Hands-On Demonstrations of the Physiology-Based Pharmacokinetic Software, PK-Sim«
J÷rg Lippert, Corina Becker, Wolfgang Weiss
Bayer Technology Services GmbH, Germany
PK-Sim® is a software tool for physiology-based pharmacokinetic whole-body modelling, especially designed for pre-clinical and clinical use in the pharmaceutical research and development environment.
The focus of the presentation will be on the two following modules included in the clinical version of the PK-Sim® software:
The PK-Sim® "Pop" module can be used for a priori testing of the pharmacokinetic variability of a drug in a virtual human population with a user-defined gender-, age-, height-, and weight distribution. This extension of the PK-Sim® standard package uses a Monte-Carlo process to create virtual individuals matching the user-defined parameters. The PK-Pop module contains a large database of relevant anthropometric and physiological parameters. A sophisticated algorithm accounts for cross-correlations in the variabilities of different physiological parameters via scaling laws and thus ensures that only reasonable representatives of living humans are created within the age range of 0 to 80 years. All variabilities are included in the model and do not have to be user-defined thus reducing the expected user-input parameters.
The PK-Sim® "Clearance Scaling" Module uses validated models to scale renal and hepatic clearance from adults to children of all ages. Integration with the population module allows for a determination of the pharmacokinetic variability expected in a young population. The approach can be used to support pediatric study design, dosing and safety strategies for PIPs and PDPs.
In this software demonstration we provide an overview of PK-Sim®'s capabilities to simulate the pharmacokinetic behavior of chemical compounds in different populations including children, adults, and elderly. Applications to the different stages of clinical development will be discussed.
An application example will be presented at the poster session:
"Whole-Body Physiologically-based Pharmacokinetic (WB-PBPK) Population Modelling to Simulate the Influence of Weight and Age on the Pharmacokinetics (PK) of a combined Oral Contraceptive Containing Drospirenone (DRSP) and Ethinylestradiol (EE)"