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Generic Drugs (generic + drug)
Selected AbstractsVariability and Impact on Design of Bioequivalence StudiesBASIC AND CLINICAL PHARMACOLOGY & TOXICOLOGY, Issue 3 2010Achiel Van Peer Revisions of the regulatory guidance are based upon many questions over the past years and sometimes continuing scientific discussions on the use of the most suitable statistical analysis methods and study designs, particularly for drugs and drug products with high within-subject variability. Although high within-subject variability is usually associated with a coefficient of variation of 30% or more, new approaches are available in the literature to allow a gradual increase and a levelling off of the bioequivalence limits to some maximum wider values (e.g. 75,133%), dependent on the increase in the within-subject variability. The two-way, cross-over single dose study measuring parent drug is still the design of first choice. A partial replicate design with repeating the reference product and scaling the bioequivalence for the reference variability are proposed for drugs with high within-subject variability. In case of high variability, more regulatory authorities may accept a two-stage or group-sequential bioequivalence design using appropriately adjusted statistical analysis. This review also considers the mechanisms why drugs and drug products may exhibit large variability. The physiological complexity of the gastrointestinal tract and the interaction with the physicochemical properties of drug substances may contribute to the variation in plasma drug concentration-time profiles of drugs and drug products and to variability between and within subjects. A review of submitted bioequivalence studies at the Food and Drug Administration's Office of Generic Drugs over the period 2003,2005 indicated that extensive pre-systemic metabolism of the drug substance was the most important explanation for consistently high variability drugs, rather than a formulation factor. These scientific efforts are expected to further lead to revisions of earlier regulatory guidance in other regions as is the current situation in Europe. [source] Boosted protease inhibitors as a therapeutic option in the treatment of HIV-infected childrenHIV MEDICINE, Issue 9 2009JT Ramos Objective Paediatric HIV treatment must address various special considerations. Administration of pharmacokinetically enhanced protease inhibitors (PIs) can improve paediatric therapeutic outcomes. The objective of this study was to review the use of boosted PI regimens in children. Methods Systematic literature searches of published manuscripts and conference databases using generic drug names and specific keywords were performed to ensure thorough and balanced reporting of available data. Results Boosted PI regimens offer multiple options across a range of ages and are efficacious in naïve and experienced children; safety and tolerability are similar to those observed in adults. Novel boosted PI simplification approaches may foster adherence and diminish resistance. Conclusions Boosted PIs are key components of first- and second-line treatments in children. Identifying factors associated with the response to highly active antiretroviral therapy in children may ultimately permit individualized therapies. [source] Impact of Alternative Interventions on Changes in Generic Dispensing RatesHEALTH SERVICES RESEARCH, Issue 5 2006A. James O'Malley Objectives. To evaluate the effectiveness of four alternative interventions (member mailings, advertising campaigns, free generic drug samples to physicians, and physician financial incentives) used by a major health insurer to encourage its members to switch to generic drugs. Methods. Using claim-level data from Blue Cross Blue Shield of Michigan, we evaluated the success of four interventions implemented during 2000,2003 designed to increase the use of generic drugs among its members. Around 13 million claims involving seven important classes of drugs were used to assess the effectiveness of the interventions. For each intervention a control group was developed that most closely resembled the corresponding intervention group. Logistic regression models with interaction effects between the treatment group (intervention versus control) and the status of the intervention (active versus not active) were used to evaluate if the interventions had an effect on the generic dispensing rate (GDR). Because the mail order pharmacy was considered more aggressive at converting prescriptions to generics, separate generic purchasing models were fitted to retail and mail order claims. In secondary analyses separate models were also fitted to claims involving a new condition and claims refilled for preexisting conditions. Results. The interventions did not appear to increase the market penetration of generic drugs for either retail or mail order claims, or for claims involving new or preexisting conditions. In addition, we found that the ratio of copayments for brand name to generic drugs had a large positive effect on the GDR. Conclusions. The interventions did not appear to directly influence the GDR. Financial incentives expressed to consumers through benefit designs have a large influence on their switching to generic drugs and on the less-costly mail-order mode of purchase. [source] The Political Economy of AIDS Treatment: Intellectual Property and the Transformation of Generic SupplyINTERNATIONAL STUDIES QUARTERLY, Issue 3 2007Kenneth C. Shadlen This article examines the relationship between intellectual property (IP) and public health, with a focus on the extension of AIDS treatment in the developing world. While most of the literature on IP and health examines the conditions affecting poor countries' capacities to acquire essential medicines, I show the distinct,and more complicated,political economy of production and supply. IP regulations alter the structure of generic pharmaceutical sectors in the countries capable of supplying essential medicines, and changes in market structure affect actors' economic and political interests and capacities. These new constellations