Téléchargez le livre : Bioequivalence Requirements in Various Global Jurisdictions

Bioequivalence Requirements in Various Global Jurisdictions

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Springer


Collection :

AAPS Advances in the Pharmaceutical Sciences Series

Paru le : 2017-12-05

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Description

Although the Bioequivalence (BE) requirements in many global jurisdictions have much in common, differences in certain approaches and requirements such as definitions and terms, choice of comparator (reference) product, acceptance criteria, fasted and fed studies, single and multi-dose studies, biowaivers and products not intended for absorption into the systemic circulation (locally acting medicines and dosage forms), amongst others, provide food for thought that standardisation should be a high priority objective in order to result in a harmonized international process for the market approval of products using BE. An important objective of Bioequivalence Requirements in Various Global Jurisdictions is to attempt to gather the various  BE requirements used in different global jurisdictions to provide a single source of relevant information. This information from, Brazil, Canada, China, European Union, India, Japan, MENA, Russia South Africa, the
USA and WHO will be of value 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.
Pages
345 pages
Collection
AAPS Advances in the Pharmaceutical Sciences Series
Parution
2017-12-05
Marque
Springer
EAN papier
9783319680774
EAN PDF
9783319680781
Informations sur l'ebook
Nombre pages copiables
3
Nombre pages imprimables
34
Taille du fichier
4454 Ko
Prix
220,49 €
EAN EPUB
9783319680781
Informations sur l'ebook
Nombre pages copiables
3
Nombre pages imprimables
34
Taille du fichier
1024 Ko
Prix
220,49 €

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