Managing the effect of hematocrit on DBS analysis in a regulated environment

“The issue of hematocrit effect can drastically complicate DBS analysis.” The majority of preclinical and clinical pharmacokinetic studies in pharmaceutical development are performed under Good Laboratory Practice regulations, ensuring the accuracy, reproducibility and integrity of analytical results. In partial cut dried blood spot (DBS) methods, blood hematocrit is a known variable that can significantly undermine data quality and reliability. Of late, there have been numerous discussions on DBS methodology assessing the sizable impact of blood hematocrit.  The recent recommendation from the European Bioanalysis Forum on DBS states, ‘Hematocrit is currently identified as the single most important parameter influencing the spread...