Creating a method to conduct virtual studies for drug equivalence using advanced modeling.
Official title: Development and validation of a workflow to conduct virtual bioequivalence studies using PBBM-PBPK models
Funded at Simulations Plus, INC. · NIH-10928179 · Data updated 2026-11-12
This study is working on a new way to see if different versions of medications work the same in our bodies, using computer models to help understand how drugs are absorbed and processed, so we can learn more about them without needing lots of clinical trials.
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 5, 2023 |
| Project end | August 31, 2026 |
| Funding year | 2024 |
| Award (this year) | $249,392 |
| NIH project number | 5U01FD007906-02 |
| Project ID | NIH-10928179 on NIH RePORTER |
Who could benefit from this research
✓Could help
Patients who may benefit from this research include those who rely on generic medications or are involved in drug development processes.
✕Less likely to help
Patients who are not involved in drug development or do not use medications that are subject to bioequivalence studies may not receive direct benefits from this research.
What this research studies
This research focuses on developing a new workflow to assess whether different drug formulations are equivalent using advanced computer models. By utilizing two software platforms, GastroPlus and PK-SIM, the team will analyze how drugs are absorbed, distributed, metabolized, and excreted in the body. The project will involve identifying relevant case studies, validating the software's predictive capabilities, and simulating scenarios to establish a reliable method for virtual bioequivalence studies. This approach aims to enhance the understanding of drug behavior in various populations without the need for extensive clinical trials.
Why it matters
Potential benefit: If successful, this research could streamline the process of determining drug equivalence, potentially leading to faster access to generic medications for patients.
How similar studies have gone: While the use of in silico models for drug studies is gaining traction, this specific approach to virtual bioequivalence is relatively novel and has not been extensively tested.
Where this research is happening
-
Simulations Plus, INC.
Lancaster, United States Active
Researchers
- Principal investigator: Martins, Frederico Severino — Simulations Plus, INC.
- Study coordinator: Martins, Frederico Severino
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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.