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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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