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Methodological approaches to conducting pharmacological studies
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METHODOLOGICAL APPROACHES TO CONDUCTING PHARMACOLOGICAL STUDIES
UDK 615 Лекарствоведение. Фармакология. Общая терапия. Токсикология
Lyashev A. Yu. 1
Mal G. S. 2
Pyzhova O. V. 3
Authors:
1.  Research Institution of Experimental Medicine

2.  Kursk State Medical University (Department of pharmacology, Head)

Russian Federation
3.  Kursk State Medical University (Department of Philosophy, Assistant Professor)

Type:
Article
Pages:
from 65 to 70
Status:
Published
Received:
22.03.2024
Accepted:
09.07.2024
Published:
09.07.2024
Subject area:
UDK 615 Лекарствоведение. Фармакология. Общая терапия. Токсикология
Language:
Russian
Keywords:
methodology; pharmacology; preclinical and clinical studies; medications; combination drugs
Abstract and keywords
Abstract (English):
The article discusses the specifics of methodological approaches to pharmacological studies, considers the peculiarities of organizing preclinical studies of new pharmacological preparations, the task of which is to analyze the pharmacological activity, pharmacokinetic and toxicological properties of the active substance and the dosage form. The article emphasizes that the development of medical science, the introduction of new methods of treating human diseases strongly require the search for new effective pharmacological drugs. Taking into consideration the social significance of the problem under discussion, it goes without saying that ethical and legal regulation of this sphere by the state is an integral part of the successful development for the benefit of the society.

Keywords:
methodology; pharmacology; preclinical and clinical studies; medications; combination drugs
Text
Publication text (PDF): Read Download
References

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11. Vrijens B. Current situation of medication adherence in hypertension [Tekst] / B. Vrijens, S. Antoniou, M. Burnier et al. // Frontiers in Pharmacology.- 2018.- Vol. 100.- N 8. URL: https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2017.00100/full.

12. Vasil'ev A.N. Kachestvennye doklinicheskie issledovaniya – neobhodimyy etap razrabotki i vnedreniya v klinicheskuyu praktiku novyh lekarstvennyh preparatov [Tekst] / A.N. Vasil'ev // Antibiotiki i himioterapiya.- 2012.- T. 57.- № 1-2.- S. 41-49. URL: https://www.antibioticschemotherapy.ru/jour/article/view/421. 3, Vasil'ev A.N., Klinicheskie issledovaniya. Metodologiya razrabotki i principy provedeniya [Tekst] / A.N. Vasil'ev, R.R. Niyazov, E.Yu. Parfenova i dr. // Vedomosti Nauchnogo centra ekspertizy sredstv medicinskogo primeneniya.- 2012.- №4.- S. 19-25. URL: https://cyberleninka.ru/article/n/klinicheskie-issledovaniya-metodologiya-razrabotkii-printsipy-provedeniya/viewer.

13. Dobrovol'skiy A.V. Podhody k klinicheskoy razrabotke kombinirovannyh preparatov v Rossiyskoy Federacii i Evropeyskom ekonomicheskom soyuze s uchetom trebovaniy deystvuyuschego zakonodatel'stva [Tekst] / A.V. Dobrovol'skiy // Vedomosti Nauchnogo centra ekspertizy sredstv medicinskogo primeneniya.- 2019.- T. 9. - № 1.- S. 14-27. URL: https://www.vedomostincesmp.ru/jour/article/view/208.

14. Edronova V.N. Metody, metodologiya i logika nauchnyh issledovaniy [Tekst] / V.N. Edronova, V.O. Ovcharov // Ekonomicheskiy analiz: teoriya i praktika.2013.- № 9(312).- S. 14-23. URL: https://www.finizdat.ru/journal/analiz/detail.php?ID=55538.

15. Edronova V.N. Sistema metodov v nauchnyh issledovaniyah [Tekst] / V.N. Edronova, V.O. Ovcharov // Ekonomicheskiy analiz: teoriya i praktika.- 2013.- № 10(313).- S. 33-47. URL: https://www.finizdat.ru/journal/analiz/detail.php?ID=55642.

16. Engalycheva G.N. Ekspertnaya ocenka doklinicheskih issledovaniy pervichnoy i vtorichnoy farmakodinamiki lekarstvennyh sredstv [Tekst] / G.N. Engalycheva, R.D. Syubaev, D.V. Goryachev, Yu.V. Olefir // Vedomosti Nauchnogo centra ekspertizy sredstv medicinskogo primeneniya.- 2018.- T. 8.- № 3.- S. 138-144. URL: https://www.vedomostincesmp.ru/jour/article/view/174/168.

17. Rukovodstvo po ekspertize lekarstvennyh sredstv dlya medicinskogo primeneniya. M: GOETAR. 2022. 164 s. URL: https://www.regmed.ru/upload/iblock/eee/ni9gqb04jn1c4qwatet0wlxofb8fli0w/%D0 %A0%D1%83%D0%BA%D0%BE%D0%B2%D0%BE%D0%B4%D1%81%D1%8 2%D0%B2%D0%BE%20%D0%BF%D0%BE%20%D1%8D%D0%BA%D1%81% D0%BF%D0%B5%D1%80%D1%82%D0%B8%D0%B7%D0%B5%20%D0%BB% D0%B5%D0%BA%D0%B0%D1%80%D1%81%D1%82%D0%B2%D0%B5%D0% BD%D0%BD%D1%8B%D1%85%20%D1%81%D1%80%D0%B5%D0%B4%D1% 81%D1%82%D0%B2%20%D0%B4%D0%BB%D1%8F%20%D0%BC%D0%B5% D0%B4%D0%B8%D1%86%D0%B8%D0%BD%D1%81%D0%BA%D0%BE%D0 %B3%D0%BE%20%D0%BF%D1%80%D0%B8%D0%BC%D0%B5%D0%BD%D 0%B5%D0%BD%D0%B8%D1%8F.pdf.

18. Guidelines on Repeated Dose Toxicity. Committee on Human Medicinal Products (CPMP/CWP/1042/99 Rev 1 Sorr*. [Elektronnyy resurs] URL: http://www.ema.europa.eu/docx/en_GB/document_library/Scientific_guideline/2010/ 03/WC500079536_pdf (data obrascheniya 29.11.2011).

19. The Common Technical Document of the Registration of Pharmaceuticals for Human Use: Safety – M45(R2). Nonclinical overview and nonclinical summaries of module 2 organization of module 4. [Elektronnyy resurs]. URL: http:// www.Ich.org/fileadmin Public WebSite/ICH Products CTD/M4_R2_Safety/M45_R2_pdf (data obrascheniya 28.11.2011).

20. Vrijens B. Current situation of medication adherence in hypertension [Tekst] / B. Vrijens, S. Antoniou, M. Burnier et al. // Frontiers in Pharmacology.- 2018.- Vol. 100.N 8. URL: https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2017.0010 0/full.

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