Combination products handbook practical (23 Ergebnisse)

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Taschenbuch. Zustand: Neu. The Combination Products Handbook | A Practical Guide for Combination Products and Other Combined Use Systems | Susan Neadle | Taschenbuch | Einband - flex.(Paperback) | Englisch | 2024 | CRC Press | EAN 9781032291635 | Verantwortliche Person für die EU: Taylor & Francis Verlag GmbH, Kaufingerstr. 24, 80331 München, gpsr[at]taylorandfrancis[dot]com | Anbieter: preigu.…

Paperback. Zustand: Brand New. 614 pages. 10.00x7.00x10.00 inches. In Stock.

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Hardcover. Zustand: Brand New. 480 pages. 10.00x7.00x1.46 inches. In Stock.

Taschenbuch. Zustand: Neu. nach der Bestellung gedruckt Neuware - Printed after ordering - 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 regulationsReviews the current state-of-the-art considerations and best practices spanning the combination product lifecycle, pre-market through post-marketReviews medical product classification and assignment issues faced by global regulatory authorities and industryThe 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.…

Buch. Zustand: Neu. nach der Bestellung gedruckt Neuware - Printed after ordering - 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.…