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  1. No Access

    Article

    An Investigation of Instability in Dried Blood Spot Samples for Pharmacokinetic Sampling in Phase 3 Trials of Verubecestat

    In-clinic dried blood spot (DBS) pharmacokinetic (PK) sampling was incorporated into two phase 3 studies of verubecestat for Alzheimer’s disease (EPOCH [NCT01739348] and APECS [NCT01953601]), as a potential al...

    Melanie Anderson, Marissa F. Dockendorf, Ian McIntosh, Iris **e… in The AAPS Journal (2022)

  2. No Access

    Article

    A Model-Based Approach to Bridging Plasma and Dried Blood Spot Concentration Data for Phase 3 Verubecestat Trials

    In-clinic venous dried blood spot (DBS) pharmacokinetic (PK) sampling was incorporated into two phase 3 studies of verubecestat for Alzheimer’s disease (EPOCH [NCT01739348] and APECS [NCT01953601]), as a poten...

    Marissa F. Dockendorf, David Jaworowicz, Rebecca Humphrey… in The AAPS Journal (2022)

  3. No Access

    Protocol

    Intact Mass Quantitation of Therapeutic Antibodies for Pharmacokinetic Studies Using Immuno-Purification

    The quantitation of therapeutic antibodies by mass spectrometry often utilizes a surrogate peptide approach following enzymatic digestion of the antibody. Although this approach has been widely adopted, it is ...

    Lisa A. Vasicek, Daniel S. Spellman, Kevin P. Bateman in Therapeutic Antibodies (2022)

  4. Article

    Open Access

    An Integrated Strategy for Implementation of Dried Blood Spots in Clinical Development Programs

    Dried blood spot (DBS) sample collection has gained increased interest across the pharmaceutical industry as a potential alternative to plasma for pharmacokinetic (PK) evaluations. However, regulatory guidelin...

    Prajakti A. Kothare, Kevin P. Bateman, Marissa Dockendorf, Julie Stone… in The AAPS Journal (2016)

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