PBPK modeling to understand drug interactions in infants and young children
Official title: Application of Physiologically-Based Pharmacokinetic Modeling to Characterize Drug-Drug Interactions in Infants
Funded at Duke University · NIH-11549359 · Data updated 2026-11-12
A Duke research team will use computer models and real-world infant data to understand how mixing certain drugs affects babies’ bodies, aiming to guide safer dosing.
Quick facts
| Grant type | R01 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Duke University NIH-funded |
| Lab location | 1 site (Durham, United States) |
| Project start | May 1, 2026 |
| Project end | April 30, 2027 |
| Funding year | 2026 |
| Award (this year) | $446,228 |
| NIH project number | 3R01HD102949-06S1 |
| Project ID | NIH-11549359 on NIH RePORTER |
Who could benefit from this research
✓Could help
Infants and young children who are treated with the studied drug combinations in clinical settings.
✕Less likely to help
The study does not directly involve routine treatment changes for healthy volunteers; results apply to infants receiving specific drug combinations.
What this research studies
Infants process medicines differently from adults, so combining drugs can cause unexpected effects. This project uses physiologically-based pharmacokinetic (PBPK) modeling to simulate drug interactions for infants when two or more drugs are given together. It will focus on midazolam, fentanyl, and phenobarbital, and will compare model predictions with real-world data from infants receiving these drug combinations as part of standard care. The goal is to create age-appropriate dosing recommendations that account for potential drug interactions early in life.
Why it matters
Potential benefit: If successful, clinicians will have better guidance for safely dosing medications in infants when multiple drugs are used together.
How similar studies have gone: PBPK modeling has shown promise in translating adult dosing to children, but infant-specific DDI predictions are still being validated.
Where this research is happening
-
Duke University
Durham, United States Active
Researchers
- Principal investigator: Gonzalez, Daniel — Duke University
- Study coordinator: Gonzalez, Daniel
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.