Title International pharmaceutical product registration / edited by Anthony Cartwright, Brian R. Matthews

Edition 2nd ed Published New York : Informa Healthcare, ©2009

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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 Pharmaceutical technology -- Standards Drugs -- Testing -- Standards Drugs -- Law and legislation. Quality control. Technology, Pharmaceutical -- standards Clinical Trials as Topic -- standards Legislation, Drug Quality Control quality control. Quality control Drugs -- Law and legislation Drugs -- Testing -- Standards Pharmaceutical technology -- Standards Form Electronic book Author Cartwright, A. C. (Anthony C.), 1940- Matthews, Brian (Brian R.) ISBN 9781420081831 1420081837

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