- A Decade of Safety-Related Regulatory Action in the Netherlands A Retrospective Analysis of Direct Healthcare Professional Communications from 1999 to 2009
[作者:Mol, PGM; Straus, SMJM; Piening, S; de Vries, JTN; de Graeff, PA; Haaijer-Ruskamp, FM,期刊:Drug safety, 页码:463-474 , 文章类型: Article,,卷期:2010年33-6]
- Background: As pre-approval trials are inherently limited in assessing the complete benefit-risk profile of a new drug, serious safety issues may emerge once a drug gains widespread use after approval. Regulators face th...
- Infliximab Paediatric Crohn's Disease Educational Plan A European, Cross-Sectional, Multicentre Evaluation
[作者:Arana, A; Allen, S; Burkowitz, J; Fantoni, V; Ghatnekar, O; Rico, MT; Vanhaverbeke, N; Wentworth, CE; Brosa, M; Arellano, FM,期刊:Drug safety, 页码:489-501 , 文章类型: Article,,卷期:2010年33-6]
- Background: The infliximab (Remicade; Schering-Plough, Kenilworth, NJ, USA) Risk Management Plan included the development, execution and tracking of an education programme directed towards prescribers of infliximab for p...
- Drugs Associated with Hepatotoxicity and their Reporting Frequency of Liver Adverse Events in VigiBase (TM) Unified List Based on International Collaborative Work
[作者:Suzuki, A; Andrade, RJ; Bjornsson, E; Lucena, MI; Lee, WM; Yuen, NA; Hunt, CM; Freston, JW,期刊:Drug safety, 页码:503-522 , 文章类型: Article,,卷期:2010年33-6]
- Background: Challenges exist in the clinical diagnosis of drug-induced liver injury (DILI) and in obtaining information on hepatotoxicity in humans. Objective: (i) To develop a unified list that combines drugs incriminat...
- Psychiatric Adverse Events in Randomized, Double-Blind, Placebo-Controlled Clinical Trials of Varenicline: A Pooled Analysis (vol 33, pg 298, 2010)
[作者:Tonstad, S; Davies, S; Flammer, M,期刊:Drug safety, 页码:522-522 , 文章类型: Correction,,卷期:2010年33-6]
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