Tag: biowaiver

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

Keith Ashcroft
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March 7
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IVIVC uses lab-based dissolution testing to predict how a drug behaves in the body, allowing regulators to waive costly human bioequivalence trials. Learn how it works, where it succeeds, and why it’s reshaping generic drug approval.