Open Systems Pharmacology Qualification Reports¶
PBPK Platform Qualification for Drug-Drug Interactions, Pediatric Extrapolation, and Disease Populations¶
This library provides qualification reports from the Open Systems Pharmacology project that assess the predictive performance of the PBPK modeling platform PK-Sim® (as part of the Open Systems Pharmacology (OSP) Suite) for specific pharmacological use cases. Reports are regenerated with each OSP Suite release.
How to Use These Reports¶
Each qualification report in this library includes:
- HTML Report: Comprehensive qualification report with modeling details, validation data, and simulation results
- PDF Report: Downloadable report for offline reference
These reports cover the following areas:
- Drug-drug interaction (DDI) predictions for major CYP enzymes and transporters
- Pediatric extrapolation and enzyme/GFR ontogeny qualification
- Disease population modeling (e.g., chronic kidney disease)
Available Qualification Reports¶
Drug-Drug Interaction (DDI)¶
| Qualification Report (HTML) | PDF Report |
|---|---|
| DDI_Qualification_CYP1A2 | report.pdf |
| DDI_Qualification_CYP2C19 | report.pdf |
| DDI_Qualification_CYP3A4 | report.pdf |
| DDI_Qualification_P-gp | report.pdf |
| DDI_Qualification_UGT | report.pdf |
Pediatric Extrapolation¶
| Qualification Report (HTML) | PDF Report |
|---|---|
| Pediatric_Qualification_Package_CYP2C8_Ontogeny | report.pdf |
| Pediatric_Qualification_Package_CYP3A4_Ontogeny | report.pdf |
| Pediatric_Qualification_Package_GFR_Ontogeny | report.pdf |
Disease¶
| Qualification Report (HTML) | PDF Report |
|---|---|
| Qualification-CKD | report.pdf |
Frequently Asked Questions (FAQ)¶
What is a qualification report?¶
A qualification report documents the level of qualification of the PBPK modeling platform PK-Sim® (as part of the Open Systems Pharmacology (OSP) Suite) for a specific use case (e.g., predicting CYP3A4-mediated drug-drug interactions). Each report compares model predictions against observed clinical data, providing goodness-of-fit assessments and predictive performance metrics.
What is a PBPK model?¶
A Physiologically Based Pharmacokinetic (PBPK) model is a mathematical model that predicts the absorption, distribution, metabolism, and excretion (ADME) of drugs in the body. PBPK models incorporate anatomical, physiological, and biochemical information to simulate drug concentration-time profiles in various tissues and organs.
How can I cite these reports?¶
Each report includes specific citation information. In general, please cite the Open Systems Pharmacology project and the specific qualification report. Additional details can be found on the Open Systems Pharmacology website.
What software do I need?¶
To run the underlying models, you'll need the Open Systems Pharmacology Suite, which includes:
- PK-Sim®: For PBPK modeling and simulation
- MoBi®: For more advanced mechanistic modeling (optional)
Both tools are free and open-source, available at www.open-systems-pharmacology.org.