| 引用本文: | 李娜,郑学学,段丽,王翠杰,杜颖,李向群,谭德讲.疫苗长期稳定性数据的统计评估策略*[J].中国现代应用药学,2025,42(1):17-22. |
| lina,zhengxuexue,duanli,wangcuijie,duying,lixiangqun,tandejiang.Statistical evaluation strategy for the long-term stability data of vaccine[J].Chin J Mod Appl Pharm(中国现代应用药学),2025,42(1):17-22. |
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| 疫苗长期稳定性数据的统计评估策略* |
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李娜1,2, 郑学学1, 段丽3, 王翠杰1, 杜颖3, 李向群1, 谭德讲3
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1.北京民海生物科技有限公司;2.、国家药品监督管理局化学药品质量研究与评价重点实验室;3.国家药品监督管理局化学药品质量研究与评价重点实验室
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| 摘要: |
| 疫苗产品的长期稳定性数据分析是评价产品稳定性的重要依据，是准确制定有效期的基础，也是保障疫苗质量安全的考察要素之一。针对目前疫苗行业稳定性数据评价的科学性问题。本文基于ICH Q5C和ICH Q1E这两个稳定性试验考察和数据分析的指导原则，从实际出发，以冻干人用狂犬病疫苗（人二倍体细胞）36个月的长期稳定性数据分析为例，阐述了疫苗长期稳定性数据的统计分析方法，并初步探讨稳定性内控线和警戒线制定方法。为规范稳定性和有效期的评估方式提供思路和示例，同时为疫苗质量的安全可靠提供保障。 |
| 关键词: 疫苗稳定性 长期稳定性 有效期 统计分析 模型拟合 警戒限 |
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| 基金项目:中国医学科学院“创新疫苗质量评价和标准化研究”,项目编号:2021-I2M-5-005 |
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| Statistical evaluation strategy for the long-term stability data of vaccine |
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lina,zhengxuexue,duanli,wangcuijie,duying,lixiangqun,tandejiang
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1.Beijing Minhai Biotechnology Co., Ltd.;2.NMPA key Lab for Quality Research and Evaluation of Chemical Drug，National Institutes for Food and Drug Control
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| Abstract: |
| The analysis of the long-term stability data of vaccine products is an important basis for the evaluation of product stability, the basis for the accurate formulation of the shelf-life, and also one of the factors to ensure the quality and safety of vaccines. Aiming at the scientific problems of stability data evaluation in vaccine industry. Based on the guiding principles of stability test investigation and data analysis of ICH Q5C and ICH Q1E, this paper takes the 36 months long-term stability data analysis of rabies vaccine（human diploid cell）for human use as an example, expounds the statistical analysis method of long-term stability data, and preliminarily discusses the formulation method of stability internal control line and alert line. The purpose of this study is to provide ideas and examples for standardizing the evaluation of stability and validity, and to ensure the safety and reliability of vaccine quality. |
| Key words: Vaccine stability Long-term stability Shelf-life Statistical analysis Model fit Alert limit |
