Wolf Jeffrey C, Wolfe Marilyn J
Experimental Pathology Laboratories, Inc, Sterling, Virginia 20166, USA.
Toxicol Pathol. 2003 Jan-Feb;31 Suppl:53-7. doi: 10.1080/01926230390178739.
In the late 1970's, Good Laboratory Practice Regulations (GLP) were instituted by agencies such as the USFDA, the USEPA, and the OECD to provide a system for the monitoring of animal studies submitted in support of the safety of regulated products. Although GLP regulations are regularly employed in laboratory mammal projects, they have been comparatively under-utilized in aquatic animal research. This situation is changing due to the continuing emergence of fish as toxicological and pharmaceutical test subjects, human and animal disease models, genetically-engineered food sources, and environmental sentinels. The application of GLP principles to aquatic animal studies poses a variety of challenges, especially in the areas of Study Protocol design and the creation of Standard Operating Procedures (SOP's). This presentation will highlight differences between mammalian and fish studies in the application of GLP principles, and identify specific concerns associated with the formulation of SOP's for fish projects.
20世纪70年代末,美国食品药品监督管理局(USFDA)、美国环境保护局(USEPA)和经济合作与发展组织(OECD)等机构制定了良好实验室规范(GLP),以建立一个系统,用于监测为支持受监管产品安全性而提交的动物研究。尽管GLP法规经常用于实验室哺乳动物项目,但在水生动物研究中相对未得到充分利用。由于鱼类作为毒理学和药物测试对象、人类和动物疾病模型、基因工程食物来源以及环境哨兵不断出现,这种情况正在发生变化。将GLP原则应用于水生动物研究带来了各种挑战,特别是在研究方案设计和标准操作规程(SOP)制定方面。本报告将突出GLP原则应用中哺乳动物研究和鱼类研究之间的差异,并确定与鱼类项目SOP制定相关的具体问题。