Автор: Anthony C. Cartwright and Brian R. Matthews Название: International Pharmaceutical Product Registration, 2nd Edition Издательство: CRC Press Год: 2009 ISBN: 978-1420081763 Серия: Drugs and the Pharmaceutical Sciences (Book 200) Язык: English Формат: pdf Размер: 14,5 mb Страниц: 852
Discover the latest ICH news from international experts in the pharmaceutical industry, academia, and regulatory bodies.
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.
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.
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International Pharmaceutical Product Registration, 2nd Edition 
