Biologics Development: A Regulatory Overview
Language: English
Published by Parexel Publishing, 2004
- Hardcover
- Used
Seller: World of Books Inc, Montgomery, IL, U.S.A.World of Books Inc
AbeBooks seller since March 23, 2026
Condition: Used - Very good
US$ 7.26
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Add to basketItem description from seller
This publication is the only text on Biologics Development and Regulation in the Post-CBER/CDER Consolidation Era. Completely revised and updated to address the transfer of therapeutic biological products to CDER, this all-new edition provides the most comprehensive and up-to-date analysis of the FDA's emerging processes for regulating and approving biological products. Written by CDER and CBER officials and industry experts, Biologics Development: A Regulatory Overview offers an expansive examination of the FDA's regulation of biologic products, from preclinical testing to post-marketing regulatory requirements, and from user fees to electronic submissions. Better yet, this new text provides the first detailed look inside the re-invented FDA that will regulate and approve today's biological products.
Seller Inventory # CIN1882615670VG
- Title
- Biologics Development: A Regulatory Overview
- Author
- Mark Mathieu
- Publisher
- Parexel Publishing
- Publication year
- 2004
- Condition
- Very Good
- Binding
- Hardback
- Language
- English
- ISBN 10
- 1882615670
- ISBN 13
- 9781882615674
- Edition
- 3rd Edition
"Synopsis" may belong to another edition of this title.
World of Books Inc
Montgomery, IL, U.S.A.
AbeBooks seller since March 23, 2026
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| Item | 4 to 12 business days | 3 to 6 business days |
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| First item | US$ 0.00 | US$ 10.95 |
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