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.