Population Pharmacokinetic Modeling of Systemic Pharmacokinetic Data to Inform Bioequivalence in Regional Lung Exposure (U01) Clinical Trial Not Allowed

Orally Inhaled Drug Products (OIDPs) are complex drug-device combination products.

To establish bioequivalence for locally acting OIDPs, FDA is currently using a weight-of-evidence approach which generally includes a combination of in vitro BE studies; in vivo pharmacokinetic (PK) studies and

credit:


comparative clinical endpoint (CCEP) or pharmacodynamic (PD) studies; along with formulation sameness and device similarity.

For some OIDPs, both CCEP and PD studies can pose a challenge due to a lack of sensitivity to detect formulation differences.

The purpose of this funding opportunity is to support research that will use modeling and simulation to investigate the feasibility of assessing formulation differences in regional lung exposure based on systemic PK concentration data to establish BE for OIDPs with different drug and product properties.
Related Programs

Food and Drug Administration_Research

Department of Health and Human Services


Agency: Department of Health and Human Services

Office: Food and Drug Administration

Estimated Funding: $1,000,000


Who's Eligible


Relevant Nonprofit Program Categories





Obtain Full Opportunity Text:
FULL ANNOUNCEMENT

Additional Information of Eligibility:
Eligible OrganizationsHigher Education InstitutionsPublic/State Controlled Institutions of Higher EducationPrivate Institutions of Higher EducationThe following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education:Hispanic-serving InstitutionsHistorically Black Colleges and Universities (HBCUs)Tribally Controlled Colleges and Universities (TCCUs)Alaska Native and Native Hawaiian Serving InstitutionsAsian American Native American Pacific Islander Serving Institutions (AANAPISIs)Nonprofits Other Than Institutions of Higher EducationNonprofits 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 OrganizationsSmall BusinessesFor-Profit Organizations (Other than Small Businesses)Local GovernmentsState GovernmentsCounty GovernmentsCity or Township GovernmentsSpecial District GovernmentsIndian/Native American Tribal Governments (Federally Recognized)Indian/Native American Tribal Governments (Other than Federally Recognized)U. S. Territory or PossessionOtherIndependent School DistrictsPublic Housing Authorities/Indian Housing AuthoritiesNative American Tribal Organizations (other than Federally recognized tribal governments)Faith-based or Community-based OrganizationsRegional OrganizationsNon-domestic (non-U.S.) Entities (Foreign Institutions)

Full Opportunity Web Address:
http://grants.nih.gov/grants/guide/rfa-files/RFA-FD-23-017.html

Contact:


Agency Email Description:
shashi.malhotra@fda.hhs.gov

Agency Email:


Date Posted:
2022-12-01

Application Due Date:


Archive Date:
2023-03-30




Social Entrepreneurship
Spotlight



“I vote for a social economy” Campaign


The Social Economy Alliance members had launched its I vote for a social economy, a campaign calling for a more social economy in Britain, at an open mic event in Manchester.




Not for Profit Jobs in Nebraska

  Executive Director Jobs
  Substance Abuse Jobs
  Program Director Jobs
  Executive Director Jobs
  Social Services Jobs





More Federal Domestic Assistance Programs


Health Administration Traineeships Program | Centers for Research and Demonstration for Health Promotion and Disease Prevention | Transformation Initiative Research Grants: Demonstration and Related Small Grants | Public Transportation Research | Alcohol Traffic Safety and Drunk Driving Prevention Incentive Grants |  Site Style by YAML | Grants.gov | Grants | Grants News | Sitemap | Privacy Policy


Edited by: Michael Saunders

© 2004-2023 Copyright Michael Saunders