Predictive Methods for Characterizing Product Performance in Pediatric Patients, Case Study: Furosemide

 

This project follows after earlier CDER research projects in which in vitro furosemide dissolution and/or solubility data were collected in various dissolution media such as simulated gastric and intestinal fluids. In two different studies with different approaches and dissolution testing apparatus, furosemide dissolution was higher in medium containing milk and baby formula than that in standard buffer medium. This research project will allow collecting in vivo data when furosemide (the model drug) will be given with milk, baby formula and Ensure Plus™ to healthy adults. The suitability of the in vitro methods using dissolution media containing milk, baby formula and Ensure Plus for predicting in vivo performance of furosemide (a poorly soluble and poorly permeable drug), classified as BCS (Biopharmaceutic Classification System) Class IV drug will be determined.

Deleted 09/14/2013 (Archived.) RFA--FD-13-035 Agency: Department of Health and Human Services
Office: Food and Drug Administration Grant 3 The application receipt/due date is August 15, 2013 by 11:59PM Eastern time. 08/15/2013 This program does not have cost sharing or matching requirements. Oluyemisi (Yemisi) Akinneye
Grants Management Specialist
Phone 3018270079 http://grants.nih.gov/grants/guide/rfa-files/RFA-FD-13-035.html Oluyemisi.Akinneye@fda.hhs.gov $250,000.00 Awards up to $100,000.00