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Consolidates the information LC-MS bioanalytical scientists need to analyze small molecules and macromolecules 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. Presenting the best practices, experimental protocols, and the latest understanding of regulations, this book offers a comprehensive review of LC-MS bioanalysis of small…mehr
Consolidates the information LC-MS bioanalytical scientists need to analyze small molecules and macromolecules 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. 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. Handbook of LC-MS Bioanalysis 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: * Fundamentals of LC-MS bioanalysis in drug discovery, drug development, and therapeutic drug monitoring * The current understanding of regulations governing LC-MS bioanalysis * Best practices and detailed technical instructions for LC-MS bioanalysis method development, validation, and stability assessment of analyte(s) of interest * 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 With its focus on current bioanalytical practice, Handbook of LC-MS Bioanalysis enables bioanalytical scientists to develop and validate robust LC-MS assay methods, all in compliance with current regulations and standards.
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WENKUI LI, PhD, 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 Biomedical Chromatography. JIE ZHANG, PhD, 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. FRANCIS L. S. TSE, PhD, 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.
Inhaltsangabe
PREFACE xi
CONTRIBUTORS xiii
ABBREVIATIONS xvii
PART I OVERVIEW OF LC-MS BIOANALYSIS
1 Roles of LC-MS Bioanalysis in Drug Discovery, Development, and Therapeutic Drug Monitoring 3 Steve Unger, Wenkui Li, Jimmy Flarakos, and Francis L.S. Tse
2 Overview: Fundamentals of a Bioanalytical Laboratory 15 Shefali Patel, Qiangtao (Mike) Huang, Wenying Jian, Richard Edom, and Naidong Weng
3 International Regulations and Quality Standards of Bioanalysis 29 Surendra K. Bansal
PART II CURRENT UNDERSTANDING OF LC-MS BIOANALYSIS-RELATED REGULATIONS
4 Current Regulations for Bioanalytical Method Validations 39 Mark E. Arnold, Rafael E. Barrientos-Astigarraga, Fabio Garofolo, Shinobu Kudoh, Shrinivas S. Savale, Daniel Tang, Philip Timmerman, and Peter van Amsterdam
5 Current Understanding of Bioanalytical Assay Reproducibility: Incurred Sample Reanalysis, Incurred Sample Stability, and Incurred Sample Accuracy 47 Manish S. Yadav, Pranav S. Shrivastav, Theo de Boer, Jaap Wieling, and Puran Singhal
6 LC-MS Bioanalytical Method Transfer 65 Zhongping (John) Lin, Wenkui Li, and Naidong Weng
7 Metabolites in Safety Testing 71 Ragu Ramanathan and Dil M. Ramanathan
8 A Comparison of FDA, EMA, ANVISA, and Others on Bioanalysis in Support of Bioequivalence/ Bioavailability Studies 83 Bradley Nash
9 A Comparison of the Guidance of FDA, OECD, EPA, and Others on Good Laboratory Practice 89 J. Kirk Smith
10 Current Understanding of Bioanalysis Data Management and Trend of Regulations on Data Management 97 Zhongping (John) Lin, Michael Moyer, Jianing Zeng, Joe Rajarao, and Michael Hayes
11 Regulatory Inspection Trends and Findings of Bioanalytical Laboratories 109 Frank Chow, Martin Yau, and Leon Lachman
PART III BEST PRACTICE IN LC-MS BIOANALYSIS
12 Assessment of Whole Blood Stability and Blood/Plasma Distribution of Drugs 129 Iain Love, Graeme T. Smith, and Howard M. Hill
