Planning and evaluation of bioequivalence studies of rosuvastatin drug products

Abstract

The article reviews bioequivalence studies of Russian and foreign generic rosuvastatin preparations with the goal of harmonizing approaches to rosuvastatin bioequivalence studies in the Russian Federation. The article describes the current regulatory recommendations for and approaches to bioequivalence studies of generic drugs (and in particular of rosuvastatin preparations which are highly variable drugs) and gives recommendations on the design of rosuvastatin studies and evaluation of results.

Keywords

• исследование биоэквивалентности
• розувастатин
• высоковариабельные препараты
• фармакокинетика
• высокоэффективная жидкостная хроматография
• bioequivalence study
• rosuvastatin
• highly variable drugs
• pharmacokinetics
• high performance liquid chromatography