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Sample records for generic drugs sparks

  1. Bioequivalence of generic drugs.

    Science.gov (United States)

    Andrade, Chittaranjan

    2015-09-01

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

  2. Generic drugs in dermatology: part II.

    Science.gov (United States)

    Payette, Michael; Grant-Kels, Jane M

    2012-03-01

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

  3. Pharmaceutical policy regarding generic drugs in Belgium.

    Science.gov (United States)

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

    2005-01-01

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

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

    Science.gov (United States)

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

    2008-01-01

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

  5. Generic drugs in dermatology: part I.

    Science.gov (United States)

    Payette, Michael; Grant-Kels, Jane M

    2012-03-01

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

  6. GENERIC DRUG USER FEE: AN OVERVIEW

    Directory of Open Access Journals (Sweden)

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

    2012-09-01

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

  7. Risks and benefits of generic antiepileptic drugs.

    Science.gov (United States)

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

    2008-11-01

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

  8. Generic substitution: issues for problematic drugs.

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    Henderson, J D; Esham, R H

    2001-01-01

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

  9. Rational use of generic psychotropic drugs.

    Science.gov (United States)

    Carbon, Maren; Correll, Christoph U

    2013-05-01

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

  10. 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

  11. Are generic drugs really inferior medicines?

    Science.gov (United States)

    Moore, N; Berdaï, D; Bégaud, B

    2010-09-01

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

  12. 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...

  13. [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.

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

    OpenAIRE

    Lionberger, Robert A.

    2008-01-01

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

  15. [Generic and biosimilar drug substitution: a panacea?].

    Science.gov (United States)

    Daly, M J; Guignard, B; Nendaz, M

    2015-10-14

    Drugs are the third largest source of expenditure under Switzerland's compulsory basic health insurance. Generics, the price of which should be at least 30 per cent less than the cost of the original drugs, can potentially allow substantial savings. Their approval requires bioequivalence studies and their use is safe, although some factors may influence patients' and physicians' acceptance. The increased substitution of biosimilar drugs for more expensive biotech drugs should allow further cost savings. In an attempt to extend the monopoly granted by the original drug patent, some pharmaceutical companies implement "evergreening" strategies including small modifications of the original substance for which the clinical benefit is not always demonstrated.

  16. Generic drugs: myths, facts, and limitations

    OpenAIRE

    Antonio Marzo; Elisabetta Porro; Anna Barassi

    2012-01-01

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

  17. 77 FR 60125 - Generic Drug Facilities, Sites and Organizations

    Science.gov (United States)

    2012-10-02

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

  18. 78 FR 22553 - Generic Drug Facilities, Sites, and Organizations

    Science.gov (United States)

    2013-04-16

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

  19. Generic Drugs: The Same Medicine for Less Money

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

  20. 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.

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

    Science.gov (United States)

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

    2013-07-01

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

  2. 76 FR 79198 - Generic Drug User Fee; Public Meeting; Correction

    Science.gov (United States)

    2011-12-21

    ... HUMAN SERVICES Food and Drug Administration Generic Drug User Fee; Public Meeting; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. SUMMARY: The Food and Drug... (76 FR 76738). The document announced a public meeting entitled ``Generic Drug User Fee.''...

  3. Generic drug names and social welfare.

    Science.gov (United States)

    Lobo, Félix; Feldman, Roger

    2013-06-01

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

  4. [Generic drugs in Brazil: historical overview and legislation].

    Science.gov (United States)

    Araújo, Lorena Ulhôa; Albuquerque, Kemile Toledo de; Kato, Kelly Cristina; Silveira, Gleiciely Santos; Maciel, Náira Rezende; Spósito, Pollyanna Álvaro; Barcellos, Neila Márcia Silva; Souza, Jacqueline de; Bueno, Márcia; Storpirtis, Sílvia

    2010-12-01

    The Brazilian generic drugs policy was implemented in 1999 with the aim of stimulating competition in the market, improve the quality of drugs and improve the access of the population to drug treatment. The process of implementing this policy allowed the introduction and discussion of concepts that had never before been used in the context of drug registration in Brazil: bioavailability, bioequivalence, pharmaceutical equivalence, generic drugs, biopharmaceutical classification system, biowaiver. The present article provides definitions for these concepts in the context of Brazilian legislation as well as a historical and chronological description of the implementation of the generic drugs policy in Brazil, including a list of current generic drug legislation. This article contributes to the understanding of the Brazilian generic drugs policy and facilitates the search for information concerning the legal requirements for registration of drugs in Brazil.

  5. [Strategies for pharmaceutical research and development. II. Generic drugs].

    Science.gov (United States)

    Kuchar, M

    1996-07-01

    When the patent protection is terminated, the original registered-mark preparation becomes a generic drug, which results in a decrease in its price as compared with the original pharmaceutical. The effects of changes in price relation are discussed from the viewpoint of the generic firms and the manufacturers of original preparations. The differences in the insurance system and legislative regulations of the registration of generic preparations can markedly the size influence of the share of generic drugs in the total consumption of drugs. The future development of generic drugs from a general viewpoint is discussed in relation to the contemporary extensive expiration of patent protection of drugs. The hitherto results are summed up and the topics for the present strategy of the development of generic drugs in the Research Institute for Pharmacy and Biochemistry, or in the Czech Republic, respectively are discussed.

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

    Science.gov (United States)

    Riaz, Haris; Krasuski, Richard A

    2016-06-01

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

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

    Science.gov (United States)

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

    2005-01-01

    This study evaluated knowledge and use of generic drugs in a population-based sample of adults from a southern Brazilian city. The outcomes were: the proportion of generics in total medicines used; theoretical and practical knowledge about generics; and strategies used to buy medicines on medical prescriptions. The recall period for drug utilization was 15 days. The proportion of generics in total medicines was 3.9%. While 86.0% knew that generics cost less and 70.0% that the quality is similar to brand name medicines, only 57.0% knew any packaging characteristics that distinguish generics from other medicines. The highest proportion of generic drug utilization was in the antimicrobial pharmacological group. A brand name medicine (with a brand similar to the generic name) was mistakenly classified as a generic through photos by 48.0% of the interviewees. Among subjects who bought medicines in the 15-day period, 18.9% reported buying a generic, but this result should be interpreted with caution, because the population frequently fails to differentiate between generics and other medicines.

  8. The future of generic HIV drugs in Rhode Island.

    Science.gov (United States)

    Lee, Jennifer Y; Reece, Rebecca; Montague, Brian; Rana, Aadia; Alexander-Scott, Nicole; Flanigan, Timothy

    2013-09-06

    The number of HIV-infected persons in the United States continues to increase and most patients with HIV will be on antiretroviral therapy (ART) for many decades. The introduction of generic antiretroviral medications has the potential for significant cost savings which may then be accompanied by improved access. State AIDS Drug Assistance Programs will be made more effective by the switch to generic ARTs. Cost savings and barriers to the introduction of generic ART are discussed.

  9. High-cost generic drugs--implications for patients and policymakers.

    Science.gov (United States)

    Alpern, Jonathan D; Stauffer, William M; Kesselheim, Aaron S

    2014-11-13

    Some older generic drugs have become very expensive, owing to factors including drug shortages, supply disruptions, and consolidations in the generic-drug industry. But generics manufacturers that legally obtain a market monopoly can also unilaterally raise prices.

  10. 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.

  11. The Impact of Information on Doctors' Attitudes Toward Generic Drugs.

    Science.gov (United States)

    Tsaprantzi, Aggeliki V; Kostagiolas, Petros; Platis, Charalampos; Aggelidis, Vassilios P; Niakas, Dimitris

    2016-01-01

    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.

  12. Prices of Generic Heart Failure Drugs Vary Widely

    Science.gov (United States)

    ... medlineplus.gov/news/fullstory_162035.html Prices of Generic Heart Failure Drugs Vary Widely Patients can spend from $12 to $ ... Nov. 15, 2016 (HealthDay News) -- Cash prices of generic medicines to treat heart failure vary so widely that ...

  13. Pharmacy and generic substitution of antiepileptic drugs: missing in action?

    Science.gov (United States)

    Welty, Timothy E

    2007-06-01

    Generic substitution of antiepileptic drugs is an issue that is gathering a lot of attention in the neurology community but is not receiving much attention within pharmacy. Several proposals have been drafted that restrict a pharmacist's decision-making in generic substitution. These proposals highlight concerns about the pharmacy community related to generic substitution. Careful consideration needs to be given to these issues by pharmacists and pharmacy professional organizations. Unless pharmacy as a profession takes strong positions in support of a pharmacist's ability to make decisions about pharmacotherapy and addresses many of the pharmacy-related problems of generic substitution, policies that negatively impact pharmacy will be established.

  14. 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.

  15. [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

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

    Science.gov (United States)

    Taboulet, F; Haramburu, F; Latry, Ph

    2003-09-01

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

  17. Medicaid payment for generic drugs: achieving savings and access.

    Science.gov (United States)

    Peters, Christie Provost

    2010-09-30

    Medicaid payment for generic prescription drugs has been a point of contention for the pharmacy industry over the past few years because of reimbursement formula changes contained in the Deficit Reduction Act (DRA) of 2005. The Patient Protection and Affordable Care Act (PPACA) includes provisions to resolve some of these issues. The DRA reduced the maximum amount the federal government would pay state Medicaid programs for generic drugs, and the Centers for Medicare & Medicaid services (CMS) final regulation, to implement the DRA provisions was met with a lawsuit from the pharmacy industry. An injunction by the federal district court, followed by a congressional moratorium, kept CMS from implementing the regulation and kept the pre-DRA formula for the generic drug payment limit in place. PPACA provisions increase maximum federal reimbursement levels for Medicaid generic drugs, but the impact on the pharmacy industry depends on CMS implementation and state policies. This paper examines Medicaid payment for generic drugs, the DRA and PPACA changes to generic drug reimbursement, the concerns of the pharmacy industry, and the potential impact on access.

  18. 77 FR 51814 - Generic Drug User Fee Amendments of 2012; Public Meeting; Request for Comments

    Science.gov (United States)

    2012-08-27

    ... HUMAN SERVICES Food and Drug Administration Generic Drug User Fee Amendments of 2012; Public Meeting... discuss implementation of the Generic Drug User Fee Amendments of 2012 (GDUFA). GDUFA requires that generic drug manufacturers pay user fees to finance critical and measurable generic drug...

  19. 75 FR 47820 - Generic Drug User Fee; Public Meeting; Request for Comments

    Science.gov (United States)

    2010-08-09

    ... HUMAN SERVICES Food and Drug Administration Generic Drug User Fee; Public Meeting; Request for Comments... on the development of a generic drug user fee program. The number of human generic drug applications awaiting FDA action and the median review times for generic drug applications have increased in...

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

    Science.gov (United States)

    Cooper-DeHoff, Rhonda M; Elliott, William J

    2013-08-01

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

  1. Generic drugs: Review and experiences from South India.

    Science.gov (United States)

    Mathew, Philip

    2015-01-01

    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.

  2. Definition and Classification of Generic Drugs Across the World.

    Science.gov (United States)

    Alfonso-Cristancho, Rafael; Andia, Tatiana; Barbosa, Tatiana; Watanabe, Jonathan H

    2015-08-01

    Our aim was to systematically identify and compare how generic medications, as defined by the US Food and Drug Administration (FDA), World Health Organization (WHO), and European Medicines Agency (EMA), are classified and defined by regulatory agencies around the world. We focused on emerging markets and selected the most populated countries in each of the WHO regions: Africa, the Americas, Eastern Mediterranean, Europe, Southeast Asia, and Western Pacific. A structured review of published literature was performed through December 2013. Direct information from regulatory agencies and Ministries of Health for each country was extracted. Additionally, key informant interviews were performed for validation. Of the 21 countries selected, approximately half provided an official country-level definition for generic pharmaceuticals. The others did not have any definition or referred to the WHO. Only two-thirds of the countries had specific requirements for generic pharmaceuticals, often associated with clinical interchangeability. Most countries with requirements mention bioequivalence, but few required bioavailability studies explicitly. Over 30% of the countries had other terms associated with generics in their definitions and processes. In countries with generic drug policies, there is reference to patent and/or data protection during the drug registration process. Several countries do not mention good manufacturing practices as part of the evaluation process. Countries in Africa and Eastern Mediterranean regions appear to have a less developed regulatory framework. In summary, there is significant variability in the definition and classification of generic drugs in emerging markets. Standardization of the definitions is necessary to make international comparisons viable.

  3. 76 FR 58277 - Animal Generic Drug User Fee Act; Public Meeting; Request for Comments

    Science.gov (United States)

    2011-09-20

    ... HUMAN SERVICES Food and Drug Administration Animal Generic Drug User Fee Act; Public Meeting; Request... comments. The Food and Drug Administration (FDA) is announcing a public meeting on the Animal Generic Drug... on the Internet at...

  4. 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.

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

    Science.gov (United States)

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

    2013-10-01

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

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

    Science.gov (United States)

    Carrillo Norte, Juan Antonio; Postigo Mota, Salvador

    2012-02-01

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

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

    OpenAIRE

    Garth Boehm; Lixin Yao; Liang Han; Qiang Zheng

    2013-01-01

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

  8. 77 FR 72359 - Animal Generic Drug User Fee Act; Public Meeting; Request for Comments

    Science.gov (United States)

    2012-12-05

    ... HUMAN SERVICES Food and Drug Administration Animal Generic Drug User Fee Act; Public Meeting; Request... comments. The Food and Drug Administration (FDA) is announcing the following meeting: Animal Generic Drug... Animal Generic Drug User Fee Act (AGDUFA II). Date and Time: The meeting will be held on December...

  9. 75 FR 45636 - Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2011

    Science.gov (United States)

    2010-08-03

    ... HUMAN SERVICES Food and Drug Administration Animal Generic Drug User Fee Rates and Payment Procedures... generic new animal drug user fees. The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Animal Generic Drug User Fee Act of 2008 (AGDUFA), authorizes FDA to collect user fees for...

  10. 77 FR 65199 - Generic Drug User Fee-Backlog Fee Rate for Fiscal Year 2013

    Science.gov (United States)

    2012-10-25

    ... HUMAN SERVICES Food and Drug Administration Generic Drug User Fee--Backlog Fee Rate for Fiscal Year 2013...) is announcing the ] rate for the backlog fee related to generic drug user fees for fiscal year (FY) 2013. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Generic Drug User...

  11. 78 FR 46958 - Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2014

    Science.gov (United States)

    2013-08-02

    ... HUMAN SERVICES Food and Drug Administration Animal Generic Drug User Fee Rates and Payment Procedures... generic new animal drug user fees. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Animal Generic Drug User Fee Amendments of 2013, which was signed by the President on June...

  12. Psychosocial factors associated with the prescription of generic drugs.

    Science.gov (United States)

    Rodríguez-Calvillo, Javier A; Lana, Alberto; Cueto, Antonio; Markham, Wolfgang A; López, Maria Luisa

    2011-07-01

    To evaluate factors associated with "Generic drug prescription" (GDP) behaviour in Spain using the ASE (Attitude, Social Influence, Self-Efficacy) Model. General Practitioners were sent a validated and anonymous questionnaire measuring the ASE and Motivation variables for GDP and their generic drug prescription percentage. Most (n=486; 61.98%) responded to this cross-sectional survey. The mean scores and the 95% confidence intervals (95% CI) were calculated. A binary logistic regression was used to identify the variables that best predict GDP behaviour. The main advantages and motivations for GDP were "saving money" and "protecting professional ethics". The greatest social influences were "doctors' personal preferences" and "authorities' pressure". GDP accounted for a scarce 15% of the total prescription. ASE and Motivation items were the best predictors: they explain 25% of being a 'high prescriber'. The highest prescribers were paediatricians (OR=5.07), workers in rural settings (OR=3.68) and professionals with high Motivation (OR=1.17) and Attitude (OR=1.11) scores. GDP percentage is very low compared with other countries. Interventions to modify the Attitudes of Primary Care doctors towards generic drugs should be implemented. Better informed patients, longer doctor appointment times and more varied dosage forms of generic drugs would also facilitate improvements in GDP. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

  13. Generic substitution of antihypertensive drugs : does it affect adherence?

    NARCIS (Netherlands)

    Van Wijk, Boris L G; Klungel, Olaf H; Heerdink, Eibert R; de Boer, Anthonius

    2006-01-01

    BACKGROUND: Generic substitution is an important opportunity to reduce the costs of pharmaceutical care. However, pharmacists and physicians often find that patients and brand-name manufacturers have doubt about the equivalence of the substituted drug. This may be reflected by decreased adherence to

  14. 76 FR 76738 - Generic Drug User Fee; Public Meeting

    Science.gov (United States)

    2011-12-08

    ... $824 billion dollars in savings to the nation's health care system in the last decade alone. The additional resources called for under the agreement, an inflation-adjusted $299 million annually for each of... generic drug program in the amount of $299 million per year, adjusted for inflation, for 5 years....

  15. Lawsuits allege price fixing by generic drug makers

    Directory of Open Access Journals (Sweden)

    Robbins RA

    2016-12-01

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

  16. 76 FR 14028 - Generic Drug User Fee; Notice of Public Meeting; Reopening of the Comment Period

    Science.gov (United States)

    2011-03-15

    ... HUMAN SERVICES Food and Drug Administration Generic Drug User Fee; Notice of Public Meeting; Reopening... FR 47820), entitled ``Generic Drug User Fee; Public Meeting; Request for Comments.'' In that notice... the development of a generic drug user fee program. FDA is reopening the comment period for...

  17. 76 FR 4119 - Generic Drug User Fee; Notice of Public Meeting; Reopening of the Comment Period

    Science.gov (United States)

    2011-01-24

    ... HUMAN SERVICES Food and Drug Administration Generic Drug User Fee; Notice of Public Meeting; Reopening... comment period for the notice of public meeting entitled Generic Drug User Fee; Public Meeting; Request... development of a generic drug user fee program. FDA is reopening the comment period to permit...

  18. 76 FR 24035 - Generic Drug User Fee; Public Meeting; Request for Comments

    Science.gov (United States)

    2011-04-29

    ... HUMAN SERVICES Food and Drug Administration Generic Drug User Fee; Public Meeting; Request for Comments... gather additional stakeholder input on the development of a generic drug user fee program. A user fee..., to facilitate the timely review of human generic drug applications by FDA, and FDA is currently...

  19. 76 FR 33307 - Generic Drug User Fee; Notice of Public Meeting; Extension of Comment Period

    Science.gov (United States)

    2011-06-08

    ... HUMAN SERVICES Food and Drug Administration Generic Drug User Fee; Notice of Public Meeting; Extension... requested comments to gather stakeholder input on the development of a generic drug user fee program. The..., 75 FR 47820, FDA published a notice soliciting comment on development of a generic drug user...

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

    Science.gov (United States)

    2011-07-22

    ... HUMAN SERVICES Food and Drug Administration Generic Drug User Fee; Public Meeting; Request for Comments... gather additional stakeholder input on the development of a generic drug user fee program. A user fee..., to facilitate the timely review of human generic drug applications by FDA. FDA has been...

  1. 77 FR 43844 - Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Drug User...

    Science.gov (United States)

    2012-07-26

    ... Collection; Comment Request; Generic Drug User Fee Cover Sheet; Form FDA 3794 AGENCY: Food and Drug... 3794 entitled ``Generic Drug User Fee Cover Sheet.'' DATES: Submit either electronic or written... appropriate, and other forms of information technology. Generic Drug User Fee Cover Sheet; Form FDA...

  2. [Beer-Fick criteria and generic drugs in Brazil].

    Science.gov (United States)

    Gorzoni, Milton Luiz; Fabbri, Renato Moraes Alves; Pires, Sueli Luciano

    2008-01-01

    Determine, according to the Beer-Fick criteria, the prevalence of drugs potentially inappropriate for the elderly available as generic medication in Brazil. 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. 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 antinflammatories, antiulceratives and cardiac glycosides. These criteria do not include drugs such as cough suppressants, cinnarizine, diltiazem, piracetam, quinolones, xanthines, creams, ointments and ophthalmic solutions which are also present in the list of generic medication. The Beers-Fick criteria may prevent use of drugs potentially inappropriate for the elderly, however, it should be stressed that these criteria are not complete for Brazilian generic medications.

  3. Analysis of pharmacists' opinions, attitudes and experiences with generic drugs and generic substitution in the Czech Republic.

    Science.gov (United States)

    Maly, Josef; Dosedel, Martin; Kubena, Ales; Vlcek, Jiri

    2013-01-01

    Generic substitution (GS) is an integral part of drug policy in many countries. Similarly to other countries its introduction in the Czech Republic gave rise to a vibrant discussion. The aim of the study was to map and analyze pharmacists' opinions of, attitudes towards and experiences with generic drugs and GS after the first year from its legislative embodiment in the Czech Republic. All 7,665 members of the Czech Chamber of Pharmacists were addressed to participate in a questionnaire survey between November 2008 and March 2009. The questionnaire consisted of 28 questions concerning the issue of generic drugs and GS and was divided into five sections. All collected data were analyzed using descriptive statistics and correlations were tested by selected parametric and non-parametric tests. A total of 615 completed questionnaire forms were returned (a questionnaire return rate of 8.0%). The demographic characteristics of the respondents were as follows: 470 (76.4%) females, mean age of 37.5 years (SD = 10.4) and 429 (69.6%) pharmacists with a practice specialization. Altogether 345 (56.1%) respondents became aware of the issue of brand name and generic drugs during their undergraduate studies. 378 (61.5%) respondents considered generic drugs as bioequivalent and 455 (74.0%) respondents as therapeutically equivalent to the respective brand name drugs. 99 (16.1%) pharmacists believed that generic products are of lower quality than branded drugs and 69 (11.2%) respondents expected generics to cause more adverse drug reactions. GS was perceived as a positive tool by 476 (77.4%) respondents. Only 71 (11.5%) respondents showed acquaintance with all the legal rules for GS. Legislation awareness and attitude towards GS was correlated with age (p generic drugs and GS. Approaching patients on an individual basis and pharmacists' awareness can minimize adverse drug events caused by generic drugs and at the same time enhance the professional status of pharmacists.

  4. Dissolution testing for generic drugs: an FDA perspective.

    Science.gov (United States)

    Anand, Om; Yu, Lawrence X; Conner, Dale P; Davit, Barbara M

    2011-09-01

    In vitro dissolution testing is an important tool used for development and approval of generic dosage forms. The objective of this article is to summarize how dissolution testing is used for the approval of safe and effective generic drug products in the United States (US). Dissolution testing is routinely used for stability and quality control purposes for both oral and non-oral dosage forms. The dissolution method should be developed using an appropriate validated method depending on the dosage form. There are several ways in which dissolution testing plays a pivotal role in regulatory decision-making. It may be used to waive in vivo bioequivalence (BE) study requirements, as BE documentation for Scale Up and Post Approval Changes (SUPAC), and to predict the potential for a modified-release (MR) drug product to dose-dump if co-administered with alcoholic beverages. Thus, in vitro dissolution testing plays a major role in FDA's efforts to reduce the regulatory burden and unnecessary human studies in generic drug development without sacrificing the quality of the drug products.

  5. Questionnaire on the awareness of generic drugs among outpatients and medical staff.

    Science.gov (United States)

    Hoshi, S; Kimura, H

    2008-06-01

    Generic drugs are not as widely used in Japan as they are in the West. The objective of this study was to survey the awareness of generic drugs among outpatients and medical staff and propose methods of promoting the use of generic drugs. Our survey showed that 86.7% of respondents were aware of generic drugs. This is a higher awareness rate than that in a survey of other groups conducted last year. One reason to explain this higher awareness is the recent increase in generic drug advertisements both in newspapers and on television. However, a point of note is that generic drug usage has not increased. Our survey also showed that generic drug awareness was differed widely among age groups, as younger respondents were much more aware of generic drugs than older respondents. Still, about 40% of respondents who were aware of generic drugs did not realize that they were less expensive than name-brand drugs ? including 30% of medical staff. In addition to continuing advertisement of generic drugs in the media, medical doctors and pharmacists should also be encouraged to endorse the use of generic drugs. Furthermore a new system allowing for substitution prescriptions started in April 2008 and consequently pharmacists can now play an important role in promoting the use of generic drugs.

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

    Science.gov (United States)

    Kuribayashi, Ryosuke; Matsuhama, Maki; Mikami, Kenichi

    2015-09-01

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

  7. Generic Scrip Share and the Price of Brand-Name Drugs: The Role of the Consumer

    OpenAIRE

    John A Rizzo; Richard Zeckhauser

    2005-01-01

    Generic drug utilization has risen dramatically, from 19% of scrips in 1984 to 47% in 2001, thus bringing significant direct dollar savings. Generic drug use may also yield indirect savings if it lowers the average price of those brand-name drugs that are still purchased. Prior work indicates - and we confirm - that generic competition does not induce brand-name producers to lower prices. However, consumer choices between generic and brand-name drugs could affect the average price of those br...

  8. 75 FR 67984 - Generic Drug User Fee; Notice of Public Meeting; Reopening of the Comment Period

    Science.gov (United States)

    2010-11-04

    ... No. FDA-2010-N-0381] Generic Drug User Fee; Notice of Public Meeting; Reopening of the Comment Period... notice of public meeting entitled Generic Drug User Fee; Public Meeting; Request for Comments, published... meeting on the development of a generic drug user fee program. In that notice, FDA posed several...

  9. Generic antiretroviral drugs and HIV care: An economic review.

    Science.gov (United States)

    Yazdanpanah, Y; Schwarzinger, M

    2016-03-01

    The cost of HIV care in European countries is high. Direct medical costs, in France, have been estimated at 500,000 Euros per patient's lifetime (20,000 Euros/year/patient). Overall, 73% of these costs are related to antiretroviral treatments. In the current financial crisis context, some European countries are beginning to make economic decisions on the drugs to be used. These approaches are likely to become more frequent. It is obviously essential to prescribe the most effective, appropriate, best tolerated, and easy-to-use antiretroviral treatments to patients. However, while taking the above into consideration, and if various treatment options or combinations are available, cost should also be considered in the treatment choice. One may thus reflect on the use of generic antiretroviral agents as they have just been launched in France. We aimed to review the cost and cost-effectiveness of generic antiretroviral drugs and to review treatment strategies other than generic drugs that could help reduce HIV-related costs. HIV clinicians should consider treatment costs to avoid any future coercive measures.

  10. 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

  11. Knowledge, perceptions and use of generic drugs: a cross sectional study

    Science.gov (United States)

    de Lira, Claudio Andre Barbosa; Oliveira, Jéssica Nathalia Soares; Andrade, Marília dos Santos; Vancini-Campanharo, Cássia Regina; Vancini, Rodrigo Luiz

    2014-01-01

    Objective To assess the level of knowledge, perceptions and usage profile for generic drugs among laypersons. Methods A cross-sectional study was conducted with 278 volunteers (180 women and 98 men, aged 37.1±15.8 years). A questionnaire was drawn up with questions on their use, perceptions and knowledge of generic drugs. Results Most respondents (99.6%) knew that generic drugs exist, but only 48.6% were able to define them correctly, while 78.8% of the respondents had some information about generics. This information was obtained mainly through television (49.3%). In terms of generic drug characteristics, 79.1% stated that they were confident about their efficacy, 74.8% believed that generic drugs have the same effect as branded medications, 88.8% said that generics were priced lower than branded medications, and 80.2% stated that they bought generic drugs because of price. With regard to drugs prescribed by medical practitioners, 17.6% of the participants said that their doctors never prescribed generics and only 7.5% confirmed that their doctors always prescribed generics. Conclusion For the lay public, the sample in this study has sufficient knowledge of generic drugs in terms of definition, efficacy and cost. Consequently, the volunteers interviewed are very likely to use generics. Furthermore, the results of this study indicate that programs should be implemented in order to boost generic drug prescriptions by medical practitioners. PMID:25295444

  12. Comparison of outcomes following a switch from a brand to an authorized vs. independent generic drug.

    Science.gov (United States)

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

    2016-12-16

    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 1999-2014, 5,234 unique patients were on brand drug 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 visits was slightly higher for authorized generics compared with generics. These data suggest that generics were clinically no worse than their proxy brand comparator. This article is protected by copyright. All rights reserved.

  13. Quality of Reporting of Bioequivalence Trials Comparing Generic to Brand Name Drugs: A Methodological Systematic Review

    OpenAIRE

    Amélie van der Meersch; Agnès Dechartres; Philippe Ravaud

    2011-01-01

    BACKGROUND: Generic drugs are used by millions of patients for economic reasons, so their evaluation must be highly transparent. OBJECTIVE: To assess the quality of reporting of bioequivalence trials comparing generic to brand-name drugs. METHODOLOGY/PRINCIPAL FINDINGS: PubMed was searched for reports of bioequivalence trials comparing generic to brand-name drugs between January 2005 and December 2008. Articles were included if the aim of the study was to assess the bioequivalency of generic ...

  14. Bioequivalence of generic drugs: a simple explanation for a US Food and Drug Administration requirement.

    Science.gov (United States)

    Andrade, Chittaranjan

    2015-06-01

    There is a widespread misconception that for a generic drug to be deemed bioequivalent to a branded drug, it must contain 80%-125% of the active ingredient that is present in the branded version. More correctly, bioequivalence is studied in randomized crossover trials that compare the generic drug with the reference agent, and the relevant outcome measures are pharmacokinetic (PK) parameters such as peak drug concentration and area under the curve, which describe the rate and extent of absorption of the drug. The ratio of each PK characteristic of the generic drug to the reference drug is computed; the ideal value of this ratio is 1:1, or just 1.00 (indicating a perfect match, or perfect bioequivalence). Because this ideal is probably unattainable, the US Food and Drug Administration requires that the 90% confidence interval of the PK ratio should lie between 0.80 and 1.25. For the entire 90% confidence interval to meet this requirement, the mean PK value of the generic product should actually lie quite close to that of the reference standard. Therefore, the variation between the generic and the reference is actually small. These concepts are explained in this article with the help of simple, easy-to-understand examples.

  15. 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

  16. The generic drug market in Japan: will it finally take off?

    Science.gov (United States)

    Iizuka, Toshiaki; Kubo, Kensuke

    2011-07-01

    Historically, brand-name pharmaceuticals have enjoyed long periods of market exclusivity in Japan, given the limited use of generics after patent expiration. To improve the efficiency of the health-care system, however, the government has recently implemented various policies aimed at increasing generic substitution. Although this has created expectations that the Japanese generic drug market may finally take off, to date, generic usage has increased only modestly. After reviewing the incentives of key market participants to choose generics, we argue that previous government policies did not provide proper incentives for pharmacies to boost generic substitution. We offer some recommendations that may help to increase generic usage.

  17. Drug-related hospital admissions in a generic pharmaceutical system.

    Science.gov (United States)

    Zargarzadeh, A H; Emami, M H; Hosseini, F

    2007-01-01

    1. Generically based pharmaceutical systems exist in a few countries of the world, such as Iran. Most developed countries have free market pharmaceutical systems. Drug-related problems (DRP) have been reported mostly in the Western world but few data are available for generic systems. In this study, we tried to measure the prevalence of drug-related problems leading to hospital admissions in Isfahan, Iran. 2. One thousand consecutive hospital admissions in three major teaching hospitals were studied for a period of 6 months for the presence of DRP as a cause of hospital admissions. Two subcategories of DRP were considered: (i) drug therapy failure; and (ii) adverse drug reactions. Preventability and outcome measures were also assessed. Medications responsible for DRP were classified according to the Anatomic Therapeutic Chemical (ATC) classification of the World Health Organization. 3. Of the 1000 admissions studied, 115 (11.5%) were owing to DRP, 81% as a result of drug therapy failure and 19% as adverse drug reactions. A total of 106 out of the 115 DRP cases (92%) were either preventable or probably preventable, most of which had to do with either prescriber or patient error. An overview of DRP showed that 58.3% resulted in complete recovery, 33.9% in relative recovery and 7.8% in death. Close to 1% of hospital admissions resulted in DRP-related deaths. 4. The overall prevalence of hospital admissions caused by DRP is similar to that in free market pharmaceutical systems. The high preventability rate of these problems should alert clinicians and policy makers to design strategies to curtail this. Also, reasons for differences in subtypes of DRP between the results of this study and those of the literature from free market systems needs to be investigated further.

  18. Strategies that delay or prevent the timely availability of affordable generic drugs in the United States.

    Science.gov (United States)

    Jones, Gregory H; Carrier, Michael A; Silver, Richard T; Kantarjian, Hagop

    2016-03-17

    High cancer drug prices are influenced by the availability of generic cancer drugs in a timely manner. Several strategies have been used to delay the availability of affordable generic drugs into the United States and world markets. These include reverse payment or pay-for-delay patent settlements, authorized generics, product hopping, lobbying against cross-border drug importation, buying out the competition, and others. In this forum, we detail these strategies and how they can be prevented.

  19. [Perception, knowledge, and use of generic drugs in southern Brazil: what changed from 2002 to 2012?].

    Science.gov (United States)

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

    2016-08-01

    This study compared the perception, knowledge, and use of generic drugs by adults in Pelotas, Rio Grande do Sul State, Brazil, using two cross-sectional population-based studies from 2002 and 2012. Study outcomes were: (a) prevalence of use of generics; (b) generics as a proportion of all medication; (c) users' perceptions of prices and quality; (d) users' knowledge of generics; and (e) strategies for acquisition of medicines. Prevalence of generics use increased from 3.6% (95%CI: 3.0-4.3) to 26.1% (95%CI: 24.5-27.7) in the 10-year period. Perceptions of prices and quality of generics remained stable, identification of characteristics that distinguish generics from other drugs improved (p generics. Between 2002 and 2012 there was an increase in knowledge and use of generics, while perception of lower prices and equivalent quality remained high.

  20. 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.

  1. 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.

  2. [What are patients' attitudes towards generic drugs? The example of metformin].

    Science.gov (United States)

    Allenet, Benoît; Golay, Alain

    2013-05-08

    The success of cost containment with generic drugs is based on consumer's willingness to accept substitution. This investigation reveals 3 major themes that can explain attitudes of patients towards generics: 1) personal beliefs and knowledge (coming from the media issues, family, friends) are fragmented and sometimes erroneous, with a background of suspicion on the quality of the generics; 2) relation with the prescriber (indirectly pharmacist) is central to build up patient's trust; suspicious professionals generate an anxious patient; 3) previous experience from the consumer with generics. Starting from patients' experiences and beliefs allows to anticipate their resistance to the generic and to adapt drug prescription choices.

