ICH STABILITY VAL PRODUCT CHANGE

Russian translation: см.

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16:19 Dec 23, 2016
English to Russian translations [PRO]
Medical - Medical: Pharmaceuticals
English term or phrase: ICH STABILITY VAL PRODUCT CHANGE
Product Description:
FCT; SPFR1402.02, ICH STABILITY VAL PRODUCT CHANGE
Product Name/Strength:
SERTRALINE HCL 100MG FCT, BULK
Maxim Polukhin
Local time: 12:08
Russian translation:см.
Explanation:
При изменениях продукта выполняется оценка стабильности [продукта] в соответствии с ICH и валидация аналитических методик [изучения стабильности].


Selected response from:

Margarita Vidkovskaia
Russian Federation
Local time: 12:08
Grading comment
Спасибо!
4 KudoZ points were awarded for this answer



Summary of answers provided
4см.
Margarita Vidkovskaia
Summary of reference entries provided
ICH
liz askew

Discussion entries: 1





  

Answers


2 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5
ich stability val product change
см.


Explanation:
При изменениях продукта выполняется оценка стабильности [продукта] в соответствии с ICH и валидация аналитических методик [изучения стабильности].




Margarita Vidkovskaia
Russian Federation
Local time: 12:08
Specializes in field
Native speaker of: Native in RussianRussian
PRO pts in category: 736
Grading comment
Спасибо!
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Reference comments


9 mins
Reference: ICH

Reference information:
Stability testing requirements for vaccines--draft guidelines of the ...
https://www.ncbi.nlm.nih.gov/pubmed/8854031
by M Haase - ‎1996 - ‎Cited by 7 - ‎Related articles
The International Conference on Harmonisation (ICH) process considers ways in which the technical requirements for assuring the quality, safety and efficacy of .

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Note added at 10 mins (2016-12-23 16:29:45 GMT)
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VAL
Value?

International Council on Harmonization (ICH) (2003) Stability Testing ...
www.scirp.org/(S(vtj3fa45qm1ean45vvffcz55))/reference/Refer...
30 Nov 2016 - International Council on Harmonization (ICH) (2003) Stability Testing of New Drug Substances and Products Q1A(R2). ... Hydrochlorothiazide and their impurities are, VAL: 0.303 μg/mL, HCTZ: 0.019 μg/mL, VAL RC-B: 0.085 ...

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Note added at 11 mins (2016-12-23 16:30:41 GMT)
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Information on Product Change:

Significant Change in Pharmaceutical Stability Testing ...
www.pharmaguideline.com › Quality Control › Stability
9 Sep 2014 - According to ICH “significant change” for a drug product is defined as: 1. A 5% change in assay from its initial value; or failure to meet the ...

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Note added at 14 mins (2016-12-23 16:33:39 GMT)
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http://www.proz.com/kudoz/english_to_russian/medical_general...

liz askew
United Kingdom
Works in field
Native speaker of: Native in EnglishEnglish
PRO pts in category: 4
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