Effect of Physicochemical Properties of Ophthalmic Formulations on Ocular Bioavailability (U01)

The summary for the Effect of Physicochemical Properties of Ophthalmic Formulations on Ocular Bioavailability (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.

Effect of Physicochemical Properties of Ophthalmic Formulations on Ocular Bioavailability (U01): The purpose of this project is to study the effect of various physicochemical properties of ophthalmic suspensions and emulsions on ocular bioavailability. Formulations having the same active and inactive ingredients in the same concentrations may still exhibit differences in physicochemical properties due to differences in the manufacturing process. Key physicochemical properties which impact clearance, distribution, and drug release will be investigated.The following physicochemical properties should be investigated in the project study:Globule/particle size distribution Surface chargeOsmolalitypHViscosityDispersibility Suitable bioequivalence methods are lacking for many generic ophthalmic formulations. Suspensions and emulsions are commonly employed as ophthalmic vehicles as they can easily be applied topically to the eye. The results from this project will help to understand the relationship between physicochemical properties and their impact on ocular bioavailability, and will also be used to help determine bioequivalence study recommendations for generic ophthalmic suspensions and emulsions.

Federal Grant Title:	Effect of Physicochemical Properties of Ophthalmic Formulations on Ocular Bioavailability (U01)
Federal Agency Name:	Food and Drug Administration
Grant Categories:	Health
Type of Opportunity:	Discretionary
Funding Opportunity Number:	RFA-FD-12-020
Type of Funding:	Cooperative Agreement
CFDA Numbers:	93.103
CFDA Descriptions:	Food and Drug Administration_Research
Current Application Deadline:	Jun 22, 2012
Original Application Deadline:	Jun 22, 2012
Posted Date:	Apr 27, 2012
Creation Date:	May 04, 2012
Archive Date:	Jul 22, 2012
Total Program Funding:	$500,000
Maximum Federal Grant Award:	$500,000
Minimum Federal Grant Award:	$0
Expected Number of Awards:	1
Cost Sharing or Matching:	No

Applicants Eligible for this Grant: 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 - Others (see text field entitled "Additional Information on Eligibility" for clarification)
Additional Information on Eligibility: Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the HHS Grants Policy Statement, are allowed.
Grant Announcement Contact: Lisa Ko Grants Management Specialist
[email protected] [[email protected]]
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