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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)
legislative history,31–33
31 33
medicines vs. drugs,36
36
no clinically meaningful difference,37–38
37 38
one-size-fits-all vs. case-by-case,37
37
similarity vs. comparability,36
36
totality of the evidence,37
37
Legacy attributes,351
351
Levels of similarity,160–163
160 163
confidence-based,160–161
160 161
highly similar with fingerprintlike similarity,162–163
162 163
not highly similar,161–162
161 162
Licensed biological drugs authorized vs.,36
36
Matrix-assisted laser desorption/ionization time of flight mass spectrometry (MALDI-TOF),171
171
Measurement standards potential benefits,134
134
Mecasermin (rDNA origin),42
42
Mechanical stresses of agitation,293
293