W Li
John Wiley & Sons
e druk, 2013
9781118159248
Handbook of LC–MS Bioanalysis – Best Practices, Experimental Protocols, and Regulations
Best Practices, Experimental Protocols, and Regulations
Specificaties
Gebonden, 704 blz.
|
Engels
John Wiley & Sons |
e druk, 2013
ISBN13: 9781118159248
Rubricering
Levertijd ongeveer 15 werkdagen
Samenvatting
Reviewing up–to–date regulatory guidance,
Handbook of LC–MS Bioanalysis presents the fundamental principles of regulated LC–MS/MS bioanalytical techniques for both small molecules and macromolecules. With the techniques provided in this handbook, researches, professors, and students can develop a robust bioanalytical LC–MS/MS assay method, which can ultimately be used for the development of new drugs. Coverage includes advanced and emerging technologies, such as high resolution mass spectrometry and dried blood spot sampling, in regulated bioanalysis for drug development and therapeutic drug monitoring.
Specificaties
Inhoudsopgave
<p>PREFACE xi</p>
<p>CONTRIBUTORS xiii</p>
<p>ABBREVIATIONS xvii</p>
<p>PART I OVERVIEW OF LC–MS BIOANALYSIS</p>
<p>1 Roles of LC–MS Bioanalysis in Drug Discovery, Development, and Therapeutic Drug Monitoring 3<br /> Steve Unger, Wenkui Li, Jimmy Flarakos, and Francis L.S. Tse</p>
<p>2 Overview: Fundamentals of a Bioanalytical Laboratory 15<br /> Shefali Patel, Qiangtao (Mike) Huang, Wenying Jian, Richard Edom, and Naidong Weng</p>
<p>3 International Regulations and Quality Standards of Bioanalysis 29<br /> Surendra K. Bansal</p>
<p>PART II CURRENT UNDERSTANDING OF LC–MS BIOANALYSIS–RELATED REGULATIONS</p>
<p>4 Current Regulations for Bioanalytical Method Validations 39<br /> Mark E. Arnold, Rafael E. Barrientos–Astigarraga, Fabio Garofolo, Shinobu Kudoh, Shrinivas S. Savale, Daniel Tang, Philip Timmerman, and Peter van Amsterdam</p>
<p>5 Current Understanding of Bioanalytical Assay Reproducibility: Incurred Sample Reanalysis, Incurred Sample Stability, and Incurred Sample Accuracy 47<br /> Manish S. Yadav, Pranav S. Shrivastav, Theo de Boer, Jaap Wieling, and Puran Singhal</p>
<p>6 LC–MS Bioanalytical Method Transfer 65<br /> Zhongping (John) Lin, Wenkui Li, and Naidong Weng</p>
<p>7 Metabolites in Safety Testing 71<br /> Ragu Ramanathan and Dil M. Ramanathan</p>
<p>8 A Comparison of FDA, EMA, ANVISA, and Others on Bioanalysis in Support of Bioequivalence/ Bioavailability Studies 83<br /> Bradley Nash</p>
<p>9 A Comparison of the Guidance of FDA, OECD, EPA, and Others on Good Laboratory Practice 89<br /> J. Kirk Smith</p>
<p>10 Current Understanding of Bioanalysis Data Management and Trend of Regulations on Data Management 97<br /> Zhongping (John) Lin, Michael Moyer, Jianing Zeng, Joe Rajarao, and Michael Hayes</p>
<p>11 Regulatory Inspection Trends and Findings of Bioanalytical Laboratories 109<br /> Frank Chow, Martin Yau, and Leon Lachman</p>
<p>PART III BEST PRACTICE IN LC–MS BIOANALYSIS</p>
<p>12 Assessment of Whole Blood Stability and Blood/Plasma Distribution of Drugs 129<br /> Iain Love, Graeme T. Smith, and Howard M. Hill</p>
<p>13 Best Practice in Biological Sample Collection, Processing, and Storage for LC–MS in Bioanalysis of Drugs 139<br /> Maria Pawula, Glen Hawthorne, Graeme T. Smith, and Howard M. Hill</p>
<p>14 Best Practices in Biological Sample Preparation for LC–MS Bioanalysis 165<br /> Guowen Liu and Anne–Franc¸oise Aubry</p>
<p>15 Best Practice in Liquid Chromatography for LC–MS Bioanalysis 185<br /> Steve Unger and Naidong Weng</p>
