(biomarker) 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.

(biomarker) A biological, physiological, behavioral, or molecular indicator of a process, disease, or system; e.g., fish mortality and pollution, behavioral changes and alcoholism, neuroendocrine system changes and aging.

(biomarker) A characteristic that can be objectively measured and serves as an indicator for normal biologic processes, pathogenic processes, state of health or disease, the risk for disease development and/or prognosis, or responsiveness to a particular therapeutic intervention.

(biomarker) A defined characteristic that is measured as an indicator of normal biological processes, pathogenic processes, or responses to an exposure or intervention, including therapeutic interventions. Molecular, histologic, radiographic, or physiologic characteristics are types of biomarkers. A biomarker is not an assessment of how an individual feels, functions, or survives. Categories of biomarkers include: susceptibility/risk biomarker; diagnostic biomarker; monitoring biomarker; prognostic biomarker; predictive biomarker; safety biomarker; pharmacodynamic/response biomarker.

(biomarker) A distinctive biological indicator of an event, process, or condition.

(biomarker) A measurable and quantifiable biological parameter which serves as index for health- and physiology-related assessments, such as disease risk, psychiatric disorders, environmental exposure and its effects, disease diagnosis, metabolic processes, substance abuse, pregnancy, cell line development, epidemiologic studies, etc.

(biomarkers) Measurable and quantifiable biological parameters (e.g., specific enzyme concentration, specific hormone concentration, specific gene phenotype distribution in a population, presence of biological substances) which serve as indices for health- and physiology-related assessments, such as disease risk, psychiatric disorders, ENVIRONMENTAL EXPOSURE and its effects, disease diagnosis; METABOLIC PROCESSES; SUBSTANCE ABUSE; PREGNANCY; cell line development; EPIDEMIOLOGIC STUDIES; etc.

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.)

Biomarker, a measurable and quantifiable biological parameter that serves as an indicator of a particular physiological state. In a medical context, a biomarker is a substance whose detection indicates a particular disease state or a response to a therapeutic intervention. Examples include the...