PK and PK/PD case studies – Pharmacometric Web-based Learning Resource

These three case studies show the typical step-wise workflows to model PK and PKPD data sets. They are also part of the Pharmacometrics web-based learning resource from the Center for Translational Medicine of the University of Maryland. They are designed for beginners and show the data set formatting and visualization, the development of structural and statistical models – including the correlations and covariates, the model diagnosis using plots and results, as well as different approaches to PK/PD modeling.

Case study 1

The aim of this tutorial is to develop a population PK model and explore covariate relationships of a hypothetical test drug used in the treatment of atrial fibrillation. The workflow consists of the preparation of a data set, choosing a PK model, estimating parameters and analyzing goodness of fits and results. Thanks to the Monolix graphical user interface, libraries of models and interactive plots, the entire workflow takes only a few minutes.

Link to the written tutorial in PDF format
Link to Monolix projects





Case study 2

The aim of this tutorial is to develop a population PK model for a multiple dosing trial study of a hypothetical test drug used in the treatment of diabetes. The workflow consists of the preparation of a data set, choosing a PK model, estimating parameters and analyzing goodness of fits and results. Datxplore, Monolix and Sycomore are used.

Link to the written tutorial in PDF format
Link to Monolix projects





Case study 3

The aim of this tutorial is to show how to develop a pharmacokinetic-pharmacodynamic (PK/PD) model. It is based on a clinical study of a hypothetical test drug used in the treatment of immunosuppression and as an anti-inflammatory agent. Three different approaches are described in detail: sequential, simultaneous (joint) and intermediate (population sequential).

Link to the written tutorial in PDF format
Link to Monolix projects