Bioanalytics – Biomolecular
2019 PharmSci 360
This rapid fire presentation will provide insights that simplify the concept of Context of Use (COU) using examples that highlight the disparate contexts of biomarker application that dictate which assay validation assessments and criteria are relevant. In addition to advancing understanding of the foundational role of COU for biomarker assay development and validation, the feasibility of a single, one-size-fits-all guidance for biomarker assay validation will be discussed and an alternative approach will be presented for consideration and debate. .