Jul 4, 2020 13:26
3 yrs ago
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English term

failing points

English to Russian Medical Medical: Pharmaceuticals module 3 - quality
Acceptance Criteria

Calibration curve/Standard curve

The regression coefficient (R2) of standard curves of all individual runs must be greater than or equal to 0.980. Mean Analytical Recovery (%AR) should be within 80 to 120% of the nominal value except LLOQ and ULOQ for which it should be within 75 to 125%. Total error for each concentration should not exceed 30% and should not exceed 40% for LLOQ and ULOQ. At least 75% of the standards within the quantitation range of the calibration curve, with minimum six standards, should meet the above acceptance criteria, including the LLOQ. Do not exclude the failing points unless the cause of failure during the assay is identified. Consecutive standards within the quantitation range cannot fail.


(This is from the description of a qPCR procedure used to quantify host cell proteins in a monoclonal antibody drug)

Proposed translations

+1
35 mins
Selected

выпадающие точки

https://portal.tpu.ru/SHARED/s/SGA/academics/Tab/smetanina_e...

...Выпадающие точки могут быть исключены из расчета в таблице значений результирующего графика...

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Note added at 37 mins (2020-07-04 14:03:37 GMT)
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https://cchgeu.ru/upload/iblock/dbd/metod_sovremennaya-fizic...

...На вкладке «Графики» появится калибровочный график и таблица. Выпадающие точки можно исключить, нажав на соответствующую строку в. ...
Peer comment(s):

agree Oleg Shumilov
3 days 1 hr
Спасибо
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4 KudoZ points awarded for this answer.
1 day 44 mins

точки, не отвечающие критерию (%AR)

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4476982/
Three runs are shown with unadjusted %AR failing for all runs. This confirms that accurate determinations of recovery required adjustment for the endogenous component.
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