Biowaivers: Criteria

Biowaivers are generally provided for multiple strengths after approval of a bioequivalence study. Biowaiver is applied to a regulatory approval process when the application (dossier) is approved based on evidence of equivalence other than an invivo bioequivalence test. For solid oral dosage forms, the evidence of equivalence is determined based on an invitro dissolution profile comparison between the multisource and the comparator product. The objective of this work was to suggest the biowaivers potential of biopharmaceutical classification system which are known to increase the solubility, dissolution, oral absorption of water insoluble drugs.

Biowaivers are generally provided for multiple strengths after approval of a bioequivalence study. Biowaiver is applied to a regulatory approval process when the application (dossier) is approved based on evidence of equivalence other than an invivo bioequivalence test. For solid oral dosage forms, the evidence of equivalence is determined based on an invitro dissolution profile comparison between the multisource and the comparator product. The objective of this work was to suggest the biowaivers potential of biopharmaceutical classification system which are known to increase the solubility, dissolution, oral absorption of water insoluble drugs.

  • Waivers of Pharmaceutical Dosage Form
  • Waiver for In vivo bioavailability or bioequivalence
  • Waivers of In Vivo Study Requirements
  • Waiver in Dissolutions
  • Waivers of In Vivo Study Requirements

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