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.

General information about this opportunity
Last Known Status
Deleted 08/14/2014 (Archived.)
Program Number
RFA-FD-14-080
Federal Agency/Office
Agency: Department of Health and Human Services
Office: 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 Ko
Grants Management Specialist
Website Address
http://grants.nih.gov/grants/guide/rfa-files/RFA-FD-14-080.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

 


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