BCS分类不是很复杂,但是做起来又相对麻烦。跟剂量有关,跟溶解度检测结果有关,跟渗透性(LogP/ClogP/BA)等结果有关,所以有时候1个药物会有多个结果,甚至有的药物被归于1类,还被归于4类,似乎很冲突。当然也可能是小编理解有误。
都是英文,凑合着看吧。原文标题为:Intra-Agency Agreement Between the Eunice Kennedy ShriverNational Institute of Child Health and Human Development and the U.S. Food and Drug Administration Oral Formulations Platform—Report 1
如需原文,请自行检索或者联系小编。
具体药物,还是希望各位看官自行检索,或者自行检测然后判断,具体如何判断,可以参考FDA指导原则,Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System,里面详细描述了如何进行分类。