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 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.
General information about this opportunity
Last Known Status
Deleted 08/14/2014 (Archived.)
Program Number
RFA-FD-14-081 Federal Agency/Office
Agency: Department of Health and Human ServicesOffice: Food and Drug Administration
Type(s) of Assistance Offered
Cooperative Agreement Number of Awards Available
1 Who is eligible to apply/benefit from this assistance?
Applicant Eligibility
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. What is the process for applying and being award this assistance?
Deadlines
07/15/2014 Other Assistance Considerations
Formula and Matching Requirements
This program does not have cost sharing or matching requirements. Who do I contact about this opportunity?
Headquarters Office
Lisa KoGrants Management Specialist
Website Address
http://grants.nih.gov/grants/guide/rfa-files/RFA-FD-14-081.html
E-mail Address
lisa.ko@fda.hhs.gov
Financial Information
Obligations
$100,000.00 Range and Average of Financial Assistance
Awards up to $100,000.00
