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生物相似性FDA的观点 1558条(本栏目收费,不能显示细节,电话13136136841)
pharmaceuticals stability problem,292
292
Protein products aggregation,135
135
amended definition of “biological product,126–128
126 128
content potency testing,180
180
3D conformation,77–78
77 78
human PK and PD profiles,64–65
64 65
manufacturing process considerations,54–55
54 55
pharmacologic activity of,59–60
59 60
physicochemical characteristics,82
82
product class as,128–129
128 129
receptor-binding and immunochemical properties,84
84
structural characterization,59
59
three properties,134–135
134 135
Protein–protein interaction,300
300
Proteins posttranslational modification,14–22
14 22
glycosylation,19–22
19 22
Protein structure building elements,4,5–6
4 5 6
Licensure pathway for biological products FDA,146–148
146 148