Generic drug product development : international regulatory requirements for bioequivalence /

Discusses the worldwide legislative and regulatory requirements for the registration of generic and multi-source drug products.

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Bibliographic Details
Corporate Authors:	Knovel (Firm), CRC Press
Other Authors:	Kanfer, Isadore, Shargel, Leon, 1941-
Format:	Electronic eBook
Language:	English
Published:	New York : Informa Healthcare, ?2010.
Series:	Drugs and the pharmaceutical sciences ; v. 201.
Subjects:	Generic drugs. Generic drugs > Law and legislation. Drugs, Generic > pharmacokinetics. Drugs, Generic > standards. Biological Availability. Drug Design. International Cooperation. Legislation, Drug. Therapeutic Equivalency.
Online Access:	Full text (WIT users only)

Table of Contents:

Australasia / C.T. Hung [and others]
Brazil / Margareth R.C. Marques, S?ilvia Storpirtis, and M?arcia Martini Bueno
Canada / Iain J. McGilveray
The European Union / Roger K. Verbeeck and Joelle Warlin
India / Subhash C. Mandal and S. Ravisankar
Japan / Juichi Riku
South Africa / Isadore Kanfer, Roderick B. Walker, and Michael F. Skinner
South America and Pan American Health Organization / Silvia Susana Giarcovich and Ricardo Bola?nos
Taiwan / Li-Heng Pao, Jo-Feng Chi, and Oliver Yoa-Pu Hu
Turkey / Ilker Kanzik and A. Atilla Hincal
United States of America / Barbara M. Davit and Dale P. Connor
The World Health Organization / John Gordon [and others].

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