In vitro release tests for topical dermatological products (U01)
The summary for the In vitro release tests for topical dermatological products (U01) grant is detailed below.
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In vitro release tests for topical dermatological products (U01): 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
Federal Grant Title: | In vitro release tests for topical dermatological products (U01) |
Federal Agency Name: | Food and Drug Administration |
Grant Categories: | Health Science and Technology |
Type of Opportunity: | Discretionary |
Funding Opportunity Number: | RFA-FD-13-016 |
Type of Funding: | Cooperative Agreement |
CFDA Numbers: | 93.103 |
CFDA Descriptions: | Food and Drug Administration_Research |
Current Application Deadline: | Jun 01, 2013 |
Original Application Deadline: | Jun 01, 2013 |
Posted Date: | May 07, 2013 |
Creation Date: | May 07, 2013 |
Archive Date: | Jul 01, 2013 |
Total Program Funding: | $500,000 |
Maximum Federal Grant Award: | $500,000 |
Minimum Federal Grant Award: | $500,000 |
Expected Number of Awards: | 7 |
Cost Sharing or Matching: | No |
- Applicants Eligible for this Grant
- State governments - County governments - City or township governments - Special district governments - 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)
- 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)
- Grant Announcement Contact
- Gladys Melendez-Bohler Grants Management Officer/Specialist Phone 301-827-7175
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