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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)
Medicines drugs vs.,36
36
Meetings FDA regulatory guidance,51–53
51 53
biosimilar initial advisory,51–53
51 53
BsUFA fee structure,368–369
368 369
estimated hours and full-time equivalents,371
371
program submissions and applications volume of,370
370
sponsor,meeting with FDA,109–110
109 110
Messenger ribonucleic acid (mRNA)transcripts,2–3
2 3
Metal ion–catalyzed oxidation,297
297
Microflow imaging (MFI),273
273
Mixed graphic and numerical data,357
357
Mode of action (MoA),211
211
Molecular spectra,218
218
Monoclonal antibodies (mAb),228,260,297
228 260 297
characterization techniques,215
215
Monograph standards,173
173
Motifs and domains,9–11
9 11
Multimeric proteins,299
299