Evaluation of Aberrant Observations and Their Impact on Bioequivalence Assessment (U01)
The summary for the Evaluation of Aberrant Observations and Their Impact on Bioequivalence Assessment (U01) grant is detailed below. This summary states who is eligible for the grant, how much grant money will be awarded, current and past deadlines, Catalog of Federal Domestic Assistance (CFDA) numbers, and a sampling of similar government grants. Verify the accuracy of the data FederalGrants.com provides by visiting the webpage noted in the Link to Full Announcement section or by contacting the appropriate person listed as the Grant Announcement Contact. If any section is incomplete, please visit the website for the Food and Drug Administration, which is the U.S. government agency offering this grant.
Evaluation of Aberrant Observations and Their Impact on Bioequivalence Assessment (U01): 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.
|Federal Grant Title:||Evaluation of Aberrant Observations and Their Impact on Bioequivalence Assessment (U01)|
|Federal Agency Name:||Food and Drug Administration|
|Grant Categories:||Consumer Protection Food and Nutrition Health|
|Type of Opportunity:||Discretionary|
|Funding Opportunity Number:||RFA-FD-16-018|
|Type of Funding:||Cooperative Agreement|
|CFDA Descriptions:||Food and Drug Administration_Research|
|Current Application Deadline:||Jun 3, 2016|
|Original Application Deadline:||Jun 3, 2016|
|Posted Date:||Apr 1, 2016|
|Creation Date:||Apr 1, 2016|
|Archive Date:||Jul 3, 2016|
|Total Program Funding:||$600,000|
|Maximum Federal Grant Award:||$200,000|
|Minimum Federal Grant Award:||none|
|Expected Number of Awards:||3|
|Cost Sharing or Matching:||No|
- Applicants Eligible for this Grant
- Native American tribal governments (Federally recognized)
Special district governments
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Others (see text field entitled "Additional Information on Eligibility" for clarification)
Public and State controlled institutions of higher education
Private institutions of higher education
City or township governments
Public housing authorities/Indian housing authorities
Native American tribal organizations (other than Federally recognized tribal governments)
Independent school districts
For profit organizations other than small businesses
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
- Additional Information on Eligibility
- 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.
- Link to Full Grant Announcement
- Full Announcement of RFA-FD-16-018
- Grant Announcement Contact
- Eric Bozoian
Grants Management Specialist
Food and Drug Administration 240-402-7592
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