当前位置：药药网 / 医药文献 /生物仿制药产品开发(本栏目收费,不能显示细节,电话13136136841)
关键字：
类型：
下载页码(大于等于0,小于445)：
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)
patent register procedure,380–381
380 381
postgrant patent office challenges,381–382
381 382
regulatory requirements biosimilarity assessment,230–231
230 231
risk mitigation,381–382
381 382
capillary electrophoresis (CE),26,48
26 48
-carboxylation,119–120
119 120
case studies clinical trial designs,204,206–209
204 206 209
clinical trial sensitivity,200–201
200 201
primary endpoints,210–211
210 211
totality of evidence,199–200
199 200
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
405 407
extrapolation of indications,405–407
405 407
interchangeability,408–409
408 409
interchangeability issues,367–368
367 368
naming biosimilars,368–370
368 370
pharmacovigilance,407
407
safety profile uncertainties,365–367
365 367
substitutability issues,367–368
367 368
switching issues,367–368
367 368
tracking biosimilars,368–370
368 370
competition prospects for automatic substitution,426–427
426 427
biologics and innovation,417–418
417 418