Bioanalysis

Luca Matassa Contributes to IQ Consortium Overview of Issues Surrounding the Use of Dried Blood Spot Sampling in Pharmaceutical Research

Members of the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) produced this article to summarize and reflect on current knowledge and opinions on dried blood spot sampling (DBS), to stimulate discussion, and to encourage future creative applications of DBS.

Dried blood spot sampling is an innovative technique whereby wet blood is spotted onto absorbent paper and allowed to dry. DBS offers several benefits, namely low blood volume use, simplified collection, and convenient sample storage and transfer. It can also stabilize certain analytes or metabolites without added chemical modifiers.

This convenient methodology is already routinely used for neonatal screening, therapeutic drug monitoring, epidemiological studies, and quantitative biomarker (PD) assessment. It is also now actively employed in a growing number of drug discovery and development applications. However, it is relatively new to the pharmaceutical industry and to government regulators overseeing new drug applications and, at present, data associated with DBS technology is sparse compared with that of other matrices.

This paper is a first step toward building a scientific rationale for the appropriate use and acceptance of DBS data as an alternative to plasma data. A scientifically defendable approach for its use throughout clinical development is necessary for end-users and regulators to understand its value and make appropriate decisions regarding its acceptability in pharmaceutical research.

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