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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)
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
Neutralization assays cell-based,279–281
279 281
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
29 156
Irreversible aggregation,302
302
Isoelectric focusing (IEF),171
171