Tiered approach revisited: introducing stage-appropriate or assay-appropriate scientific validation

“This article invites the industry to take ownership on recommending more detailed categorization of study types requiring bioanalysis from ‘tiered approach’ into ‘stage appropriate scientific validation’ and ‘assay-appropriate scientific validation’, and define quality criteria for each of these areas.” Over the last 10–15 years, the bioanalytical laboratories have become increasingly involved in measuring parent drug, metabolite or biomarker concentrations in a broadening array of clinical and preclinical studies. With the current Guidelines in Regulated Bioanalysis applicable to drug R&D being largely based on the paradigms developed in the 1980s and 1990s [1,2,101,102], there is a growing gap between the scientific...