Scientists at Pfizer have reported a retrospective study of pharmacokinetics (PK) data that highlights the reliability of Gyrolab assays. Best practices for PK bioanalysis in protein therapeutics recommend analysis in duplicate and often with concurrently run standard curves. With this in mind, the group of scientists at Pfizer decided to see just how reliable Gyrolab assays were by analyzing data from a large number of PK assays.
Their retrospective study involved over 23,000 replicate pairs comprising standards, QCs, and animal samples using 23 assays run on a range of matrices. As well as looking at precision and accuracy, the group used the concordance correlation coefficient (CCC) to measure agreement and compared the first replicate from Gyrolab assays with the results of analyzing duplicates. They also examined AUC and Cmax PK parameters. The results were exceptional.