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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)
ETD see Electron transfer dissociation EudraVigilance,351,362,370
351 362 370
European Biopharmaceutical Enterprises(EBE),116
116
European developments approval process,390–391
390 391
three Rs principle,177–178
177 178
in vivo studies standard request,176–177
176 177
worldwide interpretation,181–183
181 183
European Federation of Pharmaceutical Industries and Associations(EFPIA),116
116
European Public Assessment Reports,189,199,285
189 199 285
European Union (EU) see also specific topic approved biosimilars,404–405
404 405
biosimilarity assessment,226–229
226 229
biotechnology-derived proteins,399–403
399 403
market experience,427
427
nonclinical and clinical issues,400–403
400 403
notes for guidance/guidelines,398–404
398 404
US biosimilar submissions,430–431
430 431
biotechnology-derived proteins nonclinical and clinical issues,400–403
400 403
pharmacovigilance,403
403
BLA see Biological licensing application bootstrap procedure,237–238
237 238
BPCI see Biologics Price Competition and Innovation Act bundling,431–432
431 432
biosimilar approval process,patent linkage,379
379
Health Canada Patent Register,379–380
379 380
interchangeability,289
289
NOC regulations/conventional patent infringement lawsuit,381
381