药品与包装材料相容性研究相关指导原则解读——试验结果的评估

Interpretation of the guideline of compatibility study of pharmaceutical products and packaging materials——the assessment of experimental data

本文重点对药品与包装材料相容性研究过程如何进行试验结果的评估进行解读。主要介绍了研究过程的3个评估阶段以及在相容性研究过程进行试验结果安全性评估时涉及的PDE,SCT,QT,AET的概念,同时结合实例对浸出物试验结果如何进行安全性评估进行了说明。

This article is to explain in detail of the assessment of experimental data during compatibility study of pharmaceutical products and packaging materials. Three phases in the evaluation process are introduced, together with the interpretation of the concepts of PDE, SCT, QT and AET. Examples are also given to illustrate the safety assessment process.