The new ICH guideline on bioanalytical method validation and study sample analysis (M10) has become effective on 21 January 2023. It focuses on the validation of bioanalytical methods for chemical and biological drug quantification and their analysis of study samples, in order to demonstrate suitability for its intended purpose.
Bioanalytical methods are used for concentration measurements of chemical and biological drugs and their metabolites. These measurements are conducted on biological samples such as tissues, blood, plasma, serum and other bodily fluids. These samples can be obtained in either nonclinical or clinical studies, including bioavailability or bioequivalence studies.
The results of bioanalytical studies have great importance for regulatory decision making regarding the safety and efficacy of drug products. Therefore, good characterization and validation of these methods is critical.
The ICH M10 guideline describes appropriate method development and validation strategies and elaborates on the mandatory parameters that need to be validated. The methods covered in this guideline are quantitative analysis by ligand binding assays and chromatographic methods such as liquid chromatography (LC) or gas chromatography (GC), which are typically used in combination with mass spectrometry (MS) detection. In addition, the requirements for documentation and reporting the tests and results are listed.
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