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A Landscape Analysis of Post-Marketing Studies Registered in the EU PAS Register and ClinicalTrials.gov Focusing on Pregnancy Outcomes or Breastfeeding Effects: A Contribution from the ConcePTION Project

INTRODUCTION: A large proportion of medicine product labels lack information on safety in pregnancy and breastfeeding. To address this gap, pharmaceutical companies are requested to develop post-approval studies regarding the use of drugs by pregnant and breastfeeding women. OBJECTIVE: Our study aim...

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Detalles Bibliográficos
Autores principales: Roque Pereira, Leonardo, Durán, Carlos E., Layton, Deborah, Poulentzas, Georgios, Lalagkas, Panagiotis-Nikolaos, Kontogiorgis, Christos, Sturkenboom, Miriam
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9021095/
https://www.ncbi.nlm.nih.gov/pubmed/35357659
http://dx.doi.org/10.1007/s40264-022-01154-7