Author: Caspian Sterling

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

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

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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