The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems (Neadle Susan)(Pevná vazba)

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 patches, 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 combination product regulations,
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