Understanding how food and stomach conditions affect drug release from specific formulations
Official title: From Bench to Bioequivalence: In Vitro Mechanistic Understanding of ASD Drug Products in Simulated Gastrointestinal Conditions
Funded at Simulations Plus, INC. · NIH-11064251 · Data updated 2026-11-12
This study is looking at how different foods and stomach acidity affect how well certain medications work when taken, with the goal of making these drugs more effective for patients.
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 | 2024 |
| Award (this year) | $249,485 |
| NIH project number | 1U01FD008388-01 |
| Project ID | NIH-11064251 on NIH RePORTER |
Who could benefit from this research
✓Could help
Ideal candidates for this research are patients who require medications formulated as amorphous solid dispersions and may benefit from improved drug absorption.
✕Less likely to help
Patients who are not using ASD drug products or those with conditions unrelated to drug absorption may not receive any benefit from this research.
What this research studies
This research investigates how different food types and stomach acidity levels influence the release of drugs from amorphous solid dispersion (ASD) formulations. By simulating gastrointestinal conditions, the study aims to generate data that correlates laboratory findings with real-world clinical outcomes. The project will utilize advanced modeling techniques to predict how variations in drug formulation and manufacturing processes can affect drug absorption in patients. This approach seeks to improve the effectiveness of ASD drug products by ensuring they perform optimally in the human body.
Why it matters
Potential benefit: If successful, this research could lead to more effective drug formulations that improve patient outcomes by ensuring better drug absorption and efficacy.
How similar studies have gone: Previous research has shown promise in understanding drug release mechanisms in similar contexts, indicating that this approach could yield valuable insights.
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.