Preclinical bridging studies: understanding dried blood spot and plasma exposure profiles.

Background: Understanding the distribution of the analyte between the cellular and noncellular (plasma) components of the blood is important, especially in situations where dried blood spot (DBS) data need to be compared with plasma data, or vice versa.

Results: Pearson's coefficient, Lin's coefficient and the Bland-Altman analysis are appropriate to evaluate the concordance between DBS and plasma data from bridging studies. Percent recovery plots generated using the ex vivo blood:plasma ratio and the regression equations demonstrate the best approach for predicting plasma concentrations from DBS.

Dried blood spot sampling: coupling bioanalytical feasibility, blood-plasma partitioning and transferability to in vivo preclinical studies.

Background: The adoption of dried blood spot (DBS) sampling and analysis to support drug discovery and development requires the understanding of its bioanalytical feasibility as well as the distribution of the analyte in blood.

Results: Demonstrated the feasibility of adopting DBS for four test analytes representing diverse physico-chemical as well as pharmacokinetic parameters. The key findings include the use of a single extraction procedure across all four analytes, assay range of 1 to 5000 ng/ml, stability in whole blood as well as on-card, and the non-impact of blood volume.