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Sample records for generic drug substitution

  1. Effects of hospital generic drug substitution on diabetes therapy

    Directory of Open Access Journals (Sweden)

    Chen HY

    2014-01-01

    Full Text Available Hui-Yin Chen,1 Hui-Ru Chang,2 Hui-Chu Lang3 1Department of Auditing, Mackay Memorial Hospital, Taipei, Taiwan; 2Department of Social Insurance, Ministry of Health and Welfare, Taipei, Taiwan; 3Institute of Hospital and Health Care Administration, National Yang-Ming University, Taipei, Taiwan Objectives: To evaluate the effects on physicians’ prescribing behavior and on the therapeutic outcome of non-insulin-dependent diabetes patients of substituting different generic brands of metformin. Methods: We adopt a retrospective cohort study involving 280 type-2 diabetes patients who regularly used the outpatient services of one medical center and who had changed metformin brands five times between 2003 and 2008. The aim was to examine the effects of switching brands. The generalized estimating equation was used to determine whether drug brand switching affected patient glycated hemoglobin A1c (HbA1c levels, their prescribed daily dose, or their adherence to medication with metformin. Results: HbA1c levels increased from 7.91 to 8.34 throughout the study period, although it was found that brand switching did not adversely affect HbA1c levels after controlling for patient characteristics and the time course of the study. Furthermore, the prescribed daily dose of metformin was stable throughout the study period, and was approximately 0.8 of the defined daily dose. Finally, although adherence was significantly higher with the original metformin than with the four generic brands, patients still maintained high levels of adherence of >0.8. Conclusion: Although switching between different brands of metformin slightly affected the prescribing behavior of the physicians, there was no unfavorable effect on patient HbA1c levels. Thus, the policy of substituting between different generic brands of metformin is a good cost-effective approach that does not adversely affect the quality of diabetes patient care. Keywords: metformin, generic substitution, glycemic

  2. 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

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

    Directory of Open Access Journals (Sweden)

    Francesco Trotta

    2014-12-01

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

  4. 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...... by definition are bioequivalent to their brand name counterparts there are concerns about whether generic substitution is always accompanied by clinical equivalence in terms of effectiveness and that it may cause concerns and thereby causing some skepticism towards generic substitution. There is, however...

  5. 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.

  6. Generic Drugs: Questions and Answers

    Science.gov (United States)

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

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

    African Journals Online (AJOL)

    Treatment, however, can become more affordable through generic substitution. Objective: To determine the maximum potential cost-saving through generic substitution for both originator and more expensive generic items while observing the prescribing patterns of antipsychotics. Method: Antipsychotic medicine usage was ...

  8. 40 CFR 721.2527 - Substituted diphenylazo dye (generic name).

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Substituted diphenylazo dye (generic... Specific Chemical Substances § 721.2527 Substituted diphenylazo dye (generic name). (a) Chemical substance... substituted diphenylazo dye (PMN P-95-514) is subject to reporting under this section for the significant new...

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

    Science.gov (United States)

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

    2015-12-15

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

  10. 40 CFR 721.10048 - Substituted anthraquinone (generic).

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Substituted anthraquinone (generic... Specific Chemical Substances § 721.10048 Substituted anthraquinone (generic). (a) Chemical substance and... anthraquinone (PMN P-02-869) is subject to reporting under this section for the significant new uses described...

  11. Generic substitution: a potential risk factor for medication errors in hospitals.

    Science.gov (United States)

    Håkonsen, Helle; Hopen, Heidi Skjønhaug; Abelsen, Linda; Ek, Bjørg; Toverud, Else-Lydia

    2010-02-01

    Efforts to restrain pharmaceutical costs in the Norwegian hospital sector have focused on putting pharmaceuticals out to tender with resultant frequent changes in medicine inventories. Due to the extent of physicians failing to prescribe from the hospital drug list, the nurses have to perform generic substitution on the wards. The objective of the present study is to investigate the hospital nurses' experiences with generic substitution and to explore their views on this strategy as a risk factor for medication errors. Personal interviews with 100 nurses who were employed in a large Norwegian hospital were conducted using a semistructured questionnaire. In all, 75% of nurses thought it was problematic that the hospital's drug inventory was subject to frequent changes, and 91% believed that the high number of generic products may contribute to erroneous dispensing. Nevertheless, three out of four admitted that they seldom or never verified the feasibility of the substitution with the physician, and that it was seldom documented in the medical charts. In total, 42% of the nurses had experienced mistakes that occurred as a result of substitution. They claimed that the medication errors relating to generic substitution derived from difficult drug names, frequent changes in the drug inventory, and the increasing number of generic drugs, as well as from heavy workload and insufficient training. The present study shows that generic substitution is often carried out by nurses on the wards. The nurses feel insecure about the situation and report that they do not have the necessary training for the task. They clearly believe that a high number of generic drugs and frequent generic substitutions are risk factors for medication errors. Hence, hospital managers should be aware that such strategies to reduce costs may interfere with patient safety.

  12. Ontario's plunging price-caps on generics: deeper dives may drown some drugs.

    Science.gov (United States)

    Anis, Aslam; Harvard, Stephanie; Marra, Carlo

    2011-01-01

    In April 2010, the Ontario government announced another reduction in the maximum price of generic drugs permitted under the Ontario Drug Benefit (ODB) program, demanding that generic drugs now be sold for no more than 25% of the branded product's price. Other provinces are following Ontario in setting unprecedentedly low price-caps to reduce the cost of generic drugs. Generic product substitution legislation is vital to reducing costs to provincial drug plans, yet lower and lower price-caps may undo some of the benefits of substitution legislation if generics find it difficult to survive.

  13. Ontario’s plunging price-caps on generics: deeper dives may drown some drugs

    Science.gov (United States)

    Anis, Aslam; Harvard, Stephanie; Marra, Carlo

    2011-01-01

    In April 2010, the Ontario government announced another reduction in the maximum price of generic drugs permitted under the Ontario Drug Benefit (ODB) program, demanding that generic drugs now be sold for no more than 25% of the branded product’s price. Other provinces are following Ontario in setting unprecedentedly low price-caps to reduce the cost of generic drugs. Generic product substitution legislation is vital to reducing costs to provincial drug plans, yet lower and lower price-caps may undo some of the benefits of substitution legislation if generics find it difficult to survive. PMID:22046229

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

    Science.gov (United States)

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

    2017-04-01

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

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

    African Journals Online (AJOL)

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

  16. 78 FR 22553 - Generic Drug Facilities, Sites, and Organizations

    Science.gov (United States)

    2013-04-16

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

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

    Science.gov (United States)

    Drozdowska, Aleksandra; Hermanowski, Tomasz

    2015-02-01

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

  18. [Economy of generic drugs in Latin America].

    Science.gov (United States)

    Tobar, Federico

    2008-01-01

    In terms of economics, implementing generic drug policy is nothing other than consolidating (or even, creating) drug markets that set competitive prices, the result of which favors public access to essential drugs. This article approaches the topic of generic drugs from the economic perspective by examining various regulatory models in order to evaluate and leverage generic drug policy implementation options as a mechanism for battling some of the markets' specific weaknesses. The conclusion is that there is no single unequivocal method for promoting the use of generic drugs, and that the most favorable way to integrate markets may be through a broad combination of alternatives. These alternatives are grouped and analyzed according to the market issues or challenges that must be overcome. Several options are then identified based on the degree of market consolidation to be obtained.

  19. 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.

  20. Physicians underestimate the frequency of generic carbamazepine substitution: results of a survey and review of the problem.

    Science.gov (United States)

    Wilner, Andrew N.

    2002-12-01

    Antiepileptic drugs (AEDs) possess a narrow therapeutic range, and generic substitution may lead to breakthrough seizures and adverse events. Prescribers of AEDs may be unaware how frequently generic substitution actually occurs. Surveys were administered to 845 physicians at the 2001 American Epilepsy Society (AES) meeting and the 2001 American Academy of Neurology (AAN) meeting. Two hundred fifty-eight physicians responded to the AES survey and 587 physicians to the AAN survey. Questions were multiple choice and displayed on a computer screen. Among other questions, physicians were asked: (1) What percentage of patients are substituted with a generic short-acting carbamazepine in the US annually? (2) Are you comfortable with patients receiving multiple formulations of generic carbamazepine? Responses to the first question were compared to the actual rate of generic substitution determined by an independent audit of 1,036,000 Tegretol prescriptions. In the AES survey, 10.9% of respondents estimated that 10% of patients had carbamazepine generic substitutions, 41.9% estimated a 30% substitution rate, 30.2% estimated a 50% rate, and 17.1% estimated a 70% rate. The AAN respondents had similar estimates: 17.5% guessed a 10% rate, 40.0% a 30% rate, 30.2% a 50% rate, and 12.3% a 70% rate. In the AES survey, 86.4% of respondents were not "comfortable with patients receiving multiple formulations of generic carbamazepine." Similarly, in the AAN survey, 80.3% of respondents did not endorse generic substitution of carbamazepine. An independent audit of generic substitutions revealed that of 766,000 prescriptions for 200mg of Tegretol, pharmacists substituted 551,000 (72%) with generic carbamazepine. Of 199,000 prescriptions for 100mg of Tegretol, 140,000 (70%) were filled with a generic. Of 71,000 prescriptions for Tegretol 100mg/5ml suspension, 10,000 (14%) were filled with a generic. The overall substitution rate was 701,000/1,036,000 (68%), much higher than estimated by

  1. South African patient's acceptance of generic drugs

    African Journals Online (AJOL)

    DOI: http://dx.doi.org/10.4314/ahs.v15i1.37. Introduction. Access to therapeutic drugs form an integral part of any successful healthcare system. The high cost of drugs, however, remains a barrier to accessibility and improved health to the majority of the South Afri- can population1. The promotion of generic drug con-.

  2. 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

    solutions to address issues in Europe and the United States, such as streamlining the generic drug approval process and requiring generic prescribing and substitution where such policies are not yet in place. The history of substitution laws in the United States provides insights into the economic, political, and cultural issues influencing the adoption of generic drug policies. Governments should apply coherent supply- and demand-side policies in generic drug markets. An immediate priority is to convince more physicians, pharmacists, and patients that generic drugs are bioequivalent to branded products. Special-interest groups continue to obstruct reform in Europe and the United States. © 2017 The Authors The Milbank Quarterly published by Wiley Periodicals, Inc. on behalf of The Millbank Memorial Fund.

  3. [Generic drug policy implementation in Brazil].

    Science.gov (United States)

    Dias, Cláudia Regina Cilento; Romano-Lieber, Nicolina Silvana

    2006-08-01

    A generic drug policy has been implemented in Brazil since 1999. Several political and administrative stages transpired between enactment of the legislation and the actual marketing and consumption of these drugs. This article describes the policy implementation process and examines the country's generic drug legislation, approved from 1999 to 2002. To contextualize these measures, the study compares articles published by two national periodicals and interviews with a government representative involved in drafting the legislation and a representative from the pharmaceutical industry. Generic drugs quickly gained considerable space in the Brazilian pharmaceutical market. Ongoing adaptation of the legislation, media support, and the government's involvement in spreading the policy were key success factors. The population's access to medicines did not increase significantly, but people can now purchase medicines at more affordable prices and with quality assurance and interchangeability.

  4. [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.

  5. Mixed WTO ruling on generic drug development.

    Science.gov (United States)

    Elliott, R

    2000-01-01

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

  6. Knowledge and attitudes of the pharmacists, prescribers and patients towards generic drug use in Istanbul – Turkey

    Science.gov (United States)

    Toklu, Hale Z.; Dülger, Gül A.; Hıdıroğlu, Seyhan; Akici, Ahmet; Yetim, Aslıhan; Gannemoğlu, H. Mustafa; Güneş, Haşim

    The use of generic drugs has increased significantly in recent years. Since generic drugs are available at a lower cost, they provide an opportunity for savings in drug expenditure. Thus, use of generic drugs is encouraged especially in developing countries. There are only a few studies concerning the perceptions and attitudes of the healthcare providers and patients towards generic drug use. Methods The present study was conducted by a face to face questionnaire in the Kadikoy district of Istanbul in April 2010. From randomly chosen respondents, 68 pharmacists, 56 prescribers and 101 patients consented to participate in the study. Results Thirty one and 32 % of the pharmacists and prescribers, respectively, expressed that they believed that the generics did not differ from the original drugs, whereas only 24% of the patients believed so. Forty percent of the pharmacists and 82% of the prescribers told that they were unsure about the bioequivalence of the generics. Ten percent of the patients claimed that they immediately accept generic substitution by the pharmacist, while 26% accepted it if it was substituted by the prescriber. Cost was the most important factor taken into consideration about generic substitution (92% for prescribers; 83% for patients and 82% for pharmacists). Conclusions Our findings demonstrated that healthcare providers as well as the drug consumers have insufficient knowledge about generic drugs. Therefore, they should be better educated with respect to generic substitution. PMID:24155838

  7. Generic drugs: myths, facts, and limitations

    Directory of Open Access Journals (Sweden)

    Antonio Marzo

    2012-10-01

    Full Text Available Bioequivalence (BE has always been an important pharmaceutical area, particularly (but not solely in Mediterranean region, where the use of generic drugs is a relatively recent development. The lack of new therapeutic molecules has concentrated primary research in the hands of a few large pharmaceutical companies. For smaller companies, this has created opportunities for the development of new formulations of existing drugs (orodispersible tablets that dissolve in the mouth, extended-release tablets, transdermal delivery systems, generic drugs. These applications take advantage of the Abridged New Drug Application (ANDA procedure, which exempts them from a series of expensive investigations and limits the requirement for clinical testing to bioequivalence trials. Since 1991, bioequivalence trials have been regulated by US Food and Drug Administration (FDA and European Medicines Agency (EMA guidelines that provide precise indications on the most specific procedures to be adopted. In spite of these guidelines, however, some aspects of the process have not been fully defined, the most important of which regards the management of endogenous substances. Additional problems are how to manage bioequivalence protocols with drugs that have long half-lives and those whose clearance is characterized by high intrinsic variability. The view that bioequivalence data would be more reliable if they were based on studies in target populations is a myth to be discredited. The present paper reviews issues relative to pharmacokinetics (PK, bioavailability (BA, and bioequivalence, also from an historical viewpoint, and includes a stimulating “questions and answers” section on some key aspects of the bioequivalence of generic drugs.

  8. 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.

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

    Science.gov (United States)

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

    2017-08-04

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

  10. 40 CFR 721.9480 - Resorcinol, formaldehyde substituted carbomonocycle resin (generic).

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Resorcinol, formaldehyde substituted... New Uses for Specific Chemical Substances § 721.9480 Resorcinol, formaldehyde substituted... chemical substance identified generically as resorcinol, formaldehyde substituted carbomonocycle resin (PMN...

  11. 77 FR 60125 - Generic Drug Facilities, Sites and Organizations

    Science.gov (United States)

    2012-10-02

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

  12. Price regulation and relative delays in generic drug adoption.

    Science.gov (United States)

    Costa-Font, Joan; McGuire, Alistair; Varol, Nebibe

    2014-12-01

    Increasing the adoption of generic drugs has the potential to improve static efficiency in a health system without harming pharmaceutical innovation. However, very little is known about the timing of generic adoption and diffusion. No prior study has empirically examined the differential launch times of generics across a comprehensive set of markets, or more specifically the delays in country specific adoption of generics relative to the first country of (generic) adoption. Drawing on data containing significant country and product variation across a lengthy time period (1999-2008), we use duration analysis to examine relative delays, across countries, in the adoption of generic drugs. Our results suggest that price regulation has a significant effect on reducing the time to launch of generics, with faster adoption in higher priced markets. The latter result is dependent on the degree of competition and the expected market size. Copyright © 2014 Elsevier B.V. All rights reserved.

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

    Science.gov (United States)

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

    2017-09-01

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

  14. 40 CFR 721.3810 - Formaldehyde, polymers with substituted phenols (generic).

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Formaldehyde, polymers with... New Uses for Specific Chemical Substances § 721.3810 Formaldehyde, polymers with substituted phenols... identified generically as Formaldehyde, polymers with substituted phenols (PMN P-99-0558) is subject to...

  15. 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.

  16. [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

  17. Generic drugs: Review and experiences from South India

    Directory of Open Access Journals (Sweden)

    Philip Mathew

    2015-01-01

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

  18. 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.

  19. Generic legislation of new psychoactive drugs

    NARCIS (Netherlands)

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

    2013-01-01

    New psychoactive drugs (NPDs, new psychoactive substances) enter the market all the time. However, it takes several months to ban these NPDs and immediate action is generally not possible. Several European countries and drug enforcement officers insist on a faster procedure to ban NPDs. Introduction

  20. 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 …

  1. 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.

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

    Science.gov (United States)

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

    2018-01-01

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

  3. 78 FR 46958 - Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2014

    Science.gov (United States)

    2013-08-02

    ... product fees and annual sponsor fees, is $2,748,000 each (see 21 U.S.C. 379j-21(b)). B. Inflation... drug products, and for certain sponsors of such abbreviated applications for generic new animal drugs... applications for generic new animal drugs; (2) annual fees for certain generic new animal drug products; and (3...

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

    NARCIS (Netherlands)

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

    2016-01-01

    AIMS: The aim of the present study was to investigate whether differences in total and peak drug exposure upon generic substitution are due to differences between formulations or to intrasubject pharmacokinetic variability of the active substance. METHODS: The study was designed as a retrospective

  5. REGULATORY REQUIREMENTS FOR REGISTRATION OF GENERIC DRUGS IN "BRICS" COUNTRIES

    OpenAIRE

    G.Ravi Kiran* , M.V.Nagabhushanam, Brahmaiah Bonthagarala, D.Nagarjuna Reddy

    2017-01-01

    The purpose of the study was to compare generic drug registration process and to find out the differences, lacunae among the guidelines. Brazil, Russia, India, China and South Africa are typically rendered as "the BRICS" or "the BRICS economies". The registration process for Brazil and Russia are completely different. Even though India, China and South Africa follow the CTD format the requirements for Module 1 are different. It can be concluded that the world pharmaceutical economy, the faste...

  6. Generics Substitution, Bioequivalence Standards, and International Oversight: Complex Issues Facing the FDA.

    Science.gov (United States)

    Bate, Roger; Mathur, Aparna; Lever, Harry M; Thakur, Dinesh; Graedon, Joe; Cooperman, Tod; Mason, Preston; Fox, Erin R

    2016-03-01

    The regulations for assessing the quality of generic drugs and their bioequivalence to innovator products are outdated and need to be substantially modernized. There are multiple reasons why these changes are needed, including: (i) the regulations remain largely unchanged since the passage of the Hatch-Waxman Act in 1984; (ii) medication therapies have become substantially more complex over the three decades since the passage of the Act; (iii) a switch from an innovator drug to a generic drug, or switching from one generic to another, is not a benign process - there is substantial clinical professional judgment involved and in some instances these decisions should be better informed; and (iv) pharmaceutical ingredients for finished products, whether innovator or generic, are from multiple sources of supply, adding variability in their production, and which may not be accounted for in specification tolerances. When these elements are viewed together, they clearly suggest that more transparency of responsible manufacturers in product labels and updated standards for bioequivalence are required. Copyright © 2015 Elsevier Ltd. All rights reserved.

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

    Science.gov (United States)

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

    2018-02-01

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

  8. 78 FR 27113 - Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives Public Hearing; Request...

    Science.gov (United States)

    2013-05-09

    .... Postmarketing assessment of generic drugs and their brand-name counterparts 12. Physicochemical characterization... of Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg...

  9. Physicians? Trust in the FDA?s Use of Product-Specific Pathways for Generic Drug Approval

    OpenAIRE

    Kesselheim, Aaron S.; Eddings, Wesley; Raj, Tara; Campbell, Eric G.; Franklin, Jessica M.; Ross, Kathryn M.; Fulchino, Lisa A.; Avorn, Jerry; Gagne, Joshua J.

    2016-01-01

    Background: Generic drugs are cost-effective versions of brand-name drugs approved by the Food and Drug Administration (FDA) following proof of pharmaceutical equivalence and bioequivalence. Generic drugs are widely prescribed by physicians, although there is disagreement over the clinical comparability of generic drugs to brand-name drugs within the physician community. The objective of this survey was to assess physicians' perceptions of generic drugs and the generic drug approval process....

  10. Approval rating and opinion of outpatients and general practitioners toward generic drugs: a questionnaire-based real-world study

    Directory of Open Access Journals (Sweden)

    Mattioli F

    2017-08-01

    efficacy, safety and tolerability. New education policies on generic drugs are needed. Keywords: generic drug, population-based survey, generic substitution, opinion, experience

  11. 77 FR 65199 - Generic Drug User Fee-Backlog Fee Rate for Fiscal Year 2013

    Science.gov (United States)

    2012-10-25

    ... INFORMATION CONTACT: David Miller, Office of Financial Management (HFA-100), Food and Drug Administration...] Generic Drug User Fee--Backlog Fee Rate for Fiscal Year 2013 AGENCY: Food and Drug Administration, HHS... the backlog fee related to generic drug user fees for fiscal year (FY) 2013. The Federal Food, Drug...

  12. Emerging drugs of abuse: current perspectives on substituted cathinones

    Directory of Open Access Journals (Sweden)

    Paillet-Loilier M

    2014-05-01

    Full Text Available Magalie Paillet-Loilier,1 Alexandre Cesbron,1 Reynald Le Boisselier,2 Joanna Bourgine,1 Danièle Debruyne1,2 1Toxicology and Pharmacology Laboratory, 2Centre d'Evaluation et d'Information sur la Pharmacodépendance – Addictovigilance (CEIP-A, Department of Pharmacology, University Hospital Centre, Caen, France Abstract: Substituted cathinones are synthetic analogs of cathinone that can be considered as derivatives of phenethylamines with a beta-keto group on the side chain. They appeared in the recreational drug market in the mid-2000s and now represent a large class of new popular drugs of abuse. Initially considered as legal highs, their legal status is variable by country and is rapidly changing, with government institutions encouraging their control. Some cathinones (such as diethylpropion or pyrovalerone have been used in a medical setting and bupropion is actually indicated for smoking cessation. Substituted cathinones are widely available from internet websites, retail shops, and street dealers. They can be sold under chemical, evocative or generic names, making their identification difficult. Fortunately, analytical methods have been developed in recent years to solve this problem. Available as powders, substituted cathinones are self-administered by snorting, oral injestion, or intravenous injection. They act as central nervous system stimulants by causing the release of catecholamines (dopamine, noradrenaline, and serotonin and blocking their reuptake in the central and peripheral nervous system. They may also decrease dopamine and serotonin transporter function as nonselective substrates or potent blockers and may inhibit monoamine oxidase effects. Nevertheless, considerable differences have been found in the potencies of the different substituted cathinones in vitro. Desired effects reported by users include increased energy, empathy, and improved libido. Cardiovascular (tachycardia, hypertension and psychiatric

  13. 76 FR 44014 - Generic Drug User Fee; Public Meeting; Request for Comments

    Science.gov (United States)

    2011-07-22

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

  14. 76 FR 24035 - Generic Drug User Fee; Public Meeting; Request for Comments

    Science.gov (United States)

    2011-04-29

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

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

    NARCIS (Netherlands)

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

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

  16. Substituted amylose matrices for oral drug delivery

    Science.gov (United States)

    Moghadam, S. H.; Wang, H. W.; Saddar El-Leithy, E.; Chebli, C.; Cartilier, L.

    2007-03-01

    High amylose corn starch was used to obtain substituted amylose (SA) polymers by chemically modifying hydroxyl groups by an etherification process using 1,2-epoxypropanol. Tablets for drug-controlled release were prepared by direct compression and their release properties assessed by an in vitro dissolution test (USP XXIII no 2). The polymer swelling was characterized by measuring gravimetrically the water uptake ability of polymer tablets. SA hydrophilic matrix tablets present sequentially a burst effect, typical of hydrophilic matrices, and a near constant release, typical of reservoir systems. After the burst effect, surface pores disappear progressively by molecular association of amylose chains; this allows the creation of a polymer layer acting as a diffusion barrier and explains the peculiar behaviour of SA polymers. Several formulation parameters such as compression force, drug loading, tablet weight and insoluble diluent concentration were investigated. On the other hand, tablet thickness, scanning electron microscope analysis and mercury intrusion porosimetry showed that the high crushing strength values observed for SA tablets were due to an unusual melting process occurring during tabletting although the tablet external layer went only through densification, deformation and partial melting. In contrast, HPMC tablets did not show any traces of a melting process.

  17. Substituted amylose matrices for oral drug delivery

    International Nuclear Information System (INIS)

    Moghadam, S H; Wang, H W; El-Leithy, E Saddar; Chebli, C; Cartilier, L

    2007-01-01

    High amylose corn starch was used to obtain substituted amylose (SA) polymers by chemically modifying hydroxyl groups by an etherification process using 1,2-epoxypropanol. Tablets for drug-controlled release were prepared by direct compression and their release properties assessed by an in vitro dissolution test (USP XXIII no 2). The polymer swelling was characterized by measuring gravimetrically the water uptake ability of polymer tablets. SA hydrophilic matrix tablets present sequentially a burst effect, typical of hydrophilic matrices, and a near constant release, typical of reservoir systems. After the burst effect, surface pores disappear progressively by molecular association of amylose chains; this allows the creation of a polymer layer acting as a diffusion barrier and explains the peculiar behaviour of SA polymers. Several formulation parameters such as compression force, drug loading, tablet weight and insoluble diluent concentration were investigated. On the other hand, tablet thickness, scanning electron microscope analysis and mercury intrusion porosimetry showed that the high crushing strength values observed for SA tablets were due to an unusual melting process occurring during tabletting although the tablet external layer went only through densification, deformation and partial melting. In contrast, HPMC tablets did not show any traces of a melting process

  18. The influence of generic substitution on the content of patient-pharmacist communication in Swedish community pharmacies

    DEFF Research Database (Denmark)

    Olsson, Erika; Wallach-Kildemoes, Helle; Ahmed, Ban

    2017-01-01

    OBJECTIVES: The objective was to study the relationship between the length and content of patient-pharmacist communication in community pharmacies, and generic substitution. METHODS: The study was conducted in six community pharmacies in Sweden. Non-participant observations with audio recordings...... and short structured interviews were conducted. Out of 32 pharmacists 29 agreed to participate (90.6%), as did 282 out of 407 patients (69.3%). Logistic regression analysis was applied to calculate odds ratio for occurrence of generic substitution. Linear regression (β-coefficients) was applied to test...... literacy. This study suggests that pharmacists need to further embrace their role in promoting rational use of medicines, not least when generic substitution occurs....

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

    Science.gov (United States)

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

    2017-06-26

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

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

    Science.gov (United States)

    Kuribayashi, Ryosuke; Appleton, Scott

    2017-09-01

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

  2. In vitro Approaches to Support Bioequivalence and Substitutability of Generic Proton Pump Inhibitors via Nasogastric Tube Administration.

    Science.gov (United States)

    Ren, Ping; Cui, Minglei; Anand, Om; Xia, Li; Zhao, Zhuojun J; Sun, Dajun; Sharp, Trueman; Conner, Dale P; Peters, John; Jiang, Wenlei; Stier, Ethan; Jiang, Xiaojian

    2017-11-01

    Administration of proton pump inhibitors (PPIs) through nasogastric tubes may present risks. If the PPI drug products are not prepared properly, clogging or obstruction of nasogastric tubes can pose a safety concern. In addition, the integrity of the enteric coating of the drug product may be damaged resulting in reduced bioavailability of the active moiety. From the perspective of administration of generic PPIs when compared to the reference drug product, differences in formulation can potentially result in a greater relative risk for the generic drug product. As part of the assessment of bioequivalence, the Office of Generic Drugs (OGD) has developed a suite of in vitro testing to compare the delivery of the generic and reference products via nasogastric tubes. These in vitro tests assess essential attributes associated with the likelihood of clogging and maintenance of the enteric coating. These in vitro tests include studies evaluating sedimentation, granule size distribution, drug recovery, and acid resistance. One of the challenges is that while the administration of PPIs through nasogastric tubes is common in clinical practice, this issue is not uniformly addressed in the FDA approved label of the reference drug products. This paper discusses the design and rationale for in vitro testing of PPI formulations with respect to bioequivalence via nasogastric tube administration and in addition, it summarizes commonly occurring deficiencies in the in vitro nasogastric tube testing of 14 recent Abbreviated New Drug Applications (ANDA) submitted for five generic PPI drug products.

  3. 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

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

    African Journals Online (AJOL)

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

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

    Science.gov (United States)

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

    2016-04-01

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

  6. 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.

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

    Directory of Open Access Journals (Sweden)

    Varsha Bangalee

    2016-10-01

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

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

    Science.gov (United States)

    Nardi, Elene Paltrinieri; Ferraz, Marcos Bosi

    2016-02-01

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

  9. 76 FR 76738 - Generic Drug User Fee; Public Meeting

    Science.gov (United States)

    2011-12-08

    ... to http://www.regulations.gov . Submit written comments to the Division of Dockets Management (HFA... document. Transcripts of the meeting will be available for review at the Division of Dockets Management and... generic active pharmaceutical ingredient (API) and generic finished dosage form (FDF) manufacturers with...

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

    Science.gov (United States)

    Kohli, Erol; Buller, Allison

    2013-02-01

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

  11. The Hatch-Waxman Act: encouraging innovation and generic drug competition.

    Science.gov (United States)

    Sokal, Allen M; Gerstenblith, Bart A

    2010-01-01

    Congress carefully crafted the Hatch-Waxman Act to address two competing goals: to spur new pharmaceutical development and to encourage greater public access to generic drugs. To that end, the Act contains important provisions directed to fulfilling each goal, including provisions favorable to either branded drug or generic drug manufacturers. This article addresses those provisions in the context of issues pertaining to patent rights and in light of the congressional goals.

  12. Impact of the introduction of mandatory generic substitution in South Africa: private sector sales of generic and originator medicines for chronic diseases.

    Science.gov (United States)

    Gray, Andrew Lofts; Santa-Ana-Tellez, Yared; J Wirtz, Veronika

    2016-12-01

    To assess the impact of mandatory offer of generic substitution, introduced in South Africa in May 2003, on private sector sales of generic and originator medicines for chronic diseases. Private sector sales data (June 2001 to May 2005) were obtained from IMS Health for proton pump inhibitors (PPIs; ATC code A02BC), HMG-CoA reductase inhibitors (statins; C10AA), dihydropyridine calcium antagonists (C08CA), angiotensin-converting enzyme inhibitors (ACE-I; C09AA) and selective serotonin reuptake inhibitors (SSRIs; N06AB). Monthly sales were expressed as defined daily doses per 1000 insured population per month (DDD/TIM). Interrupted time-series models were used to estimate the changes in slope and level of medicines use after the policy change. ARIMA models were used to correct for autocorrelation and stationarity. Only the SSRIs saw a significant rise in level of generic utilisation (0.2 DDD/TIM; P decrease in slope (-0.003 DDD/TIM, P = 0.046; -0.01 DDD/TIM, P cost-containment efforts. However, decisions taken outside of official policy may anticipate or differ from that policy, with important consequences. © 2016 John Wiley & Sons Ltd.

  13. Disclosure of industry payments to prescribers: industry payments might be a factor impacting generic drug prescribing.

