Carrigan G, Bradbury BD, Brookhart MA, Capra WB, Chia V, Rothman KJ, Sarsour K, Taylor MD, Brown JS. External comparator groups derived from real-world data used in support of regulatory decision making: use cases and challenges. Curr Epidemiol Rep. 2022 Dec;9:326-37. doi: 10.1007/s40471-022-00305-9
Margulis AV, Anthony M, Rivero-Ferrer E. Drug safety in pregnancy: review of study approaches requested by regulatory agencies. Curr Epidemiol Rep. 2019 Sep;6(3):380-9. doi: 10.1007/s40471-019-00212-6
Nagar SP, Rane PP, Fox KM, Meyers J, Davis K, Beaubrun A, Inomata H, Qian Y, Kajinami K. Treatment patterns, statin intolerance, and subsequent cardiovascular events among Japanese patients with high cardiovascular risk initiating statin therapy. Circ J. 2018 Mar 23;82(4):1008-16. doi: 10.1253/circj.CJ-17-0811
Andrews EB, Margulis AV, Tennis PS, West SL. Opportunities and challenges in using epidemiologic methods to monitor drug safety in the era of large automated health databases. Curr Epidemiol Rep. 2014 Oct 12;1(4):194-205.
Fleming A, Goatman KA, Sharp PF, Styles CJ, Wikes WN, Olson JA. A large scale validation of automated grading. Eur J Ophthalmol. 2009 May 1;19(3):504.