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New Drug Approval Process

New Drug Approval Process PDF Author: Richard A. Guarino
Publisher: CRC Press
ISBN: 9780824750411
Category : Medical
Languages : en
Pages : 664

Book Description
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.
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