FDA Bioequivalence Standards

Autor: Bing V. Li, Lawrence X. Yu

Jazyk:

Väzba: Brožovaná

Vydavateľ: Springer-Verlag New York Inc.

Dostupnosť: Skladom u dodávateľa

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This comprehensive reference provides an in-depth discussion on state-of-the-art regulatory science...

Informácie o knihe

Autor

Bing V. Li, Lawrence X. Yu

Jazyk

Angličtina

Väzba

Kniha - Brožovaná

Vydalo

2016

Stránok

465

EAN

9781493955589

ISBN

1493955586

Enbook ID

14277268

Vydavateľ

Springer-Verlag New York Inc.

Hmotnosť

7197

Rozmery

155 x 235 x 23

Kompletný popis

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.

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