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Discovery and validation of disease biomarkers is a long and arduous procedure that requires the collaboration of major stakeholders (academia, industry and government) and is accompanied with a high risk of failure. The challenges faced during protein‐biomarker development are multidimensional and present at every phase. Researchers need to be aware of the potential limitations in order to plan an efficient study that produces results that can be critically interpreted. The present chapter provides an insight into the barriers that a potential biomarker must overcome to move from the bench towards the clinic.

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