TY  - BOOK
AU  - Gopalaswamy,Smita
AU  - Gopalaswamy,Venky
TI  - Combination products: regulatory challenges and successful product developement 
SN  - 9781420064513 (ebook : PDF)
PY  - 2008///
CY  - Boca Raton, Fla.
PB  - Taylor & Francis
KW  - United States
KW  - Food and Drug Administration
KW  - Drugs
KW  - Standards
KW  - Medical instruments and apparatus
KW  - Biological products
KW  - Electronic books
KW  - lcsh
N1  - 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)
UR  - http://marc.crcnetbase.com/isbn/9781420064513
ER  -