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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.
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.
Who's Eligible
Obtain Full Opportunity Text:
Link to Full Announcement of RFA-FD-13-017 on NIH Guide for Grants and Contracts
Additional Information of 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.
Full Opportunity Web Address:
Contact:
Agency Email Description:
Agency Email:
lisa.ko@fda.hhs.gov
Date Posted:
2013-04-02
Application Due Date:
2013-05-24
Archive Date:
2013-06-23
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