生物仿制药产品开发 1451条(本栏目收费,不能显示细节,电话15274084725)
covalent labeling,55–58 58
CQA see Critical quality attributes criteria for biosimilarity,233–235 235
average bioequivalence,233–235 235
dissolution profile comparison similarity factor,238–239 239
masking effect,236–237 237
population/individual bioequivalence,235–237 237
profile analysis in vitro bioequivalence testing,237–238 238
criticality risk ranking,86,94 94
critical product quality attributes,332–334 334
critical quality attributes (CQAs) analytical similarity assessment,105–106 106
biopharmaceuticals,22,31 31
heterogeneity test and reference products,104 104
quality by design,111 111
quality range approach,98 98
stepwise approach,3,85 85
tier assignments,94,95–102 102
C-terminal residue,115–116 116
cysteine/disulfide bond formation,116–117 117
CZE fingerprint information,64 64
darbepoetin alfa,199–200 200
Deisenhofer IgG-Fc structure,124 124
demonstrating quality similarity,265–267 267
detection differences and assessment,69–70 70