PKPD utilizes state of the art computer-based drug modeling and clinical trial simulation techniques based on WinNonLin, NonMem, and Pharsight Trial Simulator software. Customized PK/PD models are constructed using individual pharmacokinetic and pharmacodynamic data obtained in pre-clinical and clinical studies. These PK/PD models are then integrated into clinical trial simulation software together with estimates of patient variability. Various clinical trial designs (“what-if scenarios”) can then be run using a Monte Carlo simulation approach. The effect of various parameters such as dose, schedule, drop-out rate etc. on the outcome of a particular trial design can then be determined in order to find the most robust design to take forward into the next phase of development. This rational modeling-based approach can significantly expedite drug development timelines and decrease the risks inherent in traditional empirical dose selection techniques.