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Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease
Analytical validation—“assessing [an] assay and its measurement performance characteristics, determining the range of conditions under which the assay will give reproducible and accurate data” (Wagner, 2002)
Angiotensin-converting enzyme (ACE) inhibitor—drug used to treat blood pressure; prevents formation of a protein that causes constriction of blood vessels, thus lowering blood pressure
Angiotension receptor blocker—type of medication used to treat high blood pressure. Unlike ACE inhibitors, which prevent the formation of angiotensin II, angiotensin receptor blockers, while allowing the protein to form, prevent it from functioning. Thus, blood pressure is lowered by preventing constriction of the blood vessels.
Apolipoprotein—a protein component of lipoprotein complexes
Arrhythmia—loss of rhythm, denoting especially an irregularity of the heartbeat
Assay—a biochemical or other measurement developed to quantitate a biomarker
Atherogenic dyslipidemia—abnormal lipid levels (including abnormal cholesterol levels) having the capacity to initiate, increase, or accelerate the process of atherogenesis having the capacity to initiate, increase, or accelerate the process of atherogenesis
Atherosclerosis/arteriosclerosis—condition characterized by irregularly distributed lipid deposits in the intima of large and medium-sized arteries; such deposits are associated with fibrosis and calcification, and are nearly always present to some degree in middle aged and older individuals
Authorized health claim—voluntary statement that characterizes the relationship between a substance and its ability to reduce the risk of disease or a health-related condition (Schneeman, 2007) that meets the significant scientific agreement (SSA) standard
Autocrine signaling—hormonal signalling in which a cell produces an agent that then binds to receptors within the same cell; related to stimulation of T-cell growth and growth of some breast cancers
Beta-carotene (β-carotene)—pigment-producing molecule in the skin of several fruits and vegetables; after ingestion, some -carotene in blood-stream converts to two molecules of retinol (preformed vitamin A)
Bias—the systematic but unintentional erroneous association of some characteristic with a group in a way that distorts a comparison with another group (IOM, 2007)
Biological plausibility—data elucidating how the biological pathways leading from exposure to effect are useful
Biological products (biologics)—a category of products regulated by the Food and Drug Administration, including vaccines, blood and blood