方法证据记录
Risk-based design of experiments
Risk-based design of experiments (RB-DoE) integrates formal risk assessment — typically using tools such as FMEA or fault tree analysis — with classical experimental design to prioritize which process or product factors are most critical to investigate. Rather than treating all candidate factors equally, this approach ranks factors by their risk priority number or likelihood of affecting quality, safety, or reliability, then allocates experimental runs preferentially to high-risk factors. It is widely used in pharmaceutical development, chemical process engineering, and manufacturing quality management.
源记录
引文逐字复制自方法源记录。这些引文不代表任何层级的验证。
Risk-based Design of Experiments
分类方法记录 · process-pipeline / experimental-design
- Myers, R. H., Montgomery, D. C., & Anderson-Cook, C. M. (2016). Response Surface Methodology: Process and Product Optimization Using Designed Experiments (4th ed.). Wiley. · ISBN 978-1118916018
- International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). (2009). Pharmaceutical Development Q8(R2). ICH Expert Working Group. · URL
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