Bioanalytics – Chemical
2019 PharmSci 360
Precision medicine as an emerging approach utilizes information of individual variability in genes, environment, and lifestyle for each person so individualized treatment and prevention strategy can be applied. Biomarker identification and confirmation relies on high quality bioanalytical methods. Analytical validation depends on assay context of use (COU) prior to clinical validation. Understanding of regulations from US FDA (for NDA and BLA), CDRH (In Vitro Diagnostic Methods), and CMS (CLIA assays) is critical to design a suitable assay that serves intended use. This presentation will provide review of assay performance expectations for different use and provide examples.