FDA Bioequivalence Standards Tapa dura - 2014
de Lawrence X. Yu (Editor); Bing V. Li (Editor)
Descripción de contraportada
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.
Detalles
- Título FDA Bioequivalence Standards
- Autor Lawrence X. Yu (Editor); Bing V. Li (Editor)
- Encuadernación Tapa dura
- Edición FALSE
- Páginas 465
- Volúmenes 1
- Idioma ENG
- Editorial Springer
- Fecha de publicación 2014-09-06
- Ilustrado Sí
- Features Bibliography, Illustrated, Index
- ISBN 9781493912513 / 1493912518
- Peso 2.3 libras (1.04 kg)
- Dimensiones 9.2 x 6.1 x 1.3 pulgadas (23.37 x 15.49 x 3.30 cm)
-
Temas
- Aspects (Academic): Reference
- Library of Congress subjects United States, Therapeutic Equivalency
- Número de catálogo de la Librería del Congreso de EEUU 2014945359
- Dewey Decimal Code 615.19
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