摘要
在明确药品各质量属性限度范围重要性的基础上,针对目前ICH Q6(A/B)在如何科学确定限度范围存在空白的问题,通过查找收集国内外相关文献资料,从药品限度范围及其分类、限度范围的确立和评估依据3个方面,对药品标准中限度范围的确立进行概述,并给出了利用统计区间计算限度范围的实例。最后,强调了在药品生产及质量管理领域,运用统计理念,选择合适的统计区间,是确立更切实可靠的药品标准的重要保障。
On the basis of defining the importance of the acceptance criteria of quality attribute of drugs,and aim at how ICH Q6( A/B) identify the gaps in the acceptance criteria scientifically,the approaches for the establishment of acceptance criteria in drug specification is summarized through three aspects: acceptance criteria and its classification,the establishment of limits and the basis for assessment by collecting relevant literatures at home and abroad. In addition,the example to calculate the acceptance criteria by statistic intervals is given in this paper. Finally,it is emphasized that the use of statistical concepts and the selection of appropriate statistical intervals are important guarantees for establishing more reliable drug specification in the field of drug production and quality management.
作者
马莉
杨化新
谭德讲
杭太俊
MA Li;YANG Hua-xin;TAN De-jiang;HANG Tai-jun(National Institutes for Food and Drug Control, Beijing 102629 , China;China Pharmaceutical University Nanjing 210009 , China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2019年第5期523-527,共5页
Chinese Journal of New Drugs
基金
国家"重大新药创制"科技重大专项资助项目(2015ZX09303001)
北京市科技计划课题资助项目(Z151100000115013)
关键词
药品
质量标准
质量属性
认可标准
置信区间
参考区间
容忍区间
drug
drug specification
quality attribute
acceptance criteria
confidence interval
reference interval
tolerance interval
