Автор: Richard A. Guarino
Название: New Drug Approval Process: Accelerating Global Registrations, 4th Edition
Издательство: CRC Press
Год: 2004
ISBN: 978-0824750411
Серия: Drugs and the Pharmaceutical Sciences (Book 139)
Язык: English
Формат: pdf
Размер: 12,1 mb
Страниц: 668

Offering expert guidance on the clinical, regulatory, and statistical processes involved in the development of new pharmaceutical product applications for drugs, biologicals, and medical devices, the Fourth Edition details the specific regulations, guidelines, and procedures that will advance and ensure approval of United States and global new product applications. It communicates and integrates a new approach to the world of pharmaceutical personnel on all aspects of new product development and alerts readers to clinical and regulatory tasks that require immediate attention and long-term follow-up in order to comply with the international acceptance of new product approvals.