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.

Who can apply

• 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)
• Nonprofits with 501(c)(3) status (other than higher education)
• Nonprofits without 501(c)(3) status (other than higher education)
• Private institutions of higher education
• For-profit organizations other than small businesses
• Small businesses
• Others

Contact

Lisa Ko <br/>Grants Management Specialist
lisa.ko@fda.hhs.gov