Evaluation of Aberrant Observations and Their Impact on Bioequivalence Assessment (U01)

Post Date

April 1st 2016

Application Due Date

June 3rd 2016

Funding Opportunity Number

RFA-FD-16-018

CFDA Number(s)

93.103

Funding Instrument Type(s)

Cooperative Agreement

Funding Activity Categories

Consumer Protection
Food and Nutrition
Health

Number of Awards

3

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:

  $600000

• Award Range:

  $None - $200000

Grant Description

Aberrant observations in a bioequivalence study with pharmacokinetic endpoints may impact the estimation of residual variability, within-subject variability of the test and reference products, and potentially the bioequivalence conclusion. The purpose of this study is to evaluate and compare different quantitative methods for their capability in defining aberrant observations in bioequivalence studies with different study design features. Study results will advance regulatory science by improving the detection and understanding of aberrant observations and may help generic companies to evaluate the quality and in vivo performance of their proposed products.

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-16-018