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Glossary

Potency

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(For Biologics) The measure of the biological activity using a suitably quantitative biological assay, based on the attribute of the product which is linked to the relevant biological properties.

 

Other glossary definitions

A

Adverse Device Effect (ADE)

An adverse event related to the use of a medical device. This definition includes any…

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S

Safety concern

An important identified risk, an important potential risk, or important missing information.

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