PBPK modeling and simulation in drug research and development

202 Physiologically based pharmacokinetic (PBPK) modeling has developed rapidly in the last decade within both the field of academia and the pharmaceutical industry, and has become an integral tool in drug discovery and development. In this review, the concept and methodology of PBPK modeling are briefly introduced. Several case studies were discussed based on our work about how PBPK modeling and simulation (M&S) can be utilized through various stages of drug discovery and development. The regulatory acceptance and industrial practices around PBPK modeling and simulation is also discussed.