Biomarkers in drug discovery and development.

Biomarkers have shown promising utilities at various stages of the pharmaceutical R & D. With the recent technological advancements and the introduction of protein and gene arrays, high performance instrumentation (e.g., high-field nuclear magnetic resonance and high-resolution mass spectrometers), and bioinformatics, decisions on safety and efficacy criteria can be made with a higher degree of confidence. However, there is a scarcity of robust and valid biomarkers to accelerate the drug development process from pre-clinical through all stages of clinical studies. In this article, a brief overview of current definitions, biomarker categories, challenges in biological and analytical validation, along with several clinical examples will be presented.