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Pharmaceutical product development is increasingly involving Quality by Design (QbD) elements through the use of statistical design of experiments (DOE). The structured, multivariate experiments that result are used to define the design space of a process to ensure compliance to regulatory requirements for product submissions. Compliance need not be the sole purpose of quality by design as statistical modeling also can provide great practical value to stakeholders.
This presentation utilizes the multivariate model and the known trends of process inputs to create simulations for the expected population of the manufactured drug product. The simulated results are explored with data visualization techniques to develop a robust control space for the manufacturing process. The end result is a capable process that is likely to produce high quality drug products that are compliant to specifications for critical quality attributes throughout the product life cycle.
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