of interests and capacities have profound implications for the creation and maintenance of political coalitions in support of on-going drug supply. The result is that the global AIDS treatment campaign becomes marked by mismatches of interests and capacities: those actors capable of taking the economic, legal, and political steps necessary to increase the supply and availability of essential drugs have diminished interest in doing so, and those actors with an interest in expanding treatment may lack the capacities to address the problem of undersupply. By focusing centrally on actors' interests in and capacities for economic and political action, the article restores political economy to analysis of an issue-area that has been dominated by attention to international law. And by examining the fragility of the coalitions supporting the production and supply of generic drugs, the article points to the limits of transnational activist networks as enduring agents of change. [source] Potential savings from increased use of generic drugs in the elderly: what the experience of Medicaid and other insurance programs means for a Medicare drug benefitPHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 4 2004Michael A. Fischer MD Abstract Background Generic medications provide the same clinical effect at lower cost than brand name drugs but little is known about the extent to which such savings are achieved in drug benefit programs serving the elderly. Methods Using patient-level claims data for participants aged 65 or more in one state Medicaid program and in a non-Medicaid drug insurance program for the elderly, we compared the expenditures in each program for brand name prescriptions with the amount that would have been paid for generic versions of the same agents. We then estimated potential savings from increased use of substitutable brand name drugs. Results There was an unrealized annual savings of $3.4 million (3.6% of total drug expenditure) in the Medicaid program studied and $13.7 million (9.5% of total drug expenditure) in the non-Medicaid drug insurance program for the elderly, with corresponding reductions in mean annual per-patient drug costs. Conclusions More widespread use of generic medications represents an important source of unrealized savings in drug coverage programs for the elderly. The Medicaid program limits the excess spending on brand name drugs by imposing pricing restrictions, but many non-Medicaid programs could realize even larger savings from reducing the use of brand name drugs when identical generic products are available. These findings offer some insight into the potential expense of a Medicare prescription drug benefit. Copyright © 2003 John Wiley & Sons, Ltd. [source] China,Intellectual Property Rights: Implications for the TRIPS-Plus Border MeasuresTHE JOURNAL OF WORLD INTELLECTUAL PROPERTY, Issue 5 2010Henning Grosse Ruse-Khan One of the ground-breaking features of the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) is its part III on the enforcement of intellectual property (IP) rights. In early 2009, the first WTO Dispute Settlement Panel Report primarily addressed obligations on IP enforcement. Here, the technical success of the US border measures claim comes with a crucial limitation: those Chinese measures that cover basically all of the commercially relevant activity are ab initio excluded from the panel's findings. Because they go beyond the minimum standards of TRIPS, the panel relied on one of the few TRIPS provisions that specify the relevance of TRIPS for additional "TRIPS-Plus" IP protection and enforcement. Given that such "TRIPS-Plus" measures are increasingly common in national laws and international treaties, it is time to take a closer look at how TRIPS addresses TRIPS-Plus IP protection. With a focus on border measures, I conclude that TRIPS contains not only minimum but also maximum standards or "ceilings" that impose limits on additional IP protection and enforcement. Such ceilings in TRIPS can function as limits for further extensions of IP protection and enforcement,as currently negotiated under a proposed Anti-Counterfeiting Trade Agreement or relating to border measures against generic drugs in transit. [source] General practitioners' ranking of evidence-based prescribing quality indicators: a comparative study with a prescription databaseBRITISH JOURNAL OF CLINICAL PHARMACOLOGY, Issue 2 2006Ifeanyi Okechukwu Background To ensure that indicators for assessing prescribing quality are appropriate and relevant, physicians should be involved in their development. How general practitioners (GPs) rank these indicators is not fully understood. Aims (i) To determine how GPs in Ireland rank a set of evidence-based prescribing quality indicators in order of importance and relevance to their practice, and (ii) to compare the GPs' ranking of the defined set of indicators with actual prescribing practice using a prescription database. Methods A postal questionnaire was sent to 105 GPs, who were asked to rank a set of 11 prescribing quality indicators, identified from the literature from most to least important. The results were aggregated and a weighted score for each indicator determined. These same prescribing indicators were then applied to a prescription database to compare the ranking provided with actual prescribing practice. Results Eighty-six GPs (82%) returned the completed questionnaire. The higher ranks were for quality issues,use of inhaled corticosteroids, statins and benzodiazepines. Actual prescribing data showed prolonged use of benzodiazepines in over half of the prescriptions dispensed (n = 18 171), 52.48% (95% confidence interval 51.95, 53.01) and low usage of generic drugs, 17.78% (17.70, 17.90) despite their high ranking by the GPs. Conclusion While GPs have diverse views about the value of different prescribing quality indicators, the results suggest that they do rank evidence-based guidelines on patient management highly, but those based on costs and less evidence the lowest. There was considerable divergence between theory and practice in the application of quality indices. [source] | ||||||||||