# Cutaneous pharamcokinetic-based approaches to establish bioequivalence of topically applied drug products

Source: https://welltoldgrants.com/grants/rfa-fd-22-017-cutaneous-pharamcokinetic-based-approaches-to-establish/  
Official notice: https://www.grants.gov/search-results-detail/336278

> Food and Drug Administration offered grants of up to $1.5 million (at least $50,000) to nonprofits, colleges and universities, state and local governments, tribes, small businesses and businesses. It expected to make about 2 awards worth $1.0 million in total. Applications closed on March 31, 2022.

| Field | Value |
|---|---|
| Opportunity number | RFA-FD-22-017 |
| Agency | Food and Drug Administration |
| Status | Forecast |
| Deadline | March 31, 2022 |
| Award ceiling | $1.5 million |
| Award floor | $50,000 |
| Expected awards | 2 |
| 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

## What the grant funds

The primary objective of this funding opportunity is to optimize clinical study designs and data analysis techniques that can support a comparative assessment of the relative bioavailability of topically administered drugs, and which can support a demonstration of BE for prospective generic topical products. The specific aims of this research would include comparing in vivo cutaneous PK measurements by independent techniques (e.g., dermal Open Flow Microperfusion (dOFM), dermal microdialysis (dMD), spectroscopic tomography), exploring the removal of the topical formulations at different time points and characterizing the PK profiles of the test and reference products; developing data analysis techniques (described in detail below); and identifying appropriate PK endpoints for the evaluation of topical BE. Based on the multidisciplinary nature of the research supported by this funding opportunity, it is encouraged that researchers with expertise in measuring cutaneous drug concentrations (e.g., experts in techniques such as dOFM, dMD and/or spectroscopy based techniques) collaborate with experts in PK data analysis and with statisticians, to achieve the overall objectives of the research. Specific areas of scientific interest would include the following: 1. Expansion of the current theoretical framework to describe the relationship between the concentration of drug sampled by a given technique (dOFM, dMD, or spectroscopy based techniques) and the actual amount of drug in the epidermis/dermis, and the relationships between the free drug vs protein-bound drug sampled, when relevant, so that not only could the relative amounts of drug in the epidermis/dermis be compared, but also that the actual drug exposures at the site of action could be calculated. 2. Comparison of the available techniques for characterizing cutaneous PK in parallel, within the same clinical setting. (e.g., comparison of dOFM or dMD with other technique(s) that monitor cutaneous PK, like spectroscopic tomography, ideally using commercially available instrumentation). 3. Exploration of different study designs to characterize the cutaneous PK profiles for topical drugs that may not reach the maximum drug concentration (Cmax) within the 24 hours of administration. 4.

## Questions people ask

### Is RFA-FD-22-017 still open?

No. It closed on March 31, 2022. A newer notice is open: PAR-27-017, rolling or no fixed deadline.

### Who can apply for Cutaneous pharamcokinetic-based approaches to establish bioequivalence of topically applied drug 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 Cutaneous pharamcokinetic-based approaches to establish bioequivalence of topically applied drug products?

Closed March 31, 2022. 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 $1.5 million each. About $1.0 million in total across about 2 awards.

### 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.