Spring Intro 2023

16/02/2023

Benefit-risk ratio

To obtain an MA, the benefits of the drug must outweigh the risks of treatment…

“Positive benefit-risk ratio / profile” Treatment effect must be •

Clinically relevant (i.e. worthwhile for the patient) • Statistically significant (i.e. not due to chance)

The Organisation for Professionals in Regulatory Affairs

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Benefit-risk ratio

It is NOT mandatory to be: • More effective than existing treatments • Safer than existing treatments…

…but the better your drug vs existing treatments, the higher its benefit-risk ratio and the better the chances of: • Obtaining an MA • Being commercially successful

The Organisation for Professionals in Regulatory Affairs

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