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Combination products : regulatory challenges and successful product developement / Smita Gopalaswamy, Venky Gopalaswamy
Publication details: Boca Raton : CRC Press, 2008Description: xvi, 241 p. : ill. ; 25 cmISBN:- 9781420064469 (hardcover : alk. paper)
- 1420064460 (hardcover : alk. paper)
- QV26
Contents:
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
| Item type | Current library | Home library | Collection | Call number | Materials specified | Copy number | Status | Date due | Barcode | |
|---|---|---|---|---|---|---|---|---|---|---|
| AM | PERPUSTAKAAN DR ABDUL LATIFF | PERPUSTAKAAN DR ABDUL LATIFF KOLEKSI AM-P. DR ABDUL LATIFF | - | QV26.G659c 2008 9 (Browse shelf(Opens below)) | 1 | Available | 00001505186 |
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
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