Tag: pharmacokinetics

Cmax and AUC in Bioequivalence: How Peak Concentration and Total Exposure Determine Generic Drug Equivalence

Cmax and AUC in Bioequivalence: How Peak Concentration and Total Exposure Determine Generic Drug Equivalence

Cmax and AUC are the two key pharmacokinetic measures used to prove generic drugs work the same as brand-name versions. Cmax shows peak concentration; AUC shows total exposure. Both must fall within 80%-125% for approval.