CERAXON (CITICOLINE) IN THE CONTEXT OF THE PROBLEM OF CHOICE BETWEEN ORIGINAL DRUGS AND GENERICS IN CLINICAL PRACTICE


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Abstract

By the example of Ceraxon® (citicoline), the problems of coexistence of generic drugs (generics) and original medicines on the market are discussed in details. It is emphasized that the process of creating a new drug is very time-consuming, high-tech, expensive and long, that, as a rule, determines its high cost. Generic drugs are much cheaper, but they do not pass the multi-stage procedure for evaluation of the efficacy and safety for humans and animals, which are used for the original drugs. The adequacy of the various methods of evaluation of the equivalence of original and generic drugs is discussed. In the case of citicoline, particularly, correct evaluation of bioequivalence is hard enough to perform because it is a natural compound contained in human body. As part of such research, it is extremely difficult to differentiate between exogenous and endogenous citicoline and determine their concentrations. Comparisons between Ceraxon® and its generics are embarrassed by optical isomerism phenomenon. Obviously, the use of original Ceraxon® allows the physician to be sure of the full implementation of certain pharmacodynamic effects of the drug, and hence in a potentially successful treatment of a wide range of neurological disorders, in which it is indicated and used.

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About the authors

M. V Pchelintsev

SBEI HPE “First Saint-Petersburg State Medical University n.a. Academician I.P. Pavlov" of RMPH

Email: pchelincevmv@1spbgmu.ru
PhD, assistant professor of clinical pharmacology and evidence-based medicine St. Petersburg

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