FDA Bioequivalence Standards Hardcover - 2014
by Lawrence X. Yu (Editor); Bing V. Li (Editor)
From the rear cover
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.
Details
- Title FDA Bioequivalence Standards
- Author Lawrence X. Yu (Editor); Bing V. Li (Editor)
- Binding Hardcover
- Edition FALSE
- Pages 465
- Volumes 1
- Language ENG
- Publisher Springer
- Date 2014-09-06
- Illustrated Yes
- Features Bibliography, Illustrated, Index
- ISBN 9781493912513 / 1493912518
- Weight 2.3 lbs (1.04 kg)
- Dimensions 9.2 x 6.1 x 1.3 in (23.37 x 15.49 x 3.30 cm)
-
Themes
- Aspects (Academic): Reference
- Library of Congress subjects United States, Therapeutic Equivalency
- Library of Congress Catalog Number 2014945359
- Dewey Decimal Code 615.19
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FDA Bioequivalence Standards
by Lawrence X. Yu
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Fda Bioequivalence Standards (Hb 2014)
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FDA Bioequivalence Standards (AAPS Advances in the Pharmaceutical Sciences Series, 13)
by Yu, Lawrence X. [Editor]; Li, Bing V. [Editor];
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