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)
trial results interpretation/data analysis,278–279 279
ex vivo activities,extrapolation,134 134
Fc R receptor mediation,122,134–136 136
FDA see also specic topic aggregated vs. disaggregated criteria,5 5
analytical similarity assessment,105–106 106
comparability concept,23 23
criticality risk ranking,86 86
differences and assessment,70,71 71
equivalence limit,103 103
individual bioequivalence,6 6
interchangeability,212–213 213
pharmacokinetics,204–205 205
clinical trial sensitivity case study,200–201 201
paradigm shift,201–202 202
collision-induced dissociation (CID),46 46
comparability biopharmaceuticals,22 22
consistency/biosimilarity,43–47 47
differences and assessment,69–70 70
pharmacokinetic studies,346–347 347
quality package,159,163–166 166