The Next Generation of Drug Safety Science: Coupling Detection, Corroboration, and Validation to Discover Novel Drug Effects and Drug-Drug Interactions

Clinical Pharmacology and Therapeutics
Nicholas P Tatonetti

Abstract

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.

References

May 10, 2002·Pharmacoepidemiology and Drug Safety·Eugène P van PuijenbroekAntoine C G Egberts
Sep 8, 2012·Journal of the American Medical Informatics Association : JAMIA·George Hripcsak, David J Albers
Sep 3, 2013·Clinical Pharmacology and Therapeutics·A Jacunski, N P Tatonetti
Feb 12, 2015·Clinical Pharmacology and Therapeutics·T LorberbaumN P Tatonetti
Feb 11, 2016·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Tal LorberbaumNicholas P Tatonetti
Oct 16, 2016·Journal of the American College of Cardiology·Tal LorberbaumNicholas P Tatonetti
Apr 8, 2017·Journal of the American College of Cardiology·Pietro Enea LazzeriniFranco Laghi-Pasini

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Citations

Aug 2, 2019·British Journal of Clinical Pharmacology·Florence van HunselAgnes Kant
Jan 10, 2018·Clinical Pharmacology and Therapeutics·Sreeneeranj Kasichayanula, Karthik Venkatakrishnan
Dec 18, 2020·British Journal of Clinical Pharmacology·Nicholas P GiangrecoNicholas P Tatonetti

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