仿制药一致性评价中有关物质研究的思考

有关物质是药品的关键质量属性之一,也是仿制药一致性评价的重要内容,其涉及药品的安全性及其质量的可控性。文章梳理了 仿制药有关物质的来源及研究重点,评估仿制药有关物质的文献分析方法,总结归纳仿制药与被仿制药实际样品的杂质谱分析比较及其 意义,探讨杂质限度的确定原则与方法。

Reflections on the Research of Related Substances in Consistency Evaluation for Generic Drugs

As one of the key quality attributes of drugs, related substance is an important part in consistency evaluation for generic drugs, and associated with drug safety and quality controllability. In this paper, the sources of related substances of generic drugs and the research focuses were analyzed, and the literature analysis methods for related substances of generic drugs were evaluated. In addition, the analysis and comparison of impurity spectra of generics and their brand name counterparts as well as the signi cance thereof were summarized, and the principles and methods for determining impurity limits were discussed.