Title:
Combination products : regulatory challenges and successful product developement
Author:
Gopalaswamy, Smita., author.
ISBN:
9780429149832
Physical Description:
1 online resource (xvi, 241 pages)
Contents:
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.
Corporate Subject:
Added Author:
Electronic Access:
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Library | Material Type | Item Barcode | Shelf Number | Status | Item Holds |
|---|---|---|---|---|---|
Searching... | E-Book | 547079-1001 | RM301.27 .G68 2008 | Searching... | Searching... |