Analysis of the current situation of bioequivalence trails of valsartan capsules
Valsartan capsules are commonly used to treat essential hypertension.Now,this product is one of the important formulations in the generic drug consistency evaluation.By retrieving the bioequivalence trials of valsartan capsules which have passed through the generic drug consistency evaluation in the website of CDE,NMPA,the trial designs and results of different enterprises were analyzed.It was found that the trial designs were much different among enterprises.And there were differences in the sample size and the ratio and CVintra of main pharmacokinetic parameters.In order to reduce the risk of failure and increase the scientificity and efficiency of a trial,it is very necessary to optimize the formulation and process of formulations through pharmaceutical research,conduct pilot trails,and then determine the design and sample size of the pivotal trails.
valsartanoral formulationsgeneric drug consistency evaluationbioequivalence
NETL
NSTL
万方数据
