Ligand-Binding Assays | Development, Validation, and Implementation in the Drug Development Arena | ISBN 9780470541494

Ligand-Binding Assays

Development, Validation, and Implementation in the Drug Development Arena

herausgegeben von Masood N. Khan und John W. Findlay
Mitwirkende
Herausgegeben vonMasood N. Khan
Herausgegeben vonJohn W. Findlay
Buchcover Ligand-Binding Assays  | EAN 9780470541494 | ISBN 0-470-54149-0 | ISBN 978-0-470-54149-4

„Ligand-Binding Assays, written by recognized and respectedindustry experts, covers a wide range of topics that providevaluable information to someone who is new to the field.“ (News& Analysis, 2011)
„Ligand-Binding Assays, edited by Masood Kahn and JohnFindlay offers a comprehensive, in depth description of all aspectsof the subject. The editors are directly involved in theligand-binding assay field and individual chapters are written byexperts with a thorough understanding of the specific topics. Thebook is easy to read, clear and well illustrated. The emphasis ison biologicals rather than small molecules and this reflects thecurrent application of many of the procedures covered. There is agood overview of assay validation, and this book is highlyrecommended for those with an interest in the topic.“
--Robin Thorpe, PhD FRCPath, National Institute forBiological Standards and Control
„This book is a collection of valuable articles describing theseassays in some detail, both from a historical perspective ..., butalso regarding the new developments in the field, such as newtechnologies to support drug development ... and pharmacokineticresearch.“ (ChemMedChem, July 2010)„Ligand-Binding Assays, edited by Masood Kahn and JohnFindlay offers a comprehensive, in depth description of all aspectsof the subject. The editors are directly involved in theligand-binding assay field and individual chapters are written byexperts with a thorough understanding of the specific topics. Thebook is easy to read, clear and well illustrated. The emphasis ison biologicals rather than small molecules and this reflects thecurrent application of many of the procedures covered. There is agood overview of assay validation, and this book is highlyrecommended for those with an interest in the topic.“
--Robin Thorpe, PhD FRCPath, National Institute forBiological Standards and Control
„This book is a collection of valuable articles describing theseassays in some detail, both from a historical perspective ..., butalso regarding the new developments in the field, such as newtechnologies to support drug development ... and pharmacokineticresearch.“ (ChemMedChem, July 2010)

Ligand-Binding Assays

Development, Validation, and Implementation in the Drug Development Arena

herausgegeben von Masood N. Khan und John W. Findlay
Mitwirkende
Herausgegeben vonMasood N. Khan
Herausgegeben vonJohn W. Findlay
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 Arenaanswers 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.