Vertaling van "‘clinical safety " (Nederlands → Frans) :

Een tweede onderzoek 5 is een door de farmaceutische industrie gesponsorde rapportering over cardiovasculaire voorvallen zoals vermeld in de ‘clinical safety database’ voor tiotropium.
Une deuxième étude 5 , quant à elle sponsorisée par l’industrie pharmaceutique, a fait état des événements cardiovasculaires comme mentionné dans la `clinical safety database’ du tiotropium.

‐ The Mirasol Clinical Evaluation Study Group. A randomized controlled clinical trial evaluating the performance and safety of platelets treated with MIRASOL pathogen reduction technology.
the performance and safety of platelets treated with MIRASOL pathogen reduction technology.

To ensure the quality, safety and efficacy of medicines and health products on the market and in clinical development.
To ensure the quality, safety and efficacy of medicines and health products on the market and in clinical development.

Meeting of the Advisory Committee on Blood Safety & Availability (ACSBA), 30 May 2008: Clinical Significance of Red Cell Age in Transfusions; 2008 [accessed 2008 June 17].
Meeting of the Advisory Committee on Blood Safety & Availability (ACBSA), 30 May 2008: Clinical Significance of Red Cell Age in Transfusions; 2008 [accessed 2008 June 17].

The safety of participants in clinical trials with investigational products (IMP) and of the users of the authorised medicines and health products is of fundamental importance.
The safety of participants in clinical trials with investigational products (IMP) and of the users of the authorised medicines and health products is of fundamental importance.

The evaluation is based on current standards and guidelines on the quality, safety and clinical efficacy of medicines and health products.
The evaluation is based on current standards and guidelines on the quality, safety and clinical efficacy of medicines and health products.

" 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

The FDA discussions focus on product labeling and Risk Evaluation Mitigation Strategy (REMS) as well as a safety update, but no request for more clinical studies.
Les discussions de la FDA portent sur la notice du produit et sur la stratégie de la gestion des risques (Risk Evaluation Mitigation Strategy ou REMS) ainsi que sur la mise à jour des données sur son innocuité, mais ne requiert pas plus d’études cliniques.

Clinical trials demonstrated the efficacy and safety of FTY720, with participants showing reduced relapses and delayed disease progression.
Des essais cliniques ont démontré l’efficacité et l’innocuité de FTY720 qui provoque une diminution des rechutes et un ralentissement de la progression de la maladie chez les participants.

Moreover, Gilenya has a well-studied safety and tolerability profile that has been characterized in over 2,600 clinical trial patients.
Qui plus est, Gilenya présente un profil d’innocuité et de tolérance très bien étudié chez plus de 2600 malades ayant participé aux essais cliniques.