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The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems
The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems
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Excellent- More about The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems
Combination products are therapeutic and diagnostic products that combine drugs, devices, 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. It also reviews international combination product regulations, guidance, considerations, and best practices.
Format: Hardback
Length: 592 pages
Publication date: 16 May 2023
Publisher: Taylor & Francis Ltd
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 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.
Weight: 1258g
Dimension: 184 x 261 x 39 (mm)
ISBN-13: 9781032291628
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