# CFD Models to aid the development of generic inhalation products

Source: https://welltoldgrants.com/grants/for-fd-20-023-cfd-models-to-aid-the-development-of-generic/  
Official notice: https://www.grants.gov/search-results-detail/328700

> Food and Drug Administration offered grants to nonprofits, colleges and universities, state and local governments, tribes, small businesses and businesses. It expected to make about 2 awards. It is no longer open on Grants.gov.

| Field | Value |
|---|---|
| Opportunity number | FOR-FD-20-023 |
| Agency | Food and Drug Administration |
| Status | Forecast |
| Deadline | not set |
| Award ceiling | not stated |
| Award floor | not stated |
| 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

## What the grant funds

Current US Food and Drug Administration product specific guidance (PSG) bioequivalence (BE) recommendations for orally inhaled drug products such as metered dose inhalers (MDIs) and dry powder inhalers (DPIs) typically use a weight-of-evidence approach that includes in vitro studies, an in vivo pharmacokinetics (PK) study, and either an in vivo pharmacodynamics (PD) or comparative clinical endpoint (CCEP) study. To produce a generic MDI or DPI that is capable of passing all of these recommended studies, it would be useful to have an enhanced understanding of the relationships between in vitro study metrics and the rate and extent of drug delivery to the targeted lung tissue. Computational fluid dynamics (CFD) is a technique capable of predicting these relationships between in vitro study metrics and regional lung deposition. The purpose of this grant announcement is to use CFD to produce verified and validated predictions of regional lung deposition for at least one currently marketed MDI or DPI in human upper and lower airways. Once predictions are appropriately verified and validated using either in vitro or in vivo data, a parameter sensitivity analysis will be conducted to assess the biopredictive capabilities of relevant in vitro studies. For DPIs, discrete element modeling (DEM) may be considered as a means for predicting the effects of agglomeration and deagglomeration of carrier-active pharmaceutical ingredient combination particles on regional deposition and the relationships of those phenomena with APSD. For MDIs, it is preferred that formulations considered include at least three components.

## Questions people ask

### Is FOR-FD-20-023 still open?

No. It is no longer open on Grants.gov. A newer notice is open: PAR-27-017, rolling or no fixed deadline.

### Who can apply for CFD Models to aid the development of generic inhalation products?

Food and Drug Administration accepted applications from nonprofits, colleges and universities, state and local governments, tribes, small businesses and businesses.

### What is the deadline for CFD Models to aid the development of generic inhalation products?

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

### 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.