    Science.gov (United States)

    Qian, Jingjing; Hansen, Richard A; Surry, Daniel; Howard, Jennifer; Kiptanui, Zippora; Harris, Ilene

    2017-07-01

    Pharmaceutical companies paid at least $3.91bn to prescribers in 2013, yet evidence indicating whether industry payments shift prescribing away from generics is limited. This study examined the association between amount of industry payments to prescribers and generic drug prescribing rates among Medicare Part D prescribers. A cross-sectional analysis was conducted among 770 095 Medicare Part D prescribers after linking the 2013 national Open Payments data with 2013 Medicare Provider Utilization and Payment data. The exposure variable was the categorized amount of total industry payments to prescribers (i.e., meals, travel, research, and ownership). The outcome was prescriber's annual generic drug prescribing rate. Multivariable generalized linear regression models were used to examine the association between the amount of industry payments and prescriber's annual generic drug prescribing rates, controlling for prescriber's demographic and practice characteristics. In this sample, over one-third (38.0%) of Medicare Part D prescribers received industry payments in 2013. The mean annual generic drug prescribing rate was highest among prescribers receiving no payments and lowest among those receiving more than $500 of industry payments (77.5% vs. 71.3%, respectively; p industry payments was independently associated with prescribers' generic drug prescribing rate; higher payments corresponded with lower generic drug prescribing rates. Other prescriber characteristics associated with higher annual generic drug prescribing rate included male sex, non-northeast region, specialty, and patient volume. Receipt of industry payments was associated with a decreased rate of generic drug prescribing. How this affects patient care and total medical costs warrants further study. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

  14. Cannabis as a substitute for alcohol and other drugs

    Directory of Open Access Journals (Sweden)

    Reiman Amanda

    2009-12-01

    Full Text Available Abstract Background Substitution can be operationalized as the conscious choice to use one drug (legal or illicit instead of, or in conjunction with, another due to issues such as: perceived safety; level of addiction potential; effectiveness in relieving symptoms; access and level of acceptance. This practice of substitution has been observed among individuals using cannabis for medical purposes. This study examined drug and alcohol use, and the occurrence of substitution among medical cannabis patients. Methods Anonymous survey data were collected at the Berkeley Patient's Group (BPG, a medical cannabis dispensary in Berkeley, CA. (N = 350 The sample was 68% male, 54% single, 66% White, mean age was 39; 74% have health insurance (including MediCal, 41% work full time, 81% have completed at least some college, 55% make less than $40,000 a year. Seventy one percent report having a chronic medical condition, 52% use cannabis for a pain related condition, 75% use cannabis for a mental health issue. Results Fifty three percent of the sample currently drinks alcohol, 2.6 was the average number of drinking days per week, 2.9 was the average number of drinks on a drinking occasion. One quarter currently uses tobacco, 9.5 is the average number of cigarettes smoked daily. Eleven percent have used a non-prescribed, non OTC drug in the past 30 days with cocaine, MDMA and Vicodin reported most frequently. Twenty five percent reported growing up in an abusive or addictive household. Sixteen percent reported previous alcohol and/or drug treatment, and 2% are currently in a 12-step or other recovery program. Forty percent have used cannabis as a substitute for alcohol, 26% as a substitute for illicit drugs and 66% as a substitute for prescription drugs. The most common reasons given for substituting were: less adverse side effects (65%, better symptom management (57%, and less withdrawal potential (34% with cannabis. Conclusion The substitution of one

  15. The impact of generic substitution on the activities of pharmaceutical companies - a survey from the companies' perspective one year and five years after the introduction of generic substitution in finland.

    Science.gov (United States)

    Timonen, Johanna; Bengtström, Marina; Karttunen, Pekka; Ahonen, Riitta

    2010-10-22

    Mandatory generic substitution (GS) was introduced in Finland on 1 April 2003. The aim of this study was to explore and compare the impacts of GS on the activities of pharmaceutical companies representing mainly original or generic pharmaceutical products in Finland. The self-reported impact of GS from pharmaceutical companies' perspective was explored with a focus on the number of employees, the range of sales packages on the market, the marketing activities, the research and development of new pharmaceutical products and storage of pharmaceuticals. A cross-sectional postal survey was conducted among pharmaceutical companies with an office in Finland and substitutable medicines in the Finnish pharmaceutical market one year (2004) and five years (2008) after the introduction of GS. Completed questionnaires were returned by 16 original and 7 generic product companies in 2004 (response rate 56%, n = 41) and by 16 original and 6 generic product companies in 2008 (response rate 56%, n = 39). Descriptive statistical analyses were performed. The number of employees (2004: n = 6/16, 2008: n = 7/16) and the amount of prescription medicine marketing (2004: n = 7/16, 2008: n = 8/16) decreased in many of the original product companies after the introduction of GS. GS resulted in problems related to the storage of pharmaceuticals in the original product companies shortly after GS was introduced (p = 0.032 between 2004 and 2008). In the generic product companies, the prescription medicine representatives' visits to pharmacies increased at the beginning of GS (p = 0.021 between 2004 and 2008). In addition, GS caused problems with the storage of pharmaceuticals one year and five years after the reform (2004: n = 4/7, 2008: n = 3/6). The differences between original and generic product companies regarding the impacts of GS were not, however, statistically significant. GS did not affect on the range of sales packages on the market or the research activities of the majority of

  16. Generic - equivalent drugs use in internal and general medicine patients: distrust, confusion, lack of certainties or of knowledge? Part 3. Clinical issues

    Directory of Open Access Journals (Sweden)

    Roberto Nardi

    2014-05-01

    Full Text Available There are several clinical areas or types of drugs that make prescribing branded drugs preferable, because of potential therapeutic inequivalence or confusion. Bioequivalence criteria may be fine for most drugs, but some conditions may require drug levels with modified variations, like in the case of narrow therapeutic index and critical dose drugs, highly variable drugs and modified-release formulations. Moreover, substitution with generics can be problematic in some patient subpopulations, such as elderly frail people, immunocompromised and transplant patients and patients with epilepsy. We include a list of branded drugs that are considered safer, more effective or with a lower risk of error. The therapeutic substitution is markedly different from therapeutic interchange. The replacement of a brand product with an equivalent has to occur under the control of the physician. At some point in their interaction with individual patients, physicians should let them know that generics are available as substitutes for the more expensive brand-name medications and are equivalent in terms of efficacy and safety. Finally, we hope that a tool like the American Orange book will be also implemented in Italy: it would serve as an accurate reference, that can be useful both to physicians for prescription appropriateness and to patients for their own informed consent.

  17. 42 CFR 447.506 - Authorized generic drugs.

    Science.gov (United States)

    2010-10-01

    ... means any drug sold, licensed, or marketed under an NDA approved by the FDA under section 505(c) of the..., trademark, or packaging (other than repackaging the listed drug for use in institutions) than the brand drug...

  18. Effects of anthropomorphic images and narration styles in promotional messages for generic prescription drugs.

    Science.gov (United States)

    Muzumdar, Jagannath M; Schommer, Jon C; Hadsall, Ronald S; Huh, Jisu

    2013-01-01

    Anthropomorphism is attribution of human characteristics to nonhuman objects or events. Marketers have used anthropomorphized characters to promote products and services. To promote use of generic drugs to save on prescription drug costs, health systems are in the process of developing informational materials to influence consumer's perceptions about generic prescription drugs. To evaluate the effects of anthropomorphic images (control vs caring vs authoritative) and information narration styles (first person vs third person) on (1) social presence, (2) attitude toward the overall promotional message, (3) perceived informativeness of the message content, (4) attitude toward specific message, (5) intent to seek information, and (6) intention to switch to a generic prescription drug. A 3×2 between-subject factorial design was used. Student participants were administered a mock promotional message regarding generic prescription drugs. Following the promotional message, they were asked to respond to items developed to measure the effects of the promotional message. Manipulation checks were conducted to test the desired effects of the independent variables. Pilot testing, exploratory factor analysis, and reliability testing of the item measures were conducted before their use in the study. Analysis of variance was used to analyze the data and test the proposed effects of the independent variables. Anthropomorphic images showed a positive effect on social presence and attitude toward the specific message. Narration styles had a positive effect on attitude toward the overall promotional message. Neither anthropomorphic images nor narration styles had a significant effect on perceived informativeness, intent to seek information, and intention to switch to a generic prescription drug. This research reveals that anthropomorphism of medications and narration styles could play a significant role in promotional messages for generic prescription drugs. These findings provide a

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

    Directory of Open Access Journals (Sweden)

    Farouk M Sakr

    2016-01-01

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

  20. 40 CFR 721.1735 - Alkylbisoxyalkyl (sub-sti-tut-ed-1,1-dimethylethylphenyl) ben-zo-tria-zole (generic name).

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Alkylbisoxyalkyl (sub-sti-tut-ed-1,1-dimethylethylphenyl) ben-zo-tria-zole (generic name). 721.1735 Section 721.1735 Protection of Environment... SUBSTANCES Significant New Uses for Specific Chemical Substances § 721.1735 Alkylbisoxyalkyl (sub-sti-tut-ed...

  1. 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.

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

    Science.gov (United States)

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

    2017-12-01

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

  3. 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.

  4. 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.

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

    African Journals Online (AJOL)

    Varsha Bangalee

    Has the increase in the availability of generic drugs lowered the price of cardiovascular drugs in South. Africa? Varsha Bangalee. *. , Fatima Suleman 1. Discipline of Pharmaceutical Sciences, School of Health Sciences, University of KwaZulu-Natal, Westville Campus,. Private Bag X54001, Durban, 4000, KZN, South Africa.

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

    Science.gov (United States)

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

    2016-01-01

    AIMS The aim of the present study was to investigate whether differences in total and peak drug exposure upon generic substitution are due to differences between formulations or to intrasubject pharmacokinetic variability of the active substance. Methods The study was designed as a retrospective reanalysis of existing studies. Nine replicate design bioequivalence studies representing six drug classes – i.e. for alendronate, atorvastatin, cyclosporin, ebastine, exemestane, mycophenolate mofetil, and ropinirole – were retrieved from the Dutch Medicines Regulatory Authority. Results In most studies, the intrasubject variability in total and peak drug exposure was comparable for the brand‐name [in the range 0.01–0.24 for area under the concentration–time curve (AUCt) and 0.02–0.29 for peak plasma concentration (Cmax) on a log scale] and generic (0.01–0.23 for AUCt and 0.08–0.33 for Cmax) drugs, and was comparable with the intrasubject variability upon switching between those drugs (0.01–0.23 for AUCt and 0.06–0.33 for Cmax). The variance related to subject‐by‐formulation interaction could be considered negligible (–0.069 to 0.047 for AUCt and –0.091 to 0.02 for Cmax). Conclusion In the investigated studies, the variation in total and peak exposure seen when a patient is switched from a brand‐name to a generic drug is comparable with that seen following repeated administration of the brand‐name drug in the patient. Only the intrasubject variability seems to play a crucial and decisive role in the variation in drug exposure seen; no additional formulation‐dependent variation in exposure is observed upon switching. Thus, our data support that, for the medicines that were included in the present investigation, from a clinical pharmacological perspective, the benefit–risk balance of a generic drug is comparable with that of the brand‐name drug. PMID:26574160

  7. Generic Drugs: The Same Medicine for Less Money

    Science.gov (United States)

    ... same benefit to your health, and you will save money. 7KH IHGHUDO )RRG DQG 'UXJ $GPLQLVWUDWLRQ )'$ UHJXODWHV ERWK ... drug, like a 30% co-pay, you also save money. The full cost of a brand-name drug ...

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

    Science.gov (United States)

    Gagnon, Marc-André; Volesky, Karena D

    2017-08-22

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

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

    Directory of Open Access Journals (Sweden)

    Michael A. Partridge

    2016-01-01

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

  10. Fibrous growth of strontium substituted hydroxyapatite and its drug release

    International Nuclear Information System (INIS)

    Suganthi, R.V.; Elayaraja, K.; Joshy, M.I. Ahymah; Chandra, V. Sarath; Girija, E.K.; Kalkura, S. Narayana

    2011-01-01

    The effect of strontium on the crystallization of helical ribbon of hydroxyapatite (HAp) was investigated by single diffusion technique in silica gel matrix at 27 deg. C and physiological pH. Fibers of HAp were obtained on addition of strontium. The length of the HAp fibers, were found to decrease as the strontium substitution increases. The presence of strontium ion increased the crystallinity as well as crystallite size of HAp. The strontium substituted HAp (Sr-HAp) has similar stoichiometry to that of biological apatite. Sr-HAp was found to have increased surface area (35%) compared to control. Further, strontium substitution leads to an enhancement of in vitro bioactivity. The cumulative in-vitro amoxicillin drug release in phosphate buffer solution (PBS, pH 7.2) showed a prolonged release profile for Sr-HAp.

  11. Fibrous growth of strontium substituted hydroxyapatite and its drug release

    Energy Technology Data Exchange (ETDEWEB)

    Suganthi, R.V.; Elayaraja, K.; Joshy, M.I. Ahymah; Chandra, V. Sarath [Crystal Growth Centre, Anna University, Chennai 600 025 (India); Girija, E.K. [Department of Physics, Periyar University, Salem 636 011 (India); Kalkura, S. Narayana, E-mail: kalkura@yahoo.com [Crystal Growth Centre, Anna University, Chennai 600 025 (India)

    2011-04-08

    The effect of strontium on the crystallization of helical ribbon of hydroxyapatite (HAp) was investigated by single diffusion technique in silica gel matrix at 27 deg. C and physiological pH. Fibers of HAp were obtained on addition of strontium. The length of the HAp fibers, were found to decrease as the strontium substitution increases. The presence of strontium ion increased the crystallinity as well as crystallite size of HAp. The strontium substituted HAp (Sr-HAp) has similar stoichiometry to that of biological apatite. Sr-HAp was found to have increased surface area (35%) compared to control. Further, strontium substitution leads to an enhancement of in vitro bioactivity. The cumulative in-vitro amoxicillin drug release in phosphate buffer solution (PBS, pH 7.2) showed a prolonged release profile for Sr-HAp.

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

    Science.gov (United States)

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

    2003-01-01

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

  13. 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.

  14. 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.

  15. 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

    in brand-name, form, size, colour and taste. Speculations have been raised as to whether these medication changes between generic brands or from brand-name drugs to generics or vice versa may cause patient concerns. Qualitative studies have shown problems in recognising the substituted medicine and lack...... 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...

  16. International harmonization of generic drugs: in vitro dissolution tests for Japanese and American generic tablets.

    Science.gov (United States)

    Otsuka, Makoto; Tomita, Hisako; Otsuka, Kuniko; Kamae, Isao; Jorgenson, James A

    2006-01-01

    Ibuprofen tablets on the market in Japan and the USA were compared by manual- and automatic-dissolution tests according to USP24 criteria. Dissolution test were performed in 900 ml of phosphate buffer of pH 7.2 at 37.0+/-0.5 degrees C at 50 rpm for 60 min, and the time required for 70% dissolution (T70%) and 5% dissolution after 60 min (A60) were evaluated. The dissolution profiles of both Japanese and American tablets by the automatic-method showed almost the same profiles as those of the manual method. T70% of the American and Japanese tablets by the manual method were not significantly different (p>0.05) from the automatic-method at various sampling positions. The A60 of the American and Japanese tablets by the manual-method was not significantly different (p>0.05) except at one position. The results indicate that the automatic-method was more reproducible than the manual-method, and also that systematic error was negligible. The T70% and A60 of the American tablets were significantly different (p<0.05) from the Japanese tablets. The American tablets were a film-coated over-the-counter drug and the Japanese tablets were a sugar-coated prescription drug. There was a difference in dissolution behavior between the dosage forms of the two countries.

  17. Generic anti-drug antibody assay with drug tolerance in serum samples from mice exposed to human antibodies.

    Science.gov (United States)

    Stubenrauch, Kay; Mackeben, Klaus; Vogel, Rudolf; Heinrich, Julia

    2012-11-15

    Knowledge of the anti-drug antibody (ADA) status is necessary in early research studies. Because specific assay materials are sparse and time is pressing, a generic assay format with drug tolerance for detection of ADAs in serum samples from mice exposed to immunoglobulin G (IgG) or antigen-binding fragments (Fabs) is highly desirable. This article describes a generic immune complex assay in the sandwich enzyme-linked immunosorbent assay (ELISA) format based on (i) transformation of free ADAs to immune complexes by preincubation with excess drug, (ii) the use of a murine anti-human Fab constant domain Fab as capture reagent, (iii) detection of the immune complexes by a peroxidase-labeled rabbit anti-murine Fc antibody, and (iv) ADA-positive control conjugates consisting of human Fab and murine IgG. Results of the experiments suggest that the generic immune complex assay for mouse serum samples was at least equivalent to specific ADA immune assays and even superior regarding drug tolerance. The generic immune complex assay confers versatility as it detects ADAs in complex with full-length IgG as well as with Fabs independent of the target specificity in mouse serum samples. These features help to save the sparse amounts of specific antibodies available in early research and development and speed up drug candidate selection. Copyright © 2012 Elsevier Inc. All rights reserved.

  18. 76 FR 45814 - Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2012

    Science.gov (United States)

    2011-08-01

    ...)). When certain conditions are met, FDA will waive or reduce fees for generic new animal drugs intended.... 379j-21(c)(1)). FDA calculated the average number of each of the four types of applications and... ended on June 30, 2011. The results of these calculations are presented in the first two columns of...

  19. 77 FR 45629 - Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2013

    Science.gov (United States)

    2012-08-01

    ... conditions are met, FDA will waive or reduce fees for generic new animal drugs intended solely to provide for... (21 U.S.C. 379j-21(c)(1)). FDA calculated the average number of each of the four types of applications... that ended on June 30, 2012. The results of these calculations are presented in the first two columns...

  20. Choosing a Type 2 Diabetes Drug: Why Generic Metformin is Often the Best Choice

    Science.gov (United States)

    ... Healthy Aging Medical Tests Before Surgery Pediatrics Safe Pregnancy Screening Tests Smarter, Safer Patients Treating Pain News and Notes Stories Patients’ Stories Providers’ Stories Choosing a Type 2 Diabetes Drug Why generic metformin is often the best choice

  1. Bioequivalence Evaluations of Generic Dry Powder Inhaler Drug Products: Similarities and Differences Between Japan, USA, and the European Union.

    Science.gov (United States)

    Kuribayashi, Ryosuke; Yamaguchi, Toru; Sako, Hanaka; Takishita, Tomoko; Takagi, Kazunori

    2017-03-01

    In Japan, the development of generic oral dry powder inhaler (DPI) drug products for marketing approval has recently increased. The Pharmaceuticals and Medical Devices Agency (PMDA) considers the required data for each drug product in the consultation meeting. However, guidelines for DPI drug products have been published by the US Food and Drug Administration and the European Medicines Agency. Recently, the basic principles of bioequivalence evaluations of generic DPI drug products were published in March 2016 by the Ministry of Health, Labour and Welfare. The document mainly outlines the current understanding regarding the bioequivalence evaluations of generic DPI drug products based on knowledge from PMDA consultation meetings. In this review, we compared the bioequivalence evaluations of DPI drug products among Japan, USA, and the European Union and discuss future development of generic DPI drug products in Japan.

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

    Science.gov (United States)

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

    2017-04-01

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

  3. 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.

  4. [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.

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

    NARCIS (Netherlands)

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

    2003-01-01

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

  6. The Association Between Patient Sociodemographic Characteristics and Generic Drug Use: A Systematic Review and Meta-analysis.

    Science.gov (United States)

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

    2018-03-01

    Generic drugs are bioequivalent and cost-effective alternatives to brand drugs. In 2014, $254 billion was saved because of the use of generic drugs in the United States. To critically assess evidence on the association between patient characteristics and generic drug use in order to inform the development of educational outreach for improving generic drug use among patients. We systematically searched the literature between January 2005 and December 2016 using PubMed, Web of Science, Ovid MEDLINE, Google Scholar, and EBSCO IPA-MEDLINE for potentially relevant studies. The titles and abstracts of identified articles were assessed independently by 2 reviewers. Titles and abstracts that were not written in English, were published before 2005, were not empirical, did not contain sociodemographic data, or were not policy or methodologically relevant to generic drug use were excluded. Data were pooled in a meta-analysis using the RStudio software to assess the association of patient-related factors with generic drug use. Our searches resulted in 11 articles on patient-level factors, and 6 of these articles had sufficient information to conduct meta-analyses in the domains of patients' gender, age, race/ethnicity, and income. Quantitative analysis indicated that no differences in generic drug use existed between subgroups of patients defined by gender, age, or race/ethnicity. However, patients with lower income (i.e., 75%) for all analyses but income. Patients with lower income were more likely to use generic drugs, whereas evidence was heterogeneous regarding an association between generic drug use and gender, age, or race/ethnicity. Educational outreach targeting patients with higher incomes to understand their perspectives in generic drugs may help improve generic drug use within that population. Funding for this study was made possible, in part, by the U.S. Food and Drug Administration through grant U01FD005486. Hansen has provided expert testimony for Daiichi Sankyo

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

    Directory of Open Access Journals (Sweden)

    S. Yu. Martsevich

    2016-01-01

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

  8. Survey of international regulatory bioequivalence recommendations for approval of generic topical dermatological drug products.

    Science.gov (United States)

    Braddy, April C; Davit, Barbara M; Stier, Ethan M; Conner, Dale P

    2015-01-01

    The objective of this article is to discuss the similarities and differences in accepted bioequivalence (BE) approaches for generic topical dermatological drug products between international regulatory authorities and organizations. These drug products are locally applied and not intended for systemic absorption. Therefore, the BE approaches which serve as surrogates to establish safety and efficacy for topical dosage forms tend to differ from the traditional solid oral dosage forms. We focused on 15 different international jurisdictions and organizations that currently participate in the International Generic Drug Regulators Pilot Project. These are Australia, Brazil, Canada, China, Chinese Taipei, the European Medicines Association (EMA), Japan, Mexico, New Zealand, Singapore (a member of the Association of Southeast Asian Nations), South Africa, South Korea, Switzerland, the USA and the World Health Organization (WHO). Upon evaluation, we observed that currently only Canada, the EMA, Japan, and the USA have specific guidance documents for topical drug products. Across all jurisdictions and organizations, the three approaches consistently required are (1) BE studies with clinical endpoints for most topical drug products; (2) in vivo pharmacodynamic studies, in particular the vasoconstrictor assay for topical corticosteroids; and (3) waivers from BE study requirements for topical solutions. Japan, South Africa, the USA, and the WHO are also making strides to accept other BE approaches such as in vivo pharmacokinetic studies for BE assessment, in vivo dermatopharmacokinetic studies and/or BE studies with in vitro endpoints.

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

    Directory of Open Access Journals (Sweden)

    Marcos Inocencio

    2010-06-01

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

  10. Is the term substitution relevant to Pharmacognosy and/ or vegetable crude drug industry?

    Science.gov (United States)

    Selvam, A B D

    2010-09-01

    Since each and every drug plant has its own characteristic features, in terms of its botanical characters, chemical composition and therapeutic properties, considering the highly potential drug plants as genuine plant and less potential (allied or non-allied) drug plants as substitutes is unjustifiable. Moreover, the term Substitution is being used for a couple of centuries in a wrong sense in pharmacognostic studies or in the vegetable crude drug industry. Therefore, the term 'Substitution' has to be replaced by the relevant and appropriate term, 'Alternative' or 'Alternative source'.

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

    Directory of Open Access Journals (Sweden)

    Ana Cerúlia Moraes do Carmo

    2017-01-01

    Full Text Available 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.

  12. 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…

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

    Directory of Open Access Journals (Sweden)

    Nanang Yunarto

    2016-09-01

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

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

    NARCIS (Netherlands)

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

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

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

    Science.gov (United States)

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

    2012-01-01

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

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

    DEFF Research Database (Denmark)

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

    2014-01-01

    PURPOSE: This study aims to investigate the possible association between patients' concerns about their medicine and generic switch. METHODS: Cross-sectional survey was carried out comprising responses from 2217 randomly selected persons aged 20 years or older and living in the Region of Southern...... Denmark, who had redeemed generically substitutable drugs in September 2008. For each patient, we focused on the purchase of one generically substitutable drug (index drug). We applied the specific concerns subscale from the Beliefs about Medicine Questionnaire (BMQ) to analyse lack of confidence...... in treatment. We also included general beliefs about medicine (BMQ), views on generic medicine and confidence in the health-care system. The information about the patients' generic switch was obtained from a prescription database and not provided by the patients. Data were analysed using linear regression...

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

    Science.gov (United States)

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

    2017-12-02

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

  18. 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.

  19. Requirements for generic antiepileptic medicines: a clinical perspective.

    Science.gov (United States)

    Trinka, Eugen; Krämer, Günter; Graf, Martin

    2011-12-01

    Many antiepileptic drugs (AEDs) are now available as a generic product. This can potentially save the healthcare providers massive costs. Hence, governmental authorities have introduced rules and incentives for clinicians to switch from the original branded AED to a generic product. Clinicians and patients with epilepsy are reluctant to switch. The licensing of generic AEDs is based on the equation that bioavailability means therapeutic equivalence. However, from a clinical standpoint one has to consider several other relevant issues: (1) Do generic AEDs have the same efficacy, safety and quality? (2) Can generic AEDs be used as substitutions for brand AEDs? (3) Can generic products of AEDs be used interchangeably? (4) Does the generic AED manufacturer guarantee the long-term consistency of availability on the market? (4) Do generic AEDs reduce the costs, and--if so--are these costs worth any additional risk to patient's safety? This article reviews the clinical issues related to current bioequivalence, prescribability, and switchability of AEDs.

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

    Science.gov (United States)

    Rostron, Allen

    2011-02-01

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

  1. Cannabis as a substitute for prescription drugs - a cross-sectional study.

    Science.gov (United States)

    Corroon, James M; Mischley, Laurie K; Sexton, Michelle

    2017-01-01

    The use of medical cannabis is increasing, most commonly for pain, anxiety and depression. Emerging data suggest that use and abuse of prescription drugs may be decreasing in states where medical cannabis is legal. The aim of this study was to survey cannabis users to determine whether they had intentionally substituted cannabis for prescription drugs. A total of 2,774 individuals were a self-selected convenience sample who reported having used cannabis at least once in the previous 90 days. Subjects were surveyed via an online anonymous questionnaire on cannabis substitution effects. Participants were recruited through social media and cannabis dispensaries in Washington State. A total of 1,248 (46%) respondents reported using cannabis as a substitute for prescription drugs. The most common classes of drugs substituted were narcotics/opioids (35.8%), anxiolytics/benzodiazepines (13.6%) and antidepressants (12.7%). A total of 2,473 substitutions were reported or approximately two drug substitutions per affirmative respondent. The odds of reporting substituting were 4.59 (95% confidence interval [CI], 3.87-5.43) greater among medical cannabis users compared with non-medical users and 1.66 (95% CI, 1.27-2.16) greater among those reporting use for managing the comorbidities of pain, anxiety and depression. A slightly higher percentage of those who reported substituting resided in states where medical cannabis was legal at the time of the survey (47% vs. 45%, p =0.58), but this difference was not statistically significant. These patient-reported outcomes support prior research that individuals are using cannabis as a substitute for prescription drugs, particularly, narcotics/opioids, and independent of whether they identify themselves as medical or non-medical users. This is especially true if they suffer from pain, anxiety and depression. Additionally, this study suggests that state laws allowing access to, and use of, medical cannabis may not be influencing

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

    Science.gov (United States)

    Elliott, R

    2000-01-01

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

  3. Generic Switching and Non-Persistence among Medicine Users

    DEFF Research Database (Denmark)

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

    2015-01-01

    BACKGROUND: Generic substitution means that one medicinal product is replaced by another product containing the same active substance. It is strictly regulated with respect to its bioequivalence, and all products must have undergone appropriate studies. Although generic substitution is widely...... implemented, it still remains to be answered how generic switch influences persistence to long-term treatment, and if it is modified by patients' concerns about medicine and views on generic medicine. This study focuses on users of antidepressants and antiepileptics, and their experience of generic switching......' attitudes towards generic medicines and concerns about their medicine. RESULTS: 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...

  4. Neuro-fuzzy models as an IVIVR tool and their applicability in generic drug development.

    Science.gov (United States)

    Opara, Jerneja; Legen, Igor

    2014-03-01

    The usefulness of neuro-fuzzy (NF) models as an alternative in vitro-in vivo relationship (IVIVR) tool and as a support to quality by design (QbD) in generic drug development is presented. For drugs with complicated pharmacokinetics, immediate release drugs or nasal sprays, suggested level A correlations are not capable to satisfactorily describe the IVIVR. NF systems were recognized as a reasonable method in comparison to the published approaches for development of IVIVR. Consequently, NF models were built to predict 144 pharmacokinetic (PK) parameter ratios required for demonstration of bioequivalence (BE) for 88 pivotal BE studies. Input parameters of models included dissolution data and their combinations in different media, presence of food, formulation strength, technology type, particle size, and spray pattern for nasal sprays. Ratios of PK parameters Cmax or AUC were used as output variables. The prediction performance of models resulted in the following values: 79% of models have acceptable external prediction error (PE) below 10%, 13% of models have inconclusive PE between 10 and 20%, and remaining 8% of models show inadequate PE above 20%. Average internal predictability (LE) is 0.3%, and average external predictability of all models results in 7.7%. In average, models have acceptable internal and external predictabilities with PE lower than 10% and are therefore useful for IVIVR needs during formulation development, as a support to QbD and for the prediction of BE study outcome.

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

    Science.gov (United States)

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

    2014-06-01

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

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

    Science.gov (United States)

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

    2003-05-25

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

  7. 78 FR 3900 - Generic Drug User Fee-Active Pharmaceutical Ingredient and Finished Dosage Form Facility Fee...

    Science.gov (United States)

    2013-01-17

    ... March 4, 2013. FOR FURTHER INFORMATION CONTACT: David Miller, Office of Financial Management (HFA-100... reference the user fee payment ID number when completing your transfer. The originating financial...] Generic Drug User Fee--Active Pharmaceutical Ingredient and Finished Dosage Form Facility Fee Rates for...

  8. 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.

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

    Directory of Open Access Journals (Sweden)

    Chin-Fun Chu

    2012-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Chin-Fun Chu

    2012-01-01

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

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

    Science.gov (United States)

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

    2018-03-01

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

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

    International Nuclear Information System (INIS)

    Gebran, N.; Al-Haldari, K.

    2006-01-01

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

  13. Are biosimilars really generics?

    Science.gov (United States)

    Misra, Anoop

    2010-04-01

    Ever since the formation of the first biotechnology company almost three decades ago, more than 150 biopharmaceutical products have been marketed across the globe. The oldest of these biotechnology-derived products are now at the end of their patent lives, as a result of which, the development of 'biosimilars' is increasing. The review highlights aspects in which biosimilars differ from generic drugs. The active substance of a biosimilar medicine is similar to the one of the biological reference medicine; however, biosimilars differ from generics of pharmacological drugs in aspects like size and complexity of the active substance, and the nature of the manufacturing process. The manufacture of a biopharmaceutical product is complex and involves several isolation and purification steps. These procedures are proprietary to the manufacturer of the originator product and hence even minor changes in production can have serious implications in terms of safety and efficacy of the product. Biosimilars should not be brought to market using the same procedure applied to generics, and existing and future regulation should prevent inappropriate and automatic substitution of a biosimilar for a reference biopharmaceutical product.

  14. 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.

  15. Cannabis as a substitute for prescription drugs – a cross-sectional study

    Directory of Open Access Journals (Sweden)

    Corroon Jr JM

    2017-05-01

    Full Text Available James M Corroon Jr,1 Laurie K Mischley,2 Michelle Sexton3 1Center for Medical Cannabis Education, Del Mar, CA, 2Bastyr University Research Institute, Kenmore, WA, 3Department of Medical Research, Center for the Study of Cannabis and Social Policy, Seattle, WA, USA Background: The use of medical cannabis is increasing, most commonly for pain, anxiety and depression. Emerging data suggest that use and abuse of prescription drugs may be decreasing in states where medical cannabis is legal. The aim of this study was to survey cannabis users to determine whether they had intentionally substituted cannabis for prescription drugs.Methods: A total of 2,774 individuals were a self-selected convenience sample who reported having used cannabis at least once in the previous 90 days. Subjects were surveyed via an online anonymous questionnaire on cannabis substitution effects. Participants were recruited through social media and cannabis dispensaries in Washington State.Results: A total of 1,248 (46% respondents reported using cannabis as a substitute for prescription drugs. The most common classes of drugs substituted were narcotics/opioids (35.8%, anxiolytics/benzodiazepines (13.6% and antidepressants (12.7%. A total of 2,473 substitutions were reported or approximately two drug substitutions per affirmative respondent. The odds of reporting substituting were 4.59 (95% confidence interval [CI], 3.87–5.43 greater among medical cannabis users compared with non-medical users and 1.66 (95% CI, 1.27–2.16 greater among those reporting use for managing the comorbidities of pain, anxiety and depression. A slightly higher percentage of those who reported substituting resided in states where medical cannabis was legal at the time of the survey (47% vs. 45%, p=0.58, but this difference was not statistically significant.Discussion: These patient-reported outcomes support prior research that individuals are using cannabis as a substitute for prescription drugs

  16. [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.

  17. 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.

  18. 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

  19. Cannabis as a substitute for prescription drugs – a cross-sectional study

    Science.gov (United States)

    Corroon, James M; Mischley, Laurie K; Sexton, Michelle

    2017-01-01

    Background The use of medical cannabis is increasing, most commonly for pain, anxiety and depression. Emerging data suggest that use and abuse of prescription drugs may be decreasing in states where medical cannabis is legal. The aim of this study was to survey cannabis users to determine whether they had intentionally substituted cannabis for prescription drugs. Methods A total of 2,774 individuals were a self-selected convenience sample who reported having used cannabis at least once in the previous 90 days. Subjects were surveyed via an online anonymous questionnaire on cannabis substitution effects. Participants were recruited through social media and cannabis dispensaries in Washington State. Results A total of 1,248 (46%) respondents reported using cannabis as a substitute for prescription drugs. The most common classes of drugs substituted were narcotics/opioids (35.8%), anxiolytics/benzodiazepines (13.6%) and antidepressants (12.7%). A total of 2,473 substitutions were reported or approximately two drug substitutions per affirmative respondent. The odds of reporting substituting were 4.59 (95% confidence interval [CI], 3.87–5.43) greater among medical cannabis users compared with non-medical users and 1.66 (95% CI, 1.27–2.16) greater among those reporting use for managing the comorbidities of pain, anxiety and depression. A slightly higher percentage of those who reported substituting resided in states where medical cannabis was legal at the time of the survey (47% vs. 45%, p=0.58), but this difference was not statistically significant. Discussion These patient-reported outcomes support prior research that individuals are using cannabis as a substitute for prescription drugs, particularly, narcotics/opioids, and independent of whether they identify themselves as medical or non-medical users. This is especially true if they suffer from pain, anxiety and depression. Additionally, this study suggests that state laws allowing access to, and use of, medical

  20. 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.

