In vitro release tests for transdermal drug delivery systems (U01)

The summary for the In vitro release tests for transdermal drug delivery systems (U01) grant is detailed below. This summary states who is eligible for the grant, how much grant money will be awarded, current and past deadlines, Catalog of Federal Domestic Assistance (CFDA) numbers, and a sampling of similar government grants. Verify the accuracy of the data FederalGrants.com provides by visiting the webpage noted in the Link to Full Announcement section or by contacting the appropriate person listed as the Grant Announcement Contact. If any section is incomplete, please visit the website for the Food and Drug Administration, which is the U.S. government agency offering this grant.
In vitro release tests for transdermal drug delivery systems (U01): Background Many transdermal delivery systems (TDDS) are labeled to warn against applying heat to the TDDS as it may increase the rate of drug release. When the reference product contains these warnings, the generic product must also have the same labeling. As part of its review FDA does require evidence that the formulation of a generic product is not less safe than the RLD. It is possible that different transdermal formulations of the same drug may have different responses to heat. To ensure that the RLD labeling with respect to heat is applicable to the ANDA product, the ANDA applicant should provide information about the formulation performance to ensure that the sensitivity to heat of the generic product is not more pronounced than that of the RLD. Because the identified concern is specifically related to differences in product formulation, in vitro data provides a direct measure of the formulation properties and thus is more appropriate than in vivo studies for this evaluation. Objectives This project will investigate in vitro - in vivo correlations of transdermal systems. The goal is to identity in vitro release test conditions that best identify heat effects on transdermal system release. These in vitro tests would be used in the review process to ensure that the performance of the proposed generic products does not introduce any additional safety risk. Detailed Description This project will investigate in vitro - in vivo correlations of transdermal systems. The project has several phases 1) Identification or generation of an in vivo data set of heat effects on transdermal products. The in vivo data set may be obtained from the literature or generated as a part of this grant. It may include identification of approved transdermal systems with in vivo heat effects on systemic exposure mentioned in the approved labeling. 2) Evaluation of these transdermal systems in a range of different in vitro test conditions to identify the in vitro conditions and study design that best identify the effect of heat on transdermal systems. These studies should be in-vitro skin flux permeation studies and include comparative in vitro release data at normal and elevated temperatures. 3) Evaluation of approved generic products with no in vivo heat effect data using the optimal in vitro conditions from phase 2.
Federal Grant Title: In vitro release tests for transdermal drug delivery systems (U01)
Federal Agency Name: Food and Drug Administration
Grant Categories: Health Science and Technology
Type of Opportunity: Discretionary
Funding Opportunity Number: RFA-FD-13-015
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
County governments - City or township governments - Native American tribal governments (Federally recognized) - 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 - For profit organizations other than 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; Native American Tribal Organizations (other than Federally recognized tribal governments); Faith-based or Community-based Organizations; Regional Organizations; Non-domestic (non-U.S.) Entitites (Foreign Institutions)
Grant Announcement Contact
Gladys Melendez-Bohler Grants Management Officer/Specialist Phone 301-827-7175

FDA Office Email [[email protected]]
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