(170e) QbD in the Generic Pharmaceutical Industry: Anticipating Its Effects On the Development of Immediate and Modified Release Dosage Forms

FDA and the generic pharmaceutical industry have been engaged in discussions regarding the implementation of specific quality by design principles since 2009. Though many elements of quality by design have long been utilized in generic product development, the expectations of FDA and an overall strategy for adoption of these principles in the generic industry remain unclear. This presentation will discuss the main elements of QbD which have been proposed for immediate release and modified release dosage forms, and will attempt to anticipate how these elements can be formally incorporated into generic product development.