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)
of proposed biosimilar product,55,111–112,114–117 117
Ligand-gated ion channels,182 182
Liquid aqueous formulation,290 290
Liquid chromatography–mass spectroscopy (LC-MS),171 171
Liraglutide (rDNA origin),44,45 45
Lots multiple,59,77–79 79
originator number of,37 37
proposed products,77,78,173 173
reference,77,78,173,180,315,319,320,322,325,327,332 332
U.S.-licensed comparator,114 114
Lower limit of quantification(LLOQ),189 189
Low–molecular weight heparin(LMWH),163–165 165
Nuclear magnetic resonance (NMR),211 211
Number of selected lots defined,353–355 355
Obama,Barack,31,32,146 146