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”

Bone mineral density (BMD)—may correlate with bone strength and a bone’s ability to bear weight; may be possible to predict fracture risk using BMD as a measure

Calcium channel blocker—drug used 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

Calibration—the use of measurement standards and standard measurement protocols to ensure the precision and reproducibility of an instrument or other measurement method

Cardiotoxic—having a deleterious effect on the action of the heart, due to poisoning of the cardiac muscle or of its conducting system

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

Choi criteria—a measure used to assess tumor progression in gastrointestinal stromal tumor (GIST); incorporate tumor size and tumor density into a metric of tumor progression; demonstrated to more accurately predict overall survival in GIST than reduction in tumor size

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

Chromium picolinate—biologically active chromium salt that is used as a dietary supplement

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 feels, functions, or survives (Biomarkers Definitions Working Group, 2001)

Clinical triala 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)



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