Post-authorization clinical trials

Abstract

The article describes post-authorization clinical trials of medicinal products for medical use conducted by pharmaceutical manufacturers after state registration, in order to collect additional data on safety and efficacy, expand indications for use, and identify adverse reactions.

Keywords

• пострегистрационные клинические исследования
• постмаркетинговые исследования
• пострегистрационные исследования безопасности
• интервенционные исследования
• рандомизированное клиническое исследование
• надлежащая клиническая практика
• post-authorization clinical trial
• post-marketing study
• post-authorization safety studies
• interventional study
• randomized clinical trial
• good clinical practice