The evolving role of in vitro – in vivo correlation in Model-Informed Drug Development: A multi-stakeholder perspective

This paper presents consolidated insights from academia, industry, and service providers on the topic of in vitro–in vivo correlation/relationship (IVIVC/R) models, including physiologically based biopharmaceutics modeling (PBBM), and their importance in pharmaceutical development and regulatory decision-making.

The authors, Sylvain Fouliard and Matthieu Jacobs from Servier, Karl Brendel from Ipsen, Hans Lennernäs from Uppsala University and Marylore Chenel, Erik Sjögren, Martin Bergstrand, and Emma Hansson from Pharmetheus explore future opportunities, organizational challenges, regulatory perspectives, and gaps in competencies that need addressing to make use of these tools and their potential fully.

These modeling approaches are transforming drug development by linking biopharmaceutical properties directly to clinical performance. They help accelerate timelines, reduce the need for costly experimental studies and clinical trials, and provide solid justification for regulatory decisions — especially around drug formulation questions.