摘要
安全性药理学(safety pharmacology)试验是最晚列入良好实验室规范(good laboratory practice,GLP)管理的毒理学试验。安全性药理学试验为多个小型试验的组合,涉及到多组生理功能的检测,在药品非临床研究质量管理规范和质量保证方面有其特殊性。该文从安全性药理学的定义和范围、研究内容、执行GLP的要求、实验室资质的确认、试验关键阶段的检查、原始资料和报告的审核等方面分析了安全性药理学试验质量保证的程序、要求和注意事项。
Safety pharmacology tests are the latest toxicological tests listed in the study categories regulated by the Good Laboratory Practice(GLP)Regulation.These studies consist of different types of small and short-term experiments involving examination of many groups of physiological functions.They have particularity in drug non-clinical research quality contral standard and Quality Assurance(QA).In the present article,the procedure,requirements,and some special concerns for the QA of the safety pharmacology tests are briefly outlined,with particular emphasis on the definition,scope and the GLP requirements of the safety pharmacology studies,qualifications of the safety pharmacology labs,the inspection of the critical study process,and the audit of the raw data and study reports.
出处
《军事医学科学院院刊》
CSCD
北大核心
2010年第2期184-186,共3页
Bulletin of the Academy of Military Medical Sciences
基金
国家重大新药创制科技重大专项(2008ZX09305-003)