  3. 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.

  4. 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

  5. 78 FR 46977 - Generic Drug User Fee-Abbreviated New Drug Application, Prior Approval Supplement, Drug Master...

    Science.gov (United States)

    2013-08-02

    ..., Prior Approval Supplement, Drug Master File, Final Dosage Form Facility, and Active Pharmaceutical... active pharmaceutical ingredient (API), and finished dosage form (FDF) facilities user fees related to... one or more finished dosage forms of a human generic drug or an active pharmaceutical ingredient...

  6. Is there a role for generic antiretroviral drugs in the United States?

    Science.gov (United States)

    Wormser, Gary P; Lappas, Thomas

    2014-08-01

    The high cost of antiretroviral drugs has limited access to treatment for some HIV-infected patients in the United States and strained public resources. With the introduction of much cheaper generic versions of some of these agents, and with more to come in the next few years, the need increases to define the role of generic antiretroviral drugs in patient management.

  7. Interchangeability of generic anti-epileptic drugs: a quantitative analysis of topiramate and gabapentin.

    NARCIS (Netherlands)

    Maliepaard, M.; Banishki, N.; Gispen-de Wied, C.C.; Teerenstra, S.; Elferink, A.J.

    2011-01-01

    PURPOSE: The objective of this study was to determine whether the so-called "shift" or "drift" problem might occur when generic anti-epileptic drugs are interchanged, and thus to assess if generic anti-epileptic drugs are interchangeable and can be used in an efficacious and safe way on the basis of

  8. WHAT IS THERAPEUTIC EQUIVALENCE OF GENERIC DRUG AND HOW TO PROVE IT

    Directory of Open Access Journals (Sweden)

    N. P. Kutishenko

    2011-01-01

    Full Text Available The problem of generic drugs use in clinical practice and confirmation of their therapeutic equivalence is discussed. The significance of studies on generic drugs bioequivalence, as well as details of international practice and regulations in this area is explained.

  9. 78 FR 70953 - Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers...

    Science.gov (United States)

    2013-11-27

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Generic Drug User Fee... Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers (Revision 1)'', published in... draft guidance entitled ``Draft Guidance for Industry on Generic Drug User Fee Amendments of...

  10. 77 FR 51814 - Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers...

    Science.gov (United States)

    2012-08-27

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Generic Drug User Fee... draft guidance for industry entitled ``Generic Drug User Fee Amendments of 2012: Questions and Answers... effective generic drugs to the public and reduce costs to industry. GDUFA enables FDA to assess user fees...

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

    Science.gov (United States)

    2012-08-27

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

  12. 78 FR 55261 - Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers...

    Science.gov (United States)

    2013-09-10

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Generic Drug User Fee... a draft guidance for industry entitled ``Generic Drug User Fee Amendments of 2012: Questions and... delivery of safe and effective generic drugs to the public and reduce costs to industry. GDUFA enables...

  13. 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.

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

    National Research Council Canada - National Science Library

    Bangalee, Varsha; Suleman, Fatima

    2016-01-01

    .... 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...

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

    National Research Council Canada - National Science Library

    Varsha Bangalee; Fatima Suleman

    2016-01-01

    ...: 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...

  16. Factors affecting the opinions of family physicians regarding generic drugs--a questionnaire based study.

    Science.gov (United States)

    Lewek, Pawel; Smigielski, Janusz; Kardas, Przemyslaw

    2014-12-17

    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 of 170 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 (pgeneric drugs (pgeneric 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.

  17. 78 FR 78366 - Draft Generic Drug User Fee Act Information Technology Plan; Availability for Comment

    Science.gov (United States)

    2013-12-26

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

  18. Bioequivalence studies: need for the reability of generic drugs

    OpenAIRE

    Laosa, Olga; Centro de Farmacología Clínica, Departamento de Farmacología y Terapéutica, Facultad de Medicina, Universidad Autónoma de Madrid. Madrid, España. Médico especialista en Farmacología Clínica.; Guerra, Pedro; Centro de Farmacología Clínica, Departamento de Farmacología y Terapéutica, Facultad de Medicina, Universidad Autónoma de Madrid. Madrid, España. Médico especialista en Farmacología Clínica.; López-Durán, Jose Luis; Centro de Farmacología Clínica, Departamento de Farmacología y Terapéutica, Facultad de Medicina, Universidad Autónoma de Madrid. Madrid, España. Médico especialista en Farmacología Clínica.; Mosquera, Beatriz; Centro de Farmacología Clínica, Departamento de Farmacología y Terapéutica, Facultad de Medicina, Universidad Autónoma de Madrid. Madrid, España. Licenciada en Ciencias Químicas.; Frías, Jesús; Centro de Farmacología Clínica, Departamento de Farmacología y Terapéutica, Facultad de Medicina, Universidad Autónoma de Madrid. Madrid, España. Servicio de Farmacología Clínica, Hospital Universitario la Paz. Madrid, España. Médico especialista en Farmacología Clínica.

    2009-01-01

    A generic medicine is a pharmaceutical product containing an active ingredient already known and previously developed and invented by others. The cost of these generic or multisource products should be less than their counterparts original. The clinical effects and the risk-benefit balance of a medicine do not depend exclusively on the activity of a pharmacologically active substance. Demonstration of bioequivalence of generic medicine is of great importance. In Europe and the United States g...

  19. Bioequivalence studies: need for the reability of generic drugs

    OpenAIRE

    Laosa, Olga; Centro de Farmacología Clínica, Departamento de Farmacología y Terapéutica, Facultad de Medicina, Universidad Autónoma de Madrid. Madrid, España. Médico especialista en Farmacología Clínica.; Guerra, Pedro; Centro de Farmacología Clínica, Departamento de Farmacología y Terapéutica, Facultad de Medicina, Universidad Autónoma de Madrid. Madrid, España. Médico especialista en Farmacología Clínica.; López-Durán, Jose Luis; Centro de Farmacología Clínica, Departamento de Farmacología y Terapéutica, Facultad de Medicina, Universidad Autónoma de Madrid. Madrid, España. Médico especialista en Farmacología Clínica.; Mosquera, Beatriz; Centro de Farmacología Clínica, Departamento de Farmacología y Terapéutica, Facultad de Medicina, Universidad Autónoma de Madrid. Madrid, España. Licenciada en Ciencias Químicas.; Frías, Jesús; Centro de Farmacología Clínica, Departamento de Farmacología y Terapéutica, Facultad de Medicina, Universidad Autónoma de Madrid. Madrid, España. Servicio de Farmacología Clínica, Hospital Universitario la Paz. Madrid, España. Médico especialista en Farmacología Clínica.

    2009-01-01

    A generic medicine is a pharmaceutical product containing an active ingredient already known and previously developed and invented by others. The cost of these generic or multisource products should be less than their counterparts original. The clinical effects and the risk-benefit balance of a medicine do not depend exclusively on the activity of a pharmacologically active substance. Demonstration of bioequivalence of generic medicine is of great importance. In Europe and the United States g...

  20. Generic script share and the price of brand-name drugs: the role of consumer choice.

    Science.gov (United States)

    Rizzo, John A; Zeckhauser, Richard

    2009-09-01

    Pharmaceutical expenditures have grown rapidly in recent decades, and now total nearly 10% of health care costs. Generic drug utilization has risen substantially alongside, from 19% of scripts in 1984 to 47% in 2001, thus tempering expenditure growth through significant direct dollar savings. However, generic drugs may lead to indirect savings as well if their use reduces the average price of those brand-name drugs that are still purchased. Prior work indicates that brand-name producers do not lower their prices in the face of generic competition, and our study confirms that finding. However, prior work is silent on how the mix of consumer choices between generic and brand-name drugs might affect the average price of those brand-name drugs that are purchased. We use a nationally representative panel of data on drug utilization and costs for the years 1996-2001 to examine how the share of an individual's prescriptions filled by generics (generic script share) affects his average out-of-pocket cost for brand-name drugs, and the net cost paid by the insurer. Our principal finding is that a higher generic script share lowers average brand-name prices to consumers, presumably because consumers are more likely to substitute generics when brand-name drugs would cost them more. This effect is substantial: a 10% increase in the consumer's generic script share is associated with a 15.6% decline in the average price paid for brand-name drugs by consumers. This implies that the potential cost savings to consumers from generic substitution are far greater than prior work suggests. In contrast, the percentage reduction in average brand costs to health plans is far smaller, and statistically insignificant.

  1. Strategic development on generic anti-cancer drugs Bevacizumab and Erlotinib Hydrochloride for Harbin Pharmaceutical Group

    Institute of Scientific and Technical Information of China (English)

    Cheung Fat Ping

    2011-01-01

    @@ With improved economy, changing life styles, aging population and health care reform, China had a very potential anti-cancer drug market.The patents of popular anti-cancer drugs Avastin and Tarceva would expire in few years.Generic versions of Avastin and Tarceva were Bevacizumab and Erlotinib Hydrochloride respectively.Harbin Pharmaceutical Group was proposed to develop strategically both generic medicines to enter the high-end anti-cancer drug market for targeted cancer therapies.The vital to success of developing the generic drugs were discussed.

  2. 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.

  3. 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.

  4. 76 FR 79195 - Animal Generic Drug User Fee Act; Reopening of the Comment Period

    Science.gov (United States)

    2011-12-21

    ... HUMAN SERVICES Food and Drug Administration Animal Generic Drug User Fee Act; Reopening of the Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; reopening of the comment period. SUMMARY: The Food and Drug Administration (FDA or Agency) is extending to January 15, 2013, the...

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

    Science.gov (United States)

    Yamada, Mikiko; Welty, Timothy E

    2011-11-01

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

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

    Science.gov (United States)

    Sørensen, Per Soelberg

    2016-01-01

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

  7. Generic drugs for the treatment of ocular conditions: changing the treatment landscape.

    Science.gov (United States)

    Aref, Ahmad A

    2014-09-01

    As global spending on medicinal products continues to rise, the availability of lower-cost generic substitutes is increasingly driving health care decision-making. US FDA does not require strict demonstration of human bioequivalence and/or therapeutic studies for the approval of generic ophthalmic compounds. Bioequivalence between generic and innovator compounds is presumed on the basis of matching active and inactive ingredient profiles. Generic compounds may differ from innovator agents with regards to performance under environmental stress, relative acidity and bottle size/rigidity. Matching ingredient profiles may therefore not result in consistently comparable drug compositions and clinical effects.

  8. Patterns and predictors of generic narrow therapeutic index drug use among older adults.

    Science.gov (United States)

    Gagne, Joshua J; Polinski, Jennifer M; Kesselheim, Aaron S; Choudhry, Niteesh K; Hutchins, David; Matlin, Olga S; Tong, Angela; Shrank, William H

    2013-09-01

    To ascertain predictors of initiation of brand-name versus generic narrow therapeutic index (NTI) drugs. Retrospective cohort study. Data from CVS Caremark were linked to Medicare claims and to U.S. census data. Individuals aged 65 and older who initiated an NTI drug in 2006 and 2007 (N = 36,832). Demographic, health service utilization, and geographic predictors of whether participants initiated a generic or brand-name version of their NTI drug were identified using logistic regression. Overall, 30,014 (81.5%) participants started on a generic version of their NTI drug. The most commonly initiated NTI drugs were warfarin (n = 17,790; 48%), levothyroxine (n = 10,779; 29%), and digoxin (n = 6,414; 17%). Older age (odds ratio (OR) = 1.12, 95% confidence interval (CI) = 1.02-1.22 comparing aged ≥ 85 with 65-74), higher burden of comorbidity (OR = 1.05, 95% CI = 1.04-1.07 for each 1-point increase in comorbidity score), and prior use of any generic drug (OR = 1.55, 95% CI = 1.29-1.87) were positively associated with generic drug initiation. Independent of other predictors, residing in the census block group with the highest generic use was positively associated with greater odds of generic NTI drug initiation (OR = 1.24, 95% CI = 1.14-1.35 compared with the lowest quintile). Demographic, health service utilization, and geographic characteristics are important determinants of whether individuals initiate treatment with a brand-name or generic NTI drug. These factors may contribute to disparities in care and highlight potential targets for educational campaigns. © 2013, Copyright the Authors Journal compilation © 2013, The American Geriatrics Society.

  9. Generic Drugs - Decreasing Costs and Room for Increased Number of Kidney Transplantations.

    Science.gov (United States)

    Spasovski, Goce

    2015-01-01

    Kidney transplantation is the best treatment option in comparison to dialysis, although patients are obliged to receive life-long medical treatment with immunosuppressive drugs (ISDs) for prevention of the graft rejection. Such immunosuppressive treatment may be costly and associated with multiple adverse effects. Since costs are viewed as one of the major constraints for the increasing number of transplantation, the use of generic ISDs may decrease the overall cost of transplantation and raise the possibility for its further development. An ideal ISD should have the security margin between toxic and therapeutic dose, and prevent development of acute or chronic rejection of the transplanted kidney. This is particularly important for drugs with a "narrow therapeutical index" (NTI), where small differences in dose or concentration lead to dose and concentration-dependent, serious therapeutic failures and/or adverse drug reactions. The NTI generic drug is approved if within 90%-112% of the area under the curve of the original product the pharmacokinetics fulfills the strict criteria of pharmaceutical equivalence and bioequivalence. Every generic has to be proven to be bioequivalent to the innovator product, and not to other generic products because of the possible generic "drift". Thus, the generic ISDs may be economically attractive, but theoretically, they may pose a risk to transplant patients. Such risks may be reduced if a long-term clinical studies showing cost-effectiveness of generic ISDs in de novo and prevalent transplant patients for every new generic ISD are performed. In conclusion, the increased number of solid organ transplantation goes in line with the increased health care expenditure for ISDs. The generic immunosuppressants could be a possible solution if safely substituted for innovator products or other generic drug of choice. The substantial cost reduction needs to be redirected into organ donation initiatives so that more patients can benefit

  10. 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.

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

    Directory of Open Access Journals (Sweden)

    Luca Gallelli

    2013-01-01

    Full Text Available Generic drugs are equivalent to the brand formulation if they have the same active substance, the same pharmaceutical form and the same therapeutic indications and a similar bioequivalence respect to the reference medicinal product. The use of generic drugs is indicated from many countries in order to reduce medication price. However some points, such as bioequivalence and the role of excipients, may be clarified regarding the clinical efficacy and safety during the switch from brand to generic formulations. In conclusion, the use of generic drugs could be related with an increased days of disease (time to relapse or might lead to a therapeutic failure; on the other hand, a higher drug concentration might expose patients to an increased risk of dose-dependent side-effects.

  12. [Switching to a generic drugA blessing or a curse?].

    Science.gov (United States)

    Ebbelaar, C F; Lammers, H A; Schobben, A F A M

    2016-01-01

    A patient suffering from Zollinger-Ellison was treated with Nexium, but after patent expiry only the costs of generic omeprazol were reimbursed. Generic tablets and capsules, pantoprazol and rabeprazol, were tried without success and finally the pharmacist dispensed Nexium at his own expense. Registered generic drugs have been shown to be bioequivalent with the originator drug within narrow margins. When two batches of the originator are compared, the same requirements are valid. Although the subject has received a lot of negative publicity, meta-analyses on outcome comparison support generic substitution; problems associated with switching can be partially explained by the loss of trust in the treatment, and differences in appearance also cause confusion. Generic prescribing should be encouraged to keep medical treatment affordable; however, in order to prevent the problems described it is desirable to keep to the same product as far as possible. Effective education and patient information are essential if switching is to be successful.

  13. Pharmaceutical equivalence by design for generic drugs: modified-release products.

    Science.gov (United States)

    Raw, André Sirota; Lionberger, Robert; Yu, Lawrence X

    2011-07-01

    The Office of Generic Drugs has ensured the high quality of generic products based upon two requirements: pharmaceutical equivalence and bioequivalence to the reference listed drug (RLD). This paradigm has been used with success toward ensuring quality generic drug products that provide the same therapeutic benefit as the RLD. Drug products have increased in design complexity; as a result, approaches to ensure therapeutic equivalence must evolve to provide assurance of quality generic drug products. The Food and Drug Administration quality by design initiative (QbD) provides an enhanced evaluation approach by introducing the concept of a quality target product profile (QTPP). The QTPP introduces, within the context of the current regulatory framework, the quality concept of "pharmaceutical equivalence by design." This article illustrates through several examples how this QbD element in the evaluation of modified-release drug products enhances the current framework to ensure generic drug product equivalence. It achieves this by complementing the traditional paradigm, "equivalence by testing," where product equivalence is based upon inferences from a limited bioequivalence study, to one that also considers whether the drug product was developed to be an equivalent to the RLD, using appropriate quality surrogates that target "pharmaceutical equivalence by design."

  14. Statistics on BCS Classification of Generic Drug Products Approved Between 2000 and 2011 in the USA

    OpenAIRE

    Nair, Anil K.; Anand, Om; Chun, Nam; Conner, Dale P.; Mehta, Mehul U.; Nhu, Duong T.; Polli, James E.; Yu, Lawrence X.; Davit, Barbara M.

    2012-01-01

    The Biopharmaceutics Classification system (BCS) classifies drug substances based on aqueous solubility and intestinal permeability. The objective of this study was to use the World Health Organization Model List of Essential Medicines to determine the distribution of BCS Class 1, 2, 3, and 4 drugs in Abbreviated New drug Applications (ANDA) submissions. To categorize solubility and intestinal permeability properties of generic drugs under development, we used a list of 61 drugs which were cl...

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

    Science.gov (United States)

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

    2012-04-01

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

  16. 77 FR 57094 - Draft Guidance for Industry on Self-Identification of Generic Drug Facilities, Sites, and...

    Science.gov (United States)

    2012-09-17

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

  17. 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.

  18. Scaling-up the use of generic antiretrovirals in resource-limited countries: generic drugs for health.

    Science.gov (United States)

    Beck, Eduard J; Passarelli, Carlos; Lui, Iris; Guichard, Anne-Claire; Simao, Mariangela; De Lay, Paul; Loures, Luiz

    2014-01-01

    The number of people living with HIV (PLHIV) continues to increase around the world because of the increasing number on antiretroviral therapy (ART) and their associated increase of life expectancy, in addition to the number of people newly infected with HIV each year. Unless a 'cure' can be found for HIV infection, PLHIV can anticipate the need to take antiretroviral drugs (ARVs) for the rest of their lives. Because ARVs are now being used for HIV prevention, as well as for therapeutic purposes, the need for effective, affordable ARVs with few adverse effects will continue to rise. It is important to note that the dramatic growth in treatment coverage of PLHIV seen during the past decade has been primarily due to the increased use of generic ARVs. Thus, there will be a need to scale-up the research and development, production, distribution and access to generic ARVs and ART regimens. However, these processes must occur within national and international regulated free-market economic systems and must deal with increasingly multifaceted patent issues affecting the price while ensuring the quality of the ARVs. National and international regulatory mechanisms will have to evolve, which will affect broader national and international economic and trade issues. Because of the complexity of these issues, the Editors of this Supplement conceived of asking experts in their fields to describe the various steps from relevant research and development, to production of generic ARVs, their delivery to countries and subsequently to PLHIV in low- and middle-income countries. A main objective was to highlight how these steps are interrelated, how the production and delivery of these drugs to PLHIV in resource-limited countries can be made more effective and efficient, and what the lessons are for the production and delivery of a broader set of drugs to people in low- and middle-income countries.

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

    Science.gov (United States)

    Carrillo Norte, Juan Antonio; Postigo Mota, Salvador

    2015-05-01

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

  20. 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.

  1. Quality of reporting of bioequivalence trials comparing generic to brand name drugs: a methodological systematic review.

    Science.gov (United States)

    van der Meersch, Amélie; Dechartres, Agnès; Ravaud, Philippe

    2011-01-01

    Generic drugs are used by millions of patients for economic reasons, so their evaluation must be highly transparent. To assess the quality of reporting of bioequivalence trials comparing generic to brand-name drugs. PubMed was searched for reports of bioequivalence trials comparing generic to brand-name drugs between January 2005 and December 2008. Articles were included if the aim of the study was to assess the bioequivalency of generic and brand-name drugs. We excluded case studies, pharmaco-economic evaluations, and validation dosage assays of drugs. We evaluated whether important information about funding, methodology, location of trials, and participants were reported. We also assessed whether the criteria required by the Food and Drug Administration (FDA) and the European Medicine Agency (EMA) to conclude bioequivalence were reported and that the conclusions were in agreement with the results. We identified 134 potentially relevant articles but eliminated 55 because the brand-name or generic drug status of the reference drug was unknown. Thus, we evaluated 79 articles. The funding source and location of the trial were reported in 41% and 56% of articles, respectively. The type of statistical analysis was reported in 94% of articles, but the methods to generate the randomization sequence and to conceal allocation were reported in only 15% and 5%, respectively. In total, 65 articles of single-dose trials (89%) concluded bioequivalence. Of these, 20 (31%) did not report the 3 criteria within the limits required by the FDA and 11 (17%) did not report the 2 criteria within the limits required by the EMA. Important information to judge the validity and relevance of results are frequently missing in published reports of trials assessing generic drugs. The quality of reporting of such trials is in need of improvement.

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

    Science.gov (United States)

    Bialer, Meir; Midha, Kamal K

    2010-06-01

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

  3. 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.

  4. 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.

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

    Science.gov (United States)

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

    2012-03-01

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

  6. Paying Physicians to Prescribe Generic Drugs and Follow-On Biologics in the United States: e1001802

    National Research Council Canada - National Science Library

    Ameet Sarpatwari; Niteesh K Choudhry; Jerry Avorn; Aaron S Kesselheim

    2015-01-01

    .... * Strategies to promote greater prescribing of generic drugs and follow-on biologics include traditional information-supplying programs such as formulary decision support and academic detailing...

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

    Science.gov (United States)

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

    2016-01-01

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

  8. 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.

  9. 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.

  10. An Update of the Brazilian Regulatory Bioequivalence Recommendations for Approval of Generic Topical Dermatological Drug Products.

    Science.gov (United States)

    Soares, Kelen Carine Costa; Santos, Gustavo Mendes Lima; Gelfuso, Guilherme M; Gratieri, Tais

    2015-11-01

    This note aims to clarify the Brazilian regulatory bioequivalence recommendations for approval of generic topical dermatological drug products, since the legal framework of the "Brazilian Health Surveillance Agency" (ANVISA) is only available in Portuguese. According to Resolutions RE n. 1170 (December 19th 2006) and RDC n. 37 (August 3rd 2011) in Brazil, only in vitro studies are required for registration of generic topical dermatological drug products. Current Regulatory Agenda of ANVISA, which contains possible future resolutions to be revised over 2015-2016, includes a discussion on biowaiver requirements and on possible in vitro and in vivo comparability tests for these products.

  11. In vitro release of diclofenac diethylamine from gels: evaluation of generic semisolid drug products in Brazil

    Directory of Open Access Journals (Sweden)

    Karin Goebel

    2013-06-01

    Full Text Available In order for the pharmacological action of a topical dermal drug product to occur, the drug must first be released from the vehicle to be available to penetrate the skin layers and reach the site of action. Drug release is mainly dependent on the characteristics of the formulation. Currently, to register a generic or a similar drug product in Brazil performance testing of topical drug products for local action is not required. In this context, this aim of this study was to evaluate the in vitro release of commercial diclofenac diethylamine gel products available on the Brazilian pharmaceutical market, using the vertical diffusion cell method. Factors which may influence the test, such as the type of membrane used, and the effect of the formulation characteristics on the diffusion rate were evaluated. Brazilian legislation currently allows generic drug products to contain excipients other than the reference drug, which may affect the drug release from the vehicle. Only one of the four generic drug products tested could be considered equivalent to the reference Cataflam Emulgel®. The cellulose acetate and polyethersulfone membranes tested were found to be interchangeable in the in vitro release studies carried out on this product.

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

    Science.gov (United States)

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

    2013-12-01

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

  13. spark chamber

    CERN Multimedia

    A few cosmic rays pass through your body every second of every day, no matter where you are. Look at the spark chamber to your right – every flash is the track made by a cosmic ray from outer space. The spark chamber is filled with a special gas mixture. Cosmic rays knock electrons out of the atoms in the gas. These electrons accelerate towards high voltage metal strips layered throughout the chamber, creating sparks like little bolts of lightning.

  14. spark chamber

    CERN Multimedia

    A few cosmic rays pass through your body every second of every day, no matter where you are. Look at the spark chamber to your right – every flash is the track made by a cosmic ray from outer space. The spark chamber is filled with a special gas mixture. Cosmic rays knock electrons out of the atoms in the gas. These electrons accelerate towards high voltage metal strips layered throughout the chamber, creating sparks like little bolts of lightning.

  15. [Equivalence studies of pravastatin original and generic drugs by dissolution test].

    Science.gov (United States)

    Nakauchi, Takao; Takeuchi, Ena; Okamoto, Takuya; Teramoto, Katsuya; Nozaki, Aoi; Seko, Fuko; Yuminoki, Kayo; Katakawa, Junichi; Hashimoto, Naofumi

    2012-01-01

    There are various opinions regarding the different functions of original and generic drugs. We used the paddle method to perform dissolution tests on pravastatin sodium tablets (10 mg) to investigate the causes for these differences. We used water and buffer solutions adjusted to pH 1.2 (JP1) and pH 6.8 (JP2), which are described in the Japanese Pharmacopoeia. The pravastatin concentration was measured by UV spectroscopy and HPLC. There were significant differences in the percentages dissolved of original and generic drugs after 5 and 10 min. On the other hand, the dissolution behaviors using water and JP2 measured by HPLC were similar to the results obtained by UV spectroscopy. However, the percentage dissolved of pravastatin using JP1 decreased with time because pravastatin degraded in JP1. There were also significant differences in the pravastatin concentrations of the original and generic drugs at 5, 15, 30, and 45 min. Based on the above results, since the original drug has a slower dissolution rate than the generic drugs, it is necessary to be cautious about the degradation of pravastatin in the stomach and the bioavailability of pravastatin due to the different dissolution rates and the different residual amount of pravastatin in the stomach.

  16. [The effect of generic price competition on drug consumption and health insurance pharmaceutical expenditures in Hungary].

    Science.gov (United States)

    Répásy, Balázs; Endrei, Dóra; Zemplényi, Antal; Agoston, István; Hornyák, Lajos; Nagy, Zsolt; Csákvári, Tímea; Vajda, Réka; Boncz Imre

    2015-01-01

    The aim of our study was to analyze the Hungarian montelukast sodium drug market. We examined the effect of the appearance of generic drugs on the price and turnover of the brand-name drug, Singulair. Data derived from the nationwide pharmaceutical database of Hungarian National Health Insurance Fund Administration (2007-2014). We analized the turnover and price of the medicaments containing the active substance montelukast sodium. Accordingly our indicators were: consumer price, social insurance subsidy, patients' co-payment and days of treatment (DOT). First the generics started from a significantly lower price of 18 USD which was lower than the price of brand-name Singulair (32 USD). Then the prices of the generics started to diminish. While in 2007 the DOT was below 2 million, it increased over 10 million days by 2014. The increase of DOT was followed by the increase of health insurance subsidy until 2011. Then the amount of health insurance subsidy decreased from 10,5 million USD to 7 million USD in 2012. In 2013 and 2014 there was a further reduction, the amount of the health insurance subsidy decreased to 4,1 million USD in 2013, and in 2014 it was reduced to 2.2 million USD. Following the introduction of generic drugs, the price of the medicaments containing montelukast sodium was significantly reduced, while the days on treatment (DOT) increased. The patients' access to drugs containing montelukast sodium increased significantly. The annual health insurance subsidy was significantly reduced as well.

  17. 76 FR 45814 - Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2012

    Science.gov (United States)

    2011-08-01

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

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

    Directory of Open Access Journals (Sweden)

    M L Maksimov

    2013-10-01

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

  19. The trials and tribulations of repurposing metformin and other generic drugs for tuberculosis.

    Science.gov (United States)

    Bloom, Bruce E

    2016-01-01

    There are a number of generic drugs that might be useful in treating tuberculosis, but will they ever get to the patients who need them? They might, but not without a lot of help. There are intellectual property issues, endpoint issues, cost of research issues, economic incentive issues, preclinical validation issues, "who is in charge" issues and many more. It is clear that repurposed generic drugs have the potential to make a safe, effective, quick and affordable impact on a global disease of poverty such as tuberculosis. But without the economic incentives that are usually in place for drug development, can we muster the scientific, economic and governmental support to bring them to the patients?

  20. 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.

  1. Biopharmaceutics classification system-based biowaivers for generic oncology drug products: case studies.

    Science.gov (United States)

    Tampal, Nilufer; Mandula, Haritha; Zhang, Hongling; Li, Bing V; Nguyen, Hoainhon; Conner, Dale P

    2015-02-01

    Establishing bioequivalence (BE) of drugs indicated to treat cancer poses special challenges. For ethical reasons, often, the studies need to be conducted in cancer patients rather than in healthy volunteers, especially when the drug is cytotoxic. The Biopharmaceutics Classification System (BCS) introduced by Amidon (1) and adopted by the FDA, presents opportunities to avoid conducting the bioequivalence studies in humans. This paper analyzes the application of the BCS approach by the generic pharmaceutical industry and the FDA to oncology drug products. To date, the FDA has granted BCS-based biowaivers for several drug products involving at least four different drug substances, used to treat cancer. Compared to in vivo BE studies, development of data to justify BCS waivers is considered somewhat easier, faster, and more cost effective. However, the FDA experience shows that the approval times for applications containing in vitro studies to support the BCS-based biowaivers are often as long as the applications containing in vivo BE studies, primarily because of inadequate information in the submissions. This paper deliberates some common causes for the delays in the approval of applications requesting BCS-based biowaivers for oncology drug products. Scientific considerations of conducting a non-BCS-based in vivo BE study for generic oncology drug products are also discussed. It is hoped that the information provided in our study would help the applicants to improve the quality of ANDA submissions in the future.

  2. 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

  3. Implementation of a reference-scaled average bioequivalence approach for highly variable generic drug products by the US Food and Drug Administration.

    Science.gov (United States)

    Davit, Barbara M; Chen, Mei-Ling; Conner, Dale P; Haidar, Sam H; Kim, Stephanie; Lee, Christina H; Lionberger, Robert A; Makhlouf, Fairouz T; Nwakama, Patrick E; Patel, Devvrat T; Schuirmann, Donald J; Yu, Lawrence X

    2012-12-01

    Highly variable (HV) drugs are defined as those for which within-subject variability (%CV) in bioequivalence (BE) measures is 30% or greater. Because of this high variability, studies designed to show whether generic HV drugs are bioequivalent to their corresponding HV reference drugs may need to enroll large numbers of subjects even when the products have no significant mean differences. To avoid unnecessary human testing, the US Food and Drug Administration's Office of Generic Drugs developed a reference-scaled average bioequivalence (RSABE) approach, whereby the BE acceptance limits are scaled to the variability of the reference product. For an acceptable RSABE study, an HV generic drug product must meet the scaled BE limit and a point estimate constraint. The approach has been implemented successfully. To date, the RSABE approach has supported four full approvals and one tentative approval of HV generic drug products.

  4. Comparative evaluation of adverse drug reaction reporting forms for introduction of a spontaneous generic ADR form

    Directory of Open Access Journals (Sweden)

    Anshi Singh

    2012-01-01

    Full Text Available Despite comprehensive and stringent phases of clinical trials and surveillance efforts, unexpected and serious adverse drug reactions (ADRs repeatedly occur after the drug is marketed. ADR reporting is an important aspect of an efficient and effective pharmacovigilance program. Although Medwatch, Yellow Card, CDSCO form, etc. are the protocol forms of ADR collection and reports, a number of countries design and use their respective ADR forms. This review compares similarities and dissimilarities of 13 ADR forms of countries representing their geographical location. This study extracted 73 data elements mentioned in 13 different ADR forms. Only 13 elements were common. An ADR form of Malaysia and Canada covers the highest number of data 43, while Brazil falls to the opposite end with a number of 17 data elements in lieu with the Generic ADR Form. The result of this review highlights 58 data elements of the proposed generic ADR form which ensures that requisite reporting information essential for correct causality assessment of ADRs are included. The proposed "Generic ADR form" could be adopted worldwide mandatorily for reporting any/all ADRs associated with marketed drugs.

  5. [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.

  6. 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 sys

  7. Low-cost generic drugs under the President's Emergency Plan for AIDS Relief drove down treatment cost; more are needed.

    Science.gov (United States)

    Venkatesh, Kartik K; Mayer, Kenneth H; Carpenter, Charles C J

    2012-07-01

    The President's Emergency Plan for AIDS Relief (PEPFAR) was originally authorized in 2003 with the goal of supporting HIV prevention, treatment, and care within fifteen focus countries in the developing world. By September 2011 nearly 13 million people around the world were receiving HIV/AIDS-related care through PEPFAR, and 3.9 million were receiving antiretroviral treatment. However, in the early years of the program, access to antiretroviral drugs was hampered by the lack of a licensing process that the US government recognized for generic versions of these medications. Ultimately, the obstacle to approval of generic antiretroviral drugs was removed, which led to PEPFAR's considerable success at making these treatments widely available. This article outlines PEPFAR's evolving use of generic antiretroviral drugs to treat HIV in the developing world, highlights ongoing initiatives to increase access to generic antiretrovirals, and points to the need for mechanisms that will speed up the approval of new generic drugs. The striking decline in antiretroviral treatment costs, from $1,100 per person annually in 2004 to $335 per person annually in 2012, is due to the availability of effective generic antiretrovirals. Given growing resistance to existing drugs and the planned expansion of treatment to millions more people, access to newer generations of generic antiretrovirals will have to be expedited.

