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