The clinical utility of pharmacometric models

Pharmacometric models are powerful tools that can be used for a variety of purposes in clinical pharmacology, drug development and dose individualization. Lewis Sheiner famously described the process of learning versus confirming in the setting of drug development 1 and as applied to pharmacometrics. An example of learning is the quantitative description of the human coagulation network 2 which was then paired with prospective clinical data 3 to confirm the predictive performance of this model. Additionally, models can be used to help design clinical trials via simulation 4 and even provide information for the labelling of drug products 5 . The clinically relevant goal is to determine if and how doses can be individualized.