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关于药物代谢物在生物等效性评价中的地位已经争论数十年,目前对于达到最后统一的意见还有相当的距离。一部分人认为检测母体药物就足以反映药物制剂间的性能差异,而另一部分人则认为建立一个能反映所有药物制剂有效性和安全性的生物等效性标准是保证药物间相互替代的可靠方法,而且在实际应用中也存在着很多需要探讨的问题。通过相关情况的综述使我们意识到,对于在生物等效性评价中是否使用代谢物资料没有简单的规则,而众多争议问题的解决必须更多地依赖于以后对于影响药物和代谢物浓度因素的全面了解,药物代谢相关模拟试验的完善和药物基因组学的研究必将大大推动这一问题的解决。
The position of drug metabolites in the assessment of bioequivalence has been debated for decades and there is still a considerable distance between reaching the final unification. While some believe that testing for parent drugs is sufficient to reflect differences in performance among pharmaceuticals, others believe that establishing a bioequivalence standard that reflects the effectiveness and safety of all pharmaceuticals is a reliable way to ensure that drugs are interchangeable, And there are many problems to be discussed in practice. A review of the relevant circumstances led us to realize that there is no simple rule as to whether to use metabolite data in bioequivalence assessments and that the resolution of numerous controversial issues must rely more on the subsequent evaluation of the effects on the concentration of drugs and metabolites A comprehensive understanding of the improvement of drug metabolism related simulation tests and the study of pharmacogenomics will greatly promote the solution of this problem.