Peculiarities of approaches to assessing the interchangeability of antiepileptic drugs
The adequacy of the interchangeability of original and generic drugs is an important economic and social problem in healthcare. In this article we look at the problem of the replacement of antiepileptic drugs. Sometimes when their bioequivalence is proved they still can be not equivalent therapeutic...
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| Format: | Article |
| Language: | Russian |
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Ministry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»
2018-02-01
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| Series: | Безопасность и риск фармакотерапии |
| Subjects: | |
| Online Access: | https://www.risksafety.ru/jour/article/view/17 |
| _version_ | 1797224611682713600 |
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| author | E. O. Zhuravleva E. Yu. Pasternak K. E. Zatolochina |
| author_facet | E. O. Zhuravleva E. Yu. Pasternak K. E. Zatolochina |
| author_sort | E. O. Zhuravleva |
| collection | DOAJ |
| description | The adequacy of the interchangeability of original and generic drugs is an important economic and social problem in healthcare. In this article we look at the problem of the replacement of antiepileptic drugs. Sometimes when their bioequivalence is proved they still can be not equivalent therapeutically. The results of the therapy for these kinds of drugs can differ. As well as the individual characteristics of the metabolism that can affect the results of the treatment, there are other possible factors - the diet of the patient or the time of day,when patient takes medication. The cases when for the replacement of one drug for another it was necessary to have both biological and therapeutic equivalence are described in this article. The research data of interchangeability of neurotropic drugs in different countries are presented. The article provides a classification of the Medicines and Healthcare products Regulatory Agency (MHRA) to estimate the possibility of replacement of drugs with recommendations to minimize the risk of adverse reactions for use in clinical practice. |
| first_indexed | 2024-03-08T22:27:25Z |
| format | Article |
| id | doaj.art-6ee8e535dd574af5b2390d00513b4783 |
| institution | Directory Open Access Journal |
| issn | 2312-7821 2619-1164 |
| language | Russian |
| last_indexed | 2024-04-24T13:55:52Z |
| publishDate | 2018-02-01 |
| publisher | Ministry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» |
| record_format | Article |
| series | Безопасность и риск фармакотерапии |
| spelling | doaj.art-6ee8e535dd574af5b2390d00513b47832024-04-03T17:56:36ZrusMinistry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»Безопасность и риск фармакотерапии2312-78212619-11642018-02-0103132117Peculiarities of approaches to assessing the interchangeability of antiepileptic drugsE. O. Zhuravleva0E. Yu. Pasternak1K. E. Zatolochina2Федеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской ФедерацииФедеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской ФедерацииФедеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской ФедерацииThe adequacy of the interchangeability of original and generic drugs is an important economic and social problem in healthcare. In this article we look at the problem of the replacement of antiepileptic drugs. Sometimes when their bioequivalence is proved they still can be not equivalent therapeutically. The results of the therapy for these kinds of drugs can differ. As well as the individual characteristics of the metabolism that can affect the results of the treatment, there are other possible factors - the diet of the patient or the time of day,when patient takes medication. The cases when for the replacement of one drug for another it was necessary to have both biological and therapeutic equivalence are described in this article. The research data of interchangeability of neurotropic drugs in different countries are presented. The article provides a classification of the Medicines and Healthcare products Regulatory Agency (MHRA) to estimate the possibility of replacement of drugs with recommendations to minimize the risk of adverse reactions for use in clinical practice.https://www.risksafety.ru/jour/article/view/17взаимозаменяемостьбиоэквивалентностьтерапевтическая эквива-лентностьвоспроизведенные препаратыпротивоэпилептические препаратыinterchangeabilitybioequivalencetherapeutic equivalencegeneric drugsantiepileptic drugs |
| spellingShingle | E. O. Zhuravleva E. Yu. Pasternak K. E. Zatolochina Peculiarities of approaches to assessing the interchangeability of antiepileptic drugs Безопасность и риск фармакотерапии взаимозаменяемость биоэквивалентность терапевтическая эквива-лентность воспроизведенные препараты противоэпилептические препараты interchangeability bioequivalence therapeutic equivalence generic drugs antiepileptic drugs |
| title | Peculiarities of approaches to assessing the interchangeability of antiepileptic drugs |
| title_full | Peculiarities of approaches to assessing the interchangeability of antiepileptic drugs |
| title_fullStr | Peculiarities of approaches to assessing the interchangeability of antiepileptic drugs |
| title_full_unstemmed | Peculiarities of approaches to assessing the interchangeability of antiepileptic drugs |
| title_short | Peculiarities of approaches to assessing the interchangeability of antiepileptic drugs |
| title_sort | peculiarities of approaches to assessing the interchangeability of antiepileptic drugs |
| topic | взаимозаменяемость биоэквивалентность терапевтическая эквива-лентность воспроизведенные препараты противоэпилептические препараты interchangeability bioequivalence therapeutic equivalence generic drugs antiepileptic drugs |
| url | https://www.risksafety.ru/jour/article/view/17 |
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