MODERN PARADIGM OF THE PREGNANT-INVOLVING PHARMACOLOGICAL STUDY: RISK ASSESSMENT, ETHICAL PRINCIPLES AND REGULATORY ASPECT
This article is dedicated to the issue of studying drug efficacy and safety in pregnant women, i.e. to their participation in clinical studies. The authors emphasize that lack of evidence base on drug use makes physicians helpless against diseases and gestational pathological conditions. The authors...
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| Format: | Article |
| Language: | Russian |
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Union of pediatricians of Russia
2014-03-01
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| Series: | Педиатрическая фармакология |
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| Online Access: | https://www.pedpharma.ru/jour/article/view/115 |
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| _version_ | 1850046019393290240 |
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| author | K. A. Lutsevich O. V. Reshetko T. S. Lutsevich |
| author_facet | K. A. Lutsevich O. V. Reshetko T. S. Lutsevich |
| author_sort | K. A. Lutsevich |
| collection | DOAJ |
| description | This article is dedicated to the issue of studying drug efficacy and safety in pregnant women, i.e. to their participation in clinical studies. The authors emphasize that lack of evidence base on drug use makes physicians helpless against diseases and gestational pathological conditions. The authors demonstrate results of the completed clinical studies involving pregnant women. In this article, they analyze possible risks and ethical complications of pregnant women taking part in clinical studies, as well as modern possibilities of medicine and legislative base of a range of countries, which allow minimizing risks of taking part in a study both for mothers and their fetuses. The authors demonstrate that the international experience of resolving ethical and legal issues of clinical studies among children may facilitate settlement of many problems of this issue. |
| format | Article |
| id | doaj-art-7c12e4c5a1e54cf48d6572f3f2aeb328 |
| institution | DOAJ |
| issn | 1727-5776 2500-3089 |
| language | Russian |
| publishDate | 2014-03-01 |
| publisher | Union of pediatricians of Russia |
| record_format | Article |
| series | Педиатрическая фармакология |
| spelling | doaj-art-7c12e4c5a1e54cf48d6572f3f2aeb3282025-08-20T02:54:33ZrusUnion of pediatricians of RussiaПедиатрическая фармакология1727-57762500-30892014-03-01112222910.15690/pf.v11i2.953115MODERN PARADIGM OF THE PREGNANT-INVOLVING PHARMACOLOGICAL STUDY: RISK ASSESSMENT, ETHICAL PRINCIPLES AND REGULATORY ASPECTK. A. Lutsevich0O. V. Reshetko1T. S. Lutsevich2Razumovskiy Saratov State Medical University of the Ministry of Health of the Russian FederationRazumovskiy Saratov State Medical University of the Ministry of Health of the Russian FederationRazumovskiy Saratov State Medical University of the Ministry of Health of the Russian FederationThis article is dedicated to the issue of studying drug efficacy and safety in pregnant women, i.e. to their participation in clinical studies. The authors emphasize that lack of evidence base on drug use makes physicians helpless against diseases and gestational pathological conditions. The authors demonstrate results of the completed clinical studies involving pregnant women. In this article, they analyze possible risks and ethical complications of pregnant women taking part in clinical studies, as well as modern possibilities of medicine and legislative base of a range of countries, which allow minimizing risks of taking part in a study both for mothers and their fetuses. The authors demonstrate that the international experience of resolving ethical and legal issues of clinical studies among children may facilitate settlement of many problems of this issue.https://www.pedpharma.ru/jour/article/view/115pregnancypharmacological studyethicsregulatory process |
| spellingShingle | K. A. Lutsevich O. V. Reshetko T. S. Lutsevich MODERN PARADIGM OF THE PREGNANT-INVOLVING PHARMACOLOGICAL STUDY: RISK ASSESSMENT, ETHICAL PRINCIPLES AND REGULATORY ASPECT Педиатрическая фармакология pregnancy pharmacological study ethics regulatory process |
| title | MODERN PARADIGM OF THE PREGNANT-INVOLVING PHARMACOLOGICAL STUDY: RISK ASSESSMENT, ETHICAL PRINCIPLES AND REGULATORY ASPECT |
| title_full | MODERN PARADIGM OF THE PREGNANT-INVOLVING PHARMACOLOGICAL STUDY: RISK ASSESSMENT, ETHICAL PRINCIPLES AND REGULATORY ASPECT |
| title_fullStr | MODERN PARADIGM OF THE PREGNANT-INVOLVING PHARMACOLOGICAL STUDY: RISK ASSESSMENT, ETHICAL PRINCIPLES AND REGULATORY ASPECT |
| title_full_unstemmed | MODERN PARADIGM OF THE PREGNANT-INVOLVING PHARMACOLOGICAL STUDY: RISK ASSESSMENT, ETHICAL PRINCIPLES AND REGULATORY ASPECT |
| title_short | MODERN PARADIGM OF THE PREGNANT-INVOLVING PHARMACOLOGICAL STUDY: RISK ASSESSMENT, ETHICAL PRINCIPLES AND REGULATORY ASPECT |
| title_sort | modern paradigm of the pregnant involving pharmacological study risk assessment ethical principles and regulatory aspect |
| topic | pregnancy pharmacological study ethics regulatory process |
| url | https://www.pedpharma.ru/jour/article/view/115 |
| work_keys_str_mv | AT kalutsevich modernparadigmofthepregnantinvolvingpharmacologicalstudyriskassessmentethicalprinciplesandregulatoryaspect AT ovreshetko modernparadigmofthepregnantinvolvingpharmacologicalstudyriskassessmentethicalprinciplesandregulatoryaspect AT tslutsevich modernparadigmofthepregnantinvolvingpharmacologicalstudyriskassessmentethicalprinciplesandregulatoryaspect |