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

Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. According to the FDA, "a combination product is one composed of any combination of a drug, a device, and a biological product. Examples include prefilled syringes, pen injectors, auto-injectors, inhalers, transdermal pumps and patches, and kits containing drug administration devices or components. This handbook provides the most up to date information on the development of combination products, from the technology involved to successful delivery. The authors present important and up to the minute pre and post market reviews of combination products as well as regulation.Features : This handbook provides guidance and regulations to clarify the regulation of combination products.Reviews medical product classification and assignment issues for agency staff 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 contributorsEndorsed by AAMI - Association for the Advancement of Medical Instrumentation