Generic Drug Product Development: International Regulatory Requirements for Bioequivalence, 1st Edition (Hardback) book cover

Generic Drug Product Development

International Regulatory Requirements for Bioequivalence, 1st Edition

Edited by Isadore Kanfer, Isadore Kanfer, Leon Shargel, Leon Shargel

CRC Press

332 pages | 50 B/W Illus.

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Hardback: 9780849377853
pub: 2010-03-25
eBook (VitalSource) : 9780429132919
pub: 2016-04-19
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Due to a worldwide need for lower cost drug therapy, use of generic and multi-source drug products have been increasing. To meet international patent and trade agreements, the development and sale of these products must conform to national and international laws, and generic products must prove that they are of the same quality and are therapeutically equivalent to the brand name alternative. However, many countries have limited resources to inspect and verify the quality of all drug products for sale in their country.  This title discusses the worldwide legislative and regulatory requirements for the registration of generic and multi-source drug products.

Table of Contents


Isadore Kanfer


C. T.Hung, D. Ren, L. A. Folland, F. C. Lam, Noelyn AnneHung,

and R. Smart


Margareth R. C. Marques, Sılvia Storpirtis, and Marcia Martini Bueno


Iain J. McGilveray

The European Union

Roger K. Verbeeck and Joelle Warlin


Subhash C. Mandal and S. Ravisankar


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 Bolaños


Li-Heng Pao, Jo-Feng Chi, and Oliver Yoa-Pu Hu


Ilker Kanzik and A. Atilla Hincal

United States of America

Barbara M. Davit and Dale P. Conner

TheWorld Health Organization

John Gordon, Henrike Potthast, Matthias Stahl, and Lembit Rago

About the Series

Drugs and the Pharmaceutical Sciences

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Subject Categories

BISAC Subject Codes/Headings:
MEDICAL / Pharmacology