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Gopalaswamy, Smita.

Combination products regulatory challenges and successful product developement / [electronic resource] : Smita Gopalaswamy and Venky Gopalaswamy. - Boca Raton, Fla. : Taylor & Francis, 2008. - xvi, 241 p. : ill.

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.




Mode of access: World Wide Web.

9781420064513 (ebook : PDF)


United States. Food and Drug Administration.


Drugs--Standards--United States.
Medical instruments and apparatus--Standards--United States.
Biological products--Standards--United States.


Electronic books.

QV 26 / G659c 2008

Khulna University of Engineering & Technology

Funded by: HEQEP, UGC, Bangladesh