ABSTRACT

Effective biomarkers are among the most sought after tools in the area of human health. They are used to diagnose diseases, monitor drug efficacy and safety, aid in drug selection, and monitor overall general health. Many different endpoints are considered biomarkers: Elevated blood pressure can indicate the risk of stroke, elevated liver enzymes can indicate liver injury, and genetic signatures can indicate predisposition to certain diseases. Protein levels and activity are often used in health assessments as biomarkers [1]. For example, the activity level of alanine transaminase (ALT) in the blood indicates how well the liver is functioning, and elevated

2.1 Introduction .................................................................................................... 55 2.2 The Role of Chromatography in Protein Biomarker Assays .......................... 58

2.2.1 Modes of Separations ......................................................................... 59 2.2.2 LC System Selection ...........................................................................60 2.2.3 Additional Considerations .................................................................. 61

2.3 Integrating Analytical Platforms .................................................................... 62 2.3.1 Mass Spectrometry ............................................................................. 62 2.3.2 Other Interfaces and Detectors ...........................................................65 2.3.3 Data Systems ......................................................................................66