方案摘要
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目 录 一、概述·····························1 二、稳定性研究设计的要点·····················1 (一)样品的批次和规模······················1 (二)包装及放置条件·······················2 (三)考察时间点·························2 (四)考察项目··························2 (五)分析方法··························3 三、稳定性研究的试验方法·····················3 (一)影响因素试验························4 1.1 高温试验···························4 1.2 高湿试验···························4 1.3 光照试验···························5 (二)加速试验··························5 (三)长期试验··························6 (四)药品上市后的稳定性研究···················6 四、稳定性研究的结果·······················7 (一)贮存条件的确定·······················7 (二)包装材料/容器的确定···················· 7 (三)有效期的确定························7 五、名词解释·························· 7 六、参考文献···························8 七、附录·····························9 (一)国际气候带·························9 (二)低温和冻融试验·······················10 (三)稳定性研究报告的一般内容··················10 八、著者·····························11
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