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Shchulkin A.V.

Pavlov Ryazan State Medical University

Filimonova A.A.

Ryazan State Medical University

Original and generic drugs: what does the clinician need to know?

Authors:

Shchulkin A.V., Filimonova A.A.

More about the authors

Journal: S.S. Korsakov Journal of Neurology and Psychiatry. 2021;121(10‑2): 99‑104

DOI: 10.17116/jnevro202112110199

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Table of contents

ORIGINAL AND GENERIC DRUGS: WHAT DOES THE CLINICIAN NEED TO KNOW?
ORIGINAL AND GENERIC DRUGS: WHAT DOES THE CLINICIAN NEED TO KNOW?

To cite this article:

Shchulkin AV, Filimonova AA. Original and generic drugs: what does the clinician need to know? S.S. Korsakov Journal of Neurology and Psychiatry. 2021;121(10‑2):99‑104. (In Russ.)
https://doi.org/10.17116/jnevro202112110199

Подписка 2026 Журнал неврологии и психиатрии им. С.С. Корсакова. Спецвыпуски (S.S. Korsakov Journal of Neurology and Psychiatry (special issues))
МСФ на ЯМ
Использование инфографики авторами научных работ
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Abstract:

In the review article modern approaches to testing and registration of generic drugs are discussed. The article presents the history of the formation of the methodology for testing generic drugs and the current legislation of the Russian Federation. The stages of confirmation of equivalence of original and generic drugs are described: pharmaceutical equivalence, bioequivalence and therapeutic equivalence. The methods of assessing bioequivalence — as the main research in the registration of generic drugs — are discussed in detail. Using the example of the original neuroprotector — Mexidol (ethylmethylhydroxypyridine succinate) and its generics, it is described how legislative acts are implemented in practice. It is concluded that not all generic drugs are interchangeable for the original drug.

Keywords:

original and generics drugs
ethylmethylhydroxypyridine succinate
mexidol

Authors:

Shchulkin A.V.

Pavlov Ryazan State Medical University

Filimonova A.A.

Ryazan State Medical University

Received:

20.09.2021

Accepted:

30.09.2021

Close metadata

References:

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