This text addresses the many aspects of development necessary to launch a new drug or medical device on the market.... It is intended as a general overview of the entire process, accessible to many levels of experience in the pharmaceutical, biotech and medical-device industries. Important regulatory issues are addressed as well. Key concepts, tips, principles and lessons are addresses in a readable style. The audience includes the companies themselves, contract research organizations (CRO's) that sell products and services to the industry, and smaller segments in academia, hospitals, government and independent laboratories.
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