Biochemical markers are urgently needed to improve diagnosis, guide molecularly targeted therapy, and monitor activity and therapeutic response in traumatic brain injury. Proteomics methods based on mass spectrometry hold special promise for the discovery of novel biomarkers that might form the foundation for new clinical blood tests, but to date there are no biomarkers of brain injury approved by Food and Drug Administration (FDA). This chapter will provide a detailed outline of the overall process of biomarker discovery, the regulatory considerations necessary for a biomarker to file for approval by FDA, and information on their clinical utility for diagnosis, management, and prognosis of patients exposed to severe brain injuries.

Utilities of TBI Biomarkers in Various Clinical Settings

MONDELLO, STEFANIA;
2012

Abstract

Biochemical markers are urgently needed to improve diagnosis, guide molecularly targeted therapy, and monitor activity and therapeutic response in traumatic brain injury. Proteomics methods based on mass spectrometry hold special promise for the discovery of novel biomarkers that might form the foundation for new clinical blood tests, but to date there are no biomarkers of brain injury approved by Food and Drug Administration (FDA). This chapter will provide a detailed outline of the overall process of biomarker discovery, the regulatory considerations necessary for a biomarker to file for approval by FDA, and information on their clinical utility for diagnosis, management, and prognosis of patients exposed to severe brain injuries.
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/11570/2670769
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