Ligand-Binding Assays: Development, Validation, and Implementation in the Drug Development Arena
Language: English
Published by John Wiley & Sons Inc, 2009
- Hardcover
- New
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- Title
- Ligand-Binding Assays: Development, Validation, and Implementation in the Drug Development Arena
- Author
- Masood N. Khan
- Publisher
- John Wiley & Sons Inc
- Publication year
- 2009
- Condition
- New
- Binding
- Hardback
- Language
- English
- ISBN 10
- 0470041382
- ISBN 13
- 9780470041383
- Item weight
- 738 grams
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:
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A general discussion of challenges and proven approaches in the development of ligand-binding assays
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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
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A concise, but detailed, discussion of validation of ligand-binding assays for macromolecules
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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.
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About the Author
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.
"About the title" may belong to another edition of this title.
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