Definition

The ongoing evaluation comparing a medicine's therapeutic benefits against its risks to determine if the overall profile remains favorable for patients.

Example

A new serious adverse reaction is identified. Benefit-risk assessment considers: How often does it occur? How severe is it? Can it be prevented or managed? How does this compare to the drug's benefits?

Regulatory source

EU GVP Module V, ICH E2C(R2)

Common mistakes

Focusing only on risks without adequately considering benefits, or making benefit-risk determinations without sufficient data.

Inspector question

How do you conduct benefit-risk assessments? Walk me through a recent example where new safety data impacted the assessment.

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