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- 2007043090 contributor B10800678.
- 2007043090 contributor B10800679.
- 2007043090 created "c2008.".
- 2007043090 date "2008".
- 2007043090 date "c2008.".
- 2007043090 dateCopyrighted "c2008.".
- 2007043090 description "Includes bibliographical references and index.".
- 2007043090 description "Overview of combination products -- Ensuring successful combination product development -- Overview of FDA and other regulatory agency expectations -- Resource requirements -- Manufacturing of combination products -- Challenges and pitfalls to avoid with combination products -- Postlaunch compliance requirements -- Agency audits and challenges.".
- 2007043090 extent "xvi, 241 p. :".
- 2007043090 identifier "1420064460 (hardcover : alk. paper)".
- 2007043090 identifier "9781420064469 (hardcover : alk. paper)".
- 2007043090 identifier 2007043090.html.
- 2007043090 issued "2008".
- 2007043090 issued "c2008.".
- 2007043090 language "eng".
- 2007043090 publisher "Boca Raton : CRC Press,".
- 2007043090 spatial "United States.".
- 2007043090 subject "615/.1 22".
- 2007043090 subject "Biological Products standards United States.".
- 2007043090 subject "Biological products Standards United States.".
- 2007043090 subject "Device Approval standards United States.".
- 2007043090 subject "Drugs Standards United States.".
- 2007043090 subject "Equipment Design standards United States.".
- 2007043090 subject "Equipment and Supplies standards United States.".
- 2007043090 subject "Medical instruments and apparatus Standards United States.".
- 2007043090 subject "Pharmaceutical Preparations standards United States.".
- 2007043090 subject "QV 26 G659c 2008".
- 2007043090 subject "RM301.27 .G68 2008".
- 2007043090 subject "United States. Food and Drug Administration.".
- 2007043090 tableOfContents "Overview of combination products -- Ensuring successful combination product development -- Overview of FDA and other regulatory agency expectations -- Resource requirements -- Manufacturing of combination products -- Challenges and pitfalls to avoid with combination products -- Postlaunch compliance requirements -- Agency audits and challenges.".
- 2007043090 title "Combination products : regulatory challenges and successful product developement / Smita Gopalaswamy, Venky Gopalaswamy.".
- 2007043090 type "text".