Bioequivalence Requirements in Various Global Jurisdictions

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Éditeur :

Springer


Collection :

AAPS Advances in the Pharmaceutical Sciences Series

Paru le : 2025-04-29

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Description

An important objective of Bioequivalence Requirements in Various Global Jurisdictions is to attempt to gather current and updated information, collated in a single source, regarding the various bioequivalence and related requirements to satisfy the regulatory requirements for the market approval of multi-source (generic) drug products in various global jurisdictions.
In view of the dynamic nature of regulatory requirements which are usually regularly updated, updating these requirements to remain current is an important necessity to provide such information to drug manufacturers, regulatory agencies, pharmaceutical scientists and related health organizations and governments around the world in the quest to harmonize regulatory requirements for the market approval of generic products. The revised volume includes updated information based on recent guidances and guidelines from the respective regulatory agencies as well as important trends and descriptions relating to innovative approaches for bioequivalence assessment.
Pages
237 pages
Collection
AAPS Advances in the Pharmaceutical Sciences Series
Parution
2025-04-29
Marque
Springer
EAN papier
9783031767739
EAN PDF
9783031767746

Informations sur l'ebook
Nombre pages copiables
2
Nombre pages imprimables
23
Taille du fichier
6584 Ko
Prix
200,44 €
EAN EPUB
9783031767746

Informations sur l'ebook
Nombre pages copiables
2
Nombre pages imprimables
23
Taille du fichier
8212 Ko
Prix
200,44 €