Population PK models allow to integrate pharmacokinetic data from different studies, formulations, doses, and populations. We identify complex absorption and elimination pathways and assess sources of variability in drug concentrations in the target population. This allows to support confident clinical dosing, study design, and go/no-go decision.
Complex mechanisms of action and novel drug-targets require advanced PK/PD modelling for interpretation of results. Exprimo has extensive experience with application of cutting edge PK/PD/mPBPK models to accurately predict study outcomes.
A combined PK/PD/disease model allows to include disease progression in the prediction of biomarkers and clinical outcomes for patients. This can enable quick go/no-go decisions early in development, as well as predicting likelihood of trial success and trial optimization in the target population.
Reviewing documents prior to regulatory submission, writing summaries of M&S work. Exprimo consultants can participate in mock advisory committee meetings. Exprimo has extensive regulatory experience and several of our consultants have accompanied drugs to market.
We developed Simulo as an efficient tool to run drug trial simulations including complex adaptive protocol designs. We can also support you with optimal design, therapeutic drug monitoring, or custom trainings.