实时和扩展控制温度条件 (ECTC) 稳定性数据分析疫苗的统计考虑
Deok Ryun Kim1, Young Ae You1, Hyeon Seon Ahn1
1International Vaccine Institute, Seoul, Republic of Korea.
Vaccine
|September 23, 2023
概括
开发了一种新的统计方法来评估扩展控制温度条件 (ECTC) 的疫苗稳定性. 这种方法支持冷链之外的疫苗管理,这对低收入和中等收入国家至关重要.
科学领域:
- 制药科学 制药科学
- 生物统计学 生物统计学
- 疫苗学 疫苗学 疫苗学
背景情况:
- 保持疫苗冷链在低收入和中等收入国家面临重大后勤和财务挑战.
- 扩展控制温度条件 (ECTC) 是一个潜在的解决方案,允许在传统冷链之外存储后在有限的时间内使用疫苗.
- 由于稳定性数据评估的复杂性,目前很少有疫苗获得ECTC批准.
研究的目的:
- 开发和提出一个强大的统计方法来评估疫苗稳定性数据,以支持ECTC应用.
- 建立一个计算ECTC批准所需的最低释放强度 (MRP) 的框架.
- 为未来的疫苗稳定性评估提供实用指南,包括R代码.
主要方法:
- 设计了一个全面的统计框架,包括数据收集,分析计划,建模和报告.
- 来自假设疫苗产品的稳定性数据使用R程序进行分析,并使用SAS软件进行验证.
- 一个稳定性测试方案涉及实时 (2-8°C) 和ECTC (40°C) 条件在指定持续时间,通过线性回归分析日志转换数据.
主要成果:
- 线性回归分析在实时和ECTC条件下证实了随着时间的推移稳定的抗原含量.
- 没有观察到任何显著的批量变化,表明可聚合的稳定性数据.
- 在实时条件下储存24个月的疫苗的最低释放强度 (MRP) 确定为966,随后在ECTC下储存14天.
结论:
- 开发的统计框架为ECTC应用提供了一种可靠的方法来评估疫苗稳定性数据.
- 该方法和附带的R代码可以指导未来的疫苗ECTC评估前性稳定性研究.
- 这种方法可以通过支持监管部门批准冷链之外的储存来促进更广泛的疫苗获取.
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