Predictive Methods for Characterizing Product Performance in Pediatric Patients, Case Study: Furosemide
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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.
Federal Grant Title: | Predictive Methods for Characterizing Product Performance in Pediatric Patients, Case Study: Furosemide |
Federal Agency Name: | Food and Drug Administration |
Grant Categories: | Consumer Protection Food and Nutrition |
Type of Opportunity: | Discretionary |
Funding Opportunity Number: | RFA--FD-13-035 |
Type of Funding: | Grant |
CFDA Numbers: | 93.103 |
CFDA Descriptions: | Food and Drug Administration_Research |
Current Application Deadline: | Aug 15, 2013 The application receipt/due date is |
Original Application Deadline: | Aug 15, 2013 The application receipt/due date is |
Posted Date: | Jul 19, 2013 |
Creation Date: | Jul 19, 2013 |
Archive Date: | Sep 14, 2013 |
Total Program Funding: | $250,000 |
Maximum Federal Grant Award: | $100,000 |
Minimum Federal Grant Award: | $0 |
Expected Number of Awards: | 3 |
Cost Sharing or Matching: | No |
- Applicants Eligible for this Grant
- Public and State controlled institutions of higher education
- Link to Full Grant Announcement
- NIH Guide for Grants and Contracts
- Grant Announcement Contact
- Oluyemisi (Yemisi) Akinneye
Grants Management Specialist
Phone 3018270079
[email protected]
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