Development and validation of a fit-for-purpose biomarker LC-MS/MS assay measuring 15 plasma bile acids

WRIB 2024 -- Here we discuss a high-performance liquid chromatography tandem mass spectrometry (LC-MS/MS) method to simultaneously quantify 15 human bile acids (BAs) in patient plasma and the specific validation tests performed to provide analytical data support for clinical studies. Additionally, we show an analysis evaluating the difference in statistical power to achieve the study goals, justifying a widened acceptance criteria as being appropriate in the context of use of the biomarker data.