Risk-based Box-Behnken Design
Risk-based Box-Behnken Design combines the classical three-level Box-Behnken response surface design with a formal risk assessment step — typically a risk ranking tool such as FMEA or Ishikawa analysis — to prioritize which process or formulation factors deserve experimental investigation. Widely adopted in pharmaceutical Quality by Design (QbD) and engineering process optimization, the approach ensures that experimental resources are directed toward the factor combinations most likely to affect product quality or process performance, reducing unnecessary runs while preserving predictive power.
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- Box, G. E. P., & Behnken, D. W. (1960). Some new three level designs for the study of quantitative variables. Technometrics, 2(4), 455–475. · DOI 10.1080/00401706.1960.10489912
- International Council for Harmonisation (ICH). (2009). ICH Q8(R2): Pharmaceutical Development. ICH Harmonised Tripartite Guideline. · URL
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