Pharmacovigilance

Definisi

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.

Contoh

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

Istilah Terkait

Adverse Drug Reaction ADR Drug Recall Clinical Trial Phases

Disebutkan dalam Panduan

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