Development of Advanced Analytical Methods for the Characterization of Iron Carbohydrate Complex - Ferric Derisomaltose (U01) Clinical Trials Not Allowed

Development of advanced analytical methods for the characterization and comparative analysis of complex products are important for linking product attributes to safety, quality and clinical performance, which is helpful for facilitating development of generic complex products. The purpose of this study is to develop advanced analytical methods for the characterization and analysis of ferric derisomaltose which is a complex drug product. The results from this study will help the development and review of generic ferric derisomaltose.