Elements to assess the quality of information of case reports in pregnancy pharmacovigilance data-a ConcePTION project

• Main Authors: Yrea R. J. van Rijt-Weetink (Author), Khoezik Chamani (Author), Antoine C. G. Egberts (Author), Florence P. A. M. van Hunsel (Author), David J. Lewis (Author), Laura M. Yates (Author), Ursula Winterfeld (Author), Eugène P. van Puijenbroek (Author)
• Format: Book
• Published: Frontiers Media S.A., 2023-06-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

To assess the risk of exposure to a medicinal product during pregnancy in an individual case report, the necessary information should be present, complete and clearly described. Previously designed grading tools were not developed for pregnancy pharmacovigilance data. This study aims to identify the...