药品稳定性试验方法 847条(本栏目收费,不能显示细节,电话15274084725)
Statistical assessment ...242, 250, 252, 253 253
definition of indices... 250 250
registered specification limits.. 252 252
release limits .. 253 253
regression model (see Regression) release limits .. 234 234
stability design... 235 235
User requirements...175 175
components .. 182, 183 183
employee training/accountability ..182 182
User requirement specification (URS) ... 144–146, 168,184, 189, 248 248
Validation V-model ...191 191
Vendor selection... 189, 190 190
Veterinary International Cooperation 0
on Harmonization (VICH) .. 3 3
Waters®-based U(H)PLC systems .. 103, 105 105
Wide-angle X-ray scattering (WAXS)...298 298
Worksheet header... 170, 171 171
World Health Organization (WHO) stability requirements ..4, 5 5
X-ray scattering ...298 298
Zeneth (computer program) absolute reasoning ... 58, 60, 61 61
degradation profile prediction..55, 56 56
degradation tree .. 57 57