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Biomarker Assay Development, Qualification, and Validation

In: Statistical Methods in Biomarker and Early Clinical Development

Author

Listed:
  • Guang Chen

    (Gilead Sciences Inc.)

  • Shuguang Huang

    (Stat4ward LLC)

  • Winnie Weng

    (Gilead Sciences Inc.)

  • Cheng Su

    (BioMarin Pharmaceutical Inc.)

Abstract

Biomarker is defined as a characteristic that is objectively measured and evaluated as an indicator of biological processes. A bioanalytical method that can accurately and reproducibly measure such characteristic is essential for the success of biomarker application. Biomarker assay development and validation is an important component of biomarker development and qualification. The objective of this chapter is to introduce the processes of assay development and validation, the key analytical parameters of an assay that need to be evaluated, and the statistical consideration and methodology commonly used in study design and data analysis.

Suggested Citation

  • Guang Chen & Shuguang Huang & Winnie Weng & Cheng Su, 2019. "Biomarker Assay Development, Qualification, and Validation," Springer Books, in: Liang Fang & Cheng Su (ed.), Statistical Methods in Biomarker and Early Clinical Development, pages 87-115, Springer.
    • Handle: RePEc:spr:sprchp:978-3-030-31503-0_6
    DOI: 10.1007/978-3-030-31503-0_6
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