Bioanalytics – Chemical
2019 PharmSci 360
It is widely acknowledged that parallelism should be performed early in method development and validation of Biomarkers ligand-binding assay, as it yields substantial information on the performance of an assay, notably regarding the selectivity and MRD of a method and the presence or absence of matrix interference. While consensus has been reached on the necessity to assess parallelism, the acceptance criteria are still subject to discussion. During this rapid fire presentation, previously proposed acceptance criteria, such as theoretical concentration established based on the concentration measured in the neat sample, will be questioned. Parallelism results from different methods using different sets of acceptance criteria will be showcased, highlighting situations where more stringent criteria has allowed a gain in confidence in Biomarkers validation and study-related data. This presentation will emphasize the need to revisit parallelism acceptance criteria in order to meet the current needs in biomarkers assay development.