PRA understands that biomarker assays are not PK assays and that their Context of Use (CoU) must be defined prior to setting up a method. Since most often no representative blank matrix can be obtained and reference standards are often recombinant versions of the real analytes, biomarker assays require a unique approach. It is of utmost importance to understand the biology of the biomarker to be able to build a high-quality assay.

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