  8. Generic drug exclusivity system in United States%美国的仿制药独占制度研究

    Institute of Scientific and Technical Information of China (English)

    杨莉; 袁红梅; 连桂玉

    2011-01-01

    [Abstract] Generic drug exclusivity is a unique form of administrative protection for pharmaceutical products in United States. This paper introduced the generic drug exclusivity system in detail, analyzed its legal nature, and objectively evaluated the effectiveness of generic drug exclusivity since its implementation. We propose the necessity and suggestion of establishing the generic drug exclusivity system in China.%仿制药独占制度是美国特有的一种药品行政保护形式.文中详细地介绍了美国的仿制药独占制度,对其法律性质进行了分析,客观评价了仿制药独占制度实施以来发挥的效用,并提出我国建立仿制药独占制度的必要性及建议.

  9. Modified Regulatory Pathways to Approve Generic Drugs in the US and a Systematic Review of Their Outcomes.

    Science.gov (United States)

    Kesselheim, Aaron S; Polinski, Jennifer M; Fulchino, Lisa A; Isaman, Danielle L; Gagne, Joshua J

    2015-04-01

    Generic drugs are approved on the basis of pharmaceutical equivalence and bioequivalence. Some drug products have unique structural or functional attributes, necessitating modified approaches to bioequivalence determinations. The aim of this systematic review was to identify studies that evaluated laboratory or clinical outcomes of six drugs approved via modified bioequivalence approaches. We conducted a systematic review of articles published through February 2014 in MEDLINE, EMBASE, and International Pharmaceutical Abstracts related to six recent drugs subject to modified regulatory approaches: venlafaxine extended release tablet (Effexor XR), acarbose (Precose), enoxaparin (Lovenox), vancomycin capsules (Vancocin), sodium ferric gluconate (Ferrlecit), and calcitonin salmon nasal spray (Miacalcin NS). We included all empirical evaluations (whether in vivo or in vitro) and excluded case studies, qualitative analyses, and pharmacoeconomic evaluations. Studies were summarized and evaluated on their methodological quality and assessed for bias using the Cochrane Risk of Bias Assessment Tool. Articles were divided into studies of US FDA-approved generics and non-FDA-approved generics available in non-US locations. We extracted drug(s) studied, study design, setting, sample size, population characteristics, study endpoints and results, and source of funding. After retrieving 1408 articles and searching through the full text of 106 articles, we found 26 articles that met our inclusion criteria-8 examining FDA-approved versions and 18 examining non-FDA-approved versions. Among FDA-approved generics, five studies of enoxaparin showed minor variations in biologic activities of unclear clinical importance, and no publications involved acarbose, venlafaxine ER, or vancomycin capsules. Among non-FDA-approved generics, nine studies of enoxaparin supported generic bioequivalence, despite three showing minor variations in drug activity. Four of six studies of venlafaxine ER

  10. Greek Physicians' Perceptions on Generic Drugs in the Era of Austerity.

    Science.gov (United States)

    Labiris, Georgios; Fanariotis, Michael; Kastanioti, Catherine; Alexias, Georgios; Protopapas, Adonis; Karampitsakos, Theodoros; Niakas, Dimitris

    2015-01-01

    Purpose. To assess the beliefs and preferences of Greek physicians, regarding generic drugs, in the years of financial crisis. Setting. Multicentered, nationwide survey. Material and Methods. A custom questionnaire based on former similar studies was developed and administered to Greek physicians. The variable "perception on generics" was constructed after an exploratory study and the instrument was validated by conventional and Rasch analysis methods. 22 items formed 5 subscales that constructed the variable in question. Results. 908 physicians successfully participated in the study (response rate: 80%). Mean total scores to the instrument were 60.63 ± 12.12 for men and significantly less (58.24 ± 11.73) for women (p = 0.04). Greek physicians were not persuaded on the potential economic gain (45.79 ± 10.53); moreover they identified that Greek authorities cannot address the increased pharmacovigilance mandates. Physicians working in Athens and those working in surgical units demonstrated significantly worse scores than their colleagues from the rest of Greece and those working in Internal Medicine wards (p = 0.03).  Conclusion. Our results suggest an overall poor acceptance of the national initiative on generic drugs by Greek physicians. This trial is registered with Clinicaltrials.gov identifier: NCT01855802.

  11. Taste acceptability of pulverized brand-name and generic drugs containing amlodipine or candesartan.

    Science.gov (United States)

    Uestuener, Peter; Ferrarini, Alessandra; Santi, Maristella; Mardegan, Chiara; Bianchetti, Mario G; Simonetti, Giacomo D; Milani, Gregorio P; Lava, Sebastiano A G

    2014-07-01

    Trials with pulverized brand-name antihypertensive drugs suggest that, from the perspective of taste acceptability, crushed candesartan, chlortalidon, hydrochlorothiazide, lercanidipine and lisinopril should be preferred to pulverized amlodipine, atenolol, bisoprolol, enalapril, irbesartan, losartan, ramipril, telmisartan and valsartan. Brand-name antihypertensive drugs and the corresponding generic medicines have never been compared with respect to their taste acceptability. We therefore investigated among healthy health care workers the taste acceptability of a pulverized 1 mg-test dose of the brand-name and two generics containing either the dihydropyridine calcium-channel blocker amlodipine (Norvasc(®), Amlodipin-Mepha(®) and Amlodipin Pfizer(®)) or the angiotensin receptor antagonist candesartan (Atacand(®), Cansartan-Mepha(®) and Pemzek(®)). For this purpose, a smiley-face scale depicting four degrees of pleasure was used. Between November and December 2013, the taste test was performed among 19 nurses (15 female and 4 male subjects) and 12 physicians (5 female and 7 male subjects) aged between 25 and 49 years. Pulverized brand-names and generics containing either amlodipine or candesartan did not differ with respect to their taste acceptability.

  12. International Guidelines for Bioequivalence of Systemically Available Orally Administered Generic Drug Products: A Survey of Similarities and Differences

    OpenAIRE

    Davit, Barbara; Braddy, April C.; Conner, Dale P.; Yu, Lawrence X.

    2013-01-01

    The objective of this article is to discuss the similarities and differences among bioequivalence approaches used by international regulatory authorities when reviewing applications for marketing new generic drug products which are systemically active and intended for oral administration. We focused on the 13 jurisdictions and organizations participating in the International Generic Drug Regulators Pilot. These are Australia, Brazil, Canada, China, Chinese Taipei, the European Medicines Assoc...

  13. Cost of treatment as a placebo effect in psychopharmacology: importance in the context of generic drugs.

    Science.gov (United States)

    Andrade, Chittaranjan

    2015-04-01

    Nonspecific factors have long been known in both psychotherapy and psychopharmacology. In recent years, 2 studies showed that placebo benefits were lower when the treated subjects were told that the placebo, presented as an active treatment, cost less. One of these studies had assessed motor and other outcomes in Parkinson disease patients; the other had assessed analgesia in paid, healthy volunteers to whom electric shocks were administered. The implication of the finding that lower treatment cost may diminish treatment gains is that patients who receive generic medicines may have lower expectations and may consequently derive less placebo-related benefit. This could be of concern in psychiatric disorders that are characterized by a large placebo response. Although the 2 "placebo cost" studies cannot be easily generalized to clinical and especially psychiatric contexts, clinicans should consider offering reassurance to patients receiving generic drugs that cost, per se, has no bearing on treatment-related benefit.

  14. VALUE OF THERAPEUTIC EQUIVALENCE IN SUBSTITUTION OF ORIGINAL DRUG WITH GENERIC BY EXAMPLE OF FOSINIPRIL

    Directory of Open Access Journals (Sweden)

    N. P. Kutishenko

    2011-01-01

    Full Text Available Aim. To study the therapeutic equivalence of original and generic fosinopril in patients with arterial hypertension (HT of 1-2 degrees, and to evaluate the cost effectiveness of original drug substitution with generic. Material and methods. Patients (n=36 with HT of 1-2 degree aged 41-82 years and disease duration up 3 to 22 years included in an open, crossover , randomized trial. All patients had two courses of treatment: with generic (Fosicard and the original drug (Monopril; sequence of courses was determined by randomization. Wash-out period (10-14 days preceded each course. Treatment duration was 6 weeks; drugs were administered QD; initial dose - 10 mg/day. Blood pressure (BP and heart rate (HR were evaluated at the end of the wash-out period, and in 2, 4 and 6 weeks of therapy. In case of ineffective BP control (>140/90 mm Hg hydrochlorothiazide 12.5 mg was added initially and dose fosinopril was increased up to 20 mg/day next. Results. Patients in groups were comparable by basic clinical parameters. Both fosinopril based drugs have comparable antihypertensive effect. Differences between their effect on systolic and diastolic BP as well as HR at all steps of treatment were not significant. The individual analysis revealed a tendency to more pronounced Monopril antihypertensive effect compared with Fosicard, but the differences were not significant. An average dose of Monopril was 11.8±3.9 mg/day , and Fosicard — 13.2±4.7 mg/day (p=0.13; the rate of monotherapy with both drugs of fosinopril at dose of 10 mg/day was similar (in 41% and 44% of patients, respectively; the rate of combined therapies with various composition differed insignificantly. Reduction in BP <140/90 mmHg was recorded at the end of the study in 29 (85.3% patients treated with Monorpil and in 27 (79.4% — Fosicard (p=0.52. Both drugs showed a good safety profile. Conclusion. Fosicard or its combination with hydrochlorothiazide is therapeutically equivalent to

  15. Generic - equivalent drugs use in internal and general medicine patients: distrust, confusion, lack of certainties or knowledge? Part 1. Pharmacological issues

    OpenAIRE

    Roberto Nardi; Marco Masina; Giorgio Cioni; Paolo Leandri; Paola Zuccheri

    2014-01-01

    Despite compelling evidence and guidelines, in Italy, generic/equivalent drugs are still underused. The failure to adopt existing generic drugs may result into a missed opportunity to further reduce healthcare costs. Equivalent drugs are approved based on data deriving from bioequivalence studies. In the first part of the article, the concepts of generic/equivalent drugs are defined, emphasizing the differences between pharmaceutical equivalence, therapeutic equivalence, bioequivalence and bi...

  16. Main Reasons for Registration Application Refusal of Generic and Similar Pharmaceutical Drug Products by the Brazilian Health Regulatory Agency (ANVISA)

    Science.gov (United States)

    do Carmo, Ana Cerúlia Moraes; Piras, Stefânia Schimaneski; Rocha, Nayrton Flávio Moura

    2017-01-01

    Objective. The marketing authorization of generic and similar pharmaceutical drug products involves the analysis of proposing company's administrative aspects as well as drug product technical description and scientific evaluations. This study evaluated the main reasons for registration refusal of generic and similar pharmaceutical drug products in Brazil. The aim is to help future applicants to better organize the proposal. Methods. A retrospective search of drug products registration processes was performed on the Brazilian Government Official Gazette from January 1, 2015, and December 31, 2015. Results. Drug product quality control, drug product stability study, deadline accomplishment, API quality control made by drug manufacturer, active pharmaceutical ingredient (API), and production report were the main reasons for marketing authorization application refusal of generic and similar pharmaceutical drug products in 2015. Conclusion. Disclosure of the reasons behind failed applications is a step forward on regulatory transparency. Sharing of experiences is essential to international regulatory authorities and organizations to improve legislation requirements for the marketing authorization of generic and similar pharmaceutical drug products. PMID:28280742

  17. Main Reasons for Registration Application Refusal of Generic and Similar Pharmaceutical Drug Products by the Brazilian Health Regulatory Agency (ANVISA).

    Science.gov (United States)

    do Carmo, Ana Cerúlia Moraes; Piras, Stefânia Schimaneski; Rocha, Nayrton Flávio Moura; Gratieri, Tais

    2017-01-01

    Objective. The marketing authorization of generic and similar pharmaceutical drug products involves the analysis of proposing company's administrative aspects as well as drug product technical description and scientific evaluations. This study evaluated the main reasons for registration refusal of generic and similar pharmaceutical drug products in Brazil. The aim is to help future applicants to better organize the proposal. Methods. A retrospective search of drug products registration processes was performed on the Brazilian Government Official Gazette from January 1, 2015, and December 31, 2015. Results. Drug product quality control, drug product stability study, deadline accomplishment, API quality control made by drug manufacturer, active pharmaceutical ingredient (API), and production report were the main reasons for marketing authorization application refusal of generic and similar pharmaceutical drug products in 2015. Conclusion. Disclosure of the reasons behind failed applications is a step forward on regulatory transparency. Sharing of experiences is essential to international regulatory authorities and organizations to improve legislation requirements for the marketing authorization of generic and similar pharmaceutical drug products.

  18. 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…

  19. Greek Physicians’ Perceptions on Generic Drugs in the Era of Austerity

    Directory of Open Access Journals (Sweden)

    Georgios Labiris

    2015-01-01

    Full Text Available Purpose. To assess the beliefs and preferences of Greek physicians, regarding generic drugs, in the years of financial crisis. Setting. Multicentered, nationwide survey. Material and Methods. A custom questionnaire based on former similar studies was developed and administered to Greek physicians. The variable “perception on generics” was constructed after an exploratory study and the instrument was validated by conventional and Rasch analysis methods. 22 items formed 5 subscales that constructed the variable in question. Results. 908 physicians successfully participated in the study (response rate: 80%. Mean total scores to the instrument were 60.63 ± 12.12 for men and significantly less (58.24 ± 11.73 for women (p = 0.04. Greek physicians were not persuaded on the potential economic gain (45.79 ± 10.53; moreover they identified that Greek authorities cannot address the increased pharmacovigilance mandates. Physicians working in Athens and those working in surgical units demonstrated significantly worse scores than their colleagues from the rest of Greece and those working in Internal Medicine wards (p = 0.03.  Conclusion. Our results suggest an overall poor acceptance of the national initiative on generic drugs by Greek physicians. This trial is registered with Clinicaltrials.gov identifier: NCT01855802.

  20. Potential to enhance the prescribing of generic drugs in patients with mental health problems in Austria; implications for the future

    Directory of Open Access Journals (Sweden)

    Brian eGodman

    2013-01-01

    Full Text Available Introduction: Scrutiny over pharmaceutical expenditure is increasing leading to multiple reforms. This includes Austria with measures to lower generic prices and enhance their utilisation. However the situation for newer antidepressants and atypical antipsychotic drugs (AAPs is different to PPIs, statins and renin-angiotensin drugs with greater tailoring of therapy and no wish to switch products in stable patients. Authorities welcome generics though given high costs particularly of patented AAPs. Objective: Assess (a changes in utilisation of venlafaxine versus other newer anti-depressants before and after availability of generics, (b utilisation of generic versus originator venlafaxine, (c price reductions of venlafaxine over time and influence on total expenditure, (d utilisation of risperidone versus other AAPs, (e suggest potential additional reforms that could be introduced if pertinent. Methodology: A quasi-experimental study design with a segmented time series and an observational study. Utilisation measured in defined daily doses (DDDs and total expenditure per DDD and over time. Results: No appreciable changes in the utilization patterns of venlafaxine and risperidone after generics. The reduction in expenditure/ DDD for venlafaxine decreased overall expenditure on antidepressants by 5% by the end of the study versus just before generics despite a 37% increase in utilization. Expenditure will further decrease if there was reduced prescribing of duloxetine. Conclusion: Depression, schizophrenia and bipolar diseases are complex diseases. As a result, specific measures are needed to encourage prescribing of generic risperidone and venlafaxine when multiple choices are appropriate, and authorities cannot rely on a ´Hawthorne´ effect between classes to enhance use of generics first line. Measures may include prescribing restrictions for duloxetine. No specific measures planned for AAPs with more generics becoming available.

  1. A Bioequivalence Approach for Generic Narrow Therapeutic Index Drugs: Evaluation of the Reference-Scaled Approach and Variability Comparison Criterion

    OpenAIRE

    Jiang, Wenlei; Makhlouf, Fairouz; Schuirmann, Donald J.; Zhang, Xinyuan; Zheng, Nan; Conner, Dale; Yu, Lawrence X.; Lionberger, Robert

    2015-01-01

    Various health communities have expressed concerns regarding whether average bioequivalence (BE) limits (80.00–125.00%) for the 90% confidence interval of the test-to-reference geometric mean ratio are sufficient to ensure therapeutic equivalence between a generic narrow therapeutic index (NTI) drug and its reference listed drug (RLD). Simulations were conducted to investigate the impact of different BE approaches for NTI drugs on study power, including (1) direct tightening of average BE lim...

  2. Clinical pharmacology of tyrosine kinase inhibitors becoming generic drugs: the regulatory perspective.

    Science.gov (United States)

    Eckstein, Niels; Röper, Lea; Haas, Bodo; Potthast, Henrike; Hermes, Ulrike; Unkrig, Christoph; Naumann-Winter, Frauke; Enzmann, Harald

    2014-02-07

    Over the last decades, billions have been spent and huge efforts have been taken in basic and clinical cancer research [CA Cancer J Clin63:11-30]. About a decade ago, the arms race between drugs and cancer cells reached a new level by introduction of tyrosine kinase inhibitors (TKI) into pharmacological anti-cancer therapy. According to their molecular mechanism of action, TKI in contrast to so-called "classic" or "conventional" cytostatics belong to the group of targeted cancer medicines, characterized by accurately fitting with biological structures (i.e. active centers of kinases). Numerous (partly orphan) indications are covered by this new class of substances. Approximately ten years after the first substances of this class of medicines were authorized, patent protection will end within the next years. The following article covers clinical meaning and regulatory status of anti-cancer TKI and gives an outlook to what is expected from the introduction of generic anti-cancer TKI.

  3. 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.

  4. Generic - equivalent drugs use in internal and general medicine patients: distrust, confusion, lack of certainties or knowledge? Part 1. Pharmacological issues

    Directory of Open Access Journals (Sweden)

    Roberto Nardi

    2014-05-01

    Full Text Available Despite compelling evidence and guidelines, in Italy, generic/equivalent drugs are still underused. The failure to adopt existing generic drugs may result into a missed opportunity to further reduce healthcare costs. Equivalent drugs are approved based on data deriving from bioequivalence studies. In the first part of the article, the concepts of generic/equivalent drugs are defined, emphasizing the differences between pharmaceutical equivalence, therapeutic equivalence, bioequivalence and bioavailability. A summary of the methods adopted to define bioequivalence (pharmacokinetic studies; pharmacodynamic studies; comparative clinical trials; in vitro studies is also included.

  5. [Switching to a generic drugA blessing or a curse?

    NARCIS (Netherlands)

    Ebbelaar, C.F.; Lammers, H.A.; Schobben, A.F.

    2016-01-01

    A patient suffering from Zollinger-Ellison was treated with Nexium, but after patent expiry only the costs of generic omeprazol were reimbursed. Generic tablets and capsules, pantoprazol and rabeprazol, were tried without success and finally the pharmacist dispensed Nexium at his own expense. Regist

  6. International guidelines for bioequivalence of systemically available orally administered generic drug products: a survey of similarities and differences.

    Science.gov (United States)

    Davit, Barbara; Braddy, April C; Conner, Dale P; Yu, Lawrence X

    2013-10-01

    The objective of this article is to discuss the similarities and differences among bioequivalence approaches used by international regulatory authorities when reviewing applications for marketing new generic drug products which are systemically active and intended for oral administration. We focused on the 13 jurisdictions and organizations participating in the International Generic Drug Regulators Pilot. These are Australia, Brazil, Canada, China, Chinese Taipei, the European Medicines Association, Japan, Mexico, Singapore, South Korea, Switzerland, the USA, and the World Health Organization. We began with a comparison of how the various jurisdictions and organizations define a generic product and its corresponding reference product. We then compared the following bioequivalence approaches: recommended bioequivalence study designs, method of pharmacokinetic calculations and bioequivalence acceptance limits, recommendations for modifying bioequivalence study designs and limits for highly variable drugs and narrow therapeutic index drugs, provisions for waiving bioequivalence study requirements (granting biowaivers), and implementation of the Biopharmaceutics Classification System. We observed that, overall, there are more similarities than differences in bioequivalence approaches among the regulatory authorities surveyed.

  7. 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

  8. Meta-analysis for bioequivalence studies: interchangeability of generic drugs and similar containing Hydrochlorothiazide is possible but not with Enalapril Maleate.

    Science.gov (United States)

    Lopes, Renato Almeida; Neves, Francisco de Assis Rocha

    2010-01-01

    The generic drugs program provided a better population's access to medicines. To ensure interchangeability between a brand-name and generic or similar drugs is necessary that they are bioequivalent. With the growing number of generic drugs, it is common for patients to replace a generic to another or one similar. However, this exchange can not guarantee the maintenance of bioequivalence. To evaluate the safety interchangeability between different generic and similar drugs with Hydrochlorothiazide and Enalapril Maleate, a meta-analysis was carried out with several bioequivalence studies with these drugs. Data from bioequivalence of generic and similar drugs approved by the National Health Surveillance Agency (Anvisa) (drug regulatory agency in Brazil) were used. The compatibility of data from each study was analyzed and the determination of a confidence interval for the differences between the means of pharmacokinetic parameters, area under the curve (ASC0-t) and maximum plasma concentration (Cmax), was made for each study by meta-analysis. The interchangeability between the combinations of the three products with Hydrochlorothiazide was confirmed based on the obtained confidence intervals. For the drugs studied with Enalapril Maleate interchangeability has not been confirmed for 50% of the product comparisons. The exchange was established between the three products with hydrochlorothiazide. However, for the Enalapril Maleate half of the products studied are not interchangeable, considering they do not match the established intervals for bioequivalence tests, so the pharmacokinetics behavior and thus the effectiveness of the product may be changed.

  9. Regulatory Considerations for Approval of Generic Inhalation Drug Products in the US, EU, Brazil, China, and India.

    Science.gov (United States)

    Lee, Sau L; Saluja, Bhawana; García-Arieta, Alfredo; Santos, Gustavo Mendes Lima; Li, Ying; Lu, Sarah; Hou, Shuguang; Rebello, Juliet; Vaidya, Abhijit; Gogtay, Jaideep; Purandare, Shrinivas; Lyapustina, Svetlana

    2015-09-01

    This article describes regulatory approaches for approval of "generic" orally inhaled drug products (OIDPs) in the United States, European Union, Brazil, China and India. While registration of a generic OIDP in any given market may require some documentation of the formulation and device similarity to the "original" product as well as comparative testing of in vitro characteristics and in vivo performance, the specific documentation approaches, tests and acceptance criteria vary by the country. This divergence is due to several factors, including unique cultural, historical, legal and economic circumstances of each region; the diverse healthcare and regulatory systems; the different definitions of key terms such as "generic" and "reference" drug; the acknowledged absence of in vitro in vivo correlations for OIDPs; and the scientific and statistical issues related to OIDP testing (such as how best to account for the batch-to-batch variability of the Reference product, whether to use average bioequivalence or population bioequivalence in the statistical analysis of results, whether to use healthy volunteers or patients for pharmacokinetic studies, and which pharmacodynamic or clinical end-points should be used). As a result of this discrepancy, there are ample opportunities for the regulatory and scientific communities around the world to collaborate in developing more consistent, better aligned, science-based approaches. Moving in that direction will require both further research and further open discussion of the pros and cons of various approaches.

  10. 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.

  11. 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.

  12. A Bioequivalence Approach for Generic Narrow Therapeutic Index Drugs: Evaluation of the Reference-Scaled Approach and Variability Comparison Criterion.

    Science.gov (United States)

    Jiang, Wenlei; Makhlouf, Fairouz; Schuirmann, Donald J; Zhang, Xinyuan; Zheng, Nan; Conner, Dale; Yu, Lawrence X; Lionberger, Robert

    2015-07-01

    Various health communities have expressed concerns regarding whether average bioequivalence (BE) limits (80.00-125.00%) for the 90% confidence interval of the test-to-reference geometric mean ratio are sufficient to ensure therapeutic equivalence between a generic narrow therapeutic index (NTI) drug and its reference listed drug (RLD). Simulations were conducted to investigate the impact of different BE approaches for NTI drugs on study power, including (1) direct tightening of average BE limits and (2) a scaled average BE approach where BE limits are tightened based on the RLD's within-subject variability. Addition of a variability comparison (using a one-tailed F test) increased the difficulty for generic NTIs more variable than their corresponding RLDs to demonstrate bioequivalence. Based on these results, the authors evaluate the fully replicated, 2-sequence, 2-treatment, 4-period crossover study design for NTI drugs where the test product demonstrates BE based on a scaled average bioequivalence criterion and a within-subject variability comparison criterion.

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

    Science.gov (United States)

    Kesselheim, Aaron S; Gagne, Joshua J

    2015-10-01

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

  14. The influences of Taiwan's generic grouping price policy on drug prices and expenditures: evidence from analysing the consumption of the three most-used classes of cardiovascular drugs.

    Science.gov (United States)

    Chen, Chi-Liang; Chen, Likwang; Yang, Wei-Chih

    2008-04-12

    Controlling the growth of pharmaceutical expenditures is a major global challenge. Promotion of generic drug prescriptions or use is gaining increased support. There are substantial contextual differences in international experiences of implementing pharmaceutical policies related to generic drugs. Reporting these experiences from varied perspectives can inform future policy making. This study describes an experience of Taiwan, where patients with chronic (long-term) conditions are usually managed in hospitals and drugs are provided in this setting with costs reimbursed through the National Health Insurance (NHI). It investigates the effects of Taiwan's reimbursement rate adjustment based on chemical generic grouping in 2001. This research also demonstrates the use of micro-level longitudinal data to generate policy-relevant information. The research can be used to improve efficiency of health care resource use. We chose the three most-used classes of cardiovascular drugs for this investigation: beta blocking agents, calcium channel blockers mainly with vascular effects, and plain ACE inhibitors. For each drug class, we investigated changes in daily expense, consumption volume, and total expenditures from a pre-action period to a corresponding post-action period. We compared an exposure or "intervention" group of patients targeted by the action with a comparisonor "control" group of patients not targeted by the action. The data sources are a longitudinal database for 200,000 NHI enrolees, corresponding NHI registration data of health care facilities, and an archive recording all historical data on the reimbursement rates of drugs covered by the NHI. We adopted a fixed effects linear regression model to control for unobserved heterogeneity among patient-hospital groups. Additional descriptive statistics were applied to examine whether any inappropriate consumption of drugs in the three classes existed. The daily drug expense significantly decreased from the pre

  15. The influences of Taiwan's generic grouping price policy on drug prices and expenditures: Evidence from analysing the consumption of the three most-used classes of cardiovascular drugs

    Directory of Open Access Journals (Sweden)

    Chen Likwang

    2008-04-01

    Full Text Available Abstract Background Controlling the growth of pharmaceutical expenditures is a major global challenge. Promotion of generic drug prescriptions or use is gaining increased support. There are substantial contextual differences in international experiences of implementing pharmaceutical policies related to generic drugs. Reporting these experiences from varied perspectives can inform future policy making. This study describes an experience of Taiwan, where patients with chronic (long-term conditions are usually managed in hospitals and drugs are provided in this setting with costs reimbursed through the National Health Insurance (NHI. It investigates the effects of Taiwan's reimbursement rate adjustment based on chemical generic grouping in 2001. This research also demonstrates the use of micro-level longitudinal data to generate policy-relevant information. The research can be used to improve efficiency of health care resource use. Methods We chose the three most-used classes of cardiovascular drugs for this investigation: beta blocking agents, calcium channel blockers mainly with vascular effects, and plain ACE inhibitors. For each drug class, we investigated changes in daily expense, consumption volume, and total expenditures from a pre-action period to a corresponding post-action period. We compared an exposure or "intervention" group of patients targeted by the action with a comparisonor "control" group of patients not targeted by the action. The data sources are a longitudinal database for 200,000 NHI enrolees, corresponding NHI registration data of health care facilities, and an archive recording all historical data on the reimbursement rates of drugs covered by the NHI. We adopted a fixed effects linear regression model to control for unobserved heterogeneity among patient-hospital groups. Additional descriptive statistics were applied to examine whether any inappropriate consumption of drugs in the three classes existed. Results The daily

  16. Medicamentos genéricos: uma alternativa para o mercado brasileiro Generic drugs: an alternative for the Brazilian market

    Directory of Open Access Journals (Sweden)

    Jorge Bermudez

    1994-09-01

    Full Text Available A análise das características da indústria farmacêutica no mundo e os aspectos mercadológicos desse segmento no Brasil deixam evidentes a dependência externa e a oligopolização, com predomínio de empresas de caráter mutinacional, refletindo uma tendência mundial. As iniciativas governamentais recentes no Brasil, com o objetivo de diminuir essa dependência, aliadas à gravidade da questão dos preços e custos de medicamentos no Brasil, comparados a preços mundiais, fundamentam a proposta de avaliar os medicamentos genéricos como uma alternativa viável para o mercado brasileiro. Um dos aspectos mais alarmantes é a verificação do superfaturamento de matérias-primas evidenciada pelos denominados "preços de transferência", prática constatada em diversos países. Analisando os conceitos internacionais sobre medicamentos genéricos, denominação genérica e equivalência farmacêutica, com base ainda em recomendações da Organização Mundial da Saúde e avaliando as experiências de diversos países, são propostas uma série de medidas destinadas a implementar, gradativamente, uma política de medicamentos genéricos bioequivalentes e intercambiáveis como um dos mecanismos de regulação do mercado brasileiro.The analysis of the main characteristics of the pharmaceutical industry worldwide and market aspects of that industry in Brazil leads us to consider a high share of external dependency and oligopolization. This situation is not peculiar to our country, but is rather a global trend. Recent Government initiatives in Brazil, aiming at reducing that dependency, associated with the critical aspects regarding the prices and costs of drugs as compared to international prices, are the background that support the proposal of evaluating generic drugs as an alternative for Brazilian market. One of the most striking aspect is the verification of overpricing of raw materials as demonstrated by "transfer prices", a practice that has

  17. 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.

  18. ElectroSpark Deposition

    Science.gov (United States)

    2007-01-25

    ElectroSpark Deposition Hard Chrome Alternatives Team Joint Cadmium Alternatives Team Canadian Hard Chrome Alternatives Team Joint Group on Pollution...00-2007 to 00-00-2007 4. TITLE AND SUBTITLE ElectroSpark Deposition 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S...Processes, Inc. ElectroSpark Deposition (ESD) Results of Materials Testing and Technology Insertion January 25, 2007 Advanced Surfaces And Processes, Inc. 3

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

    OpenAIRE

    PARTRIDGE, MICHAEL A.; Shobha Purushothama; Chinnasamy Elango; Yanmei Lu

    2016-01-01

    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, a...

  20. Generic - equivalent drugs use in internal and general medicine patients: distrust, confusion, lack of certainties or of knowledge? Part 2. Misconceptions, doubts and critical aspects when using generic drugs in the real world

    Directory of Open Access Journals (Sweden)

    Roberto Nardi

    2014-05-01

    Full Text Available A lot of issues have been raised to argue that equivalent drugs may not work as well or at least the same as what the drug industry likes to call innovator products. Many doubts and biases are also reported in connection with the use of generic drugs. Doctors are mostly concerned about their efficacy, their tolerability, the quality and amount of active ingredients, their formulation or excipients, their packaging, their pharmaceutical form and their palatability. We describe the differences between prescribability (equivalence when prescribing a drug to a patient for the first time and switchability (interchangeability of drugs for a patient already in treatment considering the notions of average bioequivalence, population bioequivalence and individual bioequivalence as well as the usefulness of the U.S. Orange Book in the assessment of bioequivalence. Other key issues deserve attention, such as: duplicate applications for medicinal products, different salt forms, formulations used in the development of each medicinal product and excipients, product quality. Clinicians in collaboration with pharmacists and research pharmacologists have to find solutions for unanswered questions and unsolved doubts, by developing targeted studies, communication tools and shared guidelines.

  1. 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?

  2. Representações sociais do medicamento genérico por usuários Social representations of the generic drug by drug users

    Directory of Open Access Journals (Sweden)

    Maria Cleide Ribeiro Dantas de Carvalho

    2006-12-01

    Full Text Available O artigo objetivou captar as representações sociais do medicamento genérico por usuários de medicamentos no intuito de que seus resultados possam ser utilizados no aprimoramento da política desse tipo de medicamento no Brasil. Utilizou-se a Teoria das Representações Sociais como suporte teórico-metodológico. A pesquisa foi realizada no período de abril de 2002 a fevereiro de 2003, na cidade do Natal/RN, com 116 usuários de medicamentos, abordados em farmácias e/ou drogarias. O instrumento de coleta de dados foi a entrevista semi-estruturada, com uso de gravador. Os dados foram avaliados através do programa ALCESTE 4.5, além da análise de conteúdo preconizada por Laurence Bardin. O ALCESTE isolou 5 classes semânticas e a análise de conteúdo identificou 10 categorias. Para os usuários, o genérico representa um medicamento comercializado a preço mais barato, sem marca, equivalente a outro mais caro, mas que supre as necessidades imediatas de consumo, além do que a palavra genérico encerra uma representação mais ampla, absorvendo e englobado quaisquer produtos que tenham a característica dos medicamentos genéricos, porém com qualidade duvidosa.The paper aimed to apprehend the social representations of the generic drug by drug users, establishing mechanisms that could be used to improve the policy of this type of medicines in Brazil. The Theory of Social Representations was employed as theoretic-methodological support. The research was done from April, 2002 through February, 2003 in the city of Natal/RN with 116 drug users approached at pharmacies and/or drugstores. The instrument of data collection was a semistructured interview with a tape recorder. The data analysis was performed with the aid of both the ALCESTE 4.5 program and the content analysis recommended by Laurence Bardin. The ALCESTE isolated 5 semantic classes and the content analysis identified 10 categories. For users the generic drug stands for a medicine

  3. 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.

  4. Spark-hdf5

    Energy Technology Data Exchange (ETDEWEB)

    2016-07-05

    The spark-hdf5 package is an extension to the Apache Spark program to allow native access to HDF5 files. It allows users to query the structured files using SQL-like syntax, and can parallelize large queries across several workers.

  5. 78 FR 27113 - Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives Public Hearing; Request...

    Science.gov (United States)

    2013-05-09

    ... FY 2013 Regulatory Science Plan consisted of the following research topics: 1. Bioequivalence of local acting, orally inhaled drug products 2. Bioequivalence of local acting topical dermatological drug products 3. Bioequivalence of local acting gastrointestinal drug products 4. Quality by design of...

