Tag: biowaiver

3 December 2025

Kellen Gardner 0

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

IVIVC uses lab-based dissolution testing to predict how a drug behaves in the human body, replacing costly and time-consuming clinical trials. When properly validated, it enables regulatory biowaivers for generic drugs - especially extended-release formulations.

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