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le dossier du médicament

English translation: drug master file

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12:51 Jul 11, 2008
French to English translations [PRO]
Medical - Medical: Pharmaceuticals / amendments to clinical trial protocol
French term or phrase: le dossier du médicament
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.**
Ysabel812
English translation:drug master file
Explanation:
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 »
Selected response from:

xxx::::::::::
Iraq
Local time: 09:18
Grading comment
Selected automatically based on peer agreement.
4 KudoZ points were awarded for this answer

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Summary of answers provided
5 +4drug master filexxx::::::::::
4 +2Investigational Medicinal Product Dossier
Helen Genevier
2 +1EMD [experimental medical dossier]liz askew


Discussion entries: 2





  

Answers


8 mins   confidence: Answerer confidence 5/5 peer agreement (net): +4
drug master file


Explanation:
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 »


xxx::::::::::
Iraq
Local time: 09:18
Native speaker of: Native in EnglishEnglish
PRO pts in category: 79
Grading comment
Selected automatically based on peer agreement.

Peer comments on this answer (and responses from the answerer)
agree  narasimha
20 mins
  -> merci

agree  Cristián Bianchi-Bruna
37 mins
  -> merci

agree  mdcdc: Yes, as simple as that
2 hrs
  -> merci

agree  GILOU
1 day2 hrs
  -> merci
Login to enter a peer comment (or grade)

17 mins   confidence: Answerer confidence 2/5Answerer confidence 2/5 peer agreement (net): +1
EMD [experimental medical dossier]


Explanation:
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

liz askew
United Kingdom
Local time: 08:18
Works in field
Native speaker of: Native in EnglishEnglish
PRO pts in category: 413

Peer comments on this answer (and responses from the answerer)
agree  Karen Tkaczyk: Yes, IND if the target is USA (FDA regs, I mean)
3 hrs
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43 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +2
le dossier du médicament expérimental
Investigational Medicinal Product Dossier


Explanation:
"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...


Helen Genevier
France
Local time: 09:18
Specializes in field
Native speaker of: Native in EnglishEnglish
PRO pts in category: 289

Peer comments on this answer (and responses from the answerer)
agree  xxxtransdoctor: exactly http://www.pharmes.fr/catalog/exemple-veille-reglementaire.p...
3 mins

agree  Karen Tkaczyk: Yes if the target is EU.
2 hrs
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