A novel approach for pharmacological substantiation of safety signals using plasma concentrations of medication and administrative/healthcare databases: A case study using Danish registries for an FDA warning on lamotrigine

• Main Authors: Wenyi Wang (Author), Vera Battini (Author), Carla Carnovale (Author), Raymond Noordam (Author), Ko Willems van Dijk (Author), Kristian Hay Kragholm (Author), Diana van Heemst (Author), Hiie Soeorg (Author), Maurizio Sessa (Author)
• Format: Book
• Published: Elsevier, 2023-07-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

PHARMACOM-EPI is a novel framework to predict plasma concentrations of drugs at the time of occurrence of clinical outcomes. In early 2021, the U.S. Food and Drug Administration (FDA) issued a warning on the antiseizure drug lamotrigine claiming that it has the potential to increase the risk of arrh...