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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)
Comparability of Biotechnology/Biological Products Subject of Changes in their Manufacturing Process,265
265
Comparative Bioavailability Standards: Formulations Used for Systemic Effects,270
270
physiochemical “window of consistency,34–36
34 36
regulatory requirements,337–338
337 338
differences detection and assessment,69–70
69 70
EU regulatory challenges,405–407
405 407
qualitative/quantitative,187
187
differential scanning microcalorimetry (DSC),124
124
Directive 2003/63/EC,397
397
Directive 2004/27/RV,397
397
disaggregated criteria,4,5–6
4 5 6
dissolution profile comparison similarity factor,238–239
238 239
distribution function,316
316
disulfide and cysteine bond formation,116–117
116 117
drug safety pharmacovigilance,361–362
361 362
DSC see Differential scanning microcalorimetry dual-assay approach,337
337
ECD see Electron capture dissociation efalizumab,407
407
electron capture dissociation (ECD),46
46
electron transfer dissociation (ETD),46
46
electrophoresis,41–42
41 42
electrospray ionization (ESI),43
43
Eli Lilly vs. University of Pennsylvania,390
390
Enbrel case study,200–201
200 201