Combination products : regulatory challenges and successful product development / Smita Gopalaswamy, Venky Gopalaswamy.
Material type:
TextPublication details: Boca Raton, Fla. : CRC ; London : Taylor & Francis [distributor], 2008.Description: xvi, 241 p. : ill. ; 25 cmISBN: - 9781420064469 (hbk.) :
- 1420064460 (hbk.) :
- 9781420064469:
- United States. Food and Drug Administration
- Drugs -- Standards -- United States
- Medical instruments and apparatus -- Standards -- United States
- Biological products -- Standards -- United States
- Biomedical engineering
- Production & quality control management
- Pharmaceutical chemistry & technology
- Medical specialties, branches of medicine
- 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
- 615.1
| Item type | Current library | Call number | Copy number | Status | Date due | Barcode |
|---|---|---|---|---|---|---|
| General Lending | Carlow Campus Library General Lending | 615.1 (Browse shelf(Opens below)) | 1 | Available | 79412 |
Formerly CIP. Uk
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.
132.00