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and throughout stability

Russian translation: в ходе исследования стабильности

07:56 Jan 10, 2021
English to Russian translations [PRO]
Medical - Medical: Pharmaceuticals
English term or phrase: and throughout stability
Контроль. лек. веществ

Acceptance criteria for specified, identified unspecified, unspecified and total impurities have been established based on consideration of the levels of impurities present in batches of X and Y used in toxicological and clinical studies and present at release and throughout stability in batches of Y representative of the commercial process and commercial scale and by consideration of the philosophies outlined in ICH Q3A(R) and ICH Q6A.

Критерии приемлемости... были установлены .... на основе данных стабильности...?

Спасибо!
Nadezhda Wenzel
Russian translation:в ходе исследования стабильности
Explanation:
Критерии приемлемости... были установлены ... исходя из содержания примесей в препарате серий... при его выпуске и в ходе исследования стабильности...

То есть в течение периода изучения стабильности.

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Note added at 11 hrs (2021-01-10 19:31:48 GMT)
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Наверное, речь действительно идет не о периоде изучения стабильности, а о периоде, в течение которого препарат остается стабильным, то есть в течение установленного срока хранения. Хотя формулировка странная... В любом случае термин "период стабильности" лучше не употреблять!
Selected response from:

mas63
Russian Federation
Local time: 17:46
Grading comment
Благодарю.
4 KudoZ points were awarded for this answer



Summary of answers provided
4в ходе исследования стабильности
mas63


Discussion entries: 2





  

Answers


11 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5
в ходе исследования стабильности


Explanation:
Критерии приемлемости... были установлены ... исходя из содержания примесей в препарате серий... при его выпуске и в ходе исследования стабильности...

То есть в течение периода изучения стабильности.

--------------------------------------------------
Note added at 11 hrs (2021-01-10 19:31:48 GMT)
--------------------------------------------------

Наверное, речь действительно идет не о периоде изучения стабильности, а о периоде, в течение которого препарат остается стабильным, то есть в течение установленного срока хранения. Хотя формулировка странная... В любом случае термин "период стабильности" лучше не употреблять!

mas63
Russian Federation
Local time: 17:46
Specializes in field
Native speaker of: Russian
PRO pts in category: 1262
Grading comment
Благодарю.
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