{"product_id":"the-combination-products-handbook-susan-neadle-9781032291628","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\/\u003cbr\u003eor biological products. According to the US Food and Drug Administration (FDA), \"a combination\u003cbr\u003eproduct is one composed of any combination of a drug and a device; a biological product and\u003cbr\u003ea device; a drug and a biological product; or a drug, device and a biological product.\" Examples\u003cbr\u003einclude prefilled syringes, pen injectors, autoinjectors, inhalers, transdermal patches, drug-eluting\u003cbr\u003estents, and kits containing drug administration devices co-packaged with drugs and\/or biological\u003cbr\u003eproducts. This handbook provides the most up-to-date information on the development of combination\u003cbr\u003eproducts, from the technology involved to successful delivery to market. The authors present\u003cbr\u003eimportant and up-to-the-minute pre- and post-market reviews of combination product regulations, \u003cbr\u003eguidance, considerations and best practices.\u003c\/p\u003e \u003cp\u003eThis handbook: \u003c\/p\u003e \u003cp\u003e- Brings clarity of understanding for combination products guidance and regulations\u003c\/p\u003e \u003cp\u003e- Reviews the current state-of-the-art considerations and best practices spanning the combination\u003cbr\u003e product lifecycle, pre-market through post-market\u003c\/p\u003e \u003cp\u003e- Reviews medical product classification and assignment issues faced by global regulatory\u003cbr\u003e authorities and industry \u003cbr\u003e\u003c\/p\u003e \u003cp\u003e\u003cbr\u003eThe editor is a recognized international Combination Products and Medical Device expert with\u003cbr\u003eover 35 years of industry experience and has an outstanding team of contributors. Endorsed by\u003cbr\u003eAAMI - 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 1032291621\u003cbr\u003e\u003cb\u003eISBN-13:\u003c\/b\u003e 9781032291628\u003cbr\u003e\u003cb\u003ePublisher:\u003c\/b\u003e CRC Press\u003cbr\u003e\u003cb\u003eLanguage:\u003c\/b\u003e English\u003cbr\u003e\u003cb\u003ePublished:\u003c\/b\u003e 05\/16\/2023\u003cbr\u003e\u003cb\u003ePages:\u003c\/b\u003e 592\u003cbr\u003e\u003cb\u003eFormat:\u003c\/b\u003e Hardcover\u003cbr\u003e\u003cb\u003eWeight:\u003c\/b\u003e 2.81lbs\u003cbr\u003e\u003cb\u003eSize:\u003c\/b\u003e 10.00h x 7.00w x 1.31d","brand":"Susan Neadle","offers":[{"title":"Hardcover","offer_id":44919912136959,"sku":"9781032291628","price":180.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0662\/2982\/9887\/files\/img_4f7f65dd-343c-4e91-9bad-1028bc0b23af.jpg?v=1710359724","url":"https:\/\/www.whiterainbookhouse.com\/products\/the-combination-products-handbook-susan-neadle-9781032291628","provider":"WR Book House","version":"1.0","type":"link"}