Opportunity ID: 233484
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-13-016 |
| Funding Opportunity Title: | In vitro release tests for topical dermatological products (U01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health Science and Technology and other Research and Development |
| Category Explanation: | – |
| Expected Number of Awards: | 7 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | May 07, 2013 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | Jun 01, 2013 |
| Current Closing Date for Applications: | Jun 01, 2013 |
| Archive Date: | Jul 01, 2013 |
| Estimated Total Program Funding: | $500,000 |
| Award Ceiling: | $500,000 |
| Award Floor: | $500,000 |
Eligibility
| Eligible Applicants: | State governments Others (see text field entitled “Additional Information on Eligibility” for clarification) Private institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments Public housing authorities/Indian housing authorities City or township governments Native American tribal governments (Federally recognized) For profit organizations other than small businesses Native American tribal organizations (other than Federally recognized tribal governments) Small businesses County governments |
| Additional Information on Eligibility: | Eligible Agencies of the Federal Government; U.S. Territory or Possession;Independent School Districts; 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) |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | Background:
Developing appropriate methods to determine bioequivalence of topical dermatological products has been a longstanding challenge to FDA. FDA has begun to identify situations when alternatives to clinical endpoint bioequivalence studies are possible. FDA will consider different bioequivalence approaches based on how similar formulations are to each other. If formulations contain the same inactive ingredients in the same amounts, then there is lower risk of in equivalence. For formulations that A differ in composition, FDA is interested in when in vitro release testing can predict that there will be no difference in drug delivery to and across the skin. Objectives: The goal is to identity in vitro release test conditions that are best correlated with in vivo performance. An in vitro release test could be used as part of the bioequivalence evaluation of topical products to evaluate whether a change in inactive ingredients would result in a change in drug delivery to and across the skin. Detailed Description: This project will investigate in vitro – in vivo correlations of topical dermatological products. The project has several phases as noted below: 1) Selection or manufacture of test formulations. The formulations should contain the same active ingredient and have different inactive ingredients. They may be currently marketed formulation. 2) Identification or generation of the in vivo data set. The in vivo data set may be obtained from the literature or generated as a part of this grant. In vivo performance could be assessed by either human PK data, human microdialysis data or any other proposed source. 3) In vitro in vivo correlation: The test formulations should be evaluated under a range of in vitro release test conditions. In vitro release tests could include using excised human skin or artificial membranes. 4) Optimization of the in vitro release testing protocol. The in vitro release test protocol with the best prediction of in vivo results should be identified. 5) A protocol for the external validation of the optimal method should be developed |
| Link to Additional Information: | NIH Guide for Grants and Contracts |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Gladys Melendez-Bohler
Grants Management Officer/Specialist Phone 301-827-7175 Email:gladys.bohler@fda.hhs.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
Packages
| Agency Contact Information: | Gladys Melendez-Bohler Grants Management Officer/Specialist Phone 301-827-7175 Email: gladys.bohler@fda.hhs.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| 93.103 | PKG00178090 | May 15, 2013 | Jul 02, 2013 | View |
Package 1
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