Abstract
The accuracy of reported sample results is contingent upon the quality of the assay calibration curve, and as such, calibration curves are critical components of ligand binding and other quantitative methods. Regulatory guidance and lead publications have defined many of the requirements for calibration curves which encompass design, acceptance criteria, and selection of a regression model. However, other important aspects such as preparation and editing guidelines have not been addressed by health authorities. The goal of this publication is to answer many of the commonly asked questions and to present a consensus and the shared views of members of the ligand binding assay (LBA) community on topics related to calibration curves with focus on providing recommendations for the preparation and editing of calibration curves.
Highlights
Calibration curves illustrate the relationship between the detected response variable and the concentration of a reference standard that is presumed to be representative of the analyte of interest in a test sample
Calibration curves are prepared by spiking the target analyte into a matrix that has been judged to be representative of the test sample matrix
The content of this publication may be applicable to subsets of biomarker assays, its focus remains on calibration curves for quantitative pharmacokinetic (PK) ligand binding assay (LBA)
Summary
Calibration curves illustrate the relationship between the detected response variable and the concentration of a reference standard that is presumed to be representative of the analyte of interest in a test sample. The general requirements for the design of calibration curves, the acceptance criteria for individual calibrators, and the guidelines for the selection of an appropriate regression model have been defined in regulatory guidance documents and lead publications by subject matter experts [1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17].
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