Risk-Based Predictive Stability (RBPS) tools, such as the Accelerated Stability Assessment Program (ASAP) and other models, are used routinely within pharmaceutical development to quickly assess stability characteristics, especially to understand mechanisms of degradation. These modeling tools provide stability insights within weeks that could take months or years to understand using long-term stability conditions only. Despite their usefulness, the knowledge gained through these tools are not as broadly used to support regulatory filing strategies. This paper aims to communicate how industry has used RBPS data to support regulatory submissions and discuss the regulatory feedback that was received.

中文翻译：

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在监管文件中利用基于风险的预测稳定性；行业经验

基于风险的预测稳定性（RBPS）工具，例如加速稳定性评估程序（ASAP）和其他模型，在药物开发过程中通常用于快速评估稳定性特征，尤其是了解降解机理。这些建模工具可以在数周或数年之内提供稳定性见解，而这可能需要数月或数年才能了解仅使用长期稳定性条件。尽管有用，但通过这些工具获得的知识并未广泛用于支持监管备案策略。本文旨在交流行业如何使用RBPS数据来支持法规提交，并讨论收到的法规反馈。