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  1. Article

    Open Access

    Best practices for the development and fit-for-purpose validation of biomarker methods: a conference report

    This conference report summarized a full-day workshop, “best practices for the development and fit-for-purpose validation of biomarker methods,” which was held prior to the American Association of Pharmaceutic...

    Joel Mathews, Lakshmi Amaravadi, Steven Eck, Lauren Stevenson… in AAPS Open (2022)

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    Article

    Considerations for Soluble Protein Biomarker Blood Sample Matrix Selection

    Blood-based soluble protein biomarkers provide invaluable clinical information about patients and are used as diagnostic, prognostic, and pharmacodynamic markers. The most commonly used blood sample matrices a...

    Joel A. Mathews, Yan G. Ni, Connie Wang, Jon E. Peterson, Chad Ray… in The AAPS Journal (2020)

  3. Article

    Recommendations for Use and Fit-for-Purpose Validation of Biomarker Multiplex Ligand Binding Assays in Drug Development

    Multiplex ligand binding assays (LBAs) are increasingly being used to support many stages of drug development. The complexity of multiplex assays creates many unique challenges in comparison to single-plexed a...

    Darshana Jani, John Allinson, Flora Berisha, Kyra J. Cowan… in The AAPS Journal (2016)

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    Article

    Fit-for-Purpose Method Development and Validation for Successful Biomarker Measurement

    Despite major advances in modern drug discovery and development, the number of new drug approvals has not kept pace with the increased cost of their development. Increasingly, innovative uses of biomarkers are...

    Jean W. Lee, Viswanath Devanarayan, Yu Chen Barrett… in Pharmaceutical Research (2006)