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The application of capillary microsampling in GLP toxicology studies

    Tom Verhaeghe

    *Author for correspondence:

    E-mail Address: tverhaeg@its.jnj.com

    Development Bioanalysis, Janssen Research & Development, Division of Janssen Pharmaceutica NV, Turnhoutseweg 30, 2340 Beerse, Belgium

    ,
    Lieve Dillen

    Development Bioanalysis, Janssen Research & Development, Division of Janssen Pharmaceutica NV, Turnhoutseweg 30, 2340 Beerse, Belgium

    ,
    Hans Stieltjes

    Development Bioanalysis, Janssen Research & Development, Division of Janssen Pharmaceutica NV, Turnhoutseweg 30, 2340 Beerse, Belgium

    ,
    Loeckie de Zwart

    Pharmacokinetics, Dynamics & Metabolism, Janssen Research & Development, Division of Janssen Pharmaceutica NV, Turnhoutseweg 30, 2340 Beerse, Belgium

    ,
    Bianca Feyen

    Preclinical Development & Safety, Janssen Research & Development, Division of Janssen Pharmaceutica NV, Turnhoutseweg 30, 2340 Beerse, Belgium

    ,
    Luc Diels

    Development Bioanalysis, Janssen Research & Development, Division of Janssen Pharmaceutica NV, Turnhoutseweg 30, 2340 Beerse, Belgium

    ,
    Ann Vroman

    Development Bioanalysis, Janssen Research & Development, Division of Janssen Pharmaceutica NV, Turnhoutseweg 30, 2340 Beerse, Belgium

    &
    Philip Timmerman

    Development Bioanalysis, Janssen Research & Development, Division of Janssen Pharmaceutica NV, Turnhoutseweg 30, 2340 Beerse, Belgium

    Published Online:https://doi.org/10.4155/bio-2016-0297

    Aim: Capillary microsampling (CMS) to collect microplasma volumes is gradually replacing traditional, larger volume sampling from rats in GLP toxicology studies. Methodology: About 32 µl of blood is collected with a capillary, processed to plasma and stored in a 10- or 4-µl capillary which is washed out further downstream in the laboratory. CMS has been standardized with respect to materials, assay validation experiments and application for sample analysis. Conclusion: The implementation of CMS has resulted in blood volume reductions in the rat from 300 to 32 µl per time point and the elimination of toxicokinetic satellite groups in the majority of the rat GLP toxicology studies. The technique has been successfully applied in 26 GLP studies for 12 different projects thus far.

    Papers of special note have been highlighted as: •• of considerable interest

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