This U01 grant is established to comprehensively investigate how various physicochemical properties of ophthalmic suspensions and emulsions impact ocular bioavailability. Despite identical active and inactive ingredients, manufacturing differences can alter properties crucial for clearance, distribution, and drug release. The project will meticulously examine globule/particle size distribution, surface charge, osmolality, pH, viscosity, and dispersibility. Currently, robust bioequivalence methods are often lacking for generic ophthalmic formulations, particularly common topical suspensions and emulsions. The insights gained from this research will elucidate the critical relationship between physicochemical characteristics and ocular bioavailability. Ultimately, the findings will inform and shape future bioequivalence study recommendations for generic ophthalmic suspensions and emulsions, addressing a significant gap in pharmaceutical development.
Opportunity ID: 168033
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: | Cooperative Agreement |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | 1 |
| Assistance Listings: | 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: | Public housing authorities/Indian housing authorities Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education 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 State governments City or township governments Special district governments For profit organizations other than small businesses Others (see text field entitled “Additional Information on Eligibility” for clarification) Independent school districts Public and State controlled institutions of higher education Private institutions of higher education Native American tribal governments (Federally recognized) Small businesses County 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: | Full Announcement RFA-FD-12-020 NIH Guide for Grants and Contracts |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Lisa Ko
Grants Management Specialist Email:lisa.ko@fda.hhs.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| Correction in Estimated Total Program Funding and Award Ceiling amounts. | May 04, 2012 | |
| May 04, 2012 | ||
| May 02, 2012 |
DISPLAYING: Synopsis 3
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: | Cooperative Agreement |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | 1 |
| Assistance Listings: | 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: | Public housing authorities/Indian housing authorities Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education 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 State governments City or township governments Special district governments For profit organizations other than small businesses Others (see text field entitled “Additional Information on Eligibility” for clarification) Independent school districts Public and State controlled institutions of higher education Private institutions of higher education Native American tribal governments (Federally recognized) Small businesses County 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: | Full Announcement RFA-FD-12-020 NIH Guide for Grants and Contracts |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Lisa Ko
Grants Management Specialist Email:lisa.ko@fda.hhs.gov |
DISPLAYING: Synopsis 2
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: | Cooperative Agreement |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | 1 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | May 04, 2012 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Jun 22, 2012 |
| Archive Date: | Jul 22, 2012 |
| Estimated Total Program Funding: | $400,000 |
| Award Ceiling: | $400,000 |
| Award Floor: | $0 |
Eligibility
| Eligible Applicants: | Others (see text field entitled “Additional Information on Eligibility” for clarification) Special district governments State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments County governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Small businesses For profit organizations other than small businesses Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) Public and State controlled institutions of higher education Independent school districts |
| 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: | Full Announcement RFA-FD-12-020 NIH Guide for Grants and Contracts |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Lisa Ko
Grants Management Specialist Email:lisa.ko@fda.hhs.gov |
DISPLAYING: Synopsis 1
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: | Cooperative Agreement |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | 1 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | May 02, 2012 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | May 31, 2012 |
| Archive Date: | Jun 30, 2012 |
| Estimated Total Program Funding: | $400,000 |
| Award Ceiling: | $400,000 |
| Award Floor: | $0 |
Eligibility
| Eligible Applicants: | Others (see text field entitled “Additional Information on Eligibility” for clarification) Special district governments State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments County governments Private institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses For profit organizations other than small businesses Native American tribal governments (Federally recognized) Native American tribal organizations (other than Federally recognized tribal governments) Public housing authorities/Indian housing authorities Public and State controlled institutions of higher education Independent school districts |
| 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 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: | Full Announcement RFA-FD-12-020 NIH Guide for Grants and Contracts |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Lisa Ko
Grants Management Specialist Email:lisa.ko@fda.hhs.gov |
Related Documents
Folder 168033 Other Supporting Documents-SF424 R&R Guide General Adobe Version B 1 -> sf424_rr_guide_general_adobe_verb.pdf
Packages
| Agency Contact Information: | Lisa Ko Grants Management Specialist Email: lisa.ko@fda.hhs.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| 93.103 | PKG00119390 | May 01, 2012 | Jun 22, 2012 | View |
Package 1
Mandatory forms
168033 RR_SF424_1_2-1.2.pdf
168033 PerformanceSite_1_4-1.4.pdf
168033 RR_OtherProjectInfo_1_3-1.3.pdf
168033 RR_KeyPersonExpanded_1_2-1.2.pdf
168033 RR_Budget-1.1.pdf
168033 PHS398_CoverPageSupplement_1_4-1.4.pdf
168033 PHS398_ResearchPlan_1_3-1.3.pdf
168033 PHS398_Checklist_1_3-1.3.pdf
Optional forms
168033 RR_SubawardBudget30-1.2.pdf
168033 PHS_CoverLetter_1_2-1.2.pdf
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