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llb1978

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[交流] 【取消求助】求International Pharmaceutical Product Registration, 2nd pdf电子书已有5人参与

https://catalogue.informahealthc ... roduct-Registration,-Second-Edition-ISBN-9781420081763,%201420081764;jsessionid=B6934F95EBB1E32C8F430D70306C4DC4
Listed in: Pharmaceutical & Biotechnology

International Pharmaceutical Product Registration, Second Edition
Series: Drugs and the Pharmaceutical Sciences
Anthony Cartwright (Pharmaceutical Regulatory Consultant, Harpenden, UK)
Brian R. Matthews (Alcon Laboratories, Hemel Hempstead, UK)
Book
Pub Date September 2009 Edition Second Series Drugs and the Pharmaceutical Sciences Volume 200 Pages 856 Size 7 x 10 ISBN 9781420081763, 1420081764 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 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 discussed.

The book is organized into six practical segments:

• CTD, eCTD, Module 1, and Environmental Risk Assessment
• CTD Summaries
• Quality Topics
• Nonclinical Topics
• Clinical Topics
• Other Topics, such as drug-device combination products
谢谢高手帮忙。

[ Last edited by llb1978 on 2011-5-26 at 11:57 ]

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