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

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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Bibliographic Details
Main Authors: K. A. Lutsevich, O. V. Reshetko, T. S. Lutsevich
Format: Article
Language:English
Published: Paediatrician Publishers, LLC 2014-03-01
Series:Pediatričeskaâ Farmakologiâ
Subjects:
pregnancy
pharmacological study
ethics
regulatory process
Online Access:https://www.pedpharma.ru/jour/article/view/115

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