Published November 20, 2018
Robert Bies, associate professor, pharmaceutical sciences, is principal investigator on an $880,000 grant from the Food and Drug Administration for his project entitled “Physiologically-based model of the female reproductive tract: vaginal and intrauterine delivery components.”
The work is being led from Bies' lab at the UB School of Pharmacy and Pharmaceutical Sciences and includes a collaboration for human tissue measurements at the Magee Womens Research Institute at the University of Pittsburgh.
The overarching aim of the project is to develop a physiologically-based pharmacokinetic (PBPK) modeling and simulation platform that describes the female urogenital tract. This can then be used by the FDA, as well as organizations involved in the development of products delivered via this route, to determine the pharmacokinetic profiles of these complex products.
"This platform has the potential to inform future strategies to determine bioequivalence for complex vaginal and intrauterine drug products," says Bies.
The project runs through Sept. 2020.