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.
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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.
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]
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