Critical Path Institute’s new disease simulation tool for improving clinical trial design for mild and moderate Alzheimer’s disease has been favorably received by both the U.S. Food and Drug Administration and European Medicines Agency—the first such instrument to ever receive this regulatory designation.
The new virtual tool applies computerized models to simulate “what-if” scenarios for clinical trials. The goal is to serve as a public resource for sponsors designing trials of new Alzheimer’s disease therapies, and lead to greater efficiency in drug development.
Tucson-based C-Path received the regulatory letters from the two agencies in June.
For more information:
“U.S. Food and Drug Administration and European Medicines Agency reach landmark decisions on Critical Path Institute’s clinical trial simulation tool for Alzheimer’s Disease,” Critical Path Institute, 7/10/13