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OCR for page 103
Perspectives on Biomarker and Surrogate Endpoint Evaluation: Discussion Forum Summary Acronyms ACCORD Action to Control Cardiovascular Risk in Diabetes ACE inhibitor angiotensin-converting enzyme inhibitor ADA American Dietetic Association APOE apolipoprotein E CAST Cardiac Arrhythmia Suppression Trial CBER Center for Biologics Evaluation and Research CD4 cells CD4+ T-lymphocytes CDC Centers for Disease Control and Prevention CDER Center for Drug Evaluation and Research CDRH Center for Devices and Radiological Health CEA carcinoembryonic antigen CFSAN Center for Food Safety and Applied Nutrition CHD coronary heart disease CLIA Clinical Laboratory Improvement Amendments CMS Centers for Medicare & Medicaid Services COAG Clarification of Optimal Coagulation through Genetics COPD chronic obstructive pulmonary disease CRN Council for Responsible Nutrition CRP C-reactive protein CSPI Center for Science in the Public Interest CVD cardiovascular disease
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Perspectives on Biomarker and Surrogate Endpoint Evaluation: Discussion Forum Summary DDT drug development tools DHA docosahexaenoic acid EMEA European Medicines Agency ESA erythropoiesis-stimulating agent FAA Federal Aviation Administration FDA Food and Drug Administration FDAAA Food and Drug Administration Amendments Act GAO Government Accountability Office GI gastrointestinal GMA Grocery Manufacturers Association HDL high-density lipoprotein HDL-C high-density lipoprotein cholesterol HER2 human epidermal growth factor receptor 2 HHS Department of Health and Human Services HIV human immunodeficiency virus HRT hormone replacement therapy IOM Institute of Medicine IVD in vitro diagnostic LDL low-density lipoprotein LDL-C low-density lipoprotein cholesterol MI myocardial infarction MRI magnetic resonance imaging NCI National Cancer Institute NHANES National Health and Nutrition Examination Survey NHLBI National Heart, Lung, and Blood Institute NIH National Institutes of Health NLEA Nutrition, Labeling, and Education Act ODS Office of Dietary Supplements PCI percutaneous coronary intervention PET positron emission tomography PML progressive multifocal leukoencephalopathy PRO patient-reported outcomes PSA prostate-specific antigen
OCR for page 105
Perspectives on Biomarker and Surrogate Endpoint Evaluation: Discussion Forum Summary PSTC Predictive Safety Testing Consortium RT-PCR reverse-transcriptase polymerase chain reaction SABRe Systems Approach to Biomarker Research in Cardiovascular Disease SPECT single photon emission computed tomography TLR target lesion revascularization TSH thyroid-stimulating hormone USDA United States Department of Agriculture VRE vancomycin-resistant enterococci
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