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Regulatory Science: What It Is and Why We Need It
Author(s) -
FitzGerald GA
Publication year - 2011
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/clpt.2010.276
Subject(s) - regulatory science , clinical pharmacology , food and drug administration , translational medicine , engineering ethics , incentive , translational science , regulatory agency , action (physics) , business , pharmacology , public relations , medicine , political science , public administration , engineering , economics , physics , pathology , quantum mechanics , microeconomics
“Regulatory science” could be interpreted as the “brand” of science pursued by regulatory agencies such as the US Food and Drug Administration (FDA). The discipline enhances the science base of such agencies, and offers an incentive to sponsors to accelerate understanding of the spectrum of action of therapeutics in ways pertinent to the personalization of medicine. The development of expertise in translational medicine and therapeutics (TMAT) in academia and industry enhances the benefit for public health. Clinical Pharmacology & Therapeutics (2011) 89 2, 291–294. doi: 10.1038/clpt.2010.276