{"product_id":"handbook-of-lc-ms-bioanalysis-isbn-9781118159248","title":"Handbook of LC-MS Bioanalysis","description":"\u003cp\u003e\u003cb\u003eConsolidates the information LC-MS bioanalytical scientists need to analyze small molecules and macromolecules\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eThe 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.\u003c\/p\u003e \u003cp\u003ePresenting 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.\u003c\/p\u003e \u003cp\u003e\u003ci\u003eHandbook of LC-MS Bioanalysis\u003c\/i\u003e 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:\u003c\/p\u003e \u003cul\u003e \u003cli\u003eFundamentals of LC-MS bioanalysis in drug discovery, drug development, and therapeutic drug monitoring\u003c\/li\u003e \u003cli\u003eThe current understanding of regulations governing LC-MS bioanalysis\u003c\/li\u003e \u003cli\u003eBest practices and detailed technical instructions for LC-MS bioanalysis method development, validation, and stability assessment of analyte(s) of interest\u003c\/li\u003e \u003cli\u003eExperimental 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\u003c\/li\u003e \u003c\/ul\u003e \u003cp\u003eWith its focus on current bioanalytical practice, \u003ci\u003eHandbook of LC-MS Bioanalysis\u003c\/i\u003e enables bioanalytical scientists to develop and validate robust LC-MS assay methods, all in compliance with current regulations and standards.\u003c\/p\u003e \u003cp\u003ePreface xi\u003c\/p\u003e \u003cp\u003eContributors xiii\u003c\/p\u003e \u003cp\u003eAbbreviations xvii\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart I Overview of LC-MS Bioanalysis\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e1 Roles of LC-MS Bioanalysis in Drug Discovery, Development, and Therapeutic Drug Monitoring 3\u003cbr\u003e \u003ci\u003eSteve Unger, Wenkui Li, Jimmy Flarakos, and Francis L.S. Tse\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e2 Overview: Fundamentals of a Bioanalytical Laboratory 15\u003cbr\u003e \u003ci\u003eShefali Patel, Qiangtao (Mike) Huang, Wenying Jian, Richard Edom, and Naidong Weng\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e3 International Regulations and Quality Standards of Bioanalysis 29\u003cbr\u003e \u003ci\u003eSurendra K. Bansal\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart II Current Understanding of LC-MS Bioanalysis-related Regulations\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e4 Current Regulations for Bioanalytical Method Validations 39\u003cbr\u003e \u003ci\u003eMark E. Arnold, Rafael E. Barrientos-Astigarraga, Fabio Garofolo, Shinobu Kudoh, Shrinivas S. Savale, Daniel Tang, Philip Timmerman, and Peter van Amsterdam\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e5 Current Understanding of Bioanalytical Assay Reproducibility: Incurred Sample Reanalysis, Incurred Sample Stability, and Incurred Sample Accuracy 47\u003cbr\u003e \u003ci\u003eManish S. Yadav, Pranav S. Shrivastav, Theo de Boer, Jaap Wieling, and Puran Singhal\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e6 LC-MS Bioanalytical Method Transfer 65\u003cbr\u003e \u003ci\u003eZhongping (John) Lin, Wenkui Li, and Naidong Weng\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e7 Metabolites in Safety Testing 71\u003cbr\u003e \u003ci\u003eRagu Ramanathan and Dil M. Ramanathan\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e8 A Comparison of FDA, EMA, ANVISA, and Others on Bioanalysis in Support of Bioequivalence\/ Bioavailability Studies 83\u003cbr\u003e \u003ci\u003eBradley Nash\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e9 A Comparison of the Guidance of FDA, OECD, EPA, and Others on Good Laboratory Practice 89\u003cbr\u003e \u003ci\u003eJ. Kirk Smith\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e10 Current Understanding of Bioanalysis Data Management and Trend of Regulations on Data Management 97\u003cbr\u003e \u003ci\u003eZhongping (John) Lin, Michael Moyer, Jianing Zeng, Joe Rajarao, and Michael Hayes\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e11 Regulatory Inspection Trends and Findings of Bioanalytical Laboratories 109\u003cbr\u003e \u003ci\u003eFrank Chow, Martin Yau, and Leon Lachman\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart III Best Practice in LC-MS Bioanalysis\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e12 Assessment of Whole Blood Stability and Blood\/Plasma Distribution of Drugs 129\u003cbr\u003e \u003ci\u003eIain Love, Graeme T. Smith, and Howard M. Hill\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e13 Best Practice in Biological Sample Collection, Processing, and Storage for LC-MS in Bioanalysis of Drugs 139\u003cbr\u003e \u003ci\u003eMaria Pawula, Glen Hawthorne, Graeme T. Smith, and Howard M. Hill\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e14 Best Practices in Biological