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Item Details
| Title:
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INTERNATIONAL PHARMACEUTICAL PRODUCT REGISTRATION, SECOND EDITION
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| By: |
Anthony C. Cartwright (Editor), Brian R. Matthews (Editor) |
| Format: |
Electronic book text |
| List price:
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£153.00 |
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We believe that this item is permanently unavailable, and so we cannot source
it.
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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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