Description: Further DetailsTitle: The Combination Products HandbookCondition: NewSubtitle: A Practical Guide for Combination Products and Other Combined Use SystemsEAN: 9781032291628ISBN: 9781032291628Publisher: CRC PressFormat: HardbackRelease Date: 05/16/2023Description: 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 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.Language: EnglishCountry/Region of Manufacture: GBItem Height: 254mmItem Length: 178mmItem Weight: 1300gContributor: Susan Neadle (Edited by)Author: Susan NeadleGenre: Science Nature & MathTopic: Medicine, Technology & EngineeringRelease Year: 2023 Missing Information?Please contact us if any details are missing and where possible we will add the information to our listing.
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Book Title: The Combination Products Handbook
Title: The Combination Products Handbook
Subtitle: A Practical Guide for Combination Products and Other Combined Use
EAN: 9781032291628
ISBN: 9781032291628
Release Date: 05/16/2023
Release Year: 2023
Country/Region of Manufacture: GB
Item Height: 254mm
Item Length: 178mm
Item Weight: 1300g
Contributor: Susan Neadle (Edited by)
Genre: Science Nature & Math
Topic: Technology & Engineering
Publisher: CRC Press LLC
Publication Year: 2023
Subject: Pharmacy
Number of Pages: 480 Pages
Publication Name: Combination Products Handbook : A Practical Guide for Combination Products and Other Combined Use Systems
Language: English
Type: Textbook
Author: Susan W. Neadle
Subject Area: Medical
Format: Hardcover
