Tiered approach into practice: scientific validation for chromatography-based assays in early development – a recommendation from the European Bioanalysis Forum

Abstract

The principles of tiered approach have been part of the bioanalytical toolbox for some years. Nevertheless, an in spite of many valuable discussions in industry, they remain difficult to apply in a harmonized way for a broad array of studies in early drug development where these alternative approaches to regulated validation would make sense. The European Bioanalysis Forum has identified the need to proposes some practical workflows for five categories of studies for chromatography based assays where scientific validation will allow additional freedom while safeguarding scientific rigor and robust documentation: quantification of metabolites in plasma in relation to ICH M3(R2), urine analysis, tissue homogenate analysis, and preclinical and clinical studies in early stages of drug development. The recommendation would introduce a common language and harmonized best practice for these study categories and can help to refocus towards optimized scientific and resource investments for bioanalysis in early drug development.