Highly variable medicines - specific aspects of bioequivalence studies
At present a specific group of medicines - highly variable medicines - is distinguished based on intraindividual variability data (CVintra > 30%). It is quite difficult to confirm therapeutic equivalence of highly variable medicines by pharmacokinetic bioequivalence studies, and quite a large num...
Saved in:
| Main Authors: | , , , , , , |
|---|---|
| Format: | Article |
| Language: | Russian |
| Published: |
Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)
2018-02-01
|
| Series: | Регуляторные исследования и экспертиза лекарственных средств |
| Subjects: | |
| Online Access: | https://www.vedomostincesmp.ru/jour/article/view/57 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1839583235268411392 |
|---|---|
| author | D. P. Romodanovsky T. V. Eremenkova M. A. Dranitsyna D. V. Goryachev R. R. Niyazov E. V. Gavrishina V. A. Merkulov |
| author_facet | D. P. Romodanovsky T. V. Eremenkova M. A. Dranitsyna D. V. Goryachev R. R. Niyazov E. V. Gavrishina V. A. Merkulov |
| author_sort | D. P. Romodanovsky |
| collection | DOAJ |
| description | At present a specific group of medicines - highly variable medicines - is distinguished based on intraindividual variability data (CVintra > 30%). It is quite difficult to confirm therapeutic equivalence of highly variable medicines by pharmacokinetic bioequivalence studies, and quite a large number of subjects need to be included into the study in order to confirm bioequivalence within standard limits of 80-125%. Variability may be caused by many factors which include physiological and pathophysiological differences in absorption and metabolism processes; factors associated with properties of the active substance and factors associated with the finished product. In general factors impacting variability in bioequivalence studies could be divided into controllable and uncontrollable. The influence of controllable factors can be neutralized by proper performance of the bioequivalence study or proper development of the finished product. The influence of uncontrollable factors cannot be neutralized, and due to these factors medicines can be recognized as highly variable. This article provides a definition of a highly variable medicine, describes reasons for high variability and outlines current regulatory recommendations for and approaches to studying bioequivalence of highly variable medicines, proposes recommendations for designing such studies. |
| format | Article |
| id | doaj-art-4dcfd83ba7e94e3aa7dc6a76b7d27a75 |
| institution | Matheson Library |
| issn | 3034-3062 3034-3453 |
| language | Russian |
| publishDate | 2018-02-01 |
| publisher | Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’) |
| record_format | Article |
| series | Регуляторные исследования и экспертиза лекарственных средств |
| spelling | doaj-art-4dcfd83ba7e94e3aa7dc6a76b7d27a752025-08-03T19:56:42ZrusFederal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)Регуляторные исследования и экспертиза лекарственных средств3034-30623034-34532018-02-010451055Highly variable medicines - specific aspects of bioequivalence studiesD. P. Romodanovsky0T. V. Eremenkova1M. A. Dranitsyna2D. V. Goryachev3R. R. Niyazov4E. V. Gavrishina5V. A. Merkulov6Federal 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 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 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 FederationAt present a specific group of medicines - highly variable medicines - is distinguished based on intraindividual variability data (CVintra > 30%). It is quite difficult to confirm therapeutic equivalence of highly variable medicines by pharmacokinetic bioequivalence studies, and quite a large number of subjects need to be included into the study in order to confirm bioequivalence within standard limits of 80-125%. Variability may be caused by many factors which include physiological and pathophysiological differences in absorption and metabolism processes; factors associated with properties of the active substance and factors associated with the finished product. In general factors impacting variability in bioequivalence studies could be divided into controllable and uncontrollable. The influence of controllable factors can be neutralized by proper performance of the bioequivalence study or proper development of the finished product. The influence of uncontrollable factors cannot be neutralized, and due to these factors medicines can be recognized as highly variable. This article provides a definition of a highly variable medicine, describes reasons for high variability and outlines current regulatory recommendations for and approaches to studying bioequivalence of highly variable medicines, proposes recommendations for designing such studies.https://www.vedomostincesmp.ru/jour/article/view/57исследования биоэквивалентностибиоэквивалентностьвысоковариабельные препаратыbioequivalence studiesbioequivalencehighly variable medicines |
| spellingShingle | D. P. Romodanovsky T. V. Eremenkova M. A. Dranitsyna D. V. Goryachev R. R. Niyazov E. V. Gavrishina V. A. Merkulov Highly variable medicines - specific aspects of bioequivalence studies Регуляторные исследования и экспертиза лекарственных средств исследования биоэквивалентности биоэквивалентность высоковариабельные препараты bioequivalence studies bioequivalence highly variable medicines |
| title | Highly variable medicines - specific aspects of bioequivalence studies |
| title_full | Highly variable medicines - specific aspects of bioequivalence studies |
| title_fullStr | Highly variable medicines - specific aspects of bioequivalence studies |
| title_full_unstemmed | Highly variable medicines - specific aspects of bioequivalence studies |
| title_short | Highly variable medicines - specific aspects of bioequivalence studies |
| title_sort | highly variable medicines specific aspects of bioequivalence studies |
| topic | исследования биоэквивалентности биоэквивалентность высоковариабельные препараты bioequivalence studies bioequivalence highly variable medicines |
| url | https://www.vedomostincesmp.ru/jour/article/view/57 |
| work_keys_str_mv | AT dpromodanovsky highlyvariablemedicinesspecificaspectsofbioequivalencestudies AT tveremenkova highlyvariablemedicinesspecificaspectsofbioequivalencestudies AT madranitsyna highlyvariablemedicinesspecificaspectsofbioequivalencestudies AT dvgoryachev highlyvariablemedicinesspecificaspectsofbioequivalencestudies AT rrniyazov highlyvariablemedicinesspecificaspectsofbioequivalencestudies AT evgavrishina highlyvariablemedicinesspecificaspectsofbioequivalencestudies AT vamerkulov highlyvariablemedicinesspecificaspectsofbioequivalencestudies |