Tag: bioequivalence
Dec, 30 2025
How to Compare Dissolution Profiles and What They Mean for Generic and Brand Drugs
Dissolution profiles determine if generic drugs work like brand names. Learn how regulators use f2 similarity factors, biowaivers, and advanced testing to ensure safety and equivalence without human trials.
Dec, 15 2025
How the FDA Ensures Generic Drugs Work the Same as Brands
The FDA ensures generic drugs work just like brand-name versions through strict bioequivalence testing, identical active ingredients, and the same manufacturing standards. Over 90% of U.S. prescriptions are filled with generics that save billions annually.
Nov, 27 2025
How the FDA Ensures Generic Drug Safety Through Manufacturing Oversight
The FDA ensures generic drug safety through strict manufacturing oversight, bioequivalence testing, global inspections, and continuous monitoring. Learn how generics meet the same standards as brand-name drugs.