Results and Conclusions Since the introduction of the Biopharmaceutics Classification System(BCS),in vitro testing as a reliable surrogate for an in vivo BE study(biowaiver) becomes possible.

• 结果与结论自生物药剂分类系统(BCS)提出以来,对于普通口服固体制剂采用体外溶出对比研究来替代体内生物等效性研究(即生物等效豁免)已成为可能。