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
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.
Karve SJ, Panish JM, Dirani RG, Candrilli SD. Health care utilization and costs among Medicaid-enrolled patients with schizophrenia experiencing multiple psychiatric relapses. Health Outcomes Res Med. 2012 Nov 1;3(4):e183-94.
Karve S, Misurski D, Miller J, Davis KL. Costs of sequelae associated with invasive meningococcal disease: findings from a US managed care population. Health Outcomes Res Med. 2011 Nov 1;2(4):e215-26.
Westfall PH, Prillaman B, Ho SY. Properties of multiple intersection-union tests for multiple endpoints in combination therapy trials. J Biopharm Stat. 2001;11(3):125-38. doi: 10.1081/BIP-100107653