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

Hardcover

ISBN 10: 0470041382 ISBN 13: 9780470041383

Publisher: Wiley, 2009

Synopsis

With increasing use of ligand-binding assays (LBAs) in the pharmaceutical industry, the need to critically evaluate technical and regulatory issues related to the use of these technologies has increased greatly. This book fills that void and provides a reference text covering critical aspects of the development, validation, and implementation of LBAs in the drug development field. It includes: immunochemistry and protein chemistry, method development, validation, statistics, software, regulatory issues, and applications to immunogenicity and biomarkers. This is a key resource for bioanalytical personnel, laboratory analysts, and clinical and regulatory pharmacologists.

About this title

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)

From the Back Cover

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.

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.