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