Definition

Estimates of the number of patients or patient-time exposed to a medicinal product, providing context for interpreting adverse event data.

Example

Exposure data shows: 500,000 patients treated in the period, approximately 250,000 patient-years of exposure based on average treatment duration of 6 months.

Regulatory source

ICH E2C(R2), EU GVP Module VII

Common mistakes

Using different exposure methodologies inconsistently, or not clearly stating assumptions and limitations.

Inspector question

How do you estimate patient exposure? What data sources do you use?

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