Combination products [electronic resource] : regulatory challenges and successful product developement / Smita Gopalaswamy and Venky Gopalaswamy.
Material type: TextPublication details: Boca Raton, Fla. : Taylor & Francis, 2008.Description: xvi, 241 p. : illISBN:- 9781420064513 (ebook : PDF)
- QV 26
- Also available in print edition. CRC Press (http://www.crcpress.com)
Includes bibliographical references and index.
Overview and definitions of combination products -- Ensuring successful development -- Overview of FDA and other regulatory agency expectations -- Resource requirements -- Manufacturing of combination products -- Challenges and pitfalls to avoid with combination products -- Post launch compliance requirements -- Agency audits and challenges.
Also available in print edition. CRC Press (http://www.crcpress.com)
Mode of access: World Wide Web.
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