  1. A Bone Graft Substitutes Hydroxyapatite Coated Gentamycin (Bonigent) As Drug Delivery System

    International Nuclear Information System (INIS)

    Rusnah Mustaffa; Fauziah Othman; Asmah Rahmat; Mohd Reusmaazran Yusof; Shaaban Kasim; Narimah Abu Baka; Nasani Nasrul

    2014-01-01

    Porous hydroxyapatite coated with antibiotic gentamycin for drug delivery system is namely Bonigent. In this product, antibiotic (gentamycin) is coated into the scaffolds HA porous and Would then be released slowly into the bone tissue upon implantation, this way would increase drug penetration, thus avoiding systemic infection, preventing the formation of biofilm and improved healing. When a foreign material (implants or scaffolds of bone graft substitutes) is introduced into the body, there would be normally formation of biofilm that can lead to systemic infection and cause device failure. Surgeon will use antibiotic such as gentamycin to avoid these effects. The purpose of this project is to investigate the feasibility of fabricating a drug delivery system (DDS) that serves dual functions, to combating biofilms and to enhance bone in growths. We also successfully producing a scaffold HA bone graft substitutes incorporated with antibiotic gentamycin to combating bio-film and prevent the failure medical device implant for healthy and human nation. Bone graft substitutes into porous scaffolds suitable for drug delivery; loading the scaffolds with gentamycin; and study release rate in vivo were studied. Porous bone grafts substitutes are coated with antibiotic gentamycin by immerse technique. In order to limit biofilm formation, biomaterials loaded with suitable antibiotics can be used as a preventative measure. The biomaterials hydroxyapatite (HA) is an osteoconductive space filler and is produced locally by Malaysian Nuclear Agency. Porous HA and HA/ TCP has the potential to be used as synthetic bone graft materials because it is bioactive and biocompatible with bone tissues. Development of a product as bone graft substitute (BGS) with special ability of delivering drug (gentamycin) to bone tissue for better and more effective healing process. Characterization of the physical analysis, porosity, surface morphology by Scanning Electron Microscopy Analysis (SEM) and

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

    DEFF Research Database (Denmark)

    Østergaard Rathe, Jette

    BACKGROUND: Generic substitution means that one medicinal product is replaced by another product containing the same active substance. Generic substitution has existed in Denmark since 1991, and pharmacies are obliged to substitute a generic version of a medication, unless the general practitioner...... in brand-name, form, size, colour and taste. Speculations have been raised as to whether these medication changes between generic brands or from brand-name drugs to generics or vice versa may cause patient concerns. Qualitative studies have shown problems in recognising the substituted medicine and lack...... to their specific drug (index drug) in every question and index date printed on the questionnaire. The questionnaire comprises scales from the validated Beliefs about Medicine Questionnaire (BMQ) and ad hoc constructed scales. By means of OPED data it was possible to conduct a cohort study comprising information...

  3. 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.

  4. 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.

  5. 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.

  6. 78 FR 78366 - Draft Generic Drug User Fee Act Information Technology Plan; Availability for Comment

    Science.gov (United States)

    2013-12-26

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

  7. 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

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

    Science.gov (United States)

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

    2018-03-05

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

  9. AcrB drug-binding pocket substitution confers clinically relevant resistance and altered substrate specificity.

    Science.gov (United States)

    Blair, Jessica M A; Bavro, Vassiliy N; Ricci, Vito; Modi, Niraj; Cacciotto, Pierpaolo; Kleinekathӧfer, Ulrich; Ruggerone, Paolo; Vargiu, Attilio V; Baylay, Alison J; Smith, Helen E; Brandon, Yvonne; Galloway, David; Piddock, Laura J V

    2015-03-17

    The incidence of multidrug-resistant bacterial infections is increasing globally and the need to understand the underlying mechanisms is paramount to discover new therapeutics. The efflux pumps of Gram-negative bacteria have a broad substrate range and transport antibiotics out of the bacterium, conferring intrinsic multidrug resistance (MDR). The genomes of pre- and posttherapy MDR clinical isolates of Salmonella Typhimurium from a patient that failed antibacterial therapy and died were sequenced. In the posttherapy isolate we identified a novel G288D substitution in AcrB, the resistance-nodulation division transporter in the AcrAB-TolC tripartite MDR efflux pump system. Computational structural analysis suggested that G288D in AcrB heavily affects the structure, dynamics, and hydration properties of the distal binding pocket altering specificity for antibacterial drugs. Consistent with this hypothesis, recreation of the mutation in standard Escherichia coli and Salmonella strains showed that G288D AcrB altered substrate specificity, conferring decreased susceptibility to the fluoroquinolone antibiotic ciprofloxacin by increased efflux. At the same time, the substitution increased susceptibility to other drugs by decreased efflux. Information about drug transport is vital for the discovery of new antibacterials; the finding that one amino acid change can cause resistance to some drugs, while conferring increased susceptibility to others, could provide a basis for new drug development and treatment strategies.

  10. 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.

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

    Science.gov (United States)

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

    2002-01-01

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

  12. 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.

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

    Science.gov (United States)

    Rosina, Mônica Steffen Guise; Shaver, Lea

    2012-01-01

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

  14. 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

  15. 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.

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

    Science.gov (United States)

    Carrier, Michael A

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

  17. Substituted 2-phenylimidazopyridines: a new class of drug leads for human African trypanosomiasis.

    Science.gov (United States)

    Tatipaka, Hari Babu; Gillespie, J Robert; Chatterjee, Arnab K; Norcross, Neil R; Hulverson, Matthew A; Ranade, Ranae M; Nagendar, Pendem; Creason, Sharon A; McQueen, Joshua; Duster, Nicole A; Nagle, Advait; Supek, Frantisek; Molteni, Valentina; Wenzler, Tanja; Brun, Reto; Glynne, Richard; Buckner, Frederick S; Gelb, Michael H

    2014-02-13

    A phenotypic screen of a compound library for antiparasitic activity on Trypanosoma brucei, the causative agent of human African trypanosomiasis, led to the identification of substituted 2-(3-aminophenyl)oxazolopyridines as a starting point for hit-to-lead medicinal chemistry. A total of 110 analogues were prepared, which led to the identification of 64, a substituted 2-(3-aminophenyl)imidazopyridine. This compound showed antiparasitic activity in vitro with an EC50 of 2 nM and displayed reasonable druglike properties when tested in a number of in vitro assays. The compound was orally bioavailable and displayed good plasma and brain exposure in mice. Compound 64 cured mice infected with Trypanosoma brucei when dosed orally down to 2.5 mg/kg. Given its potent antiparasitic properties and its ease of synthesis, compound 64 represents a new lead for the development of drugs to treat human African trypanosomiasis.

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

    Science.gov (United States)

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

    2014-10-01

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

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

    Science.gov (United States)

    Zapatero Miguel, Pablo

    2015-01-01

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

  20. 76 FR 58277 - Animal Generic Drug User Fee Act; Public Meeting; Request for Comments

    Science.gov (United States)

    2011-09-20

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

  1. 77 FR 72359 - Animal Generic Drug User Fee Act; Public Meeting; Request for Comments

    Science.gov (United States)

    2012-12-05

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

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

    Science.gov (United States)

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

    2014-06-01

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

  3. Integrating narrow therapeutic index drug formulations in transplantation

    NARCIS (Netherlands)

    A. Johnston (Andrew); L. Schick (Liz); T. van Gelder (Teun)

    2012-01-01

    textabstractThere is considerable debate regarding generic drug substitution in solid organ transplant recipients, and various European transplant associations and societies have expressed caution about the potential adverse consequences from uncontrolled switching between the different narrow

  4. 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.

  5. Trends of people using drugs and opioid substitute treatment recorded in England and wales general practice (1994-2012.

    Directory of Open Access Journals (Sweden)

    Hilary R Davies

    Full Text Available Illicit drug use is a multifaceted public-health problem with potentially serious impacts. The United Kingdom has one of the highest prevalence of illegal drug use in Europe. Reduction of overall illegal drug use in England and Wales has decreased from 11% to 8.2% (2012/13 over the past 10 years. People who use drugs often seek help from their family doctors.To investigate General Practitioners (family doctors first recording of drug use and opioid substitute treatment in primary care settings.A descriptive study design. Males and females (16-64 years old were extracted from The Health Improvement Network (THIN database.England and Wales primary care.The first recording of drug use and opioid substitution treatment in primary care was estimated for the period (1994-2012. Poisson regressions were conducted to estimate incidence risk ratios (IRR.We identified 33,508 first recordings of drug use and 10,869 individuals with prescriptions for opioid substitute treatment. Overall, males (IRR 2.02, 95% CI:1.97-2.07, people in the age-group; 16-24 (IRR 6.7, 95% CI:6.4-6.9 compared to those over 25 years and the most deprived (IRR 4.2, 95% CI:3.9-4.4 were more likely to have a recording of drug use. Males (IRR 1.2 95% CI:1.2-1.3, in the age-group; 25-34 (IRR 1.8 95% CI:1.7-1.9 and the most deprived (IRR 3.9 95% CI:3.6-4.3 were the groups more likely to have a opioid substitute treatment prescription.It is evident from this study that there is little recording of drug use and opioid substitute treatment in primary care. Most drug users do not receive treatment in primary care.

  6. 75 FR 45636 - Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2011

    Science.gov (United States)

    2010-08-03

    ... animal drugs (21 U.S.C. 379j-21(a)). When certain conditions are met, FDA will waive or reduce fees for.... 379j-21(c)(1)). FDA calculated the average number of each of the four types of applications and... ended on June 30, 2010. The results of these calculations are presented in the first two columns of...

  7. Medicineringsfejl ved generisk substitution

    DEFF Research Database (Denmark)

    Rölfing, Jan

    2012-01-01

    Generic substitution is a major cause of medical mistakes in the general population. Danish legislation obligates pharmacies to substitute prescribed medicine with the cheapest equivalent formulation, despite variations in product name, packaging, shape and colour. Consequently, medical mistakes ...... occur. Scientific evidence on the consequences of generic substitution is sparse. Call upon fellow health workers to report medical mistakes to the national entities and scientific peers, in order to increase awareness and scientific evidence about the problem....

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

    OpenAIRE

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

    2011-01-01

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

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

    Czech Academy of Sciences Publication Activity Database

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

    2018-01-01

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

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

    Science.gov (United States)

    Masri, Marwan

    2003-06-01

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

  11. 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. 

  12. Buprenorphine substitution treatment in France: drug users' views of the doctor-user relationship

    Science.gov (United States)

    Guichard, Anne; Lert, France; Brodeur, Jean-Marc; Richard, Lucie

    2007-01-01

    The French system for drug substitution, or maintenance treatment, established in 1996, differs from the often strict conditions attached to methadone clinics in other countries. Because of the predominant role of general practitioners and the flexible prescription rules for Subutex® in France, the relationship between the physician and the drug user becomes a central element in the treatment. This article deals with the expectations that these users have of the physician, and their perception of his or her attitude towards them. In order to identify possible reasons for the absence of treatment compliance and of Subutex® misuse, it focuses on the users’ assessment of the physician’s response to the problems they report. This study, based on a diversified sample of 28 persons in treatment, showed 4 patterns of relationships between physicians and users, which differed in their focus: a) dosage, b) compliance, c) the person and d) obtaining a prescription. In all four case types, users had difficulty reporting other drug use or intravenous Subutex® injection within this relationship in which the stigma attached to drug dependence seems to reappear. Moreover, the lack of clarity about the treatment objectives and time frame limits the users’ ability to integrate the treatment into their lives and to commit themselves to it. The heterogeneity and fragility of the users’ situations are elements related to dependence that, during contact with the physician, require regular assessment of the individual’s situation and of the treatment objectives. This constant reappraisal of the situation with the physician should help to optimize the treatment and avoid the hiatus that can generate or continue “misuse.” PMID:17442473

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

    Science.gov (United States)

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

    2011-07-01

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

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

    Science.gov (United States)

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

    2016-01-01

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

  15. Knowledge, attitudes and practices of community pharmacists on generic medicines in Palestine: a cross-sectional study.

    Science.gov (United States)

    Shraim, Naser Y; Al Taha, Tasneem A; Qawasmeh, Rawan F; Jarrar, Hiba N; Shtaya, Maram A N; Shayeb, Lama A; Sweileh, Waleed M

    2017-12-28

    Generic substitution in several countries has become a common practice. Besides, it is considered as a major cost minimizing strategy meant to contain pharmaceutical expenditure without compromising healthcare quality. However, the safety and quality issues of generic products are of top concerns of general practitioners and health work professionals. This study aimed to investigate community pharmacist's knowledge, attitudes and practices toward generic medicines in Palestine. This study was a cross-sectional observational study employing a self-administered questionnaire. The questionnaire was of four main sections: demographic and practice details of the participants, knowledge, attitudes and the influencing factors related to selection and dispensing of generic medicines. A convenience sampling technique was implemented in this study in which the data collection form was distributed in West Bank- Palestine among a set of practicing pharmacists. Mann-Whitney-U or Kruskal-Wallis tests were used to comparison of different issues as appropriate. P-values of medicines was (5.91 ± 1.27) where the highest score was 8 of 10. Knowledge score was not significantly influenced by any of the socio-demographic characteristics. Our data showed that most of included pharmacists in the study (95.4%) agreed that health authorities should implement bioequivalence policies prior to marketing approval of generics, while 87.4% of participants agreed that they should be given the right to substitute generics and the majority (62.3%) support generic substitution for brand name drugs in all cases when a generic is available The main two factors affect pharmacists' selection and dispensing of generic medicines are personal faith in the product (86.1%) and cost effectiveness of generic medicines (84.1%). Generic medicines substitution among pharmacists is widespread and prevalent. Our data found that participant pharmacists in Palestine had basic knowledge with regards to generic

  16. Antiviral Drug-Resistant Influenza B Viruses Carrying H134N Substitution in Neuraminidase, Laos, February 2016.

    Science.gov (United States)

    Baranovich, Tatiana; Vongphrachanh, Phengta; Ketmayoon, Pakapak; Sisouk, Thongchanh; Chomlasack, Khampheng; Khanthamaly, Viengphone; Nguyen, Ha Thuy; Mishin, Vasiliy P; Marjuki, Henju; Barnes, John R; Garten, Rebecca J; Stevens, James; Wentworth, David E; Gubareva, Larisa V

    2017-04-01

    In February 2016, three influenza B/Victoria/2/87 lineage viruses exhibiting 4- to 158-fold reduced inhibition by neuraminidase inhibitors were detected in Laos. These viruses had an H134N substitution in the neuraminidase and replicated efficiently in vitro and in ferrets. Current antiviral drugs may be ineffective in controlling infections caused by viruses harboring this mutation.

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

    Science.gov (United States)

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

    2018-04-01

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

  18. Biochemical analysis of the role of G118R-linked dolutegravir drug resistance substitutions in HIV-1 integrase.

    Science.gov (United States)

    Quashie, Peter K; Mesplède, Thibault; Han, Ying-Shan; Veres, Tamar; Osman, Nathan; Hassounah, Said; Sloan, Richard D; Xu, Hong-Tao; Wainberg, Mark A

    2013-12-01

    Drug resistance mutations (DRMs) have been reported for all currently approved anti-HIV drugs, including the latest integrase strand transfer inhibitors (INSTIs). We previously used the new INSTI dolutegravir (DTG) to select a G118R integrase resistance substitution in tissue culture and also showed that secondary substitutions emerged at positions H51Y and E138K. Now, we have characterized the impact of the G118R substitution, alone or in combination with either H51Y or E138K, on 3' processing and integrase strand transfer activity. The results show that G118R primarily impacted the strand transfer step of integration by diminishing the ability of integrase-long terminal repeat (LTR) complexes to bind target DNA. The addition of H51Y and E138K to G118R partially restored strand transfer activity by modulating the formation of integrase-LTR complexes through increasing LTR DNA affinity and total DNA binding, respectively. This unique mechanism, in which one function of HIV integrase partially compensates for the defect in another function, has not been previously reported. The G118R substitution resulted in low-level resistance to DTG, raltegravir (RAL), and elvitegravir (EVG). The addition of either of H51Y or E138K to G118R did not enhance resistance to DTG, RAL, or EVG. Homology modeling provided insight into the mechanism of resistance conferred by G118R as well as the effects of H51Y or E138K on enzyme activity. The G118R substitution therefore represents a potential avenue for resistance to DTG, similar to that previously described for the R263K substitution. For both pathways, secondary substitutions can lead to either diminished integrase activity and/or increased INSTI susceptibility.

  19. Hepatitis C virus drug resistance associated substitutions and their clinical relevance: Update 2018.

    Science.gov (United States)

    Sorbo, Maria C; Cento, Valeria; Di Maio, Velia C; Howe, Anita Y M; Garcia, Federico; Perno, Carlo F; Ceccherini-Silberstein, Francesca

    2018-03-01

    Nowadays, due to the development of potent Direct-Acting Antiviral Agents (DAAs) that specifically target NS3, NS5A and NS5B viral proteins, several new and highly efficacious options to treat chronic Hepatitis C virus (HCV) infection are available. The natural presence of resistance associated substitutions (RASs), as well as their rapid emergence during incomplete drug-pressure, are intrinsic characteristics of HCV that greatly affect treatment outcome and the chances to achieve a virolgical cure. To date, a high number of RASs in NS3, NS5A, and NS5B have been associated in vivo and/or in vitro with reduced susceptibility to DAAs, but no comprehensive RASs list is available. This review thus provides an updated, systematic overview of the role of RASs to currently approved DAAs or in phase II/III of clinical development against HCV-infection, discriminating their impact in different HCV-genotypes and DAAs, providing assistance for a fruitful use of HCV resistance testing in clinical practice. Copyright © 2018 Elsevier Ltd. All rights reserved.

  20. ECONOMIC REASONS FOR GENERIC CHOICE

    Directory of Open Access Journals (Sweden)

    N. P. Kutishenko

    2008-01-01

    Full Text Available Many generic medicines appear in the pharmaceutical market now. However, they are not always completely comparable with original drugs on efficacy and safety. In this article pharmacoeconomical estimation of some generics and original drugs was performed on example of therapeutic equivalency studies.

  1. 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

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

    Science.gov (United States)

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

    2012-01-01

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

  3. 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.

  4. Multiple and substitute addictions involving prescription drugs misuse among 12th graders: gateway theory revisited with Market Basket Analysis.

    Science.gov (United States)

    Jayawardene, Wasantha Parakrama; YoussefAgha, Ahmed Hassan

    2014-01-01

    This study aimed to identify the sequential patterns of drug use initiation, which included prescription drugs misuse (PDM), among 12th-grade students in Indiana. The study also tested the suitability of the data mining method Market Basket Analysis (MBA) to detect common drug use initiation sequences in large-scale surveys. Data from 2007 to 2009 Annual Surveys of Alcohol, Tobacco, and Other Drug Use by Indiana Children and Adolescents were used for this study. A close-ended, self-administered questionnaire was used to ask adolescents about the use of 21 substance categories and the age of first use. "Support%" and "confidence%" statistics of Market Basket Analysis detected multiple and substitute addictions, respectively. The lifetime prevalence of using any addictive substance was 73.3%, and it has been decreasing during past few years. Although the lifetime prevalence of PDM was 19.2%, it has been increasing. Males and whites were more likely to use drugs and engage in multiple addictions. Market Basket Analysis identified common drug use initiation sequences that involved 11 drugs. High levels of support existed for associations among alcohol, cigarettes, and marijuana, whereas associations that included prescription drugs had medium levels of support. Market Basket Analysis is useful for the detection of common substance use initiation sequences in large-scale surveys. Before initiation of prescription drugs, physicians should consider the adolescents' risk of addiction. Prevention programs should address multiple addictions, substitute addictions, common sequences in drug use initiation, sex and racial differences in PDM, and normative beliefs of parents and adolescents in relation to PDM.

  5. Generic Advantages

    Indian Academy of Sciences (India)

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

  6. Biotransformation of 17α-ethynyl substituted steroidal drugs with microbial and plant cell cultures: a review.

    Science.gov (United States)

    Shah, Syed Adnan Ali; Sultan, Sadia; Hassan, Normahanim Binti; Muhammad, Fauzia Khadija Binti; Faridz, Muhammad Afifi Bin Mohd; Hussain, Fatimah Bebe M; Hussain, Munawar; Adnan, Humera Syed

    2013-12-20

    Structural modification of steroids through whole-cell biocatalysis is an invaluable procedure for the production of active pharmaceutical ingredients (APIs) and key intermediates. Modifications could be carried out with regio- and stereospecificity at positions hardly available for chemical agents. Much attention has been focused recently on the biotransformation of 17α-ethynyl substituted steroidal drugs using fungi, bacteria and plant cell cultures in order to obtained novel biologically active compounds with diverse structure features. Present article includes studies on biotransformation on 17α-ethynyl substituted steroidal drugs using microorganisms and plant cell cultures. Various experimental and structural elucidation methods used in biotransformational processes are also highlighted. Copyright © 2013 Elsevier Inc. All rights reserved.

  7. Generic variation?

    DEFF Research Database (Denmark)

    Jensen, Torben Juel

    2009-01-01

    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 traditional...... generic pronoun man, it is not a new variant in Danish if we by “new” mean that it has come into existence within the last 30–40 years. To all appearances, it has been used before the influence from English became significant in the last part of the 20th century, and the generic du as such need therefore...... not be explained by contact with English, as often assumed. In order to study the spread of the generic use of du we analysed the use of pronouns with generic reference in a large sample of speakers, most of whom were recorded during sociolinguistic interviews twice – the first time in the period 1978...

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

    Science.gov (United States)

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

    2014-09-01

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

  9. Advertising and generic market entry.

    Science.gov (United States)

    Königbauer, Ingrid

    2007-03-01

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

  10. Evaluation of a generic immunoassay with drug tolerance to detect immune complexes in serum samples from cynomolgus monkeys after administration of human antibodies.

    Science.gov (United States)

    Stubenrauch, Kay; Wessels, Uwe; Essig, Ulrich; Vogel, Rudolf; Schleypen, Julia

    2010-06-05

    Current state of the art bridging ELISA technologies for detection of anti-drug antibodies (ADAs) against therapeutic antibodies bear the risk of false-negative results due to interference by circulating drug. Methods to remove the drug in the sample or sample pre-treatment techniques such as acid dissociation of the immune complexes are limited, laborious and may destroy ADAs resulting again in false-negative results. The immune complex ELISA described in this publication provides a simple solution. It is designed to analyze samples from cynomolgus monkeys dosed with human antibodies; it can be used for all human antibodies since it is independent of the specific antibody and its target. The generic applicability of the ADA assay is enabled by the use of (1) a murine anti-human Fc monoclonal antibody (MAb) as capture reagent; (2) a murine anti-cynomolgus monkey IgG MAb as detection reagent; and (3) an ADA positive control conjugate consisting of cynomolgus IgG complexed with human IgG. In its basic version, the generic ADA ELISA specifically detects only immune complexes formed in vivo. Validation of the ADA assay revealed a lower limit of quantitation of 15.6 ng/mL in serum samples. Intra-assay and inter-assay precision was characterized by a coefficient of variation of less than 10% and accuracy was within 8%. Matrix effects were low as evidenced by a mean recovery of 95%. In vitro pre-incubation of the serum samples with drug makes also the free ADA in the sample amenable to measurement by the immune complex ELISA as demonstrated by analysis of ADAs from two cynomolgus monkey studies with two different antibodies. The generic and versatile nature of this ADA assay favors its use in pilot pharmacokinetic and safety studies in cynomolgus monkeys during candidate selection of antibodies. The assay can help to explain unexpected drug clearance profiles, loss of efficacy or safety events caused by immune complexes and guide further development. Copyright (c) 2010

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

    Science.gov (United States)

    2012-08-27

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0881...; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...- identify, what information must be requested, how the information should be submitted to FDA, and what the...

  12. 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.

  13. Kinetic barriers in the isomerization of substituted ureas: implications for computer-aided drug design

    Science.gov (United States)

    Loeffler, Johannes R.; Ehmki, Emanuel S. R.; Fuchs, Julian E.; Liedl, Klaus R.

    2016-05-01

    Urea derivatives are ubiquitously found in many chemical disciplines. N, N'-substituted ureas may show different conformational preferences depending on their substitution pattern. The high energetic barrier for isomerization of the cis and trans state poses additional challenges on computational simulation techniques aiming at a reproduction of the biological properties of urea derivatives. Herein, we investigate energetics of urea conformations and their interconversion using a broad spectrum of methodologies ranging from data mining, via quantum chemistry to molecular dynamics simulation and free energy calculations. We find that the inversion of urea conformations is inherently slow and beyond the time scale of typical simulation protocols. Therefore, extra care needs to be taken by computational chemists to work with appropriate model systems. We find that both knowledge-driven approaches as well as physics-based methods may guide molecular modelers towards accurate starting structures for expensive calculations to ensure that conformations of urea derivatives are modeled as adequately as possible.

  14. 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. 

  15. Family Genericity

    DEFF Research Database (Denmark)

    Ernst, Erik

    2006-01-01

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

  16. 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. Copyright © 2014 Elsevier B.V. All rights reserved.

  17. 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

  18. "Bureaucracy & Beliefs": Assessing the Barriers to Accessing Opioid Substitution Therapy by People Who Inject Drugs in Ukraine.

    Science.gov (United States)

    Bojko, Martha J; Mazhnaya, Alyona; Makarenko, Iuliia; Marcus, Ruthanne; Dvoriak, Sergii; Islam, Zahedul; Altice, Frederick L

    Opioid substitution therapy (OST) is an evidence-based HIV prevention strategy for people who inject drugs (PWIDs). Yet, only 2.7% of Ukraine's estimated 310,000 PWIDs receive it despite free treatment since 2004. The multi-level barriers to entering OST among opioid dependent PWIDs have not been examined in Ukraine. A multi-year mixed methods implementation science project included focus group discussions with 199 PWIDs in 5 major Ukrainian cities in 2013 covering drug treatment attitudes and beliefs and knowledge of and experiences with OST. Data were transcribed, translated into English and coded. Coded segments related to OST access, entry, knowledge, beliefs and attitudes were analyzed among 41 PWIDs who were eligible for but had never received OST. A number of programmatic and structural barriers were mentioned by participants as barriers to entry to OST, including compulsory drug user registration, waiting lists, and limited number of treatment slots. Participants also voiced strong negative attitudes and beliefs about OST, especially methadone. Their perceptions about methadone's side effects as well as the stigma of being a methadone client were expressed as obstacles to treatment. Despite expressed interest in treatment, Ukrainian OST-naïve PWIDs evade OST for reasons that can be addressed through changes in program-level and governmental policies and social-marketing campaigns. Voiced OST barriers can effectively inform public health and policy directives related to HIV prevention and treatment in Ukraine to improve evidence-based treatment access and availability.

  19. Incidence of hepatitis C in drug injectors: the role of homelessness, opiate substitution treatment, equipment sharing, and community size.

    Science.gov (United States)

    Craine, N; Hickman, M; Parry, J V; Smith, J; Walker, A M; Russell, D; Nix, B; May, M; McDonald, T; Lyons, M

    2009-09-01

    A prospective cohort study estimated the incidence of hepatitis C virus (HCV) in drug injectors in South Wales (UK). In total, 286/481 eligible seronegative individuals were followed up after approximately 12 months. Dried blood spot samples were collected and tested for anti-HCV antibody and behavioural data were collected at baseline and follow-up. HCV incidence was 5.9/100 person-years [95% confidence interval (CI) 3.4-9.5]. HCV incidence was predicted by community size [incident rate ratio (IRR) 6.6, 95% CI 2.11-20.51, P = 0.001], homelessness (IRR 2.9, 95% CI 1.02-8.28, P = 0.047) and sharing injecting equipment (IRR 12.7, 95% CI 1.62-99.6, P = 0.015). HCV incidence was reduced in individuals in opiate substitution treatment (IRR 0.34, 95% CI 0.12-0.99, P = 0.047). In order to reduce follow-up bias we used multiple imputation of missing data using switching regression; after imputation estimated HCV incidence was 8.5/100 person-years (95% CI 5.4-12.7). HCV incidence varies with community size, equipment sharing and homelessness are associated with increased HCV incidence and opiate substitution treatment may be protective against HCV.

  20. 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

  1. Replacing hormone therapy-is the decline in prescribing sustained, and are nonhormonal drugs substituted?

    NARCIS (Netherlands)

    Vegter, Stefan; Kolling, Pieternel; Toben, Marjolijn; Visser, Sipke T.; de Jong-van den Berg, Lolkje T. W.

    2009-01-01

    Objectives: After two cautioning landmark studies in 2002 and 2003, a dramatic decrease in hormonal therapy (HT) prescribing for menopausal symptoms was seen. Our objectives were to (1) determine whether this decline in HT prescribing sustained until 2007 and (2) investigate nonhormonal drug

  2. Type Substitution for Object-Oriented Programming

    DEFF Research Database (Denmark)

    Schwartzbach, Michael Ignatieff; Palsberg, Jens

    1990-01-01

    Genericity allows the substitution of types in a class. This is usually obtained through parameterized classes, although they are inflexible since any class can be inherited but is not in itself parameterized. We suggest a new genericity mechanism, type substitution, which is a subclassing concep...

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

    Science.gov (United States)

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

    2017-11-01

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

  4. The effects of fluorine substitution on the chemical properties and inhibitory capacity of Donepezil anti-Alzheimer drug; density functional theory and molecular docking calculations.

    Science.gov (United States)

    Khosravan, Azita; Marani, Safora; Sadeghi Googheri, Mohammad Sadegh

    2017-01-01

    Drug fluorination has the potential to reproduce useful drugs with decreasing the side effect of them. Identifying the effect of this improvement on the chemical properties and biological interactions of drug symbolizes a meaningful progress in drug design. Here the fluorination of Donepezil as an anti-Alzheimer drug, including 7 fluorinated derivatives of it, was investigated computationally. In the first part of our calculations, the most important chemical properties of drug that affects the drug efficiency were investigated by applying the M06/6-31g (d, p) and M062X/6-31g (d, p) levels of theories. Findings showed that the fluorine substitution changed the drug stability as altered the solubility and molecular polarity. Furthermore, the intramolecular hydrogen bonding, charge distribution and electron delocalization of the drug were affected by this replacement. In the second section, the effect of fluorination on the drug⋯enzyme interactions was evaluated by using two effective methods Based on the molecular docking and density functional theory (DFT) calculations fluorine substitution influenced the Donepezil⋯Acetylcholinesterase interactions. Calculated binding energies by two computational methods displayed that the fluorine replacement changed the binding affinity of drug. Finally, the most significant non-bonded interactions between drugs and involved residues were investigated by bond length data analysis. Copyright © 2016 Elsevier Inc. All rights reserved.

  5. [Oral loading dose of phenytoin in the treatment of serial seizures, prevention of seizure recurrence and rapid drug substitution].

    Science.gov (United States)

    Sokić, D; Janković, S M

    1994-01-01

    Over a period of nine months twenty-five epileptic patients were treated with the oral loading dose of phenytoin. The dose ranged from 12 to 23 mg/kg body weight during 1 to 12 hours. In 20 patients with serial seizures or intolerance to other antiepileptic drugs this treatment was effective. Seizures also stopped in 2 of 4 patients with serial partial motor seizures. These 2 patients required both higher loading dose and faster rate of administration than the other patients. A patient with epilepsia partialis continua failed to respond to the treatment. Patients that received phenytoin through the naso-gastric tube, in respect to oral administration, required higher doses to obtain therapeutic plasma levels of phenytoin. One patient had mild nausea, 3 mild dizziness, and 1 tinitus on the first day of the treatment. There was no correlation between a given dose and the achieved phenytoin plasma levels. In our opinion the therapy with oral loading dose of phenytoin is highly effective in the treatment of serial generalized seizures and rapid antiepileptic drug substitution, and partially effective in the prevention of partial motor seizures. It produces only mild and transient side-effects.

