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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

S

Somatic-Cell Therapy medicinal Products (sCTP)

These contain cells or tissues that have been manipulated to change their biological characteristics or…

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P

Pre-Market Approval (PMA)

The US Food and Drug Administration FDA requires Premarket Approval PMA for high-risk class III…

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