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pivotal, comparative Phase III study

Dutch translation: centraal, vergelijkend fase III-onderzoek

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GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
English term or phrase:pivotal, comparative Phase III study
Dutch translation:centraal, vergelijkend fase III-onderzoek
Entered by: Lianne van de Ven
Options:
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15:57 Dec 20, 2010
English to Dutch translations [PRO]
Medical - Medical: Pharmaceuticals
English term or phrase: pivotal, comparative Phase III study
Context:

"Under this agreement, (...) will design and execute the global clinical development of Spanidin®, which includes a pivotal, comparative Phase III study for patients suffering from WG relapse. "

WG staat voor "Wegener´s Granulomatosis"
solejnicz
Netherlands
Local time: 10:05
centraal, vergelijkend fase III-onderzoek
Explanation:
In drie van de vier fase III korte-termijnstudies, welke alle als de belangrijkste studies (de zogenaamde “pivotal studies”) kunnen worden beschouwd, werden de werkzaamheid en veiligheid van rizatriptan in de behandeling van één aanval van matige tot ernstige migraine onderzocht.
db.cbg-meb.nl/mri/par/nlh-0144-001-002-003-004.pdf
Selected response from:

Lianne van de Ven
United States
Local time: 04:05
Grading comment
Heb hiervoor gekozen, bedankt.
4 KudoZ points were awarded for this answer

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Summary of answers provided
4 +2centraal, vergelijkend fase III-onderzoek
Lianne van de Ven
3doorslaggevend, vergelijkend fase III- onderzoekJosephine Isaacs
Summary of reference entries provided
Pivotal is al een paar keer eerder gevraagd.
Koen Speetjens

  

Answers


6 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +2
pivotal, comparative phase iii study
centraal, vergelijkend fase III-onderzoek


Explanation:
In drie van de vier fase III korte-termijnstudies, welke alle als de belangrijkste studies (de zogenaamde “pivotal studies”) kunnen worden beschouwd, werden de werkzaamheid en veiligheid van rizatriptan in de behandeling van één aanval van matige tot ernstige migraine onderzocht.
db.cbg-meb.nl/mri/par/nlh-0144-001-002-003-004.pdf

Lianne van de Ven
United States
Local time: 04:05
Native speaker of: Native in DutchDutch
PRO pts in category: 24
Grading comment
Heb hiervoor gekozen, bedankt.

Peer comments on this answer (and responses from the answerer)
agree  Jan Willem van Dormolen
2 mins

agree  Barend van Zadelhoff: lijkt me goed
1 hr
Login to enter a peer comment (or grade)

5 hrs   confidence: Answerer confidence 3/5Answerer confidence 3/5
pivotal, comparative phase iii study
doorslaggevend, vergelijkend fase III- onderzoek


Explanation:
Dus, het onderzoek is van doorslaggevend belang

To play a pivotal role: een doorslaggevende rol spelen

--------------------------------------------------
Note added at 6 hrs (2010-12-20 22:12:35 GMT)
--------------------------------------------------

See also : http://wiki.answers.com/Q/What_is_a_pivotal_phase_three_tria...

and for a definition of pivotal phase III trials:
http://www.adisinsight.com/aClientServiceinfo/RDI Phases of ...

--------------------------------------------------
Note added at 7 hrs (2010-12-20 23:23:39 GMT)
--------------------------------------------------

In the above ADIS reference it says: .... to be considered pivotal, a study must meet at least the following 4 FDA-defined criteria: ....

Since a pivotal study appears to be clearly defined, it would be best to include this term in brackets:

doorslaggevend, vergelijkend fase III-onderzoek (zgn. pivotal study).

Dat maakt het begrijpelijk voor de Nederlands lezer; en men kan verdere informatie vinden op de term pivotal study.

Josephine Isaacs
Australia
Local time: 19:05
Specializes in field
Native speaker of: Native in DutchDutch, Native in EnglishEnglish
PRO pts in category: 15
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Reference comments


5 hrs
Reference: Pivotal is al een paar keer eerder gevraagd.

Reference information:
(Ik ga ervan uit dat dit het woord is dat problemen oplevert.)
IATE geeft "hoofdstudie".


    Reference: http://www.proz.com/kudoz/english_to_dutch/medical%3A_pharma...
    Reference: http://www.proz.com/kudoz/english_to_dutch/medical_general/3...
Koen Speetjens
Specializes in field
Native speaker of: Native in DutchDutch
PRO pts in category: 12
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Changes made by editors
Dec 25, 2010 - Changes made by Lianne van de Ven:
Created KOG entryKudoZ term » KOG term


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