13 Best Practice in Biological Sample Collection, Processing, and Storage for LC-MS in Bioanalysis of Drugs 139 Maria Pawula, Glen Hawthorne, Graeme T. Smith, and Howard M. Hill
14 Best Practices in Biological Sample Preparation for LC-MS Bioanalysis 165 Guowen Liu and Anne-Franc¸oise Aubry
15 Best Practice in Liquid Chromatography for LC-MS Bioanalysis 185 Steve Unger and Naidong Weng
16 Best Practice in Mass Spectrometry for LC-MS 205 Richard B. van Breemen and Elizabeth M. Martinez
17 Use of Internal Standards in LC-MS Bioanalysis 217 Aimin Tan and Kayode Awaiye
18 System Suitability in LC-MS Bioanalysis 229 Chad Briscoe
19 Derivatization in LC-MS Bioanalysis 239 Tomofumi Santa
20 Evaluation and Elimination of Matrix Effects in LC-MS Bioanalysis 249 Bernd A. Bruenner and Christopher A. James
21 Evaluation and Elimination of Carryover and/or Contamination in LC-MS Bioanalysis 259 Howard M. Hill and Graeme T. Smith
22 Automation in LC-MS Bioanalysis 275 Joseph A. Tweed
23 LC-MS Bioanalysis of Drugs in Tissue Samples 297 Hong Gao, Stacy Ho, and John Williams
24 LC-MS Bioanalysis of Drugs in Urine 307 Allena J. Ji
25 LC-MS Bioanalysis of Unbound Drugs in Plasma and Serum 317 Theo de Boer and Jaap Wieling
26 LC-MS Bioanalysis of Drugs in Bile 327 Hong Gao and John Williams
27 LC-MS Bioanalysis of Intracellular Drugs 337 Fagen Zhang and Michael J. Bartels
28 LC-MS Bioanalysis of Endogenous Compounds as Biomarkers 353 Wenying Jian, Richard Edom, and Naidong Weng
29 LC-MS Bioanalysis of Drugs in Hemolyzed and Lipemic Samples 369 Min Meng, Spencer Carter, and Patrick Bennett
30 Best Practices in LC-MS Method Development and Validation for Dried Blood Spots 379 Jie Zhang, Tapan K. Majumdar, Jimmy Flarakos, and Francis L.S. Tse
31 LC-MS Method Development Strategies for Enhancing Mass Spectrometric Detection 391 Yuan-Qing Xia and Jeffrey D. Miller
32 LC-MS Bioanalysis-Related Statistics 403 David Hoffman
33 Simultaneous LC-MS Quantitation and Metabolite Identification in Drug Metabolism and Pharmacokinetics 417 Patrick J. Rudewicz
PART IV REPRESENTATIVE GUIDELINES AND/OR EXPERIMENTAL PROTOCOLS OF LC-MS BIOANALYSIS
34 LC-MS Bioanalysis of Ester Prodrugs and Other Esterase Labile Molecules 431 Wenkui Li, Yunlin Fu, Jimmy Flarakos, and Duxi Zhang
35 LC-MS Bioanalysis of Acyl Glucuronides 447 Jin Zhou, Feng (Frank) Li, and Jeffery X. Duggan
36 Regulated Bioassay of N-Oxide Metabolites Using LC-MS: Dealing with Potential Instability Issues 461 Tapan K. Majumdar
37 Hydrolysis of Phase II Conjugates for LC-MS Bioanalysis of Total Parent Drugs 471 Laixin Wang, Weiwei Yuan, Scott Reuschel, and Min Meng
38 LC-MS Bioanalysis of Reactive Compounds 479 Hermes Licea-Perez, Christopher A. Evans, and Yi (Eric) Yang
39 LC-MS Bioanalysis of Photosensitive and Oxidatively Labile Compounds 491 Corey M. Ohnmacht
40 LC-MS Bioanalysis of Interconvertible Compounds 505 Nico van de Merbel
41 LC-MS Bioanalysis of Chiral Compounds 519 Naidong Weng
42 LC-MS Bioanalysis of Peptides and Polypeptides 535 Hongyan Li and Christopher A. James
43 LC-MS Bioanalysis of Nucleosides 551 Laixin Wang and Min Meng
44 LC-MS Bioanalysis of Nucleotides 559 Sabine Cohen, Marie-Claude Gagnieu, Isabelle Lefebvre, and J´er^ome Guitton
45 LC-MS Bioanalysis of Steroids 573 Jie Zhang and Frank Z. Stanczyk
46 LC-MS Bioanalysis of Liposomal Drugs and Lipids 591 Troy Voelker and Roger Demers
