摘要
以我国临床试验相关法律与法规为准则,以与该类制品有类似功能、使用人群基本接近的旧结核菌素和结核菌素/卡介菌素纯蛋白衍生物临床报告的不良反应为参考,在受试药品合格、使用方法正确的前提下,对新型结核病皮内诊断试剂临床研究中可能产生的风险进行分析,并提出相应的控制措施,为降低此类制品的临床研究风险提供参考。
XU Miao,PU Jiang,YANG Lei,LU Jin-biao,TAO Li-feng,ZHONG Zai-xin,CHEN Bao-wen,DU Wei-xin,WANG Guo-zhi.（Division of Tuberculosis Vaccines,National Institutes for Food and Drug Control,Beijing 100050,China ）
In order to reduce the risk of clinical trial for new tuberculosis intradermal diagnostic reagents in China,we made the risk assessment and provided the corresponding prevention and control measures for their clinical trial under the normal usage of qualified products.During the risk assessment,we took the Chinese laws and regulations on clinical trials as the guideline and referring to the evaluation of reported adverse events of OT and TB/BCG PPD close to such products in function and applicable people.
出处
《中国防痨杂志》
CAS
2013年第6期460-462,共3页
Chinese Journal of Antituberculosis
基金
"十二五"国家重大科技项目(2012ZX10004701)
关键词
结核
诊断
皮内试验
指示剂和试剂
危险性评估
Tuberculosis/diagnosis
Intradermal tests
Indicators and reagents
Risk assessment
