Tag: Cmax

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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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 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.

Published ON: 30 Dec
Patent Exclusivity vs Market Exclusivity: What’s the Real Difference for Drug Prices?
Patent Exclusivity vs Market Exclusivity: What’s the Real Difference for Drug Prices?

Patent exclusivity and market exclusivity are two different legal tools that protect new drugs. One comes from the patent office, the other from the FDA. Understanding the difference explains why drug prices stay high-and who controls when generics arrive.

Published ON: 10 Dec
Post-Market Surveillance: How Side Effects Are Discovered After Approval
Post-Market Surveillance: How Side Effects Are Discovered After Approval

Post-market surveillance uncovers hidden side effects of drugs and medical devices after approval, using real-world data from millions of users. Learn how systems like MedWatch and AI-powered analytics catch dangers clinical trials miss.

Published ON: 5 Dec
Why the First Generic Filer Gets 180-Day Exclusivity in the U.S. Drug Market
Why the First Generic Filer Gets 180-Day Exclusivity in the U.S. Drug Market

The first generic drug company to file a patent challenge gets 180 days of exclusive sales rights. But this rule, meant to lower drug prices, is often manipulated-delaying competition and keeping patients from affordable medicines.

Published ON: 15 Dec
How to File a Direct Complaint with the FDA as a Patient
How to File a Direct Complaint with the FDA as a Patient

Learn how patients can file direct complaints with the FDA about adverse reactions, product failures, or safety issues with drugs, devices, and supplements. Step-by-step guide on using MedWatch and the Safety Reporting Portal.

Published ON: 25 Dec

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