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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.

 

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Chemistry, Manufacturing & Controls (CMC)

Overcome regulatory, scientific and technical challenges ensuring compliance, flexibility on the production…
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Biologics

Biologic drugs are manufactured in living systems or extracted from biologic sources.…

Other glossary definitions

I

In Vitro Diagnostic Medical Device (IVDMD)

Any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus,…

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O

Orphan Drug Designation (ODD)

Most health authorities promote the development of orphan drugs, by offering a series of incentives…

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