eBook: ICH M10 Bioanalytical Method Validation

This eBook reviews impressions on the ICH M10 guidance as well as key feedback gathered during the public consultation period. Different regulatory agencies have each issued their own bioanalytical method validation guidelines, but the aim of the ICH M10 guideline is to overcome the regional differences and provide a harmonized recommendation for the validation of both chromatographic and ligand-binding assays. The ICH M10 guideline describes the procedures and acceptance criteria for the assessment of the selectivity, specificity, calibration curve, limits of quantitation, accuracy, precision, dilution linearity, carry over and stability during method validation.

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