Affiliation:
1. Biomarker Services, PPD Laboratories, 2244 Dabney Road, Richmond, VA 23230, USA
Abstract
Parallelism is an essential experiment characterizing relative accuracy for a ligand-binding assay (LBA). By assessing the effects of dilution on the quantitation of endogenous analyte(s) in matrix, selectivity, matrix effects, minimum required dilution, endogenous levels of healthy and diseased populations and the LLOQ are assessed in a single experiment. This review compares and discusses all available approaches that can be used to assess key assay parameters for pharmacokinetic and biomarker LBAs, as well as the advantages and disadvantages of each approach. This review also summarizes a systematic approach that can apply to guide endogenous LBA method development and optimization with a suggested way to interpret parallelism data.
Subject
Medical Laboratory Technology,Clinical Biochemistry,General Pharmacology, Toxicology and Pharmaceutics,General Medicine,Analytical Chemistry
Cited by
43 articles.
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