The FDA is offering a grant to study dissolution methods for ocular semisolid drug products to determine bioequivalence of generic formulations. The objectives include formulating semisolids under different manufacturing conditions, conducting dissolution studies using various release methods, and identifying a method to discriminate between formulations. The research will involve comparing physicochemical properties of test formulations with a chosen reference product, analyzing current dissolution methods, and developing dissolution methods tailored to drug properties and physiological release environment. This study aims to provide valuable insights for the FDA to develop recommendations for assessing generic ocular semisolid drug products’ bioequivalence.
Opportunity ID: 253189
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-14-008 |
| Funding Opportunity Title: | Dissolution Methods for Semisolid 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 4 |
| Posted Date: | Mar 30, 2014 |
| Last Updated Date: | Apr 07, 2014 |
| Original Closing Date for Applications: | May 02, 2014 |
| Current Closing Date for Applications: | May 02, 2014 |
| Archive Date: | Jun 01, 2014 |
| Estimated Total Program Funding: | $700,000 |
| Award Ceiling: | $350,000 |
| Award Floor: | $300,000 |
Eligibility
| Eligible Applicants: | Independent school districts Public housing authorities/Indian housing authorities Others (see text field entitled “Additional Information on Eligibility” for clarification) Native American tribal organizations (other than Federally recognized tribal governments) Public and State controlled institutions of higher education For profit organizations other than small businesses County governments State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Native American tribal governments (Federally recognized) City or township governments Special district governments 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 semisolid 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 an ocular semisolid drug product. The results from this study will help the FDA in developing recommendations to determine bioequivalence of generic ocular semisolid drug products.Objectives(1) To formulate Q1/Q2 semisolids (intended for topical ocular administration) under different manufacturing conditions(2) To conduct dissolution studies with the prepared semisolid formulations using various in vitro release methods(3) To identify a dissolution method that can discriminate different semisolid formulations Detailed DescriptionAdditional details regarding the study objectives listed above:(1) The ocular semisolid 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 semisolid 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. |
| 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 |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| The FDA and partner components intend to commit an estimated total of $350,000 per award. Up to 2 awards may be funded. | Apr 07, 2014 | |
| Edited Eligible recipients. | Apr 07, 2014 | |
| Edited Eligible Recipients. | Apr 01, 2014 | |
| Apr 01, 2014 |
DISPLAYING: Synopsis 4
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-14-008 |
| Funding Opportunity Title: | Dissolution Methods for Semisolid 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 4 |
| Posted Date: | Mar 30, 2014 |
| Last Updated Date: | Apr 07, 2014 |
| Original Closing Date for Applications: | May 02, 2014 |
| Current Closing Date for Applications: | May 02, 2014 |
| Archive Date: | Jun 01, 2014 |
| Estimated Total Program Funding: | $700,000 |
| Award Ceiling: | $350,000 |
| Award Floor: | $300,000 |
Eligibility
| Eligible Applicants: | Independent school districts Public housing authorities/Indian housing authorities Others (see text field entitled “Additional Information on Eligibility” for clarification) Native American tribal organizations (other than Federally recognized tribal governments) Public and State controlled institutions of higher education For profit organizations other than small businesses County governments State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Native American tribal governments (Federally recognized) City or township governments Special district governments 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 semisolid 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 an ocular semisolid drug product. The results from this study will help the FDA in developing recommendations to determine bioequivalence of generic ocular semisolid drug products.Objectives(1) To formulate Q1/Q2 semisolids (intended for topical ocular administration) under different manufacturing conditions(2) To conduct dissolution studies with the prepared semisolid formulations using various in vitro release methods(3) To identify a dissolution method that can discriminate different semisolid formulations Detailed DescriptionAdditional details regarding the study objectives listed above:(1) The ocular semisolid 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 semisolid 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. |
| 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 |
DISPLAYING: Synopsis 3
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-14-008 |
