4类
参考文献:
[1] Tracleer™FDA原研说明书.
[2] 波生坦片FDA指导原则.
[3] 波生坦片日本IF文件.
[4] 徐毅超 楼洪刚 阮邹荣 陈金亮 江 波 邵 蓉 杨丹丹 波生坦片在中国健康受试者中的生物等效性研究[J]临床药理药理学2019 Jun; 24( 6) : 675-680
[5] Parekh Jignesh M,Shah Dhaval K,Sanyal Mallika et al. Development of an SPE-LC-MS/MS method for simultaneous quantification of bosentan and its active metabolite hydroxybosentan in human plasma to support a bioequivalence study.[J] .J Pharm Biomed Anal, 2012, 70: 462-70.