# Designing and performing a virtual bioequivalence trial for physiologically-based pharmacokinetic and other mechanism-based models

Source: https://welltoldgrants.com/grants/rfa-fd-23-016-designing-and-performing-a-virtual-bioequivalence-trial-for/  
Official notice: https://www.grants.gov/search-results-detail/344255

> 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 one award worth $500,000 in total. Applications closed on February 15, 2023.

| Field | Value |
|---|---|
| Opportunity number | RFA-FD-23-016 |
| Agency | Food and Drug Administration |
| Status | Forecast |
| Deadline | February 15, 2023 |
| Award ceiling | $500,000 |
| Award floor | $50,000 |
| Expected awards | 1 |
| Total funding | $500,000 |
| 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 Organizations

## What the grant funds

The purpose of this funding opportunity is to develop a workflow for designing and performing a reliable virtual bioequivalence study by leveraging a physiologically-based pharmacokinetic (PBPK) model, validated for its intended purpose, to detect formulation differences between the reference standard product and a prospective generic drug product. The workflow will explore considerations and reasonable assumptions related to performing a virtual bioequivalence assessment using mechanistic modeling and simulation tools of increased complexity, such as PBPK models.

## Questions people ask

### Is RFA-FD-23-016 still open?

No. It closed on February 15, 2023. A newer notice is open: PAR-27-017, rolling or no fixed deadline.

### Who can apply for Designing and performing a virtual bioequivalence trial for physiologically-based pharmacokinetic and other mechanism-based models?

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 Designing and performing a virtual bioequivalence trial for physiologically-based pharmacokinetic and other mechanism-based models?

Closed February 15, 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 $500,000 in total for one award.

### 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.