药动学和毒理学的研究中质量保证的几个关键环节.docVIP

药动学和毒理学研究中质量保证的几个关键环节 摘要：对药动学和毒理学研究中质量保证工作需要注意的几个关键环节进行讨论，并指出检查的重点；同时对多地点试验中质量保证工作的注意事项加以讨论。 关键词：质量保证；GLP；多地点试验Key Aspects of Quality Assurance on Pharmacokinetics and Toxicology LIU Yue，GONG Ai-shen，TANG Peng-cho (Shanghai Hengrui Pharmaceutical Co, LTD Shanghai 200245,China;) ABSTRACTS: Key aspects of quality assurance on pharmacokinetics and toxicology were discussed for both one-site and multi-site studies and the emphasis to inspections for facility and study audits were pointed too. KEY WORDS: quality assurance, GLP, multi-site studies. 当今世界，与药品注册有关、用于评价目的物安全性的有关试验都要求执行良好实验室规范(good la