Pulmonary artery hypertension is a serious disease in respiratory system and a key tache in the mechanism of pulmonary-heart disease. The pathological changes include the contraction and remodeling of the pulmonary ve...
详细信息
Pulmonary artery hypertension is a serious disease in respiratory system and a key tache in the mechanism of pulmonary-heart disease. The pathological changes include the contraction and remodeling of the pulmonary vessels. There are more and more studies on the pulmonary artery hypertension because of its refractory character and the following increasing mortality. This article summarizes the updating research of the factors and mechanism studied on pulmonary artery hypertension recently,to provide a new view for the clinical and basic medical investigation.
生物等效性是指在合适的实验设计下,在给药条件和给药剂量相同时,药物等价物或替代物中的活性或半活性成分在药物作用位点的利用率和利用程度上没有明显的差异~[1].生物等效性试验的目的在于确认药物等价物或替代物是具有相同的疗效和安全性,从而能够相互替代使用~[2].美国食品药品管理局(USFood and Drug Admi Iustration,FDA)~[3]规定在注册药品的专利保护失效后,药品厂商可以通过证明其开发的仿制药品与注册药品生物等效来避免新药的申报程序,按照缩略申报程序来进行药品上市申报.除此之外,当厂商开发出已注册药物的新剂型并且对新剂型与原剂型进行比较,或者注册药物的生产工艺或生产地点等发生变化后,都需要进行生物等效性试验来确认受试药物与参比药物的药物动力学参数是否等同~[4].因此,生物等效性在新药开发与临床试验中具右置要意义
暂无评论