This repository contains a qualification plan (qualification_plan.json) including references to respective model snapshots and static content (e.g. text blocks, *.md files) to produce a qualification report evaluating the ability to perform simulations with the intended purpose to predict permeability glycoprotein (P-gp)-mediated drug-drug interactions (DDI) of the PBPK platform PK-Sim (as part of the open systems pharmacology (OSP) suite) .
The latest release of the qualification plan and the static content can be found here.
The latest release of the qualification report can be found here.
To demonstrate the level of confidence, the predictive performance of the platform for this indented purpose is assessed via a network of PBPK models of selected index P-gp DDI perpetrators, and the sensitive index P-gp victim drug digoxin and a comprehensive dataset from published clinical DDI studies. All PBPK models represent whole-body PBPK models, which allow dynamic DDI simulations in organs expressing P-gp.
Everyone interacting in the Open Systems Pharmacology community (codebases, issue trackers, chat rooms, mailing lists etc...) is expected to follow the Open Systems Pharmacology code of conduct.
We encourage contribution to the Open Systems Pharmacology community. Before getting started please read the contribution guidelines. If you are contributing code, please be familiar with the coding standard.
The model code is distributed under the GPLv2 License.
[1] tbd.