北京大学医学部机构知识库
Advanced  
IR@PKUHSC  > 北京大学第一临床医学院  > 临床药理研究所  > 期刊论文
学科主题: 药理学
题名:
Ⅰ期新药临床试验中安全性数据规范化分析探讨
其他题名: Discussions on the standardized safety evaluation of new drugs in phase I clinical trials
作者: 魏敏吉1; 王水强1; 赵彩芸1; 郭旭光1
关键词: Ⅰ期临床试验 ; 安全性分析 ; 规范化 ; 药物安全性 ; 不良事件 ; phase I clinical trial ; safety evaluation ; standardization ; drug safety ; adverse event
刊名: 中国临床药理学杂志
发表日期: 2014
DOI: 10.13699/j.cnki.1001-6821.2014.10.029
期: 10, 页:966-969
收录类别: 中国科技核心期刊 ; 中文核心期刊 ; CSCD
文章类型: Journal Article
摘要: 推进创新药物Ⅰ期临床试验的策略是基于药物的获益/风险比分析,因此,在早期临床阶段就进行规范化的药物安全性评价是一个良好的开端。本文对国内完成的Ⅰ期临床试验安全性评价资料进行了分析,发现存在一些需要改进和提高的方面,如不良事件术语需要统一以及规范化呈交、实验室检查指标的分级、需要关注的重要和未期望的不良事件等。针对这些不足,建议按照人用药品注册技术要求国际协调会(ICH)指导原则的要求进行规范化的安全性分析。 The strategies for pushing phase Ⅰ new drug clinical trials for-ward are based on the ratio of benefit to risk.Thus it would be a good starting to perform a standardized safety evaluation when a new drug enters its early phase trial.In the present paper, we evaluated the safety information contained in the phase I clinical study reports of new drugs and found improvements needed to be done in the following areas , such as the standard terminology used for adverse events , presentation of adverse events, classification of laboratory parameters and special atten -tions to the important and unexpected adverse events , etc.Finally, we proposed to adopt a standardized practice based on Technical Requirements for Registration of Pharmaceuticals for Human Use of International Confer -ence on Harmonization(ICH) guidelines in the assessment of drug safety.
语种: 中文
原文出处: 查看原文
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/44583
Appears in Collections:北京大学第一临床医学院_临床药理研究所_期刊论文

Files in This Item:

There are no files associated with this item.


作者单位: 1.北京大学 第一医院 临床药理研究所,北京,100034
2.国家食品药品管理总局 药品审评中心,北京,100038
3.Westat Inc.Durham,North Carolina 27703,USA

Recommended Citation:
魏敏吉,王水强,赵彩芸,等. Ⅰ期新药临床试验中安全性数据规范化分析探讨[J]. 中国临床药理学杂志,2014(10):966-969.
Service
Recommend this item
Sava as my favorate item
Show this item's statistics
Export Endnote File
Google Scholar
Similar articles in Google Scholar
[魏敏吉]'s Articles
[王水强]'s Articles
[赵彩芸]'s Articles
CSDL cross search
Similar articles in CSDL Cross Search
[魏敏吉]‘s Articles
[王水强]‘s Articles
[赵彩芸]‘s Articles
Related Copyright Policies
Null
Social Bookmarking
Add to CiteULike Add to Connotea Add to Del.icio.us Add to Digg Add to Reddit

Items in IR are protected by copyright, with all rights reserved, unless otherwise indicated.

 

 

Valid XHTML 1.0!
Copyright © 2007-2017  北京大学医学部 - Feedback
Powered by CSpace