bioequivalence
Bioequivalence refers to the relationship between two drugs—typically a brand-name and its generic version—when they are shown to deliver the same amount of active substance into the bloodstream in a similar timeframe. This means that they should work the same way in the body and have the same effectiveness and safety profile. Regulatory agencies require studies to demonstrate bioequivalence before a generic drug can be approved, ensuring that patients can trust generic medications to be equivalent to their brand-name counterparts.
Additional Insights
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Bioequivalence refers to the comparison between two different formulations of the same drug, typically a brand-name medication and its generic counterpart. For a generic drug to be considered bioequivalent, it must release the same active ingredient into the bloodstream at the same rate and to the same extent as the original drug. This ensures that both versions have similar therapeutic effects and safety profiles when taken by patients. Regulatory agencies, like the FDA, require bioequivalence studies to confirm that generic medications can be used interchangeably with their branded versions.