Modelling and simulation in drug development is not new. What is new is the vision for moving from a descriptive role (what happened) to a predictive and therefore decision making role. While seemingly attractive, important hurdles, both scientific and practical, must be overcome.
The applicability of physiologically-based pharmacokinetic modelling (PBPK) far exceeds that of classical PK in predictive pharmacokinetics, tissue dosimetry, drug efficacy, and drug safety. This in silico technique, in conjunction with in vitro and in vivo studies, can greatly reduce drug failure rates, improve time to market and decrease overall R&D costs.