Certara touts its Simcyp Simulator as the pharmaceutical industry’s most sophisticated physiologically based pharmacokinetic (PBPK) modeling and simulation platform for determining first-in-human dose selection, predicting drug-drug interactions (DDIs), understanding drug disposition in pediatrics and other special populations, and bridging to virtual ethnic populations. It increasingly has been used to inform drug label language, with regulatory acceptance from the FDA, the EMA, and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).
“Our work provides a framework for assessing inter-individual variability in pharmacokinetics and pharmacodynamics using virtual human populations and integrating general knowledge of the physical chemistry of a drug with human biology, anatomy, physiology and genetics,” said Simcyp President Steve Toon, Ph.D. “The Simcyp Simulator allows us to accurately model drug disposition within human and various animal species so that we can inform on dose and dose regimen selection, DDIs, assess the impact of food effect on orally-administered medicines and evaluate impacts of disease and lifestyle factors.”
The Simcyp whole body simulation methodology can predict the pharmacokinetics and pharmacodynamics of small molecule and biological medicines using laboratory-derived data. The simulator includes a unique set of genetic, physiological and epidemiological databases that facilitate the simulation of virtual populations of differing demographies and ethnicities.
The majority of the Top 40 pharma companies (including all of the Top 10) are members of the Simcyp Consortium. Version 15 of the simulator contains several new models and features requested by the Simcyp Consortium.