Original Publication Date: 9 September, 2016
Publication / Source: Bioanalysis 8(19)
Authors: Zhao Y, Liu G, Angeles A et al
Biomarkers are endogenous compounds and include small molecules, peptides and proteins. Alteration in the normal levels of these molecules are frequently indications of biological conditions including particular disease states, pathogenic processes or pharmacologic responses to a therapeutic administration. Biomarkers have been extensively utilized in screening, diagnosing, staging and therapeutic monitoring of patients to facilitate drug discovery and development [1,2]. With an increasing emphasis on translational research in drug discovery and development across the pharmaceutical industry, additional efforts have been targeted toward their monitoring in clinical studies. In addition to the recently issued US FDA draft guidance on ‘Bioanalytical Method Validation’ , which discussed endogenous biomarkers in one section, American Association of Pharmaceutical Scientists recently held a workshop on approaches for biomarker measurement during drug development in 2015. Applications, such as patient selection criteria and safety, necessitate a high level of rigor for the bioanalytical assay, including requiring validation [4,5].