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Development of a virtual bioequivalence trial simulation platform that integrates population pharmacokinetic modeling algorithms into physiologically-based pharmacokinetic models (U01)
The purpose of this project is to develop and implement a virtual bioequivalence trial simulation platform that can be used to perform population-based statistical analysis in complex and computationally intensive physiologically based pharmacokinetic (PBPK) models developed to describe the absorption,
distribution and elimination of active pharmaceutical ingredients formulated in complex and non-complex dosage forms administered via oral or non-oral routes.
The developed virtual bioequivalence trial simulation platform will be used to generate predictions on the in vivo drug product performance, to perform bioequivalence assessments between brand name and generic drug products and to inform regulatory decisions relating to generic drug development.
distribution and elimination of active pharmaceutical ingredients formulated in complex and non-complex dosage forms administered via oral or non-oral routes.
The developed virtual bioequivalence trial simulation platform will be used to generate predictions on the in vivo drug product performance, to perform bioequivalence assessments between brand name and generic drug products and to inform regulatory decisions relating to generic drug development.
Agency: Department of Health and Human Services
Office: Food and Drug Administration
Estimated Funding: $94,976
Office: Food and Drug Administration
Estimated Funding: $94,976
Who's Eligible
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Additional Information of Eligibility:
Eligible Organizations Higher Education Institutions • Public/State Controlled Institutions of Higher Education • Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education: o Hispanic-serving Institutions o Historically Black Colleges and Universities (HBCUs) o Tribally Controlled Colleges and Universities (TCCUs) o Alaska Native and Native Hawaiian Serving Institutions o Asian American Native American Pacific Islander Serving Institutions (AANAPISIs) Nonprofits Other Than Institutions of Higher Education • Nonprofits 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 Organizations • Small Businesses • For-Profit Organizations (Other than Small Businesses) Governments • State Governments • County Governments • City or Township Governments • Special District Governments • Indian/Native American Tribal Governments (Federally Recognized) • Indian/Native American Tribal Governments (Other than Federally Recognized) • Eligible Agencies of the Federal Government • U. S. Territory or Possession Other • Independent School Districts • Public Housing Authorities/Indian Housing Authorities • Native American Tribal Organizations (other than Federally recognized tribal governments) • Faith-based or Community-based Organizations • Regional Organizations • Non-domestic (non-U.S.) Entities (Foreign Institutions)
Full Opportunity Web Address:
https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-18-018.html
Contact:
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Date Posted:
2018-04-20
Application Due Date:
Archive Date:
2018-07-20
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