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生物仿制药产品开发 1451条(本栏目收费,不能显示细节,电话13136136841)
covalent labeling,55–58
55 58
covalent PTMs,29,31
29 31
CQA see Critical quality attributes criteria for biosimilarity,233–235
233 235
average bioequivalence,233–235
233 235
dissolution profile comparison similarity factor,238–239
238 239
masking effect,236–237
236 237
population/individual bioequivalence,235–237
235 237
profile analysis in vitro bioequivalence testing,237–238
237 238
criticality risk ranking,86,94
86 94
critical product quality attributes,332–334
332 334
critical quality attributes (CQAs) analytical similarity assessment,105–106
105 106
biopharmaceuticals,22,31
22 31
heterogeneity test and reference products,104
104
quality by design,111
111
quality range approach,98
98
stepwise approach,3,85
3 85
tier assignments,94,95–102
94 95 102
C-terminal residue,115–116
115 116
cysteine/disulfide bond formation,116–117
116 117
CZE fingerprint information,64
64
darbepoetin alfa,199–200
199 200
Deisenhofer IgG-Fc structure,124
124
demonstrating quality similarity,265–267
265 267
detection differences and assessment,69–70
69 70