Evaluating Predictive Methods and Product Performance in Healthy Adults for Pediatric Patients, Case Study: Furosemide (U01)

Post Date

June 10th 2014

Application Due Date

July 15th 2014

Funding Opportunity Number

RFA-FD-14-081

CFDA Number(s)

93.103

Funding Instrument Type(s)

Cooperative Agreement

Funding Activity Categories

Consumer Protection
Food and Nutrition
Health

Number of Awards

1

Eligibility Categories

State Governments
County Governments
City or Township Governments
Special District Governments
Independent School Districts
Public and State Controlled Institutions of Higher Education
Federally Recognized Native American Tribal Governments
Public Housing Authorities or Indian Housing Authorities
Non-Federally Recognized Native American Tribal Organizations
Non-Profits With 501 (c) (3) Status With The IRS (Except Higher Education Institutions)
Non-Profits Without 501 (c) (3) Status With The IRS (Except Higher Education Institutions)
Private Institutions of Higher Education
For-Profit Organizations (Except Small Businesses)
Small Businesses
Other

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the HHS Grants Policy Statement, are allowed.

Funding

• Estimated Total Funding:

  $100000

• Award Range:

  $None - $100000

Grant Description

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 vivo in an environment similar to that seen in pediatric patients Furosemide will be given with milk, baby formula and Ensure Plus╙ to healthy adults. The studies will be designed with emphasis on the absorption phase and the changes that may be detected during the first 4 to 6 hours after dosing.

Contact Information

• Agency

  Department of Health and Human Services

• Office:

  Food and Drug Administration

• Agency Contact:

  Lisa Ko
  Grants Management Specialist
  

• Agency Mailing Address:

  lisa.ko@fda.hhs.gov

• Agency Email Address:

  lisa.ko@fda.hhs.gov

• More Information:

  Full Announcement RFA-FD-14-081