47 LC-MS Bioanalysis of Proteins 601 Ziping Yang, Wenkui Li, Harold T. Smith, and Francis L.S. Tse
48 LC-MS Bioanalysis of Oligonucleotides 607 Michael G. Bartlett, Buyun Chen, and A. Cary McGinnis
49 LC-MS Bioanalysis of Platinum Drugs 629 Troy Voelker and Min Meng
50 Microflow LC-MS for Quantitative Analysis of Drugs in Support of Microsampling 639 Heather Skor and Sadayappan V. Rahavendran
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 Wenlin Li, Lucinda Cohen, and Erick Kindt
Appendix 1 Body and Organ Weights and Physiological Parameters in Laboratory Animals and Humans 659
Appendix 2 Anticoagulants Commonly Used in Blood Sample Collection 661
Appendix 3 Solvents and Reagents Commonly Used in LC-MS Bioanalysis 663
Appendix 4 Glossary of Terms Used in LC-MS Bioanalysis 665
1 Roles of LC-MS Bioanalysis in Drug Discovery, Development, and Therapeutic Drug Monitoring 3 Steve Unger, Wenkui Li, Jimmy Flarakos, and Francis L.S. Tse
2 Overview: Fundamentals of a Bioanalytical Laboratory 15 Shefali Patel, Qiangtao (Mike) Huang, Wenying Jian, Richard Edom, and Naidong Weng
3 International Regulations and Quality Standards of Bioanalysis 29 Surendra K. Bansal
PART II CURRENT UNDERSTANDING OF LC-MS BIOANALYSIS-RELATED REGULATIONS
4 Current Regulations for Bioanalytical Method Validations 39 Mark E. Arnold, Rafael E. Barrientos-Astigarraga, Fabio Garofolo, Shinobu Kudoh, Shrinivas S. Savale, Daniel Tang, Philip Timmerman, and Peter van Amsterdam
5 Current Understanding of Bioanalytical Assay Reproducibility: Incurred Sample Reanalysis, Incurred Sample Stability, and Incurred Sample Accuracy 47 Manish S. Yadav, Pranav S. Shrivastav, Theo de Boer, Jaap Wieling, and Puran Singhal
6 LC-MS Bioanalytical Method Transfer 65 Zhongping (John) Lin, Wenkui Li, and Naidong Weng
7 Metabolites in Safety Testing 71 Ragu Ramanathan and Dil M. Ramanathan
8 A Comparison of FDA, EMA, ANVISA, and Others on Bioanalysis in Support of Bioequivalence/ Bioavailability Studies 83 Bradley Nash
9 A Comparison of the Guidance of FDA, OECD, EPA, and Others on Good Laboratory Practice 89 J. Kirk Smith
10 Current Understanding of Bioanalysis Data Management and Trend of Regulations on Data Management 97 Zhongping (John) Lin, Michael Moyer, Jianing Zeng, Joe Rajarao, and Michael Hayes
11 Regulatory Inspection Trends and Findings of Bioanalytical Laboratories 109 Frank Chow, Martin Yau, and Leon Lachman
PART III BEST PRACTICE IN LC-MS BIOANALYSIS
12 Assessment of Whole Blood Stability and Blood/Plasma Distribution of Drugs 129 Iain Love, Graeme T. Smith, and Howard M. Hill
13 Best Practice in Biological Sample Collection, Processing, and Storage for LC-MS in Bioanalysis of Drugs 139 Maria Pawula, Glen Hawthorne, Graeme T. Smith, and Howard M. Hill
14 Best Practices in Biological Sample Preparation for LC-MS Bioanalysis 165 Guowen Liu and Anne-Franc¸oise Aubry
15 Best Practice in Liquid Chromatography for LC-MS Bioanalysis 185 Steve Unger and Naidong Weng
16 Best Practice in Mass Spectrometry for LC-MS 205 Richard B. van Breemen and Elizabeth M. Martinez
17 Use of Internal Standards in LC-MS Bioanalysis 217 Aimin Tan and Kayode Awaiye
18 System Suitability in LC-MS Bioanalysis 229 Chad Briscoe
19 Derivatization in LC-MS Bioanalysis 239 Tomofumi Santa
20 Evaluation and Elimination of Matrix Effects in LC-MS Bioanalysis 249 Bernd A. Bruenner and Christopher A. James
21 Evaluation and Elimination of Carryover and/or Contamination in LC-MS Bioanalysis 259 Howard M. Hill and Graeme T. Smith
