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Item Details
Title: INTERNATIONAL PHARMACEUTICAL PRODUCT REGISTRATION, SECOND EDITION
By: Anthony C. Cartwright (Editor), Brian R. Matthews (Editor)
Format: Electronic book text

List price: £153.00


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ISBN 10: 1420081837
ISBN 13: 9781420081831
Publisher: TAYLOR & FRANCIS INC
Pub. date: 19 April, 2016
Edition: 2nd New edition
Pages: 852
Synopsis: Discover the latest ICH news from international experts in the pharmaceutical industry, academia, and regulatory bodies.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.This cutting-edge resource includes the major headings in the modular structure of the Common Technical Document (CTD), which is now the agreed format for product information submission. The format, specification, and technical requirements of the e-CTD, the electronic version of CTD, are also thoroughly discussed.The book is organized into six highly practical segments:Part I: CTD, eCTD, Module 1, and Environmental Risk AssessmentPart II: CTD SummariesPart III: Quality TopicsPart IV: Nonclinical TopicsPart V: Clinical TopicsPart VI: Other Topics (including drug-device combination products)This text is a must-have for those in the pharmaceutical industry determining regulatory requirements for the major world markets in Europe, the US, Canada, and Japan.
Illustrations: 150 Illustrations, black and white
Publication: US
Imprint: CRC Press Inc
Returns: Non-returnable
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