Ligand-binding assays (LBAs) stand as the cornerstone of help for definition of the pharmaco-kinetics and toxicokinetics of macromolecules, an area of burgeoning curiosity in the pharmaceutical industry. Yet, exterior of the Crystal Metropolis Convention proceedings, little steerage has been out there for LBA validation, notably for assays used to support macromolecule drug development. Ligand-Binding Assays: Growth, Validation, and Implementation within the Drug Improvement Enviornment solutions that rising want, serving as a reference textual content discussing important facets of the development, validation, and implementation of ligand-binding assays within the drug development field.
Ligand-Binding Assays covers important matters related to ligand-binding assays, from pharmacokinetic studies, the development of LBAs, assay validation, statistical LBA elements, and regulatory aspects, to software program for LBAs and robotics and different rising methodologies for LBAs. Highlights embrace:
A basic dialogue of challenges and confirmed approaches within the improvement of ligand-binding assays
Extra detailed examination of traits of those assays when applied to help of pharmacokinetic and toxicokinetic studies of compounds at totally different phases in the discovery or improvement timeline
A concise, however detailed, discussion of validation of ligand-binding assays for macromolecules
A sensible strategy to "match-for-function" validation of assays for biomarkers, these molecules receiving increased attention as potentially demonstrating that the target chosen in discovery is being modulated by the candidate therapeutic, both in nonclinical and medical studies
Written by a group of world-recognized authorities within the area, Ligand-Binding Assays gives key information to a broad vary of practitioners, each in the pharmaceutical and allied industries and in related contract analysis organizations and academic laboratories and, maybe, even in the subject of diagnostics and clinical chemistry.
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