Analysis of the quality of bioequivalence and pharmacokinetics studies in Russia Federation

Abstract

In Russia the evaluation of bioequivalence of drugs for more than ten years the main requirement of medical and biological control of generic drugs. Regardless of manufacturer to the generic drugs are exactly the same as the original drug, must meet the following requirements: quality, efficiency and safety. In connection with the increase in recent years of bioequivalence studies of medicinal products requires careful control over the quality of these studies on the territory of the Russian Federation.

Keywords

• исследования биоэквивалентности
• исследования фармакокинетики
• качество проведения исследований
• фармакогенетическое тестирование
• bioequivalence studies
• pharmacokinetic studies
• quality of research
• pharmacogenetic testing