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 cytochrome P450 3A4 (CYP3A4)-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 CYP3A4 DDI perpetrators (covering the range from strong induction to strong inhibition), and respective sensitive index CYP3A4 victim drugs 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 CYP3A4.
To qualify the OSP suite for the prediction of the CYP3A4 DDI potential of new drugs, a set of verified PBPK models of index perpetrators, covering the range from strong CYP3A4 induction to strong inhibition, and respective CYP3A4 DDI victim drugs is specified to set up a CYP3A4-mediated DDI modeling network.
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The model code is distributed under the GPLv2 License.