Planning and evaluation of bioequivalence studies of rosuvastatin drug products
The article reviews bioequivalence studies of Russian and foreign generic rosuvastatin preparations with the goal of harmonizing approaches to rosuvastatin bioequivalence studies in the Russian Federation. The article describes the current regulatory recommendations for and approaches to bioequivale...
| Main Authors: | , |
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| Format: | Article |
| Language: | Russian |
| Published: |
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/133 |
| _version_ | 1797199043977281536 |
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| author | D. P. Romodanovsky D. V. Goryachev |
| author_facet | D. P. Romodanovsky D. V. Goryachev |
| author_sort | D. P. Romodanovsky |
| collection | DOAJ |
| description | The article reviews bioequivalence studies of Russian and foreign generic rosuvastatin preparations with the goal of harmonizing approaches to rosuvastatin bioequivalence studies in the Russian Federation. The article describes the current regulatory recommendations for and approaches to bioequivalence studies of generic drugs (and in particular of rosuvastatin preparations which are highly variable drugs) and gives recommendations on the design of rosuvastatin studies and evaluation of results. |
| first_indexed | 2024-03-07T19:17:53Z |
| format | Article |
| id | doaj.art-33e87e9a678e4e5088f60a627f4001d3 |
| institution | Directory Open Access Journal |
| issn | 1991-2919 2619-1172 |
| language | Russian |
| last_indexed | 2024-04-24T07:09:29Z |
| publishDate | 2018-02-01 |
| publisher | NEICON ISP LLC |
| record_format | Article |
| series | Ведомости Научного центра экспертизы средств медицинского применения |
| spelling | doaj.art-33e87e9a678e4e5088f60a627f4001d32024-04-21T11:46:33ZrusNEICON ISP LLCВедомости Научного центра экспертизы средств медицинского применения1991-29192619-11722018-02-0173142149131Planning and evaluation of bioequivalence studies of rosuvastatin drug productsD. P. Romodanovsky0D. V. Goryachev1Scientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsThe article reviews bioequivalence studies of Russian and foreign generic rosuvastatin preparations with the goal of harmonizing approaches to rosuvastatin bioequivalence studies in the Russian Federation. The article describes the current regulatory recommendations for and approaches to bioequivalence studies of generic drugs (and in particular of rosuvastatin preparations which are highly variable drugs) and gives recommendations on the design of rosuvastatin studies and evaluation of results.https://www.vedomostincesmp.ru/jour/article/view/133исследование биоэквивалентностирозувастатинвысоковариабельные препаратыфармакокинетикавысокоэффективная жидкостная хроматографияbioequivalence studyrosuvastatinhighly variable drugspharmacokineticshigh performance liquid chromatography |
| spellingShingle | D. P. Romodanovsky D. V. Goryachev Planning and evaluation of bioequivalence studies of rosuvastatin drug products Ведомости Научного центра экспертизы средств медицинского применения исследование биоэквивалентности розувастатин высоковариабельные препараты фармакокинетика высокоэффективная жидкостная хроматография bioequivalence study rosuvastatin highly variable drugs pharmacokinetics high performance liquid chromatography |
| title | Planning and evaluation of bioequivalence studies of rosuvastatin drug products |
| title_full | Planning and evaluation of bioequivalence studies of rosuvastatin drug products |
| title_fullStr | Planning and evaluation of bioequivalence studies of rosuvastatin drug products |
| title_full_unstemmed | Planning and evaluation of bioequivalence studies of rosuvastatin drug products |
| title_short | Planning and evaluation of bioequivalence studies of rosuvastatin drug products |
| title_sort | planning and evaluation of bioequivalence studies of rosuvastatin drug products |
| topic | исследование биоэквивалентности розувастатин высоковариабельные препараты фармакокинетика высокоэффективная жидкостная хроматография bioequivalence study rosuvastatin highly variable drugs pharmacokinetics high performance liquid chromatography |
| url | https://www.vedomostincesmp.ru/jour/article/view/133 |
| work_keys_str_mv | AT dpromodanovsky planningandevaluationofbioequivalencestudiesofrosuvastatindrugproducts AT dvgoryachev planningandevaluationofbioequivalencestudiesofrosuvastatindrugproducts |