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100   $a20120517d2012      uy         0
101 0 $aeng
135   $aur|n|---|||||
181   $ctxt
182   $cc
183   $acr
200 10$aScientific standards for studies on modified risk tobacco products /$fInstitute of Medicine of the National Academies
205   $a1st ed.
210   $aWashington, D.C. $cNational Academies Press$d2012
215   $a1 online resource (370 p.)
300   $a"Committee on Scientific Standards for Studies on Modified Risk Tobacco Products, Board on Population Health and Public Health Practice."
311   $a0-309-22398-9 
320   $aIncludes bibliographical references.
327   $a""Front Matter""; ""Reviewers""; ""Preface""; ""Contents""; ""Acronyms and Abbreviations""; ""Summary""; ""1 Introduction""; ""2 Governance and Conduct of Studies""; ""3 Evidence Base and Methods for Studying Health Effects""; ""4 Methods for Investigating Addictive Potential""; ""5 Methods for Studying Risk Perception and Risk Communication""; ""6 Decision Making and Oversight of MRTP Studies: Findings and Recommendations""; ""Appendix A: Section 911 of the Family Smoking Prevention and Tobacco Control Act of 2009""
327   $a""Appendix B: Chapters 1 and 2 from *Evaluation of Biomarkers andSurrogate Endpoints in Chronic Disease*""""[Appendix B] 1 Introduction""; ""[Appendix B] 2 Review: Evaluating and Regulating Biomarker Use""; ""Appendix C: Committee Biographies""; ""Appendix D: Meeting Agendas""
330   $a"Smoking-related diseases kill more Americans than alcohol, illegal drugs, murder and suicide combined. The passage of the Family Smoking Prevention and Tobacco Control Act of 2009 gave the FDA authority to regulate "modified risk tobacco products" (MRTPs), tobacco products that are either designed or advertised to reduce harm or the risk of tobacco-related disease. MRTPs must submit to the FDA scientific evidence to demonstrate the product has the potential to reduce tobacco related harms as compared to conventional tobacco products. The IOM identifies minimum standards for scientific studies that an applicant would need to complete to obtain an order to market the product from the FDA."--Publisher's description.
606   $aTobacco$xRisk assessment$xResearch$zUnited States
606   $aTobacco use$xHealth aspects$xResearch$zUnited States
606   $aProducts liability$xTobacco$zUnited States
606   $aNicotine addiction$xResearch$zUnited States
615  0$aTobacco$xRisk assessment$xResearch
615  0$aTobacco use$xHealth aspects$xResearch
615  0$aProducts liability$xTobacco
615  0$aNicotine addiction$xResearch
676   $a616.86506
712 02$aInstitute of Medicine (U.S.).$bCommittee on Scientific Standards for Studies on Modified Risk Tobacco Products.
712 02$aInstitute of Medicine (U.S.).$bBoard on Population Health and Public Health Practice.
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801  1$bMiAaPQ
801  2$bMiAaPQ
906   $aBOOK
912   $a9910822830003321
996   $aScientific standards for studies on modified risk tobacco products$94127934
997   $aUNINA