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Bioequivalence requirements in various global jurisdictions

Record Type:	Electronic resources : Monograph/item
Title/Author:	Bioequivalence requirements in various global jurisdictionsedited by Isadore Kanfer.
other author:	Kanfer, Isadore.
Published:	Cham :Springer Nature Switzerland :2025.
Description:	xiii, 237 p. :ill. (chiefly color), digital ;24 cm.
Contained By:	Springer Nature eBook
Subject:	DrugsTherapeutic equivalency.
Online resource:	https://doi.org/10.1007/978-3-031-76774-6
ISBN:	9783031767746$q(electronic bk.)

Bioequivalence requirements in various global jurisdictions
Bioequivalence requirements in various global jurisdictions[electronic resource] /edited by Isadore Kanfer. - Second edition. - Cham :Springer Nature Switzerland :2025. - xiii, 237 p. :ill. (chiefly color), digital ;24 cm. - AAPS advances in the pharmaceutical sciences series,v. 612210-738X ;. - AAPS advances in the pharmaceutical sciences series ;3..

Brazil -- Canada -- The European Union (EU) -- India -- Japan -- The United States of America -- World Health Organization (WHO).

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.

ISBN: 9783031767746$q(electronic bk.)

Standard No.: 10.1007/978-3-031-76774-6doiSubjects--Topical Terms:

265612
Drugs
--Therapeutic equivalency.

LC Class. No.: RM301.45

Dewey Class. No.: 615.1

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