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Tag: Cmax

Cmax and AUC in Bioequivalence: How Peak Concentration and Total Exposure Determine Generic Drug Equivalence
  • by Yitong Shen
  • 19 Nov 2025
  • 0 Comments

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.

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