0 or 3 credits
Fall 2023 Distance Learning Departmental CreditUpper DivisionData from last updated 8/23/2024
Fall 2023
Fall 2023 Instructors:
(TLI 52100) A review of drug discovery and drug development, with emphasis on the regulatory aspects of these activities. Animal preclinical research and human clinical research are discussed in detail. In addition, the process for the assembly of an IND and NDA is discussed along with the Phases (I,II,III) of human clinical trials. The CMC (chemistry manufacturing and control) aspects of drug development are presented along with ICH documents and manufacturing process analytical technologies. The course concludes with a brief review of international regulatory issues and patents.
Course ABE 511 from Purdue University - West Lafayette.Prerequisites
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