Combination products : regulatory challenges and successful product developement
by
Gopalaswamy, Smita., author.
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
:
United States. Food and Drug Administration.
Subject Term
:
Medical instruments and apparatus -- Standards -- United States.
Biological products -- Standards -- United States.
Drugs -- Standards -- United States.
Added Author
:
Gopalaswamy, Venky.
Electronic Access
:
| Library | Material Type | Item Barcode | Shelf Number | [[missing key: search.ChildField.HOLDING]] | Status |
|---|
| Online Library | E-Book | 547079-1001 | RM301.27 .G68 2008 | | CRC E-Books |