESULTS The preference for purchasing generic drugs was 63.2% (95%CI 61.4–64.9. The variables correlated with this preference in the fully adjusted models were: male (prevalence ratio [PR] = 1.08; 95%CI 1.03–1.14, age of 20–39 years (PR = 1.10; 95%CI 1.02–1.20, low socioeconomic status (PR = 1.15; 95%CI 1.03–1.28, and good knowledge about generic drugs (PR= 4.66; 95%CI 2.89–7.52. Among those who preferred to purchase generic drugs, 55.1% have reported accepting to replace the prescribed drug (if not a generic with the equivalent generic drug. Another correlate of the preference for purchasing generic drugs was because individuals consider their quality equivalent to reference medicines (PR = 2.15; 95%CI 1.93–2.41. CONCLUSIONS Knowledge about generic drugs was the main correlate of the preference for purchasing generic drugs. The greater the knowledge or positive perception about generic drugs, the greater is the preference to purchase them. Therefore, educational campaigns for healthcare professionals and consumers appear to be the best strategy for expanding the use of generic drugs in Brazil.

  3. Factors influencing the preference for purchasing generic drugs in a Southern Brazilian city.

    Science.gov (United States)

    Guttier, Marília Cruz; Silveira, Marysabel Pinto Telis; Luiza, Vera Lucia; Bertoldi, Andréa Dâmaso

    2017-06-26

    The objective of this study is to identify factors associated with the preference for purchasing generic drugs in a medium-sized municipality in Southern Brazil. We have analyzed data from a population-based cross-sectional study conducted in 2012 with a sample of 2,856 adults (≥ 20 years old). The preference for purchasing generic drugs was the main outcome. The explanatory variables were the demographic and socioeconomic variables. Statistical analyses included Poisson regressions. The preference for purchasing generic drugs was 63.2% (95%CI 61.4-64.9). The variables correlated with this preference in the fully adjusted models were: male (prevalence ratio [PR] = 1.08; 95%CI 1.03-1.14), age of 20-39 years (PR = 1.10; 95%CI 1.02-1.20), low socioeconomic status (PR = 1.15; 95%CI 1.03-1.28), and good knowledge about generic drugs (PR= 4.66; 95%CI 2.89-7.52). Among those who preferred to purchase generic drugs, 55.1% have reported accepting to replace the prescribed drug (if not a generic) with the equivalent generic drug. Another correlate of the preference for purchasing generic drugs was because individuals consider their quality equivalent to reference medicines (PR = 2.15; 95%CI 1.93-2.41). Knowledge about generic drugs was the main correlate of the preference for purchasing generic drugs. The greater the knowledge or positive perception about generic drugs, the greater is the preference to purchase them. Therefore, educational campaigns for healthcare professionals and consumers appear to be the best strategy for expanding the use of generic drugs in Brazil.

  4. Factors affecting the opinions of family physicians regarding generic drugs – a questionnaire based study

    Directory of Open Access Journals (Sweden)

    Pawel Lewek

    2014-12-01

    Full Text Available A range of factors are believed to exert a negative influence on opinions of physicians about generic drugs.The aim of this study was to survey the opinions of primary care doctors on generics, and determine the factors which may affect them. A questionnaire comprising thirty eight questions was distributed among primary care doctors working in seventy out-patient clinics of the Lodzkie province, Poland, during the period of January 1, 2010 – December 31, 2010. A total of170 of 183 participants completed the survey (average age 48.5; 70.0% women: a 92.9%response rate. While 38.8% of physicians claimed that generics were worse than brand name drugs, 54.1% considered them to be better. However, 36.5% of the doctors did not choose generics for their own use. Two key opinions were identified among the responses concerning the effectiveness of generic drugs: use of generic drugs by the physician (p<0.001, and their opinion that pharmacists do inform patients about generic drugs (p<0.05. Although existing evidence confirms that generic and brand name drugs are equally effective, many physicians doubt this, which prevents them from being used as cost effective drug therapy. In order to increase healthcare savings through the use of generics, these factors should be addressed: for example, convincing a physician to adopt generics for personal use may be an efficient way to support more cost effective treatment of his patients.

  5. Comparison of Generic Drug Reviews for Marketing Authorization between Japan and Canada.

    Science.gov (United States)

    Kuribayashi, Ryosuke; Appleton, Scott

    2017-09-01

    Generic drugs are assuming an increasingly important role in sustaining modern healthcare systems, as the cost of healthcare, including drug usage, is gradually expanding around the world. To date, published articles comparing generic drug reviews between different countries are scarce. The objective of this study was to examine generic drug reviews in Japan and Canada. We surveyed generic drug reviews from Japan and Canada and compared the following points: general matter (application types, type of partial change or Supplement to an Abbreviated New Drug Submission, application and approval numbers, review period, application format, review report, responsibility for review), bioequivalence studies for solid oral dosage forms, and bioequivalence guidelines, guidance, or basic principles regarding various dosage forms. This survey described the many similarities and differences in generic drug reviews between the two countries and points that should be improved to promote better generic drug reviews. In particular, regulations for the definition of the same or different active pharmaceutical ingredients (APIs) are similar for both authorities. The results clarified the future challenges of generic drug reviews, and the differences highlighted by this survey will be important considerations for the future. This is the first article to present and discuss the details of generic drug reviews between Japan and Canada.

  6. HIV/AIDS drugs for Sub-Saharan Africa: how do brand and generic supply compare?

    Directory of Open Access Journals (Sweden)

    Colleen V Chien

    Full Text Available BACKGROUND: Significant quantities of antiretroviral drugs (ARVs to treat HIV/AIDS have been procured for Sub-Saharan Africa for the first time in their 20-year history. This presents a novel opportunity to empirically study the roles of brand and generic suppliers in providing access to ARVs. METHODOLOGY/PRINCIPAL FINDINGS: An observational study of brand and generic supply based on a dataset of 2,162 orders of AIDS drugs for Sub-Saharan Africa reported to the Global Price Reporting Mechanism at the World Health Organization from January 2004-March 2006 was performed. Generic companies supplied 63% of the drugs studied, at prices that were on average about a third of the prices charged by brand companies. 96% of the procurement was of first line drugs, which were provided mostly by generic firms, while the remaining 4%, of second line drugs, was sourced primarily from brand companies. 85% of the generic drugs in the sample were manufactured in India, where the majority of the drugs procured were ineligible for patent protection. The remaining 15% was manufactured in South Africa, mostly under voluntary licenses provided by brand companies to a single generic company. In Sub-Saharan African countries, four first line drugs in the dataset were widely patented, however no general deterrent to generic purchasing based on a patent was detected. CONCLUSIONS/SIGNIFICANCE: Generic and brand companies have played distinct roles in increasing the availability of ARVs in Sub-Saharan Africa. Generic companies provided most of the drugs studied, at prices below those charged by brand companies, and until now, almost exclusively supplied several fixed-dose combination drugs. Brand companies have supplied almost all second line drugs, signed voluntary licenses with generic companies, and are not strictly enforcing patents in certain countries. Further investigation into how price reductions in second line drugs can be achieved and the cheapest drugs can

  7. 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.

  8. 76 FR 45814 - Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2012

    Science.gov (United States)

    2011-08-01

    ... . (The Pay.gov payment option is available to you after you submit a cover sheet. Click the ``Pay Now... generic new animal drugs, FDA is assuming that the number of applications that will pay fees in FY 2012... submissions of abbreviated applications for generic new animal drugs is 14.5 per year, which is the average of...

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

    African Journals Online (AJOL)

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

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

    Directory of Open Access Journals (Sweden)

    Varsha Bangalee

    2016-12-01

    Conclusion: Increased generic competition is not a predictor of lower drug prices. The study also concludes that the current South African pharmaceutical policies have not yet achieved the lowest prices for drugs when compared internationally.

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

    Directory of Open Access Journals (Sweden)

    Varsha Bangalee

    2016-10-01

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

  12. Competition in prescription drug markets: the roles of trademarks, advertising, and generic names.

    Science.gov (United States)

    Feldman, Roger; Lobo, Félix

    2013-08-01

    We take on two subjects of controversy among economists-advertising and trademarks-in the context of the market for generic drugs. We outline a model in which trademarks for drug names reduce search costs but increase product differentiation. In this particular framework, trademarks may not benefit consumers. In contrast, the generic names of drugs or "International Nonproprietary Names" (INN) have unquestionable benefits in both economic theory and empirical studies. We offer a second model where advertising of a brand-name drug creates recognition for the generic name. The monopoly patent-holder advertises less than in the absence of a competitive spillover.

  13. 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.

  14. 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.

  15. Factors influencing consumer purchasing patterns of generic versus brand name over-the-counter drugs.

    Science.gov (United States)

    Kohli, Erol; Buller, Allison

    2013-02-01

    US consumers spend more than $20 billion/year on over-the-counter (OTC) drugs. Although generic and brand name OTC drugs share the same active ingredients and undergo the same rigorous Food and Drug Administration approval process, brand name formulations continue to lead the OTC drug market with a higher market share. There is a limited amount of publicly available information regarding consumer perceptions and awareness about generic and brand name OTC drugs. The main objective of this research was to understand what factors influence US consumers to purchase generic versus brand name OTC drugs. The researchers used a 20-question, self-administered, multiple-choice survey to collect data on the factors influencing consumers' preferences for generic versus brand name OTC drugs. Results revealed that the single most influential factor for participants when purchasing OTC drugs was lower cost. Although economic factors play an important role in influencing consumers to choose generic formulations, a variety of other factors including advertisements, duration of the OTC effectiveness, severity of sickness, preferable form of OTC medication, safety of the OTC, relief of multiple symptoms, and preferred company will persuade others to pay more for brand name drugs. Ultimately, increased awareness and use of generic OTC drugs may result in substantial cost savings for consumers.

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

    Science.gov (United States)

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

    2014-04-01

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

  17. 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.

  18. Pharmaceutical quality of docetaxel generics versus originator drug product: a comparative analysis.

    Science.gov (United States)

    Vial, Jérôme; Cohen, Mélanie; Sassiat, Patrick; Thiébaut, Didier

    2008-07-01

    The aim of this study was to evaluate the quality of 31 commercially available generic formulations of docetaxel purchased in 14 countries by comparing their docetaxel content, impurity levels and pH versus those of the proprietary product Taxotere (Tx). Generic formulations were purchased in 14 countries in Asia, Africa, the Middle East and Latin America. Levels of docetaxel and impurities (chromatographic peaks above 0.05%) were obtained for each sample using reverse-phase liquid chromatography with ultraviolet detection. The pH of aqueous solutions of generic docetaxel formulations and Tx was also measured. A global evaluation of quality was conducted on each product using a multicriteria desirability analysis based on standards defined by the International Conference on Harmonisation guidelines and the US Pharmacopeia paclitaxel injection monograph. Most generic formulations contained a lower than expected amount of docetaxel and/or a high level of impurities: 21 generic docetaxel formulations had an average mass of docetaxel that was generic docetaxel formulations had a total impurity content of >3.0%, almost twice the level of impurities in Tx 20 mg. In total, 33 impurities not present in Tx were detected in the generic samples. Desirability analysis demonstrated that none of the generic docetaxel formulations had composition characteristics similar to those of Tx. This study demonstrated that from an analytical point of view, 90% of the generic docetaxel formulations evaluated contained insufficient active drug, high levels of impurities or both. This has the potential to affect both efficacy and safety of the drug.

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

    OpenAIRE

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

    2013-01-01

    Generic drugs are equivalent to the brand formulation if they have the same active substance, the same pharmaceutical form and the same therapeutic indications and a similar bioequivalence respect to the reference medicinal product. The use of generic drugs is indicated from many countries in order to reduce medication price. However some points, such as bioequivalence and the role of excipients, may be clarified regarding the clinical efficacy and safety during the switch from brand to gener...

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

    Science.gov (United States)

    Löfgren, Hans

    2007-06-01

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

  1. Factors influencing anti-asthmatic generic drug consumption in Morocco: 1999-2010.

    Science.gov (United States)

    Ghanname, Imane; Ahid, Samir; Berrada, Ghizlane; Belaiche, Abdelmjid; Hassar, Mohammed; Cherrah, Yahia

    2014-01-01

    The increasing availability of generic drugs (GD) resulted in a remarkable reduction in treatment costs that allowed a better access to health care.The aim of this study is to evaluate the share of anti-asthmatic generic drugs during the period 1999-2010 in Morocco and to look at the factors influencing generic development. In this study, we used Moroccan sales data from IMS Health (Intercontinental Marketing Services). The consumption of the drugs was expressed in DDD/1000 inhabitants/day according to the WHO ATC/DDD methodology. Between 1999 and 2010, anti-asthmatic consumption increased from 3.91 to 14.43 DDD/1000 inhabitants/day. The market of anti-asthmatic generic drugs progressed from 1.83 (47%) to 2.18 (23%) DDD/1000 inhabitants/day from 1999 to 2010. In 2010, inhaled glucocorticosteroids ranked first (0.83 DDD/1000 inhabitants/day), followed by inhaled short acting beta agonists (0.73 DDD/1000 inhabitants/day). The number of brands went from 27 in 1999 to 34 in 2010, with a generic share increasing from 55.55% to 70.59%. The number of anti-asthmatic pharmaceutical preparations increased from 57 to 64 during the same period, of which 31 and 42 were generic preparations. In 2010, the total cost of anti-asthmatic dugs was about 22 million euro, the generics representing 14 million euro. Despite the introduction of a compulsory insurance scheme called "AMO", that allows a refund for 69.5% of anti-asthmatic specialties marketed in Morocco, anti-asthmatic generic drug consumption remains limited. The Moroccan market is still largely dominated by the originator drugs with still valid patents.

  2. Evaluation of the quality and pharmacoeconomics of some generic drugs versus their reputed counterpart brands in the Saudi market

    Directory of Open Access Journals (Sweden)

    Farouk M Sakr

    2016-01-01

    Conclusions: Pharmacopeial examinations showed that generic tablets are quantitatively and qualitatively equivalent to their internationally reputed brands within the tested tablet groups with the advantage for the generic drugs being significantly the cheapest.

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

    Science.gov (United States)

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

    2017-08-01

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

  4. From generic to biosimilar drugs: why take an innovative pace?

    Directory of Open Access Journals (Sweden)

    Fereshteh Barei

    2012-12-01

    Full Text Available BACKGROUND: The transition of the generic/biotechnology industry to innovation by investing in innovative R&D will enhance business expertise in biopharmaceutical development and manufacturing. The major impact of this evolution is on patient access to treatment and savings for the health care systems. OBJECTIVES: The aim of this paper is to investigate the innovative aspect of biosimilar and biobetter products, manufactured by some big generic companies. We will also try to explore the innovative business strategy, implementing this high risk product differentiation policy. METHODS: This qualitative research is conducted by a series of interviews with CEOs, physicians, and academics in different countries. The qualitative data obtained were analyzed by Nvivo9.2 software. A literature review has also contributed to our key findings. RESULTS: The results show that switching into biosimilars/biobetters is an innovative strategic choice, approved by some big generic pharmaceutical companies. The biosimilar/biobetter products can be considered innovative because of their value added quality. CONCLUSION: Expanding the product portfolio to biosimilars/biobetter can be considered as a long run strategy in the innovative business plans aiming to ensure the market access. Patients and their access to better treatments are major components of these innovative business models.

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

    Science.gov (United States)

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

    2017-12-01

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

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

    Science.gov (United States)

    Bloom, Bruce E

    2015-12-01

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

  7. Emerging Technologies and Generic Assays for the Detection of Anti-Drug Antibodies

    Directory of Open Access Journals (Sweden)

    Michael A. Partridge

    2016-01-01

    Full Text Available Anti-drug antibodies induced by biologic therapeutics often impact drug pharmacokinetics, pharmacodynamics response, clinical efficacy, and patient safety. It is critical to assess the immunogenicity risk of potential biotherapeutics in producing neutralizing and nonneutralizing anti-drug antibodies, especially in clinical phases of drug development. Different assay methodologies have been used to detect all anti-drug antibodies, including ELISA, radioimmunoassay, surface plasmon resonance, and electrochemiluminescence-based technologies. The most commonly used method is a bridging assay, performed in an ELISA or on the Meso Scale Discovery platform. In this report, we aim to review the emerging new assay technologies that can complement or address challenges associated with the bridging assay format in screening and confirmation of ADAs. We also summarize generic anti-drug antibody assays that do not require drug-specific reagents for nonclinical studies. These generic assays significantly reduce assay development efforts and, therefore, shorten the assay readiness timeline.

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

    Science.gov (United States)

    Gagnon, Marc-André; Volesky, Karena D

    2017-08-22

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

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

    Science.gov (United States)

    Puig-Junoy, Jaume

    2010-01-01

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

  10. [Intention of purchasing generic prescription drugs on the part of consumers in Asturias, Spain].

    Science.gov (United States)

    González Hernando, Santiago; González Mieres, Celina; Díaz Martín, Ana M

    2003-01-01

    Ascertaining how consumers perceive the risk related to the use of generic prescription drugs and those factors which have the greatest impact on the intention to request a generic drug from the prescribing physician and/or the pharmacist for the purpose of determining any possible barriers or hindrances to the acceptance of generics and to gather information to aid healthcare managers in their decision-making processes. Study on prescription drug use revolving around the degree to which patients are willing to request an EFG. In this quantitative transversal study, a total of 542 individuals were individually surveyed upon exiting a healthcare center or pharmacy in Asturias. A scale for measuring the perceived risk involved in the purchase of a prescription drug including 15 attributes grouped into five aspects was included in the questionnaire. Information was also gathered regarding the intention of using generic prescription drugs and on the demographic and socioeconomic characteristics of those surveyed. For the analysis of the results, a factorial confirmational analysis, multiple regression and univariate analysis were used. The data was processed using the EQS and SPSS statistics programs. Mean perception of the risk (scales 1-7): functional: 2.75; physical: 2.68: financial: 2.19; psychological: 1.99; social: 1.42. Factors having a bearing on the intention of requesting generic prescription drugs from their physician: psychological risk (p = 0.000). On requesting the same from their pharmacist: psychological risk (p = 0.000) and social risk (p = 0.020). The agents interested in the development on the EFG market should target their communication efforts on putting the functional and financial aspects of the manufacturer's specialties and generic specialties on the same level, but should not leave out psychological and social aspects of the consumers' purchasing behavior.

  11. Modeling HIV/AIDS drug price determinants in Brazil: is generic competition a myth?

    Science.gov (United States)

    Meiners, Constance; Sagaon-Teyssier, Luis; Hasenclever, Lia; Moatti, Jean-Paul

    2011-01-01

    Brazil became the first developing country to guarantee free and universal access to HIV/AIDS treatment, with antiretroviral drugs (ARVs) being delivered to nearly 190,000 patients. The analysis of ARV price evolution and market dynamics in Brazil can help anticipate issues soon to afflict other developing countries, as the 2010 revision of the World Health Organization guidelines shifts demand towards more expensive treatments, and, at the same time, current evolution of international legislation and trade agreements on intellectual property rights may reduce availability of generic drugs for HIV care. Our analyses are based on effective prices paid for ARV procurement in Brazil between 1996 and 2009. Data panel structure was exploited to gather ex-ante and ex-post information and address various sources of statistical bias. In-difference estimation offered in-depth information on ARV market characteristics which significantly influence prices. Although overall ARV prices follow a declining trend, changing characteristics in the generic segment help explain recent increase in generic ARV prices. Our results show that generic suppliers are more likely to respond to factors influencing demand size and market competition, while originator suppliers tend to set prices strategically to offset compulsory licensing threats and generic competition. In order to guarantee the long term sustainability of access to antiretroviral treatment, our findings highlight the importance of preserving and stimulating generic market dynamics to sustain developing countries' bargaining power in price negotiations undertaken with originator companies.

  12. Modeling HIV/AIDS drug price determinants in Brazil: is generic competition a myth?

    Directory of Open Access Journals (Sweden)

    Constance Meiners

    Full Text Available BACKGROUND: Brazil became the first developing country to guarantee free and universal access to HIV/AIDS treatment, with antiretroviral drugs (ARVs being delivered to nearly 190,000 patients. The analysis of ARV price evolution and market dynamics in Brazil can help anticipate issues soon to afflict other developing countries, as the 2010 revision of the World Health Organization guidelines shifts demand towards more expensive treatments, and, at the same time, current evolution of international legislation and trade agreements on intellectual property rights may reduce availability of generic drugs for HIV care. METHODS AND FINDINGS: Our analyses are based on effective prices paid for ARV procurement in Brazil between 1996 and 2009. Data panel structure was exploited to gather ex-ante and ex-post information and address various sources of statistical bias. In-difference estimation offered in-depth information on ARV market characteristics which significantly influence prices. Although overall ARV prices follow a declining trend, changing characteristics in the generic segment help explain recent increase in generic ARV prices. Our results show that generic suppliers are more likely to respond to factors influencing demand size and market competition, while originator suppliers tend to set prices strategically to offset compulsory licensing threats and generic competition. SIGNIFICANCE: In order to guarantee the long term sustainability of access to antiretroviral treatment, our findings highlight the importance of preserving and stimulating generic market dynamics to sustain developing countries' bargaining power in price negotiations undertaken with originator companies.

  13. Comparison of brand versus generic antiepileptic drug adverse event reporting rates in the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS).

    Science.gov (United States)

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

    2017-09-01

    Despite the cost saving role of generic anti-epileptic drugs (AEDs), debate exists as to whether generic substitution of branded AEDs may lead to therapeutic failure and increased toxicity. This study compared adverse event (AE) reporting rates for brand vs. authorized generic (AG) vs. generic AEDs. Since AGs are pharmaceutically identical to brand but perceived as generics, the generic vs. AG comparison minimized potential bias against generics. Events reported to the U.S. Food and Drug Administration Adverse Event Reporting System between January 2004 to March 2015 with lamotrigine, carbamazepine, and oxcarbazepine listed as primary or secondary suspect were classified as brand, generic, or AG based on the manufacturer. Disproportionality analyses using the reporting odds ratio (ROR) assessed the relative rate of reporting of labeled AEs compared to reporting these events with all other drugs. The Breslow-Day statistic compared RORs across brand, AG, and other generics using a Bonferroni-corrected Pbrand and generics for all three drugs of interest (Breslow-Day Pbrands and generics have similar reporting rates after accounting for generic perception biases. Disproportional suicide reporting was observed for generics compared with AGs and brand, although this finding needs further study. Copyright © 2017 Elsevier B.V. All rights reserved.

  14. A comparison of generic drug prices in seven European countries: a methodological analysis.

    Science.gov (United States)

    Wouters, Olivier J; Kanavos, Panos G

    2017-03-31

    Policymakers and researchers frequently compare the prices of medicines between countries. Such comparisons often serve as barometers of how pricing and reimbursement policies are performing. The aim of this study was to examine methodological challenges to comparing generic drug prices. We calculated all commonly used price indices based on 2013 IMS Health data on sales of 3156 generic drugs in seven European countries. There were large differences in generic drug prices between countries. However, the results varied depending on the choice of index, base country, unit of volume, method of currency conversion, and therapeutic category. The results also differed depending on whether one looked at the prices charged by manufacturers or those charged by pharmacists. Price indices are a useful statistical approach for comparing drug prices across countries, but researchers and policymakers should interpret price indices with caution given their limitations. Price-index results are highly sensitive to the choice of method and sample. More research is needed to determine the drivers of price differences between countries. The data suggest that some governments should aim to reduce distribution costs for generic drugs.

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

    Science.gov (United States)

    Thomas, M; Lexchin, J

    1990-01-01

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

  16. Brand-name drug, generic drug, orphan drug. Pharmacological therapy with biosimilar drugs – provision of due diligence in the treatment process

    Science.gov (United States)

    Zajdel, Justyna

    2013-01-01

    Due diligence in the process of provision of healthcare services refers, among other elements, to the application of pharmacological therapy at a time which offers the greatest chance for a successful outcome of treatment, i.e. for achieving the optimum expected effect understood as an improvement in the patient's health, reduction of health risks or elimination of the disease. However, due diligence may also refer to actions aimed at ensuring that neither the patient nor the healthcare payer is required to incur unreasonable costs in the process of treatment. The validity of that statement stems not only from normative acts but also from ethical standards laid down in the Medical Code of Ethics (Article 57 section 2). It often happens that the provision of optimal treatment calls for deviations from the formal provisions included in Summary Product Characteristics (SPCs), and the application of drugs that are bioequivalent to reference drugs, which translates into a significant reduction of costs. The present study addresses the problem of acceptability of a specific form of drug substitution consisting in the replacement of a reference drug with a generic drug. Also explored are legal aspects associated with the possibility of therapy based on “off-label use”. The study reviews normative acts existing in the Polish and EU legislation. It also provides a clear definition of orphan drug, which has made it possible to make a distinction and investigate mutual relations between the concepts of brand-name (reference) drug, orphan drug and generic drug. PMID:24592133

  17. Brand-name drug, generic drug, orphan drug. Pharmacological therapy with biosimilar drugs - provision of due diligence in the treatment process.

    Science.gov (United States)

    Zajdel, Justyna; Zajdel, Radosław

    2013-01-01

    Due diligence in the process of provision of healthcare services refers, among other elements, to the application of pharmacological therapy at a time which offers the greatest chance for a successful outcome of treatment, i.e. for achieving the optimum expected effect understood as an improvement in the patient's health, reduction of health risks or elimination of the disease. However, due diligence may also refer to actions aimed at ensuring that neither the patient nor the healthcare payer is required to incur unreasonable costs in the process of treatment. The validity of that statement stems not only from normative acts but also from ethical standards laid down in the Medical Code of Ethics (Article 57 section 2). It often happens that the provision of optimal treatment calls for deviations from the formal provisions included in Summary Product Characteristics (SPCs), and the application of drugs that are bioequivalent to reference drugs, which translates into a significant reduction of costs. The present study addresses the problem of acceptability of a specific form of drug substitution consisting in the replacement of a reference drug with a generic drug. Also explored are legal aspects associated with the possibility of therapy based on "off-label use". The study reviews normative acts existing in the Polish and EU legislation. It also provides a clear definition of orphan drug, which has made it possible to make a distinction and investigate mutual relations between the concepts of brand-name (reference) drug, orphan drug and generic drug.

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

    Science.gov (United States)

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

    2018-02-01

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

  19. Economic Impacts of the Generic Drug User Fee Act Fee Structure.

    Science.gov (United States)

    Dong, Ke; Boehm, Garth; Zheng, Qiang

    2017-06-01

    A Food and Drug Administration (FDA) Generic Drug User system, Generic Drug User Fee Amendment of 2012 (GDUFA), started October 1, 2012, and has been in place for over 3 years. There is controversy about the GDUFA fee structure but no analysis of GDUFA data that we could find. To look at the economic impact of the GDUFA fee structure. We compared the structure of GDUFA with that of other FDA Human Drug User fees. We then, using FDA-published information, analyzed where GDUFA facility and Drug Master File fees are coming from. We used the Orange Book to identify the sponsors of all approved Abbreviated New Drug Applications (ANDAs) and the S&P Capital IQ database to find the ultimate parent companies of sponsors of approved ANDAs. The key differences between the previous structure for Human Drug User fees and the GDUFA are as follows: GDUFA has no approved product fee and no first-time or small business fee exemptions and GDUFA charges facility fees from the time of filing and charges a foreign facility levy. Most GDUFA fees are paid by or on behalf of foreign entities. The top 10 companies hold nearly 50% of all approved ANDAs but pay about 14% of GDUFA facility fees. We conclude that the regressive nature of the GDUFA fee structure penalizes small, new, and foreign firms while benefiting the large established firms. A progressive fee structure in line with other human drug user fees is needed to ensure a healthy generic drug industry. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  20. Impacts of generic competition and benefit management practices on spending for prescription drugs: evidence from Medicare's Part D benefit.

    Science.gov (United States)

    Sheingold, Steven; Nguyen, Nguyen Xuan

    2014-01-01

    This study estimates the effects of generic competition, increased cost-sharing, and benefit practices on utilization and spending for prescription drugs. We examined changes in Medicare price and utilization from 2007 to 2009 of all drugs in 28 therapeutic classes. The classes accounted for 80% of Medicare Part D spending in 2009 and included the 6 protected classes and 6 classes with practically no generic competition. All variables were constructed to measure each drug relative to its class at a specific plan sponsor. We estimated that the shift toward generic utilization had cut in half the rate of increase in the price of a prescription during 2007-2009. Specifically, the results showed that (1) rapid generic penetration had significantly held down costs per prescription, (2) copayment and other benefit practices shifted utilization to generics and favored brands, and (3) price increases were generally greater in less competitive classes of drugs. In many ways, Part D was implemented at a fortuitous time; since 2006, there have been relatively few new blockbuster drugs introduced, and many existing high-volume drugs used by beneficiaries were in therapeutic classes with multiple brands and generic alternatives. Under these conditions, our paper showed that plan sponsors have been able to contain costs by encouraging use of generics or drugs offering greater value within therapeutic classes. It is less clear what will happen to future Part D costs if a number of new and effective drugs for beneficiaries enter the market with no real competitors.

  1. Extent of Drug Coverage across Generic Drug Discount Programs offered by Community Pharmacies: A look at five Chronic Conditions

    Directory of Open Access Journals (Sweden)

    Harshali K. Patel, MS

    2012-01-01

    Full Text Available Background: Chronic conditions are expensive to treat because of the ongoing prescription cost burden. Generic drug discount programs (GDDPs that offer generics at discounted price may prove beneficial to reduce pharmacy costs for the same.Objective: The objective of this study was to assess the extent to which GDDPs provide drug coverage for five common chronic conditions.Methods: A content analyses of preexisting information was conducted. Extent of coverage based on top 200 generic drugs prescribed during 2008 for the treatment of chronic conditions such as hypertension, mental disorders, arthritis, pulmonary/respiratory conditions, and diabetes were identified. Commonly prescribed medications for these diseases were identified using published peer reviewed clinical guidelines. List of drugs covered under a GDDP for stores, Wal-Mart, Walgreens, CVS, Kroger, HEB, Target, and Randalls were obtained and compared to assess drug coverage by retail dollar sales and sales volume. Descriptive statistics and frequency/percentage of coverage were reported using SAS 9.2.Results: GDDPs covered the highest number of drugs for hypertension (21-27 across different GDDPs and the least (3-5 across different GDDPs for pulmonary/respiratory conditions. Arthritis (5-11, mental disorders (6-11 and diabetes (5-7 had similar coverage. When compared to the top 200 drugs by retail dollars spent during 2008, hypertension (68%-87% and diabetes (63%-88% had the highest coverage followed by respiratory conditions (30%-50%, arthritis (22%-48%, and mental disorders (21%-38%. Similar result was obtained when GDDP coverage was compared with the top 200 generic drugs by sales volume, where diabetes (63-88% and hypertension (57%-74% had the highest coverage and mental disorders remained the lowest (23%-37%.Conclusion/Implications: Drug coverage in GDDPs varied by pharmacies across the five common chronic conditions evaluated which may limit accessibility of these programs for

  2. Optimal Anti-cancer Drug Profiles for Effective Penetration of the Anti-cancer Drug Market by Generic Drugs in Japan.

    Science.gov (United States)

    Shibata, Shoyo; Matsushita, Maiko; Saito, Yoshimasa; Suzuki, Takeshi

    2017-01-01

    The increased use of generic drugs is a good indicator of the need to reduce the increasing costs of prescription drugs. Since there are more expensive drugs compared with other therapeutic areas, "oncology" is an important one for generic drugs. The primary objective of this article was to quantify the extent to which generic drugs in Japan occupy each level of the Anatomical Therapeutic Chemical (ATC) classification system. The dataset used in this study was created from publicly available information obtained from the IMS Japan Pharmaceutical Market database. Data on the total amount of sales and number of prescriptions for anti-cancer drugs between 2010 and 2016 in Japan were selected. The data were categorized according to the third level of the ATC classification system. All categories of the ATC classification system had increased market shares in Japan between 2010 and 2016. The barriers to market entry were relatively low in L01F (platinum anti-neoplastics), L01C (plant-based neoplastics), L02B (cytostatic hormone antagonists), and L01D (anti-neoplastic antibiotics) but were high in L02A (cytostatic hormones), L01H (protein kinase inhibitors), and L01B (anti-metabolites). Generic cancer drugs could bring savings to Japanese health care systems. Therefore, their development should be directed toward niche markets, such as L02A, L01H, and L01B, and not competitive markets.

  3. [Competition between branded and generic drugs in Austria: evidence from the market for ACE inhibitors].

    Science.gov (United States)

    Mahlich, J C; Stadler, I

    2012-01-01

    The market for pharmaceuticals in Austria is highly regulated and manufacturers cannot set prices freely after patent expiration of the pioneer drug. We wanted to examine the effect of price regulation on price competition between branded and generic drugs in Austria. We examined the Austrian market for ACE inhibitors and describe competitive dynamics by means of 6 indices. We compared our results with those of Grabowski and Vernon who studied the US market. According to our analysis the competition amongst the producers of generic drugs is not great and consequently, compared to the USA, over time the prices for generic products decrease less and their market share increases less. This is due to a market-oriented system in the USA which waives most regulatory provisions. Our conclusions are in line with the findings by Danzon und Chao (2000) who argue that in a price-regulated market competitive dynamics are less strongly developed. From a politico-economic view, the necessity of price regulations in the pharmaceutical market seems questionable, as price regulations generally also cause other negative effects, such as distorted economic incentives for research and development investments. © Georg Thieme Verlag KG Stuttgart · New York.

  4. Spark Channels

    Energy Technology Data Exchange (ETDEWEB)

    Haydon, S. C. [Department of Physics, University of New England, Armidale, NSW (Australia)

    1968-04-15

    A brief summary is given of the principal methods used for initiating spark channels and the various highly time-resolved techniques developed recently for studies with nanosecond resolution. The importance of the percentage overvoltage in determining the early history and subsequent development of the various phases of the growth of the spark channel is discussed. An account is then given of the recent photographic, oscillographic and spectroscopic investigations of spark channels initiated by co-axial cable discharges of spark gaps at low [{approx} 1%] overvoltages. The phenomena observed in the development of the immediate post-breakdown phase, the diffuse glow structure, the growth of the luminous filament and the final formation of the spark channel in hydrogen are described. A brief account is also given of the salient features emerging from corresponding studies of highly overvolted spark gaps in which the spark channel develops from single avalanche conditions. The essential differences between the two types of channel formation are summarized and possible explanations of the general features are indicated. (author)

  5. Generic solid phase extraction-liquid chromatography-tandem mass spectrometry method for fast determination of drugs in biological fluids

    NARCIS (Netherlands)

    Schellen, A.; Ooms, B.; Lagemaat, D. van de; Vreeken, R.; Dongen, W.D. van

    2003-01-01

    A generic method was developed for the fast determination of a wide range of drugs in serum or plasma. The methodology comprises generic solid-phase extraction, on-line coupled to gradient HPLC with tandem mass spectrometric detection (SPE-LC-MS/MS). The individual components of the SPE-LC-MS/MS

  6. ACHIEVEMENT OF TARGET BLOOD PRESSURE LEVEL IN HYPERTENSIVE PATIENTS WITH AMLODIDINE: ORIGINAL DRUG VERSUS GENERIC

    Directory of Open Access Journals (Sweden)

    S. Yu. Martsevich

    2009-01-01

    Full Text Available Aim. To evaluate antihypertensive effects of new generic amlodipine (Stamlo M in comparison with original amlodipine (Norvasc in monotherapy and in combination with angiotensin converting enzyme (ACE inhibitor and diuretic in patients with arterial hypertension (HT of 1-2 degree.Material and methods. 60 patients with HT of 1-2 degree were included in the open randomized parallel comparative study. Patients were split into 2 groups. Study duration was 10 weeks. Efficacy control, dose correction, addition of ACE inhibitor and diuretic was performed each 2 weeks.Results. The significant antihypertensive effect of monotherapy was observed in both groups already by the 2-4 weeks of therapy. Significant differences between amlodipines in influence on blood pressure (BP level and heart rate was not found. Monotherapy with generic amlodipine (10 mg OD provided target BP level more than in half of patients. Achievement of target BP levels was found in 89% and 96% of patients treated with generic and original amlodipine, respectively, when they were combined with lisinopril (10 mg OD and hydrochlorothiazide (12,5 mg OD.Conclusion. New generic amlodipine (Stamlo M is an effective and safe antihypertensive drug comparable with original amlodipine in clinical efficacy.

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

    Directory of Open Access Journals (Sweden)

    Marcos Inocencio

    2010-06-01

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

  8. Clinical equivalence of generic and brand-name drugs used in cardiovascular disease: a systematic review and meta-analysis.

    Science.gov (United States)

    Kesselheim, Aaron S; Misono, Alexander S; Lee, Joy L; Stedman, Margaret R; Brookhart, M Alan; Choudhry, Niteesh K; Shrank, William H

    2008-12-03

    Use of generic drugs, which are bioequivalent to brand-name drugs, can help contain prescription drug spending. However, there is concern among patients and physicians that brand-name drugs may be clinically superior to generic drugs. To summarize clinical evidence comparing generic and brand-name drugs used in cardiovascular disease and to assess the perspectives of editorialists on this issue. Systematic searches of peer-reviewed publications in MEDLINE, EMBASE, and International Pharmaceutical Abstracts from January 1984 to August 2008. Studies compared generic and brand-name cardiovascular drugs using clinical efficacy and safety end points. We separately identified editorials addressing generic substitution. We extracted variables related to the study design, setting, participants, clinical end points, and funding. Methodological quality of the trials was assessed by Jadad and Newcastle-Ottawa scores, and a meta-analysis was performed to determine an aggregate effect size. For editorials, we categorized authors' positions on generic substitution as negative, positive, or neutral. We identified 47 articles covering 9 subclasses of cardiovascular medications, of which 38 (81%) were randomized controlled trials (RCTs). Clinical equivalence was noted in 7 of 7 RCTs (100%) of beta-blockers, 10 of 11 RCTs (91%) of diuretics, 5 of 7 RCTs (71%) of calcium channel blockers, 3 of 3 RCTs (100%) of antiplatelet agents, 2 of 2 RCTs (100%) of statins, 1 of 1 RCT (100%) of angiotensin-converting enzyme inhibitors, and 1 of 1 RCT (100%) of alpha-blockers. Among narrow therapeutic index drugs, clinical equivalence was reported in 1 of 1 RCT (100%) of class 1 antiarrhythmic agents and 5 of 5 RCTs (100%) of warfarin. Aggregate effect size (n = 837) was -0.03 (95% confidence interval, -0.15 to 0.08), indicating no evidence of superiority of brand-name to generic drugs. Among 43 editorials, 23 (53%) expressed a negative view of generic drug substitution. Whereas evidence does not

  9. Searches for Randomized Controlled Trials of Drugs in MEDLINE and EMBASE Using Only Generic Drug Names Compared with Searches Applied in Current Practice in Systematic Reviews

    Science.gov (United States)

    Waffenschmidt, Siw; Guddat, Charlotte

    2015-01-01

    Background: It is unclear which terms should be included in bibliographic searches for randomized controlled trials (RCTs) of drugs, and identifying relevant drug terms can be extremely laborious. The aim of our analysis was to determine whether a bibliographic search using only the generic drug name produces sufficient results for the generation…

  10. Formulation of Dihydroartemisinin-Piperaquine (DHP Generic Tablet as Antimalarials Drug

    Directory of Open Access Journals (Sweden)

    Nanang Yunarto

    2016-09-01

    Full Text Available The incidence of malaria in Indonesia is about two million cases annually. Dihydroartemisinin-piperaquine (DHP is the first line therapy recommended for uncomplicated malaria treatment, whereas  DHP is still fully imported. The generic DHP tablet formulation has the potential to become the first of DHP drug which is locally produced. This study is aimed to formulate generic DHP film coated tablets for antimalaria drug. Tablets were compressed with the combination of wet granulation for piperaquine phosphate (PQP and direct compression method for DHA and coated with a moisture barier coating material. The parameters to evaluate the quality of DHP tablets are physical properties, assay, and dissolution test. DHA and PQP assay were performed by HPLC method. The dissolution testing was conducted by in house method using HCl 0.1 N medium. The result shows physical properties of film-coated tablets meet the requirement, i.e. uniform weight, 7.0-8.5 kp hardness, 0.02% friability and 3 minute 22 seconds disintegration. The assay to determine  DHA in tablet was 95.17% and PQP was 97.05%. The result of dissolution testing shows the content of DHA and PQP in the tablet were 113.51% and 96.55%, respesctively. The formulation which is developed meets the general requirement of API in tablet 90–110% and dissolution requirement >75%.

