Specific features of the bioequivalence study of drugs - analogs of endogenous compounds
This paper presents an analysis of leading foreign regulatory authorities’ requirements for the bioequivalence studies of medicinal products containing analogues of endogenous substances. US Food and Drug Administration, European Medicines Agency, and Eurasian Economic Union’s approaches are discuss...
| Main Authors: | , , |
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| Format: | Article |
| Language: | Russian |
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NEICON ISP LLC
2018-02-01
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| Series: | Ведомости Научного центра экспертизы средств медицинского применения |
| Subjects: | |
| Online Access: | https://www.vedomostincesmp.ru/jour/article/view/44 |
| _version_ | 1797199074582069248 |
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| author | V. K. Adonin D. P. Romodanovskiy R. R. Niyazov |
| author_facet | V. K. Adonin D. P. Romodanovskiy R. R. Niyazov |
| author_sort | V. K. Adonin |
| collection | DOAJ |
| description | This paper presents an analysis of leading foreign regulatory authorities’ requirements for the bioequivalence studies of medicinal products containing analogues of endogenous substances. US Food and Drug Administration, European Medicines Agency, and Eurasian Economic Union’s approaches are discussed. The scientific literature on the bioequivalence studies of endogenous substances, as well as the results of clinical trial and marketing authorization applications assessments which were conducted by the FSBI “SCEEMP” in 2013-2015 are analyzed. General recommendations and principles for design and conduction of the bioequivalence studies of such medicinal products and reporting of their results are proposed, basing on the results of analysis of the foreign requirements, scientific data and domestic experience. |
| first_indexed | 2024-03-07T19:18:18Z |
| format | Article |
| id | doaj.art-9f649c4049db4640853e827739d9d3d8 |
| institution | Directory Open Access Journal |
| issn | 1991-2919 2619-1172 |
| language | Russian |
| last_indexed | 2024-04-24T07:09:58Z |
| publishDate | 2018-02-01 |
| publisher | NEICON ISP LLC |
| record_format | Article |
| series | Ведомости Научного центра экспертизы средств медицинского применения |
| spelling | doaj.art-9f649c4049db4640853e827739d9d3d82024-04-21T11:46:32ZrusNEICON ISP LLCВедомости Научного центра экспертизы средств медицинского применения1991-29192619-11722018-02-01033742Specific features of the bioequivalence study of drugs - analogs of endogenous compoundsV. K. Adonin0D. P. Romodanovskiy1R. R. Niyazov2Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian FederationFederal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian FederationFederal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian FederationThis paper presents an analysis of leading foreign regulatory authorities’ requirements for the bioequivalence studies of medicinal products containing analogues of endogenous substances. US Food and Drug Administration, European Medicines Agency, and Eurasian Economic Union’s approaches are discussed. The scientific literature on the bioequivalence studies of endogenous substances, as well as the results of clinical trial and marketing authorization applications assessments which were conducted by the FSBI “SCEEMP” in 2013-2015 are analyzed. General recommendations and principles for design and conduction of the bioequivalence studies of such medicinal products and reporting of their results are proposed, basing on the results of analysis of the foreign requirements, scientific data and domestic experience.https://www.vedomostincesmp.ru/jour/article/view/44биоэквивалентностьсравнительные фармакокинетические клинические исследования in vivoэндогенные соединениялекарственные препаратыпротокол клинического исследованияевразийский экономический союзbioequivalencecomparative pharmacokinetic clinical studies in vivoendogenous compoundsdrugsclinical research protocolthe eurasian economic union |
| spellingShingle | V. K. Adonin D. P. Romodanovskiy R. R. Niyazov Specific features of the bioequivalence study of drugs - analogs of endogenous compounds Ведомости Научного центра экспертизы средств медицинского применения биоэквивалентность сравнительные фармакокинетические клинические исследования in vivo эндогенные соединения лекарственные препараты протокол клинического исследования евразийский экономический союз bioequivalence comparative pharmacokinetic clinical studies in vivo endogenous compounds drugs clinical research protocol the eurasian economic union |
| title | Specific features of the bioequivalence study of drugs - analogs of endogenous compounds |
| title_full | Specific features of the bioequivalence study of drugs - analogs of endogenous compounds |
| title_fullStr | Specific features of the bioequivalence study of drugs - analogs of endogenous compounds |
| title_full_unstemmed | Specific features of the bioequivalence study of drugs - analogs of endogenous compounds |
| title_short | Specific features of the bioequivalence study of drugs - analogs of endogenous compounds |
| title_sort | specific features of the bioequivalence study of drugs analogs of endogenous compounds |
| topic | биоэквивалентность сравнительные фармакокинетические клинические исследования in vivo эндогенные соединения лекарственные препараты протокол клинического исследования евразийский экономический союз bioequivalence comparative pharmacokinetic clinical studies in vivo endogenous compounds drugs clinical research protocol the eurasian economic union |
| url | https://www.vedomostincesmp.ru/jour/article/view/44 |
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