Endocrine Disorders Associated with Medicinal Products: Approaches to Preclinical Safety Assessment
The endocrine system coordinates almost all organs and other systems in vertebrates. In particular, it regulates such important biological functions as metabolism, development, reproduction, and behaviour. To date, a significant amount of information has accumulated on endocrine disorders associated...
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| Format: | Article |
| Language: | Russian |
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NEICON ISP LLC
2023-03-01
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| Series: | Ведомости Научного центра экспертизы средств медицинского применения |
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| Online Access: | https://www.vedomostincesmp.ru/jour/article/view/401 |
| _version_ | 1797198967701766144 |
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| author | K. L. Kryshen N. M. Faustova M. N. Makarova V. G. Makarov |
| author_facet | K. L. Kryshen N. M. Faustova M. N. Makarova V. G. Makarov |
| author_sort | K. L. Kryshen |
| collection | DOAJ |
| description | The endocrine system coordinates almost all organs and other systems in vertebrates. In particular, it regulates such important biological functions as metabolism, development, reproduction, and behaviour. To date, a significant amount of information has accumulated on endocrine disorders associated with chemical compounds (endocrine disruptors) used in various fields of human activity. The aim of this study was to evaluate the possibility of preclinical risk assessment for the endocrine function disorders attributable to new medicinal products. Endocrine disruptors are associated with a wide range of adverse events, including developmental problems arising from functional abnormalities of the endocrine system. Endocrine disorders caused by endocrine-disrupting chemicals are characterised by a long latency period between exposure and manifestation of a dysfunction; a nonlinear dose–response relationship; and a linear correlation of damage severity to exposure timing and duration. The chemicals influence the endocrine system through multiple mechanisms, the main of which being the interaction with cellular receptors sensitive to certain hormones and the influence on gene expression, intracellular signalling, and hormone transport, etc. This paper discusses the possibility of using hormone levels as indicators of endocrine disruption and presents the literature and authors’ own data on normal levels of relevant hormones in the blood of animals. An analysis of animal blood hormone levels in preclinical programmes will provide an opportunity to evaluate potential iatrogenic risks. |
| first_indexed | 2024-03-07T19:16:47Z |
| format | Article |
| id | doaj.art-13de28c2fa4b48d3a4a42f0645eab822 |
| institution | Directory Open Access Journal |
| issn | 1991-2919 2619-1172 |
| language | Russian |
| last_indexed | 2024-04-24T07:08:16Z |
| publishDate | 2023-03-01 |
| publisher | NEICON ISP LLC |
| record_format | Article |
| series | Ведомости Научного центра экспертизы средств медицинского применения |
| spelling | doaj.art-13de28c2fa4b48d3a4a42f0645eab8222024-04-21T11:46:35ZrusNEICON ISP LLCВедомости Научного центра экспертизы средств медицинского применения1991-29192619-11722023-03-01131274110.30895/1991-2919-2022-12-401322Endocrine Disorders Associated with Medicinal Products: Approaches to Preclinical Safety AssessmentK. L. Kryshen0N. M. Faustova1M. N. Makarova2V. G. Makarov3Joint Stock Company “Scientific and Production Association HOME OF PHARMACY”Joint Stock Company “Scientific and Production Association HOME OF PHARMACY”Joint Stock Company “Scientific and Production Association HOME OF PHARMACY”Joint Stock Company “Scientific and Production Association HOME OF PHARMACY”The endocrine system coordinates almost all organs and other systems in vertebrates. In particular, it regulates such important biological functions as metabolism, development, reproduction, and behaviour. To date, a significant amount of information has accumulated on endocrine disorders associated with chemical compounds (endocrine disruptors) used in various fields of human activity. The aim of this study was to evaluate the possibility of preclinical risk assessment for the endocrine function disorders attributable to new medicinal products. Endocrine disruptors are associated with a wide range of adverse events, including developmental problems arising from functional abnormalities of the endocrine system. Endocrine disorders caused by endocrine-disrupting chemicals are characterised by a long latency period between exposure and manifestation of a dysfunction; a nonlinear dose–response relationship; and a linear correlation of damage severity to exposure timing and duration. The chemicals influence the endocrine system through multiple mechanisms, the main of which being the interaction with cellular receptors sensitive to certain hormones and the influence on gene expression, intracellular signalling, and hormone transport, etc. This paper discusses the possibility of using hormone levels as indicators of endocrine disruption and presents the literature and authors’ own data on normal levels of relevant hormones in the blood of animals. An analysis of animal blood hormone levels in preclinical programmes will provide an opportunity to evaluate potential iatrogenic risks.https://www.vedomostincesmp.ru/jour/article/view/401endocrine systemdisordersendocrine disruptorspreclinical studiespharmaceuticals |
| spellingShingle | K. L. Kryshen N. M. Faustova M. N. Makarova V. G. Makarov Endocrine Disorders Associated with Medicinal Products: Approaches to Preclinical Safety Assessment Ведомости Научного центра экспертизы средств медицинского применения endocrine system disorders endocrine disruptors preclinical studies pharmaceuticals |
| title | Endocrine Disorders Associated with Medicinal Products: Approaches to Preclinical Safety Assessment |
| title_full | Endocrine Disorders Associated with Medicinal Products: Approaches to Preclinical Safety Assessment |
| title_fullStr | Endocrine Disorders Associated with Medicinal Products: Approaches to Preclinical Safety Assessment |
| title_full_unstemmed | Endocrine Disorders Associated with Medicinal Products: Approaches to Preclinical Safety Assessment |
| title_short | Endocrine Disorders Associated with Medicinal Products: Approaches to Preclinical Safety Assessment |
| title_sort | endocrine disorders associated with medicinal products approaches to preclinical safety assessment |
| topic | endocrine system disorders endocrine disruptors preclinical studies pharmaceuticals |
| url | https://www.vedomostincesmp.ru/jour/article/view/401 |
| work_keys_str_mv | AT klkryshen endocrinedisordersassociatedwithmedicinalproductsapproachestopreclinicalsafetyassessment AT nmfaustova endocrinedisordersassociatedwithmedicinalproductsapproachestopreclinicalsafetyassessment AT mnmakarova endocrinedisordersassociatedwithmedicinalproductsapproachestopreclinicalsafetyassessment AT vgmakarov endocrinedisordersassociatedwithmedicinalproductsapproachestopreclinicalsafetyassessment |