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sobre la base de los valores AUC0-24 al NOAEL

English translation: ...on the basis of the AUCO-24 values at the NOAEL, for studies of toxicity at 6 months in rats, for

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Spanish term or phrase:sobre la base de los valores AUC0-24 al NOAEL
English translation:...on the basis of the AUCO-24 values at the NOAEL, for studies of toxicity at 6 months in rats, for
Entered by: Adam Burman
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18:34 Oct 20, 2006
Spanish to English translations [PRO]
Medical - Medical (general) / Research report for new drug
Spanish term or phrase: sobre la base de los valores AUC0-24 al NOAEL
I am having doubts about my previous translations related to NOAEL. How would the above be best translated. "Al" is confusing me here.

Se calcularon las relaciones de exposición entre la exposición animal y la humana a desvenlafaxina, sobre la base de los valores AUC0-24 al NOAEL en los estudios de toxicidad de 6 meses en ratas, de toxicidad con dosis repetidas de 3 y 9 meses en perros, de toxicidad en la fertilidad y/o el desarrollo en ratas y conejos y datos mezclados de exposición humana normalizados según la dosis (1000 mg) de sujetos sanos normales utilizados en estudios de fase 1. Las relaciones de exposición al NOAEL en los estudios de toxicidad por dosis repetidas variaron de 4,4 a 0,5 (ratas macho) y de 30 a 3,8 (ratas hembra), y en perros de 6,1 a 0,8 y de 12,5 a 1,6 para 50 y 400 mg, respectivamente.
Adam Burman
United Kingdom
Local time: 11:25
...on the basis of the AUCO-24 values at the NOAEL, for studies of toxicity at 6 months in rats, for
Explanation:
...on the basis of the AUCO-24 values at the NOAEL***, for studies of toxicity at 6 months in rats, for repeated-dose toxicity at 3 and at 9 months in dogs ….

*** NOAEL is a LEVEL, and they are referring to the AUC value for that level.

So, if you remember that NOAEL is a LEVEL, it might help.

NOAEL is the LEVEL of dose at which there is no significant increase in the incidence of any important adverse biological effect.

There is no DIRECT relationship between the Area Under the Curve (AUC) and a particular NOAEL (no ratio, no relationship). The AUC is simply a feature or aspect of the NOAEL, a measurement taken for that partictular level of dose (the NOAE level of dose). For another dose, there would be another AUC, i.e. different doses would produce different AUCs, but for a specific NOAEL-- i.e. referring to a specific dose (and a specific drug, animal, etc in this case)-- there is just one AUC.







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Note added at 16 hrs (2006-10-21 10:34:22 GMT)
--------------------------------------------------

In relation to my comment on Liz's answer and her use of "in relation to": there is no DIRECT relationship between the Area Under the Curve (AUC) and a particular NOAEL (no ratio, no relationship).

The "AL" is not expressing a relationship (eg, al 3%), it's saying "a el nivel de" becuase the L in NOAEL refers to "level"

--------------------------------------------------
Note added at 16 hrs (2006-10-21 10:36:04 GMT)
--------------------------------------------------

IE:

"a el(al) nivel de efects adversos no observables"
Selected response from:

xxxLia Fail
Spain
Local time: 12:25
Grading comment
As you point out, remembering that NOAEL is a level does help. Thanks Lia!
4 KudoZ points were awarded for this answer

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Summary of answers provided
4 +1on the basis of/based under (the curve) AUCo-24 values on NOAEL (No Observed Adverse Effect Dose)
Margarita Ezquerra (Smart Translators, S.L.)
3...on the basis of the AUCO-24 values at the NOAEL, for studies of toxicity at 6 months in rats, forxxxLia Fail
3[exposure relationships were calculated] based on AUCo-24 hr. values in relation to NOAEL valuesliz askew


Discussion entries: 5





  

Answers


12 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +1
on the basis of/based under (the curve) AUCo-24 values on NOAEL (No Observed Adverse Effect Dose)


