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,124–125 125
demonstrating biosimilarity,58–71 71
pediatric BPCI Act for extrapolating,121–122 122
publicly-available FDA and,118–119 119
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,193–196,195 195
Interchangeable biosimilars/interchangeability biological product,193–196 196
Interchangeable product,34–35,147 147
Interferon alfa-2b,42,44 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