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differences during assessment,69–70 70
fingerprint information,64 64
generics vs. biosimilars,26–27 27
immunogenicity assessment,68–69 69
limited number of RP lots,37–38 38
biosimilarity structural assessment (cont.)low-resolution biophysical tools,52–53 53
MS footprinting assessment,55–58 58
native MS assessment,58–61 61
physiochemical challenges,26–27 27
posttranslational modifications,27–31 31
primary fingerprint information,64 64
primary structure,41–51 51
reference product,33–40 40
sample handling/processing steps,36–37 37
sourcing limitations,39–40 40
“window of consistency,31–40 40
biosimilars see also Follow-on biologics candidate format presentation data,345 345
mAbs guideline,178–179 179
pharmacovigilance,363–364 364