QbD not always justified
This article was originally published in The Gold Sheet
Executive Summary
Nicholas Cappuccino of Eagle Pharmaceuticals told the recent Pharmaconference meeting in Bethesda, Md., that the design space concept is "poorly understood by the generic drug industry and the brand industry as well." He said complex dosage forms could benefit the most from QbD, while "simple dosage forms such as uncomplicated immediate-release tablets and capsules do not justify the time and expense of QbD filings.