Archive: 2026/02

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 like brand-name versions. Cmax shows peak concentration, AUC shows total exposure-both must fall within 80%-125% for approval.

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Serious vs Non-Serious Adverse Events: When to Report in Clinical Trials
Serious vs Non-Serious Adverse Events: When to Report in Clinical Trials

Learn the critical difference between serious and non-serious adverse events in clinical trials, when to report each, and how misclassification wastes time and endangers patients. Based on FDA, ICH, and NIH guidelines.

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Therapeutic Failures: When a Generic Drug Doesn't Work as Expected
Therapeutic Failures: When a Generic Drug Doesn't Work as Expected

Generic drugs are supposed to be safe and effective alternatives to brand-name medications, but when they fail to work as expected, the consequences can be serious. Learn why some generics don't deliver the same results-and what you can do about it.

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