Home About us Contact
|
Home About us Contact | ||
|
|
||
Generic Products (generic + products)
Selected AbstractsGeneric Products of Antiepileptic Drugs (AEDs): Is It an Issue?EPILEPSIA, Issue 10 2007Meir Bialer Summary:, The availability of generic products of antiepileptic drugs (AEDs) has raised the following concerns: (1) Do generic AEDs work as well as brand AEDs in terms of their efficacy, safety and quality? (2) Can generic AEDs be used as substitutions for brand AEDs? and (3) Can generic products of AEDs be used interchangeably? The traditional average bioequivalence analysis addresses concern 1 but does not provide a complete adequate response to concerns 2 and 3. Drug interchangeability can be classified as drug prescribability or drug switchability. Drug prescribability refers to the situation where a patient is treated for the first time so that either a brand or a bioequivalent generic AED can be chosen. Drug switchability refers to the situation in which a brand AED is switched to a bioequivalent generic product of the same AED. The traditional average bioequivalence approach is sufficient to evaluate the prescribability of generic products, but does not ensure the switchability between prescribable formulations. The necessity of assuring switchability of two formulations can be addressed by individual bioequivalence. While the switch to generic AEDs is well tolerated by many patients and in general cost-effective, seizure control should not be sacrificed on the basis of cost alone, as the major end point in treating epilepsy with AEDs is seizure control without side effects. Until we have individual (within patient) bioequivalence data on generic AEDs and/or the tools to a priori identify the subset of patients susceptible to the generic switch, a switch of AED products in seizure-free patients is not recommended. [source] Bioavailability of generic ritonavir and lopinavir/ritonavir tablet products in a dog modelJOURNAL OF PHARMACEUTICAL SCIENCES, Issue 2 2010Kevin W. Garren Abstract In this study, we explored the bioavailability in dogs and chemical potency of generic ritonavir and lopinavir/ritonavir tablet products manufactured by various pharmaceutical companies. Chemical potency of the products was examined by HPLC quantitation of ritonavir and lopinavir. Using a dog model, we determined point estimates for Cmax and AUC of ritonavir and lopinavir/ritonavir for eight generic products compared to Abbott's Norvir® capsule and Kaletra® tablet. Chemical potencies ranged from 79.0% to 104.6%. Point estimates for AUC in the generic tablet products ranged from 0.01 to 1.11, indicating that the relative bioavailability of these formulations was in the range of 1,111% compared to the branded products. This study showed significant variability in bioavailability in a dog model amongst generic tablet products containing the protease inhibitors ritonavir or lopinavir/ritonavir. The chemical potency of the generic products was not indicative of the plasma levels of ritonavir or lopinavir that were achieved. These results reinforce the need for human bioequivalence testing of generic products containing ritonavir or lopinavir/ritonavir to assure that efficacy in patients is not compromised prior to these products being made available to patients. Procurement policies of funding agencies should require such quality assurance processes. © 2009 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 99:626,631, 2010 [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] Investigation on different levels of in vitro,in vivo correlation: gemfibrozil immediate release capsuleBIOPHARMACEUTICS AND DRUG DISPOSITION, Issue 6 2008Mohammad-Reza Rouini Abstract Gemfibrozil is a practically water-insoluble, high-dose drug. It represents a typical drug with dissolution rate controlled bioavailability. The aim of this study was to select a dissolution condition for gemfibrozil immediate release capsules, resulting in the best in vitro/in vivo correlation (IVIVC). Five 300,mg gemfibrozil products, including the innovator and four generic products were selected. In vitro dissolution test methods with a standard paddle, round-bottomed vessel of 1,l capacity, and potassium phosphate buffer as the dissolution medium (referred to as conditions I, II and III, respectively) were developed. The products were administered to 12 healthy volunteers and thereby different pharmacokinetic parameters were calculated. Correlations between the in vitro and in vivo calculated parameters were investigated. Of the single point parameters investigated, the best results were seen in the relation between the percent dissolved in 10, 20 and 45,min and the time to 90% dissolution from the in vitro side and the AUCs and Cmax from the in vivo side. The correlation between MRT and MDT was also investigated, and no significant correlation was found in the three above-mentioned conditions. The Wagner-Nelson method was used to calculate the percent remaining to be absorbed. Superimposition of the percent in vivo absorption and the in vitro dissolution curves was used to investigate a multiple point correlation. A remarkable superimposition between in vivo and in vitro curves in conditions I and II was observed. Copyright © 2008 John Wiley & Sons, Ltd. [source] Therapeutic drug monitoring in a developing country: an overviewBRITISH JOURNAL OF CLINICAL PHARMACOLOGY, Issue S1 2001N. J. Gogtay Therapeutic Drug Monitoring (TDM) was introduced in India in the mid and late 1980s and the last 10 years have seen it grow, together with the growth of separate Clinical Pharmacology departments. The TDM service in the country is broadly of two types: in large teaching hospitals where the service is available through departments of Clinical Pharmacology, and in the private sector, where drug estimations are done by clinical biochemistry departments with minimal interpretation. This article is based on literature review and our own experiences over a 10 year period in a department of Clinical Pharmacology. It focuses on the evolution of TDM, its problems such as lack of funding, special aspects such as the impact of ethnic diff;erences, nutritional defi;ciencies, quality of medicines and availability of generic products; its utility as a research tool and its future. [source] | ||||||||||