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.
General information about this opportunity
Last Known Status
Deleted 05/27/2015 (Archived.)
Program Number
RFA-FD-15-008 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
3 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
04/27/2015 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-15-008.html
E-mail Address
lisa.ko@fda.hhs.gov
Financial Information
Obligations
$600,000.00 Range and Average of Financial Assistance
Awards up to $200,000.00
