Advances in clinical evaluation of the new lipid-altering agents from the perspective of drug administration guidance
Tao Wang · Zhongguo xin yao zazhi · 2012
The cardiovascular death ranks first place among all causes of death in China.Lipid disorder is an important risk factor of cardiovascular diseases.Research of lipid-altering drug is one of the hot spots in the discovery and development of the cardiovascular agents.Clinical research is the essential stage of evaluating the efficacy and safety of new drugs.The rational design and implementation of a clinical trial have major impact on the study results.Therefore,the drug administration agency provides technical suggestions for the industry in the form of guidance generally.This article reviews the guidances on clinical investigation of agents for the treatment of lipid disorders.It may provide references for clinical research of new lipid-altering drugs in China.