Session: TI Application of Quality by Design in Drug Product Process Development

Quality-by-Design (Qbd), formally defined in ICH Q8(R1) Pharmaceutical Development, involves understanding the relationship between the manufacturing process and the drug product quality attributes. It requires defining a "design space" for the range of material or process inputs that will yield a product with acceptable attributes. Speakers are invited to present first-principles, experimental, or semi-empirical methods used to develop design spaces during drug product development. Speakers are also invited to discuss methods and case studies using risk assessment to determine what variables do and do not need to be included in design spaces.