The Evolving Role of In Vitro–In Vivo Correlation in Model‐Informed Drug Development: A Multi‐Stakeholder Perspective
Year: 2025
Type: article
Abstract: 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.
DOI: 10.1002/psp4.70137
Authors: Marylore Chenel, Sylvain Fouliard, Emma Hansson, Karl Brendel, Matthieu Jacobs, Hans Lennernäs, Erik Sjögren, Martin Bergstrand
Institutions: Ipsen (France), Uppsala University
Language: English
Subfield: Pharmaceutical Science
Domain: Life Sciences
Open Access status: gold
Estimated APC paid: $4,140
OpenAlex ID: W4415618786