Jul 11, 2008 12:51
16 yrs ago
16 viewers *
French term
le dossier du médicament
French to English
Medical
Medical: Pharmaceuticals
amendments to clinical trial protocol
This is from guidelines on amendments to clinical trials.
Under the heading: "Modifications visant à clarifier les documents de l'essai/ corriger des erreurs typographiques" we have:
modifications visant à apporter des clarifications aux documents de l'essai (tels que le protocole ou le dossier du médicament expérimental par exemple), sans que ces clarifications n'aient d'impact sur la sécurité des personnes se prêtant à l'essai..."
Thanks!
**I'd like to ask only native English speakers to reply to this question.**
Under the heading: "Modifications visant à clarifier les documents de l'essai/ corriger des erreurs typographiques" we have:
modifications visant à apporter des clarifications aux documents de l'essai (tels que le protocole ou le dossier du médicament expérimental par exemple), sans que ces clarifications n'aient d'impact sur la sécurité des personnes se prêtant à l'essai..."
Thanks!
**I'd like to ask only native English speakers to reply to this question.**
Proposed translations
(English)
| 5 +4 | drug master file |
:::::::::: (X)
|
| 4 +2 | Investigational Medicinal Product Dossier |
Helen Genevier
|
| 2 +1 | EMD [experimental medical dossier] |
liz askew
|
Proposed translations
+4
8 mins
Selected
drug master file
WikipédiaUn Drug Master File (ou Active Substance Master File pour l'Europe) est un document renfermant des informations sur le mode de préparation d'une substance ...
fr.wikipedia.org/wiki/Drug_Master_File - 19k - En cache - Pages similaires - À noter
Drug Master Files- [ Traduire cette page ]The list of DMFs is current as of March 31, 2008, through DMF 21536. ... DMF holders can forestall the sending of an ONL by updating their DMFs, ...
www.fda.gov/cder/dmf/ - 53k - En cache - Pages similaires - À noter
Drug Master Files Guidance- [ Traduire cette page ]B. Listing of Persons Authorized To Refer to a Drug Master File ... A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that ...
www.fda.gov/cder/guidance/dmf.htm - 65k - En cache - Pages similaires - À noter
Autres résultats, domaine www.fda.gov »
fr.wikipedia.org/wiki/Drug_Master_File - 19k - En cache - Pages similaires - À noter
Drug Master Files- [ Traduire cette page ]The list of DMFs is current as of March 31, 2008, through DMF 21536. ... DMF holders can forestall the sending of an ONL by updating their DMFs, ...
www.fda.gov/cder/dmf/ - 53k - En cache - Pages similaires - À noter
Drug Master Files Guidance- [ Traduire cette page ]B. Listing of Persons Authorized To Refer to a Drug Master File ... A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that ...
www.fda.gov/cder/guidance/dmf.htm - 65k - En cache - Pages similaires - À noter
Autres résultats, domaine www.fda.gov »
Peer comment(s):
| agree |
narasimha (X)
20 mins
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merci
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| agree |
Cristián Bianchi-Bruna
37 mins
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merci
|
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| agree |
mdcdc
: Yes, as simple as that
2 hrs
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merci
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| agree |
GILLES MEUNIER
1 day 2 hrs
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merci
|
4 KudoZ points awarded for this answer.
Comment: "Selected automatically based on peer agreement."
+1
17 mins
EMD [experimental medical dossier]
http://216.239.59.104/search?q=cache:qWkQpxslwiUJ:www.afm-fr...
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Note added at 21 mins (2008-07-11 13:12:15 GMT)
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Sorry
I think it is just "Drug Dossier":
http://216.239.59.104/search?q=cache:IINIBEh2h94J:www.scienc...
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Note added at 22 mins (2008-07-11 13:13:10 GMT)
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International Pharmaceutical Registration - Google Books Result
by Alan Chalmers A Chalmers, Alan A. Chalmers - 2000 - Law - 872 pages
... clinical trials and registration are different for domestic and foreign drugs. ... Certain parts of the drug dossier must be translated into Russian. ...
books.google.co.uk/books?isbn=1574911031...
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Note added at 24 mins (2008-07-11 13:15:11 GMT)
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OR
IND [investigational new drug] dossier
PLoS Hub for Clinical Trials: The Clinical Trials Directive: How ...
