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
Wu JJ, Rowan CG, Bebchuk JD, Anthony MS. No association between TNF inhibitor and methotrexate therapy versus methotrexate in changes in hemoglobin A1C and fasting glucose among psoriasis, psoriatic arthritis, and rheumatoid arthritis patients. J Drugs Dermatol. 2015 Feb;14(2):159-66.
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.
Loughlin J, Quinn S, Rivero E, Wong J, Huang J, Kralstein J. Tegaserod and the risk of cardiovascular ischemic events: an observational cohort study. J Cardiovasc Pharmacol. 2010 Jun;15(2):151-7.
Dubrey SW, Gnanasakthy A, Stein WK, Song JG, Hardman T, Hynd J, Noble MI. Enoximone in chronic stable angina: a double-blind placebo-controlled cross-over trial. J Cardiovasc Pharmacol. 1994 Apr;23(4):532-8.