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)
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 36
regulatory requirements,337–338 338
differences detection and assessment,69–70 70
EU regulatory challenges,405–407 407
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 6
dissolution profile comparison similarity factor,238–239 239
distribution function,316 316
disulfide and cysteine bond formation,116–117 117
dossiers,222,335–336,397,398 398
drug safety pharmacovigilance,361–362 362
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
electrospray ionization (ESI),43 43
Eli Lilly vs. University of Pennsylvania,390 390
Enbrel case study,200–201 201