Abstract

Fundamentals of Biosensor Process Validation for Trace Element Quantitative Determination

Author(s): Noah Jones

Bioanalytical methods are used to quantitatively assess the quantity of medications, biotransformation products, or other specified chemicals in biological matrices, and are frequently used to assist regulatory submissions by providing important data to pharmacokinetic or bioequivalence studies. Bioanalytical methods are subjected to a thorough method validation process to guarantee that they can generate reliable, reproducible data that meets or exceeds current regulatory guidance. Regulatory advice does not always account for subtleties unique to trace element findings at the moment. From the authors' standpoint, this study is designed to provide guidance on trace element bioanalytical method validation for two common and powerful experimental techniques: inductively coupled plasma-optical emission spectrometry and inductively coupled plasma-MS.