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Glossary

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

O

Overdose

Administration of a quantity of a medicinal product given per administration or cumulatively which is…

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A

Adverse Event (AE)

Any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including an…

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