Pharmacovigilance

Définition

The science and activities relating to the detection, assessment, understanding, and prevention of adverse drug effects. Pharmacovigilance continues throughout a drug's entire market life and includes spontaneous reporting systems (like FDA MedWatch), signal detection, and risk management.

Exemple

Post-marketing pharmacovigilance detected the link between rofecoxib (Vioxx) and heart attacks, leading to its withdrawal in 2004.

Termes Associés

Adverse Drug Reaction ADR Drug Recall Clinical Trial Phases

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