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13136136841)
orthogonal PLS, 217–20 220
partial least squares, 208–17 217
principal component analysis, 202–8 202,20 8
Normal operating range, 147–8, 222, 329 329
Process analytical technology (PAT), 220,227–55 255
crystallization processes, use in, 78–80 80
drug product manufacture, use in, 151,247–52, 299 299
process analysers, 230, 233–40, 303–4 304
process sensors, 230, 233, 237, 302–5, 315 315
real‐time release testing, 151, 245, 316 316
regulatory requirements, 240, 242 242
Process capability, 111, 153, 297 297
Process design, 136–9, 295–7 297
regulatory submission content, 325 325
enhanced approach, 63, 145, 151, 258,260–62 262
facilities, systems and equipment,application to, 285–6 286
process equipment design, impact of QbD,300–2 302
Quality risk management (QRM), 11–45, 112,286, 296–7, 324 324
risk assessment, 12, 15, 83, 104, 113–14,124, 129–33, 140, 263–4, 270–1, 286 263
risk priority number, 21, 85, 287–8 288
risk process, 15–17, 297 297
risk tools, 17–22, 138 138