WORLD EXPERIENCE IN THE ASSESSMENT OF THE INTERCHANGEABILITY OF PRODUCTS FOR MEDICAL USE

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Issue: 
8
Year: 
2015

A. Vasiliev, V. Kukes, V. Merkulov, N. Bunyatyan, A. Prokofiev, B. Romanov, R. Niyazov, V. Arkhipov, L. Krasnykh, G. Ramenskaya, E. Sokova, V. Smirnov Scientific Centre for Expert Evaluation of Medicinal Products of the Ministry of Health of the Russian Federation, Moscow

The paper summarizes the regulations governing the interchangeability of drugs for medical use in the US, the EU and the countries of EurAsEC. The process of interchangeability regulation of generic and biological medicinal products is represented.
Keywords: 
generic medicinal product
reference product therapeutic equivalence
bioequivalence
interchangeability

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