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附录： 何时进行肾功能损伤研究的决策树
1.代谢物（活性或毒性）依据相同的决策树。 2.研究者可以选择在ESRD患者中进行简化研究或全面研究。 3.在ESRD患者中进行而不是在透析患者中使用。 4.按照药物的暴露-效应，PK变化具有临床意义时，结果为“阳性”。 5.看 IV.B 部分进行全面研究设计或进行附加研究包括群体药代动力学研究。 注意：如果临床上有相关要求，可以存在推荐单一剂量在肾脏损伤中使用的情况。这方面的例子如抗生素，肾功能损伤研究也推荐对治疗性蛋白质药物，如细胞因子或细胞因子调节剂，其分子量小于69 KDa。 |