  6. In Vitro Culture and Drug Sensitivity Assay of Plasmodium falciparum with Nonserum Substitute and Acute-Phase Sera

    Science.gov (United States)

    Ringwald, Pascal; Meche, Fleurette Solange; Bickii, Jean; Basco, Leonardo K.

    1999-01-01

    The short-term in vitro growth of Plasmodium falciparum parasites in the asexual erythrocytic stage and the in vitro activities of eight standard antimalarial drugs were assessed and compared by using RPMI 1640 medium supplemented with 10% nonimmune human serum, 10% autologous or homologous acute-phase serum, or 0.5% Albumax I (lipid-enriched bovine serum albumin). In general, parasite growth was maximal with autologous (or homologous) serum, followed by Albumax I and nonimmune serum. The 50% inhibitory concentrations (IC50s) varied widely, depending on the serum or serum substitute. The comparison of IC50s between assays with autologous and nonimmune sera showed that monodesethylamodiaquine, halofantrine, pyrimethamine, and cycloguanil had similar IC50s. Although the IC50s of chloroquine, monodesethylamodiaquine, and dihydroartemisinin were similar with Albumax I and autologous sera, the IC50s of all test compounds obtained with Albumax I differed considerably from the corresponding values obtained with nonimmune serum. Our results suggest that Albumax I and autologous and homologous sera from symptomatic, malaria-infected patients may be useful alternative sources of serum for in vitro culture of P. falciparum isolates in the field. However, autologous sera and Albumax I do not seem to be suitable for the standardization of isotopic in vitro assays for all antimalarial drugs. PMID:9986835

  7. Metabolic switching of drug pathways as a consequence of deuterium substitution

    International Nuclear Information System (INIS)

    Horning, M.G.; Haegele, K.D.; Sommer, K.R.; Nowlin, J.; Stafford, M.

    1975-01-01

    An investigation was made of the metabolism of deuterated analogs of caffeine (1-CD 3 -caffeine and 7-CD 3 -caffeine) and antipyrine (N-CD 3 -antipyrine and 3-CD 3 -antipyrine) because both caffeine and antipyrine are metabolized by multiple alternate pathways. Since it is well established that carbon-deuterium bonds are more stable than carbon-hydrogen bonds, it was postulated that oxidation of the CD 3 group would be depressed and that metabolism of the labeled compounds would be shifted to another pathway that did not involve cleavage of a carbon-deuterium bond. Metabolic switching of drug pathways was observed in vivo for both of the caffeine analogs and was observed both in vivo and in vitro for 3-CD 3 -antipyrine

  8. “Bureaucracy & Beliefs”: Assessing the Barriers to Accessing Opioid Substitution Therapy by People Who Inject Drugs in Ukraine

    Science.gov (United States)

    Bojko, Martha J.; Mazhnaya, Alyona; Makarenko, Iuliia; Marcus, Ruthanne; Dvoriak, Sergii; Islam, Zahedul; Altice, Frederick L.

    2016-01-01

    Aims Opioid substitution therapy (OST) is an evidence-based HIV prevention strategy for people who inject drugs (PWIDs). Yet, only 2.7% of Ukraine’s estimated 310,000 PWIDs receive it despite free treatment since 2004. The multi-level barriers to entering OST among opioid dependent PWIDs have not been examined in Ukraine. Methods A multi-year mixed methods implementation science project included focus group discussions with 199 PWIDs in 5 major Ukrainian cities in 2013 covering drug treatment attitudes and beliefs and knowledge of and experiences with OST. Data were transcribed, translated into English and coded. Coded segments related to OST access, entry, knowledge, beliefs and attitudes were analyzed among 41 PWIDs who were eligible for but had never received OST. Findings A number of programmatic and structural barriers were mentioned by participants as barriers to entry to OST, including compulsory drug user registration, waiting lists, and limited number of treatment slots. Participants also voiced strong negative attitudes and beliefs about OST, especially methadone. Their perceptions about methadone’s side effects as well as the stigma of being a methadone client were expressed as obstacles to treatment. Conclusions Despite expressed interest in treatment, Ukrainian OST-naïve PWIDs evade OST for reasons that can be addressed through changes in program-level and governmental policies and social-marketing campaigns. Voiced OST barriers can effectively inform public health and policy directives related to HIV prevention and treatment in Ukraine to improve evidence-based treatment access and availability. PMID:27087758

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

    Directory of Open Access Journals (Sweden)

    S. N. Tolpygina

    2008-01-01

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

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

    Science.gov (United States)

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

    2009-05-01

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

  11. Pricing of drugs with heterogeneous health insurance coverage.

    Science.gov (United States)

    Ferrara, Ida; Missios, Paul

    2012-03-01

    In this paper, we examine the role of insurance coverage in explaining the generic competition paradox in a two-stage game involving a single producer of brand-name drugs and n quantity-competing producers of generic drugs. Independently of brand loyalty, which some studies rely upon to explain the paradox, we show that heterogeneity in insurance coverage may result in higher prices of brand-name drugs following generic entry. With market segmentation based on insurance coverage present in both the pre- and post-entry stages, the paradox can arise when the two types of drugs are highly substitutable and the market is quite profitable but does not have to arise when the two types of drugs are highly differentiated. However, with market segmentation occurring only after generic entry, the paradox can arise when the two types of drugs are weakly substitutable, provided, however, that the industry is not very profitable. In both cases, that is, when market segmentation is present in the pre-entry stage and when it is not, the paradox becomes more likely to arise as the market expands and/or insurance companies decrease deductibles applied on the purchase of generic drugs. Copyright © 2012 Elsevier B.V. All rights reserved.

  12. Impact of opioid substitution therapy on the HIV prevention benefit of antiretroviral therapy for people who inject drugs.

    Science.gov (United States)

    Mukandavire, Christinah; Low, Andrea; Mburu, Gitau; Trickey, Adam; May, Margaret T; Davies, Charlotte F; French, Clare E; Looker, Katharine J; Rhodes, Tim; Platt, Lucy; Guise, Andy; Hickman, Matthew; Vickerman, Peter

    2017-05-15

    A recent meta-analysis suggested that opioid substitution therapy (OST) increased uptake of antiretroviral treatment (ART) and HIV viral suppression. We modelled whether OST could improve the HIV prevention benefit achieved by ART among people who inject drugs (PWID). We modelled how introducing OST could improve the coverage of ART across a PWID population for different baseline ART coverage levels. Using existing data on how yearly HIV-transmission risk is related to HIV plasma viral load, changes in the level of viral suppression across the population were used to project the relative reduction in yearly HIV-transmission risk achieved by ART, with or without OST, compared with if there was no ART - defined here as the prevention effectiveness of ART. Owing to OST use increasing the chance of being on ART and achieving viral suppression if on ART, the prevention effectiveness of ART for PWID on OST (compared with PWID not on OST) increases by 44, 31, or 20% for a low (20%), moderate (40%), or high (60%) baseline ART coverage, respectively. Improvements in the population-level prevention effectiveness of ART are also achieved across all PWID, compared with if OST was not introduced. For instance, if OST is introduced at 40% coverage, the population-level prevention effectiveness of ART could increase by 27, 20, or 13% for a low (20%), moderate (40%), or high (60%) baseline ART coverage, respectively. OST could improve the HIV prevention benefit of ART; supporting strategies that aim to concurrently scale-up OST with ART.

  13. Studies in Multifunctional Drug Development: Preparation and Evaluation of 11beta-Substituted Estradiol-Drug Conjugates, Cell Membrane Targeting Imaging Agents, and Target Multifunctional Nanoparticles

    Science.gov (United States)

    Dao, KinhLuan Lenny D.

    Cancer is the second leading cause of death after cardiovascular disease in the United State. Despite extensive research in development of antitumor drugs, most of these therapeutic entities often possess nonspecific toxicity, thus they can only be used to treat tumors in higher doses or more frequently. Because of the cytotoxicity and severe side effects, the drug therapeutic window normally is limited. Beside the toxicity issue, antitumor drug are also not selectively taken up by tumor cells, thus the necessitating concentrations that would eradicate the tumor can often not be used. In addition, tumor cells tend to develop resistance against the anticancer drugs after prolonged treatment. Therefore, alleviating the systemic cytotoxicity and side effects, improving in tumor selectivity, high potency, and therapeutic efficacy are still major obstacles in the area of anticancer drug development. A more promising approach for developing a selective agent for cancer is to conjugate a potent therapeutic drug, or an imaging agent with a targeting group, such as antibody or a high binding-specificity small molecule, that selectively recognize the overexpressed antigens or proteins on tumor cells. My research combines several approaches to describe this strategy via using different targeting molecules to different diseases, as well as different potent cytotoxic drugs for different therapies. Three studies related to the preparation and biological evaluation of new therapeutic agents, such as estradiol-drug hybrids, cell membrane targeted molecular imaging agents, and multifunctional NPs will be discussed. The preliminary results of these studies indicated that our new reagents achieved their initial objectives and can be further improved for optimized synthesis and in vivo experiments. The first study describes the method in which we employed a modular assembly approach to synthesize a novel 11beta-substituted steroidal anti-estrogen. The key intermediate was synthesized

  14. Generic switching of warfarin and risk of excessive anticoagulation

    DEFF Research Database (Denmark)

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

    2016-01-01

    PURPOSE: Generic switching of warfarin was recently repealed in Denmark, as adverse drug reaction (ADR) reports suggested risk of excessive anticoagulation following switches from branded to generic warfarin. We investigated this putative association in a formalized pharmacoepidemiological analys...

  15. 40 CFR 721.9100 - Substituted quinoline.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Substituted quinoline. 721.9100... Substances § 721.9100 Substituted quinoline. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as substituted quinoline (PMN P-93-1183) is...

  16. 40 CFR 721.9488 - Substituted resorcinols.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Substituted resorcinols. 721.9488... Substances § 721.9488 Substituted resorcinols. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as substituted resorcinols (PMNs P-95-1103, P...

  17. 40 CFR 721.10152 - Oxirane, substituted silylmethyl-, hydrolysis products with alkanol zirconium(4+) salt and silica...

    Science.gov (United States)

    2010-07-01

    ...-, hydrolysis products with alkanol zirconium(4+) salt and silica, acetates (generic). 721.10152 Section 721... Oxirane, substituted silylmethyl-, hydrolysis products with alkanol zirconium(4+) salt and silica... substance identified generically as oxirane, substituted silylmethyl-, hydrolysis products with alkanol...

  18. Generic medicine and prescribing: A quick assessment

    Directory of Open Access Journals (Sweden)

    Mainul Haque

    2017-01-01

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

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

    Data.gov (United States)

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

  20. Effects of the W153L substitution in HIV reverse transcriptase on viral replication and drug resistance to multiple categories of reverse transcriptase inhibitors.

    Science.gov (United States)

    Xu, Hong-Tao; Colby-Germinario, Susan P; Oliveira, Maureen; Rajotte, Daniel; Bethell, Richard; Wainberg, Mark A

    2014-08-01

    A W153L substitution in HIV-1 reverse transcriptase (RT) was recently identified by selection with a novel nucleotide-competing RT inhibitor (NcRTI) termed compound A that is a member of the benzo[4,5]furo[3,2,d]pyrimidin-2-one NcRTI family of drugs. To investigate the impact of W153L, alone or in combination with the clinically relevant RT resistance substitutions K65R (change of Lys to Arg at position 65), M184I, K101E, K103N, E138K, and Y181C, on HIV-1 phenotypic susceptibility, viral replication, and RT enzymatic function, we generated recombinant RT enzymes and viruses containing each of these substitutions or various combinations of them. We found that W153L-containing viruses were impaired in viral replicative capacity and were hypersusceptible to tenofovir (TFV) while retaining susceptibility to most nonnucleoside RT inhibitors. The nucleoside 3TC retained potency against W153L-containing viruses but not when the M184I substitution was also present. W153L was also able to reverse the effects of the K65R substitution on resistance to TFV, and K65R conferred hypersusceptibility to compound A. Biochemical assays demonstrated that W153L alone or in combination with K65R, M184I, K101E, K103N, E138K, and Y181C impaired enzyme processivity and polymerization efficiency but did not diminish RNase H activity, providing mechanistic insights into the low replicative fitness associated with these substitutions. We show that the mechanism of the TFV hypersusceptibility conferred by W153L is mainly due to increased efficiency of TFV-diphosphate incorporation. These results demonstrate that compound A and/or derivatives thereof have the potential to be important antiretroviral agents that may be combined with tenofovir to achieve synergistic results. Copyright © 2014, American Society for Microbiology. All Rights Reserved.

  1. Adoption of new HIV treatment guidelines and drug substitutions within first-line as a measure of quality of care in rural Lesotho: health centers and hospitals compared.

    Science.gov (United States)

    Labhardt, Niklaus D; Sello, Motlalepula; Lejone, Thabo; Ehmer, Jochen; Mokhantso, Mohlaba; Lynen, Lutgarde; Pfeiffer, Karolin

    2012-10-01

    In 2007, Lesotho launched new national antiretroviral treatment (ART) guidelines, prioritising tenofovir and zidovudine over stavudine as a backbone together with lamivudine. We compared the rate of adoption of these new guidelines and substitution of first-line drugs by health centers (HC) and hospitals in two catchment areas in rural Lesotho. Retrospective cohort analysis. Patients aged ≥16 years were stratified into a HC- and a hospital-group. Type of backbone at ART-initiation (i), substitutions within first line (ii) and type of backbone among patients retained by December 2010 (iii). A multiple logistic regression model including HC vs. hospital, patient characteristics (sex, age, WHO-stage, baseline CD4-count, concurrent pregnancy, concurrent tuberculosis treatment) and year of ART-start, was used. Of 3936 adult patients initiated on ART between 2007 and 2010, 1971 started at hospitals and 1965 at HCs. Hospitals were more likely to follow the new guidelines as measured by prescription of backbones without stavudine (Odds-ratio 1.55; 95%CI: 1.32-1.81) and had a higher rate of drug substitutions while on first-line ART (2.39; 1.83-3.13). By December 2010, patients followed at health centres were more likely to still receive stavudine (2.28; 1.83-2.84). Health centers took longer to adopt the new guidelines and substituted drugs less frequently. Decentralised ART-programmes need close support, supervision and mentoring to absorb new guidelines and to adhere to them. © 2012 Blackwell Publishing Ltd.

  2. Generic tacrolimus in solid organ transplantation

    DEFF Research Database (Denmark)

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

    2014-01-01

    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......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...

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

    Directory of Open Access Journals (Sweden)

    Philip J Domeyer

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

  4. Ring-opening Polymerization (ROP of Poly Lactied by Cellulose Diacetate and Substitution with Different Amino Acids and Studying Release of Drug

    Directory of Open Access Journals (Sweden)

    Sana. H. Awad

    2018-02-01

    Full Text Available Novel and promising macromolecular were directly synthesized by ring opening of polylactied by hydroxyl groups in cellulose diacetate as biodegradable polymers and amino acids  substitution  for the development of a polymeric implantable delivery carrier The remain of carboxylic groups of amino acid substitution with different drug. The toxicof the synthesized matrices were evaluated using a bacterial Staphylococcus aureuse , Micrococcus, Pseudmonasaeruginosa, klebsiella, Streptococcus. A  twonew amid  bond was formed between the carboxyl  end-groups of the synthesized polymer matrices and an amine group ofamino acids , The structure of the polymeric conjugates was characterized by various spectroscopy techniques. A study of hydrogen nuclear magnetic resonance (1H-NMR and differential scanning calorimetry (DSC thermodiagrams indicated that the presence of drug  pendant groups in the macromolecule structures increased the polymer’s rigidity alongside increasing thermal stability. It has been found that the kinetic release of amino acids and drugs  from the obtained macromolecular conjugates, tested in vitro under different conditions, is strongly dependent on the physicochemical properties of polymeric matrices.

  5. The calculated genetic barrier for antiretroviral drug resistance substitutions is largely similar for different HIV-1 subtypes

    NARCIS (Netherlands)

    Vijver, D.A. van de; Wensing, A.M.J.; Angarano, G.; Asjo, B.; Balotta, C.; Camacho, R.; Chaix, M.; Costagliola, D.; De Luca, A.; Derdelinckx, I.; Grossman, Z.; Hamouda, O.; Hatzakis, A.; Hemmer, R.; Hoepelman, A.I.M.; Horban, A.; Korn, K.; Kücherer, C.; Leitner, T.; Loveday, C.; MacRae, E.; Maljkovic, I.; Mendoza, C. de; Meyer, L.; Nielsen, C.; Op de Coul, E.L.M.; Omaasen, V.; Paraskevis, D.; Perrin, L.; Puchhammer-Stöckl, E.; Salminen, M.; Schmit, J.; Scheider, F.; Schuurman, R.; Soriano, V.; Stanczak, G.; Stanojevic, M.; Vandamme, A.; Laethem, K. van; Violin, M.; Wilde, K.; Yerly, S.; Zazzi, M.; Boucher, C.A.B.

    The genetic barrier, defined as the number of mutations required to overcome drug-selective pressure, is an important factor for the development of HIV drug resistance. Because of high variability between subtypes, particular HIV-1 subtypes could have different genetic barriers for drug

  6. The generic article

    NARCIS (Netherlands)

    Farkas, D.F.; Swart, Henriëtte de

    2005-01-01

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

  7. Generating generic functions

    NARCIS (Netherlands)

    Jeuring, J.T.; Rodriquez, A.; Smeding, G.

    2006-01-01

    We present an approach to the generation of generic functions from user-provided specifications. The specifications consist of the type of a generic function, examples of instances that it should “match” when specialized, and properties that the generic function should satisfy. We use the

  8. Drug/substance reversal effects of a novel tri-substituted benzoflavone moiety (BZF) isolated from Passiflora incarnata Linn.--a brief perspective.

    Science.gov (United States)

    Dhawan, Kamaldeep

    2003-12-01

    The present work is a mini-review of the author's original work on the plant Passiflora incarnata Linn., which is used in several parts of the world as a traditional medicine for the management of anxiety, insomnia, epilepsy and morphine addiction. A tri-substituted benzoflavone moiety (BZF) has been isolated from the bioactive methanol extract of this plant, which has been proposed in the author's earlier work to be responsible for the biological activities of this plant. The BZF moiety has exhibited significantly encouraging results in the reversal of tolerance and dependence of several addiction-prone psychotropic drugs, including morphine, nicotine, ethanol, diazepam and delta-9-tetrahydrocannabinol, during earlier pharmacological studies conducted by the author. In addition to this, the BZF moiety has exhibited aphrodisiac, libido-enhancing and virility-enhancing properties in 2-year-old male rats. When administered concomitantly with nicotine, ethanol and delta-9-tetrahydrocannabinol for 30 days in male rats, the BZF also prevented the drug-induced decline in sexuality in male rats. Because the BZF moiety isolated from P. incarnata is a tri-substituted derivative of alpha-naphthoflavone (7,8-benzoflavone), a well-known aromatase-enzyme inhibitor, the mode of action of BZF has been postulated to be a neurosteroidal mechanism vide in which the BZF moiety prevents the metabolic degradation of testosterone and upregulates blood - testosterone levels in the body. As several flavonoids (e.g. chrysin, apigenin) and other phytoconstituents also possess aromatase-inhibiting properties, and the IC50 value of such phytomoieties is the main factor determining their biochemical efficacy, by altering their chemical structures to attain a desirable IC50 value new insights in medical therapeutics can be attained, keeping in view the menace of drug abuse worldwide.

  9. P1-Substituted Symmetry-Based Human Immunodeficiency Virus Protease Inhibitors with Potent Antiviral Activity against Drug-Resistant Viruses

    Energy Technology Data Exchange (ETDEWEB)

    DeGoey, David A.; Grampovnik, David J.; Chen, Hui-Ju; Flosi, William J.; Klein, Larry L.; Dekhtyar, Tatyana; Stoll, Vincent; Mamo, Mulugeta; Molla, Akhteruzzaman; Kempf, Dale J. (Abbott)

    2013-03-07

    Because there is currently no cure for HIV infection, patients must remain on long-term drug therapy, leading to concerns over potential drug side effects and the emergence of drug resistance. For this reason, new and safe antiretroviral agents with improved potency against drug-resistant strains of HIV are needed. A series of HIV protease inhibitors (PIs) with potent activity against both wild-type (WT) virus and drug-resistant strains of HIV was designed and synthesized. The incorporation of substituents with hydrogen bond donor and acceptor groups at the P1 position of our symmetry-based inhibitor series resulted in significant potency improvements against the resistant mutants. By this approach, several compounds, such as 13, 24, and 29, were identified that demonstrated similar or improved potencies compared to 1 against highly mutated strains of HIV derived from patients who previously failed HIV PI therapy. Overall, compound 13 demonstrated the best balance of potency against drug resistant strains of HIV and oral bioavailability in pharmacokinetic studies. X-ray analysis of an HIV PI with an improved resistance profile bound to WT HIV protease is also reported.

  10. 40 CFR 721.640 - Amine substituted metal salts.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Amine substituted metal salts. 721.640... Substances § 721.640 Amine substituted metal salts. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as amine substituted metal salts...

  11. Structure-activity relationships for novel drug precursor N-substituted-6-acylbenzothiazolon derivatives: A theoretical approach

    Science.gov (United States)

    Sıdır, Yadigar Gülseven; Sıdır, İsa

    2013-08-01

    In this study, the twelve new modeled N-substituted-6-acylbenzothiazolon derivatives having analgesic analog structure have been investigated by quantum chemical methods using a lot of electronic parameters and structure-activity properties; such as molecular polarizability (α), dipole moment (μ), EHOMO, ELUMO, q-, qH+, molecular volume (Vm), ionization potential (IP), electron affinity (EA), electronegativity (χ), molecular hardness (η), molecular softness (S), electrophilic index (ω), heat of formation (HOF), molar refractivity (MR), octanol-water partition coefficient (log P), thermochemical properties (entropy (S), capacity of heat (Cv)); as to investigate activity relationships with molecular structure. The correlations of log P with Vm, MR, ω, EA, EHOMO - ELUMO (ΔE), HOF in aqueous phase, χ, μ, S, η parameters, respectively are obtained, while the linear relation of log P with IP, Cv, HOF in gas phase are not observed. The log P parameter is obtained to be depending on different properties of compounds due to their complexity.

  12. Drug product selection: legal issues.

    Science.gov (United States)

    Christensen, T P; Kirking, D M; Ascione, F J; Welage, L S; Gaither, C A

    2001-01-01

    To review the potential legal liability of the pharmacist in the drug product selection process. Published articles identified through MEDLINE, published law reviews identified through InfoTrac, and appellate court decisions. Search terms used included pharmacist liability, drug product selection, and generic substitution. Additional articles, books, and appellate court decisions were identified from the bibliographies of retrieved articles and citations in appellate court decisions. Pharmacists engaging in drug product selection are civilly liable under three legal theories: negligence, express or implied warranties, and strict product liability. Potential criminal liability includes prosecution for insurance fraud, deceptive business practices, and violation of state drug product selection laws and regulation. Pharmacists increase their liability when engaging in drug product selection, but the increase is small. Still, the law continues to evolve as pharmacists seek expanded roles and responsibilities. When courts give closer examination to pharmacists' expanded role, it is likely that pharmacists' liability will increase.

  13. The Combination of the R263K and T66I Resistance Substitutions in HIV-1 Integrase Is Incompatible with High-Level Viral Replication and the Development of High-Level Drug Resistance.

    Science.gov (United States)

    Liang, Jiaming; Mesplède, Thibault; Oliveira, Maureen; Anstett, Kaitlin; Wainberg, Mark A

    2015-11-01

    The R263K substitution in integrase has been selected in tissue culture with dolutegravir (DTG) and has been reported for several treatment-experienced individuals receiving DTG as part of salvage therapy. The R263K substitution seems to be incompatible with the presence of common resistance mutations associated with raltegravir (RAL), a different integrase strand transfer inhibitor (INSTI). T66I is a substitution that is common in individuals who have developed resistance against a different INSTI termed elvitegravir (EVG), but it is not known whether these two mutations might be compatible in the context of resistance against DTG or what impact the combination of these substitutions might have on resistance against INSTIs. E138K is a common secondary substitution observed with various primary resistance substitutions in RAL- and EVG-treated individuals. Viral infectivity, replicative capacity, and resistance against INSTIs were measured in cell-based assays. Strand transfer and 3' processing activities were measured biochemically. The combination of the R263K and T66I substitutions decreased HIV-1 infectivity, replicative capacity, and strand transfer activity. The addition of the E138K substitution partially compensated for these deficits and resulted in high levels of resistance against EVG but not against DTG or RAL. These findings suggest that the presence of the T66I substitution will not compromise the activity of DTG and may also help to prevent the additional generation of the R263K mutation. Our observations support the use of DTG in second-line therapy for individuals who experience treatment failure with EVG due to the T66I substitution. The integrase strand transfer inhibitors (INSTIs) elvitegravir and dolutegravir are newly developed inhibitors against human immunodeficiency virus type 1 (HIV-1). HIV drug-resistant mutations in integrase that can arise in individuals treated with elvitegravir commonly include the T66I substitution, whereas R263K is a

  14. Generic tacrolimus in solid organ transplantation

    DEFF Research Database (Denmark)

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

    2014-01-01

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

  15. Rilpivirine resistance and the dangerous liaisons with substitutions at position 184 among patients infected with HIV-1: analysis from a national drug-resistance database (ARCA).

    Science.gov (United States)

    Rossotti, Roberto; Fonte, Luigi; Meini, Genny; Maggiolo, Franco; Zazzi, Maurizio; Rusconi, Stefano

    2014-09-01

    Rilpivirine (RPV) is a novel NNRTI with a mutational pattern different from first-generation drugs of the same class: 16 resistance-associated mutations (RAM) are listed, but the combination E138K + M184I seems to be the most important. Aims of the present study were to evaluate the prevalence of these RAMs in Italian HIV-1 infected patients and to assess if previous drug history could represent a risk to develop RPV-related RAMs. The analysis was performed using the ARCA database, which contains data on resistance and therapy from subjects throughout Italy. Prevalence of RPV-associated and first-generation NNRTI-associated RAMs was evaluated. Linear regression model, odds ratio and 95% Confidence Interval were used to assess factors associated with the development of RPV RAMs, substitutions at position 184 and their combinations. A total of 8,067 tests were selected within the database. In Italian HIV-positive HAART-naïve patients, prevalence of the main RAMs for RPV is low except for E138A (present in 5.1% of subjects). The combination E138K + M184I is absent in both naïve and experienced subjects. A previous exposure to NVP might increase the risk to develop RPV-associated RAMs. TDF, EFV, and possibly FTC may predispose to the selection for M184I. Among Italian patients the susceptibility to RPV is widespread since some severe substitutions (e.g., E138K are rare), whereas issues exist for others (i.e., E138A, Y181C) which are more frequent. Appropriate use of RPV within a therapeutic sequencing might be controversial. © 2014 Wiley Periodicals, Inc.

  16. 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.

  17. 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.

  18. Nonbioequivalent prescription drug interchangeability, concerns on patient safety and drug market dynamics in Brazil.

    Science.gov (United States)

    Paumgartten, Francisco José Roma; Oliveira, Ana Cecilia Amado Xavier de

    2017-08-01

    Since the enforcement of Generics Act (1999), three types of pharmaceutically equivalent products are marketed in Brazil: innovative reference (REF), "similar" (S) and generic (G) drugs. The S (brand name) and G (generic name) borrow from REF (brand name) clinical data on safety and efficacy and dosage regimen. G (but not S) is bioequivalent to and interchangeable with REF. Starting in 2003, Brazilian Sanitary Surveillance Agency (Anvisa) has required data on relative bioavailability tests (with REF) to approve (or renew registration of) S drugs. In 2014, Anvisa extended interchangeability notion to similar drugs with a "comparable" bioavailability, i.e., an "equivalent" similar drug (EQ). Drugs for chronic diseases and "critical dose medicines" are listed among the EQ drugs approved. Interchangeability of nonbioequivalent medicines raises deep concerns regarding therapeutic failures and adverse events. Concerns are even more worrisome if patients switch from one drug to another during an ongoing treatment for illnesses such as epilepsy, congestive heart failure, hypertension, diabetes and/or substitutable drugs have a narrow therapeutic index.

  19. Nonbioequivalent prescription drug interchangeability, concerns on patient safety and drug market dynamics in Brazil

    Directory of Open Access Journals (Sweden)

    Francisco José Roma Paumgartten

    Full Text Available Abstract Since the enforcement of Generics Act (1999, three types of pharmaceutically equivalent products are marketed in Brazil: innovative reference (REF, “similar” (S and generic (G drugs. The S (brand name and G (generic name borrow from REF (brand name clinical data on safety and efficacy and dosage regimen. G (but not S is bioequivalent to and interchangeable with REF. Starting in 2003, Brazilian Sanitary Surveillance Agency (Anvisa has required data on relative bioavailability tests (with REF to approve (or renew registration of S drugs. In 2014, Anvisa extended interchangeability notion to similar drugs with a “comparable” bioavailability, i.e., an “equivalent” similar drug (EQ. Drugs for chronic diseases and “critical dose medicines” are listed among the EQ drugs approved. Interchangeability of nonbioequivalent medicines raises deep concerns regarding therapeutic failures and adverse events. Concerns are even more worrisome if patients switch from one drug to another during an ongoing treatment for illnesses such as epilepsy, congestive heart failure, hypertension, diabetes and/or substitutable drugs have a narrow therapeutic index.

  20. 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.

  1. Therapeutic drug monitoring of methotrexate on the pediatric oncology ward: can blood sampling from central venous accesses substitute for capillary finger punctures?

    Science.gov (United States)

    Ritzmo, Carina; Albertioni, Freidoun; Cosic, Karin; Söderhäll, Stefan; Eksborg, Staffan

    2007-08-01

    Intravenous methotrexate therapy with subsequent calcium folinate rescue is widely used for treatment of various neoplastic diseases, both in adults and in children. The optimization of the methotrexate dose and/or the calcium folinate rescue is based on pharmacokinetic data calculated from plasma concentrations collected after cessation of the methotrexate infusion. The aim of the present study was to evaluate the possibility of substituting capillary blood samples with blood samples drawn from central venous catheters (PORT-A-CATH) for therapeutic drug monitoring of methotrexate on the pediatric oncology ward. Nine cancer patients (4 females and 5 males; median age: 15 years; range: 5-20 years) were included. The quantitative analysis of methotrexate was carried out by fluorescence polarization immunoassay (FPIA). The concentrations of methotrexate in venous and capillary samples were closely correlated (rs = 0.98; P plasma concentration ratio was 1.00 [median value; interquartile range (IQR): 0.882-1.094]; for 85% of the data points the ratio was 0.8 to 1.2, independent of drug concentration. The observed plasma concentration differences in blood samples drawn from central venous accesses and obtained from capillary blood samples in this study could have altered the calcium folinate rescue at 1 treatment occasion only. Plotting all measured methotrexate concentration time data for the individual patients during the elimination phase, on a chart including a normal elimination curve, is mandatory to enable proper handling of the subsequent rescue after high-dose methotrexate therapy. Blood sampling from the central venous access can be used only under certain circumstances for therapeutic drug monitoring of methotrexate. Carefully evaluated standardized instructions regarding rinsing, flushing, and discarding waste volumes, as well as precautions to minimize the required blood volume, are needed.

  2. 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....

  3. Scripting XML with Generic Haskell

    NARCIS (Netherlands)

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

    2007-01-01

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

  4. Scripting XML with Generic Haskell

    NARCIS (Netherlands)

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

    2003-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Michael R Law

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

  6. Substitutional analysis

    CERN Document Server

    Rutherford, Daniel Edwin

    2013-01-01

    Classic monograph, suitable for advanced undergraduates and graduate students. Topics include calculus of permutations and tableaux, semi-normal representation, orthogonal and natural representations, group characters, and substitutional equations. 1968 edition.

  7. Generic phytosanitary irradiation treatments

    International Nuclear Information System (INIS)

    Hallman, Guy J.

    2012-01-01

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

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

    African Journals Online (AJOL)

    The Medical Schemes Act (No 131 of 1998) provides for the definition of Prescribed Minimum Benefits, which stipulate a package of services or care a medical scheme ... This study assessed the potential savings that would be achievable by substituting generics for brand name (originator) medicines listed in the chronic ...

  9. 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.

  10. 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.

  11. 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.

  12. Generic Kalman Filter Software

    Science.gov (United States)

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

    2005-01-01

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

  13. Integration of generic issues

    International Nuclear Information System (INIS)

    Thatcher, D.

    1989-01-01

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

  14. 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.

  15. Needle and syringe programmes and opioid substitution therapy for preventing HCV transmission among people who inject drugs: findings from a Cochrane Review and meta-analysis.