  11. 77 FR 51811 - Draft Guidance for Industry on Self-Identification of Generic Drug Facilities, Sites, and...

    Science.gov (United States)

    2012-08-27

    ... generic drugs program. GDUFA will also significantly improve global supply chain transparency by requiring... promote global supply chain transparency. The information provided through self-identification will enable... Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD...

  12. A Generic Multi-Compartmental CNS Distribution Model Structure for 9 Drugs Allows Prediction of Human Brain Target Site Concentrations

    NARCIS (Netherlands)

    Yamamoto, Yumi; Valitalo, Pyry A.; van den Berg, Dirk-Jan; Hartman, Robin; van den Brink, Willem; Wong, Yin Cheong; Huntjens, Dymphy R.; Proost, Johannes H.; Vermeulen, An; Krauwinkel, Walter; Bakshi, Suruchi; Aranzana-Climent, Vincent; Marchand, Sandrine; Dahyot-Fizelier, Claire; Couet, William; Danhof, Meindert; van Hasselt, Johan G. C.; de lange, Elizabeth C. M.

    Purpose Predicting target site drug concentration in the brain is of key importance for the successful development of drugs acting on the central nervous system. We propose a generic mathematical model to describe the pharmacokinetics in brain compartments, and apply this model to predict human

  13. Generic drug discount programs: are prescriptions being submitted for pharmacy benefit adjudication?

    Science.gov (United States)

    Tungol, Alexandra; Starner, Catherine I; Gunderson, Brent W; Schafer, Jeremy A; Qiu, Yang; Gleason, Patrick P

    2012-01-01

      In 2006, pharmacies began offering select generic prescription drugs at discount prices (e.g., $4 for a 30-day supply) through nonmembership and membership programs. As part of the contract in membership generic drug discount programs, the member agrees to forgo submission of the claim to the insurance company. Claims not submitted for insurance adjudication may result in incomplete pharmacy benefit manager (PBM) and health plan data, which could negatively influence adherence reporting and clinical programs. To address potentially missing claims data, the Centers for Medicare Medicaid Services (CMS) encourages Medicare Part D sponsors to incentivize network pharmacies to submit claims directly to the plan for drugs dispensed outside of a member's Part D benefit, unless a member refuses. The extent of PBM and health plan claims capture loss due to generic drug discount programs is unknown. To identify changes in levothyroxine utilizers' prescription claims capture rate following the advent of generic drug discount membership and nonmembership programs. This retrospective concurrent cohort study used claims data from 3.5 million commercially insured members enrolled in health plans located in the central and southern United States with Prime Therapeutics pharmacy benefit coverage. Members were required to be 18 years or older and younger than 60 years as of January 1, 2006, and continuously enrolled from January 1, 2006, through December 31, 2010. Members utilizing generic levothyroxine for at least 120 days during January 1, 2006, through June 30, 2006 (baseline period) from the same pharmacy group with supply on July 1, 2006, were placed into 1 of 3 pharmacy groups: (1) nonmembership (Walmart, Sam's Club, Target, Kroger, City Market, and King Soopers pharmacies), (2) membership (Walgreens, CVS, Albertsons, and Savon pharmacies), or (3) the reference group of all other pharmacies. The index date was defined as July 1, 2006. The levothyroxine claim providing

  14. Mixed Approach Retrospective Analyses of Suicide and Suicidal Ideation for Brand Compared with Generic Central Nervous System Drugs.

    Science.gov (United States)

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

    2018-04-01

    Several different types of drugs acting on the central nervous system (CNS) have previously been associated with an increased risk of suicide and suicidal ideation (broadly referred to as suicide). However, a differential association between brand and generic CNS drugs and suicide has not been reported. This study compares suicide adverse event rates for brand versus generic CNS drugs using multiple sources of data. Selected examples of CNS drugs (sertraline, gabapentin, zolpidem, and methylphenidate) were evaluated via the US FDA Adverse Event Reporting System (FAERS) for a hypothesis-generating study, and then via administrative claims and electronic health record (EHR) data for a more rigorous retrospective cohort study. Disproportionality analyses with reporting odds ratios and 95% confidence intervals (CIs) were used in the FAERS analyses to quantify the association between each drug and reported suicide. For the cohort studies, Cox proportional hazards models were used, controlling for demographic and clinical characteristics as well as the background risk of suicide in the insured population. The FAERS analyses found significantly lower suicide reporting rates for brands compared with generics for all four studied products (Breslow-Day P brand CNS drugs in FAERS and adjusted retrospective cohort analyses remained significant only for sertraline. However, even for sertraline, temporal confounding related to the close proximity of black box warnings and generic availability is possible. Additional analyses in larger data sources with additional drugs are needed.

  15. Prescription for fairness: a new approach to tort liability of brand-name and generic drug manufacturers.

    Science.gov (United States)

    Rostron, Allen

    2011-02-01

    Over the past two decades, courts have consistently ruled that the manufacturer of a brand-name prescription drug cannot be liable for injuries suffered by those taking generic imitations of its product. This meant that a patient injured by a generic drug could have no remedy at all because in many instances the generic drug manufacturer would escape liability on the ground that it did not produce any information on which the patient's doctor relied. It was a perplexing dilemma. The generic drug manufacturer made the product that the plaintiff received, the brand-name manufacturer produced all of the information the patient's doctor saw, and neither manufacturer could be held liable even if each acted negligently. The California Court of Appeal recently issued a stunning decision in which it concluded that a brand-name drug manufacturer could be liable to a plaintiff who took a generic version of its product. The reaction to the decision has been overwhelmingly negative. Commentators have condemned the decision as one of the worst rulings made by any court in recent years. Judges around the country have dismissed it as a misguided aberration from the otherwise strong judicial consensus on the issue. Although the decision has been the subject of scathing criticism, this Article argues that the California court's ruling actually represents the first time that a court has properly examined this issue. In addition, the Article points out some weaknesses in the California court's reasoning and proposes a novel general framework for analyzing the liability of brand-name and generic drug manufacturers.

  16. Canada ordered to implement WTO ruling against "stockpiling" of generic drugs.

    Science.gov (United States)

    Elliott, R

    2000-01-01

    In the last issue, we reported on a mixed World Trade Organization (WTO) ruling regarding Canada's patent laws, based on a complaint by the member states of the European Communities (joined by the United States). In March 2000, a WTO Panel accepted the provision in Canada's Patent Act that creates an "early working exception" to patent rights--in other words, that allows a third party to use a patented invention during the term of patent protection, as long as the use is for obtaining regulatory approval of an equivalent product to be sold once the patent expires. This was an important victory from the perspective of allowing earlier access to generic versions of patented drugs.

  17. Generic solid phase extraction-liquid chromatography-tandem mass spectrometry method for fast determination of drugs in biological fluids.

    Science.gov (United States)

    Schellen, Anniek; Ooms, Bert; van de Lagemaat, Dick; Vreeken, Rob; van Dongen, William D

    2003-05-25

    A generic method was developed for the fast determination of a wide range of drugs in serum or plasma. The methodology comprises generic solid-phase extraction, on-line coupled to gradient HPLC with tandem mass spectrometric detection (SPE-LC-MS/MS). The individual components of the SPE-LC-MS/MS system were optimized in an integrated approach to maximize the application range and minimize the method development time. The optimized generic SPE-LC-MS/MS protocol was evaluated for 11 drugs with different physicochemical properties. Good quantification for 10 out of 11 of the pharmaceuticals in serum or plasma could be readily achieved. The quantitative assays gave recoveries better than 95%, lower quantification limits of 0.2-2.0 ng/ml, acceptable precision and accuracy and good linearity over 2-4 orders of magnitude. Carry-over was determined to be in the range of 0.02-0.10%, without optimization.

  18. 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.

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

    Directory of Open Access Journals (Sweden)

    Chin-Fun Chu

    2012-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Chin-Fun Chu

    2012-01-01

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

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

    Science.gov (United States)

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

    2009-10-01

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

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

    Science.gov (United States)

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

    2018-03-01

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

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

    International Nuclear Information System (INIS)

    Gebran, N.; Al-Haldari, K.

    2006-01-01

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

  4. A comparison of the intrasubject variation in drug exposure between generic and brand-name drugs: a retrospective analysis of replicate design trials.

    Science.gov (United States)

    Yu, Yang; Teerenstra, Steven; Neef, Cees; Burger, David; Maliepaard, Marc

    2016-04-01

    The aim of the present study was to investigate whether differences in total and peak drug exposure upon generic substitution are due to differences between formulations or to intrasubject pharmacokinetic variability of the active substance. The study was designed as a retrospective reanalysis of existing studies. Nine replicate design bioequivalence studies representing six drug classes - i.e. for alendronate, atorvastatin, cyclosporin, ebastine, exemestane, mycophenolate mofetil, and ropinirole - were retrieved from the Dutch Medicines Regulatory Authority. In most studies, the intrasubject variability in total and peak drug exposure was comparable for the brand-name [in the range 0.01-0.24 for area under the concentration-time curve (AUCt ) and 0.02-0.29 for peak plasma concentration (Cmax ) on a log scale] and generic (0.01-0.23 for AUCt and 0.08-0.33 for Cmax ) drugs, and was comparable with the intrasubject variability upon switching between those drugs (0.01-0.23 for AUCt and 0.06-0.33 for Cmax ). The variance related to subject-by-formulation interaction could be considered negligible (-0.069 to 0.047 for AUCt and -0.091 to 0.02 for Cmax ). In the investigated studies, the variation in total and peak exposure seen when a patient is switched from a brand-name to a generic drug is comparable with that seen following repeated administration of the brand-name drug in the patient. Only the intrasubject variability seems to play a crucial and decisive role in the variation in drug exposure seen; no additional formulation-dependent variation in exposure is observed upon switching. Thus, our data support that, for the medicines that were included in the present investigation, from a clinical pharmacological perspective, the benefit-risk balance of a generic drug is comparable with that of the brand-name drug. © 2015 The British Pharmacological Society.

  5. 77 FR 65198 - Generic Drug User Fee-Abbreviated New Drug Application, Prior Approval Supplement, and Drug...

    Science.gov (United States)

    2012-10-25

    ..., U.S. postal money order, or wire transfer. FDA has partnered with the U.S. Department of the... money order and make payable to the order of the Food and Drug Administration. Your payment can be mailed to: Food and Drug Administration, P.O. Box 979108, St. Louis, MO 63197-9000. If checks are to be...

  6. The impact of generic-only drug benefits on patients' use of inhaled corticosteroids in a Medicare population with asthma

    Directory of Open Access Journals (Sweden)

    Newhouse Joseph P

    2008-07-01

    Full Text Available Abstract Background Patients face increasing insurance restrictions on prescription drugs, including generic-only coverage. There are no generic inhaled corticosteroids (ICS, which are a mainstay of asthma therapy, and patients pay the full price for these drugs under generic-only policies. We examined changes in ICS use following the introduction of generic-only coverage in a Medicare Advantage population from 2003–2004. Methods Subjects were age 65+, with asthma, prior ICS use, and no chronic obstructive pulmonary disorder (n = 1,802. In 2004, 74.0% switched from having a $30 brand-copayment plan to a generic-only coverage plan (restricted coverage; 26% had $15–25 brand copayments in 2003–2004 (unrestricted coverage. Using linear difference-in-difference models, we examined annual changes in ICS use (measured by days-of-supply dispensed. There was a lower-cost ICS available within the study setting and we also examined changes in drug choice (higher- vs. lower-cost ICS. In multivariable models we adjusted for socio-demographic, clinical, and asthma characteristics. Results In 2003 subjects had an average of 188 days of ICS supply. Restricted compared with unrestricted coverage was associated with reductions in ICS use from 2003–2004 (-15.5 days-of-supply, 95% confidence interval (CI: -25.0 to -6.0. Among patients using higher-cost ICS drugs in 2003 (n = 662, more restricted versus unrestricted coverage subjects switched to the lower-cost ICS in 2004 (39.8% vs. 10.3%. Restricted coverage was not associated with decreased ICS use (2003–2004 among patients who switched to the lower-cost ICS (18.7 days-of-supply, CI: -27.5 to 65.0, but was among patients who did not switch (-38.6 days-of-supply, CI: -57.0 to -20.3. In addition, restricted coverage was associated with decreases in ICS use among patients with both higher- and lower-risk asthma (-15.0 days-of-supply, CI: -41.4 to 11.44; and -15.6 days-of-supply, CI: -25.8 to -5

  7. Some drugs more equal than others: pseudo-generics and commercial practice.

    Science.gov (United States)

    Probyn, Andrew J

    2004-11-08

    This article analyses the impact of the Department of Health and Ageing's brand price premium policy for some products listed on the Pharmaceutical Benefits Scheme. The policy, introduced in 1990, allows pharmaceutical companies to charge patients an out-of-pocket expense for post-patent brands of pharmaceuticals. One of the policy's intended goals was to increase consumer awareness of price differentials between competing brands, with a view to encouraging greater use of cheaper generic products. More than fourteen years since its introduction, it is debatable whether the policy has achieved this aim. This article looks at how the brand price premium policy can be exploited by global pharmaceutical giants to entrench big-name brands in the Australian pharmaceutical market and, in some cases, prevent 'true' competition from generic pharmaceuticals. This is being done through the establishment of 'pseudo-generics' that are sourced from the same factory floor as the original product.

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

    LENUS (Irish Health Repository)

    Dunne, Suzanne S

    2015-07-01

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

  9. Complement activation as a bioequivalence issue relevant to the development of generic liposomes and other nanoparticulate drugs

    International Nuclear Information System (INIS)

    Szebeni, Janos; Storm, Gert

    2015-01-01

    Liposomes are known to activate the complement (C) system, which can lead in vivo to a hypersensitivity syndrome called C activation-related pseudoallergy (CARPA). CARPA has been getting increasing attention as a safety risk of i.v. therapy with liposomes, whose testing is now recommended in bioequivalence evaluations of generic liposomal drug candidates. This review highlights the adverse consequences of C activation, the unique symptoms of CARPA triggered by essentially all i.v. administered liposomal drugs, and the various features of vesicles influencing this adverse immune effect. For the case of Doxil, we also address the mechanism of C activation and the opsonization vs. long circulation (stealth) paradox. In reviewing the methods of assessing C activation and CARPA, we delineate the most sensitive porcine model and an algorithm for stepwise evaluation of the CARPA risk of i.v. liposomes, which are proposed for standardization for preclinical toxicology evaluation of liposomal and other nanoparticulate drug candidates. - Highlights: • Outlining of difficulties in generic development of liposomal drugs. • New regulatory requirements to evaluate CARPA in preclinical studies. • Review of complement activation by liposomes and its adverse consequences (CARPA). • Assays of C activation in vitro and CARPA in vivo, with the porcine test in focus. • Decision tree how to handle the risk of CARPA assessed by a battery of tests.

  10. Complement activation as a bioequivalence issue relevant to the development of generic liposomes and other nanoparticulate drugs

    Energy Technology Data Exchange (ETDEWEB)

    Szebeni, Janos, E-mail: jszebeni2@gmail.com [Nanomedicine Research and Education Center, Semmelweis University, Budapest & SeroScience Ltd, Budapest (Hungary); Storm, Gert [Department of Pharmaceutics, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht (Netherlands)

    2015-12-18

    Liposomes are known to activate the complement (C) system, which can lead in vivo to a hypersensitivity syndrome called C activation-related pseudoallergy (CARPA). CARPA has been getting increasing attention as a safety risk of i.v. therapy with liposomes, whose testing is now recommended in bioequivalence evaluations of generic liposomal drug candidates. This review highlights the adverse consequences of C activation, the unique symptoms of CARPA triggered by essentially all i.v. administered liposomal drugs, and the various features of vesicles influencing this adverse immune effect. For the case of Doxil, we also address the mechanism of C activation and the opsonization vs. long circulation (stealth) paradox. In reviewing the methods of assessing C activation and CARPA, we delineate the most sensitive porcine model and an algorithm for stepwise evaluation of the CARPA risk of i.v. liposomes, which are proposed for standardization for preclinical toxicology evaluation of liposomal and other nanoparticulate drug candidates. - Highlights: • Outlining of difficulties in generic development of liposomal drugs. • New regulatory requirements to evaluate CARPA in preclinical studies. • Review of complement activation by liposomes and its adverse consequences (CARPA). • Assays of C activation in vitro and CARPA in vivo, with the porcine test in focus. • Decision tree how to handle the risk of CARPA assessed by a battery of tests.

  11. 78 FR 78366 - Draft Generic Drug User Fee Act Information Technology Plan; Availability for Comment

    Science.gov (United States)

    2013-12-26

    ... increases FDA's authorities and responsibilities to address issues such as drug shortages, drug supply chain... and describes new standards and processes affecting drug and biologics approvals, drug supply chain... Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD...

  12. Generic substitution of antidiabetic drugs in the elderly does not affect adherence

    Directory of Open Access Journals (Sweden)

    Francesco Trotta

    2014-12-01

    Full Text Available INTRODUCTION: The possibility that variation in packaging and pill appearance may reduce adherence is a reason for concern, especially for chronic diseases. The objectives of the study were to quantify the extent of switches between generic antidiabetics and to verify whether switching between different products of the same substance affects adherence. MATERIALS AND METHODS: All elderly residents of the Umbria Region who received at least 2 prescriptions of antidiabetics in 2010 and 2011 were included in the study. Switching was defined as the dispensing of two different products of the same substance in a series of two prescriptions. Single and multiple switchers were identified according to the number of switches during 2011. Switching relevant to the three off-patent substances with generic use ≥ 5% (metformin, gliclazide and repaglinide was quantified. The effect of switching on adherence, defined as the proportion of days in 2011 covered by prescriptions (Medication Possession Ratio, MPR, was estimated. RESULTS: Among the 15 964 patients receiving antidiabetics (14.4% of the elderly population 9211 were prescribed at least one of the generic substances. Of these patients, 23.3% experienced a single switch and 15.7% were multiple switchers (61.0% never switched. The proportion of multiple switchers increased with the number of prescriptions, reaching 26% among patients with ≥ 11 prescriptions. MPR was 62%, 62% and 72%, respectively among non-switchers, single and multiple switchers. CONCLUSIONS: In elderly patients treated with antidiabetics, the substitution between branded and unbranded products (as well as between generics of the same substance, did not negatively affect adherence.

  13. Comparison of adherence to generic multi-tablet regimens vs. brand multi-tablet and brand single-tablet regimens likely to incorporate generic antiretroviral drugs by breaking or not fixed-dose combinations in HIV-infected patients.

    Science.gov (United States)

    Rwagitinywa, Joseph; Lapeyre-Mestre, Maryse; Bourrel, Robert; Montastruc, Jean-Louis; Sommet, Agnès

    2018-03-05

    Adherence to antiretroviral (ARV) is crucial to achieve viral load suppression in HIV-infected patients. This study aimed to compare adherence to generic multi-tablet regimens (MTR) vs. brand MTR likely to incorporate ARV drugs without breaking fixed-dose combinations (FDC) and brand single-tablet regimens (STR) likely to incorporate generics by breaking the FDC. Patients aged of 18 years or over exposed to one of the generic or the brand of lamivudine (3TC), zidovudine/lamivudine (AZT/TC), nevirapine (NVP), or efavirenz (EFV), or the brand STR of efavirenz/emtricitabine/tenofovir (EFV/FTC/TDF). Adherence was measured by medication possession ratio (MPR) using both defined daily dose (DDD) and daily number of tablet recommended for adults (DNT). Adherence to generic MTR vs. brand MTR and brand STR was compared using Kruskal-Wallis. The overall median adherence was 0.97 (IQR 0.13) by DNT method and 0.97 (0.14) by DDD method. Adherence in patients exposed to generic MTR (n = 165) vs. brand MTR (n = 481) and brand STR (n = 470) was comparable by DNT and DDD methods. In conclusion, adherence to generic MTR was high and comparable with adherence to brand MTR and to STR. Utilization of DDD instead DNT to measure the MPR led to small but nonsignificant difference that has no clinical impact. © 2018 Société Française de Pharmacologie et de Thérapeutique.

  14. 78 FR 27113 - Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives Public Hearing; Request...

    Science.gov (United States)

    2013-05-09

    ... Hearing; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notification of public hearing; request for public comments. The Food and Drug Administration (FDA or the Agency) is announcing a... of complex drug substances 13. Develop a risk-based understanding of potential adverse impacts to...

  15. Why are generic drugs being held up in transit? Intellectual property rights, international trade, and the right to health in Brazil and beyond.

    Science.gov (United States)

    Rosina, Mônica Steffen Guise; Shaver, Lea

    2012-01-01

    Access to medicines faces a new legal threat: "border enforcement" of drug patents. Using Brazil as an example, this article shows how the right to health depends on international trade. Border seizures of generic drugs present human rights and trade institutions with a unique challenge. Can public health advocates rise to meet it? © 2012 American Society of Law, Medicine & Ethics, Inc.

  16. Determinants of Generic vs. Brand Drug Choice: Evidence from Population-wide Danish Data

    DEFF Research Database (Denmark)

    Skipper, Niels; Vejlin, Rune Majlund

    driven. We use population-wide Danish register data including all prescriptions for seven blockbuster drugs from 1998-2008. At the outset, descriptive statistics suggest large variation in drug choice over doctors. Nonetheless, using a two-way fixed effects model we find that the primary determinants...... of brand drug use are unobserved patient characteristics and price effects, while observed and unobserved doctor characteristics in general explain only 0.7 % of the variation in drug choice. This is suggestive evidence that the doctors in the Danish setting with no incentives to push expensive brand drugs...

  17. Similarity between generic and brand-name antihypertensive drugs for primary prevention of cardiovascular disease: evidence from a large population-based study.

    Science.gov (United States)

    Corrao, Giovanni; Soranna, Davide; Merlino, Luca; Mancia, Giuseppe

    2014-10-01

    Although generic and earlier brand-name counterparts are bioequivalent, their equivalence in preventing relevant clinical outcomes is of concern. To compare effectiveness of generic and brand-name antihypertensive drugs for preventing the onset of cardiovascular (CV) outcomes. A population-based, nested case-control study was carried out by including the cohort of 78 520 patients from Lombardy (Italy) aged 18 years or older who were newly treated with antihypertensive drugs during 2005. Cases were the 2206 patients who experienced a hospitalization for CV disease from initial prescription until 2011. One control for each case was randomly selected from the same cohort that generated cases. Logistic regression was used to model the CV risk associated with starting on and/or continuing with generic or brand-name agents. There was no evidence that patients who started on generics experienced different CV risk than those on brand-name product (OR 0·86; 95% CI 0·63-1·17). Patients at whom generics were main dispensed had not significantly difference in CV outcomes than those mainly on brand-name agents (OR 1·19; 95% CI 0·86-1·63). Compared with patients who kept initial brand-name therapy, those who experienced brand-to-generic or generic-to-brand switches, and those always on generics, did not show differential CV risks, being the corresponding ORs (and 95% CIs), 1·18 (0·96-1·47), 0·87 (0·63-1·21) and 1·08 (0·80-1·46). Our findings do not support the notion that brand-name antihypertensive agents are superior to generics for preventing CV outcomes in the real-world clinical practice. © 2014 Stichting European Society for Clinical Investigation Journal Foundation.

  18. Fastdata processing with Spark

    CERN Document Server

    Karau, Holden

    2013-01-01

    This book will be a basic, step-by-step tutorial, which will help readers take advantage of all that Spark has to offer.Fastdata Processing with Spark is for software developers who want to learn how to write distributed programs with Spark. It will help developers who have had problems that were too much to be dealt with on a single computer. No previous experience with distributed programming is necessary. This book assumes knowledge of either Java, Scala, or Python.

  19. 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.

  20. Legal and policy foundations for global generic competition: Promoting affordable drug pricing in developing societies.

    Science.gov (United States)

    Zapatero Miguel, Pablo

    2015-01-01

    The so-called 'TRIPS flexibilities' restated in 2001 by the World Trade Organization's Doha Declaration on TRIPS and Public Health offer a variety of policy avenues for promoting global price-based competition for essential medicines, and thus for improving access to affordable medicines in the developing world. In recent years, developing countries and international organisations alike have begun to explore the potentialities of global generic markets and competition generally, and also of using compulsory licensing to remedy anti-competitive practices (e.g. excessive pricing) through TRIPS-compatible antitrust enforcement. These and other 'pro-competitive' TRIPS flexibilities currently available provide the critical leverage and policy space necessary to improve access to affordable medicines in the developing world.

  1. Generic antibiotics in Japan.

    Science.gov (United States)

    Fujimura, Shigeru; Watanabe, Akira

    2012-08-01

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

  2. 76 FR 58277 - Animal Generic Drug User Fee Act; Public Meeting; Request for Comments

    Science.gov (United States)

    2011-09-20

    ... support for lower-cost alternatives to brand drugs for consumers. Under AGDUFA, FDA agreed to meet review... Parklawn Dr., Element Bldg., Rockville, MD 20857. Dated: September 13, 2011. Leslie Kux, Acting Assistant...

  3. 77 FR 72359 - Animal Generic Drug User Fee Act; Public Meeting; Request for Comments

    Science.gov (United States)

    2012-12-05

    ... Parklawn Dr., Element Bldg., Rockville, MD 20857. Comments: Interested persons may submit either written... to brand name drugs for consumers. Under AGDUFA I, FDA agreed to meet review performance goals for...

  4. Establishment of in vitro-in vivo equivalence of highly variable drugs - a generic product development perspective.

    Science.gov (United States)

    Pathak, Shriram M; Aggarwal, Deepika; Venkateswarlu, V

    2014-06-01

    In vivo equivalence of highly variable drugs (HVD) has always been a subject of great concern, in terms of both safety and efficacy, for regulatory agencies. Successful demonstration of their bioequivalence thus presents the most crucial component of a generic application, significantly contributing toward the cost and time of development. For poorly soluble drugs, such as telmisartan, dissolution represents the rate-limiting step in the gastric region and in many cases may not be complete, thereby contributing to low and highly variable bioavailability. Consequently, simulation of gastrointestinal conditions is essential to adequately predict the in vivo behavior of drug formulations. In this study, we evaluated usefulness of physiologically relevant dissolution method over commonly used acidic media to forecast comparable in vivo performance of telmisartan formulation to that of reference samples. In the present study, telmisartan was classified as a HVD and a partial replicate design with repeating the reference product and scaling the bioequivalence for the reference variability has been presented. The design has effectively decreased sample size, without increasing patient risk. Results from this project suggest that scaled average bioequivalence (SABE) provides a good approach for evaluating the bioequivalence of HVD, meeting the need for international guidelines for bioequivalence.

  5. Dramatyping: a generic algorithm for detecting reasonable temporal correlations between drug administration and lab value alterations

    Directory of Open Access Journals (Sweden)

    Axel Newe

    2016-03-01

    Full Text Available According to the World Health Organization, one of the criteria for the standardized assessment of case causality in adverse drug reactions is the temporal relationship between the intake of a drug and the occurrence of a reaction or a laboratory test abnormality. This article presents and describes an algorithm for the detection of a reasonable temporal correlation between the administration of a drug and the alteration of a laboratory value course. The algorithm is designed to process normalized lab values and is therefore universally applicable. It has a sensitivity of 0.932 for the detection of lab value courses that show changes in temporal correlation with the administration of a drug and it has a specificity of 0.967 for the detection of lab value courses that show no changes. Therefore, the algorithm is appropriate to screen the data of electronic health records and to support human experts in revealing adverse drug reactions. A reference implementation in Python programming language is available.

  6. 78 FR 46958 - Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2014

    Science.gov (United States)

    2013-08-02

    ... send a check by a courier such as Federal Express or United Parcel Service, the courier may deliver the... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0007... of the Treasury notifies FDA of payment. U.S. Bank and the United States Treasury are required to...

  7. Comparison of Clobetasol Propionate Generics Using Simplified in Vitro Bioequivalence Method for Topical Drug Products.

    Science.gov (United States)

    Soares, Kelen Carine Costa; de Souza, Weidson Carlos; de Souza Texeira, Leonardo; da Cunha-Filho, Marcilio Sergio Soares; Gelfuso, Guilherme Martins; Gratieri, Tais

    2017-11-20

    The aim of this paper is to propose a simple in vitro skin penetration experiment in which the drug is extracted from the whole skin piece as a test valid for formulation screening and optimization during development process, equivalence assessment during quality control or post-approval after changes to the product. Twelve clobetasol propionate (CP) formulations (six creams and six ointments) from the local market were used as a model to challenge the proposed methodology in comparison to in vitro skin penetration following tape-stripping for drug extraction. To support the results, physicochemical tests for pH, viscosity, density and assay, as well as in vitro release were performed. Both protocols, extracting the drug from the skin using the tape-stripping technique or extracting from the full skin were capable of differentiating CP formulations. Only one formulation did not present statistical difference from the reference drug product in penetration tests and only other two oitments presented equivalent release to the reference. The proposed protocol is straightforward and reproducible. Results suggest the bioinequavalence of tested CP formulations reinforcing the necessity of such evaluations. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  8. Modeling HIV/AIDS Drug Price Determinants in Brazil: Is Generic Competition a Myth?

    OpenAIRE

    Meiners, Constance; Sagaon-Teyssier, Luis; Hasenclever, Lia; Moatti, Jean-Paul

    2011-01-01

    BACKGROUND: Brazil became the first developing country to guarantee free and universal access to HIV/AIDS treatment, with antiretroviral drugs (ARVs) being delivered to nearly 190,000 patients. The analysis of ARV price evolution and market dynamics in Brazil can help anticipate issues soon to afflict other developing countries, as the 2010 revision of the World Health Organization guidelines shifts demand towards more expensive treatments, and, at the same time, current evolution of internat...

  9. Iterative photoinduced chain functionalization as a generic platform for advanced polymeric drug delivery systems

    Czech Academy of Sciences Publication Activity Database

    Al Samad, A.; Bethry, A.; Janoušková, Olga; Ciccione, J.; Wenk, C.; Coll, J.-L.; Subra, G.; Etrych, Tomáš; El Omar, F.; Bakkour, Y.; Coudane, J.; Nottelet, B.

    2018-01-01

    Roč. 39, č. 3 (2018), s. 1-5, č. článku 1700502. ISSN 1022-1336 R&D Projects: GA MŠk(CZ) LO1507; GA MŠk(CZ) LQ1604 Institutional support: RVO:61389013 Keywords : drug delivery systems * functionalization of polymers * photochemistry Subject RIV: CD - Macromolecular Chemistry OBOR OECD: Polymer science Impact factor: 4.265, year: 2016

  10. [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

  11. Optical spark chamber

    CERN Multimedia

    CERN PhotoLab

    1971-01-01

    An optical spark chamber developed for use in the Omega spectrometer. On the left the supporting frame is exceptionally thin to allow low momentum particles to escape and be detected outside the magnetic field.

  12. Production of peptides as generic drugs: a patent landscape of octreotide.

    Science.gov (United States)

    Sabatino, Giuseppina; Guryanov, Ivan; Rombecchi, Andrea; Zanon, Jacopo; Ricci, Antonio; Cabri, Walter; Papini, Anna Maria; Rovero, Paolo

    2016-01-01

    New low-cost strategies and enhancement of the already described methods to manufacture peptide molecules on an industrial scale are highly requested, particularly for peptides such as octreotide, which, along with goserelin and leuprolide, dominate the global peptide market. A number of patents related to the production of octreotide can be found, concerning both solution and solid-phase synthesis. Thus, there is a need to revise the existing synthetic approaches in order to organize them in a more comprehensible way. The octreotide patent landscape could help improvement of the methods for manufacturing of octreotide in industrial scale, leading to the appearance of innovative approaches. The pharmaceutical value of octreotide can be seen from its high market percentage among other peptide drugs. The complex chemical structure of octreotide represents the main challenge for its industrial production. Two synthetic steps are crucial in the preparation of octreotide: (i) threoninol attachment or on resin formation working in solid-phase and (ii) disulphide bond formation to achieve cyclic structure. Analysis of various patents filed to date allows us to see the trend in simplification of the synthetic approaches from the labor intensive syntheses in solution to the more versatile and rapid solid-phase methods.

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

    Science.gov (United States)

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

    2011-07-01

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

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

    Science.gov (United States)

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

    2017-07-17

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

  15. Clinical and economic consequences of treating patients with peripheral neuropathic pain with brand name or generic drugs in routine clinical practice: The effects of age and sex.

    Science.gov (United States)

    Navarro-Artieda, R; Rejas-Gutiérrez, J; Pérez-Paramo, M; Sicras-Mainar, A

    2018-04-01

    We aimed to analyse the effects of age and sex on pain and cost for patients with chronic peripheral neuropathic pain (PNP) who have started treatment with brand name gabapentin versus generic gabapentin (EFG). We conducted a retrospective multicentre study using electronic medical records (EMR) for patients of both sexes, older than 18, who began treatment with brand name or generic gabapentin. Adherence (medication possession ratio [MPR]), persistence, use of healthcare resources, cost, and pain reduction were measured for one year. We analysed 1369 EMRs [61.1% women; mean age 64.6 (15.9), 52.4%≥65 years]; 400 used brand name drugs while 969 used generic gabapentin. Persistence and adherence were higher in patients using brand name gabapentin (7.3 vs 6.3 months, Pbrand-name gabapentin in both age groups (brand treatment showed greater pain relief: 13.5% (10.9-16.2) and 10.8% (8.2-13.5) in brand name medication showed greater persistence and adherence to treatment than those taking generic drugs. Brand name treatment also involved lower healthcare costs, and greater pain relief. Copyright © 2016 Sociedad Española de Neurología. Publicado por Elsevier España, S.L.U. All rights reserved.

  16. Comparative study of the pharmacopeial quality and dissolution profiles of generic and other drug forms of sodium metamizole (dipyrone sold in Brazil

    Directory of Open Access Journals (Sweden)

    Morenna Alana Giordani

    2012-08-01

    Full Text Available In Brazil, in order for a pharmaceutical company to register a drug form as generic or ‘similar’ with the Brazilian food and drug agency (Anvisa, it must be proved bioequivalent to its innovatory branded form (reference drug. This requires comparative trials, carried out in conformity with official compendia (Brazilian Pharmacopeia or another officially recognized code. Additionally, according to the Anvisa resolution RDC 31/2010, the dissolution profile of the drug must be tested and compared with that of the branded reference, as a benchmark of quality. The aim of this study was to assess the quality of 500 mg sodium metamizole (dipyrone tablets produced by seven different laboratories in Brazil: three generic drugs (G1, G2, G3, three (branded similar drugs (S1, S2,S3 and their reference branded product (Novalgina®, Sanofi-Aventis, drug R. All tests were carried out by methods specified in the Brazilian Pharmacopeia 4th edition (Farmacopeia Brasileira IV. The following tests were performed: uniformity of mass, friability, disintegration time, hardness, assay, uniformity of dosage units, salicylic acid limit assay, dissolution and identification. The dissolution profile was also recorded, as recommended in RDC 31/2010. Whereas every sample was approved in all the Farmacopeia Brasileira IV tests, the results in the dissolution profile test showed that four of the test drugs (G1, G2, S1 and S2 were notpharmaceutically equivalent to drug R. Thus, only drugs G3 and S3 showed dissolution profiles similar to that of drug R and the other four drugs could not be considered equivalent to it and were not approved.

  17. SPARK Version 1.1 user manual

    International Nuclear Information System (INIS)

    Weissenburger, D.W.

    1988-01-01

    This manual describes the input required to use Version 1.1 of the SPARK computer code. SPARK 1.1 is a library of FORTRAN main programs and subprograms designed to calculate eddy currents on conducting surfaces where current flow is assumed zero in the direction normal to the surface. Surfaces are modeled with triangular and/or quadrilateral elements. Lorentz forces produced by the interaction of eddy currents with background magnetic fields can be output at element nodes in a form compatible with most structural analysis codes. In addition, magnetic fields due to eddy currents can be determined at points off the surface. Version 1.1 features eddy current streamline plotting with optional hidden-surface-removal graphics and topological enhancements that allow essentially any orientable surface to be modeled. SPARK also has extensive symmetry specification options. In order to make the manual as self-contained as possible, six appendices are included that present summaries of the symmetry options, topological options, coil options and code algorithms, with input and output examples. An edition of SPARK 1.1 is available on the Cray computers at the National Magnetic Fusion Energy Computer Center at Livermore, California. Another more generic edition is operational on the VAX computers at the Princeton Plasma Physics Laboratory and is available on magnetic tape by request. The generic edition requires either the GKS or PLOT10 graphics package and the IMSL or NAG mathematical package. Requests from outside the United States will be subject to applicable federal regulations regarding dissemination of computer programs. 22 refs

  18. SPARK Version 1. 1 user manual

    Energy Technology Data Exchange (ETDEWEB)

    Weissenburger, D.W.

    1988-01-01

    This manual describes the input required to use Version 1.1 of the SPARK computer code. SPARK 1.1 is a library of FORTRAN main programs and subprograms designed to calculate eddy currents on conducting surfaces where current flow is assumed zero in the direction normal to the surface. Surfaces are modeled with triangular and/or quadrilateral elements. Lorentz forces produced by the interaction of eddy currents with background magnetic fields can be output at element nodes in a form compatible with most structural analysis codes. In addition, magnetic fields due to eddy currents can be determined at points off the surface. Version 1.1 features eddy current streamline plotting with optional hidden-surface-removal graphics and topological enhancements that allow essentially any orientable surface to be modeled. SPARK also has extensive symmetry specification options. In order to make the manual as self-contained as possible, six appendices are included that present summaries of the symmetry options, topological options, coil options and code algorithms, with input and output examples. An edition of SPARK 1.1 is available on the Cray computers at the National Magnetic Fusion Energy Computer Center at Livermore, California. Another more generic edition is operational on the VAX computers at the Princeton Plasma Physics Laboratory and is available on magnetic tape by request. The generic edition requires either the GKS or PLOT10 graphics package and the IMSL or NAG mathematical package. Requests from outside the United States will be subject to applicable federal regulations regarding dissemination of computer programs. 22 refs.

  19. Generic drugs in Brazil: known by many, used by few Medicamentos genéricos no Brasil: conhecidos por muitos, usados por poucos

    Directory of Open Access Journals (Sweden)

    Andréa D. Bertoldi

    2005-12-01

    Full Text Available 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.Este estudo avaliou o conhecimento e utilização de medicamentos genéricos em uma amostra populacional de adultos de uma cidade no sul do Brasil. Os desfechos foram: proporção de genéricos sobre o total de medicamentos usados; conhecimento teórico e prático sobre medicamentos genéricos; estratégias usadas para compra de medicamentos com prescrição médica. O período recordatório para uso de medicamentos foi de 15 dias. A proporção de genéricos no total de medicamentos foi de 3,9%. Enquanto 86,0% sabiam que o preço dos genéricos era menor e 70,0% que a qualidade era equivalente aos medicamentos de marca, apenas 57,0% conheciam alguma característica da embalagem que diferencia os genéricos de outros medicamentos. A maior proporção de uso de genéricos foi encontrada no grupo farmacológico dos antimicrobianos. Um medicamento de marca (com nome

  20. SparkRS - Spark for Remote Sensing, Phase I

    Data.gov (United States)

    National Aeronautics and Space Administration — The proposed innovation is Spark-RS, an open source software project that enables GPU-accelerated remote sensing workflows in an Apache Spark distributed computing...

