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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.
In a bioequivalence study, the individual kinetic responses are evaluated from the measured concentrations. The means of the logarithmic responses of the two formulations are calculated. These sample averages estimate the true population means. A variance is also estimated for each kinetic response.
Cmax, the maximum plasma concentration or peak exposure, and the time to maximum plasma concentration, tmax, are parameters that are influenced by absorption rate. It is the objective of this guideline to specify the requirements for the design, conduct, and evaluation of bioequivalence studies.
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.
Bioequivalence Studies with Pharmacokinetic Endpoints for Refresh the concepts of pharmaceutical equivalence (PE) and bioequivalence (BE) for a generic drug product.
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.
6 paź 2009 · Some examples of such cases are: (a) when the parent drug is rapidly and extensively metabolized such that only metabolite (s) data is available, (b) the metabolite is more highly correlated to therapeutic efficacy than the parent, or (c) both the parent and metabolite (s) are responsible for therapeutic effect (10).
