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Разработка и регистрация лекарственных средств

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ВАЛИДАЦИЯ ХРОМАТОГРАФИЧЕСКИХ МЕТОДИК: ИССЛЕДОВАНИЕ РОБАСТНОСТИ С ИСПОЛЬЗОВАНИЕМ МАТЕМАТИЧЕСКОГО ПЛАНИРОВАНИЯ ЭКСПЕРИМЕНТОВ

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Аннотация

Рассмотрены теоретические и практические основы исследования робастности хроматографических методик с использованием планов Плакетта - Бермана. Пошагово, с пояснениями и примерами рассмотрено установление значимых (потенциально критических) факторов, а так же определение допустимых пределов изменения значимых факторов и откликов. Оценка этих пределов важна для обоснования требований к пригодности хроматографической системы. Даны рекомендации по выполнению необходимых вычислений в Excel и оценке робастности хроматографических методик.

Об авторе

Н. А. Эпштейн
АО «ШТАДА ФармДевелопмент» АО «НИЖФАРМ»
Россия


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Для цитирования:


Эпштейн Н.А. ВАЛИДАЦИЯ ХРОМАТОГРАФИЧЕСКИХ МЕТОДИК: ИССЛЕДОВАНИЕ РОБАСТНОСТИ С ИСПОЛЬЗОВАНИЕМ МАТЕМАТИЧЕСКОГО ПЛАНИРОВАНИЯ ЭКСПЕРИМЕНТОВ. Разработка и регистрация лекарственных средств. 2018;(3):96-108.

For citation:


Epshtein N.A. VALIDATION OF CHROMATOGRAPHIC METHODS: ROBUSTNESS INVESTIGATION WITH USE OF EXPERIMENTAL DESIGN. Drug development & registration. 2018;(3):96-108. (In Russ.)

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