    Science.gov (United States)

    Platt, Lucy; Minozzi, Silvia; Reed, Jennifer; Vickerman, Peter; Hagan, Holly; French, Clare; Jordan, Ashly; Degenhardt, Louisa; Hope, Vivian; Hutchinson, Sharon; Maher, Lisa; Palmateer, Norah; Taylor, Avril; Bruneau, Julie; Hickman, Matthew

    2018-03-01

    To estimate the effects of needle and syringe programmes (NSP) and opioid substitution therapy (OST), alone or in combination, for preventing acquisition of hepatitis C virus (HCV) in people who inject drugs (PWID). Systematic review and meta-analysis. Bibliographic databases were searched for studies measuring concurrent exposure to current OST (within the last 6 months) and/or NSP and HCV incidence among PWID. High NSP coverage was defined as regular NSP attendance or ≥ 100% coverage (receiving sufficient or greater number of needles and syringes per reported injecting frequency). Studies were assessed using the Cochrane risk of bias in non-randomized studies tool. Random-effects models were used in meta-analysis. We identified 28 studies (n = 6279) in North America (13), United Kingdom (five), Europe (four), Australia (five) and China (one). Studies were at moderate (two), serious (17) critical (seven) and non-assessable risk of bias (two). Current OST is associated with 50% [risk ratio (RR) =0.50, 95% confidence interval (CI) = 0.40-0.63] reduction in HCV acquisition risk, consistent across region and with low heterogeneity (I 2  = 0, P = 0.889). Weaker evidence was found for high NSP coverage (RR = 0.79, 95% CI = 0.39-1.61) with high heterogeneity (I 2  = 77%, P = 0.002). After stratifying by region, high NSP coverage in Europe was associated with a 56% reduction in HCV acquisition risk (RR = 0.44, 95% CI = 0.24-0.80) with low heterogeneity (I 2  = 12.3%, P = 0.337), but not in North America (RR = 1.58, I 2  = 89.5%, P = Grades of Recommendation Assessment, Development and Evaluation (GRADE) criteria, the evidence on OST and combined OST/NSP is low quality, while NSP is very low. Opioid substitution therapy reduces risk of hepatitis C acquisition and is strengthened in combination with needle and syringe programmes (NSP). There is weaker evidence for the impact of needle syringe programmes alone, although stronger evidence

  16. The generic strategy trap.

    Science.gov (United States)

    Miller, D

    1992-01-01

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

  17. Generic Clearance Values

    International Nuclear Information System (INIS)

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

    2010-01-01

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

  18. Generic clearance values

    International Nuclear Information System (INIS)

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

    2009-01-01

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

  19. 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

  20. Generic phytosanitary irradiation treatments

    Science.gov (United States)

    Hallman, Guy J.

    2012-07-01

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

  1. of some generic characters

    African Journals Online (AJOL)

    1986-06-12

    Jun 12, 1986 ... The new species is closest to Homopholis fascists of East Africa and Ethiopia Some generic characters are discussed. 'n Nuwe geitjie-spesie, Homopholis mulleri, van Noord-Transvaal (Suid-Afrika), word beskryf. Dit word met die ander twee spesies van die genus in Afrika vergelyk. Die nuwe spesie is ...

  2. Compaction properties, drug release kinetics and fronts movement studies of matrices combining mixtures of swellable and inert polymers. III: effect of polymer substitution type.

    Science.gov (United States)

    Escudero, J J; Ferrero, C; Casas, M; Jiménez-Castellanos, M R

    2012-09-15

    Theophylline radial release from cellulose derivatives with different substitution type (HPMC K4M, HPC H, MC A4M) matrix tablets has been modulated by the introduction of a new inert polymeric excipient, at different proportions (75, 50, 25%). The new polymer was hydroxypropylcellulose-methyl methacrylate (HCMMA), which was dried either in a vacuum oven (OD-HCMMA) or freeze-dried (FD-HCMMA). MC A4M and its mixtures presented the best compaction properties results, especially mixed with FD-HCMMA, according to 100% mixtures. Only high levels of HCMMA (75%) in the matrices showed interesting differences to drug release modulation. Also, at this proportion (75:25), the HPC H mixtures presented the highest differences in relation with OD or FD HCMMA respect to the other cellulose polymers. HPMC K4M and HPC H mixtures showed a combination of diffusion and erosion release mechanisms. The last one was nearly negligible in MC A4M mixtures, according with its highest diffusion rate constant values, and the absence of hydroxypropyl substituents. Only HPMC K4M mixtures presented a diffusion front that moves outwards, while HPC H and MC A4M moves inwards. The modulation of theophylline radial release was obtained using a high percentage of HCMMA, and the use of two cellulosic ethers, one of them with just one type of substituent (MC A4M or HPC H) and the other with two types of substituent (HPMC K4M). Another possibility is changing the HCMMA copolymer (OD or FD) in the 75/25 mixture with HPC. Copyright © 2012 Elsevier B.V. All rights reserved.

  3. The elasticity of drugs demand in Colombia’s pharmaceutical market

    Directory of Open Access Journals (Sweden)

    Johanna Vásquez Velásquez

    2013-06-01

    Full Text Available Based on a dynamic specification of the AIDS model arisen from cointegration techniques, this research estimated the elasticity of the intra-molecular, brand and generic demand for three tracer conditions: essential hypertension, diabetes and hyperlipidemia both in the non-profit and private Colombian market. The estimate of the intra-molecular demand elasticity allows us to conclude that both brand-name and generic drugs are inelastic to price changes, they are luxury goods according to expenditure elasticity and intra-molecular replacement seems to exist due to the elasticity of substitution.

  4. 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.

  5. Drugs Approved for Skin Cancer

    Science.gov (United States)

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

  6. 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.

  7. 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.

  8. Drugs Approved for Esophageal Cancer

    Science.gov (United States)

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

  9. Drugs Approved for 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.

  10. 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.

  11. 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.

  12. 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.

  13. Solvent substitution

    International Nuclear Information System (INIS)

    1990-01-01

    The DOE Environmental Restoration and Waste Management Office of Technology Development and the Air Force Engineering and Services Center convened the First Annual International Workshop on Solvent Substitution on December 4--7, 1990. The primary objectives of this joint effort were to share information and ideas among attendees in order to enhance the development and implementation of required new technologies for the elimination of pollutants associated with industrial use of hazardous and toxic solvents; and to aid in accelerating collaborative efforts and technology transfer between government and industry for solvent substitution. There were workshop sessions focusing on Alternative Technologies, Alternative Solvents, Recovery/Recycling, Low VOC Materials and Treatment for Environmentally Safe Disposal. The 35 invited papers presented covered a wide range of solvent substitution activities including: hardware and weapons production and maintenance, paint stripping, coating applications, printed circuit boards, metal cleaning, metal finishing, manufacturing, compliance monitoring and process control monitoring. This publication includes the majority of these presentations. In addition, in order to further facilitate information exchange and technology transfer, the US Air Force and DOE solicited additional papers under a general ''Call for Papers.'' These papers, which underwent review and final selection by a peer review committee, are also included in this combined Proceedings/Compendium. For those involved in handling, using or managing hazardous and toxic solvents, this document should prove to be a valuable resource, providing the most up-to-date information on current technologies and practices in solvent substitution. Individual papers are abstracted separated

  14. Solvent substitution

    Energy Technology Data Exchange (ETDEWEB)

    1990-01-01

    The DOE Environmental Restoration and Waste Management Office of Technology Development and the Air Force Engineering and Services Center convened the First Annual International Workshop on Solvent Substitution on December 4--7, 1990. The primary objectives of this joint effort were to share information and ideas among attendees in order to enhance the development and implementation of required new technologies for the elimination of pollutants associated with industrial use of hazardous and toxic solvents; and to aid in accelerating collaborative efforts and technology transfer between government and industry for solvent substitution. There were workshop sessions focusing on Alternative Technologies, Alternative Solvents, Recovery/Recycling, Low VOC Materials and Treatment for Environmentally Safe Disposal. The 35 invited papers presented covered a wide range of solvent substitution activities including: hardware and weapons production and maintenance, paint stripping, coating applications, printed circuit boards, metal cleaning, metal finishing, manufacturing, compliance monitoring and process control monitoring. This publication includes the majority of these presentations. In addition, in order to further facilitate information exchange and technology transfer, the US Air Force and DOE solicited additional papers under a general Call for Papers.'' These papers, which underwent review and final selection by a peer review committee, are also included in this combined Proceedings/Compendium. For those involved in handling, using or managing hazardous and toxic solvents, this document should prove to be a valuable resource, providing the most up-to-date information on current technologies and practices in solvent substitution. Individual papers are abstracted separated.

  15. Sugar Substitutes

    Science.gov (United States)

    ... and drinks. You may have heard them called “artificial sweeteners” or “non-caloric sweeteners.” They can be used ... a food or drink contains. What sugar substitutes/artificial sweeteners are approved by the FDA? The following sugar ...

  16. 40 CFR 721.10199 - Substituted aliphatic amine (generic).

    Science.gov (United States)

    2010-07-01

    ...-specific cartridge) and should include a particulate filter (N100 if oil aerosols are absent, R100, or P100... (HEPA) filters; supplied-air respirator operated in pressure demand or continuous flow mode and equipped...

  17. 40 CFR 721.5546 - Halogen substituted oxetanes (generic).

    Science.gov (United States)

    2010-07-01

    ..., and any information on methods for protecting against such risk, into a Material Safety Data Sheet... notification as follows: (A) If as a result of the test data required under the TSCA section 5(e) consent order...

  18. 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.

  19. Generic safety documentation model

    International Nuclear Information System (INIS)

    Mahn, J.A.

    1994-04-01

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

  20. How Abbott’s Fenofibrate Franchise Avoided Generic Competition

    Science.gov (United States)

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

    2013-01-01

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

  1. Prescribing Generic Medication in Chronic Musculoskeletal Pain Patients: An Issue of Representations, Trust, and Experience in a Swiss Cohort.

    Directory of Open Access Journals (Sweden)

    Valérie Piguet

    Full Text Available Parallel to an ever stronger advocacy for the use of generics, various sources of information report concerns regarding substitution. The literature indicates that information regarding substitution is not univocal. The aim of this qualitative study was to explore patients' representations regarding generics in patients suffering from non-specific disabling chronic musculoskeletal pain, as these patients are confronted with the issue of the prescription and/or substitution of original formulations with generics.Qualitative methods were selected because the aim was to access the range of patients' representations and to consider their conceptions. Standardized face-to-face semi-structured interviews were used, and transcripts were submitted to content analysis.Patients' representations suggest that they might be confident in taking a generic medication: when he/she has an understanding of generics as resulting from a development process that has become part of the public domain; the generic medication is prescribed by the physician; each prescription is discussed, i.e., the patient is prescribed the generic version of a given medication and not a generic medication.Economic arguments are not sufficient to justify substitution, and may even raise issues calling upon cognitive dissonance. Even in non-life-threatening diseases, negative cues require attention and need be de-emphasized - in particular lower price as an indication of lower quality, and generic status as contradictory with advocating individualization of medication.

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

    Science.gov (United States)

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

    2017-05-01

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

  3. 40 CFR 721.7220 - Polymer of substituted phenol, formaldehyde, epichlorohydrin, and disubstituted benzene.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Polymer of substituted phenol... SUBSTANCES Significant New Uses for Specific Chemical Substances § 721.7220 Polymer of substituted phenol... subject to reporting. (1) The chemical substance identified generically as polymer of substituted phenol...

  4. An update of the Hong Kong Epilepsy Guideline: consensus statement on the use of antiepileptic drugs in Hong Kong.

    Science.gov (United States)

    Fong, J Ky; Chan, E Ly; Leung, H; Chan, I; Chang, R Sk; Fong, G Cy; Fung, E Lw; Lui, C Ht; Fung, B Bh; Poon, T L; Siu, D; Wong, H T; Yeung, E; Yung, A Wy; Zhu, C Xl

    2017-02-01

    New information about antiepileptic drugs has arisen since the publication of the Hong Kong Epilepsy Guideline in 2009. This article set out to fill the knowledge gap between 2007 and 2016 on the use of antiepileptic drugs in Hong Kong. Between May 2014 and April 2016, four consensus meetings were held in Hong Kong, where a group comprising 15 professionals (neurologists, paediatricians, neurosurgeons, radiologists, and clinical psychologists) from both public and private sectors aimed to review the best available evidence and update all practising physicians on a range of clinical issues including drug-related matters. All participants were council members of The Hong Kong Epilepsy Society. A literature review of the clinical use of antiepileptic drugs as monotherapy suggested Level A evidence for levetiracetam and Level B evidence for lacosamide. No change in the level of evidence was found for oxcarbazepine (Level A evidence) or pregabalin (undesignated), and no evidence was found for perampanel. A literature review on the clinical use of antiepileptic drugs as adjunctive therapy suggested Level A evidence for both lacosamide and perampanel. No change to the level of evidence was found for levetiracetam (Level A evidence), oxcarbazepine (Level A evidence), or pregabalin (Level A evidence). A literature search on the use of generic antiepileptic drugs suggested Level A evidence for the use of lamotrigine in generic substitution. Three lead authors of the Subcommittee drafted the manuscript that consisted of two parts-part A: evidence on new antiepileptic drugs, and part B: generic drugs. The recommendations on monotherapy/adjunctive therapy were presented during the meetings. The pros and cons for our health care system of generic substitution were discussed. The recommendations represent the 'general consensus' of the participants in keeping with the evidence found in the literature. Recommendations for the use of levetiracetam, lacosamide, oxcarbazepine

  5. 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.

  6. 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...

  7. Cyclosporine: A Commentary on Brand versus Generic Formulation Exchange

    Directory of Open Access Journals (Sweden)

    A. K. Singh

    2011-01-01

    Full Text Available The evidence for conversion from brand name to generic equivalent cyclosporine is conflicting. Cyclosporine is a narrow therapeutic-range drug for which small variations in exposure may have severe clinical consequences for transplant patients. There is currently a lack of comparative outcome data relating to the pharmacokinetics of the reference formulation, Neoral, and generic formulations in transplant recipients. A major common concern is the potential inability to attain similar trough levels, an issue that can be easily corrected by ongoing therapeutic drug monitoring to ensure that the new steady state falls within an intended target range. Prospective clinical studies investigating the efficacy and safety of generic formulations in both de novo and long-term transplant patients are also awaited. Until further evidence is available on the conversion of transplant patients to or between generic formulations of cyclosporine, any transfer to a different cyclosporine formulation should be undertaken with close supervision. The best available information to date, however, does not support the frequently held but unsubstantiated belief that generic preparations of immunosuppressive drugs are not as effective as brand names or that conversion from brand to generic is associated with significant danger. This paper attempts to initiate a discussion of these issues.

  8. 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...

  9. NET 40 Generics Beginner's Guide

    CERN Document Server

    Mukherjee, Sudipta

    2012-01-01

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

  10. Trends in Medicaid fee-for-service outpatient drug utilization ...

    African Journals Online (AJOL)

    in the total number of prescriptions as also the prices of generic drugs. Thus, higher utilization of generic drugs may offer substantial savings to Medicaid programs at the state level. Keywords: Fee-for-service programs, Medicaid program, Generic drug utilization; Branded drugs,. Patient Protection and Affordable Care Act.

  11. Drugs Approved for Lung Cancer

    Science.gov (United States)

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

  12. Drugs Approved for Pancreatic Cancer

    Science.gov (United States)

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

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

    Directory of Open Access Journals (Sweden)

    V. V. Yakusevich

    2015-12-01

    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.

  14. 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.

  15. 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

  16. Drugs Approved for Rhabdomyosarcoma

    Science.gov (United States)

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

  17. Article choice in plural generics

    NARCIS (Netherlands)

    Farkas, D.F.; Swart, Henriëtte de

    2007-01-01

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

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

    Science.gov (United States)

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

    2014-05-01

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

  19. 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.

  20. 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.

  1. Drugs Approved for Gastrointestinal Stromal Tumors

    Science.gov (United States)

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

  2. Drugs Approved for Stomach (Gastric) Cancer

    Science.gov (United States)

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

  3. 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.

  4. Global alteration of the drug-binding pocket of human P-glycoprotein (ABCB1) by substitution of fifteen conserved residues reveals a negative correlation between substrate size and transport efficiency.

    Science.gov (United States)

    Vahedi, Shahrooz; Chufan, Eduardo E; Ambudkar, Suresh V

    2017-11-01

    P-glycoprotein (P-gp), an ATP-dependent efflux pump, is linked to the development of multidrug resistance in cancer cells. However, the drug-binding sites and translocation pathways of this transporter are not yet well-characterized. We recently demonstrated the important role of tyrosine residues in regulating P-gp ATP hydrolysis via hydrogen bond formations with high affinity modulators. Since tyrosine is both a hydrogen bond donor and acceptor, and non-covalent interactions are key in drug transport, in this study we investigated the global effect of enrichment of tyrosine residues in the drug-binding pocket on the drug binding and transport function of P-gp. By employing computational analysis, 15 conserved residues in the drug-binding pocket of human P-gp that interact with substrates were identified and then substituted with tyrosine, including 11 phenylalanine (F72, F303, F314, F336, F732, F759, F770, F938, F942, F983, F994), two leucine (L339, L975), one isoleucine (I306), and one methionine (M949). Characterization of the tyrosine-rich P-gp mutant in HeLa cells demonstrated that this major alteration in the drug-binding pocket by introducing fifteen additional tyrosine residues is well tolerated and has no measurable effect on total or cell surface expression of this mutant. Although the tyrosine-enriched mutant P-gp could transport small to moderate size (transport large (>1000 Daltons) substrates such as NBD-cyclosporine A, Bodipy-paclitaxel and Bodipy-vinblastine was significantly decreased. This was further supported by the physico-chemical characterization of seventeen tested substrates, which revealed a negative correlation between drug transport and molecular size for the tyrosine-enriched P-gp mutant. Published by Elsevier Inc.

  5. Quality of generic medicines in South Africa

    DEFF Research Database (Denmark)

    Patel, Aarti; Gauld, Robin; Norris, Pauline

    2012-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Elaine Silva Miranda

    2009-10-01

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

  7. Drug-like property-driven optimization of 4-substituted 1,5-diarylanilines as potent HIV-1 non-nucleoside reverse transcriptase inhibitors against rilpivirine-resistant mutant virus.

    Science.gov (United States)

    Wei, Lei; Wang, Hui-Ling; Huang, Li; Chen, Chin-Ho; Morris-Natschke, Susan L; Lee, Kuo-Hsiung; Xie, Lan

    2017-06-15

    On the basis of our prior structure-activity relationship (SAR) results, our current lead optimization of 1,5-diarylanilines (DAANs) focused on the 4-substituent (R 1 ) on the central phenyl ring as a modifiable position related simultaneously to improved drug resistance profiles and drug-like properties. Newly synthesized p-cyanovinyl-DAANs (8a-8g) with different R 1 side chains plus prior active p-cyanoethyl-DAANs (4a-4c) were evaluated not only for anti-HIV potency against both wild-type HIV virus and rilpivirine-resistant (E138K, E138K+M184I) viral replication, but also for multiple drug-like properties, including aqueous solubility, lipophilicity, and metabolic stability in human liver microsomes and human plasma. This study revealed that both ester and amide R 1 substituents led to low nanomolar anti-HIV potency against wild-type and rilpivirine-resistant viral strains (E138K-resistance fold changes<3). The N-substituted amide-R 1 side chains were superior to ester-R 1 likely due to improved aqueous solubility, lipophilicity, and higher metabolic stability in vitro. Thus, three amide-DAANs 8e, 4a, and 4b were identified with high potency against wild-type and rilpivirine-resistant viral strains and multiple desirable drug-like properties. Copyright © 2017 Elsevier Ltd. All rights reserved.

  8. PLS-based quantitative structure-activity relationship for substituted benzamides of clebopride type. Application of experimental design in drug design.

    Science.gov (United States)

    Norinder, U; Högberg, T

    1992-04-01

    The advantageous approach of using an experimentally designed training set as the basis for establishing a quantitative structure-activity relationship with good predictive capability is described. The training set was selected from a fractional factorial design scheme based on a principal component description of physico-chemical parameters of aromatic substituents. The derived model successfully predicts the activities of additional substituted benzamides of 6-methoxy-N-(4-piperidyl)salicylamide type. The major influence on activity of the 3-substituent is demonstrated.

  9. Nonallergic hypersensitivity to nonsteroidal antiinflammatory drugs, angiotensin-converting enzyme inhibitors, radiocontrast media, local anesthetics, volume substitutes and medications used in general anesthesia.

    Science.gov (United States)

    Jurakić Toncić, Ruzica; Marinović, Branka; Lipozencić, Jasna

    2009-01-01

    Urticaria and angioedema are common allergic manifestations and medications are one of common triggering factors. The most severe immediate drug reaction is anaphylaxis. Apart from the well established IgE-mediated immediate type hypersensitivity reactions, the pathogenesis of drug-induced urticaria, angioedema and anaphylaxis often remains obscure. In this article, emphasis is put on nonallergic reactions to the most commonly used drug groups of nonsteroidal antiinflammatory drugs, angiotensin-converting enzyme inhibitors, radiocontrast media, volume expanders and drugs used in general anesthesia. Urticaria is the second most common drug eruption after maculopapular exanthema. The mechanisms of acute urticarial reactions are multiple, mostly IgE mediated, but some drugs can induce immune complex reactions and activate complement cascade, while others can induce direct activation of mast cells and degranulation or activation of complement by non-immune mechanisms. With different types of medications different pathomechanisms are involved. Non-steroid anti-inflammatory drugs are thought to cause reaction due to cyclooxygenase-1 inhibition and overproduction of leukotrienes, blamed for cutaneous and respiratory symptoms. Angiotensin-converting enzyme inhibitors can cause fatal angioedema, which is partially explained with bradykinin excess and impairment of aminopeptidase P and dipeptidyl peptidase IV that are involved in the metabolism of substance P and bradykinin. It remains unknown what additional mechanisms are involved. Radiocontrast media and local anesthetics mostly cause nonallergic hypersensitivity reaction, but in rare cases true allergic reaction can occur. Dextran is known to cause IgG mediated, immune complex anaphylaxis and it is recommended to use human serum albumin as the safest colloid.

  10. 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.

  11. The Generic Data Capture Facility

    Science.gov (United States)

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

    1987-01-01

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

  12. Hanford Generic Interim Safety Basis

    International Nuclear Information System (INIS)

    Lavender, J.C.

    1994-01-01

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

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

    Science.gov (United States)

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

    2012-01-01

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

  14. 21 CFR 184.1259 - Cocoa butter substitute.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 3 2010-04-01 2009-04-01 true Cocoa butter substitute. 184.1259 Section 184.1259... Listing of Specific Substances Affirmed as GRAS § 184.1259 Cocoa butter substitute. (a) The common or usual name for the triglyceride 1-palmitoyl-2-oleoyl-3-stearin is “cocoa butter substitute primarily...

  15. 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.

  16. A generic coding approach for the examination of meal patterns.

    Science.gov (United States)

    Woolhead, Clara; Gibney, Michael J; Walsh, Marianne C; Brennan, Lorraine; Gibney, Eileen R

    2015-08-01

    Meal pattern analysis can be complex because of the large variability in meal consumption. The use of aggregated, generic meal data may address some of these issues. The objective was to develop a meal coding system and use it to explore meal patterns. Dietary data were used from the National Adult Nutrition Survey (2008-2010), which collected 4-d food diary information from 1500 healthy adults. Self-recorded meal types were listed for each food item. Common food group combinations were identified to generate a number of generic meals for each meal type: breakfast, light meals, main meals, snacks, and beverages. Mean nutritional compositions of the generic meals were determined and substituted into the data set to produce a generic meal data set. Statistical comparisons were performed against the original National Adult Nutrition Survey data. Principal component analysis was carried out by using these generic meals to identify meal patterns. A total of 21,948 individual meals were reduced to 63 generic meals. Good agreement was seen for nutritional comparisons (original compared with generic data sets mean ± SD), such as fat (75.7 ± 29.4 and 71.7 ± 12.9 g, respectively, P = 0.243) and protein (83.3 ± 26.9 and 80.1 ± 13.4 g, respectively, P = 0.525). Similarly, Bland-Altman plots demonstrated good agreement (<5% outside limits of agreement) for many nutrients, including protein, saturated fat, and polyunsaturated fat. Twelve meal types were identified from the principal component analysis ranging in meal-type inclusion/exclusion, varying in energy-dense meals, and differing in the constituents of the meals. A novel meal coding system was developed; dietary intake data were recoded by using generic meal consumption data. Analysis revealed that the generic meal coding system may be appropriate when examining nutrient intakes in the population. Furthermore, such a coding system was shown to be suitable for use in determining meal-based dietary patterns. © 2015

  17. Clinical review: impact of statin substitution policies on patient outcomes

    DEFF Research Database (Denmark)

    Atar, Dan; Carmena, Rafael; Clemmensen, Peter

    2009-01-01

    BACKGROUND: The increasing awareness of cost issues in health care has led to the increasing use of policy-driven substitution of branded for generic medications, particularly relative to statin treatment for cardiovascular diseases. While there are potential short-term health care savings, the c...

  18. Clinical review: impact of statin substitution policies on patient outcomes

    NARCIS (Netherlands)

    Atar, Dan; Carmena, Rafael; Clemmensen, Peter; K-Laflamme, Annik; Wassmann, Sven; Lansberg, Peter; Hobbs, Richard

    2009-01-01

    The increasing awareness of cost issues in health care has led to the increasing use of policy-driven substitution of branded for generic medications, particularly relative to statin treatment for cardiovascular diseases. While there are potential short-term health care savings, the consequences for

  19. What's in a name? Generics and the persistence of the pharmaceutical brand in American medicine.

    Science.gov (United States)

    Greene, Jeremy A

    2011-10-01

    This paper explores the complex role that brand names have played in the maintenance of therapeutic standards within twentieth-century American medicine. What made a generic drug generic in the second half of the twentieth century--and by extension, what made a nonproprietary drug not proprietary in the first half--was dependent on changing drug branding practices and evolving standards of evidence attached to claims of therapeutic efficacy and safety. This article maps three eras of shifting oppositions between branded and unbranded pharmaceuticals. First, an era of "ethical marketing," extending from before the Pure Food and Drug Act of 1906 into roughly the 1930s, which pitted nonproprietary or "ethical" pharmaceuticals against proprietary or patent medicines; second, an era of ascendant brand-name prescribing from the 1930s until roughly the 1960s, as manufacturers of innovative and patent-protected "specialty" drugs depicted generic production as a form of counterfeiting; and finally, an era of generic backlash from the 1960s onwards, which assumed the interchangeability of branded and generic drugs. This article uses clinical, popular, policy, and trade literatures to explore the enduring roles of brand-logic in the face of generic competition in the American drug market.

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

    Science.gov (United States)

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

    2017-05-01

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

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

    Directory of Open Access Journals (Sweden)

    Gerson Rosenberg

    2010-04-01

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

  2. [Contingency management in opioid substitution treatment].

    Science.gov (United States)

    Specka, M; Böning, A; Scherbaum, N

    2011-07-01

    The majority of opiate-dependent patients in substitution treatment show additional substance-related disorders. Concomitant use of heroin, alcohol, benzodiazepines or cocaine compromises treatment success. Concomitant drug use may be treated by using contingency management (CM) which is based on learning theory. In CM, abstinence from drugs, as verified by drug screenings, is reinforced directly and contingently. Reinforcers used in CM studies with substituted patients were, amongst others, vouchers and take-home privileges. Studies in the USA show a medium average effect of CM on drug consumption rates and abstinence. The effects decrease markedly after the end of the intervention. We discuss whether CM is applicable within the German substitution treatment system and how it can be combined with other interventions such as selective detoxification treatments or cognitive-behavioural programmes. © Georg Thieme Verlag KG Stuttgart · New York.

  3. 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.

  4. Drugs Approved for Cervical Cancer

    Science.gov (United States)

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

  5. Drugs Approved for Hodgkin Lymphoma

    Science.gov (United States)

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

  6. 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.

  7. Drugs Approved for Myeloproliferative Neoplasms

    Science.gov (United States)

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

  8. Drugs Approved for Testicular Cancer

    Science.gov (United States)

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

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

    Science.gov (United States)

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

    2014-01-01

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

  10. 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.

  11. 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

  12. 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...

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

    Science.gov (United States)

    Sun, Jing

    2013-05-01

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

  14. Pharmacy discounts on generic medicines in France: is there room for further efficiency savings?

    Science.gov (United States)

    Kanavos, Panos; Taylor, David

    2007-10-01

    In France control of pharmaceutical expenditure has been a policy priority for many years and generic policies have featured prominently on the policy agenda. Measures including reference pricing, generic substitution and international non-proprietary name (INN) prescribing have been introduced in recent years. Generic manufacturers and wholesalers may offer discounts, rebates or promotions to pharmacies in order to gain an edge over their competitors, but their true extent is unknown. To identify the amplitude of discounts on generic medicines, and whether wholesalers or generic manufacturers offer these beyond officially negotiated margins and allowable discounts, by conducting a pilot study. Data on net prices were acquired for all available presentations of 11 generic molecules selected across different therapeutic categories included in the 40 most selling generic products in 2005. Data were obtained via a questionnaire survey followed by interview with selected pharmacies (n = 4) and whole-salers (n = 2). Pharmacies and wholesalers participated in this study subject to confidentiality and anonymity. Pharmacies usually prefer to buy generic products directly from manufacturers rather than from wholesalers in order to avoid paying additional margins imposed by wholesalers. Discounts are mostly price-related and generally vary from 20 to 70% off the wholesaler selling price (WSP), on top of the officially allowed 10.74%. Discounts on the ex-factory price (EFP) are much lower, typically around 7.5%. Discounts are prohibited for branded products, beyond the officially allowed ceiling of 2.5%. While horizontal integration among pharmacies is disallowed, pharmacies may form purchasing groups allowing them to realise greater discounts from suppliers. Overall, the evidence suggests that discounts occur in France beyond what may be allowable and their extent can be significant. If general discount levels for generic medicines are as high as this pilot study suggests

  15. Analyses of marketplace tacrolimus drug product quality: bioactivity, NMR and LC-MS.

    Science.gov (United States)

    Sommers, Cynthia D; Pang, Eric S; Ghasriani, Houman; Berendt, Robert T; Vilker, Vincent L; Keire, David A; Boyne, Michael T

    2013-11-01

    Tacrolimus (FK506) is a potent, narrow therapeutic index, immunosuppressive drug used to avoid organ rejection in patients that have undergone organ transplantation. Recent clinical reports suggested a significant reduction in the tacrolimus concentration/dose ratio in the plasma of liver and kidney recipients when the reference listed drug was substituted with a generic drug. In response to these concerns about switching between tacrolimus from different approved manufacturers during treatment, the FDA initiated purity, potency and quality studies of the innovator and generic tacrolimus products available in the US marketplace. A combination of analytical methods, including mass spectrometry (LC-MS), nuclear magnetic resonance (NMR) and bioactivity assay were developed and validated to assess the quality of tacrolimus. These tests measured the identity, impurities and activity of tacrolimus from active pharmaceutical ingredient (API) sources and with formulated drug product from five different approved manufactures. In addition, some testing was performed on tacrolimus capsules obtained from a non US approved Indian source. The data obtained showed no discernible difference in the impurity profiles and potency between the generic and innovator tacrolimus products. Copyright © 2013. Published by Elsevier B.V.

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

    Directory of Open Access Journals (Sweden)

    Alrasheedy AA

    2014-04-01

    such misconceptions varied from one country to another. However, in many countries, there was a meaningful percentage of patients who had negative perceptions and misconceptions about generic medicines. Moreover, such misconceptions and negative perceptions were reported as major obstacles to the use and acceptance of generic medicines among patients. Further, studies that focused on specific populations (eg, patients with epilepsy, psychosis, or renal disease reported a more negative perception and more resistance to the use of generic medicines. The type of medical condition and its level of seriousness or severity, recommendations by health care professionals, price difference (ie, cost saving, previous experience of generic medicines, and knowledge/information about generic medicines were considered to be important factors that affect a patient’s decision to use a generic medicine or a brand medicine. Conclusion: The results from this literature search show that patients and medicine consumers tend to prefer original brand medicines over generic medicines. Further, in many countries, there is still a considerable proportion of patients and consumers who lack adequate knowledge or have insufficient information about generic medicines. Thus, there is a need for educational interventions and activities to educate patients about generic medicines. It is also evident in the literature that health care professionals (physicians and pharmacists play a key role in the promotion of generic medicines and in patients’ acceptance of generic medicines and generic substitution. Hence, health care professionals need to play a more active role by educating patients and recommending generic medicines to their patients. Keywords: patients, generic substitution, perceptions, policy

  17. Proceedings Workshop on Generic Programming (WGP2000)

    NARCIS (Netherlands)

    Jeuring, J.T.

