The combination products handbook : a practical guide for combination products and other combined use systems /: a practical guide for combination products and other combined use systems. (2023)

• Record Type: Book
• Further Information: Note: Edited by Susan Neadle.
• Editors: Neadle, Susan W
• Contents: Foreword Part 1: Foundation Chapter 1 Introduction John Barlow Weiner Chapter 2 What is a Combination Product? Susan Neadle Chapter 3 Regulatory Strategies Suzette Roan Chapter 4 cGMPs Susan Neadle and Mike Wallenstein Chapter 5 Integrated Development Susan Neadle Chapter 6 Risk Management Susan Neadle, Richard Wedge, and Edwin Bills Chapter 7 Human Factors Engineering in the Design, Development and Lifecycle of Combination Products Shannon Hoste, Stephanie Canfield, Susan Neadle, Bjorg Hunter, Theresa Scheuble Chapter 8 Lifecycle Management: Design Transfer through Post Market Susan Neadle and Khaudeja Bano Chapter 9 9A. Best Practices and Considerations for Combination Products Inspection Readiness Susan Neadle 9B. US Combination Product Inspections Kim Trautman Part 2: Special Topics Chapter 10 Supplier Quality Considerations Fran DeGrazio and Meera Raghuram Chapter 11 Analytical Testing Considerations Daniel Bantz and Jennifer Riter Chapter 12 Biological Products Considerations Manfred Maeder Chapter 13 Connected Health Ryan McGowan Chapter 14 Evolving Global Regulatory Landscape Stephanie Goebel, Viky Verna, Chery Marty and Susan Neadle Appendices Comparative Overview of Global Combination Product Regulatory Landscape Dhiraj Biehl and Susan Neadle Glossary
• Edition: 1st
• Publisher Details: Boca Raton : CRC Press
• Publication Date: 2023
• Extent: 1 online resource (480 pages), illustrations (black and white, and colour)
• Subjects: 615.19; Pharmaceutical technology
• Languages: English
• ISBNs: 9781000874587; 9781000874563
• Related ISBNs: 9781032291628
• Notes: Note: Description based on CIP data; resource not viewed.
• 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.