Creating a method to conduct virtual studies for drug equivalence using advanced modeling.
Development and validation of a workflow to conduct virtual bioequivalence studies using PBBM-PBPK models
['FUNDING_U01'] · SIMULATIONS PLUS, INC. · NIH-10928179
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
| Phase | ['FUNDING_U01'] |
|---|---|
| Study type | Nih_funding |
| Sex | All |
| Sponsor | SIMULATIONS PLUS, INC. (nih funded) |
| Locations | 1 site (LANCASTER, UNITED STATES) |
| Trial ID | NIH-10928179 on ClinicalTrials.gov |
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.
Who could benefit from this research
Good fit: Patients who may benefit from this research include those who rely on generic medications or are involved in drug development processes.
Not a fit: 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.
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 performed: 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
LANCASTER, UNITED STATES
- SIMULATIONS PLUS, INC. — LANCASTER, UNITED STATES (ACTIVE)
Researchers
- Principal investigator: MARTINS, FREDERICO SEVERINO — SIMULATIONS PLUS, INC.
- Study coordinator: MARTINS, FREDERICO SEVERINO
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 below.