Designing and performing a virtual bioequivalence trial for physiologically-based pharmacokinetic and other mechanism-based models
The summary for the Designing and performing a virtual bioequivalence trial for physiologically-based pharmacokinetic and other mechanism-based models grant is detailed below.
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Designing and performing a virtual bioequivalence trial for physiologically-based pharmacokinetic and other mechanism-based models: The purpose of this funding opportunity is to develop a workflow for designing and performing a reliable virtual bioequivalence study by leveraging a physiologically-based pharmacokinetic (PBPK) model, validated for its intended purpose, to detect formulation differences between the reference standard product and a prospective generic drug product. The workflow will explore considerations and reasonable assumptions related to performing a virtual bioequivalence assessment using mechanistic modeling and simulation tools of increased complexity, such as PBPK models.
Federal Grant Title: | Designing and performing a virtual bioequivalence trial for physiologically-based pharmacokinetic and other mechanism-based models |
Federal Agency Name: | Food and Drug Administration (HHS-FDA) |
Grant Categories: | Consumer Protection Science and Technology |
Type of Opportunity: | Discretionary |
Funding Opportunity Number: | RFA-FD-23-016 |
Type of Funding: | Cooperative Agreement |
CFDA Numbers: | 93.103 |
CFDA Descriptions: | Information not provided |
Current Application Deadline: | February 15th, 2023 |
Original Application Deadline: | February 15th, 2023 |
Posted Date: | December 1st, 2022 |
Creation Date: | December 1st, 2022 |
Archive Date: | March 17th, 2023 |
Total Program Funding: | $500,000 |
Maximum Federal Grant Award: | $500,000 |
Minimum Federal Grant Award: | $50,000 |
Expected Number of Awards: | 1 |
Cost Sharing or Matching: | No |
Last Updated: | December 1st, 2022 |
- Applicants Eligible for this Grant
- State governments - County governments - City or township governments - Special district governments - Independent school districts - Public and State controlled institutions of higher education - Native American tribal governments (Federally recognized) - Public housing authorities/Indian housing authorities - Native American tribal organizations (other than Federally recognized tribal governments) - 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 - Private institutions of higher education - For-profit organizations other than small businesses - Small businesses - Others (see text field entitled "Additional Information on Eligibility" for clarification.)
- Additional Information on Eligibility
- Eligible OrganizationsHigher Education InstitutionsPublic/State Controlled Institutions of Higher EducationPrivate Institutions of Higher EducationThe following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education:Hispanic-serving InstitutionsHistorically Black Colleges and Universities (HBCUs)Tribally Controlled Colleges and Universities (TCCUs)Alaska Native and Native Hawaiian Serving InstitutionsAsian American Native American Pacific Islander Serving Institutions (AANAPISIs)Nonprofits Other Than Institutions of Higher EducationNonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)For-Profit OrganizationsSmall BusinessesFor-Profit Organizations (Other than Small Businesses)Local GovernmentsState GovernmentsCounty GovernmentsCity or Township GovernmentsSpecial District GovernmentsIndian/Native American Tribal Governments (Federally Recognized)Indian/Native American Tribal Governments (Other than Federally Recognized)U.S. Territory or PossessionOtherIndependent School DistrictsPublic Housing Authorities/Indian Housing AuthoritiesNative American Tribal Organizations (other than Federally recognized tribal governments)Faith-based or Community-based Organizations
- Link to Full Grant Announcement
- FULL ANNOUNCEMENT
- Grant Announcement Contact
- Shashi Malhotra
Grants Management Specialist
Phone 2404027592
[email protected] - Similar Government Grants
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