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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)
differences during assessment,69–70
69 70
fingerprint information,64
64
generics vs. biosimilars,26–27
26 27
glycosylation,47–50
47 50
immunogenicity assessment,68–69
68 69
limited number of RP lots,37–38
37 38
biosimilarity structural assessment (cont.)low-resolution biophysical tools,52–53
52 53
MS footprinting assessment,55–58
55 58
native MS assessment,58–61
58 61
physiochemical challenges,26–27
26 27
posttranslational modifications,27–31
27 31
primary fingerprint information,64
64
primary structure,41–51
41 51
reference product,33–40
33 40
sample handling/processing steps,36–37
36 37
sourcing limitations,39–40
39 40
“window of consistency,31–40
31 40
biosimilars see also Follow-on biologics candidate format presentation data,345
345
mAbs guideline,178–179
178 179
pharmacovigilance,363–364
363 364