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Book Cover
E-book

Title Generic drug product development : international regulatory requirements for bioequivalence / edited by Isadore Kanfer, Leon Shargel
Published New York : Informa Healthcare, ©2010
Online access available from:
Taylor and Francis ebooks    View Resource Record  

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Description 1 online resource (xxi, 309 pages) : illustrations
Series Drugs and the pharmaceutical sciences ; 201
Drugs and the pharmaceutical sciences ; v. 201
Contents Australasia / C.T. Hung [and others] -- Brazil / Margareth R.C. Marques, Sílvia Storpirtis, and Márcia 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 Bolaños -- 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]
Summary Discusses the worldwide legislative and regulatory requirements for the registration of generic and multi-source drug products
Bibliography Includes bibliographical references and index
Subject Generic drugs.
Generic drugs -- Law and legislation
Bioavailability.
Drugs -- Design.
International cooperation.
Drugs -- Therapeutic equivalency.
Drugs, Generic -- pharmacokinetics
Drugs, Generic -- standards
Biological Availability
Drug Design
International Cooperation
Legislation, Drug
Therapeutic Equivalency
Drugs, Generic
MEDICAL -- Pharmacology.
International cooperation
Drugs -- Therapeutic equivalency
Drugs -- Design
Bioavailability
Generic drugs
Generic drugs -- Law and legislation
Form Electronic book
Author Kanfer, Isadore
Shargel, Leon, 1941-
ISBN 9781420020021
1420020021
9781841847849
1841847844