Generic Drug Product Development
International Regulatory Requirements for Bioequivalence
1st Edition
Published on 19. April 2016
332 pages
978-1-4200-2002-1 (ISBN)
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
More details
Edition
1. Auflage
Language
English
Place of publication
Baton Rouge
United States
Publishing group
Taylor & Francis Inc
Target group
Professional and scholarly
Specialists and researchers in pharmaceutical drug development, regulation, manufacturing, and engineering.
Illustrations
50 s/w Abbildungen
50 b/w images
File size
2,74 MB
ISBN-13
978-1-4200-2002-1 (9781420020021)
Copyright in bibliographic data and cover images is held by Nielsen Book Services Limited or by the publishers or by their respective licensors: all rights reserved.
Schweitzer Classification
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Additional editions
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Content
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.
