ВАЛИДАЦИЯ ХРОМАТОГРАФИЧЕСКИХ МЕТОДИК: ИССЛЕДОВАНИЕ РОБАСТНОСТИ С ИСПОЛЬЗОВАНИЕМ МАТЕМАТИЧЕСКОГО ПЛАНИРОВАНИЯ ЭКСПЕРИМЕНТОВ
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.
Ключевые слова
робастность,
планы Плакетта - Бермана,
риск,
валидация,
хроматографические методики,
пригодность системы
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Рецензия
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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