目的 比较2种生物药剂学分类系统的异同及应用现状。方法 搜集生物药剂学分类系统(biopharmaceutics classification system,BCS)和基于药物体内处置的生物药剂学分类系统(biopharmaceutics drug disposition classification system,BDDCS)的文献及指导原则,比较概念、分类标准和应用进展方面的差异,及使用时应注意的问题。结果 BCS和BDDCS使用时涉及溶解性、渗透性、代谢程度等问题,判定方法的不同有可能会导致不同的分类结果。不同监管机构对两者的认知尚未完全统一。结论 BCS和BDDCS分类对于理解药物特性、特别是在药物研发、仿制药一致性评价中有重要应用,但引用时要明确数据来源,考虑可能带来的风险,做到合理使用。
Abstract
OBJECTIVE To compare the difference between two kinds of biopharmaceutics classification systems and their applications. METHODS Literatures and guidelines on biopharmaceutics classification system(BCS) and biopharmaceutics drug disposition classification system(BDDCS) were collected, the differences in conception, classification criteria, and application were compared, and problems which should be paid attention to in application were summarized. RESULTS A lot of issues such as solubility, permeability, extent of metabolism and so on are involved in the application of BCS and BDDCS. Different classification criteria may have different results. The recognition for the two kinds of pharmaceutics classification systems by different administration organizations is not yet completely consistent. CONCLUSION BCS and BDDCS play important roles in understanding the properties of drugs, especially in drug development and evaluation of generic drug conformance, however, the source of data should be identified when quoting the data. Possible risks should be considered for rational use of the data.
关键词
生物药剂学分类系统(BCS) /
基于药物体内处置的生物药剂学分类系统(BDDCS) /
溶解性 /
渗透性 /
代谢程度 /
仿制药一致性评价
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Key words
biopharmaceutics classification system /
biopharmaceutics drug disposition classification system /
solubility /
permeability /
metabolism extent /
generic drug conformance evaluation
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中图分类号：
R284
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参考文献
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脚注
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基金
国家“重大新药创制”科技重大专项项目资助(2017ZX09101001)
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