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. This summary states who is eligible for the grant, how much grant money will be awarded, current and past deadlines, Catalog of Federal Domestic Assistance (CFDA) numbers, and a sampling of similar government grants. Verify the accuracy of the data FederalGrants.com provides by visiting the webpage noted in the Link to Full Announcement section or by contacting the appropriate person listed as the Grant Announcement Contact. If any section is incomplete, please visit the website for the Food and Drug Administration, which is the U.S. government agency offering this grant.
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.
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
bryce.jones@fda.hhs.gov

Food and Drug Administration 240-402-7592
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