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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)
pharmacovigilance,403,407
403 407
product-specific guidance,403–404
403 404
regulatory requirements,226–229
226 229
similar biological products,398–400
398 400
evidence totality of background,84
84
clinical development biosimilar drugs,198–200
198 200
evidence totality of (cont.)extrapolation,212
212
extrapolation of indications,275
275
stepwise approach,2–3
2 3
exaggerated pharmacology,185
185
exclusivity competition,418–420
418 420
external comparability,24
24
extinction coefficient,65–66
65 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
402 403
clinical considerations,268–275
268 275
immunogenicity,272–273
272 273
pharmacokinetic/pharmacodynamic studies,269–271
269 271
quality considerations,265–268
265 268
quality similarity,265–267
265 267
statistical considerations,275–279
275 279