Understanding Therapeutic Equivalence Codes: How the FDA Rates Generic Drugs
Learn how the FDA uses therapeutic equivalence codes and the Orange Book to determine if generic drugs can be safely substituted for brand-name medications.
Learn how the FDA uses therapeutic equivalence codes and the Orange Book to determine if generic drugs can be safely substituted for brand-name medications.
Ever feel different after switching to a generic medication? Discover why bioequivalence and inactive ingredients cause individual reactions, especially with NTI drugs.
Cmax and AUC are the two key metrics used globally to prove generic drugs work the same as brand-name versions. Cmax measures peak concentration, while AUC measures total exposure-both must fall within 80-125% of the original to ensure safety and effectiveness.
Generic and brand-name drugs have the same active ingredients, so their risk for drug interactions is essentially identical. Learn the science behind bioequivalence and why switching to generics is safe for most people.