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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

E

Early Dialogues Committee (EDC)

The Early Dialogue Committee (EDC) is constituted for a specific product and the members will…

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T

Trend reporting

A reporting type used by the manufacturer when a significant increase in events not normally…

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