This two-day, hands-on course will focus on the theories and application of our state-of-the-art PBPK modeling and simulation software for first-in-human (FIH) predictions in adults and extrapolation to pediatric populations, food effect predictions, and modeling & simulation of non-oral delivery pathways. A combination of presentations and interactive examples, taken from actual experience and using GastroPlus, illustrate how to recognize and deal with the multiple interacting phenomena which impact these activities.