A novel biomarker assay qualification strategy for rare human matrices – a case study of biomarkers in aqueous humor
Jennifer A Getz,
Trung Nguy,
Randall Dere
et al.
Abstract:Background: Measuring pharmacodynamic biomarkers near the therapeutic site of action presents considerable challenges for sites with limited matrix volume or difficult access. Bioanalytical method qualification requires the use of numerous matrix samples, which is problematic for rare matrices. The aim of this study was to design and implement a streamlined, fit-for-purpose strategy for qualification of biomarker assays in rare matrices. Materials & methods: A multiplexed biomarker immunoassay was develope… Show more
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