3 projets européens trouvés
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TERMINÉ
Global Research in Paediatrics (GRiP)
Date du début: 1 janv. 2011, Date de fin: 30 juin 2017,
Paediatric drugs (PD) lack appropriate testing. Most drugs have inadequate information about dosing regimen, dose adjustment and how to administer them. These are longstanding problems that unquestionably require concerted efforts at the international level. Both the US and the EU have introduced paediatric legislation that facilitates participation of children in research and pharmaceutical innov ...
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24
Participants partenaires
TERMINÉ
Safety Evaluation of Adverse Reactions in Diabetes (SAFEGUARD)
Date du début: 1 oct. 2011, Date de fin: 30 sept. 2015,
"In 2010 a widely marketed drug for the treatment of type 2 diabetes (T2DM) (rosiglitazone) was taken from the market as it was associated with an increased risk of myocardial infarction, a T2DM complication it was actually supposed to prevent. This example shows several things. First, the approval requirements do not guarantee a longer term positive benefit risk profile. Second, large scale postm ...
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19
Participants partenaires
TERMINÉ
Arrhythmogenic potential of drugs (ARITMO)
Date du début: 1 janv. 2010, Date de fin: 30 juin 2013,
The ability of some compounds to prolong the QT interval of the electrocardiogram and to precipitate Torsade de Pointes (TdP, a potentially fatal arrhythmia) has caused several regulatory interventions, including drug withdrawals. Specific guidelines have been implemented to detect QT liability of new compounds as early as possible. However there is growing evidence that an increase in the QT inte ...
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