AUC、Cmax、Tmax 与制剂之间的关联要怎么调整?这个问题好大,也很现实, 确实不能一言尽数。我试试从不同角度抛准引玉:1.BE studies:?Usually two-way crossover, single-dose study (replicate cross over for high variable drug )?Normal volunteers ?Fasting –BE criteria: 90% CI between 80 and 125% (AUC, Cmax) ?Fed (point-estimate between 80 and 125)2. Example BE results 3. Reasons for “Failure” of BE Studies?Under-powered study ?Unusual study designs ?“Outlier” response from one or more subjects ?Assay issues ?Wrong reference?Baseline-corrected vs. not corrected ?Incorrect statistical analysis ?Compliance issues ?Formulation that is not truly bioequivalent to the reference (配方只是BE失败其中一个原因) 查看更多