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Comparability Protocol

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A comprehensive, prospectively written plan for assessing the effect of a proposed CMC post-approval change on the identity, strength, quality, purity, and potency of a drug product or biological product.


Other glossary definitions


Serious Adverse Event (SAE)

Adverse event (AE) means any untoward medical occurrence associated with the use of a drug…

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Incident for IVDMD (IVDR definition)

Any malfunction or deterioration in the characteristics or performance of a device made available on…

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