按照ICH指导原则Q1E附录B对药物有效期的评价方法，利用Minitab统计软件的统计分析功能，对药品实际稳定性考察中的数据进行拟合回归，准确推断出药物有效期，为药物有效期的准确判断提供一种方法。%In accordance with the ICH Guideline(Appendix B of Q1E), we performed fitting and regression analysis to the data obtained in stability study with Minitab17.0 Software. Finally, we concluded the shelf life of drug exactly, which provide a method to determine the shelf life of drug.
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