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Description

The culmination of work to integrate the international guidelines on bioanalytical method validation and sample analysis into one standard document was reached on June 2022 with the ICH publication of the M10 Guidance of ‘Bioanalytical Method Validation and Study Sample Analysis’ (M10). The European Medical Association (EMA) adopted the guidance in July of 2022 with an effective date of January 21, 2023, followed by the issuance of the guidance on November 4, 2022, by the US Food and Drug Administration (FDA). Unlike the 2018 US FDA bioanalytical method validation guidance, the M10 guidance does not apply to biomarkers. There were several aspects of the M10 that varied significantly from both the 2012 EMA and 2018 FDA bioanalytical guidances on method validation, such as the approaches to determining matrix effects and the requirement to conduct whole blood stability and lipemic assessment with human clinical sample, as well as the approach to conducting selectivity studies, precision and accuracy experiments and defining the acceptance ranges of the different levels of QCs. Most notably are the changes in reporting requirements. This webinar will discuss the various aspects of the ICH M10 guidance and highlight the differences between the M10 guidance and the previous bioanalytical method validation and sample analysis guidances.