Utilization of DBS within drug discovery: development of a serial microsampling pharmacokinetic study in mice. (August 2010)

• Record Type: Journal Article
• Authors: Clark, Graeme T; Haynes, Julian J; Bayliss, Mark A J; Burrows, Lisa
• Is Part Of: Bioanalysis. Volume 2:Number 8(2010)
• Page Start: 1477
• Page End: 1488
• Publication Date: 2010-08
• Subjects: Drugs -- Analysis -- Periodicals; 615.19005
• DOI: 10.4155/bio.10.91
• Languages: English
• ISSNs: 1757-6180

Abstract

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.