The Combination Products Handbook : A Practical Guide for Combination Products and Other Combined Use Systems Hardback
Edited by Susan (Combination products Consulting Services LLC, USA) Neadle
Hardback
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Description
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. This handbook:Brings clarity of understanding for global combination products guidance and regulationsReviews the current state-of-the-art considerations and best practices spanning the combination product lifecycle, pre-market through post-marketReviews medical product classification and assignment issues faced by global regulatory authorities and industryThe 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.
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Out of StockMore expected soonContact us for further information
- Format:Hardback
- Pages:592 pages, 117 Tables, black and white; 119 Line drawings, black and white; 29 Halftones, black and
- Publisher:Taylor & Francis Ltd
- Publication Date:16/05/2023
- Category:
- ISBN:9781032291628
£145.00
£116.83
Information
-
Out of StockMore expected soonContact us for further information
- Format:Hardback
- Pages:592 pages, 117 Tables, black and white; 119 Line drawings, black and white; 29 Halftones, black and
- Publisher:Taylor & Francis Ltd
- Publication Date:16/05/2023
- Category:
- ISBN:9781032291628