  1. [National and regional market penetration rates of generic's high dosage buprenorphine: its evolution from 2006 to 2008, using reimbursed drug database].

    Science.gov (United States)

    Boczek, Christelle; Frauger, Elisabeth; Micallef, Joëlle; Allaria-Lapierre, Véronique; Reggio, Patrick; Sciortino, Vincent

    2012-01-01

    To assess the national market penetration rate (PR) of generic high-dosage buprenorphine (HDB) in 2008 and its evolution since their marketing (2006), and making a point for each dosage and at regional level. Retrospective study over data using national and regional health reimbursement database over three years (2006-2008). In 2008, the generic HDB's national MPR was 31%. The PR for each dosage were 45% for 0.4 mg, 36% for 2 mg and 19% for 8 mg. The (PR) based on Defined Daily Dose (DDD) was 23% in 2008, 15% in 2007 and 4% in 2006. In 2008, at the regional level, disparities were observed in the adjusted penetration rate from 15% in Île de France to 39% in Champagne Ardennes Lorraine. The national PR of generic HDB has increased. There are differences in MPR in terms of dosage and area. However, this PR is still low (in 2008, 82% of the delivered drugs are generics). © 2012 Société Française de Pharmacologie et de Thérapeutique.

  2. Generic Advantages

    Indian Academy of Sciences (India)

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

  3. Formation of small sparks

    International Nuclear Information System (INIS)

    Barreto, E.; Jurenka, H.; Reynolds, S.I.

    1977-01-01

    The formation of a small incendiary spark at atmospheric pressure is identified with the transition from a weakly to a strongly ionized plasma. It is shown that initial gaseous ionization produced by avalanches and/or streamers always creates a high-temperature ideal electron gas that can shield the applied voltage difference and reduce ionization in the volume of the gas. The electron gas is collision dominated but able to maintain its high temperature, for times long compared to discharge events, through long-range Coulomb forces. In fact, electrons in the weakly ionized plasma constitute a collisionless independent fluid with a thermodynamic state that can be affected directly by field or density changes. Accordingly, with metal electrodes, cathode spot emission is always associated with the transition to a strongly ionized plasma. Neutral heating can be accomplished in two different ways. Effective dispersal of the electrons from the cathode leads to electron heating dominated by diffusion effects. Conversely, a fast rate of emission or rapid field changes can produce nonlinear wave propagation. It is shown that solitary waves are possible, and it is suggested that some spark transitions are associated with shock waves in the collisionless electron gas. In either the diffuse or nonlinear regime, neutral gas heating is controlled by collisions of ions with isotropic thermal electrons. This interaction is always subsequent to changes in state of the electron gas population. The basic results obtained should apply to all sparks

  4. Advertising and generic market entry.

    Science.gov (United States)

    Königbauer, Ingrid

    2007-03-01

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

  5. Fast data processing with Spark

    CERN Document Server

    Sankar, Krishna

    2015-01-01

    Fast Data Processing with Spark - Second Edition is for software developers who want to learn how to write distributed programs with Spark. It will help developers who have had problems that were too big to be dealt with on a single computer. No previous experience with distributed programming is necessary. This book assumes knowledge of either Java, Scala, or Python.

  6. Tool grinding and spark testing

    Science.gov (United States)

    Widener, Edward L.

    1993-01-01

    The objectives were the following: (1) to revive the neglected art of metal-sparking; (2) to promote quality-assurance in the workplace; (3) to avoid spark-ignited explosions of dusts or volatiles; (4) to facilitate the salvage of scrap metals; and (5) to summarize important references.

  7. Primary Science Interview: Science Sparks

    Science.gov (United States)

    Bianchi, Lynne

    2016-01-01

    In this "Primary Science" interview, Lynne Bianchi talks with Emma Vanstone about "Science Sparks," which is a website full of creative, fun, and exciting science activity ideas for children of primary-school age. "Science Sparks" started with the aim of inspiring more parents to do science at home with their…

  8. Analysis of Intra- and Intersubject Variability in Oral Drug Absorption in Human Bioequivalence Studies of 113 Generic Products.

    Science.gov (United States)

    Sugihara, Masahisa; Takeuchi, Susumu; Sugita, Masaru; Higaki, Kazutaka; Kataoka, Makoto; Yamashita, Shinji

    2015-12-07

    In this study, the data of 113 human bioequivalence (BE) studies of immediate release (IR) formulations of 74 active pharmaceutical ingredients (APIs) conducted at Sawai Pharmaceutical Co., Ltd., was analyzed to understand the factors affecting intra- and intersubject variabilities in oral drug absorption. The ANOVA CV (%) calculated from area under the time-concentration curve (AUC) in each BE study was used as an index of intrasubject variability (Vintra), and the relative standard deviation (%) in AUC was used as that of intersubject variability (Vinter). Although no significant correlation was observed between Vintra and Vinter of all drugs, Vintra of class 3 drugs was found to increase in association with a decrease in drug permeability (P(eff)). Since the absorption of class 3 drugs was rate-limited by the permeability, it was suggested that, for such drugs, the low P(eff) might be a risk factor to cause a large intrasubject variability. To consider the impact of poor water solubility on the variability in BE study, a parameter of P(eff)/Do (Do; dose number) was defined to discriminate the solubility-limited and dissolution-rate-limited absorption of class 2 drugs. It was found that the class 2 drugs with a solubility-limited absorption (P(eff)/Do high intrasubject variability. Furthermore, as a reason for high intra- or intersubject variability in AUC for class 1 drugs, effects of drug metabolizing enzymes were investigated. It was demonstrated that intrasubject variability was high for drugs metabolized by CYP3A4 while intersubject variability was high for drugs metabolized by CYP2D6. For CYP3A4 substrate drugs, the Km value showed the significant relation with Vintra, indicating that the affinity to the enzyme can be a parameter to predict the risk of high intrasubject variability. In conclusion, by analyzing the in house data of human BE study, low permeability, solubility-limited absorption, and high affinity to CYP3A4 are identified as risk factors for

  9. Brand name to generic substitution of antiepileptic drugs does not lead to seizure-related hospitalization: a population-based case-crossover study.

    Science.gov (United States)

    Polard, Elisabeth; Nowak, Emmanuel; Happe, André; Biraben, Arnaud; Oger, Emmanuel

    2015-11-01

    There is still controversy on brand-to-generic (B-G) antiepileptic drugs (AEDs) substitution. To assess association between B-G AED substitution and seizure-related hospitalization, we designed a case crossover using the French National Health Insurance Database. We identified a cohort of adult patients who filled a prescription in 2009-2011 for AEDs with at least one brand name and one generic form. The outcome date was defined as the date of hospitalization, coded G40.x or G41.x, with a G40/G41 hospitalization-free period of at least 1 year. Patients with a medical history of cancer and women who gave birth in 2009-2011 were excluded. We required individuals to have regular dispensations of AEDs within the year preceding the outcome date. Free patients were defined as patients who had only brand name dispensations before the control period. Eight thousand three hundred seventy nine patients (mean age ± standard deviation, 52.7 ± 18.8 years; sex ratio male/female, 1.27) were analyzed. Discordant pairs were 491 with B-G substitution in the control period only and 478 with B-G substitution in the case period only; odds ratio (95% confidence interval) 0.97 (0.86-1.10). No statistically significant interaction was detected among the four prespecified subgroup analyses (gender, age strata, free or non-free, and strict AED monotherapy or not). Controlling for non-seizure-related hospitalizations made no material difference. Sensitivity analyses yielded similar results. Brand-to-generic AED substitution was not associated with an elevated risk of seizure-related hospitalization. Copyright © 2015 John Wiley & Sons, Ltd.

  10. 78 FR 3900 - Generic Drug User Fee-Active Pharmaceutical Ingredient and Finished Dosage Form Facility Fee...

    Science.gov (United States)

    2013-01-17

    ... in U.S. currency drawn on a U.S. bank by electronic check, check, bank draft, U.S. postal money order... money order, and make payable to the order of the Food and Drug Administration. Your payment can be mailed to: Food and Drug Administration, P.O. Box 979108, St. Louis, MO 63197-9000. If checks are to be...

  11. 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. 

  12. 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....

  13. Critérios de Beers-Fick e medicamentos genéricos no Brasil Beer-Fick criteria and generic drugs in Brazil

    Directory of Open Access Journals (Sweden)

    Milton Luiz Gorzoni

    2008-08-01

    Full Text Available OBJETIVO: Determinar a prevalência de fármacos potencialmente inapropriados para idosos em medicamentos genéricos brasileiros pelos critérios de Beers-Fick. MÉTODOS: Análise da lista de medicamentos genéricos publicada no Diário Oficial da União de 12 de julho de 2004 e copiada da página da Agência Nacional de Vigilância Sanitária (ANVISA - www.anvisa.gov.br, utilizando-se os critérios de Beers-Fick. RESULTADOS: Contendo 299 produtos e/ou apresentações, a lista analisada apresentava 20 deles (6,7% do total incluídos nos critérios de Beers-Fick, concentrados nas categorias de ansiolíticos, antiagregantes plaquetários, antialérgicos, antiangionosos e vasodilatadores, antiarrítmicos, antidepressivos, antiespasmódicos, anti-hipertensivos, antiinflamatórios não esteroidais, antiulcerosos e glicosídeos cardíacos. Esses critérios não incluem fármacos como antitussígenos, cinarizina, diltiazem, piracetam, quinolonas, xantinas, cremes, pomadas e colírios que fazem parte dessa lista de medicamentos genéricos. CONCLUSÃO: Critérios de Beers-Fick são úteis para a prevenção do uso de fármacos potencialmente inapropriados em idosos, com a ressalva de que não são completos para medicamentos genéricos brasileiros.BACKGROUND: Determine, according to the Beer-Fick criteria, the prevalence of drugs potentially inappropriate for the elderly available as generic medication in Brazil. METHODS: Analysis of the list of generic medications issued by " Diário Oficial da União" on July/12/2004 and of the page of the National Agency for Sanitary Surveillance (ANVISA - www.anvisa.gov.br, using the Beers-Fick criteria. RESULTS: From the list of 299 products 20 (6.7% of the total included in the Beers-Fick criteria were analyzed, mainly in the categories of anxiolytics, platelet antiaggregants, antiallergics, anti-angina and vasodilators, antiarrythmics, antidepressants, antispasmodics, anti-hypertensive's, non steroid

  14. Skin rash during treatment with generic itraconazole

    OpenAIRE

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

    2014-01-01

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

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

    Science.gov (United States)

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

    2018-06-01

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

  16. Cost-Effectiveness and Cost Thresholds of Generic and Brand Drugs in a National Chronic Hepatitis B Treatment Program in China.

    Directory of Open Access Journals (Sweden)

    Mehlika Toy

    Full Text Available Chronic liver disease and liver cancer associated with chronic hepatitis B (CHB are leading causes of death among adults in China. Although newborn hepatitis B immunization has successfully reduced the prevalence of CHB in children, about 100 million Chinese adults remain chronically infected. If left unmanaged, 15-25% will die from liver cancer or liver cirrhosis. Antiviral treatment is not necessary for all patients with CHB, but when it is indicated, good response to treatment would prevent disease progression and reduce disease mortality and morbidity, and costly complications. The aim of this study is to analyze the cost-effectiveness of generic and brand antiviral drugs for CHB treatment in China, and assessing various thresholds at which a highly potent, low resistance antiviral drug would be cost-saving and/or cost-effective to introduce in a national treatment program. We developed a Markov simulation model of disease progression using effectiveness and cost data from the medical literature. We measured life-time costs, quality adjusted life years (QALYs, incremental cost-effectiveness ratios (ICERs, and clinical outcomes. The no treatment strategy incurred the highest health care costs ($12,932-$25,293 per patient, and the worst health outcomes, compared to the antiviral treatment strategies. Monotherapy with either entecavir or tenofovir yielded the most QALYs (14.10-19.02 for both HBeAg-positive and negative patients, with or without cirrhosis. Threshold analysis showed entercavir or tenofovir treatment would be cost saving if the drug price is $32-75 (195-460 RMB per month, highly cost-effective at $62-110 (379-670 RMB per month and cost-effective at $63-120 (384-734 RMB per month. This study can support policy decisions regarding the implementation of a national health program for chronic hepatitis B treatment in China at the population level.

  17. Proton pump inhibitors while belonging to the same family of generic drugs show different anti-tumor effect.

    Science.gov (United States)

    Lugini, Luana; Federici, Cristina; Borghi, Martina; Azzarito, Tommaso; Marino, Maria Lucia; Cesolini, Albino; Spugnini, Enrico Pierluigi; Fais, Stefano

    2016-08-01

    Tumor acidity represents a major cause of chemoresistance. Proton pump inhibitors (PPIs) can neutralize tumor acidity, sensitizing cancer cells to chemotherapy. To compare the anti-tumor efficacy of different PPIs in vitro and in vivo. In vitro experiments PPIs anti-tumor efficacy in terms of cell proliferation and cell death/apoptosis/necrosis evaluation were performed. In vivo PPIs efficacy experiments were carried out using melanoma xenograft model in SCID mice. Lansoprazole showed higher anti-tumor effect when compared to the other PPIs. The lansoprazole effect lasted even upon drug removal from the cell culture medium and it was independent from the lipophilicity of the PPIs formulation. These PPIs have shown different anti-tumoral efficacy, and the most effective at low dose was lansoprazole. The possibility to contrast tumor acidity by off-label using PPIs opens a new field of oncology investigation.

  18. Are Crab nanoshots Schwinger sparks?

    Energy Technology Data Exchange (ETDEWEB)

    Stebbins, Albert [Fermi National Accelerator Lab. (FNAL), Batavia, IL (United States); Yoo, Hojin [Univ. of Wisconsin, Madison, WI (United States); Fermi National Accelerator Lab. (FNAL), Batavia, IL (United States); Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States); Univ. of California, Berkeley, CA (United States)

    2015-05-21

    The highest brightness temperature ever observed are from "nanoshots" from the Crab pulsar which we argue could be the signature of bursts of vacuum e± pair production. If so this would be the first time the astronomical Schwinger effect has been observed. These "Schwinger sparks" would be an intermittent but extremely powerful, ~103 L, 10 PeV e± accelerator in the heart of the Crab. These nanosecond duration sparks are generated in a volume less than 1 m3 and the existence of such sparks has implications for the small scale structure of the magnetic field of young pulsars such as the Crab. As a result, this mechanism may also play a role in producing other enigmatic bright short radio transients such as fast radio bursts.

  19. Bright Sparks of Our Future!

    Science.gov (United States)

    Riordan, Naoimh

    2016-04-01

    My name is Naoimh Riordan and I am the Vice Principal of Rockboro Primary School in Cork City, South of Ireland. I am a full time class primary teacher and I teach 4th class, my students are aged between 9-10 years. My passion for education has developed over the years and grown towards STEM (Science, Technology, Engineering and Mathematics) subjects. I believe these subjects are the way forward for our future. My passion and beliefs are driven by the unique after school programme that I have developed. It is titled "Sparks" coming from the term Bright Sparks. "Sparks" is an after school programme with a difference where the STEM subjects are concentrated on through lessons such as Science, Veterinary Science Computer Animation /Coding, Eco engineering, Robotics, Magical Maths, Chess and Creative Writing. All these subjects are taught through activity based learning and are one-hour long each week for a ten-week term. "Sparks" is fully inclusive and non-selective which gives all students of any level of ability an opportunity to engage into these subjects. "Sparks" is open to all primary students in County Cork. The "Sparks" after school programme is taught by tutors from the different Universities and Colleges in Cork City. It works very well because the tutor brings their knowledge, skills and specialised equipment from their respective universities and in turn the tutor gains invaluable teaching practise, can trial a pilot programme in a chosen STEM subject and gain an insight into what works in the physical classroom.

  20. COMPARISON OF EFFICACY AND TOLERABILITY OF ORIGINAL AND GENERIC DRUGS OF SIMVASTATIN IN PATIENTS WITH HYPERLIPIDAEMIA AND HIGH RISK OF ISCHEMIC HEART DISEASE COMPLICATIONS

    Directory of Open Access Journals (Sweden)

    S. N. Tolpygina

    2008-01-01

    Full Text Available Aim. To assess efficacy and safety of generic simvastatin, Simvahexal, in comparison with original drug of simvastatin, Zocor, in patients with hyperlipidaemia in short-term study.Material and methods. 30 patients (19 men and 11 women, 64,0±1,8 y.o. with low density lipoprotein (LDL cholesterol ≥3,0 mmol/l and high cardiovascular risk were involved into the study. During 5 weeks before study including patients kept the hypolipidaemic diet and did not receive any hypolipidaemic drug. 28 patients completed study, 2 patients drop out: one patient because of nettle rash on Zocor therapy, another one – because of personal reason. Efficacy was assessed by dynamic of lipid profile and a number of patients who reached target level of LDL cholesterol (<3 mmol/l. Safety was assessed by side effect rate registration. Patients were randomized in 2 groups (G1 and G2: G1 patients (n=15 received Zocor 20 mg/day during 6 weeks, G2 patients (n=15 – Simvahexal 20 mg/day. After 6 weeks of therapy G1 patients were switched from Zocor to Simvahexal, G2 patients did not change their therapy. Simvahexal dose was increased to 30 mg/day, if the target level of LDL cholesterol had not been reached after first 6 weeks of therapy.Results. After switching therapy from Zocor to Simvahexal 11 patients increased the dose to 30 mg/day, 3 patients kept the dose of 20 mg/day, 1 patient drop out. At the beginning of the study 15 patients received Simvahexal 20 mg/day, after 6 weeks the dose was increased to 30 mg/day in 8 patients, 7 patients kept the dose of 20 mg/day. After 6 weeks of therapy with Zocor 20 mg/day levels of the total cholesterol (TC and LDL cholesterol reduced on 25,2% and 33,6% (p<0,001, respectively. Next 6 weeks of therapy with Simvahexal in the average dose of 27,7 mg/day this reduction reached to 30,9% and 39,9% (p<0,001, respectively. After 6 weeks of therapy with Simvahexal 20mg/day levels of the TC and LDL cholesterol reduced on 28,2%and 38%(p<0

  1. High rates of regimen change due to drug toxicity among a cohort of South Indian adults with HIV infection initiated on generic, first-line antiretroviral treatment.

    Science.gov (United States)

    Sivadasan, Ajith; Abraham, O C; Rupali, Priscilla; Pulimood, Susanne A; Rajan, Joyce; Rajkumar, S; Zachariah, Anand; Kannangai, Rajesh; Kandathil, Abraham Joseph; Sridharan, G; Mathai, Dilip

    2009-05-01

    To determine the rates, reasons and predictors of treatment change of the initial antiretroviral treatment (ART) regimen in HIV-infected south Indian adults. In this prospective cohort study, ART-naive adults initiated on generic, fixed dose combination ART as per the National AIDS Control Organization guidelines were followed up at an academic medical center. Treatment change was defined as any event which necessitated a change in or discontinuation of the initial ART regimen. Two hundred and thirty persons with HIV infection (males 74.8% and median age 37 years) were followed up for median duration of 48 weeks. The majority (98.7%) had acquired HIV infection through the heterosexual route. Most (70.4%) had advanced IV infection (WHO clinical stage 3 or 4) and 78% had CD4+ T-lymphocyte counts below 200 cells/microL. The initial ART regimens used were: Lamivudine (3TC) with Stavudine (d4T) (in 76%) or Azidothymidine (AZT) and Nevirapine (NVP) (in 86%) or Efavirenz (EFV). The cumulative incidence of treatment change was 39.6% (91 patients). Drug toxicity (WHO grade 3 or 4) was the reason for treatment change among 62 (27%) (incidence rate 35.9/100 person-years). The most common toxicities were attributable to the thymidine analogue nucleoside reverse transcriptase inhibitors (NRTIs), d4T and AZT [lactic acidosis (8.7%), anemia (7%) and peripheral neuropathy (5.2%)]. The other toxicities were rash (3.9%) and hepatitis (1.3%) due to NVP. The mortality (4.6/100 person-years) and disease progression rates (4.1/100 person-years) were low. The ART regimens used in this study were effective in decreasing disease progression and death. However, they were associated with high rates of drug toxicities, particularly those attributable to thymidine analogue NRTI. As efforts are made to improve access to ART, treatment regimens chosen should not only be potent, but also safe.

  2. Spark channel propagation in a microbubble liquid

    Energy Technology Data Exchange (ETDEWEB)

    Panov, V. A.; Vasilyak, L. M., E-mail: vasilyak@ihed.ras.ru; Vetchinin, S. P.; Pecherkin, V. Ya.; Son, E. E. [Russian Academy of Sciences, Joint Institute for High Temperatures (Russian Federation)

    2016-11-15

    Experimental study on the development of the spark channel from the anode needle under pulsed electrical breakdown of isopropyl alcohol solution in water with air microbubbles has been performed. The presence of the microbubbles increases the velocity of the spark channel propagation and increases the current in the discharge gap circuit. The observed rate of spark channel propagation in microbubble liquid ranges from 4 to 12 m/s, indicating the thermal mechanism of the spark channel development in a microbubble liquid.

  3. Pressure dependence of the spark constant

    Energy Technology Data Exchange (ETDEWEB)

    Hess, H; Radtke, R; Deparade, W [Akademie der Wissenschaften der DDR, Berlin. Zentralinstitut fuer Elektronenphysik

    1978-02-21

    The author's theory on the development of LTE plasmas in low-inductance spark discharges has proved to be a useful tool in predicting the electric behaviour of such sparks. Their earlier experimental work was restricted to only one initial pressure, and in this paper they extend the examined pressure range to obtain some general conclusions on the pressure dependence of the spark behaviour.

  4. Skin rash during treatment with generic itraconazole.

    Science.gov (United States)

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

    2014-04-01

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

  5. Fiber coupled optical spark delivery system

    Science.gov (United States)

    Yalin, Azer; Willson, Bryan; Defoort, Morgan

    2008-08-12

    A spark delivery system for generating a spark using a laser beam is provided, the spark delivery system including a laser light source and a laser delivery assembly. The laser delivery assembly includes a hollow fiber and a launch assembly comprising launch focusing optics to input the laser beam in the hollow fiber. In addition, the laser delivery assembly includes exit focusing optics that demagnify an exit beam of laser light from the hollow fiber, thereby increasing the intensity of the laser beam and creating a spark. In accordance with embodiments of the present invention, the assembly may be used to create a spark in a combustion engine. In accordance with other embodiments of the present invention, a method of using the spark delivery system is provided. In addition, a method of choosing an appropriate fiber for creating a spark using a laser beam is also presented.

  6. Generic medicine and prescribing: A quick assessment

    Directory of Open Access Journals (Sweden)

    Mainul Haque

    2017-01-01

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

  7. 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...

  8. Brand and generic medications: Are they interchangeable

    International Nuclear Information System (INIS)

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

    2008-01-01

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

  9. 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...

  10. Sample preparations for spark source mass spectrography

    International Nuclear Information System (INIS)

    Catlett, C.W.; Rollins, M.B.; Griffin, E.B.; Dorsey, J.G.

    1977-10-01

    Methods have been developed for the preparation of various materials for spark source mass spectrography. The essential features of these preparations (all which can provide adequate precision in a cost-effective manner) consist in obtaining spark-stable electrode sample pieces, a common matrix, a reduction of anomolous effects in the spark, the incorporation of a suitable internal standard for plate response normalization, and a reduction in time

  11. The pressure dependence of the spark constant

    International Nuclear Information System (INIS)

    Hess, H.; Radtke, R.; Deparade, W.

    1978-01-01

    The author's theory on the development of LTE plasmas in low-inductance spark discharges has proved to be a useful tool in predicting the electric behaviour of such sparks. Their earlier experimental work was restricted to only one initial pressure, and in this paper they extend the examined pressure range to obtain some general conclusions on the pressure dependence of the spark behaviour. (author)

  12. New spark test device for material characterization

    CERN Document Server

    Kildemo, Morten

    2004-01-01

    An automated spark test system based on combining field emission and spark measurements, exploiting a discharging capacitor is investigated. In particular, the remaining charge on the capacitor is analytically solved assuming the field emitted current to follow the Fowler Nordheim expression. The latter allows for field emission measurements from pA to A currents, and spark detection by complete discharge of the capacitor. The measurement theory and experiments on Cu and W are discussed.

  13. Programmable spark counter of tracks

    International Nuclear Information System (INIS)

    Denisov, A.E.; Nikolaev, V.A.; Vorobjev, I.B.

    2005-01-01

    For the purpose, a new set-the programmable all-automatic spark counter AIST-4-has been developed and manufactured. Compared to our previous automated spark counter ISTRA, which was operated by the integrated fixed program, the new set is operated completely by a personal computer. The mechanism for pressing and pulling the aluminized foil is put into action by a step motor operated by a microcontroller. The step motor turns an axle. The axle has two eccentrics. One of them moves a pressing plate up and down. The second eccentric moves the aluminized foil by steps of ∼15mm after the end of each pulse counting. One turnover of the axle corresponds to one pulse count cycle. The step motor, the high-voltage block and the pulse count block are operated by the microcontroller PIC 16C84 (Microstar). The set can be operated either manually by keys on the front panel or by a PC using dialogue windows for radon or neutron measurements (for counting of alpha or fission fragment tracks). A number of algorithms are developed: the general procedures, the automatic stopping of the pulse counting, the calibration curve, determination of the count characteristics and elimination of the short circuit in a track

  14. 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

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

    Science.gov (United States)

    Hollis, Aidan

    2002-12-01

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

  16. Spark gap produced plasma diagnostics

    International Nuclear Information System (INIS)

    Chang, H.Y.

    1990-01-01

    A Spark Gap (Applied voltage : 2-8KV, Capacitor : 4 Micro F. Dia of the tube : 1 inch, Electrode distance : .3 ∼.5 inch) was made to generate a small size dynamic plasma. To measure the plasma density and temperature as a function of time and position, we installed and have been installing four detection systems - Mach-Zehnder type Interferometer for the plasma refractivity, Expansion speed detector using two He-Ne laser beams, Image Processing using Lens and A Optical-Fiber Array for Pointwise Radiation Sensing, Faraday Rotation of a Optical Fiber to measure the azimuthal component of B-field generated by the plasma drift. These systems was used for the wire explosion diagnostics, and can be used for the Laser driven plasma also

  17. Spark-safe power source

    Energy Technology Data Exchange (ETDEWEB)

    Mester, I M; Konushkin, N A; Nevozinskiy, A K; Rubinshteyn, B Sh; Serov, V I; Vasnev, M A

    1981-01-01

    A shortcoming of the known power sources is their low reliability. The purpose of the invention is to improve the reliability of the device. This is achieved because the spark-safe power source is equipped with a by-passing transistor and potentiometer, and also a generator of control interruptions in the circuit, an I-element, first separating transformer, control block, second separating transformer whose secondary winding has a relay winding whose contacts are connected to the load circuit are connected in series. The generator of control separations of the circuit is connected to the base of the by-passing transistor and to the power source outlet, the potentiometer is connected in series to the main thyristor. The middle point of the potentiometer is connected to the second inlet of the I-element.

  18. A multicenter experience with generic tacrolimus conversion.

    Science.gov (United States)

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

    2011-09-27

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

  19. GeoSpark SQL: An Effective Framework Enabling Spatial Queries on Spark

    Directory of Open Access Journals (Sweden)

    Zhou Huang

    2017-09-01

    Full Text Available In the era of big data, Internet-based geospatial information services such as various LBS apps are deployed everywhere, followed by an increasing number of queries against the massive spatial data. As a result, the traditional relational spatial database (e.g., PostgreSQL with PostGIS and Oracle Spatial cannot adapt well to the needs of large-scale spatial query processing. Spark is an emerging outstanding distributed computing framework in the Hadoop ecosystem. This paper aims to address the increasingly large-scale spatial query-processing requirement in the era of big data, and proposes an effective framework GeoSpark SQL, which enables spatial queries on Spark. On the one hand, GeoSpark SQL provides a convenient SQL interface; on the other hand, GeoSpark SQL achieves both efficient storage management and high-performance parallel computing through integrating Hive and Spark. In this study, the following key issues are discussed and addressed: (1 storage management methods under the GeoSpark SQL framework, (2 the spatial operator implementation approach in the Spark environment, and (3 spatial query optimization methods under Spark. Experimental evaluation is also performed and the results show that GeoSpark SQL is able to achieve real-time query processing. It should be noted that Spark is not a panacea. It is observed that the traditional spatial database PostGIS/PostgreSQL performs better than GeoSpark SQL in some query scenarios, especially for the spatial queries with high selectivity, such as the point query and the window query. In general, GeoSpark SQL performs better when dealing with compute-intensive spatial queries such as the kNN query and the spatial join query.

  20. Generic Penetration of the SSRI Market.

    Science.gov (United States)

    Cascade, Elisa F; Kalali, Amir H

    2008-04-01

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

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

    Science.gov (United States)

    Carrier, Michael A

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

  2. Analiza nawyków i zachowań związanych ze stosowaniem leków oryginalnych i generycznych = The analysis of behaviour related to the use of original and generic drugs

    Directory of Open Access Journals (Sweden)

    Piotr Kozłowski

    2015-08-01

    generic drugs. The study included 108 people. In the study group, women accounted for 67.6% of respondents, while 32.4% were men. The age of the respondents ranged from 20 to 60. The study was conducted in the period from January to February 2015 and it employed standardized interview research method. Research tool, which was used for data collection was a questionnaire consisted of 29 questions multiple-choice questions. Statistical analysis was performed using the chi-square test. All values for which p <0.05 (probability of error were considered statistically significant.                 For the participants, the most important factor influencing the choice of particular drug was the price of the product. The difference was related to gender as 58.9% of female and only 37.1% male respondents agreed on the relevance of the price. The majority of the respondents (60.2% had never been asked by a pharmacist about their price-dependent preferences. One third of the respondents (32.4% had never been offered a cheaper generic equivalent for a brand-name drug. Most participants of the study (69.4% always or occasionally chose to buy a cheaper generic equivalent fro a brand-name drug. The participants knowledge about original and generic drugs was also analysed and evaluated. According to one third (34.3% of the respondents the generic products had effects identical to the original drugs. Being asked if the two groups products have the same composition, 50.9% of respondents did not know the answer.   Key words: generic drug, generics.

  3. Bubbles, sparks, and the postwar laboratory

    International Nuclear Information System (INIS)

    Galison, P.

    1989-01-01

    The development and use of bubble chambers and spark chambers in the 1950s form the main thrust of this article, the bubble chamber as an example of ''image-producing'' instruments and the spark chamber as a ''logic'' device. Work on a cloud chamber by Glaser led to the development of the bubble chamber detector using liquid hydrogen, which was later linked to a computer for accurate automatic track analysis. It made possible demonstrations of the existence of a particle or interaction. Spark chambers were easier to build and so soon became common, various types being developed across the world. The development of spark chambers originated in the need for timing devices for the Manhattan Project, but work on their design occurred in a number of units worldwide. (UK)

  4. SPARK: Adapting Keyword Query to Semantic Search

    Science.gov (United States)

    Zhou, Qi; Wang, Chong; Xiong, Miao; Wang, Haofen; Yu, Yong

    Semantic search promises to provide more accurate result than present-day keyword search. However, progress with semantic search has been delayed due to the complexity of its query languages. In this paper, we explore a novel approach of adapting keywords to querying the semantic web: the approach automatically translates keyword queries into formal logic queries so that end users can use familiar keywords to perform semantic search. A prototype system named 'SPARK' has been implemented in light of this approach. Given a keyword query, SPARK outputs a ranked list of SPARQL queries as the translation result. The translation in SPARK consists of three major steps: term mapping, query graph construction and query ranking. Specifically, a probabilistic query ranking model is proposed to select the most likely SPARQL query. In the experiment, SPARK achieved an encouraging translation result.

  5. Experimental study of a spark-gap

    International Nuclear Information System (INIS)

    Bruzzone, H.; Moreno, C.; Vieytes, R.

    1990-01-01

    Some experimental results concerning to the resistance of an atmospheric pressure spark-gap, operating in the self breakdown regime are presented. The influence of the energy discharging through the gap on this resistance is discussed. (Author)

  6. Electro-spark deposition technology

    Energy Technology Data Exchange (ETDEWEB)

    Johnson, R.N. [Pacific Northwest National Lab., Richland, WA (United States)

    1997-12-01

    Electro-Spark Deposition (ESD) is a micro-welding process that uses short duration, high-current electrical pulses to deposit or alloy a consumable electrode material onto a metallic substrate. The ESD process was developed to produce coatings for use in severe environments where most other coatings fail. Because of the exceptional damage resistance of these coatings, and the versatility of the process to apply a wide variety of alloys, intermetallics, and cermets to metal surfaces, the ESD process has been designated critical to the life and economy of the advanced fossil energy systems as the higher temperatures and corrosive environments exceed the limits of known structural materials to accommodate the service conditions. Developments include producing iron aluminide-based coatings with triple the corrosion resistance of the best previous Fe{sub 3}Al coatings, coatings with refractory metal diffusion barriers and multi layer coatings for achieving functionally gradient properties between the substrate and the surface. A new development is the demonstration of advanced aluminide-based ESD coatings for erosion and wear applications. One of the most significant breakthroughs to occur in the last dozen years is the discovery of a process regime that yields an order of magnitude increase in deposition rates and achievable coating thicknesses. Achieving this regime has required the development of advanced ESD electronic capabilities. Development is now focused on further improvements in deposition rates, system reliability when operating at process extremes, and economic competitiveness.

  7. Papel de los fármacos antiepilépticos genéricos en el tratamiento de la epilepsia infantil Role of generic antiepileptic drugs in the treatment of childhood epilepsy

    Directory of Open Access Journals (Sweden)

    Jaime Campos-Castelló

    2009-01-01

    Full Text Available La aparición de fármacos genéricos en el mercado, en sustitución de marcas registradas®, y las adecuadas regulaciones de las autoridades sanitarias en los distintos países ha condicionado hasta la actualidad una polémica sobre el riesgo costo/beneficio de tal sustitución en el paciente afecto de epilepsia. El binomio costo/beneficio debe dar por demostrado de manera clara que el paciente puede beneficiarse de tal sustitución sin correr riesgo alguno significativo. Por ello se valoran los distintos aportes en la literatura médica al respecto, que analizan estos riesgos y beneficios y en especial el hecho esencial de la bioequivalencia de ambas formulaciones, en especial en las situaciones de aquellos fármacos antiepilépticos de margen o índice terapéutico estrecho que hagan inviable la equivalencia de la biodisponibilidad del fármaco, la ausencia de repercusión clínica real en el paciente así como la evidencia que existe un beneficio económico claro al valorar el citado binomio riesgo/beneficio. La revisión efectuada señala la clara existencia de desventajas potenciales del cambio de un fármaco antiepiléptico (FAE original de marca a un genérico como: distinta biodisponibilidad, bioequivalencia no demostrada, riesgo de reaparición de crisis en pacientes controlados y variabilidad de la respuesta de los FAE en el paciente epiléptico, imposible de predecir. Por ello se aconseja valorar la importancia de un fracaso terapéutico tras un cambio a genérico, en especial en casos de margen terapéutico estrecho, la biodisponibilidad permisible con valoración de la variabilidad individual del paciente, situación médico-legal de tal cambio y la realidad de los ahorros y costos potenciales derivados.The use of generic instead of trade mark antiepileptic drugs raises the question of cost/benefit risks. The efficacy and side effects of the generic AED should be similar to the trade mark drugs. Otherwise, the substitution is not

  8. Drugs Approved for Neuroblastoma

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for neuroblastoma. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  9. Drugs Approved for Leukemia

    Science.gov (United States)

    This page lists cancer drugs approved by the FDA for use in leukemia. The drug names link to NCI's Cancer Drug Information summaries. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters.

  10. Drugs Approved for Retinoblastoma

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for retinoblastoma. The list includes generic names and brand names. The drug names link to NCI’s Cancer Drug Information summaries.

  11. Generic maintenance immunosuppression in solid organ transplant recipients.

    Science.gov (United States)

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

    2011-11-01

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

  12. A Experimental Study of the Growth of Laser Spark and Electric Spark Ignited Flame Kernels.

    Science.gov (United States)

    Ho, Chi Ming

    1995-01-01

    Better ignition sources are constantly in demand for enhancing the spark ignition in practical applications such as automotive and liquid rocket engines. In response to this practical challenge, the present experimental study was conducted with the major objective to obtain a better understanding on how spark formation and hence spark characteristics affect the flame kernel growth. Two laser sparks and one electric spark were studied in air, propane-air, propane -air-nitrogen, methane-air, and methane-oxygen mixtures that were initially at ambient pressure and temperature. The growth of the kernels was monitored by imaging the kernels with shadowgraph systems, and by imaging the planar laser -induced fluorescence of the hydroxyl radicals inside the kernels. Characteristic dimensions and kernel structures were obtained from these images. Since different energy transfer mechanisms are involved in the formation of a laser spark as compared to that of an electric spark; a laser spark is insensitive to changes in mixture ratio and mixture type, while an electric spark is sensitive to changes in both. The detailed structures of the kernels in air and propane-air mixtures primarily depend on the spark characteristics. But the combustion heat released rapidly in methane-oxygen mixtures significantly modifies the kernel structure. Uneven spark energy distribution causes remarkably asymmetric kernel structure. The breakdown energy of a spark creates a blast wave that shows good agreement with the numerical point blast solution, and a succeeding complex spark-induced flow that agrees reasonably well with a simple puff model. The transient growth rates of the propane-air, propane-air -nitrogen, and methane-air flame kernels can be interpreted in terms of spark effects, flame stretch, and preferential diffusion. For a given mixture, a spark with higher breakdown energy produces a greater and longer-lasting enhancing effect on the kernel growth rate. By comparing the growth

  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...... 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...

  14. Efficient Generic Functional Programming

    NARCIS (Netherlands)

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

    2005-01-01

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

  15. Optimizing Generic Functions

    NARCIS (Netherlands)

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

    2004-01-01

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

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

    Science.gov (United States)

    King, Derek R; Kanavos, Panos

    2002-08-01

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

  17. In vitro dissolution of generic immediate-release solid oral dosage forms containing BCS class I drugs: comparative assessment of metronidazole, zidovudine, and amoxicillin versus relevant comparator pharmaceutical products in South Africa and India.

    Science.gov (United States)

    Reddy, Nallagundla H S; Patnala, Srinivas; Löbenberg, Raimar; Kanfer, Isadore

    2014-10-01

    Biowaivers are recommended for immediate-release solid oral dosage forms using dissolution testing as a surrogate for in vivo bioequivalence studies. Several guidance are currently available (the World Health Organization (WHO), the US FDA, and the EMEA) where the conditions are described. In this study, definitions, criteria, and methodologies according to the WHO have been applied. The dissolution performances of immediate-release metronidazole, zidovudine, and amoxicillin products purchased in South African and Indian markets were compared to the relevant comparator pharmaceutical product (CPP)/reference product. The dissolution performances were studied using US Pharmacopeia (USP) apparatus 2 (paddle) set at 75 rpm in each of three dissolution media (pH1.2, 4.5, and 6.8). Concentrations of metronidazole, zidovudine, and amoxicillin in each dissolution media were determined by HPLC. Of the 11 metronidazole products tested, only 8 could be considered as very rapidly dissolving products as defined by the WHO, whereas 2 of those products could be considered as rapidly dissolving products but did not comply with the f 2 acceptance criteria in pH 6.8. All 11 zidovudine products were very rapidly dissolving, whereas in the case of the 14 amoxicillin products tested, none of those products met any of the WHO criteria. This study indicates that not all generic products containing the same biopharmaceutics classification system (BCS) I drug and in similar strength and dosage form are necessarily in vitro equivalent. Hence, there is a need for ongoing market surveillance to determine whether marketed generic products containing BCS I drugs meet the release requirements to confirm their in vitro bioequivalence to the respective reference product.

