Creating a model to assess how well generic drugs work in the gastrointestinal tract
Development and verification of in vitro integrated mechanistic population-based PBPK model framework towards virtual bioequivalence assessment of locally acting drug products in the GI tract
['FUNDING_U01'] · UNIVERSITY OF FLORIDA · NIH-10709607
This study is working on a new way to make sure that generic medications for the stomach and intestines work just as well as the brand-name versions, so patients can trust they’re getting the same benefits from their medicine.
Quick facts
| Phase | ['FUNDING_U01'] |
|---|---|
| Study type | Nih_funding |
| Sex | All |
| Sponsor | UNIVERSITY OF FLORIDA (nih funded) |
| Locations | 1 site (GAINESVILLE, UNITED STATES) |
| Trial ID | NIH-10709607 on ClinicalTrials.gov |
What this research studies
This research focuses on developing a new model to evaluate the effectiveness of generic drugs that act locally in the gastrointestinal (GI) tract. It aims to improve the assessment of bioequivalence, which is how similar a generic drug is to its brand-name counterpart. By using advanced pharmacokinetic modeling, the study will analyze how drugs behave in the body, particularly in the GI tract, to ensure that patients receive medications that are just as effective as the originals. This approach could lead to more reliable approvals for generic drugs, ultimately benefiting patients who rely on these medications.
Who could benefit from this research
Good fit: Ideal candidates for this research are patients who require locally acting medications for gastrointestinal conditions.
Not a fit: Patients who are not using locally acting drugs or those who only require systemic medications may not benefit from this research.
Why it matters
Potential benefit: If successful, this research could lead to more effective and reliable generic drugs for patients, ensuring they receive the same therapeutic benefits as brand-name drugs.
How similar studies have performed: While pharmacokinetic modeling has been widely used in drug development, this specific approach to assessing local drug exposure in the GI tract is relatively novel and has not been extensively tested.
Where this research is happening
GAINESVILLE, UNITED STATES
- UNIVERSITY OF FLORIDA — GAINESVILLE, UNITED STATES (ACTIVE)
Researchers
- Principal investigator: CRISTOFOLETTI, RODRIGO — UNIVERSITY OF FLORIDA
- Study coordinator: CRISTOFOLETTI, RODRIGO
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.