Tag: in vitro dissolution

Bioequivalence Waivers: When the FDA Allows In Vitro Data Instead of Human Studies
  • Nov, 29 2025
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Bioequivalence Waivers: When the FDA Allows In Vitro Data Instead of Human Studies

The FDA allows bioequivalence waivers for certain generic drugs when in vitro dissolution data proves they perform like brand-name versions. This saves time and money while ensuring safety - but only for drugs meeting strict BCS Class I or III criteria.

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