Generic Equivalence
정의
The demonstration that a generic drug delivers the same amount of active ingredient to the bloodstream at the same rate as the brand-name product. The FDA requires generic drugs to have an AUC and Cmax within 80-125% of the reference drug to be considered bioequivalent.
예시
Generic omeprazole must demonstrate that its absorption profile is within the 80-125% bioequivalence window of brand Prilosec.
관련 용어
가이드에서 언급됨
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