  6. Strategy for development of generic drug superstars in China%发展我国仿制药大品种的对策

    Institute of Scientific and Technical Information of China (English)

    苏伟萍; 宋瑞霖; 王一涛; 史录文

    2011-01-01

    培养仿制药大品种是振兴民族制药企业的可行途径之一.文中通过分析印度和美国仿制药行业发展壮大的过程和原因,探讨发展我国仿制药大品种的对策,提出塑造仿制药大品种需要的支持政策,包括影响仿制药质量和疗效的监管认证程序,以及在供销环节对企业的鼓励政策.%Developing our own generic drug superstars is one of the ways to vitalize our national pharmaceutical industry. After a systematic analysis of the success of Indian and American generic drug industries, we concluded a development model of generic drug superstars. Besides, we brought up several major policies for the development of our own generic drug superstars, including the supervision policy on drug quality and drug clinical outcomes, and the encouragement policy on drug supply and sales.

  7. Comparison of the Effects of a Brand-name Drug and Its Generic Drug on the Quality of Life of Alzheimer's Disease Patients.

    Science.gov (United States)

    Sakakibara, Mikio; Kido, Mitsuhiko; Kuribayashi, Jun; Okada, Hiroshi; Igarashi, Ataru; Kamei, Hiroyuki; Nabeshima, Toshitaka

    2015-08-31

    The pharmacological effects of generic (GE) donepezil are the same as Aricept, its brand-name counterpart. However, little is known as to whether these two drugs provide the same quality of life (QOL). The study subjects were patients with Alzheimer's disease who were taking donepezil hydrochloride tablets, and were selected by visiting either the local pharmacies or the patients' homes. We chose the brand-name drug Aricept and its GE form donepezil to investigate, from a long-term caregiver's perspective, the influence of both drugs on the patients' QOL. An EuroQol-5 Dimension (EQ-5D) was used to assess the QOL of patients with Alzheimer's disease, before and after various Aricept and/or donepezil regimens. Patients were divided into four groups: first time users of Aricept (n=43), first time users of GE donepezil (n=45), users refilling previous prescriptions of Aricept (n=51), and users switching from Aricept to GE donepezil (n=51). The average change in the EQ-5D utility indices rose significantly in the patients starting a new regimen of Aricept and its GE drug. The patients continuing an existing regimen of Aricept showed no significant differences, even after Aricept was switched to a GE drug. The QOL of patients starting a new regimen of Aricept and its GE drug improved. The QOL was maintained upon switching to the GE drug form.

  8. 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...

  9. SPARK Peer Helper Program, 1993-94. OER Report.

    Science.gov (United States)

    Goldberg, Phyllis

    The Peer Helper Program was administered by Substance Prevention, Abuse Rehabilitation, and Knowledge (SPARK). Since its beginning in 1971, SPARK has addressed issues such as drug use, teenage pregnancy, HIV/AIDS, sexual abuse and other forms of violence. The Peer Helper Program was designed to train students in the skills required to assist peers…

  10. Life and death of a cardiac calcium spark.

    Science.gov (United States)

    Stern, Michael D; Ríos, Eduardo; Maltsev, Victor A

    2013-09-01

    Calcium sparks in cardiac myocytes are brief, localized calcium releases from the sarcoplasmic reticulum (SR) believed to be caused by locally regenerative calcium-induced calcium release (CICR) via couplons, clusters of ryanodine receptors (RyRs). How such regeneration is terminated is uncertain. We performed numerical simulations of an idealized stochastic model of spark production, assuming a RyR gating scheme with only two states (open and closed). Local depletion of calcium in the SR was inevitable during a spark, and this could terminate sparks by interrupting CICR, with or without assumed modulation of RyR gating by SR lumenal calcium. Spark termination by local SR depletion was not robust: under some conditions, sparks could be greatly and variably prolonged, terminating by stochastic attrition-a phenomenon we dub "spark metastability." Spark fluorescence rise time was not a good surrogate for the duration of calcium release. Using a highly simplified, deterministic model of the dynamics of a couplon, we show that spark metastability depends on the kinetic relationship of RyR gating and junctional SR refilling rates. The conditions for spark metastability resemble those produced by known mutations of RyR2 and CASQ2 that cause life-threatening triggered arrhythmias, and spark metastability may be mitigated by altering the kinetics of the RyR in a manner similar to the effects of drugs known to prevent those arrhythmias. The model was unable to explain the distributions of spark amplitudes and rise times seen in chemically skinned cat atrial myocytes, suggesting that such sparks may be more complex events involving heterogeneity of couplons or local propagation among sub-clusters of RyRs.

  11. SparkJet Efficiency

    Science.gov (United States)

    Golbabaei-Asl, Mona; Knight, Doyle; Anderson, Kellie; Wilkinson, Stephen

    2013-01-01

    A novel method for determining the thermal efficiency of the SparkJet is proposed. A SparkJet is attached to the end of a pendulum. The motion of the pendulum subsequent to a single spark discharge is measured using a laser displacement sensor. The measured displacement vs time is compared with the predictions of a theoretical perfect gas model to estimate the fraction of the spark discharge energy which results in heating the gas (i.e., increasing the translational-rotational temperature). The results from multiple runs for different capacitances of c = 3, 5, 10, 20, and 40 micro-F show that the thermal efficiency decreases with higher capacitive discharges.

  12. 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.

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

    Science.gov (United States)

    Newe, Axel

    2016-01-01

    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.

  14. Improved therapeutic entities derived from known generics as an unexplored source of innovative drug products.

    Science.gov (United States)

    Stegemann, Sven; Klebovich, Imre; Antal, István; Blume, Henning H; Magyar, Kálmán; Németh, György; Paál, Tamás L; Stumptner, Willibald; Thaler, György; Van de Putte, Armand; Shah, Vinod P

    2011-11-20

    With a New Drug Application (NDA) innovative drug therapies are reaching the market in a specific dosage form for one or more clinically proven indications of which after expiration of the patent or the data exclusivity copies are launched using Abbreviated New Drug Applications (ANDA). Advanced therapies that emerged from launched molecules during their product life-cycle have gained considerable attention as clinical practice provides evidence for additional therapeutic values, patient centric delivery systems show improved therapeutic outcomes or emerging technologies offer efficiency gains in manufacturing or access to emerging markets. The USA and European regulatory framework has set reasonable regulations in place for these "Supergenerics" or "hybrid" applications. While these regulations are relatively recent the pharmaceutical industry is just starting to use this route for their product development and life-cycle management. From a clinical perspective the potential for advanced product development have been demonstrated. Yet, there is still a lag of common understanding between the different stakeholders regarding the development, application process and commercial incentive in developing enhanced therapeutic entities based on existing drug products for the market.

  15. 77 FR 45629 - Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2013

    Science.gov (United States)

    2012-08-01

    ... FDA's Center for Veterinary Medicine. FDA records the official abbreviated application receipt date as...AGDUFA/default.htm or contact Lisa Kable, Center for Veterinary Medicine (HFV- 10), Food and Drug... the Center for Veterinary Medicine (CVM) at: cvmagdufa@fda.hhs.gov . SUPPLEMENTARY INFORMATION:...

  16. 中国仿制药品牌战略研究%Branding Strategy Research on China's Generic Drugs

    Institute of Scientific and Technical Information of China (English)

    张楠; 张露; 王一涛

    2012-01-01

    药物的品牌管理在制药行业中扮演着越来越重要的角色.作为后起者,中国仿制药想要争取更大的市场空间,必须积极开展品牌战略.合理利用自身资源和外部机会,采用模仿、挑战或借机战略,才是后起仿制药品牌在与原研药品牌的博弈中取胜的关键.%Brand management is an increasingly important business strategy in pharmaceutical industry. In order to gain greater market space, Chinese generic drugs, the newcomers and followers, must positively develop their branding strategies. Fully utilization of both inner resources and outer opportunities, and employment of imitation, challenging or opportunity - grabbing strategies, is the key to success in the game with original drug brands.

  17. [Prescribing and dispensing generic drugs in the Mambéré-Kadéï health district of the Central African Republic].

    Science.gov (United States)

    Mouala, C; Abeye, J; Somse, P; Maritoux, J; Goumba, A

    2008-04-01

    Good drug prescription and distribution practices are pre-requisites for rational use of essential generic medications. However few studies have been conducted on this topic in sub-Saharan Africa especially in rural areas. The purpose of this study in the Mambéré-Kadei health district of the Central African Republic was to evaluate drug use patterns with special attention to prescribing and dispensing, as a basis for assisting policy makers in planning and identifying intervention strategies. The transverse descriptive survey was undertaken in 14 public health facilities in the Mambéré-Kadéï health district. Data were collected by interviewing care providers and patients immediately after consultation and at the exit of the dispensary. The indicators recommended by the World Health Organization (WHO) for investigating drug use patterns in Communities were used for data collection. A total of 512 prescriptions were analysed. The average number of drugs prescribed per consultation was 3.5. Most drugs (68.6%) were prescribed by generic name. Antibiotic use (31.4% of consultations) was frequent and 29% of patients received injections. 82.1% of the drugs were compliant with the national essential drug list. The distribution survey showed that 79.46% of prescriptions were completely filled. No serious distribution errors occurred but 21.5% of the dispensed drugs were inadequately labelled. Patients understood the modalities of use for 69.6% of prescribed drugs. The average consultation and distribution times were 8.3 and 5 minutes respectively. Excessive use of antibiotics and injections and blunderbuss therapy is still observed in Mambéré-Kadei. Many drugs not included on the essential drug list and non-generics are prescribed. Other prescription and distribution problems identified in this survey include poor information on drug use, inadequate labelling of dispensed drugs, and lack of access to standard drug use tools such as a locally adapted essential drug

  18. [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

  19. Reforms and initiatives in Scotland in recent years to encourage the prescribing of generic drugs, their influence and implications for other countries.

    Science.gov (United States)

    Godman, Brian; Bishop, Iain; Finlayson, Alexander E; Campbell, Stephen; Kwon, Hye-Young; Bennie, Marion

    2013-08-01

    Scotland has introduced a number of initiatives to enhance the prescribing of low-cost generic drugs versus originators and patent products in a class where these are seen as similar. The objective of this review is to appraise the influence of the various measures on subsequent utilization patterns and expenditure in high-volume classes to provide guidance. This review is principally a narrative review of published studies. The authors' found supply-side measures resulted in generic prices as low as 3% of pre-patent loss prices. Multiple demand-side measures resulted in high international non-proprietary name prescribing, and a considerable increase in prescribing efficiency for the proton pump inhibitors, statins, renin-angiotensin inhibitor drugs and selective serotonin reuptake inhibitors. There were no specific activities encouraging the prescription of losartan versus other angiotensin receptor blockers or risperidone versus other atypical antipsychotic drugs following generics and no change in their utilization patterns post generics. The authors can conclude multiple measures are needed to change physician prescribing habits. Authorities cannot rely on any 'spillover' effects to affect future prescribing, even in closely related classes.

  20. Mars Spark Source Prototype

    Science.gov (United States)

    Eichenberg, Dennis J.; Lindamood, Glenn R.; Weiland, Karen J.; VanderWal, Randall L.

    1999-01-01

    The Mars Spark Source Prototype (MSSP) hardware has been developed as part of a proof of concept system for the detection of trace metals such as lead, cadmium, and arsenic in Martian dusts and soils. A spark discharge produces plasma from a soil sample and detectors measure the optical emission from metals in the plasma that will allow their identification and quantification. Trace metal measurements are vital for the assessment of the potential toxicity of the Martian environment for human exploration. The current method of X-ray fluorescence can yield concentrations only of major species. Other instruments are incompatible with the volume, weight, and power constraints for a Mars mission. The instrument will be developed primarily for use in the Martian environment, but would be adaptable for terrestrial use in environmental monitoring. This paper describes the Mars Spark Source Prototype hardware, the results of the characterization tests, and future plans for hardware development.

  1. THE PROBLEMS ASSOCIATED WITH SWITCHING BRAND-NAME ANTIEPILEPTIC DRUGS TO GENERICS: A FOCUS ON TOPAMAX: A REVIEW OF LITERATURE AND A CASE REPORT

    Directory of Open Access Journals (Sweden)

    K. Yu. Mukhin

    2016-01-01

    Full Text Available Despite the rather high efficiency of treatment for epilepsy (overall, 65–70 % of patients can achieve remission or show a considerable decrease in the frequency of seizures, there remains a challenge due to the need to use antiepileptic drugs long and regularly: therapy adherence, compliance, treatment tolerability, and impact of therapy on quality of patent’s life. One of the aspects of this problem is a very common tendency to switch brand-name antiepileptic drugs to their generics that are 1ess expensive, but also less predictably effective and tolerable. The authors review the literature on the interchangeability of brand-name and generic drugs and describe their case. 

  2. 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.

  3. Review & approval process of generic drugs in US%美国仿制药审评审批制度的经验分析与研究

    Institute of Scientific and Technical Information of China (English)

    雷继峰; 杨建红

    2016-01-01

    20世纪80年代以来,美国为仿制药立法并系统建立了仿制药的管理制度,仿制药产业得到规范和发展,经过FDA审批的仿制药与原研药治疗等效从而在临床上大量替代价格昂贵的原研药,为美国政府、雇主和患者节省了大量医药费用.30年来,仿制药审评审批制度随着科学认识提高不断完善.本文从稳定的基本制度框架、连贯的审评程序和系统的技术标准3个层面,全面系统地介绍美国仿制药审评审批制度的经验,为我国仿制药审评审批制度改革提供参考.%The generic drug industry in US has been well developed and regulated since the generic drug legislation was established in early 1980s.The generic drugs approved by FDA are therapeutically equivalent and therefore interchangeable with the expensive brand-name drugs,which have saved a huge amount of money for the US government,employers,and patients.The systematic approach of generic drug review process has been adopted and improved by FDA with the increasing scientific understanding of pharmaceutical products and their manufacture process in the past three decades.This paper summarized the experience of the US generic drug regulation system from three aspects:stable framework of legislation,consistent review process,and comprehensive technical requirements,which may provide reference to CFDA in regard to the current reform & initiatives on generic drug regulation in China.

  4. Formulation of Pharmacovigilance Plan of Biological Generic Drug%生物仿制药警戒计划的制订

    Institute of Scientific and Technical Information of China (English)

    张淑兰; 关丽

    2012-01-01

    目的:按照药物临床安全性和警戒性的要求,对生物仿制药的生物利用度、临床疗效安全性进行评价,以制订生物仿制药警戒计划.方法:对我国生物仿制药在前期研究、临床试验、生产等过程存在的问题进行分析.结果与结论:生物仿制药品相似但不相同,生物制剂生产过程复杂,容易出现变异,有必要进行临床安全性评价.国家各卫生医疗机构部门应高度关注,加强药品的自检、抽检、监督管理,在生物仿制药使用过程中发现问题,提高我国生物仿制药的临床安全用药水平.%OBJECTIVE: To evaluate bioavailability and safety of clinical efficacy of biological generic drug according to the requirement of drug safety and pharmacovigilance, and to formulate the pharmacovigilance plan for it. METHODS: Problems of biological generic drug in China were analyzed in terms of preliminary study, clinical trial and production. RESULTS&CONCLU-SION: Biological generic drugs are similar but not same, and the production process is complex and easily results in variable. It is necessary to evaluate clinical safety of drugs. Medical institutions should be intensely focused on self-checking, sampling inspection, supervision and management, find out problems to improve safety of biological generic drugs in China.

  5. 企业付费法案与仿制药产业发展%Generic User Fee Program and its impacts on the development of the generic drug industry

    Institute of Scientific and Technical Information of China (English)

    Garth Boehm; 姚立新; 郑强

    2013-01-01

    目的:研究美国FDA如何借助企业付费的方法来应对药品生产、供应全球化和不断增长的工作量的挑战,以便提高药品可及性和缓解药品短缺.方法:根据美国FDA、国会和政府问责办公室的资料及业界报告等,分析企业付费对保证药品安全性、可及性和监管机构透明度方面的作用.结果:采取公开、整体性的企业付费方式,有助于加速仿制药审评、实现海内外生产设施检查频率一致、保障药品的可及性和安全性及增加监管透明度.结论:仿制药企业付费法案对推动政企合作,合理利用企业资源,解决监管机构、产业界和利益攸关方共同面对的棘手问题,推动全球化时代药品监管方式的转变,提供了一条可行的途径.%Objective: To explore the user fee approach taken by the FDA to deal with the challenges from pharmaceutical manufacturing, supply globalization, and the review backlog that has kept escalating continuously to expedite the access of the drug products and mitigate the drug shortage. Methods: the impacts of the user fee on the safety, accessibility of the generic drugs and transparency of the regulatory agency were analyzed based on the reports of the FDA, U. S. Congress, GAO, and the industry. Results:The open and holistic program of the user fee can facilitate the streamlining of the generic drug review, ensuring the safety and access of the drug products, and improving the transparency of the regulatory agency. Conclusion: The generic drug user fee provides with a feasible approach to promote public-private partnership by using the enterprise resources to deal with the issues faced by the regulatory agency, industry and the stakeholders in the globalization of the pharmaceutical industry, and promote the paradigm shift of pharmaceutical regulation in the age of globalization.

  6. 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.

  7. The US generic drug industry: lessons from the first 25 years%美国仿制药行业发展头25年的经验教训

    Institute of Scientific and Technical Information of China (English)

    Garth Boehm; 姚立新; 韩亮; 郑强

    2012-01-01

    The lessons in the development of the US generic drug industry since the enacting of Drug Price Competition and Patent Term Restoration Act ( DPC & PTR Act) that resulted in the creation of the US generic drug industry were summarized. The evolution and key events in the development of the US generic drug industry in the first 25 years, including generic drug scandal, the evolution of approval for generic drugs, bioequivalence and switchability, bioequivalence for complicated dosage forms, patent evergreening, authorized generics, generic drug safety, the issues in generic drug review, the generic drug substitution system, $4 generics, were systemically reviewed and analyzed. The history of the first 25 years of the US Generic Drug Industry has presented several lessons which are of benefit to others wishing to establish or reestablish a domestic generic drug industry.%本文回顾了自《1984年药品价格竞争与专利期补偿法案》实施、创立美国仿制药行业以来,美国仿制药行业的发展经验和教训.对仿制药丑闻、仿制药审批制度发展、生物等效性与可替代性、复杂剂型的生物等效性方法、专利常青、授权仿制药、仿制药安全性、仿制药审评、仿制药替代、4美元仿制药等美国仿制药行业发展中的关键性事件和过程进行了系统回顾与分析.美国仿制药行业在头25年发展历程中的经验教训,对其他希望建立或重新建立国内仿制药行业的国家有借鉴作用.

  8. Analysis on first-time generic drug approvals 2014 in USA%2014年美国首仿药数据行为剖析

    Institute of Scientific and Technical Information of China (English)

    朱精兵; 顾东蕾

    2015-01-01

    从FDA网站上下载2014年逐月首仿药批准列表ANDA (Generic) Drug Approvals,P Ⅳ专利挑战案列表(Paragraph Ⅳ Patent Certifications)以及授权仿制药列表(FDA Listing of Authorized Generics),对相关数据进行分析,确定各层次品种及美国仿制药企业在2014年首仿药申请状态.国内研发品种选择借鉴的各层次品种有27个;建议国内一方面制定在专利到期前首仿药“暂时性批准”政策,另一方面在现有条件下,可与品牌药企业合作,进行授权仿制.

  9. Generics and the specific features of their regulation

    Directory of Open Access Journals (Sweden)

    E. A. Ushkalova

    2016-01-01

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

  10. Generic variation?

    DEFF Research Database (Denmark)

    Jensen, Torben Juel

    2009-01-01

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

  11. 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.

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

    African Journals Online (AJOL)

    1998-03-03

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

  13. Generic medications in ophthalmology.

    Science.gov (United States)

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

    2013-03-01

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

  14. The Effect of Spark Timing on the Spark Ignition

    Directory of Open Access Journals (Sweden)

    Rafeq A. Khalefa

    2013-04-01

    Full Text Available  In this work the effect of spark timing on the spark ignition engines is investigated by computer simulation and experimental test for speeds of (1500,2000,2500,3000 and 3500rpm at spark timing of (20o,30o,40o,50o and 60o before TDC for each speed. This is done in order to find a suitable  mathematical expression for spark ignition advancing with respect to the speed of the engine to predict the correct ignition advance  as in real engines .The results showed that the method of using a mathematical expression is more realistic and reasonable  comparing  with the results obtained by other workers. 

  15. 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. 

  16. PROBLEM OF GENERIC REPLACEMENT: ADVANTAGES AND DISADVANTAGES

    Directory of Open Access Journals (Sweden)

    S. N. Tolpygina

    2016-01-01

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

  17. Scaling spark on HPC systems

    OpenAIRE

    Chaimov, N; Malony, A.; Canon, S.; C. Iancu; Ibrahim, KZ; Srinivasan, J.

    2016-01-01

    Copyright © 2016 by the Association for Computing Machinery, Inc. (ACM).We report our experiences porting Spark to large production HPC systems. While Spark performance in a data center installation (with local disks) is dominated by the network, our results show that file system metadata access latency can dominate in a HPC installation using Lustre: it determines single node performance up to 4× slower than a typical workstation. We evaluate a combination of software techniques and hardware...

  18. A review of the differences and similarities between generic drugs and their originator counterparts, including economic benefits associated with usage of generic medicines, using Ireland as a case study.

    Science.gov (United States)

    Dunne, Suzanne; Shannon, Bill; Dunne, Colum; Cullen, Walter

    2013-01-05

    Generic medicines are those where patent protection has expired, and which may be produced by manufacturers other than the innovator company. Use of generic medicines has been increasing in recent years, primarily as a cost saving measure in healthcare provision. Generic medicines are typically 20 to 90% cheaper than originator equivalents. Our objective is to provide a high-level description of what generic medicines are and how they differ, at a regulatory and legislative level, from originator medicines. We describe the current and historical regulation of medicines in the world's two main pharmaceutical markets, in addition to the similarities, as well as the differences, between generics and their originator equivalents including the reasons for the cost differences seen between originator and generic medicines. Ireland is currently poised to introduce generic substitution and reference pricing. This article refers to this situation as an exemplar of a national system on the cusp of significant health policy change, and specifically details Ireland's history with usage of generic medicines and how the proposed changes could affect healthcare provision.

  19. 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....

  20. 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....

  1. Development and Application of a Generic Drug Name Query Program%药品通用名查询程序的开发与应用

    Institute of Scientific and Technical Information of China (English)

    谭跃庆; 胡吉亭

    2016-01-01

    Objective To develop a generic drug name query program so as to provide support for clinical physicians to have a familiarity with drugs and a good use of drug. Methods The generic drug name query program was developed based on the current HIS (Hospital Information System), through which the drug dictionary inquiry form, user information table and department information table were mainly established. The program was also seamless integrated with the drug dictionary table in HIS database so as to realize the data sharing and automatic transmission between two databases. Results The program was equipped with user-friendly interface as well as easy-to-maintain and safe-to-use features, which could meet the requirements of clinical physicians. Conclusion Granular design of the program made it convenient for data storage and maintenance and laid a foundation for further opening of the database.%目的:开发药品通用名查询程序,为临床医生熟悉、使用药品提供支持。方法在现有医院信息管理系统(HIS)基础上开发药品通用名查询程序,主要建立了药品字典查询表、用户信息表和科室信息表,并与HIS数据库的药品字典表无缝对接,实现两个数据库的数据共享和自动传输。结果系统操作界面简单、维护方便、使用安全,能够满足我院临床医生需求。结论程序数据颗粒化设计便于数据的存储和维护,为数据库的进一步开发奠定了基础。

  2. 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 < 0.149 × 10(-4) cm/s) showed 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

  3. Generic on-line solid phase extraction sample preparation strategies for the analysis of drugs in biological matrices by LC-MS/MS.

    Science.gov (United States)

    Bourgogne, Emmanuel; Grivet, Chantal; Varesio, Emmanuel; Hopfgartner, Gérard

    2015-01-01

    In the present work we investigate the integration of a single hardware platform (Prospekt-2) allowing on-line SPE with pre-/post-trapping dilution and direct injection of plasma extracts, and also compare the benefits and challenges of the different approaches for pharmaceutical drugs with heterogeneous physicochemical properties. In the first part, the generic use of on-line SPE with direct plasma injection or after protein precipitation was investigated for the quantitative analysis of talinolol. In the second part, pre-trapping and post-trapping dilution for on-line SPE is discussed for generic method development on an oxadiazole and its major metabolite. Finally, the difference of performance between direct plasma injection vs. off-line liquid-liquid extraction is also described for the quantification of buprenorphine and naltrexone down to 50 and 100 pg/ml using a 0.25 ml plasma aliquot. All assays were in human plasma and detection was performed by mass spectrometry detection either on simple or triple stage quadrupoles. Regardless of the tested strategy, assays were found linear, with precision and accuracy with <15% for all quality controls samples and <20% for lower limit of quantitation.

  4. 78 FR 3900 - Generic Drug User Fee-Active Pharmaceutical Ingredient and Finished Dosage Form Facility Fee...

    Science.gov (United States)

    2013-01-17

    ... drug active pharmaceutical ingredient (API) and finished dosage form (FDF) facilities user fees for... applications in the backlog as of October 1, 2012, on finished dosage form (FDF) and active pharmaceutical... Finished Dosage Form Facility Fee Rates for Fiscal Year 2013 AGENCY: Food and Drug Administration,...

  5. 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.

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

    Directory of Open Access Journals (Sweden)

    W Maek-a-Nantawat

    2012-11-01

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

  7. Off-patent generic medicines vs. off-patent brand medicines for six reference drugs: a retrospective claims data study from five local healthcare units in the Lombardy Region of Italy.

    Directory of Open Access Journals (Sweden)

    Giorgio L Colombo

    Full Text Available The scientific documentation supporting the potential clinical and economic benefits of a growing use of off-patent generic drugs in clinical practice seems to be limited in Italy as yet.We compared differences in outcomes between off-patent generic drugs and off-patent brand drugs in real clinical practice. The outcomes were: persistence and compliance with therapy, mortality, and other health resources consumption (hospitalizations, specialist examinations, other drugs and total costs. Retrospective analysis was carried out by using the administrative databases of five Local Healthcare Units (ASLs - Aziende Sanitarie Locali in the Lombardy Region of Italy. Data from the five ASLs were aggregated through a meta-analysis, which produced an estimate indicator of the mean or percentage difference between the two groups (branded vs. generic and their respective significance tests. The therapeutic areas and studied drugs were: diabetes: metformin - A10BA02; hypertension: amlodipine - C08CA01; dyslipidemia: simvastatin - C10AA01; psychiatry: sertraline - N06AB06; cardiology: propafenone - C01BC03; osteoporosis: alendronate - M05BA04.The 5 Local Healthcare Units (ASL represent a population of 3,847,004 inhabitants. The selected sample included 347,073 patients, or 9.02% of the total ASL population; 67% of the patients were treated with off-patent brand drugs. The average age was 68 years, with no difference between the two groups. After 34 months of observation, compliance and persistence were in favor to generic drugs in all therapeutic areas and statistically significant in the metformin, amlodipine, simvastatin, and sertraline groups. The clinical outcomes (hospitalizations, mortality, and other health costs show no statistically significant differences between off-patent generic vs. off-patent brand medicines.Off-patent generic drugs appear to be a therapy option of choice in Italy as well, based on clinical outcomes and economic consequences

  8. Off-patent generic medicines vs. off-patent brand medicines for six reference drugs: a retrospective claims data study from five local healthcare units in the Lombardy Region of Italy.

    Science.gov (United States)

    Colombo, Giorgio L; Agabiti-Rosei, Enrico; Margonato, Alberto; Mencacci, Claudio; Montecucco, Carlo Maurizio; Trevisan, Roberto

    2013-01-01

    The scientific documentation supporting the potential clinical and economic benefits of a growing use of off-patent generic drugs in clinical practice seems to be limited in Italy as yet. We compared differences in outcomes between off-patent generic drugs and off-patent brand drugs in real clinical practice. The outcomes were: persistence and compliance with therapy, mortality, and other health resources consumption (hospitalizations, specialist examinations, other drugs) and total costs. Retrospective analysis was carried out by using the administrative databases of five Local Healthcare Units (ASLs - Aziende Sanitarie Locali) in the Lombardy Region of Italy. Data from the five ASLs were aggregated through a meta-analysis, which produced an estimate indicator of the mean or percentage difference between the two groups (branded vs. generic) and their respective significance tests. The therapeutic areas and studied drugs were: diabetes: metformin - A10BA02; hypertension: amlodipine - C08CA01; dyslipidemia: simvastatin - C10AA01; psychiatry: sertraline - N06AB06; cardiology: propafenone - C01BC03; osteoporosis: alendronate - M05BA04. The 5 Local Healthcare Units (ASL) represent a population of 3,847,004 inhabitants. The selected sample included 347,073 patients, or 9.02% of the total ASL population; 67% of the patients were treated with off-patent brand drugs. The average age was 68 years, with no difference between the two groups. After 34 months of observation, compliance and persistence were in favor to generic drugs in all therapeutic areas and statistically significant in the metformin, amlodipine, simvastatin, and sertraline groups. The clinical outcomes (hospitalizations, mortality, and other health costs) show no statistically significant differences between off-patent generic vs. off-patent brand medicines. Off-patent generic drugs appear to be a therapy option of choice in Italy as well, based on clinical outcomes and economic consequences, both for the

  9. 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

  10. 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.

  11. Efficiency of SparkJet

    Science.gov (United States)

    Golbabaei-Asl, M.; Knight, D.; Wilkinson, S.

    2013-01-01

    The thermal efficiency of a SparkJet is evaluated by measuring the impulse response of a pendulum subject to a single spark discharge. The SparkJet is attached to the end of a pendulum. A laser displacement sensor is used to measure the displacement of the pendulum upon discharge. The pendulum motion is a function of the fraction of the discharge energy that is channeled into the heating of the gas (i.e., increasing the translational-rotational temperature). A theoretical perfect gas model is used to estimate the portion of the energy from the heated gas that results in equivalent pendulum displacement as in the experiment. The earlier results from multiple runs for different capacitances of C = 3, 5, 10, 20, and 40(micro)F demonstrate that the thermal efficiency decreases with higher capacitive discharges.1 In the current paper, results from additional run cases have been included and confirm the previous results

  12. Are Crab Nanoshots Schwinger Sparks?

    CERN Document Server

    Stebbins, Albert

    2015-01-01

    The highest brightness temperature ever observed are from "nanoshots" from the Crab pulsar which we argue could be the signature of bursts of vacuum $e^{\\pm}$ 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, $\\sim 10^3 L_{\\astrosun}$, 10 PeV $e^{\\pm}$ accelerator in the heart of the Crab. These nanosecond duration sparks are generated in a volume less than $1 m^3$ and the existence of such sparks has implications for the small scale structure of the magnetic field of young pulsars such as the Crab. This mechanism may also play a role in producing other enigmatic bright short radio transients such as fast radio bursts.

  13. 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.

  14. Fiber laser coupled optical spark delivery system

    Science.gov (United States)

    Yalin, Azer [Fort Collins, CO; Willson, Bryan [Fort Collins, CO; Defoort, Morgan [Fort Collins, CO; Joshi, Sachin [Fort Collins, CO; Reynolds, Adam [Fort Collins, CO

    2008-03-04

    A spark delivery system for generating a spark using a laser beam is provided, and includes 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. The laser delivery assembly further 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. Other embodiments use a fiber laser to generate a spark. Embodiments of the present invention may be used to create a spark in an engine. Yet other embodiments include collecting light from the spark or a flame resulting from the spark and conveying the light for diagnostics. Methods of using the spark delivery systems and diagnostic systems are provided.

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

    Science.gov (United States)

    Toy, Mehlika; Hutton, David W; So, Samuel K

    2015-01-01

    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.

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

    Science.gov (United States)

    Toy, Mehlika; Hutton, David W.; So, Samuel K.

    2015-01-01

    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. PMID:26536626

  18. Reference pricing with endogenous generic entry.

    OpenAIRE

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

    2015-01-01

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

  19. "Generic Entry and the Pricing of Pharmaceuticals"

    OpenAIRE

    Frank, Richard G.; David S. Salkever

    1995-01-01

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

  20. 仿制药和专利药临床疗效差异的技术思考%Technical discussion on the curative effect differences between generic drugs and proprietary drugs

    Institute of Scientific and Technical Information of China (English)

    胡欣; 金鹏飞

    2012-01-01

    文章旨在从技术角度思考仿制药和专利药的疗效差异.从原料药、制剂、质量标准、人体生物等效性试验等方面分析了造成疗效差异的可能原因,并针对可能的原因,有针对性地提出了技术建议.原料药、制剂、质量标准、人体生物等效性试验等各个方面都可能造成仿制药和专利药的疗效差异,都有需提高和完善之处.%In this article, we discussed the possible technical factors of curative effect differences between generic drugs and proprietary drugs. Possible technical factors of bulk drugs, pharmaceutical preparations, quality specifications and bioequivalence test were analyzed. Some technical suggestions were offered accordingly. The curative effect differences could be caused by bulk drugs, pharmaceutical preparations, quality specifications and bioequivalence tests, and all those should be upgraded.

  1. Investigation into the interchangeability of generic formulations using immunosuppressants and a broad selection of medicines

    NARCIS (Netherlands)

    Yu, Y.; Teerenstra, S.; Neef, C.; Burger, D.M.; Maliepaard, M.

