药学与临床研究2024,Vol.32Issue(2) :179-183.

江苏省药物临床试验机构Ⅰ期药物临床试验专业发展现状分析

Analysis of the Professional Development Status of Phase Ⅰ Drug Clinical trials in Jiangsu Province Drug Clinical Trial Institutions

田媛 徐厚明 刘春帅 胡晨希
药学与临床研究2024,Vol.32Issue(2) :179-183.

江苏省药物临床试验机构Ⅰ期药物临床试验专业发展现状分析

Analysis of the Professional Development Status of Phase Ⅰ Drug Clinical trials in Jiangsu Province Drug Clinical Trial Institutions

田媛 1徐厚明 1刘春帅 1胡晨希1
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作者信息

  • 1. 江苏省药品监督管理局审核查验中心,南京 210019
  • 折叠

摘要

Ⅰ期临床试验是初步的临床药理学及人体安全性评价的试验,近年来,随着创新药物研发步伐的加快,江苏省Ⅰ期药物临床试验专业备案数量和承接项目数量呈增长趋势,但省内承接Ⅰ期药物临床试验项目集中在头部机构,新备案Ⅰ期药物临床试验专业的机构承接项目较少.本文通过检索药物临床试验登记与信息公示平台和药物临床试验机构备案管理信息系统,收集近年来江苏省Ⅰ期药物临床试验专业的数量、专业的建设情况、项目承接情况等信息,对江苏省药物临床试验机构Ⅰ期药物临床试验专业的发展现状进行数据分析,结合机构的发展趋势和特点,对Ⅰ期临床试验专业的建设和发展提出相关建议.

Abstract

Phase Ⅰ clinical trials are preliminary trials of clinical pharmacology and human safety e-valuation.In recent years,with the acceleration of innovative drug research and development,the number of phase Ⅰ drug clinical trial records and the number of projects undertaken in Jiangsu Province have shown an increasing trend,but the projects undertaken in the province are concentrated in head institu-tions,fewer are undertaken by newly recorded phase Ⅰ drug clinical trial professional institutions.By searching the drug clinical trial registrations,the information publicity platform and the record management information system of drug clinical trial institutions,this paper collected information such as number and construction of phase Ⅰ drug clinical trial professionals and projects undertaken in Jiangsu Province in re-cent years,and conducted data analysis on the development status of phase Ⅰ drug clinical trial profes-sionals.Based on the development trend and characteristics of the institutions,some suggestions are put forward for the construction and development of Phase Ⅰ clinical trial professionals.

关键词

Ⅰ期药物临床试验专业/数据分析/发展趋势和特点/建议

Key words

Phase Ⅰ drug clinical trial specialty/Data analysis/Development trends and characteris-tics/Suggestion

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出版年

2024
药学与临床研究
江苏省药学会

药学与临床研究

CSTPCD
影响因子:0.95
ISSN:1673-7806
参考文献量19
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