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A biomarker is a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention (Biomarkers Definitions Working Group 2001). A biomarker can be used as an indicator of a change or, if it meets the highest standard of proof, a surrogate endpoint that is expected to predict clinical benefit (or harm, or lack of benefit or harm) based on epidemiologic, therapeutic, pathophysiologic, or other scientific evidence.
Biomarkers are widely used in medicine, drug discovery and development, and safety assessment. They serve as indicators for disease progression (diagnosis and prognosis), therapeutic responses (efficacy), and adverse side effects (safety) in organisms, organs, and/or cells. An ideal clinical biomarker should contain the following characteristics (Lesko and Atkinson 1999): (1) clinical...
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References
Biomarkers Definitions Working Group (2001) Biomarkers and surrogate endpoints: preferred definitions and conceptual framework. Clin Pharmacol Ther 69:89–95
Goodsaid FM, Frueh FW, Mattes W (2008) Strategic paths for biomarker qualification. Toxicology 245:219–223
Lesko LJ, Atkinson AJ Jr (1999) Use of biomarkers and surrogate endpoints in drug development and regulatory decision making: criteria, validation, strategies. Annu Rev Pharmacol Toxicol 41:347–366
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Mendrick, D.L., Tong, W. (2013). Biomarkers. In: Dubitzky, W., Wolkenhauer, O., Cho, KH., Yokota, H. (eds) Encyclopedia of Systems Biology. Springer, New York, NY. https://doi.org/10.1007/978-1-4419-9863-7_211
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DOI: https://doi.org/10.1007/978-1-4419-9863-7_211
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