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Biomarkers have emerged as an important tool to support early and late drug development.Biomarkers have a range of applications, including assessment of target engagement or downstream mechanistic effects; monitoring treatment response (safety and efficacy); and stratifying or selecting patients for treatment.The scientific impact ofbiomarker studies is directly related to the quality of the underlying data.However the nature of biomarker measurements often precludes direct application of existing regulatory guidelines for either pharrnacokinetic assays or diagnostic development.It is therefore important that principles be established for validation of assays used to support drug development.This