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The Next Generation of Drug Safety Science: Coupling Detection, Corroboration, and Validation to Discover Novel Drug Effects and Drug–Drug Interactions
Author(s) -
Tatonetti Nicholas P.
Publication year - 2018
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 - 10.1002/cpt.949
Subject(s) - observational study , drug , medicine , drug trial , clinical trial , intensive care medicine , drug reaction , drug discovery , pharmacology , computer science , bioinformatics , biology
Rare adverse drug reactions and drug–drug interactions (DDIs) are difficult to detect in randomized trials and impossible to prove using observational studies. We must ascribe to a new way of conducting research that has the efficiency of a retrospective analysis and the rigor of a prospective trial. This can be achieved by integrating observational data from humans with laboratory experiments in model systems. The former establishes clinical significance and the latter supports causality.