Tag: systemic exposure

Cmax and AUC in Bioequivalence: What Peak Concentration and Total Exposure Really Mean

Cmax and AUC in Bioequivalence: What Peak Concentration and Total Exposure Really Mean

Cmax and AUC are the two key measurements used to prove generic drugs work the same as brand-name versions. Cmax shows peak concentration, while AUC measures total exposure. Both must fall within 80%-125% to be approved.