Statistics Colloquium : Dr. Lie Nie

Abstract: To facilitate the application of exposure-based, biological, and statistical models in the drug  development,  the FDA has conducted many model-informed drug development activities as a part PDUFA VI commitment. One activity  is the  creation of the pilot program for MIDD approaches. Started in 2018, FDA selects 2-4 proposals quarterly each year. The pilot program provides an opportunity for industry and FDA  to discuss the application of MIDD approaches to the drug development and regulatory evaluation. Through early meetings granted under this pilot program, FDA provides advice on how the proposed MIDD approaches can be used in a specific drug development program. In this presentation, we shall briefly describe the intent, scope, and benefit of this program.  We will share current activities in the pilot program and discuss collaboration between Pharmacologists and statisticians.