Streamlining Generic Drug Development by Matching Reference Product Composition and Performance, In Vitro and In Vivo
Our inaugural workshop held October 18-19, 2018, in Baltimore, MD, addressed the issues surrounding reverse engineering methods and strategies in the context of Q1/Q2/Q3 comparisons, with an eye toward reducing the clinical burden of generic drug development programs via BCS class 3 biowaivers, in vitro-only pathways for locally-acting and complex drug products, and, where biowaivers are not possible, streamlining complex human bioequivalence studies. The program was developed to appeal to stakeholders across a broad range of disciplines and to span a diverse group of product classes.
2018 Sponsors
