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

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.