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The contemporary situation for the conduct of clinical trials in Asia

 

作者: C.G. Fenn,   E. Wong,   D. Zambrano,  

 

期刊: International Journal of Pharmaceutical Medicine  (ADIS Available online 2001)
卷期: Volume 15, issue 4  

页码: 169-173

 

ISSN:1364-9027

 

年代: 2001

 

出版商: ADIS

 

关键词: clinical trials;Asia;good clinical practice;bridging study;ICH guidelines

 

数据来源: ADIS

 

摘要:

The conduct of clinical trials in Asia is a rapidly evolving process. Herein, we attempt to outline the current status of good clinical practice (GCP) standards and regulatory requirements in the region (excluding China and Japan). These vary significantly making some countries more attractive than others for the conduct of global studies. Government bodies and the pharmaceutical industry can both contribute to the continued improvements in standards of trial conduct. There are significant clinical opportunities for studying diseases more prevalent in this region than elsewhere. Furthermore, major benefits can accrue from conducting studies in the region, to companies, to investigators, to physicians and most importantly to patients in the local population.

 

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