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.