EBF recommendation on the validation of bioanalytical methods for dried blood spots |
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Authors: | Timmerman Philip White Steve Globig Susanne Lüdtke Silke Brunet Leonarda Smeraglia John |
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Institution: | Janssen Research & Development, Bioanalysis Department, A Division of Janssen Pharmaceutica NV, Beerse, Belgium. ptimmerm@its.jnj.com |
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Abstract: | Over the last few years bioanalysts, pharmacokineticists and clinical investigators have rediscovered the technique of dried blood spots. The revival has provided pharmaceutical R&D a wealth of opportunities to optimize the drug-discovery and development process with respect to animal and patient ethics, new scientific insights and costs savings. On the bioanalytical front, multiple experiments have been performed and a lot of experience has been gained. Nevertheless, the technique still has a number of bioanalytical challenges. The European Bioanalysis Forum discussed the advantages and hurdles of the technique and summarized their current thinking in a recommendation on the validation of bioanalytical methods for dried blood spots, which can be used as a cornerstone for further discussions and experiments. |
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