Téléchargez le livre : FDA Bioequivalence Standards

FDA Bioequivalence Standards

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Éditeur :

Springer


Collection :

AAPS Advances in the Pharmaceutical Sciences Series

Paru le : 2014-09-05

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Description

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.
Pages
465 pages
Collection
AAPS Advances in the Pharmaceutical Sciences Series
Parution
2014-09-05
Marque
Springer
EAN papier
9781493912513
EAN EPUB
9781493912520
Informations sur l'ebook
Nombre pages copiables
4
Nombre pages imprimables
46
Taille du fichier
2499 Ko
Prix
231,04 €

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