PHR - 585 Clinical Pharmacology Research

This survey course describes in detail all aspects of performing clinical drug trials. It includes extensive discussion on IND applications, how drug studies differ from other types of studies, GLP certification procedures, informed consent procedures involving drugs, the characteristics of Phase I-IV studies and the special considerations involved with each, packaging and delivery considerations, role of the pharmacokineticist in the design and implementation of these studies, sample and data collection procedures, FDA oversight considerations, data analysis and interpretation, and laboratory responsibilities after the study is completed. Credit Hours: (2)