New Drug Approval Process by Richard A. Guarino
(Drugs and the Pharmaceutical Sciences, Vol 56)

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Synopsis

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.

 

About Richard A. Guarino

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Published March 14, 2007 by Marcel Dekker Inc. 664 pages
Genres: Health, Fitness & Dieting, Professional & Technical, Nature & Wildlife, Science & Math. Non-fiction

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