Improving the development of generic skin medications.
Optimized clinical dermal Open Flow Microperfusion study design to demonstrate bioequivalence based on cutaneous pharmacokinetics
This study is testing a new way to show that generic skin medications work just as well as the brand-name ones, which could help make these more affordable options available for patients who need them.
Quick facts
| Grant type | U01 cooperative agreement |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Joanneum Research Forschungsgesellschaft Mbh NIH-funded |
| Lab location | 1 site (Graz, Austria) |
| Project ID | NIH-10897842 on NIH RePORTER |
What this research studies
This research focuses on developing a new method to demonstrate that generic topical medications are equivalent to their brand-name counterparts. It utilizes a technique called dermal Open Flow Microperfusion to assess how drugs are absorbed through the skin. By comparing the pharmacokinetics of these medications, the study aims to provide a more cost-effective way to bring generic options to market, ultimately benefiting patients who rely on these treatments.
Who could benefit from this research
Good fit: Ideal candidates for this research are patients who use topical medications and may benefit from lower-cost generic alternatives.
Not a fit: Patients who do not use topical medications or who require specialized formulations that cannot be matched may not benefit from this research.
Why it matters
Potential benefit: If successful, this research could lead to more affordable generic topical medications for patients.
How similar studies have performed: Previous projects funded by the US-FDA have shown promise in using similar approaches to assess drug equivalence, indicating a potential for success in this area.
Where this research is happening
Graz, Austria
- Joanneum Research Forschungsgesellschaft Mbh — Graz, Austria (Active)
Researchers
- Principal investigator: Sinner, Frank — Joanneum Research Forschungsgesellschaft Mbh
- Study coordinator: Sinner, Frank
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.