Significance of BA/BE Studies

This section provides recommendations to the applicants, who undertake bioequivalence studies and/or who wish to request a waiver of in vivo bioequivalence studies for immediate release solid oral dosage forms.  Guidance herein explains how the bioequivalence studies should be performed, and when biowaivers can be requested in the context of the WHO Prequalification of Medicines Programme. Data on bioequivalence provide a bridge between two or more pharmaceutical equivalents when safety and efficacy data are available for one of the products, but not for the other. For multisource products bioequivalence studies/bioequivalence assessment conferences are necessary to ensure therapeutic equivalence and interchange ability of the products. Bioequivalence can also be demonstrated by comparative clinical studies, pharmacokinetic studies or appropriate in vitro studies.

This section provides recommendations to the applicants, who undertake bioequivalence studies and/or who wish to request a waiver of in vivo bioequivalence studies for immediate release solid oral dosage forms.  Guidance herein explains how the bioequivalence studies should be performed, and when biowaivers can be requested in the context of the WHO Prequalification of Medicines Programme. Data on bioequivalence provide a bridge between two or more pharmaceutical equivalents when safety and efficacy data are available for one of the products, but not for the other. For multisource products bioequivalence studies/bioequivalence assessment conferences are necessary to ensure therapeutic equivalence and interchange ability of the products. Bioequivalence can also be demonstrated by comparative clinical studies, pharmacokinetic studies or appropriate in vitro studies.

  • Analysis of BA/BE by oral vs parentral
  • Criterion for bioequivalence confidence interval approach
  • Parametric vs non-parametric tests
  • Bioequivalence of endogenous substances
  • Plasma concentration vs time curve (AUC) based dosing
  • Adverse drug reactions
  • In narrow therapeutic index drugs

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