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

Post Date

March 18th 2016

Application Due Date

May 16th 2016

Funding Opportunity Number

RFA-FD-16-026

CFDA Number(s)

93.103

Funding Instrument Type(s)

Cooperative Agreement

Funding Activity Categories

Consumer Protection
Food and Nutrition
Health

Number of Awards

2

Eligibility Categories

State Governments
County Governments
City or Township Governments
Special District Governments
Independent School Districts
Public and State Controlled Institutions of Higher Education
Federally Recognized Native American Tribal Governments
Public Housing Authorities or Indian Housing Authorities
Non-Federally Recognized Native American Tribal Organizations
Non-Profits With 501 (c) (3) Status With The IRS (Except Higher Education Institutions)
Non-Profits Without 501 (c) (3) Status With The IRS (Except Higher Education Institutions)
Private Institutions of Higher Education
For-Profit Organizations (Except Small Businesses)
Small Businesses
Other

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.

Funding

• Estimated Total Funding:

  $500000

• Award Range:

  $None - $250000

Grant 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.

Contact Information

• Agency

  Department of Health and Human Services

• Office:

  Food and Drug Administration

• Agency Contact:

  Eric Bozoian
  Grants Management Specialist
  Phone 2404027623

• Agency Mailing Address:

  eric.bozoian@fda.hhs.gov

• Agency Email Address:

  eric.bozoian@fda.hhs.gov

• More Information:

  Full Announcement of RFA-FD-16-026