Context of Use (COU) is defined by the BEST glossary and important to establish early in biomarker development. This presentation will focus on how COU can drive analytical requirements and change the COU based on the data collected.
Establish COU early in biomarker development
Different analytical data requirements are necessary for different context of use
Look at examples of biomarkers which have been qualified or are on their way to qualification to understand the analytical requirements and context of use
Please refer to the FDA CDER Biomarker Qualification Program website for resource and more information on biomarker qualification