The Division of Drug Information (DDI)- serving the public by providing information on human drug products and drug product regulation by FDA.
A new Spotlight on CDER Science has been posted. The topic is: "Lab Tests in Rodents Suggest Potential New Biomarker for Acute Pancreatic Injury.”
This spotlight is by Rodney Rouse, DVM, MBA, PhD, Research Veterinary Medical Officer and Acting Associate Director, Division of Applied Regulatory Science, Office of Translational Sciences, Center for Drug Evaluation and Research.
Biomarkers are measurable indicators in the body that can signify the presence of disease or disease severity. The identification of new, reliable and sensitive biomarkers remains a priority for the FDA. In addition to measuring disease presence and severity, a biomarker may detect early tissue injury caused by a drug. These types of biomarkers may be used in safety studies to better characterize a drug’s risk profile during drug development.
One injury requiring more sensitive biomarkers is acute pancreatic injury.
For more information, please visit: Biomarker for Acute Pancreatic Injury.