{"product_id":"the-combination-products-handbook-9781032291628","title":"The Combination Products Handbook","description":"\u003cb\u003eBook Synopsis\u003c\/b\u003e\u003cbr\u003e\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 understand\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTable of Contents\u003c\/b\u003e\u003cbr\u003e\u003cp\u003eChapter 1 Introduction\u003c\/p\u003e\n\u003cp\u003eChapter 2 What is a Combination Product?\u003c\/p\u003e\n\u003cp\u003eChapter 3 Regulatory Strategies\u003c\/p\u003e\n\u003cp\u003eChapter 4 cGMPs\u003c\/p\u003e\n\u003cp\u003eChapter 5 Integrated Development\u003c\/p\u003e\n\u003cp\u003eChapter 6 Risk Management\u003c\/p\u003e\n\u003cp\u003eChapter 7 Human Factors Engineering in the Design, Development and Lifecycle of Combination Products\u003c\/p\u003e\n\u003cp\u003eChapter 8 Lifecycle Management: Design Transfer through Post Market\u003c\/p\u003e\n\u003cp\u003eChapter 9 \u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003e9A. Best Practices and Considerations for Combination Products Inspection Readiness \u003c\/li\u003e\n\u003cli\u003e9B. US Combination Product Inspections \u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003ePart 2: Special Topics\u003c\/p\u003e\n\u003cp\u003eChapter 10 Supplier Quality Considerations\u003c\/p\u003e\n\u003cp\u003eChapter 11 Analytical Testing Considerations\u003c\/p\u003e\n\u003cp\u003eChapter 12 Biological Products Considerations\u003c\/p\u003e\n\u003cp\u003eChapter 13 Connected Health\u003c\/p\u003e\n\u003cp\u003eChapter 14 Evolving Global Regulatory Landscape\u003c\/p\u003e\n\u003c\/li\u003e\u003c\/ul\u003e","brand":"Taylor \u0026 Francis Ltd","offers":[{"title":"Default Title","offer_id":51018952671575,"sku":"9781032291628","price":137.75,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0817\/1739\/5799\/files\/9781032291628.jpg?v=1750778800","url":"https:\/\/bookcurl.com\/products\/the-combination-products-handbook-9781032291628","provider":"Book Curl","version":"1.0","type":"link"}