Evaluating predictive methods and product performance in Healthy Adults for Pediatric Patients, Case Study: Furosemide (U01)
The summary for the Evaluating predictive methods and product performance in Healthy Adults for Pediatric Patients, Case Study: Furosemide (U01) grant is detailed below.
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Evaluating predictive methods and product performance in Healthy Adults for Pediatric Patients, Case Study: Furosemide (U01): Earlier exploratory CDER research projects showed that dissolution and/or solubility of a poorly soluble drug (furosemide was studied as the model drug) was higher in medium containing milk and baby formula than that in standard buffer medium.
This research project will explore in vivo performance of furosemide in healthy adult volunteers following oral dosing of furosemide tablets with dosing liquids (i.e. water, milk, baby formula and Ensure Plus™ ). The administration of dosing liquids will mimic dosing and feeding conditions in pediatric patients (two years old and younger). The study will be designed with emphasis on the absorption phase and for careful characterization of the furosemide concentration-time profiles during the first 6 hours after dosing.
This research project will explore in vivo performance of furosemide in healthy adult volunteers following oral dosing of furosemide tablets with dosing liquids (i.e. water, milk, baby formula and Ensure Plus™ ). The administration of dosing liquids will mimic dosing and feeding conditions in pediatric patients (two years old and younger). The study will be designed with emphasis on the absorption phase and for careful characterization of the furosemide concentration-time profiles during the first 6 hours after dosing.
| Federal Grant Title: | Evaluating predictive methods and product performance in Healthy Adults for Pediatric Patients, Case Study: Furosemide (U01) |
| Federal Agency Name: | Food and Drug Administration |
| Grant Categories: | Consumer Protection Health |
| Type of Opportunity: | Discretionary |
| Funding Opportunity Number: | RFA-FD-16-048 |
| Type of Funding: | Cooperative Agreement |
| CFDA Numbers: | 323943 |
| CFDA Descriptions: | Food and Drug Administration_Research |
| Current Application Deadline: | Aug 12, 2016 |
| Original Application Deadline: | Aug 12, 2016 |
| Posted Date: | Jun 14, 2016 |
| Creation Date: | Jun 14, 2016 |
| Archive Date: | Sep 11, 2016 |
| Total Program Funding: | $250,000 |
| Maximum Federal Grant Award: | $250,000 |
| Minimum Federal Grant Award: | $0 |
| Expected Number of Awards: | 1 |
| Cost Sharing or Matching: | No |
- Applicants Eligible for this Grant
- Native American tribal governments (Federally recognized)
Small businesses
For profit organizations other than small businesses
Others (see text field entitled "Additional Information on Eligibility" for clarification)
Special district governments
Public housing authorities/Indian housing authorities
County governments
Private institutions of higher education
Independent school districts
Native American tribal organizations (other than Federally recognized tribal governments)
State governments
Public and State controlled institutions of higher education
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
City or township governments
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education - Additional Information on Eligibility
- The following addition types of institutions are eligible to apply:
Non-domestic (non-U.S.) Entities (Foreign Institutions.
Non-domestic (non-U.S.) components of U.S. Organizations.
Foreign components, as defined in the HHS Grants Policy Statement. - Link to Full Grant Announcement
- Link for announcement, RFA-FD-16-048
- Grant Announcement Contact
- Bryce Jones
Grants Management Specialist
Phone 240-402-2111
[email protected]
Food and Drug Administration 240-402-7592