方法对比

	基于风险的Box-Behnken设计	Box-Behnken Design
领域	实验设计	实验设计
方法族	Process / pipeline	Process / pipeline
起源年份	2005–2009 (QbD-era integration of risk assessment with BBD)	1960
提出者	Box & Behnken (BBD, 1960); risk integration formalized under ICH Q8/Q9 pharmaceutical QbD frameworks (~2005–2009)	George E. P. Box and Donald W. Behnken
类型	Response surface experimental design with risk prioritization	Response surface design (incomplete three-level factorial)
开创性文献	Box, G. E. P., & Behnken, D. W. (1960). Some new three level designs for the study of quantitative variables. Technometrics, 2(4), 455–475.	Box, G. E. P., & Behnken, D. W. (1960). Some new three level designs for the study of quantitative variables. Technometrics, 2(4), 455–475.
别名	Risk-based BBD, Risk-prioritized Box-Behnken, QbD Box-Behnken design, Risk-informed RSM	BBD, Box-Behnken, Box-Behnken RSM design, three-level incomplete factorial design
相关	4	3
摘要	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.	The Box-Behnken design (BBD) is an efficient response surface methodology design that fits a full second-order polynomial model using three levels of each factor. Introduced by Box and Behnken in 1960, it places experimental points at the midpoints of the edges of a hypercube and at the center, avoiding the corner points where all factors are simultaneously at their extreme levels. This structure makes BBD particularly attractive when extreme-level combinations are physically impossible, costly, or unsafe to test.