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

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Masood N. Khan, John W. Findlay
John Wiley & Sons, Oct 22, 2009 - Medical - 400 pages
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A consolidated and comprehensive reference on ligand-bindingassays

Ligand-binding assays (LBAs) stand as the cornerstone of supportfor definition of the pharmaco-kinetics and toxicokinetics ofmacromolecules, an area of burgeoning interest in thepharmaceutical industry. Yet, outside of the Crystal CityConference proceedings, little guidance has been available for LBAvalidation, particularly for assays used to support macromoleculedrug development. "Ligand-Binding Assays: Development, Validation, and Implementation in the Drug Development Arena"answers that growing need, serving as a reference text discussingcritical aspects of the development, validation, and implementationof ligand-binding assays in the drug development field.

"Ligand-Binding Assays" covers essential topics related toligand-binding assays, from pharmacokinetic studies, thedevelopment of LBAs, assay validation, statistical LBA aspects, andregulatory aspects, to software for LBAs and robotics and otheremerging methodologies for LBAs. Highlights include:

A general discussion of challenges and proven approaches in thedevelopment of ligand-binding assays

More detailed examination of characteristics of these assayswhen applied to support of pharmacokinetic and toxicokineticstudies of compounds at different stages in the discovery ordevelopment timeline

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

A practical approach to "fit-for-purpose" validation of assaysfor biomarkers, those molecules receiving increased attention aspotentially demonstrating that the target chosen in discovery isbeing modulated by the candidate therapeutic, both in nonclinicaland clinical studies

Written by a team of world-recognized authorities in the field, "Ligand-Binding Assays" provides key information to a broadrange of practitioners, both in the pharmaceutical and alliedindustries and in related contract research organizations andacademic laboratories and, perhaps, even in the field ofdiagnostics and clinical chemistry.

 

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Contents

Contributors
xv
1 LigandBinding Assays in Drug Development Introduction and Historical Perspective
1
2 LigandBinding Assays to Support Disposition Studies of Macromolecular Therapeutics
15
3 Development of LigandBinding Assays for Drug Development Support
39
4 Validation of LigandBinding Assays to Support Pharmacokinetic Assessments of Biotherapeutics
81
5 Statistical Considerations in the Validation of LigandBinding Assays
111
6 Development and Validation of LigandBinding Assays for Biomarkers
129
7 The Use of Commercial Assay Kits for PKPD Analysis in Drug Development
163
8 Development and Validation of Immunogenicity Assays for Preclinical and Clinical Studies
193
9 Macromolecular Reference Standards for Biotherapeutic Pharmacokinetic Analysis
239
10 Strategies for Successful Transfer of LigandBinding Assays for Successful Validation and Implementation in GXP Environment
265
11 Application of Automation in LigandBinding Assays
287
12 Documentation and Regulatory Compliance
327
13 Alternative and Emerging Methodologies in LigandBinding Assays
343
Index
381
Copyright

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About the author (2009)

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.

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