• Front Matter R1-R20

• Summary 1-16

• 1 Introduction 17-32

• 2 Review: Evaluating and Regulating Biomarker Use 33-96

• 3 The Biomarker Evaluation Process 97-130

• 4 Case Studies 131-196

• 5 Strengthening Evidence-Based Regulation 197-234

• Acronyms 235-238

• Glossary 239-252

• Appendix A: Table of Papers About Biomarker Qualification 253-278

• Appendix B: Recommendations from Related IOM Reports 279-286

• Appendix C: Committee Member and Consultant Biographies 287-298

• Appendix D: Staff Biographies 299-304

• Appendix E: Workshop Agenda 305-306

• Appendix F: Speaker Biographies 307-314

" 2 Review: Evaluating and Regulating Biomarker Use ." Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease . Washington, DC: The National Academies Press, 2010 .

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