Combination Products - Regulatory Challenges and Successful Product Development

Informationen zum Autor Smita Gopalaswamy, Venky Gopalaswamy Klappentext The field of combination product development is so new that very few publications, including FDA documents, are available. This text provides an overview of the process from start to finish, complete with relevant definitions, and then shows how to establish a design and development plan. It provides an overview of FDA and other regulatory expectations and covers resource requirements, manufacturing, pitfalls, post-launch compliance requirements, and agency audits and challenges. The book presents practical guidelines on how to develop combination products successfully and how to implement these products into the market successfully and in a timely manner. Zusammenfassung Focusing on the developmental process for combination products - those that combine a drug with a device such as a drug-eluting stent, this book augments the guidance provided by the FDA. It shows how to: establish a design and development plan, giving consideration to regulatory expectations, resource requirements, and manufacturing challenges. Inhaltsverzeichnis Introduction. 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. Conclusions.

Product details

• Authors: Smita Gopalaswamy, Smita (Advanced Solutions Consultants Gopalaswamy, Smita Gopalaswamy Gopalaswamy, Venky Gopalaswamy, Venky (Product Development Group Leader- Medical Device Sector) Gopalaswamy, Gopalaswamy Smita, Gopalaswamy Venky
• Publisher: Taylor & Francis Ltd.
• Languages: English
• Product format: Hardback
• Released: 22.04.2008
• EAN: 9781420064469
• ISBN: 978-1-4200-6446-9
• No. of pages: 264
• Subjects: Natural sciences, medicine, IT, technology > Medicine > Clinical medicine; SCIENCE / Life Sciences / General, MEDICAL / Pharmacy, BUSINESS & ECONOMICS / Quality Control, MEDICAL / Biotechnology, Biology, life sciences, Engineering: general, Biomedical engineering, Pharmaceutical technology, Production & quality control management, Pharmaceutical chemistry and technology, Production and quality control management