PPS 564 - INTRODUCTION TO FDA AND THE DRUG DEVELOPMENT PROCESS

College of Pharmacy

Credits: 2

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.

Prerequisite(s):
Prereq: Enrollment in the colleges of Pharmacy, Dentistry, Law, Medicine, or Public Health, the NIH K-30 program, a junior or senior undergraduate, or consent of instructor.