  18. Generic Switching and Non-Persistence among Medicine Users

    DEFF Research Database (Denmark)

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

    2015-01-01

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

  19. A propósito de un caso: ¿Sirven los genéricos para moderar el gasto en hipertensión? Apropos of a case: do generic drugs help control expenditure on hypertension?

    Directory of Open Access Journals (Sweden)

    Antonio J. García

    2004-04-01

    farmacia.Objetive: In this article we analyze the influence of generic drugs on pharmaceutical expenditure on hypertension from the payer's perspective (the public health service, by examining the most widely used drugs: angiotensin converting enzyme inhibitors (ACEi and angiotensin II receptor blockers (ARBs. Methods: Based on billing data to the public health service from all the pharmacies in the Health Area of Malaga, we studied the utilization (containers and cost of ACEi (generic drugs -ACEi+G- and brand name and ARBs (brand name only (subgroup C09 - ATC index from 1999 to 2002. The mean price (weighted according to sales and the percentage of deviation of prescriptions from one group of drugs to another was also studied. Results: The increase in consumption of packages in subgroup C09 was 20.79%; the increase was greater for ARBs (136% and for ACEi+G (177%. The total amount spent during the study period increased by more than 42%. Expenditure on ACEis decreased by almost 7%, despite the increase in expenditure on ACEi+G, whereas expenditure on ARBs increased by more than 154%. The mean price of this subgroup, weighted according to sales, increased by nearly 18%. The mean weighted price of the generic drugs, captopril and enalapril, and that of the brand name, trandolapril, decrea sed. Notable among ARBs was the increase in mean price weighted according to sales of irbesartan (9% and valsartan (16%. Conclusions: The use of generic drugs has reduced expenditure on ACEi and the mean weighted price of the subgroup. However, the increased use of generic drugs has not produced the expected savings for the Department of Health. This could be due to deviation of prescription scores toward drugs not affected by substitution by the pharmacy.

  20. Scattering profiles of sparks and combustibility of filter against hot sparks

    International Nuclear Information System (INIS)

    Asazuma, Shinichiro; Okada, Takashi; Kashiro, Kashio

    2004-01-01

    The glove-box dismantling facility in the Plutonium Fuel Production Facility is developed to dismantle after-service glove-boxes with remote-controlled devices such as an arm-type manipulator. An abrasive wheel cutter, which is used to size reduce the gloveboxes, generates sparks during operation. This dispersing spark was a problem from the fire prevention point of view. A suitable spark control measures for this operation were required. We developed panels to minimize spark dispersion, shields to prevent the income of sparks to the pre-filter, and incombustible pre-filters. The equipment was tested and effectiveness was confirmed. This report provides the results of these tests. (author)

  1. Laser spark distribution and ignition system

    Science.gov (United States)

    Woodruff, Steven [Morgantown, WV; McIntyre, Dustin L [Morgantown, WV

    2008-09-02

    A laser spark distribution and ignition system that reduces the high power optical requirements for use in a laser ignition and distribution system allowing for the use of optical fibers for delivering the low peak energy pumping pulses to a laser amplifier or laser oscillator. An optical distributor distributes and delivers optical pumping energy from an optical pumping source to multiple combustion chambers incorporating laser oscillators or laser amplifiers for inducing a laser spark within a combustion chamber. The optical distributor preferably includes a single rotating mirror or lens which deflects the optical pumping energy from the axis of rotation and into a plurality of distinct optical fibers each connected to a respective laser media or amplifier coupled to an associated combustion chamber. The laser spark generators preferably produce a high peak power laser spark, from a single low power pulse. The laser spark distribution and ignition system has application in natural gas fueled reciprocating engines, turbine combustors, explosives and laser induced breakdown spectroscopy diagnostic sensors.

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

    Science.gov (United States)

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

    2011-02-01

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

  3. Spark - a modern approach for distributed analytics

    CERN Multimedia

    CERN. Geneva; Kothuri, Prasanth

    2016-01-01

    The Hadoop ecosystem is the leading opensource platform for distributed storing and processing big data. It is a very popular system for implementing data warehouses and data lakes. Spark has also emerged to be one of the leading engines for data analytics. The Hadoop platform is available at CERN as a central service provided by the IT department. By attending the session, a participant will acquire knowledge of the essential concepts need to benefit from the parallel data processing offered by Spark framework. The session is structured around practical examples and tutorials. Main topics: Architecture overview - work distribution, concepts of a worker and a driver Computing concepts of transformations and actions Data processing APIs - RDD, DataFrame, and SparkSQL

  4. Using SPARK as a Solver for Modelica

    Energy Technology Data Exchange (ETDEWEB)

    Wetter, Michael; Wetter, Michael; Haves, Philip; Moshier, Michael A.; Sowell, Edward F.

    2008-06-30

    Modelica is an object-oriented acausal modeling language that is well positioned to become a de-facto standard for expressing models of complex physical systems. To simulate a model expressed in Modelica, it needs to be translated into executable code. For generating run-time efficient code, such a translation needs to employ algebraic formula manipulations. As the SPARK solver has been shown to be competitive for generating such code but currently cannot be used with the Modelica language, we report in this paper how SPARK's symbolic and numerical algorithms can be implemented in OpenModelica, an open-source implementation of a Modelica modeling and simulation environment. We also report benchmark results that show that for our air flow network simulation benchmark, the SPARK solver is competitive with Dymola, which is believed to provide the best solver for Modelica.

  5. High performance Spark best practices for scaling and optimizing Apache Spark

    CERN Document Server

    Karau, Holden

    2017-01-01

    Apache Spark is amazing when everything clicks. But if you haven’t seen the performance improvements you expected, or still don’t feel confident enough to use Spark in production, this practical book is for you. Authors Holden Karau and Rachel Warren demonstrate performance optimizations to help your Spark queries run faster and handle larger data sizes, while using fewer resources. Ideal for software engineers, data engineers, developers, and system administrators working with large-scale data applications, this book describes techniques that can reduce data infrastructure costs and developer hours. Not only will you gain a more comprehensive understanding of Spark, you’ll also learn how to make it sing. With this book, you’ll explore: How Spark SQL’s new interfaces improve performance over SQL’s RDD data structure The choice between data joins in Core Spark and Spark SQL Techniques for getting the most out of standard RDD transformations How to work around performance issues i...

  6. 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....

  7. Chaotic combustion in spark ignition engines

    International Nuclear Information System (INIS)

    Wendeker, Miroslaw; Czarnigowski, Jacek; Litak, Grzegorz; Szabelski, Kazimierz

    2003-01-01

    We analyse the combustion process in a spark ignition engine using the experimental data of an internal pressure during the combustion process and show that the system can be driven to chaotic behaviour. Our conclusion is based on the observation of unperiodicity in the time series, suitable stroboscopic maps and a complex structure of a reconstructed strange attractor. This analysis can explain that in some circumstances the level of noise in spark ignition engines increases considerably due to nonlinear dynamics of a combustion process

  8. The suppression of destructive sparks in parallel plate proportional counters

    Energy Technology Data Exchange (ETDEWEB)

    Cockshott, R.A.; Mason, I.M.

    1984-02-01

    The authors find that high energy background events produce localised sparks in parallel plate counters when operated in the proportional mode. These sparks increase dead-time and lead to degradation ranging from electrode damage to spurious pulsing and continuous breakdown. The problem is particularly serious in low energy photon detectors for X-ray astronomy which are required to have lifetimes of several years in the high radiation environment of space. For the parallel plate imaging detector developed for the European X-ray Observatory Satellite (EXOSAT) they investigate quantitatively the spark thresholds, spark rates and degradation processes. They discuss the spark mechanism, pointing out differences from the situation in spark chambers and counters. They show that the time profile of the sparks allows them to devise a spark suppression system which reduces the degradation rate by a factor of ''200.

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

    Science.gov (United States)

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

    2006-10-01

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

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

    Directory of Open Access Journals (Sweden)

    Michael R Law

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

  11. Scripting XML with Generic Haskell

    NARCIS (Netherlands)

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

    2003-01-01

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

  12. Scripting XML with Generic Haskell

    NARCIS (Netherlands)

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

    2007-01-01

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

  13. Modelling Spark Integration in Science Classroom

    Directory of Open Access Journals (Sweden)

    Marie Paz E. Morales

    2014-02-01

    Full Text Available The study critically explored how a PASCO-designed technology (SPARK ScienceLearning System is meaningfully integrated into the teaching of selected topics in Earth and Environmental Science. It highlights on modelling the effectiveness of using the SPARK Learning System as a primary tool in learning science that leads to learning and achievement of the students. Data and observation gathered and correlation of the ability of the technology to develop high intrinsic motivation to student achievement were used to design framework on how to meaningfully integrate SPARK ScienceLearning System in teaching Earth and Environmental Science. Research instruments used in this study were adopted from standardized questionnaires available from literature. Achievement test and evaluation form were developed and validated for the purpose of deducing data needed for the study. Interviews were done to delve into the deeper thoughts and emotions of the respondents. Data from the interviews served to validate all numerical data culled from this study. Cross-case analysis of the data was done to reveal some recurring themes, problems and benefits derived by the students in using the SPARK Science Learning System to further establish its effectiveness in the curriculum as a forerunner to the shift towards the 21st Century Learning.

  14. Generation of Nanoparticles by Spark Discharge

    NARCIS (Netherlands)

    Salman Tabrizi, N.

    2009-01-01

    Spark discharge is a method for producing nanoparticles from conductive materials. Besides the general advantages of nanoparticle synthesis in the gas phase, the method offers additional advantages like simplicity, compactness and versatility. The synthesis process is continuous and is performed at

  15. Ambient fields generated by a laser spark

    Czech Academy of Sciences Publication Activity Database

    Rohlena, Karel; Mašek, Martin

    2016-01-01

    Roč. 61, č. 2 (2016), s. 119-124 ISSN 0029-5922 R&D Projects: GA MŠk(CZ) LD14089; GA MŠk(CZ) LG13031 Institutional support: RVO:68378271 Keywords : laser spark * radiation chemistry * field generation Subject RIV: BL - Plasma and Gas Discharge Physics Impact factor: 0.760, year: 2016

  16. Electro-spark machining of cadmium antimonide

    International Nuclear Information System (INIS)

    Ivanovskij, V.N.; Stepakhina, K.A.

    1975-01-01

    Experimental data on electrical erosion of the semiconductor material (cadmium antimonide) alloyed with tellurium are given. The potentialisies and expediency of using the electric-spark method of cutting cadmium antimonide ingots with the resistivity of 1 ohm is discussed. Cutting has been carried out in distilled water and in the air

  17. Efficiency calibration of solid track spark auto counter

    International Nuclear Information System (INIS)

    Wang Mei; Wen Zhongwei; Lin Jufang; Liu Rong; Jiang Li; Lu Xinxin; Zhu Tonghua

    2008-01-01

    The factors influencing detection efficiency of solid track spark auto counter were analyzed, and the best etch condition and parameters of charge were also reconfirmed. With small plate fission ionization chamber, the efficiency of solid track spark auto counter at various experiment assemblies was re-calibrated. The efficiency of solid track spark auto counter at various experimental conditions was obtained. (authors)

  18. Medicamentos genéricos no Brasil: impactos das políticas públicas sobre a indústria nacional Generic drugs in Brazil: impacts of public policies upon the national industry

    Directory of Open Access Journals (Sweden)

    Cristiane Quental

    2008-04-01

    Full Text Available O presente artigo faz eco a trabalhos recentes da Abrasco¹, Gadelha² e Guimarães³, que enfatizam a necessidade de uma maior integração entre as políticas voltadas para o desenvolvimento do sistema de saúde e aquelas voltadas para a promoção do desenvolvimento industrial e da inovação, como forma de garantir para o país os benefícios econômicos gerados pelos gastos em saúde, assegurando a continuidade da política social, num círculo virtuoso. Embora apresente o caso dos medicamentos genéricos como uma experiência de sucesso na integração das políticas sociais voltadas para um maior acesso da população a medicamentos com qualidade garantida, com as políticas econômicas voltadas para o desenvolvimento industrial, discute os impactos e as limitações da política dialogando com a análise da competitividade da indústria de medicamentos genéricos brasileira realizada por Abreu4.This paper echoes recent works of Abrasco¹, Gadelha² and Guimarães³ emphasizing the need for a better integration between health policies and industrial development and innovation policies as the only way to keep the economic benefits generated by health expenditures in the country instead of letting them escape through imports and threaten the continuity of the social policy by growing trade deficits. Although presenting the generic drug policy as a successful case in integrating social policies aimed at a better access to quality drugs for the population with economic policies aimed at industrial development, this paper discusses the impacts and limitations of the referred policy in a dialog with Abreu's analysis of industrial competitiveness in the Brazilian generics industry.

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

    Science.gov (United States)

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

    2014-06-01

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

  20. DeepSpark: A Spark-Based Distributed Deep Learning Framework for Commodity Clusters

    OpenAIRE

    Kim, Hanjoo; Park, Jaehong; Jang, Jaehee; Yoon, Sungroh

    2016-01-01

    The increasing complexity of deep neural networks (DNNs) has made it challenging to exploit existing large-scale data processing pipelines for handling massive data and parameters involved in DNN training. Distributed computing platforms and GPGPU-based acceleration provide a mainstream solution to this computational challenge. In this paper, we propose DeepSpark, a distributed and parallel deep learning framework that exploits Apache Spark on commodity clusters. To support parallel operation...

  1. Generic phytosanitary irradiation treatments

    International Nuclear Information System (INIS)

    Hallman, Guy J.

    2012-01-01

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

  2. Is bioavailability altered in generic versus brand anticonvulsants?

    Science.gov (United States)

    Jankovic, Slobodan M; Ignjatovic Ristic, Dragana

    2015-03-01

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

  3. 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.

  4. 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.

  5. Promoting and regulating generic medicines: Brazil in comparative perspective

    Directory of Open Access Journals (Sweden)

    Elize Massard da Fonseca

    2017-04-01

    Full Text Available ABSTRACT Promoting the use of generic drugs can constitute a core instrument for countries’ national pharmaceutical policies, one that reduces drug expenditure while expanding health care access. Despite the potential importance of such policy measures and the differences among national practices, scholars embarking on comparative analysis lack a roadmap for determining which dimensions of generic drug policy to assess and compare. This report fills that gap by considering national rules and regulations across four dimensions deemed crucial to any evaluation: demonstrated therapeutic equivalence; pharmaceutical packaging and labeling; drug prescription; and drug substitution. Furthermore, this report examines how the diverse interests of public and private sector stakeholders might shape generic drug policy and its implementation. To illustrate the challenges and conflicts behind policy development and implementation, this report focuses on the case of Brazil.

  6. Integration of generic issues

    International Nuclear Information System (INIS)

    Thatcher, D.

    1989-01-01

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

  7. 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.

  8. Drugs Approved for Esophageal Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for esophageal cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  9. Drugs Approved for Liver Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for liver cancer. The list includes generic names and brand names. The drug names link to NCI’s Cancer Drug Information summaries.

  10. Drugs Approved for Kaposi Sarcoma

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for Kaposi sarcoma. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  11. Drugs Approved for Vaginal Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) to prevent vaginal cancer. The list includes generic names and brand names. The drug names link to NCI’s Cancer Drug Information summaries.

  12. Drugs Approved for Skin Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for skin cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  13. Drugs Approved for Vulvar Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for vulvar cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  14. Drugs Approved for Wilms Tumor

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for Wilms tumor and other childhood kidney cancers. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  15. Drugs Approved for Bone Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for bone cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  16. Drugs Approved for Malignant Mesothelioma

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for malignant mesothelioma. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  17. Drugs Approved for Penile Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for penile cancer. The list includes generic names and brand names. The drug names link to NCI’s Cancer Drug Information summaries.

  18. Drugs Approved for Endometrial Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for endometrial cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  19. Generic clearance values

    International Nuclear Information System (INIS)

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

    2009-01-01

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

  20. Generic Clearance Values

    International Nuclear Information System (INIS)

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

    2010-01-01

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

  1. Generic phytosanitary irradiation treatments

    Science.gov (United States)

    Hallman, Guy J.

    2012-07-01

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

  2. Generic phytosanitary irradiation treatments

    Energy Technology Data Exchange (ETDEWEB)

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

    2013-01-15

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

  3. The generic strategy trap.

    Science.gov (United States)

    Miller, D

    1992-01-01

    Management experts claim that for a company to thrive, it must concentrate on a single generic strategy--on one thing it does better than its rivals. But specialization also has its disadvantages. The author suggests that a broader, mixed approach may be preferable.

  4. Patients' concern about their medicine after a generic switch

    DEFF Research Database (Denmark)

    Østergaard Rathe, Jette; Søndergaard, Jens; Jarbøl, Dorte E

    2014-01-01

    PURPOSE: This study aims to investigate the possible association between patients' concerns about their medicine and generic switch. METHODS: Cross-sectional survey was carried out comprising responses from 2217 randomly selected persons aged 20 years or older and living in the Region of Southern...... Denmark, who had redeemed generically substitutable drugs in September 2008. For each patient, we focused on the purchase of one generically substitutable drug (index drug). We applied the specific concerns subscale from the Beliefs about Medicine Questionnaire (BMQ) to analyse lack of confidence....... RESULTS: No statistically significant associations were found between concerns about the index medicine and the generic switch (-0.02 95% CI: -0.10; 0.05). Viewing medicines as harmful in general was associated with increased concerns (BMQ general harm: 0.39 95% CI: 0.30; 0.47 and BMQ general overuse: 0...

  5. Trace amount analysis using spark mass spectrometry

    International Nuclear Information System (INIS)

    Stefani, Rene

    1975-01-01

    Characteristics of spark mass spectrometers (ion source, properties of the ion beam, ion optics, and performance) and their use in qualitative and quantitative analysis are described. This technique is very interesting for the semi-quantitative analysis of trace amounts, down to 10 -8 atoms. Examples of applications such as the analysis of high purity materials and non-conducting mineral samples, and determination of carbon and gas trace amounts are presented. (50 references) [fr

  6. Neutron bursts from long laboratory sparks

    Science.gov (United States)

    Kochkin, P.; Lehtinen, N. G.; Montanya, J.; Van Deursen, A.; Ostgaard, N.

    2016-12-01

    Neutron emission in association with thunderstorms and lightning discharges was reported by different investigators from ground-based observation platforms. In both cases such emission is explained by photonuclear reaction, since high-energy gamma-rays in sufficient fluxes are routinely detected from both, lightning and thunderclouds. The required gamma-rays are presumably generated by high-energy electrons in Bremsstrahlung process after their acceleration via cold and/or relativistic runaway mechanisms. This phenomenon attracted moderate scientific attention until fast neutron bursts (up to 10 MeV) from long 1 MV laboratory sparks have been reported. Clearly, with such relatively low applied voltage the electrons are unable to accelerate to the energies required for photo/electro disintegration. Moreover, all known elementary neutron generation processes are not capable to explain this emission right away. We performed an independent laboratory experiment on long sparks with the aim to confirm or disprove the neutron emission from them. The experimental setup was assembled at High-Voltage Laboratory in Barcelona and contained a Marx generator in a cone-cone spark gap configuration. The applied voltage was as low as 800 kV and the gap distance was only 60 cm. Two ns-fast cameras were located near the gap capturing short-exposure images of the pre-breakdown phenomenon at the expected neutron generation time. A plastic scintillation detector sensitive to neutrons was covered in 11 cm of lead and placed near the spark gap. The detector was calibrated and showed good performance in neutron detection. Apart of it, voltage, currents through both electrodes, and three X-ray detectors were also monitored in sophisticated measuring system. We will give an overview of the previous experimental and theoretical work in this topic, and present the results of our new experimental campaign. The conclusions are based on good signal-to-noise ratio measurements and are

  7. Spark plasma sintering of tantalum carbide

    International Nuclear Information System (INIS)

    Khaleghi, Evan; Lin, Yen-Shan; Meyers, Marc A.; Olevsky, Eugene A.

    2010-01-01

    A tantalum carbide powder was consolidated by spark plasma sintering. The specimens were processed under various temperature and pressure conditions and characterized in terms of relative density, grain size, rupture strength and hardness. The results are compared to hot pressing conducted under similar settings. It is shown that high densification is accompanied by substantial grain growth. Carbon nanotubes were added to mitigate grain growth; however, while increasing specimens' rupture strength and final density, they had little effect on grain growth.

  8. The generics in transplantation and the rules on their use.

    Science.gov (United States)

    Masri, Marwan

    2003-06-01

    By definition a product identified by its official chemical name rather than an advertised brand name is called a generic. If a drug exert its pharmacological effects at the same site, have the same potency, same dosage form and same bioavailability as a brand name, reference listed drug (RLD), is considered as a generic. However inactive ingredients can differ between brand name and generic. It is through the regulations of the FDA that the generics gained many ground in the drug market, they currently account to more than 42% of the total prescription in the USA. These regulations include the abbreviated new drug application (ANDA) for the registration process and drug substitution at the pharmacy level without patient or physician consent. This coupled with a keen interest of third party payers and the health authorities to reduce the high transplant health budget (over 2 Billion US $) made it a necessity to introduce the generics into the field of transplantation. Using the above mentioned definition we can theoretically say that all anti-lymphocytes, produced in the same animal species, are generic of each. Moreover, monoclonal antibodies that are directed against the same target and have the same bioavailability are also consider generics to each other. Of all the immunosuppressive drugs that have been introduced into the field of transplantation none has been as dominant as Cyclosporine. Cyclosporine became and still is the backbone for any immunosuppressive protocol. In the year 1992, Consupren, the first, non-FDA approved, generic to Sandimmun was introduced. Although Consupren was not bioequivalent to Neoral, however, long-term results in kidney transplantation have been similar for both drugs. The introduction of Consupren resulted in a near 40% reduction in the total cost of immunosuppressive therapy. Interestingly the cost of the brand name drug Neoral was also reduced by 20%. The cost reduction allowed the introduction of the new immunosuppressive

  9. [Acceptance of generic prescribing in general practice: effect of patient education and reference prices].

    Science.gov (United States)

    Vallès, J A; Barreiro, M; Cereza, G; Ferro, J J; Martínez, M J; Cucurull, E; Barceló, E

    2002-01-01

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

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

    Science.gov (United States)

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

    2017-10-01

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

  11. 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.

  12. Generics Pricing: The Greek Paradox.

    Science.gov (United States)

    Karafyllis, Ioannis; Variti, Lamprini

    2017-01-01

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

  13. Generic Reed Solomon Encorder

    Directory of Open Access Journals (Sweden)

    Petrus Mursanto

    2006-11-01

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

  14. Generic safety documentation model

    International Nuclear Information System (INIS)

    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

  15. Generic policy in Bulgaria: a policy of failure or success?

    Directory of Open Access Journals (Sweden)

    Assena Stoimenova

    2016-09-01

    Full Text Available Generic medicines play a key role in managing the financial resources for pharmaceuticals in every country. This study analysed the generic policy legislative framework in Bulgaria with the aim to identify whether the policy implementation can be considered successful in the light of an international review of such policies introduced in other countries, or on the contrary, it has failed to deliver the main benefits. Legislative analysis, desktop study and macroeconomic overview of the Bulgarian pharmaceutical market were included. The study showed that only 3 out of 11 important policy elements are implemented in the country. Bulgaria has one of the highest shares of generics, an average of 81.39% (volume, for the studied period (2006–2014. However, further research is needed to evaluate the success of the existing generic policy in Bulgaria, as the market share of generic drugs is not the only measure of the policy efficiency.

  16. An audit of generic prescribing in a general surgical department.

    LENUS (Irish Health Repository)

    Gleeson, M

    2013-01-17

    BACKGROUND: The Health Service Executive introduced a generic prescription policy to reduce costs. Despite this, generic prescription rates remain low. AIM: To audit in-patient prescription practice in a single surgical department and identify potential savings which could be realised by adherence to the generic prescribing policy. METHODS: Surgical in-patient charts were obtained at the point of discharge and their drug prescription information was recorded. RESULTS: 51 % of prescriptions involved a trade-name prescription where an appropriate generic equivalent existed. The cost implications for hospital and community patients were found to be greatly affected by substitution policies that exist at hospital pharmacy level. CONCLUSION: There is a need to promote greater adherence to generic prescribing amongst hospital doctors in line with international best practice. It can have a positive impact in terms of safe prescribing and can have cost implications at both hospital and community level.

  17. Generic switching of warfarin and risk of excessive anticoagulation

    DEFF Research Database (Denmark)

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

    2016-01-01

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

  18. Associations between generic substitution and patient-related factors

    DEFF Research Database (Denmark)

    Østergaard Rathe, Jette

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

  19. Big Data Analytics with Datalog Queries on Spark.

    Science.gov (United States)

    Shkapsky, Alexander; Yang, Mohan; Interlandi, Matteo; Chiu, Hsuan; Condie, Tyson; Zaniolo, Carlo

    2016-01-01

    There is great interest in exploiting the opportunity provided by cloud computing platforms for large-scale analytics. Among these platforms, Apache Spark is growing in popularity for machine learning and graph analytics. Developing efficient complex analytics in Spark requires deep understanding of both the algorithm at hand and the Spark API or subsystem APIs (e.g., Spark SQL, GraphX). Our BigDatalog system addresses the problem by providing concise declarative specification of complex queries amenable to efficient evaluation. Towards this goal, we propose compilation and optimization techniques that tackle the important problem of efficiently supporting recursion in Spark. We perform an experimental comparison with other state-of-the-art large-scale Datalog systems and verify the efficacy of our techniques and effectiveness of Spark in supporting Datalog-based analytics.

  20. Liquid-Arc/Spark-Excitation Atomic-Emission Spectroscopy

    Science.gov (United States)

    Schlagen, Kenneth J.

    1992-01-01

    Constituents of solutions identified in situ. Liquid-arc/spark-excitation atomic-emission spectroscopy (LAES) is experimental variant of atomic-emission spectroscopy in which electric arc or spark established in liquid and spectrum of light from arc or spark analyzed to identify chemical elements in liquid. Observations encourage development of LAES equipment for online monitoring of process streams in such industries as metal plating, electronics, and steel, and for online monitoring of streams affecting environment.

  1. Development of a SPARK Training Dataset

    International Nuclear Information System (INIS)

    Sayre, Amanda M.; Olson, Jarrod R.

    2015-01-01

    In its first five years, the National Nuclear Security Administration's (NNSA) Next Generation Safeguards Initiative (NGSI) sponsored more than 400 undergraduate, graduate, and post-doctoral students in internships and research positions (Wyse 2012). In the past seven years, the NGSI program has, and continues to produce a large body of scientific, technical, and policy work in targeted core safeguards capabilities and human capital development activities. Not only does the NGSI program carry out activities across multiple disciplines, but also across all U.S. Department of Energy (DOE)/NNSA locations in the United States. However, products are not readily shared among disciplines and across locations, nor are they archived in a comprehensive library. Rather, knowledge of NGSI-produced literature is localized to the researchers, clients, and internal laboratory/facility publication systems such as the Electronic Records and Information Capture Architecture (ERICA) at the Pacific Northwest National Laboratory (PNNL). There is also no incorporated way of analyzing existing NGSI literature to determine whether the larger NGSI program is achieving its core safeguards capabilities and activities. A complete library of NGSI literature could prove beneficial to a cohesive, sustainable, and more economical NGSI program. The Safeguards Platform for Automated Retrieval of Knowledge (SPARK) has been developed to be a knowledge storage, retrieval, and analysis capability to capture safeguards knowledge to exist beyond the lifespan of NGSI. During the development process, it was necessary to build a SPARK training dataset (a corpus of documents) for initial entry into the system and for demonstration purposes. We manipulated these data to gain new information about the breadth of NGSI publications, and they evaluated the science-policy interface at PNNL as a practical demonstration of SPARK's intended analysis capability. The analysis demonstration sought to answer

  2. Entry decisions in the generic pharmaceutical industry.

    Science.gov (United States)

    Morton, F M

    1999-01-01

    Data on all generic drug entries in the period 1984-1994 are used to estimate which markets heterogeneous potential entrants will decide to enter. I find that organizational experience predicts entry. Firms tend to enter markets with supply and demand characteristics similar to the firm's existing drugs. Larger revenue markets, markets with more hospital sales, and products that treat chronic conditions attract more entry. The simultaneous nature of entry leads to an additional interpretation: specialization is profitable because of the severe risk to profits when a market is "overentered." However, I am unable to make any conclusions about the efficiency of entry decisions.

  3. Generic antibiotic industries: Challenges and implied strategies with regulatory perspectives

    Directory of Open Access Journals (Sweden)

    M Venkatesh

    2011-01-01

    Full Text Available Ever since the discovery of antibiotics, the quality of human life greatly improved in the 20 th century. The discovery of penicillin transformed the medicine industry and initiated a search for a better antibiotic every time resulting in several synthetic and semi-synthetic antibiotics. Beginning with the 1937 sulfa drug tragedy, the drug regulations had a parallel growth along with the antibiotics and the antibiotic-based generic Pharma industries. This review article is focused on the scenario depicting current global Pharma industries based on generic antibiotics. Several regulatory aspects involved with these industries have been discussed along with the complexity of the market, issues that could affect their growth, their struggle for quality, and their compliance with the tightened regulations. With the skyrocketing commercialization of antibiotics through generics and the leveraging technologic renaissance, generic industries are involved in providing maximum safer benefits for the welfare of the people, highlighting its need today.

  4. Generic antibiotic industries: Challenges and implied strategies with regulatory perspectives

    Science.gov (United States)

    Venkatesh, M.; Bairavi, V. G.; Sasikumar, K. C.

    2011-01-01

    Ever since the discovery of antibiotics, the quality of human life greatly improved in the 20th century. The discovery of penicillin transformed the medicine industry and initiated a search for a better antibiotic every time resulting in several synthetic and semi-synthetic antibiotics. Beginning with the 1937 sulfa drug tragedy, the drug regulations had a parallel growth along with the antibiotics and the antibiotic-based generic Pharma industries. This review article is focused on the scenario depicting current global Pharma industries based on generic antibiotics. Several regulatory aspects involved with these industries have been discussed along with the complexity of the market, issues that could affect their growth, their struggle for quality, and their compliance with the tightened regulations. With the skyrocketing commercialization of antibiotics through generics and the leveraging technologic renaissance, generic industries are involved in providing maximum safer benefits for the welfare of the people, highlighting its need today.. PMID:21430959

  5. Maximum potential cost-savings attributable to generic substitution ...

    African Journals Online (AJOL)

    D. Husselmann

    community. ... Conclusions: Potential economic benefits can be generated with generic substitution. ... Available online at www.sciencedirect.com ... supply of safe, cost-effective drugs of acceptable quality to all citizens of South Africa, and the rational use of drugs by .... different types of schizophrenic diagnosis) with a claim.

  6. Drugs@FDA Database

    Data.gov (United States)

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

  7. Hybrid employment recommendation algorithm based on Spark

    Science.gov (United States)

    Li, Zuoquan; Lin, Yubei; Zhang, Xingming

    2017-08-01

    Aiming at the real-time application of collaborative filtering employment recommendation algorithm (CF), a clustering collaborative filtering recommendation algorithm (CCF) is developed, which applies hierarchical clustering to CF and narrows the query range of neighbour items. In addition, to solve the cold-start problem of content-based recommendation algorithm (CB), a content-based algorithm with users’ information (CBUI) is introduced for job recommendation. Furthermore, a hybrid recommendation algorithm (HRA) which combines CCF and CBUI algorithms is proposed, and implemented on Spark platform. The experimental results show that HRA can overcome the problems of cold start and data sparsity, and achieve good recommendation accuracy and scalability for employment recommendation.

  8. Sparking investment in Ontario's power generation industry

    International Nuclear Information System (INIS)

    Allen, J.

    2004-01-01

    This paper discusses the business strategy needed to spark investment in Ontario's power generation industry. It examines the process of decision making and investing in an uncertain environment. The paper suggests that any strategy based on one view of the future courts trouble and that strategic flexibility can prepare for what cannot be predicted. Finally the paper suggests that Ontario needs to create a stable policy and regulatory environment that allows investors to fulfill reasonable expectations and investors need to place bets that provide the flexibility to respond quickly to changing market conditions

  9. Anticipating Change, Sparking Innovation: Framing the Future

    Science.gov (United States)

    Finnegan, John R.; Spencer, Harrison C.

    2015-01-01

    As the 100th anniversary of the 1915 Welch-Rose report approaches, the Association of Schools and Programs of Public Health (ASPPH) has been pursuing two initiatives to spark innovation in academic partnerships for enhancing population health: (1) Framing the Future: The Second 100 Years of Education for Public Health and (2) Reconnecting Public Health and Care Delivery to Improve the Health of Populations. We describe how ASPPH-member schools and programs accredited by the Council on Education for Public Health, along with their extraordinarily diverse array of partners, are working to improve education that better prepares health professionals to meet 21st-century population health needs. PMID:25706017

  10. Canada's New Generic Pricing Policy: A Reasoned Approach to a Challenging Problem.

    Science.gov (United States)

    Hollis, Aidan; Grootendorst, Paul

    2015-08-01

    Alberta, quickly followed by other Canadian provinces, has introduced a new pricing model for generic drugs, in which prices are inversely related to the number of generic manufacturers of the drug. This paper examines the rationale for the new policy. Copyright © 2015 Longwoods Publishing.

  11. 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...

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

    Science.gov (United States)

    Puig-Junoy, Jaume

    2012-11-01

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

  13. Drugs Approved for Pancreatic Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for pancreatic cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters.

  14. Drugs Approved for Lung Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for lung cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters.

  15. Drugs Approved for Bladder Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for bladder cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters.

  16. Silicon nanoparticles produced by spark discharge

    International Nuclear Information System (INIS)

    Vons, Vincent A.; Smet, Louis C. P. M. de; Munao, David; Evirgen, Alper; Kelder, Erik M.; Schmidt-Ott, Andreas

    2011-01-01

    On the example of silicon, the production of nanoparticles using spark discharge is shown to be feasible for semiconductors. The discharge circuit is modelled as a damped oscillator circuit. This analysis reveals that the electrode resistance should be kept low enough to limit energy loss by Joule heating and to enable effective nanoparticle production. The use of doped electrodes results in a thousand-fold increase in the mass production rate as compared to intrinsic silicon. Pure and oxidised uniformly sized silicon nanoparticles with a primary particle diameter of 3–5 nm are produced. It is shown that the colour of the particles can be used as a good indicator of the oxidation state. If oxygen and water are banned from the spark generation system by (a) gas purification, (b) outgassing and (c) by initially using the particles produced as getters, unoxidised Si particles are obtained. They exhibit pyrophoric behaviour. This continuous nanoparticle preparation method can be combined with other processing techniques, including surface functionalization or the immediate impaction of freshly prepared nanoparticles onto a substrate for applications in the field of batteries, hydrogen storage or sensors.

  17. Power source with spark-safe outlet

    Energy Technology Data Exchange (ETDEWEB)

    Tsesarenko, N P; Alekhin, A V

    1982-01-01

    The invention refers to the technique of electrical monitoring and control in systems operating in a spark-safe medium (for example, in coal mines). A more accurate area of application is mobile objects with autonomous source of electricity (mine diesel locomotives, battery electric locomotives etc.). The purpose of the invention is to simplify and to improve the reliability of the planned device, and also to expand the area of application for conditions when it is powered from an autonomous generator of direct voltage. This goal is achieved because the power source with spark-safe outlet (the source contains a thyristor of advance disconnection, connected by anode to the delimiting throttle, one outlet of which is connected to the capacitor included between the controlling electrode and the anode of the thyristor, and the capacitor is connected through the resistor parallel to the outlet clamps of the source, while the thyristor of emergency protection connected parallel to the inlet clamps of the power source) is additionally equipped with a current sensor, hercon, transistor key (included in series in the power circuit) and optron, whose emitter is connected parallel to the current sensor connected in series to the inlet of the power source, while the receiver of the optron is connected in a circuit for controlling the thyristor of emergency protection. Hercon is built into the core of the delimiting throttle and is connected to the circuit for controlling the transistor key.

  18. Drugs Approved for Rhabdomyosarcoma

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for rhabdomyosarcoma. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries. There may be drugs used in rhabdomyosarcoma that are not listed here.

  19. Information for Consumers (Drugs)

    Science.gov (United States)

    ... approved drugs Drugs@FDA Information on FDA-approved brand name and generic drugs including labeling and regulatory history Drugs with Approved Risk Evaluation and Mitigation Strategies (REMS) REMS is a risk management plan required by FDA for certain prescription drugs, ...

  20. Development of a SPARK Training Dataset

    Energy Technology Data Exchange (ETDEWEB)

    Sayre, Amanda M. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Olson, Jarrod R. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States)

    2015-03-01

    In its first five years, the National Nuclear Security Administration’s (NNSA) Next Generation Safeguards Initiative (NGSI) sponsored more than 400 undergraduate, graduate, and post-doctoral students in internships and research positions (Wyse 2012). In the past seven years, the NGSI program has, and continues to produce a large body of scientific, technical, and policy work in targeted core safeguards capabilities and human capital development activities. Not only does the NGSI program carry out activities across multiple disciplines, but also across all U.S. Department of Energy (DOE)/NNSA locations in the United States. However, products are not readily shared among disciplines and across locations, nor are they archived in a comprehensive library. Rather, knowledge of NGSI-produced literature is localized to the researchers, clients, and internal laboratory/facility publication systems such as the Electronic Records and Information Capture Architecture (ERICA) at the Pacific Northwest National Laboratory (PNNL). There is also no incorporated way of analyzing existing NGSI literature to determine whether the larger NGSI program is achieving its core safeguards capabilities and activities. A complete library of NGSI literature could prove beneficial to a cohesive, sustainable, and more economical NGSI program. The Safeguards Platform for Automated Retrieval of Knowledge (SPARK) has been developed to be a knowledge storage, retrieval, and analysis capability to capture safeguards knowledge to exist beyond the lifespan of NGSI. During the development process, it was necessary to build a SPARK training dataset (a corpus of documents) for initial entry into the system and for demonstration purposes. We manipulated these data to gain new information about the breadth of NGSI publications, and they evaluated the science-policy interface at PNNL as a practical demonstration of SPARK’s intended analysis capability. The analysis demonstration sought to answer the

  1. Detector for recoil nuclei stopping in the spark chamber gas

    International Nuclear Information System (INIS)

    Aleksanyan, A.S.; Asatiani, T.L.; Ivanov, V.I.; Mkrtchyan, G.G.; Pikhtelev, R.N.

    1974-01-01

    A detector consisting of the combination of a drift and a wide gap spark chambers and designed to detect recoil nuclei stopping in the spark chamber gas is described. It is shown, that by using an appropriate discrimination the detector allows to detect reliably the recoil nuclei in the presence of intensive electron and γ-quanta beams

  2. Combustion and operating characteristics of spark-ignition engines

    Science.gov (United States)

    Heywood, J. B.; Keck, J. C.; Beretta, G. P.; Watts, P. A.

    1980-01-01

    The spark-ignition engine turbulent flame propagation process was investigated. Then, using a spark-ignition engine cycle simulation and combustion model, the impact of turbocharging and heat transfer variations or engine power, efficiency, and NO sub x emissions was examined.

  3. Dual Spark Plugs For Stratified-Charge Rotary Engine

    Science.gov (United States)

    Abraham, John; Bracco, Frediano V.

    1996-01-01

    Fuel efficiency of stratified-charge, rotary, internal-combustion engine increased by improved design featuring dual spark plugs. Second spark plug ignites fuel on upstream side of main fuel injector; enabling faster burning and more nearly complete utilization of fuel.

  4. 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.

  5. Protection of neutral-beam accelerator electrodes from spark discharges

    International Nuclear Information System (INIS)

    Praeg, W.F.

