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.
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