LC-MS in Bioanalysis
The Handbook of LC-MS Bioanalysis presents the fundamental principles of regulated LC-MS/MS bioanalytical techniques for both small molecules and macromolecules. With the techniques provided in this handbook, researches, professors, and students can develop a robust bioanalytical LC-MS/MS assay method, which can ultimately be used for the development of new drugs.
Coverage includes advanced and emerging technologies, such as high resolution mass spectrometry and dried blood spot sampling, in regulated bioanalysis for drug development and therapeutic drug monitoring.
GIT Interview with the Authors Wenkui Li, Jie Zhang and Francis Tse
GIT: Which role does LC-MS play in Bioanalysis?
Many scientific decisions in drug development are dependent upon the accurate quantification of drugs and endogenous components (e.g. biomarkers) in biological samples. A unique feature of contemporary bioanalysis is that the target analyte is often present at very low concentrations, typically in the low ng/mL or pg/mL range for highly potent medicines. This very low concentration, compounded by the co-existence of relatively high levels (µg/mL to mg/mL range) of endogenous or exogenous components with similar chemical structures to the target analytes, renders it difficult to accurately and definitively measure the analytes of interest. Since its commercial introduction in the 1980's, liquid chromatography-mass spectrometry (LC-MS), and more predominantly, tandem mass spectrometry (LC-MS/MS) have rapidly become the standard tools for addressing the challenges in bioanalysis. LC-MS is a combination of the physicochemical separation capabilities of liquid chromatography (LC) and the mass (m/z) separation and detection capabilities of mass spectrometry (MS or MS/MS). LC-MS is a very sensitive technique, for which assay selectivity can be readily achieved via three stages of separation of the analyte(s) of interest from unwanted components in the biological matrix: (1) sample extraction (protein precipitation, liquid-liquid extraction, solid-phase extraction, etc.), (2) column chromatography and (3) tandem mass spectrometric detection in selected reaction monitoring (SRM) or multiple reaction monitoring (MRM) mode.
GIT: What was the reason to write this book?
LC-MS bioanalysis is a heavily regulated area within the discipline of drug metabolism and pharmacokinetics which supports a large sector of drug development.
The health authorities have very specific requirements regarding quality and integrity of bioanalytical results. Both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have renewed or are renewing their guidances on bioanalytical method validation with the ultimate goal of improving the quality of bioanalytical results. Novel approaches to LC-MS bioanalytical method development as well as advents in new LC techniques and MS instruments have been reported. Various automatic laboratory procedures, electronic laboratory notebooks, and data management systems are now available. Given the rapid changes within the field of LC-MS bioanalysis and also in the larger area of drug development, Drs. Wenkui Li, Jie Zhang and Francis Tse worked together in inviting about 100 experts in LC-MS bioanalysis field across the globe to work on a comprehensive first Handbook of LC-MS Bioanalysis. The book provides an update on all important aspects of LC-MS bioanalysis of both small molecules and macromolecules. It not only addresses the needs of the bioanalytical scientists on the pivotal projects but also features perspectives on some advanced and emerging technologies including high resolution mass spectrometry and dried blood spot (DBS) microsampling. With 51 chapters, the book covers overview of LC-MS bioanalysis, current understanding of quality standards and regulatory requirement, various best practices and step-by-step experimental protocols.
GIT: Which background information does the reader need?
The book is suited for readers with various backgrounds: (1) Students in the fields of pharmaceutical science, biomedical science, medicinal chemistry, mass spectrometry, analytical chemistry, bioanalytical chemistry, pharmacokinetics, toxicokinetics and toxicology, etc. (2) Doctors, nurses and scientists in the fields of clinical pharmacology, toxicology and therapeutic drug monitoring, etc. (3) Professors and teachers who select this book as a textbook for both undergraduate and graduate courses. (4) 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.
About the Authors
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 bioanalysis for the toxicokinetic and pharmacokinetic assessment of drug candidates. Dr. Li received his Ph.D. from Peking Union Medical College and Chinese Academy of Medical Science, Beijing, China. He has published over 100 research articles and is the coeditor of three books. He was appointed to 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. Dr. Zhang received his Ph.D. degree from Karolinska Institutet, Stockholm, Sweden, and has published over 20 research articles.
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 received his Ph. D. degree from University of Wisconsin-Madison, WI, USA. Dr. Tse has published over 130 research articles and is the editor/co-editor of six books. 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.
Wenkui Li, Jie Zhang and Francis Tse
Handbook of LC-MS Bioanalysis
1. Edition, December 2013, 704 Pages, ISBN 978-1-118-15924-8