Technical aspects of inductively coupled plasma bioanalysis techniques.

摘要: This White Paper is focused on the technical aspects regarding quantifying pharmaceutically derived inorganic elements in biomatrices support of GLP nonclinical and clinical studies using inductively coupled plasma (ICP) techniques. For decades ICP has been used Environmental Protection Agency analyses more recently applied for use pharmaceutical industry. Current bioanalytical method validation sample analysis regulatory guidance applies to chromatographic platforms large- small-molecule PK TK assessments; however, it not directly applicable all various Increasingly, quadrupole high-resolution ICP-MS methods are being quantify contained compounds biomatrices. Many occur endogenously biomatrices, affecting quantification blanks, standard curve samples, QC selection appropriate levels LLOQ.