New Drug Development: Regulatory Paradigms for Clinical Pharmacology and BiopharmaceuticsКНИГИ » ЗДОРОВЬЕ И МЕДИЦИНА
Автор: Chandrahas Sahajwalla Название: New Drug Development: Regulatory Paradigms for Clinical Pharmacology and Biopharmaceutics Издательство: CRC Press Год: 2004 ISBN: 978-0824754655 Серия: Drugs and the Pharmaceutical Sciences (Book 141) Язык: English Формат: pdf Размер: 10,6 mb Страниц: 500
This volume acquaints readers with procedures that determine the success of drug development projects with updated regulatory guidelines from the FDA and ICH, solutions to hurdles in application protocols, and recommendations from more than 40 respected and experience officials from regulatory agencies around the globe. It covers topics related to the development of chiral drugs, liposomal products, and more.