Pharmaceutical industry is showing a positive approach towards Quality by Design (QbD) for discovery, development, and commercial manufacturing of biopharmaceutical products. Regulatory agencies are providing various guidelines for pharmaceutical industry to build quality, safety and efficacy into their new biopharmaceutical products. Such concept became known as Quality by Design. To assess th...

BACKGROUND The U.S. Food and Drug Administration (FDA) is the regulatory agency responsible for approving all pharmaceutical products marketed in the United States. While the FDA does not conduct research for developing pharmaceutical products, the agency does review all of the scientific evidence that a pharmaceutical sponsor submits and ensures that it demonstrates U.S. regulatory standards f...

BACKGROUND Demonstration of equivalent amounts of the same active pharmaceutical ingredient (API) between generic and innovator products (pharmaceutical equivalence) is a basic requirement of regulatory agencies for intravenous generic drugs prior to clinical use, and constitutes the pivotal point to assume therapeutic equivalence. Physicochemical methods are preferred instead of biological ass...