Proposal for a harmonized descriptive analyte nomenclature for quantitative large-molecule bioanalysis

“Rather than to discriminate between free drug or complexed drug ... we propose to discriminate between and provide definitions for active drug, target-binding competent drug and total drug...” It has been well recognized in the scientific community that bioanalysis of therapeutic proteins is not limited to one ‘correct’ result but several forms of the analyte might be quantified. The expanding numbers of terms for large-molecule analytes in quantitative bioanalysis for preclinical and clinical studies and the inconsistency in nomenclature have often led to confusion. Here, we propose a descriptive nomenclature for large-molecule analytes based on functionality. Click here to view...