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.