浅析稳定性试验中OOT的确认方法

Brief Analysis about Identification Method of OOT in Stability Testing

通过对现有OOT确认方法的总结并在借鉴质量管理工具的基础上,提出基于统计学原理的OOT确认方法。结论:现有OOT确认方法虽然简便易用,但缺乏统计学依据,而基于统计学原理的回归控制图法和时间点法则适用于稳定性试验中的OOT确认。

Thorough the summary of current OOT identification method and based on the reference to quality management tools,propose OOT identification methods based on the statistical principles.Conclusions：Current OOT identification methods are easy to use but lack of statistical foundation.Regression control chart method and by time point method,which are both based on statistical principles,are applicable to identification of OOT in stability testing.