    1977-01-01

    The high-voltage (HV) electrodes of neutral beam sources (NBS's) must be protected from occasional sparks to ground. Spark currents can be limited with special transformers and reactors which introduce time delays that are long enough to quench the spark or to disconnect the energy source. A saturated time delay transformer (STDT) connected in series with the HV power supply detects spark faults and limits the current supplied by the power supply and its capacitance to ground; it also initiates spark quenching. Nonsaturated, longitudinal reactors limit the discharge current supplied by the energy stored in the circuit capacitance of the NBS filament and arc power supplies long enough to discharge this capacitance into a resistor. The design principles of these protective circuits are presented

  6. Protection of neutral-beam-accelerator electrodes from spark discharges

    International Nuclear Information System (INIS)

    Praeg, W.F.

    1977-01-01

    The high-voltage (HV) electrodes of neutral beam sources (NBS's) must be protected from occasional sparks to ground. Spark currents can be limited with special transformers and reactors which introduce time delays that are long enough to quench the spark or to disconnect the energy source. A saturated time delay transformer (STDT) connected in series with the HV power supply detects spark faults and limits the current supplied by the power supply and its capacitance to ground; it also initiates spark quenching. Nonsaturated, longitudinal reactors limit the discharge current supplied by the energy stored in the circuit capacitance of the NBS filament and arc power supplies long enough to discharge this capacitance into a resistor. The design principles of these protective circuits are presented in this paper

  7. Protection of neutral-beam-accelerator electrodes from spark discharges

    International Nuclear Information System (INIS)

    Praeg, W.F.

    1978-01-01

    The high-voltage (HV) electrodes of neutral beam sources (NBS's) must be protected from occasional sparks to ground. Spark currents can be limited with special transformers and reactors which introduce time delays that are long enough to quench the spark or to disconnect the energy source. A saturated time delay transformer (STDT) connected in series with the HV power supply detects spark faults and limits the current supplied by the power supply and its capacitance to ground; it also initiates spark quenching. Nonsaturated, longitudinal reactors limit the discharge current supplied by the energy stored in the circuit capacitance of the NBS filament and arc power supplies long enough to discharge this capacitance into a resistor. The design principles of these protective circuits are presented in this paper

  8. Drugs Approved for Stomach (Gastric) Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for stomach (gastric) cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  9. Drugs Approved for Gastrointestinal Stromal Tumors

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for gastrointestinal stromal tumors (GIST). The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  10. Drugs Approved for Soft Tissue Sarcoma

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for soft tissue sarcoma. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  11. Drugs Approved for Head and Neck Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for head and neck cancer. The list includes generic names and brand names. The drug names link to NCI’s Cancer Drug Information summaries.

  12. Drugs Approved for Gestational Trophoblastic Disease

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for gestational trophoblastic disease. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  13. Nonlinear control of a spark ignition engine

    Energy Technology Data Exchange (ETDEWEB)

    Bidan, P [Centre National de la Recherche Scientifique (CNRS), 31 - Toulouse (France); Boverie, S; Chaumerliac, V [Siemens AutomotiveSA, MIRGAS Laboratory, 31 - Toulouse (France)

    1994-12-31

    This paper describes the improvements which can be made to spark ignition engine by extensive use of automatic control. Particular emphasis is placed on fast transient phases produced by simultaneous action on the throttle and the electronic fuel injection device. The aim is to achieve better performance for the fuel/air ratio regulation system, thereby improving engine efficiency and exhaust emission during these transient phases. The authors begin by presenting an average dynamic model of the intake manifold validated on an engine test bench and goes on to develop a closed-loop system controlling average pressure in the intake manifold using the reference tracking model method. The air supply control system is combined with a predictor to compensate for delays in the injection procedure. The paper concludes with a comparison between the results obtained using simulation and those obtained experimentally from the engine. (author) 10 refs.

  14. Spark-safe mechanical fluctuation sensor

    Energy Technology Data Exchange (ETDEWEB)

    Retek, S; Galisz, T

    1979-04-20

    The subject of the invention is a mechanical fluctuation sensor in a spark-safe design for use at mines which are dangerous for gas, as an element of different systems for remote control information transfer. The patented sensor of mechanical fluctuations contains: magnetic-induction transformer characterized by the fact that its inert mass consists of a plane permanent magnet placed in the suspended state on springs between 2 coils, which together with their cores are rigidly fixed to the walls of the ferromagnetic vessels. The ends of the coil windings are interconnected, while the beginnings of the windings are lead out with connection to the outlet of the electronic amplifier with binary outlet signal. The electronic amplifier is placed between the transformer in the common ferromagnetic housing which is a screen for protection from the effect of external magnetic fields.

  15. Spark formation as a moving boundary process

    Science.gov (United States)

    Ebert, Ute

    2006-03-01

    The growth process of spark channels recently becomes accessible through complementary methods. First, I will review experiments with nanosecond photographic resolution and with fast and well defined power supplies that appropriately resolve the dynamics of electric breakdown [1]. Second, I will discuss the elementary physical processes as well as present computations of spark growth and branching with adaptive grid refinement [2]. These computations resolve three well separated scales of the process that emerge dynamically. Third, this scale separation motivates a hierarchy of models on different length scales. In particular, I will discuss a moving boundary approximation for the ionization fronts that generate the conducting channel. The resulting moving boundary problem shows strong similarities with classical viscous fingering. For viscous fingering, it is known that the simplest model forms unphysical cusps within finite time that are suppressed by a regularizing condition on the moving boundary. For ionization fronts, we derive a new condition on the moving boundary of mixed Dirichlet-Neumann type (φ=ɛnφ) that indeed regularizes all structures investigated so far. In particular, we present compact analytical solutions with regularization, both for uniformly translating shapes and for their linear perturbations [3]. These solutions are so simple that they may acquire a paradigmatic role in the future. Within linear perturbation theory, they explicitly show the convective stabilization of a curved front while planar fronts are linearly unstable against perturbations of arbitrary wave length. [1] T.M.P. Briels, E.M. van Veldhuizen, U. Ebert, TU Eindhoven. [2] C. Montijn, J. Wackers, W. Hundsdorfer, U. Ebert, CWI Amsterdam. [3] B. Meulenbroek, U. Ebert, L. Schäfer, Phys. Rev. Lett. 95, 195004 (2005).

  16. Consumers' views on generic medicines: a review of the literature.

    Science.gov (United States)

    Hassali, Mohamed A A; Shafie, Asrul A; Jamshed, Shazia; Ibrahim, Mohamed I M; Awaisu, Ahmed

    2009-04-01

    To review the literature on consumers' knowledge, attitudes and opinions of the use of generic medicines. A narrative review of studies conducted from 1970 to 2008 on consumers perceptions and views towards generic medicines was performed. An extensive literature search was undertaken using indexing services available at the authors' institution library. The following keywords were used for the search: brand, generic, multisource, medications, medicines, drugs, pharmaceuticals and consumers, customers, and patients. Electronic databases searched were Medline, Inside Web, ISI Web of Knowledge, Science Direct, Springer Link, JSTOR, Proquest, Ebsco Host and Google Scholar. These electronic databases were searched for full text papers published in English from 1970 to October 2008. Twenty studies were identified. Eleven were from the USA, four were from Europe, two were from Canada and one each was from Australia, Brazil and Malaysia. In general, consumers showed mixed reactions towards the use of generic medicines. This was evident from the divergence of views observed by country development level, consumers' socioeconomic characteristics, drug product characteristics, pharmaceutical reimbursement system, policy environment, contact with health care professionals, past experience with medications, and knowledge of the seriousness of a medical condition. Patient confidence and knowledge pertaining to generic medicines use have increased over the past four decades, especially in developed countries. Mass educational efforts, financial incentives, and greater communication among patients and health care professionals were seen as major drivers to the uptake of generic medicines among consumers.

  17. 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

  18. 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

  19. Medication persistence and the use of generic and brand-name blood pressure-lowering agents.

    Science.gov (United States)

    Corrao, Giovanni; Soranna, Davide; La Vecchia, Carlo; Catapano, Alberico; Agabiti-Rosei, Enrico; Gensini, Gianfranco; Merlino, Luca; Mancia, Giuseppe

    2014-05-01

    Because of their lower cost, healthcare systems recommend physicians to prefer generic products, rather than brand-name medicaments. There is then considerable interest and debate concerning safety and effectiveness of generic products. Few studies have compared patients treated with brand-name and generic drugs for adherence to treatment, with somewhat inconsistent results. The primary objective of this study was to compare the risk of discontinuing antihypertensive drug therapy in patients treated with generic or brand-name agents. The 101,618 beneficiaries of the Healthcare system of Lombardy, Italy, aged 18 years or older who were newly treated on monotherapy with antihypertensive generic or brand-name drugs during 2008, were followed until the earliest date among those of the occurrence of treatment discontinuation to whatever antihypertensive drug therapy (outcome), or censoring (death, emigration, 12 months after treatment initiation). Hazard ratios of discontinuation associated with starting on generic or brand-name products (intention-to-treat analysis), and incidence rate ratio of discontinuation during periods on generic and brand-name products (as-treated analysis) were respectively estimated from a cohort and self-controlled case series analyses. Patients who started on generics did not experience a different risk of discontinuation compared with those starting on brand-name agents (hazard ratio: 1.00; 95% confidence interval 0.98-1.02). Discontinuation did not occur with different rates during periods covered by generics or brand-name agents (incidence rate ratio: 1.01; 95% confidence interval 0.96-1.11) within the same individuals. A number of sensitivity and subgroup analyses confirmed the robustness of these findings. Generic products are not responsible for the high rate of discontinuation from antihypertensive drug therapy. Assuming therapeutic equivalence, clinical implication is of prescribing generic drug therapies.

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

    Science.gov (United States)

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

    2015-11-01

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

  1. Endogenous versus exogenous generic reference pricing for pharmaceuticals.

    Science.gov (United States)

    Antoñanzas, F; Juárez-Castelló, C A; Rodríguez-Ibeas, R

    2017-12-01

    In this paper we carry out a vertical differentiation duopoly model applied to pharmaceutical markets to analyze how endogenous and exogenous generic reference pricing influence competition between generic and branded drugs producers. Unlike the literature, we characterize for the exogenous case the equilibrium prices for all feasible relevant reference prices. Competition is enhanced after the introduction of a reference pricing system. We also compare both reference pricing systems on welfare grounds, assuming two different objective functions for health authorities: (i) standard social welfare and (ii) gross consumer surplus net of total pharmaceutical expenditures. We show that regardless of the objective function, health authorities will never choose endogenous reference pricing. When health authorities are paternalistic, the exogenous reference price that maximizes standard social welfare is such that the price of the generic drug is the reference price while the price of the branded drug is higher than the reference price. When health authorities are not paternalistic, the optimal exogenous reference price is such that the price of the branded drug is the reference price while the price of the generic drug is lower than the reference price.

  2. Target fabrication using laser and spark erosion machining

    International Nuclear Information System (INIS)

    Clement, X.; Coudeville, A.; Eyharts, P.; Perrine, J.P.; Rouillard, R.

    1982-01-01

    Fabrication of laser fusion targets requires a number of special techniques. We have developed both laser and spark erosion machining to produce minute parts of complex targets. A high repetition rate YAG laser at double frequency is used to etch various materials. For example, marks or patterns are often necessary on structured or advanced targets. The laser is also used to thin down plastic coated stalks. A spark erosion system has proved to be a versatile tool and we describe current fabrication processes like cutting, drilling, and ultra precise machining. Spark erosion has interesting features for target fabrication: it is a highly controllable and reproducible technique as well as relatively inexpensive

  3. Disponibilidade no setor público e preços no setor privado: um perfil de medicamentos genéricos em diferentes regiões do Brasil Availability of generic drugs in the public sector and prices in the private sector in different regions of Brazil

    Directory of Open Access Journals (Sweden)

    Elaine Silva Miranda

    2009-10-01

    generic products, in relation to the maximum consumer price. It is estimated that price competition is occurring among bioequivalent generic drugs and between them and multisource products for the same substance, but not with reference brands.

  4. Quality of generic medicines in South Africa

    DEFF Research Database (Denmark)

    Patel, Aarti; Gauld, Robin; Norris, Pauline

    2012-01-01

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

  5. High pressure gas-filled cermet spark gaps

    International Nuclear Information System (INIS)

    Avilov, Eh.A.; Yur'ev, A.L.

    2000-01-01

    The results of modernization of the R-48 and R-49 spark gaps making it possible to improve their electrical characteristics are presented. The design is described and characteristics of gas-filled cermet spark gaps are presented. By the voltage rise time of 5-6 μs in the Marx generator scheme they provide for the pulse break-through voltage of 120 and 150 kV. By the voltage rise time of 0.5-1 μs the break-through voltage of these spark gaps may be increased up to 130 and 220 kV. The proper commutation time is equal to ≤ 0.5 ns. Practical recommendations relative to designing cermet spark gaps are given [ru

  6. Exploring the Performance of Spark for a Scientific Use Case

    Energy Technology Data Exchange (ETDEWEB)

    Sehrish, Saba [Fermilab; Kowalkowski, Jim [Fermilab; Paterno, Marc [Fermilab

    2016-01-01

    We present an evaluation of the performance of a Spark implementation of a classification algorithm in the domain of High Energy Physics (HEP). Spark is a general engine for in-memory, large-scale data processing, and is designed for applications where similar repeated analysis is performed on the same large data sets. Classification problems are one of the most common and critical data processing tasks across many domains. Many of these data processing tasks are both computation- and data-intensive, involving complex numerical computations employing extremely large data sets. We evaluated the performance of the Spark implementation on Cori, a NERSC resource, and compared the results to an untuned MPI implementation of the same algorithm. While the Spark implementation scaled well, it is not competitive in speed to our MPI implementation, even when using significantly greater computational resources.

  7. Relevance of variation in use of terminology to define generic pharmaceutical products

    Directory of Open Access Journals (Sweden)

    Elize Massard da Fonseca

    2015-02-01

    Full Text Available The World Health Organization (WHO promotes the use of generic drug policies to foster competition in the pharmaceutical sector, reduce drug prices, and increase access to therapeutic drugs. However, little is known about how countries implement these policies. This article describes different terminology adopted by national regulatory authorities to define generic versus proprietary drug products in developing countries, including those in Latin America, and challenges that arise in their application of WHO guidelines, such as labeling issues. The author concludes that variation in generics terminology in these countries is a result of institutional context (i.e., the public sector setting as well as the body of laws and regulations that exists in the country and policy legacies, such as intellectual property regimes, and highlights the need for further analysis of pharmaceutical regulations to improve understanding of the barriers and political implications of generic drug policies.

  8. Relevance of variation in use of terminology to define generic pharmaceutical products.

    Science.gov (United States)

    Fonseca, Elize Massard da

    2015-02-01

    The World Health Organization (WHO) promotes the use of generic drug policies to foster competition in the pharmaceutical sector, reduce drug prices, and increase access to therapeutic drugs. However, little is known about how countries implement these policies. This article describes different terminology adopted by national regulatory authorities to define generic versus proprietary drug products in developing countries, including those in Latin America, and challenges that arise in their application of WHO guidelines, such as labeling issues. The author concludes that variation in generics terminology in these countries is a result of institutional context (i.e., the public sector setting as well as the body of laws and regulations that exists in the country) and policy legacies, such as intellectual property regimes, and highlights the need for further analysis of pharmaceutical regulations to improve understanding of the barriers and political implications of generic drug policies.

  9. Acceptability and confidence in antiretroviral generics of physicians and HIV-infected patients in France.

    Science.gov (United States)

    Allavena, Clotilde; Jacomet, Christine; Pereira, Bruno; Morand-Joubert, Laurence; Bagheri, Haleh; Cotte, Laurent; Garaffo, Rodolphe; Gerbaud, Laurent; Dellamonica, Pierre

    2014-01-01

    Switching brand name medications to generics is recommended in France in the interest of cost effectiveness but patients and physicians are sometimes not convinced that switching is appropriate. Some antiretroviral (ARV) generics (ZDV, 3TC, NVP) have been marketed in France since 2013. A multicentric cross-sectional survey was performed in September 2013 to evaluate the perception of generics overall and ARV generics in physicians and HIV-infected patients and factors associated to their acceptability. Adult HIV outpatients were asked to complete a self-questionnaire on their perception of generics. Physicians completed a questionnaire on the acceptability of generics and ARV generics. Socio-demographic data, medical history and HIV history were collected. 116 physicians in 33 clinics (68% in University Hospital) included 556 patients (France-native 77%, active employment 59%, covered by social Insurance 100%, homosexual/bisexual contamination 47%, median HIV duration 13 years, hepatitis coinfection 16%, on ARV therapy 95%). Overall, patients accepted and had confidence in generics in 76% and 55% of the cases, respectively. Switching ARVs for generics was accepted by 44% of the patients but only by 17% if the pill burden was going to increase. 75% of the physicians would prescribe generics, but this decreased to only 26% if the combo had to be broken. The main reasons for non-prescription of generics were previous brand name ARV-induced side effects (35%), refusal of generics overall (37%), lack of understanding of generics (26%), risk of non-observance of treatment (44%), anxiety (47%) and depressive symptoms (25%). In multivariate analysis, factors associated with the acceptability of ARV generics in patients were the use of generics overall (p<0.001) and in physicians, the absence of concern regarding the drug efficacy (p<0.001) and being aware that the patient would accept generics overall (p=0.03) and ARV generics (p=0.04). No factors related to

  10. Ultra Fast, High Rep Rate, High Voltage Spark Gap Pulser

    Science.gov (United States)

    1995-07-01

    current rise time. The spark gap was designed to have a coaxial geometry reducing its inductance. Provisions were made to pass flowing gas between the...ULTRA FAST, HIGH REP RATE, HIGH VOLTAGE SPARK GAP PULSER Robert A. Pastore Jr., Lawrence E. Kingsley, Kevin Fonda, Erik Lenzing Electrophysics and...Modeling Branch AMSRL-PS-EA Tel.: (908)-532-0271 FAX: (908)-542-3348 U.S. Army Research Laboratory Physical Sciences Directorate Ft. Monmouth

  11. Radiofrequency spark chambers and delay line resonators

    International Nuclear Information System (INIS)

    Sayag, Jacques

    1971-01-01

    According to a suggestion of A. Kastler, a spark chamber was excited by an undamped radiofrequency pulse and tracks about 1 mm wide obtained; the result was interpreted by computation of the coefficients of electronic amplification and partial ambipolar diffusion. This work led us to the construction of a new fast triggering undamped wave-train generator of very high tension (patent taken out by the C.E.A. under the no.: EN 7 134 650 the 27.9.1971). Since this apparatus uses a resonant storage line, its design implied a precise knowledge of high impedance delay lines. The experimental radiofrequency spectra of the input impedance of opened or short-circuited lines were plotted completely and analysed by the circuits theory, new measuring methods were established, dispersion relations accurately checked and the equivalence of the formulas, within the third order, with theses of Debye's Dipolar Absorption demonstrated. General properties of Hilbert's transform were also investigated. From the experimental point of view, the electromagnetic energy storage process was extended to the case of a liquid nitrogen-immersed resonant delay line. The good behavior of the cryogenic experiment, where the main difficulty of icing was overcame by the construction of special electrodes, offers great promise for extrapolation to superconductivity. (author) [fr

  12. Sparks Will Fly: engineering creative script conflicts

    Science.gov (United States)

    Veale, Tony; Valitutti, Alessandro

    2017-10-01

    Scripts are often dismissed as the stuff of good movies and bad politics. They codify cultural experience so rigidly that they remove our freedom of choice and become the very antithesis of creativity. Yet, mental scripts have an important role to play in our understanding of creative behaviour, since a deliberate departure from an established script can produce results that are simultaneously novel and familiar, especially when others stick to the conventional script. Indeed, creative opportunities often arise at the overlapping boundaries of two scripts that antagonistically compete to mentally organise the same situation. This work explores the computational integration of competing scripts to generate creative friction in short texts that are surprising but meaningful. Our exploration considers conventional macro-scripts - ordered sequences of actions - and the less obvious micro-scripts that operate at even the lowest levels of language. For the former, we generate plots that squeeze two scripts into a single mini-narrative; for the latter, we generate ironic descriptions that use conflicting scripts to highlight the speaker's pragmatic insincerity. We show experimentally that verbal irony requires both kinds of scripts - macro and micro - to work together to reliably generate creative sparks from a speaker's subversive intent.

  13. Potential Cost Savings from Generic Medicines - Protecting the ...

    African Journals Online (AJOL)

    ... a pro-generic policy since the introduction of the National Drug Policy in 1996. ... Medicines provided outside of hospitals accounted for 17% of medical aid ... in the chronic disease algorithms set out by the Council for Medical Schemes ...

  14. Automatic spark counting of alpha-tracks in plastic foils

    International Nuclear Information System (INIS)

    Somogyi, G.; Medveczky, L.; Hunyadi, I.; Nyako, B.

    1976-01-01

    The possibility of alpha-track counting by jumping spark counter in cellulose acetate and polycarbonate nuclear track detectors was studied. A theoretical treatment is presented which predicts the optimum residual thickness of the etched foils in which completely through-etched tracks (i.e. holes) can be obtained for alpha-particles of various energies and angles of incidence. In agreement with the theoretical prediction it is shown that a successful spark counting of alpha-tracks can be performed even in polycarbonate foils. Some counting characteristics, such as counting efficiency vs particle energy at various etched foil thicknesses, surface spark density produced by electric breakdowns in unexposed foils vs foil thickness, etc. have been determined. Special attention was given to the spark counting of alpha-tracks entering thin detectors at right angle. The applicability of the spark counting technique is demonstrated in angular distribution measurements of the 27 Al(p,α 0 ) 24 Mg nuclear reaction at Ep = 1899 keV resonance energy. For this study 15 μm thick Makrofol-G foils and a jumping spark counter of improved construction were used. (orig.) [de

  15. The Generic Data Capture Facility

    Science.gov (United States)

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

    1987-01-01

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

  16. 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.

  17. Hanford Generic Interim Safety Basis

    International Nuclear Information System (INIS)

    Lavender, J.C.

    1994-01-01

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

  18. Scattering profiles of sparks and combustibility of filter against hot sparks

    International Nuclear Information System (INIS)

    Tobita, Noriyuki; Okada, Takashi; Kashiro, Kashio

    2004-12-01

    An event that a pre-filter burned on fire took place in the glove box dismantlement facility of Plutonium Production Facility, on April 21, 2003. The direct cause of this event was considered to be sparks generated by an abrasive wheel cutter, some of which reached the pre-filter and eventually burned the pre-filter. Further investigation revealed that there exist other deficiencies those of which formed indirect causes of the event, i.e., the wheel cutter was used without protective cover and adequate shield against sparks was not installed during the operation. To prevent similar event in the future, following corrective actions were introduced. Wheel cutter will not be used without protective cover; Incombustible pre-filter will be used; Shield will be place at the front of the pre-filter. We have conducted series of experimental tests in order to evaluate and confirm the validity of these corrective actions as well as determine the cause of the fire. This report present the results of these tests. (author)

  19. Generic Example Proving Criteria for All

    Science.gov (United States)

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

    2015-01-01

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

  20. Generic penetration in the retail antidepressant market.

    Science.gov (United States)

    Ventimiglia, Jeffrey; Kalali, Amir H

    2010-06-01

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

  1. Análise comparativa da concentração industrial e de turnover da indústria farmacêutica no Brasil para os segmentos de medicamentos de marca e genéricos Comparative analysis of the Industrial Concentration and Turnover of the pharmaceutical industry in Brazil for the segments of mark and generic drugs

    Directory of Open Access Journals (Sweden)

    Gerson Rosenberg

    2010-04-01

    Full Text Available Este artigo analisa a evolução da estrutura do segmento de medicamentos de marca e genéricos no Brasil a partir de 1997. Após a entrada dos medicamentos genéricos, constatou-se que não houve diminuição significativa da concentração na indústria farmacêutica brasileira, porém, o mesmo não ocorreu em nível mundial, verificando-se um aumento da concentração a partir de 2001, impulsionado pelo expressivo processo de fusões e aquisições nos últimos anos da década de 1990. Em relação ao turnover, notou-se que este foi muito baixo para o grupo das maiores empresas em ambos os segmentos de medicamentos. Entretanto, observa-se um elevado turnover com a entrada dos genéricos, mostrando o fortalecimento da indústria nacional. Verifica-se que o processo de fusões e aquisições entre empresas nacionais é pouco significativo, o que pode ser uma alternativa para as pequenas empresas farmacêuticas aumentarem a sua participação no mercado brasileiro.This paper analyzes the evolution of brand-name and generic drugs structure in Brazil since 1997. After the introduction of generic drugs it was not verified a significant decrease in the concentration of Brazilian pharmaceutical industry. The process of mergers and acquisitions in the 90's enhanced the process of concentration in the international market. However, a non-expressive turnover can be demonstrated in both pharmaceutical and generic markets. At the same time, the entrance of the generic industry in Brazil explains the invigoration of the national industry. The mergers and acquisitions process in the pharmaceutical industry is quite intense in Europe and in the USA, although in Brazil it is still not significant.

  2. Drugs Approved for Colon and Rectal Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for use in colon cancer and rectal cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters.

  3. Drugs Approved for Cervical Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for cervical cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters. The drug names link to NCI's Cancer Drug Information summaries.

  4. Drugs Approved for Multiple Myeloma

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for multiple myeloma and other plasma cell neoplasms. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters. The drug names link to NCI's Cancer Drug Information summaries.

  5. Drugs Approved for Testicular Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for testicular cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters. The drug names link to NCI's Cancer Drug Information summaries.

  6. Drugs Approved for Hodgkin Lymphoma

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for Hodgkin lymphoma. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters. The drug names link to NCI's Cancer Drug Information summaries.

  7. Drugs Approved for Myeloproliferative Neoplasms

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for myeloproliferative neoplasms. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters. The drug names link to NCI's Cancer Drug Information summaries.

  8. Policy objective of generic medicines from the investment perspective: The case of clopidogrel.

    Science.gov (United States)

    Elek, Péter; Harsányi, András; Zelei, Tamás; Csetneki, Kata; Kaló, Zoltán

    2017-05-01

    The objective of generic drug policies in most countries is defined from a disinvestment perspective: reduction in expenditures without compromising health outcomes. However, in countries with restricted access of patients to original patented drugs, the objective of generic drug policies can also be defined from an investment perspective: health gain by improved patient access without need for additional health budget. This study examines the investment aspect of generic medicines by analyzing clopidogrel utilization in European countries between 2004 and 2014 using multilevel panel data models. We find that clopidogrel consumption was strongly affected by affordability constraints before the generic entry around 2009, but this effect decayed by 2014. After controlling for other variables, utilization had a substantially larger trend increase in lower-income European countries than in the higher-income ones. Generic entry increased clopidogrel consumption only in lower- and average-income countries but not in the highest-income ones. An earlier generic entry was associated with a larger effect. The case of clopidogrel indicates that the entrance of generics may increase patient access to effective medicines, most notably in lower-income countries, thereby reducing inequalities between European patients. Policymakers should also consider this investment aspect of generic medicines when designing pharmaceutical policies. Copyright © 2017 Elsevier B.V. All rights reserved.

  9. Sparking protection for MFTF-B Neutral Beam Power Supplies

    International Nuclear Information System (INIS)

    Cummings, D.B.

    1983-01-01

    This paper describes the upgrade of MFTF-B Neutral Beam Power Supplies for sparking protection. High performance ion sources spark repeatedly so ion source power supplies must be insensitive to sparking. The hot deck houses the series tetrode, arc and filament supplies, and controls. Hot deck shielding has been upgraded and a continuous shield around the arc, filament, gradient grid, and control cables now extends from the hot deck, through the core snubber, to the source. The shield carries accelerating current and connects only to the source. Shielded source cables go through an outer duct which now connects to a ground plane under the hot deck. This hybrid transmission line is a low inductance path for sparks discharging the stray capacitance of the hot deck and isolation transformers, reducing coupling to building steel. Parallel DC current return cables inside the duct lower inductance to reduce inductive turn-off transients. MOVs to ground further limit surges in the remote power supply return. Single point grounding is at the source. No control or rectifier components have been damaged nor are there any known malfunctions due to sparking up to 80 kV output

  10. Research on spark discharge of floating roof tank shunt

    International Nuclear Information System (INIS)

    Bi, Xiaolei; Liu, Quanzhen; Liu, Baoquan; Gao, Xin; Hu, Haiyan; Liu, Juan

    2013-01-01

    In order to quantitatively analyze the spark discharge risk of floating roof tank shunts, the breakdown voltage of shunt has been calculated by Townsend theory, the shunt spark discharge experiment is carried out by using 1.2/50 μs impulse voltage wave, and the relationship between breakdown voltage of shunt spark discharge and air gap is analyzed. It has been indicated by theoretical analysis and experimental study that the small gap is more easily cause spark discharge than the big gap when the contact between shunt and tank shell is poor. When air gap distance is equal to 0.1 cm, average breakdown voltage is 5280 V. When the air gap distance is less than 0.3 cm, experiment data agree well with Townsend theory. Therefore, in the condition of small gap, Townsend theory can be used to calculated breakdown voltage of shunt. Finally, based on the above conclusions, improvements for avoiding the spark discharge risk of shunt of floating roof tanks have been proposed.

  11. Spark counting technique with an aluminium oxide film

    International Nuclear Information System (INIS)

    Kawai, H.; Koga, T.; Morishima, H.; Niwa, T.; Nishiwaki, Y.

    1980-01-01

    Automatic spark counting of etch-pits on a polycarbonate film produced by nuclear fission fragments is now used for neutron monitoring in several countries. A method was developed using an aluminium oxide film instead of a polycarbonate as the neutron detector. Aluminium oxide films were prepared as follows: A cleaned aluminium plate as an anode and a nickel plate as a cathode were immersed in dilute sulfuric acid solution and electric current flowed between the electrodes at 12degC for 10-30 minutes. Electric current density was about 10 mA/cm 2 . The aluminium plate was then kept in boiling water for 10-30 minutes for sealing. The thickness of the aluminium oxide layer formed was about 1μm. The aluminium plate attached to a plate of suitable fissionable material, such as uranium or thorium, was irradiated with neutrons and set in a usual spark counter for fission track counting. One electrode was the aluminium plate and the other was an aluminized polyester sheet. Sparked pulses were counted with a usual scaler. The advantage of using spark counting with an aluminium oxide film for neutron monitoring is rapid measurement of neutron exposure, since chemical etching which is indispensable for spark counting with a polycarbonate detector film, is not needed. (H.K.)

  12. Sparking protection for MFTF-B neutral beam power supplies

    International Nuclear Information System (INIS)

    Cummings, D.B.

    1983-01-01

    This paper describes the upgrade of MFTF-B Neutral Beam Power Supplies for sparking protection. High performance ion sources spark repeatedly so ion source power supplies must be insensitive to sparking. The hot deck houses the series tetrode, arc and filament supplies, and controls. Hot deck shielding has been upgraded and a continuous shield around the arc, filament, gradient grid, and control cables now extends from the hot deck, through the core snubber, to the source. The shield carries accelerating current and connects only to the source. Shielded source cables go through an outer duct which now connects to a ground plane under the hot deck. This hybrid transmission line is a low inductance path for sparks discharging the stray capacitance of the hot deck and isolation transformers, reducing coupling to building steel. Parallel dc current return cables inside the duct lower inductance to reduce inductive turn-off transients. MOVs to ground further limit surges in the remote power supply return. Single point grounding is at the source. No control or rectifier components have been damaged nor are there any known malfunctions due to sparking up to 80 kV output

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

    Science.gov (United States)

    Drozdowska, Aleksandra; Hermanowski, Tomasz

    2016-01-01

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

  14. Retailing policies for generic medicines.

    Science.gov (United States)

    Narciso, Susana

    2005-06-01

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

  15. 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...

  16. Cost Evaluation of Commonly Prescribed Antihypertensive Drugs ...

    African Journals Online (AJOL)

    It was also concluded that generic prescription should be encouraged among prescribers to lessen the financial burden of patients because drugs marketed under generic names are usually cheaper than those with brand names. Key words: Brand, Generic,Prescription, Antihypertensives,Cost. [Nig. Jnl Health & Biomedical ...

  17. Measurements of Radon Concentration in Yemen Using Spark Counter

    International Nuclear Information System (INIS)

    Arafa, W.; Abou-Leila, M.; Hafiz, M.E.; Al-Glal, N.

    2011-01-01

    Spark counter has been designed and realized and the optimum applied voltage was found to be 600 V. Excellent consistent agreements was observed between counted number of tracks by spark counter and reading by optical microscope. Radon concentration in some houses in Sana'a and Hodeidah cities in Yemen had been performed using LR-115 SSNTD and spark counter system. The average radon concentration in both cities was far lower the alert value. The results showed that radon concentration in the metropolitan area Sana'a was higher than that in Hodeidah city. Also, it was observed that old residential houses had higher levels of radon concentrations have compared to newly built houses in the metropolitan area Sana'a

  18. A miniature spark counter for public communication and education

    International Nuclear Information System (INIS)

    Mao, C.H.; Weng, P.S.

    1987-01-01

    The fabrication of a miniature spark counter for public communication and education using naturally occurring radon as a radioactive source without involving any man-made radioactivity is described. The battery-powered miniature spark counter weighs 2.07 kg with a volume of 4.844 x 10/sup -4/ m/sup 3/. The circuitry consists of seven major components: timer, high-voltage power supply, attenuator, noninverting amplifier, low-pass filter, one-shot generator, and counter. Cellulose nitrate films irradiated with alpha particles from radon emanating from soil were etched and counted. The visible sparks during counting are rather heuristic, which can be used to demonstrate naturally occurring radioactivity in classrooms or showplaces

  19. Avoidance of generic competition by Abbott Laboratories' fenofibrate franchise.

    Science.gov (United States)

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

    2012-05-14

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

  20. Cisplatin-induced hyponatremia in malignancy: comparison between brand-name and generic formulation.

    Science.gov (United States)

    Ochi, Nobuaki; Yamane, Hiromichi; Hotta, Katsuyuki; Fujii, Hiromi; Isozaki, Hideko; Honda, Yoshihiro; Yamagishi, Tomoko; Kubo, Toshio; Tanimoto, Mitsune; Kiura, Katsuyuki; Takigawa, Nagio

    2014-01-01

    Widespread use of generic drugs is considered to be indispensable if reductions in total health care costs are to be achieved, but the market share of such drugs remains low. In general, generic drugs have the same active ingredients as brand-name drugs, but this is not always the case. Thus, toxicity profiles may vary when brand-name and generic drugs are compared. We retrospectively investigated the incidence of hyponatremia in patients receiving brand-name cisplatin (CDDP) and a generic counterpart thereof. We reviewed the medical records of patients treated with brand-name CDDP (n=53) and a generic formulation (n=26), and compared the incidences of hyponatremia and renal toxicity. Toxicities were graded using the Common Terminology Criteria for Adverse Events, version 4.0. Differences between groups were evaluated using the Student's t-test, and the odds ratio for hyponatremia was estimated via logistic regression analysis. Serum creatinine levels after chemotherapy increased significantly in both the brand-name and generic CDDP groups; no significant difference was evident between the two groups. Hyponatremia of grade 3 or above developed in 30.7% of the generic CDDP group compared to 15.1% of the brand-name CDDP group (P=0.011). Multivariate analysis showed that the use of generic CDDP increased the incidence of hyponatremia (odds ratio =5.661, 95% confidence interval =1.403-22.839; P=0.015). Oncologists should be aware that use of a generic CDDP might be associated with more hyponatremia than would use of brand-name CDDP.

  1. Might generic OCs create contraceptive price war?

    Science.gov (United States)

    1987-02-01

    Genora 1/35 and 1/50, the 1st generic oral contraceptives (OCs) in the world, are now being marketed in the US. Clinicians interviewed by "Contraceptive Technology Update" (CTU) offer differing opinions as to what this new OC may mean in the marketplace. Products of Rugby Laboratories, the pills are copy products of Ortho Pharmaceutical's ON 1/35 and ON 1/50 formulations. Most clinicians believe that Genora's success or failure in the OC market depends on its eventual retail price. The price difference of $3-$4 may be sufficiently substantial for retailers to charge less for the generic OCs. If that is the case, many doctors may prescribe a pill which will save their patients $4/month. Dr. Mildred Hanson, a Minneapolis gynecologist/obstetrician, feels any cost savings from Genora will have a significant impact on the OC market. She suggests that the less expensive OCs will catch the attention of health maintenance organizations (HMOs) and the business of women who participate in such health plans. Yet James Burns, director of family planning services for the Hartford City Health Department, thinks that even a full-scale retail price war won't have much effect from a clinic standpoint. He reports that clinics are able to obtain contraceptive supplies rather inexpensively through the contracting system. Hanson also expressed doubt over the potential popularity of Genora 1/50 as clinical concerns about the effects of combined OCs on serum lipid levels and carbohydrate metabolism have resulted in a nationwide push toward OCs containing less than 50 micrograms of estrogen. He indicated concern that declines in pharmaceutical house products from pricing competition with generic pills might have a negative impact on contraceptive research and development. Dick Haskitt, director of business planning for Syntex Laboratories, Inc., who will produce the OCs for Rugby, reports that their market research shows that people are very interested in having a generic OC available

  2. Analysis of Plant Breeding on Hadoop and Spark

    Directory of Open Access Journals (Sweden)

    Shuangxi Chen

    2016-01-01

    Full Text Available Analysis of crop breeding technology is one of the important means of computer-assisted breeding techniques which have huge data, high dimensions, and a lot of unstructured data. We propose a crop breeding data analysis platform on Spark. The platform consists of Hadoop distributed file system (HDFS and cluster based on memory iterative components. With this cluster, we achieve crop breeding large data analysis tasks in parallel through API provided by Spark. By experiments and tests of Indica and Japonica rice traits, plant breeding analysis platform can significantly improve the breeding of big data analysis speed, reducing the workload of concurrent programming.

  3. Vacuum spark breakdown model based on exploding metal wire phenomena

    International Nuclear Information System (INIS)

    Haaland, J.

    1984-06-01

    Spark source mass spectra (SSMS) indicates that ions are extracted from an expanding and decaying plasma. The intensity distribution shows no dependance on vaporization properties of individual elements which indicates explosive vapour formation. This seems further to be a requirement for bridging a vacuum gap. A model including plasma ejection from a superheated anode spot by a process similar to that of an exploding metal wire is proposed. The appearance of hot plasma points in low inductance vacuum sparks can then be explained as exploding micro particles ejected from a final central anode spot. The phenomenological model is compared with available experimental results from literature, but no extensive quantification is attempted

  4. A note on preserving the spark of a matrix

    Directory of Open Access Journals (Sweden)

    Marcin Skrzynski

    2015-05-01

    Full Text Available Let Mm× n(F be the vector space of all m× n matrices over a field F. In the case where m ≥ n, char (F ≠ 2 and F has at least five elements, we give a complete characterization of linear maps Φ : Mm× n(F → Mm× n(F such that spark(Φ (A = spark(A for any A ∈ Mm× n(F.

  5. Phase characterisation in spark plasma sintered TiPt alloy

    CSIR Research Space (South Africa)

    Chikosha, S

    2011-12-01

    Full Text Available stream_source_info chikosha_2011.pdf.txt stream_content_type text/plain stream_size 4354 Content-Encoding UTF-8 stream_name chikosha_2011.pdf.txt Content-Type text/plain; charset=UTF-8 PHASE CHARACTERISATION IN SPARK... to form “necks”  Radiant Joule heat and pressure drives “neck” growth and material transfer © CSIR 2006 www.csir.co.za Page 6 Objective  Produce TiPt alloy compacts by Spark plasma sintering (SPS) of equiatomic...

  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. Testing properties of generic functions

    NARCIS (Netherlands)

    Jansson, P.; Jeuring, J.T.; Cabenda, L.; Engels, G.; Kleerekoper, J.; Mak, S.; Overeem, M.; Visser, Kees

    2007-01-01

    A datatype-generic function is a family of functions indexed by (the structure of) a type. Examples include equality tests, maps and pretty printers. Property based testing tools like QuickCheck and Gast support the de¯nition of properties and test-data generators, and they check if a

  8. Generic component failure data base

    International Nuclear Information System (INIS)

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

    1992-01-01

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

  9. 'Genericism' in Danish welfare professions

    DEFF Research Database (Denmark)

    Larsen, Verner

    and skills in the basic disciplines of the professions also termed as disciplinary and procedural knowledge '. Thus the main research question for this paper is: What consequences do recent reform actions in Danish welfare education concerning generic competence have on developing professional knowledge...

