Implementing Population Pharmacokinetic Modeling Algorithm in Physiologically-based Pharmacokinetic Models to Allow Parameter Estimation at Individual Data Level (U01)

Archived

Food and Drug Administration

Description

The purpose of this project is to develop and implement a robust optimization algorithm that can be used to perform population-based statistical analysis in complex and computationally intensive physiologically based pharmacokinetic (PBPK) models so that knowledge of parameter distributions in the population(s) of interest can be derived. The models developed will be used to generate predictions that can inform bioequivalence assessments and regulatory decisions relating to generic drug development.

Who can apply

  • 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)
  • Nonprofits with 501(c)(3) status (other than higher education)
  • Nonprofits without 501(c)(3) status (other than higher education)
  • Private institutions of higher education
  • For-profit organizations other than small businesses
  • Small businesses
  • Others

Contact

Eric Bozoian <br/>Grants Management Specialist <br/>Phone 2404027623
eric.bozoian@fda.hhs.gov

Key dates & funding
  • PostedMar 18, 2016
  • ClosesMay 16, 2016
  • Award ceiling$250,000
  • Program funding$500,000
  • Expected awards2
  • CFDA93.103

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