ppharmПедиатрическая фармакологияPediatric pharmacology1727-57762500-3089Издательство «ПедиатрЪ»10.15690/pf.v18i4.2293ppharm-2050Research ArticleОБЗОР ЛИТЕРАТУРЫREVIEWПрименение биотехнологических лекарственных средств в педиатрии на примере моноклональных антител: взгляд с позиции клинической фармакологииThe Use of Biotechnological Drugs in Pediatrics on the Example of Monoclonal Antibodies: Clinical Pharmacology Viewhttps://orcid.org/0000-0002-1919-2909КолбинА. С.KolbinAlexey S.

Колбин Алексей Сергеевич - доктор медицинских наук, профессор, заведующий кафедрой клинической фармакологии и доказательной медицины Первый Санкт-Петербургский ГМУ им. акад. И.П. Павлова.

197022, Санкт-Петербург, ул. Льва Толстого, д. 6-8, телефон: +7 (921) 759-04-49; eLibrary SPIN: 7966-0845

MD, PhD, Professor

6/8 Lva Tolstogo Str., St. Petersburg, 197089; +7 (921) 759-04-49; eLibrary SPIN: 7966-0845

alex.kolbin@mail.ruhttps://orcid.org/0000-0001-8217-0027ЕмельяноваЛ. И.YemelyanovaLiudmila I.

Емельянова Людмила Игоревна

197022, Санкт-Петербург, ул. Льва Толстого, д. 6-8, телефон: +7 (921) 759-04-49

6/8 Lva Tolstogo Str., St. Petersburg, 197089; +7 (921) 759-04-49

milena1811@yandex.ruПервый Санкт-Петербургский государственный медицинский университет имени академика И.П. Павлова; Санкт-Петербургский государственный университетРоссияPavlov First Saint Petersburg State Medical University; Saint Petersburg State UniversityRussian FederationПервый Санкт-Петербургский государственный медицинский университет имени академика И.П. ПавловаРоссияPavlov First Saint Petersburg State Medical UniversityRussian Federation202117102021184304313Copyright © Колбин А.С., Емельянова Л.И., 20212021Колбин А.С., Емельянова Л.И.Kolbin A.S., Yemelyanova L.I.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.pedpharma.ru/jour/article/view/2050

В статье рассматриваются моноклональные антитела — их структура, классификации, фармакодинамика, фармакокинетика, нежелательные явления. Даются примеры по каждому разделу. Подробно обсуждаются подходы к изучению и критериям выбора данных лекарственных средств в педиатрии: роль клинических испытаний, экстраполяции и фармакометрии. Показано, что различия в фармакокинетике моноклональных антител между взрослыми и детьми обусловлены возрастными особенностями физиологических процессов. Авторы разбирают такие параметры, как абсорбция и биодоступность, распределение, элиминация. Подробно представлена роль иммуногенности моноклональных антител в структуре нежелательных явлений у детей. Рассмотрена фармакометрия в виде моделирования и симуляции при дозировании моноклональных антител в педиатрии. Вне зависимости от принципа определения дозы моноклональных антител у детей важно учитывать, что биология развития ребенка является «движущейся мишенью» в педиатрии. По результатам статьи сделаны выводы и даны рекомендации.

The article reviews monoclonal antibodies, its structure, classifications, pharmacodynamics, pharmacokinetics, and adverse effects. There are examples for each section. Approaches to the research and criteria for drug selection in paediatrics are discussed in detail: the role of clinical trials, extrapolation and pharmacometrics. It has been shown that the differences in the pharmacokinetics of monoclonal antibodies between adults and children present due to the age-related characteristics of various physiological processes. The authors analyse such parameters as absorption, bioavailability, distribution, and elimination. The role of monoclonal antibodies immunogenicity in the structure of adverse effects in children is fully presented. Pharmacometrics is reviewed in the form of modelling and simulation in monoclonal antibodies dosing in paediatrics. It is important to consider the growth and development as “moving targets" in pediatrics regardless the principle of monoclonal antibodies dosage in children. The conclusions were made, and the guidelines were prepared based on the article results.

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