How to Optimize Your Drug Label Using Biosimulation Methodology

While biosimulation has been an important element in drug development for some time, its impact over the past 18 months with regard to label optimization has been profound. Specifically, FDA’s acceptance of Physiologically-Based Pharmacokinetic (PBPK) modeling and simulation has impacted key label elements in more than a dozen cases, driving down R&D costs and timelines, and allowing for greater population inclusion within the label. In this webinar, Dr. Steve Toon presented some recent examples of the role of PBPK modeling in the regulatory approvals process.