Bioequivalence Studies with Pharmacokinetic Endpoints for Refresh the concepts of pharmaceutical equivalence (PE) and bioequivalence (BE) for a generic drug product.
Bioavailability and Bioequivalence in Drug Development - PMC
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.
Bioequivalence - Wikipedia
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.
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.
Bioequivalence - an overview | ScienceDirect Topics
Jul 30, 2020 · Bioequivalence studies require multidisciplinary perspectives, and major input from regulatory, pharmacokinetic, and statistical subject matter experts. In a typical bioequivalence study, two products, T (test product) and R (reference product), are each administered.
Bioequivalence Studies - SpringerLink
Jan 1, 2022 · Bioequivalence studies are designed with the aim to compare the relative bioavailability between a generic drug (test formulation) and the original or innovative drug (reference formulation) by means of the assessment of the ratio of the main pharmacokinetic parameters – peak plasma concentration (C max) and area under the curve of plasma ...
Investigation of bioequivalence - Scientific guideline | European ...
bioequivalence. - Scientific. guideline. 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.
Bioequivalence - SpringerLink
Jan 1, 2022 · Bioequivalence studies are globally used to increase access to pharmaceutical products with certified quality.
The global status of bioequivalence trials: a comprehensive …
Nov 7, 2024 · This study concentrates largely on the global status and future trends of BE trials, aiming to provide references for future drug development, review and approval. ... virtual bioequivalence (VBE) based on PBBM technology utilizes computational models and physiological knowledge to simulate the absorption, distribution, metabolism and excretion ...
Bioequivalence - an overview | ScienceDirect Topics
Bioequivalence studies are special type of studies where two drugs or two sets of formulation of the same drug are compared to show that they have nearly equal bioavailability and PK/PD parameters. These studies are often done for generic drugs or when a formulation of a drug is changed during development.
- Some results have been removed