Development of Bio-relevant In-vitro Assay to Determine Labile Iron in the Parenteral Iron Complex Product (U01)
It has been suggested that generic iron complex formulations could have higher levels of labile iron, leading to the formation of a greater amount of non-transferrin bound iron (NTBI) in vivo than the reference listed drug (RLD) that would potentiate oxidative stress and inflammation, then resulting in direct cellular damage. The objectives of this study are to evaluate various in-vitro methods of determining labile iron in the parenteral iron complex formulations and develop a bio-relevant in-vitro method to predict the amount of NTBI in vivo. Such a predictive in-vitro method will allow for linkage of FDA's equivalence standards to in vivo performance.
General information about this opportunity
Last Known Status
Deleted 06/23/2013 (Archived.)
Program Number
RFA-FD-13-017 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
05/24/2013 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-13-017.html
E-mail Address
lisa.ko@fda.hhs.gov
Financial Information
Obligations
$500,000.00 Range and Average of Financial Assistance
Awards up to $500,000.00
