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

• Autores principales: K. A. Lutsevich (Autor), O. V. Reshetko (Autor), T. S. Lutsevich (Autor)
• Formato: Libro
• Publicado: Union of pediatricians of Russia, 2014-03-01T00:00:00Z.
• Materias: article
• Acceso en línea: Connect to this object online.

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...