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Tag: bioequivalence criteria

Bioequivalence Studies: What the FDA Requires Generic Drug Manufacturers to Prove
By : Gabrielle Strzalkowski 25 Nov 2025

Bioequivalence Studies: What the FDA Requires Generic Drug Manufacturers to Prove

The FDA requires generic drug manufacturers to prove bioequivalence through rigorous studies showing their product absorbs at the same rate and extent as the brand-name version. This ensures safety, effectiveness, and therapeutic equivalence.

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