药物质量设计的实用方法 407条(本栏目收费,不能显示细节,电话15274084725)
criticality of, 101, 134 134
variability, 99, 102, 107–11, 113, 204–7 207
Failure mode and effects criticality analysis(FMECA), 18, 21, 24, 32, 37–43, 85, 124,138, 286 286
Failure mode effect analysis (FMEA), 18, 20,21, 23, 138, 264, 286–9 289
Fishbone diagram, 19, 22, 83–4, 140, 159, 249,264, 326 326
Impurities, drug substance, 63–4, 82 82
International Conference on Harmonization (ICH), 3, 53–4, 222 222
guidelines, 4–6, 13–14, 118, 128, 222, 228 228
ICH Q8(R2), 5, 13, 118, 126, 147, 150, 154,227, 306 306
ICH Q9, 6, 13, 17, 104, 112–14, 118,286, 297 297
ICH Q10, 6, 53, 89, 118, 150–1, 267, 306 306
ICH Q11, 6, 62–5, 67, 89, 129, 260 260
Ishikawa cause and effect diagram, 19, 22,83–4, 140, 159, 249, 264, 326 326
Key process parameters (KPP), 136–7 137
Knowledge management, 47–50, 53, 188 188
Manufacturing process, 67, 136 136
drug product, 136–8, 247–8, 309–14 314
PAT applications, 244 244
process control, 302–5 305
process understanding, 228, 242, 295, 305 305
Material attributes, 90 90
Multivariate data analysis, 201–25 225