GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW) | ||||||
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07:37 Oct 23, 2000 |
English to French translations [PRO] Medical | |||||||
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| Selected response from: sktrans Local time: 16:41 | ||||||
Grading comment
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Summary of answers provided | ||||
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na | Dossier d'Autorisation de Mise su le Marché |
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na | FICHIER PRINCIPAL DES MÉDICAMENTS |
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na | See below |
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Dossier d'Autorisation de Mise su le Marché Explanation: Dossier d'AMM = dossier d'Autorisation de Mise sur le Marché : this is the registration file that contains the manufacturing progess, clinical trials, quality control assays and many other information required to put a new drug on the market. |
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FICHIER PRINCIPAL DES MÉDICAMENTS Explanation: Je ne crois pas qu'il s'agisse d'un terme technique en soit. Dans Termium, on trouve « fichier maître » ou « fichier principal » pour « master file ». Selon le nom de l'organisme, je pense bien qu'on parle de médicaments. Bonne chance, Marc Reference: http://www.termium.com |
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See below Explanation: I have to disagree with the first response: Dossier d'AMM which refers to a Drug Product Application that is submitted to an official agency (here the FDA) for approval to be marketed. DMFs are different: there are 5 types of DMFs: Type I deals with the manufacturing site, facilities, operating procedures, and personnel. Type II deals with Drug Substance, Drug substance intermediate, and material used intheir preparation, or Drug product. Type III deals with packaging material. Type IV deals deals with excipient, colorant, flavor, essence, or material used intheir preparation Type V deals with FDA - accepted reference information. Now, based on the above, I do not understand if for your case you are dealing with the process of a drug product, substance, colorant, excipient, etc.. Based on your text, you will have to decide what to name it with the information I provided you. Ex: "Dossier de la spécialité pharmaceutique" or " Dossier du colorant" etc.. I hope this is helpful. FDA guidelines for DMFs. |
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