This grant from the Health Department focuses on utilizing pharmacometric modeling and simulation techniques for Long Acting Injectable Products. The project aims to conduct PBPK modeling to evaluate bioequivalence and perform PK-PD modeling to reduce variability in BE assessment. The ultimate goal is to establish standards for ensuring therapeutic equivalence of generic LAI products.
Opportunity ID: 274613
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-15-008 |
| Funding Opportunity Title: | Pharmacometric Modeling and Simulation for Long Acting Injectable Products (U01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Consumer Protection Food and Nutrition Health |
| Category Explanation: | – |
| Expected Number of Awards: | 3 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Feb 17, 2015 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | Apr 27, 2015 |
| Current Closing Date for Applications: | Apr 27, 2015 |
| Archive Date: | May 27, 2015 |
| Estimated Total Program Funding: | $600,000 |
| Award Ceiling: | $200,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | County governments State governments Native American tribal governments (Federally recognized) City or township governments Native American tribal organizations (other than Federally recognized tribal governments) For profit organizations other than small businesses Public housing authorities/Indian housing authorities Special district 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 Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts Small businesses Others (see text field entitled “Additional Information on Eligibility” for clarification) Private 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. |
Additional Information
| Agency Name: | Food and Drug Administration |
| 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. |
| Link to Additional Information: | Full Announcement of RFA-FD-15-008 on NIH Guide for Grants and Contracts |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Lisa Ko
Grants Management Specialist Email:lisa.ko@fda.hhs.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
Folder 274613 Other Supporting Documents-SF424 R&R VersionC Instructions 1 -> sf424_rr_guide_general_adobe_verc.pdf
Packages
| Agency Contact Information: | Lisa Ko Grants Management Specialist Email: lisa.ko@fda.hhs.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| 93.103 | SUBTOPIC-1 | RFA-FD-15-008 | PKG00215031 | Feb 25, 2015 | Apr 27, 2015 | View |
| 93.103 | SUBTOPIC-2 | RFA-FD-15-008 | PKG00215032 | Feb 25, 2015 | Apr 27, 2015 | View |
Package 1
Mandatory forms
274613 RR_SF424_2_0-2.0.pdf
274613 PHS398_ResearchPlan_2_0-2.0.pdf
274613 PHS398_CoverPageSupplement_2_0-2.0.pdf
274613 RR_Budget_1_3-1.3.pdf
274613 RR_KeyPersonExpanded_2_0-2.0.pdf
274613 RR_OtherProjectInfo_1_3-1.3.pdf
274613 PerformanceSite_2_0-2.0.pdf
Optional forms
274613 PlannedReport-1.0.pdf
274613 PHS398_CumulativeInclusionReport-1.0.pdf
274613 RR_SubawardBudget30_1_3-1.3.pdf
Package 2
Mandatory forms
274613 RR_SF424_2_0-2.0.pdf
274613 PHS398_ResearchPlan_2_0-2.0.pdf
274613 PHS398_CoverPageSupplement_2_0-2.0.pdf
274613 RR_Budget_1_3-1.3.pdf
274613 RR_KeyPersonExpanded_2_0-2.0.pdf
274613 RR_OtherProjectInfo_1_3-1.3.pdf
274613 PerformanceSite_2_0-2.0.pdf
Optional forms
274613 PlannedReport-1.0.pdf
274613 PHS398_CumulativeInclusionReport-1.0.pdf
274613 RR_SubawardBudget30_1_3-1.3.pdf
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