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

Source: https://welltoldgrants.com/grants/rfa-fd-23-017-population-pharmacokinetic-modeling-of-systemic/  
Official notice: https://www.grants.gov/search-results-detail/344257

> Food and Drug Administration offered grants of up to $500,000 (at least $50,000) to nonprofits, colleges and universities, state and local governments, tribes, small businesses and businesses. It expected to make $1.0 million in total. Applications closed on February 28, 2023.

| Field | Value |
|---|---|
| Opportunity number | RFA-FD-23-017 |
| Agency | Food and Drug Administration |
| Status | Forecast |
| Deadline | February 28, 2023 |
| Award ceiling | $500,000 |
| Award floor | $50,000 |
| Expected awards | not stated |
| Total funding | $1.0 million |
| Cost sharing | not required |
| Assistance Listings | 93.103 |

## 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 tribal governments)
- Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
- Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
- Private institutions of higher education
- For profit organizations other than small businesses
- Small businesses
- Others (see text field entitled "Additional Information on Eligibility" for clarification)

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)

## What the grant funds

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 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.

## Questions people ask

### Is RFA-FD-23-017 still open?

No. It closed on February 28, 2023. A newer notice is open: PAR-27-017, rolling or no fixed deadline.

### Who can apply for Population Pharmacokinetic Modeling of Systemic Pharmacokinetic Data to Inform Bioequivalence in Regional Lung Exposure (U01) Clinical Trial Not Allowed?

Food and Drug Administration accepted applications from nonprofits, colleges and universities, state and local governments, tribes, small businesses and businesses. The notice adds further conditions, so read its eligibility section.

### What is the deadline for Population Pharmacokinetic Modeling of Systemic Pharmacokinetic Data to Inform Bioequivalence in Regional Lung Exposure (U01) Clinical Trial Not Allowed?

Closed February 28, 2023. Applications are no longer accepted; the program's newer notices are on this page when there are any.

### How much funding is available?

Awards of up to $500,000 each. About $1.0 million in total.

### Who has won Food and Drug Administration Research grants before?

The largest recipients over five fiscal years were The Critical Path Institute, National Environmental Health Association, Association of Food & Drug Officials. The program made 940 awards worth $1.2 billion in that time.