Evaluating the Safety of Medication Exposures During Pregnancy: A Case Study of Study Designs and Data Sources in Multiple Sclerosis

Evaluating the Safety of Medication Exposures During Pregnancy: A Case Study of Study Designs and... 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 http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Drugs - Real World Outcomes Springer Journals

Evaluating the Safety of Medication Exposures During Pregnancy: A Case Study of Study Designs and Data Sources in Multiple Sclerosis

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Publisher
Springer International Publishing
Copyright
Copyright © 2017 by The Author(s)
Subject
Medicine & Public Health; Pharmacotherapy; Pharmacology/Toxicology; Internal Medicine
ISSN
2199-1154
eISSN
2198-9788
D.O.I.
10.1007/s40801-017-0114-9
Publisher site
See Article on Publisher Site

Abstract

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

Journal

Drugs - Real World OutcomesSpringer Journals

Published: Jul 29, 2017

References

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