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PAPERBACK price:$33.75 add to cart Rights & Permissions Free PDF Access Sign in to download PDF book and chapters Free Resources Display this book on your site! Related Titles Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease Cancer Biomarkers: The Promises and Challenges of Improving Detection and Treatment Other Related Titles Perspectives on Biomarker and Surrogate Endpoint Evaluation: Discussion Forum Summary (2011) Board on Health Care Services (HCS) Board on Health Sciences Policy (HSP) Food and Nutrition Board (FNB) Citation Manager Export the bibliographic data for this book in your chosen format Web Search Builder Use this book's key terms to search within this book, across our collection, or across the Web. Skim This Chapter Skim this chapter and use this chapter's key terms to search within this book. Reference Finder Paste in your own text to find books that relate to your topic. Citation Manager . "Acronyms." Perspectives on Biomarker and Surrogate Endpoint Evaluation: Discussion Forum Summary. Washington, DC: The National Academies Press, 2011. Please select a format: Page 103   E-mail Share on facebook Facebook Share on delicious Delicious Share on stumbleupon Stumble Share on twitter Twitter More Sharing ServicesMore The following HTML text is provided to enhance online readability. Many aspects of typography translate only awkwardly to HTML. Please use the page image as the authoritative form to ensure accuracy. 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 Page 103 Front Matter (R1-R10) 1 Introduction (1-2) 2 Committee Findings and Recommendations (3-28) 3 FDA Perspectives (29-42) 4 National Institutes of Health Perspectives (43-50) 5 Industry Perspectives (51-68) 6 Public Health, Consumer, and Consulting Organization Perspectives (69-74) 7 Presentation by Thomas Fleming: Biomarkers and Surrogate Endpoints in Chronic Disease (75-86) 8 Key Themes, Challenges, and Opportunities (87-96) 9 Importance of the Biomarker Discussion Forum (97-98) References (99-102) Acronyms (103-106) Glossary (107-112) Appendix A: Discussion Forum Agenda (113-114) Appendix B: Summary from the Committee's Report *Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease* (115-130)

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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

OCR for page 104
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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Perspectives on Biomarker and Surrogate Endpoint Evaluation: Discussion Forum Summary This page intentionally left blank.