非临床毒理学实验毒性病理学家培训现状简介  

Brief Introtuction of Current Status of Training of Toxicologic Pathologists in Nonclinical Toxicology Studies

作　　者：吕建军[1] 霍桂桃[1] 林志[1] 屈哲[1] 杨艳伟[1] 张頔[1] 张硕[1] 李波[2] 

机构地区：[1]中国食品药品检定研究院国家药物安全评价监测中心药物非临床安全评价研究北京市重点实验室,北京100176 [2]中国食品药品检定研究院,北京100050

出　　处：《中国药事》2016年第10期988-996,共9页Chinese Pharmaceutical Affairs

基　　金：科技部"十二五"重大新药创制专项课题(编号2012ZX09302001);"重大新药创制"科技重大专项课题(编号2015ZX09501007-004)

摘　　要：目的:简要介绍国内外非临床毒理学实验毒性病理学家培训的现状,有助于非临床毒理学实验毒性病理学数据的产生、解释、整合及交流。方法:本文介绍了毒性病理学的概述、毒性病理学家的作用、毒性病理学家需掌握的理论知识和操作技能、毒性病理学家掌握理论知识的合适的教育方法、毒性病理学家所需操作技能的获得途径、毒性病理学家培训方案、毒性病理学家继续教育活动及我国毒性病理学家培训的现状等内容。结果:学员应在一个经过认证的机构学习至少5年的学术课程并获得临床学位(兽医学或医学),然后在住院实习期和/或在职学徒期接受至少4年的强化病理学实践,其中2年必须重点为非临床毒理学实验毒性病理学家相关的内容。强烈推荐毒性病理学家获得1个公认的病理资格认证。定期的终身继续教育(组织病理学同行评议、专业会议、读片会或短期课程)有助于保持和提高毒性病理学家现有毒性病理知识、技能和病理诊断帮助工具。结论:本文简要介绍了国内外非临床毒理学实验毒性病理学家培训的现状,为我国药物非临床安全性评价领域更好地培训毒性病理学家提供了一定参考。Objective： To introduce the current status of domestic and overseas training future toxicologic pathologists, which is helpful to generate, interpret, integrate, and exchange data of toxicologic pathology in nonclinical toxicology studies. Methods： Basic concepts of toxicologic pathology, roles of toxicologic pathologists, knowledge and skills required, suitable educational approaches to aquiring knowledge, ways of acquiring practical work-related skills, practices for training toxicologic pathologists, future educational activities as well as the current status of the training of toxicologic pathologists of China were analyzed and introduced. Results： Trainees should undertake an academic curriculum for at least five years in an accredited institution and obtain clinical degrees（veterinary medicine or medicine）. Besides trainees should practice pathology intensively in a residency and/or on-the-job ＂apprenticeship＂, for at least four years, at least two years of which must be spent on toxicologic pathology supporting nonclinical toxicology studies. Possession of a recognized pathology qualification（i.e., certification） is highly recommended. Regular and life-long education（peer review of histopatholgy, professional meetings, slide-reading conferences or short-term courses） will be necessary to maintain and enhance one＇s understanding of current knowledge, skills, and tools of toxicologic pathology for pathology diagnosis. Conclusion： The current status of domestic and overseas training future toxicologic pathologists in nonclinical toxicology studies was briefly introduced to provide some references for better training of toxicologic pathologists in the field of nonclinical safety evaluation of drugs in China.

关 键 词：非临床 毒理学实验 毒性病理学家 培训 建议 启示 

分 类 号：R95[医药卫生—药学] R99