3 Credits

Fall 2023
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Fall 2023 Instructors: Kari Clase

(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. Typically offered Fall Spring Summer.

Course ABE 51100 from Purdue University - West Lafayette.

Fall 2024 Schedule:
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