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Bioequivalence requirements in vario...

Kanfer, Isadore.

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Bioequivalence requirements in various global jurisdictions

紀錄類型:	書目-電子資源 : Monograph/item
正題名/作者:	Bioequivalence requirements in various global jurisdictions/ edited by Isadore Kanfer.
其他作者:	Kanfer, Isadore.
出版者:	Cham :Springer Nature Switzerland : : 2025.,
面頁冊數:	xiii, 237 p. :ill. (chiefly color), digital ;24 cm.
內容註:	Brazil -- Canada -- The European Union (EU) -- India -- Japan -- The United States of America -- World Health Organization (WHO).
Contained By:	Springer Nature eBook
標題:	Drugs - Therapeutic equivalency. -
電子資源:	https://doi.org/10.1007/978-3-031-76774-6
ISBN:	9783031767746

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 ;v. 61..

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

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

1359613
Drugs
--Therapeutic equivalency.

LC Class. No.: RM301.45

Dewey Class. No.: 615.1

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