Combination products : regulatory challenges and successful product developement /: regulatory challenges and successful product developement. (2008)

• Record Type: Book
• 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.