WoE Analysis and Key Risk Factors in Preclinical Development of Medicinal Products: A Review
INTRODUCTION. In recent years, the Russian Federation and the Eurasian Economic Union have included the concept of ‘weight of evidence’ (WoE) in regulatory documents. International regulators place great emphasis on data transparency in documenting and assessing the WoE, and their position is reflec...
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| Format: | Article |
| Language: | Russian |
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Ministry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»
2024-12-01
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| Series: | Безопасность и риск фармакотерапии |
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| Online Access: | https://www.risksafety.ru/jour/article/view/463 |
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| author | G. N. Engalycheva R. D. Syubaev |
| author_facet | G. N. Engalycheva R. D. Syubaev |
| author_sort | G. N. Engalycheva |
| collection | DOAJ |
| description | INTRODUCTION. In recent years, the Russian Federation and the Eurasian Economic Union have included the concept of ‘weight of evidence’ (WoE) in regulatory documents. International regulators place great emphasis on data transparency in documenting and assessing the WoE, and their position is reflected in the relevant regulatory documents. However, the Russian Federation has faced the absence of consistent Russian-language terminology in this area, the lack of a clear vision of WoE assessment principles, and the need for a sound understanding of applied WoE methods for pharmaceutical development and regulatory review of preclinical study results. These gaps require collated information on WoE assessment and practical guidance for its use.AIM. This study aimed to analyse regulatory documents as well as scientific and methodological publications on the WoE concept and assessment methods in order to investigate the opportunities and practical applications of WoE analysis in the development of medicines and the regulatory review of study results.DISCUSSION. This article covers documents by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), the Organisation for Economic Co-operation and Development (OECD), the European Chemicals Agency (ECHA), and other organisations. Using these documents and taking into account Russian terminology, the authors clarify the WoE as a concept and explain its assessment. Furthermore, the article classifies the key risk factors that must be considered in WoE analysis, with examples drawn from immunotoxicity, reproductive toxicity, and carcinogenicity studies. Analysing such data is critical to the design of preclinical studies, interpretation of their results, and safety evaluation of medicines. This article provides examples of WoE assessments conducted to consider the need for additional preclinical studies in juvenile animals in the development of small molecules and monoclonal antibodies for paediatric use.CONCLUSION. The WoE assessment algorithms and criteria described in this article may be implemented by preclinical study initiators, their research teams, and regulatory experts evaluating medicines. |
| format | Article |
| id | doaj-art-9a84c3beba544217982c591ad55b5d8d |
| institution | Kabale University |
| issn | 2312-7821 2619-1164 |
| language | Russian |
| publishDate | 2024-12-01 |
| publisher | Ministry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» |
| record_format | Article |
| series | Безопасность и риск фармакотерапии |
| spelling | doaj-art-9a84c3beba544217982c591ad55b5d8d2025-08-20T03:56:41ZrusMinistry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»Безопасность и риск фармакотерапии2312-78212619-11642024-12-0112446347610.30895/2312-7821-2024-12-4-463-476362WoE Analysis and Key Risk Factors in Preclinical Development of Medicinal Products: A ReviewG. N. Engalycheva0R. D. Syubaev1Scientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsINTRODUCTION. In recent years, the Russian Federation and the Eurasian Economic Union have included the concept of ‘weight of evidence’ (WoE) in regulatory documents. International regulators place great emphasis on data transparency in documenting and assessing the WoE, and their position is reflected in the relevant regulatory documents. However, the Russian Federation has faced the absence of consistent Russian-language terminology in this area, the lack of a clear vision of WoE assessment principles, and the need for a sound understanding of applied WoE methods for pharmaceutical development and regulatory review of preclinical study results. These gaps require collated information on WoE assessment and practical guidance for its use.AIM. This study aimed to analyse regulatory documents as well as scientific and methodological publications on the WoE concept and assessment methods in order to investigate the opportunities and practical applications of WoE analysis in the development of medicines and the regulatory review of study results.DISCUSSION. This article covers documents by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), the Organisation for Economic Co-operation and Development (OECD), the European Chemicals Agency (ECHA), and other organisations. Using these documents and taking into account Russian terminology, the authors clarify the WoE as a concept and explain its assessment. Furthermore, the article classifies the key risk factors that must be considered in WoE analysis, with examples drawn from immunotoxicity, reproductive toxicity, and carcinogenicity studies. Analysing such data is critical to the design of preclinical studies, interpretation of their results, and safety evaluation of medicines. This article provides examples of WoE assessments conducted to consider the need for additional preclinical studies in juvenile animals in the development of small molecules and monoclonal antibodies for paediatric use.CONCLUSION. The WoE assessment algorithms and criteria described in this article may be implemented by preclinical study initiators, their research teams, and regulatory experts evaluating medicines.https://www.risksafety.ru/jour/article/view/463drug developmentweight of evidencewoe assessmentpreclinical studiesrisk assessmentrisk factorsimmunotoxicityreproductive toxicitycarcinogenicityjuvenile animals |
| spellingShingle | G. N. Engalycheva R. D. Syubaev WoE Analysis and Key Risk Factors in Preclinical Development of Medicinal Products: A Review Безопасность и риск фармакотерапии drug development weight of evidence woe assessment preclinical studies risk assessment risk factors immunotoxicity reproductive toxicity carcinogenicity juvenile animals |
| title | WoE Analysis and Key Risk Factors in Preclinical Development of Medicinal Products: A Review |
| title_full | WoE Analysis and Key Risk Factors in Preclinical Development of Medicinal Products: A Review |
| title_fullStr | WoE Analysis and Key Risk Factors in Preclinical Development of Medicinal Products: A Review |
| title_full_unstemmed | WoE Analysis and Key Risk Factors in Preclinical Development of Medicinal Products: A Review |
| title_short | WoE Analysis and Key Risk Factors in Preclinical Development of Medicinal Products: A Review |
| title_sort | woe analysis and key risk factors in preclinical development of medicinal products a review |
| topic | drug development weight of evidence woe assessment preclinical studies risk assessment risk factors immunotoxicity reproductive toxicity carcinogenicity juvenile animals |
| url | https://www.risksafety.ru/jour/article/view/463 |
| work_keys_str_mv | AT gnengalycheva woeanalysisandkeyriskfactorsinpreclinicaldevelopmentofmedicinalproductsareview AT rdsyubaev woeanalysisandkeyriskfactorsinpreclinicaldevelopmentofmedicinalproductsareview |