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)
patent register procedure,380–381 381
postgrant patent office challenges,381–382 382
regulatory requirements biosimilarity assessment,230–231 231
risk mitigation,381–382 382
capillary electrophoresis (CE),26,48 48
-carboxylation,119–120 120
case studies clinical trial designs,204,206–209 209
clinical trial sensitivity,200–201 201
primary endpoints,210–211 211
totality of evidence,199–200 200
Cauchy–Schwartz inequality,318 318
Celltrion Healthcare Co. Ltd. vs. Kennedy,387 387
certolizumab pegol,201 201
CFDA see China Food and Drug Administration challenges differences,405–407 407
extrapolation of indications,405–407 407
interchangeability,408–409 409
interchangeability issues,367–368 368
naming biosimilars,368–370 370
pharmacovigilance,407 407
safety profile uncertainties,365–367 367
substitutability issues,367–368 368
switching issues,367–368 368
tracking biosimilars,368–370 370
competition prospects for automatic substitution,426–427 427
biologics and innovation,417–418 418