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 FDA, including vaccines, blood and blood components, allergenic compounds, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins

Biomarker—“a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a[n] … intervention” (Biomarkers Definitions Working Group, 2001). Example: cholesterol level. The committee defines “objectively” to mean “reliably and accurately”

Calcium channel blocker—drug used to treat heart failure caused by high blood pressure; effects the movement of calcium in the cells of the heart and blood vessels to relax blood vessels and increase the supply of blood and oxygen to the heart

Cardiovascular disease—a term encompassing diseases that affect the heart and blood vessels

CD4 cell (CD4+ T-cells)—specialized cells that play a role in measuring immune response in individuals with HIV

Cholesterol—abundant steroid metabolite produced by animals and found in cell membranes and circulating in blood; excess cholesterol can lead to fatty deposits in blood vessels, a risk factor for cardiovascular disease

Chronic disease—a culmination of a series of pathogenic processes in response to internal or external stimuli over time that results in a clinical diagnosis/ailment and health outcomes

Clinical endpoint—a characteristic or variable that reflects how a patient [or consumer] feels, functions, or survives (Biomarkers Definitions Working Group, 2001)

Clinical trial—a formal study carried out according to a prospectively defined protocol that is intended to discover or verify the safety and effectiveness of procedures or interventions in humans (IOM, 2007)

Computed tomography (CT)—a special radiographic technique that uses a computer to assimilate multiple X-ray images into a two-dimensional, cross-sectional image, which also can be reconstructed into a three-dimensional image; can reveal many soft-tissue structures not shown by conventional radiography (IOM, 2007)

Coronary heart disease (CHD)—refers to damage to the heart caused by atherosclerotic constriction of arteries supplying the heart; also known as coronary artery disease

Correlation—a statistical association between two variables that does not imply a cause-and-effect relationship

C-reactive protein (CRP)—an acute-phase, nonspecific, systemic biomarker of inflammation; in normal individuals, CRP is a trace plasma



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