Overview

Consolidates the information LC-MS bioanalytical scientistsneed to analyze small molecules and macromolecules The field of bioanalysis has advanced rapidly, propelled by newapproaches for developing bioanalytical methods, new liquidchromatographic (LC) techniques, and new mass spectrometric (MS)instruments. Moreover, there are a host of guidelines andregulations designed to ensure the quality of bioanalyticalresults. Presenting the best practices, experimental protocols, and thelatest understanding of regulations, this book offers acomprehensive review of LC-MS bioanalysis of small molecules andmacromolecules. It not only addresses the needs of bioanalyticalscientists working on routine projects, but also explores advancedand emerging technologies such as high-resolution mass spectrometryand dried blood spot microsampling. Handbook of LC-MS Bioanalysis features contributions froman international team of leading bioanalytical scientists. Theircontributions reflect a review of the latest findings, practices, and regulations as well as their own firsthand analyticallaboratory experience. The book thoroughly examines: Fundamentals of LC-MS bioanalysis in drug discovery, drugdevelopment, and therapeutic drug monitoring The current understanding of regulations governing LC-MSbioanalysis Best practices and detailed technical instructions for LC-MSbioanalysis method development, validation, and stabilityassessment of analyte(s) of interest Experimental guidelines and protocols for quantitative LC-MSbioanalysis of challenging molecules, including pro-drugs, acylglucuronides, N-oxides, reactive compounds, and photosensitive andautooxidative compounds With its focus on current bioanalytical practice, Handbook ofLC-MS Bioanalysis enables bioanalytical scientists to developand validate robust LC-MS assay methods, all in compliance withcurrent regulations and standards.

Full Product Details

Author:   Wenkui Li (Tulane University, New Orleans, LA) ,  Jie Zhang ,  Francis L. S. Tse
Publisher:   John Wiley & Sons Inc
Imprint:   John Wiley & Sons Inc
ISBN:  

9781118671344

ISBN 10:   1118671341
Pages:   704
Publication Date:   28 August 2013
Audience:   Professional and scholarly ,  Professional & Vocational
Format:   Electronic book text
Publisher's Status:   Active
Availability:   In stock  
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Table of Contents

PREFACE xi CONTRIBUTORS xiii ABBREVIATIONS xvii PART I OVERVIEW OF LC-MS BIOANALYSIS 1 Roles of LC-MS Bioanalysis in Drug Discovery, Development, andTherapeutic 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, RichardEdom, and Naidong Weng 3 International Regulations and Quality Standards of Bioanalysis29 Surendra K. Bansal PART II CURRENT UNDERSTANDING OF LC-MS BIOANALYSIS-RELATEDREGULATIONS 4 Current Regulations for Bioanalytical Method Validations39 Mark E. Arnold, Rafael E. Barrientos-Astigarraga, FabioGarofolo, Shinobu Kudoh, Shrinivas S. Savale, Daniel Tang, PhilipTimmerman, and Peter van Amsterdam 5 Current Understanding of Bioanalytical Assay Reproducibility:Incurred Sample Reanalysis, Incurred Sample Stability, and IncurredSample Accuracy 47 Manish S. Yadav, Pranav S. Shrivastav, Theo de Boer, JaapWieling, 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 inSupport of Bioequivalence/ Bioavailability Studies 83 Bradley Nash 9 A Comparison of the Guidance of FDA, OECD, EPA, and Others onGood Laboratory Practice 89 J. Kirk Smith 10 Current Understanding of Bioanalysis Data Management andTrend 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 BioanalyticalLaboratories 109 Frank Chow, Martin Yau, and Leon Lachman PART III BEST PRACTICE IN LC-MS BIOANALYSIS 12 Assessment of Whole Blood Stability and Blood/PlasmaDistribution 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-MSBioanalysis 165 Guowen Liu and Anne-Francoise Aubry 15 Best Practice in Liquid Chromatography for LC-MS Bioanalysis185 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-MSBioanalysis 249 Bernd A. Bruenner and Christopher A. James 21 Evaluation and Elimination of Carryover and/or Contaminationin 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 Serum317 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 Biomarkers353 Wenying Jian, Richard Edom, and Naidong Weng 29 LC-MS Bioanalysis of Drugs in Hemolyzed and Lipemic Samples369 Min Meng, Spencer Carter, and Patrick Bennett 30 Best Practices in LC-MS Method Development and Validation forDried Blood Spots 379 Jie Zhang, Tapan K. Majumdar, Jimmy Flarakos, and Francis L.S.Tse 31 LC-MS Method Development Strategies for Enhancing MassSpectrometric 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 Identificationin Drug Metabolism and Pharmacokinetics 417 Patrick J. Rudewicz PART IV REPRESENTATIVE GUIDELINES AND/OR EXPERIMENTALPROTOCOLS OF LC-MS BIOANALYSIS 34 LC-MS Bioanalysis of Ester Prodrugs and Other Esterase LabileMolecules 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 ofTotal 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 LabileCompounds 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, andJ'erome 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 Supportof Microsampling 639 Heather Skor and Sadayappan V. Rahavendran 51 Quantification of Endogenous Analytes in Biofluids by aCombination of LC-MS and Construction of Calibration Curves UsingStable-Isotopes as Surrogate Analytes with True Biological ControlMatrices 649 Wenlin Li, Lucinda Cohen, and Erick Kindt Appendix 1 Body and Organ Weights and Physiological Parametersin Laboratory Animals and Humans 659 Appendix 2 Anticoagulants Commonly Used in Blood SampleCollection 661 Appendix 3 Solvents and Reagents Commonly Used in LC-MSBioanalysis 663 Appendix 4 Glossary of Terms Used in LC-MS Bioanalysis 665 INDEX 673

Reviews

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)

In that, it serves as a source of information and ofliterature references for further in-depth reading. It is veryuseful to have but, like always, it does not give all answers toevery question one may have. (ChemMedChem, 1June 2014)

Author Information

WENKUI LI, PhD, is Senior Fellow in the Department ofDrug Metabolism & Pharmacokinetics at Novartis Institutes forBioMedical Research, where he focuses on regulated LC-MS/MSbioanalysis for the toxicokinetic and pharmacokinetic assessment ofdrug candidates. Dr. Li is a member of the editorial board ofBiomedical Chromatography. JIE ZHANG, PhD, is Senior Fellow in the Department ofDrug Metabolism & Pharmacokinetics at Novartis Institutes forBioMedical Research, where he focuses on regulated LC-MSbioanalysis for the toxicokinetic and pharmacokinetic assessment ofdrug candidates. In addition, Dr. Zhang evaluates and implementsnovel technologies and processes in regulated LC-MSbioanalysis. FRANCIS L. S. TSE, PhD, is Vice President of DrugMetabolism & Bioanalytics at Novartis Institutes for BioMedicalResearch, overseeing the unit's strategy and operations in NorthAmerica and Asia. Dr. Tse is a Fellow of the American Associationof Pharmaceutical Scientists, APhA Academy of PharmaceuticalResearch and Science, and American College of ClinicalPharmacology.

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