The FDA is offering a grant to evaluate in vitro release methods for complex parenteral dosage forms, such as polymeric micelles and liposomes. The study aims to assess their ability to detect formulation differences, predict in-vivo performance, and ensure method robustness. By advancing regulatory review processes, this research will enhance the availability of high quality generic complex parenteral drug products for the US public. Application deadline is May 24, 2013.
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:: | |
| Category of Funding Activity:: | Consumer Protection |
| Category Explanation:: | |
| Expected Number of Awards:: | 2 |
| Assistance Listings Number(s):: | 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:: | Special district 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:: | |
| Grantor Contact Information:: | If you have difficulty accessing the full announcement electronically, please contact: |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| Synopsis 2 | Updated anticipated number of awards and total program funding. | May 17, 2013 |
| Synopsis 1 |
Package Status
Below are CLOSED Opportunity Package(s) no longer available for this Funding Opportunity:
Package No: 1
| Assistance Listings: | 93.103 |
| Competition ID: | |
| Competition Title: | |
| Opportunity Package ID: | PKG00172250 |
| Opening Date: | Apr 15, 2013 |
| Closing Date: | May 24, 2013 |
| Agency Contact Information:: | Lisa Ko |
| Who Can Apply:: | Organization Applicants |
| mendatory_forms |
SF424 (R & R) [V1.2] Project/Performance Site Location(s) [V1.4] Research And Related Other Project Information [V1.3] Research And Related Senior/Key Person Profile (Expanded) [V1.2] Research & Related Budget [V1.1] PHS 398 Cover Page Supplement [V1.4] PHS 398 Research Plan [V1.3] PHS 398 Checklist [V1.3] |
| optional_forms |
R & R Subaward Budget Attachment(s) Form 5 YR 30 ATT [V1.2] PHS Cover Letter [V1.2] |
Packages
| Assistance Listings | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions | Who Can Apply: | |
|---|---|---|---|---|---|---|---|---|
| 93.103 | PKG00172250 | Apr 15, 2013 | May 24, 2013 | View | Lisa Ko | Organization Applicants |