Generic Equivalence

定義

The demonstration that a generic drug delivers the same amount of active ingredient to the bloodstream at the same rate as the brand-name product. The FDA requires generic drugs to have an AUC and Cmax within 80-125% of the reference drug to be considered bioequivalent.

関連用語

ガイドでの言及

• Generic vs. Brand Name Drugs
  Generic drugs contain the same active ingredient as their brand-name counterparts and must meet rigorous FDA standards. Understanding how generics …
• Generic Drugs: Safety, Savings, and Myths
  Generics account for over 90% of US prescriptions yet cost a fraction of brand-name drugs. This guide explains FDA bioequivalence …
• Biosimilar Drugs: Affordable Biologics
  Biologics revolutionized treatment for cancer, autoimmune disease, and diabetes, but their cost can be prohibitive. Biosimilars offer comparable effectiveness at …