GLP体系下体外替代技术的质量保证要点

Key points of quality assurance for alternative techniques in vitro under GLP

随着动物福利指导原则的提出,大量替代方法逐步应用于药物非临床安全性评价领域。然而,我国在药物非临床研究质量管理规范(GLP)中,体外替代技术的发展仍处于起步阶段。从人员、实验设施、标准操作规程、质量保证体系、电子数据管理等方面,阐述在GLP体系下如何规范替代方法,严格控制可能影响实验结果准确性的各种主客观因素,降低实验误差,确保实验结果的真实性,以推动替代技术在药物非临床安全性评价中的应用。

As Animal Welfare Guideline proposed, a large number of alternative methods have been applied in the non-clinical areas of drug safety evaluation. This paper describes the formation and the status quo of alternative techniques in vitro in China＇s non-clinical studies on drug law quality management standards from the views on staff, experimental facilities, standard operating procedures, quality assurance system, electronic data management. Under the GLP system, how to regulate the alternative methods and to strict the control of various subjective and objective factors that may affect the accuracy of the results, reduce experimental error, ensure the authenticity of the results are elaborated in order to promote tehe alternative techniques in non-clinical applications in drug safety evaluation.