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.
General information about this opportunity
Last Known Status
Deleted 05/27/2015 (Archived.)
Program Number
RFA-FD-15-006 Federal Agency/Office
Agency: Department of Health and Human ServicesOffice: Food and Drug Administration
Type(s) of Assistance Offered
Cooperative Agreement Number of Awards Available
1 Who is eligible to apply/benefit from this assistance?
Applicant 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 What is the process for applying and being award this assistance?
Deadlines
04/27/2015 Other Assistance Considerations
Formula and Matching Requirements
This program does not have cost sharing or matching requirements. Who do I contact about this opportunity?
Headquarters Office
Lisa KoGrants Management Specialist
Website Address
http://grants.nih.gov/grants/guide/rfa-files/RFA-FD-15-006.html
E-mail Address
lisa.ko@fda.hhs.gov
Financial Information
Obligations
$125,000.00 Range and Average of Financial Assistance
Awards up to $125,000.00
