Aspects to consider in causality assessment of safety signals: broadening the thought process

• Main Authors: Tarek A. Hammad (Author), Salman Afsar (Author), Laura B. McAvoy (Author), Hervé Le Louet (Author)
• פורמט: ספר
• יצא לאור: Frontiers Media S.A., 2023-05-01T00:00:00Z.
• נושאים: article
• גישה מקוונת: Connect to this object online.

In the field of drug safety, causality assessment aims to determine the level of plausibility of the relationship between an adverse event and exposure to a particular product. It is after the causality assessment process that we will be able to point out a product adverse reaction. While regulators...