title: Biomarkers in clinical drug development.
abstract: The primary purpose of this Commentary is to complement the description of biomarkers given in this issue in the Pharmaceutical Research and Manufacturers of America report by Lathia et al. I offer several examples of the use of biomarkers that highlight their value in drug development and regulatory decision making.
authors.affiliation: Division of Pharmacometrics, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA. jogarao.gobburu@fda.hhs.gov
authors.forename: J V S
authors.initials: JV
authors.lastname: Gobburu
mesh_terms: D000818:Animals; D015415:Biomarkers / Q000032:analysis; D002626:Chemistry, Pharmaceutical / Q000379:methods / Q000639:trends; D055808:Drug Discovery / Q000379:methods / Q000639:trends*; D004353:Drug Evaluation, Preclinical / Q000379:methods / Q000639:trends; D006801:Humans
chemical_list: D015415:Biomarkers