Department of Ophthalmology Grant: Physicochemical Properties Impacting Ocular Bioavailability Research

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The Department of Ophthalmology is offering a grant to study the effects of physicochemical properties of ophthalmic suspensions and emulsions on ocular bioavailability. The project aims to investigate key properties such as globule/particle size distribution, surface charge, osmolality, pH, viscosity, and dispersibility, and their impact on drug clearance, distribution, and release. The results will contribute to understanding the relationship between these properties and ocular bioavailability, and aid in developing bioequivalence study recommendations for generic ophthalmic formulations.

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Opportunity ID: 168033

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General Information

Document Type:: Grants Notice
Funding Opportunity Number:: RFA-FD-12-020
Funding Opportunity Title:: Effect of Physicochemical Properties of Ophthalmic Formulations on Ocular Bioavailability (U01)
Opportunity Category:: Discretionary
Opportunity Category Explanation::
Funding Instrument Type::
Category of Funding Activity:: Health
Category Explanation::
Expected Number of Awards:: 1
Assistance Listings Number(s):: 93.103 — Food and Drug Administration_Research
Cost Sharing or Matching Requirement:: No
Version:: Synopsis 3
Posted Date:: Apr 27, 2012
Last Updated Date:: May 04, 2012
Original Closing Date for Applications:: May 31, 2012
Current Closing Date for Applications:: Jun 22, 2012
Archive Date:: Jul 22, 2012
Estimated Total Program Funding:: $ 500,000
Award Ceiling:: $500,000
Award Floor:: $0

Eligibility

Eligible Applicants:: Special district governments
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.

Additional Information

Agency Name:: Food and Drug Administration
Description:: 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.
Link to Additional Information::
Grantor Contact Information:: If you have difficulty accessing the full announcement electronically, please contact:

Version History

Version Modification Description Updated Date
Synopsis 3 Correction in Estimated Total Program Funding and Award Ceiling amounts. May 04, 2012
Synopsis 2
Synopsis 1

Package Status

Below are CLOSED Opportunity Package(s) no longer available for this Funding Opportunity:

Package No: 1

Assistance Listings: 93.103
Competition ID:
Competition Title:
Opportunity Package ID: PKG00119390
Opening Date: May 01, 2012
Closing Date: Jun 22, 2012
Agency Contact Information:: Lisa Ko
Who Can Apply:: Organization Applicants
mendatory_forms SF424 (R & R) [V1.2]
Project/Performance Site Location(s) [V1.4]
Research And Related Other Project Information [V1.3]
Research And Related Senior/Key Person Profile (Expanded) [V1.2]
Research & Related Budget [V1.1]
PHS 398 Cover Page Supplement [V1.4]
PHS 398 Research Plan [V1.3]
PHS 398 Checklist [V1.3]
optional_forms R & R Subaward Budget Attachment(s) Form 5 YR 30 ATT [V1.2]
PHS Cover Letter [V1.2]

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Packages

Assistance Listings Competition ID Competition Title Opportunity Package ID Opening Date Closing Date Actions Who Can Apply:
93.103 PKG00119390 May 01, 2012 Jun 22, 2012 View Lisa Ko Organization Applicants

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