Автор: Richard A Guarino
Название: New Drug Approval Process
Издательство: CRC Press
Год: 1999
Серия: Drugs and the Pharmaceutical Sciences (Book 100)
Язык: English
Формат: pdf
Размер: 25,7 mb
Страниц: 463

The drug discovery and development process requires the close interaction of a large number of scientific disciplines for as many as 10 or 12 years. Most pharmaceutical and biotechnology firms employ teams to guide the processes involved in taking a discovery through the various drug development stages and making the drug candidate into a therapeutic product.

The book 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.