ENGLISH

New Drug Approval Process Accelerating Global Registrations

By Richard A. Guarino

Book information

Publisher
CRC Press
Year
2004
ISBN
978-0824750411
Language
english
Format
PDF
Filesize
12 MB (12697634 bytes)
Series
Drugs and the Pharmaceutical Sciences
Pages
\581
Time added
2016-12-30 22:43:04

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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