Understanding how stomach conditions affect ASD drug release to predict real-world results
Official title: From Bench to Bioequivalence: In Vitro Mechanistic Understanding of ASD Drug Products in Simulated Gastrointestinal Conditions
Funded at Simulations Plus, INC. · NIH-11401613 · Data updated 2026-11-12
A research project tests how food and stomach acidity change how amorphous solid dispersion drugs release in the gut, using lab simulations to predict how these medicines behave in people.
Quick facts
| Grant type | U01 cooperative agreement |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Simulations Plus, INC. NIH-funded |
| Lab location | 1 site (Lancaster, United States) |
| Project start | September 1, 2024 |
| Project end | August 31, 2027 |
| Funding year | 2026 |
| Award (this year) | $114,912 |
| NIH project number | 5U01FD008388-03 |
| Project ID | NIH-11401613 on NIH RePORTER |
Who could benefit from this research
✓Could help
Patients could benefit indirectly through faster development of more reliable ASD medicines and better understanding of how meals and stomach conditions affect drug release.
✕Less likely to help
Healthy volunteers or non-ASD products without human data linkage may not benefit directly.
What this research studies
This project uses simulated gastrointestinal conditions to study how different ASD drug products release their active ingredients. By testing under fasted, fed, and lower stomach pH conditions, researchers will generate data that links lab measurements to what happens in humans. They will build a modeling approach that connects in vitro dissolution results to actual clinical outcomes, and then run virtual bioequivalence scenarios to explore how formulation changes might affect exposure. A diverse set of ASD products will be examined to understand the role of manufacturing and excipients in drug release.
Why it matters
Potential benefit: If successful, this work could improve the predictability of ASD drug performance, potentially guiding better formulations and faster development of consistent and effective medicines for patients.
How similar studies have gone: Previous work has shown that linking in vitro dissolution to in vivo performance of ASDs is informative, and this project expands that with a mechanistic modeling approach.
Where this research is happening
-
Simulations Plus, INC.
Lancaster, United States Active
Researchers
- Principal investigator: Le Merdy, Maxime — Simulations Plus, INC.
- Study coordinator: Le Merdy, Maxime
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.