Biomarkers in clinical drug development.
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.
Gobburu
J V S
JV
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
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
D015415:Biomarkers