22 Automation in LC-MS Bioanalysis 275 Joseph A. Tweed
23 LC-MS Bioanalysis of Drugs in Tissue Samples 297 Hong Gao, Stacy Ho, and John Williams
24 LC-MS Bioanalysis of Drugs in Urine 307 Allena J. Ji
25 LC-MS Bioanalysis of Unbound Drugs in Plasma and Serum 317 Theo de Boer and Jaap Wieling
26 LC-MS Bioanalysis of Drugs in Bile 327 Hong Gao and John Williams
27 LC-MS Bioanalysis of Intracellular Drugs 337 Fagen Zhang and Michael J. Bartels
28 LC-MS Bioanalysis of Endogenous Compounds as Biomarkers 353 Wenying Jian, Richard Edom, and Naidong Weng
29 LC-MS Bioanalysis of Drugs in Hemolyzed and Lipemic Samples 369 Min Meng, Spencer Carter, and Patrick Bennett
30 Best Practices in LC-MS Method Development and Validation for Dried Blood Spots 379 Jie Zhang, Tapan K. Majumdar, Jimmy Flarakos, and Francis L.S. Tse
31 LC-MS Method Development Strategies for Enhancing Mass Spectrometric Detection 391 Yuan-Qing Xia and Jeffrey D. Miller
32 LC-MS Bioanalysis-Related Statistics 403 David Hoffman
33 Simultaneous LC-MS Quantitation and Metabolite Identification in Drug Metabolism and Pharmacokinetics 417 Patrick J. Rudewicz
PART IV REPRESENTATIVE GUIDELINES AND/OR EXPERIMENTAL PROTOCOLS OF LC-MS BIOANALYSIS
34 LC-MS Bioanalysis of Ester Prodrugs and Other Esterase Labile Molecules 431 Wenkui Li, Yunlin Fu, Jimmy Flarakos, and Duxi Zhang
35 LC-MS Bioanalysis of Acyl Glucuronides 447 Jin Zhou, Feng (Frank) Li, and Jeffery X. Duggan
36 Regulated Bioassay of N-Oxide Metabolites Using LC-MS: Dealing with Potential Instability Issues 461 Tapan K. Majumdar
37 Hydrolysis of Phase II Conjugates for LC-MS Bioanalysis of Total Parent Drugs 471 Laixin Wang, Weiwei Yuan, Scott Reuschel, and Min Meng
38 LC-MS Bioanalysis of Reactive Compounds 479 Hermes Licea-Perez, Christopher A. Evans, and Yi (Eric) Yang
39 LC-MS Bioanalysis of Photosensitive and Oxidatively Labile Compounds 491 Corey M. Ohnmacht
40 LC-MS Bioanalysis of Interconvertible Compounds 505 Nico van de Merbel
41 LC-MS Bioanalysis of Chiral Compounds 519 Naidong Weng
42 LC-MS Bioanalysis of Peptides and Polypeptides 535 Hongyan Li and Christopher A. James
43 LC-MS Bioanalysis of Nucleosides 551 Laixin Wang and Min Meng
44 LC-MS Bioanalysis of Nucleotides 559 Sabine Cohen, Marie-Claude Gagnieu, Isabelle Lefebvre, and J´er^ome Guitton
45 LC-MS Bioanalysis of Steroids 573 Jie Zhang and Frank Z. Stanczyk
46 LC-MS Bioanalysis of Liposomal Drugs and Lipids 591 Troy Voelker and Roger Demers
47 LC-MS Bioanalysis of Proteins 601 Ziping Yang, Wenkui Li, Harold T. Smith, and Francis L.S. Tse
48 LC-MS Bioanalysis of Oligonucleotides 607 Michael G. Bartlett, Buyun Chen, and A. Cary McGinnis
49 LC-MS Bioanalysis of Platinum Drugs 629 Troy Voelker and Min Meng
50 Microflow LC-MS for Quantitative Analysis of Drugs in Support of Microsampling 639 Heather Skor and Sadayappan V. Rahavendran
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 Wenlin Li, Lucinda Cohen, and Erick Kindt
Appendix 1 Body and Organ Weights and Physiological Parameters in Laboratory Animals and Humans 659
Appendix 2 Anticoagulants Commonly Used in Blood Sample Collection 661
Appendix 3 Solvents and Reagents Commonly Used in LC-MS Bioanalysis 663
Appendix 4 Glossary of Terms Used in LC-MS Bioanalysis 665
INDEX 673
Rezensionen
"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." (ChemMedChem, 1 June 2014)
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