Generic drugs of direct antiviral action for the treatment of hepatitis C: features of bioequivalence studies

Introduction . In the last decade, approaches to treatment of chronic viral hepatitis C (HCV) have undergone significant changes. The new WHO strategy aims eliminate HCV by 2030 reducing number infections and deaths simplifying therapy. development drugs for patients with has a features, which requires compliance special recommendations conducting clinical bioequivalence studies. Aim study was analyze guidelines protocols studies Materials methods An information analytical method used evaluate according US Food Drug Administration, European Medicines Agency, WHO. Separately, an analysis permitted trials carried out data GRLS Ministry Health Russian Federation. Results discussions According results study, it noted that on therapy, is common develop principles planning research. Special attention paid preferred design study. It also necessary variability pharmacokinetic parameters substance under are calculate required volunteers be included in Conclusions Direct antiviral currently being conducted Federation, cover large list INN. entry reproduced into pharmaceutical market will improve patients’ access effective C. order conduct high-quality thoroughly familiarize yourself nosology manuals, critical assessment information, allow you choose appropriate correctly plan its conduct.