Results of a phase I open randomized comparative crossover clinical trial to assess the safety and pharmacokinetics of Glurazyme® (imiglucerase) in comparison with the reference product in healthy volunteers

Results of a phase I open randomized comparative crossover clinical trial to assess the safety and pharmacokinetics of Glurazyme® (imiglucerase) in comparison with the reference product in healthy volunteers

Background. Currently, the main treatment for Gaucher disease is enzyme replacement therapy. Recombinant glucocerebrosidase (imiglu-cerase) is the first biotechnological drug for enzyme replacement therapy with proven clinical efficacy and safety for the treatment of patients of different ages with...

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Main Authors: S. B. Fitilev, A. V. Vozzhaev, I. I. Shkrebneva, D. A. Kudlay, E. V. Gapchenko, O. A. Markova, A. Yu. Borоzinets, A. A. Kazarov, М. S. Pantyushenko
Format: Article
Language:Russian
Published: ABV-press 2019-12-01
Series:Онкогематология
Subjects:
enzyme replacement therapy
imiglucerase
glurazyme®
safety
pharmacokinetics
healthy volunteers
Online Access:https://oncohematology.abvpress.ru/ongm/article/view/386
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https://oncohematology.abvpress.ru/ongm/article/view/386

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