Traduction de «clinical trial data are credible » (Néerlandais → Français) :

" Compliance with this standard (= GCP) provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.‰
ÿ Compliance with this standard (= GCP) provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the princinciples that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible. Ÿ

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.

Key drivers are clinical data demonstrating its prolonged efficacy in lowering blood pressure for more than 24 hours, and superiority in clinical trials over ramipril, a leading ACE inhibitor (an older class of high blood pressure medicines).
Les facteurs-clés de cette progression sont des données cliniques faisant état de sa capacité à réduire la pression sanguine pendant plus de 24 heures et de sa supériorité, lors d’essais cliniques, sur le ramipril, un inhibiteur important de l’IEC (une catégorie plus ancienne de médicaments hypotenseurs).

- Regulatory feedback expected in Q4 2010 Q4 2008 Approved Q3 2010 - Clinical trials to address US Food and Drug Administration (FDA) complete response letter (October 2009) completed in Q3 and data generated from these trials was submitted to the FDA in late September
2010 T4 2008 Autorisé T3 2010 - Essais cliniques pour répondre à la «complete response letter» de la FDA (oct. 2009) achevés au T3 et données soumises à fin septembre à la FDA

Tekturna/Rasilez (USD 290 million, +104% lc), the first in a new class of medicines known as direct renin inhibitors to treat high blood pressure, has been growing consistently since its launch in 2007 based on positive clinical data demonstrating its prolonged efficacy in lowering blood pressure for more than 24 hours and superiority in clinical trials over ramipril, a leading ACE inhibitor.
Rasilez/Tekturna (USD 290 millions, +104% en m. l.), est le premier d’une nouvelle classe de médicaments, les inhibiteurs directs de la rénine, traitant l’hypertension.

Tekturna/Rasilez (USD 119 million, +117% lc), the first new type of high blood pressure medicine in more than a decade, has accelerated its growth pace thanks to an increasing body of data affirming its ability to reduce blood pressure for more than 24 hours, its potential benefits for organ protection, and its consistent superiority in clinical trials over ramipril, a leading ACE inhibitor (another class of high blood pressure medicines).
Rasilez/Tekturna (USD 119 millions, +117% en m. l.), premier médicament d’un nouveau type contre l’hypertension depuis plus d’une décennie, a enregistré une accélération de sa croissance grâce à une masse grandissante de données faisant état de sa capacité à réduire la pression sanguine pendant plus de 24 heures, de ses bénéfices potentiels dans la protection des organes et de sa supériorité constante, manifestée lors des essais cliniques, sur le ramipril, un inhibiteur de l’IEC (une autre classe de médicaments hypotenseurs).

Recent clinical trial data demonstrated a significant delay in tumor progression in patients with metastatic neuroendocrine tumors of the midgut treated with Sandostatin LAR.
Des résultats récents d’essais cliniques ont montré que Sandostatine LAR, administré à des patients atteints de tumeurs neuro-endrocrines métastasiques de l’intestin moyen, ralentissait considérablement la progression de la tumeur.

There is one other fee that is notable for its intended purpose, since the “clinical trial” contribution (1,670,042 euros) will serve not just to cover the FAMHP’s costs but also and above all to finance the Ethics Committees. As far as the taxes are concerned, it should be
There is one other fee that is notable for its intended purpose, since the “clinical trial” contribution (1,670,042 euros) will serve not just to cover the FAMHP’s costs but also and above all to finance the Ethics Committees. As far as the taxes are concerned, it should be

Applications for clinical trials in Belgium are evaluated by an Ethics Committee or Ethics Committees and the FAMHP.
Applications for clinical trials in Belgium are evaluated by an Ethics Committee or Ethics Committees and the FAMHP.

The R&D (research and development) department of the FAMHP is responsible for the evaluation and approval of clinical research activities, ranging from the first “use” (concept) to extensive trials with medicines that are developed and carried out by university and other research centres and by the pharmaceutical industry.
The R&D (research and development) department of the FAMHP is responsible for the evaluation and approval of clinical research activities, ranging from the first “use” (concept) to extensive trials with medicines that are developed and carried out by university and other research centres and by the pharmaceutical industry.