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.
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Chen, G., Huang, S., Weng, W., Su, C. (2019). Biomarker Assay Development, Qualification, and Validation. In: Fang, L., Su, C. (eds) Statistical Methods in Biomarker and Early Clinical Development. Springer, Cham. https://doi.org/10.1007/978-3-030-31503-0_6
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DOI: https://doi.org/10.1007/978-3-030-31503-0_6
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