1. Federal law No. 61-FZ, “Circulation of Medicines”, of April 12, 2010 (with amendments and supplements in force from January 1, 2017), Moscow (2016).
2. Handbook for the Assessment of Medicines [in Russian], Grif i K, Moscow (2014); Vol. 1. ISBN 978-5-8125-1858-5.
3. Rules for Studies of Biological Medicines of the Eurasian Economic Union [in Russian] (https: // docs.eaeunion.org / docs /ru-ru / 01411955 / cncd 21112016 89 2).
4. Guidance for industry: Statistical Approaches Establishing Bioequivalence (2001); prepared by the Population and Individual Bioequivalence Working Group of the Biopharmaceutics Coordinating Committee in the Office of Pharmaceutical Science, Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA).
5. E. Diletti, D. Hauschke, and V. W. Steinijans, Int. J. Clin. Pharm. Ther. Toxicol., 19, 1 – 8 (1991).