Glossary entry (derived from question below)
English term or phrase:
regulatory commitment
Dutch translation:
om te voldoen aan de eisen van de regelgevende instanties
- The asker opted for community grading. The question was closed on 2012-01-08 13:54:09 based on peer agreement (or, if there were too few peer comments, asker preference.)
Jan 4, 2012 14:31
12 yrs ago
English term
Netherlands
Medicine-Pharmaceutics-Trials-Research
Native in: Dutch (Variant: Netherlands) 
Works in: English to Dutch, Dutch to English, German to Dutch
regulatory commitment
English to Dutch
Medical
Medical (general)
study protocol
This study is a regulatory commitment to collect post marketing authorization data within the approved indication.
Proposed translations
(Dutch)
| 4 +5 | om te voldoen aan de eisen van de regelgevende instanties |
Catharina Adams
|
| 2 | bij .. is er een overeenkomst met de regelgevende instantie(s) om |
Barend van Zadelhoff
|
Proposed translations
+5
38 mins
Catharina Adams
Belgium
Belgium
Native in Dutch
Specializes in field
Belgium
Accurate and on time!
Native in: Dutch (Variant: Netherlands)
Works in: German to Dutch, English to Dutch, French to Dutch
Related KudoZ points
:
14
Selected
om te voldoen aan de eisen van de regelgevende instanties
Dus: Dit onderzoek verzamelt..... om te voldoen aan de eisen van de regelgevende instanties.
Note from asker:
| thank you! |
4 KudoZ points awarded for this answer.
Comment: "Selected automatically based on peer agreement."
51 mins
Barend van Zadelhoff
Netherlands
Netherlands
Native in Dutch
Specializes in field
Netherlands
TR is the most intimate act of reading.
Native in: Dutch
Works in: English to Dutch, Dutch to English, Dutch
Related KudoZ points
:
547
bij .. is er een overeenkomst met de regelgevende instantie(s) om
my two cents
Bij dit onderzoek is er een overeenkomst met regelgevende instantie(s) om binnen de goedgekeurde indicatie gegevens te verzamelen na het afgeven van de vergunning voor het in de handel brengen
This is a regulatory commitment and represents an area of growing unmet need, and an opportunity to optimize the utility of CUBICIN in the infectious disease armamentarium
An additional post-approval regulatory commitment that we have with the FDA is a study of CUBICIN as part of combination therapy for infective endocarditis. Here we will compare safety and efficacy of CUBICIN at 6 mg/kg with and without gentamicin. We expect this exploratory Phase 2 study should begin enrollment in the first half of 2008.
http://www.wikinvest.com/stock/Cubist_Pharmaceuticals_(CBST)...
Bij dit onderzoek is er een overeenkomst met regelgevende instantie(s) om binnen de goedgekeurde indicatie gegevens te verzamelen na het afgeven van de vergunning voor het in de handel brengen
This is a regulatory commitment and represents an area of growing unmet need, and an opportunity to optimize the utility of CUBICIN in the infectious disease armamentarium
An additional post-approval regulatory commitment that we have with the FDA is a study of CUBICIN as part of combination therapy for infective endocarditis. Here we will compare safety and efficacy of CUBICIN at 6 mg/kg with and without gentamicin. We expect this exploratory Phase 2 study should begin enrollment in the first half of 2008.
http://www.wikinvest.com/stock/Cubist_Pharmaceuticals_(CBST)...
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