DictionaryForumContacts

 Natuli

link 4.09.2010 5:45 
Subject: Standard Preparation Variability, vial-to-vial variability pharm.
The sample preparation or analyst-to-analyst variability was determined by eight
chemists performing three replicate potency assays on samples
(pulled from the same location of a lot to minimize the effect of manufacturing
variability) from a single lot, using the same set of reference standard solutions, using
three different HPLC systems. The results, presented in Table 3.2.P.5... reflect vial-to-vial variability as well as variations due to the analyst/sample preparation.
Standard Preparation Variability
The instrument-to-instrument (and column-to-column) variability was demonstrated by
assaying three sets of sample solutions (designated B, C, and F) via four different HPLC
systems (using instruments from the same manufacturer).
Вопрос такой: подскажите, пожалуйста, как лучше перевести:
analyst-to-analyst variability =вариабельность результатов при выполнении исследования различными аналитиками(=межаналитическая или это из другой области?)
Standard Preparation Variability=?
instrument-to-instrument (and column-to-column,vial-to-vial variability и т.д. )/обусловленная различными приборами/различными колонками и т.д?

контекст:
The sample preparation or analyst-to-analyst variability was determined by eight
chemists performing three replicate potency assays on samples
(pulled from the same location of a lot to minimize the effect of manufacturing
variability) from a single lot, using the same set of reference standard solutions, using
three different HPLC systems. The results, presented in Table 3.2.P.5... reflect vial-to-vial variability as well as variations due to the analyst/sample preparation.
Standard Preparation Variability
The instrument-to-instrument (and column-to-column) variability was demonstrated by
assaying three sets of sample solutions (designated B, C, and F) via four different HPLC
systems (using instruments from the same manufacturer).

 OlgaAvdeeva

link 4.09.2010 9:17 
Наташа, просмотрите серию ГОСТ Р ИСО 5725 Точность (правильность и прецизионность) и Вам все станет понятно. Часть 3 как раз про описанную в Вашем тексте оценку промежуточной прецизионости.
Самая полезная для нас - часть 6 "использование значений точности на практике":
http://www.stroyplan.ru/docs.php?showitem=11265

В ГОСТе используют, например, такие выражения: "Различия между результатами измерений, выполняемых разными операторами и/или с использованием различного оборудования..."

 Natuli

link 4.09.2010 10:52 
Спасибо, сейчас почитаю

 

You need to be logged in to post in the forum

Get short URL | Photo