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.
About the Authors
D. P. Romodanovsky
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
D. V. Goryachev
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
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Review
For citations:
Romodanovsky D.P., Goryachev D.V. Planning and evaluation of bioequivalence studies of rosuvastatin drug products. The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. 2017;7(3):142-149. (In Russ.)
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