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فرنسي: ampliation

أنجليزي translation: supplemental new drug application (sNDA)



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بند في مسرد المصطلحات مأخوذ من السؤال أدناه
فرنسي مصطلح أو جملة:ampliation
أنجليزي ترجمة:supplemental new drug application (sNDA)
تم إدخاله من قبل:Enza Longo
الخيارات:
- المساهمة في هذا البند

22:48 Dec 23, 2006Login or register (free) for more options.
ترجمة فرنسي إلى أنجليزي [للمحترفين]
Medical - الطب: علم الأدوية / drug approval
فرنسي مصطلح أو جملة: ampliation
NOT amplification (I've checked)
It is a new dosage and application of an existing drug that is being approved by a Ministry.

This is also referred to as 'Ajout'.
ericjanpost
فرنسا
ملاحظة(ات) إلى/من السائل
Enza Longo: 23:01 Dec 23, 2006: it could be 'expansion'. In what sense/context is the word used?
ericjanpost: 23:44 Dec 23, 2006: Ampliation - There is a drug on the market which a commercial laboratory wishes to sell in different packaging, by injection instead of through oral intake.
They require some type of authorization: 'Lettre de demande pour ajouter d'une nouvelle présentation + lettre d'accord

blavatsky: 04:30 Dec 24, 2006: Do you have the sentence concerned ?

supplemental new drug application (sNDA)
شرح:
Drugs@FDA: Glossary of TermsIn Drugs@FDA, you can find the NDA number under the column named "FDA Application." ... a company must submit a supplemental new drug application (sNDA). ...
www.fda.gov/cder/drugsatfda/glossary.htm - 35k - Cached - Similar pages

[PDF] Harmonized Core Report Style Template (Version 3.0)File Format: PDF/Adobe Acrobat - View as HTML
Using a more conservative definition of clinical benefit, requiring ... therapy might support regular approval. A supplemental NDA (sNDA) was ...
www.fda.gov/ohrms/dockets/AC/05/briefing/2005-4191B1_02_Joh... - Similar pages

Sample Contracts - Interim Supply Agreement [Amendment No. 1 ...The following definitions in Section 1.1 of the Supply Agreement are hereby ... 3 <PAGE> At such time as each Reformulation NDA and the SNDA is approved, ...
contracts.onecle.com/aaipharma/astrazeneca.supp1.2003.07.22.shtml - 26k - Cached - Similar pages

[DOC] GLOSSARYFile Format: Microsoft Word - View as HTML
Supplemental NDA (sNDA):. Documentation submitted to FDA on a drug ... For example, under this definition, hepatic necrosis would be unexpected (by virtue ...
www.temple.edu/pharmacy_qara/GLOSSARY.doc - Similar pages


--------------------------------------------------
Note added at 13 hrs (2006-12-24 12:07:13 GMT)
--------------------------------------------------

ampliation could then be translated as 'supplement'
استجابة مختارة من:

Enza Longo
كندا
ملاحظة من السائل إلى المجيب
Terrific work. Merci.
4 نقطة كودوز تم منحها لهذه الإجابة



ملخص لجميع الترجمات الـأنجليزي المقدمة
5certified copyNR_Stedman
4supplemental new drug application (sNDA)
Enza Longo
3 +1exemplified copy, exemplification
Janet Ratziu
3ampliation
Catherine Johnstone


  

الإجابات

1 ساعة   درجة الثقة: Answerer confidence 3/5Answerer confidence 3/5 موافقة الزملاء الصافي: +1
Ampliation
exemplified copy, exemplification


شرح:
This is only a guess but I think it fits the context. An exemplified copy is a copy of a legal pleading in its entirety (per wikipedia) and if you're talking about requesting a new dosage for a drug this would be required for the marketing authorization. I'd have to see the full text to be sure though.


    مرجع: http://ec.europa.eu/eurodicautom/Controller
Janet Ratziu
فرنسا
متخصص في الحقل
اللغة الأصلية هي: أنجليزي
نقاط مستوى المحترفين في الفئة: 40
ملاحظات إلى المجيب
السائل: Thanks very much Janet. The issue is not the type of copy however, but the idea of adding a supplement to a patent, without actually creating anything new (packaging, how a medication is administered: in this case, going from oral intake to injection).


تعليقات الزملاء على هذه الإجابة والاستجابات من المجيب
موافق rousselures: exemplification
2 ساعات
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12 ساعات   درجة الثقة: Answerer confidence 3/5Answerer confidence 3/5
Ampliation
ampliation


شرح:
found many refs in English but so scattered cannot give them! No doubt the same word applies
my refs if you wish to have a go, via google with either ampliation+pharmacy or ampliation+medicines

Catherine Johnstone
فرنسا
يعمل في الحقل
اللغة الأصلية هي: فرنسي, أنجليزي
نقاط مستوى المحترفين في الفئة: 8
ملاحظات إلى المجيب
السائل: Thanks Catherine. Correct answer seems to be sNDA, or supplemental new drug application. Thanks

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12 ساعات   درجة الثقة: Answerer confidence 4/5Answerer confidence 4/5
Ampliation
supplemental new drug application (sNDA)


شرح:
Drugs@FDA: Glossary of TermsIn Drugs@FDA, you can find the NDA number under the column named "FDA Application." ... a company must submit a supplemental new drug application (sNDA). ...
www.fda.gov/cder/drugsatfda/glossary.htm - 35k - Cached - Similar pages

[PDF] Harmonized Core Report Style Template (Version 3.0)File Format: PDF/Adobe Acrobat - View as HTML
Using a more conservative definition of clinical benefit, requiring ... therapy might support regular approval. A supplemental NDA (sNDA) was ...
www.fda.gov/ohrms/dockets/AC/05/briefing/2005-4191B1_02_Joh... - Similar pages

Sample Contracts - Interim Supply Agreement [Amendment No. 1 ...The following definitions in Section 1.1 of the Supply Agreement are hereby ... 3 <PAGE> At such time as each Reformulation NDA and the SNDA is approved, ...
contracts.onecle.com/aaipharma/astrazeneca.supp1.2003.07.22.shtml - 26k - Cached - Similar pages

[DOC] GLOSSARYFile Format: Microsoft Word - View as HTML
Supplemental NDA (sNDA):. Documentation submitted to FDA on a drug ... For example, under this definition, hepatic necrosis would be unexpected (by virtue ...
www.temple.edu/pharmacy_qara/GLOSSARY.doc - Similar pages


--------------------------------------------------
Note added at 13 hrs (2006-12-24 12:07:13 GMT)
--------------------------------------------------

ampliation could then be translated as 'supplement'

Enza Longo
كندا
اللغة الأصلية هي: أنجليزي
نقاط مستوى المحترفين في الفئة: 8
ملاحظة من السائل إلى المجيب
Terrific work. Merci.
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7 أيام   درجة الثقة: Answerer confidence 5/5
certified copy


شرح:
This term comes at the bottom of all French Marketing Authorisations sent back by Afssaps to the drug companies certifying that the paper copy is identical to the orginal MA.

NR_Stedman
فرنسا
متخصص في الحقل
اللغة الأصلية هي: أنجليزي
نقاط مستوى المحترفين في الفئة: 26
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