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.
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