Dissolution Methods for Long-acting Levonorgestrel Intrauterine System (U01)
The summary for the Dissolution Methods for Long-acting Levonorgestrel Intrauterine System (U01) grant is detailed below.
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Dissolution Methods for Long-acting Levonorgestrel Intrauterine System (U01): There is a lack of compendial or biorelevant in vitro drug release assays for long-acting contraceptive intrauterine systems. The objective of this study is to investigate dissolution methods, both real time and accelerated conditions, for levonorgestrel intrauterine system (5-year application) and to analyze their capability of detecting manufacturing differences, predicting in vivo performance, and to evaluate method robustness. The results from this study will help the FDA in developing recommendations to determine bioequivalence of generic intrauterine systems.
Federal Grant Title: | Dissolution Methods for Long-acting Levonorgestrel Intrauterine System (U01) |
Federal Agency Name: | Food Drug Administration |
Grant Categories: | Consumer Protection Food and Nutrition Health |
Type of Opportunity: | Discretionary |
Funding Opportunity Number: | RFA-FD-15-006 |
Type of Funding: | Cooperative Agreement |
CFDA Numbers: | 93.103 |
CFDA Descriptions: | Food and Drug Administration_Research |
Current Application Deadline: | Apr 27, 2015 |
Original Application Deadline: | Apr 27, 2015 |
Posted Date: | Feb 17, 2015 |
Creation Date: | Feb 17, 2015 |
Archive Date: | May 27, 2015 |
Total Program Funding: | $125,000 |
Maximum Federal Grant Award: | $125,000 |
Minimum Federal Grant Award: | none |
Expected Number of Awards: | 1 |
Cost Sharing or Matching: | No |
- Applicants Eligible for this Grant
- County governments
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)
Small businesses
Native American tribal governments (Federally recognized)
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
State governments
Public housing authorities/Indian housing authorities
Independent school districts
City or township governments
Public and State controlled institutions of higher education
For profit organizations other than small businesses
Native American tribal organizations (other than Federally recognized tribal governments)
Private institutions of higher education
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. - See more at: http://grants.nih.gov/grants/guide/rfa-files/RFA-FD-15-006.html#sthash.60X4gtYR.dpuf - Link to Full Grant Announcement
- Full Announcement of RFA-FD-15-006 on NIH Guide for Grants and Contracts
- Grant Announcement Contact
- Lisa Ko
Grants Management Specialist
[email protected]
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