Abstract

Dried Blood Spot (DBS) sampling is a microsampling technique used throughout the
World for neonatal screening. The work set out in this thesis shows the development
and implementation of DBS in the area of preclinical and clinical pharmaceutical drug
development, specifically in support of Toxicokinetics and Pharmacokinetics. The
advantages of the technique are explored along with the issues faced. The papers
discussed in this commentary, include in papers 1 and 2, the concept of supporting
both Toxicokinetics and Pharmacokinetics studies and the validation of bioanalytical
assays utilising DBS. Commentary paper 3 further explores the practicalities of DBS in
the Clinical environment and commentary paper 4 the transferability of DBS
technology between laboratories. Commentary paper 5 uses Incurred Sample
Reanalysis data to answer questions around specific DBS issues and commentary paper
6 looks at indicating papers for Dried Plasma Spots. Commentary papers 7 and 8
explore the use of consortia to investigate hematocrit and homogeneity when using
DBS and finally commentary paper 9 explores the training required to ensure quality
DBS samples. The impact and contributions to this field of research are demonstrated
through discussion and critical examination of selected examples of the author’s peerreviewed
publications in this area. Developments of scientific practices, where the
author has contributed intellectual, leadership and practical insight to achieve
significant improvements in the generation of knowledge, are highlighted throughout
the commentary.