Sample Preparation for LC-MS Bioanalysis 165\u003cbr\u003e \u003ci\u003eGuowen Liu and Anne-Françoise Aubry\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e15 Best Practice in Liquid Chromatography for LC-MS Bioanalysis 185\u003cbr\u003e \u003ci\u003eSteve Unger and Naidong Weng\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e16 Best Practice in Mass Spectrometry for LC-MS 205\u003cbr\u003e \u003ci\u003eRichard B. van Breemen and Elizabeth M. Martinez\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e17 Use of Internal Standards in LC-MS Bioanalysis 217\u003cbr\u003e \u003ci\u003eAimin Tan and Kayode Awaiye\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e18 System Suitability in LC-MS Bioanalysis 229\u003cbr\u003e \u003ci\u003eChad Briscoe\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e19 Derivatization in LC-MS Bioanalysis 239\u003cbr\u003e \u003ci\u003eTomofumi Santa\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e20 Evaluation and Elimination of Matrix Effects in LC-MS Bioanalysis 249\u003cbr\u003e \u003ci\u003eBernd A. Bruenner and Christopher A. James\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e21 Evaluation and Elimination of Carryover and\/or Contamination in LC-MS Bioanalysis 259\u003cbr\u003e \u003ci\u003eHoward M. Hill and Graeme T. Smith\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e22 Automation in LC-MS Bioanalysis 275\u003cbr\u003e \u003ci\u003eJoseph A. Tweed\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e23 LC-MS Bioanalysis of Drugs in Tissue Samples 297\u003cbr\u003e \u003ci\u003eHong Gao, Stacy Ho, and John Williams\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e24 LC-MS Bioanalysis of Drugs in Urine 307\u003cbr\u003e \u003ci\u003eAllena J. Ji\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e25 LC-MS Bioanalysis of Unbound Drugs in Plasma and Serum 317\u003cbr\u003e \u003ci\u003eTheo de Boer and Jaap Wieling\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e26 LC-MS Bioanalysis of Drugs in Bile 327\u003cbr\u003e \u003ci\u003eHong Gao and John Williams\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e27 LC-MS Bioanalysis of Intracellular Drugs 337\u003cbr\u003e \u003ci\u003eFagen Zhang and Michael J. Bartels\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e28 LC-MS Bioanalysis of Endogenous Compounds as Biomarkers 353\u003cbr\u003e \u003ci\u003eWenying Jian, Richard Edom, and Naidong Weng\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e29 LC-MS Bioanalysis of Drugs in Hemolyzed and Lipemic Samples 369\u003cbr\u003e \u003ci\u003eMin Meng, Spencer Carter, and Patrick Bennett\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e30 Best Practices in LC-MS Method Development and Validation for Dried Blood Spots 379\u003cbr\u003e \u003ci\u003eJie Zhang, Tapan K. Majumdar, Jimmy Flarakos, and Francis L.S. Tse\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e31 LC-MS Method Development Strategies for Enhancing Mass Spectrometric Detection 391\u003cbr\u003e \u003ci\u003eYuan-Qing Xia and Jeffrey D. Miller\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e32 LC-MS Bioanalysis-Related Statistics 403\u003cbr\u003e \u003ci\u003eDavid Hoffman\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e33 Simultaneous LC-MS Quantitation and Metabolite Identification in Drug Metabolism and Pharmacokinetics 417\u003cbr\u003e \u003ci\u003ePatrick J. Rudewicz\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart IV Representative Guidelines and\/or Experimental Protocols of LC-MS Bioanalysis\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e34 LC-MS Bioanalysis of Ester Prodrugs and Other Esterase Labile Molecules 431\u003cbr\u003e \u003ci\u003eWenkui Li, Yunlin Fu, Jimmy Flarakos, and Duxi Zhang\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e35 LC-MS Bioanalysis of Acyl Glucuronides 447\u003cbr\u003e \u003ci\u003eJin Zhou, Feng (Frank) Li, and Jeffery X. Duggan\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e36 Regulated Bioassay of N-Oxide Metabolites Using LC-MS: Dealing with Potential Instability Issues 461\u003cbr\u003e \u003ci\u003eTapan K. Majumdar\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e37 Hydrolysis of Phase II Conjugates for LC-MS Bioanalysis of Total Parent Drugs 471\u003cbr\u003e \u003ci\u003eLaixin Wang, Weiwei Yuan, Scott Reuschel, and Min Meng\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e38 LC-MS Bioanalysis of Reactive Compounds 479\u003cbr\u003e \u003ci\u003eHermes Licea-Perez, Christopher A. Evans, and Yi (Eric) Yang\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e39 LC-MS Bioanalysis of Photosensitive and Oxidatively Labile Compounds 491\u003cbr\u003e \u003ci\u003eCorey M. Ohnmacht\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e40 LC-MS Bioanalysis of Interconvertible Compounds 505\u003cbr\u003e \u003ci\u003eNico