This session will present the prediction of human pharmacokinetics and safety from in vitro data using the systems pharmacology approach.
In addition, we will discuss IVIVE (in vitro to in vivo extrapolation) and physiologically-based pharmacokinetics (PBPK), and PBPK approach-based prediction for inter-individual variability regarding pharmacokinetic prediction. Furthermore, we will show the prediction for pediatric PK/PD using PBPK approach in order to optimize the pediatric dose.
Conversely, we will focus on the safety issues regarding the prediction for QT interval prolongation. While hERG assay and clinical QT interval evaluation should be performed under the current guidelines, computer simulation and the PK/PD modeling approach for cardiac safety evaluation should become the main stream in the near future. In this program, we will present computer simulation to predict action potentials and human ECGs.