The Role Of Commercial Biomarker Assay Kits In Preclinical And Clinical Trials

The aim of this chapter is to discuss the role of commercial assay kits when quantitatively measuring biomarkers to support preclinical and clinical drug development programs. Research use only and clinical diagnostic kits will be compared and their usefulness addressed in the context of the 2013 FDA draft guidance on bioanalytical method validation. Analytical method performance characteristics will be discussed as well as mechanisms to generate consistent biomarker data throughout the life of the study.