首页   按字顺浏览 期刊浏览 卷期浏览 Principles for the conduct of non‐drug clinical studies*
Principles for the conduct of non‐drug clinical studies*

 

作者: GERHARD J. SCHMITT,  

 

期刊: International Journal of Cosmetic Science  (WILEY Available online 1994)
卷期: Volume 16, issue 1  

页码: 39-43

 

ISSN:0142-5463

 

年代: 1994

 

DOI:10.1111/j.1467-2494.1994.tb00080.x

 

出版商: Blackwell Publishing Ltd

 

关键词: non‐drug clinical studies;skin care products;principles for conduct;Declaration of Helsinki

 

数据来源: WILEY

 

摘要:

SynopsisThe World Medical Association's Declaration of Helsinki outlines the principles for the conduct of drug and non‐drug clinical studies. The key difference between drug and non‐drug biomedical research is to be seen in the fact that for non‐drugs, the potential benefits, hazards and discomforts for the volunteer enrolled in a clinical study cannot be weighed against advantages of improving current diagnostic or therapeutic methods. The principles reflected in theGuidelines for Good Clinical Practice for Trials on Medicinal Products in the European Community, issued by the Commission of the European Communities in substantial parts also apply for trials on non‐medicinal products. Specifically this is true with regard to the requirements for the privacy, integrity, and well‐being of volunteers subjected to research, and fully informing them about the risks and benefits potentially associated with the use of a test product. Skin care products are the most prominent group of non‐drug products for which clinical studies are conducted. Using these products, the key differences between executing the principles in a non‐drug and a drug clinical study ar

 

点击下载:  PDF (351KB)



返 回