European Bioanalysis Forum recommendation on embracing a context-of-use-driven scientific validation for chromatographic assays in the light of ICH M10

In this paper published in Bioanalysis, the European Bioanalysis Forum (EBF) advocates for a context-of-use (CoU)-driven approach to bioanalytical method validation in light of ICH M10, featuring insights from Stuart McDougall, Principal Research Fellow.

While ICH M10 provides a robust framework for regulatory studies, EBF emphasizes scientific flexibility for early-phase, exploratory, or internal decision-making assays. The paper introduces decision trees and validation parameter tables to guide leaner, fit-for-purpose validation strategies. It cautions against scope creep and over-validation, urging alignment of validation depth with study intent. EBF promotes scientifically justified, transparent practices that balance regulatory compliance, operational efficiency, and ethical responsibility, ultimately supporting faster, reliable drug development without compromising data integrity or patient safety