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Pharmacometric Modeling and Simulation for Long Acting Injectable Products (U01)
The purpose of this project is to:
Subtopic 1:
conduct physiologically-based pharmacokinetic modeling (PBPK) to relate critical quality attributes to in vivo performance for bioequivalence (BE) evaluation; Subtopic 2:
perform population pharmacokinetic-pharmacodynamic (PK-PD) modeling
and statistical analysis to identify ways to reduce residual variability and identify appropriate PK metrics, enabling BE assessment in parallel BE studies with acceptable sample size.
The findings from these studies will help establish scientific and regulatory standards for ensuring therapeutic equivalence of generic LAI products.
Subtopic 1:
conduct physiologically-based pharmacokinetic modeling (PBPK) to relate critical quality attributes to in vivo performance for bioequivalence (BE) evaluation; Subtopic 2:
perform population pharmacokinetic-pharmacodynamic (PK-PD) modeling
and statistical analysis to identify ways to reduce residual variability and identify appropriate PK metrics, enabling BE assessment in parallel BE studies with acceptable sample size.
The findings from these studies will help establish scientific and regulatory standards for ensuring therapeutic equivalence of generic LAI products.
Agency: Food and Drug Administration
Office:
Estimated Funding: $600,000
Office:
Estimated Funding: $600,000
Who's Eligible
Obtain Full Opportunity Text:
Full Announcement of RFA-FD-15-008 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:
2015-02-17
Application Due Date:
2015-04-27
Archive Date:
2015-05-27
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