Implementing Dried Blood Spot Sampling for Clinical Pharmacokinetic Determinations: Considerations from the IQ Consortium Microsampling Working Group
Journal Title: The AAPS Journal - Year 2015, Vol 17, Issue 2
Abstract
Rodent animal models are typically employed in these studies. The reduced blood volumes required for DBS can enable serial bleeding and, consequently, elimination of satellite animal groups and reduction of compound use. The ability to eliminate the satellite animal groups enables the assessment of exposure and toxic effects within the same animal. Studies involving expensive animal models (i.e., transgenic mice, knock-out mice, humanized mice, etc.) further highlight a persuasive scientific and economic case for DBS sampling since a complete pharmacokinetic profile can be obtained from a single study animal without the need for extra rodents merely for generating exposure data. These are perfectly in line with the principles of the 3Rs: reduction, refinement, and replacement of humane animal research (13–15). With greater emphasis from the regulatory authorities to study new drugs for infants, neonates, and pediatric populations, the requirement to conduct associated nonclinical juvenile rodent toxicity studies serves as an ideal scenario where the advantage of low blood volume in DBS sampling is undeniable. Although the advantages of DBS heavily favor rodent studies, it can also be used to refine non-rodent studies.
Authors and Affiliations
Christopher Evans, Mark Arnold, Peter Bryan, Jeffrey Duggan, Christopher A James, Wenkui Li, Steve Lowes, Luca Matassa, Timothy Olah, Philip Timmerman, Xiaomin Wang, Enaksha Wickremsinhe, John Williams, Eric Woolf, Patricia Zane
Keywords
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- EP ID EP680915
- DOI 10.1208/s12248-014-9695-3
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