EMA Opens for Consult ICH M10 Guideline on Bioanalytical Method Validation
Posted 14 March 2019 | By
The European Medicines Agency (EMA) on Thursday released for public consultation the International Council of Harmonisation’s (ICH) M10 guideline, which aims to help sponsors improve the quality and consistency of bioanalytical data in support of the development and approval of both chemical and biological drugs.
The 57-page guidance, which has been in the works since 2016, provides recommendations for the validation of bioanalytical assays for chemical and biological drug quantification and their application in the analysis of study samples for non-clinical and clinical studies.
M10 also addresses issues on method validation by considering the characteristics of the analytical methods used in bioanalysis.
“The information in this guideline applies to the quantitative analysis by ligand binding assays (LBAs) and chromatographic methods such as liquid chromatography (LC) or gas chromatography (GC), which are typically used in combination with mass spectrometry (MS) detection and occasionally with other detectors,” the guideline says.
The nine sections of the guideline deal with method development and validation, chromatography (with subsections on reference standards and validation), LBAs (with subsections on key reagents, validation and study sample analysis), incurred sample reanalysis, partial and cross validation, additional considerations (with subsections on analytes that are also endogenous compounds, parallelism, recovery, minimum required dilution, commercial and diagnostic kits, and new or alternative technologies) and documentation.
The guideline also notes that the bioanalysis of biomarkers and bioanalytical methods used for the assessment of immunogenicity are not within its scope.
“The results of pivotal nonclinical toxicokinetic (TK)/pharmacokinetic (PK) studies and of clinical trials, including comparative bioavailability/bioequivalence (BA/BE) studies, are used to make regulatory decisions regarding the safety and efficacy of drug products,” the guideline says. “It is therefore critical that the bioanalytical methods used are well characterised, appropriately validated and documented in order to ensure reliable data to support regulatory decisions.”
ICH guideline M10 on bioanalytical method validation: Step 2b