FDA Bioequivalence Standards

Name: FDA Bioequivalence Standards
Brand: Springer-Verlag New York Inc.
SKU: 9781493912513
Price: 982.22 PLN
Availability: InStock

Autor: Bing V. Li, Lawrence X. Yu

Język:

Oprawa: Twarda

Wydawca: Springer-Verlag New York Inc.

Dostępność: Dostępna u dostawcy

Wysyłamy za 10-13 dni

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

Informacje o książce

Autor

Bing V. Li, Lawrence X. Yu

Język

Angielski

Oprawa

Książka - Twarda

Data wydania

2014

strony

465

EAN

9781493912513

ISBN

1493912518

Enbook ID

02723205

Wydawca

Springer-Verlag New York Inc.

Waga

812

Wymiary

243 x 162 x 24

Pełny opis

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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