Validation of Targeted Quantitative Analysis of Endogenous Biomarkers for Good Clinical Practice Studies

Metabolon, Inc. develops and validates absolute quantitation analytical methods to measure metabolites that are biologically significant for identifying the presence of disease or other conditions. When pharmaceutical companies want to study the effect of a novel treatment for a disease in patients, it is important that supporting data follows Good Clinical Practice (GCP) requirements. The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) released the M10 Bioanalytical Method Validation and Study Sample Analysis Guidance for Industry (M10) in November 2022 as a harmonization of the regulatory expectations for clinical studies across the world. The standards help to ensure safe, effective, and high-quality medicines are developed for patients. The guidance lacks application to endogenous biomarker analysis, and there is no alternative guidance published. Metabolon, Inc., utilized the M10 guidance to prepare standard operating procedures for bioanalytical method validation of endogenous biomarkers for studies that are subject to GCP requirements. Fill in the form to get access to the poster to learn more.