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Use of pharmacodynamic/response biomarkers for therapeutic biologics regulatory submissions

    Yow-Ming C Wang

    *Author for correspondence:

    E-mail Address: yowming.wang@fda.hhs.gov

    Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation & Research, Food & Drug Administration, Silver Spring, MD 20993, USA

    ,
    David G Strauss

    Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation & Research, Food & Drug Administration, Silver Spring, MD 20993, USA

    &
    Shiew Mei Huang

    Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation & Research, Food & Drug Administration, Silver Spring, MD 20993, USA

    Published Online:https://doi.org/10.2217/bmm-2019-0197
    Free first page

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