Applying Quality-by-Design approaches to analytical method development has many benefits. It emphasizes the identification of the sources of variability and their impact on method performance. By controlling these factors, variability is reduced, leading to more robust methods. Typically, a design of experiments (DOE) approach is applied to identify and evaluate the effect of the most influential method parameters and any interactions between them.

Watch this webinar to see:

  • AQbD and regulatory insights
  • Examples of DOE in AQbD
  • Case studies demonstrating software-assisted AQbD method development