    2015-01-01

    PURPOSE: To date, the interchangeability of generic drugs has only been investigated for a limited number of medicines. The objective of this study was to investigate generic-generic drug interchangeability in a large subset of generic formulations in order to cover a broad spectrum of drugs. METHOD

  2. Bias within economic evaluations – the impact of considering the future entry of lower-cost generics on currently estimated incremental cost-effectiveness ratios of a new drug

    Directory of Open Access Journals (Sweden)

    Guertin JR

    2015-10-01

    Full Text Available Jason R Guertin,1,2 Dominic Mitchell,1,3 Farzad Ali,4 Jacques LeLorier1 1CHUM Research Center, Montréal, QC, 2Programs for Assessment of Health Technology in Health Research Institute, Hamilton, ON, 3Logimétrix Inc., Repentigny, 4Pfizer Canada Inc., Kirkland, QC, Canada Background: Most economic evaluation models compare a new patented drug (NPRx to a generic comparator. Drug costs within these models are usually limited to the retail cost of both drugs at the time of model conception. However, the retail cost of the NPRx is expected to drop once generic versions of this molecule are introduced following the expiration of the NPRx’s patent. The objective of this study was to examine the impact on the incremental cost-effectiveness ratio (ICER of the future introduction of lower-cost generic versions of the NPRx within the model’s time horizon. Methods: We examined the impact of this parameter with the use of two approaches: 1 a mathematical proof identifying its impact on the NPRx’s ICER; and 2 applying this parameter to a previously published economic model comparing a NPRx to a generic comparator and identifying what would have been the NPRx’s ICER had this model considered this parameter. Results: As expected, both the mathematical proof and the application to the previously published economic model showed that considering the future introduction of lower-cost generic versions of the NPRx within the model’s time horizon lowers the NPRx’s ICER. The timing of the future entry of lower-cost generic molecules, their relative price compared to that of the patented version, and the discount rate applied to future costs all influenced the results. Conclusion: An ICER estimated within economic evaluations comparing NPRx to generic comparators which ignore the future introduction of lower-cost generic versions of the NPRx within the model’s time horizon will tend to be overestimated. Inclusion of this parameter should be considered

  3. Skin rash during treatment with generic itraconazole

    Directory of Open Access Journals (Sweden)

    Antonio De Vuono

    2014-01-01

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

  4. What Is the Future of Generics in Transplantation?

    Science.gov (United States)

    van Gelder, Teun

    2015-11-01

    Generic immunosuppressive drugs are available in Europe, Canada, and the United States. Between countries, there are large differences in the market penetration of generic drugs in general, and for immunosuppressive drugs in particular. The registration criteria for generic immunosuppressive drugs are often criticized. However, it is unlikely that the criteria for registration of narrow therapeutic index drugs are going to change, and bioequivalence studies, performed in healthy volunteers, will remain the backbone of the registration process. It would be good if the registration authorities would demand that all generic variants of an innovator drug have the same pill appearance to reduce errors and promote drug adherence.To allow for safe substitution, a number of criteria need to be fulfilled. Generic substitution should not be taken out of the hands of the treating physicians. Generic substitution can only be done safely if initiated by the prescriber, and in well-informed and prepared patients. Payers should refrain from forcing pharmacists to dispense generic drugs in patients on maintenance treatment with innovator drug. Instead, together with transplant societies, they should design guidelines on how to implement generic immunosuppressive drugs into clinical practice. Substitutions must be followed by control visits to check if the patient is taking the medication correctly and if drug exposure remains stable. Inadvertent, uncontrolled substitutions from 1 generic to another, initiated outside the scope of the prescriber, must be avoided as they are unsafe. Repetitive subsequent generic substitutions result in minimal additional cost savings and have an inherent risk of medication errors.

  5. Mars Spark Source Prototype Developed

    Science.gov (United States)

    Eichenberg, Dennis J.; Lindamood, Glenn R.; VanderWal, Randall L.; Weiland, Karen J.

    2000-01-01

    The Mars Spark Source Prototype (MSSP) hardware was developed as part of a proof of concept system for the detection of trace metals such as lead, cadmium, and arsenic in Martian dusts and soils. A spark discharge produces plasma from a soil sample, and detectors measure the optical emission from metals in the plasma to identify and quantify them. Trace metal measurements are vital in assessing whether or not the Martian environment will be toxic to human explorers. The current method of x-ray fluorescence can yield concentrations of major species only. Other instruments are incompatible with the volume, weight, and power constraints for a Mars mission. The new instrument will be developed primarily for use in the Martian environment, but it would be adaptable for terrestrial use in environmental monitoring. The NASA Glenn Research Center at Lewis Field initiated the development of the MSSP as part of Glenn's Director's Discretionary Fund project for the Spark Analysis Detection of Trace Metal Species in Martian Dusts and Soils. The objective of this project is to develop and demonstrate a compact, sensitive optical instrument for the detection of trace hazardous metals in Martian dusts and soils.

  6. Lifecycle of laser-produced air sparks

    Energy Technology Data Exchange (ETDEWEB)

    Harilal, S. S., E-mail: hari@pnnl.gov; Brumfield, B. E.; Phillips, M. C. [Pacific Northwest National Laboratory, P.O. Box 999, Richland, Washington 99352 (United States)

    2015-06-15

    We investigated the lifecycle of laser-generated air sparks or plasmas using multiple plasma diagnostic tools. The sparks were generated by focusing the fundamental radiation from an Nd:YAG laser in air, and studies included early and late time spark dynamics, decoupling of the shock wave from the plasma core, emission from the spark kernel, cold gas excitation by UV radiation, shock waves produced by the air spark, and the spark's final decay and turbulence formation. The shadowgraphic and self-emission images showed similar spark morphology at earlier and late times of its lifecycle; however, significant differences are seen in the midlife images. Spectroscopic studies in the visible region showed intense blackbody-type radiation at early times followed by clearly resolved ionic, atomic, and molecular emission. The detected spectrum at late times clearly contained emission from both CN and N{sub 2}{sup +}. Additional spectral features have been identified at late times due to emission from O and N atoms, indicating some degree of molecular dissociation and excitation. Detailed spatially and temporally resolved emission analysis provides insight about various physical mechanisms leading to molecular and atomic emission by air sparks, including spark plasma excitation, heating of cold air by UV radiation emitted by the spark, and shock-heating.

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

    Science.gov (United States)

    Rischatsch, Maurus; Trottmann, Maria; Zweifel, Peter

    2013-06-01

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

  8. 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...

  9. Generation of nanoparticles by spark discharge

    OpenAIRE

    Tabrizi, N.S.; Ullmann, M.; Vons, V.A.; Lafont, U.; Schmidt-Ott, A.

    2008-01-01

    The production of nanoparticles by microsecond spark discharge evaporation in inert gas is studied systematically applying transmission electron microscopy, mobility analysis and BET surface area measurement. The method of spark discharge is of special interest, because it is continuous, clean, extremely flexible with respect to material, and scale-up is possible. The particle size distributions are narrow and the mean primary particle size can be controlled via the energy per spark. Separate...

  10. Plasma spark discharge reactor and durable electrode

    Energy Technology Data Exchange (ETDEWEB)

    Cho, Young I.; Cho, Daniel J.; Fridman, Alexander; Kim, Hyoungsup

    2017-01-10

    A plasma spark discharge reactor for treating water. The plasma spark discharge reactor comprises a HV electrode with a head and ground electrode that surrounds at least a portion of the HV electrode. A passage for gas may pass through the reactor to a location proximate to the head to provide controlled formation of gas bubbles in order to facilitate the plasma spark discharge in a liquid environment.

  11. SparkMaster: automated calcium spark analysis with ImageJ.

    Science.gov (United States)

    Picht, Eckard; Zima, Aleksey V; Blatter, Lothar A; Bers, Donald M

    2007-09-01

    Ca sparks are elementary Ca-release events from intracellular Ca stores that are observed in virtually all types of muscle. Typically, Ca sparks are measured in the line-scan mode with confocal laser-scanning microscopes, yielding two-dimensional images (distance vs. time). The manual analysis of these images is time consuming and prone to errors as well as investigator bias. Therefore, we developed SparkMaster, an automated analysis program that allows rapid and reliable spark analysis. The underlying analysis algorithm is adapted from the threshold-based standard method of spark analysis developed by Cheng et al. (Biophys J 76: 606-617, 1999) and is implemented here in the freely available image-processing software ImageJ. SparkMaster offers a graphical user interface through which all analysis parameters and output options are selected. The analysis includes general image parameters (number of detected sparks, spark frequency) and individual spark parameters (amplitude, full width at half-maximum amplitude, full duration at half-maximum amplitude, full width, full duration, time to peak, maximum steepness of spark upstroke, time constant of spark decay). We validated the algorithm using images with synthetic sparks embedded into backgrounds with different signal-to-noise ratios to determine an analysis criteria at which a high sensitivity is combined with a low frequency of false-positive detections. Finally, we applied SparkMaster to analyze experimental data of sparks measured in intact and permeabilized ventricular cardiomyocytes, permeabilized mammalian skeletal muscle, and intact smooth muscle cells. We found that SparkMaster provides a reliable, easy to use, and fast way of analyzing Ca sparks in a wide variety of experimental conditions.

  12. 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...

  13. 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...

  14. Storytelling through animation: Oxford Sparks

    Science.gov (United States)

    Pyle, D. M.; Cook, A.

    2013-12-01

    Oxford Sparks is a portal that launched in 2012, with the aim of bringing together resources that have been created across the University of Oxford and elsewhere for the purpose of wider engagement with science. To bring attention to this site, Oxford Sparks developed a set of high-quality short animations, each designed to tell a story relating to a current area of science. These animations have been launched on YouTube, and will shortly be available on iTunesU, and have covered broad areas of science from subduction zones (';Underwater Volcano Disaster'), through the early history of the solar system (';Rogue Planet') to the workings of the Large Hadron Collider (';A quick look around the LHC'). The animations have each been developed in close collaboration with researchers, created by a team with experience of education, engagement and outreach. The two minute scripts are intended to be both widely accessible and viewable as ';stand alone' stories. To this end, the scripts are humorous; while the animations are delightfully quirky, and created by professional animator with a degree-level science background. The animations are also intended to be used as ';lesson starters' in school, and educational activities graded for different age groups are being developed in parallel with the animations. They have been used, successfully, on pre-university summer schools, and in university classes. We are gathering both quantitative (analytics) and qualitative (school teacher and student focus group) feedback to monitor the success of the project, and to understand the strengths and weaknesses of the approach. In the first year since launch, Oxford Sparks animations were viewed over 80,000 times on YouTube, in part due to the surge of interest in the Large Hadron Collider animation after the discovery of the Higgs Boson.

  15. Generation of nanoparticles by spark discharge

    NARCIS (Netherlands)

    Tabrizi, N.S.; Ullmann, M.; Vons, V.A.; Lafont, U.; Schmidt-Ott, A.

    2008-01-01

    The production of nanoparticles by microsecond spark discharge evaporation in inert gas is studied systematically applying transmission electron microscopy, mobility analysis and BET surface area measurement. The method of spark discharge is of special interest, because it is continuous, clean, extr

  16. Spark plasma sintering and spark plasma joining of refractory ceramics

    Science.gov (United States)

    Hoefer, Jeffrey Andrew

    Consolidation of refractory ceramics such as boron carbide (B4C) and silicon carbide (SiC) by conventional sintering techniques (pressure-less sintering, hot pressing, hot isostatic pressing etc.) can prove challenging due to the high temperatures required for sintering. Typically sintering additives are used in order to decrease sintering temperature, but at the sacrifice of purity. Typically B4C requires sintering temperatures above 2000°C without the use of additives, while SiC is generally considered not sinterable without additives, and requires temperatures above 2000°C even with additives. Spark Plasma Sintering (SPS) has emerged as a technology that can reduce the sintering temperature considerably compared to more conventional techniques. The simultaneous application of pressure, heat, and current can reduce sintering temperatures without the use of sintering aids to 1600°C and 2000°C for boron carbide and silicon carbide respectively. One shortcoming of SPS, however, is the difficulty in producing complex shapes. Therefore, for carbide materials such as B4C and SiC, which are difficult to machine, the ability to produce complex shapes is worthy of investigation. One means of creating complex shapes is by joining simple shapes. Joining of monolithic ceramics, in particular SiC, has been achieved, however in all cases an intermediate joining material is used (Ti foil, Silica Powder etc.). Joining of materials using SPS, or as it is called, Spark Plasma Joining, can eliminate the need for an intermediate joining material, producing a high purity and high strength joint. This study investigates SPS of 3 different B4C Powders, as well as SPS joining of simple shape monolithic SiC. Sintering parameters such as temperature, pressure, time, and heating rate are all considered. Influence of sintering parameters on density, grain size, mechanical strength, and joint quality is investigated in detail.

  17. Brand name versus generic drugs: the ethical quandary in caring for our sophisticated patients while trying to reduce health-care costs: facts and controversies.

    Science.gov (United States)

    Payette, Michael; Grant-Kels, Jane M

    2013-01-01

    Medical ethics are the values and guidelines that govern decisions made in medical practice. Four prima facie moral principles can serve as a framework to help physicians analyze problems and make ethical decisions: (1) respect for autonomy, (2) beneficence, (3) non-maleficence, and (4) justice. With the cost of health care rising, all parties involved in the delivery of health care need to work to reduce costs, while continuing to provide quality care to our patients. One mechanism to reduce costs is to increase utilization of generic medications in daily practice, but there are many ethical issues inherent in utilizing brand name versus generic medications in dermatology.

  18. Comparison of DissoIution of MetoproIoI Tartrate tabIets between Generic drugs and Reference Listed Drug%酒石酸美托洛尔片仿制与原研的溶出度比较

    Institute of Scientific and Technical Information of China (English)

    李舸远; 何华

    2016-01-01

    OBJECTIVE Compare dissolution in vitro of generic drugs and reference listed drug of Metoprolol Tartrate Tablets, then give guidance for quality consistency evaluation of geberic drugs and reference listed drug.METHODS Selected test samples of 50mg dosage, referring to the quality standard of Metoprolol Tartrate Tablets in Chinese Pharmacopoeia ( Ver.2010 ) ,4 kinds of dissolution medium were used to determinate dissolution curve in vitro of 8 generic drugs and 1 reference listed drug,then make consistency evaluation of them by dissimilarity factor f1 ,similarity factor f2 and direct comparison method.RESULTS The dissolution of domestic generic drugs was very different between anyone and each other,only 1 generic drug was consistent with reference listed drug in 4 kinds of dissolution medium.Most generic drugs were consistent with reference listed drug in 2 or 1 kinds of dissolu-tion medium.CONCLUSION There are some differences between generic drugs and reference listed drug.Prescription,preparation process and selection of accessories of generic drugs need further study to achieve con-sistency of quality and dissolution.However,biological equivalence tests were needed in order to make comprehensive evaluation of Metoprolol Tartrate Tablets generic drugs.%目的:对酒石酸美托洛尔片国产仿制药与原研药进行体外溶出度比较,为质量一致性评价提供依据。方法参照中国药典2010版二部酒石酸美托洛尔片的质量标准,选取50mg规格样品,采用4种不同的溶出介质对国内8家企业生产的仿制药和原研药进行体外溶出行为考察,并采用差异因子f1法、相似因子f2法和直接比较法来评价仿制药与原研药溶出行为的一致性。结果8家仿制药溶出行为参差不齐,按直接比较法只有1家仿制药在四种溶出介质中的溶出曲线均与原研药一致,只在两种或一种溶出介质中的溶出曲线与原研药一致的情况较多。结论国内企业

  19. Generic tacrolimus in solid organ transplantation.

    Science.gov (United States)

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

    2014-05-01

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

  20. Analysis of Institutional Factors for Indian Generic Drug Development and Lessons for China%印度仿制药发展的制度因素分析及对我国的借鉴

    Institute of Scientific and Technical Information of China (English)

    李宁娟; 高山行

    2016-01-01

    Promoting the development generic drug needs to learn from experiences of other countries.Relying on strong in-stitutional support,the generic drug industry in India has developed significantly,and has established global competitive ad-vantage,which provides valuable experiences for China.This paper analyses the relationship of institutional changes and pharmaceutical industry development of India.Results show that there exist three stages.And patent laws,foreign invest-ment regulation,and drug price regulation institution are three most important institutional factors influencing the fast de-velopment of generic drug industry.At the same time,through comparative analyses,this paper clarifies the differences of pharmaceutical institutions between India and China.Finally,based on experiences of India,we provide some suggestions for the high quality development of generic drug in China.%借鉴其它国家经验可推动我国仿制药的发展。印度仿制药业依靠强有力的制度支持获得了飞速发展,建立了全球范围的竞争优势。分析了印度医药产业制度变迁与产业发展之间的关系:印度医药制度变迁大致经历了3个阶段,其中专利法规、外国投资管制政策、价格管制制度是3个最重要的制度因素。同时,通过对比分析,明晰了我国与印度医药制度之间的差异。最后,借鉴印度仿制药发展的经验,为推动我国仿制药高质量发展提出了建议。

  1. Finding generically stable measures

    CERN Document Server

    Simon, Pierre

    2010-01-01

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

  2. 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.

  3. The generic article

    NARCIS (Netherlands)

    Farkas, D.F.; Swart, Henriëtte de

    2005-01-01

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

  4. 注册分类6化学药品立题合理性相关问题的讨论%Issues about the rationality of subject selection in chemical generic drug registration application:a discussion

    Institute of Scientific and Technical Information of China (English)

    许真玉

    2014-01-01

    注册分类6的化学药品在注册申报过程中暴露了一些立题方面的问题。作为药物研发者,必须追踪药物最新的安全有效性和质量可控性信息,为药物研究开发提供扎实的立题基础。本文结合日常药品审评工作,从化合物、剂型、规格等方面对注册分类6化学药品立题合理性相关问题进行讨论。%Some issues about the rationality of subject selection are identified in the registration applications of chemical generic drugs. It should be the sponsor's responsibility to follow the latest information about safety, efficacy and quality control of the proposed drug, and provide a sound basis for subject selection. In this article, issues about the basis of the subject selection of chemical generic drugs are discussed from the aspects of compound, formulation and strength.

  5. Associations between generic substitution and patient-related factors

    DEFF Research Database (Denmark)

    Østergaard Rathe, Jette

    Associations between generic substitution and patient-related factors Jette Østergaard Rathe1, Pia V. Larsen1, Morten Andersen2, Janus L. Thomsen3, Maja S. Paulsen1, Jens Søndergaard1 1. Research Unit of General Practice, Institute of Public Health, University of Southern Denmark 2. Centre...... substitutable drug. Data were linked with a prescription database. Results We found no associations between generic substitution and, respectively, gender, age, drug group and polypharmacy. Earlier switches of the index drug are statistically significant associated with acceptance of generic substitution...... generics in the antiepileptic and antidepressant groups (antiepileptics OR 0.37 and antidepressants OR 0.53). Conclusion We did not find any patient-related factors associated with generic substitution; however, patients who have once experienced a generic substitution with a specific drug are more likely...

  6. Spark discharge in conductive liquid with microbubbles

    Science.gov (United States)

    Vetchinin, S. P.; Vasilyak, L. M.; Pecherkin, V. Ya; Panov, V. A.; Son, E. E.

    2016-11-01

    Pulse electrical breakdown in 15% water solution of Isopropyl alcohol with air microbubbles from a pointed anode has been studied experimentally. It is shown, that the breakdown is always initiated from the bright region near the anode (anode “spot”). Detailed investigation into dynamic current-voltage characteristics and synchronized images reveals that it is thermal instability in the near anode region that causes spark channel initiation and development. The breakdown voltage, spark channel propagation speed and short-circuit current increase when the microbubbles are presented in the solution. The spark channel propagation speed is about 4-12 m/s and grows along with microbubbles concentration.

  7. COMPUTER ALGORITHMS FOR EVALUATION OF SPARKING INDICATED BY OPTOELECTRONIC SPARKING ANALYZER

    Directory of Open Access Journals (Sweden)

    W. Zelinski

    2005-01-01

    Full Text Available Optoelectronic sparking analyzer provides the possibility to realize a number of algorithms that permit to convert indicated light signals containing information on number of sparkings in the measuring cycle and their intensity divided in ten classes. The paper presents the selected sparking indices converted with the help of a computer and these indices make it possible to evaluate sparking level of separate commutator sectors by calculating average values in the whole measuring cycle of brush-commutator contact in dc machines. The paper also contains limiting values of the presented indices. 

  8. Titian: Data Provenance Support in Spark.

    Science.gov (United States)

    Interlandi, Matteo; Shah, Kshitij; Tetali, Sai Deep; Gulzar, Muhammad Ali; Yoo, Seunghyun; Kim, Miryung; Millstein, Todd; Condie, Tyson

    2015-11-01

    Debugging data processing logic in Data-Intensive Scalable Computing (DISC) systems is a difficult and time consuming effort. Today's DISC systems offer very little tooling for debugging programs, and as a result programmers spend countless hours collecting evidence (e.g., from log files) and performing trial and error debugging. To aid this effort, we built Titian, a library that enables data provenance-tracking data through transformations-in Apache Spark. Data scientists using the Titian Spark extension will be able to quickly identify the input data at the root cause of a potential bug or outlier result. Titian is built directly into the Spark platform and offers data provenance support at interactive speeds-orders-of-magnitude faster than alternative solutions-while minimally impacting Spark job performance; observed overheads for capturing data lineage rarely exceed 30% above the baseline job execution time.

  9. 从临床疗效角度谈原研药和仿制药的区别%The difference of therapeutic effectiveness for branded and generic drugs

    Institute of Scientific and Technical Information of China (English)

    李新刚; 赵志刚

    2013-01-01

    Objective: To introduce the difference between therapeutic effectiveness for branded and generic drugs, and to explore the reasons of these differences. Methods: Articles for comparative studies of branded and generic drugs were retrieved from the databases of ISI Web of Knowledge, PubMed, ScienceDirect and CNKI, and which were arranged and analyzed. Results: Compared with branded drugs, generic drugs got the poor treatment effects in a variety of treatment fields, such as antiepileptic, anti-parkinson, anti-psychotic, immunodepressant, cardiovascular drugs, antibiotics. Conclusion: Although bioequivalence is the legal standard, it can't take place of therapeutic efficacy. Pharmaceutics is the key factor for the difference.%  目的:从临床疗效的角度对原研药与仿制药的区别进行介绍并探讨引起疗效差别可能的原因。方法:在ISI Web of Knowledge、PubMed、Science Direct和中国知网数据库中检索原研药与仿制药对比的相关中英文文献,并对文章进行分析。结果:通过对检索到的相关文献进行分析,我们发现在癫痫、帕金森、精神疾病、器官移植、心血管和感染疾病方面的仿制药与原研药相比存在一定差异。结论:对于部分药物而言,作为评价仿制药上市的标准--生物等效性(bioequivalence,BE)试验尚不能替代临床疗效的等效性。制剂因素是两种药品疗效差异的根本原因。

  10. Resistance of a water spark.

    Energy Technology Data Exchange (ETDEWEB)

    Warne, Larry Kevin; Jorgenson, Roy Eberhardt; Lehr, Jane Marie

    2005-11-01

    The later time phase of electrical breakdown in water is investigated for the purpose of improving understanding of the discharge characteristics. One dimensional simulations in addition to a zero dimensional lumped model are used to study the spark discharge. The goal is to provide better electrical models for water switches used in the pulse compression section of pulsed power systems. It is found that temperatures in the discharge channel under representative drive conditions, and assuming small initial radii from earlier phases of development, reach levels that are as much as an order of magnitude larger than those used to model discharges in atmospheric gases. This increased temperature coupled with a more rapidly rising conductivity with temperature than in air result in a decreased resistance characteristic compared to preceding models. A simple modification is proposed for the existing model to enable the approximate calculation of channel temperature and incorporate the resulting conductivity increase into the electrical circuit for the discharge channel. Comparisons are made between the theoretical predictions and recent experiments at Sandia. Although present and past experiments indicated that preceding late time channel models overestimated channel resistance, the calculations in this report seem to underestimate the resistance relative to recent experiments. Some possible reasons for this discrepancy are discussed.

  11. 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.

  12. Stavudine- and nevirapine-related drug toxicity while on generic fixed-dose antiretroviral treatment: incidence, timing and risk factors in a three-year cohort in Kigali, Rwanda.

    Science.gov (United States)

    van Griensven, Johan; Zachariah, Rony; Rasschaert, Freya; Mugabo, Jules; Atté, Edi F; Reid, Tony

    2010-02-01

    This cohort study was conducted to report on the incidence, timing and risk factors for stavudine (d4T)- and nevirapine (NVP)-related severe drug toxicity (requiring substitution) with a generic fixed-dose combination under program conditions in Kigali, Rwanda. Probability of 'time to first toxicity-related drug substitution' was estimated using the Kaplan-Meier method and Cox-proportional hazards modeling was used to identify risk factors. Out of 2190 adults (median follow-up: 1.5 years), d4T was replaced in 175 patients (8.0%) for neuropathy, 69 (3.1%) for lactic acidosis and 157 (7.2%) for lipoatrophy, which was the most frequent toxicity by 3 years of antiretroviral treatment (ART). NVP was substituted in 4.9 and 1.3% of patients for skin rash and hepatotoxicity, respectively. Use of d4T 40 mg was associated with increased risk of lipoatrophy and early (strategies.

  13. Políticas de fomento de la competencia en precios en el mercado de genéricos: lecciones de la experiencia europea Policies encouraging price competition in the generic drug market: Lessons from the European experience

    Directory of Open Access Journals (Sweden)

    Jaume Puig-Junoy

    2010-06-01

    Full Text Available Objetivos: Describir políticas alternativas para el fomento de la competencia en precios en el mercado de medicamentos genéricos de países altamente regulados, y presentar algunos casos de estudio de la experiencia europea. Métodos: Revisión sistemática de artículos e informes técnicos posteriores a 1999. Resultados: Las limitaciones a la competencia de precios de venta al público de los genéricos observadas en varios países europeos, entre los que se incluye España, se pueden mitigar mediante reformas de las políticas de reembolso o financiación pública que se pueden clasificar en tres grandes grupos: medidas de mejora y profundización del diseño de los sistemas vigentes de fijación del reembolso máximo; medidas de seguimiento de los precios competitivos con la finalidad de reembolsar a las oficinas de farmacia sólo los costes reales de adquisición; y medidas de fomento de la competencia de precios en las adquisiciones públicas basadas en instrumentos de mercado como las subastas competitivas. La experiencia de las medidas adoptadas en los últimos años en Alemania, Bélgica, Holanda, Noruega y Suecia resulta una referencia útil para los países altamente regulados, como España, caracterizados por una limitada competencia de precios de venta al público y elevados descuentos a las oficinas de farmacia. Conclusiones: Resulta posible adoptar medidas efectivas de fomento de la competencia de precios de venta al público en los mercados de medicamentos genéricos en los países con una regulación directa de los precios o sistemas de precios de referencia como instrumento privilegiado para reducir el precio de los genéricos.Objectives: 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. Methods: Systematic literature review of articles and technical reports published

  14. Electro-spark deposition technology

    Energy Technology Data Exchange (ETDEWEB)

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

    1996-08-01

    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 as one of the enabling technologies for advanced energy systems. 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. One of the most significant breakthroughs to occur in the last dozen years is the discovery of a process regime that promises an order of magnitude increase in deposition rates and achievable coating thicknesses. Since this regime borders on and exceeds the normal operating limits of existing ESD electronic equipment, development is in progress to produce equipment that can consistently and reliably achieve these conditions for a broad range of materials. Progress so far has resulted in a consistent 500% increase in deposition rates, and greater rates still are anticipated. Technology transfer activities are a significant portion of the ESD program effort. Notable successes now include the start-up of a new business to commercialize the ESD technology, the incorporation of the process into the operations of a major gas turbine manufacturer, major new applications in gas turbine blade and steam turbine blade protection and repair, and in military, medical, metal-working, and recreational equipment applications.

  15. Associations between generic substitution and patient-related factors

    DEFF Research Database (Denmark)

    Østergaard Rathe, Jette

    for Pharmacoepidemiology, Karolinska Institutet, Department of Medicine Solna, Stockholm, Sweden 3. Danish Quality Unit of General Practice, Odense, Denmark Background Generic substitution means that chemically equivalent but less expensive drugs are dispensed in place of a brand name product. Although generic medicines...... was made on beliefs about medicine, views on generic medicine and confidence in the health care system. The study comprised 2476 patients (736 users of antidepressants, 795 users of antiepileptics and 945 users of other substitutable drugs). For each patient we focused on one purchase of a generically...

  16. Comparative study of INPIStron and spark gap

    Science.gov (United States)

    Han, Kwang S.; Lee, Ja H.

    1993-01-01

    An inverse pinch plasma switch, INPIStron, was studied in comparison to a conventional spark gap. The INPIStron is under development for high power switching applications. The INPIStron has an inverse pinch dynamics, opposed to Z-pinch dynamics in the spark gap. The electrical, plasma dynamics and radiative properties of the closing plasmas have been studied. Recently the high-voltage pulse transfer capabilities or both the INPIStron and the spark gap were also compared. The INPIStron with a low impedance Z = 9 ohms transfers 87 percent of an input pulse with a halfwidth of 2 mu s. For the same input pulse the spark gap of Z = 100 ohms transfers 68 percent. Fast framing and streak photography, taken with an TRW image converter camera, was used to observe the discharge uniformity and closing plasma speed in both switches. In order to assess the effects of closing plasmas on erosion of electrode material, emission spectra of two switches were studied with a spectrometer-optical multi channel analyzer (OMA) system. The typical emission spectra of the closing plasmas in the INPIStron and the spark gap showed that there were comparatively weak carbon line emission in 658.7 nm and copper (electrode material) line emissions in the INPIStron, indicating low erosion of materials in the INPIStron.

  17. Laser spark distribution and ignition system

    Science.gov (United States)

    Woodruff, Steven; McIntyre, Dustin L.

    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.

  18. Patients' attitude about generics –Bulgarian perspective

    Directory of Open Access Journals (Sweden)

    Hristina Lebanova

    2012-01-01

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

  19. 仿制药注射用帕瑞昔布钠包材相容性研究%Study on the compatibility of generic drug - Parecoxib Sodium for Injection with its packing materials

    Institute of Scientific and Technical Information of China (English)

    宋岩珺; 蒲旭峰; 朱鹏; 刘小双

    2016-01-01

    目的:考察仿制药注射用帕瑞昔布钠与其包材的相容性。方法通过脱片、迁移试验,影响因素下正置和倒置、加速试验,观察、测定并比较仿制药注射用帕瑞昔布钠各考察时间下性状,可见异物,不溶性微粒,杂质,含量的变化。结果脱片、迁移试验较考察初期均没有显著变化(P ﹥0.05),且各指标均在可接受的安全阈值;在影响因素各条件下,正置和倒置样品各项指标无明显差异(P ﹥0.05),在加速条件(1月、2月、3月和6月)下,包材相容性样品(倒置)和稳定性考察样品(正置)各项指标无显著差异(P ﹥0.05)。结论仿制药注射用帕瑞昔布钠与包材相容。%Objective To inspect the compatibility of generic drug - Parecoxib Sodium for Injection with its packing materials. Methods By the tests of delamination and migration,positive position and inversions under the influencing factor accelerated tests to observe,determine and compare the changes of the character visible foreign matter insoluble particles, related substances,content for generic drug - Parecoxib Sodium for Injection in their study time. Results No significant differences were found in the delamination and migration tests compared with its early study(P ﹥ 0. 05),and each index was in the acceptable safety threshold;No significant differences were found in each index for samples in positive position and inversions under the influencing factor(P ﹥ 0. 05),in the accelerated treatment(1,2,3 and 6 months)each index for sam-ples of compatibility and stability were found no significant differences(P ﹥ 0. 05). Conclusion The packing materials had good compatibily with the generic drug - Parecoxib Sodium for Injection.

  20. 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

  1. Generic Fortran Containers (GFC)

    Energy Technology Data Exchange (ETDEWEB)

    2016-09-01

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

  2. Spark - a modern approach for distributed analytics

    CERN Document Server

    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

  3. 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...

  4. Generation of nanoparticles by spark discharge

    Science.gov (United States)

    Tabrizi, N. S.; Ullmann, M.; Vons, V. A.; Lafont, U.; Schmidt-Ott, A.

    2009-02-01

    The production of nanoparticles by microsecond spark discharge evaporation in inert gas is studied systematically applying transmission electron microscopy, mobility analysis and BET surface area measurement. The method of spark discharge is of special interest, because it is continuous, clean, extremely flexible with respect to material, and scale-up is possible. The particle size distributions are narrow and the mean primary particle size can be controlled via the energy per spark. Separated, unagglomerated particles, 3-12 nm in size, or agglomerates can be obtained depending on the flow rate. The nanoparticulate mass produced is typically 5 g/kWh. A formula is given, which estimates the mass production rate via thermal conductivity, evaporation enthalpy and the boiling point of the material used. We showed that with gas purified at the spot, the method produced gold particles that were so clean that sintering of agglomerated particles occurred at room temperature. The influence of a number of parameters on the primary particle size and mass production rate was studied and qualitatively understood with a model of Lehtinen and Zachariah (J Aerosol Sci 33:357-368, 2002). Surprisingly high charging probabilities for one polarity were obtained. Spark generation is therefore of special interest for producing monodisperse aerosols or particles of uniform size via electrical mobility analysis. Qualitative observations in the present study include the phenomenon of material exchange between the electrodes by the spark, which opens the possibility of producing arbitrary mixtures of materials on a nanoscale. If spark generation of nanoparticles is performed in a standing or almost standing gas, an aerogel of a web-like structure forms between surfaces of different electrical potential.

  5. 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.

  6. 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.

  7. 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.

  8. 中国制药企业在美国市场中应对授权仿制药竞争的策略研究%Research on Strategy of China Pharmaceutical Companies Coping with Competition of Authorized Generics in American Drug Market

    Institute of Scientific and Technical Information of China (English)

    刘立春; 朱雪忠

    2013-01-01

    OBJECTIVE To study the principle,feature and impact of the authorized generics strategy in American drug market,thus to provide some references for Chinese scholars who research the authorized generics strategy and for China pharmaceutical companies that would face competition in American pharmaceutical market.METHODS By case study and policies analysis,the ways how the brand-name companies used the authorized generics in American drug market were summarized.RESULTS AND CONCLUSION Successful authorized generics strategy can maintain a large market share of the brand-name companies'products.In American drug market,there are some particularities about the authorize generics strategy due to the features of American drug policies and regulations.China pharmaceutical companies should implement different authorized generics strategy according to their own conditions in American drug market at present.%目的 通过对美国授权仿制药战略原理、特点以及影响进行研究,为中国学者探讨授权仿制药战略以及中国制药企业在美国市场面临授权仿制药竞争时提供借鉴.方法 通过案例分析和政策解析,总结品牌药厂商在美国市场中使用授权仿制药策略的特点.结论与结果 成功的授权仿制药战略能够使品牌药厂商的产品在专利到期后仍能后维持较大的市场份额.中国制药企业需要根据自身的情况在美国市场选择不同的授权仿制药策略.

