Highly variable medicines - specific aspects of bioequivalence studies

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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 num...

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Bibliographic Details
Main Authors:	D. P. Romodanovsky, T. V. Eremenkova, M. A. Dranitsyna, D. V. Goryachev, R. R. Niyazov, E. V. Gavrishina, V. A. Merkulov
Format:	Article
Language:	Russian
Published:	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
Series:	Регуляторные исследования и экспертиза лекарственных средств
Subjects:	исследования биоэквивалентности биоэквивалентность высоковариабельные препараты bioequivalence studies bioequivalence highly variable medicines
Online Access:	https://www.vedomostincesmp.ru/jour/article/view/57
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