应用Excel进行药物有效期的统计分析及预测

Statistical analysis and prediction for the expiration date of drugs by Excel

按照ICH指导原则Q1E附录B中对货架寿命的评价方法从理论上进行了详细的阐述,并通过实际应用进行解释。本文通过对多批稳定性试验数据进行系统的统计学整理,准确地预测了有效期,解决了药品研发过程中的实际问题。

According to the ICH guidelines（appendix B of Q1 E） , the evaluation method of shelf life was expounded in ab- stracto and explained base on practical application in this paper. The expiration date of drugs were accurately predicted by statisti- cal analysis of several batches of stability experimental data, which solved the practical problems during research and development of drugs.