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)
Control strategy, 89, 267, 326 326
advanced process controls, 305–9 309
analytical, 262–3, 267, 274 274
excipients, 101, 111–12 112
regulatory guidance, 326–7 327
CQV see Continuous quality verification 0
Critical analytical measures, 264 264
Critical material attributes, 99, 103, 106, 133–4 134
Critical method parameters, 264 264
Critical process parameters, 88 88
drug product, 128–33, 136–9, 304–307 307
Critical quality attributes, 62, 128 128
drug substance, 62–5, 83 83
Crystallization, of drug substance, 68–77, 87, 90 90
Data management, PAT, 246–7 247
Data variation, 158–60 60
Design of experiments, 157–99, 221–3 223
analysis of variance, 166 166
analytical methods, 266, 271–3, 277–8 278
classical designs, 141, 173–4 174
drug product, 138, 141–3, 174–81, 295 295
drug substance, 87, 89 89
model fitting, 161–5, 177–81, 184–7, 204–8,211–20, 272–4 161, 165, 177, 181, 184, 187, 204, 208,211, 220,
optimization, 141, 188–90, 222 222