The assessment of biomarkers in parallel with the efficacy, safety, and mechanism of action of drugs is becoming more prominent with a focus on achieving more efficient and successful drug development. The context of use for the biomarker data is a key determining factor that influences the approach taken during method development and validation to produce a robust method that can support your pre-clinical and clinical studies.



In this article, our expert Anthony Upton, describes understanding the context of use and the design of a fit-for-purpose validation.


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