Bioanalytics – Chemical
The goal of this presentation is to define the latest scientific and regulatory considerations for the analytical validation of assays for fluid-based (any protein, peptide, nucleic acid, lipid or other chemical entity soluble in plasma, urine, saliva, etc.) biomarkers used in the qualification of Drug Development Tools. This presentation will also address the latest industry practices for exploratory biomarkers. The topics to be discussed include considerations for assay design and technology selection, optimization of pre-analytical factors, core assay performance expectations, and setting minimally acceptable assay performance criteria. Technology areas covered include singleplex ligand binding and immunometric assays, singleplex and multiplex mass spectrometry assays, and enzyme-based assays.