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The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems.
・ISBN 978-1-032-29162-8 hard GB£ 171.99
￥54,486.- (税込) ※（※）価格はご注文時の参考価格となります。
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| 著者・編者 | Neadle, Susan (ed.), |
|---|---|
| 出版社 | (CRC Press, UK) |
| 出版年月 | 2023 |
| ページ数 | 592 pp. |
| 言語 | ENG |
| ニュース番号 | ＜A01-34210＞ |
解説
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.