Are clinical data from spontaneous pharmacovigilancereports transmitted via the Ministry of Health's web portal sufficient to generate a signal without further documentation?

被引:0
作者
Grandvuillemin, Aurelie [1 ]
Jeannot, Audrey [1 ]
Valnet-Rabier, Marie-Blanche [2 ]
Pietri, Tessa [3 ]
Chouchana, Laurent [4 ]
Gautier, Sophie [5 ]
Bera, Annie-Pierre Jonville [6 ]
机构
[1] Univ Hosp Dijon Bourgogne, Reg Pharmacovigilance Ctr Burgundy, F-21000 Dijon, France
[2] Univ Hosp Besancon, Reg Pharmacovigilance Ctr Franche Comte, F-25000 Besancon, France
[3] AP HM, Reg Pharmacovigilance Ctr Marseille, Dept Clin Pharmacol & Pharmacovigilance, F-13000 Marseille, France
[4] Cochin Hosp, AP HP, Reg Pharmacovigilance Ctr, Dept Pharmacol, Paris, France
[5] Lille Univ, Reg Parmacovigilance Ctr, Ctr Pharmacovigilance, Lille Univ Hosp,Dept Clin Pharmacol, F-59000 Lille, France
[6] Univ Hosp, Reg Pharmacovigilance Ctr Ctr Val De Loire, Dept Pharmacosurveillance, F-37000 Tours, France
来源
THERAPIE | 2024年 / 79卷 / 04期
关键词
Pharmacovigilance; Spontaneous report; Safety signal; Clinical data; COMPLETENESS; QUALITY; SENT;
D O I
10.1016/j.therap.2023.10.006
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
引用
收藏
页码:493 / 496
页数:4
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