Bioequivalence Metrics and Methods for Biologies

AUC or AUCo-co AUC from zero to infinity, obtained by extrapolation Single-dose crossover Single-dose parallel Extent of exposure metric Less sensitive metric when terminal phase accounts for a large portion of AUC 

AUC0 AUC during dosing interval (x) at steady state Steady-state Steady-state exposure metric dependent on reasonable demonstration of steady-state attainment 

Cmax- Observed maximum or peak concentration Single-dose crossover Parallel group Steady-state (optional) Rate metric (historical) Subject to inaccuracy due to discrete sampling Insensitive to absorption time course differences 

Cmax/AUC Ratio of Cmax to AUC Scaled parameter Variance estimate complicated due to transformation (ratio) of correlated parameters 

Cmin- Minimum plasma concentration Steady-state Sampling and assay dependencies possible 

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