Accelerated Predictive Stability Study of a Pediatric Drug Product for a Supplemental New Drug Application

IF 4.3 3区材料科学 Q1 ENGINEERING, ELECTRICAL & ELECTRONIC ACS Applied Electronic Materials Pub Date : 2024-06-06 DOI:10.1208/s12249-024-02848-0

Viktoria Rakers, Jin Wang, Dawen Kou

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Abstract

In this paper, we report two Accelerated Stability Assessment Program (ASAP) studies for a pediatric drug product. Whereas the first study using a generic design failed to establish a predictive model, the second one was successful after troubleshooting the first study and customizing the study conditions. This work highlighted important lessons learned from designing an ASAP study for formulations containing excipients that could undergo phase change at high humidity levels. The stability predictions by the second ASAP model were consistent with available long-term stability data of the drug product under various storage conditions in two different packaging configurations. The ASAP model was part of the justifications accepted by the health authority to submit a stability package with reduced long-term stability data from the primary stability batches for a Supplemental New Drug Application (sNDA).

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为补充新药申请而进行的儿科药物产品加速预测稳定性研究。

本文报告了两项针对儿科药物产品的加速稳定性评估计划（ASAP）研究。第一项研究采用通用设计，未能建立预测模型，而第二项研究在排除了第一项研究的故障并定制了研究条件后取得了成功。这项工作强调了为含有在高湿度条件下可能发生相变的辅料的制剂设计 ASAP 研究的重要经验。第二个 ASAP 模型的稳定性预测结果与药物产品在两种不同包装配置下的各种储存条件下的现有长期稳定性数据一致。ASAP 模型是卫生部门接受的提交稳定性数据包的理由之一，该数据包减少了主要稳定性批次的长期稳定性数据，用于补充新药申请 (sNDA)。

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