This FDA grant aims to explore dissolution methods for parenteral sustained release drug products like microspheres and implants. The study seeks to develop and compare various in vitro release methods to identify a dissolution method that can differentiate between different formulations. By assessing manufacturing differences and physicochemical properties, the study intends to assist the FDA in setting guidelines for determining bioequivalence of generic parenteral sustained release drug products. Funding is available for formulating sustained release products, conducting dissolution studies, and analyzing the effectiveness of dissolution methods. Application deadline: May 02, 2014.
Opportunity ID: 253190
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD14-007 |
| Funding Opportunity Title: | Dissolution Methods for Microsphere and Implant 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: | 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: | $1,000,000 |
| Award Ceiling: | $500,000 |
| Award Floor: | $400,000 |
Eligibility
| Eligible Applicants: | Others (see text field entitled “Additional Information on Eligibility” for clarification) Independent school districts Public and State controlled institutions of higher education City or township governments Special district governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) County governments Native American tribal governments (Federally recognized) Private institutions of higher education For profit organizations other than small businesses State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education |
| 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 sustained release dosage form. Generally, a generic drug product intended for parenteral 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 a parenteral sustained release drug product. The results from this study will help the FDA in developing recommendations to determine bioequivalence of generic parenteral sustained release drug products.Objectives:(1) To formulate Q1/Q2 sustained release products (either microspheres or implants) under different manufacturing conditions(2) To conduct dissolution studies with the prepared sustained release formulations using various in vitro release methods(3) To identify a dissolution method that can discriminate different sustained release formulations Detailed Description:Additional details regarding the study objectives listed above:(1) The sustained release formulation 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 sustained release products (either microspheres or implants, depending on the dosage form chosen) 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 $500,000 per award. Up to 2 awards may be funded. | Apr 07, 2014 | |
| Modified eligible recipients. | Apr 07, 2014 | |
| Apr 01, 2014 |
DISPLAYING: Synopsis 3
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD14-007 |
| Funding Opportunity Title: | Dissolution Methods for Microsphere and Implant 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: | 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: | $1,000,000 |
| Award Ceiling: | $500,000 |
| Award Floor: | $400,000 |
Eligibility
| Eligible Applicants: | Others (see text field entitled “Additional Information on Eligibility” for clarification) Independent school districts Public and State controlled institutions of higher education City or township governments Special district governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) County governments Native American tribal governments (Federally recognized) Private institutions of higher education For profit organizations other than small businesses State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education |
| 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 sustained release dosage form. Generally, a generic drug product intended for parenteral 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 a parenteral sustained release drug product. The results from this study will help the FDA in developing recommendations to determine bioequivalence of generic parenteral sustained release drug products.Objectives:(1) To formulate Q1/Q2 sustained release products (either microspheres or implants) under different manufacturing conditions(2) To conduct dissolution studies with the prepared sustained release formulations using various in vitro release methods(3) To identify a dissolution method that can discriminate different sustained release formulations Detailed Description:Additional details regarding the study objectives listed above:(1) The sustained release formulation 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 sustained release products (either microspheres or implants, depending on the dosage form chosen) 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-FD14-007 |
| Funding Opportunity Title: | Dissolution Methods for Microsphere and Implant 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 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: | $1,000,000 |
| Award Ceiling: | $500,000 |
| Award Floor: | $400,000 |
Eligibility
| Eligible Applicants: | For profit organizations other than small businesses Others (see text field entitled “Additional Information on Eligibility” for clarification) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized) Private institutions of higher education City or township governments County governments Independent school districts State governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Special district governments Small businesses Public housing authorities/Indian housing authorities |
| 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 sustained release dosage form. Generally, a generic drug product intended for parenteral 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 a parenteral sustained release drug product. The results from this study will help the FDA in developing recommendations to determine bioequivalence of generic parenteral sustained release drug products.Objectives:(1) To formulate Q1/Q2 sustained release products (either microspheres or implants) under different manufacturing conditions(2) To conduct dissolution studies with the prepared sustained release formulations using various in vitro release methods(3) To identify a dissolution method that can discriminate different sustained release formulations Detailed Description:Additional details regarding the study objectives listed above:(1) The sustained release formulation 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 sustained release products (either microspheres or implants, depending on the dosage form chosen) 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-FD14-007 |
| Funding Opportunity Title: | Dissolution Methods for Microsphere and Implant 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: | $1,000,000 |
| Award Ceiling: | $500,000 |
| Award Floor: | $400,000 |
Eligibility
| Eligible Applicants: | Others (see text field entitled “Additional Information on Eligibility” for clarification) Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled “Additional Information on Eligibility” |
| 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 sustained release dosage form.
Generally, a generic drug product intended for parenteral 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 a parenteral sustained release drug product. The results from this study will help the FDA in developing recommendations to determine bioequivalence of generic parenteral sustained release drug products. Objectives: (1) To formulate Q1/Q2 sustained release products (either microspheres or implants) under different manufacturing conditions Detailed Description: Additional details regarding the study objectives listed above: |
| 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 253190 Full Announcement-1 -> rfa-fd-14-007 dissolution methods for microsphere and implant drug products (u01).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 | RFAFD14-007 | Office of Generic Drugs | PKG00194543 | Apr 01, 2014 | May 02, 2014 | View |
Package 1
Mandatory forms
253190 RR_SF424_2_0-2.0.pdf
253190 PHS398_ResearchPlan_2_0-2.0.pdf
253190 PHS398_CoverPageSupplement_2_0-2.0.pdf
253190 RR_Budget_1_3-1.3.pdf
253190 RR_KeyPersonExpanded_2_0-2.0.pdf
253190 RR_OtherProjectInfo_1_3-1.3.pdf
253190 PerformanceSite_2_0-2.0.pdf
Optional forms
253190 PlannedReport-1.0.pdf
253190 PHS398_CumulativeInclusionReport-1.0.pdf
253190 RR_SubawardBudget30_1_3-1.3.pdf
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