Biomarker method validation is an iterative process. An analytical validation of a biomarker ensures adequate assay performance concerning the questions addressed in the clinical study (fit-for-purpose) and the capability of distinguishing statistically significant changes.   

Biomarker qualification entails collecting sufficient evidence of the relationship between a biomarker with the relevant biological processes and clinical end points.

• Biomarker development starts with biomarker identification or discovery
• Biomarkers can be used in the preclinical development phase for preclinical safety assessments, identifying the drug’s mechanism of action, or helping with dose selection
• The validation phase of biomarker development tests its reliability and adequate sensitivity and specificity
• The objective is to link a biomarker with biological and clinical endpoints
• Qualified biomarkers reduce uncertainty in regulatory decisions at each stage of the drug development process