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,
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.
- Questions -
Bioequivalence – Highly Variable Products