Details

Handbook of LC-MS Bioanalysis


Handbook of LC-MS Bioanalysis

Best Practices, Experimental Protocols, and Regulations
1. Aufl.

von: Wenkui Li, Jie Zhang, Francis L. S. Tse

143,99 €

Verlag: Wiley
Format: EPUB
Veröffentl.: 03.09.2013
ISBN/EAN: 9781118671351
Sprache: englisch
Anzahl Seiten: 704

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Beschreibungen

<p><b>Consolidates the information LC-MS bioanalytical scientists need to analyze small molecules and macromolecules</b></p> <p>The field of bioanalysis has advanced rapidly, propelled by new approaches for developing bioanalytical methods, new liquid chromatographic (LC) techniques, and new mass spectrometric (MS) instruments. Moreover, there are a host of guidelines and regulations designed to ensure the quality of bioanalytical results.</p> <p>Presenting the best practices, experimental protocols, and the latest understanding of regulations, this book offers a comprehensive review of LC-MS bioanalysis of small molecules and macromolecules. It not only addresses the needs of bioanalytical scientists working on routine projects, but also explores advanced and emerging technologies such as high-resolution mass spectrometry and dried blood spot microsampling.</p> <p><i>Handbook of LC-MS Bioanalysis</i> features contributions from an international team of leading bioanalytical scientists. Their contributions reflect a review of the latest findings, practices, and regulations as well as their own firsthand analytical laboratory experience. The book thoroughly examines:</p> <ul> <li>Fundamentals of LC-MS bioanalysis in drug discovery, drug development, and therapeutic drug monitoring</li> <li>The current understanding of regulations governing LC-MS bioanalysis</li> <li>Best practices and detailed technical instructions for LC-MS bioanalysis method development, validation, and stability assessment of analyte(s) of interest</li> <li>Experimental guidelines and protocols for quantitative LC-MS bioanalysis of challenging molecules, including pro-drugs, acyl glucuronides, N-oxides, reactive compounds, and photosensitive and autooxidative compounds</li> </ul> <p>With its focus on current bioanalytical practice, <i>Handbook of LC-MS Bioanalysis</i> enables bioanalytical scientists to develop and validate robust LC-MS assay methods, all in compliance with current regulations and standards.</p>
<p>Preface xi</p> <p>Contributors xiii</p> <p>Abbreviations xvii</p> <p><b>Part I Overview of LC-MS Bioanalysis</b></p> <p>1 Roles of LC-MS Bioanalysis in Drug Discovery, Development, and Therapeutic Drug Monitoring 3<br /> <i>Steve Unger, Wenkui Li, Jimmy Flarakos, and Francis L.S. Tse</i></p> <p>2 Overview: Fundamentals of a Bioanalytical Laboratory 15<br /> <i>Shefali Patel, Qiangtao (Mike) Huang, Wenying Jian, Richard Edom, and Naidong Weng</i></p> <p>3 International Regulations and Quality Standards of Bioanalysis 29<br /> <i>Surendra K. Bansal</i></p> <p><b>Part II Current Understanding of LC-MS Bioanalysis-related Regulations</b></p> <p>4 Current Regulations for Bioanalytical Method Validations 39<br /> <i>Mark E. Arnold, Rafael E. Barrientos-Astigarraga, Fabio Garofolo, Shinobu Kudoh, Shrinivas S. Savale, Daniel Tang, Philip Timmerman, and Peter van Amsterdam</i></p> <p>5 Current Understanding of Bioanalytical Assay Reproducibility: Incurred Sample Reanalysis, Incurred Sample Stability, and Incurred Sample Accuracy 47<br /> <i>Manish S. Yadav, Pranav S. Shrivastav, Theo de Boer, Jaap Wieling, and Puran Singhal</i></p> <p>6 LC-MS Bioanalytical Method Transfer 65<br /> <i>Zhongping (John) Lin, Wenkui Li, and Naidong Weng</i></p> <p>7 Metabolites in Safety Testing 71<br /> <i>Ragu Ramanathan and Dil M. Ramanathan</i></p> <p>8 A Comparison of FDA, EMA, ANVISA, and Others on Bioanalysis in Support of Bioequivalence/ Bioavailability Studies 83<br /> <i>Bradley Nash</i></p> <p>9 A Comparison of the Guidance of FDA, OECD, EPA, and Others on Good Laboratory Practice 89<br /> <i>J. Kirk Smith</i></p> <p>10 Current Understanding of Bioanalysis Data Management and Trend of Regulations on Data Management 97<br /> <i>Zhongping (John) Lin, Michael Moyer, Jianing Zeng, Joe Rajarao, and Michael Hayes</i></p> <p>11 Regulatory Inspection Trends and Findings of Bioanalytical Laboratories 109<br /> <i>Frank Chow, Martin Yau, and Leon Lachman</i></p> <p><b>Part III Best Practice in