THERAPEUTIC EQUIVALENCE, BIOEQUIVALENCE AND INTERCHANGEABILITY OF MEDICINAL PRODUCTS

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Issue: 
10
Year: 
2015

A. Sokolov, Professor V. Kukes, Academian of the Russian Academy os Science; N. Bunatyan, PD; T. Rodina, A. Prokofiev, V. Arkhipov, L. Krasnykh, E. Sokova FScientific Centre for Expert Evaluation of Medicinal Products of the Ministry of Health of the Russian Federation, Moscow

This article addresses the issues concerning assessment of generic drugs and their correspondence to original drug product. Discusses concepts such as pharmaceutical, pharmacokinetic (biological) and therapeutic equivalence. The problem of governmental regulation of quality and submission for obtaining marketing authorization for generic drug products in Russia are discussed.
Keywords: 
generic medicinal product
reference product therapeutic equivalence
bioequivalence
interchangeability

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