Comparison of Pharmacokinetics, Bioequivalence, and Safety of Femorix<sup>®</sup>(Valenta Pharm Company, Russia) and Aubagio<sup>®</sup>(Sanofi Winthrop Industrie, France) Film-Coated Tablets (14 mg)
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01.02.2018 |
Reikhart D.
Arnautov V.
Belostotskii A.
Globenko A.
Lopukhov I.
Torshina E.
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Pharmaceutical Chemistry Journal |
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Ссылка
© 2018, Springer Science+Business Media, LLC, part of Springer Nature. The pharmacokinetics, bioequivalence, and safety of Femorix®(Valenta Pharm Co., Russia) and Aubagio®(SanofiWinthrop Industrie, France) film-coated tablets (14 mg) were compared in a double-blind randomized investigation in parallel groups of healthy volunteers. The bioavailabilities of Femorix®film-coated tablets (14 mg, Valenta Pharm Co., Russia) were 96.18% [87.92 – 105.22%] for ln(Cmax) and 96.24% [88.67 – 104.44%] for ln(AUC0–72) of those for Aubagio®film-coated tablets (14 mg, Sanofi Winthrop Industrie, France), which fell in the commonly accepted range (80 – 125%) for proving the bioequivalence of the tested products.
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Clinical pharmacological approaches in the study of pharmacokinetic parameters of drugs - Analogs of endogenous calcium-containing compounds
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01.01.2018 |
Eremenko N.
Shikh E.
Serebrova S.
Goryachev D.
Prokof'Ev A.
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Eksperimental'naya i Klinicheskaya Farmakologiya |
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Ссылка
© 2018 Izdatel'stvo Meditsina. All rights reserved. Results of studying the comparative bioavailability of pharmaceutical preparations - alternative analogs of endogenous compounds containing calcium and colecalciferol are presented. The drug concentrations were recalculated with allowance for the endogenous calcium level, in accordance with the relevant normative guidelines. The standard methodology of bioequivalence studies can be used to evaluate the quality of reproduced calcium preparations, taking into account low values of intra-individual variability of pharmacokinetic parameters.
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