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)
stability summary and conclusions... 38 38
Stability-indicating ..100 100
ED phase (see Early development (ED)) forced degradation study .. 103 103
impurities and degradation products ... 108 108
Stability-indicating assays..340 340
Stability management system audit handling ... 173 173
LIMS (see Laboratory instrument management system (LIMS)) SOP (see Standard operating procedure (SOP)) specially designed and approved facility... 143 143
(see also Stability chambers; Stability control system software) Stability, protein see also Protein stability Stability software program..189 189
Stability studies... 208–210 210
Storage .. 264, 272, 273, 276–279 279
Arrhenius Plot .. 284, 287 287
coefficient of determination .. 265, 267 267
for control samples.. 321 321
impact of humidity... 279–281 281
laws and regulations.. 261 261
at Manufacturer’s Warehouse.. 287, 288 288
MATLAB program... 289, 290 290
regression analysis .. 281, 282 282
stability data, evaluation of Arrhenius equation ... 273 273
Arrhenius Plot .. 284, 287 287
degradation rate .. 272 272
linear decomposition process ... 278 278
short-term stability... 276, 277 277
slope, linear regression line.. 272, 273 273
storage after shipment... 279 279
statistical analysis (see Statistical analysis) statistical computer programs... 281 281
temperature excursions ... 262 262