Price: ₹5,243.09
(as of May 29,2023 03:43:42 UTC – Details)
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.
Publisher : CRC Press; 1st edition (16 May 2023)
Language : English
Hardcover : 592 pages
ISBN-10 : 1032291621
ISBN-13 : 978-1032291628
Item Weight : 1 kg 300 g
Dimensions : 17.78 x 3.33 x 25.4 cm
Country of Origin : India
