A new strategy of pharmacokinetic analysis - Complete integration of top-down and bottom-up approaches -

Abstract

To overcome disadvantages in a bottom-up approach of the in vitro to in vivo extrapolation, we are developing a new analysis framework designated as STADAM (STAtic Drug Absorption Models). STADAM analyzes in vitro and in vivo information of numerous drugs completely simultaneously to adjust biases and errors appropriately in a data-driven manner. Thousands of exposure changes due to drug interactions between various substrates and inhibitors were successfully estimated from in vivo observations of exposure changes of some combinations obtained so far, and observations of in vitro experiments for each drug.