\'\'staged TTC\'\'

17:13 Feb 2, 2016
This question was closed without grading. Reason: Answer found elsewhere

English to French translations [PRO]
Medical - Medical: Pharmaceuticals / Guideline on the Limits of Genotoxic Impurities
English term or phrase: \'\'staged TTC\'\'
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?
Bertrand Leduc
United Kingdom
Local time: 16:39


Summary of answers provided
4 +1seuil de préoccupation toxicologique
Drmanu49
Summary of reference entries provided
possibly useful
liz askew

Discussion entries: 3





  

Answers


4 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +1
"staged ttc"
seuil de préoccupation toxicologique


Explanation:
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.

--------------------------------------------------
Note added at 9 minutes (2016-02-02 17:22:44 GMT)
--------------------------------------------------

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 ...

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

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].



--------------------------------------------------
Note added at 29 minutes (2016-02-02 17:43:24 GMT)
--------------------------------------------------

staged correspond aux variations doses quotidiennes limites selon le seuil de préoccupation toxicologique

Drmanu49
France
Local time: 17:39
Specializes in field
Native speaker of: Native in EnglishEnglish, Native in FrenchFrench
PRO pts in category: 1923
Notes to answerer
Asker: Merci Manu, mais TTC je sais le traduire, c'est staged qui m'intéresse.


Peer comments on this answer (and responses from the answerer)
agree  PLR TRADUZIO (X): http://ansm.sante.fr/var/ansm_site/storage/original/applicat...
5 mins
  -> Thank you.
Login to enter a peer comment (or grade)




Reference comments


4 mins
Reference: possibly useful

Reference information:
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 ...

--------------------------------------------------
Note added at 7 mins (2016-02-02 17:20:56 GMT)
--------------------------------------------------

of course you are looking for "staged", but I have yet to find anything in French.

Nothing with "étagé"

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

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 ...

liz askew
United Kingdom
Works in field
Native speaker of: Native in EnglishEnglish
PRO pts in category: 113
Note to reference poster
Asker: Merci Liz !

Login to enter a peer comment (or grade)



Login or register (free and only takes a few minutes) to participate in this question.

You will also have access to many other tools and opportunities designed for those who have language-related jobs (or are passionate about them). Participation is free and the site has a strict confidentiality policy.

KudoZ™ translation help

The KudoZ network provides a framework for translators and others to assist each other with translations or explanations of terms and short phrases.


See also:
Term search
  • All of ProZ.com
  • Term search
  • Jobs
  • Forums
  • Multiple search