Clinical trials in pregnancy: evaluation of benefit/risk?
In terms of pharmacotherapy, pregnancy is a specific phase of life that is different from all the other phases of the life of medical, ethical and legal framework. The article examines the scientific, ethical and regulatory principles of inclusion of pregnant women in the clinical trials of drugs, t...
| 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/61 |
| _version_ | 1797199056924049408 |
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| author | E. A. Sokova N. D. Bunyatyan I. A. Mazerkina O. A. Demidova T. V. Aleksandrova |
| author_facet | E. A. Sokova N. D. Bunyatyan I. A. Mazerkina O. A. Demidova T. V. Aleksandrova |
| author_sort | E. A. Sokova |
| collection | DOAJ |
| description | In terms of pharmacotherapy, pregnancy is a specific phase of life that is different from all the other phases of the life of medical, ethical and legal framework. The article examines the scientific, ethical and regulatory principles of inclusion of pregnant women in the clinical trials of drugs, the necessity for them is justified from the point of clinical pharmacology. The clinical value assessment studies regarding the expected benefits to the possible risks during the pharmacotherapy in pregnancy necessitates the development of this scientific direction. |
| first_indexed | 2024-03-07T19:18:03Z |
| format | Article |
| id | doaj.art-5b9c731704634ef487c2031e50a2dbcf |
| institution | Directory Open Access Journal |
| issn | 1991-2919 2619-1172 |
| language | Russian |
| last_indexed | 2024-04-24T07:09:42Z |
| publishDate | 2018-02-01 |
| publisher | NEICON ISP LLC |
| record_format | Article |
| series | Ведомости Научного центра экспертизы средств медицинского применения |
| spelling | doaj.art-5b9c731704634ef487c2031e50a2dbcf2024-04-21T11:46:32ZrusNEICON ISP LLCВедомости Научного центра экспертизы средств медицинского применения1991-29192619-11722018-02-0104263159Clinical trials in pregnancy: evaluation of benefit/risk?E. A. Sokova0N. D. Bunyatyan1I. A. Mazerkina2O. A. Demidova3T. V. Aleksandrova4Federal State Budgetary Institution «Scientific Center for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian FederationFederal State Budgetary Institution «Scientific Center for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian FederationFederal State Budgetary Institution «Scientific Center for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian FederationFederal State Budgetary Institution «Scientific Center for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian FederationFederal State Budgetary Institution «Scientific Center for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian FederationIn terms of pharmacotherapy, pregnancy is a specific phase of life that is different from all the other phases of the life of medical, ethical and legal framework. The article examines the scientific, ethical and regulatory principles of inclusion of pregnant women in the clinical trials of drugs, the necessity for them is justified from the point of clinical pharmacology. The clinical value assessment studies regarding the expected benefits to the possible risks during the pharmacotherapy in pregnancy necessitates the development of this scientific direction.https://www.vedomostincesmp.ru/jour/article/view/61pregnancydrugsclinical trialssafetyefficacymetabolismpharmacogeneticsбеременностьлекарственное средствоклиническое исследованиебезопасностьэффективностьметаболизмфармакогенетика |
| spellingShingle | E. A. Sokova N. D. Bunyatyan I. A. Mazerkina O. A. Demidova T. V. Aleksandrova Clinical trials in pregnancy: evaluation of benefit/risk? Ведомости Научного центра экспертизы средств медицинского применения pregnancy drugs clinical trials safety efficacy metabolism pharmacogenetics беременность лекарственное средство клиническое исследование безопасность эффективность метаболизм фармакогенетика |
| title | Clinical trials in pregnancy: evaluation of benefit/risk? |
| title_full | Clinical trials in pregnancy: evaluation of benefit/risk? |
| title_fullStr | Clinical trials in pregnancy: evaluation of benefit/risk? |
| title_full_unstemmed | Clinical trials in pregnancy: evaluation of benefit/risk? |
| title_short | Clinical trials in pregnancy: evaluation of benefit/risk? |
| title_sort | clinical trials in pregnancy evaluation of benefit risk |
| topic | pregnancy drugs clinical trials safety efficacy metabolism pharmacogenetics беременность лекарственное средство клиническое исследование безопасность эффективность метаболизм фармакогенетика |
| url | https://www.vedomostincesmp.ru/jour/article/view/61 |
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