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Book synopsis

This comprehensive reference provides an in-depth discussion on state-of-the-art regulatory science in bioequivalence. In sixteen 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. FDA Bioequivalence Standards is written by FDA regulatory scientists who develop regulatory policies and conduct regulatory assessment of bioequivalence. As such, both practical case studies and fundamental science are highlighted in these chapters. 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.

Book details

Book category Books in English Technology, engineering, agriculture Industrial chemistry & manufacturing technologies Industrial chemistry

• Full title: FDA Bioequivalence Standards
• Author: Bing V. Li, Lawrence X. Yu
• Language: English
• Binding: Paperback
• Number of pages: 465
• EAN: 9781493955589
• ISBN: 1493955586
• ID: 14277268
• Publisher: Springer-Verlag New York Inc.
• Weight: 7197 g
• Dimensions: 235 × 155 × 23 mm
• Date of publishing: 17. September 2016

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