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)
ETD see Electron transfer dissociation EudraVigilance,351,362,370 370
European Biopharmaceutical Enterprises(EBE),116 116
European developments approval process,390–391 391
three Rs principle,177–178 178
in vivo studies standard request,176–177 177
worldwide interpretation,181–183 183
European Federation of Pharmaceutical Industries and Associations(EFPIA),116 116
European Public Assessment Reports,189,199,285 285
European Union (EU) see also specific topic approved biosimilars,404–405 405
biosimilarity assessment,226–229 229
biotechnology-derived proteins,399–403 403
interchangeability,289–291,408–409 409
market experience,427 427
nonclinical and clinical issues,400–403 403
notes for guidance/guidelines,398–404 404
US biosimilar submissions,430–431 431
biotechnology-derived proteins nonclinical and clinical issues,400–403 403
pharmacovigilance,403 403
BLA see Biological licensing application bootstrap procedure,237–238 238
BPCI see Biologics Price Competition and Innovation Act bundling,431–432 432
biosimilar approval process,patent linkage,379 379
Health Canada Patent Register,379–380 380
interchangeability,289 289
NOC regulations/conventional patent infringement lawsuit,381 381