What is a post-authorization safety study (PASS)?
A post-authorization safety study evaluates the safety of a medicine after approval, often to characterize risks or confirm its safety profile in practice.
What is a post-marketing safety study?
A post-marketing safety study examines treatment safety after commercial launch, when a therapy is used by larger and more diverse populations.
What is safety signal detection?
Safety signal detection is the systematic search for new or changing safety concerns linked to a treatment, using real-world data.
What is a comparative safety study?
A comparative safety study compares the risk of adverse outcomes between two or more therapies used for the same condition.
Which outcomes do safety studies evaluate?
Safety studies evaluate serious adverse events, hospitalizations, mortality, treatment complications, rare events and risks in special populations.