The Combination Products Handbook

图书简介

Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. According to the US Food and Drug Administration (FDA), “a combinationproduct is one composed of any combination of a drug and a device; a biological product anda device; a drug and a biological product; or a drug, device and a biological product.” Examplesinclude prefilled syringes, pen injectors, autoinjectors, inhalers, transdermal patches, drug-elutingstents, and kits containing drug administration devices co-packaged with drugs and/or biologicalproducts. This handbook provides the most up-to-date information on the development of combinationproducts, from the technology involved to successful delivery to market. The authors presentimportant and up-to-the-minute pre- and post-market reviews of combination product regulations,guidance, considerations and best practices.This handbook:•

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

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The Combination Products Handbook 组合产品手册：实用指南 生物医学工程学

The Combination Products Handbook

组合产品手册：实用指南
生物医学工程学