PHMX 665 DOSE-RESPONSE TRIALS

Knowledge of designing and analyzing dose-response is an important component of a drug development and of regulatory review. Basics of the variety of dose-response designs such as parallel, cross-over, flexible-dose, titration, withdrawal, adaptive and enrichment trials are explained. Students perform clinical trial simulations for supporting the choice of appropriate designs and analyses. Innovative designs and data analysis make characterizing dose-response feasible within the realms of drug development. The information generated from such trials is key for both approval of new drugs as well as for drug product labeling. Pre-Requisites: PHMX 601