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Glossary
Pages 107-112

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From page 107... ... inhibitor -- drug used to treat high blood pressure; prevents formation of a protein that causes con striction of blood vessels, thus lowering blood pressure Apolipoprotein -- a protein component of lipoprotein complexes Assay -- a biochemical or other measurement developed to quantitate a biomarker 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) Read the entire page →
From page 108... ... 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 cardiovas cular disease Chronic disease -- a culmination of a series of pathogenic processes in response to internal or external stimuli over time that results in a clini cal diagnosis/ailment and health outcomes Clinical endpoint -- a characteristic or variable that reflects how a patient [or consumer] Read the entire page →
From page 109... ... and a disease or health-related condition; limited to claims about disease risk reduction and cannot be claims about the cure, mitigation, treatment, or prevention of disease High-density lipoprotein cholesterol (HDL-C) -- a lipoprotein of blood plasma that is composed of a high proportion of protein with little triglyceride and cholesterol and that is associated with decreased prob ability of developing atherosclerosis Hypertension -- abnormally high arterial blood pressure that is usually indicated by an adult systolic blood pressure of 140 mm Hg or greater or a diastolic blood pressure of 90 mm Hg or greater; can result in thick ening and inelasticity of arterial walls and damage to the heart; a risk factor for various pathological conditions or events (e.g., heart attack, heart failure, stroke, end-stage renal disease, or retinal hemorrhage) Read the entire page →
From page 110... ... Medical device -- any instrument, apparatus, appliance, material, or other article intended to be used to affect the structure or any function of a human or animal body Myocardial infarction -- an acute episode of heart disease marked by the death or damage of heart muscle due to insufficient blood supply to the heart muscle, usually as a result of a coronary thrombosis or a coronary occlusion and that is characterized especially by chest pain Nutrient content claim -- statements about the level of a nutrient or dietary substance in the product, using terms such as free, high, and low, or they compare the level of a nutrient in a food to that of another food, using terms such as more, reduced, and lite Pathophysiology -- processes leading to the incidence or progression of disease or other health-related condition; alteration in function as dis tinguished from structural defects Phase I trial -- clinical trial in a small number of patients in which the toxicity and dosing of an intervention are assessed (IOM, 2007) Phase II trial -- clinical trial in which the safety and preliminary efficacy of an intervention are assessed in patients (IOM, 2007) Read the entire page →
From page 111... ... standard Risk–benefit analysis -- the comparison of the risk of a situation to its benefit Risk biomarker -- a biomarker that indicates a risk factor for a disease Risk factors -- variables that predict outcomes and are composed of bio markers and social and environmental factors Significant scientific agreement (SSA) -- judgment that qualified experts would likely agree that the scientific evidence supports the substance– disease relationship that is the subject of a proposed health claim Structure–function claim -- statements describing the role of a nutrient or dietary ingredient intended to affect normal structure or function in humans; may characterize the means by which a nutrient or dietary ingredient acts to maintain such structure or function; may describe general well-being from consumption of a nutrient or dietary ingredi ent; manufacturer is responsible for ensuring the accuracy and truth fulness of the statement; FDA does not review these claims prior to manufacturer use Supplement -- a product taken by mouth that contains a dietary ingredi ent intended to supplement the diet; dietary ingredients may include: vitamins, minerals, herbs or other botanicals, amino acids, and sub stances such as enzymes, organ tissues, glandulars, and metabolites; may be found in forms such as tablets, capsules, softgels, gelcaps, liquids, or powders Surrogate endpoint -- a biomarker that is intended to substitute for a clinical endpoint; a surrogate endpoint is expected to predict clinical benefit (or harm or lack of benefit or harm) Read the entire page →
From page 112... ... 112 BIOMARKER AND SURROGATE ENDPOINT EVALUATION Tumor size -- inconsistently defined biomarker often used for determining efficacy of cancer therapeutics Type 2 diabetes -- diabetes mellitus of a common form that develops especially in adults and most often in obese individuals and that is characterized by hyperglycemia resulting from impaired insulin utili zation coupled with the body's inability to compensate with increased insulin production utilization -- contextual analysis based on the specific use proposed and the applicability of available evidence to this use. This includes a deter mination of whether the validation and qualification conducted pro vide sufficient support for the use proposed Read the entire page →

From page 107...

