LEADER 05801nam 2200913 450 001 9910828190403321 005 20231206210616.0 010 $a1-281-99633-5 010 $a9786611996338 010 $a1-4426-7659-0 024 7 $a10.3138/9781442676596 035 $a(CKB)2430000000001828 035 $a(EBL)3255184 035 $a(OCoLC)923070874 035 $a(SSID)ssj0000301378 035 $a(PQKBManifestationID)11217749 035 $a(PQKBTitleCode)TC0000301378 035 $a(PQKBWorkID)10260728 035 $a(PQKB)10542111 035 $a(CaBNvSL)thg00600909 035 $a(DE-B1597)479198 035 $a(OCoLC)987921952 035 $a(DE-B1597)9781442676596 035 $a(Au-PeEL)EBL4671665 035 $a(CaPaEBR)ebr11257369 035 $a(CaONFJC)MIL199633 035 $a(OCoLC)958579381 035 $a(OCoLC)1298518812 035 $a(MdBmJHUP)musev2_104918 035 $a(VaAlCD)20.500.12592/b94pgj 035 $a(schport)gibson_crkn/2009-12-01/6/418808 035 $a(MiAaPQ)EBC4671665 035 $a(MiAaPQ)EBC3255184 035 $a(EXLCZ)992430000000001828 100 $a20160913h20062006 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 00$aLaw and ethics in biomedical research $eregulation, conflict of interest, and liability /$fedited by Trudo Lemmens and Duff R. Waring 210 1$aToronto, [Ontario] ;$aBuffalo, [New York] ;$aLondon, [England] :$cUniversity of Toronto Press,$d2006. 210 4$d©2006 215 $a1 online resource (278 p.) 300 $aIncludes index. 311 $a0-8020-8643-8 320 $aIncludes bibliographical references and index. 327 $g1.$tUninformed consent : the case of Jesse Gelsinger /$rPaul L. Gelsinger --$g2.$tQuestions and challenges in the governance of research involving humans : a Canadian perspective /$rKathleen Cranley Glass --$g3.$tSwinging on the pendulum : shifting views of justice in human subjects research /$rAnna Mastroianni and Jeffrey Kahn --$g4.$tThe ethical and legal foundations of scientific 'conflict of interest' /$rSheldon Krimsky --$g5.$tSelf-censorship /$rJames Robert Brown --$g6.$tPromoting integrity in industry-sponsored clinical drug trials : conflict of interest for Canadian academic health sciences centres /$rLorraine E. Ferris and C. David Naylor --$g7.$tThe human subjects trade : ethical, legal, and regulatory remedies to deal with recruitment incentives and to protect scientific integrity /$rTrudo Lemmens and Paul B. Miller --$g8.$tBringing research into therapy : liability anyone? /$rMary M. Thomson --$g9.$tLegal liability for harm to research participants : the case of placebo-controlled trials /$rDuff R. Waring and Kathleen Cranley Glass --$g10.$tHer majesty's research subjects : liability of the crown in research involving humans /$rSana Halwani. 330 $aWhen a young man named Jesse Gelsinger died in 1999 as a result of his participation in a gene transfer research study, regulatory agencies in the United States began to take a closer look at what was happening in medical research. The resulting temporary shutdown of some of the most prestigious academic research centres confirmed what various recent reports in the United States as well as Canada had claimed; that the current system of regulatory oversight was in need of improvement. Law and Ethics in Biomedical Research uses the Gelinger case as a touchstone, illustrating how three major aspects of that case - the flaws in the regulatory system, conflicts of interest, and legal liability - embody the major challenges in the current medical research environment. Editors Trudo Lemmens and Duff R. Waring, along with a host of top scholars in the field, demonstrate why existing models of research review and human subject protection are in need of improvement, and how more stringent regulatory and legal means can be used to strengthen the protection of research subjects and the integrity of research. The contributors also address conflicts of interest, paying particular attention to the growing commercialization of medical research, as well as the legal liability of scientific investigators, research institutions, and governmental agencies. Legal liability is a growing concern in medical research and this fascinating study is, in the international context, one of the first to explore the liability of various parties involved in the research enterprise. 606 $aHuman experimentation in medicine$zCanada 606 $aMedicine$xResearch$xLaw and legislation$zCanada 606 $aMedicine$xResearch$xMoral and ethical aspects$zCanada 606 $aMedicine$xResearch$xLaw and legislation$zUnited States 606 $aMedicine$xResearch$xMoral and ethical aspects$zUnited States 606 $aHuman experimentation in medicine$zUnited States 607 $aUnited States$2fast 607 $aCanada$2fast 607 $aCanada 607 $aUnited States 608 $aTheses et ecrits academiques. 608 $aAcademic theses. 608 $aAcademic theses. 608 $aElectronic books. 