药物GLP体系下的多场所研究策略  

Multi-site Study Strategy Under Drug GLP System

作　　者：潘秋兰 吴紫君 柳璐 郭健敏 雷夏凌 杨威 Pan Qiulan;Wu Zijun;Liu Lu;Guo Jianmin;Lei Xialing;Yang Wei(Guangzhou Bay Area Institute of Biomedicine,Guangdong Lewwin Pharmaceutical Research Institute Co.Ltd.,Guangdong Provincial Key Laboratory of Drug Non-Clinical Evaluation and Research,TCM Non-clinic Evaluation Branch of National Engineering Research Center for Modernization of Traditional Chinese Medicine,Guangdong Engineering Research Center for Innovative Drug Evaluation and Research,Guangzhou 510990,China)

机构地区：[1]广州湾区生物医药研究院,广东莱恩医药研究院有限公司,广东省药物非临床评价研究企业重点实验室,国家中药现代化工程技术研究中心中药非临床评价分中心,广东省创新药物评价与研究工程技术研究中心,广州510990

出　　处：《中国药事》2024年第6期611-616,共6页Chinese Pharmaceutical Affairs

基　　金：国家重点研发计划(编号2022YFC0870700);广东省科技领军人才项目(编号210183503006)。

摘　　要：目的:探讨药物非临床研究质量管理规范(Good Laboratory Practice,GLP)体系下多场所研究策略的制定。方法:分析多场所研究开展前对分场所的考察、多场所研究中各级人员的职责与沟通协作方式以及几种多场所研究开展的策略等内容。结果:多场所研究是一项具有一个研究计划和一份最终报告的研究,必须符合GLP,因此应选择完全符合GLP标准的实验室作为分研究场所,在多场所研究开展前应仔细规划,界定好相关人员的沟通方式和职责,专题负责人作为研究的唯一控制点,必须在确保合规方面发挥核心作用。结论:在药物GLP体系下制定符合国内外GLP法规要求的多场所研究策略,必须掌握多场所研究是一项单一研究的原则,选择GLP实验室为分研究场所,仔细规划,各级人员严格履行各自的职责并建立顺畅的沟通方式,专题负责人应充分发挥推动者的角色。Objective:To explore the formulation of multi-site study strategy under drug GLP system.Methods:The investigation of sub-sites before the multi-site study,the responsibilities and ways of communication and cooperation modes of staff at all levels in the multi-site study,and several strategies for conducting multi-site study were analyzed.Results:A multi-site study was a study with a research plan and a final report,which must comply with GLP standards.Therefore,a laboratory that fully complied with GLP standards should be selected as a sub-site.Before the multi-site study,careful planning should be carried out to define the communication methods and responsibilities of relevant personnels,and as the only control point of the study,SD must play a central role in ensuring compliance.Conclusion:To formulate a multi-site study strategy that meets the requirements of GLP regulations at home and abroad under the drug GLP system,it is necessary to grasp the principle that multisite study is a single study,select the GLP laboratory as a sub-research site,carefully plan,and staff at all levels strictly perform their responsibilities and establish smooth communication methods,so that SD can fully play the role of facilitator.

关 键 词：多场所研究 GLP 职责 沟通 药品监管 

分 类 号：R95[医药卫生—药学]