# Physiologically Based Pharmacokinetic (PBPK) Models of Oral Absorption to Simulate the Results of Bioequivalence Studies (U01) Clinical Trials Optional

Source: https://welltoldgrants.com/grants/rfa-fd-21-012-physiologically-based-pharmacokinetic-pbpk-models-of-oral/  
Official notice: https://www.grants.gov/search-results-detail/330745

> Food and Drug Administration offered grants of up to $600,000 (at least $300,000) to nonprofits, colleges and universities, state and local governments, tribes, small businesses and businesses. It expected to make about 2 awards. Applications closed on March 15, 2021.

| Field | Value |
|---|---|
| Opportunity number | RFA-FD-21-012 |
| Agency | Food and Drug Administration |
| Status | Forecast |
| Deadline | March 15, 2021 |
| Award ceiling | $600,000 |
| Award floor | $300,000 |
| Expected awards | 2 |
| Total funding | not stated |
| 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 Organizations Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education: Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISIs) Nonprofits Other Than Institutions of Higher Education Nonprofits 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 Organizations Small Businesses For-Profit Organizations (Other than Small Businesses) Governments State Governments County Governments City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) U.S. Territory or Possession Other Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Regional Organizations Non-domestic (non-U.S.) Entities (Foreign Institutions)

## What the grant funds

Physiologically based pharmacokinetic (PBPK) models are an effective tool to integrate information about the product characteristics, the physiology of the individual subject, and the variability among subjects within a population to simulate the absorption and subsequent systemic disposition of the drug without conducting in vivo pharmacokinetic studies. These PBPK models have shown promise in supporting generic drug development and regulatory decision making. This opportunity solicits research proposals to expand the application of oral PBPK models to emerging issues in generic drug fields by providing the ability to simulate bioequivalence studies under various conditions.

## Questions people ask

### Is RFA-FD-21-012 still open?

No. It closed on March 15, 2021. A newer notice is open: PAR-27-017, rolling or no fixed deadline.

### Who can apply for Physiologically Based Pharmacokinetic (PBPK) Models of Oral Absorption to Simulate the Results of Bioequivalence Studies (U01) Clinical Trials Optional?

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 Physiologically Based Pharmacokinetic (PBPK) Models of Oral Absorption to Simulate the Results of Bioequivalence Studies (U01) Clinical Trials Optional?

Closed March 15, 2021. 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 $600,000 each.

### 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.