Development and Approval of Combination Products

Author:
Edition: 1
Binding: Hardcover
ISBN: 0470050942

Development and Approval of Combination Products: A Regulatory Perspective

A step-by-step, integrated approach for successful, FDA-approved combination drug products

Using a proven integrated approach to combination drug development, this book guides you step by step through all the preclinical, clinical, and manufacturing stages. Get Development and Approval of Combination Products diet books 2013 for free.
Written from an FDA regulatory perspective, the book not only enables you to bring a successful combination drug product to market, it also sets forth the most efficient and effective path to FDA approval.

The book begins with an introductory chapter presenting definitions and basic regulatory principles of combination products. Next, it reviews manufacturing and controls, preclinical testing models, pharmacology, clinical testing, regulatory submissions, FDA reviews, and approvals. Check Development and Approval of Combination Products our best diet books for 2013. All books are available in pdf format and downloadable from rapidshare, 4shared, and mediafire.

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