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)
N-acetyl acid (NANA),20 20
Nano intelligent detection system (NIDS)®,193 193
Native-to-unfolded-to-aggregate model,294 294
Nature Reviews: Drug Discovery,37 37
Neupogen,104,162,358,359 359
Neutralization assays cell-based,279–281 281
Neutralization of therapeutic protein,271 271
Neutralizing antibodies,265 265
New England Journal of Medicine Nature Reviews,37 37
New measurement standards potential benefits,134 134
N-glycolyl acid (NGNA),20 20
No clinically meaningful difference,37 37
Nonclinical safety,159 159
Nondisclosure agreement (NDA),29,156 156
Irreversible aggregation,302 302
Ishikawa diagrams,247–251,249 249
Isoelectric focusing (IEF),171 171