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Research Article

Capillary microsampling in clinical studies: opportunities and challenges in two case studies

    Tom Verhaeghe

    *Author for correspondence:

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

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

    ,
    Marc De Meulder

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

    ,
    Vera Hillewaert

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

    ,
    Lieve Dillen

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

    &
    Hans Stieltjes

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

    Published Online:https://doi.org/10.4155/bio-2020-0054

    Aim: Capillary microsampling of 15 μl whole blood from fingersticks or heelsticks was used to collect pharmacokinetic (PK) samples from pediatric subjects in two projects. Results: In a mebendazole multisite study in Ethiopia and Rwanda in subjects between 1 and 16 years old, complete PK profiles (7 timepoints) could be obtained, although some of the fingerstick samples were contaminated by the dosing formulation. In a multisite study with a respiratory syncytial virus drug in children between 1 and 24 months old, sparse PK sampling was done (2 samples). All samples were successfully analyzed even though some capillaries were not properly filled. Conclusion: CMS shows potential for PK sampling in pediatrics but may need further optimization.

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

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