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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13136136841)
approaches for formulation development,103
103
blind men investigating elephant appearance,104
104
complexity of stability determinations during,105,106
105 106
dosage form assessment—solid versus liquid dosage forms,93,103
93 103
liquid formulation development,106,107
106 107
in silico methods to assessing protein degradation routes,105
105
stability-indicating assays development,103,105
103 105
as protein therapeutics,3
3
Mutual diffusion coefficient,169
169
Needle technology,153,154
153 154
Newtonian fluid,163,164
163 164
falling ball viscometer use,166
166
kinematic viscosity for,165
165
“Non-Newtonian” fluid,163,164
163 164
Non-site-specific oxidation,53,54
53 54
Nonenzymatic peptide fragmentation,62,64
62 64
antibodies (mAbs)at C-terminus,65
65
electrospray fragments of mAb,66
66
hinge region in IgG1 mAbs,64,65
64 65
pathways for cleavage of peptide bonds,64
64
Nonreducible cross-linking in mAbs,66,67
66 67
histidine oxidation,53,54
53 54
met oxidation,52,53
52 53
Trp oxidation,54,56
54 56