Ligand-Binding Assays (PDF)
Development, Validation, and Implementation in the Drug Development Arena
(Sprache: Englisch)
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...
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...
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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.
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.
Inhaltsverzeichnis zu „Ligand-Binding Assays (PDF)“
Preface. Chapter 1 Introduction and Historical Perspective (John W. A. Findlay and Masood N. Khan). Chapter 2 Ligand-Binding Assays to Support Disposition Studies of Macromolecular Therapeutics (Marian M. Kelley, Marjorie A. Mohler and John W. A. Findlay). Chapter 3 Development of Ligand-Binding Assays for Drug Development Support (Masood Khan, Proveen Dass, John Leete, Michele Gunsior, Richard Schuman, and Chanchal Sadhu). Chapter 4 Validation of Ligand-Binding Assays to Support Pharmacokinetic Assessments of Biotherapeutics (Binodh DeSilva and Ronald R. Bowsher). Chapter 5 Statistical Considerations in the Validation of Ligand-Binding Assays (Bruno Boulanger, Viswanath Devanarayan and Walthere & Dewe). Chapter 6 Development and Validation of Ligand-Binding Assays for Biomarkers (Jean W. Lee, Yang Pan, Peter J. O'Brien and Ren Xu). Chapter 7 The Use of Commercial Assay Kits for PK/PD Analysis in Drug Development (John L. Allinson and John D. Chappel). Chapter 8 Development and Validation of Immunogenicity Assays for Pre-Clinical and Clinical Studies (Thomas Parish, Deborah Finco-Kent and Viswanath Devanarayan). Chapter 9 Macromolecular Reference Standards for Biotherapeutic Pharmacokinetic Analysis (Marie T. Rock and Stephen Keller). Chapter 10 Strategies for Transfer of Ligand-Binding Assays for Successful Validation and Implementation in GXP Environments (Wolfgang Klump and Howard Hill). Chapter 11 Application of Automation in Ligand-Binding Assays (Chris Morrow). Chapter 12 Documentation and Regulatory Compliance (Jacqueline A. O'Shaughnessy and C. T. Viswanathan). Chapter 13 Alternative and Emerging Methodologies in Ligand-Binding Assays (Huifen F. Wang and John W. A. Findlay).
Autoren-Porträt
Masood N. Khan, PhD, received his PhD from Aligarh MuslimUniversity, 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.
Bibliographische Angaben
- 2009, 1. Auflage, 432 Seiten, Englisch
- Herausgegeben: Masood N. Khan, John W. Findlay
- Verlag: John Wiley & Sons
- ISBN-10: 0470541490
- ISBN-13: 9780470541494
- Erscheinungsdatum: 04.11.2009
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