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Bioequivalence studies for pharmaceutical products
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This review is the summary of Bioequivalence, Bioavailability and its related parameters. Brief description of Bioavailability and Bioequivalence is explained along with the post approval changes. There is a major role played by Bioavailability and Bioequivalence or the development of a drug for generic products. A bioequivalence study is required for generic products so that the rate and extent of drug can be explained which is clinically trivial. The design and conduct of Bioequivalence studies is explained which includes the selection of subject, number of subjects and dosing pattern. This article reviews the role and studies of Bioavailability and Bioequivalence in pharmaceutics.
Title: Bioequivalence studies for pharmaceutical products
Description:
This review is the summary of Bioequivalence, Bioavailability and its related parameters.
Brief description of Bioavailability and Bioequivalence is explained along with the post approval changes.
There is a major role played by Bioavailability and Bioequivalence or the development of a drug for generic products.
A bioequivalence study is required for generic products so that the rate and extent of drug can be explained which is clinically trivial.
The design and conduct of Bioequivalence studies is explained which includes the selection of subject, number of subjects and dosing pattern.
This article reviews the role and studies of Bioavailability and Bioequivalence in pharmaceutics.
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BioequivalenceArticle originally published in
Encyclopedia of Biostatistics, 2nd Edition
(2005, John Wiley & Sons, Ltd).
BioequivalenceArticle originally published in
Encyclopedia of Biostatistics, 2nd Edition
(2005, John Wiley & Sons, Ltd).
Abstract
Bioequivalence is defined as the comparable bioavailability of alternative drug formulations. Kinetic measures of bioavailability are reviewed, leading to a disc...
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