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Paediatric populations
The Simcyp Paediatric Simulator allows pharmacokinetic behaviour to be modelled in infants, neonates and children. This provides valuable information relevant to first-time dosing decisions and the design of clinical studies.
The Simulator includes a full physiologically-based pharmacokinetic (PBPK) model together with extensive libraries on demographics, developmental physiology and the ontogeny of drug elimination pathways. It allows population variability in pharmacokinetics to be simulated over any age range and potential drug-drug interactions to be quantified.
Predictions can be made either from in vitro data, or from adult in vivo values by retrograde modelling.
Figure 6. Prediction of the clearance of caffeine from birth through to adulthood. LHS: The grey data points indicate individual values in 2000 virtual subjects simulated from in vitro data using Simcyp; the median value (continuous line) and 5th and 95th percentiles (dashed lines) are indicated. The ellipses indicate data from actual in vivo studies with respect to the spread of clearance values and subject weight. RHS: Each ellipse defines the extent of variability observed in in vivo studies and that predicted using Simcyp.
