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)
Quality systems (QS), 47 47
roles and responsibilities, 49–50 50
Quality target product profile (QTPP), 120,126–8, 135–6, 324 324
Real time release testing (RTRT), 316–17 see 317
Process analytical technology (PAT) 0
Regulatory guidance, 321–33 333
Risk management, 12 see also Quality risk 0
Scale‐up, 143–4, 242, 309–10 310
Science‐ and risk‐based approaches, 4–6, 129,149, 228–9, 259, 262, 270, 274, 284–5,292–3, 316 4, 6, 129,149, 228, 229, 259, 262, 270, 274, 284,
Quality target product profile 0
Technology transfer packages, 52–5 55
facilities and equipment, 282–92 292
impact assessment, 288–90 290
user requirement specification, 288, 290 290
9.4.1 Process Sensors . Univariate 233 233
9.4.2 Process Analysers . Multivariate 233 233
9.4.3 Infrared (IR) 233 233
9.4.4 Near Infrared (NIR) 238 238
9.4.5 Tunable Diode Laser Spectroscopy (TDLS) 239 239
9.4.6 Ultraviolet乚Visible (UV乚Vis) 239 239
9.4.8 Focused Beam Reflectance Measurements (FBRM) and Laser Diffraction 239 239
9.4.9 Particle Vision and Measurement (PVM) 239 239
9.4.10 X‐Ray Fluorescence (XRF) 240 240
11.8 The Tablet Press as Part of a Continuous Tableting Line 312 312