The Combination Products Handbook
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|No. of pages:||614 pages|
|Illustrations:||119 Illustrations, black & white; 29 Halftones, black & white; 119 Line drawings, black & white; 117 Tables, black & white|
Provides the most up to date information on the development of combination products, from the technology involved to successful delivery. This handbook discusses important and up to the minute pre and post market reviews of combination products as well as regulation.
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 combination product is one composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device and a biological product.? Examples include prefilled syringes, pen injectors, autoinjectors, inhalers, transdermal delivery systems, drug-eluting stents, and kits containing drug administration devices co-packaged with drugs and/or biological products. This handbook provides the most up-to-date information on the development of combination products, from the technology involved to successful delivery to market. The authors present important and up-to-the-minute pre- and post-market reviews of international combination product regulations, guidance, considerations, and best practices.
- Brings clarity of understanding for global combination products guidance and regulations
- Reviews the current state-of-the-art considerations and best practices spanning the combination product lifecycle, pre-market through post-market
- Reviews medical product classification and assignment issues faced by global regulatory authorities and industry
The editor is a recognized international Combination Products and Medical Device expert with over 35 years of industry experience and has an outstanding team of contributors. Endorsed by AAMI ? Association for the Advancement of Medical Instrumentation.
Chapter 1 Introduction
Chapter 2 What is a Combination Product?
Chapter 3 Regulatory Strategies
Chapter 4 cGMPs
Chapter 5 Integrated Development
Chapter 6 Risk Management
Chapter 7 Human Factors Engineering in the Design, Development and Lifecycle of Combination Products
Chapter 8 Lifecycle Management: Design Transfer through Post Market
- 9A. Best Practices and Considerations for Combination Products Inspection Readiness
- 9B. US Combination Product Inspections
Part 2: Special Topics
Chapter 10 Supplier Quality Considerations
Chapter 11 Analytical Testing Considerations
Chapter 12 Biological Products Considerations
Chapter 13 Connected Health
Chapter 14 Evolving Global Regulatory Landscape