Tag: FDA guidance

IVIVC and Waivers: How In Vitro Methods Are Replacing In Vivo Bioequivalence Testing

• Robin Tudge
• December 6, 2025
• 0 Comments

IVIVC lets generic drug makers replace costly human bioequivalence tests with lab-based dissolution data. Learn how Level A correlations work, why most submissions fail, and how biorelevant methods are changing the game.