Drugs - Real World Outcomes (2017) 4:139–149 DOI 10.1007/s40801-017-0114-9 ORIGINAL RESEARCH ARTICLE Evaluating the Safety of Medication Exposures During Pregnancy: A Case Study of Study Designs and Data Sources in Multiple Sclerosis 1 1 2 3 • • • • Whitney S. Krueger Mary S. Anthony Catherine W. Saltus Andrea V. Margulis 3 4 4 4 • • • • Elena Rivero-Ferrer Brigitta Monz Ceri Hirst David Wormser Elizabeth Andrews Published online: 29 July 2017 The Author(s) 2017. This article is an open access publication Abstract study population, produced timely and robust results for Background Regulatory agencies often request prospec- spontaneous abortions and major congenital malformations, tive, product-speciﬁc post-authorization pregnancy expo- considering study duration, achievement of target enrollment sure registries to monitor safety during pregnancy, even numbers, inclusion of internal comparators, and publication of though studies using existing health databases could also results. Building on the successful use of existing healthcare be employed. databases to investigate drug safety during pregnancy in other Objectives Using multiple sclerosis (MS) as a case study, disease areas, we identiﬁed 13 data sources that could be used we evaluated various study designs and data sources pre- to study intravenous DMT exposures in women with
Drugs - Real World Outcomes – Springer Journals
Published: Jul 29, 2017
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