References

ppharm

Педиатрическая фармакология

Pediatric pharmacology

1727-57762500-3089

Издательство «ПедиатрЪ»

10.15690/pf.v11i2.953

ppharm-115

Research Article

ДИСКУССИОННЫЕ ВОПРОСЫ ФАРМАКОТЕРАПИИ

DEBATABLE ISSUES OF PHARMACOTHERAPY

СОВРЕМЕННАЯ ПАРАДИГМА ФАРМАКОЛОГИЧЕСКОГО ИССЛЕДОВАНИЯ С УЧАСТИЕМ БЕРЕМЕННЫХ ЖЕНЩИН: ОЦЕНКА РИСКА, МОРАЛЬНО-ЭТИЧЕСКИЕ ПРИНЦИПЫ И РЕГУЛЯТОРНЫЙ АСПЕКТ

MODERN PARADIGM OF THE PREGNANT-INVOLVING PHARMACOLOGICAL STUDY: RISK ASSESSMENT, ETHICAL PRINCIPLES AND REGULATORY ASPECT

Луцевич

К. А.

Lutsevich

K. A.

кандидат медицинских наук, доцент кафедры фармакологии ГБОУ ВПО «Саратовский государственный медицинский университет им. В.И. Разумовского» Минздрава РФ

MD, assistant professor at the pharmacology department of Razumovskii Saratov State Medical University of the Ministry of Health of the RF (State Budgetary Educational Institution of Higher Professional Education)

lutsevich78@mail.ru

Решетько

О. В.

Reshetko

O. V.

Луцевич

Т. С.

Lutsevich

T. S.

Саратовский государственный медицинский университет им. В.И. Разумовского Минздрава Российской ФедерацииРоссияRazumovskiy Saratov State Medical University of the Ministry of Health of the Russian FederationRussian Federation

2014

04042014

112

Педиатрическая фармакология

2229

2014

Луцевич К.А., Решетько О.В., Луцевич Т.С.

Lutsevich K.A., Reshetko O.V., Lutsevich T.S.

This work is licensed under a Creative Commons Attribution 4.0 License.

https://www.pedpharma.ru/jour/article/view/115

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.

беременностьфармакологическое исследованиеэтикарегуляторный процесс

pregnancypharmacological studyethicsregulatory process

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The authors declare that there are no conflicts of interest present.