615 0$aHuman experimentation in medicine 615 0$aMedicine$xResearch$xLaw and legislation 615 0$aMedicine$xResearch$xMoral and ethical aspects 615 0$aMedicine$xResearch$xLaw and legislation 615 0$aMedicine$xResearch$xMoral and ethical aspects 615 0$aHuman experimentation in medicine 676 $a344.7104196 702 $aLemmens$b Trudo 702 $aWaring$b Duff William Ramus$f1955- 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910828190403321 996 $aLaw and ethics in biomedical research$94078179 997 $aUNINA LEADER 05155nam 22005894a 450 001 9910143567103321 005 20200520144314.0 010 $a1-280-72143-X 010 $a9786610721436 010 $a0-470-05552-9 010 $a0-470-05551-0 035 $a(CKB)1000000000355280 035 $a(EBL)281827 035 $a(OCoLC)476027084 035 $a(SSID)ssj0000171061 035 $a(PQKBManifestationID)11153986 035 $a(PQKBTitleCode)TC0000171061 035 $a(PQKBWorkID)10237350 035 $a(PQKB)10207036 035 $a(MiAaPQ)EBC281827 035 $a(EXLCZ)991000000000355280 100 $a20060324d2007 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 10$aHigh-performance gradient elution $ethe practical application of the linear-solvent-strength model /$fLloyd R. Snyder, John W. Dolan 210 $aHoboken, NJ $cJohn Wiley$dc2007 215 $a1 online resource (491 p.) 300 $aDescription based upon print version of record. 311 $a0-471-70646-9 320 $aIncludes bibliographical references and index. 327 $aHIGH-PERFORMANCE GRADIENT ELUTION; CONTENTS; PREFACE; GLOSSARY OF SYMBOLS AND TERMS; 1 INTRODUCTION; 1.1 The "General Elution Problem" and the Need for Gradient Elution; 1.2 Other Reasons for the Use of Gradient Elution; 1.3 Gradient Shape; 1.4 Similarity of Isocratic and Gradient Elution; 1.4.1 Gradient and Isocratic Elution Compared; 1.4.2 The Linear-Solvent-Strength Model; 1.5 Computer Simulation; 1.6 Sample Classification; 1.6.1 Sample Compounds of Related Structure ("Regular Samples"); 1.6.2 Sample Compounds of Unrelated Structure ("Irregular" Samples); 2 GRADIENT ELUTION FUNDAMENTALS 327 $a2.1 Isocratic Separation2.1.1 Retention; 2.1.2 Peak Width and Plate Number; 2.1.3 Resolution; 2.1.4 Role of Separation Conditions; 2.1.4.1 Optimizing Retention [Term a of Equation (2.7)]; 2.1.4.2 Optimizing Selectivity ? [Term b of Equation (2.7)]; 2.1.4.3 Optimizing the Column Plate Number N [Term c of Equation (2.7)]; 2.2 Gradient Separation; 2.2.1 Retention; 2.2.1.1 Gradient and Isocratic Separation Compared for "Corresponding" Conditions; 2.2.2 Peak Width; 2.2.3 Resolution; 2.2.3.1 Resolution as a Function of Values of S for Two Adjacent Peaks ("Irregular" Samples) 327 $a2.2.3.2 Using Gradient Elution to Predict Isocratic Separation2.2.4 Sample Complexity and Peak Capacity; 2.3 Effect of Gradient Conditions on Separation; 2.3.1 Gradient Steepness b: Change in Gradient Time; 2.3.2 Gradient Steepness b: Change in Column Length or Diameter; 2.3.3 Gradient Steepness b: Change in Flow Rate; 2.3.4 Gradient Range ?ø: Change in Initial Percentage B (ø(0)); 2.3.5 Gradient Range ?ø: Change in Final %B (ø(f)); 2.3.6 Effect of a Gradient Delay; 2.3.6.1 Equipment Dwell Volume; 2.3.7 Effect of Gradient Shape (Nonlinear Gradients) 327 $a2.3.8 Overview of the Effect of Gradient Conditions on the Chromatogram2.4 Related Topics; 2.4.1 Nonideal Retention in Gradient Elution; 2.4.2 Gradient Elution Misconceptions; 3 METHOD DEVELOPMENT; 3.1 A Systematic Approach to Method Development; 3.1.1 Separation Goals (Step 1 of Fig. 3.1); 3.1.2 Nature of the Sample (Step 2 of Fig. 3.1); 3.1.3 Initial Experimental Conditions; 3.1.4 Repeatable Results; 3.1.5 Computer Simulation: Yes or No?; 3.1.6 Sample Preparation (Pretreatment); 3.2 Initial Experiments; 3.2.1 Interpreting the Initial Chromatogram (Step 3 of Fig. 3.1) 327 $a3.2.1.1 "Trimming" a Gradient Chromatogram3.2.1.2 Possible Problems; 3.3 Developing a Gradient Separation: Resolution versus Conditions; 3.3.1 Optimizing Gradient Retention k* (Step 4 of Fig. 3.1); 3.3.2 Optimizing Gradient Selectivity ?* (Step 5 of Fig. 3.1); 3.3.3 Optimizing the Gradient Range (Step 6 of Fig. 3.1); 3.3.3.1 Changes in Selectivity as a Result of Change in k*; 3.3.4 Segmented (Nonlinear) Gradients (Step 6 of Fig. 3.1 Continued); 3.3.5 Optimizing the Column Plate Number N* (Step 7 of Fig. 3.1); 3.3.6 Column Equilibration Between Successive Sample Injections 327 $a3.3.7 Fast Separations 330 $aGradient elution demystifiedOf the various ways in which chromatography is applied today, few have been as misunderstood as the technique of gradient elution, which presents many challenges compared to isocratic separation. When properly explained, however, gradient elution can be less difficult to understand and much easier to use than often assumed.Written by two well-known authorities in liquid chromatography, High-Performance Gradient Elution: The Practical Application of the Linear-Solvent-Strength Model takes the mystery out of the practice of gradient elution and helps r 606 $aHigh performance liquid chromatography 615 0$aHigh performance liquid chromatography. 676 $a543/.84 700 $aSnyder$b Lloyd R$075155 701 $aDolan$b John W$0278317 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910143567103321 996 $aHigh-performance gradient elution$9759045 997 $aUNINA