Potential risk

What is Potential risk?

Potential risk definition and meaning on Health terms:
An unexpected event for which there is suspicion of an association with a medicinal product, but where this association has not been confirmed. Some examples are: toxicological findings seen in non-clinical safety studies which have not been observed in clinical studies; adverse events observed in clinical trials or epidemiological studies for which the difference compared with the control group raises a suspicion of an association, but is not large enough to suggest a causal relationship; a signal arising from a spontaneous adverse reaction reporting system; an event associated with other active substances within the same class or which could be expected to occur based on the similar properties of the medicinal product.

 

reference: https://www.eupati.eu/glossary/

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