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.
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