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 ochernen

link 5.12.2013 17:37 
Subject: Impact Summary med.
Исследования лекарственного препарата
Оригинал:

3.1.2 Method Change and Impact Summary
The obsolete IEF method (TM-061) was replaced by new technology, imaged capillary
isoelectric focusing (icIEF).
The obsolete method was a qualitative method comparing the charge variant banding pattern
of the sample on a gel to that of the reference material. The current method, icIEF, provides
a quantitative measure for monitoring charge variants (% acidic, % basic, and % main) and
comparing charge variant distribution of the sample to that of the reference material. All
samples and reference show comparable %area quantitative response for charge species.
Proposed commercial specifications establish quantitative limits for charge species.
Bridging studies conducted during stability testing demonstrated that samples tested by both
methods passed the qualitative acceptance criteria for “comparable to reference”.

Как здесь перевести Impact Summary? Резюме влияния на исследование в результате изменения метода??

Заранее благодарен.

 gni153

link 6.12.2013 6:25 
Справка о результате (как-то так) или просто- Результат

 kem-il

link 6.12.2013 8:08 
Изменение метода и последствия

 gni153

link 6.12.2013 8:25 
неотвратимые:-)

 ochernen

link 6.12.2013 10:12 
Я перевел как Замена метода и заключение о влиянии замены метода ..
Нормально??

 

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