Abstract

Large molecule pharmaceutical products frequently require refrigerated storage at 2–8 ¨C to maintain their efficacy and safety over the duration of their shelf life, but there are benefits if a product can be stored at room temperature, such as 25 ¨C, for the last few weeks of its shelf life, prior to use. With this type of “hybrid storage,” common methods for estimating shelf life may not be applicable because the products stability trends may change when the product is moved from refrigerated storage to room temperature storage. We propose using linear splines to extend a common method for estimating shelf life and accommodate the change in the stability trend. We show that the proposed method works well with a simulated dataset.

摘要

大分子药品通常需要在 2–8 °C 的温度下冷藏储存，以在保质期内保持其功效和安全性，但如果产品可以在室温（例如 25 °C）下储存，则有好处使用前，保质期的最后几周。对于这种类型的“混合存储”，估计保质期的常用方法可能不适用，因为当产品从冷藏存储转移到室温存储时，产品稳定性趋势可能会发生变化。我们建议使用线性样条来扩展估计保质期的常用方法并适应稳定性趋势的变化。我们表明，所提出的方法适用于模拟数据集。