{"product_id":"targeted-biomarker-quantitation-by-lc-ms-isbn-9781119103066","title":"Targeted Biomarker Quantitation by LC-MS","description":"\u003cp\u003e\u003cb\u003eThe first book to offer a blueprint for overcoming the challenges to successfully quantifying biomarkers in living organisms\u003c\/b\u003e \u003c\/p\u003e \u003cp\u003eThe demand among scientists and clinicians for targeted quantitation experiments has experienced explosive growth in recent years. While there are a few books dedicated to bioanalysis and biomarkers in general, until now there were none devoted exclusively to addressing critical issues surrounding this area of intense research. \u003ci\u003eTarget Biomarker Quantitation by LC-MS\u003c\/i\u003e provides a detailed blueprint for quantifying biomarkers in biological systems. It uses numerous real-world cases to exemplify key concepts, all of which were carefully selected and presented so as to allow the concepts they embody to be easily expanded to future applications, including new biomarker development. \u003c\/p\u003e \u003cp\u003e\u003ci\u003eTarget Biomarker Quantitation by LC-MS\u003c\/i\u003e primarily focuses on the assay establishment for biomarker quantitation—a critical issue rarely treated in depth. It offers comprehensive coverage of three core areas of biomarker assay establishment: the relationship between the measured biomarkers and their intended usage; contemporary regulatory requirements for biomarker assays (a thorough understanding of which is essential to producing a successful and defendable submission); and the technical challenges of analyzing biomarkers produced inside a living organism or cell.\u003c\/p\u003e \u003cul\u003e \u003cli\u003eCovers the theory of and applications for state-of-the-art mass spectrometry and chromatography and their applications in biomarker analysis\u003c\/li\u003e \u003cli\u003eFeatures real-life examples illustrating the challenges involved in target biomarker quantitation and the innovative approaches which have been used to overcome those challenges\u003c\/li\u003e \u003cli\u003eAddresses potential obstacles to obtain effective biomarker level and data interpretation, such as specificity establishment and sample collection\u003c\/li\u003e \u003cli\u003eOutlines a tiered approach and fit-for-purpose assay protocol for target biomarker quantitation\u003c\/li\u003e \u003cli\u003eHighlights the current state of the biomarker regulatory environment and protocol standards\u003c\/li\u003e \u003c\/ul\u003e \u003cp\u003e\u003ci\u003eTarget Biomarker Quantitation by LC-MS\u003c\/i\u003e is a valuable resource for bioanalytical scientists, drug metabolism and pharmacokinetics scientists, clinical scientists, analytical chemists, and others for whom biomarker quantitation is an important tool of the trade. It also functions as an excellent text for graduate courses in pharmaceutical, biochemistry and chemistry.\u003c\/p\u003e \u003cp\u003eList of Contributors xv\u003c\/p\u003e \u003cp\u003ePreface xix\u003c\/p\u003e \u003cp\u003eAbbreviations xxiii\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart I Overview 1\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e1 Overview of Targeted Quantitation of Biomarkers and Its Applications 3\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eNaidong Weng\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e1.1 Introduction 3\u003c\/p\u003e \u003cp\u003e1.2 Biomarker Definition 4\u003c\/p\u003e \u003cp\u003e1.3 Current Challenges of a Biomarker 5\u003c\/p\u003e \u003cp\u003e1.4 Biomarker Validation Process 6\u003c\/p\u003e \u003cp\u003e1.5 Current Regulatory Requirement for Target Biomarker Quantitation 6\u003c\/p\u003e \u003cp\u003e1.6 Challenges of Biomarker Quantitation 7\u003c\/p\u003e \u003cp\u003e1.7 Current Technologies for Biomarker Quantitation 8\u003c\/p\u003e \u003cp\u003e1.8 Current Biomarker Quantitation Applications 