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 53
biosimilar initial advisory,51–53 53
BsUFA fee structure,368–369 369
estimated hours and full-time equivalents,371 371
program submissions and applications volume of,370 370
sponsor,meeting with FDA,109–110 110
Messenger ribonucleic acid (mRNA)transcripts,2–3 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),228,260,297 297
characterization techniques,215 215
Monograph standards,173 173
Motifs and domains,9–11 11
Multimeric proteins,299 299