    2000-01-01

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

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

    African Journals Online (AJOL)

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

  19. 76 FR 69294 - Proposed Generic Communication Draft Generic Letter on Seismic Risk Evaluations for Operating...

    Science.gov (United States)

    2011-11-08

    ... COMMISSION Proposed Generic Communication Draft Generic Letter on Seismic Risk Evaluations for Operating... public comment Draft Generic Letter 2011-XX: Seismic Risk Evaluations for Operating Reactors. The public... for public comment Draft Generic Letter 2011-XX: Seismic Risk Evaluations for Operating Reactors to...

  20. 77 FR 30560 - Proposed Generic Communication; Generic Letter on Seismic Risk Evaluations for Operating Reactors

    Science.gov (United States)

    2012-05-23

    ... COMMISSION Proposed Generic Communication; Generic Letter on Seismic Risk Evaluations for Operating Reactors... Regulatory Commission (NRC) is withdrawing draft Generic Letter 2011-XX, ``Seismic Risk Evaluations for Operating Reactors'' published on September 1, 2011 (76 FR 54507). The draft Generic Letter, ``Seismic Risk...

  1. 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.

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

    Directory of Open Access Journals (Sweden)

    Ajay Babu Pazhayattil

    2017-09-01

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

  3. The physical properties of generic latanoprost ophthalmic solutions are not identical

    DEFF Research Database (Denmark)

    Kolko, Miriam; Koch Jensen, Peter

    2017-01-01

    PURPOSE: To compare various characteristics of Xalatan® and five generic latanoprost ophthalmic solutions. METHODS: Drop size, volume, pH values, buffer capacity, viscosity, hardness of bottles and costs were determined. Drop sizes were measured in triplicates by micropipettes, and the number...... of drops counted in three separate bottles of each generic product was determined. pH values were measured in triplicates by a calibrated pH meter. Buffer capacity was exploited by titrating known quantities of strong base into 2.5 ml of each brand and interpolated to neutral pH. Kinematic viscosity...... and the number of drops in the bottles varied significantly between the generic drugs. The control value of pH in the brand version (Xalatan® ) was markedly lower compared to the generic latanoprost products. Titration of Xalatan® to neutrality required substantially more NaOH compared to the generic latanoprost...

  4. GenMed 010: a one day workshop on generic medicines

    Directory of Open Access Journals (Sweden)

    Shankar PR

    2011-03-01

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

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

    Science.gov (United States)

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

    2015-09-01

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

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

    Directory of Open Access Journals (Sweden)

    Béatrice Riner

    2017-11-01

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

  7. Assessing website pharmacy drug quality: safer than you think?

    Directory of Open Access Journals (Sweden)

    Roger Bate

    Full Text Available BACKGROUND: Internet-sourced drugs are often considered suspect. The World Health Organization reports that drugs from websites that conceal their physical address are counterfeit in over 50 percent of cases; the U.S. Food and Drug Administration (FDA works with the National Association of Boards of Pharmacy (NABP to regularly update a list of websites likely to sell drugs that are illegal or of questionable quality. METHODS AND FINDINGS: This study examines drug purchasing over the Internet, by comparing the sales of five popular drugs from a selection of websites stratified by NABP or other ratings. The drugs were assessed for price, conditions of purchase, and basic quality. Prices and conditions of purchase varied widely. Some websites advertised single pills while others only permitted the purchase of large quantities. Not all websites delivered the exact drugs ordered, some delivered no drugs at all; many websites shipped from multiple international locations, and from locations that were different from those advertised on the websites. All drug samples were tested against approved U.S. brand formulations using Raman spectrometry. Many (17 websites substituted drugs, often in different formulations from the brands requested. These drugs, some of which were probably generics or perhaps non-bioequivalent copy versions, could not be assessed accurately. Of those drugs that could be assessed, none failed from "approved", "legally compliant" or "not recommended" websites (0 out of 86, whereas 8.6% (3 out of 35 failed from "highly not recommended" and unidentifiable websites. CONCLUSIONS: Of those drugs that could be assessed, all except Viagra(R passed spectrometry testing. Of those that failed, few could be identified either by a country of manufacture listed on the packaging, or by the physical location of the website pharmacy. If confirmed by future studies on other drug samples, then U.S. consumers should be able to reduce their risk by

  8. 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.

  9. 40 CFR 721.9220 - Reaction products of secondary alkyl amines with a substituted benzenesulfonic acid and sulfuric...

    Science.gov (United States)

    2010-07-01

    ... amines with a substituted benzenesulfonic acid and sulfuric acid (generic name). 721.9220 Section 721... Reaction products of secondary alkyl amines with a substituted benzenesulfonic acid and sulfuric acid... benzenesulfonic acid and sulfuric acid (PMNs P-89-703, P-89-755, and P-89-756) are subject to reporting under this...

  10. The effect of Paragraph IV decisions and generic entry before patent expiration on brand pharmaceutical firms.

    Science.gov (United States)

    Panattoni, Laura E

    2011-01-01

    This purpose of this paper is to investigate the impact of Paragraph IV patent infringement decisions on brand drug pharmaceutical firms. Paragraph IV decisions determine whether a generic firm can enter before the period of exclusivity ends. I construct a novel dataset of all Paragraph IV decisions and find that they disproportionately involve the highest revenue drugs, significant periods of patent protection, and a non-trivial portion of all brand drugs facing generic entry. I also estimate the impact of Paragraph IV decisions on brand firm profitability and find they have large value consequences. Copyright © 2010 Elsevier B.V. All rights reserved.

  11. 75 FR 47599 - Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Food and...

    Science.gov (United States)

    2010-08-06

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

  12. A Generic Solution? Pharmaceuticals and the Politics of the Similar in Mexico

    OpenAIRE

    Hayden, Corinne P.

    2007-01-01

    In 1997 and 1998 the Mexican government encouraged the introduction of generic drugs into Mexico, Latin America’s biggest and fastest-growing pharmaceutical market. In contrast to the situation in Brazil, where anti-retrovirals and HIV/AIDS treatment have been the centerpiece of a powerful state-led generics “revolution,” in Mexico the move to cheaper, copied medicines has made its strongest mark in the private sector. The rapidly growing pharmaceutical chain Farmacias Similares, whose populi...

  13. 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.

  14. 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)

  15. Generic Hurricane Extreme Seas State

    DEFF Research Database (Denmark)

    Wehmeyer, Christof; Skourup, Jesper; Frigaard, Peter

    2012-01-01

    . Especially in the initial phase of floating foundation concept development, site specific metocean data are usually not available. As the areas of interest are furthermore not covered by any design standard, in terms of design sea states, generic and in engineering terms applicable environmental background...... data is required for a type specific conceptual design. ULS conditions for different return periods are developed, which can subsequently be applied in siteindependent analysis and conceptual design. Recordings provided by National Oceanic and Atmospheric Administration (NOAA), of hurricanes along...

  16. Generic thin-shell gravastars

    Energy Technology Data Exchange (ETDEWEB)

    Martin-Moruno, Prado; Visser, Matt [School of Mathematics, Statistics, and Operations Research, Victoria University of Wellington, PO Box 600, Wellington 6140 (New Zealand); Garcia, Nadiezhda Montelongo [Departamento de Física, Centro de Investigación y Estudios avanzados del I.P.N., A.P. 14-700,07000 México, DF (Mexico); Lobo, Francisco S.N., E-mail: prado@msor.vuw.ac.nz, E-mail: nmontelongo@fis.cinvestav.mx, E-mail: flobo@cii.fc.ul.pt, E-mail: matt.visser@msor.vuw.ac.nz [Centro de Astronomia e Astrofísica da Universidade de Lisboa, Campo Grande, Edifício C8 1749-016 Lisboa (Portugal)

    2012-03-01

    We construct generic spherically symmetric thin-shell gravastars by using the cut-and-paste procedure. We take considerable effort to make the analysis as general and unified as practicable; investigating both the internal physics of the transition layer and its interaction with 'external forces' arising due to interactions between the transition layer and the bulk spacetime. Furthermore, we discuss both the dynamic and static situations. In particular, we consider 'bounded excursion' dynamical configurations, and probe the stability of static configurations. For gravastars there is always a particularly compelling configuration in which the surface energy density is zero, while surface tension is nonzero.

  17. Generic maximum likely scale selection

    DEFF Research Database (Denmark)

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

    2007-01-01

    in this work is on applying this selection principle under a Brownian image model. This image model provides a simple scale invariant prior for natural images and we provide illustrative examples of the behavior of our scale estimation on such images. In these illustrative examples, estimation is based......The fundamental problem of local scale selection is addressed by means of a novel principle, which is based on maximum likelihood estimation. The principle is generally applicable to a broad variety of image models and descriptors, and provides a generic scale estimation methodology. The focus...

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

    Science.gov (United States)

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

    1996-01-01

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

  19. Generic domain models in software engineering

    Science.gov (United States)

    Maiden, Neil

    1992-01-01

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

  20. 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.

  1. Availability of prescription drugs for bipolar disorder at online pharmacies.

    Science.gov (United States)

    Monteith, Scott; Glenn, Tasha; Bauer, Rita; Conell, Jörn; Bauer, Michael

    2016-03-15

    There is increasing use of online pharmacies to purchase prescription drugs. While some online pharmacies are legitimate and safe, there are many unsafe and illegal so-called "rogue" online pharmacies. This study investigated the availability of psychotropic drugs online to consumers in the US, using 5 commonly prescribed drugs for bipolar disorder. Using the search term "buy [drug name]" in the Google, Yahoo and Bing search engines, the characteristics of the online pharmacies found on the first two pages of search results were investigated. The availability of the requested dosage and formulations of two brand (Seroquel XR, Abilify) and three generic drugs (lamotrigine, lithium carbonate and bupropion SR) were determined. Of 30 online pharmacies found, 17 (57%) were rated as rogue by LegitScript. Of the 30 pharmacies, 15 (50%) require a prescription, 21 (70%) claim to be from Canada, with 20 of these having a Canadian International Pharmacy association (CIPA) seal on the website. Only 13 of the 20 sites with a CIPA seal were active CIPA members. There were about the same number of trust verification seals on the rogue and legitimate pharmacy sites. Some rogue pharmacies are professional in appearance, and may be difficult for consumers to recognize as rogue. All five brand and generic drugs were offered for sale online, with or without a prescription. However, many substitutions were presented such as different strengths and formulations including products not approved by the FDA. No evaluation of product quality, packaging or purchasing. Psychotropic medications are available online with or without a prescription. The majority of online pharmacy websites were rogue. Physicians should ask about the use of online pharmacies. For those who choose to use online pharmacies, two measures to detect rogue pharmacies are recommended: (1) only purchase drugs from pharmacies that require a prescription, and (2) check all pharmacy verification seals directly on the website

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

    Science.gov (United States)

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

    2011-08-05

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

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

    Science.gov (United States)

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

    2014-10-01

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

  4. 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.

  5. 40 CFR 721.981 - Substituted naphtholoazo-substituted naphthalenyl-substituted azonaphthol chromium complex.

    Science.gov (United States)

    2010-07-01

    ... naphthalenyl-substituted azonaphthol chromium complex. 721.981 Section 721.981 Protection of Environment...-substituted naphthalenyl-substituted azonaphthol chromium complex. (a) Chemical substance and significant new... naphtholoazo-substituted naphthalenyl-substituted azonaphthol chromium complex (PMN P-93-1631) is subject to...

  6. Assessment of Rational Prescribing of Antihypertensive Drug ...

    African Journals Online (AJOL)

    Results: The average number of drugs prescribed per encounter was 2.9. Encounters with injections were 0.5%. The percentage of drugs prescribed by generic name was 31.6%. All the drugs prescribed were from the National Essential Drugs List. Calcium antagonists were the most frequently used group of drugs (41.3%), ...

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

  8. 76 FR 57767 - Proposed Generic Communication; Draft NRC Generic Letter 2011-XX: Seismic Risk Evaluations for...

    Science.gov (United States)

    2011-09-16

    ... From the Federal Register Online via the Government Publishing Office NUCLEAR REGULATORY COMMISSION Proposed Generic Communication; Draft NRC Generic Letter 2011-XX: Seismic Risk Evaluations for... NRC Generic Letter 2011- XX: Seismic Risk Evaluations for Operating Reactors. This action is necessary...

  9. European healthcare policies for controlling drug expenditure.

    Science.gov (United States)

    Ess, Silvia M; Schneeweiss, Sebastian; Szucs, Thomas D

    2003-01-01

    In the last 20 years, expenditures on pharmaceuticals - as well as total health expenditures - have grown faster than the gross national product in all European countries. The aim of this paper was to review policies that European governments apply to reduce or at least slow down public expenditure on pharmaceutical products. Such policies can target the industry, the wholesalers and retailers, prescribers, and patients. The objectives of pharmaceutical policies are multidimensional and must take into account issues relating to public health, public expenditure and industrial incentives. Both price levels and consumption patterns determine the level of total drug expenditure in a particular country, and both factors vary greatly across countries. Licensing and pricing policies intend to influence the supply side. Three types of pricing policies can be recognised: product price control, reference pricing and profit control. Profit control is mainly used in the UK. Reference pricing systems were first used in Germany and The Netherlands and are being considered in other countries. Product price control is still the most common method for establishing the price of drugs. For the aim of fiscal consolidation, price-freeze and price-cut measures have been frequently used in the 1980s and 1990s. They have affected all types of schemes. For drug wholesalers and retailers, most governments have defined profit margins. The differences in price levels as well as the introduction of a Single European Pharmaceutical Market has led to the phenomenon of parallel imports among member countries of the European Union. This may be facilitated by larger and more powerful wholesalers and the vertical integration between wholesalers and retailers. To control costs, the use of generic drugs is encouraged in most countries, but only few countries allow pharmacists to substitute generic drugs for proprietary brands. Various interventions are used to reduce the patients' demand for drugs by

  10. Electricity/oil substitution

    International Nuclear Information System (INIS)

    Melvin, J.G.

    1980-09-01

    The extent to which electricity could substitute for imported oil in Canada is assessed and it is concluded that the bulk of projected oil imports could be displaced. This substitution of electricity for oil could be largely completed within two decades, with existing technology, using Canadian resources. The substitution of electricity for imported oil would result in relatively low energy costs and would stimulate economic growth. Energy self-sufficiency through the substitution of electricity for oil is uniquely a Canadian option; it is not open to other industrial countries. The option exists because of Canada's resources of oil sands for essential liquid fuels, hydraulic and nuclear electrical potential, and natural gas as an interim source of energy. While other countries face an energy crisis due to declining supplies of oil, Canada faces opportunities. The policies of Federal and Provincial governments, as perceived by individual decision makers, will have a major influence on Canada's ability to realize opportunities. (auth)

  11. The substitutability of reinforcers

    OpenAIRE

    Green, Leonard; Freed, Debra E.

    1993-01-01

    Substitutability is a construct borrowed from microeconomics that describes a continuum of possible interactions among the reinforcers in a given situation. Highly substitutable reinforcers, which occupy one end of the continuum, are readily traded for each other due to their functional similarity. Complementary reinforcers, at the other end of the continuum, tend to be consumed jointly in fairly rigid proportion, and therefore cannot be traded for one another except to achieve that proportio...

  12. Synthesis of substituted pyrazines

    Science.gov (United States)

    Pagoria, Philip F.; Zhang, Mao Xi

    2016-10-04

    A method for synthesizing a pyrazine-containing material according to one embodiment includes contacting an iminodiacetonitrile derivative with a base and a reagent selected from a group consisting of hydroxylamine, a hydroxylamine salt, an aliphatic primary amine, a secondary amine, an aryl-substituted alkylamine a heteroaryl-substituted alkyl amine, an alcohol, an alkanolamine and an aryl alcoholamine. Additional methods and several reaction products are presented. ##STR00001##

  13. Improving viable low cost generic medication prescription rate in primary care pediatric practice

    Science.gov (United States)

    Sudhanthar, Sathyanarayan; Turner, Jane; Thakur, Kripa; Sigal, Yakov

    2015-01-01

    The pediatric clinics of the Michigan State University College of Human Medicine (MSU-CHM) consist of academic pediatricians serving two clinics with a patient population of 5200. The internal quality measures published by the MSU health team had consistently indicated our generic medications prescription rate to be very low, with an average of about 21% for the years 2009, 2010, and 2011. There was an earnest need to increase our generic medication prescription rates, which is considered an indicator of good practice. The stakeholders identified were physicians, nurses, care managers, and the health information technology (HIT) team. The purpose of the project was to increase the prescribing rate of viable low cost and approved generic medications for the patients of the MSU-CHM general pediatric clinics. The stakeholders regularly met every few months to work on increasing the generic medication prescription rates based on the PDSA cycle. Help was sought from HIT to identify and acquire the top 10 brand names the group was prescribing along with individual provider data. The team reviewed the brand names most prescribed, and made a recommendation that the best group to target were the stimulant medications, allergy and asthma medications, and other psychotropics. The HIT team was then requested to add the available generics for all stimulant medications, asthma medications, and others in the electronic medical record (EMR). They were also clearly marked for ease of use, for example: amphetamine-dextroamphetamine extended release “generic for Adderall XR." It was decided that providers would prescribe all stimulants as a generic, unless not available, and nurses would change each brand name of stimulants to a generic every time they refilled a medicine, based on a protocol outlining the appropriate generic medications corresponding to the respective brand names. The physicians and nurses were also urged to discuss with the patients the substitution process and

  14. HTGR generic technology program plan (FY 80)

    Energy Technology Data Exchange (ETDEWEB)

    1980-01-01

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

  15. Generic selection criteria for safety and patient benefit [VII]: Comparing the physicochemical and pharmaceutical properties of brand-name and generic terbinafine hydrochloride cream.

    Science.gov (United States)

    Nozawa, Mitsuru; Goto, Miho; Wada, Yuko; Kumazawa, Miyuki; Shimokawa, Ken-Ichi; Ishii, Fumiyoshi

    2018-03-19

    We measured and compared the physicochemical properties (pH, yield value, and squeeze force) of a drug for dermatomycosis, terbinafine hydrochloride-containing cream (brand-name product), and 12 generic products to clarify the characteristics of each product. On pH measurement, the pH value of the brand-name product, Lamisil, was 4.8, and those of the generic products ranged from 4.3 to 5.5, showing no marked difference. Furthermore, the yield value of Lamisil, as an index of cream ductility, was 122.2 dyn/cm 2 , and those of the generic products ranged from 42.1 to 1,621.5 dyn/cm 2 . In particular, the value of a generic product, Taiyo (42.1 dyn/cm 2 ), was significantly lower, whereas that of another one, Viras (1,621.0 dyn/cm 2 ), was significantly higher. In addition, the squeeze force was measured by attaching a HapLog ® to the thumb and second finger. The value of Lamisil was 12.9 N, and those of the generic products ranged from 8.0 to 15.4 N. The values of generic products, Mylan (8.6 N), Tebinaceil (9.0 N), and Kelger (8.0 N), were significantly lower, whereas that of another one, Viras (15.4 N), was significantly higher. These results showed that there were marked differences in the pharmaceutical properties between the generic and brand-name products. The above pharmaceutical characteristics of drugs facilitated the presentation of reasons for differences in the sense of use, which characterizes external preparations, suggesting that products appropriate for individual patients can be recommended.

  16. Efficacy and motor complications of original and generic levodopa in Parkinson's disease treatment

    Directory of Open Access Journals (Sweden)

    Kasemsap N

    2016-05-01

    Full Text Available Narongrit Kasemsap,1 Satrirat Onsanit,2 Piyawan Chiewthanakul,3 Kannikar Kongbunkiat,1 Chonthicha Tanking,1 Nisa Vorasoot,1 Kittisak Sawanyawisuth,1,4 Somsak Tiamkao1,5 1Department of Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, 2Department of Medicine, Udonthani Hospital, Udonthani, 3Department of Medicine, Khon Kaen Hospital, 4Research Center in Back, Neck, Other Joint Pain and Human Performance (BNOJPH, 5Neuroscience Research and Development Group (NRDG, Khon Kaen University, Khon Kaen, Thailand Background: In general, a generic drug is considered interchangeable with the original formulated drug. In Parkinson’s disease (PD, generic drug use remains debated. This study was aimed to investigate whether the generic drug was as effective as the original in improving the symptoms of PD and the prevalence of motor complications.Methods: This study was a multicenter cohort study of patients with PD enrolled from three northeast hospitals in Thailand between February 2013 and February 2014. The patients were categorized into original and generic levodopa groups. The clinical characteristics, efficacy, and motor complications were compared between the groups.Results: There were 400 eligible patients. Of these, 327 patients (81.75% met the study criteria and were classified as the original levodopa group (200 patients, 61.16% and the generic levodopa group (127 patients, 38.84%. The average age of all patients with PD was 65 years. The duration of PD and the modified Hoehn–Yahr stages were not different between the groups. The total doses of original and generic levodopa-equivalent doses were significantly different (199.97±127.08 versus 305.58±138.27 mg; P-value <0.001 and the actual doses were 198.10±117.92 versus 308.85±139.40 mg (P-value <0.001. Approximately 80% of patients with PD in both groups had good responses (P-value >0.999, but the development of motor complications was significantly greater in the original

  17. Use of Generics-A Critical Cost Containment Measure for All Healthcare Professionals in Europe?

    Science.gov (United States)

    Godman, Brian; Shrank, William; Wettermark, Bjorn; Andersen, Morten; Bishop, Iain; Burkhardt, Thomas; Garuolienè, Kristina; Kalaba, Marija; Laius, Ott; Joppi, Roberta; Sermet, Catherine; Schwabe, Ulrich; Teixeira, Inês; Tulunay, F Cankat; Wendykowska, Kamila; Zara, Corinne; Gustafsson, Lars L

    2010-08-05

    Pharmaceutical expenditures in ambulatory care rose rapidly in Europe in the 1990s and early 2000s. This was typically faster than other components of healthcare spending, leading to reforms to moderate future growth. A number of these centered on generic medicines with measures to lower reimbursed prices as well as enhance their prescribing and dispensing. The principal objective of this paper is to review additional measures that some European countries can adopt to further reduce reimbursed prices for generics. Secondly, potential approaches to address concerns with generics when they arise to maximize savings. Measures to enhance the prescribing of generics will also briefly be discussed. A narrative review of the extensive number of publications and associated references from the co-authors was conducted supplemented with known internal or web-based articles. In addition, health authority and health insurance databases, principally from 2001 to 2007, were analyzed to assess the impact of the various measures on price reductions for generic omeprazole and generic simvastatin vs. pre-patent loss prices, as well as overall efficiency in Proton Pump Inhibitor (PPI) and statin prescribing. The various initiatives generally resulted in considerable lowering of the prices of generics as well as specifically for generic omeprazole and generic simvastatin vs. pre-patent loss prices. At one stage in the UK, generic simvastatin was just 2% of the originator price. These measures also led to increased efficiency for PPI and statin prescribing with reimbursed expenditure for the PPIs and statins either falling or increasing at appreciably lower rates than increases in utilization. A number of strategies have also been introduced to address patient and physician concerns with generics to maximize savings. In conclusion, whilst recent reforms have been successful, European countries must continue learning from each other to fund increased volumes and new innovative drugs as

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

    Science.gov (United States)

    Walker, A D; Adachi, J D

    2011-09-01

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

  19. COMPARATIVE PHARMACOKINETICS AND EFFECT ON THE HEMODYNAMICS OF ORIGINAL AND GENERIC NEBIVOLOL IN HEALTHY VOLUNTEERS

    Directory of Open Access Journals (Sweden)

    E. I. Bambysheva

    2016-01-01

    Full Text Available Beta-blockers are an important part of modern pharmacotherapy in cardiology. The introduction of generics into clinical practice requires clear evidence of bioequivalence to the original drug.Aim. To study the pharmacokinetics and effect on hemodynamic parameters of the original and a generic nebivolol in healthy volunteers in the fasting state. Material and methods. 18 healthy volunteers were included into the randomized open study on cross-balanced design. They received single dose (5 mg of two compared preparations of nebivolol under fasting condition. The concentration of unchanged nebivolol in blood plasma was determined by gas chromatography-tandem mass spectrometry. Calculation of pharmacokinetic parameters and assessment of the hemodynamic were performed.Results. The concentrations of nebivolol after the original and generic drugs intake did not differ significantly in any time point (AUC0-∞ 41.09±46.82 vs 47.16±66.58 ng•hr/mL and T1/2 30.84±10.78 vs 29.59±12.08 hours, respectively. Blood pressure reduction was slightly more pronounced when taking generic nebivolol, while the reduction in heart rate at 2 and 4 hours – after original nebivolol intake.Conclusion. A comparative pharmacokinetic study of the genetic nebivolol showed its bioequivalence to the original drug. The effect on hemodynamic parameters with single dose (5 mg of generic and original nebivolol in healthy volunteers was comparable.

  20. Generic adversary characteristics: summary report

    International Nuclear Information System (INIS)

    Stewart, J.B. Jr.; Davidson, J.J.; Jones, H.B.; Fulwiler, C.H.; Mullen, S.A.

    1978-07-01

    The adversaries studied were found to be complex, often unpredictable, and dynamic. The adversary typically goes through a complex decision-making process between the time a potential target is identified and the moment the decision to act is made. This study analyzes the adversary characteristics, and the following conclusions are made: one of the least likely methods of attack is an overt armed assault. Terrorists and psychotics depend upon a high degree of personal dedication. No single generic adversary group or individual exhibits strength in every characteristic. Physical danger appears to have some deterrent effect on all adversaries except the psychotics. Organized and professional criminals often try to recruit insiders. Disoriented persons, white-collar criminals, and disgruntled employees tend to operate as insiders. Professional criminals, many terrorist groups, some extremist protest groups, and certain disoriented persons plan carefully before initiating a criminal mission. Organized crime and miscellaneous criminal adversaries rely on deception and ruse to bypass security. After the decision to commit a crime, the resources deployed by terrorists or organized criminals will be a function of their perception of the operational requirements of the crime. The nature of ''threat'' is dynamic; adversary behavior and capability appear to be related to prevailing political, economic, and social conditions

  1. Generic Local Hamiltonians are Gapless

    Science.gov (United States)

    Movassagh, Ramis

    2017-12-01

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

  2. Generic physical protection logic trees

    Energy Technology Data Exchange (ETDEWEB)

    Paulus, W.K.

    1981-10-01

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

  3. Generic physical protection logic trees

    International Nuclear Information System (INIS)

    Paulus, W.K.

    1981-10-01

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

  4. Can authorities appreciably enhance the prescribing of oral generic risperidone to conserve resources? Findings from across Europe and their implications

    Science.gov (United States)

    2014-01-01

    Background Generic atypical antipsychotic drugs offer health authorities opportunities for considerable savings. However, schizophrenia and bipolar disorders are complex diseases that require tailored treatments. Consequently, generally there have been limited demand-side measures by health authorities to encourage the preferential prescribing of generics. This is unlike the situation with hypertension, hypercholaesterolaemia or acid-related stomach disorders. The objectives of this study were to compare the effect of the limited demand-side measures in Western European countries and regions on the subsequent prescribing of risperidone following generics; to utilise the findings to provide future guidance to health authorities; and where possible, to investigate the utilisation of generic versus originator risperidone and the prices for generic risperidone. Methods Principally, this was a segmented regression analysis of retrospective time-series data of the effect of the various initiatives in Belgium, Ireland, Scotland and Sweden following the introduction of generic risperidone. The study included patients prescribed at least one atypical antipsychotic drug up to 20 months before and up to 20 months after generic risperidone. In addition, retrospective observational studies were carried out in Austria and Spain (Catalonia) from 2005 to 2011 as well as one English primary care organisation (Bury Primary Care Trust (PCT)). Results There was a consistent steady reduction in risperidone as a percentage of total selected atypical antipsychotic utilisation following generics. A similar pattern was seen in Austria and Spain, with stable utilisation in one English PCT. However, there was considerable variation in the utilisation of generic risperidone, ranging from 98% of total risperidone in Scotland to only 14% in Ireland. Similarly, the price of generic risperidone varied considerably. In Scotland, generic risperidone was only 16% of pre-patent loss prices versus 72

  5. Can authorities appreciably enhance the prescribing of oral generic risperidone to conserve resources? Findings from across Europe and their implications.

    Science.gov (United States)

    Godman, Brian; Petzold, Max; Bennett, Kathleen; Bennie, Marion; Bucsics, Anna; Finlayson, Alexander E; Martin, Andrew; Persson, Marie; Piessnegger, Jutta; Raschi, Emanuel; Simoens, Steven; Zara, Corinne; Barbui, Corrado

    2014-06-13

    Generic atypical antipsychotic drugs offer health authorities opportunities for considerable savings. However, schizophrenia and bipolar disorders are complex diseases that require tailored treatments. Consequently, generally there have been limited demand-side measures by health authorities to encourage the preferential prescribing of generics. This is unlike the situation with hypertension, hypercholaesterolaemia or acid-related stomach disorders.The objectives of this study were to compare the effect of the limited demand-side measures in Western European countries and regions on the subsequent prescribing of risperidone following generics; to utilise the findings to provide future guidance to health authorities; and where possible, to investigate the utilisation of generic versus originator risperidone and the prices for generic risperidone. Principally, this was a segmented regression analysis of retrospective time-series data of the effect of the various initiatives in Belgium, Ireland, Scotland and Sweden following the introduction of generic risperidone. The study included patients prescribed at least one atypical antipsychotic drug up to 20 months before and up to 20 months after generic risperidone. In addition, retrospective observational studies were carried out in Austria and Spain (Catalonia) from 2005 to 2011 as well as one English primary care organisation (Bury Primary Care Trust (PCT)). There was a consistent steady reduction in risperidone as a percentage of total selected atypical antipsychotic utilisation following generics. A similar pattern was seen in Austria and Spain, with stable utilisation in one English PCT. However, there was considerable variation in the utilisation of generic risperidone, ranging from 98% of total risperidone in Scotland to only 14% in Ireland. Similarly, the price of generic risperidone varied considerably. In Scotland, generic risperidone was only 16% of pre-patent loss prices versus 72% in Ireland. Consistent

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

    Science.gov (United States)

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

    2010-05-01

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

  7. Bone substitute biomaterials

    CERN Document Server

    Mallick, K

    2014-01-01

    Bone substitute biomaterials are fundamental to the biomedical sector, and have recently benefitted from extensive research and technological advances aimed at minimizing failure rates and reducing the need for further surgery. This book reviews these developments, with a particular focus on the desirable properties for bone substitute materials and their potential to encourage bone repair and regeneration. Part I covers the principles of bone substitute biomaterials for medical applications. One chapter reviews the quantification of bone mechanics at the whole-bone, micro-scale, and non-scale levels, while others discuss biomineralization, osteoductivization, materials to fill bone defects, and bioresorbable materials. Part II focuses on biomaterials as scaffolds and implants, including multi-functional scaffolds, bioceramics, and titanium-based foams. Finally, Part III reviews further materials with the potential to encourage bone repair and regeneration, including cartilage grafts, chitosan, inorganic poly...

  8. Drug allergy

    Directory of Open Access Journals (Sweden)

    Warrington Richard

    2011-11-01

    Full Text Available Abstract Drug allergy encompasses a spectrum of immunologically-mediated hypersensitivity reactions with varying mechanisms and clinical presentations. This type of adverse drug reaction (ADR not only affects patient quality of life, but may also lead to delayed treatment, unnecessary investigations, and even mortality. Given the myriad of symptoms associated with the condition, diagnosis is often challenging. Therefore, referral to an allergist experienced in the identification, diagnosis and management of drug allergy is recommended if a drug-induced allergic reaction is suspected. Diagnosis relies on a careful history and physical examination. In some instances, skin testing, graded challenges and induction of drug tolerance procedures may be required. The most effective strategy for the management of drug allergy is avoidance or discontinuation of the offending drug. When available, alternative medications with unrelated chemical structures should be substituted. Cross-reactivity among drugs should be taken into consideration when choosing alternative agents. Additional therapy for drug hypersensitivity reactions is largely supportive and may include topical corticosteroids, oral antihistamines and, in severe cases, systemic corticosteroids. In the event of anaphylaxis, the treatment of choice is injectable epinephrine. If a particular drug to which the patient is allergic is indicated and there is no suitable alternative, induction of drug tolerance procedures may be considered to induce temporary tolerance to the drug. This article provides a backgrounder on drug allergy and strategies for the diagnosis and management of some of the most common drug-induced allergic reactions, such allergies to penicillin, sulfonamides, cephalosporins, radiocontrast media, local anesthetics, general anesthetics, acetylsalicylic acid (ASA and non-steroidal anti-inflammatory drugs.

  9. Muon substituted free radicals

    International Nuclear Information System (INIS)

    Burkhard, P.; Fischer, H.; Roduner, E.; Strub, W.; Gygax, F.N.; Brinkman, G.A.; Louwrier, P.W.F.; McKenna, D.; Ramos, M.; Webster, B.C.

