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Handbook of LC–MS Bioanalysis – Best Practices, Experimental Protocols, and Regulations

Autor W Li
en Limba Engleză Hardback – 5 dec 2013
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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Specificații

ISBN-13: 9781118159248
ISBN-10: 1118159241
Pagini: 704
Dimensiuni: 221 x 285 x 42 mm
Greutate: 1.86 kg
Editura: Wiley
Locul publicării:Hoboken, United States

Public țintă

Researchers, Professors, and Students in the fields of pharmaceutical science, biomedical science, medicinal chemistry, mass spectrometry, analytical chemistry, bioanalytical chemistry, pharmacokinetics, toxicokinetics and toxicology, etc. Researchers and developers in the areas of pharmaceutical research and development, pharmaceutical contract research, drug safety testing, clinical study, therapeutic drug monitoring and drug regulatory affairs, etc.
Research doctors, nurses and scientists in the fields of clinical pharmacology, toxicology and therapeutic drug monitoring, etc.

Notă biografică

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.

Descriere

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.