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5.1.1.10. Параллелизм
При наличии испытуемых образцов в целях выявления возможного
эффекта матрицы или различающейся аффинности к метаболитам
необходимо оценить параллелизм между соответствующими значениями на
градуировочной кривой и результатами испытуемых образцов, подвергшихся
серийному разведению. Испытуемый образец с высокой концентрацией
(предпочтительно, близкой к Cmax) следует развести с помощью холостого
образца минимум в 3 раза. Прецизионность между образцами в сериях
разведений не должна превышать 30%. Если образцы разведены нелинейно
(непараллельно), необходимо заранее определить процедуру представления
результатов. Если в ходе валидации метода/методики испытуемые образцы
недоступны, параллелизм следует изучить, как только станут доступны
испытуемые образцы.
======================

Интересно, что это значит по-русски..

http://goo.gl/BkM5dt

7.1.1.10. Parallelism
If study samples are available, parallelism between the calibration standard curve and serially diluted study samples should be assessed to detect possible matrix effect or differing affinities for metabolites. A high concentration study sample (preferably close to Cmax) should be diluted to at least three concentrations with blank matrix. The precision between samples in a dilution series should not exceed 30%. In case the sample does not dilute linearly (i.e. in a non parallel manner), a procedure for reporting a result should be defined a priori. If study samples are not available during the validation of the method, parallelism should be evaluated as soon as study samples become available.

====================
Parallelism -"A condition in which dilution of test samples does not result in
biased measurements of the analyte concentration”

• It is not dilutional linearity
• But the experimental design is similar

“Uses incurred samples to demonstrate that the sample-dilution response
curve is parallel to the standard-concentration response curve”

• It is not a method issue
• It is a sample issue

http://goo.gl/FYqTcx

http://www.dec.gov.ua/site/file_uploads/ua/Bioekvivalentnist/method_validation.pdf

http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/08/WC500109686.pdf

I don't have anything to add here. Just narrow technical terms. It's all there. ... аналита в клинических образцах (incurred-samples) .... It's all translated and explained.

Hope it was helpful

Надеюсь, понял правильно.. ^_^

Technical language sometimes departs from strict grammar rules. I would have used 'among' instead of 'between' but scientists are not language experts, not by a long shot. And there's nothing wrong with the phrase '(differences in) precision between X and Y'. Some trollettes would poke fun at such sentences if they were in Russian, trying to find a missing comma or misspelling. Well, they are as far from hard science as it can be, passing meaningless comments.

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The precision of an analytical procedure expresses the closeness of agreement (degree of scatter) between a series of measurements obtained from multiple sampling of the same homogenous sample under the prescribed conditions. Precision may be considered at three levels: repeatability, intermediate precision, and reproducibility.

http://goo.gl/EXYoLt