生物相似性FDA的观点 1558条(本栏目收费,不能显示细节,电话15274084725)
Peptide bonds,7–8,299 299
Peptide mapping,225–226 226
pH optimization of,302 302
Pharmaceutical development aim of,243 243
Pharmacodynamics (PD) assays considerations,93–95 95
clinical immunogenicity assessment,63–65 65
clinical pharmacology studies,89–91 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 95
time profile appropriate,100 100
Pharmacokinetics (PK) assay considerations,93–95 95
assessment ADA on,189–190 190
clinical immunogenicity assessment,63–65 65
clinical pharmacology studies,89–91 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