Mar 4, 2006 18:05
18 yrs ago
1 viewer *
Spanish term
United States
ambitos teoricos normativos
Spanish to English
Science
Medical: Pharmaceuticals
Tiene que ver que la determinacion de bioequivalencia en un ensayo clinico. La frase entera: Para la toma de decisión, se aplican los ámbitos teóricos (AT) normativos de bioequivalencia:
Proposed translations
(English)
| 3 +1 | theoretical parameters |
Robert Forstag
|
| 4 | acceptance ranges |
Helen Casas
|
| 3 | standard theoretical environments |
Muriel Vasconcellos
|
Proposed translations
+1
25 mins
Robert Forstag
United States
United States
Native in English
United States
Translating words, preserving meaning
Native in: English
Works in: Spanish to English, English
Related KudoZ points
:
66
Selected
theoretical parameters
My reading.
Suerte
Suerte
4 KudoZ points awarded for this answer.
Comment: "This seems to make the most sense, since the context is how much of the "ambitos teoricos" were attained, i.e. 20% of AT). However, I am not completely convinced."
2 hrs
Muriel Vasconcellos
United States
United States
Native in English
Works in field
United States
Each translation a gem!
Native in: English (Variant: US) 
Works in: Spanish to English, Portuguese to English
Related KudoZ points
:
267
standard theoretical environments
This is my take on it, and it makes sense, though I couldn't find any supporting references on Google.
8 days
Helen Casas
Native in English
Specializes in field
Degree in Chemical Engineering, MIT 1979
Native in: English 
Works in: Spanish to English, Catalan to English, English
Related KudoZ points
:
8
acceptance ranges
I have been using "acceptance range(s)" for some time, which is used by the FDA, ICH and EUDRA in some documents. In bioequivalence, certain pharmacokinetic parameters must be relatively equivalent, I think either 80%-125%, to the original drug.
See
http://dg3.eudra.org/F2/eudralex/vol-3/pdfs-en/3cc15aen.pdf
http://www.fda.gov/ohrms/dockets/dailys/03/jul03/070203/99D-...
http://pharmacos.eudra.org/F2/eudralex/download/volpdf/vol3/...
"acceptance intervals" is also used; see
www.emea.eu.int/pdfs/human/ewp/140198en.pdf
www.fda.gov/cder/guidance/5341fnl.doc
I do not know how widespread the terms are, however.
Other input is welcome.
See
http://dg3.eudra.org/F2/eudralex/vol-3/pdfs-en/3cc15aen.pdf
http://www.fda.gov/ohrms/dockets/dailys/03/jul03/070203/99D-...
http://pharmacos.eudra.org/F2/eudralex/download/volpdf/vol3/...
"acceptance intervals" is also used; see
www.emea.eu.int/pdfs/human/ewp/140198en.pdf
www.fda.gov/cder/guidance/5341fnl.doc
I do not know how widespread the terms are, however.
Other input is welcome.
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