Tag: bioequivalence
Drug Interactions: Same Risk for Generic and Brand Medications
Generic and brand-name drugs have the same active ingredients, so their risk for drug interactions is essentially identical. Learn what really matters - and what doesn't - when switching medications.
read more
Partial AUC in Bioequivalence: How Advanced Metrics Ensure Drug Safety and Efficacy
Partial AUC is a precise pharmacokinetic tool used to assess bioequivalence in complex drug formulations. Unlike total AUC, it focuses on specific time windows critical for drug effectiveness and safety-especially for extended-release and abuse-deterrent products. Regulators like the FDA now require it for over 127 drug products.
read more
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.
read more
Generic Drug Approval Standards: Safety, Quality, and Strength Requirements
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.
read more
