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Fig. 2 | AAPS Open

Fig. 2

From: Best practices for the development and fit-for-purpose validation of biomarker methods: a conference report

Fig. 2

Pre-workshop survey—key criteria for validation method. A large majority of the 41 survey respondents (75%) pronounced in favor of establishing a minimal requirement for method validation (center graph). The respondents also indicated the key validation criteria which should be included in a method validation (outer ring, shown as the percentage of total respondents). Of note, for protein biomarker assay (ligand binding and mass spectrometry), accuracy is often referred to as relative accuracy given that calibrators composed of recombinant protein are not typically identical to the endogenous biomarker, thus the concentration is relative to the specific assay used. However, the survey did not highlight this point. For cellular biomarkers, accuracy is even more challenging due to the lack of appropriate cellular reference materials for multiparametric flow cytometry

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