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)
US submissions,430–431
430 431
vs. generics physiochemical challenges,26–27
26 27
biosimilars approval process Canadian approval process,379
379
European approval process,390–391
390 391
patent exclusivities,378
378
United States approval process,383–388
383 388
biosimilars product development absolute change vs. relative change,5
5
aggregated vs. disaggregated criteria,5–6
5 6
biosimilarity index development,11–12
11 12
criteria for biosimilarity,4–7
4 7
differences from generics,3
3
drug interchangeability,10–11
10 11
immunogenicity problem,10
10
manufacturing process,8–9
8 9
moment-based criteria,6–7
6 7
probability-based criteria,6–7
6 7
statistical methods,7–8
7 8
biosimilars prospects for competition automatic substitution,426–427
426 427
biologics and innovation,417–418
417 418
biologics vs. chemical drugs,416–417
416 417
case study drug development,420
420
consumer welfare gains,434
434