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Pharmacometric Modeling and Simulation for Long Acting Injectable Products (U01)

Post Date

February 17th 2015

Application Due Date

April 27th 2015

Funding Opportunity Number


CFDA Number(s)


Funding Instrument Type(s)

Cooperative Agreement

Funding Activity Categories

Consumer Protection
Food and Nutrition

Number of Awards


Eligibility Categories

State Governments
County Governments
City or Township Governments
Special District Governments
Independent School Districts
Public and State Controlled Institutions of Higher Education
Federally Recognized Native American Tribal Governments
Public Housing Authorities or Indian Housing Authorities
Non-Federally Recognized Native American Tribal Organizations
Non-Profits With 501 (c) (3) Status With The IRS (Except Higher Education Institutions)
Non-Profits Without 501 (c) (3) Status With The IRS (Except Higher Education Institutions)
Private Institutions of Higher Education
For-Profit Organizations (Except Small Businesses)
Small Businesses

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.


  • Estimated Total Funding:


  • Award Range:

    $None - $200000

Grant Description

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.

Contact Information

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