    1984-01-01

    Spin polarized energetic positive muons are injected as magnetic probes into unsaturated organic liquids. They are implemented via fast chemical processes ( -10 s) in various molecules. Of particular interest among these are muonium substituted free radicals. The technique allows determination of accurate rate coefficients for fast chemical reactions of radicals. Furthermore, radiochemical processes occuring in picoseconds after injection of the muon are studied. Of fundamental interest are also the structural and dynamical implications of substituting a proton by a muon, or in other terms, a hydrogen atom by a muonium atom. Selected examples for each of these three types of experiments are given. (Auth.)

  10. State Medicaid programs missed $220 million in uncaptured savings as generic fluoxetine came to market, 2001-05.

    Science.gov (United States)

    Kelton, Christina M L; Chang, Lenisa V; Kreling, David H

    2013-07-01

    Patent expiration of brand-name pharmaceuticals creates opportunities for large savings for state Medicaid programs because generic versions of medications frequently represent a lower-cost alternative. State Medicaid programs that quickly recognize the availability of generics and adjust their drug payments in response to falling market prices can obtain the greatest benefit. We examined one such case: the movement to generic fluoxetine following patent expiration for Prozac, a widely prescribed antidepressant and an expensive drug for Medicaid. We found large differences in states' responses to generic availability. States took between two and ten calendar quarters to reach 90 percent use of generic rather than brand-name fluoxetine and four to eight quarters to achieve a 50 percent decrease in reimbursement per pill. We estimated that states failed to realize $220 million in uncaptured savings during 2001-05. By coordinating their efforts, perhaps with federal help, states could gain access in a more timely way to market prices for generic drugs and, hence, take greater advantage of the savings that those drugs offer.

  11. Molecularly Imprinted Polymer Technology: A Powerful, Generic ...

    African Journals Online (AJOL)

    Molecularly Imprinted Polymer Technology: A Powerful, Generic, Facile and Cost Effective Alternative for Enantio-recognition and Separation: A Glance at Advances and Applications. JYN Philip, DMS Mosha ...

  12. Substitution treatment for opioid addicts in Germany

    Directory of Open Access Journals (Sweden)

    Gerlach Ralf

    2007-02-01

    Full Text Available Abstract Background After a long and controversial debate methadone maintenance treatment (MMT was first introduced in Germany in 1987. The number of patients in MMT – first low because of strict admission criteria – increased considerably since the 1990s up to some 65,000 at the end of 2006. In Germany each general practitioner (GP, who has completed an additional training in addiction medicine, is allowed to prescribe substitution drugs to opioid dependent patients. Currently 2,700 GPs prescribe substitution drugs. Psychosocial care should be made available to all MMT patients. Results The results of research studies and practical experiences clearly indicate that patients benefit substantially from MMT with improvements in physical and psychological health. MMT proves successful in attaining high retention rates (65 % to 85 % in the first years, up to 50 % after more than seven years and plays a major role in accessing and maintaining ongoing medical treatment for HIV and hepatitis. MMT is also seen as a vital factor in the process of social re-integration and it contributes to the reduction of drug related harms such as mortality and morbidity and to the prevention of infectious diseases. Some 10 % of MMT patients become drug-free in the long run. Methadone is the most commonly prescribed substitution medication in Germany, although buprenorphine is attaining rising importance. Access to MMT in rural areas is very patchy and still constitutes a problem. There are only few employment opportunities for patients participating in MMT, although regular employment is considered unanimously as a positive factor of treatment success. Substitution treatment in German prisons is heterogeneous in access and treatment modalities. Access is very patchy and the number of inmates in treatment is limited. Nevertheless, substitution treatment plays a substantial part in the health care system provided to drug users in Germany. Conclusion In Germany, a

  13. Generic Dynamic Scaling in Kinetic Roughening

    OpenAIRE

    Ramasco, JJ; Lopez, JM; Rodriguez, MA

    2000-01-01

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

  14. Progressive compression of generic surface meshes

    OpenAIRE

    Caillaud , Florian; Vidal , Vincent; Dupont , Florent; Lavoué , Guillaume

    2015-01-01

    International audience; This paper presents a progressive compression method for generic surface meshes (non-manifold and/or polygonal). Two major contributions are proposed : (1) generic edge collapse and vertex split operators allowing surface simplication and renement of a mesh, whatever its connectivity; (2) a distortion-aware collapse clustering strategy that adapts the decima-tion granularity in order to optimize the rate-distortion tradeoff.

  15. [Artificial bone substitutes].

    Science.gov (United States)

    Koníček, Petr

    Bone tissue substitutes are divided into basic classification with its pros and cons described. Arteficial bone grafts are especially pointed out in article, publishing our own experience with two specific synthetic preps. Finally there is a blink in the near future of bone tissue augmentation.

  16. 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

    (GP) has explicitly stated that it should not be done, or the patient insists on having the more expensive drug. Generic prescribing, that is prescribing the substance name, is not allowed in Denmark. Some specialists and patients cast doubt on the real interchangeability of generics, although...

  17. Generic Tobacco Use among Four Ethnic Groups in a School Age Population.

    Science.gov (United States)

    De Moor, Carl; And Others

    1989-01-01

    Compared generic tobacco use among Hispanic, White, Black, and Asian youths (N=4,980) in grades 4, 7, 10, and 12. Found prevalence of regular use was highest among Whites, followed by Hispanics, Blacks, and Asians. Marijuana, alcohol, and other drug use explained approximately 40 percent of variance in tobacco use in each ethnic group. Other…

  18. Authorized Generic Entry prior to Patent Expiry: Reassessing Incentives for Independent Generic Entry

    OpenAIRE

    Appelt, Silvia

    2010-01-01

    Patent holders frequently attempt to mitigate the loss of monopoly power by authorizing generic entry prior to patent expiry (early entry). Competition in off-patent pharmaceutical markets may be adversely affected if early entry substantially impairs the attractiveness of subsequent market entry. I examine generic entry decisions made in the course of recent patent expiries to quantify the impact of early entry on incentives for generic entry. Using unique micro data and accounting for th...

  19. The physical properties of generic latanoprost ophthalmic solutions are not identical.

    Science.gov (United States)

    Kolko, Miriam; Koch Jensen, Peter

    2017-06-01

    To compare various characteristics of Xalatan ® and five generic latanoprost ophthalmic solutions. Drop size, volume, pH values, buffer capacity, viscosity, hardness of bottles and costs were determined. Drop sizes were measured in triplicates by micropipettes, and the number of drops counted in three separate bottles of each generic product was determined. pH values were measured in triplicates by a calibrated pH meter. Buffer capacity was exploited by titrating known quantities of strong base into 2.5 ml of each brand and interpolated to neutral pH. Kinematic viscosity was determined by linear regression of timed gravity flow from a vertical syringe through a 21-G cannula. The hardness of the bottles was evaluated by gradually increasing tension on a hook placed around each bottle until a drop was expelled reading the tension on an attached spring scale. Drop sizes and the number of drops in the bottles varied significantly between the generic drugs. The control value of pH in the brand version (Xalatan ® ) was markedly lower compared to the generic latanoprost products. Titration of Xalatan ® to neutrality required substantially more NaOH compared to the generic latanoprost products. Finally, the viscosity revealed a significant variability between brands. Remarkable differences were found in bottle shapes, bottle hardness and costs of the latanoprost generics. Generic latanoprost eye drops should not be considered identical to the original brand version as regards to drop size, volumes, pH values, buffer capacity, viscosity, hardness of bottles and costs. It is likely that these issues affect compliance and intraocular pressure (IOP)-lowering effect. Therefore, re-evaluation of the requirements for introducing generic eye drops seems reasonable. © 2017 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

  20. MEANINGS ATTRIBUTED TO GENERIC DRUGS BY THE ELDERLY

    Directory of Open Access Journals (Sweden)

    Sabrina Brena de Nóbrega

    2012-04-01

    Full Text Available Objetivo: Conhecer as representações sociais sobre os medicamentos genéricos utilizados pelos idosos de idosos atendidos em Unidades de Saúde da Família. Método: Trata-se de uma pesquisa de campo de natureza exploratória, utilizando a Teoria das Representações Sociais (TRS como suporte teórico-metodológico, compreedendo 250 idosos de ambos os sexos. Para análise dos dados apreendidos através da entrevista, utilizou-se o software Alceste (2010. Resultados: A presente pesquisa desvelou um perfil da população idosa da cidade de João Pessoa/Paraíba/Brasil que apresenta um percentual significativo de mulheres, com rendimento de um salário mínimo. De modo geral, as representações sociais dos medicamentos genéricos, produzidas por esses idosos tiveram uma conotação dúbia. Conclusão: Entendemos que o senso comum do conjunto social aqui estudado possui uma percepção positiva no âmbito econômico e negativa no horizonte político, não podendo afirmar se as representações interferem na não adesão dos medicamentos genéricos. 

  1. Projecting future drug expenditures--2012.

    Science.gov (United States)

    Hoffman, James M; Li, Edward; Doloresco, Fred; Matusiak, Linda; Hunkler, Robert J; Shah, Nilay D; Vermeulen, Lee C; Schumock, Glen T

    2012-03-01

    Factors likely to influence drug expenditures, drug expenditure trends in 2010 and 2011, and projected drug expenditures for 2012 are discussed. Data were analyzed to provide drug expenditure trends for total drug expenditures and the hospital and clinic sectors. Data were obtained from the IMS Health National Sales Perspectives database. From 2009 to 2010, total U.S. drug expenditures increased by 2.7%, with total spending rising from $299.2 billion to $307.5 billion. Drug expenditures in clinics grew by 6.0% from 2009 to 2010. Hospital drug expenditures increased at the moderate rate of 1.5% from 2009 to 2010; through the first nine months of 2011, hospital drug expenditures increased by only 0.3% compared with the same period in 2010. The dominant trend over the past several years is substantial moderation in expenditure growth for widely used drugs, primarily due to the ongoing introduction and wide use of generic versions of high-cost, frequently used medications. At the end of 2010, generic drugs accounted for 78% of all retail prescriptions dispensed. Another pattern is substantial increases in expenditures for specialized medications, particularly in the outpatient setting as growth in prescription drug expenditures for clinic-administered drugs consistently outpaces growth in total expenditures. Various factors are likely to influence drug expenditures in 2012, including drugs in development, the diffusion of new drugs, generic drugs, drug shortages, and biosimilars. For 2012, we project a 3-5% increase in total drug expenditures across all settings, a 5-7% increase in expenditures for clinic-administered drugs, and a 0-2% increase in hospital drug expenditures.

  2. [Currently available skin substitutes].

    Science.gov (United States)

    Oravcová, Darina; Koller, Ján

    2014-01-01

    The current trend of burn wound care has shifted to more holistic approach of improvement in the long-term form and function of the healed burn wounds and quality of life. Autologous split or full-thickness skin graft are the best definitive burn wound coverage, but it is constrained by the limited available sources, especially in major burns. Donor site morbidities in term of additional wounds and scarring are also of concern of the autograft application. This has demanded the emergence of various skin substitutes in the management of acute burn injury as well as post burn reconstructions. This paper reviews currently available skin substitutes, produced in not for-profit skin banks as well as commercially available. They are divided according to type of material included, as biological, biosynthetic and synthetic and named respectively.

  3. Essential to increase the use of generics in Europe to maintain comprehensive health care?

    Directory of Open Access Journals (Sweden)

    Brian Godman

    2012-12-01

    Full Text Available INTRODUCTION: Reforms have been introduced across Europe to increase prescribing efficiency with existing drugs. These include measures to lower prices of generics as well as increase their prescribing versus originators and patented products in a class or related class. This is essential to maintain comprehensive health care in Europe given continued pressures. The alternative is insufficient funds for new innovative drugs and increasing drug volumes with ageing populations. OBJECTIVE: To review the influence of measures and initiatives to increase the prescribing and dispensing of generics at low prices on ambulatory care prescribing efficiency. In view of this, provide guidance as authorities strive to introduce further reforms to meet their goals. METHODOLOGY: A narrative review of published papers combined with case histories. RESULTS: The different supply- and demand-side measures have reduced generic prices to as low as 2% to 3% of pre-patent loss prices in some cases as well as appreciably enhanced their utilisation. As a result, prescribing efficiency has increased without compromising care. In some cases, the reforms have led to expenditure actually falling despite appreciably increased volumes. CONCLUSIONS: Increasing use of generics at low prices will help maintain the European ideals of comprehensive and equitable health care. However, countries will continually need to learn from each other.

  4. Republicans Resolve to Address High Drug Prices: Rhetoric Meets Reality With PPACA Replacement.

    Science.gov (United States)

    Barlas, Stephen

    2017-04-01

    As legislation is drafted to replace Obamacare, pharmaceutical issues-including controlling drug prices, expanding or contracting drug access, and incentivizing the development of generic drugs-are expected to be at the forefront of debate.

  5. Approved Animal Drug Products (Green Book)

    Data.gov (United States)

    U.S. Department of Health & Human Services — On November 16, 1988, the President of the United States signed into law the Generic Animal Drug and Patent Restoration Act (GADPTRA). Among its major provisions,...

  6. The microculture-kinetic (MiCK) assay: the role of a drug-induced apoptosis assay in drug development and clinical care.

    Science.gov (United States)

    Bosserman, Linda; Prendergast, Franklyn; Herbst, Roy; Fleisher, Martin; Salom, Emery; Strickland, Steven; Raptis, Anastasios; Hallquist, Allan; Perree, Mathieu; Rajurkar, Swapnil; Karimi, Misagh; Rogers, Karl; Davidson, Dirk; Willis, Carl; Penalver, Manuel; Homesley, Howard; Burrell, Matthew; Garrett, Audrey; Rutledge, James; Chernick, Michael; Presant, Cary A

    2012-08-15

    A drug-induced apoptosis assay, termed the microculture-kinetic (MiCK) assay, has been developed. Blinded clinical trials have shown higher response rates and longer survival in groups of patients with acute myelocytic leukemia and epithelial ovarian cancer who have been treated with drugs that show high apoptosis in the MiCK assay. Unblinded clinical trials in multiple tumor types have shown that the assay will be used frequently by clinicians to determine treatment, and when used, results in higher response rates, longer times to relapse, and longer survivals. Model economic analyses suggest possible cost savings in clinical use based on increased generic drug use and single-agent substitution for combination therapies. Two initial studies with drugs in development are promising. The assay may help reduce costs and speed time to drug approval. Correlative studies with molecular biomarkers are planned. This assay may have a role both in personalized clinical therapy and in more efficient drug development. ©2012 AACR.

  7. Generic magnetic fusion reactor cost assessment

    International Nuclear Information System (INIS)

    Sheffield, J.

    1985-01-01

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

  8. The SENSEI Generic In Situ Interface

    Energy Technology Data Exchange (ETDEWEB)

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

    2017-04-11

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

  9. Do national drug policies influence antiretroviral drug prices? Evidence from the Southern African Development community.

    Science.gov (United States)

    Liu, Yao; Galárraga, Omar

    2017-03-01

    The efficacy of low- and middle-income countries’ (LMIC) national drug policies in managing antiretroviral (ARV) pharmaceutical prices is not well understood. Though ARV drug prices have been declining in LMIC over the past decade, little research has been done on the role of their national drug policies. This study aims to (i) analyse global ARV prices from 2004 to 2013 and (ii) examine the relationship of national drug policies to ARV prices. Analysis of ARV drug prices utilized data from the Global Price Reporting Mechanism from the World Health Organization (WHO). Ten of the most common ARV drugs (first-line and second-line) were selected. National drug policies were also assessed for 12 countries in the South African Development Community (SADC), which self-reported their policies through WHO surveys. The best predictor of ARV drug price was generic status—the generic versions of 8 out of 10 ARV drugs were priced lower than branded versions. However, other factors such as transaction volume, HIV prevalence, national drug policies and PEPFAR/CHAI involvement were either not associated with ARV drug price or were not consistent predictors of price across different ARV drugs. In the context of emerging international trade agreements, which aim to strengthen patent protections internationally and potentially delay the sale of generic drugs in LMIC, this study shines a spotlight on the importance of generic drugs in controlling ARV prices. Further research is needed to understand the impact of national drug policies on ARV prices.

  10. Drugs Approved for Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

    Science.gov (United States)

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

  11. 40 CFR 721.530 - Substituted aliphatic acid halide (generic name).

    Science.gov (United States)

    2010-07-01

    ... hydrolysis product is less than 10 ppm prior to discharge or purifying the waste stream so that the first hydrolysis product is less than 10 ppm. Those purified waste streams may be reused or sold. All of the... consumer activities. Requirements as specified in § 721.80(k). (iv) Disposal. Requirements as specified in...

  12. Different initiatives across Europe to enhance losartan utilization post generics: impact and implications

    Science.gov (United States)

    Moon, James C.; Godman, Brian; Petzold, Max; Alvarez-Madrazo, Samantha; Bennett, Kathleen; Bishop, Iain; Bucsics, Anna; Hesse, Ulrik; Martin, Andrew; Simoens, Steven; Zara, Corinne; Malmström, Rickard E.

    2014-01-01

    Introduction: There is an urgent need for health authorities across Europe to fully realize potential savings from increased use of generics to sustain their healthcare systems. A variety of strategies were used across Europe following the availability of generic losartan, the first angiotensin receptor blocker (ARB) to be approved and marketed, to enhance its prescribing vs. single-sourced drugs in the class. Demand-side strategies ranged from 100% co-payment for single-sourced ARBs in Denmark to no specific measures. We hypothesized this heterogeneity of approaches would provide opportunities to explore prescribing in a class following patent expiry. Objective: Contrast the impact of the different approaches among European countries and regions to the availability of generic losartan to provide future guidance. Methodology: Retrospective segmented regression analyses applying linear random coefficient models with country specific intercepts and slopes were used to assess the impact of the various initiatives across Europe following the availability of generic losartan. Utilization measured in defined daily doses (DDDs). Price reductions for generic losartan were also measured. Results: Utilization of losartan was over 90% of all ARBs in Denmark by the study end. Multiple measures in Sweden and one English primary care group also appreciably enhanced losartan utilization. Losartan utilization actually fell in some countries with no specific demand-side measures. Considerable differences were seen in the prices of generic losartan. Conclusion: Delisting single-sourced ARBs produced the greatest increase in losartan utilization. Overall, multiple demand-side measures are needed to change physician prescribing habits to fully realize savings from generics. There is no apparent “spill over” effect from one class to another to influence future prescribing patterns even if these are closely related. PMID:25339902

  13. Safety of switching from brand-name to generic levetiracetam in patients with epilepsy

    Directory of Open Access Journals (Sweden)

    Bosak M

    2017-08-01

    Full Text Available Magdalena Bosak, Agnieszka Słowik, Wojciech Turaj Department of Neurology, Jagiellonian University Medical College, Kraków, Poland Purpose: The approach to the use of generic antiepileptic drugs has recently evolved from major concern to general acceptance, but the evidence related specifically to the safety of switching from brand-name to generic levetiracetam (LEV is scarce. The aim of the study was to assess the risk of increased frequency of seizures or other adverse events after replacement of a brand-name LEV with a generic one.Patients and methods: This retrospective analysis included 159 patients treated with LEV in a tertiary outpatient epilepsy clinic. We included all patients diagnosed with epilepsy who were treated with LEV as at March 1, 2013. Most patients were forced to switch to the generic LEV because of the sudden rise in cost of the branded LEV. We recorded data on age, sex, age at onset of epilepsy, type of epilepsy, and its treatment. We analyzed data from one visit before potential switching and from two visits after the potential switching. The interval between visits was typically 3 months. We registered an increase in the frequency of seizures and in the occurrence of adverse events.Results: Among 151 subjects who switched to generic LEV after March 1, 2013, increased frequency of seizures was noted in 9 patients (6% during the first follow-up visit. Patients with increased frequency of seizures did not differ from other patients regarding sex, age, age at the onset of epilepsy, and the median dose of LEV before switching or the median duration of treatment with LEV before switching. Two patients returned to brand-name LEV. Adverse events were noted in six other patients (4% and included somnolence, irritability, or dizziness.Conclusion: Switching from brand-name to generic LEV is generally safe. Keywords: levetiracetam, generic, branded, epilepsy, switching, adverse event 

  14. Efficiency of Original versus Generic Intravenous Iron Formulations in Patients on Haemodialysis

    Science.gov (United States)

    Alvarez-Lara, Maria Antonia; Garcia-Montemayor, Victoria Eugenia; Canton, Petra; Soriano, Sagrario; Aljama, Pedro

    2015-01-01

    Aims The appropriate use of intravenous (IV) iron is essential to minimise the requirements for erythropoiesis-stimulating agents (ESAs). The clinical efficacy of generic IV iron compared to the original formulation is controversial. We evaluated the changes that were induced after switching from a generic IV iron to an original formulation in a stable, prevalent haemodialysis (HD) population. Methods A total of 342 patients were included, and the follow-up period was 56 weeks for each formulation. Anaemia parameters and doses of ESA and IV iron were prospectively recorded before and after the switch from generic to original IV iron. Results To maintain the same haemoglobin (Hb) levels after switching from the generic to the original formulation, the requirements for IV iron doses were reduced by 34.3% (from 52.8±33.9 to 34.7±31.8mg/week, p<0.001), and the ESA doses were also decreased by 12.5% (from 30.6±23.6 to 27±21μg/week, p<0.001). The erythropoietin resistance index declined from 8.4±7.7 to 7.4±6.7 IU/kg/week/g/dl after the switch from the generic to the original drug (p = 0.001). After the switch, the transferrin saturation ratio (TSAT) and serum ferritin levels rose by 6.8%(p<0.001) and 12.4%(p = 0.001), respectively. The mortality rate was similar for both periods. Conclusions The iron and ESA requirements are lower with the original IV iron compared to the generic drug. In addition, the uses of the original formulation results in higher ferritin and TSAT levels despite the lower dose of IV iron. Further studies are necessary to analyse the adverse effects of higher IV iron dosages. PMID:26322790

  15. Definición de medicamento genérico: ¿un fin o un medio? Análisis de la regulación en 14 países de la Región de las Américas Defining generic drugs: an end or a means? Analysis of regulations in 14 countries in the Region of the Americas

    Directory of Open Access Journals (Sweden)

    Claudia Patricia Vacca González

    2006-11-01

    éuticos nacionales y sus políticas de estímulo a la competencia.OBJECTIVES: To characterize current regulatory practices and trends relating to competing medications in 14 Latin American and Caribbean countries. METHODS: Between July 2004 and April 2005 we collected information on national regulations and policies that established or contained a definition of "generic drug" and related terms in 14 Latin American and Caribbean countries: Argentina, Barbados, Bolivia, Brazil, Colombia, Costa Rica, Ecuador, Guatemala, Mexico, Nicaragua, Panama, Paraguay, Peru, and Venezuela. We also compiled information on the incentives to register and produce competing medications, promotion of the use of International Nonproprietary Names (INNs for pharmaceutical substances, the regulation of bioequivalence studies, and the replacement of prescription medications with less expensive alternatives. RESULTS: We noted three patterns in the regulations: (1 countries that encourage financial support for competing medications, extensively promote the use of INNs, and place no restrictions on the replacement of innovative (proprietary medications with competing products (Argentina, Colombia, Costa Rica, Ecuador, and Paraguay; (2 countries with policies aimed at showing therapeutic equivalence, which limits substitutions to approved products from a list of authorized competing medications that must be prescribed by their INN and must use distinctive labeling (Brazil, Mexico, Panama, and Venezuela; and (3 countries at a beginning stage in the process of regulation (Barbados, Bolivia, Guatemala, Nicaragua, and Peru. This variety leads to difficulties in characterizing pharmaceutical markets, and can lead to misleading categorizations. CONCLUSIONS: Efforts to harmonize policies should consider the possible relationship among definitions adopted in different countries, the development of national pharmaceutical markets, and national policies to stimulate competition.

  16. 21 CFR 172.861 - Cocoa butter substitute from coconut oil, palm kernel oil, or both oils.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 3 2010-04-01 2009-04-01 true Cocoa butter substitute from coconut oil, palm... PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION Multipurpose Additives § 172.861 Cocoa butter substitute from coconut oil, palm kernel oil, or both oils. The food additive, cocoa butter substitute from...

  17. Calculation of direct antiretroviral treatment costs and potential cost savings by using generics in the German HIV ClinSurv cohort.

    Science.gov (United States)

    Stoll, Matthias; Kollan, Christian; Bergmann, Frank; Bogner, Johannes; Faetkenheuer, Gerd; Fritzsche, Carlos; Hoeper, Kirsten; Horst, Heinz-August; van Lunzen, Jan; Plettenberg, Andreas; Reuter, Stefan; Rockstroh, Jürgen; Stellbrink, Hans-Jürgen; Hamouda, Osamah; Bartmeyer, Barbara

    2011-01-01

    BACKGROUND/AIM OF THE STUDY: The study aimed to determine the cost impacts of antiretroviral drugs by analysing a long-term follow-up of direct costs for combined antiretroviral therapy, cART, -regimens in the nationwide long-term observational multi-centre German HIV ClinSurv Cohort. The second aim was to develop potential cost saving strategies by modelling different treatment scenarios. Antiretroviral regimens (ART) from 10,190 HIV-infected patients from 11 participating ClinSurv study centres have been investigated since 1996. Biannual data cART-initiation, cART-changes, surrogate markers, clinical events and the Centre of Disease Control- (CDC)-stage of HIV disease are reported. Treatment duration was calculated on a daily basis via the documented dates for the beginning and end of each antiretroviral drug treatment. Prices were calculated for each individual regimen based on actual office sales prices of the branded pharmaceuticals distributed by the license holder including German taxes. During the 13-year follow-up period, 21,387,427 treatment days were covered. Cumulative direct costs for antiretroviral drugs of €812,877,356 were determined according to an average of €42.08 per day (€7.52 to € 217.70). Since cART is widely used in Germany, the costs for an entire regimen increased by 13.5%. Regimens are more expensive in the advanced stages of HIV disease. The potential for cost savings was calculated using non-nucleotide-reverse-transcriptase-inhibitor, NNRTI, more frequently instead of ritonavir-boosted protease inhibitor, PI/r, in first line therapy. This calculation revealed cumulative savings of 10.9% to 19.8% of daily treatment costs (50% and 90% substitution of PI/r, respectively). Substituting certain branded drugs by generic drugs showed potential cost savings of between 1.6% and 31.8%. Analysis of the data of this nationwide study reflects disease-specific health services research and will give insights into the cost impacts of

  18. Calculation of direct antiretroviral treatment costs and potential cost savings by using generics in the German HIV ClinSurv cohort.

    Directory of Open Access Journals (Sweden)

    Matthias Stoll

    Full Text Available UNLABELLED: BACKGROUND/AIM OF THE STUDY: The study aimed to determine the cost impacts of antiretroviral drugs by analysing a long-term follow-up of direct costs for combined antiretroviral therapy, cART, -regimens in the nationwide long-term observational multi-centre German HIV ClinSurv Cohort. The second aim was to develop potential cost saving strategies by modelling different treatment scenarios. METHODS: Antiretroviral regimens (ART from 10,190 HIV-infected patients from 11 participating ClinSurv study centres have been investigated since 1996. Biannual data cART-initiation, cART-changes, surrogate markers, clinical events and the Centre of Disease Control- (CDC-stage of HIV disease are reported. Treatment duration was calculated on a daily basis via the documented dates for the beginning and end of each antiretroviral drug treatment. Prices were calculated for each individual regimen based on actual office sales prices of the branded pharmaceuticals distributed by the license holder including German taxes. RESULTS: During the 13-year follow-up period, 21,387,427 treatment days were covered. Cumulative direct costs for antiretroviral drugs of €812,877,356 were determined according to an average of €42.08 per day (€7.52 to € 217.70. Since cART is widely used in Germany, the costs for an entire regimen increased by 13.5%. Regimens are more expensive in the advanced stages of HIV disease. The potential for cost savings was calculated using non-nucleotide-reverse-transcriptase-inhibitor, NNRTI, more frequently instead of ritonavir-boosted protease inhibitor, PI/r, in first line therapy. This calculation revealed cumulative savings of 10.9% to 19.8% of daily treatment costs (50% and 90% substitution of PI/r, respectively. Substituting certain branded drugs by generic drugs showed potential cost savings of between 1.6% and 31.8%. CONCLUSIONS: Analysis of the data of this nationwide study reflects disease-specific health services research

  19. Resources, recycle, and substitution

    International Nuclear Information System (INIS)

    Wymer, R.G.

    A two-fold strategy appears necessary to ensure that the resource needs of the developed and developing nations are met. First, recycle and substitution must be encouraged in those instances where they do find application. Although these measures have limited applicability, they may be of vital importance in those instances where they do apply; in any event, they buy time. Second, practical and economical technologies must be developed to exploit the lower-grade and marginal ores and the oftentimes abundant but highly refractory ores, as well as to greatly increase the recovery of secondary elements present in the ores - elements whose form and amounts in the ores make them economically unrecoverable by themselves, but which are economically recoverable as by-products. It is often the case that if these elements are not recovered during the initial mining and milling operations, they are rendered unrecoverable, in a practical sense, forever. Furthermore, they may even become environmental pollutants. Specific examples of recovery from refractory ores, by-product recovery, and recycle are given. Also, some suggestions of substitutes for important resources are tabulated

  20. Generic hyper-diversity in Stachybotriaceae

    Czech Academy of Sciences Publication Activity Database

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

    2016-01-01

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

  1. Generic Checklist for Day Care Monitoring.

    Science.gov (United States)

    Children's Services Monitoring Transfer Consortium.

    This guide presents the results of research on day care monitoring methods conducted by the Children's Services Monitoring Transfer Consortium. It suggests a set of generic predictor items that can be used to monitor day care providers' compliance with standards. The predictor items are at the licensing or minimal compliance level and have been…

  2. Intermediates and Generic Convergence to Equilibria

    DEFF Research Database (Denmark)

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

    2017-01-01

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

  3. Comparison of Generic Accelerated Nursing Students

    Science.gov (United States)

    Kaddorura, Mahmood; Williams, Collette

    2012-01-01

    Case study pedagogy is a teaching strategy in which teachers hope to help students develop and use critical thinking (CT) abilities. This study compared CT skills of 75 second year generic accelerated baccalaureate nursing students during their Fundamentals of Nursing course before and after being educated using case study pedagogical method.…

  4. Comparing Generic Parameter Controllers for EAs

    NARCIS (Netherlands)

    Karafotias, G.; Hoogendoorn, M.

    2014-01-01

    Parameter controllers for Evolutionary Algorithms (EAs) deal with adjusting parameter values during an evolutionary run. Many ad hoc approaches have been presented for parameter control, but few generic parameter controllers exist and, additionally, no comparisons or in depth analyses of these

  5. Generic competences in Higher Education: Studying their ...

    African Journals Online (AJOL)

    Generic competences in Higher Education: Studying their development in undergraduate social science studies by means of a specific methodology. ... A methodology for the study of competence acquisition and for the characterisation of a competence-focused educational model is thus implicitly developed. The aim of the ...

  6. Climate Change: Generic Implications for Agriculture

    Indian Academy of Sciences (India)

    First page Back Continue Last page Overview Graphics. Climate Change: Generic Implications for Agriculture. Increasing carbon dioxide: Good for most crops. Increase in mean temperature: orter crop durations, higher evapotranspiration, other effects on growth and yield. Intermittent periods of extreme heat stress: highly ...

  7. Generic 'du' in time and context

    DEFF Research Database (Denmark)

    Jensen, Torben Juel

    2017-01-01

    This article considers the way individual speakers respond to a macro-level process of language change: an increased use of the second-person pronoun du for generic reference. Real time panel studies show that life span change is much more common than is often assumed, particularly among adult...

  8. Baldrige Theory into Practice: A Generic Model

    Science.gov (United States)

    Arif, Mohammed

    2007-01-01

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

  9. Matatti’s generic names for fungi

    NARCIS (Netherlands)

    Donk, M.A.

    1975-01-01

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

  10. Economic consequence of switching to citalopram after its generic entry for adult patients with major depressive disorder (MDD) treated with escitalopram: a 6-month retrospective study.

