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OCR for page 235
Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease Acronyms AAPS American Association of Pharmaceutical Scientists ACC American College of Cardiology ACE inhibitor angiotensin-converting enzyme inhibitor ACR American College of Radiology ACS acute coronary syndrome ACT-UP AIDS Coalition to Unleash Power AERS Adverse Event Reporting System AHA American Heart Association AIDS acquired immune deficiency syndrome BQRT biomarker qualification review team C-Path Critical Path Institute CAD coronary artery disease 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 CETP cholesteryl ester transfer protein C.F.R. Code of Federal Regulations CFSAN Center for Food Safety and Applied Nutrition CHD coronary heart disease
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Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease CHF congestive heart failure CIN cervical intraepithelial neoplasia CLIA Clinical Laboratory Improvement Amendments CMOD International Partnership for Critical Markers of Disease CMS Centers for Medicare & Medicaid Services CPI Critical Path Initiative CRP C-reactive protein CRT cardiac resynchronization therapy CSCR Cardiac Safety Research Consortium CSPI Center for Science in the Public Interest CT computed tomography cTn cardiac troponin CVD cardiovascular disease DHA docosahexaenoic acid DIA Drug Information Association DRV daily recommended value DSHEA Dietary Supplement Health and Education Act DTC direct-to-consumer EMEA European Medicines Agency EPA eicosapentaenoic acid FAERS FDA Adverse Event Reporting System FDA Food and Drug Administration FDAAA Food and Drug Administration Amendments Act FDAMA FDA Modernization Act FDCA Food, Drug, and Cosmetic Act FDG-PET [18F]-2-fluoro-2-deoxy-D-glucose positron emission tomography FNIH Foundation for the National Institutes of Health FOP front of packaging FR Federal Register FY fiscal year GAO Government Accountability Office GIST gastrointestinal stromal tumor GTV gross tumor volume HDL high-density lipoprotein HDL-C high-density lipoprotein cholesterol HHS Department of Health and Human Services
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Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease HIV human immunodeficiency virus HIV-1 RNA HIV-1 (strain of HIV) ribonucleic acid HMG CoA 3-hydroxy-3-methylglutaryl-coenzyme A HPV human papillomavirus HRT hormone replacement therapy Hs-CRP high-sensitivity C-reactive protein ICH International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use IFICF International Food Information Council Foundation IFT Institute of Food Technologists IOM Institute of Medicine IPRG Interdisciplinary Pharmacogenomics Review Group iSAEC International Serious Adverse Events Consortium ISPY-2 Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging and Molecular Analysis IT infomation technology LDL low-density lipoprotein LDL-C low-density lipoprotein cholesterol LDL-P low-density lipoprotein particle number LPS lipopolysaccharide LVH left ventricular hypertrophy MI myocardial infarction MRI magnetic resonance imaging MTHFR 5,10 methylenetetrahydrofolate reductase NACB National Academy of Clinical Biochemistry NCCTG North Central Cancer Treatment Group NCEP National Cholesterol Education Program NCFST National Center for Food Science and Technology NCI National Cancer Institute NDA New Drug Application NHLBI National Heart, Lung, and Blood Institute NIH National Institutes of Health NLEA Nutrition, Labeling, and Education Act NLM National Library of Medicine NSABP National Surgical Adjuvant Breast and Bowel Project NSCLC non-small-cell lung cancer
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Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease OBQI Oncology Biomarker Quality Iniative OMOP Observational Medical Outcomes Partnership OSE Office of Surveillance and Epidemiology (FDA) PDUFA Prescription Drug User Fee Act PET positron emission tomography PhRMA Pharmaceutical Research and Manufacturers of America PPAR peroxisome proliferator–activated receptor PSA prostate-specific antigen PSTC Predictive Safety Testing Consortium RACC reference amount customarily consumed RCT randomized controlled trial or reverse cholesterol transport RDI Reference Daily Intake REMS risk evaluation and mitigation strategies RiskMAPS risk minimization action plans RNA ribonucleic acid SSA significant scientific agreement TMUGS tumor marker utility grading system US ultrasound USDA U.S. Department of Agriculture VLDL very low-density lipoprotein VXDS voluntary exploratory data submission WHO World Health Organization