Certara, a leading provider of software and scientific consulting services to improve productivity and decision-making from drug discovery through drug development, has launched its Cardiac Safety Simulator (CSS), based on an in-silico model of human ventricular heart cells. When the CSS is integrated with Certara’s Simcyp Population-based Simulator, it allows for the in-vitro to in-vivo extrapolation of the pharmacokinetic and pharmacodynamic data to predict the likelihood that a drug candidate will exhibit cardiac toxicity.
As the CSS includes a virtual population generator, it enables sponsors to model variability between individuals as well as within them. Sponsors are no longer looking at average individuals, but at entire populations in which they can determine the number, gender and age of participants. The CSS can predict differences in response based on demographic, physiological, and genetic variations. It also factors in chronopharmacology and the fact that individuals can respond differently to a drug dose at different times of the day. Results are displayed as pseudo ECGs.
The CSS’ initial focus will be on QT prolongation, however Certara plans to include additional electrophysiology endpoints, as well as heart contractility and heart muscle cell metabolism modules in the simulator.