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)
pharmacovigilance,403,407 407
product-specific guidance,403–404 404
regulatory requirements,226–229 229
similar biological products,398–400 400
evaluation immunogenicity,343–344,352–353 353
evidence totality of background,84 84
clinical development biosimilar drugs,198–200 200
evidence totality of (cont.)extrapolation,212 212
extrapolation of indications,275 275
exaggerated pharmacology,185 185
exclusivity competition,418–420 420
external comparability,24 24
extinction coefficient,65–66 66
extrapolation clinical trial designs,212 212
in vitro/ex vivo to in vivo activities,134 134
extrapolation of indications biologics complexity,265 265
biotechnology-derived proteins,402–403 403
clinical considerations,268–275 275
immunogenicity,272–273 273
pharmacokinetic/pharmacodynamic studies,269–271 271
quality considerations,265–268 268
quality similarity,265–267 267
statistical considerations,275–279 279