... inhibitor -- drug used to treat high blood pressure; prevents formation of a protein that causes con striction of blood vessels, thus lowering blood pressure Apolipoprotein -- a protein component of lipoprotein complexes Assay -- a biochemical or other measurement developed to quantitate a biomarker 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)

Read the entire page →

From page 108...

... 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 cardiovas cular disease Chronic disease -- a culmination of a series of pathogenic processes in response to internal or external stimuli over time that results in a clini cal diagnosis/ailment and health outcomes Clinical endpoint -- a characteristic or variable that reflects how a patient [or consumer]

Read the entire page →

From page 109...

... and a disease or health-related condition; limited to claims about disease risk reduction and cannot be claims about the cure, mitigation, treatment, or prevention of disease High-density lipoprotein cholesterol (HDL-C) -- a lipoprotein of blood plasma that is composed of a high proportion of protein with little triglyceride and cholesterol and that is associated with decreased prob ability of developing atherosclerosis Hypertension -- abnormally high arterial blood pressure that is usually indicated by an adult systolic blood pressure of 140 mm Hg or greater or a diastolic blood pressure of 90 mm Hg or greater; can result in thick ening and inelasticity of arterial walls and damage to the heart; a risk factor for various pathological conditions or events (e.g., heart attack, heart failure, stroke, end-stage renal disease, or retinal hemorrhage)

Read the entire page →

From page 110...

... Medical device -- any instrument, apparatus, appliance, material, or other article intended to be used to affect the structure or any function of a human or animal body Myocardial infarction -- an acute episode of heart disease marked by the death or damage of heart muscle due to insufficient blood supply to the heart muscle, usually as a result of a coronary thrombosis or a coronary occlusion and that is characterized especially by chest pain Nutrient content claim -- statements about the level of a nutrient or dietary substance in the product, using terms such as free, high, and low, or they compare the level of a nutrient in a food to that of another food, using terms such as more, reduced, and lite Pathophysiology -- processes leading to the incidence or progression of disease or other health-related condition; alteration in function as dis tinguished from structural defects Phase I trial -- clinical trial in a small number of patients in which the toxicity and dosing of an intervention are assessed (IOM, 2007) Phase II trial -- clinical trial in which the safety and preliminary efficacy of an intervention are assessed in patients (IOM, 2007)

Read the entire page →

From page 111...

... standard Risk–benefit analysis -- the comparison of the risk of a situation to its benefit Risk biomarker -- a biomarker that indicates a risk factor for a disease Risk factors -- variables that predict outcomes and are composed of bio markers and social and environmental factors Significant scientific agreement (SSA) -- judgment that qualified experts would likely agree that the scientific evidence supports the substance– disease relationship that is the subject of a proposed health claim Structure–function claim -- statements describing the role of a nutrient or dietary ingredient intended to affect normal structure or function in humans; may characterize the means by which a nutrient or dietary ingredient acts to maintain such structure or function; may describe general well-being from consumption of a nutrient or dietary ingredi ent; manufacturer is responsible for ensuring the accuracy and truth fulness of the statement; FDA does not review these claims prior to manufacturer use Supplement -- a product taken by mouth that contains a dietary ingredi ent intended to supplement the diet; dietary ingredients may include: vitamins, minerals, herbs or other botanicals, amino acids, and sub stances such as enzymes, organ tissues, glandulars, and metabolites; may be found in forms such as tablets, capsules, softgels, gelcaps, liquids, or powders Surrogate endpoint -- a biomarker that is intended to substitute for a clinical endpoint; a surrogate endpoint is expected to predict clinical benefit (or harm or lack of benefit or harm)

Read the entire page →

From page 112...

... 112 BIOMARKER AND SURROGATE ENDPOINT EVALUATION Tumor size -- inconsistently defined biomarker often used for determining efficacy of cancer therapeutics Type 2 diabetes -- diabetes mellitus of a common form that develops especially in adults and most often in obese individuals and that is characterized by hyperglycemia resulting from impaired insulin utili zation coupled with the body's inability to compensate with increased insulin production utilization -- contextual analysis based on the specific use proposed and the applicability of available evidence to this use. This includes a deter mination of whether the validation and qualification conducted pro vide sufficient support for the use proposed

Read the entire page →

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Glossary Pages 107-112

Glossary
Pages 107-112