Generic Equivalence

定义

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.

相关术语

在指南中提及

• Generic vs. Brand Name Drugs
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• Generic Drugs: Safety, Savings, and Myths
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• Biosimilar Drugs: Affordable Biologics
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