Vertaling van "trials and amendments " (Nederlands → Frans) :

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.

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.

In regulatory terms, the R&D department played an active part in the elaboration of the guidelines relating to substantial amendments, (N)IMP and specific arrangements for non-commercial trials.
In regulatory terms, the R&D department played an active part in the elaboration of the guidelines relating to substantial amendments, (N)IMP and specific arrangements for non-commercial trials.

The extension is the result of a major amendment to the application to include an additional 12 months of data to provide a median of five years of follow up of the pivotal Austrian Breast & Colorectal Cancer Study Group Trial 12 (ABCSG-12).
Cette prolongation est le résultat d’une modification importante de l’utilisation destinée à inclure des données portant sur douze mois de manière à fournir une moyenne sur cinq ans de suivi de l'essai pivot dénommé «Austrian Breast & Colorectal Cancer Study Group Trial 12» (ABCSG-12) sur le cancer du sein et du côlon.

Extension is the result of a major amendment to the application to include an additional 12 months of data to provide a median of five years of follow up of the pivotal Austrian Breast & Colorectal Cancer Study Group Trial 12 (ABCSG-12) study.
Cette prolongation est le résultat d’une modification importante de la demande destinée à inclure des données portant sur douze mois de manière à fournir une moyenne sur cinq ans de suivi de l'essai pivot dénommé «Austrian Breast & Colorectal Cancer Study Group Trial 12» (ABCSG-12) sur le cancer du sein et du côlon.