Physiology-based pharmacokinetic modeling: ready to be used

The prediction of human pharmacokinetics today is often based on a combination of animal and in vitro data with appropriate scaling to man. Physiologically-based pharmacokinetic (PBPK) modeling and simulation of the absorption process and drug-drug interactions has been studied for several decades. However, only very recently commercial software became available bringing these approaches closer to the scientist in drug discovery and development. Walter Schmitt and Stefan Willmann have many years of experience in the area and are therefore well placed to review here the status of physiology based PK modeling in comparing the Bayer approach with some of the other alternatives.