Simulation-based evaluation of the Pharmpy Automatic Model Development tool for population pharmacokinetic modeling in early clinical drug development.

ABSTRACT: The Pharmpy Automatic Model Development (AMD) tool automates the building of population pharmacokinetic (popPK) models by utilizing a systematic stepwise process. In this study, the performance of the AMD tool was assessed using simulated datasets. Ten true models mimicking classical popPK models were created. From each true model, dataset replicates were simulated assuming a typical phase I study design-single and multiple ascending doses with/without dichotomous food effect, with rich PK sampling. For every dataset replicate, the AMD tool automatically built an AMD model utilizing NONMEM for parameter estimation. The AMD models were compared to the true and reference models (true model fitted to simulated datasets) based on their model components, predicted population and individual seco

SUBMITTER: Duvnjak Z 

PROVIDER: S-EPMC11494917 | biostudies-literature | 2024 Oct

REPOSITORIES: biostudies-literature