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)
Storage chambers ..169 169
Storage conditions ..233 233
Strengths, Weaknesses, Opportunities and Threats 0
Stress testing... 204, 205 205
API and drug product .. 77 77
Brazilian agency ANVISA... 77 77
(see also Drug products) drug substance and product ... 76 76
drug substance-specific literatures.. 78 78
forced degradation ..76–78 78
ICH guidelines..76, 77 77
practical approaches .. 78 78
Structure elucidation ..76, 88 88
Student’s t-distribution ... 268–270 270
Substitution ... 316, 317, 327 327
Temperature and humidity distribution diagram..155 155
Temperature excursion ...262, 272, 278, 279 279
see also Shipment Temperature excursion studies...137 137
Tentatively identified structures ...131 131
Test allotment process ..172 172
Test material drug products... 82, 85, 86 86
long-term stability studies .. 89 89
Therapeutic Goods Administration (TGA)... 12 12
Threshold of toxicological concern (TTC) concept accelerated stress conditions and photostress studies ..127 127
actual degradation products ...125 125
excessive stress testing...127 127