Part of the Office of Clinical Pharmacology, the Division of Applied Regulatory Science (DARS) performs applied research to “develop and evaluate novel tools, standards, and approaches to assess the safety, efficacy, quality, and performance of CDER regulated products”. Division staff also consult with CDER reviewers on safety evaluations of new products, using their expertise on in vitro/in vivo/in silico pharmacology models as well as clinical pharmacology experience and other knowledge to clarify why a side effect occurs. DARS has a number of interesting projects underway, including development and validation of chemical and biochemical informatics tools, tissue based biomarkers for digital quantification of organ injury, and working with an international consortium on the Comprehensive in vitro Proarrhythmia Assay (CiPA) initiative (read more about CiPA here). Read more about the Division and its activities at their web site.

Text Copyright © 2018 Katrina Rogers