  9. 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.

  10. Optical diagnostics integrated with laser spark delivery system

    Science.gov (United States)

    Yalin, Azer; Willson, Bryan; Defoort, Morgan; Joshi, Sachin; Reynolds, Adam

    2008-09-02

    A spark delivery system for generating a spark using a laser beam is provided, and includes 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. The laser delivery assembly further 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. Other embodiments use a fiber laser to generate a spark. Embodiments of the present invention may be used to create a spark in an engine. Yet other embodiments include collecting light from the spark or a flame resulting from the spark and conveying the light for diagnostics. Methods of using the spark delivery systems and diagnostic systems are provided.

  11. Evaluation of Innovative High Pulse Rate, Purged Spark Gap Concepts

    Science.gov (United States)

    1989-06-01

    gugh the switch and the pressure loss through the gas circulation system. The pressure loss is the sum of the losses in the spark gap , flow ducting...developed to solve the mass, momentum, and energy conservation equations which govern the purging process in a spark gap flow channel following arc...formation. [2,3] In this model, gas properties and spark gap flow channel area varied with distance along the flow axis from the spark gap and with

  12. 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.

  13. 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.

  14. 拉曼光谱快速鉴别品牌药与仿制药的研究%Rapid Screening of the branded and generic drugs by Raman Spectroscopy

    Institute of Scientific and Technical Information of China (English)

    陈辉; 王晓钰; 李丹; 陆峰; 褚克丹

    2015-01-01

    In this paper, Raman spectroscopy in combination with Random forest method were used to distinguish the differences between the same drugs of different manufacturers efficiently. The captopril tablets were used as the experimental samples, and one of them was branded version, the others were generic drug manufacturers. Additionally, the pretreatment methods of spectra wavelength range cutting, smoothing, and baseline correcting, mean-centralizing and so on. After optimization of parameters, the prediction model was established by method of Principal component analysis (PCA) and Random forests (RF). The results show that PCA cannot differentiate the branded version and six generic drug manufacturers, while the RF characterized the differences very well. So one can draw a conclusion that the application of RF can make a great contribution to Raman spectroscopy for the drug fast screening efficiently and accurately.%本文用拉曼光谱结合随机森林法很好的区分了相同药品不同厂家之间差异,为拉曼光谱用于快速区分仿制药和品牌药奠定基础。选用了1个品牌药厂家和6个仿制药厂家生产的卡托普利片作为实验研究对象,经过截取拉曼波长范围、光谱平滑、背景扣除、中心化等预处理,优化参数后,用随机森林法和主成分分析投影判别分别建立分析模型。计算结果表明:随机森林法所建立的分类模型可以区分卡托普利片的品牌药与仿制药厂家间的差异性,结果优于的主成分分析降维后不同主成分数下的投影判别分析效果。因此结合随机森林法能为拉曼光谱在药品快检中的高效、快速、无损分析提供有力保障。

  15. 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.

  16. Vaporization of atherosclerotic plaques by spark erosion

    NARCIS (Netherlands)

    C.J. Slager (Cornelis); C.E. Essed; J.C.H. Schuurbiers (Johan); N. Bom (Klaas); P.W.J.C. Serruys (Patrick); G.T. Meester (Geert)

    1985-01-01

    textabstractAn alternative to the laser irradiation of atherosclerotic lesions has been developed. A pulsed electrocardiogram R wave-triggered electrical spark erosion technique is described. Controlled vaporization of fibrous and lipid plaques with minimal thermal side effects was achieved and docu

  17. 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

  18. 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

  19. 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...

  20. 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....

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

    Directory of Open Access Journals (Sweden)

    Michael R Law

    Full Text Available BACKGROUND: 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. METHODS: 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. RESULTS: 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. DISCUSSION: 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.

  2. 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.

  3. Development and validation of a generic liquid chromatographic method for the simultaneous determination of five commonly used antimalarial drugs: Application to pharmaceutical formulations and human plasma.

    Science.gov (United States)

    Mannemala, Sai Sandeep; Nagarajan, Janaki Sankarachari Krishnan

    2015-05-01

    A simple, sensitive, and rapid liquid chromatographic method was developed and validated using diode array detection for the determination of five commonly used antimalarial drugs in pharmaceutical formulations and in human plasma. Chromatographic separation of antimalarial drugs and internal standard (ibuprofen) was achieved on a C18 column with a mobile phase composed of 10 mM dipotassium orthophosphate at pH 3.0, methanol, and acetonitrile in a ratio of 20:38:42 v/v, at a flow rate of 1 mL/min. The analytes were monitored at 220 nm and separated in ˂10 min. The method was validated for linearity, accuracy, precision, limit of quantification, and robustness. Both intra- and interday precisions (in terms of %RSD) were lower than 3% and accuracy ranged from 98.1 to 104.5%. Extraction recoveries were ≥96% in plasma. The limits of quantitation for artemether, lumefantrine, pyrimethamine, sulfadoxine, and mefloquine were 0.3, 0.03, 0.06, 0.15, and 0.15 μg/mL in human plasma. Stability under various conditions was also investigated. The method was successfully applied for quantification of antimalarial drugs in marketed formulations and in spiked human plasma. The method can be employed for routine QC purposes and in pharmacokinetic investigations.

  4. Use of physiologically based pharmacokinetic models coupled with pharmacodynamic models to assess the clinical relevance of current bioequivalence criteria for generic drug products containing Ibuprofen.

    Science.gov (United States)

    Cristofoletti, Rodrigo; Dressman, Jennifer B

    2014-10-01

    Physiologically based pharmacokinetic models coupled with pharmacodynamic (PBPK/PD) models can be useful to identify whether current bioequivalence criteria is overly conservative or venturesome for different drugs. A PBPK model constructed with Simcyp Simulator(®) using reported biopharmaceutics parameters for ibuprofen was coupled with two published PD models: one for antipyresis and one for dental pain relief. Using products with doses of 400 mg and 10 mg/kg as "reference (R)" drug products, virtual products with doses of 280 mg and 7 mg/kg, respectively, could be interpreted as representing bioinequivalent test (T) drug products, as the point estimate for the ratios T/R are well below the bioequivalence limits. Despite being bioinequivalent in terms of PK, these lower doses were shown to be therapeutically equivalent to the higher doses because of the flat dose-response relationship of ibuprofen. Sensitivity analysis of the PBPK/PD models demonstrated that gastric emptying time, dissolution rate and small intestine pH are variables that influence ibuprofen PK, but do not seem to significantly affect its PD. It was concluded that current bioequivalent guidance might be unnecessarily restrictive for ibuprofen products.

  5. A price and use comparison of generic versus originator cardiovascular medicines: a hospital study in Chongqing, China

    OpenAIRE

    Zeng, Wenjie

    2013-01-01

    Background Developed countries use generic competition to contain pharmaceutical expenditure. China, as a developing and transitional country, has not yet deemed an increase in the use of generic products as important; otherwise, much effort has been made to decrease the drug prices. This paper aims to explore dynamically the price and use comparison of generic and originator drugs in China, and estimate the potential savings of patients from switching originator drugs to generics. Methods A ...

  6. Studies on effect of spark advance angle and spark gap on cycle-by-cycle fluctuations in four stroke spark ignition engine

    Energy Technology Data Exchange (ETDEWEB)

    Bhaskar, H.B.; Chandrasheaker, T.K. [Sri Siddhartha Inst. of Technology, Maralur, Tumkur (India). Dept. of Mechanical Engineering; Antony, A.J. [Sahyedri Inst. of Technology, Mangalore (India)

    2009-07-01

    In response to environmental concerns and the depletion of fossil fuels, the automotive industry is striving to increase fuel efficiency and reduce emissions such as soot and nitrous oxides (NOx). This paper focused on the nature of cyclic variability and its manifestation in the characteristics of spark-ignition (SI) engine combustion. Cycle-by-cycle fluctuation is a major phenomenon that limits the range of operating conditions. The parameters affecting cycle-by-cycle fluctuation include mixture distribution, mixture homogeneity, spark intensity, spark timing, spark plug location, spark plug gap, number of spark plugs, swirl, combustion chamber geometry, compression ratio, equivalence ratio, load and speed. The degree to which these parameters influence cycle-by-cycle fluctuations was investigated. The cycle-by-cycle fluctuations in the engine reduces the power output, but increases the engine roughness and emissions. Experiments were carried out on a four stroke single cylinder computerized spark ignition engine. The results revealed the best operating spark gap and advanced spark angle to minimize the cycle-by-cycle fluctuations. The overall engine performance was improved with better drivability. 6 refs., 3 tabs., 10 figs.

  7. 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.

  8. 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.

  9. Generic immunosuppression in solid organ transplantation: systematic review and meta-analysis

    OpenAIRE

    Molnar, Amber O; Fergusson, Dean; Tsampalieros, Anne K.; Bennett, Alexandria; Fergusson, Nicholas; Ramsay, Timothy; Knoll, Greg A.

    2015-01-01

    Objective To compare the clinical efficacy and bioequivalence of generic immunosuppressive drugs in patients with solid organ transplants. Design Systematic review and meta-analysis of all studies comparing generic with innovator immunosuppressive drugs. Data sources Medline and Embase from 1980 to September 2014. Review methods A literature search was performed for all studies comparing a generic to an innovator immunosuppressive drug in solid organ transplantation. Two reviewers independent...

  10. Generic Airspace Survey

    Science.gov (United States)

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

    2013-01-01

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

  11. 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.

  12. Towards spark-proof gaseous pixel detectors

    Science.gov (United States)

    Tsigaridas, S.; Beuzekom, M. v.; Chan, H. W.; Graaf, H. v. d.; Hartjes, F.; Heijhoff, K.; Hessey, N. P.; Prodanovic, V.

    2016-11-01

    The micro-pattern gaseous pixel detector, is a promising technology for imaging and particle tracking applications. It is a combination of a gas layer acting as detection medium and a CMOS pixelated readout-chip. As a prevention against discharges we deposit a protection layer on the chip and then integrate on top a micromegas-like amplification structure. With this technology we are able to reconstruct 3D track segments of particles passing through the gas thanks to the functionality of the chip. We have turned a Timepix3 chip into a gaseous pixel detector and tested it at the SPS at Cern. The preliminary results are promising and within the expectations. However, the spark protection layer needs further improvement to make reliable detectors. For this reason, we have created a setup for spark-testing. We present the first results obtained from the lab-measurements along with preliminary results from the testbeam.

  13. Representações sociais do medicamento genérico por consumidores residentes em Natal, Rio Grande do Norte, Brasil Social representations of generic drugs by consumers from Natal, Rio Grande do Norte, Brazil

    Directory of Open Access Journals (Sweden)

    Maria Cleide Ribeiro Dantas de Carvalho

    2006-03-01

    Full Text Available O trabalho objetivou determinar os núcleos central e periférico das representações sociais do medicamento genérico por consumidores, estabelecendo mecanismos que poderão ser utilizados no aprimoramento da política desse tipo de medicamento no Brasil. A pesquisa foi realizada no período de abril de 2002 a fevereiro de 2003, na Cidade do Natal, Rio Grande do Norte, com quatrocentos consumidores. O teste utilizado foi o de associação de palavras, e o estímulo indutor, as palavras medicamento genérico. Foi solicitada a evocação de três palavras, de acordo com a estratégia de acesso ao Núcleo Central de Vergès. A análise dos dados foi realizada com o auxílio do programa EVOC 2000 e da análise de conteúdo preconizada por Bardin. Os resultados demonstraram que o núcleo central era composto pelas categorias preço, qualidade e equivalência farmacêutica, e o sistema periférico, representado pelas categorias opção, eficácia, governo, benefício social e acessibilidade.This paper aimed to determine the central and peripheral roles of consumers' social representations concerning generic drugs, establishing mechanisms that could be used to improve policies for this type of medication in Brazil. The research was done from April 2002 to February 2003 in the city of Natal, Rio Grande do Norte, with 400 consumers. The study employed the word association test with the words "generic drug" as the inductive stimulus. Evocation of three words was requested, according to the access strategy to Vergès' Central Nucleus. Data analysis used the EVOC 2000 software and the content analysis proposed by Bardin. The results demonstrated that the central nucleus consisted of the categories price, quality, and pharmaceutical equivalence, while the peripheral system was represented by the categories option, effectiveness, government, social benefit, and accessibility.

  14. 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.

  15. Suprathermal electrons in a vacuum spark discharge

    Energy Technology Data Exchange (ETDEWEB)

    Bashutin, O. A., E-mail: boa308@mail.ru; Savjolov, A. S., E-mail: savjolov@plasma.mephi.ru [National Research Nuclear University MEPhI (Russian Federation)

    2016-04-15

    Results of experiments on the detection of suprathermal electron beams in the plasma of a highcurrent low-inductance vacuum spark by means of space-resolved spectral X-ray polarimetry are presented. It is shown that the observed polarization of bremsstrahlung may be caused by an ~100-keV electron beam propagating along the discharge axis from the pinching region toward the anode. The influence of the discharge initiation conditions on the parameters of the generated electron beams is analyzed.

  16. Toward better quality of anticancer generics in India

    Directory of Open Access Journals (Sweden)

    V S Gota

    2014-01-01

    Full Text Available Treatment of cancer is limited by affordability of patients in the many developing countries including India. Generic drug manufacturers have responded to this scenario by making drugs available at affordable costs, often at less than 10% the cost of the original brand. In our practice, it is found that there is a three-fold higher prescription of generic brands compared to innovator, accompanied by cost savings of up to 80% per prescription. Unfortunately, the regulatory environment prevailing in India is not geared to ensure satisfactory quality of generic products. The standards set by the regulatory agencies for establishing equivalence of generics vis-ΰ-vis the innovator product allow anticancer generics to enter markets without undergoing clinical evaluation. Many drug manufacturing units in India flout good manufacturing practice norms, which was evident during the center for drug evaluation and research classifications inspection in the year 2006. Inferior drugs have therefore, made their way into the Indian markets, compromising the quality of care. The system of drug manufacturing and marketing approval needs a major overhaul, including regular inspection of manufacturing facilities. Bioequivalence should be made mandatory for all oral formulations. Unless these measures are rigidly implemented, the benefits of generic substitution would be seriously undermined.

  17. Toward better quality of anticancer generics in India.

    Science.gov (United States)

    Gota, V S; Patial, P

    2014-01-01

    Treatment of cancer is limited by affordability of patients in the many developing countries including India. Generic drug manufacturers have responded to this scenario by making drugs available at affordable costs, often at less than 10% the cost of the original brand. In our practice, it is found that there is a three-fold higher prescription of generic brands compared to innovator, accompanied by cost savings of up to 80% per prescription. Unfortunately, the regulatory environment prevailing in India is not geared to ensure satisfactory quality of generic products. The standards set by the regulatory agencies for establishing equivalence of generics vis-ΰ-vis the innovator product allow anticancer generics to enter markets without undergoing clinical evaluation. Many drug manufacturing units in India flout good manufacturing practice norms, which was evident during the center for drug evaluation and research classifications inspection in the year 2006. Inferior drugs have therefore, made their way into the Indian markets, compromising the quality of care. The system of drug manufacturing and marketing approval needs a major overhaul, including regular inspection of manufacturing facilities. Bioequivalence should be made mandatory for all oral formulations. Unless these measures are rigidly implemented, the benefits of generic substitution would be seriously undermined.

  18. Interchangeability of gabapentin generic formulations in the Netherlands: a comparative bioavailability study

    NARCIS (Netherlands)

    Yu, Y.; Teerenstra, S.; Vanmolkot, F.; Neef, C.; Burger, D.M.; Maliepaard, M.

    2013-01-01

    To investigate the so-called "drift" with generic-generic drug substitution, a single-dose, four-way crossover comparative bioavailability study was performed involving 24 healthy subjects and three generic and one branded formulation of a tablet containing 800 mg gabapentin as test medication. The

  19. 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.

  20. Generic Kalman Filter Software

    Science.gov (United States)

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

    2005-01-01

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

  1. SI Engine with repetitive NS spark plug

    Science.gov (United States)

    Pancheshniy, Sergey; Nikipelov, Andrey; Anokhin, Eugeny; Starikovskiy, Andrey; Laplase Team; Mipt Team; Pu Team

    2013-09-01

    Now de-facto the only technology for fuel-air mixtures ignition in IC engines exists. It is a spark discharge of millisecond duration in a short discharge gap. The reason for such a small variety of methods of ignition initiation is very specific conditions of the engine operation. First, it is very high-pressure of fuel-air mixture - from 5-7 atmospheres in old-type engines and up to 40-50 atmospheres on the operating mode of HCCI. Second, it is a very wide range of variation of the oxidizer/fuel ratio in the mixture - from almost stoichiometric (0.8-0.9) at full load to very lean (φ = 0.3-0.5) mixtures at idle and/or economical cruising mode. Third, the high velocity of the gas in the combustion chamber (up to 30-50 m/s) resulting in a rapid compression of swirling inlet flow. The paper presents the results of tests of distributed spark ignition system powered by repetitive pulse nanosecond discharge. Dynamic pressure measurements show the increased pressure and frequency stability for nanosecond excitation in comparison with the standard spark plug. Excitation by single nanosecond high-voltage pulse and short train of pulses was examined. In all regimes the nanosecond pulsed excitation demonstrate a better performance.

  2. Price regulation and generic competition in the pharmaceutical market.

    Science.gov (United States)

    Dalen, Dag Morten; Strøm, Steinar; Haabeth, Tonje

    2006-09-01

    In March 2003 the Norwegian government implemented yardstick-based price regulation schemes on a selection of drugs subjected to generic competition. The retail price cap, termed the "index price," on a drug (chemical substance) was set equal to the average of the three lowest producer prices on that drug, plus a fixed wholesale and retail margin. This is supposed to lower barriers of entry for generic drugs and to trigger price competition. Using monthly data over the period 1998-2004 for the six drugs (chemical entities) included in the index price system, we estimate a structural model enabling us to examine the impact of the reform on both demand and market power. Our results suggest that the index price helped to increase the market shares of generic drugs and succeeded in triggering price competition.

  3. Levantamento de dados sobre o conhecimento e informação acerca dos medicamentos genéricos em uma população de pacientes do serviço de saúde ambulatorial do Recife, Pernambuco, Brasil Knowledge and information concerning generic drugs in a public outpatient population in Recife, Pernambuco, Brazil

    Directory of Open Access Journals (Sweden)

    Chiara Erminia da Rocha

    2007-05-01

    Full Text Available A Lei nº. 9.787/99, que regulamenta os medicamentos genéricos, contempla normas para o registro e prevê a expansão do acesso da população a medicamentos seguros, eficazes, com qualidade e baixo custo. Após um quadriênio da introdução dos genéricos no Brasil, propõe-se verificar o conhecimento e a informação sobre genéricos entre os usuários dos serviços públicos de saúde ambulatorial do Recife, Pernambuco. No ano de 2002, foi aplicado um questionário pré-elaborado. Dos entrevistados, 76,1% eram do sexo feminino. Ouviram falar sobre o "medicamento genérico" 95,7% e 68,1% conheciam o medicamento genérico. As ações adotadas pelo governo, quanto à divulgação das propriedades desta especialidade farmacêutica e às vantagens oferecidas ao consumidor, atingiram sobremaneira esta população.Brazilian Federal Act 9,787/99, regulating generic medicines, includes rules for drug registration and provides for the population's access to safe, effective, high-quality, and low-cost medication. Four years after the introduction of generic drugs on the Brazilian market, we proposed to measure knowledge and information on generic drugs among the clientele at a public outpatient clinic in Recife, Pernambuco State, applying a questionnaire in 2000. 76.1% of the interviewees were women, 95.7% had heard of generic drugs, and 68.1% could define generic medication. Government action to publicize the properties of such medicines and their advantages for consumers has thus reached the vast majority of the population.

  4. Relationship between Exploding Bridgewire & Spark Initiation of Low Density PETN

    Science.gov (United States)

    Lee, Elizabeth; Drake, Rod

    2015-06-01

    Recent work has shown that the energy delivered after bridgewire burst affects the function time of an EBW detonator. The spark which is formed post bridgewire burst is the means by which the remaining fireset energy is delivered into the detonator. Therefore, by studying the characteristics of spark-gap detonators insight into the contribution of spark initiation to the functioning of EBW detonators may be achieved. Spark initiation of low density explosives consists of; (i) spark formation, (ii) spark interaction with the bed, and (iii) ignition and growth of reaction. Experiments were performed in which beds of an inert simulant were used to study the formation and propagation of sparks. The effect of the spark on inert porous beds was studied over a limited delivered energy range. The disruption of the bed was found to be dependent on the particle size / pore structure of the bed. The effect of spark initiation on a low density PETN bed was then examined, the relationship between delivered energy and function time was found to be the same as for EBW detonators. This necessitated the development of electrical diagnostic techniques to measure the energy delivered to the spark.

  5. Exploring Generic Haskell

    NARCIS (Netherlands)

    Löh, A.

    2004-01-01

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

  6. Generic Market Models

    NARCIS (Netherlands)

    R. Pietersz (Raoul); M. van Regenmortel

    2005-01-01

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

  7. 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

    of confidence in the identical effect of the substitutable medicines. Several studies have focused on one specific drug group such as antihypertensive drugs. However, the influence of generic switching may affect concerns about medicine differently, depending on drug categories. Research on generic substitution...... reduced persistence. So far, studies of the effect of generic drug substitution on drug continuation have not focused on patients' overall experience of generic switches within one specific drug. AIMS: To analyse associations between generic substitution and patient characteristics as well as patients......' views on generic medicines, confidence in the healthcare system, beliefs about medicine, and experience with earlier generic substitution. To investigate the possible association between a specific generic switch and patients' concerns about their medicine. To examine how generic switch influences...

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

    DEFF Research Database (Denmark)

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

    2014-01-01

    . 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......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...

  9. Price regulation and generic competition in the pharmaceutical market

    OpenAIRE

    Dalen, Dag Morten; Strøm, Steinar; Haabeth, Tonje

    2009-01-01

    In March 2003 the Norwegian government implemented yardstick based price regulation schemes on a selection of drugs experiencing generic competition. The retail price cap, termed “index price”, on a drug (chemical substance) was set equal to the average of the three lowest producer prices on that drug, plus a fixed wholesale and retail margin. This is supposed to lower barriers of entry for generic drugs and to trigger price competition. Using monthly data over the period 1998-2004 for the 6 ...

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  1. 印度仿制药产业现状及发展策略浅析%Current Situation and Development Strategy of India’s Generic Drug and Biosimilars Industry

    Institute of Scientific and Technical Information of China (English)

    任晓明

    2013-01-01

      印度制药业充分利用本国专利法和国家药品政策,以及国际上相关的药品法规的不完善,抓住发展机遇,实现了从单纯仿制到仿研结合、自主研发的转变.从 20 世纪 80 年代末,印度制药企业大量制造仿制药,至 2000 年前后,印度药品 50% 以上(大部分为仿制药)供出口,成为全球药品出口大国.印度生物制药企业能够生产生物仿制药 40 余种,2012 年,其生物仿制药市场达到 5.8 亿美元.印度仿制药产业的成功带给我们诸多启示,如:应注重国际知识产权游戏规则的研究;应有效利用外包,以提升自主研发的能力,等等.%Benefiting from the domestic patent law and preferential medicine policies, India’s pharmaceutical industry enjoys significant development by taking advantage of the defectiveness in relevant international pharmaceutical legislation. It opens up a new road to development, from simple copy via combination of copy&research and finally to independent R&D. From the end of 1980s, India pharmaceutical companies started the mass-manufacture of generic drugs and India became a dominant medicine exporter with its 50%of total outputs ( majority being generics) for international market in 2000. Indian pharmaceutical enterprises can produce more than 40 kinds of bio-similars. In 2012, the market value of Indian bio-similars reached 580 million USD. The success achieved by Indian pharmaceutical industry can give us some inspirations, such as, pay attention to the research on game rules of international intellectual property;take full advantage of outsourcing to enhance the ability of independent research and development, and so on.

  2. 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.

  3. Dual channel formation in a laser-triggered spark gap

    Science.gov (United States)

    Kushner, M. J.; Kimura, W. D.; Ford, D. H.; Byron, S. R.

    1985-12-01

    During self-break in spark-gap switches, multiple streamers can form in close proximity to one another. The rate of expansion of these streamers is sufficiently fast that they can interact during the current pulse. To help understand how these closely spaced, expanding spark columns interact, a laser-triggered spark gap has been studied in which two parallel columns (separation 1.3 mm) are simultaneously preionized, resulting in a pair of nearly identical, axisymmetric spark columns. The spark gap (electrode separation 1.2 cm) switches a 100 ns, 40-60 kV, 12-20 kA, 1.5 Ω waterline. Interferograms of the expanding arc channels are obtained with a laser interferometer having a time and spatial resolution of 5 ns and 10 μm, respectively. Voltage and current were measured with an internal capacitive-voltage divider and a current viewing resistor. The interferograms show that for initially identical axisymmetric columns, the individual channels do not merge into a single larger axisymmetric spark column. Instead, regions of high gas density remain inside the combined column long into the recovery period. The columns also do not remain axisymmetric as they grow, indicating a long-range interaction between the channels. The voltage drop and resistance of the dual channel spark gaps changes by less than 15% from that of a single spark channel. A scaling model is presented to explain the resistance measurements and to predict the change in resistance for multichannel spark gaps.

  4. Reliable Field Distortion Spark Gap for Plasma Focus

    Institute of Scientific and Technical Information of China (English)

    S.HUSSAIN; M.ZAKAULLAH

    2007-01-01

    A simple,low cost,easily maintained,and reliable field distortion spark gap has been developed to operate at a voltage up to 30 kV.The header construction necessary to attach the spark gap switch to a single 12.5μF,40 kV(10 kJ)capacitor is described.The main features of the spark gap are its wide range of voltage operation,high current capacity,low inductance and long lifetime.The performance of spark gap has been tested in a plasma focus and results are presented in this report.

  5. The Electrostatic Spark Sensitiveness of Initiators. Part 4. Initiation of Explosion by Spark Radiation

    Science.gov (United States)

    1959-10-01

    including :,ire I. Hardy) Engineer Research and Development Laboratories, Fort Belvoir, Va, U.S.A. (Attn: Dr. Z.V. Harv-alik) Through Frankford...troublesome electrical interference associated with the discharge. The light intensity/time characteristics of sparks were determined using a Mazda 2Ti3

  6. Anticipating change, sparking innovation: framing the future.

    Science.gov (United States)

    Petersen, Donna J; Finnegan, John R; Spencer, Harrison C

    2015-03-01

    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.

  7. Generic wormhole throats

    CERN Document Server

    Visser, M; Visser, Matt; Hochberg, David

    1997-01-01

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

  8. 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.

  9. Generic switching of warfarin and risk of excessive anticoagulation

    DEFF Research Database (Denmark)

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

    2015-01-01

    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...

  10. 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.

  11. Generic safety documentation model

    Energy Technology Data Exchange (ETDEWEB)

    Mahn, J.A.

    1994-04-01

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

  12. Generic Network Location Service

    Directory of Open Access Journals (Sweden)

    Laban Mwansa

    2010-11-01

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

  13. 我国某省原研药与仿制药价格差异与市场份额实证研究%Empirical research of price difference and market share between brand-name drugs and generics in one province in China

    Institute of Scientific and Technical Information of China (English)

    李晗; 管晓东; 许立平; 刘洋; 韩晟; 史录文

    2012-01-01

    Objective: To provide scientific reference for the country's price management of brand-name drugs and generics. Methods:We analyzed price comparison and market share between brand-name drugs and generics in a province with the data from the database of medicine bidding and purchase center in the province. Results: The average price ratio of the 198 samples between brand-name drugs and generics was 3.6 in the province. This was higher than the price difference rate as required by the Governmental Pricing Method for the Pharmaceuticals in China. Conclusion:The price difference between brand-name drugs and generics is bigger than the one the government required.%目的:为完善国家原研药与仿制药管理工作提供科学参考.方法:根据某省药品招标采购中心数据库的数据,分析该省原研药与仿制药的价格差异与市场份额.结果:该省198个样本药品中,原研药与仿制药的价格差异倍数的均值为3.6倍,高于《药品政府定价办法》规定的差价率.结论:我国原研药与仿制药的价格差异高于国家规定.

  14. Relativistic electrons from sparks in the laboratory

    Science.gov (United States)

    Østgaard, N.; Carlson, B. E.; Nisi, R. S.; Gjesteland, T.; Grøndahl, Ø.; Skeltved, A.; Lehtinen, N. G.; Mezentsev, A.; Marisaldi, M.; Kochkin, P.

    2016-03-01

    Discharge experiments were carried out at the Eindhoven University of Technology in 2013. The experimental setup was designed to search for electrons produced in meter-scale sparks using a 1 MV Marx generator. Negative voltage was applied to the high voltage (HV) electrode. Five thin (1 mm) plastic detectors (5 cm2 each) were distributed in various configurations close to the spark gap. Earlier studies have shown (for HV negative) that X-rays are produced when a cloud of streamers is developed 30-60 cm from the negative electrode. This indicates that the electrons producing the X-rays are also accelerated at this location, that could be in the strong electric field from counterstreamers of opposite polarity. Comparing our measurements with modeling results, we find that ˜300 keV electrons produced about 30-60 cm from the negative electrode are the most likely source of our measurements. A statistical analysis of expected detection of photon bursts by these fiber detectors indicates that only 20%-45% of the detected bursts could be from soft (˜10 keV) photons, which further supports that the majority of detected bursts are produced by relativistic electrons.

  15. Relativistic electrons from sparks in the laboratory

    CERN Document Server

    Østgaard, N; Nisi, R S; Gjesteland, T; Grøndahl, Ø; Skeltved, A; Lehtinen, N G; Mezentsev, A; Marisaldi, M; Kochkin, P

    2016-01-01

    Discharge experiments were carried out at the Eindhoven University of Technology in 2013. The experimental setup was designed to search for electrons produced in meter-scale sparks using a 1 MV Marx generator. Negative voltage was applied to the high voltage (HV) electrode. Five thin (1 mm) plastic detectors (5 $\\rm cm^2$ each) were distributed in various configurations close to the spark gap. Earlier studies have shown (for HV negative) that X-rays are produced when a cloud of streamers is developed 30-60 cm from the negative electrode. This indicates that the electrons producing the X-rays are also accelerated at this location, that could be in the strong electric field from counterstreamers of opposite polarity. Comparing our measurements with modeling results, we find that $\\sim$300 keV electrons produced about 30-60 cm from the negative electrode are the most likely source of our measurements. A statistical analysis of expected detection of photon bursts by these fiber detectors indicates that only 20%-4...

  16. 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 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..

  17. 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.

  18. 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

  19. 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.

  20. Calcium sparks in the intact gerbil spiral modiolar artery

    Directory of Open Access Journals (Sweden)

    Berge Samantha

    2011-08-01

    Full Text Available Abstract Background Calcium sparks are ryanodine receptor mediated transient calcium signals that have been shown to hyperpolarize the membrane potential by activating large conductance calcium activated potassium (BK channels in vascular smooth muscle cells. Along with voltage-dependent calcium channels, they form a signaling unit that has a vasodilatory influence on vascular diameter and regulation of myogenic tone. The existence and role of calcium sparks has hitherto been unexplored in the spiral modiolar artery, the end artery that controls blood flow to the cochlea. The goal of the present study was to determine the presence and properties of calcium sparks in the intact gerbil spiral modiolar artery. Results Calcium sparks were recorded from smooth muscle cells of intact arteries loaded with fluo-4 AM. Calcium sparks occurred with a frequency of 2.6 Hz, a rise time of 17 ms and a time to half-decay of 20 ms. Ryanodine reduced spark frequency within 3 min from 2.6 to 0.6 Hz. Caffeine (1 mM increased spark frequency from 2.3 to 3.3 Hz and prolonged rise and half-decay times from 17 to 19 ms and from 20 to 23 ms, respectively. Elevation of potassium (3.6 to 37.5 mM, presumably via depolarization, increased spark frequency from 2.4 to 3.2 Hz. Neither ryanodine nor depolarization changed rise or decay times. Conclusions This is the first characterization of calcium sparks in smooth muscle cells of the spiral modiolar artery. The results suggest that calcium sparks may regulate the diameter of the spiral modiolar artery and cochlear blood flow.

  1. Generic patch inference

    DEFF Research Database (Denmark)

    Andersen, Jesper; Lawall, Julia

    2010-01-01

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

  2. Knowledge and attitudes of physicians and pharmacists towards the use of generic medicines in Bosnia and Herzegovina.

    Science.gov (United States)

    Čatić, Tarik; Avdagić, Lejla; Martinović, Igor

    2017-02-01

    Aim To investigate and assess knowledge and attitudes of pharmacists and physicians towards generic drugs prescription in order to evaluate current trends, obstacles to prescribe/dispense generics and suggest possible improvements of rational and economic prescribing having in mind scarce public budgets for drugs. Methods A cross-sectional survey among 450 primary care physicians (prescribers) and pharmacists in four major cities in Bosnia and Herzegovina (Sarajevo, Banja Luka, Tuzla and Mostar) during the period between January and March 2016 was conducted. The survey (questionnaire) was developed and physicians' and pharmacists' perception was examined using the 5-point Likert scale. Descriptive statistics was used to examine respondents' characteristics and their responses to survey questions. The respondents perception based on different characteristics was assessed using ordinal logistic regression. Results Generally, positive attitudes towards generic drugs were found. Majority of respondents, 392 (87.0%) considered generic drugs the same as originators and they could be mutually substituted. Physicians were more likely to prescribe branded drugs, 297 (66.6%), even 391 (86.8%) were aware of generic alternatives. Respondents believed that patients considered generic drugs less effective, 204 (45.4%), and 221 (49.0%) disapproved generic substitution. Conclusion Our findings suggest that further education and more information about benefits of generic drugs should be provided to key stakeholders including patients. Also, clearer generic drugs policies should be introduced in order to improve generic prescribing and potentially improve access and optimize pharmaceutical public expenditures.

  3. 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...

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

    Science.gov (United States)

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

    2013-01-01

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

  5. 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.

