Definition

A study examining how a medicine is marketed, prescribed, and used in practice, providing context for safety data interpretation.

Example

A DUS reveals that 30% of use is off-label in pediatric patients. This context is important when interpreting spontaneous pediatric adverse event reports.

Regulatory source

EU GVP Module VIII

Common mistakes

Interpreting adverse event data without considering actual usage patterns, potentially over- or underestimating risk.

Inspector question

Do you conduct drug utilization studies? How do you use this data to inform your safety evaluation?

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