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New Drug Approval Process

Accelerating Global Registrations

New Drug Approval Process by Richard A. Guarino
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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.
Informa Healthcare; Read online
Title: New Drug Approval Process
Author: Richard A. Guarino; Richard Guarino
 
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