计划在冷冻条件下存放的原料药,其再检验日期应当建立在长期存放条件下试验的实际数据之上。
For drug substances intended for storage in a freezer, the retest period should be based on the real time data obtained at the long-term storage condition.
计划在冷冻条件下存放的原料药,其再检验日期应当建立在长期存放条件下试验的实际数据之上。
For drug substances intended for storage in a freezer, the retest period should be based on the real time data obtained at the long-term storage condition.
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