New Drug Approval Process: Accelerating Global Registrations (Drugs and the Pharmaceutical Sciences) - Hardcover

Hardcover

ISBN 10: 0824750411 ISBN 13: 9780824750411

Publisher: CRC Press, 2004

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 this title

Review

..."a useful road map to understanding the requirements that a drug product must fulfill to achieve approval." Journal of Medicinal Chemistry "There are very useful formats, brochures, statistics, addresses and checklists provided...in order to have a clean picture of the entire drug approval process. "The book has accomplished the laborious task of obtaining about 600 indispensable acronyms.a must for researchers, libraries, project consultants and...regulatory personnel." Pharmaceutical Development and Technology

Edition details

• Publisher: CRC Press
• Publication date: 2004
• Language: English
• ISBN 10: 0824750411
• ISBN 13: 9780824750411
• Binding: Hardcover
• Edition number: 4
• Number of pages: 668
• Editor: Guarino Richard A.