Read time: 4:30 mins
In this column, Afshin Safavi differentiates between ‘assay qualification’ and ‘assay validation’ explaining current industry guidance, the translation of this guidance into the exploratory biomarker world, and how Bioagilytix (NC, USA) approaches these challenges.
Read time: 4:30 mins
Implementing a tiered approach to bioanalytical method validation for large-molecule ligand-binding assay methods in pharmacokinetic assessments
Bioanalytical methods must enable the delivery of data that meet sound, scientifically justified, fit-for-purpose criteria. This perspective piece highlights three tiers of method validation – regulatory, scientific and research validations. The criteria for selecting the appropriate application of each of these PK method validation workflows are discussed.
Improving the sensitivity and specificity of a bioanalytical assay for the measurement of certolizumab pegol
This article looks at a new electrochemiluminescence immunoassay developed to measure certolizumab pegol levels in human plasma. Learn more in this article from Bioanalysis.
A new report has outlined the validation of a new next-generation sequencing assay for genetic mutations in a variety of different tumors.
In the penultimate installment of Ask the Experts on Biomarkers we ask our experts the importance of collaboration among bioanalysts especially in the challenges of assay qualification & validation.
In this special report from Bioanalysis , the authors report on the importance of physiologically relevant quantitative bioanalytical assays. They share experiences from project support (internal and at CROs) that suggests the need to be ever vigilant translating the needs of bioanalysis with those of project teams.
Validation of a ligand-binding assay for active protein drug quantification following the ‘free analyte QC concept’
In this research article the authors describe the validation of a ligand-binding assay for active protein drug quantification and address practical challenges as well as regulatory implications.
A validated LC–MS/MS method for the quantitative measurement of creatinine as an endogenous biomarker in human plasma
In this publication, the authors present the development and validation of an LC–MS/MS method to measure creatinine concentration in human EDTA plasma using a different approach of ‘surrogate analyte’.
LC–MS quantification of protein drugs: validating protein LC–MS methods with predigestion immunocapture
The purpose of this paper is to describe validation experiments that measure immunocapture efficiency, digestion efficiency, matrix effect and selectivity/specificity that can be used during method optimization and validation to test the resistance of the method to these potential interferences. The designs and benefits of these experiments are discussed in this report using an actual assay case study.