<p>16 Best Practice in Mass Spectrometry for LC–MS 205<br /> Richard B. van Breemen and Elizabeth M. Martinez</p>
<p>17 Use of Internal Standards in LC–MS Bioanalysis 217<br /> Aimin Tan and Kayode Awaiye</p>
<p>18 System Suitability in LC–MS Bioanalysis 229<br /> Chad Briscoe</p>
<p>19 Derivatization in LC–MS Bioanalysis 239<br /> Tomofumi Santa</p>
<p>20 Evaluation and Elimination of Matrix Effects in LC–MS Bioanalysis 249<br /> Bernd A. Bruenner and Christopher A. James</p>
<p>21 Evaluation and Elimination of Carryover and/or Contamination in LC–MS Bioanalysis 259<br /> Howard M. Hill and Graeme T. Smith</p>
<p>22 Automation in LC–MS Bioanalysis 275<br /> Joseph A. Tweed</p>
<p>23 LC–MS Bioanalysis of Drugs in Tissue Samples 297<br /> Hong Gao, Stacy Ho, and John Williams</p>
<p>24 LC–MS Bioanalysis of Drugs in Urine 307<br /> Allena J. Ji</p>
<p>25 LC–MS Bioanalysis of Unbound Drugs in Plasma and Serum 317<br /> Theo de Boer and Jaap Wieling</p>
<p>26 LC–MS Bioanalysis of Drugs in Bile 327<br /> Hong Gao and John Williams</p>
<p>27 LC–MS Bioanalysis of Intracellular Drugs 337<br /> Fagen Zhang and Michael J. Bartels</p>
<p>28 LC–MS Bioanalysis of Endogenous Compounds as Biomarkers 353<br /> Wenying Jian, Richard Edom, and Naidong Weng</p>
<p>29 LC–MS Bioanalysis of Drugs in Hemolyzed and Lipemic Samples 369<br /> Min Meng, Spencer Carter, and Patrick Bennett</p>
<p>30 Best Practices in LC–MS Method Development and Validation for Dried Blood Spots 379<br /> Jie Zhang, Tapan K. Majumdar, Jimmy Flarakos, and Francis L.S. Tse</p>
<p>31 LC–MS Method Development Strategies for Enhancing Mass Spectrometric Detection 391<br /> Yuan–Qing Xia and Jeffrey D. Miller</p>
<p>32 LC–MS Bioanalysis–Related Statistics 403<br /> David Hoffman</p>
<p>33 Simultaneous LC–MS Quantitation and Metabolite Identification in Drug Metabolism and Pharmacokinetics 417<br /> Patrick J. Rudewicz</p>
<p>PART IV REPRESENTATIVE GUIDELINES AND/OR EXPERIMENTAL PROTOCOLS OF LC–MS BIOANALYSIS</p>
<p>34 LC–MS Bioanalysis of Ester Prodrugs and Other Esterase Labile Molecules 431<br /> Wenkui Li, Yunlin Fu, Jimmy Flarakos, and Duxi Zhang</p>
<p>35 LC–MS Bioanalysis of Acyl Glucuronides 447<br /> Jin Zhou, Feng (Frank) Li, and Jeffery X. Duggan</p>
<p>36 Regulated Bioassay of N–Oxide Metabolites Using LC–MS: Dealing with Potential Instability Issues 461<br /> Tapan K. Majumdar</p>
<p>37 Hydrolysis of Phase II Conjugates for LC–MS Bioanalysis of Total Parent Drugs 471<br /> Laixin Wang, Weiwei Yuan, Scott Reuschel, and Min Meng</p>
<p>38 LC–MS Bioanalysis of Reactive Compounds 479<br /> Hermes Licea–Perez, Christopher A. Evans, and Yi (Eric) Yang</p>
<p>39 LC–MS Bioanalysis of Photosensitive and Oxidatively Labile Compounds 491<br /> Corey M. Ohnmacht</p>
<p>40 LC–MS Bioanalysis of Interconvertible Compounds 505<br /> Nico van de Merbel</p>
<p>41 LC–MS Bioanalysis of Chiral Compounds 519<br /> Naidong Weng</p>
<p>42 LC–MS Bioanalysis of Peptides and Polypeptides 535<br /> Hongyan Li and Christopher A. James</p>
<p>43 LC–MS Bioanalysis of Nucleosides 551<br /> Laixin Wang and Min Meng</p>
<p>44 LC–MS Bioanalysis of Nucleotides 559<br /> Sabine Cohen, Marie–Claude Gagnieu, Isabelle Lefebvre, and J´er ome Guitton</p>
<p>45 LC–MS Bioanalysis of Steroids 573<br /> Jie Zhang and Frank Z. Stanczyk</p>
<p>46 LC–MS Bioanalysis of Liposomal Drugs and Lipids 591<br /> Troy Voelker and Roger Demers</p>
<p>47 LC–MS Bioanalysis of Proteins 601<br /> Ziping Yang, Wenkui Li, Harold T. Smith, and Francis L.S. Tse</p>
