| 霍桂桃,吕建军,杨艳伟,屈哲,林志,张頔,王雪,李波.毒性病理学家全球资质认证的必要性及关注点[J].中国药事,2018,32(2):184-189 |
| 毒性病理学家全球资质认证的必要性及关注点 |
| Necessities and Focus of Global Qualification Certification of Toxicologic Pathologists |
| 投稿时间：2017-02-06 |
| DOI：10.16153/j.1002-7777.2018.02.005 |
| 中文关键词: 毒性病理学家 全球认证 非临床毒理学实验 安全性评价 毒性病理学 |
| 英文关键词: toxicologic pathologists global certification nonclinical toxicology study safety evaluation toxicologic pathology |
| 基金项目:十二五国家科技重大专项课题“符合中药特点的有毒中药安评关键技术”（编号2015ZX09501004-002）；十二五国家科技重大专项课题“生物大分子药物特殊评价关键技术研究”（编号2015ZX09501007-004） |
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| 摘要点击次数: 1187 |
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| 中文摘要: |
| 毒性病理学是非临床药物安全性评价的重要组成部分，是毒理学实验中确定化合物引起实验动物组织、器官形态学改变的金标准，因而毒性病理学家的资质及能力对非临床药物毒理学实验的结论至关重要。目前，发达国家和发展中国家毒性病理学家的教育培训、资格认证机制尚未达成一致，未实现相互认可，毒性病理学家的全球认证制度也未建立，再加上全球各国及地区间的教育制度、经济及文化背景的差异，造成了不同国家和地区间毒性病理学家水平差异较大，严重影响了毒性病理学学科的发展、毒性病理学家的培训及非临床药物安全性评价领域国际间的交流与合作。本文从当前非临床药物安全性评价的毒性病理学资质全球认证的重要性出发，介绍了毒性病理学家的职责及全球资质认证的必要性，重点阐述了毒性病理学家资质全球认证的关注点，以期为我国毒性病理学家资质认证以及参加将来国际毒性病理学家资质全球认证提供一定参考并做好相关准备。 |
| 英文摘要: |
| Toxicologic pathology is an important part of the nonclinical safety evaluation of drugs and is the "gold standard" to determine the morphologic changes of the tissues and organs of experiment animals induced by the compounds in the nonclinical toxicology studies, so the qualifcation and ability of toxicologic pathologist are of great importance to the conclusion of nonclinical toxicology studies. So far, the education and training programs, qualification certification systems of the toxicologic pathologists in developed and developing countries have not been unifed and recognized by each other, and the global certifcation system of the toxicologic pathologists has not been established. Moreover, differences between national and regional education systems, economic and cultural background result in huge difference of diagnostic levels of the toxicologic pathologists in different countries and regions and adversely affect the development of toxicologic pathology, toxicologic pathologist's training and the international communications and cooperation in the field of nonclinical safety evaluation of drugs. Based on the importance of the global qualification certification of toxicologic pathologists in the field of nonclinical safety evaluation of drugs, the author introduced the responsibilities and necessities of the global qualification certification, emphasized on the considerations of global qualification certification of toxicologic pathologists, and proposed to provide some references and preparations for the qualification certification of toxicologic pathologists in China and participation in the global qualification certification of toxicologic pathologist in the future. |
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