ICH STABILITY VAL PRODUCT CHANGE
Russian translation: см.
| 16:19 Dec 23, 2016 |
| English to Russian translations [PRO] Medical - Medical: Pharmaceuticals | |||||||
|---|---|---|---|---|---|---|---|
|
| ||||||
|  Selected response from: Margarita Vidkovskaia Russian Federation Local time: 14:52 | ||||||
Grading comment
| |||||||
| Summary of answers provided | ||||
|---|---|---|---|---|
| 4 | см. |
|
| Summary of reference entries provided | |||
|---|---|---|---|
| ICH |
|
| Discussion entries: 1 | |
|---|---|
Answers
2 hrs confidence: 
| ich stability val product change см. Explanation: При изменениях продукта выполняется оценка стабильности [продукта] в соответствии с ICH и валидация аналитических методик [изучения стабильности]. |
| |
Grading comment
| ||
| Login to enter a peer comment (or grade) | ||
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 . -------------------------------------------------- Note added at 10 mins (2016-12-23 16:29:45 GMT) -------------------------------------------------- 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 ... -------------------------------------------------- Note added at 11 mins (2016-12-23 16:30:41 GMT) -------------------------------------------------- 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 ... -------------------------------------------------- Note added at 14 mins (2016-12-23 16:33:39 GMT) -------------------------------------------------- http://www.proz.com/kudoz/english_to_russian/medical_general... |
| |
| Login to enter a peer comment (or grade) | ||
Login or register (free and only takes a few minutes) to participate in this question.
You will also have access to many other tools and opportunities designed for those who have language-related jobs (or are passionate about them). Participation is free and the site has a strict confidentiality policy.
KudoZ™ translation help
The KudoZ network provides a framework for translators and others to assist each other with translations or explanations of terms and short phrases.
See also:
Search millions of term translations