Methodology Spooner, Denniff, Michielsen et al. Executive summary
• A blood sampler has been developed that simplifies the sample collection of a specific fixed volume and bioanalytical workflows compared to dried blood spot (DBS) and conventional plasma samples.
• Issues associated with sample homogeneity for DBS sampling are eliminated as the entire sample is extracted. • The device minimizes the effect of hematocrit on the volume of the sample analyzed that is observed for DBS samples.
• While the between-laboratory variation in human and rat blood volumes collected was within acceptable limits, there is notable interoperator variability, which will need to be further investigated, and appropriate operator training will need to be conducted.
References A paper of special note has been highlighted as: •• of considerable interest
1
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Spooner N, Lad R, Barfield M. Dried blood spots as a sample collection technique for the determination of pharmacokinetics in clinical studies: considerations for the validation of a quantitative bioanalytical method. Anal. Chem. 81, 1557–1563 (2009).
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Spooner N, Ramakrishnan Y, Barfield M, Dewit O, Miller S. Use of DBS sample collection to determine circulating drug concentrations in clinical trials: practicalities and considerations. Bioanalysis 2(8), 1515–1522 (2010).
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12 D’Arienzo CJ, Li QC, Discenza L et al. DBS sampling can be used to stabilize prodrugs in drug discovery rodent studies without the addition of esterase inhibitors. Bioanalysis 2(8), 1415–1422 (2010).
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