生物相似性FDA的观点 1558条(本栏目收费,不能显示细节,电话15274084725)
legislative history,31–33 33
medicines vs. drugs,36 36
no clinically meaningful difference,37–38 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,160–163 163
confidence-based,160–161 161
highly similar with fingerprintlike similarity,162–163 163
not highly similar,161–162 162
Licensed biological drugs authorized vs.,36 36
Mass spectrometry (MS),177,212–217,213–214,215 215
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