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Combination products [electronic resource] : regulatory challenges and successful product developement / Smita Gopalaswamy and Venky Gopalaswamy.

By: Contributor(s): Material type: TextPublication details: Boca Raton, Fla. : Taylor & Francis, 2008.Description: xvi, 241 p. : illISBN:
  • 9781420064513 (ebook : PDF)
Subject(s): Genre/Form: Additional physical formats: No titleNLM classification:
  • QV 26
Online resources: Available additional physical forms:
  • Also available in print edition. CRC Press (http://www.crcpress.com)
Contents:
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.
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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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