Jul 19, 2022 04:45
1 yr ago
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English term

drug tolerance of the assay

English to Russian Medical Medical: Pharmaceuticals валидация аналитичской методики
Drug Tolerance
The concentration of *** that can be added to the LQC while remaining above the screening cut
point is considered to be the drug tolerance of the assay. Samples of negative base pool with zero, 140
and 350 μg/mL of anti-*** were pre-incubated with *** at concentrations ranging from 0.1
to 5.0 μg/mL prior to assay. All antibody-spiked samples ran above cut point at all levels of ***
tested. The method is tolerant up to > 5.0 μg/mL

Proposed translations

+2
4 hrs
Selected

толерантность анализа к лекарственному препарату

Двуязычный документ:

Русс.:
"Оценка чувствительности анализа в присутствии ожидаемых уровней мешающего терапевтического белкового препарата, также известная как толерантность анализа к лекарству, критична для понимания чувствительности и пригодности метода обнаружения АКЛ у дозированных субъектов".

Англ.:
"The assessment of assay sensitivity in the presence of the expected levels of interfering therapeutic protein product, also known as the assay’s drug tolerance, is critical to understanding the sensitivity and suitability of the method for detecting ADA in dosed subjects".


IV. Элементы дизайна анализа (IV. Assay design elements) —> C. Чувствительность (C. Sensitivity) —> 2. Толерантность к лекарству, чувствительность и пригодность анализа (2. Drug Tolerance, Sensitivity, and Assay Suitability) — https://pharmadvisor.ru/documents/ss3919/ss3919.html

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"Толерантность (устойчивость) методики к присутствию ЛП (Drug tolerance)".
https://www.pharmjournal.ru/jour/article/view/707/681
Note from asker:
Peer comment(s):

agree Tatiana Nikitina : Больше всего нравится вариант "толерантность (устойчивость) методики к присутствию ЛП". В первом фрагменте напрягают "дозированные субъекты".
6 hrs
agree Tymur Buliekov
1 day 1 hr
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4 KudoZ points awarded for this answer. Comment: "Спасибо!"

Reference comments

1 hr
Reference:

assay - A laboratory test to find and measure the amount of a specific substance. - https://www.cancer.gov/publications/dictionaries/cancer-term...
What is drug tolerance? Drug tolerance occurs when someone's body or brain no longer responds to a prescription or recreational drug in the same way it once did. In many cases, tolerance happens when someone has been taking a certain drug for an extended period of time. - https://www.medicalnewstoday.com/articles/drug-tolerance#wha...


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Note added at 2 horas (2022-07-19 07:02:07 GMT)
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The screening cut point is defined as the level of response of the screening assay at and above which a sample is considered to be reactive for the presence of antibodies. - https://www.celerion.com/wp-content/uploads/2012/01/Celerion...
The cut point of an ADA assay is the level of response that defines the sample response as positive or negative - https://www.sciencedirect.com/science/article/pii/S002217591...
ADA=antidrug antibody
LQC - low concentration quality control; assay - A laboratory test to find and measure the amount of a specific substance. - https://www.cancer.gov/publications/dictionaries/cancer-term...
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