Virtual Populations in the Simcyp Simulator
The utility of in vitro-in vivo extrapolation has historically been limited by:
- Projections are usually only made to mean data collected in studies in healthy, young, Caucasian, male individuals.
- Other approaches provide inadequate estimates of intersubject variability based solely on simple demographic parameters.
This limits their ability to address the extremes of risk. Simcyp® Simulator algorithms account for variability in populations including:
- Demographics (gender, age, body size, ethnicity etc.)
- Societal factors (environmental effects, dietary habits etc.)
- Genetic differences (in enzymes etc.)
Simcyp Simulator users can conduct simulations in representative virtual populations. Simulating physiological variability enables predictions drug disposition in relevant individuals with realistic variability. The ability to predict pharmacokinetic outcomes in ‘real world’ patient populations is essential. To achieve this, our algorithms incorporate known variability in demographic and biological components within relevant disease populations. Accounting for physiological variability is crucial to identifying individuals who are predisposed to the extremes of drug exposure prior to clinical studies. Linking drug-specific physicochemical and in vitro data on absorption and disposition in Simcyp algorithms allows prediction of drug behavior in the ‘virtual patient population’ as opposed to a ‘virtual reference man.’
Learn more about the science of the Simcyp Simulator: