Qualification Plan Release version 1.0

Qualification-DDI-P-gp

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 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.