Challenges of PKPD Modeling for Statisticians
*Kuenhi Tsai, Merck 


With the prevalence of PKPD modeling in clinical studies, involvement of statisticians has become significant. Due to complexity of PKPD modeling, we face several new challenges of our work. The challenges include (1) how to build basic knowledge for PKPD modeling, (2) what software we should learn, (3) can we propose alternative approaches that might contradict common procedures used by PK people that would be more in line with statistical teachings, (4) how to introduce new methods without causing friction, (5) how we can build good data base for PKPD modeling, and (6) how we can reconcile the outcome of clinical study and PKPD modeling.