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)
enzyme-linked immunosorbent assay (ELISA),61,442 442
EPO see Erythropoietin epoetin,404 404
epoetin alfa immunogenicity,202–203 203
naming and tracking,369 369
nonclinical studies,343 343
product quality variables,335 335
sensitive study population,348,350 350
equivalence limit,103 103
equivalence margins,277 277
equivalence test,95–97,163–165 165
equivalence trials,271,278 278
errors,34,105,419–420 420
erythropoietin (EPO)background,110 110
glycosylation,120–121 121
inconsistencies apparent,168 168
interchangeability,290 290
market experience,427 427
product class-specific guidelines,228 228
safety profile uncertainties,365–366 366
Escherichia coli,155,442 442
ESI see Electrospray ionization etanercept see also Enbrel case study,201 201