Ligand-Binding Assays: Development, Validation, and Implementation in the Drug Development Arena - Hardcover

Hardcover

ISBN 10: 0470041382 ISBN 13: 9780470041383

Publisher: Wiley, 2009

Synopsis

A consolidated and comprehensive reference on ligand-binding assays

Ligand-binding assays (LBAs) stand as the cornerstone of support for definition of the pharmaco-kinetics and toxicokinetics of macromolecules, an area of burgeoning interest in the pharmaceutical industry. Yet, outside of the Crystal City Conference proceedings, little guidance has been available for LBA validation, particularly for assays used to support macromolecule drug development. Ligand-Binding Assays: Development, Validation, and Implementation in the Drug Development Arena answers that growing need, serving as a reference text discussing critical aspects of the development, validation, and implementation of ligand-binding assays in the drug development field.

Ligand-Binding Assays covers essential topics related to ligand-binding assays, from pharmacokinetic studies, the development of LBAs, assay validation, statistical LBA aspects, and regulatory aspects, to software for LBAs and robotics and other emerging methodologies for LBAs. Highlights include:

• A general discussion of challenges and proven approaches in the development of ligand-binding assays

• More detailed examination of characteristics of these assays when applied to support of pharmacokinetic and toxicokinetic studies of compounds at different stages in the discovery or development timeline

• A concise, but detailed, discussion of validation of ligand-binding assays for macromolecules

• A practical approach to "fit-for-purpose" validation of assays for biomarkers, those molecules receiving increased attention as potentially demonstrating that the target chosen in discovery is being modulated by the candidate therapeutic, both in nonclinical and clinical studies

Written by a team of world-recognized authorities in the field, Ligand-Binding Assays provides key information to a broad range of practitioners, both in the pharmaceutical and allied industries and in related contract research organizations and academic laboratories and, perhaps, even in the field of diagnostics and clinical chemistry.

About this title

About the Author

Masood N. Khan, PhD, received his PhD from Aligarh Muslim University, India, and did postdoctoral research at the National Institute of Environmental Health Sciences, Research Triangle Park, North Carolina, in immunology and cell biology. He subsequently moved to McGill University, Montreal, Canada, and served as assistant professor in the Department of Medicine. In 1988, he established and successfully directed the Ligand-Binding Assay Bioanalytical (LBAB) Department at Phoenix International Life Sciences (currently MDS Life Sciences), Montreal. Dr. Khan is a founding member of the LBAB Focus Group at AAPS and has coauthored authoritative reviews on validation of LBA and biomarker assays. He has over 100 publications and presentations to his credit. He is currently the Chief Scientist at GLP Solutions Inc. in Rockville, Maryland.

John W. A. Findlay, PhD, earned his PhD from the University of Aberdeen, Scotland, and did postdoctoral work in organic and medicinal chemistry at the University of Virginia. He has extensive experience in successful drug development with several major pharmaceutical companies, particularly in the areas of bioanalysis and drug disposition. Dr. Findlay was a participant in the first AAPS/FDA workshop on bioanalytical method validation in 1990 and in subsequent AAPS/FDA workshops on this topic, as well as a coauthor of a guiding review article in this field published in 2000. Dr. Findlay has coauthored more than 140 original papers, reviews, book chapters, patents, and abstracts. He is currently a Senior Director in Clinical Pharmacology at Gilead Sciences in Durham, North Carolina.

Review

"Ligand-Binding Assays, written by recognized and respected industry experts, covers a wide range of topics that provide valuable information to someone who is new to the field." (News & Analysis, 2011)

"Ligand-Binding Assays, edited by Masood Kahn and John Findlay offers a comprehensive, in depth description of all aspects of the subject. The editors are directly involved in the ligand-binding assay field and individual chapters are written by experts with a thorough understanding of the specific topics. The book is easy to read, clear and well illustrated. The emphasis is on biologicals rather than small molecules and this reflects the current application of many of the procedures covered. There is a good overview of assay validation, and this book is highly recommended for those with an interest in the topic."
—Robin Thorpe, PhD FRCPath, National Institute for Biological Standards and Control

"This book is a collection of valuable articles describing these assays in some detail, both from a historical perspective ..., but also regarding the new developments in the field, such as new technologies to support drug development ... and pharmacokinetic research." (ChemMedChem, July 2010)

Edition details

• Publisher: Wiley
• Publication date: 2009
• ISBN 10: 0470041382
• ISBN 13: 9780470041383
• Binding: Hardcover
• Language: English
• Edition number: 1
• Number of pages: 432
• Editor: Khan Masood N., Findlay John W. A.