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Vertaling van "phase i trials " (Nederlands → Frans) :

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.


In 2008, there was a significant increase observed in the number of applications for clinical trials and amendments (changes to an existing file) and of the percentage of phase I trials. The absolute number of non-commercial (“academic”) trials remained stable.

In 2008, there was a significant increase observed in the number of applications for clinical trials and amendments (changes to an existing file) and of the percentage of phase I trials. The absolute number of non-commercial (“academic”) trials remained stable.


Trials are underway examining the use of Tasigna in CML with suboptimal response to Glivec, as well as a Phase III trial in patients with GIST.

Des essais sont en cours pour étudier l’utilisation de Tasigna dans la LMC qui répond mal au Glivec, ainsi que des essais de phase III chez des malades atteints de GIST.


Afinitor is being studied in many cancer types: Phase III studies are underway in neuroendocrine tumors (NET), breast cancer, lymphoma and tuberous sclerosis complex (TSC), while Phase III trials are planned to be initiated in hepatocellular carcinoma (HCC) and gastric cancer.

Afinitor fait l’objet d'études dans de nombreux types de cancer: Des études de phase III sont en cours dans les tumeurs neuroendocrines (TNE), le cancer du sein, le lymphome et la sclérose tubéreuse complexe (STC), tandis qu’il est prévu de commencer des essais de phase III dans le carcinome hépatocellulaire (CHC) et le cancer de l'estomac.


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.


One striking point is the clear trend towards an increasing number of phase I trials, from 17% in 2004 to 24% in 2007, as well as the increase in the number of submitted academic clinical trials: from 3% in 2004 to 7% in 2007.

One striking point is the clear trend towards an increasing number of phase I trials, from 17% in 2004 to 24% in 2007, as well as the increase in the number of submitted academic clinical trials: from 3% in 2004 to 7% in 2007.


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


Explorative (phase 0) trials are required in order to make the right choice both quickly and with little expenditure.

Explorative (phase 0) trials are required in order to make the right choice both quickly and with little expenditure.


In 2007, 560 new complete applications were submitted, 24% of which were for phase I trials, while 1214 amendments to existing or current applications were also submitted.

In 2007, 560 new complete applications were submitted, 24% of which were for phase I trials, while 1214 amendments to existing or current applications were also submitted.


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.




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Date index: 2022-06-16
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