Tag: bioequivalence

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
Posted by: Dorian Wellings in: Health and Medicine
30 Dec | 12:05 PM

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, while AUC measures total exposure. Both must fall within 80%-125% of the original for approval.

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Generic Drug Approval Standards: Safety, Quality, and Strength Requirements

Generic Drug Approval Standards: Safety, Quality, and Strength Requirements
Posted by: Dorian Wellings in: Medications
29 Dec | 12:58 PM

Generic drugs must meet the same safety, quality, and strength standards as brand-name drugs. The FDA ensures this through strict bioequivalence testing, manufacturing inspections, and rigorous review of every application before approval.

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