A broad overview of the regulatory and scientific principles employed in pharmaceutical development including the regulatory framework and pre- clinical experimentation necessary to initiate a first time in human (Phase 1) trial through the objectives, principles, study designs, methods and reporting to evaluate a new pharmaceutical in a human. Students will develop an understanding of how certain forms of translational, or "bench to bedside" research must be organized and executed.
Prefix:
PPS
Course Number:
564
Credits:
2.0