£120.75

CRC Press The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems

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£139.99 £89.08 £100.19 £111.30 £122.40 £133.51 £144.62 22 February 2026 08 March 2026 23 March 2026 07 April 2026 22 April 2026

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17 days 26 days · current 2 days 1 day 14 days 0 7 13 20 26 £94 £121 £131 £137 £140 Days at Price

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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 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.

Product Specifications

Format
hardcover
Domain
Amazon UK
Release Date
16 May 2023
Listed Since
04 November 2022

Barcode

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