  10. The effect of generic switching on concerns about medicine and non-persistence among Danish adults in a general practice setting

    DEFF Research Database (Denmark)

    Østergaard Rathe, Jette

    BACKGROUND: Generic substitution means that one medicinal product is replaced by another product containing the same active substance. Generic substitution has existed in Denmark since 1991, and pharmacies are obliged to substitute a generic version of a medication, unless the general practitioner...... international studies have shown that most patients have positive attitudes towards generic substitution. The severity of disease is known to be associated with patients being more concerned about generic substitution. The generic substitution scheme implies changing from one drug to another that may vary...... in brand-name, form, size, colour and taste. Speculations have been raised as to whether these medication changes between generic brands or from brand-name drugs to generics or vice versa may cause patient concerns. Qualitative studies have shown problems in recognising the substituted medicine and lack...

  11. Exploring the opinions and experiences of patients with generic substitution: a representative study of Polish society.

    Science.gov (United States)

    Drozdowska, Aleksandra; Hermanowski, Tomasz

    2015-02-01

    Generics have the potential to contain drug therapy costs; successful implementation of generic substitution policy largely depends on consumers' willingness to choose generics. This study aims to analyse the opinions, experiences and preferences of Polish patients towards generic medicines. The study was performed in Poland. The survey was conducted in June 2013 by means of face-to-face interviews. Respondents were drawn from the general population according to a population structure. The study covered a representative sample of 1,000 Poles; the results can be generalized to apply to the Polish population at large. Fifty-two percent of respondents declared to be more often choosing generics, twenty-three percent did not have any specific preferences, and twenty-five percent were more willing to choose brand-name medicines. Past experience with cheaper generic medicines, secondary or lower education, low income and residence in specific regions of Poland were all significantly associated with an increased willingness to choose generics. Respondents' attitudes towards generics were mostly influenced by the opinions of doctors and pharmacists. According to respondents, attitudes towards generics among doctors, pharmacists, family and friends, and in the mass media were mostly positive. There was no relationship between the preference of respondents for generics and factors such as their age, life stage, gender, household size or urban/rural locality. As a result of substituting a brand-name drug with its generic equivalent, 72 % of respondents reported that they had not noticed any difference in drug effectiveness; 21 % had experienced a reduced effectiveness of treatment or increased side effects at least once; and 7 % claimed the generic worked better. The majority of respondents who used cheaper substitutes claimed that generics represented good or very good quality. The study demonstrates that, when choosing medicines, Poles rely mainly on the opinions of their

  12. Biopharmaceutic Risk Assessment of Brand and Generic Lamotrigine Tablets.

    Science.gov (United States)

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

    2015-07-06

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

  13. Practice and Exploration of New Rural Construction in West Bank of Taiwan Strait Led by Spark Science and Technology

    OpenAIRE

    Li, Chaocan

    2013-01-01

    According to practice and exploration of spark program for 26 years in Quanzhou, the main model and their effects of new rural construction in west bank of Taiwan Strait led by spark science and technology were expounded. Six spark program systems were established, consisting of policy support guide, science and technology project lead, experts’ intelligence support, spark science and technology training, sci-tech information service and spark program demonstration. Five spark projects were...

  14. Impact of brand or generic labeling on medication effectiveness and side effects.

    Science.gov (United States)

    Faasse, Kate; Martin, Leslie R; Grey, Andrew; Gamble, Greg; Petrie, Keith J

    2016-02-01

    Branding medication with a known pharmaceutical company name or product name bestows on the drug an added assurance of authenticity and effectiveness compared to a generic preparation. This study examined the impact of brand name and generic labeling on medication effectiveness and side effects. 87 undergraduate students with frequent headaches took part in the study. Using a within-subjects counterbalanced design, each participant took tablets labeled either as brand name "Nurofen" or "Generic Ibuprofen" to treat each of 4 headaches. In reality, half of the tablets were placebos, and half were active ibuprofen (400 mg). Participants recorded their headache pain on a verbal descriptor and visual analogue scale prior to taking the tablets, and again 1 hour afterward. Medication side effects were also reported. Pain reduction following the use of brand name labeled tablets was similar in active ibuprofen or a placebo. However, if the tablets had a generic label, placebo tablets were significantly less effective compared to active ibuprofen. Fewer side effects were attributed to placebo tablets with brand name labeling compared to the same placebo tablets with a generic label. Branding of a tablet appears to have conferred a treatment benefit in the absence of an active ingredient, while generic labeled tablets were substantially less effective if they contained no active ingredient. Branding is also associated with reduced attribution of side effects to placebo tablets. Future interventions to improve perceptions of generics may have utility in improving treatment outcomes from generic drugs. (c) 2016 APA, all rights reserved).

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

    Science.gov (United States)

    Phillips, Karen; Reddy, Prabashni; Gabardi, Steven

    2017-02-01

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

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

    Science.gov (United States)

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

    2014-09-01

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

  17. SparkText: Biomedical Text Mining on Big Data Framework

    Science.gov (United States)

    He, Karen Y.; Wang, Kai

    2016-01-01

    Background Many new biomedical research articles are published every day, accumulating rich information, such as genetic variants, genes, diseases, and treatments. Rapid yet accurate text mining on large-scale scientific literature can discover novel knowledge to better understand human diseases and to improve the quality of disease diagnosis, prevention, and treatment. Results In this study, we designed and developed an efficient text mining framework called SparkText on a Big Data infrastructure, which is composed of Apache Spark data streaming and machine learning methods, combined with a Cassandra NoSQL database. To demonstrate its performance for classifying cancer types, we extracted information (e.g., breast, prostate, and lung cancers) from tens of thousands of articles downloaded from PubMed, and then employed Naïve Bayes, Support Vector Machine (SVM), and Logistic Regression to build prediction models to mine the articles. The accuracy of predicting a cancer type by SVM using the 29,437 full-text articles was 93.81%. While competing text-mining tools took more than 11 hours, SparkText mined the dataset in approximately 6 minutes. Conclusions This study demonstrates the potential for mining large-scale scientific articles on a Big Data infrastructure, with real-time update from new articles published daily. SparkText can be extended to other areas of biomedical research. PMID:27685652

  18. Stopping particles in the Mont Blanc spark chamber telescopes

    Energy Technology Data Exchange (ETDEWEB)

    Bergamasco, L; Bilokon, H; Piazzoli, B E; Mannocchi, G; Picchi, P [Consiglio Nazionale delle Ricerche, Turin (Italy). Lab. di Cosmo-Geofisica; Turin Univ. (Italy). Ist. di Fisica Generale)

    1982-02-01

    We present the final results on the ratio of stopping to traversing muons as measured by two spark chamber telescopes in the Mont Blanc Station, Italy, at 4300 hg/cm/sup 2/. The experimental results are in agreement with the theoretical values within the limits of the error.

  19. Evolution of Spark plasma using nitrogen laser shadowgraphy system

    International Nuclear Information System (INIS)

    Ishiekwene, G.C.

    1994-07-01

    A simple, low cost, home built high power nitrogen laser is used as the light source for a shadowgraphy system. A series of shadowgrams depicting the temporal growth of a spark plasma discharge is obtained. The results could be useful in plasma diagnostic studies. (author). 5 refs, 6 figs

  20. knock characteristics analysis of a supercharged spark ignition

    African Journals Online (AJOL)

    user

    The power output of a spark ignition engine could be improved by boosting the ... that the presence of aromatics was responsible for the better anti-knock ..... System, a Master's Thesis in the Institutionen för ... Maintenance and Reliability, Vol.

  1. SPARK RttT: Year One Fidelity and Implementation

    Science.gov (United States)

    Rochford, Joseph A.; O'Neill, Adrienne; Gelb, Adele; Ross, Kimberly

    2014-01-01

    Developed in 2003 by the Sisters of Charity Foundation of Canton with a grant from the Kellogg Foundation, "Supporting Partnerships to Assure Ready Kids" ("SPARK Ohio") is a family-centered kindergarten readiness program that works with families, schools, and the community. From its initial sites in Stark County, "SPARK…

  2. Towards constrained optimal control of spark-ignition engines

    NARCIS (Netherlands)

    Feru, E.; Luo, X.

    2015-01-01

    In this paper, the torque control problem for spark-ignition engines is considered. The objective is to provide good output torque tracking with minimum fuel consumption, while avoiding engine knock and misre. To this end, three control strategies are proposed: a feed-forward controller with

  3. Utilization of Alcohol Fuel in Spark Ignition and Diesel Engines.

    Science.gov (United States)

    Berndt, Don; Stengel, Ron

    These five units comprise a course intended to prepare and train students to conduct alcohol fuel utilization seminars in spark ignition and diesel engines. Introductory materials include objectives and a list of instructor requirements. The first four units cover these topics: ethanol as an alternative fuel (technical and economic advantages,…

  4. SparkText: Biomedical Text Mining on Big Data Framework.

    Directory of Open Access Journals (Sweden)

    Zhan Ye

    Full Text Available Many new biomedical research articles are published every day, accumulating rich information, such as genetic variants, genes, diseases, and treatments. Rapid yet accurate text mining on large-scale scientific literature can discover novel knowledge to better understand human diseases and to improve the quality of disease diagnosis, prevention, and treatment.In this study, we designed and developed an efficient text mining framework called SparkText on a Big Data infrastructure, which is composed of Apache Spark data streaming and machine learning methods, combined with a Cassandra NoSQL database. To demonstrate its performance for classifying cancer types, we extracted information (e.g., breast, prostate, and lung cancers from tens of thousands of articles downloaded from PubMed, and then employed Naïve Bayes, Support Vector Machine (SVM, and Logistic Regression to build prediction models to mine the articles. The accuracy of predicting a cancer type by SVM using the 29,437 full-text articles was 93.81%. While competing text-mining tools took more than 11 hours, SparkText mined the dataset in approximately 6 minutes.This study demonstrates the potential for mining large-scale scientific articles on a Big Data infrastructure, with real-time update from new articles published daily. SparkText can be extended to other areas of biomedical research.

  5. SparkText: Biomedical Text Mining on Big Data Framework.

    Science.gov (United States)

    Ye, Zhan; Tafti, Ahmad P; He, Karen Y; Wang, Kai; He, Max M

    Many new biomedical research articles are published every day, accumulating rich information, such as genetic variants, genes, diseases, and treatments. Rapid yet accurate text mining on large-scale scientific literature can discover novel knowledge to better understand human diseases and to improve the quality of disease diagnosis, prevention, and treatment. In this study, we designed and developed an efficient text mining framework called SparkText on a Big Data infrastructure, which is composed of Apache Spark data streaming and machine learning methods, combined with a Cassandra NoSQL database. To demonstrate its performance for classifying cancer types, we extracted information (e.g., breast, prostate, and lung cancers) from tens of thousands of articles downloaded from PubMed, and then employed Naïve Bayes, Support Vector Machine (SVM), and Logistic Regression to build prediction models to mine the articles. The accuracy of predicting a cancer type by SVM using the 29,437 full-text articles was 93.81%. While competing text-mining tools took more than 11 hours, SparkText mined the dataset in approximately 6 minutes. This study demonstrates the potential for mining large-scale scientific articles on a Big Data infrastructure, with real-time update from new articles published daily. SparkText can be extended to other areas of biomedical research.

  6. Material machining with pseudo-spark electron beams

    International Nuclear Information System (INIS)

    Benker, W.; Christiansen, J.; Frank, K.; Gundel, H.; Redel, T.; Stetter, M.

    1989-01-01

    The authors give a brief description of the production of pseudo-spark (low pressure gas discharge) electron beams. They illustrate the use of these electron beams for machining not only conducting, semiconducting and insulating materials, but also thin layers of such materials as high temperature superconducting ceramics

  7. Multi-spark discharge system for preparation of nutritious water

    Science.gov (United States)

    Nakaso, Tetsushi; Harigai, Toru; Kusumawan, Sholihatta Aziz; Shimomura, Tomoya; Tanimoto, Tsuyoshi; Suda, Yoshiyuki; Takikawa, Hirofumi

    2018-01-01

    The nitrogen compound concentration in water is increased by atmospheric-pressure plasma discharge treatment. A rod-to-water electrode discharge treatment system using plasma discharge has been developed by our group to obtain water with a high concentration of nitrogen compounds, and this plasma-treated water improves the growth of chrysanthemum roots. However, it is difficult to apply the system to the agriculture because the amount of treated water obtained by using the system too small. In this study, a multi-spark discharge system (MSDS) equipped multiple spark plugs is presented to obtain a large amount of plasma-treated water. The MSDS consisted of inexpensive parts in order to reduce the system introduction cost for agriculture. To suppress the temperature increase of the spark plugs, the 9 spark plugs were divided into 3 groups, which were discharged in order. The plasma-treated water with a NO3- concentration of 50 mg/L was prepared using the MSDS for 90 min, and the treatment efficiency was about 6 times higher than that of our previous system. It was confirmed that the NO2-, O3, and H2O2 concentrations in the water were also increased by treating the water using the MSDS.

  8. Saffman-Taylor streamers: Mutual finger interaction in spark formation

    NARCIS (Netherlands)

    Luque, A.; Brau, F.; Ebert, U.

    2008-01-01

    Bunches of streamers form the early stages of sparks and lightning but theory presently concentrates on single streamers or on coarse approximations of whole breakdown trees. Here a periodic array of interacting streamer discharges in a strong homogeneous electric field is studied in density or

  9. The physics of photoconductive spark gap switching : pushing the frontiers

    NARCIS (Netherlands)

    Hendriks, J.

    2006-01-01

    Photoconductive switching of an atmospheric, air-¯lled spark gap by a high-power fem- tosecond laser is a novel approach for switching high voltages into pulses with a very fast rise time (order ps) and almost no shot-to-shot time variation (jitter). Such a switch makes it possible to synchronize

  10. Simulation of muon transport through the aragats spark chamber calorimeter

    International Nuclear Information System (INIS)

    Asatiani, T.L.; Ter-Antonyan, S.V.

    1981-01-01

    The algorithm is presented of the program on simulation of muon transport through Aragats spark calorimeter. Statistic test method with account of fluctuations and angular distributions of cascade showers is used. The program is worked out on the Fortran algorithm language for EVM BESM-6 and is calibrated by experimental data of Aragats complex installation [ru

  11. Theoretical investigation of a photoconductively switched high-voltage spark gap

    NARCIS (Netherlands)

    Broks, B.H.P.; Hendriks, J.; Brok, W.J.M.; Brussaard, G.J.H.; Mullen, van der J.J.A.M.

    2006-01-01

    In this contribution, a photoconductively switched high-voltage spark gap with an emphasis on theswitching behavior is modeled. It is known experimentally that not all of the voltage that is present at the input of the spark gap is switched, but rather a fraction of it drops across the spark gap.

  12. The Results of a Randomized Control Trial Evaluation of the SPARK Literacy Program

    Science.gov (United States)

    Jones, Curtis J.; Christian, Michael; Rice, Andrew

    2016-01-01

    The purpose of this report is to present the results of a two-year randomized control trial evaluation of the SPARK literacy program. SPARK is an early grade literacy program developed by Boys & Girls Clubs of Greater Milwaukee. In 2010, SPARK was awarded an Investing in Innovation (i3) Department of Education grant to further develop the…

  13. INFLUENCE OF ELECTRIC SPARK ON HARDNESS OF CARBON STEEL

    Directory of Open Access Journals (Sweden)

    I. O. Vakulenko

    2014-03-01

    Full Text Available Purpose. The purpose of work is an estimation of influence of an electric spark treatment on the state of mouldable superficial coverage of carbon steel. Methodology. The steel of fragment of railway wheel rim served as material for research with chemical composition 0.65% С, 0.67% Mn, 0.3% Si, 0.027% P, 0.028% S. Structural researches were conducted with the use of light microscopy and methods of quantitative metallography. The structural state of the probed steel corresponded to the state after hot plastic deformation. The analysis of hardness distribution in the micro volumes of cathode metal was carried out with the use of microhardness tester of type of PMT-3. An electric spark treatment of carbon steel surface was executed with the use of equipment type of EFI-25M. Findings. After electric spark treatment of specimen surface from carbon steel the forming of multi-layered coverage was observed. The analysis of microstructure found out the existence of high-quality distinctions in the internal structure of coverage metal, depending on the probed area. The results obtained in the process are confirmed by the well-known theses, that forming of superficial coverage according to technology of electric spark is determined by the terms of transfer and crystallization of metal. The gradient of structures on the coverage thickness largely depends on development of structural transformation processes similar to the thermal character influence. Originality. As a result of electric spark treatment on the condition of identical metal of anode and cathode, the first formed layer of coverage corresponds to the monophase state according to external signs. In the volume of coverage metal, the appearance of carbide phase particles is accompanied by the decrease of microhardness values. Practical value. Forming of multi-layered superficial coverage during electric spark treatment is accompanied by the origin of structure gradient on a thickness. The effect

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

    African Journals Online (AJOL)

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

  15. Comparing approaches to generic programming in Haskell

    NARCIS (Netherlands)

    Hinze, R.; Jeuring, J.T.; Löh, A.

    2006-01-01

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

  16. Comparing approaches to generic programming in Haskell

    NARCIS (Netherlands)

    Hinze, R.; Jeuring, J.T.; Löh, A.

    2006-01-01

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

  17. Proceedings Workshop on Generic Programming (WGP2000)

    NARCIS (Netherlands)

    Jeuring, J.T.

    2000-01-01

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

  18. Erosion on spark plug electrodes; Funkenerosion an Zuendkerzenelektroden

    Energy Technology Data Exchange (ETDEWEB)

    Rager, J.

    2006-07-01

    Durability of spark plugs is mainly determined by spark gap widening, caused by electrode wear. Knowledge about the erosion mechanisms of spark plug materials is of fundamental interest for the development of materials with a high resistance against electrode erosion. It is therefore crucial to identify those parameters which significantly influence the erosion behaviour of a material. In this work, a reliable and reproducible testing method is presented which produces and characterizes electrode wear under well-defined conditions and which is capable of altering parameters specifically. Endurance tests were carried out to study the dependence of the wear behaviour of pure nickel and platinum on the electrode temperature, gas, electrode gap, electrode diameter, atmospheric pressure, and partial pressure of oxygen. It was shown that erosion under nitrogen is negligible, irrespective of the material. This disproves all common mechanism discussed in the literature explaining material loss of spark plug electrodes. Based on this observation and the variation of the mentioned parameters a new erosion model was deduced. This relies on an oxidation of the electrode material and describes the erosion of nickel and platinum separately. For nickel, electrode wear is caused by the removal of an oxide layer by the spark. In the case of platinum, material loss occurs due to the plasma-assisted formation and subsequent evaporation of volatile oxides in the cathode spot. On the basis of this mechanism a new composite material was developed whose erosion resistance is superior to pure platinum. Oxidation resistant metal oxide particles were added to a platinum matrix, thus leading to a higher erosion resistance of the composite. However, this can be decreased by a side reaction, the separation of oxygen from the metal oxides, which effectively assists the oxidation of the matrix. This reaction can be suppressed by using highly stable oxides, characterized by a large negative Gibbs

  19. 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.

  20. Excipient Usage Technical Risk Assessment for Generic Solid Dose Products

    Directory of Open Access Journals (Sweden)

    Ajay Babu Pazhayattil

    2017-09-01

    Full Text Available This paper proposes an assessment methodology for solid dose generic small molecule drug products. It addresses the ‘usage of the excipient’ portion of the trinomial by utilizing the systematic approach of Risk Identification, Risk Analysis and Risk Evaluation as per ICH Q9 Quality Risk Management outlined for developing risk control strategies. The assessment and maintenance of excipient risk profile is essential to minimize any potential risk associated to excipients impacting patients.

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

    Directory of Open Access Journals (Sweden)

    Béatrice Riner

    2017-11-01

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

  2. Multi-zone thermodynamic modelling of spark-ignition engine combustion - An overview

    International Nuclear Information System (INIS)

    Verhelst, S.; Sheppard, C.G.W.

    2009-01-01

    'Multi-zone thermodynamic engine model' is a generic term adopted here for the type of model also referred to as quasi-dimensional, two-zone, three-zone, etc.; based on the laws of mass and energy conservation and using a mass burning rate sub-model (as opposed to a prescribed mass burning rate) to predict the in-cylinder pressure and temperature throughout the power cycle. Such models have been used for about three decades and provide valuable tools for rapid evaluation of the influence of key engine parameters. Numerous papers have been published on the development of models of varying complexity and their application. The current work is not intended as a comprehensive review of all these works, but presents an overview of multi-zone thermodynamic models for spark-ignition engines, their pros and cons, the model equations and sub-models used to account for various processes such as turbulent wrinkling, flame development, flame geometry, heat transfer, etc. It is suggested that some past terminology adopted to distinguish combustion models (e.g. 'entrainment' versus 'flamelet') is artificial and confusing; it can also be difficult to compare the different models used. Naturally, different models use varying underlying assumptions; however, the influence of several physical processes has frequently been incorporated into one term, not always well documented or clearly described. The authors propose a unified framework that can be used to compare different sub-models on the same basis, with particular focus on turbulent combustion models.

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

    Science.gov (United States)

    Ting, Tricia Y; Jiang, Wenlei; Lionberger, Robert; Wong, Jessica; Jones, Jace W; Kane, Maureen A; Krumholz, Allan; Temple, Robert; Polli, James E

    2015-09-01

    To test the current U.S. Food and Drug Administration (FDA) bioequivalence standard in a comparison of generic and brand-name drug pharmacokinetic (PK) performance in "generic-brittle" patients with epilepsy under clinical use conditions. This randomized, double-blind, multiple-dose, steady-state, fully replicated bioequivalence study compared generic lamotrigine to brand-name Lamictal in "generic-brittle" patients with epilepsy (n = 34) who were already taking lamotrigine. Patients were repeatedly switched between masked Lamictal and generic lamotrigine. Intensive PK blood sampling at the end of each 2-week treatment period yielded two 12-h PK profiles for brand-name and generic forms for each patient. Steady-state area under the curve (AUC), peak plasma concentration (Cmax ), and minimum plasma concentration (Cmin ) data were subjected to conventional average bioequivalence (ABE) analysis, reference-scaled ABE analysis, and within-subject variability (WSV) comparisons. In addition, generic-versus-brand comparisons in individual patients were performed. Secondary clinical outcomes included seizure frequency and adverse events. Generic demonstrated bioequivalence to brand. The 90% confidence intervals of the mean for steady-state AUC, Cmax , and Cmin for generic-versus-brand were 97.2-101.6%, 98.8-104.5%, and 93.4-101.0%, respectively. The WSV of generic and brand were also similar. Individual patient PK ratios for generic-versus-brand were similar but not identical, in part because brand-versus-brand profiles were not identical, even though subjects were rechallenged with the same product. Few subjects had seizure exacerbations or tolerability issues with product switching. One subject, however, reported 267 focal motor seizures, primarily on generic, although his brand and generic PK profiles were practically identical. Some neurologists question whether bioequivalence in healthy volunteers ensures therapeutic equivalence of brand and generic antiepileptic drugs

  4. Automated analysis in generic groups

    Science.gov (United States)

    Fagerholm, Edvard

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

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

    Directory of Open Access Journals (Sweden)

    Sara Rahimkhani, Saeed Ghanbarzadeh, Ali Nokhodchi, Hamed Hamishehkar

    2017-03-01

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

  6. 75 FR 47599 - Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Food and...

    Science.gov (United States)

    2010-08-06

    ... frequency of response was determined by the maximum number of questionnaires that will be sent to any... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0380] Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Food and Drug...

  7. The impact of price-cap regulations on market entry by generic pharmaceutical firms.

    Science.gov (United States)

    Zhang, Wei; Sun, Huiying; Guh, Daphne; Anis, Aslam H

    2017-04-01

    In 1998, the province of Ontario, Canada implemented price-cap '70/90' regulations: the first generic must be priced at ≤70% of the associated brand-name price and subsequent generics must be priced at ≤90% of the first generics' price. The price-cap was further lowered to 50% in 2006 and 25% in 2010 for all generic drugs regardless of the first or subsequent generic entrants. This study assessed the impact of such price-cap regulations on market entry by generic firms using the formulary database from 9 provinces (January 2004-March 2013). A logistic regression was estimated to compare the probability of entry during the three policy periods in Ontario ('70/90', '25', versus '50'). Since different price-caps were subsequently introduced in other provinces, Alberta, British Columbia, New Brunswick and Saskatchewan, difference-in-differences was used to compare market entry. In Ontario, compared with the period '50', generic firms were 76% and 63% less likely to enter markets in the periods '25' and '70/90', respectively. The difference-in-differences showed that the entry probability decreased the most in Ontario during the '25' period from the '50' period. Lowering the price-cap level to 25% leads to a significantly lower probability of market entry by generic firms.

  8. 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.

  9. GLAD: a generic lattice debugger

    International Nuclear Information System (INIS)

    Lee, M.J.

    1992-01-01

    Today, numerous simulation and analysis codes exist for the design, commission, and operation of accelerator beam lines. There is a need to develop a common user interface and database link to run these codes interactively. This paper will describe a proposed system, GLAD (Generic LAttice Debugger), to fulfill this need. Specifically, GLAD can be used to find errors in beam lines during commissioning, control beam parameters during operation, and design beam line optics and error correction systems for the next generation of linear accelerators and storage rings. (author)

  10. Generic maximum likely scale selection

    DEFF Research Database (Denmark)

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

    2007-01-01

    in this work is on applying this selection principle under a Brownian image model. This image model provides a simple scale invariant prior for natural images and we provide illustrative examples of the behavior of our scale estimation on such images. In these illustrative examples, estimation is based......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...

  11. Magnetic field influence on substructure formed by electric spark treatment

    International Nuclear Information System (INIS)

    Reza Rahbari, G.; Ivanov, A.N.

    1996-01-01

    The substructure of surface layer (about 10 microns thick) has been studied by x-ray line broadening technique in the samples of plain carbon steel (0.45%C) after electric spark doping with and without magnetic field (MF). The applied spark pulse energy was 0.12 J and MF induction varied from 0 to 0.08 T. The electrode material was the same as that of the treated sample. It has been observed that the MF reduces the tensile residual surface stresses from 660 ± 15MPa (no MF) to 260 ± 15MPa (B=0.053 T). The analysis of x-ray line broadening has revealed only the existence of microstrains, which are dependent of the MF magnitude. The microstrains have been related to the randomly distributed dislocation with the density of about 3x10 sup 11 cm sup -2

  12. 100 kV reliable accurately-synchronized spark gap

    International Nuclear Information System (INIS)

    Bosamykin, V.S.; Gerasimov, A.I.; Zenkov, D.I.

    1987-01-01

    100 kV three-electrode spark gap filled with 40% SF 6 +60% N 2 mixture under the pressure of ∼ 1 MPa, which has spread Δt ≤ ± 5 ns of operating time delay in the range of 10 4 triggerings and commutation energy of 2.5 kJ, providing electric strength is 100%, is described; at 10 kJ Δt is less than ± 10 ns for 10 3 triggerings. Parallel connection of 16 groups, each consisting of 5 spark gaps with series connection, electric strength being 100%, in the pulse charging unit of Arkadiev-Marx generator being in operation for several years manifested their high efficiency; mutual group spread is ≤ ± 15 ns

  13. Striated filamentary sparks produced by a CO2 TEA laser

    International Nuclear Information System (INIS)

    Schmieder, R.W.

    1979-01-01

    Sparks in the form of long, thin filaments having quasi-periodic longitudinal light and dark regions (striations) in time-integrated images have been ovserved in various gases using a CO 2 TEA laser. Typically, a 50-mJ pulse will produce a filament 1 cm long and 130 μm in diameter, with more than 150 striations spaced 50 μm apart in atmospheric air. Each striation is associated with the formation of a plasma region by one pulse in train of pulses from the mode-locked laser, and the filament results from the formation of successive (nearly identical) region, each displaced from the previous one toward the laser. The possible use of these sparks as a light source in diagnostics is noted

  14. Large area spark counters with fine time and position resolution

    International Nuclear Information System (INIS)

    Ogawa, A.; Atwood, W.B.; Fujiwara, N.; Pestov, Yu.N.; Sugahara, R.

    1983-10-01

    Spark counters trace their history back over three decades but have been used in only a limited number of experiments. The key properties of these devices include their capability of precision timing (at the sub 100 ps level) and of measuring the position of the charged particle to high accuracy. At SLAC we have undertaken a program to develop these devices for use in high energy physics experiments involving large detectors. A spark counter of size 1.2 m x 0.1 m has been constructed and has been operating continuously in our test setup for several months. In this talk I will discuss some details of its construction and its properties as a particle detector. 14 references

  15. CMS Analysis and Data Reduction with Apache Spark

    Energy Technology Data Exchange (ETDEWEB)

    Gutsche, Oliver [Fermilab; Canali, Luca [CERN; Cremer, Illia [Magnetic Corp., Waltham; Cremonesi, Matteo [Fermilab; Elmer, Peter [Princeton U.; Fisk, Ian [Flatiron Inst., New York; Girone, Maria [CERN; Jayatilaka, Bo [Fermilab; Kowalkowski, Jim [Fermilab; Khristenko, Viktor [CERN; Motesnitsalis, Evangelos [CERN; Pivarski, Jim [Princeton U.; Sehrish, Saba [Fermilab; Surdy, Kacper [CERN; Svyatkovskiy, Alexey [Princeton U.

    2017-10-31

    Experimental Particle Physics has been at the forefront of analyzing the world's largest datasets for decades. The HEP community was among the first to develop suitable software and computing tools for this task. In recent times, new toolkits and systems for distributed data processing, collectively called "Big Data" technologies have emerged from industry and open source projects to support the analysis of Petabyte and Exabyte datasets in industry. While the principles of data analysis in HEP have not changed (filtering and transforming experiment-specific data formats), these new technologies use different approaches and tools, promising a fresh look at analysis of very large datasets that could potentially reduce the time-to-physics with increased interactivity. Moreover these new tools are typically actively developed by large communities, often profiting of industry resources, and under open source licensing. These factors result in a boost for adoption and maturity of the tools and for the communities supporting them, at the same time helping in reducing the cost of ownership for the end-users. In this talk, we are presenting studies of using Apache Spark for end user data analysis. We are studying the HEP analysis workflow separated into two thrusts: the reduction of centrally produced experiment datasets and the end-analysis up to the publication plot. Studying the first thrust, CMS is working together with CERN openlab and Intel on the CMS Big Data Reduction Facility. The goal is to reduce 1 PB of official CMS data to 1 TB of ntuple output for analysis. We are presenting the progress of this 2-year project with first results of scaling up Spark-based HEP analysis. Studying the second thrust, we are presenting studies on using Apache Spark for a CMS Dark Matter physics search, comparing Spark's feasibility, usability and performance to the ROOT-based analysis.

  16. Loits skandaalitses gaalal. Sparks Rabarockil. Pärimusmuusika Ait

    Index Scriptorium Estoniae

    2008-01-01

    Pärnu Kontserdimajas Eesti muusikaauhindade galal üle astunud rockansambel Loits röövis koostöös kultuskirjaniku Sven Kivisildnikuga aasta metal/punk-artisti auhinna, mis pidi minema industrial-metal-artistile Finish Me Off. Ameerika bänd Sparks 14. juunil Järvakandis Rabarockil. Viljandis Tasuja pst.6 avati Eesti Pärimusmuusika Keskuse uus kodu - Pärimusmuusika Ait

  17. effect of gasket of varying thickness on spark ignition engines

    African Journals Online (AJOL)

    DJFLEX

    In the study of Toyota, In-line, 4 cylinders, spark ignition engine using gaskets of varying thicknesses. (1.75mm, 3.5mm, 5.25mm, 7mm and 8.75mm) between the cylinder head and the engine block, the performance characteristics of the engine was investigated via the effect of engine speed on brake power, brake thermal ...

  18. High repetition rate burst-mode spark gap

    International Nuclear Information System (INIS)

    Faltens, A.; Reginato, L.; Hester, R.; Chesterman, A.; Cook, E.; Yokota, T.; Dexter, W.

    1978-01-01

    Results are presented on the design and testing of a pressurized gas blown spark gap switch capable of high repetition rates in a burst mode of operation. The switch parameters which have been achieved are as follows: 220-kV, 42-kA, a five pulse burst at 1-kHz, 12-ns risetime, 2-ns jitter at a pulse width of 50-ns

  19. Modeling of the Inductance of a Blumlein Circuit Spark Gap

    International Nuclear Information System (INIS)

    Aboites, V; Rendón, L; Hernández, A I; Valdés, E

    2015-01-01

    In this paper we present an analysis of the time-varying inductance in the spark gap of a Blumlein circuit. We assume several mathematical expressions to describe the inductance and compare theoretical and computational calculations with experimental results. The time-varying inductance is approximated by a constant, a straight line and two parables which differ in their concavity. This is the first time to our knowledge, in which the time-varying ignition inductance of a nitrogen laser is modeled

  20. SparkJet characterizations in quiescent and supersonic flowfields

    Science.gov (United States)

    Emerick, T.; Ali, M. Y.; Foster, C.; Alvi, F. S.; Popkin, S.

    2014-12-01

    The aerodynamic community has studied active flow control actuators for some time, and developments have led to a wide variety of devices with various features and operating mechanisms. The design requirements for a practical actuator used for active flow control include reliable operation, requisite frequency and amplitude modulation capabilities, and a reasonable lifespan while maintaining minimal cost and design complexity. An active flow control device called the SparkJet actuator has been developed for high-speed flight control and incorporates no mechanical/moving parts, zero net mass flux capabilities and the ability to tune the operating frequency and momentum throughput. This actuator utilizes electrical power to deliver high-momentum flow with a very fast response time. The SparkJet actuator was characterized on the benchtop using a laser-based microschlieren visualization technique and maximum blast wave and jet front velocities of ~400 and ~310 m/s were, respectively, measured in the flowfield. An increase in jet front velocity from 240 to 310 m/s during subatmospheric (60 kPa) testing reveals that the actuator may have greater control authority at lower ambient pressures, which correspond to high-altitude flight conditions for air vehicles. A SparkJet array was integrated into a flat plate and tested in a Mach 1.5 crossflow. Phase-conditioned shadowgraph results revealed a maximum flow deflection angle of 5° created by the SparkJet 275 µs after the actuator was triggered in single-shot mode. Burst mode operation of frequencies up to 700 Hz revealed similar results during wind tunnel testing. Following these tests, the actuator trigger mechanism was improved and the ability of the actuator to be discharged in burst mode at a frequency of 1 kHz was achieved.

  1. The time response function of spark counters and RPCs

    International Nuclear Information System (INIS)

    Gobbi, A.; Mangiarotti, A.

    2003-01-01

    The fluctuation theory for the avalanche growth with and without space charge effects is briefly summarized and compared to a broad field of applications. These include spark counters as well as timing and trigger RPCs operated in avalanche mode. A large domain in electrical field strength, pressure, gap size and gas mixture type is covered. A reasonable agreement with the experiment is observed, giving confidence on the validity of both assumptions and treatment of the theory

  2. Production of uranium-molybdenum particles by spark-erosion

    International Nuclear Information System (INIS)

    Cabanillas, E.D.; Lopez, M.; Pasqualini, E.E.; Cirilo Lombardo, D.J.

    2004-01-01

    With the spark-erosion method we have produced spheroidal particles of an uranium-molybdenum alloy using pure water as dielectric. The particles were characterized by optical metallography, scanning electron microscopy, energy dispersive spectrometry and X-ray diffraction. Mostly spherical particles of UO 2 with a distinctive size distribution with peaks centered at 70 and 10 μm were obtained. The particles have central inclusions of U and Mo compounds

  3. Production of uranium-molybdenum particles by spark-erosion

    Energy Technology Data Exchange (ETDEWEB)

    Cabanillas, E.D. E-mail: cabanill@cnea.gov.ar; Lopez, M.; Pasqualini, E.E.; Cirilo Lombardo, D.J

    2004-01-01

    With the spark-erosion method we have produced spheroidal particles of an uranium-molybdenum alloy using pure water as dielectric. The particles were characterized by optical metallography, scanning electron microscopy, energy dispersive spectrometry and X-ray diffraction. Mostly spherical particles of UO{sub 2} with a distinctive size distribution with peaks centered at 70 and 10 {mu}m were obtained. The particles have central inclusions of U and Mo compounds.

  4. Particular bi-fuel application of spark ignition engines

    Science.gov (United States)

    Raţiu, S.; Alexa, V.; Kiss, I.

    2016-02-01

    This paper presents a comparative test concerning the operation of a spark-ignition engine, make: Dacia 1300, model: 810.99, fuelled alternatively with gasoline and LPG (Liquefied Petroleum Gas). The tests carried out show, on the one hand, the maintenance of power and torque performances in both engine fuelling cases, for all the engine operation regimes, and, on the other hand, a considerable decrease in CO and HC emissions when using poor mixtures related to LPG fuelling.

  5. Modelling of spark to ignition transition in gas mixtures

    Energy Technology Data Exchange (ETDEWEB)

    Akram, M.

    1996-10-01

    This thesis pertains to the models for studying sparking in chemically inert gases. The processes taking place in a spark to flame transition can be segregated into physical and chemical processes, and this study is focused on physical processes. The plasma is regarded as a single-substance material. One and two-dimensional models are developed. The transfer of electrical energy into thermal energy of the gas and its redistribution in space and time along with the evolution of a plasma kernel is studied in the time domain ranging from 10 ns to 40 micros. In the case of ultra-fast sparks, the propagation of the shock and its reflection from a rigid wall is presented. The influence of electrode shape and the gap size on the flow structure development is found to be a dominating factor. It is observed that the flow structure that has developed in the early stage more or less prevails at later stages and strongly influences the shape and evolution of the hot kernel. The electrode geometry and configuration are responsible for the development of the flow structure. The strength of the vortices generated in the flow field is influenced by the power input to the gap and their location of emergence is dictated by the electrode shape and configuration. The heat transfer after 2 micros in the case of ultra-fast sparks is dominated by convection and diffusion. The strong mixing produced by hydrodynamic effects and the electrode geometry give the indication that the magnetic pinch effect might be negligible. Finally, a model for a multicomponent gas mixture is presented. The chemical kinetics mechanism for dissociation and ionization is introduced. 56 refs

  6. Open source biotechnology : A drug for developing countries' health problems?

    NARCIS (Netherlands)

    Schellekens, M.H.M.

    2008-01-01

    In developing countries, many people suffer from diseases for which there are no drugs or for which drugs exist that they cannot afford because they are too expensive. The advent of genomics has sparked the idea that new drugs can be more easily developed and that genomics thus could lessen the

  7. Innovative high-performance liquid chromatography method development for the screening of 19 antimalarial drugs based on a generic approach, using design of experiments, independent component analysis and design space.

