Abstract
The results of a disease are specific changes in the profiles (chemical and biochemical) of biological fluids and tissues before the development of clinical symptoms. Proteomic and metabolomics analysis of biological samples can reveal changes in abundance levels of proteins and metabolites that can function as useful diagnostic and prognostic clinical tests. To become a clinically approved test, a potential biomarker should be confirmed and validated. Confirmation and validation applies to the analytical methodology and the candidate biomarker. A search of the scientific and medical literature indicates that many studies reported the discovery of potential biomarkers without proper validation. In this chapter, the discussion will center on biomarker study design and execution and will point out the needed steps for a successful biomarker discovery.
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