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Published by CRC Press (edition 1), 2024
ISBN 10: 103229163X ISBN 13: 9781032291635
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Language: English
Published by CRC Press (edition 1), 2024
ISBN 10: 103229163X ISBN 13: 9781032291635
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Published by Taylor & Francis Ltd, 2024
ISBN 10: 103229163X ISBN 13: 9781032291635
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Language: English
Published by Taylor and Francis Ltd, GB, 2024
ISBN 10: 103229163X ISBN 13: 9781032291635
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First Edition
Paperback. Condition: New. 1st. 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.
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Language: English
Published by Taylor and Francis Ltd, GB, 2024
ISBN 10: 103229163X ISBN 13: 9781032291635
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First Edition
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Add to basketPaperback. Condition: New. 1st. 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.
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Taschenbuch. Condition: 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.
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Published by Taylor and Francis Ltd, GB, 2024
ISBN 10: 103229163X ISBN 13: 9781032291635
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First Edition
Paperback. Condition: New. 1st. 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.
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Language: English
Published by Taylor and Francis Ltd, GB, 2024
ISBN 10: 103229163X ISBN 13: 9781032291635
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First Edition
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Add to basketPaperback. Condition: New. 1st. 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.
Condition: New. - New chapters on Advanced Therapy Medicinal Products (including cell and gene therapies), Combination Products, and Pharmacovigilance- Presents new and updated case studies, including lessons learned from the development of COVID Vaccines- More in-.
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Paperback. Condition: Brand New. 2nd edition. 450 pages. 9.25x7.50x9.25 inches. In Stock.
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