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Tag: ANDA approval

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

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

bioequivalence studies FDA requirements generic drugs ANDA approval bioequivalence criteria
Caspian Sterling
28.11.2025

The FDA requires generic drug manufacturers to prove bioequivalence through strict pharmacokinetic studies to ensure their products match the brand-name version in absorption and effectiveness. Learn how the 80/125 rule, biowaivers, and product-specific guidances make generics safe and affordable.

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