Application And Evaluation Of A Cross-validation Exercise Of The Dried Blood Spot Technique Between BASi® UK And BASi® US

Neil Doleman (BASi® UK), Robin Lane (BASi® UK) and Rachel Sun (BASi® US)
BASi®, Suite 2 Building 500, Abbey Park, Stareton, Kenilworth, Warwickshire, UK

Background

 
The Dried Blood Spot (DBS) technique had been previously evaluated at BASi® UK for the determination of quetiapine, norquetiapine and quetiapine sulphoxide in human whole blood. DBS offers a range of benefits over traditional sampling techniques including:

  • Refinement - elimination/reduction of rodent warming
  • Reduction - reduced volumes enables serial sampling from one rodent reducing animal numbers and eases sampling in paediatric studies
  • Reduced costs - animal numbers, test substance, simplified procedures (collection and laboratory), shipping and storage

 

 
Objective

To cross-validate an analytical method in human whole blood from the BASi® UK site to BASi® US. A key feature was to ship DBS samples of known concentration from the UK to US monitoring the temperature and humidity during transportation and to compare the concentrations of quetiapine, norquetiapine and quetiapine sulphoxide determined at the two BASi® analytical sites.