Bioequivalence Requirements in Various Global Jurisdictions (Hardcover, 1st ed. 2017)

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.

General

Imprint:	Springer International Publishing AG
Country of origin:	Switzerland
Series:	AAPS Advances in the Pharmaceutical Sciences Series, 28
Release date:	December 2017
First published:	2017
Editors:	Isadore Kanfer
Dimensions:	235 x 155mm (L x W)
Format:	Hardcover
Pages:	345
Edition:	1st ed. 2017
ISBN-13:	978-3-319-68077-4
Categories:	Books > Professional & Technical > Industrial chemistry & manufacturing technologies > Industrial chemistry > Pharmaceutical technology
LSN:	3-319-68077-3
Barcode:	9783319680774

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