DRUG FLOW, GOOD MANUFACTURING PRACTICES, GOOD CLINICAL PRACTICES

被引:0
|
作者
DUPINSPRIET, T
SPRIET, A
机构
来源
THERAPIE | 1991年 / 46卷 / 01期
关键词
GOOD CLINICAL PRACTICES; GOOD MANUFACTURING PRACTICES;
D O I
暂无
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
On a worldwide basis, the drug development circuit in clinical trials undergoes a general movement towards improvement which is sensitive to the degree of quality. The methods used to achieve this are found at the interface of Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP). They consist primarily of two types, for which examples are given here: - strengthening of controls (verification of the resemblance of test drugs in double-blind comparison by a <<jury>> and computerized systems of drug accountability), - improvement in <<compliance with therapy at the site of investigation>> (use of more <<intelligent>> drug packages and labels).
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页码:69 / 74
页数:6
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