Predictive in vitro Methods for Characterizing Product Performance, Case Study: Furosemide (U01)

The summary for the Predictive in vitro Methods for Characterizing Product Performance, 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 Drug Administration, which is the U.S. government agency offering this grant.

Predictive in vitro Methods for Characterizing Product Performance, Case Study: Furosemide (U01): 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 explore additional methodology to characterize dissolution of furosemide (the model drug) in media containing milk, baby formula and Ensure Plus™. The suitability of methods including 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 explored and determined.

Federal Grant Title:	Predictive in vitro Methods for Characterizing Product Performance, Case Study: Furosemide (U01)
Federal Agency Name:	Food Drug Administration
Grant Categories:	Consumer Protection Food and Nutrition Health
Type of Opportunity:	Discretionary
Funding Opportunity Number:	RFA-FD-14-080
Type of Funding:	Cooperative Agreement
CFDA Numbers:	93.103
CFDA Descriptions:	Food and Drug Administration_Research
Current Application Deadline:	Jul 15, 2014
Original Application Deadline:	Jul 15, 2014
Posted Date:	Jun 9, 2014
Creation Date:	Jun 9, 2014
Archive Date:	Aug 14, 2014
Total Program Funding:	$100,000
Maximum Federal Grant Award:	$100,000
Minimum Federal Grant Award:	none
Expected Number of Awards:	1
Cost Sharing or Matching:	No

Applicants Eligible for this Grant: Public and State controlled institutions of higher education
For profit organizations other than small businesses
Special district governments
Private institutions of higher education
City or township governments
Others (see text field entitled "Additional Information on Eligibility" for clarification)
Public housing authorities/Indian housing authorities
Native American tribal organizations (other than Federally recognized tribal governments)
Small businesses
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
State governments
Independent school districts
County governments
Native American tribal governments (Federally recognized)
Additional Information on 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.
Link to Full Grant Announcement: Full Announcement RFA-FD-14-080
Grant Announcement Contact: Lisa Ko Grants Management Specialist
[email protected]

Food & Drug Administration 301-443-5869
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