Ethical review of radiolabelled drug clinical trial
10.13699/j.cnki.1001-6821.2016.01.024
- VernacularTitle:放射性同位素标记药物临床试验的伦理审查
- Author:
Xu HUANG
1
;
Xiu-Qin WANG
;
Lu-Ning SUN
Author Information
1. 南京医科大学 第一附属医院 科技处
- Keywords:
radiolabelled drugs;
14 C;
clinical trial;
ethical review;
risk and benefit
- From:
The Chinese Journal of Clinical Pharmacology
2016;32(1):75-77,94
- CountryChina
- Language:Chinese
-
Abstract:
The use of radioisotope tracer technique in human new drug trials has some ethical issues , such as the risk of radiation damage to the subject and to the staff , the concern of environmental contamination by the radiolabeled drugs.This article describes the process of the ethical review of a radiolabelled drug clinical trial and our ethical considerations , for the purpose of peer discussion and reference to promote the improve-ment of ethical review of clinical trials for such technology .
