ISBN 9780824750411,New Drug Approved Process: Accelerating Global Registrations

New Drug Approved Process: Accelerating Global Registrations



Routledge a Taylor & Francis Group

Publication Year 2004

ISBN 9780824750411

ISBN-10 0824750411

Hard Back

Edition 4th
Number of Pages 664 Pages
Language (English)

Medicine: general issues

Clarifying how to develop and market new drugs efficiently and economically for global markets, this text covers the emphasis on over-the-counter drugs in the long-range plans of many companies and discusses license applications review boards.

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.