Glossary entry

French term or phrase:

a une valeur non actualisée de prise maximale quotidienne

English translation:

non reviewed/updated maximum daily dose/intake

Added to glossary by Drmanu49
Oct 3, 2016 13:50
7 yrs ago
French term

a une valeur non actualisée de prise maximale quotidienne

French to English Science Chemistry; Chem Sci/Eng tox limits
Taken from a report discussing mistakes made when testing a substance for toxic impurities:

Dans la synthèse du rapport on lit : « La décision de mettre au rebut les lots fabriqués avec les filtres non qualifiés apparaît ne pas avoir été prise sur la base d'informations techniques précises, ni sur la base de toutes les informations raisonnablement disponibles et utilisables à l'époque ». 5 points sont développés pour étayer cette conclusion :
1. La dose maximale quotidienne tolérable de prise de lixiviats pour l'ABC a une valeur non actualisée de prise maximale quotidienne d'ABC


Where ABC is the name of a drug substance.

I cannot make any sense of this whatsoever. I have made a very loose guess at "the maximum tolerable daily intake of leachates from ABC has not been updated to reflect the maximum daily dose of ABC", but this is very tenuous and would be grateful for any corroboration/overruling from others.

Thanks.
Change log

Oct 5, 2016 08:48: Drmanu49 Created KOG entry

Discussion

Drmanu49 Oct 5, 2016:
Thank you for the feedback.
Wendy Cummings (asker) Oct 5, 2016:
Context I managed to get a further reference doc from my client, which is actually the source of this quote, and it has been misquoted:
"Lorsqu'elle a calcule la dose maximale quotidienne tolerable de prise de lixiviats pour l'ABC, il apparait que XYZ a utilise une valeur non actualisee de prise maximale quotidienne d'ABC".
This makes it much easier to understand!

Proposed translations

3 mins
Selected

non reviewed/updated maximum daily dose/intake

Inactive Ingredient Database - FDA Update -
www.fda.gov/downloads/AboutFDA/.../CDER/UCM375889.pdf
Traduire cette page
30 oct. 2013 - FDA Update - ... administration and dosage form, it is not considered new and may ... Drugs (OGD) including Chemistry, Bioequivalence, Clinical Review, ... Maximum Daily Intake (MDI) for the inactive ingredient in IID is.
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4 KudoZ points awarded for this answer. Comment: "Thanks, and when read in the correct context (see discussion), it makes it easier to understand"
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