LC-MS Bioanalysis</b></p> <p>12 Assessment of Whole Blood Stability and Blood/Plasma Distribution of Drugs 129<br /> <i>Iain Love, Graeme T. Smith, and Howard M. Hill</i></p> <p>13 Best Practice in Biological Sample Collection, Processing, and Storage for LC-MS in Bioanalysis of Drugs 139<br /> <i>Maria Pawula, Glen Hawthorne, Graeme T. Smith, and Howard M. Hill</i></p> <p>14 Best Practices in Biological Sample Preparation for LC-MS Bioanalysis 165<br /> <i>Guowen Liu and Anne-Françoise Aubry</i></p> <p>15 Best Practice in Liquid Chromatography for LC-MS Bioanalysis 185<br /> <i>Steve Unger and Naidong Weng</i></p> <p>16 Best Practice in Mass Spectrometry for LC-MS 205<br /> <i>Richard B. van Breemen and Elizabeth M. Martinez</i></p> <p>17 Use of Internal Standards in LC-MS Bioanalysis 217<br /> <i>Aimin Tan and Kayode Awaiye</i></p> <p>18 System Suitability in LC-MS Bioanalysis 229<br /> <i>Chad Briscoe</i></p> <p>19 Derivatization in LC-MS Bioanalysis 239<br /> <i>Tomofumi Santa</i></p> <p>20 Evaluation and Elimination of Matrix Effects in LC-MS Bioanalysis 249<br /> <i>Bernd A. Bruenner and Christopher A. James</i></p> <p>21 Evaluation and Elimination of Carryover and/or Contamination in LC-MS Bioanalysis 259<br /> <i>Howard M. Hill and Graeme T. Smith</i></p> <p>22 Automation in LC-MS Bioanalysis 275<br /> <i>Joseph A. Tweed</i></p> <p>23 LC-MS Bioanalysis of Drugs in Tissue Samples 297<br /> <i>Hong Gao, Stacy Ho, and John Williams</i></p> <p>24 LC-MS Bioanalysis of Drugs in Urine 307<br /> <i>Allena J. Ji</i></p> <p>25 LC-MS Bioanalysis of Unbound Drugs in Plasma and Serum 317<br /> <i>Theo de Boer and Jaap Wieling</i></p> <p>26 LC-MS Bioanalysis of Drugs in Bile 327<br /> <i>Hong Gao and John Williams</i></p> <p>27 LC-MS Bioanalysis of Intracellular Drugs 337<br /> <i>Fagen Zhang and Michael J. Bartels</i></p> <p>28 LC-MS Bioanalysis of Endogenous Compounds as Biomarkers 353<br /> <i>Wenying Jian, Richard Edom, and Naidong Weng</i></p> <p>29 LC-MS Bioanalysis of Drugs in Hemolyzed and Lipemic Samples 369<br /> <i>Min Meng, Spencer Carter, and Patrick Bennett</i></p> <p>30 Best Practices in LC-MS Method Development and Validation for Dried Blood Spots 379<br /> <i>Jie Zhang, Tapan K. Majumdar, Jimmy Flarakos, and Francis L.S. Tse</i></p> <p>31 LC-MS Method Development Strategies for Enhancing Mass Spectrometric Detection 391<br /> <i>Yuan-Qing Xia and Jeffrey D. Miller</i></p> <p>32 LC-MS Bioanalysis-Related Statistics 403<br /> <i>David Hoffman</i></p> <p>33 Simultaneous LC-MS Quantitation and Metabolite Identification in Drug Metabolism and Pharmacokinetics 417<br /> <i>Patrick J. Rudewicz</i></p> <p><b>Part IV Representative Guidelines and/or Experimental Protocols of LC-MS Bioanalysis</b></p> <p>34 LC-MS Bioanalysis of Ester Prodrugs and Other Esterase Labile Molecules 431<br /> <i>Wenkui Li, Yunlin Fu, Jimmy Flarakos, and Duxi Zhang</i></p> <p>35 LC-MS Bioanalysis of Acyl Glucuronides 447<br /> <i>Jin Zhou, Feng (Frank) Li, and Jeffery X. Duggan</i></p> <p>36 Regulated Bioassay of N-Oxide Metabolites Using LC-MS: Dealing with Potential Instability Issues 461<br /> <i>Tapan K. Majumdar</i></p> <p>37 Hydrolysis of Phase II Conjugates for LC-MS Bioanalysis of Total Parent Drugs 471<br /> <i>Laixin Wang, Weiwei Yuan, Scott Reuschel, and Min Meng</i></p> <p>38 LC-MS Bioanalysis of Reactive Compounds 479<br /> <i>Hermes Licea-Perez, Christopher A. Evans, and Yi (Eric) Yang</i></p> <p>39 LC-MS Bioanalysis of Photosensitive and Oxidatively Labile Compounds 491<br /> <i>Corey M. Ohnmacht</i></p> <p>40 LC-MS Bioanalysis of Interconvertible Compounds 505<br /> <i>Nico van de Merbel</i></p> <p>41 LC-MS Bioanalysis of Chiral Compounds 519<br /> <i>Naidong Weng</i></p> <p>42 LC-MS Bioanalysis of Peptides and Polypeptides 535<br /> <i>Hongyan Li and Christopher A. James</i></p> <p>43 LC-MS Bioanalysis of Nucleosides 551<br /> <i>Laixin Wang and Min Meng</i></p> <p>44 LC-MS Bioanalysis of Nucleotides 559<br /> <i>Sabine Cohen, Marie-Claude Gagnieu, Isabelle Lefebvre, and Jérôme Guitton</i></p> <p>45 LC-MS Bioanalysis of Steroids 573<br /> <i>Jie Zhang and Frank Z. Stanczyk</i></p> <p>46 LC-MS Bioanalysis of Liposomal Drugs and Lipids 591<br /> <i>Troy Voelker and Roger Demers</i></p> <p>47 LC-MS Bioanalysis of Proteins 601<br /> <i>Ziping Yang, Wenkui Li, Harold T. Smith, and Francis L.S. Tse</i></p> <p>48 LC-MS Bioanalysis