Utilization of DBS within drug discovery: development of a serial microsampling pharmacokinetic study in mice

Background: Dried blood spots (DBS) are rapidly gaining a foothold in the pharmaceutical industry. However, applications in exploratory drug discovery are limited mainly owing to method development time. The development of a generic DBS assay is presented with its application in serial microsampling from mice. Results: A generic ‘fit-for-purpose’ assay was developed on FTA® Elute, which allowed 90% of compounds tested to reach sensitivity levels of 1 ng/ml. A ten-time point serial mouse pharmacokinetic study was conducted using 20-µl microsamples and DBS. Application of generic ‘fit-for-purpose’ approach did not compromise data delivery or quality. Conclusions: Serial microsampling and DBS in exploratory mouse pharmacokinetic has been shown to provide superior data quality when compared with traditional plasma-based composite studies.