Application Note
ICH M10 Guidance: Harmonization and Modification to Bioanalytical Method Variation
Global regulatory standards govern bioanalytical method development, validation and the subsequent assays. When those standards are updated, industry stakeholders should actively partake in their evolution and prepare for the ensuing changes. The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) is in the process of revising M10, one of its multidisciplinary guidelines regarding bioanalytical method validation. Drug developers need to prepare for the changes M10 presents in bioanalytics and adjust resources, methods and testing to comply with this latest regulatory standard.
