{"product_id":"the-combination-products-handbook-susan-neadle-9781032291635","title":"The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems","description":"\u003cp\u003eCombination 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.\u003c\/p\u003e\u003cp\u003eThis handbook: \u003c\/p\u003e\u003cul\u003e \u003cli\u003eBrings clarity of understanding for global combination products guidance and regulations\u003c\/li\u003e \u003cli\u003eReviews the current state-of-the-art considerations and best practices spanning the combination product lifecycle, pre-market through post-market\u003c\/li\u003e \u003cli\u003eReviews medical product classification and assignment issues faced by global regulatory authorities and industry\u003c\/li\u003e \u003c\/ul\u003e\u003cp\u003eThe 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.\u003c\/p\u003e\u003cbr\u003e\u003cbr\u003e\u003cb\u003eAuthor:\u003c\/b\u003e Susan Neadle\u003cbr\u003e\u003cb\u003eISBN-10:\u003c\/b\u003e 103229163X\u003cbr\u003e\u003cb\u003eISBN-13:\u003c\/b\u003e 9781032291635\u003cbr\u003e\u003cb\u003ePublisher:\u003c\/b\u003e CRC Press\u003cbr\u003e\u003cb\u003eLanguage:\u003c\/b\u003e English\u003cbr\u003e\u003cb\u003ePublished:\u003c\/b\u003e 10\/09\/2024\u003cbr\u003e\u003cb\u003ePages:\u003c\/b\u003e 592\u003cbr\u003e\u003cb\u003eFormat:\u003c\/b\u003e Paperback\u003cbr\u003e\u003cb\u003eWeight:\u003c\/b\u003e 2.32lbs\u003cbr\u003e\u003cb\u003eSize:\u003c\/b\u003e 10.00h x 7.00w x 1.24d","brand":"Susan Neadle","offers":[{"title":"Paperback","offer_id":46431544279295,"sku":"9781032291635","price":79.99,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0662\/2982\/9887\/files\/img_478a8b07-09b7-4c01-8b1f-e952ffc37499.jpg?v=1735141655","url":"https:\/\/www.whiterainbookhouse.com\/products\/the-combination-products-handbook-susan-neadle-9781032291635","provider":"WR Book House","version":"1.0","type":"link"}