FDA R01 Predictive Methods for Characterizing Product Performance in Pediatric Patients, Case Study: Furosemide

Internal Due Date: 07-31-2013 Contact OSP

Foundation Due Date: 08-08-2013 (Letters of Intent); 08-15-2013 (Full Applications)

Number of Applications: 1

Discipline:

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. 

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