Design Space Verification for Tablet Dosage Form Using Modeling

Quality by Design principles are well established in the pharmaceutical industry. It is becoming common place to develop the design space for a drug product and include it in the regulatory filing. There are a broad range of methods to establish design space, some of which are focused on individual unit operations and others that take a holistic view of the entire product processing. A new challenge is developing approaches for verifying the design space for commercial production, especially for those defined using data obtained from modeling or small scale experiments. In this talk, a proposal for verifying the design space for a drug product with multiple CPPs, KPPs and CQAs will be discussed using principles of scale-dependencies, use of precedented models, and (when necessary) large scale confirmation batches.