of Oligonucleotides 607<br /> <i>Michael G. Bartlett, Buyun Chen, and A. Cary McGinnis</i></p> <p>49 LC-MS Bioanalysis of Platinum Drugs 629<br /> <i>Troy Voelker and Min Meng</i></p> <p>50 Microflow LC-MS for Quantitative Analysis of Drugs in Support of Microsampling 639<br /> <i>Heather Skor and Sadayappan V. Rahavendran</i></p> <p>51 Quantification of Endogenous Analytes in Biofluids by a Combination of LC-MS and Construction of Calibration Curves Using Stable-Isotopes as Surrogate Analytes with True Biological Control Matrices 649<br /> <i>Wenlin Li, Lucinda Cohen, and Erick Kindt</i></p> <p>Appendix 1 Body and Organ Weights and Physiological Parameters in Laboratory Animals and Humans 659</p> <p>Appendix 2 Anticoagulants Commonly Used in Blood Sample Collection 661</p> <p>Appendix 3 Solvents and Reagents Commonly Used in LC-MS Bioanalysis 663</p> <p>Appendix 4 Glossary of Terms Used in LC-MS Bioanalysis 665</p> <p>Index 673</p>
<p>“In that, it serves as a source of information and of literature references for further in-depth reading. It is very useful to have but, like always, it does not give all answers to every question one may have.”  (<i>ChemMedChem</i>, 1 June 2014)</p>
<p><b>WENKUI LI, PhD,</b> is Senior Fellow in the Department of Drug Metabolism & Pharmacokinetics at Novartis Institutes for BioMedical Research, where he focuses on regulated LC-MS/MS bioanalysis for the toxicokinetic and pharmacokinetic assessment of drug candidates. Dr. Li is a member of the editorial board of <i>Biomedical Chromatography</i>.</p> <p><b>JIE ZHANG, PhD,</b> is Senior Fellow in the Department of Drug Metabolism & Pharmacokinetics at Novartis Institutes for BioMedical Research, where he focuses on regulated LC-MS bioanalysis for the toxicokinetic and pharmacokinetic assessment of drug candidates. In addition, Dr. Zhang evaluates and implements novel technologies and processes in regulated LC-MS bioanalysis.</p> <p><b>FRANCIS L. S. TSE, PhD,</b> is Vice President of Drug Metabolism & Bioanalytics at Novartis Institutes for BioMedical Research, overseeing the unit's strategy and operations in North America and Asia. Dr. Tse is a Fellow of the American Association of Pharmaceutical Scientists, APhA Academy of Pharmaceutical Research and Science, and American College of Clinical Pharmacology.</p>
<p><b>Consolidates the information LC-MS bioanalytical scientists need to analyze small molecules and macromolecules</b></p> <p>The field of bioanalysis has advanced rapidly, propelled by new approaches for developing bioanalytical methods, new liquid chromatographic (LC) techniques, and new mass spectrometric (MS) instruments. Moreover, there are a host of guidelines and regulations designed to ensure the quality of bioanalytical results.</p> <p>Presenting the best practices, experimental protocols, and the latest understanding of regulations, this book offers a comprehensive review of LC-MS bioanalysis of small molecules and macromolecules. It not only addresses the needs of bioanalytical scientists working on routine projects, but also explores advanced and emerging technologies such as high-resolution mass spectrometry and dried blood spot microsampling.</p> <p><i>Handbook of LC-MS Bioanalysis</i> features contributions from an international team of leading bioanalytical scientists. Their contributions reflect a review of the latest findings, practices, and regulations as well as their own firsthand analytical laboratory experience. The book thoroughly examines:</p> <ul> <li>Fundamentals of LC-MS bioanalysis in drug discovery, drug development, and therapeutic drug monitoring</li> <li>The current understanding of regulations governing LC-MS bioanalysis</li> <li>Best practices and detailed technical instructions for LC-MS bioanalysis method development, validation, and stability assessment of analyte(s) of interest</li> <li>Experimental guidelines and protocols for quantitative LC-MS bioanalysis of challenging molecules, including pro-drugs, acyl glucuronides, N-oxides, reactive compounds, and photosensitive and autooxidative compounds</li> </ul> <p>With its focus on current bioanalytical practice, <i>Handbook of LC-MS Bioanalysis</i> enables bioanalytical scientists to develop and validate robust LC-MS assay methods, all in compliance with current regulations and standards.</p>

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