Generic Drug Product Development International Regulatory Requirements for Bioequivalence

by Isadore Kanfer

Part of the Drugs and the Pharmaceutical Sciences Series

Generic Drug Product Development International Regulatory Requirements for Bioequivalence Synopsis

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.

Book Information

ISBN: 9780849377853
Publication date: 15th April 2009
Author: Isadore Kanfer
Publisher: CRC Press Inc an imprint of Taylor & Francis Inc
Format: Hardback
Pagination: 332 pages
Categories: Pharmaceutical technology, Pharmaceutical industries,

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