<n0:ComplexDefinition xmlns:n0="http://ncicb.nci.nih.gov/xml/owl/EVS/ComplexProperties.xsd#"><n0:def-definition>A characteristic that is objectively measured and evaluated as an indicator of normal biologic processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention. (From: FDA Guidance for Industry: Pharmacogenomic Data Submissions.)</n0:def-definition><n0:def-source>FDA</n0:def-source></n0:ComplexDefinition><n0:ComplexDefinition xmlns:n0="http://ncicb.nci.nih.gov/xml/owl/EVS/ComplexProperties.xsd#"><n0:def-definition>A biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease. A biomarker may be used to see how well the body responds to a treatment for a disease or condition.</n0:def-definition><n0:def-source>NCI-GLOSS</n0:def-source></n0:ComplexDefinition>
<n0:ComplexDefinition xmlns:n0="http://ncicb.nci.nih.gov/xml/owl/EVS/ComplexProperties.xsd#"><n0:def-definition>A variation in cellular or biochemical components or processes, structures, or functions that is objectively measurable in a biological system and that characterizes normal biologic processes, pathogenic processes, an organism's state of health or disease, likelihood of developing a disease, prognosis, or response to a particular therapeutic intervention. Biomarkers include but not limited to such phenotypic parameters as specific enzyme or hormone concentration, specific gene phenotype, presence or absence of biological substances.</n0:def-definition><n0:def-source>NCI</n0:def-source></n0:ComplexDefinition>