Regulatory Science - An Underappreciated Component of Translational Research

Rodney Rouse; Issam Zineh; David G Strauss

doi:10.1016/j.tips.2017.12.006

Regulatory Science - An Underappreciated Component of Translational Research

Trends Pharmacol Sci. 2018 Mar;39(3):225-229. doi: 10.1016/j.tips.2017.12.006. Epub 2018 Jan 9.

Authors

Rodney Rouse¹, Issam Zineh², David G Strauss³

Affiliations

¹ Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD 20993, USA.
² Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD 20993, USA.
³ Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD 20993, USA. Electronic address: David.Strauss@fda.hhs.gov.

PMID: 29329784
DOI: 10.1016/j.tips.2017.12.006

Abstract

Translational science refers to translating basic scientific findings to practical application (i.e., 'bench-to-bedside'). An underappreciated aspect of translational science is regulatory science. Herein, we focus on the importance of regulatory science to facilitate development of innovative new drugs and optimize use of approved drugs, with a call for community participation.

Keywords: drug development; regulatory science; translational science.

Published by Elsevier Ltd.

MeSH terms

Animals
Biomarkers, Pharmacological / analysis
Drug Discovery / methods*
Drug Discovery / organization & administration
Drug Discovery / standards
Humans
Translational Research, Biomedical / methods*
Translational Research, Biomedical / standards
United States
United States Food and Drug Administration

Substances

Biomarkers, Pharmacological