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

The summary for the Pharmacometric Modeling and Simulation for Long Acting Injectable Products (U01) grant is detailed below. This summary states who is eligible for the grant, how much grant money will be awarded, current and past deadlines, Catalog of Federal Domestic Assistance (CFDA) numbers, and a sampling of similar government grants. Verify the accuracy of the data FederalGrants.com provides by visiting the webpage noted in the Link to Full Announcement section or by contacting the appropriate person listed as the Grant Announcement Contact. If any section is incomplete, please visit the website for the Food Drug Administration, which is the U.S. government agency offering this grant.

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.

Federal Grant Title:	Pharmacometric Modeling and Simulation for Long Acting Injectable Products (U01)
Federal Agency Name:	Food Drug Administration
Grant Categories:	Consumer Protection Food and Nutrition Health
Type of Opportunity:	Discretionary
Funding Opportunity Number:	RFA-FD-15-008
Type of Funding:	Cooperative Agreement
CFDA Numbers:	93.103
CFDA Descriptions:	Food and Drug Administration_Research
Current Application Deadline:	Apr 27, 2015
Original Application Deadline:	Apr 27, 2015
Posted Date:	Feb 17, 2015
Creation Date:	Feb 17, 2015
Archive Date:	May 27, 2015
Total Program Funding:	$600,000
Maximum Federal Grant Award:	$200,000
Minimum Federal Grant Award:	none
Expected Number of Awards:	3
Cost Sharing or Matching:	No

Applicants Eligible for this Grant: County governments
City or township governments
Others (see text field entitled "Additional Information on Eligibility" for clarification)
Small businesses
Private institutions of higher education
Public housing authorities/Indian housing authorities
State governments
Special district governments
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Independent school districts
For profit organizations other than small businesses
Native American tribal governments (Federally recognized)
Native American tribal organizations (other than Federally recognized tribal governments)
Public and State controlled institutions of higher education
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Additional Information on 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.
Link to Full Grant Announcement: Full Announcement of RFA-FD-15-008 on NIH Guide for Grants and Contracts
Grant Announcement Contact: Lisa Ko Grants Management Specialist
[email protected]

Food & Drug Administration 301-443-5869
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