This grant is for advancing the regulatory review process of complex parenteral drug products. Despite the increasing number of complex parenteral dosage forms, including polymeric micelles and liposomes, a critical gap exists in compendial or biorelevant in vitro drug release assays. This study will evaluate current in vitro release methods for these complex dosage forms, analyzing their capability to detect formulation differences, predict in-vivo performance, and demonstrate robustness. The research aims to enhance regulatory understanding, ultimately providing the US public with access to high-quality generic complex parenteral drug products.
Opportunity ID: 229074
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-13-019 |
| Funding Opportunity Title: | Evaluation of Dissolution Methods for Complex Parenteral Dosage Forms (U01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Consumer Protection Food and Nutrition Health |
| Category Explanation: | – |
| Expected Number of Awards: | 2 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Apr 03, 2013 |
| Last Updated Date: | May 17, 2013 |
| Original Closing Date for Applications: | May 24, 2013 |
| Current Closing Date for Applications: | May 24, 2013 |
| Archive Date: | Jun 23, 2013 |
| Estimated Total Program Funding: | $1,000,000 |
| Award Ceiling: | $500,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Public and State controlled institutions of higher education Public housing authorities/Indian housing authorities Independent school districts Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) Special district governments County governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Private institutions of higher education Small businesses State governments For profit organizations other than small businesses Native American tribal governments (Federally recognized) Native American tribal organizations (other than Federally recognized tribal 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: | Despite the increasing number of complex parenteral dosage forms including polymeric micelles, liposomes, nanosuspensions and others, currently there is still a lack of compendial or biorelevant in vitro drug release assays for these complex dosage forms. The purpose of this study is to evaluate current in vitro release methods for complex parenteral dosage forms and analyze their capability of detecting formulation differences, predicting in-vivo performance, as well as their method robustness. This study is intended to advance the regulatory review process of complex parenteral drug products, which in turn will help provide the US public with access to high quality generic complex parenteral drug products. |
| Link to Additional Information: | Link to Full Announcement for RFA-FD-13-019 on 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 |
|---|---|---|
| Updated anticipated number of awards and total program funding. | May 17, 2013 | |
| May 17, 2013 |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-13-019 |
| Funding Opportunity Title: | Evaluation of Dissolution Methods for Complex Parenteral Dosage Forms (U01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Consumer Protection Food and Nutrition Health |
| Category Explanation: | – |
| Expected Number of Awards: | 2 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Apr 03, 2013 |
| Last Updated Date: | May 17, 2013 |
| Original Closing Date for Applications: | May 24, 2013 |
| Current Closing Date for Applications: | May 24, 2013 |
| Archive Date: | Jun 23, 2013 |
| Estimated Total Program Funding: | $1,000,000 |
| Award Ceiling: | $500,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Public and State controlled institutions of higher education Public housing authorities/Indian housing authorities Independent school districts Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) Special district governments County governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Private institutions of higher education Small businesses State governments For profit organizations other than small businesses Native American tribal governments (Federally recognized) Native American tribal organizations (other than Federally recognized tribal 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: | Despite the increasing number of complex parenteral dosage forms including polymeric micelles, liposomes, nanosuspensions and others, currently there is still a lack of compendial or biorelevant in vitro drug release assays for these complex dosage forms. The purpose of this study is to evaluate current in vitro release methods for complex parenteral dosage forms and analyze their capability of detecting formulation differences, predicting in-vivo performance, as well as their method robustness. This study is intended to advance the regulatory review process of complex parenteral drug products, which in turn will help provide the US public with access to high quality generic complex parenteral drug products. |
| Link to Additional Information: | Link to Full Announcement for RFA-FD-13-019 on 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-13-019 |
| Funding Opportunity Title: | Evaluation of Dissolution Methods for Complex Parenteral Dosage Forms (U01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Consumer Protection Food and Nutrition 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 17, 2013 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | May 24, 2013 |
| Archive Date: | Jun 23, 2013 |
| Estimated Total Program Funding: | $500,000 |
| Award Ceiling: | $500,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Public and State controlled institutions of higher education City or township governments County governments Native American tribal organizations (other than Federally recognized tribal governments) State governments Special district governments Private institutions of higher education Independent school districts Small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities Others (see text field entitled “Additional Information on Eligibility” for clarification) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses Native American tribal governments (Federally recognized) |
| 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: | Despite the increasing number of complex parenteral dosage forms including polymeric micelles, liposomes, nanosuspensions and others, currently there is still a lack of compendial or biorelevant in vitro drug release assays for these complex dosage forms. The purpose of this study is to evaluate current in vitro release methods for complex parenteral dosage forms and analyze their capability of detecting formulation differences, predicting in-vivo performance, as well as their method robustness. This study is intended to advance the regulatory review process of complex parenteral drug products, which in turn will help provide the US public with access to high quality generic complex parenteral drug products. |
| Link to Additional Information: | Link to Full Announcement for RFA-FD-13-019 on 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
There are no related documents on this grant.
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 | PKG00172250 | Apr 15, 2013 | May 24, 2013 | View |
Package 1
Mandatory forms
229074 RR_SF424_1_2-1.2.pdf
229074 PerformanceSite_1_4-1.4.pdf
229074 RR_OtherProjectInfo_1_3-1.3.pdf
229074 RR_KeyPersonExpanded_1_2-1.2.pdf
229074 RR_Budget-1.1.pdf
229074 PHS398_CoverPageSupplement_1_4-1.4.pdf
229074 PHS398_ResearchPlan_1_3-1.3.pdf
229074 PHS398_Checklist_1_3-1.3.pdf
Optional forms
229074 RR_SubawardBudget30-1.2.pdf
229074 PHS_CoverLetter_1_2-1.2.pdf
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