OpportunityTitle: Pharmacokinetics Studies of Tacrolimus in Transplant Patients (U01)
AdditionalInformationOnEligibility: 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 FDA Grants Policy Statement, are allowed.
Description: The goal of this proposal is to compare the pharmacokinetics of two sources of generic tacrolimus capsules to Prograf in stable transplant patients. Patients will be switched between both brand and generic. The outcome of this study can help address the public concerns regarding the quality of generic tacrolimus and improve review practices of generic tacrolimus if necessary.
GrantorContactEmailDescription: lisa.ko@fda.hhs.gov
GrantorContactText: Lisa Ko &lt;br/&gt;Grants Management Specialist