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Title International pharmaceutical product registration / edited by Anthony Cartwright, Brian R. Matthews
Edition Second edition
Published New York : Informa Healthcare, [2009]
Online access available from:
ProQuest Ebook Central (owned titles)    View Resource Record  


Description 1 online resource (xvi, 835 pages)
Series Drugs and the pharmaceutical sciences ; v. 200
Drugs and the pharmaceutical sciences ; v. 200
Contents pt. 1. Introduction and specific requirements -- pt. 2. Common technical document summaries -- pt. 3. Quality : drug substance and drug product -- pt. 4. Nonclinical studies -- pt. 5. Clinical studies -- pt. 6. Special products and modeling
Summary The recent International Conference on Harmonisation (ICH) revisions of regulatory requirements for quality, nonclinical, and clinical pharmaceutical product registration are the focus of this timely update
Bibliography Includes bibliographical references and index
Notes Print version record
Subject Drugs -- Law and legislation.
Drugs -- Testing -- Standards.
Pharmaceutical technology -- Standards.
Technology, Pharmaceutical -- standards.
Clinical Trials as Topic -- standards.
Legislation, Drug.
Quality Control.
Form Electronic book
Author Cartwright, A. C. (Anthony C.), 1940-
Matthews, Brian (Brian R.)
ISBN 1420081837 (electronic bk.)
9781420081831 (electronic bk.)