Generic Equivalence

Определение

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.

Пример

Generic omeprazole must demonstrate that its absorption profile is within the 80-125% bioequivalence window of brand Prilosec.

Связанные Термины

Peak Plasma Concentration Cmax Area Under the Curve AUC Generic Drug

Упоминается в Руководствах

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