Feedback from a workshop by the European Bioanalysis Forum on assay validation requirements for in vitro assays following the publication of ICH M12 guideline - a plea for context-of-use over ICH M10 standards.

The release of the ICH M12 Guideline on Drug Interaction Studies has reignited discussions around assay validation requirements for in vitro assays such as plasma protein-binding studies. Even though the ICH M12 does not directly reference the ICH M10 Guideline on Bioanalytical Method Validation and Sample Analysis, its release prompted further discussions on assay validation requirements for these studies during the 17th European Bioanalysis Forum Open Symposium held in Barcelona, Spain, from 19 to 21 November 2024, where we advocated for a Context-of-Use driven approach over rigid adherence to ICH M10 standards. Context-of-Use driven validation ensures assays are tailored to the specific scientific and regulatory needs, optimizing resource allocation and innovation in drug development. This short opinion paper explores the potential and undesired implications of ICH M12 on bioanalytical validation practices, highlights the distinction between exploratory assays and assays having a clinical impact, and underscores the necessity for tailored validation strategies.