Qualification Plan Release version 1.2

This release contains the 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 report can be found here.

Major updates

• 3 Rifampicin / midazolam DDI studies with in total 8 new data points added: Björkhem-Bergman 2013, Chattopadhyay 2018, Lutz 2018

Minor updates

• updates to latest model snapshot releases due to minor updates in the course of the migration to PK-Sim 10: rifampicin, efavirenz, cimetidine, verapamil, erythromycin, clarithromycin, itraconazole, midazolam, triazolam, alprazolam, alfentanil
• minor editorial updates and bug fixes: #9, #10, #13, #15