Bioequivalence Protocols : In vivo/ In vitro studies

Both bioavailability and bioequivalence focus on the release of a drug substance from its dosage form and subsequent absorption into the systemic circulation. Bioavailability and Bioequivalence studies are required by regulations to ensure therapeutic equivalence between a pharmaceutically equivalent test product and a reference product. Several in vivo and in vitro methods are used to measure product quality.

  • Drug formulations
  • Fixed-dose combination products
  • Manufacturing drugs

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