9\u003c\/p\u003e \u003cp\u003e1.9 Conclusion and Future Perspective 12\u003c\/p\u003e \u003cp\u003eReferences 13\u003c\/p\u003e \u003cp\u003e\u003cb\u003e2 Translational Application of Biomarkers 17\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eRay Bakhtiar\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e2.1 Introduction 17\u003c\/p\u003e \u003cp\u003e2.2 Translational Medicine 17\u003c\/p\u003e \u003cp\u003e2.3 Biomarkers 18\u003c\/p\u003e \u003cp\u003e2.4 Biomarker Categories 18\u003c\/p\u003e \u003cp\u003e2.5 Neurobiological Disorders 21\u003c\/p\u003e \u003cp\u003e2.6 Cardiovascular Disorders 22\u003c\/p\u003e \u003cp\u003e2.7 Chronic Obstructive Pulmonary Disease 23\u003c\/p\u003e \u003cp\u003e2.8 Oncology 24\u003c\/p\u003e \u003cp\u003e2.9 Biomarker Measurements and Regulatory Considerations 26\u003c\/p\u003e \u003cp\u003e2.10 Conclusions 27\u003c\/p\u003e \u003cp\u003eReferences 29\u003c\/p\u003e \u003cp\u003e\u003cb\u003e3 Current Regulatory Guidance Pertaining Biomarker Assay Establishment and Industrial Practice of Fit‐for‐Purpose and Tiered Approach 35\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eNaidong Weng\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e3.1 Introduction 35\u003c\/p\u003e \u003cp\u003e3.2 Current Regulatory Guidance and Interpretation 36\u003c\/p\u003e \u003cp\u003e3.3 Current Industrial Discussion and Recommendations 37\u003c\/p\u003e \u003cp\u003e3.4 Considerations for Assay Validation and Sample Analysis 39\u003c\/p\u003e \u003cp\u003e3.5 Examples of Fit‐for‐Purpose and Tiered Approach 41\u003c\/p\u003e \u003cp\u003e3.6 Conclusion 42\u003c\/p\u003e \u003cp\u003eReferences 42\u003c\/p\u003e \u003cp\u003e\u003cb\u003e4 Modern Liquid Chromatography and Mass Spectrometry for Targeted Biomarker Quantitation 45\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eWenying Jian\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e4.1 Introduction 45\u003c\/p\u003e \u003cp\u003e4.2 Liquid Chromatography 45\u003c\/p\u003e \u003cp\u003e4.3 Mass Spectrometry 51\u003c\/p\u003e \u003cp\u003e4.4 Summary and Future Perspectives 58\u003c\/p\u003e \u003cp\u003eReferences 59\u003c\/p\u003e \u003cp\u003e\u003cb\u003e5 Comparison Between LC–MS and Ligand‐Binding Assay Approaches for Biomarker Quantification 65\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eQingQing Wang, Lili Guo, and Ian A. Blair\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e5.1 General Considerations: LBAs or LC–MS Assays 65\u003c\/p\u003e \u003cp\u003e5.2 General Quantification Approaches 66\u003c\/p\u003e \u003cp\u003e5.3 Analytical Issues Specifically Related to LBAs 67\u003c\/p\u003e \u003cp\u003e5.4 Analytical Features Specifically Related to LC–MS Methods 68\u003c\/p\u003e \u003cp\u003e5.5 Case Studies: Comparison Between ELISA and LC–MS 72\u003c\/p\u003e \u003cp\u003e5.6 Summary and Future Perspective 74\u003c\/p\u003e \u003cp\u003eReferences 74\u003c\/p\u003e \u003cp\u003e\u003cb\u003e6 Sample Preparation Methods for Targeted Biomarker Quantification by LC‐MS 79\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eShichen Shen, Bo An, and Jun Qu\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e6.1 Introduction 79\u003c\/p\u003e \u003cp\u003e6.2 Sample Preparation Strategies for Small Molecule Biomarkers 79\u003c\/p\u003e \u003cp\u003e6.3 Sample Preparation Strategies for Macromolecule Biomarkers 86\u003c\/p\u003e \u003cp\u003e6.4 Conclusive Remarks 94\u003c\/p\u003e \u003cp\u003eReferences 95\u003c\/p\u003e \u003cp\u003e\u003cb\u003e7 Overcome the Endogenous Levels in Biomarker Quantitation Using LC–MS 107\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eGuowen Liu\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e7.1 Introduction 107\u003c\/p\u003e \u003cp\u003e7.2 How Does Matrix Effect Affect Quantitation? 