Biowaiver as a Bioequivalence Study Option
SCIENTIFIC RELEVANCE. Biowaiver is a procedure for establishing the bioequivalence of generic and reference products without in vivo studies. Regulatory requirements for this procedure, as described in a variety of documents, differ in certain features and aspects. These differences need to be analy...
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| Format: | Article |
| Language: | Russian |
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Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)
2024-02-01
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| Series: | Регуляторные исследования и экспертиза лекарственных средств |
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| Online Access: | https://www.vedomostincesmp.ru/jour/article/view/569 |
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| author | E. A. Volkova Yu. V. Medvedev E. N. Fisher I. E. Shohin |
| author_facet | E. A. Volkova Yu. V. Medvedev E. N. Fisher I. E. Shohin |
| author_sort | E. A. Volkova |
| collection | DOAJ |
| description | SCIENTIFIC RELEVANCE. Biowaiver is a procedure for establishing the bioequivalence of generic and reference products without in vivo studies. Regulatory requirements for this procedure, as described in a variety of documents, differ in certain features and aspects. These differences need to be analysed.AIM. The aim was to compare international and Russian regulatory approaches to the Biopharmaceutics Classification System-based biowaivers, provide recommendations on comparative dissolution testing, and outline opportunities for streamlining the regulatory framework of the Eurasian Economic Union (EAEU).DISCUSSION. In this article, the authors analyse biowaiver requirements and describe procedures for assessing the permeability and pH-dependent solubility of medicines, comparing dissolution profiles in various media that simulate the gastrointestinal environment, and interpreting test results. This paper shows the role of excipients in the solubility and permeability of an active substance.CONCLUSIONS. The authors recommend a methodological approach to the biowaiver procedure for replacing in vivo bioequivalence studies with in vitro tests under the current EAEU regulatory framework and list the characteristics of medicines that limit the applicability of the procedure. In conclusion, this article provides a rationale for harmonising the existing guidelines and requirements. |
| format | Article |
| id | doaj-art-82ae18b02df645fb9464495a3d62b9a7 |
| institution | Kabale University |
| issn | 3034-3062 3034-3453 |
| language | Russian |
| publishDate | 2024-02-01 |
| 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-82ae18b02df645fb9464495a3d62b9a72025-08-20T03:57:31ZrusFederal 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 средств3034-30623034-34532024-02-01141425210.30895/1991-2919-2023-537399Biowaiver as a Bioequivalence Study OptionE. A. Volkova0Yu. V. Medvedev1E. N. Fisher2I. E. Shohin3I.M. Sechenov First Moscow State Medical University (Sechenov University); Laboratory of Pharmaceutical ResearchI.M. Sechenov First Moscow State Medical University (Sechenov University); Laboratory of Pharmaceutical ResearchI.M. Sechenov First Moscow State Medical University (Sechenov University); Laboratory of Pharmaceutical ResearchCentre of Pharmaceutical AnalyticsSCIENTIFIC RELEVANCE. Biowaiver is a procedure for establishing the bioequivalence of generic and reference products without in vivo studies. Regulatory requirements for this procedure, as described in a variety of documents, differ in certain features and aspects. These differences need to be analysed.AIM. The aim was to compare international and Russian regulatory approaches to the Biopharmaceutics Classification System-based biowaivers, provide recommendations on comparative dissolution testing, and outline opportunities for streamlining the regulatory framework of the Eurasian Economic Union (EAEU).DISCUSSION. In this article, the authors analyse biowaiver requirements and describe procedures for assessing the permeability and pH-dependent solubility of medicines, comparing dissolution profiles in various media that simulate the gastrointestinal environment, and interpreting test results. This paper shows the role of excipients in the solubility and permeability of an active substance.CONCLUSIONS. The authors recommend a methodological approach to the biowaiver procedure for replacing in vivo bioequivalence studies with in vitro tests under the current EAEU regulatory framework and list the characteristics of medicines that limit the applicability of the procedure. In conclusion, this article provides a rationale for harmonising the existing guidelines and requirements.https://www.vedomostincesmp.ru/jour/article/view/569biopharmaceutics classification systembcsbiowaivercomparative dissolution testph-dependent solubilitypermeabilityabsorption |
| spellingShingle | E. A. Volkova Yu. V. Medvedev E. N. Fisher I. E. Shohin Biowaiver as a Bioequivalence Study Option Регуляторные исследования и экспертиза лекарственных средств biopharmaceutics classification system bcs biowaiver comparative dissolution test ph-dependent solubility permeability absorption |
| title | Biowaiver as a Bioequivalence Study Option |
| title_full | Biowaiver as a Bioequivalence Study Option |
| title_fullStr | Biowaiver as a Bioequivalence Study Option |
| title_full_unstemmed | Biowaiver as a Bioequivalence Study Option |
| title_short | Biowaiver as a Bioequivalence Study Option |
| title_sort | biowaiver as a bioequivalence study option |
| topic | biopharmaceutics classification system bcs biowaiver comparative dissolution test ph-dependent solubility permeability absorption |
| url | https://www.vedomostincesmp.ru/jour/article/view/569 |
| work_keys_str_mv | AT eavolkova biowaiverasabioequivalencestudyoption AT yuvmedvedev biowaiverasabioequivalencestudyoption AT enfisher biowaiverasabioequivalencestudyoption AT ieshohin biowaiverasabioequivalencestudyoption |