Releases: Open-Systems-Pharmacology/Qualification-DDI-CYP3A4
Qualification Plan Release version 1.5
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
- Carbamazepine added to the CYP3A4 DDI network: The interactions between carbamazepine as perpetrator and the victim drugs alprazolam, efavirenz, and midazolam are included as well as the interactions between carbamazepine as victim drug and cimetidine, efavirenz, and erythromycin as perpetrators.
Minor updates
- minor editorial updates and bug fixes: #31
- updated with cimetidine release version v1.2
Full Changelog: v1.4...v1.5
Qualification Plan Release version 1.4
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.
Qualification Plan Release version 1.3
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
- Fluconazole added to DDI network (#21): Interactions between fluconazole and midazolam, triazolam and alfentanil included.
Minor updates
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
Qualification Plan Release version 1.1
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
- Cimetidine (v1.0) included with DDIs between cimetidine and alfentanil, alprazolam, midazolam, triazolam and verapamil
- Rifampicin / verapamil DDI added (Barbarash 1988)
Minor updates
- updated references to updated releases of mother repositories for Alfentanil (v2.1), Clarithromycin (v1.1), Erythromycin (v1.1), Fluvoxamine (v1.1), Itraconazole (v1.2), Rifampicin (v1.1) and Verapamil (v1.1)
- updated references to updated released of all former DDI repositories, e.g. Rifampicin-Midazolam-DDI etc. due to optimized simulation time resolutions in snapshots
- updated reference to new OSP PK database release (v1.1)
- minor editorial updates and bug fixes
Qualification Plan Release version 1.0
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.