单克隆抗体应对最终药物的生产,配制,递送和稳定性方面的挑战 407条(本栏目收费,不能显示细节,电话15274084725)
approaches for formulation development,103 103
blind men investigating elephant appearance,104 104
complexity of stability determinations during,105,106 106
dosage form assessment—solid versus liquid dosage forms,93,103 103
liquid formulation development,106,107 107
in silico methods to assessing protein degradation routes,105 105
stability-indicating assays development,103,105 105
as protein therapeutics,3 3
Mutual diffusion coefficient,169 169
Needle technology,153,154 154
Newtonian fluid,163,164 164
falling ball viscometer use,166 166
kinematic viscosity for,165 165
“Non-Newtonian” fluid,163,164 164
Non-site-specific oxidation,53,54 54
Nonenzymatic peptide fragmentation,62,64 64
antibodies (mAbs)at C-terminus,65 65
electrospray fragments of mAb,66 66
hinge region in IgG1 mAbs,64,65 65
pathways for cleavage of peptide bonds,64 64
Nonreducible cross-linking in mAbs,66,67 67
histidine oxidation,53,54 54