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Traduction de «these trials » (Néerlandais → Français) :

The number of early phase trials is per capita one of the highest in Europe. Since the publication of the guideline trials for conducting explorative studies in Belgium, in mid June 2007, 25 applications for conducting these clinical trials have been submitted to the FAMHP.

The number of early phase trials is per capita one of the highest in Europe. Since the publication of the guideline trials for conducting explorative studies in Belgium, in mid June 2007, 25 applications for conducting these clinical trials have been submitted to the FAMHP.


Encouraging clinical trials and the inherent evaluation of applications for these trials, as well as the creation of a scientific subgroup for oncology, means that the FAMHP will need to have the necessary autonomy to attract the essential expertise for this relatively complex domain from the point of concept of innovative medicines.

Encouraging clinical trials and the inherent evaluation of applications for these trials, as well as the creation of a scientific subgroup for oncology, means that the FAMHP will need to have the necessary autonomy to attract the essential expertise for this relatively complex domain from the point of concept of innovative medicines.


- 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


The results of these trials are concordant with previous trials, except one where bupropion was evaluated in an unmotivated population.

The results of these trials are concordant with previous trials, except one where Bupropion was evaluated in an unmotivated population.


Therefore, organising consultation between both of these bodies for specific trials is also one of the short-term goals.

Therefore, organising consultation between both of these bodies for specific trials is also one of the short-term goals.


Furthermore, the Agency intends to take a leading role in producing guidelines for these early phase trials.

Furthermore, the Agency intends to take a leading role in producing guidelines for these early phase trials.


It is important that the most promising products are identified so that available means (such as time, trial animals, working time, money) can quickly be concentrated on further development of these products.

It is important that the most promising products are identified so that available means (such as time, trial animals, working time, money) can quickly be concentrated on further development of these products.




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Date index: 2024-06-08
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