The situation
Co-medications and organ impairment are coming. A dedicated study for each is slow, expensive, and possibly unnecessary.
What we do
- Build the PBPK model from in vitro and clinical data
- Verify it against data it was never fitted to
- Simulate the interactions and the impaired populations
What you get
- A qualified model, calibration documented
- Predicted exposure ratios per scenario
- A ranking of which studies you still need
Regulatory basis
Under ICH M12, PBPK can be used to predict untested interactions and, in some cases, in place of a dedicated clinical study. The model has to be verified against clinical data before it is relied on.