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土耳其药品试验管理规定。

Regulations governing drug trials in Turkey.

作者信息

Aydin Erdem

机构信息

Faculty of Medicine, Department of Medical Ethics and History, Hacettepe University, Ankara, Turkey.

出版信息

Med Law. 2003;22(1):95-103.

Abstract

The ethical issues involved in drug trials using human subjects have become a challenge to the investigators involved. The needs of the drug industry and the increase in the number of such trials have added to these problems. In Turkey activity in the field is increasing. The legal provisions governing the conduct of drug trials in humans are progressive and improvement is largely directed towards better trial design and protection of volunteers.

摘要

使用人类受试者进行药物试验所涉及的伦理问题,已成为相关研究人员面临的一项挑战。制药行业的需求以及此类试验数量的增加,加剧了这些问题。在土耳其,该领域的活动正在增加。规范人体药物试验行为的法律规定不断进步,改进主要朝着更好的试验设计和保护志愿者的方向发展。

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