Well-developed ligand-binding assays demonstrate robust performance using singlet analysis

In this Research Article, published by Bioanalysis, investigators from Biogen (MA, USA) and Stat4ward LLC (PA, USA) describe their re-evaluation, in singlet, of data from five pharmacokinetic assay validations and five clinical and preclinical studies, originally run in duplicate. The results of the study confirm that well-developed ligand-binding assays (LBAs) produce comparable data whether evaluated in singlet or duplicate. Keywords: assay validation, AUC, Cmax, LBA, MRD, precision, singlet, variance component analysis Aim: Replicate sample testing has long been regarded as a necessity for bioanalytical laboratory testing, especially in the realm of ligand-binding assays (LBAs). In an era in which results were derived from crude test tube-based assays, the replication of...