Targeted biomarker quantitation by LC-MS / edited by Dr. Naidong Weng and Dr. Wenying Jian, Janssen Research & Development, LLC.

Includes bibliographical references and index.

Print version record and CIP data provided by publisher.

Title Page ; Copyright Page; Contents; List of Contributors; Preface; Abbreviations; Part 1 Overview; Chapter 1 Overview of Targeted Quantitation of Biomarkers and Its Applications; 1.1 Introduction; 1.2 Biomarker Definition; 1.3 Current Challenges of a Biomarker; 1.4 Biomarker Validation Process; 1.5 Current Regulatory Requirement for Target Biomarker Quantitation; 1.6 Challenges of Biomarker Quantitation; 1.7 Current Technologies for Biomarker Quantitation; 1.7.1 LC-MS; 1.7.2 GC-MS; 1.7.3 Ligand-Binding Assay ; 1.7.4 Flow Cytometry; 1.7.5 Quantitative PCR (qPCR).

1.8 Current Biomarker Quantitation Applications1.8.1 Protein Biomarkers; 1.8.2 Peptide Biomarkers; 1.8.3 RNA Biomarkers; 1.8.4 Nucleotide Biomarkers; 1.8.5 Small Molecule Biomarkers; 1.9 Conclusion and Future Perspective; References; Chapter 2 Translational Application of Biomarkers; 2.1 Introduction; 2.2 Translational Medicine; 2.3 Biomarkers; 2.4 Biomarker Categories; 2.5 Neurobiological Disorders; 2.6 Cardiovascular Disorders; 2.7 Chronic Obstructive Pulmonary Disease; 2.8 Oncology; 2.9 Biomarker Measurements and Regulatory Considerations; 2.10 Conclusions; Acknowledgment; References.

Chapter 3 Current Regulatory Guidance Pertaining Biomarker Assay Establishment and Industrial Practice of Fit-for-Purpose and Tiered Approach 3.1 Introduction; 3.2 Current Regulatory Guidance and Interpretation; 3.3 Current Industrial Discussion and Recommendations; 3.4 Considerations for Assay Validation and Sample Analysis; 3.4.1 Sensitivity; 3.4.2 Specificity and Selectivity; 3.4.3 Matrix Effects and Sample Variables; 3.4.3.1 Authentic Analyte/Authentic Matrix Approach; 3.4.3.2 Surrogate Analyte/Authentic Matrix Approach; 3.4.3.3 Authentic Analyte/Surrogate Matrix Approach.

4.2.1 Importance of Separation4.2.2 Basic Principle of LC; 4.2.3 Major Modes of LC Used for Targeted Biomarker Quantitation; 4.2.4 Modern LC Technologies; 4.2.4.1 HPLC and UHPLC; 4.2.4.2 Miniaturized Column LC; 4.2.4.3 2D-LC ; 4.3 Mass Spectrometry; 4.3.1 Major Types of MS Used for Targeted Biomarker Quantitation; 4.3.2 Ionization Techniques; 4.3.3 Ion Mobility; 4.3.4 Fragmentation Mode; 4.3.5 Emerging MS Techniques; 4.3.5.1 MS Imaging; 4.3.5.2 Other Surface Analysis MS Techniques; 4.4 Summary and Future Perspectives; References.