9781032291628 - The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems (17 resultados)

Condición: As New. Unread book in perfect condition.

Condición: As New. Unread book in perfect condition.

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Condición: New.

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Hardback. Condición: New. New copy - Usually dispatched within 4 working days.

Hardback. Condición: New. 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.

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

Hardback. Condición: New. 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.

Condición: New. Dieser Artikel ist ein Print on Demand Artikel und wird nach Ihrer Bestellung fuer Sie gedruckt. Susan Neadle, MS, BS, FAAO is a recognized international Combination Products and Medical Device expert with over 35 years of industry experience. Networked, published, highly active in numerous industry groups and with links to a number of teaching inst.

Buch. Condición: Neu. This item is printed on demand - it takes 3-4 days longer - Neuware -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. 616 pp. Englisch.

HRD. Condición: New. New Book. Delivered from our UK warehouse in 4 to 14 business days. THIS BOOK IS PRINTED ON DEMAND. Established seller since 2000.

HRD. Condición: New. New Book. Shipped from UK. THIS BOOK IS PRINTED ON DEMAND. Established seller since 2000.

Condición: New. PRINT ON DEMAND.

Buch. Condición: 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.