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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)
trial results interpretation/data analysis,278–279
278 279
ex vivo activities,extrapolation,134
134
Fc R receptor mediation,122,134–136
122 134 136
FDA see also specic topic aggregated vs. disaggregated criteria,5
5
analytical similarity assessment,105–106
105 106
comparability concept,23
23
criticality risk ranking,86
86
differences and assessment,70,71
70 71
equivalence limit,103
103
individual bioequivalence,6
6
interchangeability,212–213
212 213
pharmacokinetics,204–205
204 205
clinical trial sensitivity case study,200–201
200 201
paradigm shift,201–202
201 202
collision-induced dissociation (CID),46
46
comparability biopharmaceuticals,22
22
biosimilarity,23–26
23 26
consistency/biosimilarity,43–47
43 47
differences and assessment,69–70
69 70
pharmacokinetic studies,346–347
346 347