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.
Sobre o autor
WENKUI LI, Ph D, is Senior Fellow in the Department of
Drug Metabolism & Pharmacokinetics at Novartis Institutes for
Bio Medical 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, Ph D, is Senior Fellow in the Department of
Drug Metabolism & Pharmacokinetics at Novartis Institutes for
Bio Medical 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, Ph D, is Vice President of Drug
Metabolism & Bioanalytics at Novartis Institutes for Bio Medical
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, APh A Academy of Pharmaceutical
Research and Science, and American College of Clinical
Pharmacology.
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