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权威解读:仿制药生物等效性该如何计算
王亚宁:具体来说,生物等效性试验中的受试者通常需在不同周期、按照不同序列、交叉服用仿制药和参照药,因此计算时需对固定效应和随机效应进行校正。仿制药和参照药的几何平均数直接相除得到的是描述性结果,不能用于统计推断。T/R比值的90%置信区间是采用模型的 ...
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