2019 PharmSci 360
Biomarkers are measured using a variety of assay platforms and used for a wide range of applications and target populations. Therefore, it is critical to apply a fit-for-purpose strategy for method development and validation. A key consideration in establishing the fitness of use relates to the analytical and physiological variability of biomarker measurements. In this talk, the impact of different levels of analytical and biological variability on the biomarker utility for diagnostics and drug development will be presented. This will be further studied in the context of popular biomarkers of Alzheimer's disease where the effect of additional variability on the diagnostic accuracy and clinical study design will be evaluated. Insights from such investigations will be used for defining fit-for-purpose biomarker method acceptance.