Aug 1, 2018 06:17
5 yrs ago
3 viewers *
Portuguese term
United States
M.S. Leg/Fin Translator - 12 yrs - MemoQ
Native in: English (Variants: British, UK, US) 
Works in: Spanish to English, Portuguese to English, French to English, and 2 more.
estudo de estresse em condição básica.
Portuguese to English
Medical
Medical (general)
"study under basic stress conditions" or "stress study under basic conditions?
Context:
"Na seção XXX Impurities, a empresa informou que não houve evidência de degradação nas condições de armazenamento do ativo (25oC/60% UR) por 60 meses e que houve formação das impurezas 2-hydroxy e 2-methoxy no estudo de estresse em condição básica. Porém, conforme o § 3o, do art. 6o, da RDC no. XXX, os estudos de degradação devem promover degradação em extensão suficiente a fim de permitir avaliação da formação de produtos de degradação e os resultados dos ensaios servirão de suporte para o desenvolvimento e validação da metodologia de análise do(s) produto(s) de degradação formado(s) e para a análise crítica do perfil de degradação do medicamento."
Context:
"Na seção XXX Impurities, a empresa informou que não houve evidência de degradação nas condições de armazenamento do ativo (25oC/60% UR) por 60 meses e que houve formação das impurezas 2-hydroxy e 2-methoxy no estudo de estresse em condição básica. Porém, conforme o § 3o, do art. 6o, da RDC no. XXX, os estudos de degradação devem promover degradação em extensão suficiente a fim de permitir avaliação da formação de produtos de degradação e os resultados dos ensaios servirão de suporte para o desenvolvimento e validação da metodologia de análise do(s) produto(s) de degradação formado(s) e para a análise crítica do perfil de degradação do medicamento."
Proposed translations
(English)
| 4 +4 | stress study under normal conditions |
Gilmar Fernandes
|
| 4 +1 | stress studies under ordinary conditions |
Elenice Brasseland
|
| 4 | stress study under basic conditions |
Oliver Simões
|
Proposed translations
+4
4 hrs
Gilmar Fernandes
United States
United States
Native in Portuguese
&
English
United States
25 + yrs. Business experience PORT- ENG
Native in: Portuguese 
, English
Works in: Portuguese to English, English to Portuguese
Related KudoZ points
:
129
Selected
stress study under normal conditions
https://www.omicsonline.org/rp-hplc-method-for-estimation-an...
Results and Discussions
Stress studies were performed under conditions of dry heat (thermal studies), hydrolysis (acidic, alkaline and neutral), oxidation, and photolysis, as mentioned in ICH Q1A (R2). A minimum of four samples were generated for every stress condition, viz., blank solution stored under **normal conditions**, the blank subjected to stress in the same manner as the drug (Paclitaxel), a zero time sample containing the drug (which was stored under **normal conditions)**, and the drug solution subjected to stress treatment.
Results and Discussions
Stress studies were performed under conditions of dry heat (thermal studies), hydrolysis (acidic, alkaline and neutral), oxidation, and photolysis, as mentioned in ICH Q1A (R2). A minimum of four samples were generated for every stress condition, viz., blank solution stored under **normal conditions**, the blank subjected to stress in the same manner as the drug (Paclitaxel), a zero time sample containing the drug (which was stored under **normal conditions)**, and the drug solution subjected to stress treatment.
4 KudoZ points awarded for this answer.
Comment: "Selected automatically based on peer agreement."
6 hrs
Oliver Simões
United States
United States
Native in Portuguese
United States
BA in Transl., MA in ESL, 15 yrs of exp.
Native in: Portuguese
Works in: English to Portuguese, Portuguese to English, Spanish to Portuguese, and 2 more.
Related KudoZ points
:
76
stress study under basic conditions
I would definitely stick to "under basic conditions". Check out the definition of "basic" in the Aulete: https://youtu.be/_nuDQoVKOjU There is no reference to "normal".
There are several examples online pointing to studies under "basic conditions". Check out this YouTube video describing a chemical experiment "under basic conditions".
https://youtu.be/_nuDQoVKOjU
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Note added at 6 hrs (2018-08-01 12:56:51 GMT)
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In any event, I suggest clarifying whether "basic" is referring to the conditions of the study or the stress itself. The context, in my opinion, is not sufficient to draw a conclusion.
There are several examples online pointing to studies under "basic conditions". Check out this YouTube video describing a chemical experiment "under basic conditions".
https://youtu.be/_nuDQoVKOjU
--------------------------------------------------
Note added at 6 hrs (2018-08-01 12:56:51 GMT)
--------------------------------------------------
In any event, I suggest clarifying whether "basic" is referring to the conditions of the study or the stress itself. The context, in my opinion, is not sufficient to draw a conclusion.
Example sentence:
This short video takes you through the steps to balance redox reactions that occur under basic conditions.
+1
11 days
Elenice Brasseland
Native in Portuguese
Specializes in field
Committed to excellence!
Native in: Portuguese
Works in: Norwegian to Portuguese, English to Portuguese, Portuguese to Norwegian, and 1 more.
Related KudoZ points
:
4
stress studies under ordinary conditions
É minha sugestão.
Outras alternativas a serem consideradas: "stress testing ..." e "stress analysis ..."
Bom trabalho! :)
Outras alternativas a serem consideradas: "stress testing ..." e "stress analysis ..."
Bom trabalho! :)
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