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Highly variable medicines - specific aspects of bioequivalence studies

At present a specific group of medicines - highly variable medicines - is distinguished based on intraindividual variability data (CVintra > 30%). It is quite difficult to confirm therapeutic equivalence of highly variable medicines by pharmacokinetic bioequivalence studies, and quite a large number...

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Principais autores: D. P. Romodanovsky, T. V. Eremenkova, M. A. Dranitsyna, D. V. Goryachev, R. R. Niyazov, E. V. Gavrishina, V. A. Merkulov
Formato: Artigo
Idioma:Russo
Publicado em: Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’) 2018-02-01
coleção:Регуляторные исследования и экспертиза лекарственных средств
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Acesso em linha:https://www.vedomostincesmp.ru/jour/article/view/57
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