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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)
Peptide bonds,7–8,299
7 8 299
Peptide mapping,225–226
225 226
pH optimization of,302
302
Pharmaceutical development aim of,243
243
Pharmacodynamics (PD) assays considerations,93–95
93 95
clinical immunogenicity assessment,63–65
63 65
clinical pharmacology studies,89–91
89 91
data comparative human,152
152
human study considerations,153
153
animal inclusion of,62
62
results statistical comparison,100
100
studies integrity of bioanalytical methods in,93–95
93 95
time profile appropriate,100
100
Pharmacokinetics (PK) assay considerations,93–95
93 95
assessment ADA on,189–190
189 190
clinical immunogenicity assessment,63–65
63 65
clinical pharmacology studies,89–91
89 91
data comparative human,152
152
human study considerations,153
153
animal inclusion of,62
62
Pharmacokinetic parameter evaluation of bevacizumab,345
345
Pharmacopoeial Convention US,173
173
Information on biosimilarity 351(k),148
148
CMC data submission,76
76