<p>48 LC–MS Bioanalysis of Oligonucleotides 607<br /> Michael G. Bartlett, Buyun Chen, and A. Cary McGinnis</p>
<p>49 LC–MS Bioanalysis of Platinum Drugs 629<br /> Troy Voelker and Min Meng</p>
<p>50 Microflow LC–MS for Quantitative Analysis of Drugs in Support of Microsampling 639<br /> Heather Skor and Sadayappan V. Rahavendran</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 /> Wenlin Li, Lucinda Cohen, and Erick Kindt</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>CONTRIBUTORS xiii</p>
<p>ABBREVIATIONS xvii</p>
<p>PART I OVERVIEW OF LC–MS BIOANALYSIS</p>
<p>1 Roles of LC–MS Bioanalysis in Drug Discovery, Development, and Therapeutic Drug Monitoring 3<br /> Steve Unger, Wenkui Li, Jimmy Flarakos, and Francis L.S. Tse</p>
<p>2 Overview: Fundamentals of a Bioanalytical Laboratory 15<br /> Shefali Patel, Qiangtao (Mike) Huang, Wenying Jian, Richard Edom, and Naidong Weng</p>
<p>3 International Regulations and Quality Standards of Bioanalysis 29<br /> Surendra K. Bansal</p>
<p>PART II CURRENT UNDERSTANDING OF LC–MS BIOANALYSIS–RELATED REGULATIONS</p>
<p>4 Current Regulations for Bioanalytical Method Validations 39<br /> Mark E. Arnold, Rafael E. Barrientos–Astigarraga, Fabio Garofolo, Shinobu Kudoh, Shrinivas S. Savale, Daniel Tang, Philip Timmerman, and Peter van Amsterdam</p>
<p>5 Current Understanding of Bioanalytical Assay Reproducibility: Incurred Sample Reanalysis, Incurred Sample Stability, and Incurred Sample Accuracy 47<br /> Manish S. Yadav, Pranav S. Shrivastav, Theo de Boer, Jaap Wieling, and Puran Singhal</p>
<p>6 LC–MS Bioanalytical Method Transfer 65<br /> Zhongping (John) Lin, Wenkui Li, and Naidong Weng</p>
<p>7 Metabolites in Safety Testing 71<br /> Ragu Ramanathan and Dil M. Ramanathan</p>
<p>8 A Comparison of FDA, EMA, ANVISA, and Others on Bioanalysis in Support of Bioequivalence/ Bioavailability Studies 83<br /> Bradley Nash</p>
<p>9 A Comparison of the Guidance of FDA, OECD, EPA, and Others on Good Laboratory Practice 89<br /> J. Kirk Smith</p>
<p>10 Current Understanding of Bioanalysis Data Management and Trend of Regulations on Data Management 97<br /> Zhongping (John) Lin, Michael Moyer, Jianing Zeng, Joe Rajarao, and Michael Hayes</p>
<p>11 Regulatory Inspection Trends and Findings of Bioanalytical Laboratories 109<br /> Frank Chow, Martin Yau, and Leon Lachman</p>
<p>PART III BEST PRACTICE IN LC–MS BIOANALYSIS</p>
<p>12 Assessment of Whole Blood Stability and Blood/Plasma Distribution of Drugs 129<br /> Iain Love, Graeme T. Smith, and Howard M. Hill</p>
<p>13 Best Practice in Biological Sample Collection, Processing, and Storage for LC–MS in Bioanalysis of Drugs 139<br /> Maria Pawula, Glen Hawthorne, Graeme T. Smith, and Howard M. Hill</p>
<p>14 Best Practices in Biological Sample Preparation for LC–MS Bioanalysis 165<br /> Guowen Liu and Anne–Franc¸oise Aubry</p>
<p>15 Best Practice in Liquid Chromatography for LC–MS Bioanalysis 185<br /> Steve Unger and Naidong Weng</p>
<p>16 Best Practice in Mass Spectrometry for LC–MS 205<br /> Richard B. van Breemen and Elizabeth M. Martinez</p>
<p>17 Use of Internal Standards in LC–MS Bioanalysis 217<br /> Aimin Tan and Kayode Awaiye</p>
<p>18 System Suitability in LC–MS Bioanalysis 229<br /> Chad Briscoe</p>
<p>19 Derivatization in LC–MS Bioanalysis 239<br /> Tomofumi Santa</p>
<p>20 Evaluation and Elimination of Matrix Effects in LC–MS Bioanalysis 249<br /> Bernd A. Bruenner and Christopher A. James</p>
