The Evolving Role of In Vitro–In Vivo Correlation in Model‐Informed Drug Development: A Multi‐Stakeholder Perspective

In vitro-in vivo correlation/relationship (IVIVC/R) models such as physiologically based biopharmaceutics modeling (PBBM) are crucial tools that link biopharmaceutical properties to clinical performance. They accelerate development, reduce costly experimental studies and clinical trials, and justify regulatory decisions for drug formulation related questions of interest (QOI). This paper consolidates insights from academia, industry, and service providers, exploring future opportunities, organizational challenges, regulatory perspectives, and competency gaps for further enhanced application in pharmaceutical development and regulatory decision-making.