药品稳定性试验方法 847条(本栏目收费,不能显示细节,电话15274084725)
dimerizations ...60, 62 62
drug degradation knowledge ... 55 55
environmental conditions ... 55 55
excipients and counterions ...62, 63 63
forced degradation pathways.. 55 55
(see also Knowledge base)pathway likelihood ..63, 65 65
relative reasoning ..60, 61 61
sets of reaction conditions ..55, 56 56
transformation library ...57–59 59
Zeta potential (ZP) ...298 298
performance qualification ... 151 151
Stability dossier authorities .. 50 50
critical evaluation... 42 42
(see also Deficiencies) IMPs .. 49 49
life cycle management ... 49 49
pharmaceutical companies .. 31 31
post-approval stability commitments ... 44 44
presentation of data ... 44, 46, 47 47
regulatory authority .. 32 32
(see also Regulatory guidance) sections .. 37 37
shelf life and storage conditions .. 39, 48–49 49