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Making methods rugged for regulated bioanalysis

    Steve Unger

    *Author for correspondence:

    E-mail Address: steve.unger@wwctrials.com

    Worldwide Clinical Trials, Early Phase Services, Bioanalytical Sciences, 8609 Cross Park Dr, Austin, TX 78754, USA

    ,
    Thomas Horvath

    The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030, USA

    ,
    Melvin Tan

    Worldwide Clinical Trials, Early Phase Services, Bioanalytical Sciences, 8609 Cross Park Dr, Austin, TX 78754, USA

    ,
    Jing Zhou

    Worldwide Clinical Trials, Early Phase Services, Bioanalytical Sciences, 8609 Cross Park Dr, Austin, TX 78754, USA

    ,
    Thomas Lloyd

    Worldwide Clinical Trials, Early Phase Services, Bioanalytical Sciences, 8609 Cross Park Dr, Austin, TX 78754, USA

    ,
    Kevin McManus

    Worldwide Clinical Trials, Early Phase Services, Bioanalytical Sciences, 8609 Cross Park Dr, Austin, TX 78754, USA

    &
    Edward Wells

    Worldwide Clinical Trials, Early Phase Services, Bioanalytical Sciences, 8609 Cross Park Dr, Austin, TX 78754, USA

    Published Online:https://doi.org/10.4155/bio.14.317

    Methods started in discovery are optimized as they progress through preclinical and clinical development. Making a robust assay includes testing individual steps for consistency and points of failure. Assays may be transferred, optimized and revalidated several times. A rugged assay will not only meet regulatory requirements, but will execute with a low failure rate and confirm results under repeat analysis. Challenging aspects such as differential recovery, sample stabilization, resolution of isomers or conjugate analysis must be tackled and made routine. The proper selection of the IS can overcome limitations. It is best to know the potential points of failure before a study has started, but lessons learned from each study also provide invaluable insights to improve assay ruggedness.

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

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