title: EBF recommendation on the validation of bioanalytical methods for dried blood spots.
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.
authors.affiliation: Janssen Research & Development, Bioanalysis Department, A Division of Janssen Pharmaceutica NV, Beerse, Belgium. ptimmerm@its.jnj.com
authors.forename: Philip
authors.initials: P
authors.lastname: Timmerman
authors.forename: Steve
authors.initials: S
authors.lastname: White
authors.forename: Susanne
authors.initials: S
authors.lastname: Globig
authors.forename: Silke
authors.initials: S
authors.lastname: Lüdtke
authors.forename: Leonarda
authors.initials: L
authors.lastname: Brunet
authors.forename: John
authors.initials: J
authors.lastname: Smeraglia
mesh_terms: D000925:Anticoagulants / Q000737:chemistry; D002623:Chemistry Techniques, Analytical / Q000379:methods* / Q000592:standards*; D059788:Dried Blood Spot Testing / Q000379:methods* / Q000592:standards*; D005060:Europe; D006400:Hematocrit; D006801:Humans; D004364:Pharmaceutical Preparations / Q000097:blood*; D015203:Reproducibility of Results
chemical_list: D000925:Anticoagulants; D004364:Pharmaceutical Preparations