The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems

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Synopsis
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 combinationproduct is one composed of any combination of a drug and a device; a biological product anda device; a drug and a biological product; or a drug, device and a biological product.” Examplesinclude prefilled syringes, pen injectors, autoinjectors, inhalers, transdermal patches, drug-elutingstents, and kits containing drug administration devices co-packaged with drugs and/or biologicalproducts. This handbook provides the most up-to-date information on the development of combinationproducts, from the technology involved to successful delivery to market. The authors presentimportant and up-to-the-minute pre- and post-market reviews of combination product regulations,guidance, considerations and best practices. This handbook: • Brings clarity of understanding for 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 withover 35 years of industry experience and has an outstanding team of contributors. Endorsed byAAMI – Association for the Advancement of Medical Instrumentation.
Copyright:
2023

Book Details

Book Quality:
Publisher Quality
ISBN-13:
9781000874587
Related ISBNs:
9781003300298, 9781032291635, 9781032291628
Publisher:
CRC Press
Date of Addition:
Copyrighted By:
selection and editorial matter, Susan W. B. Neadle
Adult content:
No
Language:
English
Has Image Descriptions:
No
Categories:
Nonfiction, Science, Medicine
Submitted By:
Bookshare Staff
Usage Restrictions:
This is a copyrighted book.
Edited by:
Susan Neadle

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