摘要
药物临床试验机构是进行药物临床试验的主要执行单位,药物临床试验机构的规范化管理及高效有序运行对确保高质量完成新药的临床试验具有重要作用。结合湖北省中医院药物临床试验机构建设情况、药物临床试验机构资格认定的准备以及药物临床试验机构日常管理的实际情况,试述如何保障药物临床试验机构高效有序运行,以期为国内同行提供参考。
Drug clinical trial institutions are major drug clinical trial execution units,and the standardized management and the highly efficient and orderly operation of drug clinical trial institutions play an important role to complete the clinical trials of new drugs with high quality.Based on the construction of drug clinical trial institution in Hubei Provincial Hospital of Traditional Chinese Medicine,the accreditation preparation of drug clinical trial institution,and the daily management of drug clinical trial institution,the ensurance of the highly efficient and orderly operation of drug clinical trial institution was described,so as to provide the reference for the other drug clinical trial institution.
出处
《药物评价研究》
CAS
2013年第1期5-7,共3页
Drug Evaluation Research
关键词
药物临床试验机构
新药
临床试验
drug clinical trial institutions
new drug
clinical trials
