method operational design regions (MODRs)
Russian translation: область проектных рабочих характеристик метода (MODR)
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| 06:34 Sep 6, 2022 |
| English to Russian translations [PRO] Medical - Medical: Pharmaceuticals / ICH Q14 | |||||||
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|  Selected response from: cherepanov Ukraine Local time: 17:08 | ||||||
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| 3 +1 | область проектных рабочих характеристик метода (MODR) |
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Answers
2 hrs confidence: 
peer agreement (net): +1
peer agreement (net): +1| method operational design regions (modrs) область проектных рабочих характеристик метода (MODR) Explanation: Подход описан здесь: https://www.academia.edu/49898200/Analytical_Quality_by_Desi... MODR used to develop operational region for routine operation (e.g., analysis time, procedure and limits). In accordance with the requirement of ICH Q8 guidelines, regarding “design space” in product development, method operable design region (MODR) can also be established in method development phase, which could serve as a source for robust and cost effective method... а упомянутое выше design space: https://www.ansys.soften.com.ua/about-ansys/blog/440-optimiz... ...При этом описываются границы области проектных параметров (design space) |
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