| Funding Opportunity Title: | Dissolution Methods for Semisolid 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 3 |
| Posted Date: | Apr 07, 2014 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | May 02, 2014 |
| Archive Date: | Jun 01, 2014 |
| Estimated Total Program Funding: | $700,000 |
| Award Ceiling: | $350,000 |
| Award Floor: | $300,000 |
Eligibility
| Eligible Applicants: | County governments City or township governments Private institutions of higher education 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) State governments Native American tribal governments (Federally recognized) Public and State controlled institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses Independent school districts Public housing authorities/Indian housing authorities For profit organizations other than small businesses Special district governments 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 semisolid 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 an ocular semisolid drug product. The results from this study will help the FDA in developing recommendations to determine bioequivalence of generic ocular semisolid drug products.Objectives(1) To formulate Q1/Q2 semisolids (intended for topical ocular administration) under different manufacturing conditions(2) To conduct dissolution studies with the prepared semisolid formulations using various in vitro release methods(3) To identify a dissolution method that can discriminate different semisolid formulations Detailed DescriptionAdditional details regarding the study objectives listed above:(1) The ocular semisolid 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 semisolid 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. |
| 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 |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-14-008 |
| Funding Opportunity Title: | Dissolution Methods for Semisolid 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: | Apr 01, 2014 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | May 02, 2014 |
| Archive Date: | Jun 01, 2014 |
| Estimated Total Program Funding: | $700,000 |
| Award Ceiling: | $350,000 |
| Award Floor: | $300,000 |
Eligibility
| Eligible Applicants: | County governments City or township governments Private institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education State governments Native American tribal organizations (other than Federally recognized tribal governments) Native American tribal governments (Federally recognized) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education Small businesses Independent school districts Public housing authorities/Indian housing authorities For profit organizations other than small businesses Special district governments 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 semisolid 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 an ocular semisolid drug product. The results from this study will help the FDA in developing recommendations to determine bioequivalence of generic ocular semisolid drug products.Objectives(1) To formulate Q1/Q2 semisolids (intended for topical ocular administration) under different manufacturing conditions(2) To conduct dissolution studies with the prepared semisolid formulations using various in vitro release methods(3) To identify a dissolution method that can discriminate different semisolid formulations Detailed DescriptionAdditional details regarding the study objectives listed above:(1) The ocular semisolid 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 semisolid 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. |
| 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 |
DISPLAYING: Synopsis 1
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-14-008 |
| Funding Opportunity Title: | Dissolution Methods for Semisolid 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 1 |
| Posted Date: | Apr 01, 2014 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | May 02, 2014 |
| Archive Date: | Jun 01, 2014 |
| Estimated Total Program Funding: | $700,000 |
| Award Ceiling: | $350,000 |
| Award Floor: | $300,000 |
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 semisolid 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 an ocular semisolid drug product. The results from this study will help the FDA in developing recommendations to determine bioequivalence of generic ocular semisolid drug products. Objectives 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 253189 Full Announcement-1 -> rfa-fd-14-008 dissolution methods for semisolid ocular drug products (u01).pdf
Folder 253189 Other Supporting Documents-Application Guide and Electronic Submission information 1 -> index[1].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 | ADOBE-FORMS-C | RFA-FD-008 | PKG00194669 | Apr 01, 2014 | May 02, 2014 | View |
Package 1
Mandatory forms
253189 RR_SF424_2_0-2.0.pdf
253189 PHS398_ResearchPlan_2_0-2.0.pdf
253189 PHS398_CoverPageSupplement_2_0-2.0.pdf
253189 RR_Budget_1_3-1.3.pdf
253189 RR_KeyPersonExpanded_2_0-2.0.pdf
253189 RR_OtherProjectInfo_1_3-1.3.pdf
253189 PerformanceSite_2_0-2.0.pdf
Optional forms
253189 PlannedReport-1.0.pdf
253189 PHS398_CumulativeInclusionReport-1.0.pdf
253189 RR_SubawardBudget30_1_3-1.3.pdf
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