From Guidelines to Implementation: A Case Study on Applying ICH M10 for Bioanalytical Assay Cross-Validation

Mianzhi Gu,Andrew Gehman, Brady Nifong,Andrew P. Mayer, Vicky Li, Mary Birchler,Kai Wang,Huaping Tang

The AAPS Journal（2025）

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cross-validation,free biomarker assay,ICH M10,regulatory bioanalysis,statistical analysis

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