Abstract: While drugs and delivery systems become more complex, QbD principles and modeling tools become more essential to be implemented early in the development process to maintain drug products’ stability profile throughout the life cycle. These approaches are used to define packaging design parameters and attributes in order to choose appropriate packaging and sorbent options systematically for optimum shelf life stability. This session will include both invited talks as well as submitted papers on adoption of the QbD paradigm for packaging design for different dosage forms and for shelf life estimation while keeping in mind the patients who use its products and physicians who prescribe them. There will be discussions of how a design space can be defined by taking into account complex drug products and delivery systems, users, physicians and stability considerations. Other issues to be discussed include: - How can developers efficiently implement QbD based approaches in packaging design early in the process without extensive and expensive trial and error? - What are the tools that are available to predict and simulate drug formulation, manufacturing and packaging interaction with formulation throughout the life cycle of the product?

Topical I: Comprehensive Quality by Design in Pharmaceutical Development and Manufacture

Pharmaceuticals (15b)