Poster: A Gyros Platform Pharmacokinetic Assay for Rituximab Using Microsampling with Simultaneous Analysis of a Pharmacodynamic Marker: An Animal-sparing Strategy (MPI Research)

15 Jul 2014

Pharmacokinetic studies in mice traditionally require one animal per time point. This strategy will result in euthanizing large numbers of mice placed on study. Dosing large numbers of animals may induce errors that may adversely impact the study. Animal-to-animal variation is inherent in this design. These studies are time-consuming, labor intensive, and costly.

We describe a sampling strategy allowing for fewer animals placed on drug safety studies.This strategy allows both pharmacokinetic (PK) and pharmacodynamic (PD) sample analysis at each of eight time points from serially drawn 25 uL blood samples from a single mouse. C-Reactive Protein (CRP) is a surrogate PD marker for this study and Rituximab is the test article for PK. The Gyros immunoassay platform was chosen for this evaluation as this technology features rapid assay development time, automation, assays with wide dynamic ranges, short assay run times, and minimal sample volume requirements.