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Bioequivalence is a term in pharmacokinetics used to assess the expected in vivo biological equivalence of two proprietary preparations of a drug. If two products are said to be bioequivalent it means that they would be expected to be, for all intents and purposes, the same.
Scientific guidelines. This document specifies the requirements for the design, conduct, and evaluation of bioequivalence studies for immediate release dosage forms with systemic action. Read together with Appendix IV.
concept of bioequivalence is fundamental. The purpose of establishing bioequivalence is to demonstrate equivalence in biopharmaceutics quality between the generic medicinal product and a reference medicinal product in order to allow bridging of preclinical tests and of clinical trials associated with the reference medicinal product.
This section includes the European Medicines Agency's (EMA) product-specific bioequivalence guidance, which summarises in a standardised format the relevant study design principles for demonstration of bioequivalence.
30 lip 2020 · Bioequivalence is the absence of a significant difference in the rate and extent of drug available at the site of action after dosing of a test product, compared to a reference product. In general, bioequivalence is evaluated by comparing the bioavailability of the test, and the reference products, in crossover clinical studies on healthy subjects.
24 lip 2012 · The aim of the present paper is to summarize the revised European Union (EU) Guideline on the Investigation of Bioequivalence and to discuss critically with respect to previous European requirements and present US Food and Drug Administration guidelines its more relevant novelties such as the following: in order to facilitate the development of ...
1 sty 2022 · Bioequivalence studies are used to compare the bioavailability of the API from the generic and original product under standardized conditions. Therefore, bioequivalence studies can be considered as a performance measure of the in vivo dissolution of the drug product.