    Science.gov (United States)

    Debrus, B; Lebrun, P; Kindenge, J Mbinze; Lecomte, F; Ceccato, A; Caliaro, G; Mbay, J Mavar Tayey; Boulanger, B; Marini, R D; Rozet, E; Hubert, Ph

    2011-08-05

    An innovative methodology based on design of experiments (DoE), independent component analysis (ICA) and design space (DS) was developed in previous works and was tested out with a mixture of 19 antimalarial drugs. This global LC method development methodology (i.e. DoE-ICA-DS) was used to optimize the separation of 19 antimalarial drugs to obtain a screening method. DoE-ICA-DS methodology is fully compliant with the current trend of quality by design. DoE was used to define the set of experiments to model the retention times at the beginning, the apex and the end of each peak. Furthermore, ICA was used to numerically separate coeluting peaks and estimate their unbiased retention times. Gradient time, temperature and pH were selected as the factors of a full factorial design. These retention times were modelled by stepwise multiple linear regressions. A recently introduced critical quality attribute, namely the separation criterion (S), was also used to assess the quality of separations rather than using the resolution. Furthermore, the resulting mathematical models were also studied from a chromatographic point of view to understand and investigate the chromatographic behaviour of each compound. Good adequacies were found between the mathematical models and the expected chromatographic behaviours predicted by chromatographic theory. Finally, focusing at quality risk management, the DS was computed as the multidimensional subspace where the probability for the separation criterion to lie in acceptance limits was higher than a defined quality level. The DS was computed propagating the prediction error from the modelled responses to the quality criterion using Monte Carlo simulations. DoE-ICA-DS allowed encountering optimal operating conditions to obtain a robust screening method for the 19 considered antimalarial drugs in the framework of the fight against counterfeit medicines. Moreover and only on the basis of the same data set, a dedicated method for the

  8. Gas temperature of capacitance spark discharge in air

    International Nuclear Information System (INIS)

    Ono, Ryo; Nifuku, Masaharu; Fujiwara, Shuzo; Horiguchi, Sadashige; Oda, Tetsuji

    2005-01-01

    Capacitance spark discharge has been widely used for studying the ignition of flammable gas caused by electrostatic discharge. In the present study, the gas temperature of capacitance spark discharge is measured. The gas temperature is an important factor in understanding the electrostatic ignition process because it influences the reaction rate of ignition. Spark discharge is generated in air with a pulse duration shorter than 100 ns. The discharge energy is set to 0.03-1 mJ. The rotational and vibrational temperatures of the N 2 molecule are measured using the emission spectrum of the N 2 second positive system. The rotational and vibrational temperatures are estimated to be 500 and 5000 K, respectively, which are independent of the discharge energy. This result indicates that most of the electron energy is consumed in the excitation of vibrational levels of molecules rather than the heating of the gas. The gas temperature after discharge is also measured by laser-induced fluorescence of OH radicals. It is shown that the gas temperature increases after discharge and reaches approximately 1000 K at 3 μs after discharge. Then the temperature decreases at a rate in the range of 8-35 K/μs depending on the discharge energy

  9. Spark igniter having precious metal ground electrode inserts

    International Nuclear Information System (INIS)

    Ryan, N.A.

    1988-01-01

    This patent describes an igniter comprising a shell of a shell metal alloy which is resistant to spark erosion and corrosion, the shell having a firing end which terminates at its lower end in an annular ring, an insulator sealed within the metal shell and having a central bore and a surface extending inwardly toward the bore from the annular ring, a center electrode sealed within the bore of the insulator and having a firing end which is in spark gap relation with the annular ring of the shell and so positioned that a spark discharge between the firing end and the annular ring occurs along the inwardly extending surface of the insulator, and a plurality of oxidation and erosion resistant inserts, each of the inserts comprising a body of a metal selected from the group consisting of iridium, osmium, ruthenium, rhodium, platinum, and tungsten or an alloy or a ductile alloy of one of the foregoing metals, each of the bodies being embedded within a matching opening which extends from the exterior of the shell through the annular ring, being bonded to the shell

  10. River water remediation using pulsed corona, pulsed spark or ozonation

    Energy Technology Data Exchange (ETDEWEB)

    Izdebski, T.; Dors, M. [Polish Academy of Sciences, Szewalski Inst. of Fluid Flow Machiney, Fiszera (Poland). Centre for Plasma and Laser Engineering; Mizeraczyk, J. [Polish Academy of Sciences, Szewalski Inst. of Fluid Flow Machiney, Fiszera (Poland). Centre for Plasma and Laser Engineering; Gdynia Maritime Univ., Morska (Poland). Dept. of Marine Electronics

    2010-07-01

    The most common reason for epidemic formation is the pollution of surface and drinking water by wastewater bacteria. Pathogenic microorganisms that form the largest part of this are fecal bacteria, such as escherichia coli (E. coli). Wastewater treatment plants reduce the amount of the fecal bacteria by 1-3 orders of magnitude, depending on the initial number of bacteria. There is a lack of data on waste and drinking water purification by the electrohydraulic discharges method, which causes the destruction and inactivation of viruses, yeast, and bacteria. This paper investigated river water cleaning from microorganisms using pulsed corona, spark discharge and ozonization. The paper discussed the experimental setup and results. It was concluded that ozonization is the most efficient method of water disinfection as compared with pulsed spark and pulsed corona discharges. The pulsed spark discharge in water was capable of killing all microorganism similarly to ozonization, but with much lower energy efficiency. The pulsed corona discharge was found to be the less effective method of water disinfection. 21 refs., 4 figs.

  11. Research on retailer data clustering algorithm based on Spark

    Science.gov (United States)

    Huang, Qiuman; Zhou, Feng

    2017-03-01

    Big data analysis is a hot topic in the IT field now. Spark is a high-reliability and high-performance distributed parallel computing framework for big data sets. K-means algorithm is one of the classical partition methods in clustering algorithm. In this paper, we study the k-means clustering algorithm on Spark. Firstly, the principle of the algorithm is analyzed, and then the clustering analysis is carried out on the supermarket customers through the experiment to find out the different shopping patterns. At the same time, this paper proposes the parallelization of k-means algorithm and the distributed computing framework of Spark, and gives the concrete design scheme and implementation scheme. This paper uses the two-year sales data of a supermarket to validate the proposed clustering algorithm and achieve the goal of subdividing customers, and then analyze the clustering results to help enterprises to take different marketing strategies for different customer groups to improve sales performance.

  12. Generic Performance Measures. Chapter 8

    Energy Technology Data Exchange (ETDEWEB)

    Daube-Witherspoon, M. E. [Department of Radiology, University of Pennsylvania, Philadelphia, PA (United States)

    2014-12-15

    The generic nuclear medicine imager, whether a gamma camera, single photon emission computed tomography (SPECT) system or positron emission tomography (PET) scanner, comprises several main components: a detection system, a form of collimation to select γ rays at specific angles, electronics and a computing system to create the map of the radiotracer distribution. This section discusses these components in more detail. The first stage of a generic nuclear medicine imager is the detection of the γ rays emitted by the radionuclide. In the case of PET, the radiation of interest are the 511 keV annihilation photons that result from the interaction of the positron emitted by the radionuclide with an electron in the tissue. For general nuclear medicine and SPECT, there is one or sometimes more than one γ ray of interest, with energies in the range of <100 to >400 keV. The γ rays are detected when they interact and deposit energy in the crystal(s) of the imaging system. There are two main types of detector: crystals that give off light that can be converted to an electrical signal when the γ ray interacts (‘scintillators’) and semiconductors, crystals that generate an electrical signal directly when the γ ray deposits energy in the crystal. Scintillation detectors include NaI(Tl), bismuth germanate (BGO) and lutetium oxyorthosilicate (LSO); semiconductor detectors used in nuclear medicine imagers include cadmium zinc telluride (CZT). Radiation detectors are described in more detail in Chapter 6.

  13. Prioritization of generic safety issues

    International Nuclear Information System (INIS)

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

    1983-12-01

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

  14. Generic communications index: User's manual

    International Nuclear Information System (INIS)

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

    1987-12-01

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

  15. Randomized, double blind comparison of brand and generic antibiotic suspensions: II. A study of taste and compliance in children.

    Science.gov (United States)

    El-Chaar, G M; Mardy, G; Wehlou, K; Rubin, L G

    1996-01-01

    The taste of oral liquid medications influences compliance in children. Generic preparations are prescribed to reduce cost and may taste worse than brand name products. This was a prospective, randomized, double blind, crossover trial of the differences in taste and compliance between brand and generic antibiotic suspensions in children 3 to 14 years of age. Verbal and visual assessment methods were used to assess taste, and compliance was measured by the amount of drug returned after use. Ten children in each of the cephalexin and erythromycin-sulfisoxazole groups did not report that the brand and generic formulations tasted differently. Fifteen children thought that brand trimethoprim-sulfamethoxazole tasted better than the generic preparation. Brand name oral liquid antibiotics do not necessarily taste better than their generic counterparts. Despite preference for the taste of brand trimethoprim-sulfamethoxazole, all of the children in this study were compliant with both brand and generic medications.

  16. Projecting future drug expenditures--2009.

    Science.gov (United States)

    Hoffman, James M; Shah, Nilay D; Vermeulen, Lee C; Doloresco, Fred; Martin, Patrick K; Blake, Sharon; Matusiak, Linda; Hunkler, Robert J; Schumock, Glen T

    2009-02-01

    Drug expenditure trends in 2007 and 2008, projected drug expenditures for 2009, and factors likely to influence drug expenditures are discussed. Various factors are likely to influence drug expenditures in 2009, including drugs in development, the diffusion of new drugs, drug safety concerns, generic drugs, Medicare Part D, and changes in the drug supply chain. The increasing availability of important generic drugs and drug safety concerns continue to moderate growth in drug expenditures. The drug supply chain remains dynamic and may influence drug expenditures, particularly in specialized therapeutic areas. Initial data suggest that the Medicare Part D benefit has influenced drug expenditures, but the ultimate impact of the benefit on drug expenditures remains unclear. From 2006 to 2007, total U.S. drug expenditures increased by 4.0%, with total spending rising from $276 billion to $287 billion. Drug expenditures in clinics continue to grow more rapidly than in other settings, with a 9.9% increase from 2006 to 2007. Hospital drug expenditures increased at a moderate rate of only 1.6% from 2006 to 2007; through the first nine months of 2008, hospital drug expenditures increased by only 2.8% compared with the same period in 2007. In 2009, we project a 0-2% increase in drug expenditures in outpatient settings, a 1-3% increase in expenditures for clinic-administered drugs, and a 1-3% increase in hospital drug expenditures.

  17. 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.

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

    Science.gov (United States)

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

    2015-12-15

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

  19. 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.

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

    Science.gov (United States)

    Puig-Junoy, Jaume

    2010-01-01

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

  1. Are generic and brand-name statins clinically equivalent? Evidence from a real data-base.

    Science.gov (United States)

    Corrao, Giovanni; Soranna, Davide; Arfè, Andrea; Casula, Manuela; Tragni, Elena; Merlino, Luca; Mancia, Giuseppe; Catapano, Alberico L

    2014-10-01

    Use of generic drugs can help contain drug spending. However, there is concern among patients and physicians that generic drugs may be clinically inferior to brand-name ones. This study aimed to compare patients treated with generic and brand-name statins in terms of therapeutic interruption and cardiovascular (CV) outcomes. 13,799 beneficiaries of the health care system of Lombardy, Italy, aged 40 years or older who were newly treated with generic or brand-name simvastatin during 2008, were followed until 2011 for the occurrence of two outcomes: 1) therapeutic discontinuation and 2) hospitalization for CV events. Hazard ratios (HR) associated with use of generic or brand-name at starting therapy (intention-to-treat analysis) and during follow-up (as-treated analysis) were estimated by fitting proportional hazard Cox models. A Monte-Carlo sensitivity analysis was performed to account for unmeasured confounders. Patients who started on generic did not experience a different risk of discontinuation (HR: 0.98; 95% CI 0.94 to 1.02) nor of CV outcomes (HR: 0.98; 95% CI 0.79 to 1.22) from those starting on brand-name. Patients who spent >75% of time of follow-up with statin available on generics did not experience a different risk of discontinuation (HR: 0.94; 95% CI 0.87 to 1.01), nor of CV outcomes (HR: 1.06; 95% CI 0.83 to 1.34), compared with those who mainly or only used brand-name statin. Our findings do not support the notion that in the real world clinical practice brand-name statins are superior to generics for keeping therapy and preventing CV outcomes. Copyright © 2014. Published by Elsevier B.V.

  2. Generic Hurricane Extreme Seas State

    DEFF Research Database (Denmark)

    Wehmeyer, Christof; Skourup, Jesper; Frigaard, Peter

    2012-01-01

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

  3. Sintering, consolidation, reaction and crystal growth by the spark plasma system (SPS)

    Energy Technology Data Exchange (ETDEWEB)

    Omori, M. [Tohoku Univ., Sendai (Japan). Inst. for Materials Research

    2000-08-15

    The graphite die set in spark plasma system (SPS) is heated by a pulse direct current. Weak plasma, discharge impact, electric field and electric current, which are based on this current, induce good effects on materials in the die. The surface films of aluminum and pure WC powders are ruptured by the spark plasma. Pure AlN powder is sintered without sintering additives in the electric field. The spark plasma leaves discharge patterns on insulators. Organic fibers are etched by the spark plasma. Thermosetting polyimide is consolidated by the spark plasma. Insoluble polymonomethylsilane is rearranged into the soluble one by the spark plasma. A single crystal of CoSb{sub 3} is grown from the compound powders in the electric field by slow heating. Coupled crystals of eutectic powder are connected with each other in the electric field. (orig.)

  4. 76 FR 57767 - Proposed Generic Communication; Draft NRC Generic Letter 2011-XX: Seismic Risk Evaluations for...

    Science.gov (United States)

    2011-09-16

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

  5. Spark Ignition Characteristics of a L02/LCH4 Engine at Altitude Conditions

    Science.gov (United States)

    Kleinhenz, Julie; Sarmiento, Charles; Marshall, William

    2012-01-01

    The use of non-toxic propellants in future exploration vehicles would enable safer, more cost effective mission scenarios. One promising "green" alternative to existing hypergols is liquid methane/liquid oxygen. To demonstrate performance and prove feasibility of this propellant combination, a 100lbf LO2/LCH4 engine was developed and tested under the NASA Propulsion and Cryogenic Advanced Development (PCAD) project. Since high ignition energy is a perceived drawback of this propellant combination, a test program was performed to explore ignition performance and reliability versus delivered spark energy. The sensitivity of ignition to spark timing and repetition rate was also examined. Three different exciter units were used with the engine s augmented (torch) igniter. Propellant temperature was also varied within the liquid range. Captured waveforms indicated spark behavior in hot fire conditions was inconsistent compared to the well-behaved dry sparks (in quiescent, room air). The escalating pressure and flow environment increases spark impedance and may at some point compromise an exciter s ability to deliver a spark. Reduced spark energies of these sparks result in more erratic ignitions and adversely affect ignition probability. The timing of the sparks relative to the pressure/flow conditions also impacted the probability of ignition. Sparks occurring early in the flow could trigger ignition with energies as low as 1-6mJ, though multiple, similarly timed sparks of 55-75mJ were required for reliable ignition. An optimum time interval for spark application and ignition coincided with propellant introduction to the igniter and engine. Shifts of ignition timing were manifested by changes in the characteristics of the resulting ignition.

  6. Spark Ignition Characteristics of a LO2/LCH4 Engine at Altitude Conditions

    Science.gov (United States)

    Kleinhenz, Julie; Sarmiento, Charles; Marshall, William

    2012-01-01

    The use of non-toxic propellants in future exploration vehicles would enable safer, more cost effective mission scenarios. One promising "green" alternative to existing hypergols is liquid methane/liquid oxygen. To demonstrate performance and prove feasibility of this propellant combination, a 100lbf LO2/LCH4 engine was developed and tested under the NASA Propulsion and Cryogenic Advanced Development (PCAD) project. Since high ignition energy is a perceived drawback of this propellant combination, a test program was performed to explore ignition performance and reliability versus delivered spark energy. The sensitivity of ignition to spark timing and repetition rate was also examined. Three different exciter units were used with the engine's augmented (torch) igniter. Propellant temperature was also varied within the liquid range. Captured waveforms indicated spark behavior in hot fire conditions was inconsistent compared to the well-behaved dry sparks (in quiescent, room air). The escalating pressure and flow environment increases spark impedance and may at some point compromise an exciter.s ability to deliver a spark. Reduced spark energies of these sparks result in more erratic ignitions and adversely affect ignition probability. The timing of the sparks relative to the pressure/flow conditions also impacted the probability of ignition. Sparks occurring early in the flow could trigger ignition with energies as low as 1-6mJ, though multiple, similarly timed sparks of 55-75mJ were required for reliable ignition. An optimum time interval for spark application and ignition coincided with propellant introduction to the igniter and engine. Shifts of ignition timing were manifested by changes in the characteristics of the resulting ignition.

  7. Spark Ignition LPG for Hydrogen Gas Combustion the Reduction Furnace ME-11 Process

    International Nuclear Information System (INIS)

    Achmad Suntoro

    2007-01-01

    Reverse engineering method for automatic spark-ignition system of LPG to burn hydrogen gaseous in the reducing process of ME-11 furnace has been successfully implemented using local materials. A qualitative study to the initial behaviour of the LPG flame system has created an idea by modification to install an automatic spark-ignition of the LPG on the reducing furnace ME-11. The automatic spark-ignition system has been tested and proved working well. (author)

  8. Measurements of some parameters of thermal sparks with respect to their ability to ignite aviation fuel/air mixtures

    Science.gov (United States)

    Haigh, S. J.; Hardwick, C. J.; Baldwin, R. E.

    1991-01-01

    A method used to generate thermal sparks for experimental purposes and methods by which parameters of the sparks, such as speed, size, and temperature, were measured are described. Values are given of the range of such parameters within these spark showers. Titanium sparks were used almost exclusively, since it is particles of this metal which are found to be ejected during simulation tests to carbon fiber composite (CFC) joints. Tests were then carried out in which titanium sparks and spark showers were injected into JP4/(AVTAG F40) mixtures with air. Single large sparks and dense showers of small sparks were found to be capable of causing ignition. Tests were then repeated using ethylene/air mixtures, which were found to be more easily ignited by thermal sparks than the JP4/ air mixtures.

  9. A Generic Approach to Parameter Control

    NARCIS (Netherlands)

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

    2012-01-01

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

  10. 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

  11. HTGR generic technology program plan (FY 80)

    International Nuclear Information System (INIS)

    1980-01-01

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

  12. Development of Augmented Spark Impinging Igniter System for Methane Engines

    Science.gov (United States)

    Marshall, William M.; Osborne, Robin J.; Greene, Sandra E.

    2017-01-01

    The Lunar Cargo Transportation and Landing by Soft Touchdown (Lunar CATALYST) program is establishing multiple no-funds-exchanged Space Act Agreement (SAA) partnerships with U.S. private sector entities. The purpose of this program is to encourage the development of robotic lunar landers that can be integrated with U.S. commercial launch capabilities to deliver payloads to the lunar surface. NASA can share technology and expertise under the SAA for the benefit of the CATALYST partners. MSFC seeking to vacuum test Augmented Spark Impinging (ASI) igniter with methane and new exciter units to support CATALYST partners and NASA programs. ASI has previously been used/tested successfully at sea-level, with both O2/CH4 and O2/H2 propellants. Conventional ignition exciter systems historically experienced corona discharge issues in vacuum. Often utilized purging or atmospheric sealing on high voltage lead to remedy. Compact systems developed since PCAD could eliminate the high-voltage lead and directly couple the exciter to the spark igniter. MSFC developed Augmented Spark Impinging (ASI) igniter. Successfully used in several sea-level test programs. Plasma-assisted design. Portion of ox flow is used to generate hot plasma. Impinging flows downstream of plasma. Additional fuel flow down torch tube sleeve for cooling near stoichiometric torch flame. Testing done at NASA GRC Altitude Combustion Stand (ACS) facility 2000-lbf class facility with altitude simulation up to around 100,000 ft. (0.2 psia [10 Torr]) via nitrogen driven ejectors. Propellant conditioning systems can provide temperature control of LOX/CH4 up to test article.

  13. Comparison of Compounded, Generic, and Innovator-Formulated Itraconazole in Dogs and Cats.

    Science.gov (United States)

    Renschler, Janelle; Albers, Amanda; Sinclair-Mackling, Hanna; Wheat, Lawrence Joseph

    2018-05-14

    The triazole antifungal itraconazole may be cost prohibitive in brand name form; therefore, compounded and generic products are often used as alternatives. Itraconazole blood concentrations have not been studied in clinical patients receiving these formulations. Itraconazole bioassay was performed on serum/plasma from 95 dogs and 20 cats receiving itraconazole (compounded from bulk powder, generic pelletized, or brand name) for systemic mycosis treatment. Mean itraconazole concentration was lower in the compounded group (n = 42) as compared with the generic (n = 40) or brand name (n = 33) groups (0.5 µg/mL versus 8.3 µg/mL and 6.5 µg/mL, respectively; P 10 µg/mL; 37.5 and 24%, respectively). Compounded itraconazole should be avoided, but generic itraconazole appears to serve as a reasonable alternative to brand name itraconazole. Therapeutic drug monitoring may be beneficial in all cases.

  14. Lack of efficacy during the switch from brand to generic allopurinol.

    Science.gov (United States)

    De Vuono, Antonio; Scicchitano, Francesca; Palleria, Caterina; Russo, Emilio; De Sarro, Giovambattista; Gallelli, Luca

    2013-07-01

    We report for the first time the lack of therapeutic effects after the switch from a brand formulation of allopurinol to a generic one. A 56-year-old man, with a 5 years history of well-treated gout arthropathy with allopurinol (Zyloric(®) 300 mg/die), developed acute gout arthropathy after the switch from the brand formulation of allopurinol to a generic one. Clinical evaluation and laboratory findings confirmed the diagnosis of acute gout arthropathy. Generic formulation of the drug was dismissed and Zyloric(®) was administered with an improvement of both clinical symptoms and laboratory findings. In conclusion, even if generic formulations are considered to have the same effects in comparison to the brand one, more data are necessaries in order to well define their effectiveness and rationale use. Copyright © 2013 Elsevier Ltd and Faculty of Forensic and Legal Medicine. All rights reserved.

  15. Low temperature spark plasma sintering of YIG powders

    International Nuclear Information System (INIS)

    Fernandez-Garcia, L.; Suarez, M.; Menendez, J.L.

    2010-01-01

    A transition from a low to a high spin state in the magnetization saturation between 1000 and 1100 o C calcination temperature is observed in YIG powders prepared by oxides mixture. Spark plasma sintering of these powders between 900 and 950 o C leads to dense samples with minimal formation of YFeO 3 , opening the way to co-sintering of YIG with metals or metallic alloys. The optical properties depend on the sintering stage: low (high) density samples show poor (bulk) optical absorption.

  16. Spark gap overpressures in the transfer capacitor device

    International Nuclear Information System (INIS)

    Burkhardt, L.C.; Dike, R.S.

    1977-01-01

    A designer of spark gaps is often faced with two gas pressure problems, one static and one dynamic. The former is easy to obtain data on which to base intelligent design specifications; about the latter, less is known. It is the total internal pressure environment we have attempted to measure, in an un-time-resolved way, in order to give the designer some rationale in designing gaps of this category. We measure overpressures of approximately 400 PSI in a 13 cubic inch gap passing currents of approximately 200 kA

  17. Search for an optimum time response of spark counters

    International Nuclear Information System (INIS)

    Devismes, A.; Finck, Ch.; Kress, T.; Gobbi, A.; Eschke, J.; Herrmann, N.; Hildenbrand, K.D.; Koczon, P.; Petrovici, M.

    2002-01-01

    A spark counter of the type developed by Pestov has been tested with the aim of searching for an optimum time response function, changing voltage, content of noble and quencher gases, pressure and energy-loss. Replacing the usual argon by neon has brought an improvement of the resolution and a significant reduction of tails in the time response function. It has been proven that a counter as long as 90 cm can deliver, using neon gas mixture, a time resolution σ<60 ps with about 1% absolute tail and an efficiency of about 90%

  18. Compaction of lithium-silicate ceramics using spark plasma sintering

    Czech Academy of Sciences Publication Activity Database

    Kubatík, Tomáš František; Lukáč, František; Mušálek, Radek; Brožek, Vlastimil; Stehlíková, K.; Chráska, Tomáš

    2017-01-01

    Roč. 61, č. 1 (2017), s. 40-44 ISSN 0862-5468 R&D Projects: GA ČR GB14-36566G Institutional support: RVO:61389021 Keywords : Li2Si2O5 * Li2SiO3 * Spark plasma sintering (SPS) * Quantitative Rietveld refinement * X-ray diffraction (XRD) Subject RIV: JG - Metallurgy OBOR OECD: Materials engineering Impact factor: 0.439, year: 2016 http://www.ceramics-silikaty.cz/index.php?page=cs_detail_doi&id=789

  19. Generic substitution comparing the clinical efficacy of a generic ...

    African Journals Online (AJOL)

    Long-acting neuroleptics have become the mainstay of the long-term treatment of schizophrenia, improving compliance and thus preventing relapse. Since schizophrenia is a common condition and ... Concerns about the quality and efficacy of these drugs should be investigated. In this study, no significant differences in the ...

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

    Science.gov (United States)

    Magazzini, Laura; Pammolli, Fabio; Riccaboni, Massimo

    2004-06-01

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

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

    Science.gov (United States)

    Walker, A D; Adachi, J D

    2011-09-01

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

  2. Effects of tetracaine on voltage-activated calcium sparks in frog intact skeletal muscle fibers.

    Science.gov (United States)

    Hollingworth, Stephen; Chandler, W Knox; Baylor, Stephen M

    2006-03-01

    The properties of Ca(2+) sparks in frog intact skeletal muscle fibers depolarized with 13 mM [K(+)] Ringer's are well described by a computational model with a Ca(2+) source flux of amplitude 2.5 pA (units of current) and duration 4.6 ms (18 degrees C; Model 2 of Baylor et al., 2002). This result, in combination with the values of single-channel Ca(2+) current reported for ryanodine receptors (RyRs) in bilayers under physiological ion conditions, 0.5 pA (Kettlun et al., 2003) to 2 pA (Tinker et al., 1993), suggests that 1-5 RyR Ca(2+) release channels open during a voltage-activated Ca(2+) spark in an intact fiber. To distinguish between one and greater than one channel per spark, sparks were measured in 8 mM [K(+)] Ringer's in the absence and presence of tetracaine, an inhibitor of RyR channel openings in bilayers. The most prominent effect of 75-100 microM tetracaine was an approximately sixfold reduction in spark frequency. The remaining sparks showed significant reductions in the mean values of peak amplitude, decay time constant, full duration at half maximum (FDHM), full width at half maximum (FWHM), and mass, but not in the mean value of rise time. Spark properties in tetracaine were simulated with an updated spark model that differed in minor ways from our previous model. The simulations show that (a) the properties of sparks in tetracaine are those expected if tetracaine reduces the number of active RyR Ca(2+) channels per spark, and (b) the single-channel Ca(2+) current of an RyR channel is normal voltage-activated sparks (i.e., in the absence of tetracaine) are produced by two or more active RyR Ca(2+) channels. The question of how the activation of multiple RyRs is coordinated is discussed.

  3. Knowledge, attitudes and practices of community pharmacists on generic medicines in Palestine: a cross-sectional study.

    Science.gov (United States)

    Shraim, Naser Y; Al Taha, Tasneem A; Qawasmeh, Rawan F; Jarrar, Hiba N; Shtaya, Maram A N; Shayeb, Lama A; Sweileh, Waleed M

    2017-12-28

    Generic substitution in several countries has become a common practice. Besides, it is considered as a major cost minimizing strategy meant to contain pharmaceutical expenditure without compromising healthcare quality. However, the safety and quality issues of generic products are of top concerns of general practitioners and health work professionals. This study aimed to investigate community pharmacist's knowledge, attitudes and practices toward generic medicines in Palestine. This study was a cross-sectional observational study employing a self-administered questionnaire. The questionnaire was of four main sections: demographic and practice details of the participants, knowledge, attitudes and the influencing factors related to selection and dispensing of generic medicines. A convenience sampling technique was implemented in this study in which the data collection form was distributed in West Bank- Palestine among a set of practicing pharmacists. Mann-Whitney-U or Kruskal-Wallis tests were used to comparison of different issues as appropriate. P-values of marketing approval of generics, while 87.4% of participants agreed that they should be given the right to substitute generics and the majority (62.3%) support generic substitution for brand name drugs in all cases when a generic is available The main two factors affect pharmacists' selection and dispensing of generic medicines are personal faith in the product (86.1%) and cost effectiveness of generic medicines (84.1%). Generic medicines substitution among pharmacists is widespread and prevalent. Our data found that participant pharmacists in Palestine had basic knowledge with regards to generic medicine. However, their knowledge score pertaining the technical and regulatory aspects of bioequivalence and pharmacokinetic parameters in particular was insufficient.

  4. Generic Local Hamiltonians are Gapless

    Science.gov (United States)

    Movassagh, Ramis

    2017-12-01

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

  5. Generic physical protection logic trees

    International Nuclear Information System (INIS)

    Paulus, W.K.

    1981-10-01

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

  6. 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.

  7. Generic theory for channel sinuosity.

    Science.gov (United States)

    Lazarus, Eli D; Constantine, José Antonio

    2013-05-21

    Sinuous patterns traced by fluid flows are a ubiquitous feature of physical landscapes on Earth, Mars, the volcanic floodplains of the Moon and Venus, and other planetary bodies. Typically discussed as a consequence of migration processes in meandering rivers, sinuosity is also expressed in channel types that show little or no indication of meandering. Sinuosity is sometimes described as "inherited" from a preexisting morphology, which still does not explain where the inherited sinuosity came from. For a phenomenon so universal as sinuosity, existing models of channelized flows do not explain the occurrence of sinuosity in the full variety of settings in which it manifests, or how sinuosity may originate. Here we present a generic theory for sinuous flow patterns in landscapes. Using observations from nature and a numerical model of flow routing, we propose that flow resistance (representing landscape roughness attributable to topography or vegetation density) relative to surface slope exerts a fundamental control on channel sinuosity that is effectively independent of internal flow dynamics. Resistance-dominated surfaces produce channels with higher sinuosity than those of slope-dominated surfaces because increased resistance impedes downslope flow. Not limited to rivers, the hypothesis we explore pertains to sinuosity as a geomorphic pattern. The explanation we propose is inclusive enough to account for a wide variety of sinuous channel types in nature, and can serve as an analytical tool for determining the sinuosity a landscape might support.

  8. Generic adversary characteristics: summary report

    International Nuclear Information System (INIS)

    Stewart, J.B. Jr.; Davidson, J.J.; Jones, H.B.; Fulwiler, C.H.; Mullen, S.A.

    1978-07-01

    The adversaries studied were found to be complex, often unpredictable, and dynamic. The adversary typically goes through a complex decision-making process between the time a potential target is identified and the moment the decision to act is made. This study analyzes the adversary characteristics, and the following conclusions are made: one of the least likely methods of attack is an overt armed assault. Terrorists and psychotics depend upon a high degree of personal dedication. No single generic adversary group or individual exhibits strength in every characteristic. Physical danger appears to have some deterrent effect on all adversaries except the psychotics. Organized and professional criminals often try to recruit insiders. Disoriented persons, white-collar criminals, and disgruntled employees tend to operate as insiders. Professional criminals, many terrorist groups, some extremist protest groups, and certain disoriented persons plan carefully before initiating a criminal mission. Organized crime and miscellaneous criminal adversaries rely on deception and ruse to bypass security. After the decision to commit a crime, the resources deployed by terrorists or organized criminals will be a function of their perception of the operational requirements of the crime. The nature of ''threat'' is dynamic; adversary behavior and capability appear to be related to prevailing political, economic, and social conditions

  9. Advances in the electro-spark deposition coating process

    International Nuclear Information System (INIS)

    Johnson, R.N.; Sheldon, G.L.

    1986-04-01

    Electro-spark deposition (ESD) is a pulsed-arc micro-welding process using short-duration, high-current electrical pulses to deposit an electrode material on a metallic substrate. It is one of the few methods available by which a fused, metallurgically bonded coating can be applied with such a low total heat input that the bulk substrate material remains at or near ambient temperatures. The short duration of the electrical pulse allows an extremely rapid solidification of the deposited material and results in an exceptionally fine-grained, homogenous coating that approaches (and with some materials, actually is) an amorphous structure. This structure is believed to contribute to the good tribological and corrosion performance observed for hardsurfacing materials used in the demanding environments of high temperatures, liquid metals, and neutron irradiation. A brief historical review of the process is provided, followed by descriptions of the present state-of-the-art and of the performance and applications of electro-spark deposition coatings in liquid-metal-cooled nuclear reactors

  10. Observations of dense plasma formation in the vacuum spark

    International Nuclear Information System (INIS)

    Chuaqui, H.; Favre, M.; Wyndham, E.; Aliaga R, R.; Choi, P.; Dumitrescu-Zoita, C.

    1994-01-01

    A series of experimental observations have been performed on the dense plasma formations or Hot Spots generated in the Vacuum Spark. The plasma discharges are driven by a 1.5 Ohm, 120 ns line at currents up to 100 KA. The line may be used to deliver a rectangular current pulse when the line gap is used. Alternatively when the line gap is shorted, the Vacuum Spark itself switches the line. A Nd: Yag Laser, with an energy of 0.5 J in an 8 ns pulse, is used to pre ionizing the discharge. The formation of Hot Spots is studied under a range of different conditions. These include the pre ionizing conditions, as well as the Anode shape and the Anode Cathode separation. The optimization of these parameters permit very reproducible shot to shot behaviour. Of particular interest is the Hot Spot size dependence as a function of its temperature and of time. The use of a new variant on the Pin Hole Camera, the Slit Wire Camera provides a new method of measuring with precision the Hot Spot dimensions in different X-ray emission energy ranges. A quadruple hole Camera is used to measure the temperature of the Hot Spots. The temporal and spatial evolution of the X-ray emission is measured using using a Slit Wire, Scintillator, Fibre Optic, Photomultiplier array. The temporal emission of the X-rays is also observed using an array of PIN X-ray diodes. (author). 5 refs, 6 figs

  11. Exploratory studies on a passively triggered vacuum spark

    Energy Technology Data Exchange (ETDEWEB)

    Rout, R.K. [High Pressure Physics Division, Bhabha Atomic Research Centre, Mumbai (India)]. E-mail: rkrout@apsara.barc.ernet.in; Auluck, S.K.H.; Kulkarni, L.V. [High Pressure Physics Division, Bhabha Atomic Research Centre, Mumbai, India (India); Nagpal, J.S. [Radiation Standards and Instrumentation Division, Bhabha Atomic Research Centre, Mumbai (India)

    1999-12-07

    The results of an experimental investigation on a passively triggered vacuum spark device are presented. The diagnostics include the current, x-ray and optical emission measurements. The sharp dips in the current derivative signal indicate the occurrence of pinching at an early stage of the discharge (at current {approx} 5 kA). A well-confined plasma with a central hot region was recorded using a streak camera. The pinched plasma was observed to undergo kink-type oscillations with a time period of 10-15 ns. Repeated plasma fronts were seen to move from the anode to the cathode with an average velocity of {approx}5x10{sup 6} cm s{sup -1}. Soft x-ray emission having a radiation intensity of a few hundred mR per discharge was observed. The x-ray signals obtained using photodiodes showed multiple bursts. A soft x-ray pinhole camera recorded micro-pinches of {approx}100 {mu}m. The x-ray emitting regions were confined to the inter-electrode gap. The x-ray emission characteristics were influenced by the electrolytic resistance, which was connected across the spark gap to initiate discharge. (author)

  12. Exploratory studies on a passively triggered vacuum spark

    Science.gov (United States)

    Rout, R. K.; Auluck, S. K. H.; Nagpal, J. S.; Kulkarni, L. V.

    1999-12-01

    The results of an experimental investigation on a passively triggered vacuum spark device are presented. The diagnostics include the current, x-ray and optical emission measurements. The sharp dips in the current derivative signal indicate the occurrence of pinching at an early stage of the discharge (at current icons/Journals/Common/approx" ALT="approx" ALIGN="TOP"/>5 kA). A well-confined plasma with a central hot region was recorded using a streak camera. The pinched plasma was observed to undergo kink-type oscillations with a time period of 10-15 ns. Repeated plasma fronts were seen to move from the anode to the cathode with an average velocity of icons/Journals/Common/approx" ALT="approx" ALIGN="TOP"/>5 × 106 cm s-1. Soft x-ray emission having a radiation intensity of a few hundred mR per discharge was observed. The x-ray signals obtained using photodiodes showed multiple bursts. A soft x-ray pinhole camera recorded micro-pinches of icons/Journals/Common/approx" ALT="approx" ALIGN="TOP"/>100 µm. The x-ray emitting regions were confined to the inter-electrode gap. The x-ray emission characteristics were influenced by the electrolytic resistance, which was connected across the spark gap to initiate discharge.

  13. Influence of hydrox on spark ignition engine performance

    International Nuclear Information System (INIS)

    Naude, A.F.

    2003-01-01

    An experimental investigation was performed on the influence of the addition of small quantities of Hydrox (hydrogen and oxygen) as generated through electrolysis of water on the performance of a spark ignition engine. A Mazda 1600 cc fuel injected engine connected to a Superflow SF901 dynamometer system was used in this project. The engine was also equipped with a Unichip engine management system in order to enable changes in the spark timing and the amount of fuel injected. Hydrox was generated by an electrolysis process that could either be powered by the engine's alternator or from a separate power source. This hydrox gas produced from the electrolyzer was introduced into the engine's intake manifold and the influence of this was measured on the engine's performance, emissions and fuel consumption. For these tests a typical load condition as experienced for a light passenger car vehicle driven at 100 km/h on the open road was simulated. Typical results for the change in emissions with the hydrox introduction showed a significant reduction in hydrocarbons at lean air-fuel ratio operation of the engine. Additionally with the electrolysis process being driven by the engine a small improvement in fuel consumption was experienced. (author)

  14. Air spark-like plasma source for antimicrobial NOx generation

    International Nuclear Information System (INIS)

    Pavlovich, M J; Galleher, C; Curtis, B; Clark, D S; Graves, D B; Ono, T; Machala, Z

    2014-01-01

    We demonstrate and analyse the generation of nitrogen oxides and their antimicrobial efficacy using atmospheric air spark-like plasmas. Spark-like discharges in air in a 1 L confined volume are shown to generate NO x at an initial rate of about 1.5  ×  10 16 NO x molecules/J dissipated in the plasma. Such a discharge operating in this confined volume generates on the order of 6000 ppm NO x in 10 min. Around 90% of the NO x is in the form of NO 2 after several minutes of operation in the confined volume, suggesting that NO 2 is the dominant antimicrobial component. The strong antimicrobial action of the NO x mixture after several minutes of plasma operation is demonstrated by measuring rates of E. coli disinfection on surfaces and in water exposed to the NO x mixture. Some possible applications of plasma generation of NO x (perhaps followed by dissolution in water) include disinfection of surfaces, skin or wound antisepsis, and sterilization of medical instruments at or near room temperature. (paper)

  15. A new and efficient mechanism for spark ignition engines

    International Nuclear Information System (INIS)

    Shadloo, M.S.; Poultangari, R.; Abdollahzadeh Jamalabadi, M.Y.; Rashidi, M.M.

    2015-01-01

    Highlights: • A new slider–crank mechanism, with superior performance is presented. • Thermodynamic processes as well as vibration and internal forces have been modeled. • Comparison with the conventional four-stroke spark ignition engines is made. • Advantages and disadvantages of the proposed mechanism are discussed. - Abstract: In this paper a new symmetrical crank and slider mechanism is proposed and a zero dimensional model is utilized to study its combustion performance enhancement in a four-stroke spark ignition (SI) engine. The main features of this new mechanism are superior thermodynamic efficiency, lower internal frictions, and lower pollutants. Comparison is made between its performance and that of the conventional four-stroke SI engines. Presented mechanism is designed to provide better fuel consumption of internal combustion engines. These advantages over standard engine are achieved through synthesis of new mechanism. Numerical calculation have been performed for several cases of different mechanism parameters, compression ratio and engine speed. A comprehensive comparison between their thermodynamic processes as well as vibration and internal forces has been done. Calculated efficiency and power diagrams are plotted and compared with performance of a conventional SI engine. Advantages and disadvantages of the proposed mechanism are discussed in details

  16. Turbulent spark-jet ignition in SI gas fuelled engine

    Directory of Open Access Journals (Sweden)

    Pielecha Ireneusz

    2017-01-01

    Full Text Available The article contains a thermodynamic analysis of a new combustion system that allows the combustion of stratified gas mixtures with mean air excess coefficient in the range 1.4-1.8. Spark ignition was used in the pre-chamber that has been mounted in the engine cylinder head and contained a rich mixture out of which a turbulent flow of ignited mixture is ejected. It allows spark-jet ignition and the turbulent combustion of the lean mixture in the main combustion chamber. This resulted in a two-stage combustion system for lean mixtures. The experimental study has been conducted using a single-cylinder test engine with a geometric compression ratio ε = 15.5 adapted for natural gas supply. The tests were performed at engine speed n = 2000 rpm under stationary engine load when the engine operating parameters and toxic compounds emissions have been recorded. Analysis of the results allowed to conclude that the evaluated combustion system offers large flexibility in the initiation of charge ignition through an appropriate control of the fuel quantities supplied into the pre-chamber and into the main combustion chamber. The research concluded with determining the charge ignition criterion for a suitably divided total fuel dose fed to the cylinder.

