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Glossary

Appropriately Reduce (risk)

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The reduction of risk to an acceptable level as determined by the manufacturer and regulatory authority (reducing risk as low as reasonably practicable, reducing risk as low as reasonably achievable, or reducing risk as far as possible) without adversely affecting the benefit-risk ratio. 

Other glossary definitions

A

Anonymization

The process of rendering data into a form which does not identify individuals and where…

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N

New Chemical Entity (NCE)

A New Chemical Entity (NCE) is a compound, without any precedent among the regulated and…

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