FDA Bioequivalence Standards

Publication Date: 2014-09-14

Edited by Lawrence X. Yu and Bing V. Li

This comprehensive reference provides an in-depth discussion on state-of-the-art regulatory science in bioequivalence. In 16 chapters the volume explores a broad range of topics pertaining to bioequivalence, including its origin and principles, statistical considerations, food effect studies, conditions for waivers of bioequivalence studies, Biopharmaceutics Classification Systems, Biopharmaceutics Drug Disposition Classification System, bioequivalence modeling/simulation, and best practices in bioanalysis. It also discusses bioequivalence studies with pharmacodynamic and clinical endpoints as well as bioequivalence approaches for highly variable drugs, narrow therapeutic index drugs, liposomes, locally acting gastrointestinal drug products, topical products, and nasal and inhalation products. Written by FDA regulatory scientists who develop regulatory policies and conduct regulatory assessment of bioequivalence, the book is a valuable resource for scientists who work in the pharmaceutical industry, regulatory agencies, and academia as well as undergraduate and graduate students looking to expand their knowledge about bioequivalence standards.

ISBN: 978-1-4939-1251-3

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