Qualification of OSP platform for CYP2C19-mediated DDI
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 2C19 (CYP2C19)-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 intended purpose is assessed via a network of PBPK models of selected index CYP2C19 DDI perpetrators, and respective sensitive CYP2C19 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 CYP2C19.
For your questions and comments about the models please create a new issue. A full publication about models presented is available at: https://www.mdpi.com/1999-4923/12/12/1191 .
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The model code is distributed under the GPLv2 License.