108\u003c\/p\u003e \u003cp\u003e7.3 Commonly Used Strategies 109\u003c\/p\u003e \u003cp\u003e7.4 Discussions and Future Perspectives 114\u003c\/p\u003e \u003cp\u003eReferences 115\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart II Challenges and Approaches 119\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e8 Sample Collection for Targeted Biomarker Quantitation by LC–MS 121\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eYuzhong Deng and Xiaorong Liang\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e8.1 Introduction 121\u003c\/p\u003e \u003cp\u003e8.2 Timing of Biomarker Sample Collection 121\u003c\/p\u003e \u003cp\u003e8.3 Matrix Type 122\u003c\/p\u003e \u003cp\u003e8.4 Collection Methods 124\u003c\/p\u003e \u003cp\u003e8.5 Sample Storage Stability 128\u003c\/p\u003e \u003cp\u003e8.6 Summary 129\u003c\/p\u003e \u003cp\u003eReferences 130\u003c\/p\u003e \u003cp\u003e\u003cb\u003e9 Nonspecific Binding in LC–MS Bioanalysis 137\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eAimin Tan and John C. Fanaras\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e9.1 Introduction 137\u003c\/p\u003e \u003cp\u003e9.2 Identification and Evaluation of NSB 137\u003c\/p\u003e \u003cp\u003e9.3 Causes for NSB 140\u003c\/p\u003e \u003cp\u003e9.4 Overcoming NSB Challenges 140\u003c\/p\u003e \u003cp\u003e9.5 Conclusion 144\u003c\/p\u003e \u003cp\u003eReferences 146\u003c\/p\u003e \u003cp\u003e\u003cb\u003e10 Strategies for Improving Sensitivity for Targeted Quantitation by LC–MS 149\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eLong Yuan and Qin C. Ji\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e10.1 Introduction 149\u003c\/p\u003e \u003cp\u003e10.2 Sample Preparation Strategies for Improving Sensitivity 150\u003c\/p\u003e \u003cp\u003e10.3 LC Separation Strategies for Improving Sensitivity 156\u003c\/p\u003e \u003cp\u003e10.4 MS Detection Strategies for Improving Sensitivity 160\u003c\/p\u003e \u003cp\u003e10.5 Conclusions 163\u003c\/p\u003e \u003cp\u003eReferences 163\u003c\/p\u003e \u003cp\u003e\u003cb\u003e11 Strategies to Improve Specificity for Targeted Biomarker Quantitation by LC–MS 171\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eYuan‐Qing Xia and Jeffrey D. Miller\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e11.1 Introduction 171\u003c\/p\u003e \u003cp\u003e11.2 Differential Mobility Spectrometry 171\u003c\/p\u003e \u003cp\u003e11.3 High‐Resolution Mass Spectrometry 175\u003c\/p\u003e \u003cp\u003e11.4 Conclusions 180\u003c\/p\u003e \u003cp\u003eReferences 180\u003c\/p\u003e \u003cp\u003e\u003cb\u003e12 Biomarker Quantitation Using Relative Approaches 183\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eShane M. Lamos and Katrina E. Wiesner\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e12.1 Introduction 183\u003c\/p\u003e \u003cp\u003e12.2 Relative Quantitation Isotope Labeling Approaches 183\u003c\/p\u003e \u003cp\u003e12.3 Conclusions 191\u003c\/p\u003e \u003cp\u003eReferences 192\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart III Applications 195\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e13 Targeted Quantification of Amino Acid Biomarkers Using LC‐MS 197\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eBarry R. Jones, Raymond F. Biondolillo, and John E. Buckholz\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e13.1 Introduction 197\u003c\/p\u003e \u003cp\u003e13.2 Amino Acids as Biomarkers 198\u003c\/p\u003e \u003cp\u003e13.3 Methods of Measurement 201\u003c\/p\u003e \u003cp\u003e13.4 Accuracy, Precision, Selectivity, and Stability Considerations 203\u003c\/p\u003e \u003cp\u003e13.5 Assay Design 207\u003c\/p\u003e \u003cp\u003e13.6 Conclusion 207\u003c\/p\u003e \u003cp\u003eReferences 208\u003c\/p\u003e \u003cp\u003e\u003cb\u003e14 Targeted Quantification of Peptide Biomarkers: A Case Study of Amyloid Peptides 211\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eLieve Dillen, Marc De Meulder, and Tom Verhaeghe\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e14.1 