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生物等效性评价是指同一种药物的不同制剂在相同实验条件下,给予相同的剂量,判断其吸收速度和程度有无显著差异的过程。本文对生物等效性研究中出现的新情况进行归纳总结。
Bioequivalence assessment refers to the same drug in different formulations under the same experimental conditions, given the same dose, to determine whether the rate of absorption and the extent of significant difference between the process. This article summarizes the new developments in the bioequivalence studies.