Targeted Biomarker Quantitation by LC-MS -

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Résumé :

List of Contributors xv

Preface xix

Abbreviations xxiii

Part I Overview 1

1 Overview of Targeted Quantitation of Biomarkers and Its Applications 3
Naidong Weng

1.1 Introduction 3

1.2 Biomarker Definition 4

1.3 Current Challenges of a Biomarker 5

1.4 Biomarker Validation Process 6

1.5 Current Regulatory Requirement for Target Biomarker Quantitation 6

1.6 Challenges of Biomarker Quantitation 7

1.7 Current Technologies for Biomarker Quantitation 8

1.8 Current Biomarker Quantitation Applications 9

1.9 Conclusion and Future Perspective 12

References 13

2 Translational Application of Biomarkers 17
Ray Bakhtiar

2.1 Introduction 17

2.2 Translational Medicine 17

2.3 Biomarkers 18

2.4 Biomarker Categories 18

2.5 Neurobiological Disorders 21

2.6 Cardiovascular Disorders 22

2.7 Chronic Obstructive Pulmonary Disease 23

2.8 Oncology 24

2.9 Biomarker Measurements and Regulatory Considerations 26

2.10 Conclusions 27

References 29

3 Current Regulatory Guidance Pertaining Biomarker Assay Establishment and Industrial Practice of Fit?for?Purpose and Tiered Approach 35
Naidong Weng

3.1 Introduction 35

3.2 Current Regulatory Guidance and Interpretation 36

3.3 Current Industrial Discussion and Recommendations 37

3.4 Considerations for Assay Validation and Sample Analysis 39

3.5 Examples of Fit?for?Purpose and Tiered Approach 41

3.6 Conclusion 42

References 42

4 Modern Liquid Chromatography and Mass Spectrometry for Targeted Biomarker Quantitation 45
Wenying Jian

4.1 Introduction 45

4.2 Liquid Chromatography 45

4.3 Mass Spectrometry 51

4.4 Summary and Future Perspectives 58

References 59

5 Comparison Between LC-MS and Ligand?Binding Assay Approaches for Biomarker Quantification 65
QingQing Wang, Lili Guo, and Ian A. Blair

5.1 General Considerations: LBAs or LC-MS Assays 65

5.2 General Quantification Approaches 66

5.3 Analytical Issues Specifically Related to LBAs 67

5.4 Analytical Features Specifically Related to LC-MS Methods 68

5.5 Case Studies: Comparison Between ELISA and LC-MS 72

5.6 Summary and Future Perspective 74

References 74

6 Sample Preparation Methods for Targeted Biomarker Quantification by LC?MS 79
Shichen Shen, Bo An, and Jun Qu

6.1 Introduction 79

6.2 Sample Preparation Strategies for Small Molecule Biomarkers 79

6.3 Sample Preparation Strategies for Macromolecule Biomarkers 86

6.4 Conclusive Remarks 94

References 95

7 Overcome the Endogenous Levels in Biomarker Quantitation Using LC-MS 107
Guowen Liu

7.1 Introduction 107

7.2 How Does Matrix Effect Affect Quantitation? 108

7.3 Commonly Used Strategies 109

7.4 Discussions and Future Perspectives 114

References 115

Part II Challenges and Approaches 119

8 Sample Collection for Targeted Biomarker Quantitation by LC-MS 121
Yuzhong Deng and Xiaorong Liang

8.1 Introduction 121

8.2 Timing of Biomarker Sample Collection 121

8.3 Matrix Type 122

8.4 Collection Methods 124

8.5 Sample Storage Stability 128

8.6 Summary 129

References 130

9 Nonspecific Binding in LC-MS Bioanalysis 137
Aimin Tan and John C. Fanaras

9.1 Introduction 137

9.2 Identification and Evaluation of NSB 137

9.3 Causes for NSB 140

9.4 Over...

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