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- Questions - Bioequivalence – Highly Variable Products

- Questions - Bioequivalence – Highly Variable Products. Highly variable drugs or drug products may be defined as those exhibiting intra-subject variability of 30% CV or greater in AUC or Cmax. Does the committee concur?

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- Questions - Bioequivalence – Highly Variable Products

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  1. - Questions -Bioequivalence – Highly Variable Products • Highly variable drugs or drug products may be defined as those exhibiting intra-subject variability of 30% CV or greater in AUC or Cmax. Does the committee concur? • The Advisory Committee is asked to comment on the following approaches and whether there is promise in developing one or both of these approaches to improve the bioequivalence assessment of HVDs. • Direct Expansion of Bioequivalence Limits: Change from 80-125%, and restrict the mean T/R difference, e.g.,  20? What information is necessary to properly set these new confidence interval limits? • Reference Scaling: Scale current bioequivalence criterion based on the reference variability in each study and restrict the mean T/R difference as above.

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