References

vsp

Вопросы современной педиатрии

Current Pediatrics

1682-55271682-5535

Издательство «ПедиатрЪ»

10.15690/vsp.v23i1.2654

vsp-3398

Research Article

МНЕНИЕ ПО ПРОБЛЕМЕ

EXPERT OPINION

Лекарственные препараты передовой терапии: перспективы внедрения в клиническую практику в педиатрии

Advanced-Therapy Medicinal Products: Challenges for Implementation in Pediatric Clinical Practice

https://orcid.org/0000-0001-7704-9900

Гомон

Ю. М.

Gomon

Yulia M.

Гомон Юлия Михайловна, доктор медицинских наук, профессор кафедры клинической фармакологии и доказательной медицины; врач клинический фармаколог

194354, Санкт-Петербург, Северный пр., д. 1

тел.: +7 (911) 960-62-68

St. Petersburg

gomonmd@yandex.ru

https://orcid.org/0000-0002-1919-2909

Колбин

А. С.

Kolbin

Alexey S.

Санкт-Петербург

St. Petersburg

Первый СПбГМУ им. акад. И.П. Павлова; Городская больница Святого Великомученика ГеоргияРоссияPavlov First Saint Petersburg State Medical University; St. George the Great Martyr City HospitalRussian Federation

Первый СПбГМУ им. акад. И.П. Павлова; СПбГУРоссияPavlov First Saint Petersburg State Medical University; St. Petersburg State UniversityRussian Federation

2024

25022024

2313447

2024

Гомон Ю.М., Колбин А.С.

Gomon Y.M., Kolbin A.S.

Данная работа распространяется под лицензией Creative Commons Attribution 4.0.

This work is licensed under a Creative Commons Attribution 4.0 License.

https://vsp.spr-journal.ru/jour/article/view/3398

В статье обсуждаются классификации лекарственных средств для генной и клеточной терапии. Представлены данные о лекарственных средствах, зарегистрированных в России, а также в странах Европейского союза, Великобритании, США и Японии. Рассмотрены ограничения использования таких лекарственных средств, в том числе их высокая утилитарная стоимость и высокий риск нежелательных явлений. Проанализирован потенциал повышения клинической эффективности и экономической целесообразности медицинских технологий для передовой терапии, в том числе в педиатрии.

The article discusses classifications of medicines for gene and cell therapy. Data on medicinal products registered in Russia, as well as in the European Union countries, Great Britain, USA, and Japan is presented. The limitations on using such medicinal products were considered, including their high utilitarian cost and high risk of adverse events. The potential for increasing clinical efficacy and economic feasibility of advanced therapies (pediatrics included) has been analyzed.

передовые медицинские технологиигенная терапияклеточная терапиярегистрация

advanced medical technologiesgene therapycell therapyregistration

Отсутствует.

Not specified.

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