This question was closed without grading. Reason: Answer found elsewhere
Feb 2, 2016 17:13
8 yrs ago
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English term

\'\'staged TTC\'\'

English to French Medical Medical: Pharmaceuticals Guideline on the Limits of Genotoxic Impurities
Is the CHMP in agreement with the principles of “staged TTC” dependent on the duration of clinical exposure, i.e. higher levels allowed for marketed drugs used to treat acute conditions, e.g. antibiotics. If ‘yes’, what levels would be acceptable?
Proposed translations (French)
4 +1 seuil de préoccupation toxicologique

Discussion

Bertrand Leduc (asker) Feb 2, 2016:
Merci PLR, ça répond à ma question
PLR TRADUZIO (X) Feb 2, 2016:
https://www.google.fr/url?sa=t&rct=j&q=&esrc=s&source=web&cd...

presentation session etude injectables et compatibilite avec ...
session.injectables.sfstp.myevent.evenium.com/.../slidessession27092012...
27 sept. 2012 - Notion de limites analytiques: AET (seuil d'évaluation analytique ..... Concept de « Control Space ». Développer ...... /FDA staged TTC concept.

Le TTC est indexé à un seuil Bertrand.
Bertrand Leduc (asker) Feb 2, 2016:
threshold of toxicological concern (TTC)

Proposed translations

+1
4 mins
English term (edited): "staged ttc"

seuil de préoccupation toxicologique

Seuil de préoccupation toxicologique | Autorité européenne ...
www.efsa.europa.eu/fr/topics/topic/thresholdtoxicologicalco...
12 févr. 2015 - The Threshold of Toxicological Concern (TTC) approach has been developed to ... Qu'est-ce que le seuil de préoccupation toxicologique ?

Evaluation du risque lié à l'utilisation des huiles ... - ANSM
ansm.sante.fr/var/ansm.../599485607ae049abfac313b71943d612.pdf
1 déc. 2010 - Approche fondée sur le seuil de préoccupation toxicologique. ... Etude de la toxicité fondée sur des méthodes in vitro. ...... Le concept de seuil de préoccupation toxicologique (Threshold of Toxicological Concern ou TTC) peut.

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Note added at 9 minutes (2016-02-02 17:22:44 GMT)
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éventuellement voir stades en fonction des seuils ou approches selon le seuil de...

étude évaluation - CHU de Rouen
www.chu-rouen.fr/page/detail/fr/CIS_TR_112
... Quelle est la précision diagnostique de la stadification laparoscopique après ... l'anémie du prématuré - Seuil de préoccupation toxicologique pour l'analyse ...

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Note added at 11 minutes (2016-02-02 17:25:04 GMT)
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Staged TTC

The staged TTC concept, proposed by Mueller et al. [15] and based on an earlier publication by Bos et al. [16] on the virtually safe dose (VSD), can be used during clinical development and marketing. This concept takes into account the fact that duration of exposure is a key factor impacting on the probability of a carcinogenic response. The recommended limits for daily intake of GTIs are: 1.5, 5, 10, 20 and 60μg/day for greater than 12-months, 6-12-months, 3-6-months, 1-3-months and less than 1-month, respectively. For single doses, an intake of 120μg/day is acceptable [11].



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Note added at 29 minutes (2016-02-02 17:43:24 GMT)
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staged correspond aux variations doses quotidiennes limites selon le seuil de préoccupation toxicologique
Note from asker:
Merci Manu, mais TTC je sais le traduire, c'est staged qui m'intéresse.
Peer comment(s):

agree PLR TRADUZIO (X) : http://ansm.sante.fr/var/ansm_site/storage/original/applicat...
5 mins
Thank you.
Something went wrong...

Reference comments

4 mins
Reference:

possibly useful

Evaluation du risque lié à l'utilisation des huiles ... - ANSM
ansm.sante.fr/.../599485607ae049abfac313b71943d6...
Translate this page
Dec 1, 2010 - Approche fondée sur l'équivalence en substances à une huile essentielle .... HE de moutarde Brassica juncea (L.) Czerniak. et autres extraits de ..... Dans le cas d'une HE définie comme suffisamment similaire à une HE ou à .... Le concept de seuil de préoccupation toxicologique (Threshold of Toxicological ...

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Note added at 7 mins (2016-02-02 17:20:56 GMT)
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of course you are looking for "staged", but I have yet to find anything in French.

Nothing with "étagé"

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Note added at 1 hr (2016-02-02 18:52:21 GMT)
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oh look

also known as "step-wise"


A Comprehensive Guide to Toxicology in Preclinical Drug ...
https://books.google.co.uk/books?isbn=0123878152
Ali S. Faqi - 2013 - ‎Medical
TABLE 7.7 Staged-Threshold of Toxicological Concern (TTC) for Clinical Trials ... lifetime exposures, a step-wise or staged-TTC approach has been accepted ...
Note from asker:
Merci Liz !
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