  17. Spark and HPC for High Energy Physics Data Analyses

    Energy Technology Data Exchange (ETDEWEB)

    Sehrish, Saba; Kowalkowski, Jim; Paterno, Marc

    2017-05-01

    A full High Energy Physics (HEP) data analysis is divided into multiple data reduction phases. Processing within these phases is extremely time consuming, therefore intermediate results are stored in files held in mass storage systems and referenced as part of large datasets. This processing model limits what can be done with interactive data analytics. Growth in size and complexity of experimental datasets, along with emerging big data tools are beginning to cause changes to the traditional ways of doing data analyses. Use of big data tools for HEP analysis looks promising, mainly because extremely large HEP datasets can be represented and held in memory across a system, and accessed interactively by encoding an analysis using highlevel programming abstractions. The mainstream tools, however, are not designed for scientific computing or for exploiting the available HPC platform features. We use an example from the Compact Muon Solenoid (CMS) experiment at the Large Hadron Collider (LHC) in Geneva, Switzerland. The LHC is the highest energy particle collider in the world. Our use case focuses on searching for new types of elementary particles explaining Dark Matter in the universe. We use HDF5 as our input data format, and Spark to implement the use case. We show the benefits and limitations of using Spark with HDF5 on Edison at NERSC.

  18. 78 FR 59911 - Generic Information Collection for Land Management Planning

    Science.gov (United States)

    2013-09-30

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

  19. Laser ignition - Spark plug development and application in reciprocating engines

    Science.gov (United States)

    Pavel, Nicolaie; Bärwinkel, Mark; Heinz, Peter; Brüggemann, Dieter; Dearden, Geoff; Croitoru, Gabriela; Grigore, Oana Valeria

    2018-03-01

    Combustion is one of the most dominant energy conversion processes used in all areas of human life, but global concerns over exhaust gas pollution and greenhouse gas emission have stimulated further development of the process. Lean combustion and exhaust gas recirculation are approaches to improve the efficiency and to reduce pollutant emissions; however, such measures impede reliable ignition when applied to conventional ignition systems. Therefore, alternative ignition systems are a focus of scientific research. Amongst others, laser induced ignition seems an attractive method to improve the combustion process. In comparison with conventional ignition by electric spark plugs, laser ignition offers a number of potential benefits. Those most often discussed are: no quenching of the combustion flame kernel; the ability to deliver (laser) energy to any location of interest in the combustion chamber; the possibility of delivering the beam simultaneously to different positions, and the temporal control of ignition. If these advantages can be exploited in practice, the engine efficiency may be improved and reliable operation at lean air-fuel mixtures can be achieved, making feasible savings in fuel consumption and reduction in emission of exhaust gasses. Therefore, laser ignition can enable important new approaches to address global concerns about the environmental impact of continued use of reciprocating engines in vehicles and power plants, with the aim of diminishing pollutant levels in the atmosphere. The technology can also support increased use of electrification in powered transport, through its application to ignition of hybrid (electric-gas) engines, and the efficient combustion of advanced fuels. In this work, we review the progress made over the last years in laser ignition research, in particular that aimed towards realizing laser sources (or laser spark plugs) with dimensions and properties suitable for operating directly on an engine. The main envisaged

  20. Can authorities appreciably enhance the prescribing of oral generic risperidone to conserve resources? Findings from across Europe and their implications.

    Science.gov (United States)

    Godman, Brian; Petzold, Max; Bennett, Kathleen; Bennie, Marion; Bucsics, Anna; Finlayson, Alexander E; Martin, Andrew; Persson, Marie; Piessnegger, Jutta; Raschi, Emanuel; Simoens, Steven; Zara, Corinne; Barbui, Corrado

    2014-06-13

    Generic atypical antipsychotic drugs offer health authorities opportunities for considerable savings. However, schizophrenia and bipolar disorders are complex diseases that require tailored treatments. Consequently, generally there have been limited demand-side measures by health authorities to encourage the preferential prescribing of generics. This is unlike the situation with hypertension, hypercholaesterolaemia or acid-related stomach disorders.The objectives of this study were to compare the effect of the limited demand-side measures in Western European countries and regions on the subsequent prescribing of risperidone following generics; to utilise the findings to provide future guidance to health authorities; and where possible, to investigate the utilisation of generic versus originator risperidone and the prices for generic risperidone. Principally, this was a segmented regression analysis of retrospective time-series data of the effect of the various initiatives in Belgium, Ireland, Scotland and Sweden following the introduction of generic risperidone. The study included patients prescribed at least one atypical antipsychotic drug up to 20 months before and up to 20 months after generic risperidone. In addition, retrospective observational studies were carried out in Austria and Spain (Catalonia) from 2005 to 2011 as well as one English primary care organisation (Bury Primary Care Trust (PCT)). There was a consistent steady reduction in risperidone as a percentage of total selected atypical antipsychotic utilisation following generics. A similar pattern was seen in Austria and Spain, with stable utilisation in one English PCT. However, there was considerable variation in the utilisation of generic risperidone, ranging from 98% of total risperidone in Scotland to only 14% in Ireland. Similarly, the price of generic risperidone varied considerably. In Scotland, generic risperidone was only 16% of pre-patent loss prices versus 72% in Ireland. Consistent

  1. The optimization of some of the conditions for analysis by spark-source mass spectrometry

    International Nuclear Information System (INIS)

    Pearton, D.C.P.; Sobiecki, A.

    1980-01-01

    The need for improved precision in spark-source mass spectrometry is highlighted. Several parameters, such as photoplate-development technique, instrumental stability and focus, and sparking conditions, were optimized. Measurements made under these optimum conditions attained precisions of more than 12 per cent

  2. Development of spark cathode E-guns. Draft final reprt, Phase I, July--October 1978

    International Nuclear Information System (INIS)

    Loda, G.; Lindstrand, R.

    1979-01-01

    A 12 sided spark cathode is designed and constructed to replace the bladed, cold cathode structure in the electron gun of the Los Alamos Scientific Laboratory Antares prototype power amplifier. Design work includes computer modeling and full scale low voltage modeling. Life testing to 100,000 pulses is documented. The spark cathode offers precise control of emission site location and a high reliability

  3. 2-Methylfuran: A bio-derived octane booster for spark-ignition engines

    KAUST Repository

    Sarathy, Mani; Shankar, Vijai; Tripathi, Rupali; Pitsch, Heinz; Sarathy, Mani

    2018-01-01

    The efficiency of spark-ignition engines is limited by the phenomenon of knock, which is caused by auto-ignition of the fuel-air mixture ahead of the spark-initiated flame front. The resistance of a fuel to knock is quantified by its octane index

  4. Automated qualification and analysis of protective spark gaps for DC accelerators

    Energy Technology Data Exchange (ETDEWEB)

    Banerjee, Srutarshi; Rajan, Rehim N.; Dewangan, S.; Sharma, D.K.; Patel, Rupesh; Bakhtsingh, R.I.; Gond, Seema; Waghmare, Abhay; Thakur, Nitin; Mittal, K.C. [Accelerator and Pulse Power Division, Bhabha Atomic Research Centre, Mumbai (India)

    2014-07-01

    Protective spark gaps are used in the high voltage multiplier column of a 3 MeV DC Accelerator to prevent excessive voltage build-ups. Precise gap of 5 mm is maintained between the electrodes in these spark gaps for obtaining 120 kV± 5 kV in 6 kg/cm{sup 2} SF{sub 6} environment which is the dielectric medium. There are 74 such spark gaps used in the multiplier. Each spark gap has to be qualified for electrical performance before fitting in the accelerator to ensure reliable operation. As the breakdown voltage stabilizes after a large number of sparks between the electrodes, the qualification process becomes time consuming and cumbersome. For qualifying large number of spark gaps an automatic breakdown analysis setup has been developed. This setup operates in air, a dielectric medium. The setup consists of a flyback topology based high voltage power supply with maximum rating of 25 kV. This setup works in conjunction with spark detection and automated shutdown circuit. The breakdown voltage is sensed using a peak detector circuit. The voltage breakdown data is recorded and statistical distribution of the breakdown voltage has been analyzed. This paper describes details of the diagnostics and the spark gap qualification process based on the experimental data. (author)

  5. Ignition of turbulent swirling n-heptane spray flames using single and multiple sparks

    Energy Technology Data Exchange (ETDEWEB)

    Marchionea, T.; Ahmeda, S.F.; Mastorakos, E. [Department of Engineering, University of Cambridge (United Kingdom)

    2009-01-15

    This paper examines ignition processes of an n-heptane spray in a flow typical of a liquid-fuelled burner. The spray is created by a hollow-cone pressure atomiser placed in the centre of a bluff body, around which swirling air induces a strong recirculation zone. Ignition was achieved by single small sparks of short duration (2 mm; 0.5 ms), located at various places inside the flow so as to identify the most ignitable regions, or larger sparks of longer duration (5 mm; 8 ms) repeated at 100 Hz, located close to the combustion chamber enclosure so as to mimic the placement and characteristics of a gas turbine combustor surface igniter. The air and droplet velocities, the droplet diameter, and the total (i.e. liquid plus vapour) equivalence ratio were measured in inert flow by phase Doppler anemometry and sampling respectively. Fast camera imaging suggested that successful ignition events were associated with flamelets that propagated back towards the spray nozzle. Measurements of ignition probability with the single spark showed that localised ignition inside the spray is more likely to result in successful flame establishment when the spark is located in a region of negative velocity, relatively small droplet Sauter mean diameter, and mean equivalence ratio within the flammability limits. Ignition with the single spark was not possible at the location where the multiple spark experiments were performed. For those, the multiple spark sequence lasted approximately 1 to 5 s. It was found that a long spark sequence increases the ignition efficiency, which reached a maximum of 100% at the axial distance where the recirculation zone had maximum width. Ignition was not feasible with the spark downstream of about two burner diameters. Visualisation showed that small flame kernels emanate very often from the spark, which can be stretched as far as 20 mm from the electrodes by the turbulent velocity fluctuations. These kernels survive very little time. Successful overall

  6. SciSpark: Highly Interactive and Scalable Model Evaluation and Climate Metrics for Scientific Data and Analysis

    Data.gov (United States)

    National Aeronautics and Space Administration — We will construct SciSpark, a scalable system for interactive model evaluation and for the rapid development of climate metrics and analyses. SciSpark directly...

  7. A new spark detection system for the electrostatic septa of the SPS North (experimental) Area

    CERN Multimedia

    Barlow, R A; Borburgh, J; Carlier, E; Chanavat, C; Pinget, B

    2013-01-01

    Electrostatic septa (ZS) are used in the extraction of the particle beams from the CERN SPS to the North Area experimental zone. These septa employ high electric fields, generated from a 300 kV power supply, and are particularly prone to internal sparking around the cathode structure. This sparking degrades the electric field quality, consequently affecting the extracted beam, vacuum and equipment performance. To mitigate these effects, a Spark Detection System (SDS) has been realised, which is based on an industrial SIEMENS S7-400 programmable logic controller and deported Boolean processors modules interfaced through a PROFINET fieldbus. The SDS interlock logic uses a moving average spark rate count to determine if the ZS performance is acceptable. Below a certain spark rate it is probable that the ZS septa tank vacuum can recover, thus avoiding transition into a\

  8. Academe Should Oppose Speedier Approval of Generic Drugs

    Science.gov (United States)

    Steinbach, Sheldon Elliot

    2008-01-01

    Biotechnology, usually commercialized in collaboration with the private sector, has been among the most fruitful university-based research endeavors, for the public as well as universities. Biological medications have made possible crucial advances in the treatment of life-threatening illnesses and yielded significant royalty streams for the…

  9. Drugs, money, and power: the Canadian drug shortage.

    Science.gov (United States)

    Kaposy, Chris

    2014-03-01

    This article describes the shortage of generic injectable medications in Canada that affected hospitals in 2012. It traces the events leading up to the drug shortage, the causes of the shortage, and the responses by health administrators, pharmacists, and ethicists. The article argues that generic drug shortages are an ethical problem because health care organizations and governments have an obligation to avoid exposing patients to resource scarcity. The article also discusses some options governments could pursue in order to secure the drug supply and thereby fulfill their ethical obligations.

  10. Molecularly Imprinted Polymer Technology: A Powerful, Generic ...

    African Journals Online (AJOL)

    Molecularly Imprinted Polymer Technology: A Powerful, Generic, Facile and Cost Effective Alternative for Enantio-recognition and Separation: A Glance at Advances and Applications. ... Tanzania Journal of Science. Journal Home · ABOUT ...

  11. Controlling spark timing for consecutive cycles to reduce the cyclic variations of SI engines

    International Nuclear Information System (INIS)

    Kaleli, Alirıza; Ceviz, Mehmet Akif; Erenturk, Köksal

    2015-01-01

    Minimization of the cyclic variations is one of the most important design goal for spark-ignited engines. Primary motivation of this study is to reduce the cyclic variations in spark ignition engines by controlling the spark timing for consecutive cycles. A stochastic model was performed between spark timing and in–cylinder maximum pressure by using the system identification techniques. The incylinder maximum pressure of the next cycle was predicted with this model. Minimum variance and generalized minimum variance controllers were designed to regulate the in–cylinder maximum pressure by changing the spark timing for consecutive cycles of the test engine. The produced control algorithms were built in LabView environment and installed to the Field Programmable Gate Arrays (FPGA) chassis. According to the test results, the in–cylinder maximum pressure of the next pressure cycle can be predicted fairly well, and the spark timing can be regulated to keep the in–cylinder maximum pressure in a desired band to reduce the cyclic variations. At fixed spark timing experiments, the COV Pmax and COV imep were 3.764 and 0.677%, whereas they decreased to 3.208 and 0.533% when GMV controller was applied, respectively. - Highlights: • Cycle per cycle spark timing control was carried out. • A stochastic process model was described between P max and the spark timing. • The cyclic variations in P max was decreased by keeping it in a desired band. • Different controllers were used to adjust spark timing signal of the next cycle. • COV Pmax was decreased by about 15% by using GMV controller

  12. Reconstruction of data for an experiment using multi-gap spark chambers with six-camera optics

    International Nuclear Information System (INIS)

    Maybury, R.; Daley, H.M.

    1983-06-01

    A program has been developed to reconstruct spark positions in a pair of multi-gap optical spark chambers viewed by six cameras, which were used by a Rutherford Laboratory experiment. The procedure for correlating camera views to calculate spark positions is described. Calibration of the apparatus, and the application of time- and intensity-dependent corrections are discussed. (author)

  13. Brands or generics: the dilemma of pharmaceutical marketing in a developing country.

    Science.gov (United States)

    Quraeshi, Z A; Luqmani, M; Malhotra, N

    1983-01-01

    A significant issue in pharmaceutical marketing in many developing countries is whether drugs should be sold by generic or by brand names. In Pakistan, legislation prohibited the sale of brand name drugs in order to increase price competition, and strengthen the market position of indigenous manufacturers to compete against multinationals. However, the government's objectives were not achieved for reasons discussed in the article. The Pakistan case has implications for multinational firms and for other developing countries in similar situations.

  14. Development of microwave-enhanced spark-induced breakdown spectroscopy

    International Nuclear Information System (INIS)

    Ikeda, Yuji; Moon, Ahsa; Kaneko, Masashi

    2010-01-01

    We propose microwave-enhanced spark-induced breakdown spectroscopy with the same measurement and analysis processes as in laser-induced breakdown spectroscopy, but with a different plasma generation mechanism. The size and lifetime of the plasma generated can contribute to increased measurement accuracy and expand its applicability to industrial measurement, such as an exhaust gas analyzer for automobile engine development and its regulation, which has been hard to operate by laser at an engineering evaluation site. The use of microwaves in this application helps lower the cost, reduce the system size, and increase the ease of operation to make it commercially viable. A microwave frequency of 2.45 GHz was used to enhance the volume and lifetime of the plasma at atmospheric condition even at elevated pressure.

  15. Overvoltage protection by point-plane spark gaps

    International Nuclear Information System (INIS)

    Scarlett, W.R.; Riepe, K.B.

    1979-01-01

    In electron-beam-controlled discharge CO 2 lasers, such as those used in the Antares and Helios laser-fusion drivers at the Los Alamos Scientific Laboratory (LASL), protection needs to be provided against possible damage due to overvoltage. A passive (self-breakdown) point-plane spark gap has been developed and successfully used in the Helios power amplifiers which operate at voltages up to 300 kV. A gap of similar design is planned for use in the Antares power amplifiers which operate at 550 kV. These gaps must reliably hold off the normal discharge voltage, but break down with short delay if overvoltaged, diverting the discharge energy to a resistor. A prototype of the Antares gap has been built and is undergoing tests. Parameters being investigated include voltage polarity, gap spacing, gas composition, and gas pressure. Results of these measurements and the operational experience of the Helios gaps will be presented

  16. The Spark of Life: Darwin and the Primeval Soup

    Science.gov (United States)

    Zimmer, Carl

    It's possible that within a decade, a space probe may swing into orbit around Europa and hurl a drill-tipped robot into its icy crust. If that turns out to be the case, no one will watch its performance more anxiously than Christopher Wills and Jeffrey Bada, the coauthors of The Spark of Life. As Europa orbits around Jupiter, the giant planet's gravity exerts enormous tidal forces on the moon with clock-like regularity-forces that Wills and Bada predict should create an environment favorable to the origin of life. If the probe does uncover some kind of indigenous life on Europa, it may bolster the central claim of this intriguing book: that similar processes made life possible on our own planet.

  17. A prediction study of a spark ignition supercharged hydrogen engine

    International Nuclear Information System (INIS)

    Al-Baghdadi, Maher A.R. Sadiq.; Al-Janabi, Haroun A.K. Shahad

    2003-01-01

    Hydrogen is found to be a suitable alternative fuel for spark ignition engines with certain drawbacks, such as high NO x emission and small power output. However, supercharging may solve such problems. In this study, the effects of equivalence ratio, compression ratio and inlet pressure on the performance and NO x emission of a four stroke supercharged hydrogen engine have been analyzed using a specially developed computer program. The results are verified and compared with experimental data obtained from tests on a Ricardo E6/US engine. A chart specifying the safe operation zone of the hydrogen engine has been produced. The safe operation zone means no pre-ignition, acceptable NO x emission, high engine efficiency and lower specific fuel consumption in comparison with the gasoline engine. The study also shows that supercharging is a more effective method to increase the output of a hydrogen engine rather than increasing the compression ratio of the engine at the knock limited equivalence ratio

  18. Quasi-spherical compression of a spark-channel plasma

    International Nuclear Information System (INIS)

    Panarella, E.

    1980-01-01

    An axial spark channel in deuterium has been used as a target for implosive shock waves created with a conventional cylindrical theta-pinch device. The compression of the channel by the implosive waves raised the plasma electron temperature to approximately 120 eV for approximately 6 kJ of condenser bank energy and 1 Torr initial gas pressure. In order to improve the efficiency of compression of the channel plasma and to reduce the end losses inherent in the cylindrical configuration, the theta-pinch geometry was then converted from cylindrical into spherical. Under identical conditions of gas pressure and condenser bank energy, the electron temperature now peaked at approximately 400 eV. When the bank energy was increased to approximately 10 kJ, neutron production was observed. The total neutron output per shot ranged from 10 5 to 10 6 and increased inversely with the pinch discharge volume

  19. Parallel combinations of pre-ionized low jitter spark gaps

    International Nuclear Information System (INIS)

    Fitzsimmons, W.A.; Rosocha, L.A.

    1979-01-01

    The properties of 10 to 30 kV four electrode field emission pre-ionized triggered spark gaps have been studied. A mid-plane off-axis trigger electrode is biased at +V 0 /2, and a field emission point is located adjacent to and biased at the grounded cathode potential. Simultaneous application of a -V 0 trigger rapid pulse to both the electrodes results in the rapid sequential closing of the anode-trigger and trigger-cathode gaps. The observed jitter is about 1.5 ns. Parallel operation of these gaps (up to 10 so far) connected to a common capacitive load has been studied. A simple theory that predicts the number of gaps that may be expected to operate in parallel is discussed

  20. Research on personalized recommendation algorithm based on spark

    Science.gov (United States)

    Li, Zeng; Liu, Yu

    2018-04-01

    With the increasing amount of data in the past years, the traditional recommendation algorithm has been unable to meet people's needs. Therefore, how to better recommend their products to users of interest, become the opportunities and challenges of the era of big data development. At present, each platform enterprise has its own recommendation algorithm, but how to make efficient and accurate push information is still an urgent problem for personalized recommendation system. In this paper, a hybrid algorithm based on user collaborative filtering and content-based recommendation algorithm is proposed on Spark to improve the efficiency and accuracy of recommendation by weighted processing. The experiment shows that the recommendation under this scheme is more efficient and accurate.

  1. Distributed Parallel Endmember Extraction of Hyperspectral Data Based on Spark

    Directory of Open Access Journals (Sweden)

    Zebin Wu

    2016-01-01

    Full Text Available Due to the increasing dimensionality and volume of remotely sensed hyperspectral data, the development of acceleration techniques for massive hyperspectral image analysis approaches is a very important challenge. Cloud computing offers many possibilities of distributed processing of hyperspectral datasets. This paper proposes a novel distributed parallel endmember extraction method based on iterative error analysis that utilizes cloud computing principles to efficiently process massive hyperspectral data. The proposed method takes advantage of technologies including MapReduce programming model, Hadoop Distributed File System (HDFS, and Apache Spark to realize distributed parallel implementation for hyperspectral endmember extraction, which significantly accelerates the computation of hyperspectral processing and provides high throughput access to large hyperspectral data. The experimental results, which are obtained by extracting endmembers of hyperspectral datasets on a cloud computing platform built on a cluster, demonstrate the effectiveness and computational efficiency of the proposed method.

  2. COMPACTION OF LITHIUM-SILICATE CERAMICS USING SPARK PLASMA SINTERING

    Directory of Open Access Journals (Sweden)

    Tomas Frantisek Kubatik

    2016-12-01

    Full Text Available This paper deals with the compaction of ceramics based on lithium-silicate by spark plasma sintering (SPS. The initial powder was prepared by calcination in a resistance furnace at a temperature of 1300 °C with the ratio of Li/Si = 1. Compacting by SPS was carried out at temperatures of 800 - 1000 °C with a maximum pressure of 80 MPa. Samples with open porosity of less than 1 % were prepared at the temperature of 1000 °C. According to the quantitative Rietveld refinement of x-ray diffraction data, the dominant phases in all samples were Li₂Si₂O₅ and Li₂SiO₃, together representing over 80 wt. % of the sintered material.

  3. ZrB₂-CNTs Nanocomposites Fabricated by Spark Plasma Sintering.

    Science.gov (United States)

    Jin, Hua; Meng, Songhe; Xie, Weihua; Xu, Chenghai; Niu, Jiahong

    2016-11-29

    ZrB₂-based nanocomposites with and without carbon nanotubes (CNTs) as reinforcement were prepared at 1600 °C by spark plasma sintering. The effects of CNTs on the microstructure and mechanical properties of nano-ZrB₂ matrix composites were studied. The results indicated that adding CNTs can inhibit the abnormal grain growth of ZrB₂ grains and improve the fracture toughness of the composites. The toughness mechanisms were crack deflection, crack bridging, debonding, and pull-out of CNTs. The experimental results of the nanograined ZrB₂-CNTs composites were compared with those of the micro-grained ZrB₂-CNTs composites. Due to the small size and surface effects, the nanograined ZrB₂-CNTs composites exhibited stronger mechanical properties: the hardness, flexural strength and fracture toughness were 18.7 ± 0.2 GPa, 1016 ± 75 MPa, and 8.5 ± 0.4 MPa·m 1/2 , respectively.

  4. Quartz crystal reinforced quartz glass by spark plasma sintering

    International Nuclear Information System (INIS)

    Torikai, D.; Barazani, B.; Ono, E.; Santos, M.F.M.; Suzuki, C.K.

    2011-01-01

    The Spark Plasma Sintering presents fast processing time when compared to conventional sintering techniques. This allows to control the grain growth during sintering as well as the diffusion rate of a multi-material compounds, and make possible obtainment of functionally graded materials and nanostructured compounds. Powders of high purity silica glass and crystalline silica were sintered in a SPS equipment at temperatures around 1350° C, i.e., above the softening temperature of silica glass and below the melting temperature of quartz crystal. As a result, glass ceramics with pure silica glass matrix reinforced with crystalline alpha-quartz grains were fabricated at almost any desired range of composition, as well as controlled size of the crystalline reinforcement. X-ray diffraction and density measurements showed the possibility to manufacture a well controlled density and crystallinity glass-ceramic materials. (author)

  5. Human resource recommendation algorithm based on ensemble learning and Spark

    Science.gov (United States)

    Cong, Zihan; Zhang, Xingming; Wang, Haoxiang; Xu, Hongjie

    2017-08-01

    Aiming at the problem of “information overload” in the human resources industry, this paper proposes a human resource recommendation algorithm based on Ensemble Learning. The algorithm considers the characteristics and behaviours of both job seeker and job features in the real business circumstance. Firstly, the algorithm uses two ensemble learning methods-Bagging and Boosting. The outputs from both learning methods are then merged to form user interest model. Based on user interest model, job recommendation can be extracted for users. The algorithm is implemented as a parallelized recommendation system on Spark. A set of experiments have been done and analysed. The proposed algorithm achieves significant improvement in accuracy, recall rate and coverage, compared with recommendation algorithms such as UserCF and ItemCF.

  6. What sparks interest in science? A naturalistic inquiry

    Science.gov (United States)

    Jackson, Julie Kay Cropper

    This study examined how career scientists became interested in science. Eight practicing scientists were asked a focus question, "What sparked your interest in science?" Their responses recorded during personal interviews and reported in correspondence frame this qualitative study. Analysis of the data revealed a variety of influences. The influences were coded, arranged into lists, and grouped by theme. A total of 18 themes emerged from the data. Five of the emerging themes were common across all of the participants. They were the influence of a family member, the influence of a teacher, being naturally curious, being interested in science, and reading books, magazines, and/or encyclopedias. Five themes were common among 5 to 7 participants. These themes included visiting museums, having broad exposure, enjoyment of mathematics, enjoying being outside, and freedom to play and explore. Eight themes were common among 2 to 4 of the participants. They were financial incentive, influence of religion, participation in science fairs, influence of the manned space program, having a scientist in the family, having the opportunity to teach others, not seeing self as a scientist, and first generation college graduate. The emerging themes were compared and contrasted with historical and contemporary literature. Vocational psychology's leading career choice and development literature was also aligned with the emerging themes. Data from this study supports tenets of Trait and Factor Theory, Developmental Theory, and Social Learning Theory. Reported data also supports the proposed movement toward a unified theory of career choice and development. A combination of personality traits, developmental stages, self-efficacy, and learning experiences influenced the vocational decisions of the scientists who participated in this study. The study concludes with suggestions for sparking and sustaining interest in science that people responsible for preparing future scientists may find

  7. Mechanochemical synthesis and spark plasma sintering of the cerium silicides

    Energy Technology Data Exchange (ETDEWEB)

    Alanko, Gordon A.; Jaques, Brian; Bateman, Allyssa [Department of Materials Science and Engineering, College of Engineering, Boise State University, 1910 University Drive, Boise, ID 83725 (United States); Butt, Darryl P., E-mail: darrylbutt@boisestate.edu [Department of Materials Science and Engineering, College of Engineering, Boise State University, 1910 University Drive, Boise, ID 83725 (United States); Center for Advanced Energy Studies, 995 University Boulevard, Idaho Falls, ID 83401 (United States)

    2014-12-15

    Highlights: • Ce{sub 5}Si{sub 3}, Ce{sub 3}Si{sub 2}, CeSi, CeSi{sub 2−x} and CeSi{sub 2} were mechanochemically synthesized. • Temperature and pressure were monitored to investigate reaction progress. • All syntheses proceeded through a MSR event followed by rapid solid-state diffusion. • Milling time before MSR correlates well with effective heat of formation. • Some synthesized material was densified by spark plasma sintering. - Abstract: The cerium silicides, Ce{sub 5}Si{sub 3}, Ce{sub 3}Si{sub 2}, CeSi, CeSi{sub 2−y}, and CeSi{sub 2−x}, have been prepared from the elements by mechanochemical processing in a planetary ball mill. Preparation of the cerium silicide Ce{sub 5}Si{sub 4} was unsuccessfully attempted and potential reasons for this are discussed. Temperature and pressure of the milling vial were monitored in situ to gain insight into the mechanochemical reaction kinetics, which include a mechanically-induced self-propagating reaction (MSR). Some prepared powders were consolidated by spark plasma sintering to high density. Starting materials, as-milled powders, and consolidated samples were characterized by X-ray diffraction, scanning electron microscopy, and energy dispersive spectroscopy. The results obtained help elucidate key questions in mechanochemical processing of intermetallics, showing first phase formation similar to thin films, MSR ignition times that are composition- and milling speed-dependent, and sensitivity of stable compound formation on the impact pressure. The results demonstrate mechanochemical synthesis as a viable technique for rare earth silicides.

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

    Directory of Open Access Journals (Sweden)

    Philip J Domeyer

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

  9. Statistical Techniques For Real-time Anomaly Detection Using Spark Over Multi-source VMware Performance Data

    Energy Technology Data Exchange (ETDEWEB)

    Solaimani, Mohiuddin [Univ. of Texas-Dallas, Richardson, TX (United States); Iftekhar, Mohammed [Univ. of Texas-Dallas, Richardson, TX (United States); Khan, Latifur [Univ. of Texas-Dallas, Richardson, TX (United States); Thuraisingham, Bhavani [Univ. of Texas-Dallas, Richardson, TX (United States); Ingram, Joey Burton [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States)

    2015-09-01

    Anomaly detection refers to the identi cation of an irregular or unusual pat- tern which deviates from what is standard, normal, or expected. Such deviated patterns typically correspond to samples of interest and are assigned different labels in different domains, such as outliers, anomalies, exceptions, or malware. Detecting anomalies in fast, voluminous streams of data is a formidable chal- lenge. This paper presents a novel, generic, real-time distributed anomaly detection framework for heterogeneous streaming data where anomalies appear as a group. We have developed a distributed statistical approach to build a model and later use it to detect anomaly. As a case study, we investigate group anomaly de- tection for a VMware-based cloud data center, which maintains a large number of virtual machines (VMs). We have built our framework using Apache Spark to get higher throughput and lower data processing time on streaming data. We have developed a window-based statistical anomaly detection technique to detect anomalies that appear sporadically. We then relaxed this constraint with higher accuracy by implementing a cluster-based technique to detect sporadic and continuous anomalies. We conclude that our cluster-based technique out- performs other statistical techniques with higher accuracy and lower processing time.

  10. Approved Animal Drug Products (Green Book)

    Data.gov (United States)

    U.S. Department of Health & Human Services — On November 16, 1988, the President of the United States signed into law the Generic Animal Drug and Patent Restoration Act (GADPTRA). Among its major provisions,...

  11. Drugs Approved for Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for ovarian cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters. The drug names link to NCI's Cancer Drug Information summaries.

  12. Do national drug policies influence antiretroviral drug prices? Evidence from the Southern African Development community.

    Science.gov (United States)

    Liu, Yao; Galárraga, Omar

    2017-03-01

    The efficacy of low- and middle-income countries’ (LMIC) national drug policies in managing antiretroviral (ARV) pharmaceutical prices is not well understood. Though ARV drug prices have been declining in LMIC over the past decade, little research has been done on the role of their national drug policies. This study aims to (i) analyse global ARV prices from 2004 to 2013 and (ii) examine the relationship of national drug policies to ARV prices. Analysis of ARV drug prices utilized data from the Global Price Reporting Mechanism from the World Health Organization (WHO). Ten of the most common ARV drugs (first-line and second-line) were selected. National drug policies were also assessed for 12 countries in the South African Development Community (SADC), which self-reported their policies through WHO surveys. The best predictor of ARV drug price was generic status—the generic versions of 8 out of 10 ARV drugs were priced lower than branded versions. However, other factors such as transaction volume, HIV prevalence, national drug policies and PEPFAR/CHAI involvement were either not associated with ARV drug price or were not consistent predictors of price across different ARV drugs. In the context of emerging international trade agreements, which aim to strengthen patent protections internationally and potentially delay the sale of generic drugs in LMIC, this study shines a spotlight on the importance of generic drugs in controlling ARV prices. Further research is needed to understand the impact of national drug policies on ARV prices.

  13. 76 FR 54507 - Proposed Generic Communication; Draft NRC Generic Letter 2011-XX: Seismic Risk Evaluations for...

    Science.gov (United States)

    2011-09-01

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

  14. [Significance of various implantate localizations of Sparks prostheses, experimental studies in rats].

    Science.gov (United States)

    Brieler, H S; Parwaresch, R; Thiede, A

    1976-01-01

    Our investigations show that Sparks prostheses after subcutaneous implantation are suitable for vascular grafting. At the end of the organization period the connective tissue becomes strong, and after the third and fourth weeks collagenous and elastic fibers can be seen. Ten weeks after s.c. implantation, collagenous fibers predominate. After this the Sparks prostheses can be used as a vascular graft. Intraperitoneal implantation, however, shows a histologically different picture with characteristic findings: only fat cells can be observed, a strong granulation tissue with elastic and collagenous fibers is not present. After intraperitoneal implantation Sparks prostheses are therefore unsuitable for vascular grafts.

  15. The secular and the supernatural: madness and psychiatry in the short stories of Muriel Spark.

    Science.gov (United States)

    Beveridge, A W

    2015-01-01

    Edinburgh-born Muriel Spark is one of modern Scotland's greatest writers. Examination of her work reveals that the subjects of madness and psychiatry are recurrent themes in her writing. She herself had a mental breakdown when she was a young woman and she took an interest in the world of psychiatry and psychoanalysis. In her short stories, Spark approaches the subject of madness in a variety of ways: she relates it to the supernatural; to writing fiction; and to religion. She frequently juxtaposes secular and supernatural explanations of mental disturbance. Spark adopts a sceptical and, at times, mocking view of psychiatrists and psychiatric treatment. Both psychoanalysis and pills are seen as problematic.

  16. Experimental evaluation of a spark-ignited engine using biogas as fuel

    Directory of Open Access Journals (Sweden)

    Juan Miguel Mantilla González

    2008-05-01

    Full Text Available Different CH4 and CO2 mixtures were used as fuel in this work; they were fed into a spark-ignited engine equipped with devices allowing spark advance, gas delivery and gas consumption to be measured. Engine bench-tests re-vealed changes in the main operation parameters and emissions. The results showed that increasing CO2 percen-tage in the mixture increased the spark angle, reduced maximum power and torque and reduced exhaust emissions (by 90% in some cases when DAMA resolution 1015/2005 was applied. The main components to be considered when an engine of this type operates with gas fuel were also recognised.

  17. Improving the Tribological Properties of Spark-Anodized Titanium by Magnetron Sputtered Diamond-Like Carbon

    OpenAIRE

    Zhaoxiang Chen; Xipeng Ren; Limei Ren; Tengchao Wang; Xiaowen Qi; Yulin Yang

    2018-01-01

    Spark-anodization of titanium can produce adherent and wear-resistant TiO2 film on the surface, but the spark-anodized titanium has lots of surface micro-pores, resulting in an unstable and high friction coefficient against many counterparts. In this study, the diamond-like carbon (DLC) was introduced into the micro-pores of spark-anodized titanium by the magnetron sputtering technique and a TiO2/DLC composite coating was fabricated. The microstructure and tribological properties of TiO2/DLC ...

  18. Damping Resonant Current in a Spark-Gap Trigger Circuit to Reduce Noise

    Science.gov (United States)

    2009-06-01

    DAMPING RESONANT CURRENT IN A SPARK- GAP TRIGGER CIRCUIT TO REDUCE NOISE E. L. Ruden Air Force Research Laboratory, Directed Energy Directorate, AFRL...REPORT TYPE N/A 3. DATES COVERED - 4. TITLE AND SUBTITLE Damping Resonant Current In A Spark- Gap Trigger Circuit To Reduce Noise 5a...thereby triggering 2 after delay 0, is 1. Each of the two rail- gaps (represented by 2) is trig- gered to close after the spark- gap (1) in the

  19. Essential to increase the use of generics in Europe to maintain comprehensive health care?

    Directory of Open Access Journals (Sweden)

    Brian Godman

    2012-12-01

    Full Text Available INTRODUCTION: Reforms have been introduced across Europe to increase prescribing efficiency with existing drugs. These include measures to lower prices of generics as well as increase their prescribing versus originators and patented products in a class or related class. This is essential to maintain comprehensive health care in Europe given continued pressures. The alternative is insufficient funds for new innovative drugs and increasing drug volumes with ageing populations. OBJECTIVE: To review the influence of measures and initiatives to increase the prescribing and dispensing of generics at low prices on ambulatory care prescribing efficiency. In view of this, provide guidance as authorities strive to introduce further reforms to meet their goals. METHODOLOGY: A narrative review of published papers combined with case histories. RESULTS: The different supply- and demand-side measures have reduced generic prices to as low as 2% to 3% of pre-patent loss prices in some cases as well as appreciably enhanced their utilisation. As a result, prescribing efficiency has increased without compromising care. In some cases, the reforms have led to expenditure actually falling despite appreciably increased volumes. CONCLUSIONS: Increasing use of generics at low prices will help maintain the European ideals of comprehensive and equitable health care. However, countries will continually need to learn from each other.

  20. The impact of reference pricing and extension of generic substitution on the daily cost of antipsychotic medication in Finland.

    Science.gov (United States)

    Koskinen, Hanna; Ahola, Elina; Saastamoinen, Leena K; Mikkola, Hennamari; Martikainen, Jaana E

    2014-12-01

    To assess the impact of reference pricing and extension of generic substitution on the daily cost of antipsychotic drugs in Finland during the first year after its launch. Furthermore, the additional impact of reference pricing on prior implemented generic substitution is assessed. A retrospective analysis was performed between 2006 and 2010. A segmented linear regression analysis of interrupted time series was used to estimate changes in the levels and trends in the cost of one day of treatment. Of the study drugs, clozapine belonged to generic substitution already at the start of the study period while olanzapine and quetiapine were included in generic substitution alongside with reference pricing in 2009. Risperidone was included in generic substitution in 2008, before reference pricing. A substantial decrease in the daily cost of all four antipsychotic substances was seen after one year of the implementation of reference pricing and the extension of generic substitution. The impact ranged from -29.9% to -66.3%, and it was most substantial on the daily cost of olanzapine. Also in the daily cost of risperidone a substantial decrease of -43.3% was observed. However, most of these savings, -32.6%, were generated by generic substitution which had been adopted prior. Reference pricing and the extension of generic substitution produced substantial savings on antipsychotic medication costs during the first year after its launch, but the intensity of the impact differed between active substances. Furthermore, our results suggest that the additional cost savings from reference pricing after prior implemented generic substitution, are comparatively low.