Tag: FDA bioequivalence
Partial AUC in Bioequivalence: How Advanced Metrics Ensure Drug Safety and Efficacy
Partial AUC is a precise pharmacokinetic tool used to assess bioequivalence in complex drug formulations. Unlike total AUC, it focuses on specific time windows critical for drug effectiveness and safety-especially for extended-release and abuse-deterrent products. Regulators like the FDA now require it for over 127 drug products.
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