The FDA is offering a grant to investigate dissolution methods for ocular suspension and emulsion drug products to determine bioequivalence of generic versions compared to the Reference Listed Drug. The study aims to formulate Q1/Q2 topical ocular formulations under varying manufacturing conditions, conduct dissolution studies using different methods, and identify a discriminating dissolution method. Applicants can choose either a suspension or emulsion dosage form for study, with one award granted for each. The deadline for applications is 30 days after the Open Date.
Opportunity ID: 253191
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-14-009 |
| Funding Opportunity Title: | Dissolution Methods for Suspension and Emulsion Ocular Drug Products |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health Science and Technology and other Research and Development |
| Category Explanation: | – |
| Expected Number of Awards: | 5 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Mar 30, 2014 |
| Last Updated Date: | Apr 01, 2014 |
| Original Closing Date for Applications: | May 08, 2014 |
| Current Closing Date for Applications: | May 08, 2014 |
| Archive Date: | Jun 07, 2014 |
| Estimated Total Program Funding: | $500,000 |
| Award Ceiling: | $250,000 |
| Award Floor: | $200,000 |
Eligibility
| Eligible Applicants: | Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education Special district governments State governments Native American tribal organizations (other than Federally recognized tribal governments) County governments Public housing authorities/Indian housing authorities City or township governments 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 Private institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) Native American tribal governments (Federally recognized) Independent school districts Small businesses |
| Additional Information on Eligibility: | Foreign Recipients |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | Dissolution testing is recommended as part of the demonstration of bioequivalence between test and reference products in the approval of most generic drugs. Drug release measurements are useful for evaluating the effect of manufacturing differences and to assess performance characteristics of a suspension or emulsion dosage form. Generally, a generic drug product intended for ocular use contains the same inactive ingredients (Q1) and in the same concentration (Q2) as the Reference Listed Drug (RLD). However, there may be differences in manufacturing of the generic and RLD products, which may affect bioavailability. Dissolution testing can be used as one of several standard methods to evaluate physicochemical differences of the drug product caused by manufacturing differences. The purpose of this study is to investigate dissolution methods for either an ocular suspension or emulsion drug product. The results from this study will help the FDA in developing recommendations to determine bioequivalence of generic ocular suspension and emulsion drug products.ObjectivesThe investigator should choose either an ocular suspension or emulsion dosage form for study. One award will be granted for each dosage form. Applicants are encouraged to apply to RFA-FD-14-008 Dissolution Methods for Semisolid Ocular Drug Products for investigating formulations which exhibit semisolid properties.The objectives of this project are:(1) To formulate Q1/Q2 topical ocular formulations (either as suspensions or emulsions) under different manufacturing conditions(2) To conduct dissolution studies with the prepared formulations using various in vitro release methods(3) To identify a dissolution method that can discriminate different formulations Detailed DescriptionAdditional details regarding the study objectives listed above:(1) The suspension or emulsion chosen to serve as the reference product for this study can either be a marketed product or an investigational formulation. Formulations which are Q1/Q2 to this reference product should be developed under different manufacturing conditions. Physicochemical characterization should be performed on these test formulations to determine key attributes that may affect bioavailability.(2) Before initiating the dissolution studies, an analysis of current dissolution methods used for suspension or emulsion products should be conducted. A report of this analysis should include the advantages and disadvantages for each method and an assessment on the capability of detecting manufacturing differences, predicting in vivo performance, and method robustness. Test formulations which have the largest differences in physicochemical properties (and which are expected to affect bioavailability) are chosen for testing in the dissolution study. Dissolution methods should be developed with considerations in drug substance and drug product properties and the physiological release environment.(3) An analysis of the dissolution methods used in the study should include the advantages and disadvantages for each method and an assessment on the capability of detecting manufacturing differences, predicting in vivo performance, and method robustness.4. # of awards: 2 (one award for a suspension, the other award for an emulsion)5. Due Date should be 30 days after the Open Date |
| Link to Additional Information: | How to Apply |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Gladys Melendez-Bohler
Grants Management Specialist Phone 301-827-7175 Email:gladys.bohler@fda.hhs.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| Modified recipients and uploaded pdf copy of RFA-FD-14-009. | Apr 01, 2014 | |
| Apr 01, 2014 |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-14-009 |
| Funding Opportunity Title: | Dissolution Methods for Suspension and Emulsion Ocular Drug Products |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health Science and Technology and other Research and Development |
| Category Explanation: | – |
| Expected Number of Awards: | 5 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Mar 30, 2014 |
| Last Updated Date: | Apr 01, 2014 |
| Original Closing Date for Applications: | May 08, 2014 |
| Current Closing Date for Applications: | May 08, 2014 |
| Archive Date: | Jun 07, 2014 |
| Estimated Total Program Funding: | $500,000 |
| Award Ceiling: | $250,000 |
| Award Floor: | $200,000 |
Eligibility
| Eligible Applicants: | Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education Special district governments State governments Native American tribal organizations (other than Federally recognized tribal governments) County governments Public housing authorities/Indian housing authorities City or township governments 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 Private institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) Native American tribal governments (Federally recognized) Independent school districts Small businesses |
