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, [2008], ©2008.
Items in the Library & Off-site
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1 Item
| Status | Format | Access | Call Number | Item Location |
|---|---|---|---|---|
| Text | Request in advance | RM301.27 .G68 2008 | Off-site |
Holdings
Details
- Additional Authors
- Gopalaswamy, Venky.
- Description
- xvi, 241 pages : illustrations; 25 cm
- Summary
- "The field of combination product development (products born of the integration of medical devices, biologics, and drugs) is so new that, while literature abounds on each part individually, there are very few publications, including FDA documents, available concerning the unique challenges posed by this nascent but fast-growing area." "Providing the first in-depth look at this breakthrough field, Combination Products includes practical guidelines and a detailed step-by-step process for the development of these novel technologies. It addresses the technical, scientific, regulatory, and quality issues that arise when combining drugs, biologics, and medical devices into a single product. It takes a practical, readily applicable approach to discussing the challenges, victories, and pitfalls associated with merging technologies and systems and how to implement these products into the market successfully and in a timely manner."--BOOK JACKET.
- 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
- Pharmaceutical Preparations > standards
- Biological Factors > standards
- Device Approval > standards
- Equipment and Supplies > standards
- United States
- Bibliography (note)
- Includes bibliographical references and index.
- Contents
- 1. Introduction -- 2. Overview and Definitions of Combination Products -- 3. Ensuring Successful Combination Product Development -- 4. Overview of FDA and other Regulatory Agency Expectations -- 5. Resource Requirements -- 6. Manufacturing of Combination Products -- 7. Challenges and Pitfalls to Avoid with Combination Products -- 8. Post Launch Compliance Requirements -- 9. Agency Audits and Challenges -- 10. Conclusions.
- ISBN
- 9781420064469 (hardcover : alk. paper)
- 1420064460 (hardcover : alk. paper)
- LCCN
- 2007043090
- OCLC
- ocn175174367
- 175174367
- SCSB-5411138
- Owning Institutions
- Columbia University Libraries