Evaluation of Dissolution Methods for Complex Parenteral Dosage Forms (U01)

The summary for the Evaluation of Dissolution Methods for Complex Parenteral Dosage Forms (U01) grant is detailed below. This summary states who is eligible for the grant, how much grant money will be awarded, current and past deadlines, Catalog of Federal Domestic Assistance (CFDA) numbers, and a sampling of similar government grants. Verify the accuracy of the data FederalGrants.com provides by visiting the webpage noted in the Link to Full Announcement section or by contacting the appropriate person listed as the Grant Announcement Contact. If any section is incomplete, please visit the website for the Food and Drug Administration, which is the U.S. government agency offering this grant.
Evaluation of Dissolution Methods for Complex Parenteral Dosage Forms (U01): 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.
Federal Grant Title: Evaluation of Dissolution Methods for Complex Parenteral Dosage Forms (U01)
Federal Agency Name: Food and Drug Administration
Grant Categories: Consumer Protection Food and Nutrition Health
Type of Opportunity: Discretionary
Funding Opportunity Number: RFA-FD-13-019
Type of Funding: Cooperative Agreement
CFDA Numbers: 93.103
CFDA Descriptions: Food and Drug Administration_Research
Current Application Deadline: May 24, 2013
Original Application Deadline: May 24, 2013
Posted Date: Apr 03, 2013
Creation Date: Apr 03, 2013
Archive Date: Jun 23, 2013
Total Program Funding: $500,000
Maximum Federal Grant Award: $500,000
Minimum Federal Grant Award:
Expected Number of Awards: 1
Cost Sharing or Matching: No
Applicants Eligible for this Grant
State governments - County governments - City or township governments - Special district governments - Independent school districts - Public and State controlled institutions of higher education - Native American tribal governments (Federally recognized) - Public housing authorities/Indian housing authorities - Native American tribal organizations (other than Federally recognized tribal governments) - Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education - Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education - Private institutions of higher education - For profit organizations other than small businesses - Small businesses - Others (see text field entitled "Additional Information on Eligibility" for clarification)
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.
Grant Announcement Contact
Lisa Ko Grants Management Specialist

[email protected] [[email protected]]
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