The algorithm of evaluation of interchangeability of pharmaceuticals

Boris K. Romanov; I. V Sakaeva; N. D Bunyatyan; A. N Vasilyev; V. P Bondarev; A. B Prokofyev; R. I Yagudina; R. N Alyautdin; E. L Kovaleva; A. P Pereversev; K. E Zatolochina; A. S Kazakov; A. V Komratov; K. A Koshechkin; E. Yu Pasternak

doi:10.17816/rmj38292

Russian Medicine ›› 2015, Vol. 21 ›› Issue (5) : 43 -47. DOI: 10.17816/rmj38292

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The algorithm of evaluation of interchangeability of pharmaceuticals

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Abstract

The article presents originally developed algorithm of expertise of interchangeability of pharmaceuticals for medical application. The interchangeable pharmaceutical is a pharmaceutical with evidenced therapeutic equivalence or bioequivalence concerning reference (original) pharmaceutical with equivalent qualitative and quantitative compound of active substances, auxiliary substances, medicinal form, identical way of administration and mode of application and manufactured according requirements of rules of proper processing practice. The interchangeability of pharmaceutical to reference pharmaceutical is established during state registration of pharmaceutical or at introduction of changes into documents contained in registration dossier of already registered pharmaceutical in the Russian Federation. The application about establishment of interchangeability by applicant - holder or owner of registration certification of pharmaceutical for medical application is required.

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interchangeability / pharmaceutical / bioequivalence / therapeutic equivalence / algorithm / expertise

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Boris K. Romanov, I. V Sakaeva, N. D Bunyatyan, A. N Vasilyev, V. P Bondarev, A. B Prokofyev, R. I Yagudina, R. N Alyautdin, E. L Kovaleva, A. P Pereversev, K. E Zatolochina, A. S Kazakov, A. V Komratov, K. A Koshechkin, E. Yu Pasternak. The algorithm of evaluation of interchangeability of pharmaceuticals. Russian Medicine, 2015, 21(5): 43-47 DOI:10.17816/rmj38292

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