Explanation:
Mira esta referencia:


PDF] EXECUTIVE SUMMARYFormato de archivo: PDF/Adobe Acrobat - Versión en HTML
micropigs the NOAEL was 1 .O% (6 mg/kg/day; 162 mg/m2/day; Month 6 AUCo-24 hr = 168. ng=hr/ml) in this study. The NOAEL dose is 8-9X the MRHD based on AUC ...
www.fda.gov/ohrms/dockets/ac/00/backgrd/3659b1b.pdf - Páginas similares





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Note added at 14 minutos (2006-10-20 18:48:35 GMT)
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No sé si he puesto bien sintácticamente la oración. Creo que habría que darle la vuelta de alguna forma, pero ahora no se me ocurre.



Margarita Ezquerra (Smart Translators, S.L.)
Spain
Local time: 12:25
Native speaker of: Native in SpanishSpanish
PRO pts in category: 541

Peer comments on this answer (and responses from the answerer)
agree  Cecilia Della Croce
11 mins
  -> many thanks Cecilia

neutral  liz askew: Don't know enough about this; however, shouldn't it be "AUCo-24 hr"?
22 mins
  -> Also...

neutral  xxxLia Fail: the problem is the translation of "AL" as "ON"
16 hrs
Login to enter a peer comment (or grade)

42 mins   confidence: Answerer confidence 3/5Answerer confidence 3/5
[exposure relationships were calculated] based on AUCo-24 hr. values in relation to NOAEL values


Explanation:
Just an "educated" interpretation, open to contradiction and correction, of course...

liz askew
United Kingdom
Local time: 11:25
Specializes in field
Native speaker of: Native in EnglishEnglish
PRO pts in category: 3849

Peer comments on this answer (and responses from the answerer)
neutral  xxxLia Fail: it's not "in relation to" NOAEL values, becuase NOAEL is a level, it's teh AUC of this particular level of dose
14 hrs
Login to enter a peer comment (or grade)

15 hrs   confidence: Answerer confidence 3/5Answerer confidence 3/5
...on the basis of the AUCO-24 values at the NOAEL, for studies of toxicity at 6 months in rats, for


Explanation:
...on the basis of the AUCO-24 values at the NOAEL***, for studies of toxicity at 6 months in rats, for repeated-dose toxicity at 3 and at 9 months in dogs ….

*** NOAEL is a LEVEL, and they are referring to the AUC value for that level.

So, if you remember that NOAEL is a LEVEL, it might help.

NOAEL is the LEVEL of dose at which there is no significant increase in the incidence of any important adverse biological effect.

There is no DIRECT relationship between the Area Under the Curve (AUC) and a particular NOAEL (no ratio, no relationship). The AUC is simply a feature or aspect of the NOAEL, a measurement taken for that partictular level of dose (the NOAE level of dose). For another dose, there would be another AUC, i.e. different doses would produce different AUCs, but for a specific NOAEL-- i.e. referring to a specific dose (and a specific drug, animal, etc in this case)-- there is just one AUC.







--------------------------------------------------
Note added at 16 hrs (2006-10-21 10:34:22 GMT)
--------------------------------------------------

In relation to my comment on Liz's answer and her use of "in relation to": there is no DIRECT relationship between the Area Under the Curve (AUC) and a particular NOAEL (no ratio, no relationship).

The "AL" is not expressing a relationship (eg, al 3%), it's saying "a el nivel de" becuase the L in NOAEL refers to "level"

--------------------------------------------------
Note added at 16 hrs (2006-10-21 10:36:04 GMT)
--------------------------------------------------

IE:

"a el(al) nivel de efects adversos no observables"

xxxLia Fail
Spain
Local time: 12:25
Specializes in field
Native speaker of: Native in EnglishEnglish
PRO pts in category: 100
Grading comment
As you point out, remembering that NOAEL is a level does help. Thanks Lia!
Login to enter a peer comment (or grade)




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