pharmjournalРазработка и регистрация лекарственных средствDrug development & registration2305-20662658-5049LLC «CPHA»10.33380/2305-2066-2021-10-2-137-146pharmjournal-869Research ArticleРЕГУЛЯТОРНЫЕ ВОПРОСЫREGULATORY ISSUESТрансфер методик определения примесей: сравнительное испытание, валидация, критерии приемлемости (обзор)Transfer of Impurities Determination Methods: Comparative Testing, Validation, Acceptance Criteria (Review)https://orcid.org/0000-0001-8047-4078ЭпштейнН. А.EpshteinN. A.

Эпштейн Наум Аронович

115446, г. Москва, Коломенский проезд, д. 13А

Naum A. Epshtein

13A, Kolomensky proezd, Moscow, 115446

naumepshtein@gmail.comДепартамент регистрации и разработки лекарственных средств ООО «ИРВИН 2»Department of registration and development of medicines LLC «IRWIN 2»202131052021102137146Copyright © Эпштейн Н.А., 20212021Эпштейн Н.А.Epshtein N.A.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.pharmjournal.ru/jour/article/view/869

Введение. При трансфере методик определения примесей используют различные подходы. В большинстве случаев проводят сравнительное испытание образцов или частичную валидацию методик. При этом до сих пор остается актуальным ряд важных для практики вопросов.Текст. Рассмотрены особенности валидации методик и сравнительного испытания образцов при трансфере методик определения примесей. Приведены потенциальные критерии приемлемости – требования к допустимому различию результатов передающей и принимающей лабораторий. Рассмотрены расчетные формулы теста TOST и приведено критическое условие для сравнительного испытания образцов. Обсуждены ключевые моменты, которые следует учитывать при трансфере методик.Заключение. Представлены данные и рекомендации, которые важны для повышения надежности трансфера методик определения примесей.

Introduction. Different approaches are used for transfer of impurities determination methods. In most cases, comparative testing of samples or partial validation of methods is performed. At the same time, a number of issues important for practice are still relevant.Text. The features of methods validation and comparative testing of samples during the transfer of impurities determination methods are considered. Potential acceptance criteria – requirements to the permissible difference between results of transmitting and receiving laboratories – are given. The calculation formulas of the TOST test are considered, and the critical condition for the comparative testing of samples is given. The key points that should be taken into account when transferring the methods are discussed.Conclusion. The data and recommendations are presented, which are important for increasing the reliability of the transfer of the impurities determination methods.

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The authors declare that there are no conflicts of interest present.