Overview 211\u003c\/p\u003e \u003cp\u003e14.2 Challenges and Approaches 212\u003c\/p\u003e \u003cp\u003e14.3 Application to the Quantification of Alzheimer’s Disease Biomarkers 216\u003c\/p\u003e \u003cp\u003e14.4 Conclusion 222\u003c\/p\u003e \u003cp\u003eReferences 222\u003c\/p\u003e \u003cp\u003e\u003cb\u003e15 Targeted Protein Biomarker Quantitation by LC‐MS 227\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eYongle Pang, Chuan Shi, and Wenying Jian\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e15.1 Introduction 227\u003c\/p\u003e \u003cp\u003e15.2 Sample Preparation for Targeted Protein Biomarker Quantitation 231\u003c\/p\u003e \u003cp\u003e15.3 “Bottom‐Up” Approach for Targeted Protein Biomarker Quantitation Using LC‐MS 233\u003c\/p\u003e \u003cp\u003e15.4 “Top Down” Approach for Targeted Protein Biomarker Quantitation Using LC‐MS 235\u003c\/p\u003e \u003cp\u003e15.5 Key Considerations in Targeted Protein Biomarker Quantitation Using LC‐MS 236\u003c\/p\u003e \u003cp\u003e15.6 Summary and Future Perspectives 239\u003c\/p\u003e \u003cp\u003eReferences 240\u003c\/p\u003e \u003cp\u003e\u003cb\u003e16 Glycoprotein Biomarkers 245\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eShuwei Li, Stefani N. Thomas, and Shuang Yang\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e16.1 Introduction 245\u003c\/p\u003e \u003cp\u003e16.2 Technologies for Glycoprotein Analysis 246\u003c\/p\u003e \u003cp\u003e16.3 Glycoprotein Biomarker Quantification Using LC‐MS 255\u003c\/p\u003e \u003cp\u003e16.4 Protein Biomarkers for Clinical Applications 259\u003c\/p\u003e \u003cp\u003e16.5 Summary and Future Direction 264\u003c\/p\u003e \u003cp\u003eReferences 265\u003c\/p\u003e \u003cp\u003e\u003cb\u003e17 Targeted Lipid Biomarker Quantitation Using Liquid Chromatography–Mass Spectrometry (LC–MS) 273\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eAshkan Salamatipour, Ian A. Blair, and Clementina Mesaros\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e17.1 Introduction of Lipids 273\u003c\/p\u003e \u003cp\u003e17.2 LC–MS Analysis of Lipids 276\u003c\/p\u003e \u003cp\u003e17.3 Examples of LC–MS Analysis of Lipids 278\u003c\/p\u003e \u003cp\u003e17.4 Summary and Future Directions 283\u003c\/p\u003e \u003cp\u003eReferences 283\u003c\/p\u003e \u003cp\u003e\u003cb\u003e18 Targeted LC–MS Quantification of Androgens and Estrogens for Biomarker Development 289\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eDaniel Tamae\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e18.1 Introduction 289\u003c\/p\u003e \u003cp\u003e18.2 Current Considerations in Biomarker Validation 292\u003c\/p\u003e \u003cp\u003e18.3 Current Considerations in LC–MS Method Development 293\u003c\/p\u003e \u003cp\u003e18.4 Clinical Application of LC–MS Quantification of Estrogens and Androgens 296\u003c\/p\u003e \u003cp\u003e18.5 Conclusion and Perspective 301\u003c\/p\u003e \u003cp\u003eReferences 301\u003c\/p\u003e \u003cp\u003e\u003cb\u003e19 Steroid Biomarkers 307\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eMike (Qingtao) Huang, Shefali Patel, and Zhongping (John) Lin\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e19.1 Introduction 307\u003c\/p\u003e \u003cp\u003e19.2 Sterols as Endogenous Biomarkers and Their Quantitation 307\u003c\/p\u003e \u003cp\u003e19.3 Cortisol and 6 β‐Hydroxycortisol (6β‐HC) as Biomarkers and Their Quantitation 312\u003c\/p\u003e \u003cp\u003e19.4 Summary 316\u003c\/p\u003e \u003cp\u003eReferences 316\u003c\/p\u003e \u003cp\u003e\u003cb\u003e20 Bile Acids as Biomarkers 321\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eClara John, Philipp Werner, Joerg Heeren, and Markus Fischer\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e20.1 Introduction 321\u003c\/p\u003e \u003cp\u003e20.2 Analytical Platform for Bile Acids 323\u003c\/p\u003e \u003cp\u003e20.3 Summary 327\u003c\/p\u003e \u003cp\u003eReferences 327\u003c\/p\u003e \u003cp\u003e\u003cb\u003e21 Biomarkers for Vitamin Status and Deficiency: LC‐MS Based Approach 331\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eStanley (Weihua) Zhang and Jonathan Crowther\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e21.1 Introduction to Vitamin and Vitamin Deficiency 331\u003c\/p\u003e \u003cp\u003e21.2 Detection of Vitamin D by LC‐MS\/MS and Comparison with Other Methods 332\u003c\/p\u003e \u003cp\u003e21.3 Other Vitamin Biomarkers 338\u003c\/p\u003e \u003cp\u003e21.4 Conclusions and Perspectives 340\u003c\/p\u003e \u003cp\u003eReferences 341\u003c\/p\u003e \u003cp\u003e\u003cb\u003e22 Quantitation of Acyl‐Coenzyme A Thioesters as Metabolic Biomarkers 347\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eNathaniel Snyder\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e22.1 Introduction 347\u003c\/p\u003e \u003cp\u003e22.2 Structure and Function of Acyl‐CoAs 347\u003c\/p\u003e \u003cp\u003e22.3 Detection and Quantitation of Acyl‐CoAs 349\u003c\/p\u003e \u003cp\u003e22.4 Acyl‐CoA Analysis for Current Drug Targets 352\u003c\/p\u003e \u003cp\u003e22.5 Acyl‐CoAs as Biomarkers in Metabolic Disease 352\u003c\/p\u003e \u003cp\u003e22.6 The Involvement of Acyl‐CoAs in Drug Metabolism 353\u003c\/p\u003e \u003cp\u003eReferences 353\u003c\/p\u003e \u003cp\u003e\u003cb\u003e23 Neurotransmitter Biomarkers 357\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eGuodong Zhang\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e23.1 Introduction 357\u003c\/p\u003e \u003cp\u003e23.2 Chromatographic Platforms of Biological Measurement for Neurotransmitters 358\u003c\/p\u003e \u003cp\u003e23.3 Bioanalytical Methodologies 359\u003c\/p\u003e \u003cp\u003e23.4 Conclusion 367\u003c\/p\u003e \u003cp\u003eReferences 367\u003c\/p\u003e \u003cp\u003e\u003cb\u003e24 Targeted Quantification of Carbohydrate Biomarkers Using LC–MS 371\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eCong Wei and Hong Gao\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e24.1 Introduction 371\u003c\/p\u003e \u003cp\u003e24.2 Overview 371\u003c\/p\u003e \u003cp\u003e24.3 Bioanalytical Method Development for Carbohydrate Biomarkers 374\u003c\/p\u003e \u003cp\u003e24.4 Conclusions 384\u003c\/p\u003e \u003cp\u003eReferences 384\u003c\/p\u003e \u003cp\u003e\u003cb\u003e25 Nucleoside\/Nucleotide Biomarkers 389\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eGuodong Zhang\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e25.1 Introduction 389\u003c\/p\u003e \u003cp\u003e25.2 Chromatographic Platforms for Nucleosides\/Nucleotides 390\u003c\/p\u003e \u003cp\u003e25.3 Bioanalytical Methodologies 391\u003c\/p\u003e \u003cp\u003e25.4 Nucleoside\/Nucleotide Biomarkers and Case Studies 398\u003c\/p\u003e \u003cp\u003e25.5 Conclusion 399\u003c\/p\u003e \u003cp\u003eReferences 402\u003c\/p\u003e \u003cp\u003e\u003cb\u003e26 LC–MS of RNA Biomarkers 407\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eMichael G. Bartlett, Babak Basiri, and Ning li\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e26.1 Introduction 407\u003c\/p\u003e \u003cp\u003e26.2 Role in Disease and Therapeutics 408\u003c\/p\u003e \u003cp\u003e26.3 Role of Mass Spectrometry in RNA Biomarkers 409\u003c\/p\u003e \u003cp\u003e26.4 LC–MS Approaches for RNA Determination 411\u003c\/p\u003e \u003cp\u003e26.5 Case Studies 415\u003c\/p\u003e \u003cp\u003eReferences 418\u003c\/p\u003e \u003cp\u003eIndex 425\u003c\/p\u003e   \u003cp\u003e\u003cb\u003e Naidong Weng, PhD,\u003c\/b\u003e is Scientific Director, Janssen Fellow, and Head of Bioanalytical Chemistry and Pharmacokinetics within Department of Pharmacokinetics, Dynamics and Metabolism at US East Coast, Janssen Research \u0026amp; Development, Johnson and Johnson. He has over 25 years of experiences on quantitative bioanalysis. His research interest includes using HILIC-MS\/MS for quantitation of highly polar analytes as well as chiral analysis. He has published more than 110 journal papers and book chapters.   \u003c\/p\u003e\u003cp\u003e\u003cb\u003e Wenying Jian, PhD,\u003c\/b\u003e a Senior Principal Scientist of Bioanalytical Chemistry and Pharmacokinetics within Department of Pharmacokinetics, Dynamics and Metabolism at US East Coast, Janssen Research \u0026amp; Development, Johnson and Johnson. Her research experience and interest center on application of advanced LC-MS methodologies in detection, identification, and quantitation of endogenous molecules, drugs and their metabolites, including small and large molecules, and in complicated biological matrices. She has published more than 40 journal papers and book chapters.    \u003c\/p\u003e\u003cp\u003e\u003cb\u003eThe first book to offer a blueprint for overcoming the challenges to successfully quantifying biomarkers in living organisms \u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eThe demand among scientists and clinicians for targeted quantitation experiments has experienced explosive growth in recent years. While there are a few books dedicated to bioanalysis and biomarkers in general, until now there were none devoted exclusively to addressing critical issues surrounding this area of intense research. \u003ci\u003eTargeted Biomarker Quantitation by LC-MS\u003c\/i\u003e provides a detailed blueprint for quantifying biomarkers in biological systems. It uses numerous real-world cases to exemplify key concepts, all of which were carefully selected and presented so as to allow the concepts they embody to be easily expanded to future applications, including new biomarker development.\u003c\/p\u003e \u003cp\u003eTargeted Biomarker Quantitation by LC-MS primarily focuses on the assay establishment for biomarker quantitation—a critical issue rarely treated in depth. It offers comprehensive coverage of three core areas of biomarker assay establishment: the relationship between the measured biomarkers and their intended usage; contemporary regulatory requirements for biomarker assays (a thorough understanding of which is essential for producing a successful and defendable submission); and the technical challenges of analyzing biomarkers produced inside a living organism or cell.\u003c\/p\u003e \u003cul\u003e \u003cli\u003eCovers the theory of and applications for state-of-the-art mass spectrometry and chromatography and their applications in biomarker analysis\u003c\/li\u003e \u003cli\u003eFeatures real-life examples illustrating the challenges involved in targeted biomarker quantitation and the innovative approaches which have been used to overcome those challenges\u003c\/li\u003e \u003cli\u003eAddresses potential obstacles to obtain effective biomarker level and data interpretation, such as specificity establishment and sample collection\u003c\/li\u003e \u003cli\u003eOutlines a tiered approach and fit-for-purpose assay protocol for targeted biomarker quantitation\u003c\/li\u003e \u003cli\u003eHighlights the current state of the biomarker regulatory environment and protocol standards\u003c\/li\u003e \u003c\/ul\u003e \u003cp\u003e\u003ci\u003eTargeted Biomarker Quantitation by LC-MS\u003c\/i\u003e is a valuable resource for bioanalytical scientists, drug metabolism and pharmacokinetics scientists, clinical scientists, analytical chemists, and others for whom biomarker quantitation is an important tool of the trade. It also functions as an excellent text for graduate courses in pharmaceutical, biochemistry, and chemistry.\u003c\/p\u003e","brand":"Wiley","offers":[{"title":"Default Title","offer_id":47990132441317,"sku":"NP9781119103066","price":218.95,"currency_code":"USD","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1842\/7735\/files\/9781119103066.jpg?v=1761786627","url":"https:\/\/k12savings.com\/products\/targeted-biomarker-quantitation-by-lc-ms-isbn-9781119103066","provider":"K12savings","version":"1.0","type":"link"}