Generic Drug Product Development: International Regulatory Requirements for Bioequivalence, 1st Edition (e-Book) 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

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Hardback: 9780849377853
pub: 2010-03-25
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pub: 2016-04-19
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Description

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 therapeutica

Table of Contents

Introduction. Australasia. Brazil. Canada. The European Union. India. Japan. South Africa. South America and Pan American Health Organization. Taiwan. Turkey. United States of America. The World Health Organization.

Subject Categories

BISAC Subject Codes/Headings:
MED071000
MEDICAL / Pharmacology