Pdufa Vi: It Is Time To Unleash The Full Potential Of Model-Informed Drug Development

With years of experience in modeling and simulation (M&S), and model informed drug development (MIDD) as one of the goals in PDUFA VI authorization, it is now the right time to apply MIDD for high impact decisions. Over the last two decades, current applications of MIDD in drug discovery, dose selection, benefit-risk assessment, and labeling have been useful. The value proposition of M&S is acknowledged in the PDUFA VI authorization, which provides an excellent opportunity for industry and regulators to collaborate in further advancing the applications of MIDD, potentially changing drug development paradigms. This article is protected by copyright. All rights reserved.