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

    Directory of Open Access Journals (Sweden)

    V. V. Yakusevich

    2005-01-01

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

  7. 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.

  8. Drugs Approved for Breast Cancer

    Science.gov (United States)

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

  9. Metanálise de estudos de bioequivalência: a intercambiabilidade de genéricos e similares que contêm Hidroclorotiazida é possível, mas não àqueles com Maleato de Enalapril Meta-analysis for bioequivalence studies: interchangeability of generic drugs and similar containing Hydrochlorothiazide is possible but not with Enalapril Maleate

    Directory of Open Access Journals (Sweden)

    Renato Almeida Lopes

    2010-06-01

    Full Text Available INTRODUÇÃO: O programa de genéricos no Brasil propiciou maior acesso da população a medicamentos. Para garantir a intercambiabilidade entre medicamentos referência e genérico ou similar, é necessário que eles sejam bioequivalentes. Com o crescimento do número de medicamentos genéricos, é comum que pacientes o substituam por outro genérico ou similar. Contudo, essa troca pode não garantir a manutenção da bioequivalência. Para avaliar a segurança na intercambiabilidade entre diferentes genéricos e similares com Hidroclorotiazida e Maleato de Enalapril, foi realizada metanálise de vários estudos de bioequivalência que utilizaram esses medicamentos. MÉTODOS: Foram utilizados dados provenientes de estudos de bioequivalência de genéricos e similares registrados pela Agência Nacional de Vigilância Sanitária (Anvisa. A compatibilidade dos dados de cada um dos estudos foi analisada, e a determinação de um intervalo de confiança para as diferenças entre as médias dos parâmetros farmacocinéticos, área sob a curva (ASC e concentração plasmática máxima (Cmáx , foi feita para cada estudo por meio da metanálise. RESULTADOS: A intercambiabilidade entre as combinações dos três produtos com Hidroclorotiazida foi confirmada com base nos intervalos de confiança obtidos. Para os medicamentos com Maleato de Enalapril, a intercambiabilidade não foi confirmada em 50% das comparações estudadas dos produtos. CONCLUSÃO: A intercambiabilidade foi comprovada entre os três produtos com Hidroclorotiazida. No entanto, para o Maleato de Enalapril, metade dos produtos estudados não é intercambiável, uma vez que não contempla os intervalos preconizados pelos testes de bioequivalência; portanto, a resposta farmacocinética e, por conseguinte, a efetividade do medicamento podem ser alteradas.INTRODUCTION: The generic drugs program provided a better population's access to medicines. To ensure interchangeability between a brand

  10. Generic Quantum Fourier Transforms

    CERN Document Server

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

    2003-01-01

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

  11. Dimensional regularization is generic

    CERN Document Server

    Fujikawa, Kazuo

    2016-01-01

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

  12. Global biological generic drugs market's development difficulty and opportunity%全球生物仿制药市场的发展困难与机遇

    Institute of Scientific and Technical Information of China (English)

    殷实; 卞鹰

    2011-01-01

    OBJECTIVE:To discuss the approaches and s trategies of developing biosimilars.METHODS: Technical problems and commercial barriers of developing biosimilars were analyzed,and opportunities for global biosimilar market were discussed based on the current situation.RESULTS: Unlike traditional generics,biosimilars were characterized by high technical barriers and less short-term commercial return,however,as the patent of brand drugs expired and the demand for medical cost saving increased,the biosimilar market has been making rapid growth with great potential,so that pharmaceutical companies would be able to seize the market by shifting their business model.CONCLUSIONS: Strong RD capabilities,marketing capabilities,financial strength,network management and operation capabilities and production control capabilities are required to develop biosimilars.Large corporations might be more competitive in the biosimilar market.%目的:探讨发展生物仿制药的途径与策略。方法:分析发展生物仿制药的技术难题与商业障碍,结合现实状况讨论全球生物仿制药市场的机遇。结果:发展生物仿制药不同于传统仿制药,其技术壁垒高,短期商业回报慢,但专利药到期与节约医疗成本的需求使得生物仿制药市场的发展非常迅速,潜力巨大,制药公司可以通过改变一些运作模式来抢占这个市场。结论:发展生物仿制药需要强大的技术研发能力、市场营销能力、资金实力、网络运作能力与生产控制能力,大型制药公司在生物仿制药市场可能会更有竞争力。

  13. Generic torus canards

    Science.gov (United States)

    Vo, Theodore

    2017-10-01

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

  14. Typed combinators for generic traversal

    NARCIS (Netherlands)

    Lämmel, R.; Vonk, J.

    2001-01-01

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

  15. Article choice in plural generics

    NARCIS (Netherlands)

    Farkas, D.F.; Swart, Henriëtte de

    2007-01-01

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

  16. Changes in prescription habits with the introduction of generic fluoxetine.

    Science.gov (United States)

    McLay, Robert; Klinski, Angelica

    2008-01-01

    When the patent on fluoxetine expired in 2001, prices for it fell sharply and marketing decreased. We investigated how market share for fluoxetine changed with the introduction of the generic. Prescribing information was tracked at a military hospital where providers knew the cost of medication, but were not compelled to use the cheaper form. Market share for fluoxetine among selective serotonin reuptake inhibitors was observed for the 64 months surrounding the introduction, and changes were examined by linear regression analysis. Results showed that in the 32 months before the introduction of the generic, fluoxetine maintained a relatively steady share of prescriptions. After the introduction of the generic, fluoxetine steadily lost market share over time. No significant relationship could be seen between drug company visits and gains for their individual products. Examination of all Department of Defense prescriptions for the 16 months surrounding the introduction of generic fluoxetine showed a similar drop in its market share.

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

    Science.gov (United States)

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

    2014-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Mohamed Azmi Hassali

    2014-11-01

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

  19. Phase characterisation in spark plasma sintered TiPt alloy

    CSIR Research Space (South Africa)

    Chikosha, S

    2011-12-01

    Full Text Available The conclusions drawn from this presentation are that Spark Plasma Sintering (SPS) of equiatomic BE TiPt powder produces fully sintered specimens, with incomplete homogenisation. There is a need for improved furnace atmosphere control so...

  20. Research of EDM Spark Locations in Die-sinking

    Institute of Scientific and Technical Information of China (English)

    韩强; 何勇; 杨向萍

    2004-01-01

    Detection of 2-dimention spark locations by electromagnetic detection method in electrical discharge machining (EDM) is studied. The method, which is applied and investigated, is based on the fact that the release of energy from a spark is transformed into electromagnetic wave around the workpiece. A new sensor system composed of high precision linear Hall components and cubic ferrite is used to detect the intensity of magnetic field. Relation equation between the output of the sensor system and 2-dimention spark locations experiment under a spiculate electrode is introduced, and its diagram of curve is drawn. As a result, the information that can be achieved by detecting spark's location gives new possibilities for an extended analysis of the EDM-process.

  1. 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.

  2. 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.

  3. A price and use comparison of generic versus originator cardiovascular medicines: a hospital study in Chongqing, China.

    Science.gov (United States)

    Zeng, Wenjie

    2013-10-05

    Developed countries use generic competition to contain pharmaceutical expenditure. China, as a developing and transitional country, has not yet deemed an increase in the use of generic products as important; otherwise, much effort has been made to decrease the drug prices. This paper aims to explore dynamically the price and use comparison of generic and originator drugs in China, and estimate the potential savings of patients from switching originator drugs to generics. A typical hospital in Chongqing, China, was selected to examine the price and use comparisons of 12 cardiovascular drugs from 2006 to 2011. The market share of the 12 generic medicines studied in this paper was 34.37% for volume and 31.33% for value in the second half of 2011. The price ratio of generic to originator drugs was between 0.34 and 0.98, and the volume price index of originators to generics was 1.63. The potential savings of patients from switching originator drugs to generics is 65%. The market share of the generics was lowering and the weighted mean price kept increasing in face of the strict price control. Under the background of hospitals both prescribing and dispensing medicines, China's comprehensive healthcare policy makers should take measures from supply and demand sides to promote the consumption of generic medicines.

  4. 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.

  5. 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.

  6. Calcium sparks in the heart: dynamics and regulation

    Directory of Open Access Journals (Sweden)

    Hoang-Trong TM

    2015-10-01

    Full Text Available Tuan M Hoang-Trong,1 Aman Ullah,1 M Saleet Jafri1,21Department of Molecular Neuroscience, Krasnow Institute for Advanced Study, George Mason University, Fairfax, VA, USA; 2Biomedical Engineering and Technology, University of Maryland, Baltimore, MD, USAAbstract: Ca2+ plays a central role in the contraction of the heart. It is the bi-directional link between electrical excitation of the heart and contraction. Electrical excitation initiates Ca2+ influx across the sarcolemma and T-tubular membrane that triggered calcium release from the sarcoplasmic reticulum (SR. Ca2+ sparks are the elementary events of calcium release from the SR. Therefore, understanding the dynamics of Ca2+ sparks is essential for understanding the function of the heart. To this end, numerous experimental and computational studies have focused on this topic, exploring the mechanisms of calcium spark initiation, termination, and regulation and what role these play in normal and patho-physiology. The proper understanding of Ca2+ spark regulation and dynamics serves as the foundation for our insights into a multitude of pathological conditions that may develop and that can be the result of structural and/or functional changes at the cellular or subcellular level. Computational modeling of Ca2+ spark dynamics has proven to be a useful tool to understand Ca2+ spark dynamics. This review addresses our current understanding of Ca2+ sparks and how synchronized SR Ca2+ release, in which Ca2+ sparks is a major pathway, is linked to the different cardiac diseases, especially arrhythmias.Keywords: leak, arrhythmia, excitation-contraction coupling, phosphorylation

  7. Electro-Spark Deposited Coatings for Replacement of Chrome Electroplating

    Science.gov (United States)

    2005-06-01

    Wear and Corrosion: the Electrospark Deposition Process", published in Proceedings, American Electroplaters and Surface Finishers Society, Jan. 2002. 6...Johnson, R.N., " ElectroSpark Deposition : Principals and Applications", Society of Vacuum Coaters 45th Annual Technical Conference Proceedings, Apr...AD AD-E403 050 Contractor Report ARAET-CR-05002 ELECTRO-SPARK DEPOSITED COATINGS FOR REPLACEMENT OF CHROME PLATING R. N. Johnson J. A. Bailey Pacific

  8. 78 FR 37231 - Guidance for Industry; Guidance on Abbreviated New Drug Applications: Stability Testing of Drug...

    Science.gov (United States)

    2013-06-20

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry; Guidance on Abbreviated New Drug... the availability of a guidance for industry entitled ``ANDAs: Stability Testing of Drug Substances and... generic drug review, FDA is recommending that the generic drug industry follow the approach in...

  9. A Generic Dynamic Emulator

    CERN Document Server

    Albert, Carlo

    2011-01-01

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

  10. Electric Spark Sensitivity of Polynitro Compounds. Part V. A Relationship between Electric Spark and Impact Sensitivities of Energetic Materials

    Institute of Scientific and Technical Information of China (English)

    2001-01-01

    The spark energy, EES, required for 50 percent initiation probability of 41 polynitro compounds was determined. The relationships between the EES values and impact sensitivity, expressed as drop energies Ed of the "first reaction", were established and discussed. The conclusion is made that depending on intermolecular interaction factors in crystals of energetic materials, the mechanism of impact energy transition to the reaction centre of their molecule can be differ from that of transition of energy of electric spark.

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

    Directory of Open Access Journals (Sweden)

    Clotilde Allavena

    2014-11-01

    Full Text Available Introduction: 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. Materials and Methods: 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. Results: 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

  12. Generic interpreters and microprocessor verification

    Science.gov (United States)

    Windley, Phillip J.

    1990-01-01

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

  13. Generic ISIS Transport Module Project

    Data.gov (United States)

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

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

    NARCIS (Netherlands)

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

    2009-01-01

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

  15. Switching to generic anti-epileptic medicines : A regulatory perspective

    NARCIS (Netherlands)

    Maliepaard, Marc; Hekster, Yechiel A.; Kappelle, Arnoud; Van Puijenbroek, Eugène P.; Elferink, André J.; Welink, Jan; Gispen-de Wied, Christine C.; Lekkerkerker, Frits J.F.

    2010-01-01

    Introduction: Currently, there is a lot of discussion about whether generic substitution of anti-epileptic drugs (AEDs) with the same active moiety but from different manufacturers can take place safely. Many AEDs are considered to have a narrow therapeutic index, and the consequences of an epilepti

  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. The Generic Data Capture Facility

    Science.gov (United States)

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

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

  18. Knowledge Development Generic Framework Concept

    Science.gov (United States)

    2008-12-18

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

  19. Generic entry, reformulations and promotion of SSRIs in the US.

    Science.gov (United States)

    Huskamp, Haiden A; Donohue, Julie M; Koss, Catherine; Berndt, Ernst R; Frank, Richard G

    2008-01-01

    Previous research has shown that a manufacturer's promotional strategy for a brand name drug is typically affected by generic entry. However, little is known about how newer strategies to extend patent life, including product reformulation introduction or obtaining approval to market for additional clinical indications, influence promotion. To examine the relationships among promotional expenditures, generic entry, reformulation entry and new indication approval. We used quarterly data on national product-level promotional spending (including expenditures for physician detailing and direct-to-consumer advertising [DTCA], and the retail value of free samples distributed in physician offices) for selective serotonin reuptake inhibitors (SSRIs) over the period 1997-2004. We estimated econometric models of detailing, DTCA and total quarterly promotional expenditures as a function of the timing of generic entry, entry of new product formulations and US FDA approval for new clinical indications for existing medications in the SSRI class. Expenditures by pharmaceutical manufacturers for promotion of antidepressant medications was the main outcome measure. Over the period 1997-2004, there was considerable variation in the composition of promotional expenditures across the SSRIs. Promotional expenditures for the original brand molecule decreased dramatically when a reformulation of the molecule was introduced. Promotional spending (both total and detailing alone) for a specific molecule was generally lower after generic entry than before, although the effect of generic entry on promotional spending appears to be closely linked with the choice of product reformulation strategy pursued by the manufacturer. Detailing expenditures for Paxil were increased after the manufacturer received FDA approval to market the drug for generalized anxiety disorder (GAD), while the likelihood of DTCA outlays for the drug was not changed. In contrast, FDA approval to market Paxil and Zoloft

  20. Modelling of a Spark Ignition Engine for Power-Heat Production Optimization Modèle de moteur à allumage commandé en vue de l’optimisation de la production chaleur-force

    OpenAIRE

    Descieux D.; Feidt M.

    2011-01-01

    Spark ignition gas engine is more and more used in order to produce electricity and heat simultaneously. The engine crankshaft drives a synchronous electric generator. The thermal power output is recovered from the engine coolant system and exhaust gas, and is used to produce generally hot water for heating system. In order to have a better adequacy between supply (production of the engine) and user demand, good knowledge of the engine and implemented phenomena are necessary. A generic method...

  1. Physicochemical stability of three generic brands of metformin in solution

    Directory of Open Access Journals (Sweden)

    Radamés Alemón-Medina

    2014-07-01

    Results: All the commercial brands of metformin were stable under all storage conditions for up to 30 days. They retained more than 90% of the initial quantity of the active drug, with pH of 7.4 ± 0.3. Conclusion: extemporaneous formulations of metformin can be made with both the innovative drug and with generics; money can be saved, with the certainty that they will retain their physicochemical properties.

  2. Arc resistance of laser-triggered spark gaps

    Science.gov (United States)

    Kushner, M. J.; Kimura, W. D.; Byron, S. R.

    1985-09-01

    In the use of spark gaps as switching devices, it is desirable to maximize the power delivered to the load and to minimize the power deposited in the switch; that is, it is desirable for the resistance of the switch to be negligible as compared to the load. The hydrodynamic time scale for expansion of the arc in a spark gap and hence for the reduction in its resistance to a small value is tens to hundreds of nanoseconds. Therefore, with current pulses of duration of a few hundred nanoseconds or less, the resistance of the spark gap may be a significant fraction of that of the load. In this paper, we report on measurements that determine the resistance of the arc in a fully diagnosed laser-triggered spark gap. The spark gap switches a 100-ns, 1.5-Ω waterline into a 1.5-Ω load resistor. A capacitive voltage divider housed within the switch enclosure measures the voltage drop across the switch, a current-viewing resistor measures the current, and an interferometer measures the diameter of the plasma column, a value required to calculate its inductance. The resistance of the arc is found to remain in excess of 0.1-0.2 Ω for the duration of the current pulse for a variety of switch gas mixtures. The resistance decreases with increasing charging voltage on the waterline at the time of triggering and decreases with decreasing average molecular weight of the gas mixture in which the arc is sustained.

  3. Spark Ignition of Monodisperse Fuel Sprays. Ph.D. Thesis

    Science.gov (United States)

    Danis, Allen M.; Cernansky, Nicholas P.; Namer, Izak

    1987-01-01

    A study of spark ignition energy requirements was conducted with a monodisperse spray system allowing independent control of droplet size, equivalent ratio, and fuel type. Minimum ignition energies were measured for n-heptane and methanol sprays characterized at the spark gap in terms of droplet diameter, equivalence ratio (number density) and extent of prevaporization. In addition to sprays, minimum ignition energies were measured for completely prevaporized mixtures of the same fuels over a range of equivalence ratios to provide data at the lower limit of droplet size. Results showed that spray ignition was enhanced with decreasing droplet size and increasing equivalence ratio over the ranges of the parameters studied. By comparing spray and prevaporized ignition results, the existence of an optimum droplet size for ignition was indicated for both fuels. Fuel volatility was seen to be a critical factor in spray ignition. The spray ignition results were analyzed using two different empirical ignition models for quiescent mixtures. Both models accurately predicted the experimental ignition energies for the majority of the spray conditions. Spray ignition was observed to be probabilistic in nature, and ignition was quantified in terms of an ignition frequency for a given spark energy. A model was developed to predict ignition frequencies based on the variation in spark energy and equivalence ratio in the spark gap. The resulting ignition frequency simulations were nearly identical to the experimentally observed values.

  4. The fast algorithm of spark in compressive sensing

    Science.gov (United States)

    Xie, Meihua; Yan, Fengxia

    2017-01-01

    Compressed Sensing (CS) is an advanced theory on signal sampling and reconstruction. In CS theory, the reconstruction condition of signal is an important theory problem, and spark is a good index to study this problem. But the computation of spark is NP hard. In this paper, we study the problem of computing spark. For some special matrixes, for example, the Gaussian random matrix and 0-1 random matrix, we obtain some conclusions. Furthermore, for Gaussian random matrix with fewer rows than columns, we prove that its spark equals to the number of its rows plus one with probability 1. For general matrix, two methods are given to compute its spark. One is the method of directly searching and the other is the method of dual-tree searching. By simulating 24 Gaussian random matrixes and 18 0-1 random matrixes, we tested the computation time of these two methods. Numerical results showed that the dual-tree searching method had higher efficiency than directly searching, especially for those matrixes which has as much as rows and columns.

  5. HOW IS CURRENT PHARMACEUTICALS PRICING POLICY ON GENERICS PERFORMING IN TURKEY REGARDING PRICE EROSION?

    Directory of Open Access Journals (Sweden)

    Kadir GÜRSOY

    2017-02-01

    Full Text Available Generics are commonly accepted to contribute significantly to treating disease by improving the affordability of pharmaceuticals. Once the patent expires for an originator brand, generics erode prices through creating fierce competition. The objective of this study is to investigate on Turkish pharmaceutical policies over generics through measuring how much they lower the prices, and then develop alternative strategies to maintain higher level of price reduction, and hence saving. Claims data from Turkish Social Security Institution (SSI for all ambulatory care drugs reimbursed were collected monthly in the period of January 2009 to December 2013 and for selected 12 equivalent groups price erosion and saving impacts due to generic entry be computed. Moreover, the price erosion for 15 generics entering the reimbursement list in 2012 as first generics was measured. For 12 equivalent groups constituting nearly 7% of SSI drug spending, the price erosion was nearly 41% ranging from 8% to 74%. In the first year of the first generic entry, on average the prices were only shrank by 39% with an increase of 41% in units sold. As a result of those analyses, it is concluded that Turkey is not maximizing its full potential with respect to generic medicines. Therefore, it is of great importance that policies such as therapeutic equivalence, tendering, and aggressive generic pricing policy to stimulate higher savings need to be introduced in the near future.

  6. Inactivation of Staphylococcus aureus in water by pulsed spark discharge.

    Science.gov (United States)

    Zheng, Jiansheng

    2017-09-04

    A pulsed spark plasma discharge system was developed and tested as an energy efficient water sterilization method. A 5 log10 reduction on Staphylococcus aureus concentration of 10(8) CFU/ml was obtained. Complete inactivation was achieved for concentration of 10(6) CFU/ml. Of the various factors generated by an underwater spark discharge, ultraviolet radiation plays a major role. The inactivation was completely suppressed by the addition of 30 mg/L of a soluble sunscreen, Benzophenone-9. Results obtained using the pulsed spark plasma discharge showed that this system has several advantages, such as high energy efficiency, absence of harmful by-products and portability, over the conventional sterilization methods.

  7. Can the inner gap sparking take place in millisecond pulsars?

    Institute of Scientific and Technical Information of China (English)

    Hong-Guang Wang; Guo-Jun Qiao; Ren-Xin Xu

    2003-01-01

    The inner vacuum gap model has become the foundation stone of most theories on pulsar radio emission. The fundamental picture of this model is the sparking, which was conjectured to be induced by magnetic absorption of background gamma photons. However, a question is, can the sparking be triggered in the millisecond pulsars (MSPs) with magnetic fields (B) only about 10s G? We investigate this problem by including the pair production above the inner gap. Under the assumption that the magnetic field is dipolar, our results show the background gamma-ray emission can not be the key factor that triggers the sparking, at least not in MSPs with B ~ 108 G, if the temperature in the polar cap region is only so high as is observed (< 4 × 106 K). Some other mechanisms are required.

  8. Spark plasma sintering of hydrothermally synthesized bismuth ferrite

    Directory of Open Access Journals (Sweden)

    Zorica Branković

    2016-12-01

    Full Text Available Bismuth ferrite, BiFeO3 (BFO, powder was synthesized by hydrothermal method from Bi(NO33·5 H2O and Fe(NO33·9 H2O as precursors. The synthesized powder was further sintered using spark plasma sintering (SPS. The sintering conditions were optimized in order to achieve high density, minimal amount of secondary phases and improved ferroelectric and magnetic properties. The optimal structure and properties were achieved after spark plasma sintering at 630 °C for 20 min, under uniaxial pressure of 90 MPa. The composition, microstructure, ferroelectric and magnetic properties of the SPS samples were characterized and compared to those of conventionally sintered ceramics obtained from the same powder. Although the samples sintered using conventional method showed slightly lower amount of secondary phases, the spark plasma sintered samples exhibited favourable microstructure and better ferroelectric properties.

  9. Rational Use of Drugs: Pharmaceutical Aspects of the Drug Selection

    Directory of Open Access Journals (Sweden)

    Natalya B. Rostova, PhD, ScD

    2012-09-01

    Full Text Available In this article, the problems encountered in the rational use of drugs are discussed, one of the areas of optimization of drug supply being the rational choice of drugs, particularly, a regulatory activity regarding the approach to the selection of standardized drug lists (drug formulary for public drug supply, according to government guarantees and programs. The clinical aspects of the drug selection are expounded in detail. The characteristics of the drugs (original or generic drug (generics, the origin of drugs and the breadth of therapeutic index, have been taken into account. Certain stages have been analyzed, particularly drug use in individual diseases, drug selection, expert drug evaluation, and expert recommendations to include specific drugs in the drug list. Organizational steps have been proposed to implement the rational choice of drugs to be included in the drug formulary.

  10. Drugs Approved for Prostate Cancer

    Science.gov (United States)

    ... 2015 2014 2013 2012 Media Resources Media Contacts Multicultural ... This page lists cancer drugs approved by the Food and Drug Administration (FDA) for prostate cancer. The list includes generic ...

  11. 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.

  12. An in vitro aerosolization efficiency comparison of generic and branded salbutamol metered dose inhalers

    OpenAIRE

    Rahimkhani, Sara; Ghanbarzadeh, Saeed; Nokhodchi, Ali; Hamishehkar, Hamed

    2017-01-01

    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).\\ud \\ud...

  13. Time-lags before breakdown in the DC spark system

    CERN Document Server

    Descoeudres, A

    2008-01-01

    The voltage time evolution in the DC spark system has been measured together with the current signal during a discharge. The voltage rise-time, given by the circuitry and the HV relay is measured to be of the order of 100 ns. Measurement of the time-lags for breakdown reveals a material dependent behaviour; two populations centered at 0.1 s and at 1.3 ms are detected on stainless steel whereas on tungsten carbide only fast occurring sparks with sharp distribution around 0.1 s are found. The two populations indicate the presence of two different breakdown mechanisms.

  14. Plasma dynamics of a laser filamentation-guided spark

    CERN Document Server

    Point, Guillaume; Carbonnel, Jérôme; Mysyrowicz, André; Houard, Aurélien

    2016-01-01

    We investigate experimentally the plasma dynamics of a centimeter-scale, laser filamentation-guided spark discharge. Using electrical and optical diagnostics to study monopolar discharges with varying current pulses we show that plasma decay is dominated by free electron recombination if the current decay time is shorter than the recombination characteristic time. In the opposite case, the plasma electron density closely follows the current evolution. We demonstrate that this criterion holds true in the case of damped AC sparks, and that alternative current is the best option to achieve a long plasma lifetime for a given peak current.

  15. 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.

  16. Spark, an application based on Serendipitous Knowledge Discovery.

    Science.gov (United States)

    Workman, T Elizabeth; Fiszman, Marcelo; Cairelli, Michael J; Nahl, Diane; Rindflesch, Thomas C

    2016-04-01

    Findings from information-seeking behavior research can inform application development. In this report we provide a system description of Spark, an application based on findings from Serendipitous Knowledge Discovery studies and data structures known as semantic predications. Background information and the previously published IF-SKD model (outlining Serendipitous Knowledge Discovery in online environments) illustrate the potential use of information-seeking behavior in application design. A detailed overview of the Spark system illustrates how methodologies in design and retrieval functionality enable production of semantic predication graphs tailored to evoke Serendipitous Knowledge Discovery in users.

  17. Microstructure of Spark Plasma-Sintered Silicon Nitride Ceramics

    Science.gov (United States)

    Lukianova, O. A.; Novikov, V. Yu.; Parkhomenko, A. A.; Sirota, V. V.; Krasilnikov, V. V.

    2017-04-01

    The microstructure and phase composition of the high-content Al2O3-Y2O3-doped spark plasma-sintered silicon nitride were investigated. Fully dense silicon nitride ceramics with a typical α-Si3N4 equiaxed structure with average grain size from 200 to 530 nm, high elastic modulus of 288 GPa, and high hardness of 2038 HV were spark plasma sintered (SPSed) at 1550 °C. Silicon nitride with elongated β-Si3N4 grains, higher hardness of 1800 HV, density of 3.25 g/cm3, and Young's modulus 300 GPa SPSed at 1650 °C was also reviewed.

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

    Science.gov (United States)

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

    2011-03-01

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

  19. Establishing "abuse-deterrence equivalence" for generic abuse-deterrent opioid formulations: A proposed development framework.

    Science.gov (United States)

    Setnik, Beatrice; Cone, Edward J

    2016-01-01

    Abuse-deterrent formulations are one strategy for mitigating the epidemic of prescription opioid abuse. Regulatory guidance documents describe the requirements for developing abuse-deterrent formulations of novel drugs and formulations; however, they do not address "abuse-deterrence equivalence" for generic formulations. As generics may be produced with different excipients and formulations compared to reference drugs, differences in their properties may impact their abuse-deterrent features. Currently, it is unclear what specific studies are needed to support generic abuse-deterrence claims. This commentary outlines several recommendations on the in vitro and in vivo testing required, including the conditions for conducting a human abuse potential study.

  20. 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.

  1. Interpretation of the technical guidelines for the bioequivalence study of generic chemical drugs with pharmacokinetics parameters as the ifnal evaluation index%《以药动学参数为终点评价指标的化学药物仿制药人体生物等效性研究技术指导原则》解读

    Institute of Scientific and Technical Information of China (English)

    施孝金

    2016-01-01

    Equivalence assessment is an important part of Chinese generic drug evaluation. At present, it is based on“the technical guidelines for the study of the human bioavailability and bioequivalence of chemical pharmaceutical preparations”promulgated in 2005. The technical guideline for the bioequivalence study of generic chemical drugs with pharmacokinetics parameters as the ifnal evaluation index was issued by China Food and Drug Administration in Mar., 2016. In this paper, the differences between the two guidelines are analyzed from several aspects, such as the analysis method, the experimental design, the number of subjects and test cases, and the reference preparation and so on.%等效性评价是我国仿制药评审的重要环节,目前等效性评价均以2005年颁布的《化学药物制剂人体生物利用度和生物等效性研究技术指导原则》为依据。2016年3月,国家食品药品监督管理总局发布《以药动学参数为终点评价指标的化学药物仿制药人体生物等效性研究技术指导原则》,本文从分析方法、试验设计、受试者和试验例数、参比制剂等几个方面解读两者的差别。

  2. 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.

  3. 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.

  4. 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.

  5. Drug Induced Hearing Loss: Researchers Study Strategies to Preserve Hearing

    Science.gov (United States)

    ... page please turn JavaScript on. Feature: Drug-Induced Hearing Loss Researchers Study Strategies to Preserve Hearing Past Issues / ... about the research. What sparked your interest in hearing loss? From my earliest days in school, I always ...

  6. Testing of the J-2X Augmented Spark Igniter (ASI) and Its Electronics

    Science.gov (United States)

    Osborne, Robin

    2015-01-01

    Reliable operation of the spark ignition system electronics in the J-2X Augmented Spark Igniter (ASI) is imperative in assuring ASI ignition and subsequent Main Combustion Chamber (MCC) ignition events are reliable in the J-2X Engine. Similar to the man-rated J-2 and RS-25 engines, the J-2X ignition system electronics are equipped with spark monitor outputs intended to indicate that the spark igniters are properly energized and sparking. To better understand anomalous spark monitor data collected on the J-2X development engines at NASA Stennis Space Center (SSC), a comprehensive subsystem study of the engine's low- and high-tension spark ignition system electronics was conducted at NASA Marshall Space Flight Center (MSFC). Spark monitor output data were compared to more detailed spark diagnostics to determine if the spark monitor was an accurate indication of actual sparking events. In addition, ignition system electronics data were closely scrutinized for any indication of an electrical discharge in some location other than the firing tip of the spark igniter - a problem not uncommon in the development of high voltage ignition systems.

  7. 46 CFR 30.10-63 - Spark arrester-TB/ALL.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 1 2010-10-01 2010-10-01 false Spark arrester-TB/ALL. 30.10-63 Section 30.10-63 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY TANK VESSELS GENERAL PROVISIONS Definitions § 30.10-63 Spark arrester—TB/ALL. The term spark arrester means any device, assembly, or method of a...

  8. 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.

  9. Meter-scale spark X-ray spectrumstatistics

    CERN Document Server

    Carlson, B E; Kochkin, P; Grondahl, Ø; Nisi, R; Weber, K; Scherrer, Z; LeCaptain, K

    2016-01-01

    X-ray emission by sparks implies bremsstrahlung from a population of energetic electrons, but the details of this process remain a mystery. We present detailed statistical analysis of X-ray spectra detected by multiple detectors during sparks produced by 1 MV negative high-voltage pulses with 1 $\\mu$s risetime. With over 900 shots, we statistically analyze the signals, assuming that the distribution of spark X-ray fluence behaves as a power law and that the energy spectrum of X-rays detectable after traversing $\\sim$2 m of air and a thin aluminum shield is exponential. We then determine the parameters of those distributions by fitting cumulative distribution functions to the observations. The fit results match the observations very well if the mean of the exponential X-ray energy distribution is 86 $\\pm$ 7 keV and the spark X-ray fluence power law distribution has index -1.29 $\\pm$ 0.04 and spans at least 3 orders of magnitude in fluence.

  10. Direction finding antenna system for spark detection and localization

    Science.gov (United States)

    Topor, Raluca E.; Bucuci, Stefania C.; Tamas, Razvan D.; Danisor, Alin; Dumitrascu, Ana; Berescu, Serban

    2015-02-01

    This paper proposes a novel UWB antenna system for spark detection and localization by using the amplitude comparison direction finding (DF) method. The proposed design consists of two identical axially crossed "padlock" shaped UWB antennas, with unbalanced feeding. Simulation results show that such radiating systems can be used for assessing the direction of arrival for short pulses.

  11. 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,…

  12. Towards a general turbulent combustion model for spark ignition engines

    Energy Technology Data Exchange (ETDEWEB)

    Naji, H.; Said, R.; Borghi, R.P.

    1989-01-01

    The prediction of combustion within spark ignition engines needs to take into account the interaction of turbulent fluctuations. Previous attempts at this used a model in which the chemical processes were supposed infinitely fast and the combustion was controlled by turbulent mixing only. This paper describes their progress in extending such models in two directions.

  13. Assembly of optical spark chambers for the experiment Nue

    CERN Multimedia

    1974-01-01

    To continue the research on neutral currents after their discovery in Gargamelle in 1973, the Aachen-Padua Collaboration set up in the neutrino beam of the PS South-East Area, behind Gargamelle, an assembly of 150 optical spark chambers, 2x2 m2 extending over 8 m (experiment T230, Nue). Hans Reithler stands on the right.

  14. Determination of welding spark parameters for cyclone efficiency calculation (rus

    Directory of Open Access Journals (Sweden)

    Kitain M.B.

    2011-08-01

    Full Text Available Importance of the current work is explained by the problem of air purification in the field of breath of the worker and prevention of the fire and the explosion. To solve this problem the authors offer to use Reverse-flow cyclone as precleaner with spark extinguishing option. In case if the dust includes sparks it is very important to insure that the particles with the sparks will be totally collected in the cyclone, so the collection efficiency for such particles will be 100% in the cyclone. For the estimation of the efficiency of gas purification from the dust particles in the cyclones dust particles features should be determinate, that can be done with the satisfactory accuracy only by physical modeling results. The amount of physical experiments was made by the authors. The methods of determination of the geometric diameter and hydraulic size of the particle consisting sparks were offered. The experimental researches showed that the accuracy of using the geometric diameter of such particle is not enough, because the hydrodynamic characteristics of the particles (such as weight, effective diameter, the way of interaction with the environment can be change in the case of moving. At the same time< hydraulic size, determined in the second part of the experiment, consider all these factors and can be used for the estimation of the cyclone efficiency based on the model of turbulent diffusion with the limited velocity.