    Science.gov (United States)

    Yu, Andrew P; Xie, Jipan; Bensimon, Arielle; Parikh, Kejal; Wu, Eric Q; Ben-Hamadi, Rym; Blum, Steven; Haim Erder, M

    2010-01-01

    To estimate, from a third-party payer's perspective, the effects of switching from escitalopram to citalopram, after the generic entry of citalopram, on hospitalization and healthcare costs among adult MDD patients who were on escitalopram therapy. Adult MDD patients treated with escitalopram were identified from Ingenix Impact claims database. MDD- and mental health (MH)-related hospitalization rates and healthcare costs were compared between 'switchers' (patients who switched to citalopram after its generic entry) and 'non-switchers'. MDD- and MH-related outcomes were defined as having a primary or a secondary diagnosis of ICD-9-CM = 296.2x, 296.3x and ICD-9-CM = 290-319, respectively. A propensity score matching method that estimated the likelihood of switching using baseline characteristics was used. Outcomes were examined for both 3-month and 6-month post-index periods. The sample included 3,427 matched pairs with balanced baseline characteristics. Switchers were more likely to incur an MDD-related (odds ratio [OR] = 1.52) and MH-related hospitalization (OR = 1.34) during the 6-month post-index period (both p escitalopram to citalopram due to medical reasons versus non-medical reasons, and exclusion of indirect costs from cost calculations. Compared to patients maintaining on escitalopram, switchers from escitalopram to citalopram experienced higher risk of MDD- and MH-related hospitalization and incurred higher total MDD- and MH-related healthcare costs. The economic consequences of therapeutic substitution should take into account total healthcare costs, not just drug acquisition costs.

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

    Directory of Open Access Journals (Sweden)

    J.A. Vallès

    2002-12-01

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

  12. Distribution and trends in outpatient utilization of generic versus brand name psychopharmaceuticals during a ten-year period in Croatia.

    Science.gov (United States)

    Polić-ViŽintin, Marina; Stimac, Danijela; Sostar, Zvonimir; Tripković, Ingrid

    2014-08-15

    Drug costs increasingly pose a burden upon the otherwise inadequate health care resources and rational drug utilization is an important segment of every national health policy. Optimal patient care should be the goal of rational pharmacotherapy, whereby the economic burden of treatment is just one of the elements to be considered on choosing appropriate therapy.The aim of this study was to determine distribution and trends in the outpatient utilization of generic versus brand name psychopharmaceuticals and to evaluate the rationality of prescribing psychopharmaceuticals during a ten-year period. Using the World Health Organization Anatomical-Therapeutic-Chemical classification/Defined Daily Doses (ATC/DDD) methodology, the number of DDD was calculated from data collected from pharmacies on the number and size of drug packages. The ratio of generic and brand name drug costs served as an indicator on assessing the rationality of drug utilization. Total cost for psychopharmaceuticals increased by 20.1%, more for brand name than for generic agents (32.7% vs. 7.4%). The highest share of generic psychopharmaceuticals as compared with brand name drugs according to DDD per 1000 inhabitants per day (DDD/1000/day) was in the group of psycholeptics (83.6% in 2001 vs. 82.2% in 2010), most in hypnotics and sedatives, and least in antipsychotics. The share of generic psychopharmaceuticals in total drug utilization according to financial indicators decreased by 9.6% and according to DDD/1000/day by 12%. The greatest decrease was in antidepressants, i.e. by 33.8% according to financial indicators and by 46% according to DDD/1000/day; and in antipsychotics by 30.9% according to DDD/1000/day, while showing an increase by 8.5% according to financial indicators. In the therapeutic subgroup of mood stabilizers, the share of generic drugs in total drug utilization declined by 32% according to DDD/1000/day, but increased by 25.1% according to financial indicators. The lack of uniform

  13. 40 CFR 721.9959 - Polyurethane polymer (generic).

    Science.gov (United States)

    2010-07-01

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

  14. 40 CFR 721.324 - Alkoxylated acrylate polymer (generic).

    Science.gov (United States)

    2010-07-01

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

  15. 40 CFR 721.983 - Sulfonyl azide intermediate (generic).

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Sulfonyl azide intermediate (generic... Substances § 721.983 Sulfonyl azide intermediate (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as sulfonyl azide intermediate...

  16. 78 FR 56621 - Draft Waste Confidence Generic Environmental Impact Statement

    Science.gov (United States)

    2013-09-13

    ...-2012-0246] RIN 3150-AJ20 Draft Waste Confidence Generic Environmental Impact Statement AGENCY: Nuclear... generic environmental impact statement (DGEIS), NUREG-2157, ``Waste Confidence Generic Environmental... licensed life for operation and prior to ultimate disposal (proposed Waste Confidence rule). The NRC staff...

  17. 40 CFR 721.4610 - Mixed metal oxides (generic).

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Mixed metal oxides (generic). 721.4610... Substances § 721.4610 Mixed metal oxides (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as mixed metal oxides (PMN P-98-0002...

  18. 17 CFR 230.135a - Generic advertising.

    Science.gov (United States)

    2010-04-01

    ... 17 Commodity and Securities Exchanges 2 2010-04-01 2010-04-01 false Generic advertising. 230.135a... REGULATIONS, SECURITIES ACT OF 1933 General § 230.135a Generic advertising. (a) For the purposes only of... different generic types or having various investment objectives, such as balanced funds, growth funds...

  19. 40 CFR 721.10053 - Alkyl silane methacrylate (generic).

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Alkyl silane methacrylate (generic... Specific Chemical Substances § 721.10053 Alkyl silane methacrylate (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkyl silane...

  20. 40 CFR 721.5908 - Modified phenolic resin (generic).

    Science.gov (United States)

    2010-07-01

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

  1. 40 CFR 721.2673 - Aromatic epoxide resin (generic).

    Science.gov (United States)

    2010-07-01

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

  2. 40 CFR 721.5905 - Modified phenolic resin (generic).

    Science.gov (United States)

    2010-07-01

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

  3. 40 CFR 721.988 - Pyrazolone azomethine dye (generic).

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Pyrazolone azomethine dye (generic... Substances § 721.988 Pyrazolone azomethine dye (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as a pyrazolone azomethine dye...

  4. 40 CFR 721.5917 - Phenyl azo dye (generic).

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Phenyl azo dye (generic). 721.5917... Substances § 721.5917 Phenyl azo dye (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as a phenyl azo dye (PMN P-02-17) is subject to...

  5. 40 CFR 721.10172 - Alkylamide derivative (generic).

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Alkylamide derivative (generic). 721... Substances § 721.10172 Alkylamide derivative (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkylamide derivative (PMN P-03...

  6. 40 CFR 721.646 - Aminofluoran derivative (generic name).

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Aminofluoran derivative (generic name... Substances § 721.646 Aminofluoran derivative (generic name). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as aminofluoran derivative (PMN P...

  7. 40 CFR 721.2755 - Cycloaliphatic epoxy resin (generic).

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Cycloaliphatic epoxy resin (generic... Substances § 721.2755 Cycloaliphatic epoxy resin (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as cycloaliphatic epoxy resin (PMN...

  8. Substitution in recreation choice behavior

    Science.gov (United States)

    George L. Peterson; Daniel J. Stynes; Donald H. Rosenthal; John F. Dwyer

    1985-01-01

    This review discusses concepts and theories of substitution in recreation choice. It brings together the literature of recreation research, psychology, geography, economics, and transportation. Parallel and complementary developments need integration into an improved theory of substitution. Recreation decision behavior is characterized as a nested or sequential choice...

  9. Biological background of dermal substitutes

    NARCIS (Netherlands)

    van der Veen, V. C.; van der Wal, M.B.; van Leeuwen, M.C.; Ulrich, M.; Middelkoop, E.

    2010-01-01

    Dermal substitutes are of major importance in treating full thickness skin defects, both in acute and chronic wounds. In this review we will outline specific requirements of three classes of dermal substitutes:-natural biological materials, with a more or less intact extracellular matrix

  10. Making sense of a generic label

    DEFF Research Database (Denmark)

    Lassen, Inger

    2016-01-01

    Making sense of a generic label through linguistic context analysis: A study of genre (re)cognition among novices’ Considerable work has been done on written and spoken genres characterized by a high degree of ritualization with “predictable elements occurring in a predictable order” (Fairclough......, as in Martin, Christie and Rothery (1987) and Martin (1993), or consistency of communicative purposes as in Swales (1990) and Bhatia (1993)”. Common to these definitions are the notions of predictability and recognition of generic patterns, notions that are, however, not unproblematic. This article therefore......) that the students had studied during the course leading up to the exam. Given the lack of situated cognition (Bawarshi and Reiff, 2010: 79) of one of these genres, the students were requested to produce arguments and justification for assigning the genres presented to them to two different genre colonies...

  11. Generic Sensor Failure Modeling for Cooperative Systems

    Directory of Open Access Journals (Sweden)

    Georg Jäger

    2018-03-01

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

  12. Developing A Generic Optical Avionic Network

    DEFF Research Database (Denmark)

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

    2011-01-01

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

  13. Generic Structure Potential of Christian Apologetics

    Directory of Open Access Journals (Sweden)

    Onwu Inya

    2012-01-01

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

  14. Generic Sensor Failure Modeling for Cooperative Systems

    Science.gov (United States)

    Jäger, Georg; Zug, Sebastian

    2018-01-01

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

  15. Linguistic reflections on the generic feminine

    Directory of Open Access Journals (Sweden)

    Javier San Julián Solana

    2017-12-01

    After comparing the underlying assumptions of the feminists’ position with some linguistic principles, we analyze the conditions under which the generic interpretations of feminine forms take place in ordinary language. We then present the problems that the generalization of the phenomenon can give rise to: limitation of «displacement» capacity (Hockett, 1960, poor processing effort / cognitive effect ratio, and difficulty in accomplishing the communicative function of language. This brings us to the point that the generic feminine is most unlikely to become established in general uses of Spanish; it also seem not to be feasible to achieve a free alternation of masculine and feminine forms as a means of expressing gender neutralization. However, the occasional use of the feminine with extensive value could be made habitual —considering the social function of language— in political discourse, where it would function as a badge that shows membership of (or solidarity with a social group.

  16. Towards Generic Interaction Styles for Product Design

    DEFF Research Database (Denmark)

    Buur, Jacob; Stienstra, Marcelle

    2008-01-01

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

  17. Predicting Drug Concentration-Time Profiles in Multiple CNS Compartments Using a Comprehensive Physiologically-Based Pharmacokinetic Model

    NARCIS (Netherlands)

    Yamamoto, Yumi; Välitalo, Pyry A; Huntjens, Dymphy R; Proost, Johannes H; Vermeulen, An; Krauwinkel, Walter; Beukers, Margot W; van den Berg, Dirk-Jan; Hartman, Robin; Wong, Yin Cheong; Danhof, Meindert; van Hasselt, John G C; de Lange, Elizabeth C M

    2017-01-01

    Drug development targeting the central nervous system (CNS) is challenging due to poor predictability of drug concentrations in various CNS compartments. We developed a generic physiologically based pharmacokinetic (PBPK) model for prediction of drug concentrations in physiologically relevant CNS

  18. Basicities of some 9-substituted acridine-4-carboxamides: A density ...

    Indian Academy of Sciences (India)

    Acid-base properties of drugs are important in understanding the behaviour of these compounds under physiological condition. In order to understand such behaviour the proton affinities of acridine 4-carboxamides with substitution (R) at the 9-position are theoretically studied, and considered for the basic sites of both the ...

  19. Placebo substitution for tnethyldopa in geriatric hypertensive patients

    African Journals Online (AJOL)

    Abstract The aim of this study was to obtain an objective evaluation of the possibly inappropriate anti- hypertensive therapy of elderly patients; this was done by means ofplacebo substitution for methyl- dopa, one ofthe drugs taken by all the participat- ing patients. Forty patients were recruited from a hospital outpatient clinic ...

  20. Placebo substitution for methyldopa in geriatric hypertensive patients

    African Journals Online (AJOL)

    The aim of this study was to obtain an objective evaluation of the possibly inappropriate antihypertensive therapy of elderly patients; this was done by means of placebo substitution for methyldopa, one of the drugs taken by all the participating patients. Forty patients were recruited from a hospital outpatient clinic and ...

  1. Synthesis of some substituted pyrazole derivatives as antiprotozoal ...

    African Journals Online (AJOL)

    Compounds incorporating a pyrazole moiety have attracted a great deal of research owing to its therapeutic utility of the templates as useful drug molecule scaffolding. We report the synthesis of Pyrazoles moiety substituted with anilines at the fifth position of the ring as anti-protozoal lead moiety. All the compounds were ...

  2. Savannah River Site generic data base development

    International Nuclear Information System (INIS)

    Blanchard, A.

    2000-01-01

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

  3. Molten salts processes and generic simulation

    International Nuclear Information System (INIS)

    Ogawa, Toru; Minato, Kazuo

    2001-01-01

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

  4. Molten salts processes and generic simulation

    Energy Technology Data Exchange (ETDEWEB)

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

    2001-12-01

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

  5. Generic considerations of LMFBR hypothetical accident energetics

    Energy Technology Data Exchange (ETDEWEB)

    Fauske, H.K.; Cho, D.H.; Epstein, M.; Grolmes, M.A.; Henry, R.E.

    1978-01-01

    The paper provides a preliminary assessment of generic accident energetics issues associated with alternatives relative to the reference (U,Pu) oxide fuel in liquid metal fast breeder reactors. The alternatives considered include thorium- and uranium-based oxide, carbide and metal fuel types. This assessment is made within the context of low probability, but potentially large consequence accidents, e.g., core-disruptive accidents.

  6. A Generic Architecture for Autonomous Uninhabited Vehicles

    Science.gov (United States)

    2007-11-01

    RTO-MP-AVT-146 20 - 1 UNCLASSIFIED/UNLIMITED UNCLASSIFIED/UNLIMITED A Generic Architecture for Autonomous Uninhabited Vehicles Magali BARBIER ...it fires the event- triggered transitions of the Petri nets and runs actions associated to transitions; Barbier , M.; Gabard, J.-F.; Ayreault, H...affect the mission; a reaction is specified for each one: • in case of an engine failure, transit to the nearest emergency site; • in case of a

  7. Savannah River Site generic data base development

    Energy Technology Data Exchange (ETDEWEB)

    Blanchard , A.

    2000-01-04

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

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

    International Nuclear Information System (INIS)

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

    2008-01-01

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

  9. Making tenofovir accessible in the brazilian public health system: patent conflicts and generic production.

    Science.gov (United States)

    Veras, Juliana

    2014-08-01

    In May 2011, the Brazilian Ministry of Health announced the distribution of the first batch of locally produced generic tenofovir disoproxil fumarate (TDF) to support its program of universal and free access for the treatment of HIV/AIDS. The inclusion of TDF in the public health program illustrates what has been considered the 'Brazilian model' of HIV/AIDS response, as it illustrates the current phase of the Brazilian pharmaceutical economy. Brazil is known for having managed to control the expansion of HIV/AIDS through a unique initiative combining the public health and the industrial production of generics. But, if at first local manufacturers could freely copy ARVs and produce cheaper generic versions that were delivered to the Ministry of Health, since the country started to grant patents on drugs in 1996, the sustainability of this policy has been challenged by the high cost of patented second-line HIV/AIDS treatments. In order to assure continuity of the local production of ARVs, and keep the program of public health alive, Brazilians are now forced to deal with conflicts of drugs' intellectual property rights in order to open the path to generic production. This article aims to describe the experiences surrounding TDF in Brazil and the unprecedented conflicts and challenges it has brought for our different interviewees. Blurring the frontier between the public and the private, the TDF case was driven at the same time by an ethic of drug access and regulation of drug quality, which has inspired Brazilians to intervene and transform the world they live in. © 2014 John Wiley & Sons Ltd.

  10. Oral drug delivery system based on interpolymer complex formation between poly(acrylic acid) and poly(vinyl pyrrolidone-co-vinyl acetate)

    CSIR Research Space (South Africa)

    Germishuizen, A

    2005-07-01

    Full Text Available A number of the most successful drugs are going off patent in the next 5 years. Generic prescription drugs are continuously making up a larger proportion of the total drug market. Therefore, the drug delivery systems used to deliver the generic...

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

    Science.gov (United States)

    Fischer, Katharina Elisabeth; Stargardt, Tom

    2016-11-01

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

  12. Generic Qualitative Approaches: Pitfalls and Benefits of Methodological Mixology

    Directory of Open Access Journals (Sweden)

    Renate M. Kahlke BA Hon, MA

    2014-02-01

    Full Text Available Generic qualitative research studies are those that refuse to claim allegiance to a single established methodology. There has been significant debate in the qualitative literature regarding the extent to which rigour can be preserved outside of the guidelines of an established methodology. This article offers a starting place for researchers interested in entering the literature on generic qualitative approaches and offers some guidance to help researchers appreciate the advantages of using a generic approach and navigate the potential pitfalls. Given that generic approaches are, by definition, less defined and established, this article begins by defining generic qualitative approaches, including the descriptive qualitative approach and interpretive description subcategories. It then outlines key critiques of generic studies present in the literature, describes the benefits of generic approaches, and suggests ways in which the issues raised in critiques might be mediated.

  13. Imperative to consider multiple initiatives to maximize prescribing efficiency from generic availability: case history from Abu Dhabi.

    Science.gov (United States)

    Abuelkhair, Mohammed; Abdu, Shajahan; Godman, Brian; Fahmy, Sahar; Malmström, Rickard E; Gustafsson, Lars L

    2012-02-01

    Pharmaceutical expenditure has risen rapidly in Abu Dhabi, resulting in policies surrounding generics. However, various circumstances will reduce potential savings, including pharmacists still being free to dispense either originator or branded generics and be fully reimbursed. To research the changes in utilization patterns of proton pump inhibitors (PPIs) and lipid-lowering drugs before and after combined reforms on generics; and subsequently, calculate potential savings based on 'best practices' among Western European countries. An uncontrolled before-and-after observational study of utilization and expenditure of PPIs, statins and ezetimibe between 2004 and 2010, as well as up to 12 months before the first generic policy, to 1 year after the second generic policy, was carried out. Utilization was converted to defined daily doses (DDDs; 2011 DDDs) and DDDs/1000 inhabitants per day. Expenditure/DDD was calculated for omeprazole and simvastatin. PPI utilization rose by 6.5-fold from 2004 to 2010, principally driven by increased utilization of patent-protected PPIs, although more recently stabilization in esomperazole utilization has occurred. Similar changes were seen for statins. Introduction of best practices would reduce PPI expenditure in 2010 by 32.8 million United Arab Emirates dirham (AED; €6.26 million) and statins by over 27 million AED (€5.15 million). Limited demand-side measures led to increased utilization of patent-protected products in Abu Dhabi following the generic reforms. Successful measures will release considerable resources.

  14. The consequences of generic marketing on antibiotic consumption and the spread of microbial resistance: the need for new antibiotics.

    Science.gov (United States)

    Toutain, P-L; Bousquet-Melou, A

    2013-10-01

    In both human and veterinary medicine, it has been shown that flooding the market with different generics and/or 'me-too' branded drugs has increased overall antibiotic consumption correlating with the emergence and spread of bacterial resistance to antibiotics. Another possible undesirable consequence of the promotion of generics is the promotion of an economic incentive that encourages the use of old drug products with very poor oral bioavailability, marketed with historical dosage regimens and extensively excreted in the environment. What veterinary medicine rather needs is new innovative and 'ecofriendly' antibiotics to actually enforce a more prudent use of antibiotics. For a pharmaceutical company, generics are inexpensive to manufacture and on a short-term basis, the generic market is very appealing. However, on a long-term basis, this marketing orientation provides a disincentive to the development of new and innovative products that will be required to meet the therapeutic needs of the veterinary community while being consistent with public health concerns. Indeed, for veterinary medicine, the key issue surrounding antibiotics is public health. It is the opinion of the authors that veterinary antibiotics and/or veterinary drug formulations should be innovative in terms of selectivity (no or minimal impact on the commensal gut flora), biodegradable (with minimal environmental disruption), and more expensive, with a strictly regulated market rather than unselective, cheap, and freely available drugs. © 2013 John Wiley & Sons Ltd.

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

    Directory of Open Access Journals (Sweden)

    J. E. Semyonova

    2015-12-01

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

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

    Directory of Open Access Journals (Sweden)

    J. E. Semyonova

    2005-01-01

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

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

    International Nuclear Information System (INIS)

    Muñiz, C.C.; Bossio, M.C.

    2011-01-01

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

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

    International Nuclear Information System (INIS)

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

    1993-01-01

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

  19. Drugs in East Germany.

    Science.gov (United States)

    Dressler, J; Müller, E

    1997-09-01

    Germany was divided into two parts after World War II. The closed border and a nonconvertible currency in the Eastern part were the factors that did not allow a drug market to develop. Alcohol and medicaments were used as substitute drugs. Since Germany was reunified 5 years ago, there are now the same conditions prevailing for the procurement and sale of drugs in East Germany as there are in the Western German states. This report describes the current state of drug traffic, especially in Saxony, under the new social conditions.

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

    Directory of Open Access Journals (Sweden)

    Peter Bai James

    2018-01-01

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

  1. ORIGINAL ARTICLES Mandatory substitution successful

    African Journals Online (AJOL)

    on the market since 1970.6 As a beta-blocker, used for the treatment of hypertension, it benefits from widespread use across all population groups in South Africa and is taken on a daily basis. It was compared with three generics, namely, Ten-. Bloka, Rolab Atenolol and Adco-Atenolol. Discovery Health was used as the ...

  2. IMPROVING ACCESS TO DRUGS

    Directory of Open Access Journals (Sweden)

    Max Joseph Herman

    2012-11-01

    Full Text Available Although essentially not all therapies need drug intervention, drugs is still an important components in health sector, either in preventive, curative, rehabilitative or promotion efforts. Hence the access to drugs is a main problem, either in international or national scale even to the smallest unit. The problem on access to drugs is very complicated and cannot be separated especially from pharmacy management problems; moreover in general from the overall lack of policy development and effective of health policy, and also the implementation process. With the policy development and effective health policy, rational drug uses, sufficient health service budget so a country can overcome the health problems. Besides infrastructures, regulations, distribution and cultural influences; the main obstacles for drug access is drugs affordability if the price of drugs is an important part and determined by many factors, especially the drug status whether is still patent orgenerics that significantly decrease cost of health cares and enhance the drugs affordability. The determination of essential drug prices in developing countries should based on equity principal so that poor people pay cheaper and could afford the essential drugs. WHO predicts two third of world population can not afford the essential drugs in which in developing countries, some are because of in efficient budget allocation in consequence of drug distribution management, including incorrect selection and allocation and also irrational uses. In part these could be overcome by enhancing performances on the allocation pharmacy needs, including the management of information system, inventory management, stock management and the distribution. Key words: access, drugs, essential drugs, generic drugs

  3. COMPARISON OF PHARMACOKINETICS AND PHARMACODYNAMICS OF THE ORIGINAL AND GENERIC ENALAPRIL IN THE ELDERLY PATIENTS WITH ARTERIAL HYPERTENSION

    Directory of Open Access Journals (Sweden)

    O. P. Bobrova

    2012-01-01

    Full Text Available Aim. To study the pharmacokinetic, pharmacodynamic and pharmacoeconomic parameters of the original and generic enalaprils in the treatment of the elderly patients with hypertension (HT. Material and Methods. Patients (n=40 75–90 years with HT were included in the open randomized comparative study. Patients were randomized into two groups. Patients of the group 1 received generic enalapril, patients of the group 2 — the original enalapril consisting of combined therapy. Pharmacokinetic single-dose study of original and generic enalapril were carried out with high-performance liquid chromatography. Pharmacodynamic study was carried out in single-dose administration as well as after 2 and 4 weeks of treatment with original and generic enalapril. Pharmacoeconomic evaluation of antihypertensive drugs was carried out on the basis of cost minimization analysis. Results. Original enalapril dose necessary to achieve the target blood pressure (BP was 10 mg/day as a part of two-component therapy. This for generic enalapril was 20 mg/day consisting of three- or four-component therapy. Both drugs have shown an acceptable safety profile. Pharmacokinetic differences were revealed between original and generic enalapril: area under pharmacokinetic curve 204.14 (202.25–206.05 vs 136.23 (134.17–137.65 ng*h/ml, respectively; time of the drug retention in the blood plasma 5.42 (5.26–5.76 vs 4.88 (4.86–4.94 hours, respectively; p<0.001. Original enalapril demonstrated more stable 24-hour antihypertensive effect in once daily administration in comparison with this in generic enalapril: trough/peak ratio 78.67% (47.61–91.35% vs 44.96% (32.44–55.49%, respectively , p<0.01. The average daily cost of combined therapy containing generic enalapril was 15.91 rubles per patient, while this in combined therapy containing original enalapril — 13.78 rubles per patient. Conclusion. Medicines on the basis of original and generic enalapril have pharmacokinetic

  4. Simple, heart-smart substitutions

    Science.gov (United States)

    ... food choices does not mean you have to sacrifice flavor. The key is to substitute less healthy ... trout, and mackerel. Shrimp has less cholesterol than chicken, pork, or beef. Choose lean meats. They have ...

  5. bis(n'-substituted a

    African Journals Online (AJOL)

    Preferred Customer

    substituted acetohydrazide) ... biological activity associated with their corresponding hydrazones attributed to the presence of the active ... Hence, in this paper, we are reporting eco-friendly synthesis of some new Schiff bases by condensing 2 ...

  6. N-substituted iminodiacetic acids

    International Nuclear Information System (INIS)

    Nunn, A.; Loberg, M.

    1982-01-01

    The chemical preparation of several new N-substituted iminodiacetic acid derivatives are described. These compounds when complexed with sup(99m)Tc provide useful radiopharmaceuticals for the external imaging of the hepatobiliary system. (U.K.)

  7. Generic Inspection Planning for Steel Structures

    DEFF Research Database (Denmark)

    Sørensen, John Dalsgaard; Faber, Michael H.

    2002-01-01

    This paper presents a simplified and practically applicable approach for risk based inspection planning of fatigue sensitive structural details in steel structures. The basic idea is that the fatigue sensitive details are categorized according to their Fatigue Design Factor (FDF) and SN curve. When...... a measure of the structural redundancy and the corresponding probability of total structural failure given fatigue failure of the considered detail is known, it is possible to formulate a generic description of fatigue sensitive structural details and thereby develop pre-made inspection plans in tables...

  8. A Generic Solution Approach to Nurse Rostering

    DEFF Research Database (Denmark)

    Hansen, Anders Dohn; Mason, Andrew; Ryan, David

    In this report, we present a solution approach to the nurse rostering problem. The problem is defined by a generic model that is able to capture close to all of the problem characteristics that we have seen in the literature and in the realistic problems at hand. The model is used directly......, which is solved in a branch-and-price framework. Columns of the set partitioning problem are generated dynamically and branch-and-bound is used to enforce integrality. The column generating subproblem is modeled in three stages that utilize the inherent structure of roster-lines. Some important features...

  9. Generic Patch Inference

    DEFF Research Database (Denmark)

    Andersen, Jesper; Lawall, Julia Laetitia

    2008-01-01

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

  10. Deriving GENERIC from a Generalized Fluctuation Symmetry

    Science.gov (United States)

    Kraaij, Richard; Lazarescu, Alexandre; Maes, Christian; Peletier, Mark

    2018-02-01

    Much of the structure of macroscopic evolution equations for relaxation to equilibrium can be derived from symmetries in the dynamical fluctuations around the most typical trajectory. For example, detailed balance as expressed in terms of the Lagrangian for the path-space action leads to gradient zero-cost flow. We expose a new such fluctuation symmetry that implies GENERIC, an extension of gradient flow where a Hamiltonian part is added to the dissipative term in such a way as to retain the free energy as Lyapunov function.

  11. Generic Wing-Body Aerodynamics Data Base

    Science.gov (United States)

    Holst, Terry L.; Olsen, Thomas H.; Kwak, Dochan (Technical Monitor)

    2001-01-01

    The wing-body aerodynamics data base consists of a series of CFD (Computational Fluid Dynamics) simulations about a generic wing body configuration consisting of a ogive-circular-cylinder fuselage and a simple symmetric wing mid-mounted on the fuselage. Solutions have been obtained for Nonlinear Potential (P), Euler (E) and Navier-Stokes (N) solvers over a range of subsonic and transonic Mach numbers and angles of attack. In addition, each solution has been computed on a series of grids, coarse, medium and fine to permit an assessment of grid refinement errors.

  12. The Northeast Utilities generic plant computer system

    International Nuclear Information System (INIS)

    Spitzner, K.J.

    1980-01-01

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

  13. Generic device controller for accelerator control systems

    International Nuclear Information System (INIS)

    Mariotti, R.; Buxton, W.; Frankel, R.; Hoff, L.

    1987-01-01

    A new distributed intelligence control system has become operational at the AGS for transport, injection, and acceleration of heavy ions. A brief description of the functionality of the physical devices making up the system is given. An attempt has been made to integrate the devices for accelerator specific interfacing into a standard microprocessor system, namely, the Universal Device Controller (UDC). The main goals for such a generic device controller are to provide: local computing power; flexibility to configure; and real time event handling. The UDC assemblies and software are described

  14. The generic Gröbner walk

    DEFF Research Database (Denmark)

    Jensen, Anders Nedergaard; Lauritzen, Niels; Fukuda, Komei

    2005-01-01

    perturbation of this line. This usually involves both time and space demanding arithmetic of integers much larger than the input numbers. In this paper we show how the explicit line may be replaced by a formal line using Robbiano's characterization of group orders on . This gives rise to the generic Gröbner...... walk involving only Gröbner basis conversion over facets and computations with marked polynomials. The infinite precision integer arithmetic is replaced by term order comparisons between (small) integral vectors. This makes it possible to compute with infinitesimal numbers and perturbations...

  15. Impact of the trade-related aspects of intellectual property rights (TRIPS) agreement on India as a supplier of generic antiretrovirals.

    Science.gov (United States)

    Babovic, Sonja; Wasan, Kishor M

    2011-03-01

    This is a commentary on how the trade-related aspects of intellectual property rights (TRIPS) agreement has impacted India as a supplier of generic antiretrovirals (ARVs). We provide a systematic review of the issues related to the TRIPS agreement that affects India. This includes discussion around (a) the legal landscape underpinning India as a supplier of generic ARVs; (b) supply of second-line ARVs; and (c) the future of generic drug production in India. The proclamation into force of TRIPS-compliant intellectual property law in India is likely to affect its position as a supplier of affordable ARVs, especially drugs brought to market after 2005. Currently, mechanisms exist for the generic production of almost all ARVs in India, including second-line drugs; however, the manufacture of these drugs by generic pharmaceutical companies may require additional market incentives. Compulsory licensing may emerge as an additional mechanism by which India can provide affordable versions of patented drugs to Least Developed Countries (LDCs). Copyright © 2010 Wiley-Liss, Inc.

  16. On searching generic properties of non generic phenomena: an approach to bioinformatic theory formation

    NARCIS (Netherlands)

    Hogeweg, P.

    1999-01-01

    In this paper we first shortly review the current view of the evolution of complexity and novelty in biotic evo- lution. Next we show that the basic processes thereof do happen automatically and are generic properties of systems including the basic mechanisms of Darwini- an evolution plus local

  17. Exploring the potential for using drug indications to prevent look-alike and sound-alike drug errors.

    Science.gov (United States)

    Seoane-Vazquez, Enrique; Rodriguez-Monguio, Rosa; Alqahtani, Saad; Schiff, Gordon

    2017-10-01

    Look-alike, sound-alike (LASA) drug names are a cause of medication errors with resulting patient harm and healthcare costs. This study assessed to which extent the use of the generic drug name, therapeutic class, health problem, and the U.S. Food and Drug Administration (FDA)-approved indications might be used to differentiate LASA drug pairs. We collected information about LASA drug pairs reported by the FDA to have look-alike sound-alike similarities. To assess potential for differentiating LASA drug pairs, we compared the following drug characteristics: generic name, therapeutic class, health problem, and FDA-approved indication. For the 33 FDA reported LASA drug pairs we identified a total of 432 FDA-approved indications. Using the generic name, therapeutic class, health problem and drug indication we were able to differentiate 8 (24.2%), 24 (72.7%), 25 (75.8%) and 26 (78.8%), respectively of the 33 LASA drug pairs. Using the generic name, therapeutic class, and health problem we were able to distinguish 31 (7.2%), 212 (49.1%), and 269 (62.3%), respectively of the 432 FDA-approved indications for the LASA drug pairs. Including the FDA-approved indication in the drug prescription may be used to differentiate LASA drug pairs and thus, prevent wrong drug medication errors.

  18. Drug: D04478 [KEGG MEDICUS

    Lifescience Database Archive (English)

    Full Text Available D04478 Drug Hydroxypropylcellulose (JP17); Hydroxypropyl cellulose (NF); Low substituted hydroxypropylcellu...lose (JP17); Lacrisert (TN) ... CAS: 9004-64-2 PubChem: 47206330 DrugBank: DB00840 NIKKAJI: J257.400D ...

  19. A prioritization of generic safety issues

    International Nuclear Information System (INIS)

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

    1991-07-01

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

  20. Contact Geometry of Hyperbolic Equations of Generic Type

    Directory of Open Access Journals (Sweden)

    Dennis The

    2008-08-01

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