Abstract
Confirmation and validation of a disease biomarker is a lengthy process that requires careful consideration and attention to every step of the analytical procedure. Steps in this procedure include sample selection, collection, storage, and analysis. Analytical validation involves instrument qualification and method validation. Analytical method validation encompasses patient and sample selection, collection, storage, and determination of the optimum analytical procedure that will provide high reproducibility and accuracy. Validation of the candidate biomarker involves five different phases from candidate discovery to human clinical studies, as discussed in this chapter.
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