Biowaiver

In vivo bioavailability and/or bioequivalence investigations may be waived with a Biowaiver (not considered necessary for product approval). A dissolution test could be used as a surrogate basis for determining whether two medicinal items are equal instead of expensive and time-consuming in vivo trials. At the time, the Biowaiver was only used for pharmaceutical scale-up and post-approval adjustments (SUPAC).

  • High Solubility. High Permeability
  • Low solubility. High Permeability
  • High Solubility. Low Permeability
  • Low Solubility. Low Permeability

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