Combination products : regulatory challenges and successful product developement /: regulatory challenges and successful product developement. (2008)
- Record Type:
- Book
- Title:
- Combination products : regulatory challenges and successful product developement /: regulatory challenges and successful product developement. (2008)
- Main Title:
- Combination products : regulatory challenges and successful product developement
- Further Information:
- Note: Smita Gopalaswamy and Venky Gopalaswamy.
- Other Names:
- Gopalaswamy, Smita
Gopalaswamy, Venky - 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.
- Publisher Details:
- Boca Raton : Taylor & Francis
- Publication Date:
- 2008
- Extent:
- 1 online resource
- Subjects:
- 615/.1
Drugs -- Standards -- United States
Medical instruments and apparatus -- Standards -- United States
Biological products -- Standards -- United States
Equipment Design -- standards
Pharmaceutical Preparations -- standards
Biological Agents -- standards
Device Approval -- standards
Equipment and Supplies -- standards
MEDICAL -- Drug Guides
MEDICAL -- Pharmacology
MEDICAL -- Pharmacy
MEDICAL -- Nursing -- Pharmacology
Biological products -- Standards
Drugs -- Standards
Medical instruments and apparatus -- Standards
United States
United States
Electronic books - Languages:
- English
- ISBNs:
- 9781420064513
1420064517 - Notes:
- Note: Includes bibliographical references and index.
Note: Print version record. - Access Rights:
- Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
- Access Usage:
- Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.
- View Content:
- Available online (eLD content is only available in our Reading Rooms) ↗
- Physical Locations:
- British Library HMNTS - ELD.DS.148031
- Ingest File:
- 01_079.xml