Certara’s Simcyp physiologically-based pharmacokinetic (PBPK) Simulator models describe the behavior of drugs in different body tissues and includes genetic, physiological and epidemiological databases that facilitate simulations in virtual populations. The Simcyp Simulator has been used to inform more than 250 label claims for 85+ novel drug approvals by the US Food and Drug Administration (FDA). These were achieved virtually, using PBPK modeling and simulation in lieu of performing clinical trials.