Combination products : regulatory challenges and successful product developement / Smita Gopalaswamy, Venky Gopalaswamy
Material type:
TextPublication details: Boca Raton : CRC Press, c2008Description: xvi, 241 p. : ill. ; 25 cmISBN: - 9781420064469 (hardcover : alk. paper)
- 1420064460 (hardcover : alk. paper)
- United States Food and Drug Administration
- United States Food and Drug Administration
- Drugs -- Standards -- United States
- Medical instruments and apparatus -- Standards -- United States
- Biological products -- Standards -- United States
- Equipment Design -- standards -- United States
- Pharmaceutical Preparations -- standards -- United States
- Biological Products -- standards -- United States
- Device Approval -- standards -- United States
- Equipment and Supplies -- standards -- United States
| Item type | Current library | Call number | Copy number | Status | Date due | Barcode | |
|---|---|---|---|---|---|---|---|
Open Shelf
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UMPLIB GAMBANG | RM301.27 .G67 2008 (Browse shelf(Opens below)) | 1 | Available | 0000051278 |
Includes bibliographical references and index
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