van de Merbel\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e41 LC-MS Bioanalysis of Chiral Compounds 519\u003cbr\u003e \u003ci\u003eNaidong Weng\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e42 LC-MS Bioanalysis of Peptides and Polypeptides 535\u003cbr\u003e \u003ci\u003eHongyan Li and Christopher A. James\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e43 LC-MS Bioanalysis of Nucleosides 551\u003cbr\u003e \u003ci\u003eLaixin Wang and Min Meng\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e44 LC-MS Bioanalysis of Nucleotides 559\u003cbr\u003e \u003ci\u003eSabine Cohen, Marie-Claude Gagnieu, Isabelle Lefebvre, and Jérôme Guitton\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e45 LC-MS Bioanalysis of Steroids 573\u003cbr\u003e \u003ci\u003eJie Zhang and Frank Z. Stanczyk\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e46 LC-MS Bioanalysis of Liposomal Drugs and Lipids 591\u003cbr\u003e \u003ci\u003eTroy Voelker and Roger Demers\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e47 LC-MS Bioanalysis of Proteins 601\u003cbr\u003e \u003ci\u003eZiping Yang, Wenkui Li, Harold T. Smith, and Francis L.S. Tse\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e48 LC-MS Bioanalysis of Oligonucleotides 607\u003cbr\u003e \u003ci\u003eMichael G. Bartlett, Buyun Chen, and A. Cary McGinnis\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e49 LC-MS Bioanalysis of Platinum Drugs 629\u003cbr\u003e \u003ci\u003eTroy Voelker and Min Meng\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e50 Microflow LC-MS for Quantitative Analysis of Drugs in Support of Microsampling 639\u003cbr\u003e \u003ci\u003eHeather Skor and Sadayappan V. Rahavendran\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e51 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\u003cbr\u003e \u003ci\u003eWenlin Li, Lucinda Cohen, and Erick Kindt\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eAppendix 1 Body and Organ Weights and Physiological Parameters in Laboratory Animals and Humans 659\u003c\/p\u003e \u003cp\u003eAppendix 2 Anticoagulants Commonly Used in Blood Sample Collection 661\u003c\/p\u003e \u003cp\u003eAppendix 3 Solvents and Reagents Commonly Used in LC-MS Bioanalysis 663\u003c\/p\u003e \u003cp\u003eAppendix 4 Glossary of Terms Used in LC-MS Bioanalysis 665\u003c\/p\u003e \u003cp\u003eIndex 673\u003c\/p\u003e  \u003cp\u003e“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.”  (\u003ci\u003eChemMedChem\u003c\/i\u003e, 1 June 2014)\u003c\/p\u003e  \u003cp\u003e\u003cb\u003eWENKUI LI, PhD,\u003c\/b\u003e is Senior Fellow in the Department of Drug Metabolism \u0026amp; 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 \u003ci\u003eBiomedical Chromatography\u003c\/i\u003e.\u003c\/p\u003e \u003cp\u003e\u003cb\u003eJIE ZHANG, PhD,\u003c\/b\u003e is Senior Fellow in the Department of Drug Metabolism \u0026amp; 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.\u003c\/p\u003e \u003cp\u003e\u003cb\u003eFRANCIS L. S. TSE, PhD,\u003c\/b\u003e is Vice President of Drug Metabolism \u0026amp; 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.\u003c\/p\u003e  \u003cp\u003e\u003cb\u003eConsolidates the information LC-MS bioanalytical scientists need to analyze small molecules and macromolecules\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eThe 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.\u003c\/p\u003e \u003cp\u003ePresenting 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.\u003c\/p\u003e \u003cp\u003e\u003ci\u003eHandbook of LC-MS Bioanalysis\u003c\/i\u003e 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:\u003c\/p\u003e \u003cul\u003e \u003cli\u003eFundamentals of LC-MS bioanalysis in drug discovery, drug development, and therapeutic drug monitoring\u003c\/li\u003e \u003cli\u003eThe current understanding of regulations governing LC-MS bioanalysis\u003c\/li\u003e \u003cli\u003eBest practices and detailed technical instructions for LC-MS bioanalysis method development, validation, and stability assessment of analyte(s) of interest\u003c\/li\u003e \u003cli\u003eExperimental 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\u003c\/li\u003e \u003c\/ul\u003e \u003cp\u003eWith its focus on current bioanalytical practice, \u003ci\u003eHandbook of LC-MS Bioanalysis\u003c\/i\u003e enables bioanalytical scientists to develop and validate robust LC-MS assay methods, all in compliance with current regulations and standards.\u003c\/p\u003e","brand":"Wiley","offers":[{"title":"Default Title","offer_id":47989335359717,"sku":"NP9781118159248","price":171.95,"currency_code":"USD","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1842\/7735\/files\/9781118159248.jpg?v=1761783713","url":"https:\/\/k12savings.com\/products\/handbook-of-lc-ms-bioanalysis-isbn-9781118159248","provider":"K12savings","version":"1.0","type":"link"}