Taking a new pharmaceutical product from the laboratory to the market requires years of bench research, and nonclinical research to assess the safety profile of the new drug. The most important element of the early discovery process is to select the best new molecular entities to enter clinical trials and to limit failure in full development. The next phase is careful clinical research on human subjects to assess the safety and efficacy of your product, constant interactions with drug agencies, manufacturing your product in the most efficient manner compliant with the appropriate regulations.
This course is designed to introduce the students to the main steps of the drug development process, from drug discovery, and preclinical animal testing to all phases of clinical research and post-approval drug safety surveillance from the US and international regulatory perspectives.
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