title: Biomarkers in drug discovery and development.
abstract: 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.
authors.affiliation: Wyeth Pharma, Arcola Road, Collegeville, PA 19401, United States. ray_bakhtiar@merck.com
authors.forename: Ray
authors.initials: R
authors.lastname: Bakhtiar
mesh_terms: D000818:Animals; D015415:Biomarkers / Q000032:analysis*; D003952:Diagnostic Imaging / Q000379:methods; D015195:Drug Design; D004345:Drug Industry / Q000379:methods*; D006801:Humans; D008495:Medical Oncology / Q000379:methods; D009488:Neurosciences / Q000379:methods; D014116:Toxicology / Q000379:methods
chemical_list: D015415:Biomarkers