THE EPOCH OF GENERICS: PROS AND CONS


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Abstract

Novel generics appear on the pharmaceutical market every year. They are necessary for available medical care. There are different standards for determining their therapeutic equivalence (interchangeability) in world practice. Some drugs must be thoroughly examined for their bioequivalence. Excipients as components of these medications play a key role in their efficacy and safety. Many designers of generic drugs cannot reproduce brand-name medications even if they have the same composition. By taking into account the fact that new laws on bioequivalence have come into force in Russia, it is useful for a practitioner to understand the basic principles of the manufacture of brand-name and generic medications.

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About the authors

M. V ZHURAVLEVA

Research Center for Examination of Medical Products, Ministry of Health of Russia

Email: mvzhuravleva@mail.ru

A. B PROKOFYEV

Research Center for Examination of Medical Products, Ministry of Health of Russia

Email: elmed@yandex.ru

T. M CHERNYKH

N.N. Burdenko Voronezh State Medical Academy

Email: tatiana.m.chernykh@gmail.com

N. B LAZAREVA

I.M. Sechenov First Moscow State Medical University

Email: elmed@yandex.ru

N. G BERDNIKOVA

I.M. Sechenov First Moscow State Medical University

Email: elmed@yandex.ru

S. YU SEREBROVA

Research Center for Examination of Medical Products, Ministry of Health of Russia

Email: elmed@yandex.ru

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