Core Data Elements for Pregnancy Pharmacovigilance Studies Using Primary Source Data Collection Methods: Recommendations from the IMI ConcePTION Project

INTRODUCTION AND OBJECTIVE: The risks and benefits of medication use in pregnancy are typically established through post-marketing observational studies. As there is currently no standardised or systematic approach to the post-marketing assessment of medication safety in pregnancy, data generated th...

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Detalles Bibliográficos
Autores principales: Richardson, Jonathan L., Moore, Alan, Bromley, Rebecca L., Stellfeld, Michael, Geissbühler, Yvonne, Bluett-Duncan, Matthew, Winterfeld, Ursula, Favre, Guillaume, Alexe, Amalia, Oliver, Alison M., van Rijt-Weetink, Yrea R. J., Hodson, Kenneth K., Rezaallah, Bita, van Puijenbroek, Eugene P., Lewis, David J., Yates, Laura M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2023
Materias:
Original Research Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10164024/
https://www.ncbi.nlm.nih.gov/pubmed/36976447
http://dx.doi.org/10.1007/s40264-023-01291-7

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