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 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)
long-term conditions ..126 126
mitigation and control strategies ...128 128
mutagens ...125 125
potential impurities ...126 126
QSAR assessment ..127 127
structured and model-based strategy ...125 125
tumor induction ..125 125
Transdermal patches ... 22 22
Transformation chemistry condensations and additions ... 67, 69, 70 70
hydrolytic chemistry..67, 69 69
isomerizations and rearrangements..69, 71 71
oxidative chemistry ...66, 68 68
photochemical reactions ...70–72 72
Transformation library..57–59 59
Transmission electron microscope (TEM) ..297 297
Turbidimetry ...297 297
2D-LC .. 103, 113 113
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United States Food and Drug Administration (USFDA) ... 3, 14–16, 19, 23 23
United States of America national stability guidelines ..14, 15 15
LATAM countries ... 11 11
SADC... 10 10
Regression Bayesian statistics .. 241 241
CQA1 data .. 245 245
fixed batch approach .. 239, 240 240
fixed effects ... 243, 244 244
mixed effect model.. 245 245
poolability .. 235, 236, 238 238
prediction expression .. 247 247
random batch approach .. 240 240
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