Prior knowledge was successfully used to support the clinical trial applications of two small interfering RNA (siRNA) investigational medicinal products (IMPs). A comparative, risk-based approach was used to introduce supportive stability data from three other siRNA IMPs to establish an initial 36 month drug product shelf life. The structuring of supportive data from other clinical programs into Module 3 Quality of the Common Technical Document and response from health authorities is additionally presented.

中文翻译：

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利用先验知识支持早期临床试验应用：监管 CMC 考虑因素和案例研究

先验知识已成功用于支持两种小干扰 RNA (siRNA) 研究性医药产品 (IMP) 的临床试验应用。一种基于风险的比较方法用于引入来自其他三种 siRNA IMP 的支持性稳定性数据，以建立最初 36 个月的药品保质期。此外还介绍了将来自其他临床计划的支持性数据构建到通用技术文件的模块 3 质量和卫生当局的回应中。