Tag: bioequivalence

  • Stéphane Moungabio
  • 9

Partial AUC: Advanced Bioequivalence Measurements Explained

Partial AUC is a refined pharmacokinetic tool used to assess bioequivalence in complex drug formulations where traditional metrics like Cmax and total AUC fall short. It measures drug exposure during clinically relevant time windows to ensure safety and effectiveness.

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  • Stéphane Moungabio
  • 13

Complex Generic Drugs: Why Some Products Are Harder to Approve

Complex generic drugs like liposomal injections and inhalers face major scientific and regulatory hurdles before FDA approval. Unlike simple generics, they require advanced testing, costly development, and unclear guidelines - delaying affordable access for patients.

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