Research Catalog
Combination products : regulatory challenges and successful product developement
- Title
- Combination products : regulatory challenges and successful product developement / Smita Gopalaswamy, Venky Gopalaswamy.
- Author
- Gopalaswamy, Smita.
- Publication
- Boca Raton : CRC Press, c2008.
Items in the Library & Off-site
Filter by
1 Item
| Status | Format | Access | Call Number | Item Location |
|---|---|---|---|---|
Available - Can be used on site. Please visit New York Public Library - Schwarzman Building to submit a request in person. | Text | Use in library | JBE 08-1347 | Schwarzman Building - General Research Room 315 |
Details
- Additional Authors
- Gopalaswamy, Venky.
- Description
- xvi, 241 p. : ill.; 25 cm.
- Subject
- 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
- Bibliography (note)
- Includes bibliographical references and index.
- 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.
- Call Number
- JBE 08-1347
- ISBN
- 9781420064469 (hardcover : alk. paper)
- 1420064460 (hardcover : alk. paper)
- LCCN
- 2007043090
- OCLC
- 175174367
- Author
- Gopalaswamy, Smita.
- Title
- Combination products : regulatory challenges and successful product developement / Smita Gopalaswamy, Venky Gopalaswamy.
- Imprint
- Boca Raton : CRC Press, c2008.
- Bibliography
- Includes bibliographical references and index.
- Added Author
- Gopalaswamy, Venky.
- Research Call Number
- JBE 08-1347