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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)
detailed guidance for,75
75
non-U.S.-licensed comparator product,124–125
124 125
demonstrating biosimilarity,58–71
58 71
pediatric BPCI Act for extrapolating,121–122
121 122
publicly-available FDA and,118–119
118 119
Inherent attributes,356
356
Innovator originator vs.,35
35
Insulin aspart recombinant,42
42
detemir recombinant,43
43
glulisine recombinant,44
44
Intercenter agreement (ICA),30
30
Interchangeability;see also Biosimilar(s)/biosimilarity about,193–196,195
193 196 195
Interchangeable biosimilars/interchangeability biological product,193–196
193 196
Interchangeable product,34–35,147
34 35 147
Interferon alfa-2b,42,44
42 44
Interferon beta-1a,268
268
Interferon gamma-1b,44
44
International Conference on Harmonisation (ICH),113
113
risk assessment process defined by,246
246
International Union of Pure and Applied Chemistry,19
19
Intracellular receptors,182
182
Investigator brochure (IB) study protocols and,126
126