estudo de estresse em condição básica.

English translation: stress study under normal conditions

06:17 Aug 1, 2018
Portuguese to English translations [PRO]
Medical - Medical (general)
Portuguese term or phrase: estudo de estresse em condição básica.
"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."
Seth Phillips
Mexico
Local time: 20:24
English translation:stress study under normal conditions
Explanation:
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.
Selected response from:

Gilmar Fernandes
United States
Local time: 21:24
Grading comment
Selected automatically based on peer agreement.
4 KudoZ points were awarded for this answer



Summary of answers provided
4 +4stress study under normal conditions
Gilmar Fernandes
4 +1stress studies under ordinary conditions
Elenice Abrahamsen
4stress study under basic conditions
Oliveira Simões


  

Answers


4 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +4
stress study under normal conditions


Explanation:
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.

Gilmar Fernandes
United States
Local time: 21:24
Native speaker of: Native in PortuguesePortuguese, Native in EnglishEnglish
PRO pts in category: 92
Grading comment
Selected automatically based on peer agreement.

Peer comments on this answer (and responses from the answerer)
agree  Mario Freitas:
5 hrs
  -> Thanks Mario :)

agree  itineuropa
6 hrs
  -> Obrigado, Margarida :)

agree  Matheus Chaud
6 hrs
  -> Obrigado, Matheus :)

agree  Antonio Tomás Lessa do Amaral
12 days
Login to enter a peer comment (or grade)

6 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5
stress study under basic conditions


Explanation:
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.

Example sentence(s):
  • This short video takes you through the steps to balance redox reactions that occur under basic conditions.
Oliveira Simões
United States
Local time: 18:24
Specializes in field
Native speaker of: Native in PortuguesePortuguese
PRO pts in category: 32
Login to enter a peer comment (or grade)

11 days   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +1
stress studies under ordinary conditions


Explanation:
É minha sugestão.

Outras alternativas a serem consideradas: "stress testing ..." e "stress analysis ..."

Bom trabalho! :)

Elenice Abrahamsen
Local time: 03:24
Specializes in field
Native speaker of: Portuguese
PRO pts in category: 4

Peer comments on this answer (and responses from the answerer)
agree  Antonio Tomás Lessa do Amaral
18 hrs
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