Creating a new framework to evaluate how well local drugs work in the gut
Development of PBBM Framework to Support an Assessment of Bioequivalence for Locally-Acting Drugs in the Gastrointestinal Tract in Healthy Subjects and Patients
This study is looking at how well different gut medications work by testing them in the lab and using computer models, so we can better understand their effectiveness for both healthy people and those with gut issues, which could help make future drug testing easier and more efficient.
Quick facts
| Grant type | U01 cooperative agreement |
|---|---|
| Study type | NIH-funded research |
| Funding institution | University of Bath NIH-funded |
| Lab location | 1 site (Bath, United Kingdom) |
| Project ID | NIH-10701033 on NIH RePORTER |
What this research studies
This research aims to develop a new framework for assessing the bioequivalence of locally acting drugs in the gastrointestinal tract. It combines laboratory tests (in vitro) and computer modeling (in silico) to evaluate how these drugs dissolve and are absorbed in both healthy individuals and those with gastrointestinal conditions. By analyzing existing drug products and creating new formulations, the study seeks to improve the understanding of how drug quality affects their effectiveness in the gut. This innovative approach could potentially reduce the need for extensive clinical trials in the future.
Who could benefit from this research
Good fit: Ideal candidates for this research include healthy individuals and patients with gastrointestinal conditions who are using or may benefit from locally acting drugs.
Not a fit: Patients who do not have gastrointestinal conditions or are not using locally acting drugs may not receive any benefit from this research.
Why it matters
Potential benefit: If successful, this research could lead to more efficient evaluations of drug effectiveness, ultimately improving treatment options for patients with gastrointestinal issues.
How similar studies have performed: While the approach of integrating in vitro and in silico methods is innovative, similar methodologies have shown promise in other areas of drug evaluation, suggesting potential for success.
Where this research is happening
Bath, United Kingdom
- University of Bath — Bath, United Kingdom (Active)
Researchers
- Principal investigator: Fotaki, Nikoletta — University of Bath
- Study coordinator: Fotaki, Nikoletta
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.