When trying to understand how the EU Clinical Trials Directive (CTD .... In the US, a single initial investigational new drug (IND) dossier has to be ...
clinicaltrials.ploshubs.org/article/info:doi%2F10.1371%2Fjournal.pctr.0010013;jsessionid=AABA30927EA93F3E... - 71k - Cached - Similar pages
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Note added at 24 mins (2008-07-11 13:15:52 GMT)
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Hi
because you have "experimental" at the end of your phrase,
I would suggest it =
IND dossier
--------------------------------------------------
Note added at 21 mins (2008-07-11 13:12:15 GMT)
--------------------------------------------------
Sorry
I think it is just "Drug Dossier":
http://216.239.59.104/search?q=cache:IINIBEh2h94J:www.scienc...
--------------------------------------------------
Note added at 22 mins (2008-07-11 13:13:10 GMT)
--------------------------------------------------
International Pharmaceutical Registration - Google Books Result
by Alan Chalmers A Chalmers, Alan A. Chalmers - 2000 - Law - 872 pages
... clinical trials and registration are different for domestic and foreign drugs. ... Certain parts of the drug dossier must be translated into Russian. ...
books.google.co.uk/books?isbn=1574911031...
--------------------------------------------------
Note added at 24 mins (2008-07-11 13:15:11 GMT)
--------------------------------------------------
OR
IND [investigational new drug] dossier
PLoS Hub for Clinical Trials: The Clinical Trials Directive: How ...
When trying to understand how the EU Clinical Trials Directive (CTD .... In the US, a single initial investigational new drug (IND) dossier has to be ...
clinicaltrials.ploshubs.org/article/info:doi%2F10.1371%2Fjournal.pctr.0010013;jsessionid=AABA30927EA93F3E... - 71k - Cached - Similar pages
--------------------------------------------------
Note added at 24 mins (2008-07-11 13:15:52 GMT)
--------------------------------------------------
Hi
because you have "experimental" at the end of your phrase,
I would suggest it =
IND dossier
+2
43 mins
French term (edited):
le dossier du médicament expérimental
Investigational Medicinal Product Dossier
"Investigational Medicinal Product Dossier (IMPD)
Following implementation of the European Clinical Trials Directive (2001/20/EC) into national law of the European Member States, an Investigational Medicinal Product Dossier (IMPD) is now required to accompany an application to perform clinical trials in any European Member State. The IMPD provides a summary of information on quality of the investigational medicinal product to be used in the clinical trial, including reference products and placebos. It also provides data from non-clinical studies and available previous clinical experience with the use of the investigational medicinal product. An overall risk-benefit assessment, critically analysing the non-clinical and clinical data in relation to the potential risks and benefits of the proposed trial must also be included."
http://www.eudrac.com/glossary/Investigational-Medicinal-Pro...
"4 Format and content of applications and notifications
4.1 Request for a clinical trial authorisation
4.1.1 Covering Letter
4.1.2 Allocation of the Eudract number
4.1.3 Application form
4.1.4 Protocol
4.1.5 Investigators Brochure
4.1.6 Investigational Medicinal Product Dossier (IMPD)
4.1.6.1 Full IMPD
4.1.6.2 Simplified IMPD
4.2 Notification of amendments"
http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/doc...
Following implementation of the European Clinical Trials Directive (2001/20/EC) into national law of the European Member States, an Investigational Medicinal Product Dossier (IMPD) is now required to accompany an application to perform clinical trials in any European Member State. The IMPD provides a summary of information on quality of the investigational medicinal product to be used in the clinical trial, including reference products and placebos. It also provides data from non-clinical studies and available previous clinical experience with the use of the investigational medicinal product. An overall risk-benefit assessment, critically analysing the non-clinical and clinical data in relation to the potential risks and benefits of the proposed trial must also be included."
http://www.eudrac.com/glossary/Investigational-Medicinal-Pro...
"4 Format and content of applications and notifications
4.1 Request for a clinical trial authorisation
4.1.1 Covering Letter
4.1.2 Allocation of the Eudract number
4.1.3 Application form
4.1.4 Protocol
4.1.5 Investigators Brochure
4.1.6 Investigational Medicinal Product Dossier (IMPD)
4.1.6.1 Full IMPD
4.1.6.2 Simplified IMPD
4.2 Notification of amendments"
http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/doc...
Peer comment(s):
| agree |
transdoctor (X)
: exactly http://www.pharmes.fr/catalog/exemple-veille-reglementaire.p...
3 mins
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| agree |
Karen Tkaczyk
: Yes if the target is EU.
2 hrs
|
Discussion