LEADER 03141nam 2200613Ia 450 001 9910791477303321 005 20230725015616.0 010 $a0-309-15727-7 010 $a1-282-78742-X 010 $a9786612787423 010 $a0-309-15130-9 035 $a(CKB)2560000000015980 035 $a(EBL)3378636 035 $a(SSID)ssj0000417279 035 $a(PQKBManifestationID)11267613 035 $a(PQKBTitleCode)TC0000417279 035 $a(PQKBWorkID)10361258 035 $a(PQKB)10448333 035 $a(MiAaPQ)EBC3378636 035 $a(Au-PeEL)EBL3378636 035 $a(CaPaEBR)ebr10405099 035 $a(CaONFJC)MIL278742 035 $a(OCoLC)923281847 035 $a(EXLCZ)992560000000015980 100 $a20100511d2010 uy 0 101 0 $aeng 135 $aurcn||||||||| 181 $ctxt 182 $cc 183 $acr 200 00$aEvaluation of biomarkers and surrogate endpoints in chronic disease$b[electronic resource] /$fCommittee on Qualification of Biomarkers and Surrogate Endpoints in Chronic Disease, Board on Health Care Services, Board on Health Sciences Policy, Food and Nutrition Board, Institute of Medicine ; Christine M. Micheel and John R. Ball, editors 210 $aWashington, DC $cNational Academies Press$dc2010 215 $a1 online resource (335 p.) 300 $aDescription based upon print version of record. 311 $a0-309-15129-5 320 $aIncludes bibliographical references. 327 $a""Front Matter""; ""Reviewers""; ""Preface""; ""Acknowledgments""; ""Contents""; ""Boxes, Figures, and Tables""; ""Summary""; ""1 Introduction""; ""2 Review: Evaluating and Regulating Biomarker Use""; ""3 The Biomarker Evaluation Process""; ""4 Case Studies""; ""5 Strengthening Evidence-Based Regulation""; ""Acronyms""; ""Glossary""; ""Appendix A: Table of Papers About Biomarker Qualification""; ""Appendix B: Recommendations from Related IOM Reports""; ""Appendix C: Committee Member and Consultant Biographies""; ""Appendix D: Staff Biographies""; ""Appendix E: Workshop Agenda"" 327 $a""Appendix F: Speaker Biographies"" 330 $a"Many people naturally assume that the claims made for foods and nutritional supplements have the same degree of scientific grounding as those for medication, but that is not always the case. The IOM recommends that the FDA adopt a consistent scientific framework for biomarker evaluation in order to achieve a rigorous and transparent process."--Publisher's description. 606 $aBiochemical markers$xEvaluation 606 $aChronic diseases 615 0$aBiochemical markers$xEvaluation. 615 0$aChronic diseases. 676 $a610.28 701 $aMicheel$b Christine$01484237 701 $aBall$b John$f1944-$01493792 712 02$aInstitute of Medicine (U.S.).$bCommittee on Qualification of Biomarkers and Surrogate Endpoints in Chronic Disease. 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910791477303321 996 $aEvaluation of biomarkers and surrogate endpoints in chronic disease$93719241 997 $aUNINA