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August 01, 2007 (Vol. 27, No. 14)

Biomarkers Transform R&D

Role Ranges from Predicting Responses to Drugs to Being a Clinical Endpoint Surrogate

  • FDA defines a biomarker as a characteristic “objectively measured and evaluated as an indicator of normal biologic processes, pathogenic processes, or pharmacologic responses to therapeutic intervention.” FDA guidance further defines possible, probable, and known biomarker categories depending on the available scientific information on the marker. Biomarkers could be used ...

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