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Review
. 2017 Mar 17:76:9.23.1-9.23.17.
doi: 10.1002/cpph.19.

Biomarkers-A General Review

Affiliations
Review

Biomarkers-A General Review

Jeffrey K Aronson et al. Curr Protoc Pharmacol. .

Abstract

A biomarker is a biological observation that substitutes for and ideally predicts a clinically relevant endpoint or intermediate outcome that is more difficult to observe. The use of clinical biomarkers is easier and less expensive than direct measurement of the final clinical endpoint, and biomarkers are usually measured over a shorter time span. They can be used in disease screening, diagnosis, characterization, and monitoring; as prognostic indicators; for developing individualized therapeutic interventions; for predicting and treating adverse drug reactions; for identifying cell types; and for pharmacodynamic and dose-response studies. To understand the value of a biomarker, it is necessary to know the pathophysiological relationship between the biomarker and the relevant clinical endpoint. Good biomarkers should be measurable with little or no variability, should have a sizeable signal to noise ratio, and should change promptly and reliably in response to changes in the condition or its therapy. © 2017 by John Wiley & Sons, Inc.

Keywords: adverse drug reactions; biomarkers; diagnosis; drug development; drug discovery; monitoring drug therapy; screening; surrogate endpoints; surrogate markers.

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References

Literature Cited

    1. Aronson, J. K. (2005). Biomarkers and surrogate endpoints. British Journal of Clinical Pharmacology, 59, 491-494. doi: 10.1111/j.1365-2125.2005.02435.x.
    1. Aronson, J. K. (2008). Biomarkers and surrogate endpoints in monitoring therapeutic interventions. In P. Glasziou , L. Irwig , & J. K. Aronson (Eds.), Evidence-based medical monitoring: From principles to practice (pp. 48-62). Oxford: Blackwell Publishing.
    1. Aronson, J. K. (2012). An agenda for UK clinical pharmacology: Research priorities in biomarkers and surrogate endpoints. British Journal of Clinical Pharmacology, 73, 900-907. doi: 10.1111/j.1365-2125.2012.04234.x.
    1. Biomarkers Definitions Working Group. (2001). Biomarkers and surrogate endpoints: Preferred definitions and conceptual framework. Clinical Pharmacology and Therapeutics, 69, 89-95. doi: 10.1067/mcp.2001.113989.
    1. Burnett, H. F. , Tanoshima, R. , Chandranipapongse, W. , Madadi, P. , Ito, S. , & Ungar, W. J. (2014). Testing for thiopurine methyltransferase status for safe and effective thiopurine administration: A systematic review of clinical guidance documents. The Pharmacogenomics Journal, 14, 493-502. doi: 10.1038/tpj.2014.47.

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