<p>21 Evaluation and Elimination of Carryover and/or Contamination in LC–MS Bioanalysis 259<br /> Howard M. Hill and Graeme T. Smith</p>
<p>22 Automation in LC–MS Bioanalysis 275<br /> Joseph A. Tweed</p>
<p>23 LC–MS Bioanalysis of Drugs in Tissue Samples 297<br /> Hong Gao, Stacy Ho, and John Williams</p>
<p>24 LC–MS Bioanalysis of Drugs in Urine 307<br /> Allena J. Ji</p>
<p>25 LC–MS Bioanalysis of Unbound Drugs in Plasma and Serum 317<br /> Theo de Boer and Jaap Wieling</p>
<p>26 LC–MS Bioanalysis of Drugs in Bile 327<br /> Hong Gao and John Williams</p>
<p>27 LC–MS Bioanalysis of Intracellular Drugs 337<br /> Fagen Zhang and Michael J. Bartels</p>
<p>28 LC–MS Bioanalysis of Endogenous Compounds as Biomarkers 353<br /> Wenying Jian, Richard Edom, and Naidong Weng</p>
<p>29 LC–MS Bioanalysis of Drugs in Hemolyzed and Lipemic Samples 369<br /> Min Meng, Spencer Carter, and Patrick Bennett</p>
<p>30 Best Practices in LC–MS Method Development and Validation for Dried Blood Spots 379<br /> Jie Zhang, Tapan K. Majumdar, Jimmy Flarakos, and Francis L.S. Tse</p>
<p>31 LC–MS Method Development Strategies for Enhancing Mass Spectrometric Detection 391<br /> Yuan–Qing Xia and Jeffrey D. Miller</p>
<p>32 LC–MS Bioanalysis–Related Statistics 403<br /> David Hoffman</p>
<p>33 Simultaneous LC–MS Quantitation and Metabolite Identification in Drug Metabolism and Pharmacokinetics 417<br /> Patrick J. Rudewicz</p>
<p>PART IV REPRESENTATIVE GUIDELINES AND/OR EXPERIMENTAL PROTOCOLS OF LC–MS BIOANALYSIS</p>
<p>34 LC–MS Bioanalysis of Ester Prodrugs and Other Esterase Labile Molecules 431<br /> Wenkui Li, Yunlin Fu, Jimmy Flarakos, and Duxi Zhang</p>
<p>35 LC–MS Bioanalysis of Acyl Glucuronides 447<br /> Jin Zhou, Feng (Frank) Li, and Jeffery X. Duggan</p>
<p>36 Regulated Bioassay of N–Oxide Metabolites Using LC–MS: Dealing with Potential Instability Issues 461<br /> Tapan K. Majumdar</p>
<p>37 Hydrolysis of Phase II Conjugates for LC–MS Bioanalysis of Total Parent Drugs 471<br /> Laixin Wang, Weiwei Yuan, Scott Reuschel, and Min Meng</p>
<p>38 LC–MS Bioanalysis of Reactive Compounds 479<br /> Hermes Licea–Perez, Christopher A. Evans, and Yi (Eric) Yang</p>
<p>39 LC–MS Bioanalysis of Photosensitive and Oxidatively Labile Compounds 491<br /> Corey M. Ohnmacht</p>
<p>40 LC–MS Bioanalysis of Interconvertible Compounds 505<br /> Nico van de Merbel</p>
<p>41 LC–MS Bioanalysis of Chiral Compounds 519<br /> Naidong Weng</p>
<p>42 LC–MS Bioanalysis of Peptides and Polypeptides 535<br /> Hongyan Li and Christopher A. James</p>
<p>43 LC–MS Bioanalysis of Nucleosides 551<br /> Laixin Wang and Min Meng</p>
<p>44 LC–MS Bioanalysis of Nucleotides 559<br /> Sabine Cohen, Marie–Claude Gagnieu, Isabelle Lefebvre, and J´er ome Guitton</p>
<p>45 LC–MS Bioanalysis of Steroids 573<br /> Jie Zhang and Frank Z. Stanczyk</p>
<p>46 LC–MS Bioanalysis of Liposomal Drugs and Lipids 591<br /> Troy Voelker and Roger Demers</p>
<p>47 LC–MS Bioanalysis of Proteins 601<br /> Ziping Yang, Wenkui Li, Harold T. Smith, and Francis L.S. Tse</p>
<p>48 LC–MS Bioanalysis of Oligonucleotides 607<br /> Michael G. Bartlett, Buyun Chen, and A. Cary McGinnis</p>
<p>49 LC–MS Bioanalysis of Platinum Drugs 629<br /> Troy Voelker and Min Meng</p>
<p>50 Microflow LC–MS for Quantitative Analysis of Drugs in Support of Microsampling 639<br /> Heather Skor and Sadayappan V. Rahavendran</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 /> Wenlin Li, Lucinda Cohen, and Erick Kindt</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>