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.

Massod 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.