Traduction de «phase » (Néerlandais → Français) :

For phase I studies, and therefore the large majority of early phase trials, the statutory time limit amounts to just 15 days.
For phase I studies, and therefore the large majority of early phase trials, the statutory time limit amounts to just 15 days.

In the course of 2008 there were at least another 99 early phase trials of which 43 trials being carried out for the first time in humans, 164 phase I trials (including those not falling under the definition of an early phase trial), 176 phase II trials and 223 phase III trials. The database currently does not always allow a distinction to be made between early phase trials as defined above and later phases.
In the course of 2008 there were at least another 99 early phase trials of which 43 trials being carried out for the first time in humans, 164 phase I trials (including those not falling under the definition of an early phase trial), 176 phase II trials and 223 phase III trials. The database currently does not always allow a distinction to be made between early phase trials as defined above and later phases.

However, the figures do clearly show that there is a considerable number of early phase trials. There are 7 units in Belgium actively undertaking phase I clinical trials and a number of early phase trials are being conducted in centres where there is expertise in specific clinical areas.
However, the figures do clearly show that there is a considerable number of early phase trials. There are 7 units in Belgium actively undertaking phase I clinical trials and a number of early phase trials are being conducted in centres where there is expertise in specific clinical areas.

in healthy volunteers and patients. This entails investigating the safety and efficacy of increasing doses of the product and the pharmacokinetics in phase I and early phase II trials.
in healthy volunteers and patients. This entails investigating the safety and efficacy of increasing doses of the product and the pharmacokinetics in phase I and early phase II trials.

Each report of an adverse effect is now processed in two phases. For the first phase “preparing” the electronic report approximately 60 % of the backlog has been removed.
Each report of an adverse effect is now processed in two phases. For the first phase “preparing” the electronic report approximately 60 % of the backlog has been removed.

Project/ Potential indication/ Planned Current News update Compound Disease area submissions Phase AG0178 Major depressive disorder 2012 III - Sublingual Phase III program initiated May 2010
Syndrome de l’X fragile 2012 II - Début d’une étude pivot chez les adultes au T4 2010 AG0178 Maladie dépressive grave 2012 III - Programme de phase III pour administration sublinguale

Selected pharmaceutical pipeline projects Project/ Potential indication/ Planned Current News update Compound Disease area submissions Phase ACZ885 Refractory gout acute 2010 III - On track for 2010 submission flares Systemic onset juvenile 2011 III idiopathic arthritis Type 2 diabetes II ≥2014 Secondary prevention of ≥2014 III - Phase III start planned end 2010 cardiovascular events Afinitor Neuroendocrine tumors 2010 III - On track for 2010 submission
Projets pharmaceutiques importants en pipeline Indication potentielle/ Projet / domaine Soumissions Phase Mises à jour molécule thérapeutique prévues actuelle ACZ885 Crises aiguës de la goutte réfractaire 2010 III - En voie d’être soumis en 2010

o Significant innovation momentum underpinned by FDA approval of Gilenya as first-inclass novel therapy for relapsing multiple sclerosis; Tasigna received positive CHMP opinion and approval in Switzerland as first-line therapy; positive Phase III trial data for Onbrez over salmeterol and positive Phase III data for MenB
o Accélération importante de l’innovation, soutenue par l’homologation par la FDA de Gilenya, un nouveau traitement, premier de sa classe, contre la sclérose en plaques cyclique; Tasigna a obtenu un préavis favorable du CHMP et a été autorisé en Suisse comme traitement de première ligne; résultats positifs d’un essai de phase III pour Onbrez comparé à salmétérol et bons résultats de phase III pour MenB

gebruik, EARLY PHASE DEVELOPMENT, PRO-ACTIEVE VIGILANTIE;
gebruik, EARLY PHASE DEVELOPMENT, PRO-ACTIEVE VIGILANTIE;

Het kan nuttig zijn date een firma zijn programma voor indiening van klinische studies (bv. phase
Il peut être utile qu’une firme vienne exposer son programme de soumission d’essais cliniques (ex. :