生物等效性(Bioequivalence,BE)是指药学等效制剂或可替换药物在相同试验条件下,给予相同的剂量,其活性成分吸收速度和程度的差异无统计学意义。《药品注册管理办法》将生物等效性试验归于临床试验,指用生物利用度研究的方法,以药代动力学参数为指标,比较同一种药 Bioequivalence (BE) means that the pharmacologically equivalent or replaceable drug is administered at the same dose under the same test conditions, with no significant difference in the rate and extent of absorption of the active ingredient. “Drug registration management approach” to bioequivalence test attributed to clinical trials, refers to the method of bioavailability studies, pharmacokinetic parameters as an indicator, compared with the same drug