  15. SPARK MACHINING FOR STEEL SURFACES TO IMPROVE PAINT COATINGS QUALITY

    Directory of Open Access Journals (Sweden)

    Sergey Levchenko

    2015-12-01

    Full Text Available Spark machining of steel surfaces enhances the subsequent paint coatings adhesion and protective properties. These factors improvement was confirmed at the salt-spray chamber testing and by both adhesion to the surface and depth of corrosion penetration below the paint coating layer measurements.

  16. 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

  17. Rectification of two generic names

    NARCIS (Netherlands)

    Büttikofer, J.

    1896-01-01

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

  18. GENERIC model for multiphase systems

    NARCIS (Netherlands)

    Sagis, L.M.C.

    2010-01-01

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

  19. Generic Hurricane Extreme Seas State

    DEFF Research Database (Denmark)

    Wehmeyer, Christof; Skourup, Jesper; Frigaard, Peter

    2012-01-01

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

  20. 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.

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

    Science.gov (United States)

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

    2016-02-01

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

  2. 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.

  3. 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

  4. [Generics: similarities, bioequivalence but no conformity].

    Science.gov (United States)

    Even-Adin, D; De Muylder, J A; Sternon, J

    2002-01-01

    The using of generic forms (GF) is presented as a potential source of budgetary "saving of money" in the field of pharmaceutical expenses. Not frequently prescribed in Belgium, they win a new interest thanks to the recent making use of the "reference repayment". Sale's authorization of GF is controlled by european rules, but some questions about their identity to original medications remain. Do similarities based only upon qualitative and quantitative composition in active molecules, pharmaceutical forms and biodisponibility give us all requested guaranties? Several cases of discordances can appear; the major elements of non conformity are the nature of excipients, notice's contents and the value of biodisponibility studies. However, in term of economy, in the drug market, development of GF appears to constitute an unavoidable phenomenon.

  5. Mylan to Offer Generic EpiPen

    Science.gov (United States)

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

  6. Long-term Medicaid excess payments from alleged price manipulation of generic lorazepam.

    Science.gov (United States)

    Bian, Boyang; Gorevski, Elizabeth; Kelton, Christina M L; Guo, Jeff J; Martin Boone, Jill E

    2012-09-01

    Cost savings from the use of generic drugs versus brand-name drugs are well known. Both private and public prescription drug plans encourage the use of generic drugs through a variety of mechanisms. The magnitude of cost savings for a given generic drug is dependent on the degree to which the generic market is competitive. Should the competitive structure become compromised, higher prices and reduced cost savings may result. An alleged conspiracy between Mylan Laboratories and its active-ingredient suppliers in 1997 was associated with an increase in seller concentration in the generic lorazepam market. The Federal Trade Commission (FTC) alleged that Mylan raised costs to consumers by $120 million because of price increases for generic lorazepam from March through December 1998 and for generic clorazepate from January through December 1998. In November 2002, a settlement with Mylan was approved by the FTC, and a federal district court required Mylan to pay $147 million, including $28.2 million to state agencies including Medicaid. To (a) describe the seller concentration in the national Medicaid generic lorazepam market over a 19-year period from January 1991 through December 2009, (b) estimate the excess payments for generic lorazepam by Medicaid between 1998 and 2009, and (c) investigate potentially increased utilization and prices of 2 substitute pharmaceuticals: branded lorazepam (Ativan) and generic alprazolam (another widely used intermediate-acting benzodiazepine). Using Medicaid State Drug Utilization Data from the Centers for Medicare Medicaid Services, we calculated the 4-firm concentration ratio (CR₄) and the Herfindahl-Hirschman Index (HHI) for the Medicaid generic lorazepam market, along with pre-rebate reimbursement for pharmacy claims, number of claims (utilization), and average pre-rebate reimbursement per claim (average "price") for generic lorazepam, from 1991 through 2009. Medicaid's excess payments were estimated under 2 different assumptions

  7. Influencia de la sustitución de medicamentos de marca por genéricos en el cumplimiento terapéutico de la hipertensión arterial y la dislipidemia Influence of substitution of brand name for generic drugs on therapeutic compliance in hypertension and dyslipidemia

    Directory of Open Access Journals (Sweden)

    Antoni Sicras Mainar

    2010-12-01

    amlodipine and simvastatin are substituted for generic drugs, and to determine patients´ and physicians´ opinions of this substitution. Patients and methods: We performed an observational study with a control group, based on a review of the medical records in six primary care centers. Participants consisted of patients >40 years old initiating treatment with a brand name drug (initial period, which was later substituted by a generic drug (final period. The study subgroups consisted of patients with hypertension (amlodipine or dyslipidemia (simvastatin. The main measures were comorbidity, compliance, treatment length, biochemistry determinations, and patients´ and physicians´ opinions (interviews. All patients received a brand name drug for a minimum of 1 year followed by a generic drug for a minimum of 1 year (minimum continuation/patient: 24 months. Results: There were 1,252 patients (groups: 49.5% amlodipine; 50.5% simvastatin. Patients treated with amlodipine (period comparison showed better compliance (65.8 vs. 61.3%; p=0.037 and blood pressure control (48.5 vs. 45.8%; p=0.039 with the brand name drug. The percentages with simvastatin were 62.8 vs. 58.4% (p=0.041, respectively. A total of 73.6% of the physicians interviewed prescribed generic drugs and 59.2% believed that both types of drug had the same efficacy. Most of the patients interviewed (79.8%; CI: 74.3-85.3% accepted the substitution; 55.3% (CI: 48.5-62.1% received the appropriate information but 61.5% were confused by the different products. Lack of compliance was reported by 18.2%. Conclusions: In patients receiving amlodipine or simvastatin, compliance decreased with time, independently of the change from a band name to a generic drug.

  8. Experimental Study on Methane Explosion Ignited by Sparks of Cable Bolt Breakage

    Institute of Scientific and Technical Information of China (English)

    MA Wen-ding; XU Jia-lin; ZHANG Shao-hua

    2004-01-01

    An experimental device was designed for studying methane explosion ignited by sparks of cable bolt breakage. With the methane concentration being in explosion range, a series of experiments were conducted to study the law of spark generation during cable bolt breakage and the probability of methane explosion caused by the spark. The results show that the probability of generating sparks during cable bolt breakage is 50%. The spark generated by the breakage of steel cable bolt strand can't ignite a methane explosion. A detection was carried out using infrared-ray imaging apparatus (IRIA) to measure temperature of the spark generated by cable bolt breakage. It is indicated that the maximum temperature of the spark generated by cable bolt breakage is far less than the required ignition temperature for a methane explosion.

  9. Compositional Design of a Generic Design Agent

    NARCIS (Netherlands)

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

    2001-01-01

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

  10. Comparing approaches to generic programming in Haskell

    NARCIS (Netherlands)

    Hinze, R.; Jeuring, J.T.; Löh, A.

    2007-01-01

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

  11. Generic switching and non-persistence among medicine users: a combined population-based questionnaire and register study.

    Directory of Open Access Journals (Sweden)

    Jette Rathe

    Full Text Available 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.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' attitudes towards generic medicines and concerns about their medicine.Patients who experience their first-time switch of a specific drug were at higher risk of non-persistence, Hazard Ratio 2.98, 95% CI (1.81;4.89 versus those who have never switched, and 35.7% became non-persistent during the first year of follow-up. Generic switching did not influence persistence considerably in those having previous experience with generic switching of the specific drug. Stratified analyses on users of antidepressants and antiepileptics underpin the results, showing higher risk of non-persistence for first-time switchers for both drug categories.In conclusion, patients who are first-time switchers of a specific drug were at higher risk of non-persistence compared to never switchers and those having experienced previous generic switching.

  12. Intermittent hypoxia in rats reduces activation of Ca2+ sparks in mesenteric arteries.

    Science.gov (United States)

    Jackson-Weaver, Olan; Osmond, Jessica M; Naik, Jay S; Gonzalez Bosc, Laura V; Walker, Benjimen R; Kanagy, Nancy L

    2015-12-01

    Ca(+) sparks are vascular smooth muscle cell (VSMC) Ca(2+)-release events that are mediated by ryanodine receptors (RyR) and promote vasodilation by activating large-conductance Ca(2+)-activated potassium channels and inhibiting myogenic tone. We have previously reported that exposing rats to intermittent hypoxia (IH) to simulate sleep apnea augments myogenic tone in mesenteric arteries through loss of hydrogen sulfide (H2S)-induced dilation. Because we also observed that H2S can increase Ca(2+) spark activity, we hypothesized that loss of H2S after IH exposure reduces Ca(2+) spark activity and that blocking Ca(2+) spark generation reduces H2S-induced dilation. Ca(2+) spark activity was lower in VSMC of arteries from IH compared with sham-exposed rats. Furthermore, depolarizing VSMC by increasing luminal pressure (from 20 to 100 mmHg) or by elevating extracellular [K(+)] increased spark activity in VSMC of arteries from sham rats but had no effect in arteries from IH rats. Inhibiting endogenous H2S production in sham arteries prevented these increases. NaHS or phosphodiesterase inhibition increased spark activity to the same extent in sham and IH arteries. Depolarization-induced increases in Ca(2+) spark activity were due to increased sparks per site, whereas H2S increases in spark activity were due to increased spark sites per cell. Finally, inhibiting Ca(2+) spark activity with ryanodine (10 μM) enhanced myogenic tone in arteries from sham but not IH rats and blocked dilation to exogenous H2S in arteries from both sham and IH rats. Our results suggest that H2S regulates RyR activation and that H2S-induced dilation requires Ca(2+) spark activation. IH exposure decreases endogenous H2S-dependent Ca(2+) spark activation to cause membrane depolarization and enhance myogenic tone in mesenteric arteries.

  13. 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.

  14. Efficient Generation of Generic Entanglement

    CERN Document Server

    Oliveira, R; Plenio, M B

    2006-01-01

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

  15. Brand name versus generic warfarin: a systematic review of the literature.

    Science.gov (United States)

    Dentali, Francesco; Donadini, Marco P; Clark, Nathan; Crowther, Mark A; Garcia, David; Hylek, Elaine; Witt, Dan M; Ageno, Walter

    2011-04-01

    The use of generic drugs has become increasingly common in clinical practice. However, for drugs with a narrow therapeutic index, such as warfarin, there may be some concern regarding the definition of bioequivalence. Clinical studies that compared brand name and generic warfarin products provided conflicting results. Therefore, we performed a systematic review of the literature to better assess the characteristics of each generic warfarin product. Several sources were searched, including MEDLINE and EMBASE, electronic records of meetings' abstracts, and reference lists of included articles. Articles were considered relevant if they were original studies, enrolled patients receiving oral anticoagulant treatment, and compared any approved generic warfarin with brand name warfarin in at least one clinical, laboratory, or management outcome. Eleven studies, with a total of more than 40,000 patients, were included; five were randomized controlled trials, and six were observational studies. In three crossover trials evaluating the mean difference of the international normalized ratio (INR) after switching to the alternate formulation of warfarin, no statistically significant difference was found between patients randomly assigned to receive brand name or generic warfarin. The two other randomized trials found no significant differences in the magnitude or number of dosage changes between patients switched to brand name or generic warfarin. The results of the observational studies are more conflicting, suggesting different features for different generic warfarin products. In these observational studies, the time in the therapeutic range and the number of thromboembolic and hemorrhagic complications were similar in studies that compared the anticoagulation control before and after the switch to a generic warfarin product. In one observational study, however, a change in therapeutic INR control after the switch to generic warfarin was reported at the individual patient

  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. Mobile Big Data Analytics Using Deep Learning and Apache Spark

    OpenAIRE

    Alsheikh, Mohammad Abu; Niyato, Dusit; Lin, Shaowei; Tan, Hwee-Pink; Han, Zhu

    2016-01-01

    The proliferation of mobile devices, such as smartphones and Internet of Things (IoT) gadgets, results in the recent mobile big data (MBD) era. Collecting MBD is unprofitable unless suitable analytics and learning methods are utilized for extracting meaningful information and hidden patterns from data. This article presents an overview and brief tutorial of deep learning in MBD analytics and discusses a scalable learning framework over Apache Spark. Specifically, a distributed deep learning i...

  18. FRACTURE FEATURES OF METAL BINDING WHEN DIAMOND-SPARK GRINDING

    Directory of Open Access Journals (Sweden)

    Yury GUTSALENKO

    2012-05-01

    Full Text Available The hypothesis of the influence of binding energy of metal on the processes of destruction and mass transfer at high-speed machining is considered. Some nonconventional processes of cleaning of intergranularity spaces from waste products at diamond-spark grinding are explained, the approach to assessment of metal resistance in these processes is proposed and eo ipso modern conception of processes in chip formation zone under condition of electric discharge effect is supplemented

  19. The time response function of spark counters and RPCs

    Energy Technology Data Exchange (ETDEWEB)

    Gobbi, A. E-mail: a.gobbi@gsi.de; Mangiarotti, A. E-mail: mangiaro@fi.infn.it

    2003-08-01

    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.

  20. Social Media Analytics using Apache Spark Application to Market Research

    OpenAIRE

    Gómez Parada, Mauro

    2016-01-01

    En este trabajo se intentará generar una herramienta de marketing de la que se pueda obtener información que puede no estar implícita en Instagram con la ayuda de Apache Spark y Apache Cassandra y con la que luego se podrán optimizar las campañas de publicidad que se hagan en esta red social.

  1. The Use of Spark Ignition Engine in Domestic Cogeneration

    Directory of Open Access Journals (Sweden)

    Feiza Memet

    2009-10-01

    Full Text Available Cogeneration plants are strongly sustained by EU energy policies, one of the best beneficiary of this technology being residential buildings. This paper focus on spark ignition engine as a cogeneration application in order to supply energy for domestic consumers. Are considered two aspects of this solution: the energetic aspect and the environmental one. The energetic aspect deals with the energetic ratios, while the environmental aspect refers to the nitrogen oxide and carbon monoxide emissions.

  2. 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

  3. 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.

  4. 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.

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

    Science.gov (United States)

    Drozdowska, Aleksandra; Hermanowski, Tomasz

    2016-02-01

    Generic uptake will increasingly be promoted by governments in the face of increasing healthcare costs and global economic uncertainties. The purpose of this study was to investigate attitudes towards generic substitution among community pharmacists, with a focus on the perception of the efficacy, knowledge of the generics characteristics, as well as the willingness to recommend generic substitution. Community pharmacies in Poland. The survey was conducted in 2013 by telephone interviews with 802 holders of an MSc degree in pharmacy working as community pharmacists. Stratified sampling was implemented to make the study representative in geographic terms. Pharmacists' attitudes towards generics drugs. The study showed that only 40 % of pharmacists always inform patients about their right to choose a generic substitute. It was also shown that the less time a pharmacist has been practising, the less likely they are to invite consumers to choose between generic and innovator products. The likelihood of informing was not affected by pharmacist's sex or age, or by pharmacy location or status (chain vs. independent pharmacy) (p > 0.05). Pharmacists varied in their approach to their statutory obligation to inform about a generic; a more or less equal share of respondents were either in favour or against it. Approximately 60 % pharmacists were shown to be familiar with the definition of a generic medicine. Pharmacists with shorter time of practice proved to know more about generics. However, more than 30 % respondents failed to choose the correct statement on generic versus reference medicine dosage. The majority of respondents (67 %) believed there are no differences in efficacy between generics and innovator drugs, whereas 31 % claimed that original brands could be more effective. A significant correlation was demonstrated between the views of pharmacists on the therapeutic efficacy and their willingness to substitute for generics whenever permitted by a physician. It is

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

    DEFF Research Database (Denmark)

    Christiansen, Asger Nyman; Bærentzen, Jakob Andreas

    2012-01-01

    in a directed cyclic graph. Furthermore, the basic productions are chosen such that Generic Graph Grammar seamlessly combines the capabilities of L-systems to imitate biological growth (to model trees, animals, etc.) and those of split grammars to design structured objects (chairs, houses, etc.). This results......Methods for procedural modelling tend to be designed either for organic objects, which are described well by skeletal structures, or for man-made objects, which are described well by surface primitives. Procedural methods, which allow for modelling of both kinds of objects, are few and usually...

  7. Relationship between exploding bridgewire and spark initiation of low density PETN

    Science.gov (United States)

    Lee, Elizabeth; Drake, Rod

    2017-01-01

    Recent work has shown that the energy delivered after bridgewire burst affects the function time of an EBW detonator. The spark which is formed post bridgewire burst is the means by which the remaining fireset energy contributes to the reaction. Therefore, by studying the characteristics of spark-gap detonators, insight into the contribution of spark initiation to the functioning of EBW detonators may be achieved. Spark initiation of low density explosives consists of: (i) spark formation, (ii) spark interaction with the bed, and (iii) ignition and growth of reaction. Experiments were performed in which an inert simulant was used to study the formation and propagation of sparks as a function of spark energy. The effect of the spark on inert porous beds was studied over a limited delivered energy range. The disruption of the bed was found to be dependent on the energy delivered. The effect of spark initiation on a low density PETN bed was then examined, the relationship between delivered energy and function time was found to be the same as for EBW detonators.

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

    Directory of Open Access Journals (Sweden)

    Fadi Towfic

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

  9. Urban-Rural Disparity of Generics Prescription in Taiwan: The Example of Dihydropyridine Derivatives

    Directory of Open Access Journals (Sweden)

    Chia-Chen Hsu

    2014-01-01

    Full Text Available The aim of the current study was to investigate the urban-rural disparity of prescribing generics, which were usually cheaper than branded drugs, within the universal health insurance system in Taiwan. Data sources were the cohort datasets of National Health Insurance Research Database with claims data in 2010. The generic prescribing ratios of dihydropyridine (DHP derivatives (the proportion of DHP prescribed as generics to all prescribed DHP of medical facilities were examined against the urbanization levels of the clinic location. Among the total 21,606,914 defined daily doses of DHP, 35.7% belonged to generics. The aggregate generic prescribing ratio rose from 6.7% at academic medical centers to 15.3% at regional hospitals, 29.4% at community hospital, and 66.1% at physician clinics. Among physician clinics, the generic prescribing ratio in urban areas was 63.9 ± 41.0% (mean ± standard deviation, lower than that in suburban (69.6 ± 38.7% and in rural (74.1% ± 35.3%. After adjusting the related factors in the linear regression model, generic prescribing ratios of suburban and rural clinics were significantly higher than those of urban clinics (β=0.043 and 0.077; P=0.024 and 0.008, resp.. The generic prescribing ratio of the most popular antihypertensive agents at a clinic was reversely associated with the urbanization level.

  10. An observational comparative study of cost between branded medicines and generic medicines

    Directory of Open Access Journals (Sweden)

    Meenu Pichholiya

    2015-04-01

    Conclusions: Most of the drugs available in the market have brand names whether they are branded or generic medicines. Hence, doctor should write a cheapest known brand with the name of the generic salt in bracket so that the patient can buy another if that brand is not available. Furthermore, the Drug Controller of India should release a website where every doctor should be able to find the cheapest and approved drugs in the market. [Int J Basic Clin Pharmacol 2015; 4(2.000: 269-272

  11. Does Reference Pricing Drive Out Generic Competition in Pharmaceutical Markets? Evidence from a Policy Reform

    OpenAIRE

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

    2015-01-01

    In this paper we study the impact of reference pricing (RP) on entry of generic firms in the pharmaceutical market. For given prices, RP increases generic firms' expected profit, but since RP also stimulates price competition, the impact on generic entry is theoretically ambiguous. In order to empirically test the effects of RP, we exploit a policy reform in Norway in 2005 that exposed a subset of drugs to RP. Having detailed product-level data for a wide set of substances from 2003 to 2013,...

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

    Science.gov (United States)

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

    2011-07-01

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

  13. Pharmaceutical meaning-making beyond marketing: racialized subjects of generic thiazide.

    Science.gov (United States)

    Pollock, Anne

    2008-01-01

    In contrast to discussions of BiDil, this paper explores racial meaning-making processes around an old generic hypertension drug. By unpacking a vignette about race and thiazide outside marketing or medicine, it shows that racialization of drugs exceeds those spheres and moves in unpredictable ways.

  14. 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.

  15. Generic behaviours in impact fragmentation

    Energy Technology Data Exchange (ETDEWEB)

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

    2008-02-15

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

  16. Generic maximum likely scale selection

    DEFF Research Database (Denmark)

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

    2007-01-01

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

  17. Characterization of a copper spark discharge plasma in argon atmosphere used for nanoparticle generation

    Science.gov (United States)

    Kohut, Attila; Galbács, Gábor; Márton, Zsuzsanna; Geretovszky, Zsolt

    2017-04-01

    Spark discharge nanoparticle generation is a dynamically developing application of discharge plasmas. In the present study a spark plasma used for nanoparticle generation is characterized by means of spatially and temporally resolved optical emission spectroscopy (OES) supplemented by fast imaging. The data acquired during the generation of copper nanoparticles in argon ambient is used to describe the spatial and temporal evolution of the species in the spark gap and to derive plasma parameters such as excitation temperature and electron concentration on one hand, and the concentration of the Cu species eroded by a single spark on the other. It is shown that temporally and spatially resolved OES together with a simple equilibrium model are efficient tools to estimate the characteristics of the spark discharge plasma that typically exists in spark discharge nanoparticle generators.

  18. Ca2+ sparks evoked by depolarization of rat ventricular myocytes involve multiple release sites

    Institute of Scientific and Technical Information of China (English)

    ZANGWei-Jin; YUXiao-Jiang; ZANGYi-Min

    2003-01-01

    AIM:To investigate the fundamental nature of calcium release events (Ca2+‘sparks’) evoked in rat ventricular myocytes during excitation-contraction (E-C) coupling. METHODS: High-resolution line-scan confocal imaging with the fluorescent calcium indicator and patch-clamp techniques were used to study the spontaneous Ca2+ sparks and sparks evoked by depolarization. RESULTS: 1)Line scans oriented along the length of the cell showed that both spontaneous sparks and sparks evoked by depolarization to -35mV appeared to arise at single sites spacing about 1.80μm apart (ie, the sarcomere length), and measurements of their longitudinal spread (full-width at halfmaximal amplitude:FWHM) followed single Gaussian distributions with means of 2.6μm. 2)Different to this,transverse line scans often revealed spontaneous and evoked sparks that appeared to arise near-synchronously from paired sites. Measurements of transverse FWHM of both spontaneous and evoked sparks showed bimodal distributions, which were fit well by the sums of two Gaussian curves with means of 1.8 and 2.9μm for spontaneous sparks and ith means of 1.9 and 3.1 μm for evoked sparks. Relative areas under the two Gaussian curves were 1.73:1 and 1.85:1, respectively, for spontaneous and evoked sparks. CONCLUSIONS: Ca2+ sparks evoked by depolarization are not ′unitary′ events, but often involve multiple sites of origin along Z-lines, as previously shown for spontaneous sparks. Thus, Ca2+ released during sparks directly triggered by influx through L-type Ca2+ channels may, in turn, trigger neighboring sites. The restricted involvement of only a few transverse release sites preserves the essential feature of the ‘local control’ theory of E-C coupling.

  19. 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.

  20. 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.

  1. Identification and characterization of calcium sparks in cardiomyocytes derived from human induced pluripotent stem cells.

    Directory of Open Access Journals (Sweden)

    Guang Qin Zhang

    Full Text Available INTRODUCTION: Ca2+ spark constitutes the elementary units of cardiac excitation-contraction (E-C coupling in mature cardiomyocytes. Human induced pluripotent stem cell (hiPSC-derived cardiomyocytes are known to have electrophysiological properties similar to mature adult cardiomyocytes. However, it is unclear if they share similar calcium handling property. We hypothesized that Ca2+ sparks in human induced pluripotent stem cell (hiPSCs-derived cardiomyocytes (hiPSC-CMs may display unique structural and functional properties than mature adult cardiomyocytes. METHODS AND RESULTS: Ca2+ sparks in hiPSC-CMs were recorded with Ca2+ imaging assay with confocal laser scanning microscopy. Those sparks were stochastic with a tendency of repetitive occurrence at the same site. Nevertheless, the spatial-temporal properties of Ca2+ spark were analogous to that of adult CMs. Inhibition of L-type Ca2+ channels by nifedipine caused a 61% reduction in calcium spark frequency without affecting amplitude of those sparks and magnitude of caffeine releasable sarcoplasmic reticulum (SR Ca2+ content. In contrast, high extracellular Ca2+ and ryanodine increased the frequency, full width at half maximum (FWHM and full duration at half maximum (FDHM of spontaneous Ca2+ sparks. CONCLUSIONS: For the first time, spontaneous Ca2+ sparks were detected in hiPSC-CMs. The Ca2+ sparks are predominately triggered by L-type Ca2+ channels mediated Ca2+ influx, which is comparable to sparks detected in adult ventricular myocytes in which cardiac E-C coupling was governed by a Ca2+-induced Ca2+ release (CICR mechanism. However, focal repetitive sparks originated from the same intracellular organelle could reflect an immature status of the hiPSC-CMs.

  2. Cavitation Erosion of Electro Spark Deposited Nitinol vs. Stellite Alloy on Stainless Steel Substrate

    Science.gov (United States)

    2015-07-15

    EROSION OF ELECTRO SPARK DEPOSITED NITINOL VS. STELLITE® ALLOY ON STAINLESS STEEL SUBSTRATE Theresa A. Hoffard Lean-Miguel San Pedro Mikhail...SUBTITLE 5a. CONTRACT NUMBER CAVITATION EROSION TESTING OF ELECTRO SPARK DEPOSITED NITINOL VS STELLITE® ALLOY ON STAINLESS STEEL SUBTRATE 5b. GRANT...of combining Nitinol (NiTi) superelastic metal alloy with ElectroSpark Deposition (ESD) technology to increase the cavitation erosion resistance of

  3. Workshop on Repetitive Spark Gap Operation Held at Tamarron, Colorado on January 17-19, 1983.

    Science.gov (United States)

    1983-05-20

    by Malyuta and Mezhevov (1979) (4) is shown schematically in Fig. 4. in this spark gap , flow of N 2 is fed axially around the first electrode... Gaps -- Flow Diagnostics The types of flow and heat transfer related measurements which have been made in the repetitive spark gap investigations which...spark gap flow physics and its influence on the performance of such switches, (15,26,27) such as is embodied by the studies done at Brown Boveri Research

  4. 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.

  5. Toward a generic UGV autopilot

    Science.gov (United States)

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

    2009-05-01

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

  6. 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.

  7. GENERIC COMMODITY PROMOTION AND PRODUCT DIFFERENTIATION

    OpenAIRE

    1999-01-01

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

  8. Increasing the isotropic properties of a discharge spark chamber with a large gap

    Science.gov (United States)

    Nurgozhin, N. N.

    1975-01-01

    The recording of particle tracks in the form of sparks or streamers running at different angles toward the electric field of the chamber was studied. The investigations were performed with two discharge spark chambers consisting of boxes filled with neon at 1 atm. The spark chambers were powered by a pulse with an amplitude of 300 kV applied from a pulse generator. The recording of particle tracks in the form of sparks took place at track angles smaller than 30 deg with respect to the electrical field. At angle larger than 40 deg the tracks are recorded in the form of streamers. Particle traces with respect to the angle are given.

  9. 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.

  10. 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

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

    Science.gov (United States)

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

    2012-08-01

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

  12. Generic modules for trivial extension algebras

    Institute of Scientific and Technical Information of China (English)

    杜先能

    1995-01-01

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

  13. 76 FR 54507 - Proposed Generic Communication; Draft NRC Generic Letter 2011-XX: Seismic Risk Evaluations for...

    Science.gov (United States)

    2011-09-01

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

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

    Science.gov (United States)

    Dylst, Pieter; Vulto, Arnold; Simoens, Steven

    2014-12-01

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

  15. Drug: D02748 [KEGG MEDICUS

    Lifescience Database Archive (English)

    Full Text Available (generical recombination) (JAN); Peginterferon alfa-2b (INN) USP drug classification [BR:br08302] Antivirals Anti-hepatitis...(JAN); Peginterferon alfa-2b (INN) Anti-hepatitis C (HCV) Agents Peginterferon Al

  16. Tailored Net-Shape Powder Composites by Spark Plasma Sintering

    Science.gov (United States)

    Khaleghi, Evan Aryan

    This dissertation investigates the ability to produce net-shape and tailored composites in spark plasma sintering (SPS), with an analysis of how grain growth, densification, and mechanical properties are affected. Using alumina and four progressively anisotropic dies, we studied the impact of specimen shape on densification. We found specimen shape had an impact on overall densification, but no impact on localized properties. We expected areas of the specimen to densify differently, or have higher grain growth, based on current anisotropy in the specimen during sintering, and preliminary results indicated this, but further investigation showed this did not occur. Overall average grain size and porosity decreased as shape complexity increased. In Fe-V-C steel, we mechanical alloyed two rapidly solidified powders, and used spark sintering to retain the properties imparted during the rapid solidification. We noticed VC grains being produced during densification, which improved the final properties. We conducted spark plasma extrusion (SPE) of aluminum to understand the effect on microstructure. We found, through an analysis of the grain structure, that SPE did have a grain deformation potential, and grain size was severely decreased compared to conventional sintering. Dynamic recrystallization did not occur, due to the reduced temperatures we were able to extrude with SPS. Finally, we examined whether there were particular sintering conditions for SPS that reduced the complexity of the grain growth and porosity relationship to one similar to conventional sintering, of the form G = k G0 ε -1/. We found that although a reasonable case could be made for free sintering, as found in the literature, for hot-pressing and SPS the conditions required go against the common knowledge in grain growth and densification kinetics. We were able to fit our data very well to the model, but the correlated results do not make physical sense.

  17. Generic development of topical dermatologic products: formulation development, process development, and testing of topical dermatologic products.

    Science.gov (United States)

    Chang, Rong-Kun; Raw, Andre; Lionberger, Robert; Yu, Lawrence

    2013-01-01

    This review presents considerations which can be employed during the development of a semi-solid topical generic product. This includes a discussion on the implementation of quality by design concepts during development to ensure the generic drug product has similar desired quality attributes to the reference-listed drug (RLD) and ensure batch to batch consistency through commercial production. This encompasses the concept of reverse-engineering to copy the RLD as a strategy during product development to ensure qualitative (Q1) and quantitative (Q2) formulation similarity, as well as similarity in formulation microstructure (Q3). The concept of utilizing in vitro skin permeation studies as a tool to justify formulation differences between the test generic product and the RLD to ensure a successful pharmacodynamic or clinical endpoint bioequivalence study is discussed. The review concludes with a discussion on drug product evaluation and quality tests as well as in vivo bioequivalence studies.

  18. Spark Plasma Sintering of Fuel Cermets for Nuclear Reactor Applications

    Energy Technology Data Exchange (ETDEWEB)

    Yang Zhong; Robert C. O' Brien; Steven D. Howe; Nathan D. Jerred; Kristopher Schwinn; Laura Sudderth; Joshua Hundley

    2011-11-01

    The feasibility of the fabrication of tungsten based nuclear fuel cermets via Spark Plasma Sintering (SPS) is investigated in this work. CeO2 is used to simulate fuel loadings of UO2 or Mixed-Oxide (MOX) fuels within tungsten-based cermets due to the similar properties of these materials. This study shows that after a short time sintering, greater than 90 % density can be achieved, which is suitable to possess good strength as well as the ability to contain fission products. The mechanical properties and the densities of the samples are also investigated as functions of the applied pressures during the sintering.

  19. Low temperature spark plasma sintering of YIG powders

    Energy Technology Data Exchange (ETDEWEB)

    Fernandez-Garcia, L. [Department of Nanostructured Materials, Centro de Investigacion en Nanomateriales y Nanotecnologia (CINN). Principado de Asturias - Consejo superior de Investigaciones Cientificas (CSIC) - Universidad de Oviedo - UO, Parque Tecnologico de Asturias, 33428 Llanera, Asturias (Spain); Suarez, M., E-mail: m.suarez@cinn.e [Department of Nanostructured Materials, Centro de Investigacion en Nanomateriales y Nanotecnologia (CINN). Principado de Asturias - Consejo superior de Investigaciones Cientificas (CSIC) - Universidad de Oviedo - UO, Parque Tecnologico de Asturias, 33428 Llanera, Asturias (Spain); Fundacion ITMA, Parque Tecnologico de Asturias, 33428, Llanera (Spain); Menendez, J.L. [Department of Nanostructured Materials, Centro de Investigacion en Nanomateriales y Nanotecnologia (CINN). Principado de Asturias - Consejo superior de Investigaciones Cientificas (CSIC) - Universidad de Oviedo - UO, Parque Tecnologico de Asturias, 33428 Llanera, Asturias (Spain)

    2010-07-16

    A transition from a low to a high spin state in the magnetization saturation between 1000 and 1100 {sup o}C calcination temperature is observed in YIG powders prepared by oxides mixture. Spark plasma sintering of these powders between 900 and 950 {sup o}C leads to dense samples with minimal formation of YFeO{sub 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.

  20. Large aluminium wire spark chambers with magnetostrictive read-out

    CERN Document Server

    Bradamante, Franco; Daum, C; Dechelette, Paul; Fidecaro, Giuseppe; Fidecaro, Maria; Giorgi, M; Penzo, Aldo L; Piemontese, L; Renevey, Max; Schiavon, Paolo; Vascotto, Alessandro

    1974-01-01

    A set of 1 cm gap wire spark chambers with a sensitive surface of 300 * 100 cm/sup 2/ was constructed for an experiment at the CERN proton synchrotron. The Coulomb scattering was limited by using aluminium wires and by adopting a crossed-wire configuration, which allowed us to minimize the number of chambers for a given number of pairs of coordinates. The wire planes were pulsed by feeding the high voltage from strip-lines along the whole boundary of the chambers. (7 refs).