目 录 一、概述·····························1 二、稳定性研究实验设计······················2 （一）样品的批次和规模···················2 （二）包装及放置条件····················2 （三）考察时间点······················2 （四）考察项目·······················3 （五）分析方法·······················3 三、稳定性研究实验方法······················3 （一）影响因素试验·····················3 1、高温试验························3 2、高湿试验························4 3、光照试验························4 （二）加速试验·······················4 （三）长期试验·······················5 （四）药品上市后的稳定性研究················5 四、稳定性研究要求与结果评价···················5 （一）稳定性研究要求····················5 1、新药··························5 2、已有国家标准药品····················6 3、其他··························6 （二）稳定性研究结果评价··················7 1、贮存条件的确定·····················7 2、包装材料/容器的确定·················· 7 3、有效期的确定······················7 五、名词解释···························8 六、参考文献···························8 七、著者·····························8 八、附录·····························8 稳定性研究报告的一般内容 |
