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pivotal trial

Italian translation: studio cardine

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
English term or phrase:pivotal trial
Italian translation:studio cardine
Entered by: sonia beraha

11:37 Jun 30, 2003
English to Italian translations [PRO]
Medical
English term or phrase: pivotal trial
Product X has completed 3 Phase I pharmacokinetic studies and 1 Phase III pivotal trial.
sonia beraha
Local time: 08:05
Studio cardine
Explanation:
Si tratta di studi fondamentali che servono per ottenere la registrazione di un farmaco presso le autorità governative.

Pivotal Study
Usually a phase III study which presents the data that the FDA uses to decide whether or not to approve a drug. A pivotal study will generally be well-controlled, randomized, of adequate size, and whenever possible, double-blind.
http://www.centerwatch.com/patient/glossary.html#P

Non è corretto tradurre, come si vede spesso, "studio pilota" (che corrisponde a "pilot study"): quest'ultimo è un piccolo studio fatto all'inizio del processo di studio di un farmaco, su un piccolo numero di pazienti, che funge da fase preliminare della ricerca.
Selected response from:

Gilberto Lacchia
Italy
Local time: 08:05
Grading comment
grazie
4 KudoZ points were awarded for this answer



Summary of answers provided
5 +4Studio cardine
Gilberto Lacchia
4 +1prova cardinale
Federica Masante


  

Answers


2 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +1
prova cardinale


Explanation:
pivotale puo' anche essere reso con essenziale, centrale...

Federica Masante
Local time: 08:05
Native speaker of: Native in EnglishEnglish, Native in ItalianItalian
PRO pts in pair: 534

Peer comments on this answer (and responses from the answerer)
agree  Henrique Magalhaes: I would just add 'fondamentale'...
3 mins
neutral  Domenica Grangiotti: cardinale non ha lo stesso significato di cardine
1 hr
Login to enter a peer comment (or grade)

28 mins   confidence: Answerer confidence 5/5 peer agreement (net): +4
Studio cardine


Explanation:
Si tratta di studi fondamentali che servono per ottenere la registrazione di un farmaco presso le autorità governative.

Pivotal Study
Usually a phase III study which presents the data that the FDA uses to decide whether or not to approve a drug. A pivotal study will generally be well-controlled, randomized, of adequate size, and whenever possible, double-blind.
http://www.centerwatch.com/patient/glossary.html#P

Non è corretto tradurre, come si vede spesso, "studio pilota" (che corrisponde a "pilot study"): quest'ultimo è un piccolo studio fatto all'inizio del processo di studio di un farmaco, su un piccolo numero di pazienti, che funge da fase preliminare della ricerca.


    Reference: http://www.google.com/search?hl=it&ie=ISO-8859-1&q=%22studio...
    Reference: http://www.memorylossonline.com/glossary/pilotstudy.html
Gilberto Lacchia
Italy
Local time: 08:05
Native speaker of: Italian
PRO pts in pair: 2333
Grading comment
grazie

Peer comments on this answer (and responses from the answerer)
agree  verbis
46 mins
agree  Domenica Grangiotti
53 mins
agree  Cecilia Di Vita
3 hrs
agree  MV Language
3054 days
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