| Additional Information on Eligibility: | Foreign Recipients |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | Dissolution testing is recommended as part of the demonstration of bioequivalence between test and reference products in the approval of most generic drugs. Drug release measurements are useful for evaluating the effect of manufacturing differences and to assess performance characteristics of a suspension or emulsion dosage form. Generally, a generic drug product intended for ocular use contains the same inactive ingredients (Q1) and in the same concentration (Q2) as the Reference Listed Drug (RLD). However, there may be differences in manufacturing of the generic and RLD products, which may affect bioavailability. Dissolution testing can be used as one of several standard methods to evaluate physicochemical differences of the drug product caused by manufacturing differences. The purpose of this study is to investigate dissolution methods for either an ocular suspension or emulsion drug product. The results from this study will help the FDA in developing recommendations to determine bioequivalence of generic ocular suspension and emulsion drug products.ObjectivesThe investigator should choose either an ocular suspension or emulsion dosage form for study. One award will be granted for each dosage form. Applicants are encouraged to apply to RFA-FD-14-008 Dissolution Methods for Semisolid Ocular Drug Products for investigating formulations which exhibit semisolid properties.The objectives of this project are:(1) To formulate Q1/Q2 topical ocular formulations (either as suspensions or emulsions) under different manufacturing conditions(2) To conduct dissolution studies with the prepared formulations using various in vitro release methods(3) To identify a dissolution method that can discriminate different formulations Detailed DescriptionAdditional details regarding the study objectives listed above:(1) The suspension or emulsion chosen to serve as the reference product for this study can either be a marketed product or an investigational formulation. Formulations which are Q1/Q2 to this reference product should be developed under different manufacturing conditions. Physicochemical characterization should be performed on these test formulations to determine key attributes that may affect bioavailability.(2) Before initiating the dissolution studies, an analysis of current dissolution methods used for suspension or emulsion products should be conducted. A report of this analysis should include the advantages and disadvantages for each method and an assessment on the capability of detecting manufacturing differences, predicting in vivo performance, and method robustness. Test formulations which have the largest differences in physicochemical properties (and which are expected to affect bioavailability) are chosen for testing in the dissolution study. Dissolution methods should be developed with considerations in drug substance and drug product properties and the physiological release environment.(3) An analysis of the dissolution methods used in the study should include the advantages and disadvantages for each method and an assessment on the capability of detecting manufacturing differences, predicting in vivo performance, and method robustness.4. # of awards: 2 (one award for a suspension, the other award for an emulsion)5. Due Date should be 30 days after the Open Date |
| Link to Additional Information: | How to Apply |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Gladys Melendez-Bohler
Grants Management Specialist Phone 301-827-7175 Email:gladys.bohler@fda.hhs.gov |
DISPLAYING: Synopsis 1
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-14-009 |
| Funding Opportunity Title: | Dissolution Methods for Suspension and Emulsion Ocular Drug Products |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health Science and Technology and other Research and Development |
| Category Explanation: | Foreign Recipients |
| Expected Number of Awards: | 5 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Apr 01, 2014 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | May 08, 2014 |
| Archive Date: | Jun 07, 2014 |
| Estimated Total Program Funding: | $250,000 |
| Award Ceiling: | $250,000 |
| Award Floor: | $200,000 |
Eligibility
| Eligible Applicants: | Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled “Additional Information on Eligibility” Others (see text field entitled “Additional Information on Eligibility” for clarification) |
| Additional Information on Eligibility: | Foreign Recipients |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | Dissolution testing is recommended as part of the demonstration of bioequivalence between test and reference products in the approval of most generic drugs. Drug release measurements are useful for evaluating the effect of manufacturing differences and to assess performance characteristics of a suspension or emulsion dosage form.
Generally, a generic drug product intended for ocular use contains the same inactive ingredients (Q1) and in the same concentration (Q2) as the Reference Listed Drug (RLD). However, there may be differences in manufacturing of the generic and RLD products, which may affect bioavailability. Dissolution testing can be used as one of several standard methods to evaluate physicochemical differences of the drug product caused by manufacturing differences. The purpose of this study is to investigate dissolution methods for either an ocular suspension or emulsion drug product. The results from this study will help the FDA in developing recommendations to determine bioequivalence of generic ocular suspension and emulsion drug products. Objectives The objectives of this project are: Detailed Description |
| Link to Additional Information: | NIH Guide for Grants and Contracts |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Gladys Melendez-Bohler
Grants Management Specialist Phone 301-827-7175 Email:gladys.bohler@fda.hhs.gov |
Related Documents
Folder 253191 Full Announcement-1 -> rfa-fd-14-009draft hdl1.pdf
Packages
| Agency Contact Information: | Gladys Melendez-Bohler Grants Management Specialist Phone 301-827-7175 Email: gladys.bohler@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 | RFA-FD-14-009 | Office of Generic Drugs | PKG00194544 | Apr 07, 2014 | May 07, 2014 | View |
Package 1
Mandatory forms
253191 RR_SF424_2_0-2.0.pdf
253191 PHS398_ResearchPlan_2_0-2.0.pdf
253191 PHS398_CoverPageSupplement_2_0-2.0.pdf
253191 RR_Budget_1_3-1.3.pdf
253191 RR_KeyPersonExpanded_2_0-2.0.pdf
253191 RR_OtherProjectInfo_1_3-1.3.pdf
253191 PerformanceSite_2_0-2.0.pdf
Optional forms
253191 PlannedReport-1.0.pdf
253191 PHS398_CumulativeInclusionReport-1.0.pdf
253191 RR_SubawardBudget30_1_3-1.3.pdf
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