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Glossary

Efficacy

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The measurement of a medicine’s desired effect as compared to another healthcare intervention under ideal conditions, such as in a clinical trial.

Other glossary definitions

B

Briefing Book (or briefing materials)

Documentation submitted to facilitate an Agency meeting, for example to request scientific advice in relation…

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S

Serious Adverse Event (SAE)

Adverse event (AE) means any untoward medical occurrence associated with the use of a drug…

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